SDOH Clinical Care
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This page is part of the SDOH Clinical Care for Multiple Domains (v2.2.0: STU 2.2) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: SDOHCCObservationPersonalCharacteristic - Detailed Descriptions

Page standards status: Trial-use

Definitions for the SDOHCC-ObservationPersonalCharacteristic resource profile.

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

0. Observation
Definition

Defines constraints that represent the minimum requirement for personal characteristic observations which are observations that are usually self-attested but may be attested to on behalf of the subject (e.g., for a minor or incapable subject) and are generally only verifiable by the source of attestation (e.g., race, ethnicity, sexual orientation, gender identity and personal pronouns), but may sometimes be verifiable by someone other than the source of attestation (e.g., recorded sex).

ShortPersonal characteristic observation
Must Supportfalse
InvariantsSDOH-Obs-1: Either subject or extension-Observation.subject must exist but not both (subject.exists() xor extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.subject').exists())
SDOH-Obs-2: Focus is only allowed if subject is present (focus.exists() implies subject.exists())
SDOH-Obs-3: Must have either performer or derivedFrom (performer.exists() or derivedFrom.exists())
2. Observation.extension
SlicingThis element introduces a set of slices on Observation.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. Observation.extension:OtherSubject
    Slice NameOtherSubject
    Control0..1
    This element is affected by the following invariants: SDOH-Obs-1
    TypeExtension(Extension Definition for Observation.subject for Version 5.0) (Extension Type: Reference(Patient, Group, Device, Location, Organization, Procedure, Practitioner, Medication, Substance, BiologicallyDerivedProduct))
    Must Supporttrue
    Requirements

    This extension is adding only US Core Practitioner as an option for Observation.subject. When the subject is Practitioner, personal characteristics should be based on the attestation and consent of the practitioner.

    6. Observation.extension:OtherSubject.value[x]
    Control1..?
    TypeReference(US Core Practitioner Profile)
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    8. Observation.status
    Definition

    The status of the observation value.

    Shortfinal | corrected | entered-in-error | unknown
    BindingThe codes SHALL be taken from SDOHCC ValueSet Observation Status
    (required to http://hl7.org/fhir/us/sdoh-clinicalcare/ValueSet/SDOHCC-ValueSetObservationStatus)
    Must Supporttrue
    Requirements

    Further constrained to values that are relevant for personal characteristic observations.

    10. Observation.category
    Control1..?
    SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ $this
    • 12. Observation.category:PersonalCharacteristic
      Slice NamePersonalCharacteristic
      Control1..1
      Must Supporttrue
      Requirements

      Used for filtering personal characteristic observations.

      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/sdoh-clinicalcare/CodeSystem/SDOHCC-CodeSystemTemporaryCodes",
          "code" : "personal-characteristic"
        }]
      }
      14. Observation.code
      Comments

      All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. NOTE: In LOINC, System Patient is used in the modeling of codes referenced by the Personal Characteristics profiles (e.g., 72826-1 Race OMB.1997, 69490-1 Ethnicity OMB.1997, 76691-5 Gender identity, 76690-7 Sexual orientation, 90778-2 Personal pronouns – Reported, and 99502-7 Recorded sex or gender). If the draft profiles are adopted, new LOINC codes without System Patient would be needed since these profiles can also be used to capture characteristics of a provider (using an extension) or a related person (using focus).

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

      Codes identifying names of simple observations.

      Must Supporttrue
      16. Observation.subject
      TypeReference(US Core Patient Profile)
      Must Supporttrue
      18. Observation.focus
      Control0..1
      This element is affected by the following invariants: SDOH-Obs-2
      TypeReference(RelatedPerson)
      20. Observation.effective[x]
      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. NOTE: dateTime is Must Support, but currently tooling does not support this.

      TypeChoice of: dateTime, Period, Timing, instant
      [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
      22. Observation.performer
      Must Supporttrue
      24. Observation.value[x]
      TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Must Supporttrue
      26. Observation.interpretation
      Control0..0
      28. Observation.bodySite
      Control0..0
      30. Observation.specimen
      Control0..0
      32. Observation.referenceRange
      Control0..0
      34. Observation.derivedFrom
      TypeReference(DocumentReference, QuestionnaireResponse, Observation)
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles

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

      0. Observation
      Definition

      Defines constraints that represent the minimum requirement for personal characteristic observations which are observations that are usually self-attested but may be attested to on behalf of the subject (e.g., for a minor or incapable subject) and are generally only verifiable by the source of attestation (e.g., race, ethnicity, sexual orientation, gender identity and personal pronouns), but may sometimes be verifiable by someone other than the source of attestation (e.g., recorded sex).


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

      ShortPersonal characteristic observationMeasurements and simple assertions
      Comments

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

      Control0..*
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate NamesVital Signs, Measurement, Results, Tests
      Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
      dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id 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())
      SDOH-Obs-1: Either subject or extension-Observation.subject must exist but not both (subject.exists() xor extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.subject').exists())
      SDOH-Obs-2: Focus is only allowed if subject is present (focus.exists() implies subject.exists())
      SDOH-Obs-3: Must have either performer or derivedFrom (performer.exists() or derivedFrom.exists())
      obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
      obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
      2. Observation.implicitRules
      Definition

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

      ShortA set of rules under which this content was created
      Comments

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

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

      An Extension


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

      ShortExtensionAdditional content defined by implementations
      Comments

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

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

        Optional Extension Element - found in all resources.

        ShortOptional Extensions Element
        Control0..1
        This element is affected by the following invariants: ele-1, SDOH-Obs-1
        TypeExtension(Extension Definition for Observation.subject for Version 5.0) (Extension Type: Reference(Patient, Group, Device, Location, Organization, Procedure, Practitioner, Medication, Substance, BiologicallyDerivedProduct))
        Is Modifierfalse
        Must Supporttrue
        Requirements

        This extension is adding only US Core Practitioner as an option for Observation.subject. When the subject is Practitioner, personal characteristics should be based on the attestation and consent of the practitioner.

        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())
        8. Observation.extension:OtherSubject.extension
        Definition

        An Extension


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

        ShortExtensionAdditional content defined by implementations
        Comments

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

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

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

          Shortidentifies the meaning of the extension
          Comments

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

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.subject
          12. Observation.extension:OtherSubject.value[x]
          Definition

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

          ShortValue of extension
          Control10..1
          TypeReference(US Core Practitioner Profile), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          14. 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())
          16. Observation.status
          Definition

          The status of the observation value.


          The status of the result value.

          Shortfinal | corrected | entered-in-error | unknownregistered | 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 SDOHCC ValueSet Observation Statushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
          (required to http://hl7.org/fhir/us/sdoh-clinicalcare/ValueSet/SDOHCC-ValueSetObservationStatus)
          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

          Further constrained to values that are relevant for personal characteristic observations.


          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()))
          18. 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.

          Control10..*
          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
          Summaryfalse
          Requirements

          Used for filtering what observations are retrieved and displayed.

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

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

            ShortClassification of type of observation
            Comments

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

            Control10..1*
            BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category
            (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 personal characteristic observations.


            Used for filtering what observations are retrieved and displayed.

            Pattern Value{
              "coding" : [{
                "system" : "http://hl7.org/fhir/us/sdoh-clinicalcare/CodeSystem/SDOHCC-CodeSystemTemporaryCodes",
                "code" : "personal-characteristic"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            22. Observation.code
            Definition

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

            ShortType of observation (code / type)
            Comments

            All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. NOTE: In LOINC, System Patient is used in the modeling of codes referenced by the Personal Characteristics profiles (e.g., 72826-1 Race OMB.1997, 69490-1 Ethnicity OMB.1997, 76691-5 Gender identity, 76690-7 Sexual orientation, 90778-2 Personal pronouns – Reported, and 99502-7 Recorded sex or gender). If the draft profiles are adopted, new LOINC codes without System Patient would be needed since these profiles can also be used to capture characteristics of a provider (using an extension) or a related person (using focus).


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

            Control1..1
            BindingThe codes SHOULD be taken from For example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
            (preferred to http://hl7.org/fhir/ValueSet/observation-codes)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

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

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

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

            ShortWho and/or what the observation is about
            Comments

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

            Control0..1
            This element is affected by the following invariants: SDOH-Obs-1, SDOH-Obs-2
            TypeReference(US Core Patient Profile, Patient, Group, Device, Location)
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            26. 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..1*
            This element is affected by the following invariants: SDOH-Obs-2
            TypeReference(RelatedPerson, Resource)
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            28. 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. NOTE: dateTime is Must Support, but currently tooling does not support this.


            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
            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()))
            30. Observation.performer
            Definition

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

            ShortWho is responsible for the observation
            Control0..*
            This element is affected by the following invariants: SDOH-Obs-3
            TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
            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()))
            32. 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
            TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Requirements

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

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            34. 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..0*
            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
            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()))
            36. 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..01
            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
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            38. 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..01
            TypeReference(Specimen)
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            40. 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..0*
            TypeBackboneElement
            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()))
            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())
            43. Observation.derivedFrom
            Definition

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

            ShortRelated measurements the observation is made from
            Comments

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

            Control0..*
            This element is affected by the following invariants: SDOH-Obs-3
            TypeReference(DocumentReference, QuestionnaireResponse, Observation, ImagingStudy, Media, MolecularSequence)
            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()))

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

            0. Observation
            Definition

            Defines constraints that represent the minimum requirement for personal characteristic observations which are observations that are usually self-attested but may be attested to on behalf of the subject (e.g., for a minor or incapable subject) and are generally only verifiable by the source of attestation (e.g., race, ethnicity, sexual orientation, gender identity and personal pronouns), but may sometimes be verifiable by someone other than the source of attestation (e.g., recorded sex).

            ShortPersonal characteristic observation
            Comments

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

            Control0..*
            Is Modifierfalse
            Must Supportfalse
            Summaryfalse
            Alternate NamesVital Signs, Measurement, Results, Tests
            Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
            dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id 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())
            SDOH-Obs-1: Either subject or extension-Observation.subject must exist but not both (subject.exists() xor extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.subject').exists())
            SDOH-Obs-2: Focus is only allowed if subject is present (focus.exists() implies subject.exists())
            SDOH-Obs-3: Must have either performer or derivedFrom (performer.exists() or derivedFrom.exists())
            2. Observation.id
            Definition

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

            ShortLogical id of this artifact
            Comments

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

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

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

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

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

            ShortA set of rules under which this content was created
            Comments

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

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

            The base language in which the resource is written.

            ShortLanguage of the 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
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            10. Observation.text
            Definition

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

            ShortText summary of the resource, for human interpretation
            Comments

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

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

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

            ShortContained, inline Resources
            Comments

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

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

            An Extension

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

              Optional Extension Element - found in all resources.

              ShortOptional Extensions Element
              Control0..1
              This element is affected by the following invariants: ele-1, SDOH-Obs-1
              TypeExtension(Extension Definition for Observation.subject for Version 5.0) (Extension Type: Reference(Patient, Group, Device, Location, Organization, Procedure, Practitioner, Medication, Substance, BiologicallyDerivedProduct))
              Is Modifierfalse
              Must Supporttrue
              Requirements

              This extension is adding only US Core Practitioner as an option for Observation.subject. When the subject is Practitioner, personal characteristics should be based on the attestation and consent of the practitioner.

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

              An Extension

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

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

                Shortidentifies the meaning of the extension
                Comments

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

                Control1..1
                Typeuri
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.subject
                24. Observation.extension:OtherSubject.value[x]
                Definition

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

                ShortValue of extension
                Control1..1
                TypeReference(US Core Practitioner Profile)
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                26. 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())
                28. Observation.identifier
                Definition

                A unique identifier assigned to this observation.

                ShortBusiness Identifier for observation
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control0..*
                TypeIdentifier
                Is Modifierfalse
                Summarytrue
                Requirements

                Allows observations to be distinguished and referenced.

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

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

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

                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()))
                32. Observation.partOf
                Definition

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

                ShortPart of referenced event
                Comments

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

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

                The status of the observation value.

                Shortfinal | corrected | entered-in-error | unknown
                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 SDOHCC ValueSet Observation Status
                (required to http://hl7.org/fhir/us/sdoh-clinicalcare/ValueSet/SDOHCC-ValueSetObservationStatus)
                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

                Further constrained to values that are relevant for personal characteristic observations.

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

                Control1..*
                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
                Summaryfalse
                Requirements

                Used for filtering what observations are retrieved and displayed.

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

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

                  ShortClassification of type of observation
                  Comments

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

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

                  Codes for high level observation categories.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summaryfalse
                  Requirements

                  Used for filtering personal characteristic observations.

                  Pattern Value{
                    "coding" : [{
                      "system" : "http://hl7.org/fhir/us/sdoh-clinicalcare/CodeSystem/SDOHCC-CodeSystemTemporaryCodes",
                      "code" : "personal-characteristic"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  40. Observation.code
                  Definition

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

                  ShortType of observation (code / type)
                  Comments

                  All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. NOTE: In LOINC, System Patient is used in the modeling of codes referenced by the Personal Characteristics profiles (e.g., 72826-1 Race OMB.1997, 69490-1 Ethnicity OMB.1997, 76691-5 Gender identity, 76690-7 Sexual orientation, 90778-2 Personal pronouns – Reported, and 99502-7 Recorded sex or gender). If the draft profiles are adopted, new LOINC codes without System Patient would be needed since these profiles can also be used to capture characteristics of a provider (using an extension) or a related person (using focus).

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

                  Codes identifying names of simple observations.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

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

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

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

                  ShortWho and/or what the observation is about
                  Comments

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

                  Control0..1
                  This element is affected by the following invariants: SDOH-Obs-1, SDOH-Obs-2
                  TypeReference(US Core Patient Profile)
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

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

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  44. 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..1
                  This element is affected by the following invariants: SDOH-Obs-2
                  TypeReference(RelatedPerson)
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  46. 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()))
                  48. 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. NOTE: dateTime is Must Support, but currently tooling does not support this.

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

                  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()))
                  50. 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
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  52. Observation.performer
                  Definition

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

                  ShortWho is responsible for the observation
                  Control0..*
                  This element is affected by the following invariants: SDOH-Obs-3
                  TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
                  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()))
                  54. 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
                  TypeCodeableConcept
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

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

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  56. 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
                  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()))
                  58. 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..0
                  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()))
                  60. Observation.note
                  Definition

                  Comments about the observation or the results.

                  ShortComments about the observation
                  Comments

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

                  Control0..*
                  TypeAnnotation
                  Is Modifierfalse
                  Summaryfalse
                  Requirements

                  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()))
                  62. 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..0
                  BindingFor example codes, see SNOMEDCTBodyStructures
                  (example to http://hl7.org/fhir/ValueSet/body-site)

                  Codes describing anatomical locations. May include laterality.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  64. 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
                  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()))
                  66. 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..0
                  TypeReference(Specimen)
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  68. 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
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  70. 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..0
                  TypeBackboneElement
                  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()))
                  obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                  81. Observation.hasMember
                  Definition

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

                  ShortRelated resource that belongs to the Observation group
                  Comments

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

                  Control0..*
                  TypeReference(Observation, QuestionnaireResponse, MolecularSequence)
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  83. Observation.derivedFrom
                  Definition

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

                  ShortRelated measurements the observation is made from
                  Comments

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

                  Control0..*
                  This element is affected by the following invariants: SDOH-Obs-3
                  TypeReference(DocumentReference, QuestionnaireResponse, 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()))
                  85. 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
                  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()))
                  87. 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
                  89. 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())
                  91. 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())
                  93. 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()))
                  95. 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()))
                  97. 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()))
                  99. 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()))
                  101. 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()))