SDOH Clinical Care
2.2.0 - STU 2.2 United States of America flag

SDOH Clinical Care, published by HL7 International / Patient Care. This guide is not an authorized publication; it is the continuous build for version 2.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-sdoh-clinicalcare/ and changes regularly. See the Directory of published versions

Resource Profile: SDOHCCObservationSexualOrientation - Detailed Descriptions

Page standards status: Trial-use

Definitions for the SDOHCC-ObservationSexualOrientation resource profile.

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

0. Observation
ShortObservation about an individual's sexual orientation
Comments

For observations about the sexual orientation of an individual.

2. Observation.code
Pattern Value{
  "coding" : [{
    "system" : "http://loinc.org",
    "code" : "76690-7"
  }]
}
4. Observation.value[x]
Control1..?
BindingThe codes SHOULD be taken from LOINC Answer List LL3323-4
(preferred to http://loinc.org/vs/LL3323-4)

Codes for sexual orientation

[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
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. NOTE: This is a value set is for testing purposes only and will ultimately need to be aligned with vetted value sets where terms like “asexual” and “pansexual” may be included.

6. Observation.value[x].extension:DataAbsentReasonMasked
Slice NameDataAbsentReasonMasked
Control0..1
TypeExtension(Data Absent Reason) (Extension Type: code)
Requirements

“Masked” is never used for data capture, but "masked" is used to suppress information when data is exchanged. For this reason, other flavors of null are included in the value set for Observation.value, but “masked” can be captured here.

8. Observation.value[x].extension:DataAbsentReasonMasked.value[x]
Definition

The information is not available due to security, privacy or related reasons.

[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Must Supporttrue
Fixed Valuemasked
10. Observation.value[x].coding
Must Supporttrue
12. Observation.dataAbsentReason
Control0..0
14. Observation.method
Control1..?
BindingUnless not suitable, these codes SHALL be taken from SDOHCC ValueSet Observation Method
(extensible to http://hl7.org/fhir/us/sdoh-clinicalcare/ValueSet/SDOHCC-ValueSetObservationMethod)

Methods for personal characteristic observations.

Must Supporttrue

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.

ShortObservation about an individual's sexual orientationMeasurements and simple assertions
Comments

For observations about the sexual orientation of an individual.


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: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())
6. 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
  • 8. 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
    10. 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()))
    12. 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())
    14. 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()))
    16. Observation.category
    Definition

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

    ShortClassification of type of observation
    Comments

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

    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
    • 18. 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()))
      20. 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
      Pattern Value{
        "coding" : [{
          "system" : "http://loinc.org",
          "code" : "76690-7"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. 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()))
      24. 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()))
      26. 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()))
      28. 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.

      Control10..1
      This element is affected by the following invariants: obs-7
      BindingThe codes SHOULD be taken from For codes, see LOINC Answer List LL3323-4
      (preferred to http://loinc.org/vs/LL3323-4)

      Codes for sexual orientation

      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. NOTE: This is a value set is for testing purposes only and will ultimately need to be aligned with vetted value sets where terms like “asexual” and “pansexual” may be included.


      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()))
      30. Observation.value[x].extension:DataAbsentReasonMasked
      Slice NameDataAbsentReasonMasked
      Definition

      Provides a reason why the expected value or elements in the element that is extended are missing.

      Shortunknown | asked | temp | notasked | masked | unsupported | astext | error
      Control0..1
      TypeExtension(Data Absent Reason) (Extension Type: code)
      Is Modifierfalse
      Summaryfalse
      Requirements

      “Masked” is never used for data capture, but "masked" is used to suppress information when data is exchanged. For this reason, other flavors of null are included in the value set for Observation.value, but “masked” can be captured here.

      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())
      32. Observation.value[x].extension:DataAbsentReasonMasked.extension
      Definition

      An Extension


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

      ShortExtensionAdditional content defined by implementations
      Comments

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

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

        The information is not available due to security, privacy or related reasons.


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

        ShortValue of extension
        Control10..1
        This element is affected by the following invariants: ext-1
        BindingThe codes SHALL be taken from For codes, see DataAbsentReason
        (required to http://hl7.org/fhir/ValueSet/data-absent-reason)
        Typecode, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summaryfalse
        Fixed Valuemasked
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        38. Observation.value[x].coding
        Definition

        A reference to a code defined by a terminology system.

        ShortCode defined by a terminology system
        Comments

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

        Control0..*
        TypeCoding
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

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

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        40. 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..01
        This element is affected by the following invariants: obs-6
        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

        TypeCodeableConcept
        Is Modifierfalse
        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()))
        42. 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()))
        44. 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()))
        46. 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.

        Control10..1
        BindingUnless not suitable, these codes SHALL be taken from For example codes, see SDOHCC ValueSet Observation Methodhttp://hl7.org/fhir/ValueSet/observation-methods
        (extensible to http://hl7.org/fhir/us/sdoh-clinicalcare/ValueSet/SDOHCC-ValueSetObservationMethod)

        Methods for personal characteristic observations.


        Methods for simple observations.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Requirements

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

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        48. 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()))
        50. 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())
        53. 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).

        ShortObservation about an individual's sexual orientation
        Comments

        For observations about the sexual orientation of an individual.

        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
              Pattern Value{
                "coding" : [{
                  "system" : "http://loinc.org",
                  "code" : "76690-7"
                }]
              }
              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.

              Control1..1
              This element is affected by the following invariants: obs-7
              BindingThe codes SHOULD be taken from LOINC Answer List LL3323-4
              (preferred to http://loinc.org/vs/LL3323-4)

              Codes for sexual orientation

              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. NOTE: This is a value set is for testing purposes only and will ultimately need to be aligned with vetted value sets where terms like “asexual” and “pansexual” may be included.

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

                Provides a reason why the expected value or elements in the element that is extended are missing.

                Shortunknown | asked | temp | notasked | masked | unsupported | astext | error
                Control0..1
                TypeExtension(Data Absent Reason) (Extension Type: code)
                Is Modifierfalse
                Summaryfalse
                Requirements

                “Masked” is never used for data capture, but "masked" is used to suppress information when data is exchanged. For this reason, other flavors of null are included in the value set for Observation.value, but “masked” can be captured here.

                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())
                62. Observation.value[x].extension:DataAbsentReasonMasked.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
                This element is affected by the following invariants: ele-1
                Typeid
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                64. Observation.value[x].extension:DataAbsentReasonMasked.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.value[x].extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 66. Observation.value[x].extension:DataAbsentReasonMasked.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/StructureDefinition/data-absent-reason
                  68. Observation.value[x].extension:DataAbsentReasonMasked.value[x]
                  Definition

                  The information is not available due to security, privacy or related reasons.

                  ShortValue of extension
                  Control1..1
                  This element is affected by the following invariants: ext-1
                  BindingThe codes SHALL be taken from DataAbsentReason
                  (required to http://hl7.org/fhir/ValueSet/data-absent-reason)
                  Typecode
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summaryfalse
                  Fixed Valuemasked
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  70. Observation.value[x].coding
                  Definition

                  A reference to a code defined by a terminology system.

                  ShortCode defined by a terminology system
                  Comments

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

                  Control0..*
                  TypeCoding
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

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

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

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

                  ShortPlain text representation of the concept
                  Comments

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

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

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

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  74. 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..0
                  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()))
                  76. 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()))
                  78. 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()))
                  80. 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()))
                  82. 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.

                  Control1..1
                  BindingUnless not suitable, these codes SHALL be taken from SDOHCC ValueSet Observation Method
                  (extensible to http://hl7.org/fhir/us/sdoh-clinicalcare/ValueSet/SDOHCC-ValueSetObservationMethod)

                  Methods for personal characteristic observations.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summaryfalse
                  Requirements

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

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  84. 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()))
                  86. 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()))
                  88. 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())
                  99. 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()))
                  101. 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()))
                  103. 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()))
                  105. 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
                  107. 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())
                  109. 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())
                  111. 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()))
                  113. 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()))
                  115. 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()))
                  117. 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()))
                  119. 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()))