MCC eCare Plan Implementation Guide
1.0.0 - STU1 United States of America flag

This page is part of the MCC eCare Plan Implementation Guide (v1.0.0: STU 1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: MCCPatientCaregiverConditionStatus - Detailed Descriptions

Active as of 2022-09-27

Definitions for the MCCPatientCaregiverConditionStatus resource profile.

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

0. Observation
Invariantsus-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present ((component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()))
2. Observation.extension
SlicingThis element introduces a set of slices on Observation.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. Observation.extension:resource-pertainesToGoal
    Slice Nameresource-pertainesToGoal
    ShortThe resource-pertainsToGoal relates the resource to the goal(s) that pertain to it. Whenever there is a goal associated with a health concern or problem, this extension should be present and populated in activity (event or intent) resources.
    TypeExtension(ServiceRequest Pertains To Goal) (Extension Type: Reference(Goal))
    Must Supporttrue
    6. Observation.status
    Must Supporttrue
    8. Observation.category
    Must Supporttrue
    10. Observation.code
    ShortObservation on patient/caregiver feelings on the condition status (what is the trend of the condition status?)
    Must Supporttrue
    LabelObservation on patient/caregiver feelings on the condition status (what is the trend of the condition status?)
    Pattern Value{
      "coding" : [{
        "system" : "http://loinc.org",
        "code" : "89253-9"
      }]
    }
    12. Observation.subject
    Control1..?
    TypeReference(US Core Patient Profile)
    Must Supporttrue
    14. Observation.focus
    Control1..*
    TypeReference(US Core Condition Problems and Health Concerns Profile, US Core Condition Encounter Diagnosis Profile)
    Must Supporttrue
    Must Support TypesNo must-support rules about the choice of types/profiles
    SlicingThis element introduces a set of slices on Observation.focus. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 16. Observation.effective[x]
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Must Supporttrue
      18. Observation.performer
      ShortRepresents the caregiver or patient who is making the observation on the condition’s trend
      Control1..?
      TypeReference(US Core Patient Profile, US Core RelatedPerson Profile)
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      LabelRepresents the caregiver or patient who is making the observation on the condition’s trend
      20. Observation.value[x]
      ShortCoded or narrative feeling about condition
      TypeChoice of: CodeableConcept, string, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      22. Observation.valueCodeableConcept
      ShortResponse for feeling about the condition
      Control0..?
      BindingFor example codes, see LOINC Answer List LL4938-8
      (example to http://loinc.org/vs/LL4938-8)

      Use CodeableConcept.text for the exact words of the patient/caregiver, or when not using a coding. valueString is also available as an alternative to valueCodeableConcept.

      TypeCodeableConcept
      Must Supporttrue
      24. Observation.valueCodeableConcept.text
      Shortcan be used with or in place of code to provide a string representation
      Labelcan be used with or in place of code to provide a string representation
      26. Observation.dataAbsentReason
      Must Supporttrue

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

      0. Observation
      Definition

      -


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

      Shortassessment observationMeasurements and simple assertions
      Comments

      -


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

      Control0..*
      Is Modifierfalse
      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())
      us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present ((component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()))
      obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
      obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
      2. Observation.implicitRules
      Definition

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

      ShortA set of rules under which this content was created
      Comments

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

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

      An Extension


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

      ShortExtensionAdditional content defined by implementations
      Comments

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

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

        Indicates that the resource is related to either the measurement, achievement or progress towards the referenced goal. For example, a Procedure to exercise pertainsToGoal of losing weight.

        ShortThe resource-pertainsToGoal relates the resource to the goal(s) that pertain to it. Whenever there is a goal associated with a health concern or problem, this extension should be present and populated in activity (event or intent) resources.
        Comments

        This extension is limited to subject-specific activity-related resources (events & intents). I.e. This can't be put on Goal or Patient. This association isn't for the purpose of goal management, but for things such as noting that a particular observation result, prescription or other activity is pertinent to the achievement (or possibly non-achievement) of the referenced goal.

        Control0..*
        TypeExtension(ServiceRequest Pertains To Goal) (Extension Type: Reference(Goal))
        Is Modifierfalse
        Must Supporttrue
        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())
        8. 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())
        10. Observation.status
        Definition

        The status of the result value.

        Short(USCDI) registered | preliminary | final | amended +registered | preliminary | final | amended +
        Comments

        This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

        Control1..1
        BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
        (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

        Codes providing the status of an observation.

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

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

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

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

        Short(USCDI) Classification of type of observationClassification 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
        Must Supporttrue
        Summaryfalse
        Requirements

        Used for filtering what observations are retrieved and displayed.

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

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

          Short(USCDI) Classification of type of observationClassification of type of observation
          Comments

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

          Control0..*
          BindingThe codes SHALL be taken from The codes SHOULD be taken from US Core Simple Observation Categoryhttp://hl7.org/fhir/ValueSet/observation-category
          (required to http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category)

          Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


          Codes for high level observation categories.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Requirements

          Used for filtering what observations are retrieved and displayed.

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

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

          ShortObservation on patient/caregiver feelings on the condition status (what is the trend of the condition status?)Type of observation (code / type)
          Comments

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

          Control1..1
          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)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Requirements

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

          LabelObservation on patient/caregiver feelings on the condition status (what is the trend of the condition status?)
          Alternate NamesName
          Pattern Value{
            "coding" : [{
              "system" : "http://loinc.org",
              "code" : "89253-9"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          18. 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.

          Short(USCDI) Who and/or what the observation is aboutWho and/or what the observation is about
          Comments

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

          Control10..1
          TypeReference(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()))
          20. 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.

          Control10..*
          TypeReference(US Core Condition Problems and Health Concerns Profile, US Core Condition Encounter Diagnosis Profile, Resource)
          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()))
          SlicingThis element introduces a set of slices on Observation.focus. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 22. 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".


            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.

            Short(USCDI) Clinically relevant time/time-period for observationClinically relevant time/time-period for observation
            Comments

            At least a date should be present unless this observation is a historical report.


            At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

            Control0..1
            TypeChoice of: dateTime, Period, Timing, instant
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Must Support TypesdateTime
            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()))
            24. Observation.performer
            Definition

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

            ShortRepresents the caregiver or patient who is making the observation on the condition’s trendWho is responsible for the observation
            Control10..*
            TypeReference(US Core Patient Profile, US Core RelatedPerson Profile, 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.

            LabelRepresents the caregiver or patient who is making the observation on the condition’s trend
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            26. Observation.value[x]
            Definition

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

            ShortCoded or narrative feeling about conditionActual result
            Comments

            An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

            Control0..1
            This element is affected by the following invariants: obs-7
            TypeChoice of: CodeableConcept, string, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            Must Support TypesChoice of: CodeableConcept, string, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range
            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()))
            SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 28. Observation.value[x]:valueCodeableConcept
              Slice NamevalueCodeableConcept
              Definition

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

              ShortResponse for feeling about the conditionActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              BindingFor example codes, see For codes, see LOINC Answer List LL4938-8
              (example to http://loinc.org/vs/LL4938-8)

              Use CodeableConcept.text for the exact words of the patient/caregiver, or when not using a coding. valueString is also available as an alternative to valueCodeableConcept.

              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
              Must Support TypesCodeableConceptQuantity
              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()))
              30. Observation.dataAbsentReason
              Definition

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

              ShortWhy the result is missing
              Comments

              Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

              Control0..1
              This element is affected by the following invariants: obs-6
              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Summaryfalse
              Requirements

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

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

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

              0. Observation
              Definition

              -

              Shortassessment observation
              Comments

              -

              Control0..*
              Is Modifierfalse
              Summaryfalse
              Alternate NamesVital Signs, Measurement, Results, Tests
              Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
              dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
              dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
              dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
              dom-6: A resource should have narrative for robust management (text.`div`.exists())
              obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
              obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
              us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present ((component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.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:resource-pertainesToGoal
                Slice Nameresource-pertainesToGoal
                Definition

                Indicates that the resource is related to either the measurement, achievement or progress towards the referenced goal. For example, a Procedure to exercise pertainsToGoal of losing weight.

                ShortThe resource-pertainsToGoal relates the resource to the goal(s) that pertain to it. Whenever there is a goal associated with a health concern or problem, this extension should be present and populated in activity (event or intent) resources.
                Comments

                This extension is limited to subject-specific activity-related resources (events & intents). I.e. This can't be put on Goal or Patient. This association isn't for the purpose of goal management, but for things such as noting that a particular observation result, prescription or other activity is pertinent to the achievement (or possibly non-achievement) of the referenced goal.

                Control0..*
                TypeExtension(ServiceRequest Pertains To Goal) (Extension Type: Reference(Goal))
                Is Modifierfalse
                Must Supporttrue
                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.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())
                20. 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()))
                22. 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()))
                24. 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()))
                26. Observation.status
                Definition

                The status of the result value.

                Short(USCDI) registered | preliminary | final | amended +
                Comments

                This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

                Control1..1
                BindingThe codes SHALL be taken from ObservationStatus
                (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

                Codes providing the status of an observation.

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

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

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

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

                Short(USCDI) Classification of type of observation
                Comments

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

                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
                Must Supporttrue
                Summaryfalse
                Requirements

                Used for filtering what observations are retrieved and displayed.

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

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

                  Short(USCDI) Classification of type of observation
                  Comments

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

                  Control0..*
                  BindingThe codes SHALL be taken from US Core Simple Observation Category
                  (required to http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category)

                  Note that other codes are permitted, see Required Bindings When Slicing by Value Sets

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summaryfalse
                  Requirements

                  Used for filtering what observations are retrieved and displayed.

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

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

                  ShortObservation on patient/caregiver feelings on the condition status (what is the trend of the condition status?)
                  Comments

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

                  Control1..1
                  BindingThe codes SHOULD be taken from LOINCCodes
                  (preferred to http://hl7.org/fhir/ValueSet/observation-codes)
                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

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

                  LabelObservation on patient/caregiver feelings on the condition status (what is the trend of the condition status?)
                  Alternate NamesName
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://loinc.org",
                      "code" : "89253-9"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  34. Observation.subject
                  Definition

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

                  Short(USCDI) Who and/or what the observation is about
                  Comments

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

                  Control1..1
                  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()))
                  36. 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.

                  Control1..*
                  TypeReference(US Core Condition Problems and Health Concerns Profile, US Core Condition Encounter Diagnosis Profile)
                  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()))
                  SlicingThis element introduces a set of slices on Observation.focus. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 38. 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()))
                    40. 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".

                    Short(USCDI) Clinically relevant time/time-period for observation
                    Comments

                    At least a date should be present unless this observation is a historical report.

                    Control0..1
                    TypeChoice of: dateTime, Period, Timing, instant
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supporttrue
                    Must Support TypesdateTime
                    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()))
                    42. 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()))
                    44. Observation.performer
                    Definition

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

                    ShortRepresents the caregiver or patient who is making the observation on the condition’s trend
                    Control1..*
                    TypeReference(US Core Patient Profile, US Core RelatedPerson Profile)
                    Is Modifierfalse
                    Must Supporttrue
                    Must Support TypesNo must-support rules about the choice of types/profiles
                    Summarytrue
                    Requirements

                    May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

                    LabelRepresents the caregiver or patient who is making the observation on the condition’s trend
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    46. Observation.value[x]
                    Definition

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

                    ShortCoded or narrative feeling about condition
                    Comments

                    An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                    Control0..1
                    This element is affected by the following invariants: obs-7
                    TypeChoice of: CodeableConcept, string
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supporttrue
                    Must Support TypesChoice of: CodeableConcept, string
                    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()))
                    SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • type @ $this
                    • 48. Observation.value[x]:valueCodeableConcept
                      Slice NamevalueCodeableConcept
                      Definition

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

                      ShortResponse for feeling about the condition
                      Comments

                      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                      Control0..1
                      This element is affected by the following invariants: obs-7
                      BindingFor example codes, see LOINC Answer List LL4938-8
                      (example to http://loinc.org/vs/LL4938-8)

                      Use CodeableConcept.text for the exact words of the patient/caregiver, or when not using a coding. valueString is also available as an alternative to valueCodeableConcept.

                      TypeCodeableConcept
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      Is Modifierfalse
                      Must Supporttrue
                      Must Support TypesCodeableConcept
                      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()))
                      50. Observation.value[x]:valueCodeableConcept.id
                      Definition

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

                      ShortUnique id for inter-element referencing
                      Control0..1
                      Typestring
                      Is Modifierfalse
                      XML FormatIn the XML format, this property is represented as an attribute.
                      Summaryfalse
                      52. Observation.value[x]:valueCodeableConcept.extension
                      Definition

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

                      ShortAdditional content defined by implementations
                      Comments

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

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

                        A reference to a code defined by a terminology system.

                        ShortCode defined by a terminology system
                        Comments

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

                        Control0..*
                        TypeCoding
                        Is Modifierfalse
                        Summarytrue
                        Requirements

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

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

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

                        Shortcan be used with or in place of code to provide a string representation
                        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.

                        Labelcan be used with or in place of code to provide a string representation
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        58. Observation.dataAbsentReason
                        Definition

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

                        ShortWhy the result is missing
                        Comments

                        Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

                        The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

                        Control0..1
                        This element is affected by the following invariants: obs-6
                        BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                        (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supporttrue
                        Summaryfalse
                        Requirements

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

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

                        A categorical assessment of an observation value. For example, high, low, normal.

                        ShortHigh, low, normal, etc.
                        Comments

                        Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                        Control0..*
                        BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                        (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

                        Codes identifying interpretations of observations.

                        TypeCodeableConcept
                        Is Modifierfalse
                        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()))
                        62. 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()))
                        64. Observation.bodySite
                        Definition

                        Indicates the site on the subject's body where the observation was made (i.e. the target site).

                        ShortObserved body part
                        Comments

                        Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

                        If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

                        Control0..1
                        BindingFor example codes, see SNOMEDCTBodyStructures
                        (example to http://hl7.org/fhir/ValueSet/body-site)

                        Codes describing anatomical locations. May include laterality.

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

                        Indicates the mechanism used to perform the observation.

                        ShortHow it was done
                        Comments

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

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

                        Methods for simple observations.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

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

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

                        The specimen that was used when this observation was made.

                        ShortSpecimen used for this observation
                        Comments

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

                        Control0..1
                        TypeReference(Specimen)
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        70. 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()))
                        72. Observation.referenceRange
                        Definition

                        Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

                        ShortProvides guide for interpretation
                        Comments

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

                        Control0..*
                        TypeBackboneElement
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        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())
                        74. Observation.referenceRange.id
                        Definition

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

                        ShortUnique id for inter-element referencing
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        76. Observation.referenceRange.extension
                        Definition

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

                        ShortAdditional content defined by implementations
                        Comments

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

                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Alternate Namesextensions, user content
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        78. Observation.referenceRange.modifierExtension
                        Definition

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

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

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

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

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

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

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        80. Observation.referenceRange.low
                        Definition

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

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

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

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

                        Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

                        ShortReference range qualifier
                        Comments

                        This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

                        Control0..1
                        BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
                        (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning)

                        Code for the meaning of a reference range.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

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

                        Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

                        ShortReference range population
                        Comments

                        This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

                        Control0..*
                        BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
                        (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

                        Codes identifying the population the reference range applies to.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summaryfalse
                        Requirements

                        Need to be able to identify the target population for proper interpretation.

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

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

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

                        Some analytes vary greatly over age.

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

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

                        ShortText based reference range in an observation
                        Control0..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        92. 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()))
                        94. Observation.derivedFrom
                        Definition

                        US Core Observations, DocumentReference, QuestionnaireResponse or other resource from which this observation value is derived.

                        Short(USCDI) US Core Profiles or other resource the observation is made from
                        Comments

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

                        Control0..*
                        TypeReference(Observation, US Core DocumentReference Profile, US Core QuestionnaireResponse Profile, ImagingStudy, Media, MolecularSequence)
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        96. 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()))
                        98. 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
                        100. 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())
                        102. 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())
                        104. 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()))
                        106. 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()))
                        108. 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()))
                        110. 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()))
                        112. 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()))