PACIO Personal Functioning and Engagement Implementation Guide
2.0.0 - STU 2 United States of America flag

PACIO Personal Functioning and Engagement Implementation Guide, published by HL7 International / Patient Care. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-pacio-pfe/ and changes regularly. See the Directory of published versions

Extension: PFEDeviceRequestClinicalJustification - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 3

Definitions for the pfe-device-request-clinical-justification extension

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

0. Extension
Definition

Groups information that supports the clinical justification for the device request. These can include assessment findings, and goals that may influence fulfillment of the device request.

  • assessments documenting the patient’s ability to use/interact with the device related to:
    • Cognition: If the patient has the cognitive capacity to use the device via the Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8)
    • Physical Functioning: If the patient is physically able to use the device via the 9-Hole Pegboard Dexterity Test (LOINC 83141-2)
    • Vision: If the patient's visual capabilities are aligned with the device features via the Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003)
    • Health Literacy: If the patient has the ability learn how to use the device via the BRIEF health literacy screening tool (LOINC 95866-0)
    • Disability: If the patient has a disability that would need to be accommodated in the selection of a device via an indication in the patient’s demographic record of having a disability (ICD-10 Z73.6)
  • Documented observation of the patient’s usage of the requested device during an assessment that may influence the fulfillment of the device.
    • Example: A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile).
  • Supporting information about the patient's goals that may influence fulfillment of the device request.
    • Example: A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include: Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element).
    • Example: A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include: Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element), Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element)

Optional Extension Element - found in all resources.

ShortExtensionOptional Extensions Element
Control0..*
This element is affected by the following invariants: ele-1
Is Modifierfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
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())
2. Extension.extension:note
Slice Namenote
Definition

Captures the clinical justification or rationale for the medical necessity of a device request. Complements the DeviceRequest.reasonCode and DeviceRequest.reasonReference data elements.

ShortClinical justification noteAdditional content defined by implementations
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())
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())
4. Extension.extension:note.extension
Definition

An Extension


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

ShortExtensionAdditional content defined by implementations
Comments

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

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

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

    Shortidentifies the meaning of the extension
    Comments

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

    Control1..1
    Typeuri
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    Fixed Valuenote
    8. Extension.extension:note.value[x]
    Definition

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

    ShortValue of extension
    Control0..1
    TypeChoice of: markdown, string, Annotation, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, Contributor, oid, instant, ContactPoint, HumanName, Money, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. Extension.extension:assessment
    Slice Nameassessment
    Definition

    Supporting information about patient assessments that may influence fulfillment of the device request. This includes assessments documenting the patient's ability to use/interact with the device related to:

    • Cognition: If the patient has the cognitive capacity to use the device (e.g., via cognitive test/scale)
    • Physical Functioning: If the patient is physically able to use the device (e.g., assessment)
    • Vision: If the patient's visual capabilities are aligned with the device features (e.g., via ICD code)
    • Health Literacy: If the patient has the ability learn how to use the device (e.g., via health literacy scale)
    • Disability: If the patient has a disability that would need to be accommodated in the selection of a device (e.g., via an demographic disability item)
    ShortSupporting assessment informationAdditional content defined by implementations
    Comments

    Examples:

    • Cognition: Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8)
    • Physical functioning: 9-Hole Pegboard Dexterity Test (LOINC 83141-2)
    • Vision: Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003)
    • Health Literacy: BRIEF health literacy screening tool (LOINC 95866-0)
    • Disability: Indication in the patient’s demographic record of having a disability (ICD-10 Z73.6)
    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())
    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())
    12. Extension.extension:assessment.extension
    Definition

    An Extension


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

    ShortExtensionAdditional content defined by implementations
    Comments

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

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

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

      Shortidentifies the meaning of the extension
      Comments

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

      Control1..1
      Typeuri
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      Fixed Valueassessment
      16. Extension.extension:assessment.value[x]
      Definition

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

      ShortValue of extension
      Control0..1
      TypeReference(Personal Functioning and Engagement Clinical Test Observation, Personal Functioning and Engagement Collection, Personal Functioning and Engagement Single Observation), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      18. Extension.extension:use-of-device
      Slice Nameuse-of-device
      Definition

      Supporting information about the patient's usage of the requested device during an assessment that may influence fulfillment of the device request.

      ShortSupporting device usage informationAdditional content defined by implementations
      Comments

      Example:

      • A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile).
      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())
      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())
      20. Extension.extension:use-of-device.extension
      Definition

      An Extension


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

      ShortExtensionAdditional content defined by implementations
      Comments

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

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

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

        Shortidentifies the meaning of the extension
        Comments

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

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        Fixed Valueuse-of-device
        24. Extension.extension:use-of-device.value[x]
        Definition

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

        ShortValue of extension
        Control0..1
        TypeReference(Personal Functioning and Engagement Use of Device), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        26. Extension.extension:goal
        Slice Namegoal
        Definition

        Supporting information about the patient's goals that may influence fulfillment of the device request.

        ShortSupporting goal informationAdditional content defined by implementations
        Comments

        Examples:

        • A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include:
        • Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element).
        • A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include:
        • Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element)
        • Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element)
        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())
        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())
        28. Extension.extension:goal.extension
        Definition

        An Extension


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

        ShortExtensionAdditional content defined by implementations
        Comments

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

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

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

          Shortidentifies the meaning of the extension
          Comments

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

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Valuegoal
          32. Extension.extension:goal.value[x]
          Definition

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

          ShortValue of extension
          Control0..1
          TypeReference(Personal Functioning and Engagement Goal Profile), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. Extension.url
          Definition

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

          Shortidentifies the meaning of the extension
          Comments

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

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Valuehttp://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-device-request-clinical-justification
          36. Extension.value[x]
          Definition

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

          ShortValue of extension
          Control0..01
          TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
          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()))
          ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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

          0. Extension
          Definition

          Groups information that supports the clinical justification for the device request. These can include assessment findings, and goals that may influence fulfillment of the device request.

          • assessments documenting the patient’s ability to use/interact with the device related to:
            • Cognition: If the patient has the cognitive capacity to use the device via the Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8)
            • Physical Functioning: If the patient is physically able to use the device via the 9-Hole Pegboard Dexterity Test (LOINC 83141-2)
            • Vision: If the patient's visual capabilities are aligned with the device features via the Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003)
            • Health Literacy: If the patient has the ability learn how to use the device via the BRIEF health literacy screening tool (LOINC 95866-0)
            • Disability: If the patient has a disability that would need to be accommodated in the selection of a device via an indication in the patient’s demographic record of having a disability (ICD-10 Z73.6)
          • Documented observation of the patient’s usage of the requested device during an assessment that may influence the fulfillment of the device.
            • Example: A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile).
          • Supporting information about the patient's goals that may influence fulfillment of the device request.
            • Example: A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include: Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element).
            • Example: A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include: Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element), Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element)
          2. Extension.extension:note
          Slice Namenote
          Definition

          Captures the clinical justification or rationale for the medical necessity of a device request. Complements the DeviceRequest.reasonCode and DeviceRequest.reasonReference data elements.

          ShortClinical justification note
          Control0..*
          4. Extension.extension:note.extension
          Control0..0
          6. Extension.extension:note.url
          Fixed Valuenote
          8. Extension.extension:note.value[x]
          TypeChoice of: markdown, string, Annotation
          [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
          10. Extension.extension:assessment
          Slice Nameassessment
          Definition

          Supporting information about patient assessments that may influence fulfillment of the device request. This includes assessments documenting the patient's ability to use/interact with the device related to:

          • Cognition: If the patient has the cognitive capacity to use the device (e.g., via cognitive test/scale)
          • Physical Functioning: If the patient is physically able to use the device (e.g., assessment)
          • Vision: If the patient's visual capabilities are aligned with the device features (e.g., via ICD code)
          • Health Literacy: If the patient has the ability learn how to use the device (e.g., via health literacy scale)
          • Disability: If the patient has a disability that would need to be accommodated in the selection of a device (e.g., via an demographic disability item)
          ShortSupporting assessment information
          Comments

          Examples:

          • Cognition: Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8)
          • Physical functioning: 9-Hole Pegboard Dexterity Test (LOINC 83141-2)
          • Vision: Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003)
          • Health Literacy: BRIEF health literacy screening tool (LOINC 95866-0)
          • Disability: Indication in the patient’s demographic record of having a disability (ICD-10 Z73.6)
          Control0..*
          12. Extension.extension:assessment.extension
          Control0..0
          14. Extension.extension:assessment.url
          Fixed Valueassessment
          16. Extension.extension:assessment.value[x]
          TypeReference(Personal Functioning and Engagement Clinical Test Observation, Personal Functioning and Engagement Collection, Personal Functioning and Engagement Single Observation)
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          18. Extension.extension:use-of-device
          Slice Nameuse-of-device
          Definition

          Supporting information about the patient's usage of the requested device during an assessment that may influence fulfillment of the device request.

          ShortSupporting device usage information
          Comments

          Example:

          • A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile).
          Control0..*
          20. Extension.extension:use-of-device.extension
          Control0..0
          22. Extension.extension:use-of-device.url
          Fixed Valueuse-of-device
          24. Extension.extension:use-of-device.value[x]
          TypeReference(Personal Functioning and Engagement Use of Device)
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          26. Extension.extension:goal
          Slice Namegoal
          Definition

          Supporting information about the patient's goals that may influence fulfillment of the device request.

          ShortSupporting goal information
          Comments

          Examples:

          • A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include:
          • Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element).
          • A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include:
          • Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element)
          • Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element)
          Control0..*
          28. Extension.extension:goal.extension
          Control0..0
          30. Extension.extension:goal.url
          Fixed Valuegoal
          32. Extension.extension:goal.value[x]
          TypeReference(Personal Functioning and Engagement Goal Profile)
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          34. Extension.url
          Fixed Valuehttp://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-device-request-clinical-justification
          36. Extension.value[x]
          Control0..0

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

          0. Extension
          Definition

          Groups information that supports the clinical justification for the device request. These can include assessment findings, and goals that may influence fulfillment of the device request.

          • assessments documenting the patient’s ability to use/interact with the device related to:
            • Cognition: If the patient has the cognitive capacity to use the device via the Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8)
            • Physical Functioning: If the patient is physically able to use the device via the 9-Hole Pegboard Dexterity Test (LOINC 83141-2)
            • Vision: If the patient's visual capabilities are aligned with the device features via the Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003)
            • Health Literacy: If the patient has the ability learn how to use the device via the BRIEF health literacy screening tool (LOINC 95866-0)
            • Disability: If the patient has a disability that would need to be accommodated in the selection of a device via an indication in the patient’s demographic record of having a disability (ICD-10 Z73.6)
          • Documented observation of the patient’s usage of the requested device during an assessment that may influence the fulfillment of the device.
            • Example: A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile).
          • Supporting information about the patient's goals that may influence fulfillment of the device request.
            • Example: A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include: Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element).
            • Example: A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include: Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element), Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element)
          ShortExtension
          Control0..*
          This element is affected by the following invariants: ele-1
          Is Modifierfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          2. Extension.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
          4. Extension.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 Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 6. Extension.extension:note
            Slice Namenote
            Definition

            Captures the clinical justification or rationale for the medical necessity of a device request. Complements the DeviceRequest.reasonCode and DeviceRequest.reasonReference data elements.

            ShortClinical justification note
            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())
            8. Extension.extension:note.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
            10. Extension.extension:note.extension
            Definition

            An Extension

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

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

              Shortidentifies the meaning of the extension
              Comments

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

              Control1..1
              Typeuri
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              Fixed Valuenote
              14. Extension.extension:note.value[x]
              Definition

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

              ShortValue of extension
              Control0..1
              TypeChoice of: markdown, string, Annotation
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              16. Extension.extension:assessment
              Slice Nameassessment
              Definition

              Supporting information about patient assessments that may influence fulfillment of the device request. This includes assessments documenting the patient's ability to use/interact with the device related to:

              • Cognition: If the patient has the cognitive capacity to use the device (e.g., via cognitive test/scale)
              • Physical Functioning: If the patient is physically able to use the device (e.g., assessment)
              • Vision: If the patient's visual capabilities are aligned with the device features (e.g., via ICD code)
              • Health Literacy: If the patient has the ability learn how to use the device (e.g., via health literacy scale)
              • Disability: If the patient has a disability that would need to be accommodated in the selection of a device (e.g., via an demographic disability item)
              ShortSupporting assessment information
              Comments

              Examples:

              • Cognition: Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8)
              • Physical functioning: 9-Hole Pegboard Dexterity Test (LOINC 83141-2)
              • Vision: Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003)
              • Health Literacy: BRIEF health literacy screening tool (LOINC 95866-0)
              • Disability: Indication in the patient’s demographic record of having a disability (ICD-10 Z73.6)
              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())
              18. Extension.extension:assessment.id
              Definition

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

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

              An Extension

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

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

                Shortidentifies the meaning of the extension
                Comments

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

                Control1..1
                Typeuri
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                Fixed Valueassessment
                24. Extension.extension:assessment.value[x]
                Definition

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

                ShortValue of extension
                Control0..1
                TypeReference(Personal Functioning and Engagement Clinical Test Observation, Personal Functioning and Engagement Collection, Personal Functioning and Engagement Single Observation)
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                26. Extension.extension:use-of-device
                Slice Nameuse-of-device
                Definition

                Supporting information about the patient's usage of the requested device during an assessment that may influence fulfillment of the device request.

                ShortSupporting device usage information
                Comments

                Example:

                • A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile).
                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())
                28. Extension.extension:use-of-device.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
                30. Extension.extension:use-of-device.extension
                Definition

                An Extension

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

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

                  Shortidentifies the meaning of the extension
                  Comments

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

                  Control1..1
                  Typeuri
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  Fixed Valueuse-of-device
                  34. Extension.extension:use-of-device.value[x]
                  Definition

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

                  ShortValue of extension
                  Control0..1
                  TypeReference(Personal Functioning and Engagement Use of Device)
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  36. Extension.extension:goal
                  Slice Namegoal
                  Definition

                  Supporting information about the patient's goals that may influence fulfillment of the device request.

                  ShortSupporting goal information
                  Comments

                  Examples:

                  • A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include:
                  • Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element).
                  • A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include:
                  • Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element)
                  • Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element)
                  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())
                  38. Extension.extension:goal.id
                  Definition

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

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

                  An Extension

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

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

                    Shortidentifies the meaning of the extension
                    Comments

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

                    Control1..1
                    Typeuri
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    Fixed Valuegoal
                    44. Extension.extension:goal.value[x]
                    Definition

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

                    ShortValue of extension
                    Control0..1
                    TypeReference(Personal Functioning and Engagement Goal Profile)
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    46. Extension.url
                    Definition

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

                    Shortidentifies the meaning of the extension
                    Comments

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

                    Control1..1
                    Typeuri
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    Fixed Valuehttp://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-device-request-clinical-justification
                    48. Extension.value[x]
                    Definition

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

                    ShortValue of extension
                    Control0..0
                    TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
                    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()))