PACIO Personal Functioning and Engagement Implementation Guide
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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 3.0.0-ballot 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

Resource Profile: Personal Functioning and Engagement Device Profile

Official URL: http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-device Version: 3.0.0-ballot
Standards status: Trial-use Maturity Level: 3 Computable Name: PFEDevice
Other Identifiers: OID:2.16.840.1.113883.4.642.40.67.42.12

The purpose of this profile is to facilitate exchange of information related to a device that will be used to support a patient’s personal functioning and engagement in a post-acute care (PAC) setting (e.g., skilled nursing facility). This profile is based on the US Core Device Profile version 9.0.0.

Example Usage Scenarios:

The following are example usage scenarios for this profile:

  • A PAC provider records or updates details about a device that supports a patient's physical and cognitive functioning and/or engagement in daily activities.
  • A healthcare provider at an acute or PAC setting accesses details on a device being used by a patient or being used by a provider to facilitate patient function, safety, and independence.

How this resource was developed

This profile was developed by the Personal Functioning and Engagement (PFE) subgroup of the Post-Acute Care InterOperability (PACIO) Project (pacioproject.org). PFE includes experts in: Assessing for and ordering devices (e.g., physical therapists, speech language pathologists), EHR implementation and interoperability (e.g., EHR vendors), HL7 FHIR, and user-centered design. PACIO is sponsored by the US Centers for Medicare and Medicaid Services (CMS) and convened by the MITRE Corporation. Contact the PACIO project at info@pacioproject.org for detailed information about the specific methods used to develop this profile.

Mandatory and Must Support Data Elements

The following data elements must always be present or must be supported if the data is present in the sending system (Must Support definition). They are presented below with a simple human-readable explanation. The Formal Profile Definition below provides the formal summary, definitions, and terminology requirements. Contact the PACIO project at info@pacioproject.org for detailed information about the specific methods used to develop this profile.

Each Personal Functioning and Engagement Device must have:

  1. patient
  2. type

Each Personal Functioning and Engagement Device must support:

  1. deviceName
  2. distinctIdentifier
  3. expirationDate
  4. lotNumber
  5. manufactureDate
  6. owner
  7. serialNumber
  8. udiCarrier

Profile Specific Implementation Guidance

Implementations SHALL follow the US Core Device Profile UDI Specific Implementation Guidance when exchanging Unique Device Identifier (UDI) information.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* USCoreDeviceProfile(9.0.0) Item used in healthcare
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... udiCarrier Σ 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
... patient S 0..1 Reference(US Core Patient Profile(9.0.0)) Patient to whom Device is assigned
... owner S 0..1 Reference(Organization) Organization responsible for device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base extensible FHIR Device Types 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* USCoreDeviceProfile(9.0.0) Item used in healthcare
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
... owner S 0..1 Reference(Organization) Organization responsible for device

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* USCoreDeviceProfile(9.0.0) Item used in healthcare
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier Σ 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.
... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
... distinctIdentifier 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
... manufacturer 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
... expirationDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
... serialNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.
... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient S 0..1 Reference(US Core Patient Profile(9.0.0)) Patient to whom Device is assigned
... owner S 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base extensible FHIR Device Types 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

Summary

Must-Support: 2 elements

Maturity: 3

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* USCoreDeviceProfile(9.0.0) Item used in healthcare
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... udiCarrier Σ 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
... patient S 0..1 Reference(US Core Patient Profile(9.0.0)) Patient to whom Device is assigned
... owner S 0..1 Reference(Organization) Organization responsible for device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base extensible FHIR Device Types 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* USCoreDeviceProfile(9.0.0) Item used in healthcare
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
... owner S 0..1 Reference(Organization) Organization responsible for device

doco Documentation for this format

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* USCoreDeviceProfile(9.0.0) Item used in healthcare
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier Σ 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.
... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
... distinctIdentifier 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
... manufacturer 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
... expirationDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
... serialNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.
... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient S 0..1 Reference(US Core Patient Profile(9.0.0)) Patient to whom Device is assigned
... owner S 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base extensible FHIR Device Types 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

Summary

Must-Support: 2 elements

Maturity: 3

 

Other representations of profile: CSV, Excel, Schematron