US Quality Core Implementation Guide
0.1.0 - cibuild

US Quality Core Implementation Guide, published by ASTP. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/FHIR/us-quality-core/ and changes regularly. See the Directory of published versions

## Resource Profile: US Quality Core Device

Official URL: http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-device | Version: 0.1.0
Active as of 2026-03-31 | Computable Name: USQualityCoreDevice

Profile of Device for decision support/quality metrics. Defines the core set of elements and extensions for quality rule and measure authors.

Usage

FHIR defines the Device Resource as a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. FHIR and US Core further differentiate devices into two “classes”:

- Devices that interact with the human body but do not stay in it are referred to as non-implantable medical devices.
- Implantable devices are those which stay in the human body with a medical objective for an extended period of time, or even a lifetime.
  [Definition reference: Imam W. How to use ISO 13485:2016 to manage implantable devices, ISO 13485 Blog. July 4, 2016. Available at: https://advisera.com/13485academy/blog/2017/07/04/how-to-use-iso-134852016-to-manage-implantable-medical-devices/. Accessed 28 January 2020.]

The FHIR Device Resource addresses both implantable and non-implantable devices. US Core only references Implantable Device. US Quality Core uses Implantable Device from US Core. Separately, builds directly from FHIR to address non-implantable devices with US Quality Core profiles as the device resource.

Therefore, when creating an expression for an eCQM or a CDS artifact, assure you are using the appropriate Device or Implantable Device resource.

See the patterns page for implementation and usage patterns.

### Examples

General Device Example

Usages:

- Refer to this Profile: US Quality Core AdverseEvent, US Quality Core Communication, US Quality Core CommunicationRequest, US Quality Core DeviceUseStatement... Show 5 more, US Quality Core ImagingStudy, US Quality Core NonPatient Observation, US Quality Core QuestionnaireResponse, US Quality Core Service Not Requested and US Quality Core ServiceRequest
- Examples for this Profile: Device/example

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | 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..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | Σ | 0..1 | string | Mandatory fixed portion of UDI
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
type |  | 0..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices.
patient |  | 1..1 | Reference(US Quality Core Patient) | Patient to whom Device is affixed
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std.
Device.type | Base | example | Device Type | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Device | 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 | error | Device | 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 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Device | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

This structure is derived from Device

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
udiCarrier |  | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
deviceIdentifier |  | 0..1 | string | Mandatory fixed portion of UDI
type |  | 0..1 | CodeableConcept | The kind or type of device
patient |  | 1..1 | Reference(US Quality Core Patient) | Patient to whom Device is affixed
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | 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 Bindings | Purpose
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..* | BackboneElement | 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 | Σ | 0..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 | Σ | 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 | The distinct identification string
manufacturer |  | 0..1 | string | Name of device manufacturer
manufactureDate |  | 0..1 | dateTime | Date when the device was made
expirationDate |  | 0..1 | dateTime | Date and time of expiry of this device (if applicable)
lotNumber |  | 0..1 | string | Lot number of manufacture
serialNumber |  | 0..1 | string | Serial number assigned by the manufacturer
deviceName |  | 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 |  | 0..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): 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 |  | 1..1 | Reference(US Quality Core Patient) | Patient to whom Device is affixed
owner |  | 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
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 | example | Device Type | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Device | 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 | error | Device | 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 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Device | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

This structure is derived from Device

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

- US Quality Core Patient (http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-patient)

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | 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..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | Σ | 0..1 | string | Mandatory fixed portion of UDI
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
type |  | 0..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices.
patient |  | 1..1 | Reference(US Quality Core Patient) | Patient to whom Device is affixed
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std.
Device.type | Base | example | Device Type | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Device | 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 | error | Device | 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 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Device | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

Differential View

This structure is derived from Device

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
udiCarrier |  | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
deviceIdentifier |  | 0..1 | string | Mandatory fixed portion of UDI
type |  | 0..1 | CodeableConcept | The kind or type of device
patient |  | 1..1 | Reference(US Quality Core Patient) | Patient to whom Device is affixed
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | 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 Bindings | Purpose
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..* | BackboneElement | 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 | Σ | 0..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 | Σ | 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 | The distinct identification string
manufacturer |  | 0..1 | string | Name of device manufacturer
manufactureDate |  | 0..1 | dateTime | Date when the device was made
expirationDate |  | 0..1 | dateTime | Date and time of expiry of this device (if applicable)
lotNumber |  | 0..1 | string | Lot number of manufacture
serialNumber |  | 0..1 | string | Serial number assigned by the manufacturer
deviceName |  | 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 |  | 0..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): 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 |  | 1..1 | Reference(US Quality Core Patient) | Patient to whom Device is affixed
owner |  | 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
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 | example | Device Type | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Device | 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 | error | Device | 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 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Device | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

This structure is derived from Device

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

- US Quality Core Patient (http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-patient)

Other representations of profile: CSV, Excel, Schematron