QI-Core Implementation Guide
6.0.0 - STU6
QI-Core Implementation Guide
6.0.0 - STU6
This page is part of the Quality Improvement Core Framework (v6.0.0: STU6 (v6.0.0)) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device | Version: 6.0.0 | |||
| Active as of 2018-08-22 | Computable Name: QICoreDevice | |||
Profile of Device for decision support/quality metrics. Defines the core set of elements and extensions for quality rule and measure authors.
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”:
The FHIR Device Resource addresses both implantable and non-implantable devices. US Core only references Implantable Device. QI-Core uses Implantable Device from US Core. Separately, builds directly from FHIR to address non-implantable devices with QI-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.
| General Device Example |
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Device
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Device | Device | |||
  patient | 1..1 | Reference(QICore Patient) | (QI-Core) Patient to whom Device is affixed | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
| patient | 1..1 | Reference(QICore Patient) | (QI-Core) Patient to whom Device is affixed | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| 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(QICore Patient) | (QI-Core) 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 | ||||||||
| Path | Conformance | ValueSet | URI | |||
| Device.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1from the FHIR Standard | ||||
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | ||||
| Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reasonfrom the FHIR Standard | ||||
| Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1from the FHIR Standard | ||||
| Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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
Differential View
This structure is derived from Device
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Device | Device | |||
| patient | 1..1 | Reference(QICore Patient) | (QI-Core) Patient to whom Device is affixed | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
| patient | 1..1 | Reference(QICore Patient) | (QI-Core) Patient to whom Device is affixed | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| 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(QICore Patient) | (QI-Core) 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 | ||||||||
| Path | Conformance | ValueSet | URI | |||
| Device.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1from the FHIR Standard | ||||
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | ||||
| Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reasonfrom the FHIR Standard | ||||
| Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1from the FHIR Standard | ||||
| Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| 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
Other representations of profile: CSV, Excel, Schematron
IG © 2019+ HL7 International / Clinical Quality Information. Package hl7.fhir.us.qicore#6.0.0 based on FHIR 4.0.1. Generated 2024-03-01
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