QI-Core Implementation Guide: STU 4 (v4.0.0 for FHIR 4.0.1)

QI-Core Implementation Guide - This is the current published version.. See the Directory of published versions

D.4.1 StructureDefinition-qicore-device

Introduction:

See the patterns page for implementation and usage patterns.

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 inherits Implantable Device from US Core and builds directly from FHIR for the QI-Core 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.

Examples:

General Device Example

D.4.1.1 Formal Views of Profile Content

The official URL for this profile is: 

http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device

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

This profile builds on Device.

This profile was published on Wed Aug 22 00:00:00 UTC 2018 as a draft by Health Level Seven, Inc. - CQI WG.

Description of Profiles, Differentials, and Snapshots.

Summary

Mandatory: 1 element
Must-Support: 1 element

Structures

This structure refers to these other structures:

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*DeviceItem used in healthcare
... id Σ0..1stringLogical id of this artifact
... meta ΣI0..1MetaMetadata about the resource
... implicitRules ?!ΣI0..1uriA set of rules under which this content was created
... language I0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension I0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!I0..*ExtensionExtensions that cannot be ignored
... identifier I0..*IdentifierInstance identifier
... definition I0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier ΣI0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier ΣI0..1stringMandatory fixed portion of UDI
.... issuer I0..1uriUDI Issuing Organization
.... jurisdiction I0..1uriRegional UDI authority
.... carrierAIDC ΣI0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF ΣI0..1stringUDI Human Readable Barcode String
.... entryType I0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required)
... status ?!ΣI0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... statusReason I0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible)
... distinctIdentifier I0..1stringThe distinct identification string
... manufacturer I0..1stringName of device manufacturer
... manufactureDate I0..1dateTimeDate when the device was made
... expirationDate I0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber I0..1stringLot number of manufacture
... serialNumber I0..1stringSerial number assigned by the manufacturer
... deviceName I0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name I1..1stringThe name of the device
.... type I1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required)
... modelNumber I0..1stringThe model number for the device
... partNumber I0..1stringThe part number of the device
... type I0..1CodeableConceptThe kind or type of device
Binding: DeviceType (example)
... specialization I0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType I1..1CodeableConceptThe standard that is used to operate and communicate
.... version I0..1stringThe version of the standard that is used to operate and communicate
... version I0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type I0..1CodeableConceptThe type of the device version
.... component I0..1IdentifierA single component of the device version
.... value I1..1stringThe version text
... property I0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type I1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity I0..*QuantityProperty value as a quantity
.... valueCode I0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient SI1..1Reference(QICorePatient)Patient to whom Device is affixed
... owner I0..1Reference(Organization)Organization responsible for device
... contact I0..*ContactPointDetails for human/organization for support
... location I0..1Reference(Location)Where the device is found
... url I0..1uriNetwork address to contact device
... note I0..*AnnotationDevice notes and comments
... safety ΣI0..*CodeableConceptSafety Characteristics of Device
... parent I0..1Reference(Device)The parent device

doco Documentation for this format

Summary

Mandatory: 1 element
Must-Support: 1 element

Structures

This structure refers to these other structures:

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*DeviceItem used in healthcare
... id Σ0..1stringLogical id of this artifact
... meta ΣI0..1MetaMetadata about the resource
... implicitRules ?!ΣI0..1uriA set of rules under which this content was created
... language I0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension I0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!I0..*ExtensionExtensions that cannot be ignored
... identifier I0..*IdentifierInstance identifier
... definition I0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier ΣI0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier ΣI0..1stringMandatory fixed portion of UDI
.... issuer I0..1uriUDI Issuing Organization
.... jurisdiction I0..1uriRegional UDI authority
.... carrierAIDC ΣI0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF ΣI0..1stringUDI Human Readable Barcode String
.... entryType I0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required)
... status ?!ΣI0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... statusReason I0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible)
... distinctIdentifier I0..1stringThe distinct identification string
... manufacturer I0..1stringName of device manufacturer
... manufactureDate I0..1dateTimeDate when the device was made
... expirationDate I0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber I0..1stringLot number of manufacture
... serialNumber I0..1stringSerial number assigned by the manufacturer
... deviceName I0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name I1..1stringThe name of the device
.... type I1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required)
... modelNumber I0..1stringThe model number for the device
... partNumber I0..1stringThe part number of the device
... type I0..1CodeableConceptThe kind or type of device
Binding: DeviceType (example)
... specialization I0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType I1..1CodeableConceptThe standard that is used to operate and communicate
.... version I0..1stringThe version of the standard that is used to operate and communicate
... version I0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type I0..1CodeableConceptThe type of the device version
.... component I0..1IdentifierA single component of the device version
.... value I1..1stringThe version text
... property I0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type I1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity I0..*QuantityProperty value as a quantity
.... valueCode I0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient SI1..1Reference(QICorePatient)Patient to whom Device is affixed
... owner I0..1Reference(Organization)Organization responsible for device
... contact I0..*ContactPointDetails for human/organization for support
... location I0..1Reference(Location)Where the device is found
... url I0..1uriNetwork address to contact device
... note I0..*AnnotationDevice notes and comments
... safety ΣI0..*CodeableConceptSafety Characteristics of Device
... parent I0..1Reference(Device)The parent device

doco Documentation for this format

 

D.4.1.2 Terminology Bindings

Terminology Bindings

PathConformanceValueSet
Device.languagepreferredCommonLanguages
Max Binding: AllLanguages
Device.udiCarrier.entryTyperequiredUDIEntryType
Device.statusrequiredFHIRDeviceStatus
Device.statusReasonextensibleFHIRDeviceStatusReason
Device.deviceName.typerequiredDeviceNameType
Device.typeexampleDeviceType

D.4.1.3 Constraints

Constraints

IdPathDetailsRequirements
dom-2DeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3DeviceIf 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-4DeviceIf 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-5DeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6DeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1Device.metaAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.implicitRulesAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.languageAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.textAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.identifierAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.definitionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.udiCarrierAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.udiCarrier.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.udiCarrier.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.udiCarrier.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.udiCarrier.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.udiCarrier.deviceIdentifierAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.udiCarrier.issuerAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.udiCarrier.jurisdictionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.udiCarrier.carrierAIDCAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.udiCarrier.carrierHRFAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.udiCarrier.entryTypeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.statusAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.statusReasonAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.distinctIdentifierAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.manufacturerAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.manufactureDateAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.expirationDateAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.lotNumberAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.serialNumberAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.deviceNameAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.deviceName.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.deviceName.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.deviceName.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.deviceName.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.deviceName.nameAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.deviceName.typeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.modelNumberAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.partNumberAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.typeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.specializationAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.specialization.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.specialization.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.specialization.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.specialization.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.specialization.systemTypeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.specialization.versionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.versionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.version.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.version.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.version.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.version.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.version.typeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.version.componentAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.version.valueAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.propertyAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.property.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.property.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.property.modifierExtensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1Device.property.modifierExtensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1Device.property.typeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.property.valueQuantityAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.property.valueCodeAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.patientAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.ownerAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.contactAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.locationAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.urlAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.noteAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.safetyAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.parentAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())