Device (QDM)

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This QDM to QI Core Mapping for the QDM Datatype "Device" was reviewed by the CQI WG on April 6, 2018 for QDM version 5.3. The content presented here is based on QDM version 5.4 and removes the QDM 5.3 attribute "anatomical approach site" as there was no existing use or clear use case to retain it.
QDM defines Device as an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including a component part or accessory, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and not dependent on being metabolized to achieve any of its primary intended purposes. QDM provides three contexts for expressing devices: Device, Applied; Device, Order; and Device, Recommended.

1. Note that the current use of the QDM datatype “Device, Applied” usually references the procedure to “apply” the device (i.e., to use for the patient, to use on the patient’s body, or to implant in the patient’s body). Each of these current uses should address the concept using the QDM datatypes, Intervention, Performed, or Procedure, Performed.
2. The original intent of the QDM datatype “Device, Applied” was to reference the specific device or type of device of concern to the measure. And that reference might be as detailed a providing a device class as referenced in a Unique Device Identifier (UDI). The FHIR Device resource (http://hl7.org/fhir/device.html) does have a metadata element for UDI (http://hl7.org/fhir/device-definitions.html#Device.udi). All device metadata reference inherent qualities of the device. And timing addresses Device.manufactureDate and Device.expirationDate. Therefore, a direct map to the Device resource may not be sufficient or appropriate for the QDM Device, Applied datatype.
3. The FHIR Resource DeviceUseStatement (http://hl7.org/fhir/deviceusestatement.html) is a more appropriate resource to map QDM Device, Applied. The DeviceUseStatement has a maturity level of 0, so the mapping will need to be updated as the resource is updated. Note: this mapping will need to be reviewed with the QI Core DeviceUseStatement to assure alignment since the current QI Core content does not seem to address the most recent version of DeviceUseStatement.

Device, Applied

QDM Attribute	QI Core Metadata Element	Comment
Device Applied	DeviceUseStatement	A record of a device being used by a patient where the record is the result of a report from the patient or another clinician.
Anatomical Location Site	DeviceUseStatement.bodySite	Indicates the site on the subject's body where the device was used ( i.e. the target site).
Negation Rationale	None	A DeviceUseStatement does not address negation directly since there would be no statement if the device were absent. QDM usage is to indicate devices that have not been applied should address negation rationale for the order or the recommendation (i.e., ProcedureRequest.extension (reasonRefused)). One could address negation rationale by indicating DeviceUseStatement.status constrained to values stopped or on-hold and reference DeviceUseStatement.reason to indicate the reason (i.e., reason for not using the device).
Reason	DeviceUseStatement.indication	Reason or justification for use of the device.
Relevant Period	DeviceUseStatement.whenUsed	The time period over which the device was used. Note – the DeviceUseStatement resource also has a metadata element: DeviceUseStatement.timing(x) indicating how often the device was used (may be a period or dateTime).
Author dateTime	DeviceUseStatement.recordedOn	The time at which the DeviceUseStatement was made/recorded.
Code	DeviceUseStatement.device Device.udi.deviceIdentifier	DeviceUseStatemtn.device references Device for details of the device used. Device.udi.deviceIdentifier (DI) is a mandatory, fixed portion of a Unique Device Identified (UDI) that identifies the labeler and the specific version or model of a device.
id	DeviceUseStatement.id	Logical id of this artifact
Source	DeviceUseStatement.source	Who reported this device was being used by the patient.

Device, Order

QDM Attribute	QI Core Metadata Element	Comment
Device Order	DeviceRequest.intent	DeviceRequest.intent uses the concepts draft, active, on-hold, revoked, completed, entered-in-error, unkown. "Draft" is most consistent with the DeviceRequest when applied to clinical decision support (CDS) or expectations a provider gives to a patient. "active" or "completed" is consistent with the intent of the QDM Device, Order datatype.
Negation Rationale	None	DeviceRequest resource does not include a reason the device request did not occur. QI Core does have a ProcedureRequest.extension (http://hl7.org/fhir/StructureDefinition/procedurerequest-reasonRefused). One could address negation rationale by indicating DeviceRequest.status constrained to values suspended or cancelled and reference DeviceRequest.reasonCode to indicate the reason (i.e., reason for not using the device).
Reason	DeviceRequest.reasonCode	QDM matched to QI Core / FHIR
Author dateTime	DeviceRequest.AuthoredOn	Note - DeviceRequest.occurrence[x] defines a dateTime when the event should occur - not addressed in QDM Note: FHIR Provenance generally addresses the author of the message; the identifier/source of the original resource element is defined by the resource. Individual resource element provenance is summarized in the FHIR W5 Report (http://hl7.org/fhir/w5.html).
Code	DeviceRequest.code	Device requested
id	DeviceRequest.id	QDM matched to QI Core / FHIR
Source	DeviceRequest.requester	Who, what is requesting the diagnositics - note also, DeviceRequest.performer to indicate the requested filler of the request.

Device, Recommended

QDM Attribute	QI Core Metadata Element	Comment
Device Recommended	DeviceRequest.intent	DeviceRequest.intent uses the concepts draft, active, on-hold, revoked, copmleted, enetered-in-error, unknown. "draft" is most consistent with the DeviceRequest when applied to clinical decision support (CDS) or expectations a provider gives to a patient. "active" or "completed" is consistent with the intent of the QDM Device, Order datatype.
Negation Rationale	None	DeviceRequest resource does not include a reason the device request did not occur. QI Core does have a ProcedureRequest.extension (http://hl7.org/fhir/StructureDefinition/procedurerequest-reasonRefused). See FHIR Tracker Item 15939.
Reason	DeviceRequest.reasonCode	QDM matched to QI Core / FHIR
Author dateTime	DeviceRequest.AuthoredOn	Note - DeviceRequest.occurrence[x] defines a dateTime when the event should occur - not addressed in QDM Note: FHIR Provenance generally addresses the author of the message; the identifier/source of the original resource element is defined by the resource. Individual resource element provenance is summarized in the FHIR W5 Report (http://hl7.org/fhir/w5.html).
Code	DeviceRequest.code	Device requested
id	DeviceRequest.id	QDM matched to QI Core / FHIR
Source	DeviceRequest.requester	Who, what is requesting the diagnositics - note also, DeviceRequest.performer to indicate the requested filler of the request.