QI-Core Implementation Guide: STU 3.2 (v3.2.0 for FHIR 3.0.1)

This page is part of the Quality Improvement Core Framework (v3.2.0: STU 3) based on FHIR R3. The current version which supercedes this version is 4.1.1. For a full list of available versions, see the Directory of published versions

D.4.1.4 StructureDefinition: - Detailed Descriptions

Definitions for the StructureDefinition-qicore-deviceusestatement Profile.


1. DeviceUseStatement
Definition

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.

Control0..*
InvariantsDefined on this element
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (: contained.text.empty())
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (: contained.where(('#'+id in %resource.descendants().reference).not()).empty())
dom-4: 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())
2. DeviceUseStatement.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

3. DeviceUseStatement.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.

Control0..1
TypeMeta
4. DeviceUseStatement.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

Control0..1
Typeuri
Is Modifiertrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

5. DeviceUseStatement.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHALL be taken from Common Languages; other codes may be used where these codes are not suitable
Max Binding: All Languages
Typecode
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

6. DeviceUseStatement.text
Definition

A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Control0..1 This element is affected by the following invariants: dom-1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later.

7. DeviceUseStatement.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.

8. DeviceUseStatement.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

9. DeviceUseStatement.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

10. DeviceUseStatement.identifier
Definition

An external identifier for this statement such as an IRI.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
11. DeviceUseStatement.status
Definition

A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed.

Control1..1
BindingA coded concept indicating the current status of a the Device Usage
The codes SHALL be taken from DeviceUseStatementStatus
Typecode
Is Modifiertrue
Must Supporttrue
Comments

DeviceUseStatment is a statement at a point in time. The status is only representative at the point when it was asserted. The value set for contains codes that assert the status of the use by the patient (for example, stopped or on hold) as well as codes that assert the status of the resource itself (for example, entered in error).

This element is labeled as a modifier because the status contains the codes that mark the statement as not currently valid.

12. DeviceUseStatement.subject
Definition

The patient who used the device.

Control1..1
TypeReference(QICore-Patient)
Must Supporttrue
13. DeviceUseStatement.whenUsed
Definition

The time period over which the device was used.

Control0..1
TypePeriod
Must Supporttrue
14. DeviceUseStatement.timing[x]
Definition

How often the device was used.

Control0..1
TypeChoice of: Timing, Period, dateTime
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
15. DeviceUseStatement.recordedOn
Definition

The time at which the statement was made/recorded.

Control0..1
TypedateTime
Must Supporttrue
16. DeviceUseStatement.source
Definition

Who reported the device was being used by the patient.

Control0..1
TypeReference(Patient | Practitioner | RelatedPerson)
17. DeviceUseStatement.device
Definition

The details of the device used.

Control1..1
TypeReference(QICore-Device)
Must Supporttrue
18. DeviceUseStatement.indication
Definition

Reason or justification for the use of the device.

Control0..*
BindingThis value set includes all the "Clinical finding" [SNOMED CT](http://snomed.info/sct) codes - concepts where concept is-a 404684003 (Clinical finding (finding)).
The codes SHOULD be taken from SNOMED CT Clinical Findings
TypeCodeableConcept
Must Supporttrue
19. DeviceUseStatement.bodySite
Definition

Indicates the site on the subject's body where the device was used ( i.e. the target site).

Control0..1
BindingThis value set includes all codes from SNOMED CT where concept is-a 442083009 (Anatomical or acquired body site (body structure)).
For example codes, see SNOMED CT Body Structures
TypeCodeableConcept
Must Supporttrue
Requirements

Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/body-site-instance.

20. DeviceUseStatement.note
Definition

Details about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement.

Control0..*
TypeAnnotation