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-adverseevent Profile.

1. AdverseEvent
Definition

Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

Control0..*
Alternate NamesAE
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. AdverseEvent.id
Definition

Logical id of this artifact.

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. AdverseEvent.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. AdverseEvent.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. AdverseEvent.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. AdverseEvent.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. AdverseEvent.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. AdverseEvent.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. AdverseEvent.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. AdverseEvent.identifier
Definition

The identifier(s) of this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itsefl is not appropriate.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
11. AdverseEvent.category
Definition

The type of event which is important to characterize what occurred and caused harm to the subject, or had the potential to cause harm to the subject.

Control0..1
BindingOverall categorization of the event, e.g. real or potential
The codes SHALL be taken from AdverseEventCategory
Typecode
12. AdverseEvent.type
Definition

This element defines the specific type of event that occurred or that was prevented from occurring.

Control1..1
BindingThe type of adverse event: an incident, near-miss, or unsafe condition
For example codes, see SNOMED CT Clinical Findings
TypeCodeableConcept
Must Supporttrue
13. AdverseEvent.subject
Definition

This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented.

Control1..1
TypeReference(QICore-Patient | ResearchSubject | QICore-Medication | QICore-Device)
Must Supporttrue
Alternate Namespatient
14. AdverseEvent.date
Definition

The date (and perhaps time) when the adverse event occurred.

Control0..1
TypedateTime
15. AdverseEvent.reaction
Definition

Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

Control0..*
TypeReference(QICore-Condition)
16. AdverseEvent.location
Definition

The information about where the adverse event occurred.

Control0..1
TypeReference(QICore-Location)
17. AdverseEvent.seriousness
Definition

Describes the seriousness or severity of the adverse event.

Control0..1
BindingA subjective assessment of the severity of the adverse event as evaluated by the clinician.
For example codes, see AdverseEventSeriousness
TypeCodeableConcept
18. AdverseEvent.outcome
Definition

Describes the type of outcome from the adverse event.

Control0..1
BindingTODO (and should this be required?)
The codes SHALL be taken from AdverseEventOutcome
TypeCodeableConcept
19. AdverseEvent.recorder
Definition

Information on who recorded the adverse event. May be the patient or a practitioner.

Control0..1
TypeReference(QICore-Patient | QICore-RelatedPerson | QICore-Practitioner)
20. AdverseEvent.eventParticipant
Definition

Parties that may or should contribute or have contributed information to the Act. Such information includes information leading to the decision to perform the Act and how to perform the Act (e.g. consultant), information that the Act itself seeks to reveal (e.g. informant of clinical history), or information about what Act was performed (e.g. informant witness).

Control0..1
TypeReference(Practitioner | Device)
21. AdverseEvent.description
Definition

Describes the adverse event in text.

Control0..1
Typestring
22. AdverseEvent.suspectEntity
Definition

Describes the entity that is suspected to have caused the adverse event.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
23. AdverseEvent.suspectEntity.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
24. AdverseEvent.suspectEntity.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. 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.

25. AdverseEvent.suspectEntity.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, 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, modifiers
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.

26. AdverseEvent.suspectEntity.instance
Definition

Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

Control1..1
TypeReference(QICore-Substance | QICore-Medication | QICore-MedicationAdministration | QICore-MedicationStatement | QICore-Device)
Must Supporttrue
Alternate NamesSubstance or Medication or Device
27. AdverseEvent.suspectEntity.causality
Definition

causality1 | causality2.

Control0..1
BindingThe type of adverse event: an incident, near-miss, or unsafe condition
The codes SHALL be taken from AdverseEventCausality
Typecode
28. AdverseEvent.suspectEntity.causalityAssessment
Definition

assess1 | assess2.

Control0..1
BindingThe degree of confidence that this condition is correct
For example codes, see AdverseEventCausalityAssessment
TypeCodeableConcept
29. AdverseEvent.suspectEntity.causalityProductRelatedness
Definition

AdverseEvent.suspectEntity.causalityProductRelatedness.

Control0..1
Typestring
30. AdverseEvent.suspectEntity.causalityMethod
Definition

method1 | method2.

Control0..1
BindingTODO
For example codes, see AdverseEventCausalityMethod
TypeCodeableConcept
31. AdverseEvent.suspectEntity.causalityAuthor
Definition

AdverseEvent.suspectEntity.causalityAuthor.

Control0..1
TypeReference(Practitioner | PractitionerRole)
32. AdverseEvent.suspectEntity.causalityResult
Definition

result1 | result2.

Control0..1
BindingTODO
For example codes, see AdverseEventCausalityResult
TypeCodeableConcept
33. AdverseEvent.subjectMedicalHistory
Definition

AdverseEvent.subjectMedicalHistory.

Control0..*
TypeReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure)
34. AdverseEvent.referenceDocument
Definition

AdverseEvent.referenceDocument.

Control0..*
TypeReference(DocumentReference)
35. AdverseEvent.study
Definition

TODO.

Control0..*
TypeReference(ResearchStudy)