QI-Core Implementation Guide
4.1.0 - release

Publication Build: This will be filled in by the publication tooling

## Resource Profile: QICoreAdverseEvent - Detailed Descriptions

Definitions for the qicore-adverseevent resource 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.
Control | 0..*
Alternate Names | AE
Invariants | Defined on this element 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 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (: contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (: text.`div`.exists())
2. AdverseEvent.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Control | 0..1
Type | string
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 might not always be associated with version changes to the resource.
Control | 0..1
Type | Meta
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Control | 0..1
Type | uri
Is Modifier | true
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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. AdverseEvent.language
Definition | The base language in which the resource is written.
Control | 0..1
Binding | The codes SHOULD be taken from CommonLanguages Max Binding: AllLanguages A human language.
Type | code
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).
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. AdverseEvent.text
Definition | A human-readable narrative that contains a summary of the resource and can 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.
Control | 0..1
Type | Narrative
Alternate Names | narrative, 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 information is added later.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
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.
Control | 0..*
Type | Resource
Alternate Names | inline 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. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
8. AdverseEvent.extension
Definition | May be used to represent additional information that is not part of the basic definition of the resource. 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 can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Control | 0..*
Type | Extension
Alternate Names | extensions, 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.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Control | 0..*
Type | Extension
Is Modifier | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, 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.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
10. AdverseEvent.identifier
Definition | Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Type | Identifier
Requirements | Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.
Comments | This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. AdverseEvent.actuality
Definition | Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.
Control | 1..1
Binding | The codes SHALL be taken from AdverseEventActuality Overall nature of the adverse event, e.g. real or potential.
Type | code
Is Modifier | true
Must Support | true
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. AdverseEvent.category
Definition | The overall type of event, intended for search and filtering purposes.
Control | 0..*
Binding | The codes SHALL be taken from AdverseEventCategory; other codes may be used where these codes are not suitable Overall categorization of the event, e.g. product-related or situational.
Type | CodeableConcept
Must Support | true
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. AdverseEvent.event
Definition | This element defines the specific type of event that occurred or that was prevented from occurring.
Control | 1..1
Binding | For example codes, see SNOMEDCTClinicalFindings Detailed type of event.
Type | CodeableConcept
Must Support | true
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. AdverseEvent.subject
Definition | This subject or group impacted by the event.
Control | 1..1
Type | Reference(QICorePatient | Group | QICorePractitioner | QICoreRelatedPerson)
Must Support | true
Must Support Types | No must-support rules about the choice of types/profiles
Requirements | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
Alternate Names | patient
Comments | If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. AdverseEvent.encounter
Definition | The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.
Control | 0..1
Type | Reference(QICoreEncounter)
Must Support | true
Comments | This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. AdverseEvent.date
Definition | The date (and perhaps time) when the adverse event occurred.
Control | 0..1
Type | dateTime
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. AdverseEvent.detected
Definition | Estimated or actual date the AdverseEvent began, in the opinion of the reporter.
Control | 0..1
Type | dateTime
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. AdverseEvent.recordedDate
Definition | The date on which the existence of the AdverseEvent was first recorded.
Control | 0..1
Type | dateTime
Comments | The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. AdverseEvent.resultingCondition
Definition | Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).
Control | 0..*
Type | Reference(Condition)
Must Support | true
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. AdverseEvent.location
Definition | The information about where the adverse event occurred.
Control | 0..1
Type | Reference(QICoreLocation)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. AdverseEvent.seriousness
Definition | Assessment whether this event was of real importance.
Control | 0..1
Binding | For example codes, see AdverseEventSeriousness Overall seriousness of this event for the patient.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. AdverseEvent.severity
Definition | Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.
Control | 0..1
Binding | The codes SHALL be taken from AdverseEventSeverity The severity of the adverse event itself, in direct relation to the subject.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
23. AdverseEvent.outcome
Definition | Describes the type of outcome from the adverse event.
Control | 0..1
Binding | The codes SHALL be taken from AdverseEventOutcome TODO (and should this be required?).
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. AdverseEvent.recorder
Definition | Information on who recorded the adverse event. May be the patient or a practitioner.
Control | 0..1
Type | Reference(QICorePatient | QICoreRelatedPerson | QICorePractitioner | QICorePractitionerRole)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. AdverseEvent.contributor
Definition | Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).
Control | 0..*
Type | Reference(Practitioner | PractitionerRole | Device)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. AdverseEvent.suspectEntity
Definition | Describes the entity that is suspected to have caused the adverse event.
Control | 0..*
Type | BackboneElement
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
27. 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.
Control | 0..1
Type | string
28. AdverseEvent.suspectEntity.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. 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 can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Control | 0..*
Type | Extension
Alternate Names | extensions, 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.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
29. 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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Control | 0..*
Type | Extension
Is Modifier | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, 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.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
30. 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.
Control | 1..1
Type | Reference(QICoreImmunization | QICoreProcedure | QICoreSubstance | QICoreMedication | QICoreMedicationAdministration | QICoreMedicationStatement | QICoreDevice)
Must Support | true
Must Support Types | No must-support rules about the choice of types/profiles
Alternate Names | Substance or Medication or Device
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
31. AdverseEvent.suspectEntity.causality
Definition | Information on the possible cause of the event.
Control | 0..1
Type | BackboneElement
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. AdverseEvent.suspectEntity.causality.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Control | 0..1
Type | string
33. AdverseEvent.suspectEntity.causality.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. 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 can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Control | 0..*
Type | Extension
Alternate Names | extensions, 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.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
34. AdverseEvent.suspectEntity.causality.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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Control | 0..*
Type | Extension
Is Modifier | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, 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.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
35. AdverseEvent.suspectEntity.causality.assessment
Definition | Assessment of if the entity caused the event.
Control | 0..1
Binding | For example codes, see AdverseEventCausalityAssessment Codes for the assessment of whether the entity caused the event.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
36. AdverseEvent.suspectEntity.causality.productRelatedness
Definition | AdverseEvent.suspectEntity.causalityProductRelatedness.
Control | 0..1
Type | string
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
37. AdverseEvent.suspectEntity.causality.author
Definition | AdverseEvent.suspectEntity.causalityAuthor.
Control | 0..1
Type | Reference(Practitioner | PractitionerRole)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. AdverseEvent.suspectEntity.causality.method
Definition | ProbabilityScale | Bayesian | Checklist.
Control | 0..1
Binding | For example codes, see AdverseEventCausalityMethod TODO.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. AdverseEvent.subjectMedicalHistory
Definition | AdverseEvent.subjectMedicalHistory.
Control | 0..*
Type | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. AdverseEvent.referenceDocument
Definition | AdverseEvent.referenceDocument.
Control | 0..*
Type | Reference(DocumentReference)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
41. AdverseEvent.study
Definition | AdverseEvent.study.
Control | 0..*
Type | Reference(ResearchStudy)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))