FHIR Release 3 (STU) 4

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Regulated Clinical Research Information Management Patient Care Work Group Maturity Level : 0   Draft Trial Use Security Category : Patient Compartments : Patient , Practitioner , RelatedPerson

Detailed Descriptions for the elements in the AdverseEvent resource.

AdverseEvent.suspectEntity.causalityProductRelatedness To Do what is difference between assessment and result?
AdverseEvent
Element Id 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 Cardinality 1..1 0..*
Type DomainResource
Alternate Names AE
Summary true
AdverseEvent.identifier
Element Id AdverseEvent.identifier
Definition

The identifier(s) of Business identifiers assigned to this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the performer or other systems which remain constant as the resource itsefl is not appropriate. updated and propagates from server to server.

Note This is a business identifer, identifier, not a resource identifier (see discussion )
Control Cardinality 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.

Summary true
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.

AdverseEvent.category AdverseEvent.actuality
Element Id AdverseEvent.actuality
Definition

The type of event which is important to characterize what occurred and caused harm to Whether the subject, event actually happened, or just had the potential to cause harm to the subject. to. Note that this is independent of whether anyone was affected or harmed or how severely.

Control Cardinality 0..1 1..1
Terminology Binding AdverseEventCategory AdverseEventActuality ( Required )
Type code
Is Modifier true (Reason: This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.)
Summary true
AdverseEvent.type AdverseEvent.category
Element Id AdverseEvent.category
Definition

The overall type of event, intended for search and filtering purposes.

Cardinality 0..*
Terminology Binding AdverseEventCategory ( Extensible )
Type CodeableConcept
Summary true
AdverseEvent.event
Element Id AdverseEvent.event
Definition

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

Control Cardinality 0..1
Terminology Binding SNOMED CT Clinical Findings ( Example )
Type CodeableConcept
Summary true
AdverseEvent.subject
Element Id 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.

Control Cardinality 0..1 1..1
Type Reference ( Patient | ResearchSubject Group | Medication Practitioner | Device RelatedPerson )
Requirements

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

Alternate Names patient
Summary true
Comments

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

AdverseEvent.encounter
Element Id AdverseEvent.encounter
Definition

The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.

Cardinality 0..1
Type Reference ( Encounter )
Summary 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.

AdverseEvent.date
Element Id AdverseEvent.date
Definition

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

Control Cardinality 0..1
Type dateTime
Summary true
AdverseEvent.reaction AdverseEvent.detected
Element Id AdverseEvent.detected
Definition

Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

Cardinality 0..1
Type dateTime
Summary true
AdverseEvent.recordedDate
Element Id AdverseEvent.recordedDate
Definition

The date on which the existence of the AdverseEvent was first recorded.

Cardinality 0..1
Type dateTime
Summary true
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.

AdverseEvent.resultingCondition
Element Id 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 Cardinality 0..*
Type Reference ( Condition )
Summary true
AdverseEvent.location
Element Id AdverseEvent.location
Definition

The information about where the adverse event occurred.

Control Cardinality 0..1
Type Reference ( Location )
Summary true
AdverseEvent.seriousness
Element Id AdverseEvent.seriousness
Definition

Assessment whether this event was of real importance.

Cardinality 0..1
Terminology Binding AdverseEventSeriousness ( Example )
Type CodeableConcept
Summary true
AdverseEvent.severity
Element Id AdverseEvent.severity
Definition

Describes the seriousness or severity of the adverse event. event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.

Control Cardinality 0..1
Terminology Binding AdverseEventSeriousness AdverseEventSeverity ( Example Required )
Type CodeableConcept
Summary true
AdverseEvent.outcome
Element Id AdverseEvent.outcome
Definition

Describes the type of outcome from the adverse event.

Control Cardinality 0..1
Terminology Binding AdverseEventOutcome ( Required )
Type CodeableConcept
Summary true
AdverseEvent.recorder
Element Id AdverseEvent.recorder
Definition

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

Control Cardinality 0..1
Type Reference ( Patient | Practitioner | PractitionerRole | RelatedPerson )
Summary true
AdverseEvent.eventParticipant AdverseEvent.contributor
Element Id AdverseEvent.contributor
Definition

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

Control Cardinality 0..1 0..*
Type Reference ( Practitioner | PractitionerRole | Device )
Summary true
AdverseEvent.description AdverseEvent.suspectEntity
Definition Describes the adverse event in text. Control 0..1 Type string Summary Element Id true AdverseEvent.suspectEntity
Definition

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

Control Cardinality 0..*
Summary true
AdverseEvent.suspectEntity.instance
Element Id 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 Cardinality 1..1
Type Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device )
Alternate Names Substance or Medication or Device
Summary true
AdverseEvent.suspectEntity.causality
Definition causality1 | causality2. Control Element Id 0..1 AdverseEvent.suspectEntity.causality
Terminology Binding Definition AdverseEventCausality ( Required )

Information on the possible cause of the event.

Type Cardinality code 0..*
Summary true
To Do is this meant to be a backbone element?
AdverseEvent.suspectEntity.causalityAssessment AdverseEvent.suspectEntity.causality.assessment
Element Id AdverseEvent.suspectEntity.causality.assessment
Definition

assess1 | assess2. Assessment of if the entity caused the event.

Control Cardinality 0..1
Terminology Binding AdverseEventCausalityAssessment ( Example )
Type CodeableConcept
Summary true
Definition AdverseEvent.suspectEntity.causalityProductRelatedness. Control To Do 0..1 what is difference between assessment and result?
Type string AdverseEvent.suspectEntity.causality.productRelatedness
Summary Element Id true AdverseEvent.suspectEntity.causalityMethod AdverseEvent.suspectEntity.causality.productRelatedness
Definition

method1 | method2. AdverseEvent.suspectEntity.causalityProductRelatedness.

Control Cardinality 0..1
Terminology Binding AdverseEventCausalityMethod ( Example ) Type CodeableConcept string
Summary true
AdverseEvent.suspectEntity.causalityAuthor AdverseEvent.suspectEntity.causality.author
Element Id AdverseEvent.suspectEntity.causality.author
Definition

AdverseEvent.suspectEntity.causalityAuthor.

Control Cardinality 0..1
Type Reference ( Practitioner | PractitionerRole )
Summary true
AdverseEvent.suspectEntity.causalityResult AdverseEvent.suspectEntity.causality.method
Element Id AdverseEvent.suspectEntity.causality.method
Definition

result1 ProbabilityScale | result2. Bayesian | Checklist.

Control Cardinality 0..1
Terminology Binding AdverseEventCausalityResult AdverseEventCausalityMethod ( Example )
Type CodeableConcept
Summary true
AdverseEvent.subjectMedicalHistory
Element Id AdverseEvent.subjectMedicalHistory
Definition

AdverseEvent.subjectMedicalHistory.

Control Cardinality 0..*
Type Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference )
Summary true
AdverseEvent.referenceDocument
Element Id AdverseEvent.referenceDocument
Definition

AdverseEvent.referenceDocument.

Control Cardinality 0..*
Type Reference ( DocumentReference )
Summary true
AdverseEvent.study
Element Id AdverseEvent.study
Definition

AdverseEvent.study.

Control Cardinality 0..*
Type Reference ( ResearchStudy )
Summary true