R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: (v3.5.0: R4 Ballot 2). #2). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

Patient Care Work Group Maturity Level : 0   Draft Trial Use Compartments : Patient , Practitioner , RelatedPerson

Detailed Descriptions for the elements in the AdverseEvent resource.

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 1..1
Type DomainResource
Alternate Names AE
Summary true
AdverseEvent.identifier
Element Id 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 identifer, 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.

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.  types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

AdverseEvent.actuality
Element Id 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
Terminology Binding 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.category
Element Id AdverseEvent.category
Definition

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

Control 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 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.

Control 1..1
Type Reference ( Patient | Group | Practitioner | 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.context
Element Id AdverseEvent.context
Definition

The encounter or episode of care that establishes the context for this AdverseEvent.

Control 0..1
Type Reference ( Encounter | EpisodeOfCare )
Alternate Names encounter
Summary true
Comments

This will typically be the encounter the AdverseEvent occurred within. 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 0..1
Type dateTime
Summary true
AdverseEvent.detected
Element Id AdverseEvent.detected
Definition

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

Control 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.

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

The information about where the adverse event occurred.

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

Assessment whether this event was of real importance.

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

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

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

Describes the type of outcome from the adverse event.

Control 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 0..1
Type Reference ( Patient | Practitioner | RelatedPerson )
Summary true
AdverseEvent.contributor
Element Id 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 | Device )
Summary true
AdverseEvent.suspectEntity
Element Id AdverseEvent.suspectEntity
Definition

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

Control 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 1..1
Type Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device )
Alternate Names Substance or Medication or Device
Summary true
AdverseEvent.suspectEntity.causality
Element Id AdverseEvent.suspectEntity.causality
Definition

Information on the possible cause of the event.

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

Assessment of if the entity caused the event.

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

AdverseEvent.suspectEntity.causalityProductRelatedness.

Control 0..1
Type string
Summary true
AdverseEvent.suspectEntity.causality.author
Element Id AdverseEvent.suspectEntity.causality.author
Definition

AdverseEvent.suspectEntity.causalityAuthor.

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

ProbabilityScale | Bayesian | Checklist.

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

AdverseEvent.subjectMedicalHistory.

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

AdverseEvent.referenceDocument.

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

AdverseEvent.study.

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