type: resource-definitionsresource: AdverseEvent

AdverseEvent Definitions

AdverseEvent

An event that may be related to unintended effects on a patient or research participant

Definition: An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

Aliases: AE

Cardinality: 0..*

Mappings: rim=Act; workflow=Event; w5=clinical.general

AdverseEvent.identifier

Business identifier for the event

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.

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.

Requirements: Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: workflow=Event.identifier

AdverseEvent.status

in-progress | completed | entered-in-error | unknown

Definition: The current state of the adverse event or potential adverse event.

Comments: This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition. The adverse event status may be determined by the timing of the clinical trial assessments and is not necessarily the same as the condition status.

Cardinality: 1..1

Type: code

Binding: required:adverse-event-status

Summary: true

Is Modifier: true (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)

Mappings: workflow=Event.status; w5=FiveWs.status

AdverseEvent.actuality

actual | potential

Definition: Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.

Comments: AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.

Cardinality: 1..1

Type: code

Binding: required:adverse-event-actuality

Summary: true

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.)

Mappings: w5=FiveWs.class

AdverseEvent.category

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

Cardinality: 0..*

Type: CodeableConcept

Binding: example:adverse-event-category

Summary: true

Mappings: w5=FiveWs.class

AdverseEvent.code

Event or incident that occurred or was averted

Definition: Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:adverse-event-type

Summary: true

Mappings: workflow=Event.code; w5=FiveWs.what[x]

AdverseEvent.subject

Subject impacted by event

Definition: This subject or group impacted by the event.

Comments: If AdverseEvent.resultingEffect differs among members of the group, then use Patient as the subject.

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

Aliases: patient

Cardinality: 1..1

Type: Reference(Patient, Group, Practitioner, RelatedPerson)

Summary: true

Mappings: workflow=Event.subject; w5=FiveWs.subject

AdverseEvent.encounter

The Encounter associated with the start of the AdverseEvent

Definition: The Encounter associated with the start of the AdverseEvent.

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 associated encounter. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the associated encounter.

Cardinality: 0..1

Type: Reference(Encounter)

Summary: true

Mappings: workflow=Event.encounter; w5=FiveWs.context

AdverseEvent.effect[x]

When the effect of the AdverseEvent occurred

Definition: The date (and perhaps time) when the effect of the AdverseEvent occurred.

Cardinality: 0..1

Type: dateTime, Period

Summary: true

Mappings: workflow=Event.occurrence; w5=FiveWs.done[x]

AdverseEvent.detected

When the event was detected

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

Cardinality: 0..1

Type: dateTime

Summary: true

AdverseEvent.recordedDate

When the event was recorded

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

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.

Cardinality: 0..1

Type: dateTime

Summary: true

Mappings: workflow=Event.recorded; w5=FiveWs.recorded

AdverseEvent.resultingEffect

Effect on the subject due to this event

Definition: Information about the condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fall.

Cardinality: 0..*

Type: CodeableReference

Binding: example:clinical-findings

Summary: true

AdverseEvent.location

Location where adverse event occurred

Definition: The information about where the adverse event occurred.

Cardinality: 0..1

Type: Reference(Location)

Summary: true

Mappings: workflow=Event.location

AdverseEvent.seriousness

Seriousness or gravity of the event

Definition: Assessment whether this event, or averted event, was of clinical importance.

Comments: Using an example, a rash can have an AdverseEvent.resultingEffect.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:adverse-event-seriousness

Summary: true

AdverseEvent.outcome

Type of outcome from the adverse event

Definition: Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:adverse-event-outcome

Summary: true

AdverseEvent.recorder

Who recorded the adverse event

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

Cardinality: 0..1

Type: Reference(Patient, Practitioner, PractitionerRole, RelatedPerson)

Summary: true

Mappings: w5=FiveWs.author

AdverseEvent.participant

Who was involved in the adverse event or the potential adverse event and what they did

Definition: Indicates who or what participated in the adverse event and how they were involved.

Comments: The participant should not be used when there is another element to capture the participation, such as subject or recorder.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: workflow=Event.performer

AdverseEvent.participant.function

Type of involvement

Definition: Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:adverse-event-participant-function

Summary: true

Mappings: workflow=Event.performer.function

AdverseEvent.participant.actor

Who was involved in the adverse event or the potential adverse event

Definition: Indicates who or what participated in the event.

Comments: For example, the physician prescribing a drug, a nurse administering the drug, a device that administered the drug, a witness to the event, or an informant of clinical history. The subject can be a participant if the subject was involved in the adverse event in another capacity beyond just being the subject, such as when the subject is a contributor or informant. Using Group is only allowed when the group represents a family or a household and does not represent groups of Practitioners.

Cardinality: 1..1

Type: Reference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson, Group)

Summary: true

Mappings: workflow=Event.performer.actor; w5=FiveWs.actor; rim=.participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]

AdverseEvent.study

Research study that the subject is enrolled in

Definition: The research study that the subject is enrolled in.

Cardinality: 0..*

Type: Reference(ResearchStudy)

Summary: true

AdverseEvent.expectedInResearchStudy

Considered likely or probable or anticipated in the research study

Definition: Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Cardinality: 0..1

Type: boolean

AdverseEvent.suspectEntity

The suspected agent causing the adverse event

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

AdverseEvent.suspectEntity.instance

Refers to the specific entity that caused the adverse event

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

Cardinality: 1..1

Type: CodeableReference

Summary: true

AdverseEvent.suspectEntity.causality

Information on the possible cause of the event

Definition: Information on the possible cause of the event.

Cardinality: 0..1

Type: BackboneElement

Summary: true

AdverseEvent.suspectEntity.causality.assessmentMethod

Method of evaluating the relatedness of the suspected entity to the event

Definition: The method of evaluating the relatedness of the suspected entity to the event.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:adverse-event-causality-method

Summary: true

AdverseEvent.suspectEntity.causality.entityRelatedness

Result of the assessment regarding the relatedness of the suspected entity to the event

Definition: The result of the assessment regarding the relatedness of the suspected entity to the event.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:adverse-event-causality-assess

Summary: true

AdverseEvent.suspectEntity.causality.author

Author of the information on the possible cause of the event

Definition: The author of the information on the possible cause of the event.

Cardinality: 0..1

Type: Reference(Practitioner, PractitionerRole, Patient, RelatedPerson)

Summary: true

AdverseEvent.suspectEntity.occurrence[x]

When the suspect entity occurred

Definition: The date (and perhaps time) when the suspect entity occurred.

Cardinality: 0..1

Type: dateTime, Period

Summary: true

Mappings: workflow=Event.occurrence; w5=FiveWs.done[x]

AdverseEvent.contributingFactor

Contributing factors suspected to have increased the probability or severity of the adverse event

Definition: The contributing factors suspected to have increased the probability or severity of the adverse event.

Cardinality: 0..*

Type: CodeableReference

Binding: example:adverse-event-contributing-factor

Summary: true

AdverseEvent.preventiveAction

Preventive actions that contributed to avoiding the adverse event

Definition: Preventive actions that contributed to avoiding the adverse event.

Cardinality: 0..*

Type: CodeableReference

Binding: example:adverse-event-preventive-action

Summary: true

AdverseEvent.mitigatingAction

Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm

Definition: The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm.

Cardinality: 0..*

Type: CodeableReference

Binding: example:adverse-event-mitigating-action

Summary: true

AdverseEvent.supportingInfo

Subject medical history or document relevant to this adverse event

Definition: Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

Cardinality: 0..*

Type: CodeableReference

Binding: example:adverse-event-supporting-info

Summary: true

AdverseEvent.note

Comment on adverse event

Definition: Comments made about the adverse event by the performer, subject or other participants.

Cardinality: 0..*

Type: Annotation

Summary: false