Release 4 5 Preview #2
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Patient Care Work Group Maturity Level : 0   Trial Use Security Category : Patient Compartments : Patient , Practitioner , RelatedPerson

Detailed Descriptions for the elements in the AdverseEvent resource.

To Do is this meant to be a backbone element? To Do what is difference between assessment and result?
AdverseEvent
Element Id AdverseEvent
Definition

Actual or potential/avoided An event causing unintended physical injury resulting from or contributed (i.e. any change to by medical care, current patient status) that may be related to unintended effects on a research study patient or other healthcare setting factors that requires research subject. The unintended effects may require additional monitoring, treatment, treatment or hospitalization, hospitalization or that results may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects.

Cardinality 0..*
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 identifier, not a resource identifier (see discussion )
Cardinality 0..1 0..*
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.status
Element Id AdverseEvent.status
Definition

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

Cardinality 1..1
Terminology Binding Adverse Event Status ( Required )
Type code
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)
Summary true
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.

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.

Cardinality 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.

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

This element defines the specific type of Specific event that occurred or that was prevented from occurring. averted, such as patient fall, wrong organ removed, or wrong blood transfused.

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

This subject or group impacted by the event.

Cardinality 1..1
Type Reference ( Patient | Group | Practitioner | RelatedPerson )
Patterns Reference(Patient,Group,Practitioner,RelatedPerson): Common patterns = Participant
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 associated with the creation start of this record is tightly associated. the AdverseEvent.

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

AdverseEvent.date AdverseEvent.occurrence[x]
Element Id AdverseEvent.date AdverseEvent.occurrence[x]
Definition

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

Cardinality 0..1
Type dateTime | Period | Timing
[x] Note See Choice of Data Types for further information about how to use [x]
Alternate Names timing
Summary true
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).

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

The information about where the adverse event occurred.

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

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

Cardinality 0..1
Terminology Binding AdverseEventSeriousness ( Example )
Type CodeableConcept
Summary true
Comments

Using an example, a rash can have an AdverseEvent.resultingCondition.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.resultingCondition.severity = mild, yet a 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.resultingCondition.severity = mild, yet a AdverseEvent.seriousness = serious.

AdverseEvent.severity AdverseEvent.outcome
Element Id AdverseEvent.severity AdverseEvent.outcome
Definition

Describes the severity type of outcome from 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. such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.

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

Describes the type of outcome from Information on who recorded the adverse event. May be the patient or a practitioner.

Cardinality 0..1
Terminology Binding Type AdverseEventOutcome Reference ( Required Patient | Practitioner | PractitionerRole | RelatedPerson )
Type Patterns CodeableConcept Reference(Patient,Practitioner,PractitionerRole,RelatedPerson): Common patterns = Participant
Summary true
AdverseEvent.recorder AdverseEvent.participant
Element Id AdverseEvent.recorder AdverseEvent.participant
Definition

Information on Indicates who recorded or what participated in the adverse event. May be event and how they were involved.

Cardinality 0..*
Summary true
AdverseEvent.participant.function
Element Id AdverseEvent.participant.function
Definition

Distinguishes the patient type of involvement of the actor in the adverse event, such as contributor or a practitioner. informant.

Cardinality 0..1
Type Terminology Binding Reference AdverseEvent Participant Function ( Patient | Practitioner Example | PractitionerRole )
Type | RelatedPerson CodeableConcept )
Summary true
AdverseEvent.contributor AdverseEvent.participant.actor
Element Id AdverseEvent.contributor AdverseEvent.participant.actor
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), Indicates who or information about what activity was performed (e.g. informant witness). participated in the event.

Cardinality 0..* 1..1
Type Reference ( Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson )
Patterns Reference(Practitioner,PractitionerRole,Organization,CareTeam,Patient,Device,RelatedPerson): Common patterns = Participant
Summary true
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.

AdverseEvent.suspectEntity
Element Id AdverseEvent.suspectEntity
Definition

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

Cardinality 0..*
Summary true
AdverseEvent.suspectEntity.instance AdverseEvent.suspectEntity.instance[x]
Element Id AdverseEvent.suspectEntity.instance AdverseEvent.suspectEntity.instance[x]
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 CodeableConcept | Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement MedicationUsage | Device )
Patterns Reference(Immunization,Procedure,Substance,Medication,MedicationAdministration,MedicationUsage,Device): No common pattern
[x] Note See Choice of Data Types for further information about how to use [x]
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.

Cardinality 0..* 0..1
Summary true
AdverseEvent.suspectEntity.causality.assessment AdverseEvent.suspectEntity.causality.assessmentMethod
Element Id AdverseEvent.suspectEntity.causality.assessment AdverseEvent.suspectEntity.causality.assessmentMethod
Definition

Assessment The method of evaluating the relatedness of if the suspected entity caused to the event.

Cardinality 0..1
Terminology Binding AdverseEventCausalityAssessment AdverseEventCausalityMethod ( Example )
Type CodeableConcept
Summary true
AdverseEvent.suspectEntity.causality.productRelatedness AdverseEvent.suspectEntity.causality.entityRelatedness
Element Id AdverseEvent.suspectEntity.causality.productRelatedness AdverseEvent.suspectEntity.causality.entityRelatedness
Definition

AdverseEvent.suspectEntity.causalityProductRelatedness. The result of the assessment regarding the relatedness of the suspected entity to the event.

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

AdverseEvent.suspectEntity.causalityAuthor. The author of the information on the possible cause of the event.

Cardinality 0..1
Type Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson )
Patterns Reference(Practitioner,PractitionerRole,Patient,RelatedPerson): Common patterns = Participant
Summary true
AdverseEvent.suspectEntity.causality.method AdverseEvent.contributingFactor
Element Id AdverseEvent.suspectEntity.causality.method AdverseEvent.contributingFactor
Definition

ProbabilityScale | Bayesian | Checklist. The contributing factors suspected to have increased the probability or severity of the adverse event.

Cardinality 0..1 0..*
Summary true
AdverseEvent.contributingFactor.item[x]
Element Id AdverseEvent.contributingFactor.item[x]
Definition

The item that is suspected to have increased the probability or severity of the adverse event.

Cardinality 1..1
Terminology Binding AdverseEventCausalityMethod AdverseEvent Contributing Factor ( Example )
Type Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference )| CodeableConcept
Patterns Reference(Condition,Observation,AllergyIntolerance,FamilyMemberHistory,Immunization,Procedure,DocumentReference): No common pattern
[x] Note See Choice of Data Types for further information about how to use [x]
Summary true
AdverseEvent.subjectMedicalHistory AdverseEvent.preventiveAction
Element Id AdverseEvent.subjectMedicalHistory AdverseEvent.preventiveAction
Definition

AdverseEvent.subjectMedicalHistory. Preventive actions that contributed to avoiding the adverse event.

Cardinality 0..*
Summary true
AdverseEvent.preventiveAction.item[x]
Element Id AdverseEvent.preventiveAction.item[x]
Definition

The action that contributed to avoiding the adverse event.

Cardinality 1..1
Terminology Binding AdverseEvent Preventive Action ( Example )
Type Reference ( Condition Immunization | Observation Procedure | AllergyIntolerance DocumentReference | FamilyMemberHistory MedicationAdministration | Immunization MedicationRequest | )| CodeableConcept
Patterns Reference(Immunization,Procedure,DocumentReference,MedicationAdministration,MedicationRequest): No common pattern
[x] Note See Choice of Data Types for further information about how to use [x]
Summary true
AdverseEvent.mitigatingAction
Element Id AdverseEvent.mitigatingAction
Definition

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

Cardinality 0..*
Summary true
AdverseEvent.mitigatingAction.item[x]
Element Id AdverseEvent.mitigatingAction.item[x]
Definition

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

Cardinality 1..1
Terminology Binding AdverseEvent Mitigating Action ( Example )
Type Reference ( Procedure | Media | DocumentReference ) | MedicationAdministration | MedicationRequest )| CodeableConcept
Patterns Reference(Procedure,DocumentReference,MedicationAdministration,MedicationRequest): No common pattern
[x] Note See Choice of Data Types for further information about how to use [x]
Summary true
AdverseEvent.referenceDocument AdverseEvent.supportingInfo
Element Id AdverseEvent.referenceDocument AdverseEvent.supportingInfo
Definition

AdverseEvent.referenceDocument. Supporting information relevant to the event.

Cardinality 0..*
Summary true
AdverseEvent.supportingInfo.item[x]
Element Id AdverseEvent.supportingInfo.item[x]
Definition

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin 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 1..1
Terminology Binding AdverseEvent Supporting Information ( Example )
Type Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference ) )| CodeableConcept
Patterns Reference(Condition,Observation,AllergyIntolerance,FamilyMemberHistory,Immunization,Procedure,DocumentReference): No common pattern
[x] Note See Choice of Data Types for further information about how to use [x]
Summary true
AdverseEvent.study
Element Id AdverseEvent.study
Definition

AdverseEvent.study. The research study that the subject is enrolled in.

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