type: resourceresource: AdverseEvent

AdverseEvent

AdverseEvent is an event resource from a FHIR workflow perspective - see Workflow Event. A single Adverse Event may need to be reported in multiple ways. Choosing the appropriate form of the reporting is dependent upon workflow patterns. In particular, the implementation guides for Clinical Care adverse events and Clinical Research adverse events provide important extensions, value-sets and examples for implementing AdverseEvent.

The guides reflect that adverse event tracking in clinical care and clinical research settings can differ. In the former case, the event is tracked to meet business safety concerns and incident reporting. There is a strong interest in factors surrounding the event, if it was prevented, what happened, and if it occurred, how it was resolved or managed. In the clinical research setting, the event is additionally tracked and evaluated as part of the clinical research process for the research study, since the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment. In clinical research trials, serious adverse events are usually required to be reported to the respective health authorities (e.g., U.S. FDA). For Clinical Care or Clinical Research, the Vulcan accelerator project suggests two AdverseEvent Resource profiles.

This resource applies to events that occur during the course of medical care or medical research which may impact an individual as the recipient of care or the participant in a research study. There are also events that occur within a care setting that might or might not impact an individual but had the potential to cause an adverse event. Health care organizations monitor and report both adverse events as well as events that had the potential to cause patient harm. Data are often aggregated for reporting purposes and quality improvement initiatives.

An adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects. Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), severity, and outcome.

The context of an adverse event is also important. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause-and-effect relationship for an adverse event.

In clinical care, a potential adverse event may also be called a near miss or an error. These are also events but, since they were detected, did not cause harm to a subject. Examples of potential adverse events include a product problem such as a faulty pacemaker that is detected prior implantation, a doctor working simultaneously on two electronic health records realizing the order for a drug was entered on the incorrect patient and then canceling the order, or a patient with a peanut allergy notices that his hospital dinner tray includes peanuts, and he does not eat the peanuts.

For examples and further guidance, it is strongly suggested that an implementer consult the Clinical Care AdverseEvent Implementation Guide and the Clinical Research AdverseEvent Implementation Guide They contain valuable extensions, value sets and, importantly, examples.

Boundaries and Relationships

The AdverseEvent resource is designed to represent events that had a harmful impact on a subject, or had the potential to cause harm to a subject but were avoided. In the course of medical care, there are many actions that may impact how a subject responds to a particular treatment impacting patient safety. Therefore, the AdverseEvent resource may reference multiple other resources to represent the context or details of an adverse event such as Observation, Condition, MedicationAdministration, Immunization, Procedure, or ResearchStudy.

The AdverseEvent resource should not be used when a more specific resource exists.

The AllergyIntolerance resource is a case specific means of capturing the condition of an allergy or intolerance and the criticality (or potential for future harm) based on the response of a particular individual.
The Clinical Reasoning module provides resources and operations to enable the representation, distribution, and evaluation of clinical knowledge artifacts, such as clinical decision support rules, quality measures, order sets, and protocols. The suite of resources within the clinical reasoning module should be used to capture clinical quality measures and clinical protocols that help drive clinical best practices.
The AdverseEvent resource is not intended to be used to capture potential subject risk in a prospective manner. A more appropriate resource for this purpose would be RiskAssessment which captures predicted outcomes for a patient or population on the basis of source information. Examples include a prognosis statement for a particular condition, risk of health outcome (heart attack, particular type of cancer) on the basis of lifestyle factors and/or family history, or list of potential health risks based on a patient's genetic analysis.
A DetectedIssue reference is also related to the context of an AdverseEvent to the extent that a known risk for a potential issue, such as a drug-drug interaction, is documented. If, in the context of a known issue, an adverse event occurs, citing this relationship is important for preventing such an occurrence in the future. DetectedIssue only applies to documenting a risk associated with a specific planned or ongoing action, or the lack of an action which should be planned - not a general propensity to risk.
Flags highlight highly condensed view of information found in other resources, which may include AdverseEvent. The purpose of these other resources is to provide detailed clinical information. The purpose of a Flag is to alert practitioners to information that is important to influence their interaction with a Patient prior to detailed review of the record.

StructureDefinition

Elements (Simplified)

AdverseEvent [0..*]: - An event that may be related to unintended effects on a patient or research participant
AdverseEvent.identifier [0..*]: Identifier Business identifier for the event
AdverseEvent.status [1..1]: code required:adverse-event-status in-progress | completed | entered-in-error | unknown
AdverseEvent.actuality [1..1]: code required:adverse-event-actuality actual | potential
AdverseEvent.category [0..*]: CodeableConcept example:adverse-event-category wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
AdverseEvent.code [0..1]: CodeableConcept example:adverse-event-type Event or incident that occurred or was averted
AdverseEvent.subject [1..1]: [Reference(Patient](/Reference(Patient), Group, Practitioner, RelatedPerson)) Subject impacted by event
AdverseEvent.encounter [0..1]: Reference(Encounter) The Encounter associated with the start of the AdverseEvent
AdverseEvent.effect[x] [0..1]: dateTime, Period When the effect of the AdverseEvent occurred
AdverseEvent.detected [0..1]: dateTime When the event was detected
AdverseEvent.recordedDate [0..1]: dateTime When the event was recorded
AdverseEvent.resultingEffect [0..*]: CodeableReference example:clinical-findings Effect on the subject due to this event
AdverseEvent.location [0..1]: Reference(Location) Location where adverse event occurred
AdverseEvent.seriousness [0..1]: CodeableConcept example:adverse-event-seriousness Seriousness or gravity of the event
AdverseEvent.outcome [0..*]: CodeableConcept example:adverse-event-outcome Type of outcome from the adverse event
AdverseEvent.recorder [0..1]: [Reference(Patient](/Reference(Patient), Practitioner, PractitionerRole, RelatedPerson)) Who recorded the adverse event
AdverseEvent.participant [0..*]: BackboneElement Who was involved in the adverse event or the potential adverse event and what they did
AdverseEvent.participant.function [0..1]: CodeableConcept example:adverse-event-participant-function Type of involvement
AdverseEvent.participant.actor [1..1]: [Reference(Practitioner](/Reference(Practitioner), PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson, Group)) Who was involved in the adverse event or the potential adverse event
AdverseEvent.study [0..*]: Reference(ResearchStudy) Research study that the subject is enrolled in
AdverseEvent.expectedInResearchStudy [0..1]: boolean Considered likely or probable or anticipated in the research study
AdverseEvent.suspectEntity [0..*]: BackboneElement The suspected agent causing the adverse event
AdverseEvent.suspectEntity.instance [1..1]: CodeableReference Refers to the specific entity that caused the adverse event
AdverseEvent.suspectEntity.causality [0..1]: BackboneElement Information on the possible cause of the event
AdverseEvent.suspectEntity.causality.assessmentMethod [0..1]: CodeableConcept example:adverse-event-causality-method Method of evaluating the relatedness of the suspected entity to the event
AdverseEvent.suspectEntity.causality.entityRelatedness [0..1]: CodeableConcept example:adverse-event-causality-assess Result of the assessment regarding the relatedness of the suspected entity to the event
AdverseEvent.suspectEntity.causality.author [0..1]: [Reference(Practitioner](/Reference(Practitioner), PractitionerRole, Patient, RelatedPerson)) Author of the information on the possible cause of the event
AdverseEvent.suspectEntity.occurrence[x] [0..1]: dateTime, Period When the suspect entity occurred
AdverseEvent.contributingFactor [0..*]: CodeableReference example:adverse-event-contributing-factor Contributing factors suspected to have increased the probability or severity of the adverse event
AdverseEvent.preventiveAction [0..*]: CodeableReference example:adverse-event-preventive-action Preventive actions that contributed to avoiding the adverse event
AdverseEvent.mitigatingAction [0..*]: CodeableReference example:adverse-event-mitigating-action Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
AdverseEvent.supportingInfo [0..*]: CodeableReference example:adverse-event-supporting-info Subject medical history or document relevant to this adverse event
AdverseEvent.note [0..*]: Annotation Comment on adverse event

Mappings

AdverseEvent Mappings — 27 mapping entries

Resource Packs

list-AdverseEvent-packs.xml

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir">
  <id value="AdverseEvent-packs"/>
  <status value="current"/>
  <mode value="working"/>
</List>

Search Parameters

actuality — token — actual | potential — AdverseEvent.actuality
category — token — wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site — AdverseEvent.category
code — token — Event or incident that occurred or was averted — AdverseEvent.code
occurrence — date — When the suspect entity occurred — AdverseEvent.suspectEntity.occurrence.ofType(dateTime) | AdverseEvent.suspectEntity.occurrence.ofType(Period)
effect — date — When the effect of the event occurred — AdverseEvent.effect.ofType(dateTime) | AdverseEvent.effect.ofType(Period)
identifier — token — Business identifier for the event — AdverseEvent.identifier
location — reference — Location where adverse event occurred — AdverseEvent.location
patient — reference — Subject impacted by event — AdverseEvent.subject.where(resolve() is Patient)
recorder — reference — Who recorded the adverse event — AdverseEvent.recorder
resultingeffect-reference — reference — Effect on the subject due to this event — AdverseEvent.resultingEffect.reference
resultingeffect-code — token — Effect on the subject due to this event — AdverseEvent.resultingEffect.concept
seriousness — token — Seriousness or gravity of the event — AdverseEvent.seriousness
status — token — in-progress | completed | entered-in-error | unknown — AdverseEvent.status
study — reference — Research study that the subject is enrolled in — AdverseEvent.study
subject — reference — Subject impacted by event — AdverseEvent.subject
substance — reference — Refers to the specific entity that caused the adverse event — AdverseEvent.suspectEntity.instance.reference

Full Search Parameters

Examples

adverseevent-example — adverseevent-example
adverseevent-examples-header — adverseevent-examples-header

Full Examples

Mapping Exceptions

adverseevent-event-mapping-exceptions.xml

Divergent Elements

Event.identifier → AdverseEvent.identifier
- shortUnmatched | reason=Unknown | pattern=Business identifier for adverse event | resource=Business identifier for the event
- definitionUnmatched | reason=Unknown | pattern=Business identifiers assigned to this adverse event by the performer and/or other systems. These identifiers remain constant as the resource is updated and propagates from server to server. | resource=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.
- commentsUnmatched | reason=Unknown | pattern=Note: 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. | resource=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.
Event.status → AdverseEvent.status
- shortUnmatched | reason=Unknown | pattern=preparation | in-progress | not-done | suspended | aborted | completed | entered-in-error | unknown | resource=in-progress | completed | entered-in-error | unknown
- definitionUnmatched | reason=Unknown | pattern=The current state of the adverse event. | resource=The current state of the adverse event or potential adverse event.
- commentsUnmatched | reason=Unknown | pattern=A nominal state-transition diagram can be found in the (Event pattern documentation

Unknown does not represent "other" - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is. | resource=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.

Event.code → AdverseEvent.code
- shortUnmatched | reason=Unknown | pattern=What service was done | resource=Event or incident that occurred or was averted
- definitionUnmatched | reason=Unknown | pattern=A code that identifies the specific service or action that was or is being performed. | resource=Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.
Event.subject → AdverseEvent.subject
- extraTypes | reason=Unknown
- shortUnmatched | reason=Unknown | pattern=Individual service was done for/to | resource=Subject impacted by event
- definitionUnmatched | reason=Unknown | pattern=The individual or set of individuals the action is being or was performed on. | resource=This subject or group impacted by the event.
- requirementsUnmatched | reason=Unknown | pattern=Links the adverse event to the Patient context. May also affect access control. | resource=Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
Event.encounter → AdverseEvent.encounter
- shortUnmatched | reason=Unknown | pattern=Encounter the adverse event is part of | resource=The Encounter associated with the start of the AdverseEvent
- definitionUnmatched | reason=Unknown | pattern=The Encounter during which this adverse event was created or to which the creation of this record is tightly associated. | resource=The Encounter associated with the start of the AdverseEvent.
- commentsUnmatched | reason=Unknown | pattern=This will typically be the encounter the adverse event was created during, but some adverse events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission lab tests). | resource=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.
- requirementsUnmatched | reason=Unknown | pattern=Links the adverse event to the Encounter context. May also affect access control.
Event.occurrence[x] → AdverseEvent.effect[x]
- missingTypes | reason=Unknown | pattern=Timing
- shortUnmatched | reason=Unknown | pattern=When adverse event occurred/is occurring | resource=When the effect of the AdverseEvent occurred
- definitionUnmatched | reason=Unknown | pattern=The date, period or timing when the adverse event did occur or is occurring. | resource=The date (and perhaps time) when the effect of the AdverseEvent occurred.
- commentsUnmatched | reason=Unknown | pattern=This indicates when the activity actually occurred or is occurring, not when it was asked/requested/ordered to occur. For the latter, look at the occurence element of the Request this {{event}} is "basedOn". The status code allows differentiation of whether the timing reflects a historic event or an ongoing event. Ongoing events should not include an upper bound in the Period or Timing.bounds. .
Event.occurrence[x] → AdverseEvent.suspectEntity.occurrence[x]
- missingTypes | reason=Unknown | pattern=Timing
- shortUnmatched | reason=Unknown | pattern=When adverse event occurred/is occurring | resource=When the suspect entity occurred
- definitionUnmatched | reason=Unknown | pattern=The date, period or timing when the adverse event did occur or is occurring. | resource=The date (and perhaps time) when the suspect entity occurred.
- commentsUnmatched | reason=Unknown | pattern=This indicates when the activity actually occurred or is occurring, not when it was asked/requested/ordered to occur. For the latter, look at the occurence element of the Request this {{event}} is "basedOn". The status code allows differentiation of whether the timing reflects a historic event or an ongoing event. Ongoing events should not include an upper bound in the Period or Timing.bounds. .
Event.recorded → AdverseEvent.recordedDate
- shortUnmatched | reason=Unknown | pattern=When adverse event was first captured in the subject's record | resource=When the event was recorded
- definitionUnmatched | reason=Unknown | pattern=The date the occurrence of the adverse event was first captured in the record - potentially significantly after the occurrence of the event. | resource=The date on which the existence of the AdverseEvent was first recorded.
- commentsUnmatched | reason=Unknown | pattern=The recorded date indicates the date when the data was placed in the record maintained by the performing practitioner, or the date of disclosure by Patient or RelatedPerson, not a date of record transfer. If the record is transferred from one system to another (in paper or electronic form), it does not create a distinct recorded date. In most cases, performing practitioners will record on the same date the event occurred, but sometimes there are delays. If information is being relayed second-hand, the recorded date indicates when the system is first made aware of the data.

The recorded date is NOT intended to be the same as a database.createdTimestamp - that would be captured as part of resource.meta or possibly Provenance.

It is possible for the same event to be disclosed to different systems at different times. E.g. a patient might tell two different clinicians about a historical event at different visits. If the disclosure is from the patient rather than record transfer from clinician A to B, the recorded date would be the date each respective clinician put the data in their record. If the data flowed from clinician A to B, the recorded date would remain the recorded date as initially set in clinician A's system. | resource=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.

Event.performer → AdverseEvent.participant
- extraTypes | reason=Unknown
- shortUnmatched | reason=Unknown | pattern=Who performed adverse event and what they did | resource=Who was involved in the adverse event or the potential adverse event and what they did
- definitionUnmatched | reason=Unknown | pattern=Indicates who or what performed the adverse event and how they were involved. | resource=Indicates who or what participated in the adverse event and how they were involved.
Event.performer.function → AdverseEvent.participant.function
- shortUnmatched | reason=Unknown | pattern=Type of performance | resource=Type of involvement
- definitionUnmatched | reason=Unknown | pattern=Distinguishes the type of involvement of the performer in the adverse event.. | resource=Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant.
- requirementsUnmatched | reason=Unknown | pattern=Allows disambiguation of the types of involvement of different performers.
Event.performer.actor → AdverseEvent.participant.actor
- extraTypes | reason=Unknown
- shortUnmatched | reason=Unknown | pattern=Who performed adverse event | resource=Who was involved in the adverse event or the potential adverse event
- definitionUnmatched | reason=Unknown | pattern=Indicates who or what performed the adverse event. | resource=Indicates who or what participated in the event.
Event.location → AdverseEvent.location
- shortUnmatched | reason=Unknown | pattern=Where adverse event occurred | resource=Location where adverse event occurred
- definitionUnmatched | reason=Unknown | pattern=The principal physical location where the adverse event was performed. | resource=The information about where the adverse event occurred.
- requirementsUnmatched | reason=Unknown | pattern=Ties the event to where the records are likely kept and provides context around the event occurrence (e.g. if it occurred inside or outside a dedicated healthcare setting).