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 participant. The unintended effects may require additional monitoring, treatment, or hospitalization, or that results 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.

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.

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

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.

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

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

Whether the event actually happened, happened or just had the potential to. was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.

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.

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

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.

This subject or group impacted by the event.

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

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

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

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.

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

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

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

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.

Includes information Information about the reaction 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). chemical) or a broken leg as a result of the fall.

The information about where the adverse event occurred.

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

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.

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.

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

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

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

Information on Indicates who recorded or what participated in the adverse event. May be

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.

Parties The research study 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 subject is enrolled in.

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.

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

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

Information on the possible cause of the event.

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

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

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

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

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

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

The action that contributed to avoiding the adverse event.

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

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

AdverseEvent.referenceDocument. Supporting information relevant to the event.

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.

AdverseEvent.study. Comments made about the adverse event by the performer, subject or other participants.