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.
= Must Support, = Is Modifier, = QiCore defined extension
Field | Card. | Type | Description |
---|---|---|---|
category | 0..1 | String | The type of event which is important to characterize what occurred and caused harm to the subject, or had the potential to cause harm to the subject. Binding: Overall categorization of the event, e.g. real or potential (required) |
type | 1..1 | Concept | This element defines the specific type of event that occurred or that was prevented from occurring. Binding: The type of adverse event: an incident, near-miss, or unsafe condition (example) |
subject | 1..1 | Patient | ResearchSubject | Medication | Device | This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented. |
date | 0..1 | DateTime | The date (and perhaps time) when the adverse event occurred. |
reaction | 0..* | List<Condition> | Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical). |
location | 0..1 | Location | The information about where the adverse event occurred. |
seriousness | 0..1 | Concept | Describes the seriousness or severity of the adverse event. Binding: A subjective assessment of the severity of the adverse event as evaluated by the clinician. (example) |
recorder | 0..1 | Patient | RelatedPerson | Practitioner | Information on who recorded the adverse event. May be the patient or a practitioner. |
suspectEntity | 0..* | List<suspectEntity> | Describes the entity that is suspected to have caused the adverse event. |
study | 0..* | List<ResearchStudy> | TODO. |