{ "resourceType": "StructureDefinition", "id": "AdverseEvent", "meta": { "lastUpdated": "2021-01-01T21:58:31.578+00:00" }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-category", "valueString": "Clinical.Summary" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "trial-use" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 0 }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category", "valueCode": "patient" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "pc" }, { "url": "http://hl7.org/fhir/build/StructureDefinition/entered-in-error-status", "valueCode": ".status = entered-in-error" } ], "url": "http://hl7.org/fhir/StructureDefinition/AdverseEvent", "version": "4.6.0", "name": "AdverseEvent", "status": "draft", "date": "2021-01-01T21:58:31+00:00", "publisher": "Health Level Seven International (Patient Care)", "contact": [ { "telecom": [ { "system": "url", "value": "http://hl7.org/fhir" } ] }, { "telecom": [ { "system": "url", "value": "http://www.hl7.org/Special/committees/patientcare/index.cfm" } ] } ], "description": "An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research subject. The unintended effects may require additional monitoring, treatment or hospitalization or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects.", "fhirVersion": "4.6.0", "mapping": [ { "identity": "rim", "uri": "http://hl7.org/v3", "name": "RIM Mapping" }, { "identity": "w5", "uri": "http://hl7.org/fhir/fivews", "name": "FiveWs Pattern Mapping" }, { "identity": "workflow", "uri": "http://hl7.org/fhir/workflow", "name": "Workflow Pattern" } ], "kind": "resource", "abstract": false, "type": "AdverseEvent", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource", "derivation": "specialization", "differential": { "element": [ { "id": "AdverseEvent", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "0,0" } ], "path": "AdverseEvent", "short": "Medical care, research study or other healthcare event causing physical injury", "definition": "An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research subject. The unintended effects may require additional monitoring, treatment or hospitalization or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects.", "alias": [ "AE" ], "min": 0, "max": "*", "mapping": [ { "identity": "rim", "map": "Act" }, { "identity": "w5", "map": "clinical.general" } ] }, { "id": "AdverseEvent.identifier", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#15028." } ], "path": "AdverseEvent.identifier", "short": "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.", "comment": "This is a business identifier, not a resource identifier (see [discussion](resource.html#identifiers)). 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.", "min": 0, "max": "*", "type": [ { "code": "Identifier" } ], "isSummary": true, "mapping": [ { "identity": "workflow", "map": "Event.identifier" } ] }, { "id": "AdverseEvent.status", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#22108, J#25926." } ], "path": "AdverseEvent.status", "short": "in-progress | completed | entered-in-error | unknown", "definition": "The current state of the adverse event or potential adverse event.", "comment": "This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.", "min": 1, "max": "1", "type": [ { "code": "code" } ], "isModifier": true, "isModifierReason": "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", "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventStatus" } ], "strength": "required", "description": "Codes identifying the lifecycle stage of an event.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-status" }, "mapping": [ { "identity": "workflow", "map": "Event.status" }, { "identity": "w5", "map": "FiveWs.status" } ] }, { "id": "AdverseEvent.actuality", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "J#32990" } ], "path": "AdverseEvent.actuality", "short": "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.", "comment": "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.", "min": 1, "max": "1", "type": [ { "code": "code" } ], "isModifier": true, "isModifierReason": "This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.", "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventActuality" } ], "strength": "required", "description": "Overall nature of the adverse event, e.g. real or potential.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-actuality" }, "mapping": [ { "identity": "w5", "map": "FiveWs.class" } ] }, { "id": "AdverseEvent.category", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "FHIR-25396." } ], "path": "AdverseEvent.category", "short": "wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site", "definition": "The overall type of event, intended for search and filtering purposes.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventCategory" } ], "strength": "example", "description": "Overall categorization of the event, e.g. product-related or situational.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-category" }, "mapping": [ { "identity": "w5", "map": "FiveWs.class" } ] }, { "id": "AdverseEvent.code", "path": "AdverseEvent.code", "short": "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.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventType" } ], "strength": "example", "description": "Detailed type of event.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-type" }, "mapping": [ { "identity": "workflow", "map": "Event.code" }, { "identity": "w5", "map": "FiveWs.what[x]" } ] }, { "id": "AdverseEvent.subject", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#13890, GF#13893." } ], "path": "AdverseEvent.subject", "short": "Subject impacted by event", "definition": "This subject or group impacted by the event.", "comment": "If AdverseEvent.resultingCondition 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.", "alias": [ "patient" ], "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/Group", "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/RelatedPerson" ] } ], "isSummary": true, "mapping": [ { "identity": "workflow", "map": "Event.subject" }, { "identity": "w5", "map": "FiveWs.subject[x]" }, { "identity": "w5", "map": "FiveWs.subject" } ] }, { "id": "AdverseEvent.encounter", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#14458; FHIR-25397." } ], "path": "AdverseEvent.encounter", "short": "The Encounter associated with the start of the AdverseEvent", "definition": "The Encounter associated with the start of the AdverseEvent.", "comment": "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.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Encounter" ] } ], "isSummary": true, "mapping": [ { "identity": "workflow", "map": "Event.encounter" }, { "identity": "w5", "map": "FiveWs.context" } ] }, { "id": "AdverseEvent.occurrence[x]", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#24681." } ], "path": "AdverseEvent.occurrence[x]", "short": "When the event occurred", "definition": "The date (and perhaps time) when the adverse event occurred.", "alias": [ "timing" ], "min": 0, "max": "1", "type": [ { "code": "dateTime" }, { "code": "Period" }, { "code": "Timing" } ], "isSummary": true, "mapping": [ { "identity": "workflow", "map": "Event.occurrence" }, { "identity": "w5", "map": "FiveWs.done[x]" } ] }, { "id": "AdverseEvent.detected", "path": "AdverseEvent.detected", "short": "When the event was detected", "definition": "Estimated or actual date the AdverseEvent began, in the opinion of the reporter.", "min": 0, "max": "1", "type": [ { "code": "dateTime" } ], "isSummary": true }, { "id": "AdverseEvent.recordedDate", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#16027 and GF#17285." } ], "path": "AdverseEvent.recordedDate", "short": "When the event was recorded", "definition": "The date on which the existence of the AdverseEvent was first recorded.", "comment": "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.", "min": 0, "max": "1", "type": [ { "code": "dateTime" } ], "isSummary": true, "mapping": [ { "identity": "workflow", "map": "Event.recorded" }, { "identity": "w5", "map": "FiveWs.recorded" } ] }, { "id": "AdverseEvent.resultingCondition", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "J#26435." } ], "path": "AdverseEvent.resultingCondition", "short": "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.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Condition" ] } ], "isSummary": true }, { "id": "AdverseEvent.location", "path": "AdverseEvent.location", "short": "Location where adverse event occurred", "definition": "The information about where the adverse event occurred.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Location" ] } ], "isSummary": true, "mapping": [ { "identity": "workflow", "map": "Event.location" } ] }, { "id": "AdverseEvent.seriousness", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#22740, GF#22994, GF#22995." } ], "path": "AdverseEvent.seriousness", "short": "Seriousness or gravity of the event", "definition": "Assessment whether this event, or averted event, was of clinical importance.", "comment": "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.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventSeriousness" } ], "strength": "example", "description": "Overall seriousness of this event for the patient.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-seriousness" } }, { "id": "AdverseEvent.outcome", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "J#27784." } ], "path": "AdverseEvent.outcome", "short": "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.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventOutcome" } ], "strength": "example", "description": "Codes describing the type of outcome from the adverse event.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-outcome" } }, { "id": "AdverseEvent.recorder", "path": "AdverseEvent.recorder", "short": "Who recorded the adverse event", "definition": "Information on who recorded the adverse event. May be the patient or a practitioner.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/RelatedPerson" ] } ], "isSummary": true, "mapping": [ { "identity": "w5", "map": "FiveWs.author" } ] }, { "id": "AdverseEvent.participant", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#18853." } ], "path": "AdverseEvent.participant", "short": "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.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "workflow", "map": "Event.performer" } ] }, { "id": "AdverseEvent.participant.function", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#18853." } ], "path": "AdverseEvent.participant.function", "short": "Type of involvement", "definition": "Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventParticipantFunction" } ], "strength": "example", "description": "Codes describing the type of involvement of the actor in the adverse event.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-participant-function" }, "mapping": [ { "identity": "workflow", "map": "Event.performer.function" } ] }, { "id": "AdverseEvent.participant.actor", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#13894, GF#18853." } ], "path": "AdverseEvent.participant.actor", "short": "Who was involved in the adverse event or the potential adverse event", "definition": "Indicates who or what participated in the event.", "comment": "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.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Organization", "http://hl7.org/fhir/StructureDefinition/CareTeam", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/RelatedPerson" ] } ], "isSummary": true, "mapping": [ { "identity": "workflow", "map": "Event.performer.actor" }, { "identity": "w5", "map": "FiveWs.actor" }, { "identity": "rim", "map": ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]" } ] }, { "id": "AdverseEvent.expectedInResearchStudy", "path": "AdverseEvent.expectedInResearchStudy", "short": "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.", "min": 0, "max": "1", "type": [ { "code": "boolean" } ] }, { "id": "AdverseEvent.suspectEntity", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "400,0" } ], "path": "AdverseEvent.suspectEntity", "short": "The suspected agent causing the adverse event", "definition": "Describes the entity that is suspected to have caused the adverse event.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true }, { "id": "AdverseEvent.suspectEntity.instance[x]", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#13698." } ], "path": "AdverseEvent.suspectEntity.instance[x]", "short": "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.", "alias": [ "Substance or Medication or Device" ], "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" }, { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Immunization", "http://hl7.org/fhir/StructureDefinition/Procedure", "http://hl7.org/fhir/StructureDefinition/Substance", "http://hl7.org/fhir/StructureDefinition/Medication", "http://hl7.org/fhir/StructureDefinition/MedicationAdministration", "http://hl7.org/fhir/StructureDefinition/MedicationUsage", "http://hl7.org/fhir/StructureDefinition/Device", "http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct", "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ] } ], "isSummary": true }, { "id": "AdverseEvent.suspectEntity.causality", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#22107." } ], "path": "AdverseEvent.suspectEntity.causality", "short": "Information on the possible cause of the event", "definition": "Information on the possible cause of the event.", "min": 0, "max": "1", "type": [ { "code": "BackboneElement" } ], "isSummary": true }, { "id": "AdverseEvent.suspectEntity.causality.assessmentMethod", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#20593." } ], "path": "AdverseEvent.suspectEntity.causality.assessmentMethod", "short": "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.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventCausalityMethod" } ], "strength": "example", "description": "TODO.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-causality-method" } }, { "id": "AdverseEvent.suspectEntity.causality.entityRelatedness", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#20593." } ], "path": "AdverseEvent.suspectEntity.causality.entityRelatedness", "short": "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.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventCausalityAssessment" } ], "strength": "example", "description": "Codes for the assessment of whether the entity caused the event.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-causality-assess" } }, { "id": "AdverseEvent.suspectEntity.causality.author", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#20593." } ], "path": "AdverseEvent.suspectEntity.causality.author", "short": "Author of the information on the possible cause of the event", "definition": "The author of the information on the possible cause of the event.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/RelatedPerson" ] } ], "isSummary": true }, { "id": "AdverseEvent.contributingFactor", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#17237." } ], "path": "AdverseEvent.contributingFactor", "short": "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.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true }, { "id": "AdverseEvent.contributingFactor.item[x]", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#17237." } ], "path": "AdverseEvent.contributingFactor.item[x]", "short": "Item suspected to have increased the probability or severity of the adverse event", "definition": "The item that is suspected to have increased the probability or severity of the adverse event.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Condition", "http://hl7.org/fhir/StructureDefinition/Observation", "http://hl7.org/fhir/StructureDefinition/AllergyIntolerance", "http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory", "http://hl7.org/fhir/StructureDefinition/Immunization", "http://hl7.org/fhir/StructureDefinition/Procedure", "http://hl7.org/fhir/StructureDefinition/DocumentReference" ] }, { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventContributingFactor" } ], "strength": "example", "description": "Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor" } }, { "id": "AdverseEvent.preventiveAction", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#17237." } ], "path": "AdverseEvent.preventiveAction", "short": "Preventive actions that contributed to avoiding the adverse event", "definition": "Preventive actions that contributed to avoiding the adverse event.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true }, { "id": "AdverseEvent.preventiveAction.item[x]", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#17237." } ], "path": "AdverseEvent.preventiveAction.item[x]", "short": "Action that contributed to avoiding the adverse event", "definition": "The action that contributed to avoiding the adverse event.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Immunization", "http://hl7.org/fhir/StructureDefinition/Procedure", "http://hl7.org/fhir/StructureDefinition/DocumentReference", "http://hl7.org/fhir/StructureDefinition/MedicationAdministration", "http://hl7.org/fhir/StructureDefinition/MedicationRequest" ] }, { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventPreventiveAction" } ], "strength": "example", "description": "Codes describing the preventive actions that contributed to avoiding the adverse event.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-preventive-action" } }, { "id": "AdverseEvent.mitigatingAction", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#17237." } ], "path": "AdverseEvent.mitigatingAction", "short": "Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm", "definition": "The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true }, { "id": "AdverseEvent.mitigatingAction.item[x]", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#17237." } ], "path": "AdverseEvent.mitigatingAction.item[x]", "short": "Ameliorating action taken after the adverse event occured in order to reduce the extent of harm", "definition": "The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Procedure", "http://hl7.org/fhir/StructureDefinition/DocumentReference", "http://hl7.org/fhir/StructureDefinition/MedicationAdministration", "http://hl7.org/fhir/StructureDefinition/MedicationRequest" ] }, { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventMitigatingAction" } ], "strength": "example", "description": "Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action" } }, { "id": "AdverseEvent.supportingInfo", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#20593." } ], "path": "AdverseEvent.supportingInfo", "short": "Supporting information relevant to the event", "definition": "Supporting information relevant to the event.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true }, { "id": "AdverseEvent.supportingInfo.item[x]", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "GF#14151, GF#20593." } ], "path": "AdverseEvent.supportingInfo.item[x]", "short": "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 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.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Condition", "http://hl7.org/fhir/StructureDefinition/Observation", "http://hl7.org/fhir/StructureDefinition/AllergyIntolerance", "http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory", "http://hl7.org/fhir/StructureDefinition/Immunization", "http://hl7.org/fhir/StructureDefinition/Procedure", "http://hl7.org/fhir/StructureDefinition/DocumentReference" ] }, { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdverseEventSupportingInfo" } ], "strength": "example", "description": "Codes describing the supporting information relevant to the event.", "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-supporting-info" } }, { "id": "AdverseEvent.study", "path": "AdverseEvent.study", "short": "Research study that the subject is enrolled in", "definition": "The research study that the subject is enrolled in.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ] } ], "isSummary": true } ] } }