{ "resourceType": "StructureDefinition", "id": "qicore-adverseevent", "text": { "status": "generated", "div": "
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NameFlagsCard.TypeDescription & Constraints\"doco\"
\".\"\".\" AdverseEvent 0..*
\".\"\".\"\".\" id 0..1id
\".\"\".\"\".\" category 0..1codeAE | PAE
Binding: AdverseEventCategory (required)
\".\"\".\"\".\" type S1..1CodeableConceptactual | potential
Binding: SNOMED CT Clinical Findings (example)
\".\"\".\"\".\" subject S1..1Reference(QICore-Patient | ResearchSubject | QICore-Medication | QICore-Device)
\".\"\".\"\".\" date 0..1dateTime
\".\"\".\"\".\" reaction 0..*Reference(QICore-Condition)
\".\"\".\"\".\" location 0..1Reference(QICore-Location)
\".\"\".\"\".\" seriousness 0..1CodeableConceptMild | Moderate | Severe
Binding: AdverseEventSeriousness (example)
\".\"\".\"\".\" recorder 0..1Reference(QICore-Patient | QICore-RelatedPerson | QICore-Practitioner)
\".\"\".\"\".\" suspectEntity 0..*BackboneElement
\".\"\".\"\".\"\".\" instance S1..1Reference(QICore-Substance | QICore-Medication | QICore-MedicationAdministration | QICore-MedicationStatement | QICore-Device)
\".\"\".\"\".\"\".\" causality 0..1codecausality1 | causality2
Binding: AdverseEventCausality (required)
\".\"\".\"\".\"\".\" causalityAssessment 0..1CodeableConceptassess1 | assess2
Binding: AdverseEventCausalityAssessment (example)
\".\"\".\"\".\" study 0..*Reference(ResearchStudy)

\"doco\" Documentation for this format
" }, "url": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent", "version": "3.1.0", "name": "QICore-AdverseEvent", "status": "draft", "date": "2018-08-21T14:00:00+00:00", "publisher": "Health Level Seven, Inc. - CQI WG", "contact": [ { "telecom": [ { "system": "url", "value": "http://hl7.org/special/committees/CQI" } ] } ], "description": "An adverse event is an untoward occurrence during treatment that should be reported, for example, to a clinical study sponsor or safety oversight organization. AEs include reportable serious medical errors such as those defined by National Quality Forum (see http://www.qualityforum.org/Topics/ SREs/List_of_SREs.aspx), and Patient Safety Healthcare Events as defined by AHRQ. Some AEs can involve conditions such as \"recurring headaches\" but others do not, such as accidental falls, surgical errors, sexual abuse of patient, and sudden death. An adverse event can also be an unsafe condition that increases the probability of a patient safety event, and near-misses. An adverse event can be caused by exposure to some agent (e.g., a medication, immunization, food, or environmental agent). An adverse reaction can range from a mild reaction, such as a harmless rash to a severe and life-threatening condition. They can occur immediately or develop over time. For example, a patient may develop a rash after taking a particular medication.", "fhirVersion": "3.0.1", "mapping": [ { "identity": "qdm", "uri": "http://www.healthit.gov/quality-data-model", "name": "Quality Data Model" }, { "identity": "w5", "uri": "http://hl7.org/fhir/w5", "name": "W5 Mapping" }, { "identity": "rim", "uri": "http://hl7.org/v3", "name": "RIM Mapping" } ], "kind": "resource", "abstract": false, "type": "AdverseEvent", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/AdverseEvent", "derivation": "constraint", "differential": { "element": [ { "id": "AdverseEvent", "path": "AdverseEvent", "definition": "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.", "mustSupport": false, "isModifier": false, "mapping": [ { "identity": "qdm", "map": "Adverse Event" } ] }, { "id": "AdverseEvent.id", "path": "AdverseEvent.id", "definition": "Logical id of this artifact.", "min": 0, "max": "1", "type": [ { "code": "id" } ], "mustSupport": false, "isModifier": false, "mapping": [ { "identity": "qdm", "map": "id" } ] }, { "id": "AdverseEvent.category", "path": "AdverseEvent.category", "short": "AE | PAE", "definition": "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.", "min": 0, "max": "1", "type": [ { "code": "code" } ], "mustSupport": false, "isModifier": false, "binding": { "strength": "required", "description": "Overall categorization of the event, e.g. real or potential", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/adverse-event-category" } } }, { "id": "AdverseEvent.type", "path": "AdverseEvent.type", "short": "actual | potential", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "mustSupport": true, "isModifier": false, "binding": { "strength": "example", "description": "The type of adverse event: an incident, near-miss, or unsafe condition", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/adverse-event-type" } } }, { "id": "AdverseEvent.subject", "path": "AdverseEvent.subject", "definition": "This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient" }, { "code": "Reference", "targetProfile": "http://hl7.org/fhir/StructureDefinition/ResearchSubject" }, { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication" }, { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device" } ], "mustSupport": true, "isModifier": false }, { "id": "AdverseEvent.date", "path": "AdverseEvent.date", "definition": "The date (and perhaps time) when the adverse event occurred.", "min": 0, "max": "1", "type": [ { "code": "dateTime" } ], "mustSupport": false, "isModifier": false, "mapping": [ { "identity": "qdm", "map": "relevantPeriod" } ] }, { "id": "AdverseEvent.reaction", "path": "AdverseEvent.reaction", "definition": "Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition" } ], "mustSupport": false, "isModifier": false, "mapping": [ { "identity": "qdm", "map": "type" } ] }, { "id": "AdverseEvent.location", "path": "AdverseEvent.location", "definition": "The information about where the adverse event occurred.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-location" } ], "mustSupport": false, "isModifier": false, "mapping": [ { "identity": "qdm", "map": "facilityLocation" } ] }, { "id": "AdverseEvent.seriousness", "path": "AdverseEvent.seriousness", "short": "Mild | Moderate | Severe", "definition": "Describes the seriousness or severity of the adverse event.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "isModifier": false, "binding": { "strength": "example", "description": "A subjective assessment of the severity of the adverse event as evaluated by the clinician.", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/adverse-event-seriousness" } }, "mapping": [ { "identity": "qdm", "map": "severity" } ] }, { "id": "AdverseEvent.recorder", "path": "AdverseEvent.recorder", "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/us/qicore/StructureDefinition/qicore-patient" }, { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-relatedperson" }, { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitioner" } ], "mustSupport": false, "isModifier": false, "mapping": [ { "identity": "qdm", "map": "recorder" } ] }, { "id": "AdverseEvent.suspectEntity", "path": "AdverseEvent.suspectEntity", "definition": "Describes the entity that is suspected to have caused the adverse event.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "mustSupport": false, "isModifier": false }, { "id": "AdverseEvent.suspectEntity.instance", "path": "AdverseEvent.suspectEntity.instance", "definition": "Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-substance" }, { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication" }, { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationadministration" }, { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationstatement" }, { "code": "Reference", "targetProfile": "http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device" } ], "mustSupport": true, "isModifier": false, "mapping": [ { "identity": "qdm", "map": "code" } ] }, { "id": "AdverseEvent.suspectEntity.causality", "path": "AdverseEvent.suspectEntity.causality", "short": "causality1 | causality2", "definition": "causality1 | causality2.", "min": 0, "max": "1", "type": [ { "code": "code" } ], "mustSupport": false, "isModifier": false, "binding": { "strength": "required", "description": "The type of adverse event: an incident, near-miss, or unsafe condition", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/adverse-event-causality" } } }, { "id": "AdverseEvent.suspectEntity.causalityAssessment", "path": "AdverseEvent.suspectEntity.causalityAssessment", "short": "assess1 | assess2", "definition": "assess1 | assess2.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "isModifier": false, "binding": { "strength": "example", "description": "The degree of confidence that this condition is correct", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/adverse-event-causality-assess" } } }, { "id": "AdverseEvent.study", "path": "AdverseEvent.study", "definition": "TODO.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": "http://hl7.org/fhir/StructureDefinition/ResearchStudy" } ], "mustSupport": false, "isModifier": false } ] } }