description: An adverse event (AE) 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.
package_name: hl7.fhir.us.qicore
derivation: constraint
name: QICoreAdverseEvent
type: AdverseEvent
elements:
  category: {short: (QI) product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment, index: 1}
  actuality: {short: (QI) actual | potential, index: 0}
  date: {mustSupport: false, index: 5}
  encounter:
    type: Reference
    short: (QI) Encounter created as part of
    refers: ['http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-encounter']
    index: 4
  suspectEntity:
    mustSupport: false
    index: 11
    elements:
      instance:
        type: Reference
        short: (QI) Refers to the specific entity that caused the adverse event
        refers: ['http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-immunization', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationadministration', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationstatement', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-procedure', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-substance']
        index: 12
      causality: {mustSupport: false, index: 13}
  recordedDate: {short: (QI) When the event was recorded, index: 6}
  event:
    short: (QI) Type of the event itself in relation to the subject
    binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/adverse-event-type'}
    index: 2
  contributor:
    type: Reference
    mustSupport: false
    refers: ['http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitioner', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitionerrole']
    index: 10
  subjectMedicalHistory:
    type: Reference
    mustSupport: false
    refers: ['http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-allergyintolerance', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition-encounter-diagnosis', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition-problems-health-concerns', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-familymemberhistory', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-immunization', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-procedure', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-simple-observation']
    index: 14
  recorder:
    type: Reference
    mustSupport: false
    refers: ['http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitioner', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitionerrole', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-relatedperson']
    index: 9
  location:
    type: Reference
    mustSupport: false
    refers: ['http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-location']
    index: 8
  subject:
    type: Reference
    short: (QI) Subject impacted by event
    refers: ['http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient']
    index: 3
  resultingCondition:
    type: Reference
    short: (QI) Effect on the subject due to this event
    refers: ['http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition-encounter-diagnosis', 'http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition-problems-health-concerns']
    index: 7
package_version: 7.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent
base: http://hl7.org/fhir/StructureDefinition/AdverseEvent
version: 7.0.0-ballot
required: [event, subject]