abstractbaseDefinitioncopyrightdatedescription- Values Differ
experimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitletypeurlversion- Values Differ
| Left: | QICore AdverseEvent (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent) |
| Right: | QICore AdverseEvent (http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent) |
| Error | StructureDefinition.version | Values for version differ: '7.0.0-ballot' vs '7.0.0' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/AdverseEvent | ||
| copyright | |||
| date | 2018-08-22 | ||
| 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. | 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. |
|
| experimental | false | ||
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
| jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | QICoreAdverseEvent | ||
| publisher | HL7 International / Clinical Quality Information | ||
| purpose | |||
| status | active | ||
| title | QICore AdverseEvent | ||
| type | AdverseEvent | ||
| url | http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent | ||
| version | 7.0.0-ballot | 7.0.0 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 AdverseEvent | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury | |||||||||||
 id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ?! | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | Σ | 0..1 | Identifier | Business identifier for the event | Σ | 0..1 | Identifier | Business identifier for the event | |||||||||
| actuality | ?!Σ | 1..1 | code | (QI) actual | potential Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential. | ?!Σ | 1..1 | code | (QI) actual | potential Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential. | |||||||||
| category | Σ | 0..* | CodeableConcept | (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 Binding: ?? (extensible): Overall categorization of the event, e.g. product-related or situational. | Σ | 0..* | CodeableConcept | (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 Binding: ?? (extensible): Overall categorization of the event, e.g. product-related or situational. | |||||||||
| event | Σ | 1..1 | CodeableConcept | (QI) Type of the event itself in relation to the subject Binding: ?? (preferred): Detailed type of event. | Σ | 1..1 | CodeableConcept | (QI) Type of the event itself in relation to the subject Binding: ?? (preferred): Detailed type of event. | |||||||||
| subject | Σ | 1..1 | Reference(QICore Patient) | (QI) Subject impacted by event | Σ | 1..1 | Reference(QICore Patient) | (QI) Subject impacted by event | |||||||||
| encounter | Σ | 0..1 | Reference(QICore Encounter) | (QI) Encounter created as part of | Σ | 0..1 | Reference(QICore Encounter) | (QI) Encounter created as part of | |||||||||
| date | Σ | 0..1 | dateTime | When the event occurred | Σ | 0..1 | dateTime | When the event occurred | |||||||||
| detected | Σ | 0..1 | dateTime | When the event was detected | Σ | 0..1 | dateTime | When the event was detected | |||||||||
| recordedDate | Σ | 0..1 | dateTime | (QI) When the event was recorded | Σ | 0..1 | dateTime | (QI) When the event was recorded | |||||||||
| resultingCondition | Σ | 0..* | Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | (QI) Effect on the subject due to this event | Σ | 0..* | Reference(QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | (QI) Effect on the subject due to this event | |||||||||
| location | Σ | 0..1 | Reference(QICore Location) | Location where adverse event occurred | Σ | 0..1 | Reference(QICore Location) | Location where adverse event occurred | |||||||||
| seriousness | Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: ?? (example): Overall seriousness of this event for the patient. | Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: ?? (example): Overall seriousness of this event for the patient. | |||||||||
| severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: ?? (required): The severity of the adverse event itself, in direct relation to the subject. | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: ?? (required): The severity of the adverse event itself, in direct relation to the subject. | |||||||||
| outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: ?? (required): TODO (and should this be required?). | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: ?? (required): TODO (and should this be required?). | |||||||||
| recorder | Σ | 0..1 | Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) | Who recorded the adverse event | Σ | 0..1 | Reference(QICore Patient | QICore RelatedPerson | QICore Practitioner | QICore PractitionerRole) | Who recorded the adverse event | |||||||||
| contributor | Σ | 0..* | Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event | Σ | 0..* | Reference(QICore Practitioner | QICore PractitionerRole | QICore Device | US Core Implantable Device Profile) | Who was involved in the adverse event or the potential adverse event | |||||||||
 suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| instance | Σ | 1..1 | Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) | (QI) Refers to the specific entity that caused the adverse event | Σ | 1..1 | Reference(QICore Immunization | QICore Procedure | QICore Substance | QICore Medication | QICore MedicationAdministration | QICore MedicationStatement | QICore Device | US Core Implantable Device Profile) | (QI) Refers to the specific entity that caused the adverse event | |||||||||
 causality | Σ | 0..1 | BackboneElement | Information on the possible cause of the event | Σ | 0..1 | BackboneElement | Information on the possible cause of the event | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: ?? (example): Codes for the assessment of whether the entity caused the event. | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: ?? (example): Codes for the assessment of whether the entity caused the event. | |||||||||
| productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | |||||||||
| author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | |||||||||
| method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: ?? (example): TODO. | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: ?? (example): TODO. | |||||||||
| subjectMedicalHistory | Σ | 0..* | Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | AdverseEvent.subjectMedicalHistory | Σ | 0..* | Reference(QICore Simple Observation | QICore AllergyIntolerance | QICore FamilyMemberHistory | QICore Immunization | QICore Procedure | QICore Condition Problems Health Concerns | QICore Condition Encounter Diagnosis) | AdverseEvent.subjectMedicalHistory | |||||||||
| referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | |||||||||
| study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | |||||||||
| Documentation for this format | |||||||||||||||||