This page is part of the FHIR Specification (v1.4.0: STU 3 Ballot 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions
QICore-AdverseEvent
<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="qicore-adverseevent"/> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml">to do</div> </text> <url value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent"/> <name value="QICore-AdverseEvent"/> <status value="draft"/> <publisher value="Health Level Seven International (Clinical Quality Information - QICore)"/> <contact> <telecom> <system value="other"/> <value value="http://hl7.org/special/committees/CQI"/> </telecom> </contact> <date value="2015-02-27"/> <description value="An incident, near miss, unsafe condition, or untoward occurrence during treatment."/> <fhirVersion value="1.4.0"/> <mapping> <identity value="qdm"/> <uri value="http://www.healthit.gov/quality-data-model"/> <name value="Quality Data Model"/> </mapping> <kind value="resource"/> <abstract value="false"/> <baseType value="Basic"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Basic"/> <derivation value="constraint"/> <snapshot> <element> <path value="Basic"/> <name value="QICore-AdverseEvent"/> <short value="An incident, near miss, unsafe condition, or untoward occurrence during treatment."/> <definition value="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."/> <alias value="Z-resource"/> <alias value="Extension-resource"/> <alias value="Custom-resource"/> <min value="0"/> <max value="*"/> <base> <path value="Basic"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Basic"/> </type> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="Act, Entity or Role"/> </mapping> <mapping> <identity value="w5"/> <map value="infrastructure.structure"/> </mapping> <mapping> <identity value="qdm"/> <map value="Diagnostic Study, Adverse Event or Device, Adverse Event or Laboratory Test, Adverse Event or Medication, Adverse Effects or Procedure, Adverse Event or Substance, Adverse Event"/> </mapping> </element> <element> <path value="Basic.id"/> <short value="Logical id of this artifact"/> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/> <comments value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Bundles always have an id, though it is usually a generated UUID."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="*"/> </base> <type> <code value="id"/> </type> <isSummary value="true"/> </element> <element> <path value="Basic.meta"/> <short value="Metadata about the resource"/> <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Meta"/> </type> <isSummary value="true"/> </element> <element> <path value="Basic.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content."/> <comments value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element as much as possible."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="*"/> </base> <type> <code value="uri"/> </type> <isModifier value="true"/> <isSummary value="true"/> </element> <element> <path value="Basic.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comments value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="*"/> </base> <type> <code value="code"/> </type> <binding> <strength value="required"/> <description value="A human language."/> <valueSetUri value="http://tools.ietf.org/html/bcp47"/> </binding> </element> <element> <path value="Basic.text"/> <short value="Text summary of the resource, for human interpretation"/> <definition value="A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/> <comments value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative."/> <alias value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Narrative"/> </type> <condition value="dom-1"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element> <path value="Basic.contained"/> <short value="Contained, inline Resources"/> <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/> <comments value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again."/> <alias value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element> <path value="Basic.extension"/> <slicing> <discriminator value="url"/> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> </element> <element> <path value="Basic.extension"/> <name value="type"/> <short value="incident | near miss | unsafe condition"/> <definition value="incident | near miss | unsafe condition."/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-type"/> </type> <mustSupport value="true"/> <binding> <strength value="preferred"/> <description value="The type of adverse event: an incident, near-miss, or unsafe condition"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/qicore-adverseevent-type"/> </valueSetReference> </binding> </element> <element> <path value="Basic.extension"/> <name value="discoveryDateTime"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-discoveryDateTime"/> </type> </element> <element> <path value="Basic.extension"/> <name value="location"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-location"/> </type> </element> <element> <path value="Basic.extension"/> <name value="category"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-category"/> </type> <binding> <strength value="preferred"/> <description value="The categories associated with the event or unsafe condition."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/qicore-adverseevent-category"/> </valueSetReference> </binding> </element> <element> <path value="Basic.extension"/> <name value="cause"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause"/> </type> </element> <element> <path value="Basic.extension.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references)."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="*"/> </base> <type> <code value="id"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element> <path value="Basic.extension.extension"/> <slicing> <discriminator value="url"/> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> </element> <element> <path value="Basic.extension.extension"/> <name value="item"/> <short value="Extension"/> <definition value="An Extension"/> <min value="1"/> <max value="1"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause#item"/> </type> <mustSupport value="true"/> <mapping> <identity value="qdm"/> <map value="primary code"/> </mapping> </element> <element> <path value="Basic.extension.extension.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references)."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="*"/> </base> <type> <code value="id"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element> <path value="Basic.extension.extension.extension"/> <name value="extension"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="0"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> </element> <element> <path value="Basic.extension.extension.url"/> <representation value="xmlAttr"/> <short value="identifies the meaning of the extension"/> <definition value="Source of the definition for the extension code - a logical name or a URL."/> <comments value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition should be version specific. This will ideally be the URI for the Resource Profile defining the extension, with the code for the extension after a #."/> <min value="1"/> <max value="1"/> <base> <path value="Extension.url"/> <min value="1"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <fixedUri value="item"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element> <path value="Basic.extension.extension.value[x]"/> <short value="Value of extension"/> <definition value="Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list)."/> <min value="1"/> <max value="1"/> <base> <path value="Extension.value[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-medication"/> </type> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-medicationadministration"/> </type> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-device"/> </type> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-procedure"/> </type> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-imagingstudy"/> </type> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-communication"/> </type> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element> <path value="Basic.extension.extension"/> <name value="certainty"/> <short value="unlikely | likely | confirmed"/> <definition value="unlikely | likely | confirmed."/> <min value="1"/> <max value="1"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause#certainty"/> </type> <binding> <strength value="example"/> <description value="The degree of confidence that this condition is correct"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/qicore-condition-certainty"/> </valueSetReference> </binding> </element> <element> <path value="Basic.extension.extension.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references)."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="*"/> </base> <type> <code value="id"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element> <path value="Basic.extension.extension.extension"/> <name value="extension"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="0"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> </element> <element> <path value="Basic.extension.extension.url"/> <representation value="xmlAttr"/> <short value="identifies the meaning of the extension"/> <definition value="Source of the definition for the extension code - a logical name or a URL."/> <comments value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition should be version specific. This will ideally be the URI for the Resource Profile defining the extension, with the code for the extension after a #."/> <min value="1"/> <max value="1"/> <base> <path value="Extension.url"/> <min value="1"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <fixedUri value="certainty"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element> <path value="Basic.extension.extension.valueCodeableConcept"/> <short value="Value of extension"/> <definition value="Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list)."/> <min value="1"/> <max value="1"/> <base> <path value="Extension.value[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element> <path value="Basic.extension.url"/> <representation value="xmlAttr"/> <short value="identifies the meaning of the extension"/> <definition value="Source of the definition for the extension code - a logical name or a URL."/> <comments value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition should be version specific. This will ideally be the URI for the Resource Profile defining the extension, with the code for the extension after a #."/> <min value="1"/> <max value="1"/> <base> <path value="Extension.url"/> <min value="1"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <fixedUri value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element> <path value="Basic.extension.value[x]"/> <short value="Value of extension"/> <definition value="Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list)."/> <min value="0"/> <max value="0"/> <base> <path value="Extension.value[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="boolean"/> </type> <type> <code value="integer"/> </type> <type> <code value="decimal"/> </type> <type> <code value="base64Binary"/> </type> <type> <code value="instant"/> </type> <type> <code value="string"/> </type> <type> <code value="uri"/> </type> <type> <code value="date"/> </type> <type> <code value="dateTime"/> </type> <type> <code value="time"/> </type> <type> <code value="code"/> </type> <type> <code value="oid"/> </type> <type> <code value="id"/> </type> <type> <code value="unsignedInt"/> </type> <type> <code value="positiveInt"/> </type> <type> <code value="markdown"/> </type> <type> <code value="Annotation"/> </type> <type> <code value="Attachment"/> </type> <type> <code value="Identifier"/> </type> <type> <code value="CodeableConcept"/> </type> <type> <code value="Coding"/> </type> <type> <code value="Quantity"/> </type> <type> <code value="Range"/> </type> <type> <code value="Period"/> </type> <type> <code value="Ratio"/> </type> <type> <code value="SampledData"/> </type> <type> <code value="Signature"/> </type> <type> <code value="HumanName"/> </type> <type> <code value="Address"/> </type> <type> <code value="ContactPoint"/> </type> <type> <code value="Timing"/> </type> <type> <code value="Reference"/> </type> <type> <code value="Meta"/> </type> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element> <path value="Basic.extension"/> <name value="reaction"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-reaction"/> </type> </element> <element> <path value="Basic.extension"/> <name value="period"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-period"/> </type> <mustSupport value="true"/> <mapping> <identity value="qdm"/> <map value="start and stop datetime"/> </mapping> </element> <element> <path value="Basic.extension"/> <name value="clinicalStudy"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-clinicalStudy"/> </type> </element> <element> <path value="Basic.extension"/> <name value="severity"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-severity"/> </type> <binding> <strength value="example"/> <description value="A subjective assessment of the severity of the adverse event as evaluated by the clinician."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/condition-severity"/> </valueSetReference> </binding> </element> <element> <path value="Basic.modifierExtension"/> <name value="didNotOccur"/> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-didNotOccur"/> </type> <mustSupport value="true"/> <isModifier value="true"/> <mapping> <identity value="qdm"/> <map value="negation rationale"/> </mapping> </element> <element> <path value="Basic.identifier"/> <short value="Business identifier"/> <definition value="Identifier assigned to the resource for business purposes, outside the context of FHIR."/> <min value="0"/> <max value="*"/> <base> <path value="Basic.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="./identifier"/> </mapping> <mapping> <identity value="w5"/> <map value="id"/> </mapping> </element> <element> <path value="Basic.code"/> <short value="Kind of Resource"/> <definition value="Identifies the 'type' of resource - equivalent to the resource name for other resources."/> <comments value="Because resource references will only be able to indicate 'Basic', the type of reference will need to be specified in a Profile identified as part of the resource. Refer to the resource notes section for information on appropriate terminologies for this code."/> <requirements value="Must be able to distinguish different types of "basic" resources."/> <min value="1"/> <max value="1"/> <base> <path value="Basic.code"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <fixedCodeableConcept> <coding> <system value="http://hl7.org/fhir/basic-resource-type"/> <code value="advevent"/> </coding> </fixedCodeableConcept> <isModifier value="true"/> <isSummary value="true"/> <binding> <strength value="example"/> <description value="Codes for identifying types of resources not yet defined by FHIR"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/basic-resource-type"/> </valueSetReference> </binding> <mapping> <identity value="rim"/> <map value="./code"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element> <path value="Basic.subject"/> <short value="The person experiencing the adverse event"/> <definition value="The person who has the adverse event."/> <comments value="Optional as not all resources potential resources will have subjects. Resources associated with multiple subjects can handle this via extension."/> <requirements value="Needed for partitioning the resource by Patient."/> <min value="0"/> <max value="1"/> <base> <path value="Basic.subject"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-patient"/> </type> <mustSupport value="true"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="./participation[typeCode='SBJ'] (possibly through a ControlAct and Role)"/> </mapping> <mapping> <identity value="w5"/> <map value="who.focus"/> </mapping> </element> <element> <path value="Basic.created"/> <short value="When created"/> <definition value="Identifies when the resource was first created."/> <requirements value="Allows ordering resource instances by time."/> <min value="0"/> <max value="1"/> <base> <path value="Basic.created"/> <min value="0"/> <max value="1"/> </base> <type> <code value="date"/> </type> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="./participation[typeCode='AUT']/time (possibly through a ControlAct and Role)"/> </mapping> <mapping> <identity value="w5"/> <map value="when.recorded"/> </mapping> </element> <element> <path value="Basic.author"/> <short value="Who created"/> <definition value="Indicates who was responsible for creating the resource instance."/> <requirements value="Needed for partitioning the resource."/> <min value="0"/> <max value="1"/> <base> <path value="Basic.author"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-patient"/> </type> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-relatedperson"/> </type> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-practitioner"/> </type> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="./participation[typeCode='SUB'] (possibly through a ControlAct and Role)"/> </mapping> <mapping> <identity value="w5"/> <map value="who.author"/> </mapping> </element> </snapshot> <differential> <element> <path value="Basic"/> <name value="QICore-AdverseEvent"/> <short value="An incident, near miss, unsafe condition, or untoward occurrence during treatment."/> <definition value="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."/> <min value="0"/> <max value="*"/> <type> <code value="Basic"/> </type> <mapping> <identity value="qdm"/> <map value="Diagnostic Study, Adverse Event or Device, Adverse Event or Laboratory Test, Adverse Event or Medication, Adverse Effects or Procedure, Adverse Event or Substance, Adverse Event"/> </mapping> </element> <element> <path value="Basic.extension"/> <name value="type"/> <short value="incident | near miss | unsafe condition"/> <definition value="incident | near miss | unsafe condition."/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-type"/> </type> <mustSupport value="true"/> <binding> <strength value="preferred"/> <description value="The type of adverse event: an incident, near-miss, or unsafe condition"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/qicore-adverseevent-type"/> </valueSetReference> </binding> </element> <element> <path value="Basic.extension"/> <name value="discoveryDateTime"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-discoveryDateTime"/> </type> </element> <element> <path value="Basic.extension"/> <name value="location"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-location"/> </type> </element> <element> <path value="Basic.extension"/> <name value="category"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-category"/> </type> <binding> <strength value="preferred"/> <description value="The categories associated with the event or unsafe condition."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/qicore-adverseevent-category"/> </valueSetReference> </binding> </element> <element> <path value="Basic.extension"/> <name value="cause"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause"/> </type> </element> <element> <path value="Basic.extension.extension"/> <name value="item"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause#item"/> </type> <mustSupport value="true"/> <mapping> <identity value="qdm"/> <map value="primary code"/> </mapping> </element> <element> <path value="Basic.extension.extension"/> <name value="certainty"/> <short value="unlikely | likely | confirmed"/> <definition value="unlikely | likely | confirmed."/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause#certainty"/> </type> <binding> <strength value="example"/> <description value="The degree of confidence that this condition is correct"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/qicore-condition-certainty"/> </valueSetReference> </binding> </element> <element> <path value="Basic.extension"/> <name value="reaction"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-reaction"/> </type> </element> <element> <path value="Basic.extension"/> <name value="period"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-period"/> </type> <mustSupport value="true"/> <mapping> <identity value="qdm"/> <map value="start and stop datetime"/> </mapping> </element> <element> <path value="Basic.extension"/> <name value="clinicalStudy"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-clinicalStudy"/> </type> </element> <element> <path value="Basic.extension"/> <name value="severity"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-severity"/> </type> <binding> <strength value="example"/> <description value="A subjective assessment of the severity of the adverse event as evaluated by the clinician."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/condition-severity"/> </valueSetReference> </binding> </element> <element> <path value="Basic.modifierExtension"/> <name value="didNotOccur"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-didNotOccur"/> </type> <mustSupport value="true"/> <isModifier value="true"/> <mapping> <identity value="qdm"/> <map value="negation rationale"/> </mapping> </element> <element> <path value="Basic.code"/> <type> <code value="CodeableConcept"/> </type> <fixedCodeableConcept> <coding> <system value="http://hl7.org/fhir/basic-resource-type"/> <code value="advevent"/> </coding> </fixedCodeableConcept> </element> <element> <path value="Basic.subject"/> <short value="The person experiencing the adverse event"/> <definition value="The person who has the adverse event."/> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-patient"/> </type> <mustSupport value="true"/> </element> <element> <path value="Basic.author"/> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-patient"/> </type> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-relatedperson"/> </type> <type> <code value="Reference"/> <profile value="http://hl7.org/fhir/StructureDefinition/qicore-practitioner"/> </type> </element> </differential> </StructureDefinition>