This page is part of the Quality Improvement Core Framework (v2.1.0: STU 3 Ballot 1) based on FHIR R3. The current version which supercedes this version is 4.1.1. For a full list of available versions, see the Directory of published versions 
This page is part of the Quality Improvement Core Framework (v2.1.0: STU 3 Ballot 1) based on FHIR R3. The current version which supercedes this version is 4.1.1. For a full list of available versions, see the Directory of published versions
This is a pre-release (ballot version) of what is now QICore STU 3. For a full list of available versions, see the Directory of published versions .
<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="qicore-adverseevent"/> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/STU3/help16.png" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent" title="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.">AdverseEvent</a><a name="AdverseEvent"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">An incident, near miss, unsafe condition, or untoward occurrence during treatment.</td></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.id" title="Logical id of this artifact.">id</a><a name="AdverseEvent.id"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#id">id</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.category" title="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.">category</a><a name="AdverseEvent.category"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">AE | PAE<br/><span style="font-weight:bold">Binding: </span><a href="http://hl7.org/fhir/STU3/valueset-adverse-event-category.html">AdverseEventCategory</a> (<a href="http://hl7.org/fhir/STU3/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set">required</a>)</td></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.type">type</a><a name="AdverseEvent.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">actual | potential</span><br/><span style="font-weight:bold">Binding: </span><a href="http://hl7.org/fhir/STU3/valueset-adverse-event-type.html">SNOMED CT Clinical Findings</a> (<a href="http://hl7.org/fhir/STU3/terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">example</a>)</td></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.subject" title="This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented.">subject</a><a name="AdverseEvent.subject"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-patient.html">QICore-Patient</a>), <a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="http://hl7.org/fhir/STU3/researchsubject.html">ResearchSubject</a>), <a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-medication.html">QICore-Medication</a>), <a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-device.html">QICore-Device</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.date" title="The date (and perhaps time) when the adverse event occurred.">date</a><a name="AdverseEvent.date"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#dateTime">dateTime</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.reaction" title="Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).">reaction</a><a name="AdverseEvent.reaction"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-condition.html">QICore-Condition</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.location" title="The information about where the adverse event occurred.">location</a><a name="AdverseEvent.location"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-location.html">QICore-Location</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.seriousness" title="Describes the seriousness or severity of the adverse event.">seriousness</a><a name="AdverseEvent.seriousness"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">Mild | Moderate | Severe</span><br/><span style="font-weight:bold">Binding: </span><a href="http://hl7.org/fhir/STU3/valueset-adverse-event-seriousness.html">AdverseEventSeriousness</a> (<a href="http://hl7.org/fhir/STU3/terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">example</a>)</td></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.recorder" title="Information on who recorded the adverse event. May be the patient or a practitioner.">recorder</a><a name="AdverseEvent.recorder"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-patient.html">QICore-Patient</a>), <a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-relatedperson.html">QICore-RelatedPerson</a>), <a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-practitioner.html">QICore-Practitioner</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.suspectEntity" title="Describes the entity that is suspected to have caused the adverse event.">suspectEntity</a><a name="AdverseEvent.suspectEntity"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.suspectEntity.instance" title="Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.">instance</a><a name="AdverseEvent.suspectEntity.instance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-substance.html">QICore-Substance</a>), <a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-medication.html">QICore-Medication</a>), <a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-medicationadministration.html">QICore-MedicationAdministration</a>), <a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-medicationstatement.html">QICore-MedicationStatement</a>), <a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="qicore-device.html">QICore-Device</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.suspectEntity.causality" title="causality1 | causality2.">causality</a><a name="AdverseEvent.suspectEntity.causality"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">causality1 | causality2</span><br/><span style="font-weight:bold">Binding: </span><a href="http://hl7.org/fhir/STU3/valueset-adverse-event-causality.html">AdverseEventCausality</a> (<a href="http://hl7.org/fhir/STU3/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set">required</a>)</td></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.suspectEntity.causalityAssessment" title="assess1 | assess2.">causalityAssessment</a><a name="AdverseEvent.suspectEntity.causalityAssessment"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">assess1 | assess2</span><br/><span style="font-weight:bold">Binding: </span><a href="http://hl7.org/fhir/STU3/valueset-adverse-event-causality-assess.html">AdverseEventCausalityAssessment</a> (<a href="http://hl7.org/fhir/STU3/terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">example</a>)</td></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="qicore-adverseevent-definitions.html#AdverseEvent.study" title="TODO.">study</a><a name="AdverseEvent.study"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/researchstudy.html">ResearchStudy</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr><td colspan="5" class="hierarchy"><br/><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/STU3/help16.png" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div> </text> <url value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-adverseevent"/> <name value="QICore-AdverseEvent"/> <status value="draft"/> <date value="2017-08-21T00:00:00+10:00"/> <publisher value="Health Level Seven International (Clinical Quality Information - QICore)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/special/committees/CQI"/> </telecom> </contact> <description 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."/> <fhirVersion value="3.0.1"/> <mapping> <identity value="qdm"/> <uri value="http://www.healthit.gov/quality-data-model"/> <name value="Quality Data Model"/> </mapping> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/w5"/> <name value="W5 Mapping"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="AdverseEvent"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/AdverseEvent"/> <derivation value="constraint"/> <snapshot> <element id="AdverseEvent"> <path value="AdverseEvent"/> <short value="An incident, near miss, unsafe condition, or untoward occurrence during treatment."/> <definition value="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."/> <alias value="AE"/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <xpath value="not(parent::f:contained and f:contained)"/> <source value="DomainResource"/> </constraint> <constraint> <key value="dom-1"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain any narrative"/> <expression value="contained.text.empty()"/> <xpath value="not(parent::f:contained and f:text)"/> <source value="DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/> <source value="DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource"/> <expression value="contained.where(('#'+id in %resource.descendants().reference).not()).empty()"/> <xpath value="not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))"/> <source value="DomainResource"/> </constraint> <mustSupport value="false"/> <mapping> <identity value="rim"/> <map value="Entity. Role, or Act"/> </mapping> <mapping> <identity value="w5"/> <map value="clinical.general"/> </mapping> <mapping> <identity value="qdm"/> <map value="Adverse Event"/> </mapping> </element> <element id="AdverseEvent.id"> <path value="AdverseEvent.id"/> <short value="Logical id of this artifact"/> <definition value="Logical id of this artifact."/> <comment 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."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="id"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <mapping> <identity value="qdm"/> <map value="id"/> </mapping> </element> <element id="AdverseEvent.meta"> <path value="AdverseEvent.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="1"/> </base> <type> <code value="Meta"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.implicitRules"> <path value="AdverseEvent.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."/> <comment 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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <isModifier value="true"/> <isSummary value="true"/> </element> <element id="AdverseEvent.language"> <path value="AdverseEvent.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment 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="1"/> </base> <type> <code value="code"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueReference> <reference value="http://hl7.org/fhir/ValueSet/all-languages"/> </valueReference> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="extensible"/> <description value="A human language."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/languages"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.text"> <path value="AdverseEvent.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."/> <comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later."/> <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="1"/> </base> <type> <code value="Narrative"/> </type> <condition value="dom-1"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="AdverseEvent.contained"> <path value="AdverseEvent.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."/> <comment 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 id="AdverseEvent.extension"> <path value="AdverseEvent.extension"/> <short value="Additional Content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.modifierExtension"> <path value="AdverseEvent.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <isModifier value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.identifier"> <path value="AdverseEvent.identifier"/> <short value="Business identifier for the event"/> <definition value="The identifier(s) of this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itsefl is not appropriate."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.identifier"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Identifier"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.category"> <path value="AdverseEvent.category"/> <short value="AE | PAE"/> <definition value="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 value="0"/> <max value="1"/> <base> <path value="AdverseEvent.category"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <description value="Overall categorization of the event, e.g. real or potential"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-category"/> </valueSetReference> </binding> <mapping> <identity value="w5"/> <map value="class"/> </mapping> </element> <element id="AdverseEvent.type"> <path value="AdverseEvent.type"/> <short value="actual | potential"/> <definition value="This element defines the specific type of event that occurred or that was prevented from occurring."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <mustSupport value="true"/> <isSummary value="true"/> <binding> <strength value="example"/> <description value="The type of adverse event: an incident, near-miss, or unsafe condition"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-type"/> </valueSetReference> </binding> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="AdverseEvent.subject"> <path value="AdverseEvent.subject"/> <short value="Subject or group impacted by event"/> <definition value="This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented."/> <alias value="patient"/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.subject"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device"/> </type> <mustSupport value="true"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="who"/> </mapping> </element> <element id="AdverseEvent.date"> <path value="AdverseEvent.date"/> <short value="When the event occurred"/> <definition value="The date (and perhaps time) when the adverse event occurred."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.date"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="when.init"/> </mapping> <mapping> <identity value="qdm"/> <map value="relevantPeriod"/> </mapping> </element> <element id="AdverseEvent.reaction"> <path value="AdverseEvent.reaction"/> <short value="Adverse Reaction Events linked to exposure to substance"/> <definition value="Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical)."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.reaction"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <mapping> <identity value="qdm"/> <map value="type"/> </mapping> </element> <element id="AdverseEvent.location"> <path value="AdverseEvent.location"/> <short value="Location where adverse event occurred"/> <definition value="The information about where the adverse event occurred."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.location"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-location"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <mapping> <identity value="qdm"/> <map value="facilityLocation"/> </mapping> </element> <element id="AdverseEvent.seriousness"> <path value="AdverseEvent.seriousness"/> <short value="Mild | Moderate | Severe"/> <definition value="Describes the seriousness or severity of the adverse event."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.seriousness"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <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/adverse-event-seriousness"/> </valueSetReference> </binding> <mapping> <identity value="qdm"/> <map value="severity"/> </mapping> </element> <element id="AdverseEvent.outcome"> <path value="AdverseEvent.outcome"/> <short value="resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown"/> <definition value="Describes the type of outcome from the adverse event."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.outcome"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventOutcome"/> </extension> <strength value="required"/> <description value="TODO (and should this be required?)"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-outcome"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.recorder"> <path value="AdverseEvent.recorder"/> <short value="Who recorded the adverse event"/> <definition value="Information on who recorded the adverse event. May be the patient or a practitioner."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.recorder"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-relatedperson"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitioner"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="who.author"/> </mapping> <mapping> <identity value="qdm"/> <map value="recorder"/> </mapping> </element> <element id="AdverseEvent.eventParticipant"> <path value="AdverseEvent.eventParticipant"/> <short value="Who was involved in the adverse event or the potential adverse event"/> <definition value="Parties that may or should contribute or have contributed information to the Act. Such information includes information leading to the decision to perform the Act and how to perform the Act (e.g. consultant), information that the Act itself seeks to reveal (e.g. informant of clinical history), or information about what Act was performed (e.g. informant witness)."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.eventParticipant"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.description"> <path value="AdverseEvent.description"/> <short value="Description of the adverse event"/> <definition value="Describes the adverse event in text."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.description"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity"> <path value="AdverseEvent.suspectEntity"/> <short value="The suspected agent causing the adverse event"/> <definition value="Describes the entity that is suspected to have caused the adverse event."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.suspectEntity"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() | (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="Element"/> </constraint> <mustSupport value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.id"> <path value="AdverseEvent.suspectEntity.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). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.extension"> <path value="AdverseEvent.suspectEntity.extension"/> <short value="Additional Content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.modifierExtension"> <path value="AdverseEvent.suspectEntity.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <isModifier value="true"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.instance"> <path value="AdverseEvent.suspectEntity.instance"/> <short value="Refers to the specific entity that caused the adverse event"/> <definition value="Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device."/> <alias value="Substance or Medication or Device"/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.instance"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-substance"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationadministration"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationstatement"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device"/> </type> <mustSupport value="true"/> <isSummary value="true"/> <mapping> <identity value="qdm"/> <map value="code"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality"> <path value="AdverseEvent.suspectEntity.causality"/> <short value="causality1 | causality2"/> <definition value="causality1 | causality2."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <description value="The type of adverse event: an incident, near-miss, or unsafe condition"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-causality"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.suspectEntity.causalityAssessment"> <path value="AdverseEvent.suspectEntity.causalityAssessment"/> <short value="assess1 | assess2"/> <definition value="assess1 | assess2."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causalityAssessment"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <binding> <strength value="example"/> <description value="The degree of confidence that this condition is correct"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.suspectEntity.causalityProductRelatedness"> <path value="AdverseEvent.suspectEntity.causalityProductRelatedness"/> <short value="AdverseEvent.suspectEntity.causalityProductRelatedness"/> <definition value="AdverseEvent.suspectEntity.causalityProductRelatedness."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causalityProductRelatedness"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causalityMethod"> <path value="AdverseEvent.suspectEntity.causalityMethod"/> <short value="method1 | method2"/> <definition value="method1 | method2."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causalityMethod"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityMethod"/> </extension> <strength value="example"/> <description value="TODO"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-causality-method"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.suspectEntity.causalityAuthor"> <path value="AdverseEvent.suspectEntity.causalityAuthor"/> <short value="AdverseEvent.suspectEntity.causalityAuthor"/> <definition value="AdverseEvent.suspectEntity.causalityAuthor."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causalityAuthor"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causalityResult"> <path value="AdverseEvent.suspectEntity.causalityResult"/> <short value="result1 | result2"/> <definition value="result1 | result2."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causalityResult"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityResult"/> </extension> <strength value="example"/> <description value="TODO"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-causality-result"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.subjectMedicalHistory"> <path value="AdverseEvent.subjectMedicalHistory"/> <short value="AdverseEvent.subjectMedicalHistory"/> <definition value="AdverseEvent.subjectMedicalHistory."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.subjectMedicalHistory"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/AllergyIntolerance"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.referenceDocument"> <path value="AdverseEvent.referenceDocument"/> <short value="AdverseEvent.referenceDocument"/> <definition value="AdverseEvent.referenceDocument."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.referenceDocument"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.study"> <path value="AdverseEvent.study"/> <short value="AdverseEvent.study"/> <definition value="TODO."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.study"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <mustSupport value="false"/> <isSummary value="true"/> </element> </snapshot> <differential> <element id="AdverseEvent"> <path value="AdverseEvent"/> <short value="An incident, near miss, unsafe condition, or untoward occurrence during treatment."/> <definition value="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 value="false"/> <isModifier value="false"/> <mapping> <identity value="qdm"/> <map value="Adverse Event"/> </mapping> </element> <element id="AdverseEvent.id"> <path value="AdverseEvent.id"/> <definition value="Logical id of this artifact."/> <min value="0"/> <max value="1"/> <type> <code value="id"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="qdm"/> <map value="id"/> </mapping> </element> <element id="AdverseEvent.category"> <path value="AdverseEvent.category"/> <short value="AE | PAE"/> <definition value="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 value="0"/> <max value="1"/> <type> <code value="code"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <binding> <strength value="required"/> <description value="Overall categorization of the event, e.g. real or potential"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-category"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.type"> <path value="AdverseEvent.type"/> <short value="actual | potential"/> <min value="1"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="true"/> <isModifier value="false"/> <binding> <strength value="example"/> <description value="The type of adverse event: an incident, near-miss, or unsafe condition"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-type"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.subject"> <path value="AdverseEvent.subject"/> <definition value="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 value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device"/> </type> <mustSupport value="true"/> <isModifier value="false"/> </element> <element id="AdverseEvent.date"> <path value="AdverseEvent.date"/> <definition value="The date (and perhaps time) when the adverse event occurred."/> <min value="0"/> <max value="1"/> <type> <code value="dateTime"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="qdm"/> <map value="relevantPeriod"/> </mapping> </element> <element id="AdverseEvent.reaction"> <path value="AdverseEvent.reaction"/> <definition value="Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical)."/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-condition"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="qdm"/> <map value="type"/> </mapping> </element> <element id="AdverseEvent.location"> <path value="AdverseEvent.location"/> <definition value="The information about where the adverse event occurred."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-location"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="qdm"/> <map value="facilityLocation"/> </mapping> </element> <element id="AdverseEvent.seriousness"> <path value="AdverseEvent.seriousness"/> <short value="Mild | Moderate | Severe"/> <definition value="Describes the seriousness or severity of the adverse event."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <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/adverse-event-seriousness"/> </valueSetReference> </binding> <mapping> <identity value="qdm"/> <map value="severity"/> </mapping> </element> <element id="AdverseEvent.recorder"> <path value="AdverseEvent.recorder"/> <definition value="Information on who recorded the adverse event. May be the patient or a practitioner."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-patient"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-relatedperson"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-practitioner"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="qdm"/> <map value="recorder"/> </mapping> </element> <element id="AdverseEvent.suspectEntity"> <path value="AdverseEvent.suspectEntity"/> <definition value="Describes the entity that is suspected to have caused the adverse event."/> <min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> </element> <element id="AdverseEvent.suspectEntity.instance"> <path value="AdverseEvent.suspectEntity.instance"/> <definition value="Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device."/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-substance"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medication"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationadministration"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-medicationstatement"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-device"/> </type> <mustSupport value="true"/> <isModifier value="false"/> <mapping> <identity value="qdm"/> <map value="code"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality"> <path value="AdverseEvent.suspectEntity.causality"/> <short value="causality1 | causality2"/> <definition value="causality1 | causality2."/> <min value="0"/> <max value="1"/> <type> <code value="code"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <binding> <strength value="required"/> <description value="The type of adverse event: an incident, near-miss, or unsafe condition"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-causality"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.suspectEntity.causalityAssessment"> <path value="AdverseEvent.suspectEntity.causalityAssessment"/> <short value="assess1 | assess2"/> <definition value="assess1 | assess2."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <binding> <strength value="example"/> <description value="The degree of confidence that this condition is correct"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"/> </valueSetReference> </binding> </element> <element id="AdverseEvent.study"> <path value="AdverseEvent.study"/> <definition value="TODO."/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <mustSupport value="false"/> <isModifier value="false"/> </element> </differential> </StructureDefinition>
© HL7.org 2011+. QICore STU 3 Ballot (v2.1.0, based on FHIR v3.0.1-11917) generated on Wed, Dec 20, 2017 12:42+1100. QA Page
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