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
StructureDefinition for An incident, near miss, unsafe condition, or untoward occurrence during treatment.
{ "resourceType": "StructureDefinition", "id": "qicore-adverseevent", "text": { "status": "generated", "div": "<div>!-- Snipped for Brevity --></div>" }, "url": "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent", "name": "QICore-AdverseEvent", "status": "draft", "publisher": "Health Level Seven International (Clinical Quality Information - QICore)", "contact": [ { "telecom": [ { "system": "other", "value": "http://hl7.org/special/committees/CQI" } ] } ], "date": "2015-02-27", "description": "An incident, near miss, unsafe condition, or untoward occurrence during treatment.", "fhirVersion": "1.4.0", "mapping": [ { "identity": "qdm", "uri": "http://www.healthit.gov/quality-data-model", "name": "Quality Data Model" } ], "kind": "resource", "abstract": false, "baseType": "Basic", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Basic", "derivation": "constraint", "snapshot": { "element": [ { "path": "Basic", "name": "QICore-AdverseEvent", "short": "An incident, near miss, unsafe condition, or untoward occurrence during treatment.", "definition": "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": [ "Z-resource", "Extension-resource", "Custom-resource" ], "min": 0, "max": "*", "base": { "path": "Basic", "min": 0, "max": "*" }, "type": [ { "code": "Basic" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "Act, Entity or Role" }, { "identity": "w5", "map": "infrastructure.structure" }, { "identity": "qdm", "map": "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" } ] }, { "path": "Basic.id", "short": "Logical id of this artifact", "definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.", "comments": "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": 0, "max": "1", "base": { "path": "Resource.id", "min": 0, "max": "*" }, "type": [ { "code": "id" } ], "isSummary": true }, { "path": "Basic.meta", "short": "Metadata about the resource", "definition": "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": 0, "max": "1", "base": { "path": "Resource.meta", "min": 0, "max": "*" }, "type": [ { "code": "Meta" } ], "isSummary": true }, { "path": "Basic.implicitRules", "short": "A set of rules under which this content was created", "definition": "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": "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": 0, "max": "1", "base": { "path": "Resource.implicitRules", "min": 0, "max": "*" }, "type": [ { "code": "uri" } ], "isModifier": true, "isSummary": true }, { "path": "Basic.language", "short": "Language of the resource content", "definition": "The base language in which the resource is written.", "comments": "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": 0, "max": "1", "base": { "path": "Resource.language", "min": 0, "max": "*" }, "type": [ { "code": "code" } ], "binding": { "strength": "required", "description": "A human language.", "valueSetUri": "http://tools.ietf.org/html/bcp47" } }, { "path": "Basic.text", "short": "Text summary of the resource, for human interpretation", "definition": "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": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative.", "alias": [ "narrative", "html", "xhtml", "display" ], "min": 0, "max": "1", "base": { "path": "DomainResource.text", "min": 0, "max": "*" }, "type": [ { "code": "Narrative" } ], "condition": [ "dom-1" ], "mapping": [ { "identity": "rim", "map": "Act.text?" } ] }, { "path": "Basic.contained", "short": "Contained, inline Resources", "definition": "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": "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": [ "inline resources", "anonymous resources", "contained resources" ], "min": 0, "max": "*", "base": { "path": "DomainResource.contained", "min": 0, "max": "*" }, "type": [ { "code": "Resource" } ], "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "path": "Basic.extension", "slicing": { "discriminator": [ "url" ], "ordered": false, "rules": "open" }, "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ] }, { "path": "Basic.extension", "name": "type", "short": "incident | near miss | unsafe condition", "definition": "incident | near miss | unsafe condition.", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-type" ] } ], "mustSupport": true, "binding": { "strength": "preferred", "description": "The type of adverse event: an incident, near-miss, or unsafe condition", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/qicore-adverseevent-type" } } }, { "path": "Basic.extension", "name": "discoveryDateTime", "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-discoveryDateTime" ] } ] }, { "path": "Basic.extension", "name": "location", "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-location" ] } ] }, { "path": "Basic.extension", "name": "category", "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-category" ] } ], "binding": { "strength": "preferred", "description": "The categories associated with the event or unsafe condition.", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/qicore-adverseevent-category" } } }, { "path": "Basic.extension", "name": "cause", "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause" ] } ] }, { "path": "Basic.extension.id", "representation": [ "xmlAttr" ], "short": "xml:id (or equivalent in JSON)", "definition": "unique id for the element within a resource (for internal references).", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "*" }, "type": [ { "code": "id" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "path": "Basic.extension.extension", "slicing": { "discriminator": [ "url" ], "ordered": false, "rules": "open" }, "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ] }, { "path": "Basic.extension.extension", "name": "item", "short": "Extension", "definition": "An Extension", "min": 1, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause#item" ] } ], "mustSupport": true, "mapping": [ { "identity": "qdm", "map": "primary code" } ] }, { "path": "Basic.extension.extension.id", "representation": [ "xmlAttr" ], "short": "xml:id (or equivalent in JSON)", "definition": "unique id for the element within a resource (for internal references).", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "*" }, "type": [ { "code": "id" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "path": "Basic.extension.extension.extension", "name": "extension", "short": "Extension", "definition": "An Extension", "min": 0, "max": "0", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ] }, { "path": "Basic.extension.extension.url", "representation": [ "xmlAttr" ], "short": "identifies the meaning of the extension", "definition": "Source of the definition for the extension code - a logical name or a URL.", "comments": "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": 1, "max": "1", "base": { "path": "Extension.url", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "fixedUri": "item", "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "path": "Basic.extension.extension.value[x]", "short": "Value of extension", "definition": "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": 1, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-medication" ] }, { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-medicationadministration" ] }, { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-device" ] }, { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-procedure" ] }, { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-imagingstudy" ] }, { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-communication" ] } ], "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "path": "Basic.extension.extension", "name": "certainty", "short": "unlikely | likely | confirmed", "definition": "unlikely | likely | confirmed.", "min": 1, "max": "1", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause#certainty" ] } ], "binding": { "strength": "example", "description": "The degree of confidence that this condition is correct", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/qicore-condition-certainty" } } }, { "path": "Basic.extension.extension.id", "representation": [ "xmlAttr" ], "short": "xml:id (or equivalent in JSON)", "definition": "unique id for the element within a resource (for internal references).", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "*" }, "type": [ { "code": "id" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "path": "Basic.extension.extension.extension", "name": "extension", "short": "Extension", "definition": "An Extension", "min": 0, "max": "0", "base": { "path": "Element.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ] }, { "path": "Basic.extension.extension.url", "representation": [ "xmlAttr" ], "short": "identifies the meaning of the extension", "definition": "Source of the definition for the extension code - a logical name or a URL.", "comments": "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": 1, "max": "1", "base": { "path": "Extension.url", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "fixedUri": "certainty", "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "path": "Basic.extension.extension.valueCodeableConcept", "short": "Value of extension", "definition": "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": 1, "max": "1", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "path": "Basic.extension.url", "representation": [ "xmlAttr" ], "short": "identifies the meaning of the extension", "definition": "Source of the definition for the extension code - a logical name or a URL.", "comments": "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": 1, "max": "1", "base": { "path": "Extension.url", "min": 1, "max": "1" }, "type": [ { "code": "uri" } ], "fixedUri": "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-cause", "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "path": "Basic.extension.value[x]", "short": "Value of extension", "definition": "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": 0, "max": "0", "base": { "path": "Extension.value[x]", "min": 0, "max": "1" }, "type": [ { "code": "boolean" }, { "code": "integer" }, { "code": "decimal" }, { "code": "base64Binary" }, { "code": "instant" }, { "code": "string" }, { "code": "uri" }, { "code": "date" }, { "code": "dateTime" }, { "code": "time" }, { "code": "code" }, { "code": "oid" }, { "code": "id" }, { "code": "unsignedInt" }, { "code": "positiveInt" }, { "code": "markdown" }, { "code": "Annotation" }, { "code": "Attachment" }, { "code": "Identifier" }, { "code": "CodeableConcept" }, { "code": "Coding" }, { "code": "Quantity" }, { "code": "Range" }, { "code": "Period" }, { "code": "Ratio" }, { "code": "SampledData" }, { "code": "Signature" }, { "code": "HumanName" }, { "code": "Address" }, { "code": "ContactPoint" }, { "code": "Timing" }, { "code": "Reference" }, { "code": "Meta" } ], "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "path": "Basic.extension", "name": "reaction", "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-reaction" ] } ] }, { "path": "Basic.extension", "name": "period", "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-period" ] } ], "mustSupport": true, "mapping": [ { "identity": "qdm", "map": "start and stop datetime" } ] }, { "path": "Basic.extension", "name": "clinicalStudy", "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-clinicalStudy" ] } ] }, { "path": "Basic.extension", "name": "severity", "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-severity" ] } ], "binding": { "strength": "example", "description": "A subjective assessment of the severity of the adverse event as evaluated by the clinician.", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/condition-severity" } } }, { "path": "Basic.modifierExtension", "name": "didNotOccur", "short": "Extension", "definition": "An Extension", "min": 0, "max": "*", "base": { "path": "DomainResource.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-adverseevent-didNotOccur" ] } ], "mustSupport": true, "isModifier": true, "mapping": [ { "identity": "qdm", "map": "negation rationale" } ] }, { "path": "Basic.identifier", "short": "Business identifier", "definition": "Identifier assigned to the resource for business purposes, outside the context of FHIR.", "min": 0, "max": "*", "base": { "path": "Basic.identifier", "min": 0, "max": "*" }, "type": [ { "code": "Identifier" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "./identifier" }, { "identity": "w5", "map": "id" } ] }, { "path": "Basic.code", "short": "Kind of Resource", "definition": "Identifies the 'type' of resource - equivalent to the resource name for other resources.", "comments": "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": "Must be able to distinguish different types of \"basic\" resources.", "min": 1, "max": "1", "base": { "path": "Basic.code", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "fixedCodeableConcept": { "coding": [ { "system": "http://hl7.org/fhir/basic-resource-type", "code": "advevent" } ] }, "isModifier": true, "isSummary": true, "binding": { "strength": "example", "description": "Codes for identifying types of resources not yet defined by FHIR", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/basic-resource-type" } }, "mapping": [ { "identity": "rim", "map": "./code" }, { "identity": "w5", "map": "what" } ] }, { "path": "Basic.subject", "short": "The person experiencing the adverse event", "definition": "The person who has the adverse event.", "comments": "Optional as not all resources potential resources will have subjects. Resources associated with multiple subjects can handle this via extension.", "requirements": "Needed for partitioning the resource by Patient.", "min": 0, "max": "1", "base": { "path": "Basic.subject", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-patient" ] } ], "mustSupport": true, "isSummary": true, "mapping": [ { "identity": "rim", "map": "./participation[typeCode='SBJ'] (possibly through a ControlAct and Role)" }, { "identity": "w5", "map": "who.focus" } ] }, { "path": "Basic.created", "short": "When created", "definition": "Identifies when the resource was first created.", "requirements": "Allows ordering resource instances by time.", "min": 0, "max": "1", "base": { "path": "Basic.created", "min": 0, "max": "1" }, "type": [ { "code": "date" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "./participation[typeCode='AUT']/time (possibly through a ControlAct and Role)" }, { "identity": "w5", "map": "when.recorded" } ] }, { "path": "Basic.author", "short": "Who created", "definition": "Indicates who was responsible for creating the resource instance.", "requirements": "Needed for partitioning the resource.", "min": 0, "max": "1", "base": { "path": "Basic.author", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-patient" ] }, { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-relatedperson" ] }, { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-practitioner" ] } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "./participation[typeCode='SUB'] (possibly through a ControlAct and Role)" }, { "identity": "w5", "map": "who.author" } ] } ] }, "differential": { "element": [ { "path": "Basic", "name": "QICore-AdverseEvent", "short": "An incident, near miss, unsafe condition, or untoward occurrence during treatment.", "definition": "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. 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