{ "description": null, "_filename": "StructureDefinition-qicore-adverseevent.json", "package_name": "hl7.fhir.us.qicore", "date": "2015-02-27", "derivation": "constraint", "publisher": "Health Level Seven International (Clinical Quality Information - QICore)", "name": "Profile qicore-adverseevent", "mapping": [ { "uri": "http://www.healthit.gov/quality-data-model", "name": "Quality Data Model", "identity": "qdm" }, { "uri": "http://hl7.org/v3", "name": "RIM Mapping", "identity": "rim" }, { "uri": "http://hl7.org/fhir/w5", "name": "W5 Mapping", "identity": "w5" } ], "abstract": false, "type": "Basic", "experimental": null, "resourceType": "StructureDefinition", "title": null, "package_version": "1.6.0", "snapshot": { "element": [ { "constraint": [ { "key": "dom-2", "human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources", "xpath": "not(parent::f:contained and f:contained)", "severity": "error", "expression": "contained.contained.empty()" }, { "key": "dom-1", "human": "If the resource is contained in another resource, it SHALL NOT contain any narrative", "xpath": "not(parent::f:contained and f:text)", "severity": "error", "expression": "contained.text.empty()" }, { "key": "dom-4", "human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated", "xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))", "severity": "error", "expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()" }, { "key": "dom-3", "human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource", "xpath": "not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))", "severity": "error", "expression": "contained.where(('#'+id in %resource.descendants().reference).not()).empty()" } ], "path": "Basic", "min": 0, "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.", "short": "Resource for non-supported content", "name": "QICore-AdverseEvent", "mapping": [ { "map": "Entity. Role, or Act", "identity": "rim" }, { "map": "Act, Entity or Role", "identity": "rim" }, { "map": "infrastructure.structure", "identity": "w5" }, { "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", "identity": "qdm" } ], "mustSupport": false, "alias": [ "Z-resource", "Extension-resource", "Custom-resource" ], "max": "*", "id": "Basic:qicore-adverseevent", "base": { "max": "*", "min": 0, "path": "Basic" }, "isSummary": false }, { "path": "Basic.id", "min": 0, "definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.", "short": "Logical id of this artifact", "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.", "type": [ { "code": "id" } ], "max": "1", "id": "Basic:qicore-adverseevent.id", "base": { "max": "*", "min": 0, "path": "Resource.id" }, "isSummary": true }, { "path": "Basic.meta", "min": 0, "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.", "short": "Metadata about the resource", "type": [ { "code": "Meta" } ], "max": "1", "id": "Basic:qicore-adverseevent.meta", "base": { "max": "*", "min": 0, "path": "Resource.meta" }, "isSummary": true }, { "path": "Basic.implicitRules", "min": 0, "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.", "isModifier": true, "short": "A set of rules under which this content was created", "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.", "type": [ { "code": "uri" } ], "max": "1", "id": "Basic:qicore-adverseevent.implicitRules", "base": { "max": "*", "min": 0, "path": "Resource.implicitRules" }, "isSummary": true }, { "path": "Basic.language", "min": 0, "definition": "The base language in which the resource is written.", "short": "Language of the resource content", "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).", "type": [ { "code": "code" } ], "binding": { "strength": "extensible", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet", "valueReference": { "reference": "http://hl7.org/fhir/ValueSet/all-languages" } } ], "description": "A human language.", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/languages" } }, "max": "1", "id": "Basic:qicore-adverseevent.language", "base": { "max": "*", "min": 0, "path": "Resource.language" } }, { "path": "Basic.text", "min": 0, "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.", "short": "Text summary of the resource, for human interpretation", "comments": "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.", "mapping": [ { "map": "Act.text?", "identity": "rim" } ], "type": [ { "code": "Narrative" } ], "alias": [ "narrative", "html", "xhtml", "display" ], "max": "1", "id": "Basic:qicore-adverseevent.text", "condition": [ "dom-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.text" } }, { "path": "Basic.contained", "min": 0, "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.", "short": "Contained, inline Resources", "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.", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Resource" } ], "alias": [ "inline resources", "anonymous resources", "contained resources" ], "max": "*", "id": "Basic:qicore-adverseevent.contained", "base": { "max": "*", "min": 0, "path": "DomainResource.contained" } }, { "path": "Basic.extension", "min": 0, "definition": "An Extension", "short": "Extension", "slicing": { "id": "3", "rules": "open", "ordered": false, "discriminator": [ "url" ] }, "type": [ { "code": "Extension" } ], "max": "*", "id": "Basic:qicore-adverseevent.extension", "base": { "max": "*", "min": 0, "path": "DomainResource.extension" } }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "type", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/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/qicore/ValueSet/qicore-adverseevent-type" } }, "max": "*", "id": "Basic:qicore-adverseevent.extension:type$adverseevent-type", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "discoveryDateTime", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-discoveryDateTime" } ], "mustSupport": false, "max": "*", "id": "Basic:qicore-adverseevent.extension:discoverydatetime$adverseevent-discoveryDateTime", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "location", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-location" } ], "mustSupport": false, "max": "*", "id": "Basic:qicore-adverseevent.extension:location$adverseevent-location", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "category", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-category" } ], "mustSupport": false, "binding": { "strength": "preferred", "description": "The categories associated with the event or unsafe condition.", "valueSetReference": { "reference": "http://hl7.org/fhir/qicore/ValueSet/qicore-adverseevent-category" } }, "max": "*", "id": "Basic:qicore-adverseevent.extension:category$adverseevent-category", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "cause", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-cause" } ], "mustSupport": false, "max": "*", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.extension" }, "isSummary": false }, { "path": "Basic.extension.id", "min": 0, "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "short": "xml:id (or equivalent in JSON)", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "string" } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.id", "base": { "max": "*", "min": 0, "path": "Element.id" } }, { "path": "Basic.extension.extension", "min": 0, "definition": "An Extension", "short": "Extension", "slicing": { "id": "2", "rules": "open", "ordered": false, "discriminator": [ "url" ] }, "type": [ { "code": "Extension" } ], "max": "*", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension", "base": { "max": "*", "min": 0, "path": "Element.extension" } }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension.extension", "min": 1, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "item", "mapping": [ { "map": "primary code", "identity": "qdm" } ], "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-cause#item" } ], "mustSupport": true, "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:item$adverseevent-cause#item", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Basic.extension.extension.id", "min": 0, "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "short": "xml:id (or equivalent in JSON)", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "string" } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:item$adverseevent-cause#item.id", "base": { "max": "*", "min": 0, "path": "Element.id" } }, { "path": "Basic.extension.extension.extension", "min": 0, "definition": "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.", "short": "Additional Content defined by implementations", "comments": "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.", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:item$adverseevent-cause#item.extension", "base": { "max": "*", "min": 0, "path": "Element.extension" } }, { "path": "Basic.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "short": "identifies the meaning of the extension", "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 SHALL be a URI for the Structure Definition defining the extension.", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "uri" } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:item$adverseevent-cause#item.url", "base": { "max": "1", "min": 1, "path": "Extension.url" } }, { "path": "Basic.extension.extension.value[x]", "min": 0, "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).", "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-medication" }, { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-medicationadministration" }, { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-device" }, { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-procedure" }, { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-imagingstudy" }, { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-communication" } ], "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:item$adverseevent-cause#item.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" } }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension.extension", "min": 1, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "certainty", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-cause#certainty" } ], "mustSupport": false, "binding": { "strength": "example", "description": "The degree of confidence that this condition is correct", "valueSetReference": { "reference": "http://hl7.org/fhir/qicore/ValueSet/qicore-condition-certainty" } }, "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:certainty$adverseevent-cause#certainty", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Basic.extension.extension.id", "min": 0, "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "short": "xml:id (or equivalent in JSON)", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "string" } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:certainty$adverseevent-cause#certainty.id", "base": { "max": "*", "min": 0, "path": "Element.id" } }, { "path": "Basic.extension.extension.extension", "min": 0, "definition": "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.", "short": "Additional Content defined by implementations", "comments": "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.", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:certainty$adverseevent-cause#certainty.extension", "base": { "max": "*", "min": 0, "path": "Element.extension" } }, { "path": "Basic.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "short": "identifies the meaning of the extension", "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 SHALL be a URI for the Structure Definition defining the extension.", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "uri" } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:certainty$adverseevent-cause#certainty.url", "base": { "max": "1", "min": 1, "path": "Extension.url" } }, { "path": "Basic.extension.extension.valueCodeableConcept", "min": 0, "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).", "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:certainty$adverseevent-cause#certainty.valueCodeableConcept", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" } }, { "path": "Basic.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "short": "identifies the meaning of the extension", "fixedUri": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-cause", "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 SHALL be a URI for the Structure Definition defining the extension.", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "uri" } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.url", "base": { "max": "1", "min": 1, "path": "Extension.url" } }, { "path": "Basic.extension.value[x]", "min": 0, "definition": "Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list).", "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "base64Binary" }, { "code": "boolean" }, { "code": "code" }, { "code": "date" }, { "code": "dateTime" }, { "code": "decimal" }, { "code": "id" }, { "code": "instant" }, { "code": "integer" }, { "code": "markdown" }, { "code": "oid" }, { "code": "positiveInt" }, { "code": "string" }, { "code": "time" }, { "code": "unsignedInt" }, { "code": "uri" }, { "code": "Address" }, { "code": "Age" }, { "code": "Annotation" }, { "code": "Attachment" }, { "code": "CodeableConcept" }, { "code": "Coding" }, { "code": "ContactPoint" }, { "code": "Count" }, { "code": "Distance" }, { "code": "Duration" }, { "code": "HumanName" }, { "code": "Identifier" }, { "code": "Money" }, { "code": "Period" }, { "code": "Quantity" }, { "code": "Range" }, { "code": "Ratio" }, { "code": "Reference" }, { "code": "SampledData" }, { "code": "Signature" }, { "code": "Timing" }, { "code": "Meta" } ], "max": "1", "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" } }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "reaction", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-reaction" } ], "mustSupport": false, "max": "*", "id": "Basic:qicore-adverseevent.extension:reaction$adverseevent-reaction", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "period", "mapping": [ { "map": "start and stop datetime", "identity": "qdm" } ], "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-period" } ], "mustSupport": true, "max": "*", "id": "Basic:qicore-adverseevent.extension:period$adverseevent-period", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "clinicalStudy", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-clinicalStudy" } ], "mustSupport": false, "max": "*", "id": "Basic:qicore-adverseevent.extension:clinicalstudy$adverseevent-clinicalStudy", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "name": "severity", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-severity" } ], "mustSupport": false, "binding": { "strength": "example", "description": "A subjective assessment of the severity of the adverse event as evaluated by the clinician.", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/condition-severity" } }, "max": "*", "id": "Basic:qicore-adverseevent.extension:severity$adverseevent-severity", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "xpath": "@value|f:*|h:div", "severity": "error", "expression": "children().count() > id.count()" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Basic.modifierExtension", "min": 0, "definition": "An Extension", "isModifier": true, "short": "Extension", "name": "didNotOccur", "mapping": [ { "map": "negation rationale", "identity": "qdm" } ], "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-didNotOccur" } ], "mustSupport": true, "max": "*", "id": "Basic:qicore-adverseevent.modifierExtension:didnotoccur$adverseevent-didNotOccur", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "DomainResource.modifierExtension" }, "isSummary": false }, { "path": "Basic.identifier", "min": 0, "definition": "Identifier assigned to the resource for business purposes, outside the context of FHIR.", "short": "Business identifier", "mapping": [ { "map": "./identifier", "identity": "rim" }, { "map": "id", "identity": "w5" } ], "type": [ { "code": "Identifier" } ], "max": "*", "id": "Basic:qicore-adverseevent.identifier", "base": { "max": "*", "min": 0, "path": "Basic.identifier" }, "isSummary": true }, { "path": "Basic.code", "requirements": "Must be able to distinguish different types of \"basic\" resources.", "min": 1, "definition": "Identifies the 'type' of resource - equivalent to the resource name for other resources.", "isModifier": true, "short": "Kind of Resource", "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.", "mapping": [ { "map": "./code", "identity": "rim" }, { "map": "what", "identity": "w5" } ], "type": [ { "code": "CodeableConcept" } ], "mustSupport": false, "fixedCodeableConcept": { "coding": [ { "code": "advevent", "system": "http://hl7.org/fhir/basic-resource-type" } ] }, "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" } }, "max": "1", "id": "Basic:qicore-adverseevent.code", "base": { "max": "1", "min": 1, "path": "Basic.code" }, "isSummary": false }, { "path": "Basic.subject", "requirements": "Needed for partitioning the resource by Patient.", "min": 0, "definition": "The person who has the adverse event.", "short": "Identifies the focus of this resource", "comments": "Optional as not all resources potential resources will have subjects. Resources associated with multiple subjects can handle this via extension.", "mapping": [ { "map": "./participation[typeCode='SBJ'] (possibly through a ControlAct and Role)", "identity": "rim" }, { "map": "who.focus", "identity": "w5" } ], "type": [ { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-patient" } ], "mustSupport": true, "max": "1", "id": "Basic:qicore-adverseevent.subject", "base": { "max": "1", "min": 0, "path": "Basic.subject" }, "isSummary": false }, { "path": "Basic.created", "requirements": "Allows ordering resource instances by time.", "min": 0, "definition": "Identifies when the resource was first created.", "short": "When created", "mapping": [ { "map": "./participation[typeCode='AUT']/time (possibly through a ControlAct and Role)", "identity": "rim" }, { "map": "when.recorded", "identity": "w5" } ], "type": [ { "code": "date" } ], "max": "1", "id": "Basic:qicore-adverseevent.created", "base": { "max": "1", "min": 0, "path": "Basic.created" }, "isSummary": true }, { "path": "Basic.author", "requirements": "Needed for partitioning the resource.", "min": 0, "definition": "Indicates who was responsible for creating the resource instance.", "short": "Who created", "mapping": [ { "map": "./participation[typeCode='SUB'] (possibly through a ControlAct and Role)", "identity": "rim" }, { "map": "who.author", "identity": "w5" } ], "type": [ { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-patient" }, { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-relatedperson" }, { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-practitioner" } ], "mustSupport": false, "max": "1", "id": "Basic:qicore-adverseevent.author", "base": { "max": "1", "min": 0, "path": "Basic.author" }, "isSummary": false } ] }, "status": "draft", "id": "994f4a02-47a1-4d99-a7a1-af2d7cd9adbb", "kind": "resource", "url": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-adverseevent", "version": null, "differential": { "element": [ { "id": "Basic:qicore-adverseevent", "name": "QICore-AdverseEvent", "path": "Basic", "mapping": [ { "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", "identity": "qdm" } ], "isSummary": false, "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.", "isModifier": false, "mustSupport": false }, { "id": "Basic:qicore-adverseevent.extension:type$adverseevent-type", "name": "type", "path": "Basic.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-type" } ], "binding": { "strength": "preferred", "description": "The type of adverse event: an incident, near-miss, or unsafe condition", "valueSetReference": { "reference": "http://hl7.org/fhir/qicore/ValueSet/qicore-adverseevent-type" } }, "isSummary": false, "isModifier": false, "mustSupport": true }, { "id": "Basic:qicore-adverseevent.extension:discoverydatetime$adverseevent-discoveryDateTime", "name": "discoveryDateTime", "path": "Basic.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-discoveryDateTime" } ], "isSummary": false, "isModifier": false, "mustSupport": false }, { "id": "Basic:qicore-adverseevent.extension:location$adverseevent-location", "name": "location", "path": "Basic.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-location" } ], "isSummary": false, "isModifier": false, "mustSupport": false }, { "id": "Basic:qicore-adverseevent.extension:category$adverseevent-category", "name": "category", "path": "Basic.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-category" } ], "binding": { "strength": "preferred", "description": "The categories associated with the event or unsafe condition.", "valueSetReference": { "reference": "http://hl7.org/fhir/qicore/ValueSet/qicore-adverseevent-category" } }, "isSummary": false, "isModifier": false, "mustSupport": false }, { "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause", "name": "cause", "path": "Basic.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-cause" } ], "isSummary": false, "isModifier": false, "mustSupport": false }, { "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:item$adverseevent-cause#item", "name": "item", "path": "Basic.extension.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-cause#item" } ], "mapping": [ { "map": "primary code", "identity": "qdm" } ], "isSummary": false, "isModifier": false, "mustSupport": true }, { "id": "Basic:qicore-adverseevent.extension:cause$adverseevent-cause.extension:certainty$adverseevent-cause#certainty", "name": "certainty", "path": "Basic.extension.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-cause#certainty" } ], "binding": { "strength": "example", "description": "The degree of confidence that this condition is correct", "valueSetReference": { "reference": "http://hl7.org/fhir/qicore/ValueSet/qicore-condition-certainty" } }, "isSummary": false, "isModifier": false, "mustSupport": false }, { "id": "Basic:qicore-adverseevent.extension:reaction$adverseevent-reaction", "name": "reaction", "path": "Basic.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-reaction" } ], "isSummary": false, "isModifier": false, "mustSupport": false }, { "id": "Basic:qicore-adverseevent.extension:period$adverseevent-period", "name": "period", "path": "Basic.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-period" } ], "mapping": [ { "map": "start and stop datetime", "identity": "qdm" } ], "isSummary": false, "isModifier": false, "mustSupport": true }, { "id": "Basic:qicore-adverseevent.extension:clinicalstudy$adverseevent-clinicalStudy", "name": "clinicalStudy", "path": "Basic.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-clinicalStudy" } ], "isSummary": false, "isModifier": false, "mustSupport": false }, { "id": "Basic:qicore-adverseevent.extension:severity$adverseevent-severity", "name": "severity", "path": "Basic.extension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/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" } }, "isSummary": false, "isModifier": false, "mustSupport": false }, { "id": "Basic:qicore-adverseevent.modifierExtension:didnotoccur$adverseevent-didNotOccur", "name": "didNotOccur", "path": "Basic.modifierExtension", "type": [ { "code": "Extension", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/adverseevent-didNotOccur" } ], "mapping": [ { "map": "negation rationale", "identity": "qdm" } ], "isSummary": false, "isModifier": true, "mustSupport": true }, { "id": "Basic:qicore-adverseevent.code", "path": "Basic.code", "type": [ { "code": "CodeableConcept" } ], "isSummary": false, "isModifier": false, "mustSupport": false, "fixedCodeableConcept": { "coding": [ { "code": "advevent", "system": "http://hl7.org/fhir/basic-resource-type" } ] } }, { "id": "Basic:qicore-adverseevent.subject", "path": "Basic.subject", "type": [ { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-patient" } ], "isSummary": false, "definition": "The person who has the adverse event.", "isModifier": false, "mustSupport": true }, { "id": "Basic:qicore-adverseevent.author", "path": "Basic.author", "type": [ { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-patient" }, { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-relatedperson" }, { "code": "Reference", "profile": "http://hl7.org/fhir/qicore/StructureDefinition/qicore-practitioner" } ], "isSummary": false, "isModifier": false, "mustSupport": false } ] }, "contact": [ { "telecom": [ { "value": "http://hl7.org/special/committees/CQI", "system": "other" } ] } ], "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Basic" }