HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.0 - STU 1
HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.0 - STU 1
This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions 
@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <http://loinc.org/rdf#> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:Bundle;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "MinimumFAERSBundle"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle> ]
];
fhir:Bundle.type [ fhir:value "message"];
fhir:Bundle.entry [
fhir:index 0;
fhir:Bundle.entry.fullUrl [ fhir:value "Bundle/SampleFAERSMessageHeader" ];
fhir:Bundle.entry.resource <Bundle/SampleFAERSMessageHeader>
], [
fhir:index 1;
fhir:Bundle.entry.fullUrl [ fhir:value "Composition/SampleFAERSReport" ];
fhir:Bundle.entry.resource <Composition/SampleFAERSReport>
].
<Bundle/SampleFAERSMessageHeader> a fhir:MessageHeader;
fhir:Resource.id [ fhir:value "US-IBM-FAERS-fad94c04-29e7-5b37-e535-a8aad123cf9a"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageheader";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageheader> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "extensions" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource \"US-IBM-FAERS-fad94c04-29e7-5b37-e535-a8aad123cf9a\" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-messageheader.html\">ICSR MessageHeader</a></p></div><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: Patient Adverse Event (Details: http://terminology.hl7.org/CodeSystem/v3-ActCode code PAT_ADV_EVNT = 'patient adverse event', stated as 'Patient Adverse Event')</p><h3>Destinations</h3><table class=\"grid\"><tr><td>-</td><td><b>Endpoint</b></td><td><b>Receiver</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/CBERFAERS\">http://example.org/CBERFAERS</a></td><td><a href=\"Organization-ReceiverOrganization.html\">Organization/ReceiverOrganization</a> \"FDA\"</td></tr></table><p><b>sender</b>: <a href=\"Organization-SenderOrganization.html\">Organization/SenderOrganization</a> \"sender organization\"</p><h3>Sources</h3><table class=\"grid\"><tr><td>-</td><td><b>Endpoint</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/SENDER-IDENTIFIER\">http://example.org/SENDER-IDENTIFIER</a></td></tr></table><p><b>reason</b>: Indicates receipt of a public health report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/us/medmorph/2021Jan/CodeSystem-us-ph-triggerdefinition-namedevents.html\">US Public Health TriggerDefinition Named Events</a>#received-public-health-report)</span></p><p><b>focus</b>: <a href=\"#Composition_SampleFAERSReport\">See above (Composition/SampleFAERSReport)</a></p></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/medmorph/StructureDefinition/ext-messageProcessingCategory" ];
fhir:Extension.valueCode [ fhir:value "notification" ]
];
fhir:MessageHeader.eventCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-ActCode" ];
fhir:Coding.code [ fhir:value "PAT_ADV_EVNT" ];
fhir:Coding.display [ fhir:value "Patient Adverse Event" ]
];
fhir:MessageHeader.destination [
fhir:index 0;
fhir:MessageHeader.destination.endpoint [ fhir:value "http://example.org/CBERFAERS" ];
fhir:MessageHeader.destination.receiver [
fhir:Reference.reference [ fhir:value "Organization/ReceiverOrganization" ] ]
];
fhir:MessageHeader.sender [
fhir:Reference.reference [ fhir:value "Organization/SenderOrganization" ]
];
fhir:MessageHeader.source [
fhir:MessageHeader.source.endpoint [ fhir:value "http://example.org/SENDER-IDENTIFIER" ]
];
fhir:MessageHeader.reason [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents" ];
fhir:Coding.code [ fhir:value "received-public-health-report" ] ]
];
fhir:MessageHeader.focus [
fhir:index 0;
fhir:Reference.reference [ fhir:value "Composition/SampleFAERSReport" ]
].
<Composition/SampleFAERSReport> a fhir:Composition;
fhir:Resource.id [ fhir:value "SampleFAERSReport"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "extensions" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource \"SampleFAERSReport\" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-composition.html\">ICSR Composition</a></p></div><blockquote><p><b>AdditionalDocumentInformation</b></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>ExpeditedReport</b></p><p><b>value</b>: false</p><p><b>value</b>: Non-Expedited AE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#C53578)</span></p></blockquote><p><b>FirstSenderType</b>: Other <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#2)</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: 2020-02-10T17:18:00-05:00</p><p><b>MostRecentDate</b>: 2020-02-10T17:18:00-05:00</p><p><b>CaseIdentifier</b>: id: US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee</p><p><b>PreviousCaseIdentifier</b>: id: Other-case-identifier</p><blockquote><p><b>ReportAmendment</b></p><p><b>value</b>: 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#2)</span></p><p><b>value</b>: Fixed some identifiers</p></blockquote><p><b>identifier</b>: id: US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a</p><p><b>status</b>: final</p><p><b>type</b>: Adverse event note <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://loinc.org/\">LOINC</a>#85893-6)</span></p><p><b>category</b>: Spontaneous report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#1)</span></p><p><b>date</b>: 2020-02-10T17:18:00-05:00</p><p><b>author</b>: <a href=\"PractitionerRole-SampleAuthorRole.html\">PractitionerRole/SampleAuthorRole</a></p><p><b>title</b>: ICSR Submission</p></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "availableFlag" ];
fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ] ];
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation" ]
], [
fhir:index 1;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "localCriteriaFlag" ];
fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ] ], [
fhir:index 1;
fhir:Extension.url [ fhir:value "localCriteriaReportType" ];
fhir:Extension.valueCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003" ];
fhir:Coding.code [ fhir:value "C53578" ];
fhir:Coding.display [ fhir:value "Non-Expedited AE" ] ] ] ];
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport" ]
], [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype" ];
fhir:Extension.valueCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.3" ];
fhir:Coding.code [ fhir:value "2" ];
fhir:Coding.display [ fhir:value "Other" ] ] ]
], [
fhir:index 3;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport" ];
fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ]
], [
fhir:index 4;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate" ];
fhir:Extension.valueDateTime [ fhir:value "2020-02-10T17:18:00-05:00"^^xsd:dateTime ]
], [
fhir:index 5;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate" ];
fhir:Extension.valueDateTime [ fhir:value "2020-02-10T17:18:00-05:00"^^xsd:dateTime ]
], [
fhir:index 6;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier" ];
fhir:Extension.valueIdentifier [
fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.2" ];
fhir:Identifier.value [ fhir:value "US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee" ] ]
], [
fhir:index 7;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-previouscaseidentifier" ];
fhir:Extension.valueIdentifier [
fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.3" ];
fhir:Identifier.value [ fhir:value "Other-case-identifier" ];
fhir:Identifier.assigner [
fhir:Reference.display [ fhir:value "Case identifier source name" ] ] ]
], [
fhir:index 8;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "amendmentType" ];
fhir:Extension.valueCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.5" ];
fhir:Coding.code [ fhir:value "2" ] ] ] ], [
fhir:index 1;
fhir:Extension.url [ fhir:value "amendmentReason" ];
fhir:Extension.valueString [ fhir:value "Fixed some identifiers" ] ];
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-reportamendment" ]
];
fhir:Composition.identifier [
fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.1" ];
fhir:Identifier.value [ fhir:value "US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a" ]
];
fhir:Composition.status [ fhir:value "final"];
fhir:Composition.type [
fhir:CodeableConcept.coding [
fhir:index 0;
a loinc:85893-6;
fhir:Coding.system [ fhir:value "http://loinc.org" ];
fhir:Coding.code [ fhir:value "85893-6" ];
fhir:Coding.display [ fhir:value "Adverse event note" ] ]
];
fhir:Composition.category [
fhir:index 0;
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.2" ];
fhir:Coding.code [ fhir:value "1" ];
fhir:Coding.display [ fhir:value "Spontaneous report" ] ]
];
fhir:Composition.subject [
fhir:Reference.reference [ fhir:value "Patient/SampleICSRPatient" ]
];
fhir:Composition.date [ fhir:value "2020-02-10T17:18:00-05:00"^^xsd:dateTime];
fhir:Composition.author [
fhir:index 0;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource" ];
fhir:Extension.valueBoolean [ fhir:value "true"^^xsd:boolean ] ];
fhir:Reference.reference [ fhir:value "PractitionerRole/SampleAuthorRole" ]
];
fhir:Composition.title [ fhir:value "ICSR Submission"];
fhir:Composition.section [
fhir:index 0;
fhir:Composition.section.title [ fhir:value "Reaction/Event" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "ReactionEvent" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">No events</div>" ]
], [
fhir:index 1;
fhir:Composition.section.title [ fhir:value "Drug Information" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "DrugInformation" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">No drugs taken</div>" ]
], [
fhir:index 2;
fhir:Composition.section.title [ fhir:value "Case Summary Narrative" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "CaseSummaryNarrative" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div>No adverse event happened. Not sure why I'm sending this report.</div><div lang=\"fr\">il n'y a eu aucun événement indésirable</div></div>" ]
], [
fhir:index 3;
fhir:Composition.section.title [ fhir:value "Information about the Data Source of the AE information" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "DataSourceInformation" ] ] ];
fhir:Composition.section.entry [
fhir:index 0;
fhir:Reference.reference [ fhir:value "Observation/SampleAECountObservation" ] ], [
fhir:index 1;
fhir:Reference.reference [ fhir:value "Observation/SampleExposureCountObservation" ] ]
].
# - ontology header ------------------------------------------------------------
a owl:Ontology;
owl:imports fhir:fhir.ttl.
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.0 based on FHIR 4.0.1. Generated 2022-01-19
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