HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot
HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot
This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions 
{
"resourceType" : "Bundle",
"id" : "MinimumFAERSBundle",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-bundle"
]
},
"type" : "message",
"entry" : [
{
"fullUrl" : "Bundle/SampleFAERSMessageHeader",
"resource" : {
"resourceType" : "MessageHeader",
"id" : "US-IBM-FAERS-fad94c04-29e7-5b37-e535-a8aad123cf9a",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-messageheader"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: <span title=\"{http://terminology.hl7.org/CodeSystem/v3-ActCode PAT_ADV_EVNT}\">Patient Adverse Event</span></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\">Generated Summary: active; <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.7 2}\">Regulatory Authority</span>; name: FDA; faersedub@fda.hhs.gov</a></td></tr></table><p><b>sender</b>: <a href=\"Organization-SenderOrganization.html\">Generated Summary: active; <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.7 1}\">Pharmaceutical Company</span>; name: sender organization; Phone: +01 123 456 78, Fax: +01 123 456 89, email@city.us</a></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>: <span title=\"Codes: {http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents received-public-health-report}\">Indicates receipt of a public health report</span></p><p><b>focus</b>: <a href=\"#Composition_SampleFAERSReport\">See above (Composition/SampleFAERSReport)</a></p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/medmorph/StructureDefinition/ext-messageProcessingCategory",
"valueCode" : "notification"
}
],
"eventCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v3-ActCode",
"code" : "PAT_ADV_EVNT",
"display" : "Patient Adverse Event"
},
"destination" : [
{
"endpoint" : "http://example.org/CBERFAERS",
"receiver" : {
"reference" : "Organization/ReceiverOrganization"
}
}
],
"sender" : {
"reference" : "Organization/SenderOrganization"
},
"source" : {
"endpoint" : "http://example.org/SENDER-IDENTIFIER"
},
"reason" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents",
"code" : "received-public-health-report"
}
]
},
"focus" : [
{
"reference" : "Composition/SampleFAERSReport"
}
]
}
},
{
"fullUrl" : "Composition/SampleFAERSReport",
"resource" : {
"resourceType" : "Composition",
"id" : "SampleFAERSReport",
"meta" : {
"profile" : [
"http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><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>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.1003 C53578}\">Non-Expedited AE</span></p></blockquote><p><b>FirstSenderType</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.3 2}\">Other</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: Feb 10, 2020 10:18:00 PM</p><p><b>MostRecentDate</b>: Feb 10, 2020 10:18:00 PM</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>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.5 2}\">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>: <span title=\"Codes: {http://loinc.org 85893-6}\">Adverse event note</span></p><p><b>category</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.2 1}\">Spontaneous report</span></p><p><b>date</b>: Feb 10, 2020 10:18:00 PM</p><p><b>author</b>: <a href=\"PractitionerRole-SampleAuthorRole.html\">Generated Summary: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}\">Physician</span>; joe@anywhere.com</a></p><p><b>title</b>: ICSR Submission</p></div>"
},
"extension" : [
{
"extension" : [
{
"url" : "availableFlag",
"valueBoolean" : false
}
],
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-additionaldocumentinformation"
},
{
"extension" : [
{
"url" : "localCriteriaFlag",
"valueBoolean" : false
},
{
"url" : "localCriteriaReportType",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003",
"code" : "C53578",
"display" : "Non-Expedited AE"
}
]
}
}
],
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.3",
"code" : "2",
"display" : "Other"
}
]
}
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport",
"valueBoolean" : false
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate",
"valueDateTime" : "2020-02-10T17:18:00-05:00"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate",
"valueDateTime" : "2020-02-10T17:18:00-05:00"
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier",
"valueIdentifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.2",
"value" : "US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee"
}
},
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-previouscaseidentifier",
"valueIdentifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.3",
"value" : "Other-case-identifier",
"assigner" : {
"display" : "Case identifier source name"
}
}
},
{
"extension" : [
{
"url" : "amendmentType",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.5",
"code" : "2"
}
]
}
},
{
"url" : "amendmentReason",
"valueString" : "Fixed some identifiers"
}
],
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-reportamendment"
}
],
"identifier" : {
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.1",
"value" : "US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a"
},
"status" : "final",
"type" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "85893-6",
"display" : "Adverse event note"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.2",
"code" : "1",
"display" : "Spontaneous report"
}
]
}
],
"subject" : {
"reference" : "Patient/SampleICSRPatient"
},
"date" : "2020-02-10T17:18:00-05:00",
"author" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource",
"valueBoolean" : true
}
],
"reference" : "PractitionerRole/SampleAuthorRole"
}
],
"title" : "ICSR Submission",
"section" : [
{
"title" : "Reaction/Event",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
"code" : "ReactionEvent"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">No events</div>"
}
},
{
"title" : "Drug Information",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
"code" : "DrugInformation"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">No drugs taken</div>"
}
},
{
"title" : "Case Summary Narrative",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
"code" : "CaseSummaryNarrative"
}
]
},
"text" : {
"status" : "generated",
"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>"
}
},
{
"title" : "Information about the Data Source of the AE information",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
"code" : "DataSourceInformation"
}
]
},
"entry" : [
{
"reference" : "Observation/SampleAECountObservation"
},
{
"reference" : "Observation/SampleExposureCountObservation"
}
]
}
]
}
}
]
}
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#0.1.0 based on FHIR 4.0.1. Generated 2021-08-05
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