HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting, published by Biomedical Research & Regulation WG. This is not an authorized publication; it is the continuous build for version 1.0.1). This version is based on the current content of https://github.com/HL7/fhir-icsr-ae-reporting/ and changes regularly. See the Directory of published versions

• Narrative Content
• XML
• JSON
• TTL

: Transfusion Sample ICSR Report - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <https://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:Composition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "TransfusionExample"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Composition</b><a name=\"TransfusionExample\"> </a></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 Composition &quot;TransfusionExample&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-composition.html\">ICSR Composition</a></p></div><blockquote><p><b>AdditionalDocumentInformation</b></p><blockquote><p><b>url</b></p><code>availableFlag</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>ExpeditedReport</b></p><blockquote><p><b>url</b></p><code>localCriteriaFlag</code></blockquote><p><b>value</b>: false</p><blockquote><p><b>url</b></p><code>localCriteriaReportType</code></blockquote><p><b>value</b>: Non-Expedited AE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#2)</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>: 2021-01-05</p><p><b>MostRecentDate</b>: 2021-01-05</p><p><b>CaseIdentifier</b>: id: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</p><p><b>identifier</b>: id: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</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>: 2021-01-05</p><p><b>author</b>: <a href=\"PractitionerRole-BESTAuthorRole.html\">PractitionerRole/BESTAuthorRole</a></p><p><b>title</b>: ICSR Submission</p></div>"
  ] ; # 
  fhir:extension ( [
    ( fhir:extension [
fhir:url [ fhir:v "availableFlag"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "localCriteriaFlag"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] [
fhir:url [ fhir:v "localCriteriaReportType"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2" ] ;
fhir:display [ fhir:v "Non-Expedited AE" ]         ] )       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport"^^xsd:anyURI ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.1.3"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2" ] ;
fhir:display [ fhir:v "Other" ]       ] )     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2021-01-05"^^xsd:date ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2021-01-05"^^xsd:date ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier"^^xsd:anyURI ] ;
fhir:value [
a fhir:Identifier ;
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.3.2"^^xsd:anyURI ] ;
fhir:value [ fhir:v "BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77" ]     ]
  ] ) ; # 
  fhir:identifier [
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.3.1"^^xsd:anyURI ] ;
fhir:value [ fhir:v "BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77" ]
  ] ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
    ( fhir:coding [
a loinc:85893-6 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "85893-6" ] ;
fhir:display [ fhir:v "Adverse event note" ]     ] )
  ] ; # 
  fhir:category ( [
    ( fhir:coding [
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.3.989.2.1.1.2"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1" ] ;
fhir:display [ fhir:v "Spontaneous report" ]     ] )
  ] ) ; # 
  fhir:subject [
fhir:reference [ fhir:v "Patient/BESTPatient" ]
  ] ; # 
  fhir:date [ fhir:v "2021-01-05"^^xsd:date] ; # 
  fhir:author ( [
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource"^^xsd:anyURI ] ;
fhir:value [ fhir:v "true"^^xsd:boolean ]     ] ) ;
fhir:reference [ fhir:v "PractitionerRole/BESTAuthorRole" ]
  ] ) ; # 
  fhir:title [ fhir:v "ICSR Submission"] ; # 
  fhir:section ( [
fhir:title [ fhir:v "Reaction/Event" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ReactionEvent" ]       ] )     ] ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Allergic transfusion reaction</div>"     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "AdverseEvent/TransfusionExampleEvent" ]     ] )
  ] [
fhir:title [ fhir:v "Drug Information" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"^^xsd:anyURI ] ;
fhir:code [ fhir:v "DrugInformation" ]       ] )     ] ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Description code for blood products: E7003, Blood group and type: N/A Blood processing type: Apheresis PLATELETS|ACD-A&gt;PAS-C/XX/20-24C|ResLeu:&amp;lt;5E6|2nd container</div>"     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "Procedure/TransfusionExampleTransfusion" ]     ] [
fhir:reference [ fhir:v "MedicationAdministration/TransfusionEpinephrine" ]     ] [
fhir:reference [ fhir:v "MedicationAdministration/TransfusionDiphenhydramine" ]     ] )
  ] [
fhir:title [ fhir:v "Case Summary Narrative" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"^^xsd:anyURI ] ;
fhir:code [ fhir:v "CaseSummaryNarrative" ]       ] )     ] ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Header: FDA CBER BEST Automated AE Reporting Prototype Case BEST Detection Phenotype Algorithm: Phenotype link: rules-cd BEST Certainty: Definite BEST Severity: Non-Severe BEST Imputability: Probable Form Type: 3500 Contact Method: Email Adverse Event: 1 Center to which the case is being routed to: CBER Whether the case is being sent to DQRS: false Whether the report is related to drugs or food/cosmetics: 1 Whether the blood report is of type Transfusion or Collection: 2 Patient Race Code: 2f, Blood group of patient: N/A, Onset location for reaction: MedStar Location Description code for blood products: N/A, Blood group and type: N/A Blood processing type: N/A Product available for evaluation: 2 Volume of transfusion: NI NHSN Workup: NI Preliminary investigation results: Developed rash &amp;#38; stridor following transfusion prbc for anemia. Tx with benadryl &amp;#38; epinephrine &amp;#38; sx improved., Adverse Event Type Imputability: Blood Transfusion - Certainty: Definite; Notes: 1. notes, Eval+Plan Note, For admission to Hosp with Dx Anemia. Transfuse PRBC now., Date 20020109; 2. notes, Eval+Plan Note, Patient has developed a new maculopapular rash following transfusion. Will give Benadryl 25 mg., Date 20020109; 3. notes, Eval+Plan Note, New onset Stridor following transfusion. Will give Epinephrine .5mg, and do transfusion Rxn workup, Date 20020109; 4. notes, Eval+Plan Note, RN note - Administered Benadryl 25mg IV for skin sx. After 30 min pt. reports some improvement in skin symptoms, Date 20020109 Labs, Vitals, and Tests: 1. labs, Diastolic Blood Pressure, 75.918 mm[Hg], Date 20020109; 2. labs, Systolic Blood Pressure, 123.08 mm[Hg], Date 20020109; 3. labs, Physical findings of Skin, generalized rash, Date 20020109; 4. labs, Respiratory status finding, Stridor, Date 20020109; Illness at Time of Vaccination: 1. illness, Problem, Anemia, Date 20020109;</div>"     ]
  ] [
fhir:title [ fhir:v "Patient Information" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"^^xsd:anyURI ] ;
fhir:code [ fhir:v "PatientInformation" ]       ] )     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "Observation/BESTPatientAgeGroup" ]     ] )
  ] [
fhir:title [ fhir:v "Relevant Medical History" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"^^xsd:anyURI ] ;
fhir:code [ fhir:v "RelevantMedicalHistory" ]       ] )     ] ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">NI</div>"     ]
  ] ) . #