HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
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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

: Transfusion Sample ICSR Report - XML Representation

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<Composition xmlns="http://hl7.org/fhir">
  <id value="TransfusionExample"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition"/>
  </meta>
  <text>
    <status value="extensions"/>
    <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>
  </text>
  <extension
             url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation">
    <extension url="availableFlag">
      <valueBoolean value="false"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport">
    <extension url="localCriteriaFlag">
      <valueBoolean value="false"/>
    </extension>
    <extension url="localCriteriaReportType">
      <valueCodeableConcept>
        <coding>
          <system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.1003"/>
          <code value="2"/>
          <display value="Non-Expedited AE"/>
        </coding>
      </valueCodeableConcept>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype">
    <valueCodeableConcept>
      <coding>
        <system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.3"/>
        <code value="2"/>
        <display value="Other"/>
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension
             url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport">
    <valueBoolean value="false"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate">
    <valueDateTime value="2021-01-05"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate">
    <valueDateTime value="2021-01-05"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier">
    <valueIdentifier>
      <system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.2"/>
      <value value="BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77"/>
    </valueIdentifier>
  </extension>
  <identifier>
    <system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.1"/>
    <value value="BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77"/>
  </identifier>
  <status value="final"/>
  <type>
    <coding>
      <system value="http://loinc.org"/>
      <code value="85893-6"/>
      <display value="Adverse event note"/>
    </coding>
  </type>
  <category>
    <coding>
      <system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.2"/>
      <code value="1"/>
      <display value="Spontaneous report"/>
    </coding>
  </category>
  <subject>
    <reference value="Patient/BESTPatient"/>
  </subject>
  <date value="2021-01-05"/>
  <author>
    <extension
               url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource">
      <valueBoolean value="true"/>
    </extension>
    <reference value="PractitionerRole/BESTAuthorRole"/>
  </author>
  <title value="ICSR Submission"/>
  <section>
    <title value="Reaction/Event"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
        <code value="ReactionEvent"/>
      </coding>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">Allergic transfusion reaction</div>
    </text>
    <entry>
      <reference value="AdverseEvent/TransfusionExampleEvent"/>
    </entry>
  </section>
  <section>
    <title value="Drug Information"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
        <code value="DrugInformation"/>
      </coding>
    </code>
    <text>
      <status value="generated"/>
      <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>
    </text>
    <entry>
      <reference value="Procedure/TransfusionExampleTransfusion"/>
    </entry>
    <entry>
      <reference value="MedicationAdministration/TransfusionEpinephrine"/>
    </entry>
    <entry>
      <reference value="MedicationAdministration/TransfusionDiphenhydramine"/>
    </entry>
  </section>
  <section>
    <title value="Case Summary Narrative"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
        <code value="CaseSummaryNarrative"/>
      </coding>
    </code>
    <text>
      <status value="generated"/>
      <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>
    </text>
  </section>
  <section>
    <title value="Patient Information"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
        <code value="PatientInformation"/>
      </coding>
    </code>
    <entry>
      <reference value="Observation/BESTPatientAgeGroup"/>
    </entry>
  </section>
  <section>
    <title value="Relevant Medical History"/>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
        <code value="RelevantMedicalHistory"/>
      </coding>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">NI</div>
    </text>
  </section>
</Composition>