Genomics Reporting Implementation Guide
1.1.0 - Ballot

This page is part of the Genetic Reporting Implementation Guide (v1.1.0: STU 2 Ballot 1) based on FHIR R4. The current version which supercedes this version is 2.0.0. For a full list of available versions, see the Directory of published versions

: Example - Observation-TxImp02 - XML Representation

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<Observation xmlns="http://hl7.org/fhir">
  <id value="TxImp02"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/therapeutic-implication"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p></p><p><b>category</b>: <span title="Codes: {http://terminology.hl7.org/CodeSystem/observation-category laboratory}">Laboratory</span></p><p><b>code</b>: <span title="Codes: {http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/TbdCodes therapeutic-implication}">Therapeutic Implication</span></p><p><b>derivedFrom</b>: <a href="Observation-Pgx-geno-1001.html">Generated Summary: <span title="Codes: {http://terminology.hl7.org/CodeSystem/observation-category laboratory}">Laboratory</span>; <span title="Codes: {http://loinc.org 84413-4}">Genotype display name</span>; effective: 2020-01-01; <span title="Codes: {http://www.ncbi.nlm.nih.gov/clinvar 638797}">CYP2C19*2/*2</span></a></p><blockquote><p><b>component</b></p><p><b>code</b>: <span title="Codes: {http://loinc.org 51963-7}">Medication assessed [ID]</span></p><p><b>value</b>: <span title="Codes: {http://ncimeta.nci.nih.gov C0393080}">voriconazole</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: <span title="Codes: {http://loinc.org 53040-2}">Genetic variation's effect on drug metabolism</span></p><p><b>value</b>: <span title="Codes: {http://loinc.org LA9657-3}">Poor metabolizer</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: <span title="Codes: {http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/TbdCodes conclusion-string}">Conclusion text</span></p><p><b>value</b>: For voriconazole, higher dose-adjusted trough concentrations of voriconazole are expected in individuals with this genotype and may increase the probability of adverse events. An alternative agent that is not dependent on CYP2C19 metabolism such as isavuconazole, liposomal amphotericin B, or posaconazole is recommended as primary therapy in lieu of voriconazole. A lower than standard dosage of voriconazole with careful therapeutic drug monitoring is another alternative. Refer to current guidelines for dosage and recommendations at https://cpicpgx.org/guidelines/guideline-for-voriconazole-and-cyp2c19/.</p></blockquote></div>
  </text>
  <status value="final"/>
  <category>
    <coding>
      <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
      <code value="laboratory"/>
    </coding>
  </category>
  <code>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/TbdCodes"/>
      <code value="therapeutic-implication"/>
    </coding>
  </code>
  <derivedFrom>
    <reference value="Observation/Pgx-geno-1001"/>
  </derivedFrom>
  <component>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="51963-7"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="http://ncimeta.nci.nih.gov"/>
        <code value="C0393080"/>
        <display value="voriconazole"/>
      </coding>
    </valueCodeableConcept>
  </component>
  <component>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="53040-2"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="http://loinc.org"/>
        <code value="LA9657-3"/>
        <display value="Poor metabolizer"/>
      </coding>
    </valueCodeableConcept>
  </component>
  <component>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/TbdCodes"/>
        <code value="conclusion-string"/>
      </coding>
    </code>
    <valueString
                 value="For voriconazole, higher dose-adjusted trough concentrations of voriconazole are expected in individuals with this genotype and may increase the probability of adverse events. An alternative agent that is not dependent on CYP2C19 metabolism such as isavuconazole, liposomal amphotericin B, or posaconazole is recommended as primary therapy in lieu of voriconazole. A lower than standard dosage of voriconazole with careful therapeutic drug monitoring is another alternative. Refer to current guidelines for dosage and recommendations at https://cpicpgx.org/guidelines/guideline-for-voriconazole-and-cyp2c19/."/>
  </component>
</Observation>