<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="eom-tumor-marker-test" />
  <text>
    <status value="additional" />
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p>The EOM Tumor Marker Test Profile links directly to the mCODE Tumor Marker Test Profile.</p>
      <p>The EOM Tumor Marker Test Profile is <b>only required to be submitted for beneficiaries whose attributed cancer type is Breast Cancer.</b></p>
      <p>The EOM Tumor Marker Test Profile must be submitted for each <b>Estrogen Receptor (ER), Progesterone Receptor (PR), and HER2 Tests</b>. The test result reported should be the test result collected at initial diagnosis. If more than one test result exists with a final status in the beneficiary's record, the earliest value during the episode should be reported. If a test result within the episode does not exist, the test result closest to the start of the episode should be reported. For each ER, PR, and HER2, a qualitative or a quantitative (test code and quantity) response should be provided. </p>
      <p>The following data elements are required to be submitted using the EOM Tumor Marker Test Profile to successfully meet Performance Period (PP) 1 Clinical Data Element (CDE) requirements:</p>
      <ul>
        <li>Observation.value[CodeableConcept]
   <ul><li>For each ER, PR, and HER2, qualitative results can be reported via an Observation.value[CodeableConcept]. The LOINC code responses permitted for EOM are:
     <ul><li>Positive LA6576-8</li><li>Negative LA6577-6</li><li>Indeterminate LA11884-6</li><li>Not Tested LA13538-6</li></ul></li></ul></li>
        <li>Observation.code
   <ul><li>For each ER, PR, and HER2, there are a specific set of <a href="https://hl7.org/fhir/us/mcode/ValueSet-mcode-tumor-marker-test-vs.html">Tumor Marker Test Value Set</a> codes permitted for EOM. Refer to the <a href="https://build.fhir.org/ig/FirelyTeam/enhancing-oncology-model-ig/biomarkers.html">General Guidance - Biomarkers</a> page for the specific list of codes permitted for EOM for each ER, PR, and HER2.</li><li>NOTE: The corresponding observation.status must be "final" for EOM.</li></ul></li>
        <li>Observation.value[Quantity]
   <ul><li>Observation.value[Quantity] should be a numeric value with up to 2 decimal places. If  Observation.value[CodeableConcept] is blank and Observation.dataAbsentReason is not set to either "unknown" or "not-applicable," then there should be a valid value for Observation.value[Quantity] for each ER, PR, and HER2. </li></ul></li>
      </ul>
    </div>
  </text>
  <url value="https://globalalliantinc.com/enhancing-oncology-model/StructureDefinition/eom-tumor-marker-test" />
  <name value="EomTumorMarkerTest" />
  <title value="EOM Tumor Marker Test" />
  <status value="draft" />
  <fhirVersion value="4.0.1" />
  <mapping>
    <identity value="workflow" />
    <uri value="http://hl7.org/fhir/workflow" />
    <name value="Workflow Pattern" />
  </mapping>
  <mapping>
    <identity value="sct-concept" />
    <uri value="http://snomed.info/conceptdomain" />
    <name value="SNOMED CT Concept Domain Binding" />
  </mapping>
  <mapping>
    <identity value="v2" />
    <uri value="http://hl7.org/v2" />
    <name value="HL7 v2 Mapping" />
  </mapping>
  <mapping>
    <identity value="rim" />
    <uri value="http://hl7.org/v3" />
    <name value="RIM Mapping" />
  </mapping>
  <mapping>
    <identity value="w5" />
    <uri value="http://hl7.org/fhir/fivews" />
    <name value="FiveWs Pattern Mapping" />
  </mapping>
  <mapping>
    <identity value="sct-attr" />
    <uri value="http://snomed.org/attributebinding" />
    <name value="SNOMED CT Attribute Binding" />
  </mapping>
  <kind value="resource" />
  <abstract value="false" />
  <type value="Observation" />
  <baseDefinition value="http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-tumor-marker-test" />
  <derivation value="constraint" />
  <differential>
    <element id="Observation">
      <path value="Observation" />
      <mustSupport value="true" />
    </element>
  </differential>
</StructureDefinition>