CDA Examples
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CDA Examples, published by Health Level Seven. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/CDA-Examples/ and changes regularly. See the Directory of published versions

Example: Implant UDI Unknown

Approval Status: Approved
Task Force Approval: 2017-07-27
SDWG Approval: 2017-10-05

This is an example of a medical equipment section containing an implantable device where the full unique device identifier (UDI) is unknown.

This file includes examples of the following templates:


  <!--  This is meant to represent multiple implants during the same procedure and where one of the procedures has an unknown UDI.  -->
  <!--  This is not necessarily an ideal modeling and other changes to transition away from procedure act may be in future  -->
  <!--  That said, this is designed for compliance with current C-CDA 1.1 & 2.1 (and MU rules)  -->
  <!--  Note: This is current state and only representative of the UDI unknown. An example of multiple implants which includes UDI unknown will be release.  -->
<section xmlns="urn:hl7-org:v3">
  <templateId root="2.16.840.1.113883.10.20.22.2.23"/>
  <templateId root="2.16.840.1.113883.10.20.22.2.23" extension="2014-06-09"/>
  <code displayName="Medical Equipment" codeSystemName="LOINC"
        codeSystem="2.16.840.1.113883.6.1" code="46264-8"/>
  <title>Implants</title>
  <text>
    <table>
      <thead>
        <tr>
          <th>Device Type</th>
          <!--  This is the generic name of the device.  -->
          <th>Procedure</th>
          <th>Procedure Site</th>
          <th>Laterality</th>
          <th>Implant Date</th>
          <!--  separated out implant date  -->
          <th>Provider Name and Organization</th>
          <th>Informant</th>
        </tr>
      </thead>
      <tbody>
        <tr>
          <td ID="implantDevice1">Cardiac pacemaker</td>
          <td ID="procedureCodeTextReference1">Insertion of intracardiac pacemaker</td>
          <td ID="procedureSiteCodeReference1">Structure of upper chest wall</td>
          <td>2012</td>
          <td/>
          <!--  Laterality not appropriate for this device.  -->
          <td>Winston, Harry</td>
          <td>Patient</td>
        </tr>
      </tbody>
    </table>
  </text>
  <!--  An example where the UDI is unknown or unavailable.  In this scenario,
       the patient asserts that a pacemaker was inserted 5 years ago.   -->
  <entry>
    <procedure moodCode="EVN" classCode="PROC">
      <templateId root="2.16.840.1.113883.10.20.22.4.14"/>
      <templateId root="2.16.840.1.113883.10.20.22.4.14"
                  extension="2014-06-09"/>
      <!--  Note - not sending the 2024-05-01 C-CDA 3.0 templateId because
           that changed the requirement of date to being precise to at least the day
           See https://jira.hl7.org/browse/CDA-21387 for updates  -->
      <!--  This a different procedure at the same facility, so the extension is different while the root is the same  -->
      <id root="1.2.840.114350.1.13.5552.1.7.2.737780"
          extension="1122334455"/>
      <code displayName="Insertion of intracardiac pacemaker"
            codeSystemName="SNOMED" codeSystem="2.16.840.1.113883.6.96" code="25267002">
        <originalText>
          <reference value="#procedureCodeTextReference1"/>
        </originalText>
      </code>
      <!--  Procedure is completed, even though the implant is still active  -->
      <statusCode code="completed"/>
      <effectiveTime>
        <!--  Placed Date  -->
        <low value="2012"/>
      </effectiveTime>
      <targetSiteCode displayName="Structure of upper chest wall"
                      codeSystemName="SNOMED CT" codeSystem="2.16.840.1.113883.6.96" code="699646004">
        <originalText>
          <reference value="#procedureSiteCodeReference1"/>
        </originalText>
      </targetSiteCode>
      <performer typeCode="PRF">
        <assignedEntity>
          <id root="2.16.840.1.113883.4.6" extension="2222222222"/>
          <addr>
            <streetAddressLine>123 Any Street</streetAddressLine>
            <streetAddressLine>Suite 101</streetAddressLine>
            <city>Anytown</city>
            <state>AR</state>
            <postalCode>10010</postalCode>
            <country>US</country>
          </addr>
          <telecom value="tel:+1-(555)555-1234"/>
          <assignedPerson>
            <name>
              <family>Harry</family>
              <given>Winston</given>
            </name>
          </assignedPerson>
        </assignedEntity>
      </performer>
      <!--  The informant is identified as the patient.  -->
      <informant>
        <assignedEntity>
          <id root="1.2.840.114350.1.13.5552.1.7.2.12345" extension="12345"/>
          <!--  the informant is the patient  -->
          <code displayName="self" codeSystemName="HL7 Role code"
                codeSystem="2.16.840.1.113883.5.111" code="ONESELF"/>
          <addr use="HP">
            <streetAddressLine>222 Home Street</streetAddressLine>
            <city>Anytown</city>
            <state>NY</state>
            <postalCode>10010</postalCode>
            <country>US</country>
          </addr>
          <telecom value="tel:(555)555-2004" use="HP"/>
          <assignedPerson>
            <name>
              <given>PatientFirstName</given>
              <family>PatientLastName</family>
            </name>
          </assignedPerson>
        </assignedEntity>
      </informant>
      <participant typeCode="DEV">
        <participantRole classCode="MANU">
          <templateId root="2.16.840.1.113883.10.20.22.4.37"/>
          <id root="2.16.840.1.113883.3.3719" nullFlavor="NI"/>
          <!--  There is no UDI information available  -->
          <playingDevice>
            <code nullFlavor="OTH">
              <!--  Vendor doesn't code specific device.  -->
              <originalText>
                <reference value="#implantDevice1"/>
              </originalText>
            </code>
          </playingDevice>
          <!--  The FDA is the issuing agency as a default.  -->
          <scopingEntity>
            <id root="2.16.840.1.113883.3.3719"/>
          </scopingEntity>
        </participantRole>
      </participant>
    </procedure>
  </entry>
</section>