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Implant UDI Unknown


Approval Status

  • Approval Status: Approved
  • Example Task Force: 7/27/2017
  • SDWG: 10/5/2017

C-CDA 2.1 Example:

  • 2.16.840.1.113883.10.20.22.2.23
  • 2.16.840.1.113883.10.20.22.2.23:2014-06-09

Reference to full CDA sample:

  • Results in empty CCD

Validation location

Comments

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

Custodian

  • May Terry, may@flatiron.com (GitHub: mayterry88)

Certification

  • ONC

Keywords

  • multiple implants

Permalink

Links

 

Example: download example view on GitHub

<!-- 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>
  <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 code="46264-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Medical Equipment"/>
  <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 classCode="PROC" moodCode="EVN">
      <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"/>
      <!-- This a different procedure at the same facility, so the extension is different while the root is the same -->
      <id extension="1122334455" root="1.2.840.114350.1.13.5552.1.7.2.737780"/>
      <code code="25267002" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" displayName="Insertion of intracardiac pacemaker">
        <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 code="699646004" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Structure of upper chest wall">
        <originalText>
          <reference value="#procedureSiteCodeReference1"/> 
        </originalText>
      </targetSiteCode>
      
      <performer typeCode="PRF"> 
        <assignedEntity>
          <id extension="2222222222" root="2.16.840.1.113883.4.6" />
          <addr>
            <streetAddressLine>123 Any Street</streetAddressLine>
            <streetAddressLine>Suite 101</streetAddressLine>
            <city>Anytown</city>
            <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 extension="12345" root="1.2.840.114350.1.13.5552.1.7.2.12345" />
          <!-- the informant is the patient -->
          <code code="ONESELF" displayName="Self" codeSystem="2.16.840.1.113883.5.111" codeSystemName="HL7 Role code" /> 
          <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>
          <scopingEntity>
            <id root="2.16.840.1.113883.3.3719"/>  <!-- The FDA is the issuing agency as a default. -->
          </scopingEntity>
        </participantRole>
      </participant>
    </procedure>
  </entry>
</section>
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