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 Organizer (Approval pending)

Approval Status: Approval Pending
Task Force Approval:
SDWG Approval:

This is an example of how to record the full details of a UDI. This examples follows the design in Appendix B of the 2019 C-CDA Companion Guide.

This file includes examples of the following templates:


<section xmlns="urn:hl7-org:v3">
  <templateId root="2.16.840.1.113883.10.20.22.2.23" extension="2014-06-09"/>
  <templateId root="2.16.840.1.113883.10.20.22.2.23"/>
  <code codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"
        code="46264-8"/>
  <title>Medical Equipment</title>
  <text>
    <table>
      <colgroup>
        <col width="40%"/>
        <col width="20%"/>
        <col width="40%"/>
      </colgroup>
      <tbody>
        <tr ID="_9d1b9efd-baff-45b2-8033-cdf2fc02c35f">
          <td>
            <content ID="_d92f7e16-385c-4079-b9c8-adfb2525ef6c">Breast Implant</content>
          </td>
          <td>
            <content>Date: </content>
            <content>14-Jul-2020</content>
            <br/>
          </td>
          <td/>
        </tr>
        <tr ID="_2350e0a1-5ffb-4b6d-ba9f-be489d9dfc2f">
          <td>
            <content> •</content>
            <content>
              <content ID="BrandName_1">Example BrandName</content>
              <br/>
              <content ID="CompanyName_1">Example Company Name</content>
              <br/>
              <content>(GS1)00848486001048</content>
              <br/>
              <content>Serial: </content>
              <content ID="SerialNumber_1">bi12342222</content>
              <br/>
            </content>
          </td>
          <td>
            <content>Expires: </content>
            <content>15-Oct-2022</content>
            <br/>
            <content>Mfd: </content>
            <content>15-Oct-2018</content>
            <br/>
            <content>Model: </content>
            <content ID="ModelNumber_1">Example Model Number</content>
            <br/>
            <br/>
            <content>Catalog Number: </content>
            <content ID="CatalogNumber_1">Example Catalog Number</content>
            <br/>
            <content>Lot: </content>
            <content>ABC999</content>
            <br/>
          </td>
          <td>
            <content>Overall Status: </content>
            <content>Breast Implant (L)</content>
            <br/>
            <content>Implant Status: </content>
            <content ID="ImplantableDeviceStatus_1">Implantable DeviceStatus Text</content>
            <br/>
            <content>MRI: </content>
            <content ID="MRISafety_1">Labeling does not contain MRI Safety Information</content>
            <br/>
            <content>Latex: </content>
            <content ID="LatexSafety_1">Not Made with Natural Rubber Latex</content>
            <br/>
          </td>
        </tr>
      </tbody>
    </table>
  </text>
  <entry>
    <procedure moodCode="EVN" classCode="PROC">
      <templateId root="2.16.840.1.113883.10.20.22.4.14"
                  extension="2024-05-01"/>
      <templateId root="2.16.840.1.113883.10.20.22.4.14"
                  extension="2014-06-09"/>
      <templateId root="2.16.840.1.113883.10.20.22.4.14"/>
      <id root="1.2.840.114350.1.13.5552.1.7.2.737780" extension="6239942"/>
      <!--  The procedure that supported the implant is unknown  -->
      <!--  A patient may be informing provider of a historical implant  -->
      <code nullFlavor="UNK"/>
      <text>
        <reference value="#_9d1b9efd-baff-45b2-8033-cdf2fc02c35f"/>
      </text>
      <!--  Procedure is completed, even though the implant is still active  -->
      <statusCode code="completed"/>
      <!-- time stamp as a point in time -->
      <effectiveTime value="20200714"/>
      <!-- Product Instance Template -->
      <participant typeCode="DEV">
        <participantRole classCode="MANU">
          <templateId root="2.16.840.1.113883.10.20.22.4.37"/>
          <!--  Full HRF UDI value from GS1, which is a UDI issuing agency: (01)00848486001048(11)181015(10)ABC999(21)bi12342222(17)221015  -->
          <!--  The order of the GS1 delimiters (01)..(11)... may vary  -->
          <!--  Device Identifier (01) - 00848486001048  -->
          <!--  Manufacturing date (11) - 181015  -->
          <!--  Lot or Batch Number (10) - ABC999  -->
          <!--  Serial Number (21) - bi12342222  -->
          <!--  Expiration Date (17) - 221015  -->
          <!--  The entire UDI as a single string is scoped by the FDA OID: 2.16.840.1.113883.3.3719  -->
          <id root="2.16.840.1.113883.3.3719"
              extension="(01)00848486001048(11)181015(10)ABC999(21)bi12342222(17)221015" assigningAuthorityName="FDA"/>
          <playingDevice>
            <code displayName="Breast Implant" codeSystemName="SNOMED CT"
                  codeSystem="2.16.840.1.113883.6.96" code="2282003">
              <!--  Add original text with device type to playingDevice.code -->
              <originalText>
                <reference value="#_d92f7e16-385c-4079-b9c8-adfb2525ef6c"/>
              </originalText>
            </code>
          </playingDevice>
          <!--  From Product Instance template: The scopingEntity/id should correspond to FDA or the appropriate issuing agency.  -->
          <scopingEntity>
            <id root="2.16.840.1.113883.3.3719"/>
          </scopingEntity>
        </participantRole>
      </participant>
      <entryRelationship typeCode="COMP">
        <!--  UDI Organizer  -->
        <organizer moodCode="EVN" classCode="CLUSTER">
          <templateId root="2.16.840.1.113883.10.20.22.4.311"
                      extension="2019-06-21"/>
          <!--  UDI organizer/id matches the participantRole/id  -->
          <!--  The organizer splits the full HRF UDI value from GS1 into component observations  -->
          <id root="2.16.840.1.113883.3.3719"
              extension="(01)00848486001048(11)181015(10)ABC999(21)bi12342222(17)221015" assigningAuthorityName="FDA"/>
          <code displayName="Unique Device Identifier"
                codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1" code="74711-3"/>
          <sdtc:sdtcText xmlns:sdtc="urn:hl7-org:sdtc">
            <reference value="#_2350e0a1-5ffb-4b6d-ba9f-be489d9dfc2f"/>
          </sdtc:sdtcText>
          <statusCode code="completed"/>
          <!--  Device Identifier  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.304"
                          extension="2019-06-21"/>
              <templateId root="2.16.840.1.113883.10.20.22.4.304"
                          extension="2022-06-01"/>
              <code xsi:type="CD" displayName="Primary DI Number"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101722"/>
              <value xsi:type="II" root="1.3.160" extension="00848486001048"
                     displayable="true" assigningAuthorityName="GS1"/>
            </observation>
          </component>
          <!--  Lot or Batch Number  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.315"
                          extension="2019-06-21"/>
              <code xsi:type="CD" displayName="Lot or Batch Number"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101672"/>
              <!--  Errata logged with Structured Documents to consider ED  -->
              <value xsi:type="ED">ABC999</value>
            </observation>
          </component>
          <!--  Serial Number  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.319"
                          extension="2019-06-21"/>
              <code xsi:type="CD" displayName="Serial Number"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101671"/>
              <value xsi:type="ED">
                <reference value="#SerialNumber_1"/>
              </value>
            </observation>
          </component>
          <!--  Manufacturing Date  -->
          <!--  If the value is parsed from UDI the format is YYMMDD and is transformed to YYYYMMDD.  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.316"
                          extension="2019-06-21"/>
              <code xsi:type="CD" displayName="Manufacturing Date"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101669"/>
              <value xsi:type="TS" value="20181015"/>
            </observation>
          </component>
          <!--  Expiration Date  -->
          <!--  If the value is parsed from UDI the format is YYMMDD and is transformed to YYYYMMDD.  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.309"
                          extension="2019-06-21"/>
              <code xsi:type="CD" displayName="Expiration Date"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C101670"/>
              <value xsi:type="TS" value="20221015"/>
            </observation>
          </component>
          <!--  Distinct Identification assigned wherever donation pulled from -->
          <!--  The distinct identification code may be equivalent to the serial number, lot or batch number, or the donation identification number.   -->
          <!--  The appropriate value should be provided as the distinct identification code.  -->
          <!--  <component>
                 <observation classCode="OBS" moodCode="EVN">
                   <templateId root="2.16.840.1.113883.10.20.22.4.308" extension="2019-06-21"/>
                   <code code="C113843" codeSystem="2.16.840.1.113883.3.26.1.1"
                         displayName="Distinct Identification" codeSystemName="NCI Thesaurus" />
                   <value xsi:type="ST">1111</value>
                 </observation>
               </component>  -->
          <!--  Brand Name  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.301"
                          extension="2019-06-21"/>
              <code xsi:type="CD" displayName="Brand Name"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C71898"/>
              <value xsi:type="ED">
                <reference value="#BrandName_1"/>
              </value>
            </observation>
          </component>
          <!--  Model Number  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.317"
                          extension="2019-06-21"/>
              <code xsi:type="CD" displayName="Model Number"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C99285"/>
              <value xsi:type="ED">
                <reference value="#ModelNumber_1"/>
              </value>
            </observation>
          </component>
          <!--  Company Name  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.303"
                          extension="2019-06-21"/>
              <code xsi:type="CD" displayName="Company Name"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C54131"/>
              <value xsi:type="ED">
                <reference value="#CompanyName_1"/>
              </value>
            </observation>
          </component>
          <!--  Catalog Number  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.302"
                          extension="2019-06-21"/>
              <code xsi:type="CD" displayName="Catalog Number"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C99286"/>
              <value xsi:type="ED">
                <reference value="#CatalogNumber_1"/>
              </value>
            </observation>
          </component>
          <!--  Latex Safety  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.314"
                          extension="2019-06-21"/>
              <code xsi:type="CD" displayName="Latex Safety Status"
                    codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C160938"/>
              <value xsi:type="CD"
                     displayName="Not Made with Natural Rubber Latex" codeSystemName="NCI Thesaurus"
                     codeSystem="2.16.840.1.113883.3.26.1.1" code="C106038">
                <originalText>
                  <reference value="#LatexSafety_1"/>
                </originalText>
              </value>
            </observation>
          </component>
          <!--  MRI Safety Status  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.318"
                          extension="2019-06-21"/>
              <code xsi:type="CD" codeSystem="2.16.840.1.113883.3.26.1.1"
                    code="C106044"/>
              <value xsi:type="CD"
                     displayName="Labeling does not Contain MRI Safety Information" codeSystemName="NCI Thesaurus"
                     codeSystem="2.16.840.1.113883.3.26.1.1" code="C113844">
                <originalText>
                  <reference value="#MRISafety_1"/>
                </originalText>
              </value>
            </observation>
          </component>
          <!--  Device Status Implanted  -->
          <component>
            <observation moodCode="EVN" classCode="OBS">
              <templateId root="2.16.840.1.113883.10.20.22.4.305"
                          extension="2019-06-21"/>
              <code xsi:type="CD" codeSystem="2.16.840.1.113883.3.26.1.1"
                    code="C160939"/>
              <value xsi:type="CD" displayName="Active"
                     codeSystemName="NCI Thesaurus" codeSystem="2.16.840.1.113883.3.26.1.1" code="C45329">
                <originalText>
                  <reference value="#ImplantableDeviceStatus_1"/>
                </originalText>
              </value>
            </observation>
          </component>
        </organizer>
      </entryRelationship>
    </procedure>
  </entry>
</section>