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
This example illustrates an example of allergy to a new drug ingredient which is in a clinical trial phase and not approved by the FDA. As a result, there is no RxNorm, NDF-RT, SNOMED or UNII code. An NCI thesaurus code is in turn used as a translation code since NCI tracks new chemotherapy drugs in clinical trial phases. Additional Notes and Assumptions: The example drug, talazoparib, was in clinical trial phase at the time of this example. It is possible for this drug to be approved at some point in the future after this C-CDA example is approved.
This file includes examples of the following templates:
<section xmlns="urn:hl7-org:v3">
<templateId root="2.16.840.1.113883.10.20.22.2.6.1"/>
<templateId root="2.16.840.1.113883.10.20.22.2.6.1" extension="2015-08-01"/>
<!-- Allergies (entries required) section template -->
<code codeSystem="2.16.840.1.113883.6.1" code="48765-2"/>
<title>Allergies, Adverse Reactions and Alerts</title>
<text>
<table>
<thead>
<tr>
<th>Allergen</th>
<th>Reaction</th>
<th>Reaction Severity</th>
<th>Documentation Date</th>
<th>Onset Date</th>
<!-- Date from observation/effectiveTime -->
</tr>
</thead>
<tbody>
<tr ID="allergy1">
<td ID="allergy1allergen">talazoparib</td>
<td>
<content ID="allergy1reaction">Dyspnea</content>
</td>
<td>
<content ID="allergy1reactionseverity">Moderate</content>
</td>
<td>April 1 2018</td>
<td>April 1 2018</td>
</tr>
</tbody>
</table>
</text>
<entry typeCode="DRIV">
<act moodCode="EVN" classCode="ACT">
<!-- ** Allergy problem act ** -->
<templateId root="2.16.840.1.113883.10.20.22.4.30"/>
<templateId root="2.16.840.1.113883.10.20.22.4.30"
extension="2015-08-01"/>
<id root="4a2ac5fc-0c85-4223-baee-c2e254803974"/>
<code codeSystem="2.16.840.1.113883.5.6" code="CONC"/>
<text>
<reference value="#allergy1"/>
</text>
<statusCode code="active"/>
<!-- This is the time stamp for when the allergy was first documented as a concern -->
<!-- Apr 1, 2018 at 10:30a ET -->
<effectiveTime>
<low value="20180401103001-0500"/>
</effectiveTime>
<author>
<templateId root="2.16.840.1.113883.10.20.22.4.119"/>
<time value="20180401"/>
<assignedAuthor>
<id root="2.16.840.1.113883.4.6" extension="12345"/>
<code
displayName="Allopathic & Osteopathic Physicians; Internal Medicine, Medical Oncology" codeSystemName="Health Care Provider Taxonomy"
codeSystem="2.16.840.1.113883.6.101" code="207RX0202X"/>
<addr nullFlavor="UNK"/>
<telecom value="tel:555-555-1234" use="WP"/>
<assignedPerson>
<name>
<given>Adam</given>
<family>Anydoc</family>
</name>
</assignedPerson>
</assignedAuthor>
</author>
<entryRelationship typeCode="SUBJ">
<observation moodCode="EVN" classCode="OBS">
<!-- allergy observation template -->
<templateId root="2.16.840.1.113883.10.20.22.4.7"/>
<templateId root="2.16.840.1.113883.10.20.22.4.7"
extension="2014-06-09"/>
<!-- Substance or Device Allergy Intolerance Observation Template -->
<templateId root="2.16.840.1.113883.10.20.24.3.90"
extension="2014-06-09"/>
<id root="4d3ac7ac-0c32-8712-b3fe-c2b268808259"/>
<code xsi:type="CD" codeSystem="2.16.840.1.113883.5.4"
code="ASSERTION"/>
<text xsi:type="ED">
<reference value="#allergy1"/>
</text>
<statusCode code="completed"/>
<!-- This is the time stamp for the biological onset of the allergy. -->
<!-- Just the year is shown since a specific month and date was not reported -->
<effectiveTime>
<low value="20180401"/>
<high value="20180401"/>
</effectiveTime>
<!-- This specifies that the allergy is to a medication in contrast to other allergies (substance) -->
<value xsi:type="CD" displayName="Intolerance to drug (finding)"
codeSystemName="SNOMED CT" codeSystem="2.16.840.1.113883.6.96" code="59037007"/>
<author>
<templateId root="2.16.840.1.113883.10.20.22.4.119"/>
<time value="20180401"/>
<assignedAuthor>
<id root="2.16.840.1.113883.4.6" extension="99999999"/>
<code
displayName="Allopathic & Osteopathic Physicians; Internal Medicine, Medical Oncology" codeSystemName="Health Care Provider Taxonomy"
codeSystem="2.16.840.1.113883.6.101" code="207RX0202X"/>
<addr nullFlavor="UNK"/>
<telecom value="tel:555-555-1234" use="WP"/>
<assignedPerson>
<name>
<given>Adam</given>
<family>Anydoc</family>
</name>
</assignedPerson>
</assignedAuthor>
</author>
<participant typeCode="CSM">
<participantRole classCode="MANU">
<playingEntity classCode="MMAT">
<!-- This drug is a clinical trial drug not approved by FDA so there is no RxNorm code -->
<!-- For non-drug substances that don't have a concept you may omit codeSystem -->
<!-- Use OTH and originalText -->
<code nullFlavor="OTH" codeSystemName="RxNorm"
codeSystem="2.16.840.1.113883.6.88">
<originalText>
<reference value="#allergy1allergen"/>
</originalText>
<!-- Include clinical trial code or local code and codeSystem in translation -->
<translation xsi:type="CD" displayName="talazoparib"
codeSystemName="NCI" codeSystem="2.16.840.1.113883.3.26.1.1"
code="C95733"/>
</code>
</playingEntity>
</participantRole>
</participant>
<!-- Only one reaction recorded here, although multiple reactions may be recorded to the same substance ([0..*] -->
<entryRelationship typeCode="MFST" inversionInd="true">
<observation moodCode="EVN" classCode="OBS">
<!-- Reaction Observation template -->
<templateId root="2.16.840.1.113883.10.20.22.4.9"/>
<templateId root="2.16.840.1.113883.10.20.22.4.9"
extension="2014-06-09"/>
<id root="fea0b775-f3fe-4e0a-9c4f-4a5c235c2af0"/>
<code xsi:type="CD" codeSystem="2.16.840.1.113883.5.4"
code="ASSERTION"/>
<statusCode code="completed"/>
<effectiveTime value="20180401"/>
<value xsi:type="CD" displayName="Dyspnea"
codeSystemName="SNOMED CT" codeSystem="2.16.840.1.113883.6.96" code="267036007">
<originalText>
<reference value="#allergy1reaction"/>
</originalText>
</value>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<observation moodCode="EVN" classCode="OBS">
<!-- Severity Observation template -->
<templateId root="2.16.840.1.113883.10.20.22.4.8"/>
<templateId root="2.16.840.1.113883.10.20.22.4.8"
extension="2014-06-09"/>
<code xsi:type="CD" codeSystemName="ActCode"
codeSystem="2.16.840.1.113883.5.4" code="SEV"/>
<text xsi:type="ED">
<reference value="#allergy1reactionseverity"/>
</text>
<statusCode code="completed"/>
<value xsi:type="CD" displayName="Moderate"
codeSystemName="SNOMED CT" codeSystem="2.16.840.1.113883.6.96" code="6736007"/>
</observation>
</entryRelationship>
</observation>
</entryRelationship>
</observation>
</entryRelationship>
</act>
</entry>
</section>