C-CDA R2.1 Validator - Unexpected Allergy Reaction Observation Conformance Error

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jess....@gmail.com

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May 1, 2018, 2:18:32 PM5/1/18
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After the recent updates to the Edge Testing Tool validator, we are seeing a validation error that we believe is incorrect. It shows up when validating documents for a Rebecca Larson test case (170.315_b1_ToC_Inp / 170.315_b1_toc_inp_sample1_v14.pdf - Discharge Summary) and several others.

Error - 

Consol Reaction Observation2 SHALL contain exactly one [1..1] value with @xsi:type="CD", which SHALL be selected from ValueSet Reaction Severity 2.16.840.1.113883.3.88.12.3221.6.8 STATIC 20170915 (CONF:NEW, formerlyCONF:1098-7335, DSTU:836)

/ClinicalDocument/component/structuredBody/component[2]/section/entry[2]/act/entryRelationship/observation/entryRelationship/observation

Line number: 1

The error indicates there SHALL be 1..1 value elements that encode the allergy severity; however, the XPath directs to our Allergy Reaction observation (templateId: 2.16.840.1.113883.10.20.22.4.9) which encodes the reaction. When debugging, we noticed that replacing the reaction value in the Reaction section with the severity value from the Severity observation satisfied the validator, but this seems incorrect. 

Can you please confirm whether this is an unexpected error with the recent update, and if so, when we could expect to see it updated within the validator?


<entryRelationship typeCode="MFST" inversionInd="true">
    <observation classCode="OBS" moodCode="EVN">
        <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="1.2.840.114350.1.13.1358.1.7.4.768076.3008" extension="2"/>
        <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/>
        <text>
            <reference value="#allergy10reaction1"/>
        </text>
        <statusCode code="completed"/>
        <effectiveTime>
            <low value="19800510"/>
        </effectiveTime>
        <value code="247472004" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:type="CD" displayName="Hives (SNOMED-CT: 247472004)">
            <originalText>
                <reference value="#allergy10reaction1"/>
            </originalText>
        </value>
        <entryRelationship typeCode="SUBJ" inversionInd="true">
            <observation classCode="OBS" moodCode="EVN">
                <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 code="SEV" codeSystem="2.16.840.1.113883.5.4" codeSystemName="ActCode" displayName="Severity"/>
                <text>
                    <reference value="#allergy10severity"/>
                </text>
                <statusCode code="completed"/>
                <value code="6736007" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:type="CD" displayName="Moderate"/>
            </observation>
        </entryRelationship>
    </observation>
</entryRelationship>
<entryRelationship typeCode="SUBJ" inversionInd="true">
    <observation classCode="OBS" moodCode="EVN">
        <templateId root="2.16.840.1.113883.10.20.22.4.28"/>
        <code code="33999-4" codeSystem="2.16.840.1.113883.6.1" displayName="Status"/>
        <statusCode code="completed"/>
        <value code="55561003" codeSystem="2.16.840.1.113883.6.96" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:type="CE" displayName="Active"/>
    </observation>
</entryRelationship>

Nate Stelzner

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May 1, 2018, 2:21:02 PM5/1/18
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I am also seeing this error. I noticed that replacing the reaction code with severity code does satisfy this validator, but it causes a Vocabulary Validation error:
Error - 

Code 6736007 does not exist in the value set(s) 2.16.840.1.113883.3.88.12.3221.7.4

jess....@gmail.com

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May 1, 2018, 5:31:07 PM5/1/18
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Below are the scenarios we’ve seen affected, as well as the two errors produced. Please let us know if there’s any additional information we can provide to assist with troubleshooting. We're very eager to see a resolution to this issue. 

 

 

Error - 

Consol Reaction Observation2 SHALL contain exactly one [1..1] value with @xsi:type="CD", which SHALL be selected from ValueSet Reaction Severity 2.16.840.1.113883.3.88.12.3221.6.8 STATIC 20170915 (CONF:NEW, formerlyCONF:1098-7335, DSTU:836)

/ClinicalDocument/component/structuredBody/component[2]/section/entry/act/entryRelationship/observation/entryRelationship/observation

Line number: 1

 

Error - 

Consol Reaction Observation2 SHALL contain exactly one [1..1] value with @xsi:type="CD", which SHALL be selected from ValueSet Reaction Severity 2.16.840.1.113883.3.88.12.3221.6.8 STATIC 20170915 (CONF:NEW, formerlyCONF:1098-7335, DSTU:836)

/ClinicalDocument/component/structuredBody/component[2]/section/entry[2]/act/entryRelationship/observation/entryRelationship/observation

Line number: 1

 

 

Sender SUT Test Data

 

170.315_b1_ToC_Amb

* 170.315_b1_toc_amb_sample1_v14

 

170.315_b1_ToC_Inp

*170.315_b1_toc_inp_sample1_v14

 

170.315_b2_CIRI_Inp

*170.315_b2_ciri__r11_sample1_v6

*170.315_b2_ciri__r21_sample1_ccd_v7

*170.315_b2_ciri__r21_sample1_ds_v7

*170.315_b2_ciri__r21_sample1_rn_v7

 

170.315_b6_DE_Amb

*170.315_gb6_de_amb_sample1_v14

 

170.315_b6_DE_Inp

*170.315_gb6_de_inp_sample1_v14

 

170.315_e1_VDT_Amb

*170.315_e1_vdt_amb_sample1_v14

 

170.315_e1_VDT_Inp

*170.315_e1_vdt_inp_sample1_v14

 

170.315_g9_APIAccess_Amb

*170.315_g9_api_access_amb_sample1_v14

 

170.315_g9_APIAccess_Inp

*170.315_g9_api_access_inp_sample1_v14

Nagesh Bashyam - Drajer

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May 1, 2018, 9:12:29 PM5/1/18
to jess....@gmail.com, Edge Test Tool (ETT)
This has been addressed as part of 2.3.1.2 update tonight. Let us know if you still experience the issue.

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Nagesh Bashyam - Drajer

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May 1, 2018, 9:17:23 PM5/1/18
to Nate Stelzner, Edge Test Tool (ETT)
This issue has been addressed as part of 2.3.1.2 update tonight.

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Nagesh Bashyam - Drajer

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May 1, 2018, 9:17:43 PM5/1/18
to jess....@gmail.com, Edge Test Tool (ETT)
This has been addressed as part of 2.3.1.2 update tonight.

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Nate Stelzner

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May 2, 2018, 8:56:18 AM5/2/18
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Looks like our tests are passing again, thanks for the fast turn-around!
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