We have noticed a discrepancy between the QRDA specifications/sample file and how the calculation engines (Cypress and QualityNet) process the data in the Device, Order Not Done data element when submitting data for the 2018 reporting period (QRDA STU Release 4).

The specifications and sample file have the Reason attribute inside the supply template. Here is an excerpt from the QRDA I Sample File for 2018 reporting period found at the eCQI Resource Center:

{{ <!-- QDM Attribute: Reason -->}}
{{ <entryRelationship typeCode="RSON">}}
{{ <observation classCode="OBS" moodCode="EVN">}}
{{ <templateId root="2.16.840.1.113883.10.20.24.3.88" extension="2014-12-01" />}}
{{ <id root="aa348c15-ce6b-4988-b33b-7ae730c710e2" />}}
{{ <code code="77301-0" codeSystem="2.16.840.1.113883.6.1"}}
{{ displayName="Reason care action performed or not" codeSystemName="LOINC" />}}
{{ <statusCode code="completed" />}}
{{ <effectiveTime>}}
{{ <low value="20140105" />}}
{{ </effectiveTime>}}
{{ <value xsi:type="CD" code="125629006" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"}}
{{ displayName="Injury of colon" sdtc:valueSet="2.16.840.1.113883.3.464.1003.113.12.1036" />}}
{{ </observation>}}
{{ </entryRelationship>}}
{{ </supply>}}
{{ </entryRelationship>}}
{{ </act>}}
{{ </entry>}}

Note that the Reason attribute is inside the supply end tag.

When we were testing our QRDA files, we found that while the file was passing validation and being fully accepted by QualityNet, the Device, Order Not Done data element was not being recognized by the Cypress Validation Utility nor the QualityNet eCQM Submission and Performance Feedback report. For instance, a patient that should be in the VTE-1 Numerator due to a Device, Order Not Done element was evaluating as being in the Denominator only.

When we moved the Reason attribute outside the Planned Supply template, the Device, Order Not Done element was being found within the Cypress Validation Utility, and the QualityNet eCQM Submission and Performance Feedback report showed the patient in the VTE-1 Numerator. Here is an excerpt from one of our test files:

{{ </supply>}}
{{ </entryRelationship>}}
{{<!-- QDM Attribute: Reason --> }}
{{<entryRelationship typeCode="RSON"> }}
{{<!-- Reason (V2) --> }}
{{<observation classCode="OBS" moodCode="EVN"> }}
{{<templateId root="2.16.840.1.113883.10.20.24.3.88" extension="2014-12-01"/> }}
{{<id root="9B1C34CD-6EF1-459D-8861-442FBE532082"/> }}
{{<code code="77301-0" codeSystem="2.16.840.1.113883.6.1" displayName="Reason care action performed or not" codeSystemName="LOINC"/> }}
{{<statusCode code="completed"/> }}
{{<effectiveTime> }}
{{<low value="20180806101800"/> }}
{{<high value="20180806101800"/> }}
{{</effectiveTime> <!Device, Order not done: Medical Reason using Medical Reason SNOMEDCT Value Set> }}
{{<value xsi:type="CD" code="397745006" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMEDCT" displayName="Medical contraindication (finding)" sdtc:valueSet="2.16.840.1.113883.3.117.1.7.1.473"/> }}
{{</observation> }}
{{</entryRelationship> }}
</act>
</entry>

I have also attached a picture comparing the change we made to the files and test files. While both pass validation, the ChangedFile.xml is evaluated as being in the Numerator and the OriginalFile.xml is evaluated as being in the Denominator.

Can someone please look into the discrepancy and verify that the Reason template should be outside the Planned Supply template? Thank you very much.