Hello,

When testing the manual data entry component of the C1 certification test, we are having an issue with the negated valueset criteria for the Device Ordered entry types. These negated entries always seem to fail when uploading the QRDA1 for validation.

We have attempted to adjust our QRDA1 generation process as well as manually manipulating the file and the issue persists. in comparing the device ordered entry from our manually generated QRDA1 to the QRDA1 documents in the Cypress test deck we find no significant difference between the entries. we have also tried to upload the Cypress test deck QRDA1 with the negated valueset into the manual data entry test and we are still seeing the test fail.

upon further testing its been determined that if we swap out the:
<code nullFlavor="NA" sdtc:valueSet="2.16.840.1.113883.3.117.1.7.1.214"/>

with:
<code code="" sdtc:valueSet="2.16.840.1.113883.3.117.1.7.1.214"/>

the cypress utility will then recognize the Device ordered patient refused entry, but this now yields the following errors:
Element '

code', attribute 'code': [facet 'pattern'] The value '' is not accepted by the pattern '[^\s]+'.
Element '

code', attribute 'code': '' is not a valid value of the atomic type '

cs'.
The code in codeSystem cannot be found in the declared valueset 2.16.840.1.113883.3.117.1.7.1.214

It seems as though there are 2 separate validation passes being performed on the Device Ordered Patient Refused entry and they are potentially out of sync with the expected formatting. Could this possibly be an issue in the Cypress tool and/or would there be an example of a passing entry to be used as a template?

Thank you,