While validating Cypress for CMS108v7 and CMS190v7, Cypress was failing (Screenshot attached). It took me a while to realize that the structure of Device, Order with Negation Rationale which cypress is expecting is not in sync with that of the Implementation Guide(IG).
As per the IG, the Device Order Act says,
6. SHALL contain exactly one [1..1] entryRelationship (CONF:3343-28443) such that it
a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002) (CONF:3343-28450).
b. SHALL contain exactly one [1..1] Device Order (V4) (identifier: urn:hl7ii:2.16.840.1.113818.104.22.168.3.9:2017-08-01) (CONF:3343-28451).
Our files were generated as per IG, but when I moved the reason entry relationship outside the substance administered tags, Cypress passed.
I have attached the output file generated as per IG, and the input file provided by cypress for your reference.
Kindly clarify if we are missing something from our end.