When attempting to create a Medication Allery Patient Data entry (2.16.840.1.113883.10.20.24.3.44:2014-12-01) I got the following error:

SHOULD contain zero or one [0..1] entryRelationship (CONF:1098-32910) such that it SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002) (CONF:1098-32911). SHOULD contain exactly one [1..1] Criticality Observation (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.145) (CONF:1098-32913).

I reviewed the 2016 Base QRDA-1 HL7 IG (i.e. "HL7 CDA® R2 Implementation Guide: Quality Reporting Document Architecture Category I (QRDA I); Release 1, DSTU Release 3 - US Realm, Draft Standard for Trial Use, Volume 2 - Templates and Supporting Material, June 2015") and discovered that CONF:1098-32910, 1098-32911, 1098-32913 are not defined there. In fact, Criticality Observation (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.145) is also not in that IG.

When I attempted to create the appropriate section (guided by the assertions in the ESAC provided Schematron rules) I got this error:

SHALL contain exactly one [1..1] value with @xsi:type="CD", where the code SHALL be selected from ValueSet Criticality Observation urn:oid:2.16.840.1.113883.13.275 STATIC 2015-08-01 (CONF:1198-32928).

It turns out that the Criticality Observation valueSet is not in the VOC.xml file that was provided by ESAC with their latest Schematron rules.

So, if a Medication Allergy section is submitted without a Criticality Observation section the CONF:1098-32910, 1098-32911, 1098-32913 warning is displayed but, if an attempt is made to provide the section then there is no way to avoid the CONF:1198-32928 error and the submission is rejected.