Minor Description: The following QRDA Category I templates each have statements that require a value element that contains a code attribute that must be from the Allergy/Adverse Event Type value set (2.16.840.1.113883.3.88.12.3221.6.2):
- Act Intolerance or Adverse Event Observation
- Substance or Device Allergy - Intolerance Observation
- Allergy - Intolerance Observation
Many datatype templates inherit from these three templates and define specific code attribute values. But for most of the derived templates, the specified code is not in the required value set.
The following table shows the affected templates, conformance numbers, and required codes:
| template | requirement | code |
|---|---|---|
| Diagnostic Study Adverse Event | CONF:16408 | 281647001 |
| Diagnostic Study Intolerance | CONF:16411 | 102460003 |
| Intervention Adverse Event | CONF:16413 | 281647001 |
| Intervention Intolerance | CONF:16415 | 102460003 |
| Laboratory Test Adverse Event | CONF:16417 | 281647001 |
| Laboratory Test Intolerance | CONF:16418 | 102460003 |
| Procedure Adverse Event | CONF:16420 | 281647001 |
| Procedure Intolerance | CONF:16421 | 102460003 |
| Device Adverse Event | CONF:12189 | 281647001 |
| Device Allergy | CONF:12188 | 106190000 |
| Device Intolerance | CONF:12342 | 102460003 |
| Medication Adverse Effect | CONF:14135 | 62014003 |
HL7 QRDA DSTU Comment #172 notes that Table 297 includes these codes but that the codes are not in the value set according to PHIN VADS or NLM VSAC. The issue is "Closed, Accepted" but the intended change is unclear. Is the value set in error, such that the codes should be added to it? Or are the requirements in error, such that they should specify different codes?
This issue adversely affects QRDA Category I validation due to the associated Schematron tests: When checking certain templates, Cypress 2.2.0 reports an error because the code is not in the value set, yet other Schematron tests require the specific code.