QDM version 5.3 (Annotated) includes an attribute "negation rationale," indicating the reason that an action was not performed. Only QDM datatypes that represent actions (e.g., performed, recommended, communication, order, dispensed) allow the “negation rationale” attribute. The intent is to indicate a justification that such action did not happen as expected. Note that this attribute does not address the use case defining whether the clinical record contains (or does not contain) specified information. It only addresses the use case for which the clinical record contains a finding justifying that an action was not performed. The syntax in the human readable HQMF is addressed in CQL examples (https://ecqi.healthit.gov/cql) and in the MAT User Guide. Prior versions of QDM used the syntax, “Procedure, Performed not done.” The CQL expressions addressing the negation rationale attribute uses the syntax, “Procedure, not Performed.”

The following QDM datatypes allow use of the "negation rationale" attribute:
• Assessment, Performed
• Assessment, Recommended
• Communication: From Patient to Provider
• Communication: From Provider to Patient
• Communication: From Provider to Provider
• Device, Applied
• Device, Order
• Device, Recommended
• Diagnostic Study, Order
• Diagnostic Study, Performed
• Diagnostic Study, Recommended
• Encounter, Order
• Encounter, Performed
• Encounter Recommended
• Immunization, Administered
• Immunization, Order
• Intervention, Order
• Intervention, Performed
• Intervention, Recommended
• Laboratory Test, Order
• Laboratory Test, Performed
• Laboratory Test, Recommended
• Medication, Administered
• Medication, Discharge
• Medication, Dispensed
• Medication, Order
• Physical Exam, Order
• Physical Exam, Performed
• Physical Exam, Recommended
• Procedure, Order
• Procedure, Performed
• Procedure, Recommended
• Substance, Administered
• Substance, Order
• Substance, Recommended

The HL7 Clinical Quality Information Work Group recently reviewed of all QDM datatypes and attributes to determine the extent to which there are existing metadata elements referenced the HL7 FHIR and QI Core resources. The FHIR and QI Core resource maturity model helps to determine availability of these resources and metadata in use in within routine clinical care and those shared among clinical information systems. There are two FHIR resources that do not support capturing a reason an action was not performed; thus, there is no clear reference for negation rationale for several of the QDM datatypes. These include:

1. DeviceUseStatement: The QDM datatype Device, Applied is most closely aligned with the HL7 FHIR DeviceUseStatement, i.e., information indicating that a device has been used, specifying information about the device, the overall time period during which it is used and the specific time intervals when it was used. However, the DeviceUseStatement does not allow a statement about why a device may not have been used. The rationale is that there is no DeviceUseStatement if the device was not used. Thus, the only reference to negation rationale would occur during the ordering (or, perhaps recommendation) workflow. The CQI Work Group suggested the following workflow instances where negation rationale might apply:
a. Ordering workflow
An order set or event-condition-action Clinical Decision Support (CDS) rule suggests the provider order a device to be used. The provider indicates a reason for failing to comply with the recommendation. The software stores and can access the reason for non-compliance for use in evaluating the effectiveness of the order set or CDS rule, and to avoid repeatedly recommending the same action when reasons for non-compliance are acceptable.
a. Clinical care workflow
A clinician performs the task generated by the order and determines that fulfilling the order is inappropriate based on direct knowledge of the patient. For example, a nurse reviews the task to place anti-thrombotic pneumatic devices on the patient’s legs to reduce the likelihood of thromboembolic events. The nurse determines that use of the devices would be detrimental to healing the patient’s thermal leg burns. The nurse indicates the reason for failing to comply with the order in the electronic record.
The HL7 FHIR resource defining a device order or recommendation, DeviceRequest also fails to accommodate negation rationale.
It seems that both the ordering and the clinical care workflow must be accommodated.
With this rationale, HL7 FHIR resources that fail to address negation rationale include:
DeviceRequest (QDM datatypes Device, Order; Device Recommended)
DeviceUseStatement (QDM datatype Device, Applied)
Referral Request (QDM datatypes Encounter, Order; Encounter, Recommended)
Medication Request (QDM datatypes Medication, Order; Substance, Order; Substance, Recommended, Medication, Discharge)

To the QDM User Group - Please confirm that the QDM attribute "negation rationale" should persist for the QDM datatypes:
Device, Order
Device, Recommended
Device, Applied
Encounter, Order
Encounter, Recommended
Medication, Order
Substance, Order
Medication, Discharge
Substance, Recommended