Compliance Review Program | Compliance and Privacy Services

The Research Compliance Review Program consists of a three-prong routine audit methodology that evaluates policy compliance related to research billing and patient privacy for individual studies. The Program is designed to evaluate and correct billing and privacy practices early in a study’s life cycle and to identify study’s that warrant subsequent validation audit. The methodology may also be leveraged for workplan and for-cause audits.

Focus

Study Initiation Review
- Study Minimum Footprint in OnCore
- Research Billing Plan
Patient Zero Review
- Privacy Practices & Activities
- Subject Management in OnCore
- Order and Encounter Association in Epic
- Research Billing in Epic
Patient n Review
- Privacy Activities
- Subject Management in OnCore
- Order and Encounter Association in Epic
- Research Billing in Epic

Eligibility

Study Initiation Review
- Conduct of the protocol will result in billable charges in Epic.
- A subject (Study Initiation Subject) has enrolled beyond screening.
Patient Zero Review
- Study Initiation Review was conducted.
- Billing sample review period has passed for Study Initiation Subject.
Patient n Review
- Study Initiation Review was conducted.

Selection

Study Initiation Review
- Randomized amongst all studies meting criteria each month.
Patient Zero Review
- All studies that had a Study Initiation Review completed within 90 days will be stratified and randomized to determine the order of study selection each month.
Patient n Review
- Compliance Rate below institutional average for more than one component from either the Study Initiation or Patient Zero Reviews.
- Only a subset of studies that had Study Initiation or Patient Zero reviews.

Elements

Study Initiation Review
- Review Study’s:
  - OnCore Study Build
  - QCT Checklist
  - Billing Grid Elements
Patient Zero Review
- Review Study Initiation Subject's:
  - Privacy Practices
  - ICF and HIPAA Authorization
  - EMR Research Functionality
  - Charge Review and Disposition
  - Billing sample defined as 90 days from first charge or 10 DOS.
Patient n Review
- Review up to 5 subjects:
  - ICF and HIPAA Authorization
  - EMR Research Functionality
  - Charge Review and Disposition
  - 90-day billing sample defined for each subject.

Communication

After an eligible study is selected for review, an engagement email is sent to the responsible team describing the audit and reason for selection. The responsible team is comprised of individuals who were involved in the work under review and will receive communications during the review. An interactive close-out meeting is held with the responsible team when the audit results are available. The responsible team has the opportunity to review and refute the audit report before corrective actions are assigned. The draft report and corrective actions are issued after concurrence on the report content is received from the responsible team.

The primary policies assessed during the audit include:

Policy non-compliance observed during auditing activities is assigned mandatory root cause analysis and corrective action. Links to relevant documented best practices, summary of policy or workflow updates, and guidance are included in audit reports and communications to support the researchers in performing corrective actions and implementing process improvement. Additionally, targeted educational resources and/or customized education are provided during the course of the audit and as warranted as a component of the corrective action plan.

Compliance Review Program | Compliance and Privacy Services | UC Davis Health