Research Compliance Review Program
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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
- Privacy Practices & Activities
- Study Minimum Footprint in OnCore
- Research Billing Plan
- OnCore-Epic Subject Association Workflows
- Patient Zero Review
- Subject status management in OnCore
- Order and Encounter Association in Epic
- Research Billing in Epic
- Patient n Review
- Privacy Activities
- OnCore-Epic Subject Association Workflows
- Subject status 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
- Only a subset of studies that had Study Initiation review.
- 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:
- Bridge or OnCore Study Entry
- Billing Grid Elements
- Billing Grid Payor Designation
- Medicare Coverage
- Privacy Practices
- ICF and HIPAA Authorization
- OnCore – Epic Association Workflow
- Review Study’s:
- Patient Zero Review
- Review Study Initiation Subject's:
- EMR Research Functionality
- Charge Review and Disposition
- Billing sample defined as 90 days from first charge or 10 DOS.
- Review Study Initiation Subject's:
- Patient n Review
- Review up to 5 subjects:
- ICF and HIPAA Authorization
- OnCore – Epic Association Workflow
- EMR Research Functionality
- Charge Review and Disposition
- 90-day billing sample defined for each subject.
- Review up to 5 subjects:
The primary policies assessed during the audit include:
- Policy 1502: Charging for Research Studies
- Policy 2306: Legal Medical Record Content/Core Elements
- Policy 2317: Documentation of Research Patient Status in the Electronic Medical Record
- Policy 2410: Allowable Uses and Disclosures for Protected Health Information
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.
An interactive close-out meeting is held when the audit results are available. The research team has 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 study team.