Seven Fundamental Elements of a Voluntary Compliance Program

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The page below is a sample from the LabCE course Medicare Compliance for Clinical Laboratories. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Medicare Compliance for Clinical Laboratories (online CE course)
Seven Fundamental Elements of a Voluntary Compliance Program

The U.S. Department of Health and Human Services OIG has identified these seven fundamental elements of an effective compliance program:

  1. Written Policies and Procedures
  2. Compliance Leadership and Oversight
  3. Training and Education
  4. Effective Lines of Communication with the Compliance Officer and Disclosure Program
  5. Enforcing Standards: Consequences and Incentives
  6. Risk Assessment, Auditing, and Monitoring
  7. Responding to Detected Offenses and Developing Corrective Actions Initiatives
An example of a Voluntary Compliance Program based on these seven fundamental elements follows on the next several pages.