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 (retired 2/17/2021). Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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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:

  • Written policies, procedures, and standards of conduct
  • A compliance officer and compliance committee
  • Effective training and education
  • Effective lines of communication
  • Standards that are enforced through well-publicized disciplinary guidelines
  • Internal monitoring and auditing
  • Prompt response to detected offenses and documented corrective action
An example of a voluntary compliance program based on these seven fundamental elements follows on the next several pages.