Monitoring Compliance Program Effectiveness

There’s a principle in physics that says that you can’t observe a process without changing that process. The observer alters reality, so to speak, just by observing it.

Or to quote master chef granny’s everywhere, “If you’re cookin’, you’re lookin’!”

In the science (or the kitchen) of your corporate compliance program, the reality is that things are going to go epically wrong if you’re not watching and monitoring the process. If your recently implemented compliance program is failing, it’s because you’re not watching close enough.

Once you’ve put in the blood, sweat and tears to get through the “emerging” stage, and your corporate compliance program is actually implemented, the natural reaction is to sigh in relief, breathe a little easier, wipe the sweat from your brow and call it done.

Not. So. Fast.

In recent years, the government has shifted its expectations — healthcare facilities can no longer merely have a compliance program, it has to be effective. Specifically, outcomes need to be documented within the program in order to demonstrate effectiveness. For example, if you have appropriate vendor and employee screening in place then you should be able to document — through self-monitoring — that year over year you hire and conduct business with fewer excluded individuals.

In other words, you have to show that your program is getting results, and it’s improving the screening and vetting process.

Even with this new focus on effectiveness, the government stills uses the Federal Sentencing Guidelines and the Seven Elements as a benchmark for programs under scrutiny.

The Seven Elements of a compliance program are clearly outlined in the Federal Sentencing Guidelines as:

  1. Standards and procedures

  2. Responsible Individuals

  3. Trustworthy Individuals

  4. Training and Education

  5. Monitoring and Auditing

  6. Enforcement and Discipline

  7. Response and Prevention.

According to Section 8 of the Federal Sentencing Guidelines, and other guidance over the years, an effective compliance program is “a program that has been reasonably designed, implemented and enforced so that it generally will be effective in preventing and detecting criminal conduct.” Together, these guidelines spell out the need for continuous monitoring of your compliance program, as part of a process to constantly adjust, evolve, and enhance its effectiveness.

A look at recent enforcement actions determines how the Government is assessing effectiveness in your application of the Seven Elements. Over the next few weeks, I plan to review some recent Corporate Integrity Agreements to look at how the Government is focusing on effectiveness as it relates to the Seven Elements.

Until then, start taking a closer look at your compliance program. Don’t shy away! Even ugly babies can grow into movie stars! But it all starts with monitoring the process and adjusting course to increased effectiveness as you go.

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Kesha Boykin-McLean

About the Author
Kesha Boykin-McLean

As Chief Compliance Officer, Kesha Boykin-Mclean brings over 20 years of experience in healthcare. Prior to joining VCS, Boykin-Mclean held a number of senior-level compliance roles, including managing and developing the compliance program for St. Francis Hospital in Connecticut. She was also the Division Ethics and Compliance Officer for the Hospital Corporation of America’s Gulf Coast Division where she was responsible for oversight of compliance programs for all hospitals within the division. Most recently, she served as an independent healthcare consultant, assisting hospitals with the planning and implementation of compliance programs.

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