The government maintains lists of individuals and companies that have engaged in activities such as healthcare fraud, patient abuse, drug diversion or other improper behavior against the government.

Obviously, you want to avoid being on these lists – they can damage your business. An organization is subject to significant civil monetary penalties and a governmental investigation if it employs an individual or does business with a company that is on these governmental lists.

It’s also worth noting that medical device companies with effective compliance programs should screen their employees and vendors against these databases.

The government mandates that the following two databases should be checked at least annually if not more frequently:

In addition, medical device companies should establish a process to screen new hires and new vendors even before a contract is signed.

The Importance of Sanction Screening

In my past life as a compliance officer, we often found healthcare professionals on the list for drug diversion or for not paying their student loans.  In one instance, we found that the company picking up the kitchen grease was placed on the list by the EPA for polluting the groundwater at their factory.

So there’s the lesson: you never know what you will find until you actually conduct the screening. It can be a laborious process to conduct the screening and oftentimes an outside vendor can be a cost effective, time saving option to seriously consider.

Additional Recommendations

In addition to sanction screening, it is also worthwhile to look at the onboarding process and identify whether criminal background checks are being performed prior to an offer being made.  The performance of criminal background checks is definitely a best practice well worth the cost.

When conducting a background check, it is imperative to be mindful of any potential discriminatory behavior and to carefully evaluate any findings.  The Equal Employment Opportunity Commission has recently investigated companies for background practices which could be discriminatory.

If you have vendors on site, it is also worth asking those companies about their screening practices.  When I was working for a health care system, our security guard recognized a person who had been hired to clean one of our office buildings as a wanted sex offender.  We immediately implemented a practice requiring companies we hired with on-site vendors to undergo a thorough background check.

It is just not worth the risk to not screen employees and onsite vendor employees.

Chris can be reached at cgingras@mcra.com.