Know What’s Really Going On

Most of the recent enforcement cases that we have discussed in G2 Compliance Advisor and our sister publications have developed out of whistleblower or qui tam claims. Often these whistleblowers worked for the organization that is the subject of the allegations. So it's a good idea "to promote internal reporting to identify and address compliance issues before they get out in the public or give rise to a qui tam action," warns health care attorney Charles C. Dunham IV, of Epstein, Becker & Green.

To do that, don't overlook the importance of one of the seven "fundamental elements" of an effective compliance program the Office of Inspector General highlighted back in its 1998 compliance program guidance for clinical laboratories— effective lines of communication. "It's important to take the initiative to know what is going on in your organization and that there are appropriate reporting structures in place," advises Kristin Carter, a health care lawyer with Ober Kaler in Baltimore.

"Lab staff with boots on the ground are going to see the issues and you want it to go up the ladder," Dunham agrees. While the message isn't new, with the number of whistleblower claims that continue to arise every year, it bears repeating. Let everyone know what your communication system is, how to submit a report of potential compliance issues, and regularly encourage them to do so. Remember, too, that the OIG guidance notes it's not just misconduct or problems you want getting reported but you also want to enable staff to seek clarification or answers "in the event of any confusion or question with regard to a laboratory policy or procedure."