Make Sure Existing Compliance Policies Match Current Operations

While labs may draft a comprehensive compliance plan and policies and procedures, those policies, procedures and plan can be a liability if they aren’t being followed. There can often be “a lot of gaps between what the compliance plans say [labs] are doing and what they are actually doing,” observes health care attorney David Gee, a partner with Davis Wright Tremaine. “People get ahead of themselves in terms of thinking they are doing all these great things putting in place policies and they aren’t really syncing up the policy with what practice is.” This can create a “house of cards,” warns Gee.

Having a compliance plan or policies and procedures that you aren’t actually following can create bigger problems than having no compliance program at all. “Gaps between policy and practice, if significant, can come back to bite you,” says Gee. So labs need to be monitoring, auditing and training on a continuous basis, he advises. Train staff regularly on the details of your compliance plan and your policies and procedures. Then, monitor compliance activities and audit your policies and procedures to be sure they are being followed. Ensure that what your staff is doing in terms of compliance activities matches what they should be doing according to the compliance plan and policies you have developed. When you find gaps, make adjustments as needed to either the policies or practices. It may not always be that operations that do not align with a written policy issued previously are in violation of law. Sometimes, the guidance or protocol set forth in your written compliance program or policies may not be practical or necessary in light of your current operations and resources. So it may be prudent to revise or update your program and policies to reflect those realities, while still ensuring compliance with applicable law.

David Gee and his colleague Caitlyn Forsyth will be addressing tips for implementing and maintaining laboratory compliance best practices at G2 Intelligence’s Lab Revolution, April 7, 2016, in Chandler, Arizona.