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5 Things You Must Know about Lab Compliance Before 2021

The COVID-19 pandemic has made 2020 a year unlike any other for laboratories in the United States, and all indications are that COVID-19 testing volume will remain high, if not continue to steadily increase, well into 2021. As patients continue to seek testing for other conditions as well – an area where labs may also see an increase in volume in 2021 following a reduction in the earlier part of 2020 – many labs could be poised to see significant revenue growth in the new year.

However, as labs continue to play a critical role in the nation’s response to the COVID-19 crisis, and as concerns about COVID-19 testing fraud are garnering the attention of federal authorities, all labs are going to need to prioritize compliance going forward. With this in mind, here are five key aspects of compliance for labs heading into 2021:

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Ray Yuen

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Dennis A. Wichern
Dennis A. Wichern

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1. Thorough Compliance Documentation is Absolutely Critical

When it comes to toxicology and clinical laboratory compliance, thorough documentation is critical not only to establishing compliance, but to proving compliance as well. Many labs will face inquiries from the U.S. Department of Justice (DOJ) and other federal authorities in 2021, and those that have comprehensive compliance documentation on hand will be in the best position to resolve these inquiries without further consequences.

2. All Labs Should have a Designated Compliance Officer

In order to ensure that all compliance policies and procedures are being followed, labs should designate a compliance officer who is tasked with maintaining accountability. This must be more than a designation in title only—the compliance officer must actually perform accountability functions, and he or she must have time devoted to the compliance officer role.

3. Compliance Needs to Be Emphasized and Implemented from the Top Down

In today’s world, labs truly need to foster a culture of compliance. Company leadership need to set the example, and appropriate compliance training should be provided to personnel at all levels of the organization. From the executive leadership team to billing staff, and from clinicians to administrative personnel, all employees need to have a clear understanding of their respective roles in the lab’s ongoing compliance efforts.

4. Compliance is about More than Just Billing and Medical Records

While billing and medical records compliance are certainly important areas of compliance, they are far from the only issues that require consideration. Financial relationships with health care providers, advertising, and establishing medical necessity are just a few of numerous other areas that must be thoroughly addressed in a laboratory compliance program

5. Unawareness is Not an Excuse for Non-Compliance

While the legal and regulatory hurdles that laboratories face are both complex and constantly evolving, this does not mean that lab owners and executives have leeway when it comes to compliance. To the contrary, federal authorities expect labs to affirmatively and proactively take measures to ensure that they are maintaining full compliance with all pertinent requirements on an ongoing basis. If the DOJ or another federal agency decides to look into your lab’s practices in 2021, asserting that you were unaware of the latest regulatory requirements is not going to serve as a viable defense.

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