During the COVID-19 pandemic, testing volume was at an all-time high. Even as the pandemic has eased, patients still need to be tested not just for COVID-19 but for other diseases as well. With these tests, labs will continue to play a vital role in how the nation responds to COVID-19 and other crises in the future. As a result, labs must consider how they meet those current compliance regulations. Failing to adhere to these procedures means facilities could face severe penalties, fines, and criminal investigations.
If you want to remain compliant with your lab’s protocols and procedures, schedule a consultation with the lab compliance legal team at Oberheiden P.C.
Consider these key points regarding lab compliance:
Documentation Is Necessary and Critical
Documentation establishes compliance throughout your facility and shows evidence that you adhere to all regulations. These documents are crucial for toxicology and clinical laboratory compliance. When proper documentation is not established, it could lead to inquiries from the U.S. Department of Justice (DOJ) or other federal agencies. With comprehensive compliance documentation, you will be able to resolve any issue that may arise from federal regulators, and these documents can help to prevent any legal consequences.
Dr. Nick Oberheiden
Founder
Attorney-at-Law
John W. Sellers
Former Senior Trial Attorney
U.S. Department of Justice
Local Counsel
Joanne Fine DeLena
Former Assistant U.S. Attorney
Local Counsel
Lynette S. Byrd
Former Assistant U.S. Attorney
Partner
Amanda Marshall
Former U.S. Attorney
Local Counsel
Aaron L. Wiley
Former Federal Prosecutor
Local Counsel
Roger Bach
Former Special Agent (OIG)
Gamal Abdel-Hafiz
Former Supervisory Special Agent (FBI)
Chris Quick
Former Special Agent (FBI & IRS-CI)
Kevin M. Sheridan
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Dennis A. Wichern
Former Special Agent-in-Charge (DEA)
Designate a Compliance Officer
Having the right policies and protocols in place will not mean anything if there is no one to oversee these programs. For that reason, it is critical to have a designated compliance officer. This individual can ensure that all procedures and policies are being followed. If there is an issue, the officer will be tasked to ensure accountability in the program. This individual should be able to enforce compliance policies. Some facilities may add these responsibilities to an administrator’s job. However, choosing an individual who can be devoted to these compliance tasks is vital.
Compliance Needs To Be Established at All Levels
A lab needs to have a culture of compliance within the facility. That compliance must start at the very top of the company’s leadership. These directors and leaders must set an example by providing the appropriate training for all personnel in the facility. All staff members should know and understand their role in the facility’s compliance efforts.
Focus on More Than Medical Records and Billing
Many labs believe that compliance only means having accurate records and billing statements. That is not true. While those areas are incredibly important in compliance, there are other issues to consider. Advertising, third-party provider relationships, and medical treatments are some areas that need to be addressed when creating and implementing laboratory compliance programs in your facility.
Remain Aware of All Compliance Regulations
Laws and regulations evolve constantly. Lab owners must remain in compliance even when these rules change. Federal authorities expect all labs to maintain full compliance no matter the changes to regulations. If the DOJ or another agency examines your lab practices, you cannot say you were unaware of the changes to the regulatory requirements. It is up to your lab to remain compliant. Being unaware of any change is not a defense to any accusations of wrongdoing.
Talk To Our Lab Compliance Lawyers Today
Remaining compliant is vital for any lab. If you want to ensure your practices and procedures are adhering to federal laws, reach out to the team at Oberheiden P.C. Our attorneys and consultants can discuss your current compliance program to see whether you need to implement changes or establish new protocols. Call us at 888-680-1745 or fill out the contact form today.
