Lab Compliance

Ensuring Regulatory Adherence

Laboratories must comply with a range of regulations from various bodies, including the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Occupational Safety and Health Administration (OSHA). These regulations cover a wide array of areas, from personnel qualifications and quality control to data integrity and safety standards.

Our legal team is well-versed in the intricate requirements that laboratories face. We work with you to develop and implement compliance programs that not only meet regulatory standards but also enhance the efficiency and reliability of your lab operations.

Comprehensive Compliance Support

Navigating laboratory compliance can be challenging, especially with the constant evolution of regulations and the intricate requirements set forth by federal and state authorities. Laboratories must maintain a delicate balance between meeting stringent regulatory standards and managing day-to-day operations efficiently. Any misstep in compliance can lead to significant legal and financial consequences, including fines, penalties, and even the suspension of operations.

Our team understands the complexities involved in this process and provides expert guidance tailored to your lab’s specific needs. We work closely with you to identify potential areas of risk, streamline compliance processes, and implement robust systems that ensure ongoing adherence to regulatory requirements. By focusing on both immediate compliance needs and long-term operational sustainability, we help your lab not only meet the current standards but also stay ahead of future regulatory changes. Our comprehensive approach is designed to ensure that your lab operates smoothly, with minimal disruption, while maintaining the highest standards of accuracy and reliability in testing. Our services include:

• Compliance Program Development – We assist in creating robust compliance programs that align with federal and state regulations, ensuring your lab operates within the legal framework.
• Regulatory Audits – Our team conducts comprehensive audits to assess your current compliance status, identify gaps, and provide actionable recommendations to address potential issues.
• Licensure and Certification Assistance – We help you obtain and maintain necessary licenses and certifications, such as CLIA certification, to ensure your lab meets all legal requirements.
• Billing and Coding Compliance – We offer support in ensuring you lab’s billing practices are compliant with Medicare, Medicaid, and other payer requirements, including CPT, ICD-10, and HSPC coding.
• Policy and Procedure Development – We help draft and implement policies and procedures that ensure ongoing compliance, from daily operations to handling unexpected challenges.
• Training and Education – We provide training programs designed to keep your staff informed about the latest compliance requirements and best practices, reducing the risk of non-compliance.