Compliance Concerns: Laboratory Regulations in 2024 and Beyond

Clinical laboratories have experienced a whirlwind year of change with respect to regulations and guidance. From the U.S. Food and Drug Administration (FDA)’s final rule on laboratory-developed tests (LDTs) and its multi-year phase-in process¹ to new quality requirements for proficiency testing,² lab professionals have been making rapid adjustments to ensure that they remain in compliance with revised rules while waiting on tenterhooks for the outcomes of political shifts and legislative challenges.

Which regulatory and compliance updates have made the biggest impact on clinical labs in the past year? And will the current climate of change and uncertainty continue into 2025? To find out more, we spoke to laboratory accreditation expert Earle S. Collum, MD, FCAP, about how labs can enter the new year with confidence in their compliance.

Q: What major regulatory and compliance changes did labs contend with in 2024?

A: The biggest regulatory issue clinical laboratories faced in 2024 involved the Centers for Medicare & Medicaid Services’ publication of the final rule for personnel in laboratories, which updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA).³ The rule introduces stricter requirements for laboratory personnel; however, it also simplifies some regulations, which benefits laboratories in certain areas. Many of these simplifications, such as less stringent qualifications for moderate-complexity testing competency assessors, align with advocacy efforts by the CAP and other organizations. However, the CAP maintains higher standards in some critical areas like immunohematology. For example, the CAP requires a pathologist or other qualified MD, DO, or DPM to oversee transfusion services that require medical judgment, ensuring patient safety and quality care.

One significant regulatory change this past year impacts the qualifications for laboratory directors. Prior to December 28, 2024, a person with a doctoral degree in a physical science discipline could qualify to be a laboratory director—but, with the new update, this is no longer the case. Now, to be a director, that person also needs to have continuing education focused on topics relevant to laboratory directors’ duties (unlike in the past, when other continuing education topics were also acceptable). The new personnel rule also mandates that any experience required—usually two years of directing or supervising for high-complexity testing or one year for moderate-complexity testing—must be obtained in a laboratory performing human testing, whereas other types of laboratories also qualified before the new rule came into effect. These changes have prompted laboratories to scrutinize applicants more closely to ensure compliance.

Contributing factors to these changes include the Centers for Disease Control and Prevention’s Clinical Laboratory Improvement Advisory Committee work groups and other advocacy groups. Their efforts aimed to strike a balance between maintaining the accuracy and reliability of test results and addressing the persistent staffing shortages in clinical laboratories.

Q: What do you think will be most prominent in 2025’s regulatory and compliance landscape?

A: The new regulations’ implementation will provide an educational experience for labs and regulatory agencies. Both will face a learning curve as they navigate unforeseen challenges during the first year of enforcement. Providing the tools pathologists and laboratory leaders need to educate laboratory staff about the new rules will be crucial for a successful outcome, as will offering ample continuing education and tips for implementation. These offerings will need to be expanded and broadly communicated to all stakeholders.

I also anticipate that we will all learn from the evaluation of the pending FDA changes for LDT regulation. The challenges faced by laboratories performing LDTs appear to be daunting, but the CAP has identified groups of experts in scientific, compliance, and advocacy fields to address this task with focused vigor. Will the predicted bottlenecks from these new regulations become more problematic? Only time will tell, but I believe clinical laboratories are up to the task.

Q: From a regulatory and compliance perspective, what should lab leaders and administrators be aware of in the near future—and how can they avoid or mitigate potential issues?

A: In my opinion, laboratories that align with the CAP for their proficiency testing and laboratory accreditation will have more information to make better decisions. The CAP will keep them up to date on pending developments from a regulatory perspective. For instance, at the height of the COVID-19 pandemic, the CAP offered daily updates on regulatory and scientific recommendations via our website. This level of guidance and expediency can be expected with upcoming changes, such as the new CLIA personnel requirements and changes or clarifications to the FDA’s final rule on LDTs.

Incomplete awareness or understanding of regulatory and compliance issues can pose significant risks for laboratories. For example, risks may arise from a lack of understanding of the relationships between accrediting organizations. A hospital accreditor may have specific conditions and timelines for meeting collaboration requirements that some groups of labs may not fully understand. Educating laboratories on the regulations and assisting them with proper direction will mitigate the risk.

References:

1. 21 CFR Part 809. Medical Devices; Laboratory Developed Tests. Federal Register. May 6, 2024. https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf.
2. 42 CFR Part 493. Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance. Federal Register. July 11, 2022. https://www.govinfo.gov/content/pkg/FR-2022-07-11/pdf/2022-14513.pdf.
3. 42 CFR Part 493. Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. Federal Register. December 28, 2023. https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28170.pdf.

Earle S. Collum, MD, FCAP, is chair of the College of American Pathologists (CAP) Council on Accreditation and sits on the CAP’s board of directors. He is also medical director for Labcorp’s Mid-America division and for their Phoenix and Denver regional laboratories. Formerly director of clinical laboratories and chief of staff at St. Joseph’s Hospital and Medical Center, Collum has been a board-certified anatomic and clinical pathologist for over 40 years.