CMS Implements First Major Updates to Lab Personnel Requirements in Over 30 Years

On December 28, 2024, the Centers for Medicare & Medicaid Services (CMS) enacted a long-anticipated final rule that significantly revises laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement Amendments (CLIA). This marks the first major overhaul since 1992, impacting all clinical laboratory personnel engaged in moderate- or high-complexity laboratory tests.
These updates are a culmination of efforts that began with a proposed rule in 2022, which drew over 20,000 comments from stakeholders in the clinical laboratory sector. The final rule also addresses proficiency testing regulations, a topic previously covered in a related article.

Key Updates to CLIA Personnel Rules for Nonwaived Tests

Lab Director Requirements: For laboratory directors holding a doctor of medicine (MD) or doctor of osteopathy (DO) degree, certification in anatomic or clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology is now mandatory. Board eligibility is no longer sufficient. Nonphysician directors must possess a doctoral degree in a relevant science field, with specific experience and continuing education requirements.
Educational Qualifications: The new rule eliminates the physical science degree as a qualifying credential for positions requiring a bachelor’s degree. Only degrees in biological or chemical sciences, or in clinical or medical laboratory technology, are recognized. Those with a physical science degree must now meet additional educational requirements.
Impact on Nurses: Nurses with a Bachelor of Science in Nursing (BSN) can perform high-complexity testing only after completing additional training in laboratory science, aligning with the requirements for an associate degree in the field.
Technical Consultant Pathways: The rule introduces a new qualification route for technical consultants, allowing individuals with an associate degree and four years of clinical experience to qualify for moderate-complexity testing roles.
Military-Trained Technicians: A permanent pathway is now established for military-trained laboratory personnel to qualify as testing personnel in moderate- and high-complexity labs, expanding opportunities for veterans.
Expanded Definition for Midlevel Practitioners: The definition now includes nurse anesthetists and clinical nurse specialists, broadening the range of professionals eligible to serve in laboratory roles.

Impact on Lab Staffing and the Future

As technology and automation become integral to laboratory operations, the updated rules aim to balance the need for qualified professionals with the realities of workforce shortages. The changes are designed to expand qualification standards while ensuring patient safety and scientific expertise.
For more detailed insights and analysis, the original article by McDermott Will & Emery, authored by Gregory E. Fosheim, provides a comprehensive overview. The full text can be accessed here.