It’s been over three decades since the Centers for Medicare & Medicaid Services (CMS) last significantly revised its Clinical Laboratory Improvement Amendments (CLIA) personnel requirements. With rapid advancements in laboratory technology, evolving workforce dynamics, and the increased complexity of diagnostic testing, CMS recognized it was time for an update.
These changes—effective as of late 2024 and impacting labs throughout 2025 and beyond—set new qualification standards for lab directors, supervisors, and testing personnel. For lab leaders and healthcare providers, understanding these updates is crucial to maintaining compliance, optimizing hiring strategies, and ensuring quality patient care.
Here’s what you need to know about the latest updates and how they affect your lab operations:
Why Now?
The last major updates occurred in the early 1990s—a vastly different era for diagnostics and laboratory science. Today’s labs rely heavily on automation, molecular diagnostics, genetic testing, and increasingly diverse talent pools. CMS’s updates align standards with modern testing complexities and workforce needs, ensuring personnel have the skills and knowledge critical to maintaining quality, accuracy, and patient safety in a rapidly changing field.
Key CMS Updates at a Glance
1. Lab Directors
- Updated Qualifications:
- Physician directors must have an active medical license in the state where the lab is located and meet one of the following criteria:
- Board certification in anatomic or clinical pathology; or
- At least 1 year of documented experience supervising or directing non-waived testing plus completion of 20 hours of continuing education (CE) specifically related to laboratory director responsibilities; or
- However, under CMS’s temporary enforcement discretion memo (QSO-25-21-CLIA), allowing either at least 1 year of documented supervisory experience in non-waived testing or completion of 20 hours of CE related to lab management duties (temporary option, subject to change in future CMS guidance).
- Non-physician directors must hold doctoral degrees in relevant scientific fields with documented lab experience, supervisory experience, and meet one of the following:
- At least 1 year of documented supervisory experience in non-waived testing; or
- Completion of 20 hours of CE specifically focused on laboratory management duties.
- Physician directors must have an active medical license in the state where the lab is located and meet one of the following criteria:
- Mandatory On-site Visits: Lab directors must conduct documented, in-person visits to each lab location at least twice annually.
Why It Matters:
Clearer and stricter qualifications ensure lab directors have appropriate expertise, enhancing quality oversight and patient safety. However, these temporary flexibilities provide labs with additional pathways for compliance, particularly beneficial for labs struggling to immediately fulfill all new qualification requirements. Laboratories should document credentials and CE diligently, as these provisions are temporary, and CMS may reinstate stricter enforcement standards in future updates.
2. Supervisory Roles (Technical & General Supervisors)
- Clarified Requirements:
- Technical supervisors must hold at least a bachelor’s degree in a biological, chemical, or clinical laboratory science with defined experience levels.
- General supervisors typically require a bachelor’s degree (or associate’s degree plus additional experience) and specific lab experience.
- Competency Assessment Expansion: Experienced Medical Laboratory Technicians (MLTs) with associate degrees and sufficient experience can now perform competency assessments for both moderate and high-complexity personnel, broadening your talent pool.
Why It Matters:
Well-defined supervisory roles help labs clearly assign accountability and ensure proper oversight of testing quality and staff performance. The increased flexibility in competency assessment roles can ease staffing shortages and streamline operations.
3. Testing Personnel (Moderate & High Complexity Testing)
- Educational Standards Clarified:
- High-complexity testing personnel must have at least an associate degree in laboratory science or medical laboratory technology, or equivalent documented education and experience.
- Nursing degrees (e.g., BSN) explicitly qualify individuals for moderate—but not high—complexity testing unless supplemented with additional laboratory training.
- Recognition of Military Training: Military-trained laboratory personnel with documented experience now permanently qualify for civilian lab roles in moderate and high complexity testing.
Why It Matters:
By clearly defining educational pathways, CMS ensures testing staff possess essential scientific expertise, directly influencing patient care quality. Recognizing military training expands the qualified workforce, benefiting recruitment and diversity efforts.
4. Mandatory Continuing Education & Competency Checks
- Lab directors and supervisory personnel are strongly encouraged to maintain documented CE focused on lab responsibilities and compliance.
- Competency assessments for testing personnel are mandatory semiannually during the first year of employment and annually thereafter, with thorough documentation required.
- Note on Temporary Enforcement Flexibility: Although CE remains a critical compliance component, CMS’s recent enforcement discretion allows supervisory personnel and directors to temporarily fulfill qualification requirements through documented supervisory experience rather than mandatory CE hours. Labs should clearly document this experience as an alternative compliance pathway while continuing to prioritize ongoing education to maintain readiness for when standard enforcement resumes.
Why It Matters:
Emphasizing ongoing education and competency ensures that lab staff remain current with evolving best practices, directly impacting test accuracy, patient safety, and regulatory compliance.
Practical Tips for Smooth Compliance
- Audit Your Staff Qualifications: Review and document each team member’s credentials against updated requirements, noting any grandfathered staff and identifying educational gaps for new hires.
- Strengthen Training & Competency Programs: Enhance onboarding processes with clearly documented training protocols and regular competency evaluations.
- Document Continuing Education Carefully: Maintain detailed records of required CE, particularly for lab directors and supervisors, ensuring smooth inspections and compliance audits.
- Leverage Professional Associations: Organizations such as ASCLS, CAP, and ASCP provide valuable resources, templates, continuing education opportunities, and guidance aligned with CMS updates.
- Stay Informed & Proactive: Monitor CMS communications, regulatory announcements, and professional networks for future updates and industry trends.
Looking Ahead
The CMS updates represent an essential modernization of lab personnel standards, ensuring the quality and accuracy of clinical diagnostics in today’s rapidly evolving healthcare environment. By proactively aligning your lab with these changes, you strengthen your team’s competencies, streamline operational efficiency, and most importantly, reinforce patient trust.
Additionally, CMS has indicated plans to further clarify and potentially publish additional personnel requirements in the near future. Laboratories should remain vigilant and closely monitor upcoming CMS communications and memos, particularly given the temporary enforcement discretion provided in QSO-25-21-CLIA. Proactive preparation and clear documentation will be critical to smoothly navigating any forthcoming regulatory clarifications or adjustments.
Learn more about how Colaborate can support your laboratory by reaching out to our team today.