Limited-Time Opportunity
Submit Your Comment on Proposed Regulations
There is currently a limited-time opportunity to submit public comments on federal regulations through regulations.gov. TSPA members are encouraged to participate in this vital advocacy effort; you may use the society’s official public comment template to ensure our collective voice is heard effectively. The current active docket ID for submitting public comments on the proposed updates to CLIA personnel qualifications and virtual access regulations is CMS-2026-3235.  This format aligns with the advocacy goals of the American Association of Pathologists' Assistants (AAPA) and the ASCP, emphasizing patient safety, primary source verification efficiency, and the necessity of distinct profession-specific standards.
Submit Your Comment on Proposed Regulations
The Clinical Laboratory Improvement Amendments (CLIA) personnel qualification rules are undergoing their most significant transformation in over 30 years. Following the landmark final rule that went into effect, subsequent updates and proposed changes from CMS continue to reshape laboratory hiring, roles, and verification protocols. [1, 2, 3]
The major changes dictating laboratory personnel qualifications are organized below by category:
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1. Narrower Degree & Coursework Standards
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Physical Science Exclusion: A general degree in "physical science" is no longer automatically accepted. Degrees must now align closely with biological, chemical, or medical laboratory sciences. Any other broad degree requires a granular transcript review of semester hours in biology and chemistry.Â
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Nursing Degrees Downgraded: Nursing degrees no longer qualify individuals to perform high-complexity testing.Â
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Doctoral Clarifications: The Doctor of Clinical Laboratory Science (DCLS) is now officially recognized as an acceptable doctoral degree for laboratory leadership. Conversely, MD, DO, and DVM degrees are explicitly categorized separately from non-medical PhDs to prevent qualification loopholes.Â
Talking Points for Legislators
Use these key points when communicating the importance of Pathologists’ Assistant licensure for Texas healthcare.
- Patient Safety: Licensure ensures that macroscopic tissue examinations are performed only by qualified, certified professionals.
- Accountability: Establishes clear standards for education, clinical competency, and ethical practice under state oversight.
- Efficiency: Recognizes ASCP-certified PAs as specialized physician extenders who streamline diagnostic workflows for pathologists.
- Modernization: Aligns Texas regulation with contemporary pathology practices and national AAPA/ASCP standards.