Make your Voice Heard - Call to action
The regulatory landscape for laboratory personnel is shifting rapidly, and it demands our collective attention. On October 8, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) published a major proposed rule aimed at updating Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) personnel regulations.
While the rule intends to modernize standards, it introduces significant implications for the Pathologists' Assistant (PA) profession—particularly regarding who is authorized to perform gross tissue examinations.
The Big Update: Codifying High-Complexity Testing for Grossing
The primary headline of the October 8 proposed rule is an effort to codify existing Appendix C guidance, allowing gross tissue examination to be performed by any personnel meeting high-complexity testing qualifications
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Historically, Appendix C of the CLIA State Operations Manual operated as guidance rather than strict regulation. By formalizing this into the code, CMS and the CDC aim to establish a permanent regulatory baseline across all laboratory settings.
Why the TSPA is Concerned: The Misclassification Oversight
The Texas Society of Pathologists’ Assistants (TSPA) stands strongly for patient safety and clinical excellence. However, the TSPA is deeply concerned that this proposal expands grossing eligibility without addressing or recognizing the systematic misclassification of the PA(ASCP) certification.
By broadening the path to high-complexity testing qualifications without a distinct, localized requirement for specialized PA certification, federal regulations miss a critical distinction:
The Risk of Over-Simplification: Treating gross tissue examination as a generalized high-complexity test fails to account for the advanced, highly specialized surgical pathology training that certified Pathologists' Assistants undergo.
The Call for Unique Recognition: True workforce efficiency and patient safety rely on distinct, profession-specific standards rather than a broad-brush qualification path.
Our Advocacy Goals in Texas
This federal update intersects directly with the TSPA’s core mission here in the Lone Star State. As an organization, we are actively working to:
Advance State Licensure: Establish formal state licensure for certified Pathologists’ Assistants in Texas to safeguard the boundaries of our specialized profession.
Defend Patient Safety: Champion primary source verification and strict personnel benchmarks to ensure accuracy in macroscopic diagnostics.
Bridge Federal Gaps: Ensure that even if federal CLIA rules broaden, Texas healthcare standards respect the rigorous academic and clinical preparation of a certified PA.
Make Your Voice Heard: Submit a Public Comment
We cannot afford to stay silent while federal regulations shape the future of our laboratory roles. There is currently a limited-time opportunity to submit public comments on these proposed regulations through regulations.gov.
The TSPA, aligning with the national advocacy frameworks of the American Association of Pathologists' Assistants (AAPA) and the American Society for Clinical Pathology (ASCP), urges all members to take action:
Active Docket ID: CMS-2026-3235
How to Participate: Visit the official federal portal to submit your comment. TSPA members can access our official public comment template on the TSPA Licensure and Advocacy Page to ensure our collective voice is unified and impactful.
Let’s protect our profession, elevate our clinical standards, and ensure patient safety remains the top priority in Texas pathology.
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