Elevating Histology: Rethinking Clinical Laboratory Regulations for Modern Diagnostic Demands

Histology is the science dealing with the structure and analysis of cells and their formation into tissues and organs. The profession is responsible for the preparation of all pathological tissue samples removed and collected from the human body for the microscopic detection of tissue abnormalities for disease diagnosis and treatment. Despite advances in immunohistochemistry, molecular diagnostics, and digital pathology, the US Clinical Laboratory Improvements Amendments (CLIA) regulations from 1988 have not evolved to reflect histology’s scientific demands, including performing complex diagnostic tasks essential to patient care. Elizabeth Chlipala from Premier Laboratory (LLC), Longmont, Colorado and colleagues argue for a national certification requirement and regulatory oversight for histologists. Citing current problems including quality issues, workforce shortages, and the need for standardized practices, these experts argue that recognizing histologists under CLIA would elevate the profession, ensure competency, and improve patient outcomes, challenging the current position of the College of American Pathologists.