The National Society for Histotechnology (NSH) recently submitted formal comments to the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) in response to the federal Request for Information on modernizing the Clinical Laboratory Improvement Amendments (CLIA) regulations. NSH's recommendations focus on areas where evolving laboratory practices, emerging technologies, and advances in patient care have outpaced regulations originally established more than three decades ago.
In its response, NSH urged CMS and CDC to adopt a technology-neutral, risk-based regulatory framework that recognizes the entire histopathology testing process, from specimen collection and preparation through digital pathology and artificial intelligence-supported interpretation. NSH emphasized that quality and patient safety depend on every step of the testing workflow, not solely on the final result.
Among its key recommendations, NSH called for extending the federal retention requirement for pathology tissue blocks from two years to at least ten years, citing their growing importance for biomarker testing, precision medicine, clinical trials, research, and future diagnostic needs. NSH also advocated for greater recognition of histology professionals within CLIA, noting the critical role histotechnologists and histotechnicians play in ensuring accurate, high-quality patient results.
The comments also addressed the increasing use of digital pathology and artificial intelligence. NSH recommended that oversight of AI-enabled testing account for the entire laboratory workflow, including specimen preparation, slide scanning, image quality, software validation, and ongoing performance monitoring. The Society further emphasized the need for appropriate education, training, and competency standards for personnel involved in digital pathology and AI-supported testing.
Additional recommendations included strengthening requirements related to specimen quality, establishing clearer expectations for handling suboptimal specimens, recognizing Mohs micrographic surgery and electron microscopy as specialized testing areas, and ensuring appropriate oversight of organizations that perform digital pathology scanning and data analysis services.
NSH appreciates the opportunity to provide expert input on the future of laboratory regulation and remains committed to advocating for policies that support laboratory quality, patient safety, and the evolving role of histotechnology in modern healthcare. The Society's full comments were submitted on September 14, 2026, and can be read here.