The Clinical Laboratory Evaluation Program (CLEP), part of the Wadsworth Center, regulates clinical laboratories that perform testing on specimens originating in New York State. This oversight applies to independent laboratories, hospitals performing clinical testing, and certain physician practices. As part of its mission, CLEP provides guidance to regulated laboratories and other stakeholders on regulatory requirements and best practices. On October 22, 2026, Beverly Rauch, Director of CLEP, presented on current requirements at the Greater New York Chapter of the American Society of Clinical Pathology Annual Meeting. The chapter represents medical laboratory professionals and pathologists in the New York metropolitan area and Long Island.
Ms. Rauch reviewed new state clinical laboratory requirements adopted in September 2026. Some changes align state requirements with federal personnel standards, while others address emerging trends in the clinical laboratory industry. The regulations establish updated qualifications for clinical laboratory directors, recognize histotechnologists as a laboratory personnel category, and align with recent federal updates affecting laboratory staff. The presentation also addressed new pathways for testing outside a laboratory’s physical location. Ms. Rauch concluded with an update on the Business Express online portal, which is under development to allow laboratories to submit applications, amendments, and renewals electronically rather than via paper forms.