NYSCLA Alert to Laboratories (January 2026)

Important Notice of Rulemaking from the NY DOH

Saturday, January 3, 2026 (Last updated: Aug 6 2026 21:45)

The New York Department of Health has proposed new rules that are intended to align the current CLEP standards for laboratory directors and technical supervisors with the federal CLIA standards.  The federal CLIA program has given New York State a deadline to make this alignment, and raise the laboratory director and technical supervisor certification standards to the minimum CLIA certification standards, or risk the loss of the CLIA exemption that permits New York State to administer the CLEP program.  The proposed rules are found at Proposed Regulations open for Public Comment | New York State Department of Health, Wadsworth Center and Certificates of Qualification for Clinical Laboratory Directors.pdf.  We urge laboratories and laboratory professionals to read these regulations and provide their comments by the end of February to the address provided in the weblinks.

Please note that the new standards will prevent some individuals who currently serve as laboratory directors and technical supervisors from renewing their certificates of qualification, and NYSCLA is already aware of denials of new applications for laboratory directors and technical supervisors who appear to meet the current CLEP standards but do not have the CLIA-mandated certifications.  While it appears that the New York Department of Health will need to adopt the CLIA certification standards given the federal pressure and risk to its CLIA exemption for the CLEP program, comments are critical to inform the Department of the ramifications of shrinking the eligible workforce in a current workforce shortage, and the need for an appropriate transition period.