Subpart 58-1 of Title 10 of the New York State Codes, Rules and Regulations (NYCRR) was amended, and new Subpart 58-6 was adopted on September 2, 2026.
Subpart 58-1 is amended to update the requirements for the issuance of a clinical laboratory permit and expectations of both the laboratory director and technical directors incorporating the changes proposed in Subpart 58-6. Other amendments to these regulations include the addition of the title ‘histotechnologist’ as a recognized clinical laboratory practitioner in accordance with Education Law and recognition of this title as a qualified supervisor in histopathology; changes to the retention requirements for specimens and testing documentation; removal of references to the now obsolete cytopathologist registry; clarification on collecting stations, mobile collecting stations, transfer stations and health fairs, and removing the prohibition on testing at a collecting station in order to allow CLIA-waived testing to occur under a valid limited service laboratory registration.
Subpart 58-6 replaces Part 19. In this rulemaking, two types of Certificates of Qualification for laboratory directorship are outlined. This amendment aligns state regulations with the federal rules for laboratory directorship as established in Title 42, Part 493 of the Codes of Federal Regulations. Briefly, the regulation establishes a ‘Laboratory Director Certificate of Qualification’ for those individuals who are physicians or earned doctoral degree holders and hold certification from a board recognized by the federal Health and Human Services agency. This certificate will entitle the holder to serve as laboratory director. The regulation also establishes a “Technical Director Certificate of Qualification” for those individuals who are physician or earned doctoral degree holders who meet minimum training and/or experience expectations in one or more categories/specialties of testing and may or may not be certified by a recognized board. This certificate will entitle the holder to provide technical oversight of a given category held on the clinical laboratory permit. The laboratory director may qualify for both Certificate types. Please see our Certificate of Qualification (CQ) Requirements & Transition Guidelines webpage for more information