New York State Department of Health Amends Clinical Laboratory Regulations

The New York State Department of Health (DOH) adopted substantial regulatory amendments on September 2, 2026, that directly impact clinical laboratories and blood banks operating in New York, including out-of-state laboratories. The amendments align New York's requirements with federal Clinical Laboratory Improvement Amendments (CLIA) regulations (42 C.F.R. Part 493), modernize oversight structures and update personnel qualification standards. The amendments are effective upon publication in the New York State Register, with a transition period for current laboratory directors who do not meet the new Laboratory Director Certificate of Qualification requirements to continue serving at their current facility until January 1, 2027.

New Certificate of Qualification Framework

DOH repealed Part 19 and adopted new Subpart 58-6, titled "Certificates of Qualification for Clinical Laboratory Directors." Though laboratory directors were always required to hold a certificate of qualification, the new framework formalizes two distinct certificate types with different qualification pathways aligned with CLIA requirements:

• Laboratory Director Certificate of Qualification (LDCQ). LDCQ certification is available to physicians or doctoral degree holders (Ph.D., Sc.D. or equivalent) who hold certification from a board recognized by the U.S. Department of Health and Human Services (HHS). Applicants must demonstrate that board certification and laboratory management training (at least 20 credit hours in clinical laboratory operations) occurred within the previous 10 years or that they have served as a laboratory director in an acceptable laboratory within the previous 10 years. This certificate is valid for two years and must be renewed.
• Technical Director Certificate of Qualification (TDCQ). "Technical Director" is a new designation and replaces the former "sole assistant director" role. Each laboratory will be required to have one or more technical directors holding a Certificate of Qualification in each permit category offered by the laboratory. The TDCQ certification is available to physicians or doctoral degree holders who meet minimum training and/or experience expectations in one or more categories/specialties of testing. Board certification is not required, but applicants must present evidence of experience within the previous 10 years in each category sought. This certificate entitles the holder to provide technical oversight of a specific permit category. A laboratory director may also serve as a technical director if they hold both certificates.

A laboratory director holding a certificate of qualification who does not meet the new LDCQ qualifications (for example, a doctoral degree holder who qualified under the former experience-only pathway without obtaining board certification) may continue to serve where currently employed until January 1, 2027. These directors must immediately meet the new requirements if they seek employment as a laboratory director at another laboratory after the regulation becomes effective. The application fee for certificates of qualification has increased from $40 to $150.

Additional Amendments to Part 58: Clinical Laboratories and Blood Banks

In addition to the LDCQ and TDCQ certifications, the amendments to Part 58 introduce significant changes to laboratory leadership requirements, personnel qualifications and collecting station rules.

• State Licensure Requirement for Laboratory Directors: Laboratory directors must be licensed in the state where the laboratory is located if that jurisdiction requires licensure. This is particularly important for out-of-state laboratories accepting New York specimens.
• Five-Laboratory Limit: Both laboratory directors and technical directors are limited to serving at no more than five clinical laboratories or blood banks (or any combination thereof), whether within or outside New York. In other words, if a director serves at multiple facilities across different states that each hold a New York clinical laboratory permit, all of those facilities count toward the five-laboratory limit.
• On-Site Presence Requirements: Technical directors must be on site at least on a "regular part-time basis," defined as at least eight hours per week. Requests for reduced on-site presence may be considered based on permit categories, testing volume and complexity, and performance history. Attendance records must be maintained and made available to the DOH upon request.
• Notification Requirements: Laboratories must notify DOH within 60 days of the resignation, termination, death or incapacitation of the laboratory director or technical director. Failure to do so results in voiding the permit (for laboratory directors) or voiding specific permit categories (for technical directors).
• Expanded Supervisor Qualifications: Histotechnologists and pathology assistants may now qualify as supervisors in histopathology and cytopathology, provided they have four years of relevant experience.
• Updated Testing Personnel Qualifications: For clinical laboratory technologists and technicians, references to physical science degrees have been removed, and specific coursework requirements have been incorporated for individuals not holding a required degree, consistent with federal CLIA regulations adopted in December 2023.
• CLIA-Waived Testing at Collecting Stations Now Permitted: The prohibition on testing at collecting stations (also known as patient service centers) has been removed. Laboratories may now perform CLIA-waived testing at collecting stations, provided the location is duly registered as a limited-service laboratory.

Implications for New York and Out-of-State Laboratories

Laboratories located in New York, as well as out-of-state laboratories that accept specimens from New York patients, should carefully evaluate compliance with these amended regulations. Key considerations include:

1. Verify that your laboratory director holds (or will obtain) an LDCQ and that technical directors are in place with a TDCQ for each permit category.
2. Audit the number of laboratories at which your directors serve to ensure compliance with the five-laboratory limit.
3. Establish systems for documenting technical director on-site presence.
4. If your laboratory operates collecting stations and wishes to offer CLIA-waived testing, ensure proper registration as a limited-service laboratory.
5. Ensure supervisors and testing personnel meet the updated qualification requirements, particularly for newly recognized titles like histotechnologists.

For questions regarding compliance with the amended regulations or assistance with New York state permit applications, please contact the author or your Holland & Knight attorney.