New York State Public Health Law requires that all individuals designated as director at a clinical laboratory or blood bank holding or applying for a New York State clinical laboratory permit hold a Certificate of Qualification. Proposed Regulations at Subpart 58-1 and Subpart 58-6 will require all individuals serving as the laboratory director to hold a Laboratory Director Certificate of Qualification. Those same proposed regulations will require that one or more individuals be assigned responsibility for each category sought for a clinical laboratory or blood bank permit and those individuals must hold a Technical Director Certificate of Qualification in the corresponding category(ies). 


Note: A Laboratory Director Certificate of Qualification will not authorize the individual to be assigned responsibility for a permit category; rather a Technical Director Certificate of Qualification must be obtained.  A single individual may separately apply for both a Laboratory Director Certificate of Qualification and a Technical Director Certificate of Qualification. 


**NEW** On June 24, 2026, approval to repeal and replace Part 19 of Title 10 of the New York, Codes, Rules and Regulations was granted by the Public Health and Health Planning Council. In anticipation of the formal repeal of Part 19 and the adoption of new Subpart 58-6 of Title 10 of the New York, Codes, Rules and Regulations via publication in the State Register, the Clinical Laboratory Evaluation Program is temporarily suspending the processing of Certificate of Qualification applications. We anticipate adoption of Subpart 58-6 in the third quarter of 2026. 

  • No new Certificate of Qualification Applications or Applications to Amend Certificate of Qualification are being accepted at this time. Please visit this website for future updates.  
  • Initial Certificate of Qualification Applications received prior to June 24, 2026, will be processed. 

Note: After the Certificate of Qualification is granted any request to serve as a Laboratory Director requires the submission of a Laboratory Director Certificate of Qualification application and a fee of one hundred and fifty (150) dollars, once those applications are available.  

  • If you currently hold a Certificate of Qualification and your Certificate of Qualification is scheduled to expire in July, August, or September 2026 and you have already submitted a renewal under the current process, you will receive notification regarding your renewal and will be required to reapply using the new application format once they become available. The application fee previously submitted may be applied to only one application under the new application format (i.e., either the Laboratory Director or the Technical Director Certificate of Qualification). 
  • If you currently hold a Certificate of Qualification that expires after September 2026 AND you meet requirements set forth in Proposed Subpart 58-6 for a Laboratory Director Certificate of Qualification AND you are serving as laboratory director, you may continue to serve in that role and must apply for the Laboratory Director Certificate of Qualification approximately three months before your current Certificate expires. 
  • If you currently hold a Certificate of Qualification that expires after September 2026 AND you do not meet the requirements set forth in Proposed Subpart 58-6 for a Laboratory Director Certificate of Qualification AND you are serving as a laboratory director, you are not eligible to apply for a Laboratory Director Certificate of Qualification and the laboratory in question MUST find a new laboratory director who does meet the 58-6 requirements by January 2027. 
  • If you currently hold a Certificate of Qualification that expires after September 2026 AND you are currently serving as an assistant director, you may continue to serve in the role and must apply for a Technical Director Certificate of Qualification approximately three months before your current Certificate expires. 

The proposed Subpart 58-6 of Title 10 of the New York, Codes, Rules and Regulations can be found at Repeal of Part 19 and Addition of Subpart 58-6 to Title 10 NYCRR (Certificates of Qualification for Clinical Laboratory Directors)

If you have any questions, please contact us at CLEPCQ@health.ny.gov

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