New York State Public Health Law requires all individuals designated as a director at a clinical laboratory or blood bank (holding or applying for a NYS permit) to hold a Certificate of Qualification (CQ).
Under New York State Regulations (Subpart 58-1 and Subpart 58-6):
- Laboratory Directors must hold a Laboratory Director CQ.
- Technical Directors (individuals responsible for specific permit categories) must hold a Technical Director CQ in the corresponding category(ies).
- Important Note: A Laboratory Director CQ does not authorize you to oversee specific permit categories; a Technical Director CQ is required for category oversight. Qualified individuals may apply for both certificates separately.
Transition and Application Status
We are now accepting applications for both Laboratory Director and Technical Director CQs. The formal repeal of Part 19 and the adoption of Subpart 58-6 (Title 10 of the NYCRR) is anticipated for late August 2026.
Please review the scenarios below to determine how these changes affect you:
- If your CQ expires July, August, or September 2026 (and you already submitted a legacy renewal): You will receive a notification regarding your renewal. You will be required to reapply using the new application format. Your previously submitted application fee will be applied to only one application under the new format (either the Laboratory Director or the Technical Director CQ).
- If your CQ expires after September 2026, you meet Subpart 58-6 requirements, and you currently serve as Laboratory Director: You may continue to serve in your role. You must apply for the new Laboratory Director CQ approximately 60 days before your current certificate expires.
- If your CQ expires after September 2026, you DO NOT meet Subpart 58-6 requirements, and you currently serve as Laboratory Director: You are not eligible for the new Laboratory Director CQ. The laboratory must transition to a qualified Laboratory Director who meets Subpart 58-6 requirements by January 1, 2027.
- If your CQ expires after September 2026 and you currently serve as an Assistant Director/Technical Director: You may continue to serve in your role. You must apply for a Technical Director CQ approximately 60 days before your current certificate expires.
- If you hold a legacy CQ and a new request is submitted for you to serve as a Laboratory Director: You must immediately submit a Laboratory Director CQ application and a $150 fee. You are not authorized to serve as the Laboratory Director until the new certificate is officially issued.
If you have any questions, please contact us at clepcq@health.ny.gov.