Considering New York State Certification for Your CLIA Lab?

At Connexis Search Group, we’ve been partnering with early-stage and established CLIA-certified laboratories for over two decades—helping them scale their technical, commercial, and operational teams across the U.S.

From building teams during a lab’s first round of funding to supporting expansions into new markets, we’ve staffed:

• Pathologists/Medical Directors
• Clinical laboratory scientists
• Molecular Lab Technologist
• Supervisors and lab directors
• Managed care and reimbursement professionals
• Revenue cycle
• Logistics and Accessioning
• Commercial and sales leadership
• IT and Lab Automation Engineers

As many of our clients expand testing to patients in New York, they often turn to us for guidance on what’s required to become New York State CLEP-certified and to hire technical candidates who hold NY State certification. Below is a practical overview of the certification process and how to prepare.

What "New York State Certified" Means

New York operates its own rigorous clinical laboratory evaluation program (CLEP), separate from the federal CLIA program. Any lab—even out-of-state—performing tests on New York residents must be certified by the New York State Department of Health (NYSDOH).

Types of Lab Permits in New York:

• Clinical Laboratory Permit: Required for full-service labs performing moderate or high-complexity tests.
• Limited Service Laboratory Permit: For waived tests and provider-performed microscopy.

Facility Permit Requirements-

For Clinical Laboratory Permit:

• Application + $1,100 fee ($100 app fee + $1,000 inspection fee)
• Lab director and assistant directors must hold a Certificate of Qualification (CoQ) for each testing category.
• Pre-permit inspection by CLEP required.
• Permit valid through June 30 each year; must be renewed annually.

For Limited Service Permit:

• $200 application fee
• Valid for 2 years
• No on-site inspection required

Credentials Required-

Laboratory Director:

• Must hold NYS Certificate of Qualification in each testing category.

Clinical Laboratory Technologists:

• Must hold a NYS license from the Office of Professions
• Requirements: B.S. in clinical lab science, national certification (e.g., ASCP), and $345 fee

Clinical Laboratory Technicians:

• Requires A.S. degree and national certification
• State certification fee: $245

Supervisors & Other Staff:

• Supervisory staff typically must be licensed technologists
• Non-technical staff (accessioning, client services) generally do not require state licensure

Inspections & Compliance:

• Full-service labs undergo CLEP inspection before and after approval.
• Must participate in CMS-approved proficiency testing programs.
• All labs must notify CLEP of any significant changes (ownership, director, test menu).

Application Timeline & Links:

• Clinical Lab Application: https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit
• Limited Service Lab Permit: https://www.wadsworth.org/regulatory/clep/limited-service-lab-certs
• CoQ for Directors: https://www.wadsworth.org/regulatory/clep/certificate-requirements
• Technologist Licensure (OP): http://www.op.nysed.gov

Typical processing time:

• Limited service: ~3 weeks
• Full-service: Varies based on inspection scheduling

Ready to Pursue New York Certification? Connexis Can Help.

Whether you're hiring a New York-licensed clinical lab technologist, searching for a qualified lab director with a CoQ, or staffing a full commercial team, our experienced recruiters can guide you through the process.

Contact us today at tony@connexissearch.com or visit connexissearch.com to get started.