New York CLIA and State Lab Requirements

Does New York require a state lab license on top of CLIA?

New York runs its own program in place of federal CLIA. Labs owned and run by the practitioners Public Health Law 579(1) lists, testing only their own patients, file the CMS-116 through POLEP. Every other site needs a state permit or, for waived and PPM tests only, a Limited Service Laboratory registration.

• New York runs its own program in place of CLIA
• Clinical laboratory permit, or Limited Service Laboratory registration for waived and PPM-only sites
• Issued by New York State Department of Health, Wadsworth Center, Clinical Laboratory Evaluation Program (CLEP)
• Reaches labs doing only waived tests

Citation: N.Y. Public Health Law 579; Article 5, Title V

Who is exempt in New York?

Physician office labs entirely owned and operated by the medical professionals listed in PHL 579(1), testing personally or through their own employees solely for their own patients, follow federal CLIA through POLEP instead of state registration.

Citation: N.Y. Public Health Law 579(1)

What does New York charge?

Physician office labs under POLEP pay the federal CLIA fee instead. Volunteer ambulance services may ask to have the registration fee waived.

• Waived: $200 per location every 2 years for a Limited Service Laboratory registration (as of October 2026)
• PPM: $200 per location every 2 years for a Limited Service Laboratory registration (as of October 2026)

Citation: N.Y. Public Health Law 579(3)

How often does a New York lab registration renew?

• Renews every two years
• Due A registration is valid 2 years from issue; renewal materials are mailed about 3 months before it expires.

Do labs in other states need a New York license to test its specimens?

Only labs holding a New York clinical laboratory permit may test specimens from New York. A lab that needs to test a New York specimen only occasionally applies for a Single Use Permit through eCLEP.

Citation: N.Y. Public Health Law, Article 5, Title V

Does New York add a form to the CMS-116?

Limited Service Laboratory registration uses New York form DOH-4081, returned by mail with the $200 fee; New York issues the CLIA number on the registration certificate.

Where does a New York CMS-116 go?

• New York State Department of Health, Wadsworth Center: Physician Office Laboratory Evaluation Program for physician office labs; Clinical Laboratory Evaluation Program (clep@health.ny.gov, (518) 485-5378) for all other labs
• Email: clia@health.ny.gov
• Phone: (518) 485-5352