New York State (NYS) regulates clinical laboratories and clinical laboratory testing under Article V, Title V of the Public Health Law.  NYS laws and regulations must be followed for all testing done in this State.

If the dentist owns his or her own practice (e.g., professional corporation) and performs tests solely for his or her own patients, then he/she must apply through the Physician Office Laboratory Evaluation Program.

https://www.wadsworth.org/regulatory/polep

Please contact them at clia@health.ny.gov.

If the dental office is owned by a domestic corporation and/or intends to perform tests on individuals who are not patients of the practice, then the dental office must apply through the Clinical LaboratoryEvaluation Program.

• Sites that will perform only CLIA-waived testscan apply for a Limited Service Laboratory registration.

https://www.wadsworth.org/regulatory/clep/limited-service-lab-certs

• Sites that will perform moderate or high complexity COVID-19 tests must apply for a clinical laboratory permit. The application information is available on our website at

https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit.

PLEASE NOTE: You must copy and paste the above links