New York

New York Health Authority, Public Health Division. Clinical Laboratories. 
Wadsworth CLEP            Wadsworth POLEP

New York has a partially exempt status. New York State-licensed laboratories are exempt from CLIA requirements for six years if they have a valid permit under the New York State Public Health Law.

As a general rule, all clinical laboratories operating in New York State must be authorized by the Clinical Laboratory Evaluation Program (“CLEP”) unless they fall within one of the enumerated statutory exceptions of N.Y. Public Health Law § 579.1. Clinical laboratories operated by a licensed physician who performs lab tests or procedures “solely as an adjunct to the treatment of his or her own patients” are exempt from CLEP certification. Instead, such physician-owned labs are certified and inspected by the Physician Office Laboratory Evaluation Program (“POLEP”).

This exemption is applicable only to labs that are operated by an individual health care provider or an independently owned and managed partnership or group practice.

A lab performing moderate and/or high level clinical or forensic testing, the lab must obtain a valid clinical laboratory permit from CLEP. 

Before applying for a new permit, the director of the lab must obtain a valid certificate of qualification. The director must meet certain minimum qualifications in the applicable area of testing and must demonstrate to the department that he or she possesses the “character, competence, training, and ability to administer properly the technical and scientific operation of a clinical laboratory.” The required director qualifications differ for each category of service that the lab may offer. 

1. CLIA Application for Certification Form CMS-116
   • The facility name on the application must match the name of your business entity registered with the IRS for the facility’s federal tax identification number (e.g., EIN, TIN).
   • If your facility is doing business as (dba) under a name that is not the same as the facility name, you must provide this information on the application.
   • Provide a landline telephone number for your facility, if available. We also strongly recommend a fax number and email address be included on page 1 of the application
2.  Disclosure of Ownership Form DOH-5793
   • IRS-issued letter showing the facility’s name and federal tax identification number (EIN, TIN). The verification letter is commonly referred to as form SS-4. If you do not have an SS-4 verification letter, contact the IRS at 1-800-829-4933 to request a copy. 
   • A copy of the director’s current license to practice in New York State, if applicable.
     • For moderate and/or high complexity testing, the director must meet federal CLIA regulation for qualifications (see links below under ‘Director requirements’). Include documents supporting the director’s qualifications with all applications for testing considered moderate and/or high complexity as classified by the FDA. 
3.   If you have a management contract, please submit a copy with your application. If you do not have a management contract, please include a statement to that effect. You may email clia@health.ny.gov to provide this statement.
   • Management contract: Any laboratory that is operated and/or managed by an individual or entity on behalf of the owner must provide a copy of the written agreement (management contract) setting up the business relationship.

Specific sections pertaining to physician office laboratories (POLs) in New York State include:

• Section III: The only type of laboratory accepted in this program is a physician office.
• Section V – Multi-Site Exemption: This section does not apply to POLs in New York State. You may only test patients of your medical practice for the purposes of treatment and diagnosis. If you have questions related to testing at different locations, please contact the program at clia@health.ny.gov. 
• Section IX – Laboratory Types: POLs are Proprietary/For Profit. If the facility type does not meet this requirement, submit your application through the Clinical Laboratory Evaluation Program.

(1) Director requirements:

• Qualification requirements for Laboratory Directors for a Moderate Complexity Laboratory
  • Online course for new laboratory directors to qualify as Directors of Moderate Complexity Laboratories
• Qualification requirements for Laboratory Directors for a High Complexity Laboratory
  • Acceptable Board Certifications

Online Access to CLIA Certificates

CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool.  All certificates generated after September 27, 2023 should be available for download.  Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top).  When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.