Three forms are required for initial application:
- CLIA Application for Certification Form CMS-116
- Disclosure of Ownership Form CMS-1513
- IRS-issued form SS-4 with the EIN imprinted
Application begins with Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification. This is a federal form used throughout the United States. Some of the questions do not pertain in New York State for a Physician Office Laboratory (POL). For example:
- Section V - Multi-Site Exemption: CLIA numbers are site specific. Each physical location must apply for a unique CLIA number.
- 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.
However, all sections must be filled out. Indicate 'NO' for items that are not applicable. In Section 1 of CMS-116, the facility name must be a legal business entity name for the practice owner. All practice names are reviewed on the New York State Department of State's Division of Corporations website for legal business entities.
If applying for a Certificate of Waiver, check 'NO' testing performed in Section VII regarding PPM testing.
If applying for a Certificate of PPMP (Provider Performed Microscopy Procedures), list the waived testing menu and enter the anticipated annual testing volume in Section VI and list the PPM testing and anticipated annual testing volume in Section VII. PPM testing is considered moderately complex testing. Indicate the specialty and volume for each category in Section VIII. For a Certificate of Waiver or PPMP, the Laboratory Director must meet the minimal CMS requirements to be licensed to practice medicine in the State of New York.
The Physician Office Laboratory Evaluation Program also requires submission of the Disclosure of Ownership form (CMS1513) along with your EIN (Employer Identification Number) for testing performed in physician-owned laboratories. Please include the IRS-issued form (SS-4) with the EIN imprinted. Also, please indicate if you wish to do business under an assumed name.
If applying for a Certificate of Compliance, the Laboratory Director's qualifications supervising or directing a moderate or high complexity laboratory must accompany the initial application.
- Qualification requirements for Laboratory Directors for a Moderate Complexity Laboratory
- Qualification requirements for Laboratory Directors for a High Complexity Laboratory