These items are required for initial application:
- 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.
- Disclosure of Ownership Form CMS-1513
- 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.
- For COVID testing, be specific regarding the test name and manufacturer that you intend to use at your facility. Please check the FDA EUA website to ensure that your facility is applying for the appropriate certification (e.g., tests denoted with a 'W' under authorized setting(s) are waived and can be performed with a certificate of waiver).
- All positive and negative COVID results must be reported under federal CLIA regulation. Your facility may meet federal regulation by reporting all COVID results through the department's Electronic Clinical Laboratory Reporting System (ECLRS). Please contact email@example.com to establish a connection. Guidance on COVID reporting is available at How to Report COVID-19 Laboratory Data | CDC.
- 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 firstname.lastname@example.org 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.
The application, (CMS-116, item number one above) is a federal form used throughout the United States. Specific sections pertaining it 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 email@example.com.
- 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.
All sections of the application must be filled out. Indicate 'NA' or 'No' for items that are not applicable to your facility. Annual test volumes must be estimated, as applicable, for all waived tests, provider performed microscopy procedures (PPMP) and/or non-waived testing for each specialty selected.
- Qualification requirements for Laboratory Directors for a Moderate Complexity Laboratory
- Qualification requirements for Laboratory Directors for a High Complexity Laboratory