Complete Form CMS-116[1] when any of the following changes take place:
- Survey, Initial or Recertification
- Changes to the Type of Certificate
- Reinstatement or activation of a CLIA certificate
- Director changes for Certificate of Provider Performed Microscopy (PPM), Certificate of Accreditation, or Certificate of Compliance laboratories
- The CMS-116 requesting the change must be accompanied by documentation of director's qualifications and current New York license/registration if applicable
- Specialty or subspecialty change (along with changes in test volumes)
- Change in Accreditation Organization
- Ownership - In addition to the CMS-116, you must submit an Internal Revenue Service (IRS) Form SS-4 (or LTR147C) and a Disclosure of Ownership Form DOH-5793.[2] You must also submit a Bill of Sale indicating transfer of ownership from one entity to the other (even if both entities are owned/controlled by the same individual(s))
- If you have a management services agreement, please submit a copy with your application
- If you do not have a management services agreement, please include a statement to that effect
Written notification or a complete CMS-116[3] must be provided when the following changes occur:
- DBA Name of Laboratory (primary name remains same)
- Location (i.e., physical address)
- Telephone and Fax Numbers
- Email address and requests to receive future notifications via email
- Voluntary Closure/Termination
- Director Change – Certificate of Waiver (must include current New York license/registration if applicable)
Written notification must include:
- Laboratory name
- CLIA number
- Name of Laboratory Director
- Change(s) being made
- Signature of the Laboratory Director with date of signature
Send written notification or complete CMS-116[4] to the fax or email to the right.
