Complete Form CMS-116 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. 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 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 to the fax or email to the right.

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