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) procedures or Certificate of Compliance laboratories
    • The CMS-116 requesting the change must be accompanied by documentation of director qualifications 
  • Ownership - In addition to the CMS-116, you must submit an Internal Revenue Service (IRS) Form SS-4 with the EIN imprinted and a Disclosure of Ownership Form DOH-5793.
    • 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:

  • Tax ID (EIN) - In addition to the CMS-116, you must submit an Internal Revenue Service (IRS) Form SS-4 with the EIN imprinted and a Disclosure of Ownership Form DOH-5793.
    • 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. 
  • Name of Laboratory
  • Location (i.e., physical address)
  • Mailing address
  • Specialty or subspecialty change
  • Total test volume change
  • Telephone and Fax Numbers
  • Email address and requests to receive future notifications via email
  • Reinstatement or reactivation without Gap
  • Change in Accreditation Organization
  • Voluntary Closure/Termination
  • Personnel – Technical Supervisor
  • Director Change – Certificate of Waiver

 

Written notification must include:

  • Laboratory name
  • CLIA number
  • Name of Laboratory Director
  • Change(s) being made
  • Signature of the Laboratory Director

 

Send written notification or complete CMS-116 to the fax or email to the right.

Print