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) 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._[2]
  • 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:

• 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_[4].
  • 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_[5] to the fax or email to the right.