Change in Laboratory Operations

6016.1 - Change in Laboratory Operations (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Laboratory Changes that Require Submitting a New Form CMS-116 A new Form CMS-116 MUST be obtained when any of the following laboratory changes takes place: • Initial Application o When applying for the temporary testing site exception, a list of the temporary testing sites must be included on or attached to the Form CMS-116. For temporary testing sites at patient homes, no individual addresses need to be submitted but should be available upon request. • Survey, Initial or Recertification • Certificate Type Change • Reinstatement of CLIA certificate • Adding a multiple site exception, including temporary testing sites, to an existing CLIA certificate o A list of temporary testing sites must be included on or attached to the Form CMS-116. For temporary testing sites at patient homes, no individual addresses need to be submitted but should be available upon request. • Laboratory Director Change (Provider-Performed Microscopy (PPM) Certificate or Certificate of Compliance) • Type of Control (Ownership Type) Laboratory Changes for which Written Notification (at minimum) is Acceptable At a minimum, written notification must be obtained when any of the following laboratory changes take place: • Name of the Laboratory • Location (Physical location) • Location (Mailing Address) • Location (Corporate Address) • Tax ID (EIN) • Specialty or Subspecialty Change • Total Test Volume Change • Telephone and Fax Numbers • Email Address and requests to receive future notifications via email • Reinstatement- Activate without Gap • Changes to Multiple Site Information o Laboratories must submit written notification when changes occur to the number or location of temporary testing sites. For temporary testing sites at patient homes, no individual addresses need to be submitted but should be available upon request. • Change in Accreditation Organization • Voluntary Closure/Termination • Personnel-Technical Supervisor Written notification includes an email, fax, or hard copy letter. The written notification must include the laboratory’s name, CLIA number, the name of the Laboratory Director and/or Owner, the change(s) being made, and the signature of the Laboratory Director or designee. In lieu of written notification, a new Form CMS-116 form is also acceptable. Please note, that each section of the Form CMS-116 applicable to the certificate type must be completed in its entirety when a Form CMS-116 is submitted for changes. If a laboratory requests a revised certificate, the revised certificate will be issued to the laboratory once the appropriate fees are paid.