Notification of Change in Laboratory Operations and Retention

6016 - Notification of Change in Laboratory Operations and Retention Requirements (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) When a laboratory provides written notification or, as necessary, a new Form CMS-116 concerning changes listed in section 6016.1, the SA enters the information into the CLIA Data System and retains a copy of the laboratory’s documentation (i.e., Form CMS-116). The SA must not accept oral notices of change or intent to change.