Earlier this month, the CMS CLIA office released memorandum 23-05-CLIA outlining procedural guidance for the use of form CMS-116. The memo summarizes what laboratory changes require a new CMS-116 form to be completed, and when written notification of a change is sufficient. Providers should access memo 23-05-CLIA for a complete list of laboratory changes requiring a new CMS-116 form, versus written notification of change.
According to CMS record retention policies, form CMS-116 needs to be kept for at least seven years.