CMS Releases Procedural Guidance for CLIA Form CMS-116

Clinical Practice; CMS

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. 
Members 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. If state law says that CMS-116 forms need to be kept for a longer period or in specific formats, then state law is controlling.