Are there certain CLIA forms to complete when reporting changes to a CLIA certificate?
The CMS form 116 (PDF, 458 KB) available on the CMS Web site for CLIA may be used to report any change of information on the current CLIA certificate. A laboratory must complete a new form 116 when upgrading the laboratory testing menu from waived or provider performed microscopy (PPMP) to non-waived (moderate or high complexity). The 116 form must be signed by the laboratory director on the last page (page 4). Documentation of experience and/or education of the lab director must accompany the application. Laboratory director qualifications may be found at the CLIA website.
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