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Division of Quality Assurance: Notifications & Updates |
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Attn: Clinical Laboratories (CLIA)
Procedure Guidance for Changes regarding CLIA Form CMS-116
Memorandum Summary
CMS issues Admin Info 23-05-CLIA (PDF) summarizing what laboratory changes require a new Form CMS-116 to be completed, and when written notification of a change is sufficient.
Form CMS-116 must be retained for at least seven years.
CMS is also including updated instructions for Certificate Type Changes. CMS has updated the guidance in Admin Info: 09-09-CLIA to include email addresses and deleted the guidance for potential fraudulent Form CMS-116 applications. The fraudulent Form CMS-116 information is outdated.
Contact
For questions or concerns relating to this memorandum, please contact LabExcellence@cms.hhs.gov.
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