CLIA Application for Certification: Updated CMS Form-116
Published: 11/05/2026
Sources:
- Clinical Laboratory Improvement Amendments (CLIA),
- Centers for Medicare and Medicaid Services
Relevant To:
- Ambulatory Surgical Centers,
- Rural Emergency Hospitals,
- Urgent Care,
- Behavioral Health - Inpatient,
- Clinical Laboratory,
- Community Health Centers,
- Dialysis Facilities,
- Medical Office,
- Critical Access Hospitals,
- Hospitals,
- Long Term Care,
- Ambulatory Care,
- Office-Based Surgery,
- Inpatient Rehabilitation Facility
The Centers for Medicare & Medicaid Services (CMS) has released an updated Form CMS-116, Application for Certification under the Clinical Laboratory Improvement Amendments (CLIA). The revised form takes effect on November 9, 2026.
Laboratories must use Form CMS-116 to apply for a CLIA certificate, which is required to perform testing on human specimens. The form is available on the CMS CLIA website.
The updated form asks laboratories to:
- Provide more than one valid email address to receive …