How to get a CLIA Certificate of Waiver

Here is an explanation on how to get your CLIA Certificate of Waiver.  This is required in order to perform point-of-care tests at your pharmacy.  (Note that this is not required for collecting specimens and sending them to a lab for testing!)

 

1.  Fill out CLIA application form, CMS-116
2. Send to your appropriate state agency.

3. A very helpful video from NCPA which walks you through the process is here.

Additional information for obtaining a CLIA Certificate is available at the Centers for Medicare and Medicaid website.

Point of Care Training
A good introductory course is offered free through the CDC is here. It takes about 1 hour and is a helpful overview of the basic principles for CLIA Waived tests.