A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is a certification that allows a facility to legally examine a person through tests in order to assess and treat a patient. CLIA certificates of waiver are issued by the U.S Department of Health and Human Services and each certificate has a ten-digit CLIA number.

The purpose of CLIA certificates is to maintain laboratory standards such as reliability and accuracy in all of the various settings that testing is performed including hospitals, pharmacies, clinics, and primarily laboratories. CLIA certificates ensure each facility abide by federal and state laws and regulations for clinical laboratory testing through biannual onsite inspections.

There are various types of CLIA certificates with each granting facilities the ability to perform different diagnostic tests.

CLIA policies are set by three government agencies that share the responsibilities: the Center for Disease Control (CDC), the Food and Drug Administration (FDA), and the Center for Medicaid Services (CMS).

Here are some of the benefits of having a CLIA waiver:

• Improved patient care: Pharmacists can provide more comprehensive and coordinated care to patients when they have a CLIA waiver in place.
  
  
• Increased opportunities for pharmacists: Pharmacists who have a CLIA waiver in place may be able to take on more advanced patient care roles, such as test-to-treat services.

Scripted handles this automatically for pharmacies. But if you prefer to do it yourself, here’s how.

A facility may apply for a CLIA Certificate of Waiver on the Center for Medicaid Services (CMS) website by filling out a CMS-116 form. The form must be completed and mailed to the local CLIA State Agency for the state in which the applying facility resides in. The CMS website also offers more details on how to apply for CLIA Certificate of Waiver.

Step by Step Instructions:

1. Open the CLIA Application for Certification CMS-116 Form.
   
   
2. Fill out sections 1-6, 9 & 10.
   
   
3. Print out the completed form and sign in ink.
   
   
4. Scan the signed form and save a copy to your computer.
   
   
5. Complete additional forms and fees as required by your corresponding state (details below).
   
   
6. Send all forms to your CLIA State Agency contact.
   
   
7. Upon the completion of application, the CMS will send your tests site’s CLIA Number once your application has been processed.

CMS charges a $150 fee for a CLIA certificate of waiver. The fees could be larger depending on size and volume of testing site. Some states also have additional fees.

The Certificate of Waiver is valid for two years. 

A renewal application will need to be completed and sent to the state agency no less than 9 months before the certificate’s expiration date.

We offer free consultancy regarding regulatory compliance in all 50 states.

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