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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:
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:
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.
Drop us a line and we’ll discuss with your team.
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