CLIA Licenses

"CLIA" stands for the Clinical Laboratory Information Ammendment. Much of what it does is serve to recognize advancements in the area of point-of-care testing, allowing tests that had previously only been performed in a laboratory to be peformed at the point-of-care, by non-scientists.

Federal law requires a CLIA Certificate for any facility that performs testing on blood or body fluids. A Waived CLIA Certificate refers to tests in this category. Waived tests are considered simple and not very prone to error. Waived laboratories do not undergo inspections (except in very rare cases).

Why should a health club consider obtaining a CLIA License?

The decision for a health club to obain a CLIA or other type of license depends on (i) the type of health-related services the club plans on offering, (ii) the intended frequency of the services and (iii) the ecconomic model being used.

Having a CLIA License and a Certificate of Waiver ("COW") allows a health club to offer and charge their members for a wide range of routine point-of-care tests, such as Lipids, Cholesterol, Glucose, A1c, TSH (screens for hypothyroidsim) and dozens of other tests.

Depending on the type of testing being offered and the staff being used to perform the testing, it is often not necessary for a health club or fitness facility to obtain and maintain a CLIA License.

How hard is it to obtain a CLIA License?

It is very simple to obtain a CLIA Certificate of Waiver ("COW"). Our CLIA License consulting service provides a turnk-key program for obtaining a license. We assist with the filling out of your application and a fee is submitted to CLIA, who in turn sends the certificate ($150 biennial). Additional fees vary from state to state. As an example, California also requires an application and provides a certificate of registration ($113 annually).

How hard is it to maintain a CLIA License?

PreventTEST, Inc.'s staff have decades of experience working with CLIA Licenses. COW’s are simple to maintain, with proper oversight assistance. US Specialty labs provides this assistance. We provide the necessary Lab Director, personnel training, procedures and regular oversight to ensure testing and documentation is being performed properly.

How can PreventTEST, Inc help me with CLIA Licenses?

PreventTEST, Inc. and its partner US Specialty Labs, will complete the application. Our turn-key program options even include will provide equipment and reagents, testing flow protocols, personnel training as well as a Lab Director, which is necessary for CLIA.