2.
CAN I PERFORM TESTS OTHER THAN WAIVED TESTS
IF I HAVE A CERTIFICATE OFWAIVER?
No, only those tests that are CLIA-waived can be performed by a
laboratory with a Certificate of Waiver.
HOW DO I ENROLLIN OR APPLY TO THE CLIAPROGRAM?
You can enroll your laboratory in the CLIA program by completing an
application (Form CMS-116) available online at www
.cms.hhs.gov/clia
or from your local State Agency. Forward your completed application
to the address of the local State Agency for the State in which your
laboratory is located. A list of State Agencies is available at the web
site listed above. If you do not have online access and do not have
information about your State Agency, you may contact the CLIA
program at 410-786-3531 for the address and phone number of your
State Agency.
IF I HAVE MORE THAN ONE OFFICE AND PERFORM
WAIVED TESTING AT MORE THAN ONE SITE, DO I
NEED ADDITIONAL CERTIFICATES?
You will need a CLIA certificate for each site where you perform
testing unless you qualify for one of the exceptions listed below.
l
Laboratories that are not at a fixed location, that is, laboratories that
move from testing site to testing site, such as mobile units providing
laboratory testing, health screening fairs, or other temporary testing
locations may be covered under the certificate of the designated
primary site or home base using its address.
l
Not-for-profit or Federal, State or local government laboratories that
engage in limited public health testing may file a single application.
l
Laboratories within a hospital that are located at adjoining buildings
on the same campus and under common direction may file a single
application for the laboratory sites within the same physical location
or street address.
Contact your State Agency if you have questions or you are filing a
single application for more than one testing site.