Page 15 - Hensler Surgical - Biosciences Springhealth COVID Rapid Testing Packet 5_10_2020-WP

April 9, 2020

To Whom It May Concern,

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal
regulatory standards that apply to all clinical laboratory testing performed on humans in the
United States, except clinical trials and basic research.
The CLIA Certificate is the certificate that allows the laboratory to conduct moderate and/or
high complexity testing. This certificate is issued to a laboratory after an inspection that finds
the laboratory to be in compliance with all applicable CLIA requirements.
CLIA certification is required for facilities that test clinical specimens for the purpose of
diagnosis, treatment, or prevention of disease. If your facility only collects specimens to be sent
out for testing at another facility, then CLIA certification is not required for your facility.
To qualify for a certificate of waiver, your lab must only perform tests that have received the
CLIA waived status. If you meet this requirement, simply fill out the application form CMS-116
at the CMS website or from your state health. The COW is valid for two years.

CLIA waived tests are generally simple test that are non-technical. There are over 1,400 test
systems that have been waived. Most test meet the following requirements:
Employ methodologies that are so simple and accurate as to render the likelihood of erroneous
results negligible.
Use unprocessed specimens (whole blood or oral fluid)
Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
Are cleared by the FDA for home use.
If your lab is conducting only waived testing, you must have a valid Certificate of Waiver (COW)
from CLIA and your lab will not be routinely inspected. However, COW labs may be randomly
inspected as part of a compliance investigation to ensure that they are only performing waived
testing.

Carlos Encinas Ph.D., MBA
Chief Science Officer
M +1 (520) 444-2637
O +1 (480) 534-7275