CLIA '88 is the Clinical Laboratory Improvement Amendments of 1988.
CLIA '88 is a series of federal laws regulating laboratory testing that were
enacted to ensure high quality, reliable, safe and accurate testing in
laboratories of all types and sizes throughout the United States. It established
new standards for laboratory personnel, quality control and quality assurance
based on the complexity and risk of the tests performed. Laboratory tests are
classified into one of three categories based on the complexity: waived,
moderate complexity, and high complexity. The Cholestech LDX System is in the
waived category. Even though the LDX is a waived piece of equipment, you
still must obtain a "CLIA certificate of waiver" to perform tests on the
Procedure for obtaining a CLIA certificate:
Call the Department of Health in your state and ask for
a CLIA application, form CMS-116. Cholestech Technical Service can give you
the address and phone number of your state department of health. Or, you may
go directly to the CMS website and print a copy of the application
Fill out the application and mail it back to your
State Department of Health. Do not send a check with your application.
The State Department of Health will put the information
into the CMS computer and this will generate a coupon for the fee, $150 for
2 years. The coupon will have your CLIA ID number on it.
When you receive the coupon with the CLIA ID number you
may start testing.
Mail in the $150 fee. If the fee is not paid, your CLIA
Certificate of Waiver will not be valid and you will not be able to obtain
Medicare reimbursement for the tests you run.
Every two years you will need to
re-register and a new
certificate will be issued.
here to view the CLIA '88 Technical Bulletin