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 LDX.

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 and directions.

• 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.

Click here to view the CLIA '88 Technical Bulletin