Quality matters when it comes to almost anything in life, but especially your health. Getting the wrong lab results due to sloppy laboratory practices is something that just shouldn’t happen. By being CLIA-certified, we are held to high standards for laboratory practices, lab conditions, and documentation. But what does CLIA certification mean?

 

What is CLIA? 

OmegaQuant Analytics, LLC is fully certified under the Federal Law of the United States of America called “CLIA,” which stands for Clinical Laboratory Improvement Amendments (certificate #: 43D1105229). Yes, you can check our lab CLIA compliance status (or any CLIA lab) using our certificate # (or by clicking here). Congress passed CLIA legislation in 1988 and has continued to amend the legislation up through 2003. CLIA established quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results. In the CLIA regulation, a “laboratory” is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, the impairment of, or assessment of health.

 

Why does being CLIA-certified matter?

Being CLIA certified helps us minimize laboratory mistakes to provide consistent, high quality products to help you improve your health. Our adherence to CLIA regulations means we have highly trained technicians and quality assurance protocols which means more accurate and consistent results for you. In addition, we are the only fatty acid dedicated lab in the world that is CLIA certified. When you buy tests from OmegaQuant, you expect to get accurate information about your health. We do everything we can to make sure we provide you your “true” Omega-3 Index value, the first time and every time.

 

What does a laboratory have to do to get and maintain CLIA certification? 
  1. The laboratory director must be trained in clinical chemistry and maintain certification via organizations like the American Boards of Clinical Chemistry or Bioanalysts.
  2. Employees meet certain educational standards, that their training in laboratory methods be documented, and that they are provided with continuing education.
  3. Other mandates ensure that there are quality control and quality assurance procedures, documented instrument calibration, and participation in a proficiency testing program with other laboratories.
  4. The Federal Centers of Medicare and Medicaid Services can inspect any size laboratory for adherence to the CLIA requirements. However, if a State agency has an acceptable laboratory inspection program (as South Dakota does), then that State can perform the necessary laboratory inspections, which must be done every 2 years.
  5. If that laboratory complies with all of the quality control procedures, that laboratory is then awarded a CLIA certificate. The CLIA certification means the laboratory has met all federal requirements for operating a laboratory.

(Note: Some facilities have labs that do “low complexity” testing (like those in doctors’ offices, ambulances, drug stores, etc.), and CLIA allows for these labs to apply for Waived status. We do “high complexity” testing, and, accordingly, are held to much higher standards.)

So, now you know!

These statements have not been evaluated by the Food and Drug Administration. This test is not intended to diagnose, treat, cure, prevent or mitigate any disease. This site does not offer medical advice, and nothing contained herein is intended to establish a doctor/patient relationship. OmegaQuant, LLC is regulated under the Clinical Laboratory improvement Amendments of 1988 (CLIA) and is qualified to perform high complexity clinical testing. The performance characteristics of this test were determined by OmegaQuant, LLC. It has not been cleared or approved by the U.S. Food and Drug Administration.

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