CLIA Laboratory Testing

Recently, ContractLaboratory.com facilitated a Test Request from a corporation setting up mobile drug sampling centers needing a laboratory for CLIA Testing. So we thought we would explain more about CLIA.

CDC scanning electron micrograph (SEM) of Borrelia hermsii bacterium
CDC scanning electron micrograph (SEM) of Borrelia hermsii bacterium

CLIA stands for the Clinical Laboratory Improvement Amendments.  These regulations are overseen  by the US Government’s The Centers for Medicare & Medicaid Services (CMS)  and  regulates all laboratory testing (except research) performed on humans in the U.S.  In the Code of Federal Regulations, it is 42 CFR 493 Standards and Certification: Laboratory Requirements”  Overall, they ensure the quality of laboratory testing.   It does this by certification and proficiency programs. While they are US regulations, International Laboratories  can also can obtain CLIA certification for their laboratories.

It addresses aspects of laboratory testing such as verification of performance specifications, training equipment maintenance, fees, tests waived, laboratory instrument calibration,  laboratory documentation quality control programs, standards for performing testing, test reporting, and personnel.

It breaks down testing by complexity and  has laboratory proficiency programs for testing such as microbiology, bacteriology, mycology, parasitology, virology, diagnostic immunology, chemistry, endocrinology, hematology,  and toxicology.

The full CLIA law can be seen here: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

If you need to find a CLIA Laboratory, visit ContractLaboratory.com to SUBMIT CLINICAL LAB TEST REQUEST