Clinical Laboratory Improvement Amendments (CLIA)
Patient test results
In 1988, the United States Congress passed the Clinical Laboratory Improvement Amendments (CLIA) to establish quality standards for laboratories working with human samples and providing medical diagnostic results.
CLIA is regulated by the Centers for Medicare & Medicaid Services (CMS).
CLIA standards were established “to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.”
Significance of Accreditation
Ultimately, CLIA accreditation means that patients undergoing DNA testing at the accredited labs will receive quality services and reliable results in a timely manner.
Although CLIA standards are high, individual states may enforce accreditation and certification programs with even higher standards for their DNA testing labs. New York State and Washington State are both exempt from CLIA accreditation because their state standards are higher than those established by CLIA.
Standards of Accreditation
CLIA applies to DNA testing facilities that are focused on medical diagnostic testing. Labs that are strictly dedicated to forensics are required to meet standards other than those outlined by CLIA.
For a laboratory to earn CLIA accreditation, it must undergo proficiency testing on all of its techniques and daily procedures for testing human samples and reporting results.
For more information about CLIA, click on any of the links below.