What does CLIA mean?
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are Unite States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
What does CLIA do?
CLIA Program sets standards and issues certificates for clinical laboratory testing
CLIA was set up to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.
CLIA defines a clinical laboratory as any facility, which performs laboratory testing on specimens derived from humans for the purpose of providing information for:
• Diagnosis, prevention or treatment of disease or impairment
• Health Assessments
Centers for Medicare and Medicaid Services (CMS) have the primary responsibility for the operation of the CLIA Program.
Sober Living Facilities & CLIA
Facilities performing drug or alcohol testing and/or screening where the test results are used for the purpose of referring, offering, or making available to the test subjects treatment, must either obtain an appropriate CLIA certificate and meet the applicable CLIA standards or cease testing until they do so.
Additionally, a sober living home will need to use CLIA waived products if the test is conducted in order to determine whether an individual can continue to participate/reside at the sober house.
Use of NON CLIA products and possible actions
Using a forensic only test in a diagnostic manner without a CLIA-waived product would subject an entity to the penalties and sanctions under CLIA, this could include revocation of CLIA certificate or prohibition on obtaining a certificate for the facility and any owners/operators involved. State law may also have additional penalties including monetary penalties.
What does “Forensic Use Only” mean?
“Forensic use only” is a category of drug tests which may only be sold to companies or agencies within the criminal justice system for a purpose relevant to legal proceedings.
CLIA is specific for testing that is done “with respect to its applicability to facilities that conduct testing for the medical diagnosis and treatment of individuals.” Forensic testing is excluded under CLIA since forensic testing is conducted to determine if there has been a violation of the law and is not done for the purpose of providing remedial treatment.
*Information provided on this site is for reference only and should not be construed as legal or binding advice.
References:
• CLIA related Federal Register and Code of Federal Regulation Announcements, and the FDA’s Clinical Laboratory Improvement Amendments (CLIA). Accessed Nov. 14, 2015.
• CLIA Program homepage
• Jump up to:a b “CLIA Overview”. CMS. 11 April 2018.
• “Laboratory Developed Tests”. FDA. 26 March 2018.
• “CLIA Waived IVD Regulatory Assistance”. November 2007. Archived from the original on 2012-12-05. Retrieved 2012-12-10.