[DIYbio.org ABE] What is CLIA certification and what types of labs are required to have it?

[Jason Bobe]

Reposted from: http://ask.diybio.org/questions/what-is-clia-certification-and-what-types-of-labs-are-required-to-have/

Question:

What is CLIA certification and what types of labs are required to have it?

Answer from a Biosafety Officer:

February 13, 2013

CLIA stands for Clinical Laboratory Improvement Amendments.  CLIA sets standards for laboratories performing clinical tests.  CLIA defines a clinical lab as any facility which performs lab testing onspecimens derived from humans for the purpose of providing information (1) for the diagnosis, prevention, or treatment of disease or impairment, and (2) for the assessment of health. Academic and research laboratories do not need CLIA certification. Most academic laboratories are not 'certified' by any outside agency (although state and local regulations may apply in some locations).  While not 'certified' by an outside agency, OSHA may inspect laboratories and universities have in-house Environmental Health and Safety personnel that regularly inspect laboratories to ensure a safe workplace and compliance with OSHA and other applicable regulations.

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