What is CLIA?
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived.

Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. On February 28, 1992, regulations were published to implement CLIA. In the regulations, "waived" tests were defined as simple laboratory examinations and procedures that are cleared by the FDA for home use, employ methodologies that are so simple and accurate that mistakes are unlikely and negligible; or pose no reasonable risk of harm to the patient if performed incorrectly.


Should I use a CLIA Waived Test?
CLIA regulations do not apply to Workplace or Correctional (eg. courts, probation, prisons, and jails) related testing programs. CLIA requirements do apply to entities that perform test on ..."materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements. If any entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program. If you fall under CLIA's requirements, the advantage of using a "CLIA waived" test is that this "waives" you from having to comply with a long list of laboratory requirements (such as quality control, training, etc.)


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