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CLIAWaived.com is a new online business that services both Certificate of Waiver Labs and the professional community. If you need general information about us or about the CLIA program, please send an email to firstname.lastname@example.org or call us at 858-481-5031. Discounts are available for larger orders.
Background about 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. To view a listing of waived tests click one of the links below:
Who regulates the CLIA Program?
CMS (Center for Medicare
and Medicaid Services) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total CLIA covers approximately 175,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under CMS has the responsibility for implementing the CLIA Program.
Does my office or company need to apply for a certificate?
CLIA requires that all entities that perform even one test, including a waived 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.
Where do I mail my renewal fee for CLIA licensure?
Please DO NOT write a check to CLIAwaived,Inc. All checks for CLIA licensure fee's should be made payable to: "CLIA LABORATORY PROGRAM" and addressed to the appropriate state agency.
State Agency Contact Lists