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About CLIA cliawaived.com 4332 Corte De La Fonda San Diego, CA 92130 Telephone: 858-481-5031, Email: info@cliawaived.com CLIAWaived.com has provided many helpful links below for your review. If you need any help locating or purchasing a CLIA waived device please contact us by email at info@cliawaived.com or call us toll free at 888-882-7739. Background about CLIA The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specifiedthat laboratory requirements be based on the complexity of the testperformed and established provisions for categorizing a test as waived.Tests may be waived from regulatory oversight if they meet certainrequirements established by the statute. On February 28, 1992,regulations were published to implement CLIA. In the regulations, waivedtests were defined as simple laboratory examinations and procedures thatare cleared by the FDA for home use, employ methodologies that are sosimple and accurate that mistakes are unlikely and negligible; or poseno reasonable risk of harm to the patient if performed incorrectly. To view a listing of waived tests click one of the links below: Waived tests Waived Analytes 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 Federalrequirements. If any entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program. How do I apply for a CLIA Certificate? CLICK HERE How do I contact my state office? CLICK HERE |
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