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The Clinical Laboratory Improvement Act of 1988 (CLIA 88) was passed in the USA subsequent to the publication of an article in November 1987 in The Wall Street Journal entitled "Lax Laboratories: The Pap Test Misses Much Cervical Cancer Through Labs Errors", which alerted the public to the fact that a pap smear may be falsely negative.
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Laboratories first began receiving CAP accreditation in 1964, [8] and the organization was later given authority to accredit medical laboratories as a result of the Clinical Laboratory Improvement Amendments of 1988. [9] The CAP publishes checklists containing requirements pertaining to the performance of laboratory tests.
The examination was established under Social Security Amendments of 1972 and was offered seven times from 1975 until 1987. [1] [2] The HEW/HHS exam qualified individuals to serve as high complexity general supervisors under Clinical Laboratory Improvement Amendments(CLIA) 1992 without a degree. [2]
Laboratory developed test (LDT) is a term used to refer to a certain class of in vitro diagnostics (IVDs) that, in the U.S., were traditionally regulated under the Clinical Laboratory Improvement Amendments program. [1] Laboratory-developed tests (LDTs) are a class of in vitro diagnostics (IVDs) designed, manufactured, and used within a single ...
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The Clinical Laboratory Improvement Amendments (CLIA) regulate any laboratory testing and require laboratories to obtain certificates to do any testing on human specimens for health assessment or to diagnose, prevent, or treat disease. [33]
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