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CMS (formerly
HCFA) regulates all laboratory testing (except research or
forensic) performed on human specimens in the U.S. through
the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
If an RCAC performs simple laboratory tests, such as testing
for glucose in a diabetic person, it must apply for a CLIA
waiver. The number and types of tests waived under CLIA have
increased from 8 tests to approximately 45 since the implementation
of the program in 1992.
Waived laboratories must meet only the following requirements
under CLIA:
- Enroll in the CLIA program;
- Pay applicable certificate fees biennially; and
- Follow manufacturers' test instructions.
Call Sharon Abraham, WI Department of Health and Family Services,
at 608-266-5753, if you have questions.
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