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Highlights
Developing regulatory requirements for genetic
testing Under CLIA
Currently, laboratories performing genetic testing are subject to the
general provisions of CLIA. To provide greater assurance of quality
genetic testing, the CDC and Center for Medicare and Medicaid Services
(CMS), in consideration of the advice of the Clinical Laboratory
Improvement Advisory Committee (CLIAC), are developing specific
requirements for a genetic testing specialty under CLIA. A Notice of
Proposed Rule Making for a genetic testing specialty under CLIA is
currently under development, and is expected to be published in the
Federal Register in 2002.
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