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- A Notice of Intent (NOI): Genetic Testing under
CLIA - HTML, PDF,
was published in the Federal Register on May 4, 2000, advising the
public that the HHS would be preparing a Notice of Proposed Rule
Making (NPRM) to revise the CLIA regulations and to specifically
recognize a human genetic testing specialty. In an effort to solicit
public comments on the CLIAC recommendations for genetic testing and
their potential impact on laboratories, the NOI posed specific
questions on a range of laboratory issues, including general
requirements under CLIA, the definitions for categories of genetic
testing, and requirements applicable to the pre-analytic, analytic and
post-analytic phases of testing.
- In response to the publication of the NOI, 57
comment letters containing more than 800 comments were received from
professional organizations, government agencies, manufacturers, and
individual commenters. A summary of the NOI comments was reported at
the CLIAC meeting on September 28, 2000 - HTML,
PDF
- The CLIAC formed another Genetics Workgroup to
evaluate the NOI comments and provide input to assist the CLIAC in
making further recommendations on genetic testing. During a meeting on
December 7-8, 2000, the Genetics Workgroup addressed major issues
raised in the NOI comments and proposed additional recommendations
regarding establishing a genetic testing specialty under CLIA. A
report of the Workgroup recommendations was presented to the full
CLIAC at the meeting on February 7-8, 2001. The CLIAC supported the
Workgroup recommendations in general, and recommended proceeding with
development of a proposed rule based on the CLIAC-suggested
requirements for genetic testing under CLIA. A summary of the
Workgroup report and the CLIAC recommendations can be found in the
minutes of the February 2000 CLIAC meeting - HTML,
PDF
- Currently, a Notice of Proposed rule Making for a
genetic testing specialty under CLIA is under development, and will be published in the Federal Register.
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This page last reviewed: 8/19/2004
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