Subpart T--Consultations
Source: 57 FR 7185, Feb. 28, 1992, unless otherwise noted.
Sec. 493.2001 Establishment and function of the Clinical Laboratory
Improvement Advisory Committee.
(a) HHS will establish a Clinical Laboratory Improvement Advisory
Committee to advise and make recommendations on technical and scientific
aspects of the provisions of this part 493.
(b) The Clinical Laboratory Improvement Advisory Committee will be
comprised of individuals involved in the provision of laboratory
services, utilization of laboratory services, development of laboratory
testing or methodology, and others as approved by HHS.
(c) HHS will designate specialized subcommittees as necessary.
(d) The Clinical Laboratory Improvement Advisory Committee or any
designated subcommittees will meet as needed, but not less than once
each year.
(e) The Clinical Laboratory Improvement Advisory Committee or
subcommittee, at the request of HHS, will review and make
recommendations concerning:
(1) Criteria for categorizing nonwaived testing;
(2) Determination of waived tests;
(3) Personnel standards;
(4) Facility administration and quality systems standards;
(5) Proficiency testing standards;
(6) Applicability to the standards of new technology; and
(7) Other issues relevant to part 493, if requested by HHS.
(f) HHS will be responsible for providing the data and information,
as necessary, to the members of the Clinical Laboratory Improvement
Advisory Committee.
[57 FR 7185, Feb. 28, 1992, as amended at 58 FR 5237, Jan. 19, 1993; 60
FR 20051, Apr. 24, 1995]
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