§ 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.