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Title 42 Part 493 → Subpart T → §493.2001

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart T → §493.2001

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart T → §493.2001

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart T → §493.2001


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart T—Consultations


§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; 68 FR 3714, Jan. 24, 2003]