Clinical Laboratory Improvement Act

Summary

Clinical Laboratory Improvement Act - Requires, under the Public Health Service Act, the licensing of clinical laboratories, as defined by this Act. Sets forth the standards that must be met to receive and maintain such a license. Requires that such standards be designed to assure consistently accurate laboratory procedures and service. Directs the Secretary of Health, Education, and Welfare to promulgate and enforce such standards and to issue such licenses. Authorizes the Secretary to delegate regulation and licensing authority to a State if the Secretary determines that such State: (1) has adopted standards for such laboratories and a system of licensure which are no less stringent than the national standards and licensing system; (2) has adopted and is implementing adequate enforcement procedures; (3) will keep records and make reports as the Secretary may require; (4) permits exemptions from the requirements which are no less stringent than those exemptions from national standards; and (5) has adopted and can implement adequate procedures for the control of health hazards which may result from an activity of a clinical laboratory. Enumerates the conditions under which the Secretary may revoke the license of a clinical laboratory. Stipulates that any unlicensed person who is required to be licensed under this Act, who solicits or accepts, directly or indirectly, any specimen for laboratory examination shall be fined not more than $10,000 or imprisoned for not more than one year or both. States that no clinical laboratory which is required to be licensed but is not may receive a grant, contract or other form of financial assistance under the Public Health Service Act, or charge or collect for laboratory services for any entity which receives a grant, contract or financial assistance under such Act. Directs the Secretary to establish within the Department of Health, Education, and Welfare an administrative unit for the coordination of the regulatory functions under this Act and the laboratory certification and regulatory functions authorized by the Federal Food, Drug and Cosmetic Act and titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act. Establishes an advisory council within the Department to make recommendations to the Secretary concerning: (1) regulations promulgated under this Act; (2) implementation and administration of this Act; and (3) coordination between Federal and State programs to avoid duplicative enforcement. Directs the Secretary to conduct a study of: (1) existing voluntary certification standards and State licensure laws for laboratory technicians; and (2) qualifications of entities that certify such personnel.

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1 official file

• Introduced in House

  summary · EN · 19 January 1976

  Open at official source

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