Clinical Laboratories Improvement Act

Summary

Clinical Laboratories Improvement Act - Requires the licensing of all clinical laboratories, as defined by this Act. Directs the Secretary of Health, Education, and Welfare to issue such licenses. Authorizes the Secretary to delegate licensing authority to the States, providing the Secretary determines that State standards meet or exceed Federal standards. Sets forth the standards that must be met by clinical laboratories in order to receive and maintain the license required by this Act. Provides that such standards shall be designed to assure consistently accurate laboratory procedures and service. Directs the Secretary to establish an Office of Clinical Laboratories. Declares that the purpose of such Office shall be to centralize the laboratory regulatory functions authorized by this Act and to assume responsibility for the laboratory component of other health programs administered and enforced by the Secretary. Creates an advisory council to advise the Office with respect to guidelines for laboratory licensing, personnel, and performance standards. Provides that no grant or reimbursement which the Secretary is authorized to make, or contract which he is authorized to award, whether to or for any health care facility, including but not limited to health maintenance organizations, hospitals, skilled nursing or intermediate care facilities, or in connection with the procurement and reimbursement for clinical laboratory services shall be entered into unless the laboratory meets the standards established by the Secretary. Provides for grants and technical assistance to those States which desire to establish State licensing procedures and regulations for development, administration, and enforcement purposes. Provides that any person who willfully violates any provision of this Act or any rule or regulation promulgated thereunder shall be subject to imprisonment for not more than one year, or a fine of not more than $1,000, or both.

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Documents

2 official files

• Passed Senate amended

  summary · EN · 29 April 1976

  Open at official source

• Introduced in Senate

  summary · EN · 14 May 1975

  Open at official source

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