Clinical Laboratory Improvement Act

Summary

Clinical Laboratory Improvement Act - Title I: Public Health Service Act Amendments and Clinical Laboratory Studies - Defines the terms "laboratory" and "clinical laboratory" for purposes of the Public Health Service Act. Amends the Public Health Service Act to direct the Secretary of Health, Education, and Welfare to promulgate national standards for clinical laboratories. Directs the Secretary to develop standards for the proficiency testing of such laboratories. Applies such standards to: (1) clinical laboratories engaged in interstate commerce; and (2) any other clinical laboratories located in States which do not have primary enforcement responsibility as provided for by this Act for the regulation of such laboratories. Directs the Secretary to establish a system for the licensure of clinical laboratories subject to such standards. States that such licenses shall specify the categories of tests and procedures which which laboratories perform and shall be valid for a period not to exceed 24 months. Sets forth the requirements for issuance, renewal, and revocation of a license. Delegates to States the responsibility for primary enforcement of the national standards for clinical laboratories in certain instances. Prohibits the solicitation or acceptance of specimens for laboratory tests or procedures by a clinical laboratory which is required to be licensed by the Secretary and which either does not have such a license or is not permitted under such license to perform the planned test or procedure. Establishes a penalty of a fine or imprisonment or both for the violation of such prohibition. Authorizes the Secretary to obtain a temporary injunction or restraining order, pending issuance of a final order, against any laboratory the Secretary believes would constitute a significant hazard to the public health. Prohibits an employer from taking action against an employee who has assisted or participated in an investigation of such employer pursuant to this Act. Establishes a procedure for investigating and correcting employers' retaliatory actions against employees. Authorizes the Secretary and any State which has primary enforcement responsibility to enter into agreements with certain entities which have adopted laboratory standards at least as stringent as those set forth in this Act to make inspections of clinical laboratories and administer proficiency tests to such laboratories. Requires the Secretary to make an annual report to the Congress respecting: (1) the reliability of services performed by clinical laboratories; and (2) the effect of the costs of clinical laboratory services on health care services. Requires the Secretary to conduct a study of existing voluntary certification standards and state licensure laws for clinical laboratories and their personnel. Requires the Secretary to conduct a study of clinical laboratories exempted under the Act and provides that if such laboratories refuse to participate in such study that such laboratories will be required to meet the standards of this Act. Requires the Secretary to study the quality of the tests and procedures of highly specialized clinical laboratories exempted from national standards. Directs the Secretary, within two years of the passage of this Act, to report the result of studies on exempted laboratories and make appropriate recommendations. Title II: Social Security Act Amendments and Study and Report - Amends the Social Security Act to prohibit reimbursement under the Medicare, Medicaid, or Maternal and Child Health and Crippled Childrens' Services programs for any portion of the cost of a clinical laboratory service which represents a commission, finders fee, or rent which is unrelated to the market value of the facility. Establishes procedures for determining reasonable costs and charges for clinical laboratory services provided under the Medicare, and Medicaid programs. Directs the Secretary to conduct a study of financial arrangements between hospitals participating in the Medicare and Medicaid programs and the providers of clinical laboratory services.

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Documents

2 official files

• Reported to House amended, Part III

  summary · EN · 12 July 1978

  Open at official source

• Introduced in House

  summary · EN · 9 February 1978

  Open at official source

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