Clinical Laboratory Improvement Act

Clinical Laboratory Improvement Act - Amends the Public Health Service Act to direct the Secretary of Health, Education, and Welfare to promulgate national standards for clinical laboratories.

Defines the terms "laboratory" and "clinical laboratory" for purposes of this Act.

Directs the Secretary to develop job-related proficiency and practical examinations for clinical laboratory personnel. Directs the development of standards for the proficiency testing of clinical 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.

Delegates to States the responsibility for primary enforcement of the national standards for clinical laboratories in certain instances.

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 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.

Provides judicial review for any person aggrieved by the revocation of the license of his laboratory.

Applies the national standards to Federal clinical laboratories under the jurisdiction of the Secretary and to all other laboratories, except those under the jurisdiction of the Armed Forces or the Veterans' Administration or those under any agency which has equally stringent standards in effect.

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 consisting of a fine or imprisonment or both for the violation of such prohibition.

Prohibits false or fraudulent billing practices in connection with services provided under the Social Security Act. Establishes a penalty consisting of a fine or imprisonment or both for the violation of such prohibition.

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 to provide grants and technical assistance to States enforcement of standards established for the regulation of clinical laboratories.

Establishes an advisory council on clinical laboratories in the Department of Health, Education, and Welfare to advise the Secretary with respect to national standards promulgated under this Act, the implementation and administration of clinical laboratory regulation, and the coordination between Federal and State regulatory programs.

Directs the Secretary to establish within the Department of Health, Education, and Welfare an Office of Clinical Laboratories which shall: (1) establish a uniform regulatory policy for the administration of the functions authorized by this Act and the Medicaid and Medicare programs of the Social Security Act; and (2) provide guidance for the laboratory components of other health programs administered and enforced by the Secretary.

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 above the market value of the facility.

Prohibits the making of any grant or reimbursement by the Secretary, or the award of any contract under the Medicare or Medicaid programs of the Social Security Act, unless the laboratory meets the licensing requirements established by the Secretary.

Raises the status of the offense of defrauding the Medicare and Medicaid programs from that of a misdemeanor to that of a felony. Increases the maximum fine for such offenses from $10,000 to $25,000. Increases the maximum term of imprisonment from one to five years for such offenses.

Directs the Secretary to conduct a study of existing regulations governing the qualifications of clinical laboratory supervisors, technologists, and technicians, and of the regulatory bodies established to develop and enforce such regulations. Requires such study: (1) to assess the need for national standards for certifying laboratory technical personnel and certifying entities; (2) to project the numbers of laboratory personnel who will be needed in 1980, 1985, and 1990; and (3) to analyze the costs to laboratories of compliance with such national standards should they be promulgated as a result of such study.

Directs the Secretary to study the financial arrangements entered into by hospitals reimbursed for the provision of health services under the Medicare and Medicaid programs with persons who provide clinical laboratory services in such hospitals. Directs the Secretary to report the findings of such study to Congress within six months, and that the study include recommendations for such corrective legislation as the Secretary determines to be necessary.