Clinical Laboratory Improvement Act

(Reported to Senate from the Committee on Human Resources with amendment, S. Rept. 95-360)

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, and to develop mechanisms designed to assure the continued competence of such personnel. Directs the development of standards for the proficiency testing of clinical laboratories.

Applies such standards to: (1) clinical laboratories engaged in business 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 over clinical laboratories not engaged in interstate commerce and those that are engaged in interstate commerce and located or doing business within the State when responsibility is specifically delegated by the Secretary.

Directs the Secretary to establish a system for the licensure of clinical laboratories subject to the national standards promulgated by the Secretary. States that such licenses shall specify the categories of tests and procedures which such laboratory may 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 such laboratories, except those under the jurisdiction of the Armed Forces or the Veterans' Administration or those under any agency which has in effect equally stringent standards.

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 to assist in meeting the cost of enforcing the 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 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. States that the purpose of such Office shall be: (1) to establish a uniform regulatory policy for the administration of the functions authorized by this Act, the Federal Food, Drug, and Cosmetic act and the Medicaid and Medicare programs of the Social Security Act; (2) to provide guidance for the laboratory components of other health programs administered and enforced by the Secretary; and (3) to improve laboratory methodology and utilization promotion and funding.

Authorizes the Secretary to make grants for projects and studies respecting clinical laboratory methodology and utilization.

Authorizes any person to commence a civil action for injunctive relief against: (1) any other person who is allegedly violating a regulation promulgated under this Act; or (2) the Secretary, where there is an alleged failure to perform a non-discretionary duty.

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, including but not limited to grants to or contracts with hospitals, or skilled facilities, or in connection with the procurement and reimbursement for clinical laboratory services, unless the laboratory meets the licensing requirements established by the Secretary.

Extends until December 31, 1979, the program designed to determine the qualification of laboratory technicians, technologists, and cytotechnologists.

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.

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 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; (3) to analyze the costs to laboratories of compliance with such national standards should they be promulgated as a result of such study; and (4) to analyze rural clinical laboratory personnel problems.

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, for the provision of clinical laboratory services by persons who provide such 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.