Clinical Laboratory Improvement Act of 1979

Clinical Laboratory Improvement Act of 1979 - Title I: Public Health Service Act Amendments and Clinical Laboratory Studies - Directs the Secretary of Health, Education, and Welfare to promulgate national standards for clinical laboratories, designed to assure consistent performance of accurate and reliable tests and other procedures and services. Stipulates that such standards shall: (1) require clinical laboratories subject to the standards to maintain appropriate quality control programs; (2) require such laboratories to maintain records, equipment, and facilities necessary for effective operation; (3) include requirements for periodic proficiency testing of laboratories; and (4) prescribe qualifications for directors, supervisors, and technical personnel employed in laboratories. Provides that the standards may vary on the basis of the type of laboratory services provided or the purposes for which the services are performed.

Directs the Secretary to develop within one year of enactment standards for proficiency testing of clinical laboratories subject to the national standards.

Applies the national standards to all laboratories engaged in interstate commerce or located in States which do not have primary enforcement responsibility for the regulation of clinical laboratories. Provides that the standards provisions relating to personnel qualifications shall not apply for a two-year period to certain clinical laboratories located in rural areas.

Exempts from the national standards any clinical laboratory which: (1) is located in the office of a physician, dentist, or podiatrist and performs services only in connection with the treatment of patients; (2) performs services only for biomedical or behavioral research; or (3) engages exclusively in the assessment of cardiac or pulmonary function. Subjects Federal clinical laboratories under the jurisdiction of the Secretary to the national standards, with certain exceptions.

Directs the Secretary to establish a system for the licensing of all clinical laboratories subject to national standards provided for under this Act. Prohibits a clinical laboratory subject to such standards from performing any tests or providing any services without a valid license. Sets forth circumstances under which the Secretary may suspend or revoke a laboratory's license.

Enumerates criteria which a State must meet to have primary enforcement responsibility for the regulation of clinical laboratories. Directs the Secretary to review at least every two years the clinical laboratory regulatory activities of a State.

Prohibits the solicitation or acceptance of specimens for laboratory tests by a clinical laboratory which is required to be licensed and which either does not have such a license or is not part permitted under such license to perform such service.

Authorizes the Secretary to enjoin the continuation of any activity by a clinical laboratory required to be licensed under this Act which constitutes a significant hazard to the public health. Authorizes an inspection procedure with respect to laboratories subject to the national standards.

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 enter into agreements with: (1) qualified public or nonprofit private entities to administer tests and make inspections as provided for under this Act; and (2) States to administer the licensure program provided in this Act under the Medicare program.

Directs the Secretary to report annually to Congress with respect to the accuracy and costs of laboratory tests and procedures during the previous fiscal year.

Requires the Secretary to establish a uniform regulatory program for the administration of the laboratory certification and regulation functions under this Act, Medicare and Medicaid, and the Food, Drug, and Cosmetic Act.

Entitles the United States to recover from Alaska the value of certain medical facilities which were constructed with Public Health Service Act grants, if such facilities cease to be publicly owned and operated for the treatment of patients under Alaska's mental health program.

Directs the Secretary to conduct studies of: (1) existing voluntary certification standards and State licensure laws for laboratory personnel; (2) qualifications of entities that certify such personnel; (3) existing and proposed public and private mechanisms to determine the continued competence of such personnel; (4) existing laboratory proficiency testing methods; and (5) the relationship of requirements for such personnel and of clinical laboratory proficiency testing requirements with clinical laboratory performance. Specifies analyses to be included in such studies, and directs the Secretary to report to Congress on the results of the studies.

Directs the Secretary to provide for a study concerning the quality of performance of exempt laboratories and to report the results to Congress within two years of enactment.

Stipulates that if the results of tests performed by laboratories participating in proficiency testing programs are significantly more reliable and accurate than those of non-participants, that participation in such a program be made a condition of continued exemption from national standards.

Directs the Secretary to conduct studies of: (1) the quality of the tests and other procedures and services provided by highly specialized clinical laboratories, including highly specialized clinical laboratories exempted from the national standards; and (2) the effect of the amendments made by this Act on the quality and cost of clinical laboratory services.

Title II: Social Security Act Amendments and Study and Report - Amends title XI of the Social Security Act (General Provisions) to limit the amounts of certain payments for clinical laboratory services under the Maternal and Child Health program, Medicare, and Medicaid. Requires an independent clinical laboratory to disclose rate information to the Secretary as a condition of participation in such programs and the Grants to States for Services program.

Amends title XVIII of such Act (Medicare) to set forth requirements with respect to payment for laboratory tests under Medicare. Requires all clinical laboratories to be licensed under this Act as a condition for Medicare certification.

Amends title XIX of such Act (Medicaid) to allow a State to make arrangements for the purchase of certain laboratory services. Directs the Secretary to evaluate such arrangements and submit recommendations to Congress within two years of the date of enactment. Sets forth certain requirements with respect to a State plan's treatment of laboratory services.

Directs the Secretary to conduct, and report to Congress the findings of, a study of the financial arrangements entered into by hospitals reimbursed under Medicare and Medicaid for the provision of clinical laboratory services to determine if such arrangements are in the public interest.

Directs the Secretary to report to Congress specified billing information with respect to laboratory services under Medicare.