Clinical Laboratory Improvement Act of 1979

(Reported to Senate from the Committee on Labor and Human Resources with amendment, S. Rept. 96-130)

Clinical Laboratory Improvement Act of 1979 - Amends title III of the Public Health Service Act (General Powers and Duties of Public Health Service) to direct the Secretary of Health, Education, and Welfare 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.

Directs the Secretary 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; (4) prescribe qualifications for directors, supervisors, and technical personnel employed in laboratories; and (5) include adequate provisions for the inspection of laboratories and the enforcement of standards. 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: (1) job-related proficiency and practical examinations for clinical laboratory personnel; (2) mechanisms to assure the continued competence of such personnel; and (3) standards for the proficiency testing 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. States that the national standards for clinical laboratories shall not apply to any clinical laboratory: (1) which is located in the office of, and operated by, a licensed physician, dentist, or podiatrist, or a group of such practitioners; and (2) in which the only tests or procedures performed are performed by such a practitioner (or practitioners) in connection with the treatment of their patients. Authorizes the Secretary to exempt from the national standards clinical laboratories which: (1) are operated by a licensed physician, dentist, or podiatrist, or a group of such practitioners, or in a rural health clinic, and in which the only tests or procedures performed are performed under the supervision of such a practitioner (or practitioners) or clinic in connection with the treatment of their patients; (2) are owned or operated by a State, or any political subdivision of a State, and which do not perform laboratory services for which payments are received under title XVIII (Medicare) of the Social Security Act; (3) perform tests or procedures primarily for biomedical or behavioral research; or (4) perform tests or procedures only to assist insurers with respect to insurance contracts.

Authorizes the Secretary to enter into agreements with: (1) qualified private nonprofit organizations 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.

Subjects Federal clinical laboratories under the jurisdiction of the Secretary to the national standards, with certain exceptions.

Prohibits: (1) the solicitation or acceptance of specimens for laboratory tests or procedures by a clinical laboratory which is required to be licensed and which either does not have such a license or is not permitted under such license to perform the planned test or procedure; (2) misrepresentation with respect to the license application or conversion of an application to an unauthorized use; and (3) the solicitation or receipt, or the offer or payment, of any remuneration (including any kickback, bribe, or rebate) with respect to laboratory services.

Authorizes the Secretary to enjoin the continuation of any activity by a clinical laboratory required to be licensed under this Act which constitutes a substantial risk 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.

Requires the Secretary to designate a Director of Clinical Laboratories who shall be responsible for establishing a uniform regulatory policy with respect to laboratory provisions under this Act, the Food, Drug, and Cosmetic Act, and Medicare and Medicaid.

Directs the Secretary to provide technical assistance to: (1) States to assist their laboratory enforcement capability; and (2) laboratories, including a training program for employees where deficiencies have been documented. Authorizes the Secretary to make grants and enter into contracts with public and nonprofit private entities for projects and studies on laboratory methodology and utilization.

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.

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.

Requires the Secretary to reimburse to the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund any amount expended from such funds with respect to the licensing of non-Medicare laboratories.

Repeals the Clinical Laboratory Improvement Act of 1967.

Directs the Secretary to report to Congress with respect to the exemption of laboratories from the standards under this Act.

Amends title XVIII (Medicare) of the Social Security Act to require all clinical laboratories to be licensed under this Act as a condition for Medicare certification.

Sets forth requirements with respect to payment for laboratory tests under Medicare and Medicaid.

Disallows payments for specified costs included in laboratory services charges.