Page:United States Statutes at Large Volume 106 Part 4.djvu/818

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106 STAT. 3554 PUBLIC LAW 102-539—OCT. 27, 1992 "(C) SCOPE OF INSPECTION. — In conducting inspections, the Secretary or State agency acting on ^half of the Secretary— "(i) shall have access to all equipment, materials, records, and information that the Secretary or State agency considers necessary to determine whether the facility is being operated m accordance with this section; and "(ii) may copy, or require the facility to submit to the Secretary or the State agency, any of the materials, records, or information. "(D) QUALIFICATIONS OF INSPECTORS.— Qualified individuals, as determined by the Secretary, shall conduct all inspections. The Secretary may request that a State agency acting on behalf of the Secretary designate a qualified officer or employee to conduct the inspections, or designate a qualified Federal officer or employee to conduct inspections. The Secretary shall establish minimum qualifications and appropriate training for inspectors and criteria for certification of inspectors in order to inspect facilities for compliance with subsection (f). "(E) FREQUENCY. —The Secretary or State agency acting on behalf of the Secretary shall conduct inspections under this paragraph of each facility not less often than annually. "(F) RECORDS AND ANNUAL REPORTS. —The Secretary or a State agency acting on behalf of the Secretary which is responsible for inspecting mammography facilities shall maintain records of annual inspections required under this Paragraph for a period as prescribed by the Secretary, uch a State agency shall annually prepare and submit to the Secretary a report concerning the inspections carried out under this paragraph. Such reports shall include a description of the facilities inspected and the results of such inspections. "(2) INSPECTION OF ACCREDITED FACILITIES. —The Secretary shall inspect annually a sufficient number of the facilities accredited by an accreditation body to provide the Secretary with a reasonable estimate of the performance of such body. "(3) INSPECTION OF FACILITIES INSPECTED BY STATE AGEN- CIES.—The Secretary shall inspect annually facilities inspected by State agencies acting on behalf of the Secretary to assure a reasonable performance by such State agencies. "(4) TIMING.— The Secretary, or State agency, may conduct inspections under paragraphs (1), (2), and (3), during regular business hours or at a mutually agreeable time and after providing such notice as the Secretary may prescribe, except that the Secretary may waive such requirements if the continued performance of mammography at such facility threatens the public health. "(5) LIMITED REINSPECTION. —Nothing in this section limits the authority of the Secretary to conduct limited reinspections of facilities found not to be in compliance with this section. "(h) SANCTIONS.— "(1) IN GENERAL. — In order to promote voluntary compliance with this section, the Secretary may, in lieu of taking