Page:United States Statutes at Large Volume 106 Part 4.djvu/813

 PUBLIC LAW 102-539—OCT. 27, 1992 106 STAT. 3549 "(d) APPLICATION FOR CERTIFICATE. — "(1) SUBMISSION. —The Secretary may issue or renew a certificate for a facility if— "(A) the person who owns or leases the facility or an authorized agent of the person, submits to the Secretary, in such form and manner as the Secretary shall prescribe, an application that contains at a minimum— "(i) a description of the manufacturer, model, and type of each x-ray machine, image receptor, and processor operated in the performance of mammography by the facility; "(ii) a description of the procedures currently used to provide mammography at the facility, including— "(I) the t>pes of procedures performed and the number of such procedures performed in the prior 12 months; "(ID the methodologies for mammography; and "(III) the names and qualifications (educational background, training, and experience) of the personnel performing mammography and the physicians reading and interpreting the results from the procedures; "(iii) proof of on-site survey by a qualified medical physicist as described in subsection (fKlXE); and "(iv) proof of accreditation in such manner as the Secretary shall prescribe; and "(B) the person or agent submits to the Secretary— "(i) a satisfactory assurance that the facility vdll be operated in accordance with standards established by the Secretary under subsection (f) to assure the safety and accuracy of mammography; (ii) a satisfactory assurance that the facility will— "(I) permit inspections under subsection (g); "(II) make such records and information avail- Records, able, and submit such reports, to the Secretary Repots. as the Secretary may reauire; and "(III) update the information submitted under subparagraph (A) or assurances submitted under this subparagraph on a timely basis as required by the Secretary; and "(iii) such other information as the Secretary may require. An applicant shall not be required to provide in an application under subparagraph (A) any information which the applicant has supplied to the accreditation body which accredited the apphcant, except as required by the Secretary. "(2) APPEAL. —If the Secretary denies an application for the certification of a facility submitted under paragraph (I)(A), the Secretary shall provide the owner or lessor of the facility or the agent of the owner or lessor who submitted such application— "(A) a statement of the grounds on which the denial is based, and "(B) an opportunity for an appeal in accordance with the procedures set forth in regulations of the Secretary pubhshed at 42 C.F.R. 498 and in effect on the date of the enactment of this section.

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