| (C) has failed to comply with requests of the agency certifying body or an FDA-approved accreditation body for records, information, reports, or materials that are necessary to determine the continued eligibility of the facility for a certification or continued compliance with the requirements of this chapter; (D) has refused a request of a duly designated FDA inspector, state inspector, or an FDA-approved accreditation body representative for permission to inspect the facility or the operations and pertinent records of the facility; (E) has violated or aided and abetted in the violation of any provision of or regulation promulgated pursuant to the requirements of the Act and the requirements of this chapter; or (F) has failed to comply with prior sanctions imposed by the agency certifying body under §289.205 of this title. (2) The agency certifying body may suspend a certification of a facility before holding a hearing if it makes a finding described in paragraph (1) of this subsection and also determines that: (A) the failure to comply with requirements presents a serious risk to human health; (B) the refusal to permit inspection makes immediate suspension necessary; or (C) there is reason to believe that the violation or aiding and abetting of the violation was intentional or associated with fraud. (3) If the agency certifying body suspends a certification in accordance with paragraph (2) of this subsection: (A) the agency certifying body shall provide the facility with an opportunity for a hearing under §289.205 not later than 60 days from the effective date of this suspension; and (B) the suspension shall remain in effect until the agency certifying body determines that: (i) allegations of violations or misconduct were not substantiated; (ii) violations of requirements have been corrected to the agency certifying body's satisfaction; or (iii) the certification is revoked in accordance with paragraph (4) of this section. (4) After providing a hearing in accordance with paragraph (3)(A) of this subsection, the agency certifying body may revoke the certification if the agency determines that the facility: (A) is unwilling or unable to correct violations that were the basis for suspension; or (B) has engaged in fraudulent activity to obtain or continue certification. (5) If a facility's certification was revoked on the basis of an act described in §289.205 of this title, no person who owned or operated that facility at the time the act occurred may own or operate a mammography facility within two years of the date of revocation. (i) Appeal of adverse accreditation or reaccreditation decisions that preclude certification or recertification. (1) The appeal process described in this subsection is available only for adverse accreditation or reaccreditation decisions that preclude certification by the agency certifying body. Agency certifying body decisions to suspend or revoke certificates that are already in effect will be handled in accordance with subsection (h) of this section. (2) Upon learning that a facility has failed to become accredited or reaccredited, the agency certifying body will notify the facility that the agency certifying body is unable to certify that facility without proof of accreditation. (3) A facility that has been denied accreditation or reaccreditation and cannot achieve satisfactory resolution of an adverse accreditation decision through the FDA-approved accreditation body's appeal process is entitled to further appeal to the FDA. (4) A facility cannot perform mammography services while an adverse accreditation decision is being appealed. (j) Denial of certification. (1) The agency certifying body may deny the application if the agency certifying body has reason to believe that: (A) the facility will not be operated in accordance with the provisions of subsections (r) - (aa) of this section; (B) the facility will not permit inspections or provide access to records or information in a timely fashion; (C) any material false statement in the application or any statement of fact required under provision of the Act was made; (D) conditions revealed by such application or statement of fact or any report, record, inspection, or other means that would warrant the agency certification body to refuse to grant a certification of mammography facility on an original application; or (E) the facility failed to observe any of the terms and conditions of the Act, this chapter, or order of the agency. (2) Before the agency certification body denies an application for certification, the agency shall give notice of the denial, the facts warranting the denial, and shall afford the applicant an opportunity for a hearing in accordance with §289.205(h) of this title. If no request for a hearing is received by the director of the Radiation Control Program within 30 days of date of receipt of the notice, the agency may proceed to deny. The applicant shall have the burden of proof showing cause why the application should not be denied. (3) If the agency certifying body denies an application for certification by a facility that has received accreditation from an FDA-approved accreditation body, the agency certifying body shall provide the facility with a written statement of the grounds on which the denial is based. (k) Appeals of denial of certification. (1) The appeals procedures described in this subsection are available only to facilities that are denied certification by the agency certifying body after they have been accredited by an FDA-approved accreditation body. Appeals for facilities that have failed to become accredited with the agency accreditation body shall be in accordance with §289.234(h) of this title. (2) A facility that has been denied certification may request reconsideration and appeal of the agency certifying body's determination in accordance with the applicable provisions of §289.205 of this title. (l) Modification of certification. Modification of certification shall be in accordance with §289.226(r) of this title. (m) Specific terms and conditions of certification. Specific terms and conditions of certification shall be in accordance with §289.226(l) of this title. (n) Responsibilities of registrant. (1) In addition to the requirements of §289.226(m)(3) - (7) of this title, a registrant shall notify the agency certifying body in writing prior to any changes that would render the information contained in the application or the certification inaccurate. These include but are not limited to the following: (A) name and mailing address; (B) street address where machine(s) will be used; and (C) mammography machines. (2) Prior to employing the individuals listed in subparagraphs (A) - (E) of this paragraph, the registrant is required to verify and maintain copies of their qualifications. If a facility makes a change in the RSO, the qualifications of the RSO shall be submitted to the agency within 30 days of such change. Written notification of a change in any of the following in subparagraphs (B) - (E) of this paragraph is required within 30 days of such change: (A) radiation safety officer; (B) lead interpreting physician; (C) interpreting physicians; (D) medical radiologic technologists; or (E) medical physicist. (3) Registrants utilizing interpreting physicians or technologists from a temporary service shall verify and maintain copies of the qualifications of these individuals for inspection by the agency. The registrant does not need to notify the agency certifying body unless these personnel will be at the facility for a period exceeding four weeks. (4) All mammography facilities installing new or replacement mammography machines shall have either current accreditation or have submitted an application to an FDA-approved accreditation body for review unless exempted by subsection (e)(1) - (3) of this section. A mammography machine shall not be used to perform mammograms if an application for accreditation for that machine has been denied, or if the accreditation has been suspended or expired. (5) A facility with an existing certification may begin using a new or replacement machine before receiving an updated certification if the registrant submits to the agency certifying body and to the FDA-approved accreditation body, documentation with a medical physicist's report in accordance with subsection (v)(10) and (11) of this section, verifying compliance of the new machine with this section. The medical physicist's report is required prior to using the machine on patients. Cont'd... |
