| (5) Issuing provisional certifications. Following the agency certifying body's receipt of the accreditation body's decision that a facility has submitted the required information, the agency certifying body may issue a provisional certification to a facility upon determination that the facility has satisfied the requirements of the Act and this chapter. A provisional certification shall be effective for up to six months from the date of issuance. A provisional certification cannot be renewed, but a facility may apply for a 90-day extension of the provisional certification. (6) Extension of provisional certification. Extension of provisional certifications shall be in accordance with the following. (A) To apply for a 90-day extension to a provisional certification, a facility shall submit to the FDA-approved accreditation body who issued the original certificate, a statement of what the facility is doing to obtain certification and evidence that there would be a significant adverse impact on access to mammography in the geographic area served if such facility did not obtain an extension. (B) The agency certifying body may issue a 90-day extension for a provisional certification upon determination that the extension meets the criteria in paragraph (4) of this subsection. (C) There can be no renewal of a provisional certification beyond the 90-day extension. (7) Reinstatement policy. A previously certified facility that has allowed its certification to expire, that has been refused a renewal of its certification by the agency certifying body, or that has had its certification suspended or revoked by the agency certifying body, may reapply to have the certification reinstated so that the facility may be considered to be a new facility and thereby be eligible for a provisional certification. (A) Unless prohibited from reinstatement under subsection (h)(5) of this section, a facility applying for reinstatement shall: (i) contact an FDA-approved accreditation body for reapplication for accreditation; (ii) fully document its history as a previously provisionally certified or certified mammography facility, including the following information: (I) name and address of the facility under which it was previously provisionally certified or certified; (II) name of previous owner/lessor; (III) facility identification number assigned to the facility under its previous certification by the FDA or the agency certifying body; and (IV) expiration date of the most recent FDA or agency provisional certification; and (iii) justify application for reinstatement of accreditation by submitting to an FDA-approved accreditation body a corrective action plan that details how the facility has corrected deficiencies that contributed to the lapse of, denial of renewal, or revocation of its certification. (B) The agency certifying body may issue a provisional certification to the facility if the agency determines that the facility: (i) has adequately corrected, or is in the process of correcting, pertinent deficiencies; and (ii) has taken sufficient corrective action since the lapse of, denial of renewal, or revocation of its previous certification. (C) After receiving the provisional certification, the facility may lawfully perform mammography while completing the requirements for accreditation and certification. (h) Suspension or revocation of certification. (1) Except as provided in paragraph (2) of this subsection, the agency certifying body may suspend or revoke a certification issued by the agency certification body if it finds, after providing the owner or operator of the facility with notice and opportunity for a hearing in accordance with §289.205 of this title, that the owner, operator, or any employee of the facility: (A) has been guilty of misrepresentation in obtaining the certification; (B) has failed to comply with the requirements of this chapter; (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 Cont'd... |
