| (iii) failure to observe any of the terms and conditions of the Act, this chapter, or order of the agency. (B) Before the agency accreditation body suspends or revokes an accreditation of a mammography facility, the agency accreditation body shall give notice by personal service or by certified mail, addressed to the last known address, of the facts or conduct alleged to warrant the suspension or revocation by complaint, and order the accredited mammography facility to show cause why the mammography facility accreditation should not be suspended or revoked. The accredited mammography facility shall be given an opportunity to request a hearing on the matter no later than 30 days after receipt of the notice. (C) Any accredited mammography facility against whom the agency accreditation body contemplates an action described in subparagraph (A) of this paragraph may request a hearing by writing the director within 30 days of receipt of the notice. (i) The written request for a hearing must contain the following: (I) a statement requesting a hearing; and (II) the name, address, and identification number of the accredited mammography facility against whom the action is being taken. (ii) Failure to submit a written request for a hearing within 30 days will render the agency accreditation body action final. (D) If the agency accreditation body suspends the accreditation of a mammography facility in accordance with subparagraph (A) of this paragraph, the suspension shall remain in effect until the agency accreditation body determines the following: (i) that allegations of violations or misconduct were not substantiated; (ii) that violations of required standards have been corrected to the agency accreditation body's satisfaction; or (iii) the facility's accreditation is revoked in accordance with §289.205 of this title. (2) Revocation of accreditation of mammography facilities shall be in accordance with §289.205(g) of this title. (h) 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 §289.230(h) of this title. (2) A facility that has been denied accreditation or reaccreditation is entitled to an appeals process from the agency accreditation body, in accordance with §289.205 of this title. A facility must avail itself of the accreditation body's appeal process before requesting reconsideration from the agency certifying body. (3) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the 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. (i) Specific terms and conditions of accreditation of mammography facilities. (1) Each accreditation document issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable requirements and orders of the agency accreditation body. (2) No accreditation document issued by the agency accreditation body under this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person. (j) Responsibilities of an accredited facility. A facility shall notify the agency accreditation body of any changes that would render the information contained in the application inaccurate. (k) Expiration and renewal of accreditation of mammography facilities. (1) The accreditation expires at the end of the day in the month and year stated on the accreditation document. (2) An application for renewal of accreditation with the agency accreditation body shall be filed in accordance with subsection (d) of this section and with fees in accordance with §289.204 of this title. (3) A mammography facility filing an application for renewal in accordance with subsection (d) of this section and with fees in accordance with §289.204 of this title before the existing accreditation expires, may continue to perform mammography until the review process is complete and the accreditation status has been determined by the agency accreditation body. (4) Accreditation for a mammographic facility is valid for three years from the date of issuance, unless accreditation of the facility is suspended or revoked prior to such deadline. (5) Issuance of renewal of accreditation shall be in accordance with subsection (e) of this section. (l) Complaints. Each facility accredited by the agency accreditation body shall do the following: (1) establish a written procedure for collecting and resolving consumer complaints; (2) maintain a record of each serious complaint received by the facility in accordance with §289.230(ee)(3) of this title; and (3) report unresolved serious complaints to the accreditation body within 30 days of receiving the complaint. (m) Clinical image quality. Clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility's accreditation body. (n) Additional mammography review and patient notification. If the agency certifying body or the agency accreditation body believes that mammography quality at a facility may have been compromised and presents a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by the agency certifying body or the agency accreditation body for review by the accreditation body. (o) Record requirements. Records required by this section shall be maintained for inspection by the agency in accordance with §289.230(ee)(3) of this title. Records may be maintained electronically in accordance with §289.231(ff)(3) of this title. (p) On-site facility visit, targeted clinical image review, and random clinical image review. (1) Each accredited facility shall afford the agency accreditation body, at all reasonable times, an opportunity to audit the facility where mammography equipment or associated equipment is used or stored. (2) Each accredited facility shall make available to the agency accreditation body for inspection, upon reasonable notice, records maintained in accordance with this chapter. (3) Each accredited facility shall, upon request by the agency accreditation body or the agency certifying body, make clinical images available to the image review board for a targeted clinical image review or a random clinical image review. The agency certifying body, the agency accreditation body, another FDA-approved accreditation body, or the FDA may request a targeted clinical image review due to, but not limited to, serious complaints or severe items of non-compliance. (4) Annually, the agency accreditation body shall conduct on-site visits and random clinical image reviews of a sample of facilities to monitor and assess their compliance with standards established by the accreditation body. Other on-site visits may be conducted based on problems identified through inspections, serious complaints received from consumers or others, a previous history of noncompliance, or any other information in the possession of the accreditation body, inspectors, or FDA.