| (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. |
