| (28) Serious complaint--A report of a serious adverse event. (29) Survey--An on-site physics consultation and evaluation of a facility quality assurance program performed by a medical physicist. (30) Targeted clinical image review--A review of a minimum of two sets of "negative" clinical images from a specific date, or date range, at the request of the agency. (d) Accreditation of mammography facilities. (1) All mammography facilities shall be accredited by an FDA-approved accreditation body and shall meet the quality standards in §289.230(r) - (aa) of this title. In order to qualify for certification in accordance with §289.230 of this title, new facilities applying to the agency accreditation body shall receive acceptance of the accreditation application. (2) The facility shall submit the following information in addition to the information required in subsection §289.230(f) of this title: (A) an application for accreditation on forms and in accordance with accompanying instructions prescribed by the agency accreditation body; (B) the appropriate accreditation fee prescribed in §289.204 of this title; and (C) evidence that the medical physicist's survey and mammography equipment evaluation in accordance with §289.230(v)(10) and (11) of this title was performed within the following time frames: (i) no more than six months before the date of the accreditation application for new facilities seeking accreditation; (ii) no more than 14 months before the date of the application for accreditation for facilities changing accreditation to one issued by the agency accreditation body; or (iii) no more than 14 months before the date of the application for renewal of accreditation for facilities accredited by the agency accreditation body. (3) Upon notification by the agency accreditation body, each applicant shall submit clinical and phantom images directly to the image review board. (e) Issuance of accreditation of a mammography facility. An accreditation document will be issued when the mammography facility meets the requirements of subsection (d) of this section and §289.204 of this title and becomes accredited by the agency accreditation body. In order for an accreditation to be issued, the agency accreditation body must receive acceptable dose evaluation information from the dosimetry processor and be notified by the image review board that the applicant met the criteria for clinical images and phantom images, and dose evaluation. (f) Denial or abandonment of an application for accreditation of mammography facilities. (1) Any application for accreditation may be denied by the agency accreditation body when the applicant fails to meet established criteria for accreditation in accordance with subsection (d) of this section. (2) Before the agency accreditation body denies an application for accreditation, 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) Action on an accreditation application will be abandoned due to lack of response by the applicant to a request for information by the agency accreditation body. Abandonment of such actions does not provide an opportunity for a hearing; however, the applicant retains the right to resubmit the application and pay a reinstatement fee at any time. (g) Suspension and revocation of accreditation of mammography facilities. (1) Suspension of accreditation of mammography facilities. (A) An accreditation of a mammography facility may be suspended or revoked for any of the following reasons: (i) any material false statement in the application or any statement of fact required under provision of the Act; (ii) conditions revealed by such application or statement of fact or any report, record, inspection, or other means that would warrant the agency accreditation body to refuse to grant an accreditation of mammography facility on an original application; or (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. Cont'd... |
