| (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. (6) Loaner mammography machines may be used on patients for 60 days without adding the mammography machine to the certification. A medical physicist's report verifying compliance of the loaner mammography machine with this section shall be completed prior to use on patients. The results of the survey must be submitted to the agency with a cover letter indicating period of use. If the use period will exceed 60 days, the facility shall add the mammography machine to its certification and a fee will be assessed. (7) Records of training and experience and all other records required by this section shall be maintained for review in accordance with subsection (ee) of this section. (o) Renewal of certification. (1) A certification for a mammography system is valid for three years from the date of issuance unless the certification of the facility is suspended or revoked prior to such deadlines. (2) A mammography facility filing an application for renewal of their certification shall meet the quality standards in subsections (r) - (aa) of this section and be accredited by an FDA-approved accreditation body. The renewal shall be filed in accordance with the following: (A) §289.226(e)(1) - (3), (5) and (7) of this title and §289.226(f)(4) and (5) of this title; (B) signatures of appropriate personnel in accordance with subsection (f)(3) of this section; (C) machine information and medical physicist's survey in accordance with subsection (f)(5)(B) and (C) of this section; (D) fees in accordance with §289.204 of this title; and (E) a list of all interpreting physicians, medical radiologic technologists and medical physicists practicing at the facility. (3) A mammography facility filing an application for renewal before the existing certification expires may continue to perform mammography until the application status has been determined by the agency. (4) A facility with mammography machines used for interventional breast radiography shall file an application for renewal in accordance with subsection (gg)(8) of this section and pay the fee required by §289.204 of this title. (p) Expiration of certification. (1) Except as provided by subsection (o) of this section, each certification expires at the end of the day in the month and year stated on the mammography certificate. Expiration of the certification does not relieve the registrant of the requirements of this chapter. (2) If a registrant does not submit an application for renewal of the certification under subsection (o) of this section, as applicable, the registrant shall on or before the expiration date specified in the certification: (A) terminate use of all mammography machines; (B) notify the agency certifying body in writing of the film storage location of mammography patients' films and address how the requirements of subsection (t)(4)(D) of this section will be met; (C) pay any outstanding fees in accordance with §289.204 of this title; and (D) submit a record of the disposition of the mammography machine(s) to the agency certifying body. If the machine(s) was transferred, include to whom it was transferred. (q) Termination of certification. When a registrant decides to terminate all activities involving mammography machines authorized under the certification, the registrant shall: (1) notify the agency certifying body and the FDA-approved accreditation body immediately; (2) request termination of the certification in writing; (3) pay any outstanding fees in accordance with §289.204 of this title; (4) notify the agency certifying body, in writing, of the film storage location of mammography patients' films and address how the requirements of subsection (t)(4)(D) of this section will be met; and (5) submit a record of the disposition of the mammography machine(s) to the agency certifying body. If the machine(s) was transferred, include to whom it was transferred. (r) Personnel qualifications. The following requirements apply to all personnel involved in any aspect of mammography, including the production and interpretation of mammograms. (1) Interpreting physician. Each physician interpreting mammograms shall hold a current Texas license issued by the Texas Medical Board and meet the following qualifications. (A) Initial qualifications. Before interpreting mammograms independently, the physician shall: Cont'd... |
