| (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: (i) be certified by the American Board of Radiology, the American Osteopathic Board of Radiology, or one of the other bodies approved by the FDA to certify interpreting physicians or have at least three months of documented formal training in the interpretation of mammograms and in topics related to mammography in accordance with subsection (hh)(2) of this section; (ii) have had a minimum of 60 hours of documented category I CMEUs in mammography. At least 15 of the 60 hours shall have been acquired within three years immediately prior to the date that the physician qualified as an interpreting physician. Hours spent in residency specifically devoted to mammography will be equivalent to category I CMEUs and accepted if documented in writing by the appropriate representative of the training institution; and (iii) have interpreted or multi-read, under the direct supervision of an interpreting physician, at least 240 mammographic examinations within the six-month period immediately prior to the date that the physician qualifies as an interpreting physician. (B) Exemptions. (i) Physicians who qualified as interpreting physicians in accordance with the requirements of §289.230 that were in effect prior to April 28, 1999, or any other equivalent state or federal requirements in effect prior to April 28, 1999, are considered to have met the initial requirements of subparagraph (A) of this paragraph. (ii) Physicians who have interpreted or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician in any six month period during the last two years of a diagnostic radiology residency and who became board certified at the first allowable time, are exempt from subparagraph (A)(iii) of this paragraph. (C) Continuing education and experience. The time period for completing continuing education is a 36-month period and the time period for completing continuing experience is a 24-month period. These periods begin when a physician completes the requirements to become an interpreting physician in subparagraph (A) of this paragraph. The facility shall choose one of the dates in clause (i) of this subparagraph to determine the 36-month continuing education period and one of the dates in clause (ii) of this subparagraph to determine the 24-month continuing experience period. Each interpreting physician shall maintain qualifications by meeting the following requirements: (i) participating in education programs by completing at least 15 category I CMEUs in mammography or by teaching mammography courses. CMEUs earned through teaching a specific course can be counted only once during the 36-month period. The continuing education must be completed in the 36 months immediately preceding: (I) the date of the registrant's annual inspection; (II) the last day of the calendar quarter preceding the inspection; or (III) any date in between the two; (ii) interpreting or multi-reading at least 960 mammographic examinations that must be completed during the 24 months immediately preceding: (I) the date of the registrant's annual inspection; (II) the last day of the calendar quarter preceding the inspection; or (III) any date in between the two; and (iii) accumulating at least eight hours of CMEUs in any mammography modality in which the interpreting physician has not been previously trained, prior to independently using the new modality. (D) Re-establishing qualifications. Before resuming independent interpretation of mammograms, interpreting physicians who fail to maintain the required continuing education or experience requirements shall re-establish their qualifications by completing one or both of the following requirements, as applicable: (i) obtain a sufficient number of additional category I CMEUs to bring their total up to the 15 category I CMEU credits required in the previous 36 months; and/or (ii) within the six months immediately prior to resuming independent interpretation and under the direct supervision of an interpreting physician, interpret or multi-read one of the following, whichever is less: (I) at least 240 mammographic examinations; or Cont'd... |
