| (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 (II) a sufficient number of mammographic examinations to bring the total up to 960 examinations for the prior 24 months. (E) Additional mandatory training. Additional mandatory training may be required by the agency based on the recommendations of the American College of Radiology or the FDA. Such training will be developed on a case by case basis. (i) The agency may require pre-approval of any additional mandatory training. (ii) Documentation of the additional mandatory training shall be submitted for review by the date specified by the agency. (iii) Records of all additional mandatory training shall be maintained by the registrant for inspection by the agency in accordance with subsection (ee)(3) of this section. (2) Medical radiologic technologists (operators of equipment). Each person performing mammographic examinations shall have current certification as a medical radiologic technologist under the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601, and shall meet the following qualifications. (A) Initial requirements. Before performing mammographic examinations, the operator of equipment shall have: (i) completed a minimum of 40 contact hours of training as outlined in subsection (hh)(1) of this section by a qualified instructor; and (ii) performed a minimum of 25 mammographic examinations under the direct supervision of an individual qualified in accordance with the requirements of this paragraph. The 25 mammographic examinations may be obtained concurrently with the 40 contact hours of training specified in clause (i) of this subparagraph but shall not exceed 16 hours of the 40 contact hours. (B) Exemptions. Equipment operators who qualified as medical radiologic technologists to perform mammography in accordance with the requirements of §289.230 that were in effect prior to April 28, 1999, and any other federal requirements in effect prior to April 28, 1999, are considered to have met the initial requirements of subparagraph (A) 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. The period for continuing education begins when a technologist completes the requirements in subparagraph (A) of this paragraph. The period for continuing experience begins when a technologist completes the requirements in subparagraph (A) of this paragraph, or April 28, 1999, whichever is later. 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 medical radiologic technologist shall maintain qualifications by meeting the following requirements: (i) participating in education programs by completing at least 15 CEUs in mammography or by teaching mammography courses. CEUs 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) performing a minimum of 200 mammographic examinations that must be completed during the 24 months immediately preceding: (I) the facility'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 CEUs in any mammography modality in which the medical radiologic technologist has not been previously trained, prior to independently using the new modality. (D) Requalification. Before resuming independent performance of mammograms, medical radiologic technologists who fail to maintain the continuing education or experience requirements shall re-establish their qualifications by completing one or both of the following requirements, as applicable: (i) obtaining a sufficient number of additional CEUs to bring their total up to the 15 CEU credits required in the previous 36 months, at least six of which shall be related to each modality used by the technologist in mammography; and/or (ii) performing a minimum of 25 mammographic examinations under the direct supervision of a qualified medical radiologic technologist. (E) Additional mandatory training. Additional mandatory training may be required by the agency based on the recommendations of the American College of Radiology or the FDA. Such training will be developed on a case by case basis. Cont'd... |
