900.12(a)(2)(ii)(A): Mammography requirements. All mammographic examinations shall be performed by radiologic technologists who meet the following mammography requirements: Have, prior to April 28, 1999 qualified as a radiologic technologist under paragraph (a)(2) of this section of FDA’s interim regulations of December 21, 1993, or completed at least 40 contact hours of documented training specific to mammography under the supervision of a qualified instructor. The hours of documented training shall include, but not necessarily be limited to: (A) Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, imaging of patients with breast implants;
900.12(a)(2)(iii)(A) and (D): Continuing Education Requirements:
(A) Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed, the radiologic technologist shall have taught or completed at least 15 continuing education units in mammography during the 36 months immediately preceding the date of the facility’s annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 36-month period.
(D) Requalification. Radiologic technologists who fail to meet the continuing education requirements of paragraph (a)(2)(iii)(A) of this section shall obtain a sufficient number of continuing education units in mammography to bring their total up to at least 15 in the previous 3 years, at least 6 of which shall be related to each modality used by the technologist in mammography. The technologist may not resume performing unsupervised mammography examinations until the continuing education requirements are completed.
After consultation with the ARRT and a number of mammography professionals (technologists, radiology consultants, radiology managers, and MQSA inspectors) who have taken the ARRT Quality Management exam, it was determined that half of the exam tests the technologist’s knowledge and skills with regard to physics and quality management applicable to mammography while half of the exam tests the technologist’s knowledge and skills in physics and quality management indirectly related to mammography. Therefore, 12 credit hours will be acceptable toward the technologist’s initial training requirement. If the technologist has already satisfied his/her initial training requirement, then all 24 credit hours may be applied toward their continuing education requirement. If the 12 credit hours applied toward the initial training requirement completes/satisfies the 40 hour mammography specific training requirement, then the remaining 12 hours may be applied toward the continuing education requirement.