Personnel Requirements

Section 370 Section 370.70  Personnel Requirements Personnel.  The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities: a)         Interpreting physicians.  All physicians interpreting mammograms shall meet the following qualifications: 1)         Initial qualifications.  Unless the exemption in subsection (a)(3) of this Section applies, before beginning to interpret mammograms independently, the interpreting physician shall: A)        Be a physician licensed under the Medical Practice Act of 1987 to practice medicine in all its branches [225 ILCS 60]; B)        Be certified in diagnostic radiology by either the American Board of Radiology, the American Osteopathic Board of Radiology, or Royal College of Physicians and Surgeons of Canada or have had at least 3 months of documented formal training in the interpretation of mammograms and in topics related to mammography.  The training shall include instruction in radiation physics, including radiation physics specific to mammography, radiation effects and radiation protection.  The mammographic interpretation component shall be under the direct supervision of a physician who meets the requirements of subsection (a) of this Section; C)        Have a minimum of 60 hours of documented medical education in mammography, which shall include instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography and quality assurance and quality control in mammography.  All 60 of these hours shall be Category I and at least 15 of the Category I hours shall have been acquired within the 3 years immediately prior to the date that the physician qualifies as an interpreting physician.  Hours spent in residency specifically devoted to mammography will be considered as equivalent to Category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution; and D)        Unless the exemption in subsection (a)(3) of this Section applies, have interpreted or multi-read at least 240 mammographic examinations within the 6 month period immediately prior to the date that the physician qualifies as an interpreting physician.  This interpretation or multi-reading shall be under the direct supervision of an interpreting physician. 2)         Continuing experience and education.  All interpreting physicians shall maintain their qualifications by meeting the following requirements: A)        Following the second anniversary date of the end of the calendar quarter in which the requirements of subsection (a)(1) of  this Section were completed, the interpreting physician shall have interpreted or multi-read at least 960 mammographic examinations during the 24 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 24 month period. B)        Following the third anniversary date of the end of the calendar quarter in which the requirements of subsection (a)(1) of this Section were completed, the interpreting physician shall have taught or completed at least 15 Category I continuing medical 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.  This training shall include at least 6 Category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice. C)        Before an interpreting physician may begin independently interpreting mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality. D)        Units earned through teaching a specific course can be counted only once towards the 15 units required by subsection (a)(2) of this Section, even if the course is taught multiple times during the previous 36 months. 3)         Exemptions. A)        Those physicians who qualified as interpreting physicians under FDA's interim regulations prior to April 28, 1999, are considered to have met the initial requirements of subsection (a)(1) of this Section.  These physicians may continue to interpret mammograms provided they continue to meet the requirements of subsection (a)(1) of this Section and the continuing experience and education requirements of subsection (a)(2) of this Section. B)        Physicians who have interpreted or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician in any 6 month period during the last 2 years of a diagnostic radiology residency and who become appropriately board certified at the first allowable time, as defined by an eligible certifying body, are otherwise exempt from subsection (a)(1)(D) of this Section. 4)         Reestablishing qualifications.  Interpreting physicians who fail to maintain the required continuing experience or continuing education requirements of subsection (a)(2) of this Section, shall reestablish their qualifications before resuming the independent interpretation of mammograms as follows: A)        Interpret or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician, or interpret or multi-read a sufficient number of mammographic examinations, under the direct supervision of an interpreting physician, to bring the physician's total up to 960 examinations for the prior 24 months, whichever is less. B)        Interpreting physicians who fail to meet the continuing education requirements of subsection (a)(2)(B) of this Section shall obtain a sufficient number of additional Category I continuing medical education credits in mammography to bring their total up to the required 15 credits in the previous 36 months before resuming independent interpretation. C)        The interpretations required under this Section shall be done within the 6 months immediately prior to resuming independent interpretation. b)         Radiologic technologists who perform mammographic examinations shall be accredited by the Agency and shall meet the following: 1)         Training requirements. A)        Have, prior to  April 28, 1999, qualified as a radiologic technologist under FDA's interim regulations; or B)        Complete 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: i)          Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques and imaging of patients with breast implants; ii)         The performance of a minimum of 25 examinations under the direct supervision of an individual qualified under subsection (b) of this Section; and iii)        At least 8 hours of training in each mammography modality to be used by the technologist in performing mammography exams. 2)         Continuing education requirements. A)        Following the third anniversary date of the end of the calendar quarter in which the requirements of subsection (b)(1) of this Section were completed, the radiologic technologist who performs mammography 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. B)        Units earned through teaching a specific course can be counted only once towards the 15 hours of continuing education requirements required in subsection (b)(2) of this Section, even if the course is taught multiple times during the previous 36 months. C)        At least 6 of the continuing education units required in subsection (b)(2) of this Section shall be related to each mammographic modality used by the technologist. D)        Requalification.  Radiologic technologists who fail to meet the continuing education requirements of subsection (b)(2)(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 shall not resume performing unsupervised mammography examinations until the continuing education requirements are completed. E)        Before a radiologic technologist may begin independently performing mammography examinations using a mammographic modality other than one of those for which the technologist received training under subsection (b)(1)(B)(iii) of this Section, the technologist shall have at least 8 hours of continuing education units in the new modality. 3)         Continuing experience requirements. A)        Following the second anniversary date of the end of the calendar quarter in which the requirements of subsection (b)(1) of this Section were completed or of April 28, 1999, whichever is later, the radiologic technologist shall have performed a minimum of 200 mammography examinations during the 24 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 24 month period. B)        Requalification.  Radiologic technologists who fail to meet the continuing experience requirements of subsection (b)(3)(A) of this Section shall perform a minimum of 25 mammography examinations under the direct supervision of a qualified radiologic technologist before resuming the performance of unsupervised mammography. C)        Programs, courses or other activities intended to meet the requirement for initial, or requalification, mammography training or continuing education in mammography shall be approved by the Agency. D)        Completion of initial, or requalification, mammography training and continuing education in mammography shall be verified to the Agency. c)         Medical physicists.  All medical physicists conducting surveys of mammography facilities and providing oversight of the facility quality assurance program shall be approved by the Agency as diagnostic imaging specialists pursuant to 32 Ill. Adm. Code 410, and meet the following: 1)         Initial qualifications. A)        Be certified in diagnostic radiological physics or radiological physics by either the American Board of Radiology (ABR) or the American Board of Medical Physics (ABMP); B)        Have a masters degree or higher in a physical science from an accredited institution, with no less than 20 semester hours or equivalent (e.g., 30 quarter hours) of college undergraduate or graduate level physics; C)        Have 20 contact hours of documented specialized training in conducting surveys of mammography facilities; and D)        Have the experience of conducting surveys of at least 1 mammography facility and a total of at least 10 mammography units.  No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement.  After April 28, 1999, experience conducting surveys shall be acquired under the direct supervision of a medical physicist who meets all the requirements of subsections (c)(1), (c)(2) and (c)(3) of this Section. 2)         Alternative initial qualifications. A)        Have qualified as a medical physicist under FDA's interim regulations and retained that qualification by maintenance of the active status of any licensure, approval or certification required; B)        Have, prior to April 28, 1999, obtained a bachelor's degree or higher in a physical science from an accredited institution with no less than 10 semester hours or equivalent of college undergraduate or graduate level physics; C)        Have 40 contact hours of documented specialized training in conducting surveys of mammography facilities; and D)        Have the experience of conducting surveys of at least 1 mammography facility and a total of at least 20 mammography units.  No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement.  The training and experience requirements shall be met after fulfilling the degree requirement. 3)         Continuing education and experience.  All medical physicists shall maintain their qualifications by meeting the following requirements: A)        Continuing education.  Beginning 3 years after the end of the calendar quarter in which the requirements of subsection (c)(1) or (c)(2) of this Section were completed, the medical physicist 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 inspection, or the last day of the calendar quarter preceding the inspection or any date in between the two.  The facility shall choose one of these dates to determine the 36 month period.  This continuing education shall include hours of training appropriate to each mammographic modality evaluated by the medical physicist during his or her surveys or oversight of quality assurance programs.  Units earned through teaching a specific course can be counted only once towards the required 15 continuing education units in a 36 month period, even if the course is taught multiple times during the 36 months. B)        Continuing experience.  Beginning 2 years after the end of the calendar quarter in which the requirements of subsection (c)(1) or (c)(2) of this Section were completed or of April 28, 1999, whichever is later, the medical physicist shall have surveyed at least 2 mammography facilities and a total of at least 6 mammography units during the 24 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 shall choose one of these dates to determine the 24 month period.  No more than one survey of a specific facility within a 10 month period or a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. C)        Before a medical physicist may begin independently performing mammographic surveys of a new mammographic modality, that is, a mammographic modality other than one for which the physicist received training to qualify under subsection (c)(1) or (c)(2) of this Section, the physicist shall receive at least 8 hours of training in surveying units of the new mammographic modality. 4)         Reestablishing qualifications.  Medical physicists who fail to maintain the required continuing education and experience qualifications of subsection (c)(3) of this Section may not perform the MQSA surveys without the supervision of a qualified medical physicist.  Before independently surveying another facility, medical physicists shall reestablish their qualifications, as follows: A)        Medical physicists who fail to meet the continuing educational requirements of subsection (c)(3)(A) of this Section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 units in the previous 3 years. B)        Medical physicists who fail to meet the continuing experience requirement of subsection (c)(3)(B) of this Section shall complete a sufficient number of surveys under the direct supervision of a medical physicist who meets the qualifications of subsection (c)(1) or (c)(2) of this Section, to bring their total surveys up to the required 2 facilities and 6 units in the previous 24 months.  No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. d)         Retention of personnel records.  Facilities shall maintain records to document the qualifications of all personnel who worked at the facility as interpreting physicians, radiologic technologists or medical physicists.  These records shall be available for review by the Agency.  Records of personnel no longer employed by the facility shall not be discarded until the next annual inspection has been completed and the Agency has determined that the facility is in compliance with the personnel requirements of this Section.