| (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. (3) Medical physicist. Each medical physicist performing mammographic surveys, evaluating mammographic equipment, or providing oversight of the facility quality assurance program in accordance with subsection (u) of this section, shall hold a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, in diagnostic radiological physics and be registered with the agency or employed by an entity registered with the agency, in accordance with §289.226(j) of this title and the Act, unless exempted by §289.226(d)(6) of this title. Each medical physicist shall meet the following qualifications. (A) Initial qualifications. Before performing surveys and evaluating mammographic equipment independently, the medical physicist shall: (i) have a masters degree or higher in a physical science from an accredited institution, with no less than 20 semester hours or equivalent (30 quarter hours) of college undergraduate or graduate level physics; (ii) have 20 contact hours of documented specialized training in conducting surveys of mammography facilities; and (iii) have experience conducting surveys of at least one mammography facility and a total of at least ten mammography machines. After April 28, 1999, experience conducting surveys must be acquired under the direct supervision of a medical physicist who meets the requirements of subparagraphs (A) and (C) of this paragraph. No more than one survey of a specific machine within a period of 60 days can be counted towards the total mammography machine survey requirement. (B) Alternative initial qualifications. Individuals who qualified as a medical physicist in accordance with the requirements of this section that were in effect prior to April 28, 1999, or any other equivalent state or federal requirements in effect prior to April 28, 1999, and have met the following additional qualifications prior to April 28, 1999, are determined to have met the initial qualifications of subparagraph (A) of this paragraph: (i) a bachelor's degree or higher in a physical science from an accredited institution with no less than ten semester hours or equivalent of college undergraduate or graduate level physics; (ii) 40 contact hours of documented specialized training in conducting surveys of mammography facilities; and (iii) experience conducting surveys of at least one mammography facility and a total of at least 20 mammography machines. No more than one survey of a specific machine within a period of 60 days can be counted towards the total mammography machine survey requirement. The training and experience requirements must be met after fulfilling the degree requirements. (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 will begin when a physicist completes the requirements in subparagraph (A) of this paragraph. The time period for continuing experience will begin when a physicist 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 physicist shall maintain his/her qualifications by meeting the following requirements: (i) participating in education programs, either by teaching or completing at least 15 CEUs in mammography that shall include hours of training appropriate to each mammographic modality evaluated by the medical physicist during his or her surveys. 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) by the last day of the calendar quarter preceding the inspection; or (III) any date in between the two; (ii) performing surveys of two mammography facilities and a total of at least six mammography machines (no more than one survey of a specific facility within a ten-month period or a specific machine within a period of 60 days can be counted towards the total mammography machine survey requirement). The continuing experience must be completed during the 24 months immediately preceding: (I) the date of the facility's annual inspection; (II) by 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 physicist has not been previously trained, prior to independently using the new modality. (D) Re-establishing qualifications. Before resuming independent performance of surveys and equipment evaluations, medical physicists who fail to maintain the continuing education or experience requirements shall reestablish 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; and/or (ii) performing a sufficient number of surveys, under the direct supervision of a qualified medical physicist, to bring their total up to two mammography facilities and a total of at least six mammography machines for the prior 24 months. No more than one survey of a specific machine within a period of 60 days shall be counted towards the total mammography machine survey requirement. (4) Retention of personnel records. Records documenting the qualifications, continuing education, and experience of personnel in subsection (r)(1) - (3) shall be maintained for inspection by the agency in accordance with subsection (ee) of this section. (s) Equipment standards. Only systems meeting the following standards shall be used. (1) System design. The equipment shall have been specifically designed and manufactured for mammography and in accordance with Title 21, CFR, §§1010.2, 1020.30, and 1020.31. (2) Motion of tube-image receptor assembly. The assembly shall be capable of being fixed in any position where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion. In the event of power interruption, this mechanism shall not fail. (3) Image receptors. Systems using screen-film image receptors shall, at a minimum, provide for the following: (A) operation with image receptors of 18 x 24 cm and 24 x 30 cm; (B) operable moving grids matched to all image receptor sizes provided; (C) operation with the grid removed from between the source and image receptor for systems used for magnification procedures; and (D) image receptors to rest, post-loading, 15 minutes between exposures. (4) Magnification. Systems used to perform noninterventional problem solving procedures shall have radiographic magnification capability available for use with, at a minimum, at least one magnification value within the range of 1.4 to 2.0. (5) Focal spot and target material selection. Selection of the focal spot or target material shall be as follows. (A) When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected. (B) When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material. (C) When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure. (6) Compression. All mammography systems shall incorporate a compression device. (A) Application of compression. Effective October 28, 2002, and thereafter, each system shall provide the following features operable from both sides of the patient: (i) an initial power-driven compression activated by hands-free controls; and (ii) fine adjustment compression controls. (B) Compression paddle. (i) Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Cont'd... |
