( 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 paragraph (a)(1) of this section;
( 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.
( The interpretations required under paragraph (a)(1)(iv)(A)( 1 ) or (a)(1)(iv)(A)( 2 ) of this section shall be done within the 6 months immediately prior to resuming independent interpretation.
( Have 20 contact hours of documented specialized training in conducting surveys of mammography facilities; and
( 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 must be acquired under the direct supervision of a medical physicist who meets all the requirements of paragraphs (a)(3)(i) and (a)(3)(iii) of this section; or
( 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,
( Forty contact hours of documented specialized training in conducting surveys of mammography facilities and,
( 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 must be met after fulfilling the degree requirement.
( The lowest clinical kVp that can be measured by a kVp test device;
( The most commonly used clinical kVp;
( The highest available clinical kVp, and
( The bar pattern shall be placed 4.5 cm above the breast support surface, centered with respect to the chest wall edge of the image receptor, and with the edge of the pattern within 1 cm of the chest wall edge of the image receptor.
( When more than one target material is provided, the measurement in paragraph (e)(5)(iii)(A) of this section shall be made using the appropriate focal spot for each target material.
( When more than one SID is provided, the test shall be performed at SID most commonly used clinically.
( Test kVp shall be set at the value used clinically by the facility for a standard breast and shall be performed in the AEC mode, if available. If necessary, a suitable absorber may be placed in the beam to increase exposure times. The screen-film cassette combination used by the facility shall be used to test for this requirement and shall be placed in the normal location used for clinical procedures.
TABLE 1
Focal Spot Tolerance Limit | ||
Nominal Focal Spot Size (mm) | Maximum Measured Dimensions | |
Width(mm) | Length(mm) | |
0.10 | 0.15 | 0.15 |
0.15 | 0.23 | 0.23 |
0.20 | 0.30 | 0.30 |
0.30 | 0.45 | 0.65 |
0.40 | 0.60 | 0.85 |
0.60 | 0.90 | 1.30 |
TABLE 2
X-ray Tube Voltage (kilovolt peak) and Minimum HVL | ||
Designed Operating Range (kV) | Measured Operating Voltage (kV) | Minimum HVL (millimeters of aluminum) |
Below 50 | 20 | 0.20 |
25 | 0.25 | |
30 | 0.30 |
21 C.F.R. §900.12