| (B) instructions to workers in accordance with §289.203(c) of this title; (C) notifications and reports to individuals in accordance with §289.203(d) of this title; (D) ordering x-ray exams in accordance with §289.231(b) of this title; (E) occupational dose requirements in accordance with §289.231(m) of this title; (F) personnel monitoring requirements in accordance with §289.231(n) and (q) of this title; (G) credentialing requirements for medical radiologic technologists, and medical physicists in accordance with paragraph (11) of this subsection; (H) use of a technique chart in accordance with paragraph (22) of this subsection; (I) exposure of individuals other than the patient in accordance with paragraph (18) of this subsection; and (J) holding of patients or image receptors in accordance with subsection (dd)(7) of this section. (15) Receipt, transfer, and disposal of interventional breast radiography machines. Each registrant shall maintain records showing the receipt, transfer, and disposal of interventional breast radiography machines. These records shall include the date of receipt, transfer, or disposal; the name and signature of the individual making the record; and the manufacturer's model name and serial number on the control panel. These records shall be maintained in accordance with subsection (ee) of this section for inspection by the agency. (16) Calibration, maintenance, and modifications. Each registrant shall maintain records showing calibrations, maintenance, and modifications performed on each interventional breast radiography machine. These records shall include the date of the calibration, maintenance, or modification performed; the name of the individual making the record; and the manufacturer's model name and serial number on the control panel. These records shall be maintained in accordance with subsection (ee) of this section for inspection by the agency. (17) Viewing system. Windows, mirrors, closed circuit television, or an equivalent system shall be provided to permit the operator to continuously observe the patient during irradiation. The operator shall be able to maintain verbal, visual, and aural contact with the patient. (18) Exposure of individuals other than the patient. Only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiation exposure unless such individual's assistance is required. (19) Maintenance of records. Maintenance of applicable records in subsection (ee) of this section. (20) Inspection requirements. Inspection requirements in accordance with subsection (ff)(2) - (4) of this section. (21) Equipment requirements. Equipment requirements in accordance with §289.227(h) of this title (relating to Use of Radiation Machines in the Healing Arts). (22) Technique chart. A chart or manual shall be provided or electronically displayed in the vicinity of the control panel of each interventional breast radiography machine that specifies technique factors to be utilized versus patient's anatomical size. The technique chart shall be used by all operators. (hh) Appendices. (1) Subjects to be included in mammography training for medical radiologic technologists shall include, but not be limited to, the following: (A) breast anatomy and physiology; (B) positioning and compression; (C) quality assurance/quality control techniques; (D) imaging of patients with breast implants; and (E) at least eight hours of training in each mammography modality to be used by the technologist in performing mammography exams. (2) Subjects to be included in mammography training for interpreting physicians shall include, but not be limited to, the following: (A) radiation physics, including radiation physics specific to mammography; (B) radiation effects; (C) radiation protection; and (D) interpretation of mammograms. This shall be under the direct supervision of a physician who meets the requirements of subsection (r)(1) of this section. (3) Operating and safety procedures. The registrant's operating and safety procedures shall include, but are not limited to, the following procedures as applicable: (A) posting notices to workers in accordance with §289.203(b) of this title; (B) instructions to workers in accordance with §289.203(c) of this title; (C) notifications and reports to individuals in accordance with §289.203(d) of this title; (D) ordering x-ray exams in accordance with §289.231(b) of this title; (E) occupational dose requirements in accordance with §289.231(m) of this title; (F) personnel monitoring requirements in accordance with §289.231(n) and (q) of this title; (G) posting of a radiation area in accordance with §289.231(x) and (y) of this title; (H) credentialing requirements for lead interpreting physicians, interpreting physicians, medical radiologic technologists, and medical physicists in accordance with subsection (r) of this section; (I) retention of clinical images in accordance with subsection (t)(4) of this section; (J) quality assurance program in accordance with subsections (u) - (w) of this section; (K) image quality and corrective action for images of poor quality in accordance with subsection (u)(1)(B)(i) of this section; (L) repeat analysis in accordance with subsection (v)(3)(B) of this section; (M) procedures and techniques for mammography patients with breast implants in accordance with subsection (x) of this section; (N) procedure to handle complaints in accordance with subsection (y) of this section; (O) self-referral mammography in accordance with subsection (bb) of this section; (P) use of a technique chart in accordance with subsection (dd)(2) of this section; (Q) exposure of individuals other than the patient in accordance with subsection (dd)(5) of this section; (R) use of protective devices in accordance with subsection (dd)(6) of this section; and (S) holding of patients or image receptors in accordance with subsection (dd)(7) of this section. (4) Phantom image scoring protocol for film-screen modality. Each of the following object groups are to be scored separately. In order to receive a passing score on the phantom image, all three test object groups must pass. A failure in any one of the areas results in a phantom failure. (A) Fibers. A score of 4.0 for fibers is required to meet the evaluation criteria. The diameter size of fibers are 1.56 mm, 1.12 mm, 0.89 mm, 0.75 mm, 0.54 mm, and 0.40 mm. Score the fibers as follows. (i) Begin with the largest fiber and move down in size, adding one point for each full fiber until a score of zero or one half is given. Stop counting at the first point where you lose visibility of objects. (ii) If the entire length of the fiber can be seen and its location and orientation are correct, that fiber receives a score of one. (iii) If at least half, but not all, of the fiber can be seen and its location and orientation are correct, that fiber receives a score of one half. (iv) If less than one half of a fiber can be seen or if the location or orientation are incorrect, that fiber receives a score of zero. (v) After determining the last fiber to be counted, look at the overall background for artifacts. If there are background objects that are fiber-like in appearance and are of equal or greater brightness than the last visible half or full fiber counted, subtract the last half or full fiber scored. (B) Speck groups. A score of 3.0 for speck groups is required to meet the evaluation criteria. Diameter sizes of speck groups are 0.54 mm, 0.40 mm, 0.32 mm, 0.24 mm, and 0.16 mm. There are six specks per group. Score the speck groups as follows. (i) Begin with the largest speck group and move down in size adding one point for each full speck group until a score of one half or zero is given, then stop. (ii) If at least four of the specks in any group are visualized, the speck group is scored as one. (iii) If two or three specks in a group are visualized, the score for the group is one half. (iv) If one speck or no specks from a group are visualized, the score is zero. Cont'd... |
