| (ii) Compression paddles for special purposes, including those smaller than the full size of the image receptor (for example, spot compression) may be provided. Such paddles are not subject to the requirements of clauses (v) and (vi) of this subparagraph. (iii) Except as provided in clause (iv) of this subparagraph, the compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied. (iv) Equipment intended by the manufacturer's design to not be flat and parallel to the breast support table during compression shall meet the manufacturer's design specifications and maintenance requirements. (v) The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor. (vi) The chest wall edge may be bent upward to allow for patient comfort, but shall not appear on the image. (7) Technique factor selection and display. Technique factor selection and display shall be as follows. (A) Manual selection of milliampere seconds (mAs) or at least one of its component parts, milliampere (mA) and/or time, shall be available. (B) The technique factors (peak tube potential in kilovolts (kV) and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs) to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure control (AEC) is used, in which case the technique factors that are set prior to the exposure shall be indicated. (C) When the AEC mode is used, the system shall indicate the actual kVp and mAs used during the exposure. The mAs may be displayed as mA and time. (8) Automatic exposure control. Each screen-film system shall provide an AEC mode that is operable in all combinations of equipment configuration provided, for example, contact, magnification, and various image receptor sizes. (A) The positioning or selection of the detector shall permit flexibility in the placement of the detector under the target tissue. (i) The size and available positions of the detector shall be clearly indicated at the x-ray input surface of the breast compression paddle. (ii) The selected position of the detector shall be clearly indicated. (B) The system shall provide means to vary the selected optical density from the normal (zero) setting. (9) X-ray film. The registrant shall use x-ray film for mammography that has been designated by the film manufacturer as appropriate for mammography. (10) Intensifying screens. The registrant shall use intensifying screens for mammography that have been designated by the screen manufacturer as appropriate for mammography and shall use film that is matched to the screen's spectral output as specified by the manufacturer. (11) Film processing solutions. For processing mammography films, the registrant shall use chemical solutions that are capable of developing the films used by the facility in a manner equivalent to the minimum requirements specified by the film manufacturer. (12) Lighting. The registrant shall make available special lights for film illumination (hot lights) capable of producing light levels greater than that provided by the view box. (13) Film masking devices. Registrants shall ensure that film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available to all interpreting physicians interpreting for the facility. (14) Equipment variances. Registrants with mammography equipment that has been issued variances by FDA to Title 21, CFR, §§1020.2, 1020.30, 1020.31, or has had an alternative for a quality standard for equipment approved by the FDA under the provisions of Title 21, CFR, §900.18, shall maintain copies of those variances or alternative standards. (15) Light fields. For any mammography system with a light beam that passes through the x-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 foot candles) at 100 cm or the maximum source-image receptor distance (SID), whichever is less. (t) Medical records and mammography reports. (1) Contents and terminology. Each registrant shall prepare a written report of the results of each mammography examination that shall include the following information: (A) name of the patient and date of birth; (B) date of the examination; (C) name and signature of the interpreting physician who interpreted the mammogram (electronic signatures are acceptable); (D) overall final assessment of findings using the final assessment categories as defined in subsection (c) of this section; and (E) recommendations made to the physician about what additional actions, if any, should be taken. All clinical questions raised by the referring physician shall be addressed in the report to the extent possible, even if the assessment is negative or benign. (2) Communication of mammography results to the patient and health care providers or physicians, as applicable. Each registrant shall send reports as soon as possible, but no later than 30 days from the date of the mammography examination, to: (A) patients advising them of the results of the mammography examination and any further medical needs indicated. The report shall include a summary written in language easily understood by a lay person; and (B) referring physicians, or in the case of self-referral, to the physician indicated by the patient, advising them of the results of the mammography examination, containing the information specified in paragraph (1) of this subsection, and any further medical needs indicated. (3) Follow-up with patients and physicians. Each registrant shall follow-up to confirm the following: (A) that patients with positive findings and patients needing repeat exams have received proper notification; and (B) that physicians have received proper notification of patients with positive findings or needing repeat exams. (4) Retention of clinical images for current, closed or terminated registrants. (A) Each registrant that performs mammograms shall maintain mammography films and reports in a permanent medical record for a minimum of five years. If no additional mammograms of the patient are performed at the facility, the films and reports shall be maintained for a minimum of ten years. (B) Each registrant that performs mammograms shall, within 30 days of request by or on behalf of the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, a physician, or to the patient directly. (C) If the medical records are permanently forwarded, the receiving institution or physician shall maintain and become responsible for the original film until the fifth or tenth anniversary, as specified in subparagraph (A) of this paragraph. (D) Upon closure or termination, the registrant shall maintain the mammography films for 5 years. If the facility complies with the following: (i) within 180 days of closing, the registrant shall directly notify each patient or patient's representative with instructions on how to retrieve or authorize disposal of the patient's records; and (ii) within 60 days of closing, the registrant shall publish a notice in one or more newspapers covering the geographical area served by the closing facility. The notice shall include: (I) contact information on retrieving patient records; and (II) information that the records will be destroyed if not retrieved by the patient or the patient's representative within 5 years; and (iii) if records have not been retrieved by the patient or the patient's representative following the 5-year period after closing, the registrant may destroy the records. (5) Mammographic image identification. Each mammographic image shall have the following information indicated on it in a permanent, legible manner and placed so as not to obscure anatomic structures: (A) name of patient and date of birth; (B) date of examination; (C) view and laterality (this information shall be placed on the image in a position near the axilla); (D) facility name and location (at a minimum the location shall include city, state, and zip code); (E) technologist identification; (F) cassette/screen identification; and Cont'd... |
