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(2) Provide a tube-image receptor assembly that is capable of being fixed in any operating position where it is designed to operate and once fixed in any such position, does not undergo unintended motion and does not fail in the event of power interruption.
(3) If equipped with screen-film image receptors:
(A) Be able to be operated with image receptors of 18 x 24 centimeters (cm) and 24 x 30 cm;
(B) Have moving grids matched to all image receptor sizes provided; and
(C) Be able to be operated with the grid removed, if the system is used for magnification procedures;
(4) If used to perform noninterventional problem solving procedures, have a radiographic magnification capability with at least one magnification value within the range of 1.4 to 2.0.
(5) When equipped with more than one focal spot, indicate, prior to exposure, which focal spot has been selected.
(6) When equipped with more than one target material, indicate, prior to exposure, the preselected target material.
(7) When equipped such that the target material and/or focal spot are selected by a system algorithm that is based on the exposure or on a test exposure, display, after the exposure, the target material and/or focal spot actually used during the exposure.
(8) Incorporate a compression device that:
(A) Effective October 28, 2002, provides:
1. An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and
2. Fine adjustment compression controls operable from both sides of the patient.
(B) Provides different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for "spot compression") may be provided but shall be exempt from the requirements of subsection (b)(8)(C); and
(C) Except as provided in subsection (b)(8)(D), provides a compression paddle that is flat and parallel to the image receptor holder assembly and does not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied. The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor. The chest wall edge shall not appear on the image;
(D) If the compression paddle is intended by the manufacturer's design to not be flat and parallel to the image receptor holder assembly during compression, the paddle shall meet the manufacturer's design specifications and maintenance requirements; and
(E) If the chest wall edge is bent upward for patient comfort, the edge shall not appear on the image.
(9) Provide manual selection of milliampere-seconds (mAs) or milliamperes (mA) and time, and;
(10) Indicate kVp, mA and time and/or mAs before the exposure begins, or when AEC is used, the technique factors that are set prior to the exposure;
(11) When the AEC mode is used, indicate the actual technique factors (kVp and mAs or mA and time) used, after completion of the exposure;
(12) If it is a screen-film system, provide an AEC mode that is operable in all combinations of equipment configuration provided on that unit, such as grid, nongrid, magnification, nonmagnification and various target-filter combinations, and:
(A) Provides a positioning or selection of the detector that is flexible in the placement of the detector under the target tissue;
(B) Clearly indicates the size and available positions of the detector at the X-ray input surface of the compression paddle;
(C) Clearly indicates the selected position of the detector; and
(D) Provides a means to vary the selected optical density from the normal or baseline setting.
(13) If equipped with a light beam that passes through the X-ray beam-limiting device, the light provides an average illumination of 160 lux (15 foot candles) at the lesser of:
(A) 100 centimeters; or
(B) The maximum source-to-image-distance the machine can obtain.
(c) A facility shall not perform mammography using a screen-film mammography system unless:
(1) There are at least four image receptors of 18 x 24 centimeters (cm) and at least four image receptors of 24 x 30 cm available for use by the person performing mammographic examinations;
(2) The X-ray film and intensifying-screens are designated by the film manufacturer and the screen manufacturer as appropriate for mammography and the X-ray film matches the screen's spectral output as specified by the screen manufacturer;
(3) Chemical solutions used for processing mammograms are capable of developing the film so as to meet the minimum requirements specified by the film manufacturer;
(4) Special lights for film illumination, or hot lights, that are capable of producing light levels greater than that provided by the view box are available; and
(5) 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 physicians interpreting mammograms for the facility.
(d) Documentation demonstrating compliance with this section shall be maintained in accordance with section 30319.20.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30316.10. Evaluations of New, Replaced or Repaired Equipment.
(a) Whenever the following occur, the affected equipment shall meet the requirements specified in sections 30316 and 30316.20 before the affected equipment is used to produce or process mammograms:
(1) Installation of a new radiation machine or processor;
(2) Disassembly and reassembling of a radiation machine or processor at the same or a new location; or
(3) Repair or replacement of any major component of the mammography system.
(b) The evaluation to determine if equipment specified in subsections (a)(1) through (3) are in compliance with subsection (a) shall be performed by a medical physicist or an individual under the direct supervision of a medical physicist.
(c) To use a new radiation machine, a facility shall:
(1) Possess a current and valid facility accreditation certificate issued pursuant to section 30315.22 or interim facility accreditation certificate issued pursuant to section 30315.24;
(2) Submit the results of tests with measurements and calculated data used to establish compliance with subsection (a), the information specified in section 30315.33(a)(1), (a)(4), (a)(7), (a)(15), (a)(17) and (a)(23) and the calibration record required in section 30316.61(a); and
(3) Pass a clinical image review conducted by an entity approved by FDA pursuant to 42 United States Code Section 263b(e)(1)(A) or by the Department in which mammograms shall:
(A) Be selected in accordance with the criteria specified in title 21, Code of Federal Regulations, section 900.4(c)(4);
(B) Be submitted within 75 calendar days of being notified by the Department that subsections (c)(1) and (2) have been met; and
(C) Meet the FDA-accepted attributes as specified in title 21, Code of Federal Regulations, section 900.4(c)(2).
(d) To use a radiation machine that was disassembled and reassembled for mammography, a facility shall:
(1) Possess a current and valid facility accreditation certificate issued pursuant to section 30315.22 or interim facility accreditation certificate issued pursuant to section 30315.24;
(2) Submit the results of tests with measurements and calculated data used to establish compliance with subsection (a), the information specified in section 30315.33(a)(1), (a)(4), (a)(7), (a)(15), (a)(17) and (a)(23) and the calibration record required in section 30316.61(a); and
(3) Submit a mammography system evaluation performed by a medical physicist or an individual under the direct supervision of a medical physicist.
(e) Documentation of the tests performed, the analysis of data obtained, corrective actions and the effectiveness of those actions taken pursuant to this section shall be maintained in accordance with section 30319.20.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30316.20. Quality Assurance Testing.
(a) Each facility using screen-film systems for mammography shall adjust and maintain each processor used to develop mammograms so that the manufacturer's technical development specifications for the mammography film in use are met. Each day mammograms are processed and before processing mammograms the facility shall determine that the processor used to develop mammograms, using the mammography film of the type used clinically, meets the following:
(1) Base plus fog-density is within plus 0.03 of the established operating level;
(2) Mid-density is within plus or minus 0.15 of the established operating level; and
(3) Density difference is within plus or minus 0.15 of the established operating level.
(b) Each facility using screen-film systems for mammography shall, each week in which mammography is performed, produce an image of a phantom that meets the requirements of section 30316.22. The test shall be performed prior to mammography on the day the test is performed. Before exposing the phantom an acrylic disc measuring one centimeter in diameter and four millimeters thick shall be placed on the phantom in the image area so it will not obscure details in the phantom and where it cannot cast a shadow on any portion of the AEC detector. The phantom shall then be exposed using the mammography film of the type used clinically and the techniques used for clinical images of a standard breast. The resulting phantom image shall meet the following:
(1) The center of the image has an optical density (OD) of at least 1.40 and once an established operating level is determined, the difference does not change by more than plus or minus 0.20 OD when compared to the established operating level;
(2) The difference between the OD measured inside the image of the disc and the OD measured adjacent to the image of the disc is at least 0.40 and once an established operating level is determined, the difference does not change by more than plus or minus 0.05 OD when compared to the established operating level; and
(3) Obtains a score of at least 4.0 for fibers, 3.0 for specks and 3.0 for masses using the phantom image scoring protocol in section 30316.30.
(c) Each facility conducting mammography shall, at intervals not to exceed three months:
(1) Test the residual fixer retained in the film to determine that it is no more than 5 micrograms per square centimeter; and
(2) Perform a repeat analysis on mammograms repeated or rejected. If the total repeat or reject rate changes from the previously determined rate by more than 2.0% of the total films included in the analysis, the reason(s) for the change shall be determined by the facility. Any corrective actions shall be documented and the results of those corrective actions shall be assessed. Test films, cleared films, or film processed as a result of exposure of a film bin shall not be included in the count for repeat analysis but shall be counted to determine reject rate changes and may be disposed of following completion of the analysis.
(d) Each facility conducting mammography shall, prior to initial use and at intervals not to exceed six months:
(1) Determine that the optical density attributable to darkroom fog does not exceed 0.05, by performing a test which uses mammography film of the type used clinically in the facility in which the film is exposed such that the film has a mid-density of no less than 1.4 OD, and is exposed to typical darkroom conditions for two minutes while such film, with one-half of the film covered, is placed on the counter top, emulsion side up. If the darkroom has a safelight used for mammography film, it shall be on during this test;
(2) Conduct testing on all cassettes used for mammography in the facility for screen-film contact using 40 mesh copper screen during which the entire area of the cassette that may be clinically exposed shall be tested; and
(3) Determine that the X-ray system is able to compress the breast with a force of at least 25 pounds and maintain this compression for at least 15 seconds, except that for systems with automatic compression, the maximum force applied without manual assistance shall be greater than 25 pounds and shall not exceed 45 pounds.
(e) Each facility conducting mammography shall, annually, ensure that a medical physicist verifies that:
(1) Until October 28, 2002, the automatic exposure control (AEC) can maintain film optical density within plus or minus 0.30 of the average of the optical densities measured using homogeneous acrylic thicknesses of 2, 4, and 6 centimeters and the kilovoltage peak (kVp) is varied appropriately for such thicknesses over the kVp range used clinically in the facility. Each image of the homogenous acrylic shall have an optical density (OD) of at least 1.20. If the AEC cannot meet this requirement, a chart shall be posted that specifies appropriate techniques (kVp and density control settings) for different breast thicknesses and compositions so that optical densities within plus or minus 0.30 of the average under phototimed conditions can be produced;
(2) After October 28, 2002, the AEC can maintain film optical density within plus or minus 0.15 of the average of the optical densities measured using homogeneous breast-tissue equivalent material thicknesses of 2, 4, and 6 centimeters (cm) and the kVp is varied appropriately for such thicknesses over the kVp range used clinically in the facility. Each image of the homogenous breast-tissue equivalent material shall have an OD of at least 1.20;
(3) When the AEC mode is used and the OD is increased or decreased from the normal or baseline setting, the net overall change in OD across the range of clinically used density control settings shall exceed the OD range established under subsection (e)(12) and if that net overall change in OD is equal to or greater than the maximum difference in OD allowed under subsection (e)(12), this change shall be distributed over a minimum of two density control settings removed from the normal or baseline setting;
(4) By using the protocol specified in subsection (b), the mammography system, if a screen-film system, can produce a phantom image that meets the following:
(A) The center of the image has an OD of at least 1.40;
(B) The difference between the OD measured inside the image of the disc and the OD measured adjacent to the image of the disc is at least 0.40; and
(C) Obtains a score of 4.0 for fibers, 3.0 for specks and 3.0 for masses using the phantom image scoring protocol in section 30316.30.
(D) The difference between the OD measured inside the image of the disc and the OD measured adjacent to the image of the disc is at least 0.40 and the difference is not more than plus or minus 0.05 OD when compared to the facility's established operating level.
(5) At the most commonly used clinical settings of kVp, the coefficient of variation of reproducibility of the kVp is equal to or less than 0.02;
(6) The kVp is accurate to within plus or minus 5.0% of the indicated or selected kVp at the following:
(A) The lowest clinical kVp that can be measured by a kVp test device;
(B) The most commonly used clinical kVp; and
(C) The highest available clinical kVp.
(7) The focal spot condition meets one of the following:
(A) Until October 28, 2002, the measured focal spot length (dimension parallel to the anode cathode axis) and width (dimension perpendicular to the anode cathode axis) shall be within the tolerance limits specified in Table 1. If a star pattern is used to evaluate focal spot condition, the star pattern shall, for evaluation of the large focal spot, be no larger than 1.5 degrees and, for evaluation of the small focal spot, be no larger than 1.0 degree.
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

(B) The focal spot condition shall be evaluated by determining the mammography system resolution in accordance with the following and meet the specified criteria:
(1) Each mammography system used for mammography, in combination with the mammography screen-film combination used in the facility, shall provide a minimum resolution of 11 cycles/millimeter (mm) (line-pairs/mm) when a high contrast resolution bar test pattern is oriented with the bars perpendicular to the anode-cathode axis, and a minimum resolution of 13 line-pairs/mm when the bars are parallel to that axis;
(2) 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;
(3) When more than one target material is provided, the measurement in subsection (e)(7)(A) shall be made using the appropriate focal spot for each target material;
(4) When more than one source-image-distance (SID) is provided, the test shall be performed at the SID most commonly used clinically; and
(5) 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.
(8) The half-value layer (HVL) of the useful beam is not less than the value specified in Table 2 of section 30308(a)(3) for the minimum HVL. These values, extrapolated to the mammographic range, are shown as follows, except that values not shown in Table 2 may be determined by linear interpolation or extrapolation:
Table 2 X-ray Tube Voltage (kilovolt peak) and Minimum HVL

Designed Measured Operating Minimum HVL
Operating Range (kV) Voltage (kV) (mm of aluminum)
Below 50 20 0.20
25 0.25
30 0.30

(9) The coefficient of variation for both air kerma and milliampere-seconds (mAs) does not exceed 0.05;
(10) By performance of a test using the techniques the facility uses clinically for a standard breast, the average glandular dose delivered by screen-film systems during a single craniocaudal view of an FDA accepted phantom simulating a standard breast does not exceed 3.0 milligray (mGy) (0.3 rad) per exposure;
(11) All systems meet the following:
(A) Possess beam-limiting devices that allow the entire chest wall edge of the X-ray field to extend to the chest wall edge of the image receptor and provide means to assure that the X-ray field does not extend beyond any edge of the image receptor by more than 2.0% of the SID;
(B) Provide that if a light field that passes through the X-ray beam limitation device is used, it is aligned with the X-ray field so that the total of any misalignment of the edges of the light field and the X-ray field along either the length or the width of the visually defined field at the plane of the breast support surface shall not exceed 2.0% of the SID; and
(C) The chest wall edge of the compression paddle does not extend beyond the chest wall edge of the image receptor by more than 1.0% of the SID when tested with the compression paddle placed above the breast support surface at a distance equivalent to standard breast thickness. The shadow of the vertical edge of the compression paddle shall not be visible on the image.
(12) The uniformity of screen speed of all cassettes in the facility are tested, and that the difference between the maximum and minimum optical densities do not exceed 0.30. The optical density of the test films shall be no less than 1.4;
(13) During the uniformity of screen speed test specified in subsection (e)(12), system artifacts are evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and performed on all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. The optical density of the test films shall be no less than 1.4;
(14) System artifacts are evaluated for all available focal spot sizes and target/filter combinations used clinically;
(15) Until October 28, 2002, each machine produces, over 3.0 seconds, a minimum output of 4.5 mGy air kerma per second (513 milliroentgen (mR) per second) when operating at 28 kVp in the standard mammography (molybdenum/molybdenum) mode at any SID where the system is designed to operate and when measured by a detector with its center located 4.5 cm above the breast support surface with the compression paddle in place between the source and the detector;
(16) After October 28, 2002, each machine produces, over 3.0 seconds, a minimum output of 7.0 mGy air kerma per second (800 milliroentgen (mR) per second) when operating at 28 kVp in the standard mammography (molybdenum/molybdenum) mode at any SID where the system is designed to operate and when measured by a detector with its center located 4.5 cm above the breast support surface with the compression paddle in place between the source and the detector;
(17) If the system is equipped with a provision for automatic decompression after completion of an exposure or interruption of power to the system, it provides:
(A) An override capability to allow maintenance of compression;
(B) A continuous display of the override status; and
(C) A manual emergency compression release that can be activated in the event of power or automatic release failure.
(18) The calibration of the densitometer and sensitometer used by the facility meets the manufacturer's specifications; and
(19) For systems with image receptor modalities other than screen-film, the quality assurance program meets the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems specified in subsection (e)(10).
(f) Each facility conducting mammography shall ensure that:
(1) The darkroom or the area used to load or unload mammography film is cleaned each day before any mammography is performed;
(2) Intensifying screens are cleaned each week using a screen cleaner recommended by the screen manufacturer; and
(3) All view boxes used to score phantom images and interpret mammograms are cleaned each week. If the view box used to interpret mammograms is at a different location than where the mammograms are taken, the facility shall ensure that documentation establishing the following is available to personnel and Department inspectors:
(A) Physical location(s) where the mammograms produced by the facility are interpreted;
(B) For each location, the individual responsible for ensuring the view boxes are cleaned at intervals not to exceed seven calendar days; and
(C) A log indicating the date and who cleaned the view boxes.
(g) After completion of the tests specified in subsections (a), (b), (d) and (e)(4), (10) and (19), if any of the test results fail to meet the specified criteria, the source of the problem shall be identified and corrective actions shall be taken before any further mammographic examinations are performed or any films are processed using the component of the mammography system that failed the test.
(h) Each facility conducting mammography shall, if any of the results of the tests specified in subsections (c), (e)(1) through (3), (5) through (9) and (11) through (18) and (f) fall outside the action limits, identify the source of the problem and take corrective actions within 30 days of the test date.
(i) All quality assurance data collected during tests conducted pursuant to this section shall be analyzed and if any problems are detected by analysis of that data, the problems shall be corrected to ensure compliance with this section.
(j) Documentation of the tests performed, the analysis of data obtained, corrective actions and the effectiveness of those actions taken pursuant to this section shall be maintained in accordance with section 30319.20.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code


s 30316.22. Acceptable Phantoms.
(a) A phantom shall not be used unless it is approved by the FDA and is:
(1) Mammographic Accreditation Phantom Model 156 produced by Radiation Measurement, Inc.;
(2) Mammographic Accreditation Phantom Model 18-220 produced by Nuclear Associates; or
(3) Equivalent in thickness to a standard breast and;
(A) Contains six nylon fibers with the following diameters:
1. 1.56 millimeters (mm);
2. 1.12 mm;
3. 0.89 mm;
4. 0.75 mm;
5. 0.54 mm;
6. 0.40 mm;
(B) Contains five aluminum oxide speck groups, each containing six specks and each speck in the group has the same diameter. The diameter of the specks shall be:
1. 0.54 mm;
2. 0.40 mm;
3. 0.32 mm;
4. 0.24 mm;
5. 0.16 mm; and
(C) Contains five nylon massess with decreasing diameters and the following thicknesses:
1. 2.00 mm;
2. 1.00 mm;
3. 0.75 mm;
4. 0.50 mm;
5. 0.25 mm.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30316.30. Phantom Image Scoring Protocol.
(a) This section shall apply only to screen-film mammography systems.
(b) Phantom images shall be scored in accordance with the following protocol. Each of the following object groups shall be scored separately and shall meet the criteria specified in section 30316.20(b)(3) and (e)(4):
(1) Score the fibers as follows:
(A) 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, then stop.
(B) If the entire length of the fiber can be seen and its location and orientation are correct, that fiber receives a score of one.
(C) 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.
(D) If less than one half of a fiber can be seen or if the location or orientation is incorrect, that fiber receives a score of zero.
(E) 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.
(2) Score the speck groups as follows:
(A) 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.
(B) If at least four of the specks in any group are visualized, the speck group is scored as one.
(C) If two or three specks in a group are visualized, the score for the group is one half.
(D) If one speck or no specks from a group are visualized, the score is zero.
(E) After determining the last speck group to receive a full or one-half point, look at the overall background for artifacts. If there are speck-like artifacts within the insert region of the phantom that are of equal or greater brightness than individual specks counted in the last visible half or full speck group counted, subtract the artifact speck from the observed specks, one by one. Repeat the scoring of the last visible speck group after these deductions.
(3) Score the masses as follows:
(A) Begin with the largest mass and add one point for each full mass observed until a score of one half or zero is assigned, then stop.
(B) Score one for each mass that appears as a minus density object in the correct location that can be seen clearly enough to observe round, circumscribed borders.
(C) Score one-half if the mass is clearly present in the correct location, but the borders are not visualized as circular.
(D) After determining the last full or half mass to be counted, look at the overall background for artifacts. If there are background objects that are mass-like in appearance and are of equal or greater visibility than the last visible mass, subtract the last full or half point assigned from the original score.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30316.40. Processing of Mammograms and Phantom Images.
Each facility possessing a facility accreditation certificate and conducting screen-film mammography shall process phantom images in the processor(s) designated by the facility to process mammograms.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, Health and Safety Code.


s 30316.50. Mammographic Image Identification.
(a) The following information shall be placed on each mammogram in a permanent, legible manner that does not obscure anatomic structures:
(1) Name of patient and an additional patient identifier;
(2) Date of examination;
(3) View and laterality, which shall be indicated on the image in a position near the axilla using the abbreviations specified in subsections (b) and (c);
(4) Facility name, city, state and zip code of the facility that performed the mammogram;
(5) Technologist identification;
(6) Identification of the cassette/screen used in producing the mammographic image; and
(7) Radiation machine identification if there is more than one radiation machine used for mammography at the facility.
(b) The following abbreviations shall be used to indicate laterality:
(1) Right: "R";
(2) Left: "L".
(c) At a minimum, the following abbreviations shall be used to indicate the view:
(1) Craniocaudal: "CC";
(2) Mediolateral oblique: "MLO";
(3) Mediolateral: "ML";
(4) Lateromedial: "LM";
(5) Lateromedial oblique: "LMO".


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30316.60. Medical Physicist Survey Reports.
(a) Each facility conducting mammography shall undergo an annual survey by a medical physicist or an individual under the direct supervision of a medical physicist, and shall obtain a survey report, dated and signed by the medical physicist and, if an individual performed the survey under the direct supervision of a medical physicist, the individual being supervised, showing:
(1) The results with measurements and calculated data used for the mammography system evaluation and the calibration record required in section 30316.61(a);
(2) The results of the quality assurance testing evaluation, as well as written documentation of any corrective actions taken and their results; and
(3) Written recommendations for corrective actions according to all results required to be in the report, if applicable.
(b) The survey report, specified in subsection (a), shall be obtained within 30 calendar days of the date the medical physicist performed and completed the survey. A facility shall require the medical physicist to notify them within 72 hours of the date the tests were performed of any deficiencies that involve any of the items listed in subsection (g) of section 30316.20.
(c) The survey report shall identify each radiation machine by the serial number of the X-ray control.
(d) The survey report, reviews, and calibration documentation required by this section shall be maintained in accordance with section 30319.20.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 115100, Health and Safety Code.


s 30316.61. Instruments Used by Medical Physicists.
(a) Instruments used by medical physicists to measure the air kerma or air kerma rate from a radiation machine shall be calibrated at least once every two years and each time the instrument is repaired. The instrument calibration shall be traceable to a national standard and calibrated with an accuracy of plus or minus 6.0% (95% confidence level) in the mammography energy range. The calibration record shall be maintained in accordance with section 30319.20.
(b) Instrumentation used by the medical physicist to measure the illumination as specified in section 30316(b)(13) shall be calibrated in units of lux or foot candles and shall meet manufacturer specifications.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 115100, Health and Safety Code.


s 30317. General Facility Requirements.
(a) The facility shall designate a quality assurance technologist.
(b) Tests specified in section 30316.20(a) through (d) and (f) shall be performed by the quality assurance (QA) technologist or by other personnel qualified to perform the tasks. When other personnel are utilized for these tasks, the QA technologist shall ensure that the specified tests are performed correctly. The QA technologist shall maintain documentation of training received by the other personnel.
(c) The facility's lead interpreting physician shall verify that the provisions of this section and sections 30316.20, 30316.40, 30316.50, 30316.60, 30317.10, 30317.20, 30317.30, 30317.40, 30317.60, and 30319.20 are met.
(d) A facility shall ensure an interpreting physician is available by telephone or in person for consultation when mammographic examinations are performed.
(e) A facility shall ensure that mammographic examinations are performed under the supervision, as defined in Health and Safety Code section 114850(g), of an individual who meets the requirements of section 30315.50.
(f) Each facility shall provide and require that all operators of radiation machines used for mammography use a chart or manual that specifies technique factors to be utilized relative to the patient's body habitus.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30317.10. Mammography Quality Assurance Program.
(a) Each facility shall establish and maintain a mammography quality assurance (QA) program to ensure the safety, reliability, clarity and accuracy of mammography services performed at the facility. A review of the QA program shall be conducted and documented by the lead interpreting physician at intervals not to exceed six months. The QA program shall, at a minimum, include the following:
(1) Establishment of operating levels meeting manufacturer specifications by which the criteria specified in section 30316.20(a) is compared.
(2) Documentation of accreditation by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A) and certification by FDA;
(3) Documentation that each interpreting physician who interprets mammograms for the facility meets the requirements of section 30315.50.
(4) Documentation that each mammographic radiologic technologist who performs mammography meets the requirements of section 30315.51;
(5) Documentation that each medical physicist who performs the tests specified in section 30316.20(e) meets the requirements of section 30315.52;
(6) The QA manual required by section 30317.20;
(7) The mammography procedures manual required by section 30317.30; and
(8) If the facility is a mobile service provider, a list identifying the physical location where radiation machines are used.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30317.20. Quality Assurance Manual.
(a) Each facility that performs mammography shall establish and maintain a written quality assurance (QA) manual. The lead interpreting physician shall document a review of the QA manual at intervals not to exceed six months. At a minimum, the QA manual shall contain:
(1) A list of names identifying the following:
(A) The lead interpreting physician designated by the facility;
(B) The quality assurance technologist;
(C) The medical physicist who will perform the tests specified in subsection (e) of section 30316.20; and
(D) The company providing processor and equipment services.
(2) The procedures to be used to ensure that the tests specified in section 30316.20(a) through (d) and (f) are performed and the criteria have been met;
(3) The procedure for correcting each finding that fails to meet the requirements of section 30316.20(a) through (f);
(4) Examples of the forms to be used for each test specified in section 30316.20 (a) through (d) and (f);
(5) Documentation that equipment used during QA tests specified in section 30316.20 meet manufacturer specifications;
(6) The most recent survey report required to be obtained pursuant to section 30316.60 and evidence that instruments used by the medical physicist are calibrated pursuant to section 30316.61;
(7) Documentation of all QA tests required to be performed pursuant to section 30316.20(a) through (d) and (f);
(8) Documentation of compliance with section 30316.20(g) and (h);
(9) Documentation of compliance with section 30316.10 covering the previous two years;
(10) Documentation that each interpreting physician, mammographic radiologic technologist and medical physicist has reviewed the manual annually or, if any update has occurred, evidence that the manual has been reviewed by the said individuals; and
(11) Documentation of preventive and corrective maintenance, chemistry replacement and cleaning of each processor used to process mammograms. The documentation shall contain the signature of the individual who performed the maintenance.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30317.30. Mammography Procedures Manual.
(a) Each facility shall establish a written mammography procedures manual. The lead interpreting physician shall document a review of the manual at intervals not to exceed six months. The mammography procedures manual shall, at a minimum, contain the following:
(1) The procedure for corrective action when the images interpreting physicians are asked to interpret are of poor quality and documentation that the procedure is followed;
(2) A policy that requires each interpreting physician to participate in the mammography medical outcomes audit as specified in section 30317.60;
(3) Examples of mammographic examination reports in lay language for each assessment of findings category and the procedures used to ensure the patient, if the patient does not indicate a health care provider, is referred to a health care provider if the patient's mammogram is interpreted by an interpreting physician as a positive mammogram;
(4) The procedure used to inquire whether or not the patient has prosthetic devices implanted in the breast prior to the mammographic examination and evidence that the procedure is followed. The procedure shall specify that except where contraindicated, or unless modified by a physician's directions, patients with such implants shall have mammographic views to maximize the visualization of breast tissue;
(5) The procedure to be used by each mammographic radiologic technologist to ensure that prior to each mammographic examination the mammography equipment is disinfected. The procedure shall comply with title 29, Code of Federal Regulations section 1910.1030 as of July 1, 2001, title 8, California Code of Regulations section 5193 and with the manufacturer's recommended procedures for cleaning and disinfection of the mammography equipment used in the facility;
(6) The procedures used to comply with section 30317.70 pertaining to consumer complaints;
(7) The procedure used to ensure mammographic examination reports are sent as required by section 30317.40; and
(8) Documentation that the mammography medical outcomes audit is performed as specified in section 30317.60.
(b) Procedures and policies developed to comply with this section shall be followed by the facility.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30317.40. Mammographic Examination Reports.
(a) Each facility shall ensure that a written report of the results of each mammographic examination conducted at that facility is prepared and includes at least the following:
(1) Name of the patient and an additional patient identifier;
(2) Date of the examination;
(3) Name of the interpreting physician who interpreted the mammogram;
(4) Overall assessment of findings, classified in one of the following categories:
(A) "Negative:" Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained);
(B) "Benign:" Also a negative assessment;
(C) "Probably Benign:" Finding(s) has a high probability of being benign;
(D) "Suspicious:" Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;
(E) "Highly suggestive of malignancy:" Finding(s) has a high probability of being malignant;
(5) In cases where a final assessment category cannot be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and
(6) Recommendations made to the patient's health care provider 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 of findings is negative or benign.
(b) Each facility shall ensure that the report specified in subsection (a) is summarized in lay terms and sent no later than 30 calendar days from the date of the mammographic examination to the patient.
(c) Each facility shall ensure that the report specified in subsection (a) is sent no later than 30 calendar days from the date of the mammographic examination to the referring physician(s), or if the patient is self-referred, to the physician indicated by the patient or the physician to whom the facility refers the patient.
(d) Each facility shall verify that:
(1) Patients with an overall assessment of findings of "suspicious" or "highly suggestive of malignancy" and patients needing repeat examinations have received notification; and
(2) Physicians have received notification of patients with an overall assessment of findings of "suspicious" or "highly suggestive of malignancy" and needing repeat examinations.
(e) If an interpreting physician has given a mammogram an assessment of findings as "suspicious" or "highly suggestive of malignancy," the facility shall attempt to communicate the results to the patient within five working days and the health care provider or if the health care provider is unavailable, to a responsible designee of the health care provider within three working days.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.


s 30317.50. Mammogram and Report Retention.
Unless otherwise required by law, each facility that performs mammography shall:
(a) Unless transferred in accordance with subsection (b), maintain mammograms and the reports specified in section 30317.40 for a minimum of seven years and if no additional mammograms of the patient are taken by the facility, mammograms and reports shall be maintained for a minimum of ten years.
(b) Upon request or on behalf of the patient, permanently or temporarily transfer the original mammograms and copies of the patient's mammographic examination reports to a medical institution, a physician or to the patient directly. Any fee charged for this service shall not exceed the documented cost of the service.
(c) If the facility will discontinue the performance of mammography, notify the Department prior to discontinuing mammography of how all records kept pursuant to subsection (a) will be maintained.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 123145, Health and Safety Code.


s 30317.60. Mammography Medical Outcomes Audit.
(a) Each facility possessing a facility accreditation certificate shall collect and review outcome data for all mammograms interpreted by the facility as a positive mammogram, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammographic examination report. Each facility shall analyze these outcome data for all interpreting physicians, both individually and collectively. The lead interpreting physician or an interpreting physician designated by the lead interpreting physician shall perform the analysis.
(b) For any cases of an individual diagnosed with breast cancer who was imaged at the facility and whose identity became known to the facility, the facility shall initiate follow-up on surgical and/or pathology results and conduct a review of any mammogram taken prior to the diagnosis of a malignancy. These cases shall be included in the analysis required pursuant to subsection (a).
(c) Each facility possessing a facility accreditation certificate shall ensure that the analysis required by subsection (a) is initiated no later than 12 months after the date of issuance of the facility accreditation certificate. The analysis shall be completed within 12 months of the date the analysis was initiated. Subsequent audit analyses shall be performed at least once every 12 months thereafter.
(d) The facility's lead interpreting physician or an interpreting physician designated by the lead interpreting physician, shall:
(1) Record the dates of the audit period(s);
(2) Document the results;
(3) Review the medical outcomes audit data;
(4) Analyze the results of the audit;
(5) Provide the results of the review of a specific interpreting physician to that interpreting physician and the overall results of the review for the facility review; and
(6) Provide a written description of any follow-up actions and the nature of the follow-up actions taken.
(e) Each facility shall maintain reports, outcome data, analyses and documentation of actions taken specified in this section in accordance with section 30319.20.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30317.70. Consumer Complaints.
Each facility possessing a facility accreditation certificate shall:
(a) Establish a written procedure for collecting and resolving consumer complaints;
(b) Maintain a record of each serious complaint received by the facility in accordance with section 30319.20;
(c) Provide to the consumer, upon request, a copy of the facility's procedure required in subsection (a) and instructions for filing serious complaints to the entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A) that accredited the facility;
(d) Report unresolved serious complaints to the Department within 30 calendar days of receiving the complaint.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.


s 30318.10. Additional Requirements for Mobile Service Providers.
(a) Prior to the performance of mammography by a mobile service provider at a location other than a location identified on the application submitted pursuant to section 30315.22 or 30315.23, the provider shall notify the Department. The notification shall include:
(1) The name and address of the mobile service provider;
(2) The certificate number as shown on the facility accreditation certificate of the mobile service provider;
(3) The physical location of the new location where mammography will be performed;
(4) The name and telephone number of the individual who is allowing the service to be provided at the new location;
(5) If the radiation machine is moved to where the mammographic examinations will be performed, the designated room number within the physical building at the new location of use; and
(6) The physical location where mammograms produced at the new location will be processed.
(b) After each relocation of the radiation machine and before the performance of mammography on humans, the processor shall be tested to ensure that the criteria specified in section 30316.20(a) are met, and the radiation machine shall be tested to ensure that it meets the requirements of section 30316.20(b)(1) through (3). If a processor is not available at the location where mammography is performed, a phantom image shall be produced by using the procedure specified in section 30316.20(b). The selected kilovoltage-peak and milliampere-seconds (mAs) shall be recorded and compared to the mAs value previously established as meeting the phantom image criteria specified in section 30316.20(b). If the two mAs values are within plus or minus 10 percent of each other, mammography may be performed. If the values exceed the limits, mammography shall not be performed and corrective actions shall be taken to bring the two values within the limit.
(c) If a mobile service provider processes mammograms at a location other than where the mammograms are taken: (continued)