View Document - California Code of Regulations

Home Table of Contents

§ 30316.20. Quality Assurance Testing.

17 CA ADC § 30316.20Barclays Official California Code of Regulations

Barclays California Code of Regulations

Title 17. Public Health

Division 1. State Department of Health Services (Refs & Annos)

Chapter 5. Sanitation (Environmental) (Refs & Annos)

Subchapter 4. Radiation

Group 3. Standards for Protection Against Radiation

Article 4.5. Requirements for the Use of X-Ray in Mammography

17 CCR § 30316.20

§ 30316.20. Quality Assurance Testing.

Currentness

(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. The test shall be performed prior to mammography on the day the test is performed using film processors that may be used to develop mammograms. 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 optical density (OD) at the center of the phantom image is at least 1.20 and did not change by more than plus or minus 0.20 from the established operating level;

(2) The optical density difference between the background of the phantom image and the test object added to assess image contrast did not change by more than plus or minus 0.05 from the established operating level; and

(3) The phantom image meets the minimum scores required pursuant to section 30316.30.

(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) When conducting screen-film mammography, 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 1.2 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) When conducting screen-film mammography, 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 mammography medical physicist verifies that:

(1) 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 kilovoltage peak (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;

(2) By using the protocol specified in subsection (b), the mammography system, if a screen-film system, can produce a phantom image that meets the criteria specified in subsection (b);

(3) 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;

(4) 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

(5) For screen-film mammography, the focal spot condition shall be evaluated by determining the mammography system resolution in accordance with the following and meet the specified criteria:

(A) 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;

(B) 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;

(C) When more than one target material is provided, the measurement in paragraph (5) shall be made using the appropriate focal spot for each target material;

(D) When more than one source-image-distance (SID) is provided, the test shall be performed at the SID most commonly used clinically; and

(E) 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.

(6) 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 Operating Range (kV)	Measured Operating Voltage (kV)	Minimum HVL (mm of aluminum)

Below 50	20	0.20
	25	0.25
	30	0.30

(7) The coefficient of variation for both air kerma and milliampere-seconds (mAs) does not exceed 0.05;

(8) 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;

(9) 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.

(10) For screen-films systems, the uniformity of screen speed of all cassettes in the facility are tested, and 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;

(11) During the uniformity of screen speed test specified in paragraph (10), 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;

(12) System artifacts are evaluated for all available focal spot sizes and target/filter combinations used clinically;

(13) 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;

(14) 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

(15) For screen-film systems, the calibration of the densitometer and sensitometer used by the facility meets the manufacturer's specifications; and

(16) 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 paragraph (8).

(f) Each facility conducting screen-film 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.

(g) After completion of the tests specified in subsections (a) through (f), the test results shall be compared to the corresponding specified action limits. For non-screen-film modalities, the test results shall be compared to the manufacturer's recommended action limits. If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:

(1) Before any further examinations are performed or any clinical films are processed using a component of the mammography system that failed any of the tests described in subsections (a), (b), (d), or (e)(10); and

(2) Within 30 days of the test date for all other tests specified in this section.

(h) 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.

(i) 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 30317.20.

Credits

Note: Authority cited: Sections 114975, 115000, 115060 and 131200, Health and Safety Code. Reference: Sections 115060, 115100, 115115, 131050 and 131051, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register 2003, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-10-2003 or emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsections (b)-(b)(2), (c), (e)(2)-(3), (e)(6)(A), (e)(13) and (f)(2)-(3), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

3. Amendment of section and Note filed 12-18-2019; operative 7-1-2020 pursuant to Government Code section 11343.4(b)(2) (Register 2019, No. 51).

This database is current through 4/26/24 Register 2024, No. 17.

Cal. Admin. Code tit. 17, § 30316.20, 17 CA ADC § 30316.20

End of Document