N.J. Admin. Code § 7:28-15.4

Current through Register Vol. 56, No. 21, November 4, 2024

Section 7:28-15.4 - Mammography radiographic installations

(a) This section establishes the requirements for medical diagnostic and screening radiographic mammography procedures. Hereafter, all references to mammography shall mean mammography performed with ionizing-radiation-producing equipment.

(b) The provisions of this section are in addition to and not in substitution for the applicable provisions of N.J.A.C. 7:28.

(c) No person shall operate or permit the operation of x-ray equipment used for mammography unless the equipment and installation meet the applicable requirements of this subchapter.

(d) The registrant shall ensure that each mammography unit under the registrant's jurisdiction is operated only by a licensed diagnostic x-ray technologist or a licensed practitioner as prescribed in N.J.A.C. 7:28-19.

(e) By October 18, 1995 or within two years of the installation of a mammography unit, whichever shall be later, the registrant shall not operate or permit the operation of each mammography unit under the registrant's jurisdiction unless the mammography unit is accredited by the American College of Radiology (ACR) or meets an equivalent standard acceptable to the Commission. Current accreditation by the ACR or its equivalent acceptable to the Commission shall be maintained for each mammography unit under the registrant's jurisdiction.

1. If a mammography unit is accredited or certified by an agency or organization other than ACR, a registrant may petition the Commission in writing for recognition of this agency's or organization's accreditation or certification as equivalent to ACR accreditation. The registrant shall submit sufficient documentation to the Commission related to machine performance standards, quality assurance, operating safety standards, and any additional information that the Commission may request in order to demonstrate equivalence to ACR accreditation.

2. The Commission may approve the registrant's petition based on the information contained in the petition and the Commission's determination that the alternative agency's or organization's accreditation or certification is equivalent to ACR accreditation.

3. A mammography unit that is used exclusively for stereotactic biopsies is exempt from the requirements of (e)1 and 2 above but shall meet the other requirements of this subchapter.

(f) No person shall operate or permit the operation of any radiographic equipment for mammography unless the equipment meets the following requirements:

1. It shall be a dedicated mammography unit;

2. The tube housing assembly shall be provided with a beam-limiting device. When a light localizer used to define the x-ray field is provided on the mammography unit, the light localizer shall provide an average illuminance of not less than 160 lux (15 foot candles) at 100 centimeters or at the maximum SID, whichever is less. The average illuminance shall be based upon measurements made in the approximate center of each quadrant of the light field;

3. The tube housing assembly shall be so constructed that the leakage radiation measured at a distance of one meter (39 inches) from the source does not exceed 26 microcoulombs per kilogram (0.1 Roentgen) in any one hour when the source is operated at its leakage technique factors;

4. A mark shall be provided on the visible exterior of the source assembly which indicates the location of the focal spot;

5. An x-ray beam-limiting device shall be used to restrict the size of the x-ray beam to the size of the image receptor. Types of beam-limiting devices include, but are not limited to, diaphragms, cones, and adjustable colimators. The beam-limiting device shall provide the same primary beam attenuation as the tube housing.

i. The misalignment between the edges of the light field and the x-ray field shall be less than two percent of the SID.

ii. The x-ray beam shall be totally intercepted by the image-receptor support, except for the edge of the image-receptor support designed to be adjacent to the chest wall. The x-ray field at the edge of the image-receptor support designed to be adjacent to the chest wall shall not extend beyond the edge of the image-receptor support by more than two percent of the SID;

6. The image-receptor support shall transmit less than 0.026 microcoulombs (0.1 milliroentgens) per exposure at 5 centimeters (2 inches) beyond the support with no breast present for maximum kV and mAs values clinically used;

7. The requirements for the control panel on the mammography system are as follows:

i. The mammography system shall have the capability of automatic exposure control;

ii. The control panel shall provide visual display of the x-ray tube voltage (kVp) and either the tube current (mA) and time setting (sec) or the product of the tube current and time setting in milliampere-seconds (mAs); and

iii. The control panel shall have a device or means for emitting a signal audible to the operator which indicates when the exposure has terminated and a device such as a light or milliammeter to give a visual indication when the beam is on;

8. The radiation exposure reproducibility shall not exceed a coefficient of variation of 0.05. For manual mode this shall be for any selected technique factors. For automatic exposure control this shall be for any selected absorber or phantom;

9. The timer shall meet the following requirements:

i. The timer reproducibility shall not exceed a coefficient of variation of 0.05 for any specific combination of selected technique factors; and

ii. The timer accuracy shall not exceed the limits specified by the manufacturer. In the absence of manufacturer's specifications, the deviation shall not exceed 10 percent of the indicated value;

10. The kVp shall meet the following requirements:

i. The kVp accuracy shall not exceed the limits specified by the manufacturer. In the absence of manufacturer's specifications, the deviation shall not exceed five percent from the nominal kVp setting;

ii. The kVp reproducibility shall not exceed a coefficient of variation of 0.02;

iii. The kVp shall be capable of being selected in increments of no greater than three kVp whether kVp is selected manually or automatically; and

iv. The kVp shall be selected either manually or automatically;

11. The following linearity requirements apply to mammography x-ray equipment which allows a choice of x-ray tube current settings and is operated on a power supply as specified by the manufacturer for any fixed x-ray tube potential within the range of 40 percent to 100 percent of the maximum rating:

i. For x-ray equipment having independent selection of x-ray tube current (mA), the average ratios of exposure to the indicated milliampere-seconds product (mR/mAs) or (C/kg/mAs) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum.

ii. For equipment manufactured after May 3, 1994, x-ray equipment having a combined x-ray tube current-exposure time product (mAs) selector, the average ratios of exposure to the indicated milliampere-seconds product (mR/mAs) or (C/kg/mAs) values obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum.

iii. The average exposure ratio for (f)11i and 11ii above shall be expressed as follows:

Data in image

12. The measured HVL shall be equal to or greater than the value:

Data in image

For film-screen mammography units only, the maximum measured HVL shall be equal to or less than the value:

Data in image

13. There shall be a device to maintain parallel breast compression. The degree of compression shall be adjustable and shall remain at the set level during the exposure. A device, scale or other means shall indicate the thickness of the compressed breast. The compression plate shall attenuate the beam by no more than the attenuation provided by two mm of polymethylacrylate;

14. There shall be a means or a device on the mammography unit to indicate the SID, if this is variable. The actual SID shall be posted on the mammography unit if this distance is fixed. Accuracy of the SID indicator shall be within +/- two percent of the indicated value;

15. There shall be a means of determining the angulation on the mammography unit. This determination shall be displayed on the unit.

i. There shall be a means to lock the position and angulation of the source assembly;

ii. Such lock shall be deemed to have been provided if the position or angulation can only be changed by activation of a motor; and

16. The exposure switch shall be a dead-man type and shall be arranged so that it can only be operated when the operator is within a shielded area. The exposure control when depressed shall not energize the x-ray tube when the timer is in the "off" or "zero" position.

(g) A radiation-protection barrier for the operator shall be provided in the room for a mammography unit that requires the operator to remain in the room during the exposure. The operator shall stand behind the protective barrier provided and shall observe the patient during each mammographic exposure.

(h) No person shall operate or permit the operation of a mammography unit unless the registrant has developed and maintains a quality assurance program that meets the requirements listed in (j) below.

(i) The registrant shall ensure that no person operates the mammography unit until he or she has reviewed the quality assurance manual and has documented that such review has been completed.

(j) The requirements for the quality assurance program shall be as follows:

1. The registrant shall develop and maintain a quality assurance manual that identifies and assigns over-all quality control responsibilities. The following items shall be in the quality assurance manual:

i. A list of the individuals responsible for testing, supervising, repairing or servicing the equipment. This list shall include the specific responsibilities for the radiologist, the qualified medical physicist for the supervision of quality assurance programs for diagnostic x-ray equipment (the medical physicist), the diagnostic x-ray technologist (radiologic technologist), and repair or service personnel;

ii. A list of the equipment to be tested;

iii. A list of the tests to be performed. For each test, the following items shall be included:

(1) The frequency of performance of each test in accordance with (j)4, 6, 7, 8, 9, 10, and 11 below;

(2) The acceptability limits for each test; and

(3) A brief description of the procedures to be used for each test;

iv. The protocol for corrective action which shall be taken if the test results do not lie within the acceptability limits;

v. Sample forms to be used for each test; and

vi. Reference materials and their location;

2. The registrant shall present the quality assurance manual, records of all testing, test data, equipment maintenance and other required procedures to the department for review during any inspection;

3. For each mammography unit, the registrant shall ensure that tests are performed and records are maintained as listed below:

i. The initial test results shall be maintained for as long as the mammography unit is registered plus one year; and

ii. A record of each service to the mammography unit shall be kept for 36 months from the date of such service;

4. For each mammography unit, the registrant shall perform or have performed at least annually the test procedures listed below and shall maintain the records for as long as the mammography unit remains registered plus one year.

i. Measurement of breast entrance exposure and average glandular dose;

ii. Measurement of half-value layer;

iii. Measurement of accuracy and reproducibility of kVp settings;

iv. Measurement of linearity of exposure at various mA stations or mAs settings;

v. Measurement of accuracy and reproducibility of timer settings where these are adjustable;

vi. Measurement of exposure reproducibility at techniques representative of clinical use;

vii. Measurement of focal spot size;

viii. Assessment of performance of automatic exposure control system, including short-term reproducibility, kilovoltage and thickness compensation, density control selector function and back-up timer function;

ix. Assessment of mammography unit assembly, including accuracy of source-to-film distance indicator, physical integrity of breast thickness indicator, functioning of all locks, detents, angulation indicators and mechanical support for the x-ray tube and image-receptor-holder assembly; and

x. Assessment of collimation, including alignment of light field and x-ray field;

5. For each processor used for mammography, the registrant shall ensure that the records of maintenance and quality control tests are maintained in a processor maintenance log. Processor maintenance logs shall include preventive maintenance, cleaning performed and corrective actions taken. A record of each such measure taken shall be maintained in the log for at least 36 months;

6. For each processor used for film-screen mammography, the registrant shall perform or have performed quality control tests for each processor on each day the processor is used for mammography. For motor vehicle and mobile mammographic units with processing capability, quality control tests for each processor shall be performed at each new location.

i. Quality control tests shall include measurement of developer temperature, film sensitometry to indicate film speed, film contrast and base-plus-fog density;

ii. Logs, charts, or graphs of these measurements shall be maintained for 36 months from the dates of such measurements. The registrant may discard such records after 36 months, except that at least one representative set of quality control records from each year shall be maintained for an additional five years;

7. For each darkroom used for loading, storing or processing film used for mammography, the registrant shall ensure that:

i. Measurement of film fog is performed at least semiannually and test results are maintained for the current year and the preceding year; and

ii. Darkroom cleanliness is maintained and checked daily;

8. For each radiographic cassette used for film-screen mammography, the registrant shall ensure that:

i. The intensifying screen is cleaned and inspected at least weekly;

ii. The film-screen contact is tested at least semiannually and the record of each test is maintained for at least 36 months from the date of the test; and

iii. Uniformity of screen speed is assessed annually and the record of each test is maintained for at least 36 months from the date of the test;

9. For each component used for xeromammography, the registrant shall perform or have performed the quality control tests listed below:

i. For the conditioner, tests for light leaks, temperature of relaxation oven, charging of the plate, and optimization for the kVp used shall be performed on each day the conditioner is used for mammography;

ii. For the processor, tests for light leaks, toner supply, back bias setting, and optimization for the kVp used shall be performed on each day the processor is used for mammography;

iii. Each cassette shall be cleaned and checked for dust particles and pressure artifacts every week; and

iv. Each selenium plate shall be examined for powder deficiency spots, powder efficiency spots, dark dusting, scratches, and artifacts on a monthly basis;

10. For each mammography unit, the registrant shall ensure that the following image quality assessments are performed:

i. A phantom is used whose image can be quantitatively scored;

ii. For fixed units, mammographic phantom image quality is tested monthly;

iii. For mobile units and motor vehicle mounted units, mammographic phantom image quality is tested after each relocation and at least monthly. Equipment must be recalibrated prior to use to maintain quality of the phantom image; and

iv. At least one test phantom image for each mammography unit is maintained for each month of the current calendar year and for the preceding year. The registrant shall also maintain at least one phantom image a year for each mammography unit beginning from the year of installation;

11. Repeat analysis shall be performed at least quarterly for film-screen mammography and xeromammography; and

12. Technique charts or standard settings of factors such as density, kVp, focal spot selection, listing of all factors appropriate to the design of the mammography unit shall be posted either next to or on each mammography unit.

N.J. Admin. Code § 7:28-15.4