Section 410IAC5-6.1-127. Mammographic x-ray equipment

 

                                (a) Mammographic x-ray facilities shall comply with applicable provisions of sections 118 and 119 of this rule and this section. All mammographic x-ray facilities must be evaluated at least once every twelve (12) months by a diagnostic imaging physicist approved by the department.

                                (b) The registrant shall assure that the results of all mammography procedures are interpreted by a physician certified by the ABR, the American Osteopathic Board of Radiology, or by a physician accredited by the ACR through their mammography accreditation program.

                                (c) The registrant shall assure that the physician does the following:

(1) Has successfully completed or taught a minimum of forty (40) hours of postgraduate instruction in mammography interpretation.

(2) Has successfully completed or taught a minimum of fifteen (15) hours of postgraduate work in mammography interpretation every thirty-six (36) months.

(3) Reads the results of ten (10) or more screening or diagnostic mammographic exams per week.

(4) Prepares and signs a written report on his or her interpretation of the results of each mammography procedure.

(5) Provides a copy of the written report and the original images or films to the registrant for inclusion in the patient's medical record.

(6) Provides a written statement to the patient, either through the referring physician or his or her designee, or, if a referring physician is not available, directly to the patient. The statement shall be written in terms easily understood by a lay person and must describe the test results and the importance of the mammogram to ongoing health, as well as that person's responsibility to share with any new physician or supplier of their next mammogram the date and place of their previous mammography procedure. If the results of the mammogram are positive, the statement must describe the next step that should be taken by the patient. The statement must also record the following:

(A) The date of the mammography procedure.

(B) The name of the facility providing the mammography procedure.

(C) The physician to whom the person wants a copy of the statement to be sent, if any.

The statement must further indicate that the original images or films are being provided to the mammography facility for inclusion in the individual's medical record.

                                (d) The registrant shall assure that a physician qualified in accordance with subsection (c)(1) through (c)(3) documents at least annually that he or she:

(1) has checked the procedure manual and has observed at least monthly the performance of the operator of the mammographic x-ray equipment and has determined that both are adequate; and

(2) has verified that safe operating procedures are used and that all applicable requirements of this rule are being met.

                                (e) The registrant shall assure that all operators of mammographic x-ray equipment:

(1) have a general diagnostic x-ray machine operator's certificate in accordance with 410 IAC 5-11;

(2) have passed the advanced examination in mammography administered by the ARRT or have successfully completed ten (10) hours of specialized training in mammographic positioning, compression, and technique factor setting prior to performing mammograms; and

(3) successfully complete ten (10) hours of specialized training in mammographic positioning, compression, and technique factor setting at least every twenty-four (24) months thereafter.

                                (f) The registrant must have an orientation program for operators of mammographic x-ray equipment based on a procedure manual that is available to all members of the staff.

                                (g) All x-ray equipment used to perform mammography shall be specifically designed for mammography.

                                (h) Target-filter combinations shall comply with the following:

(1) For film/screen mammography, the target shall be constructed of molybdenum, with molybdenum filtration and a beryllium window. Tungsten targets with special filters such as palladium or rhodium are also acceptable, but only if the x-ray equipment has been accredited by the ACR.

(2) For xeroradiography, the target shall be constructed of tungsten with aluminum filtration.

                                (i) The x-ray equipment shall be capable of use with antiscatter grids.

                                (j) An x-ray control shall be incorporated such that an exposure can be terminated at any time except for exposures of one-half (1/2) second or less. The x-ray control shall provide visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated. The x-ray control panel shall have labeled control settings or meters to show all physical factors used for exposure, such as focal spot, kVp, mA, mAs, time, and automatic exposure control. The x-ray equipment must be operable only from a shielded position.

                                (k) A mark on the visible exterior surface of the source assembly shall indicate the location of the focal spot. The SID shall be no less than fifty (50) cm.

                                (l) For film/screen equipment, the half-value layer shall be no less than three-tenths (0.3) mm aluminum equivalent at a measured tube voltage of thirty (30) kVp with the compression device in the useful x-ray beam. Otherwise, the half-value layer shall be no less than that specified in section 119(f), Table I of this rule.

                                (m) For xeroradiography equipment, the half-value layer shall be no less than one (1.0) mm aluminum equivalent at the clinically employed kVp.

                                (n) A compression device shall be provided. For film/screen systems, the compression device shall be of the flat plate type, parallel to the image receptor.

                                (o) Mammographic x-ray equipment shall be provided with a means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor at any designated SID, except the edge of the image receptor designed to be adjacent to the chest wall, in which case the x-ray field may not extend beyond this edge by more than two percent (2%) of the SID.

                                (p) For mammographic x-ray equipment equipped with a beam-limiting device and a light localizer, the light field shall be aligned with the radiation field within two percent (2%) of the SID.

                                (q) For all mammographic x-ray equipment:

(1) the kVp shall be accurate within two (2) kV, plus or minus; and

(2) the coefficient of variation shall be no greater than five-hundredths (0.05) for each kVp tested.

Compliance shall be based on determination of the coefficient of variation and the average of at least four (4) consecutive measurements for the kVp at which the x-ray equipment is normally used. Compliance may be based on single measurements for other kVps over the range of use. However, if any single measurement is out of compliance, an average and coefficient of variation shall be determined at that kVp for comparison to subdivisions (1) and (2).

                                (r) Mammographic x-ray equipment shall have automatic exposure control, including the following:

(1) The coefficient of variation for automatic exposure control reproducibility shall be no greater than five-hundredths (0.05). Determination of compliance shall be based on at least four (4) consecutive measurements of exposure or optical density obtained at a fixed kVp and attenuator thickness.

(2) Mammographic x-ray equipment shall:

(A) be capable of maintaining constant film density to within plus or minus three-tenths (0.3) of the average optical density over the kVp range used for thicknesses of approximately two (2) cm, four (4) cm, and six (6) cm of acrylic or BR-12; or

(B) have kVp/thickness density control correction charts.

                                (s) The coefficient of variation for exposure timer reproducibility shall be no greater than five-hundredths (0.05). Compliance shall be based on at least four (4) consecutive measurements.

                                (t) The coefficient of variation for exposure shall be no greater than five-hundredths (0.05) when all technique factors are held constant. Determination of compliance shall be based on at least four (4) consecutive measurements.

                                (u) When mammographic x-ray equipment allows a choice of tube current settings and is operated on a power supply specified by the manufacturer in accordance with applicable federal standards, for any tube potential (kVp) within forty percent (40%) to one hundred percent (100%) of the maximum kVp rating, the absolute value of the difference between the ratio of average exposure in mR to the indicated mAs obtained at any two (2) consecutive tube current settings shall not differ by more than ten-hundredths (0.10) of the absolute value of their sum. A minimum of four (4) measurements per tube current setting are required to determine each average exposure. This requirement is expressed mathematically as:

                                                                                                                                                                                    -X₁ - X₂- ≤ 0.10 -X₁ + X₂-

Where:

X1 and X2

=

The ratios of average exposure to mAs obtained at each of two (2) consecutive tube current settings

                                (v) For a cranio-caudal view of a four and five-tenths (4.5) cm compressed breast with fifty percent (50%) glandular tissue, the average glandular dose shall not exceed the following:

(1) For a film/screen without grid, one-tenth (0.1) centigray (0.1 rad) per projection.

(2) For a film/screen with grid, three-tenths (0.3) centigray (0.3 rad) per projection.

(3) For xeroradiography, four-tenths (0.4) centigray (0.4 rad) per projection.

                                (w) There shall be a quality assurance program specific to mammography, covering all components of the x-ray equipment, from the x-ray generator to the image developer, to ensure consistently high quality images with minimum patient exposure. The quality assurance program shall be reviewed at least annually. Establishment and conduct of the quality assurance program shall be the responsibility of the registrant under the direction of a physician and a diagnostic imaging physicist approved by the department. The diagnostic imaging physicist must do the following:

(1) Conduct, or train others to conduct, equipment performance monitoring.

(2) Analyze the monitoring results to determine if there are any problems requiring correction.

(3) Serve as the liaison between the facility and service engineer.

                                (x) All quality assurance records shall be maintained for at least three (3) years and shall be readily available for inspection by the commissioner.

                                (y) The registrant shall assure that monitoring is conducted at least once each twelve (12) months at each mammographic x-ray facility as part of a quality assurance program. The monitoring shall be conducted by a diagnostic imaging physicist approved by the department in accordance with Table V and the following:

TABLE V
		Individual
Parameter	Frequency	Responsible
Darkroom cleanliness	daily	mammographer
Processor performance	daily	mammographer
Screen cleanliness	weekly	mammographer
View boxes and viewing conditions	weekly	mammographer
Image quality (phantom images)	monthly	mammographer
Repeat analysis	quarterly	mammographer
Analysis of fixer retention in film	quarterly	mammographer
Darkroom fog	semiannually	mammographer
Screen-film contact	semiannually	mammographer
Compression	semiannually	mammographer
AEC density control function	annually	diagnostic imaging physicist
Star pattern focal spot size test	annually	diagnostic imaging physicist
Uniformity of screen speed	annually	diagnostic imaging physicist
Assembly physical evaluation	annually	diagnostic imaging physicist

(1) Processor performance shall be monitored daily before the first patient examination.

(2) Image quality shall be evaluated utilizing the RMI Model 156 ACR mammography accreditation phantom (or other image quality phantom approved in advance by the commissioner) each time mammographic x-ray equipment is moved, altered in any major way (such as replacement of parts), and at least monthly between movements or alterations. Image quality shall be evaluated by obtaining a test image at the settings normally used for a four and five-tenths (4.5) cm compressed breast with fifty percent (50%) glandular tissue. A file of such images shall be maintained for review by the physician and the diagnostic imaging physicist for comparison with earlier images. Image quality of the RMI Model 156 phantom shall comply with the following:

(A) Fibrils of seventy-five hundredths (0.75) mm, eighty-nine hundredths (0.89) mm, one and twelve-hundredths (1.12) mm, and one and fifty-six hundredths (1.56) mm shall be visualized.

(B) Masses of seventy-five hundredths (0.75) mm, one (1) mm, and two (2) mm shall be visualized.

(C) Speck groups of thirty-two hundredths (0.32) mm, forty-hundredths (0.40) mm, and fifty-hundredths (0.50) mm shall be fully visualized.

If the results fall outside the acceptable range, the test must be repeated. If the results continue to be unacceptable, the cause of the problem must be identified and corrected before further examinations are conducted.

(Indiana State Department of Health; 410 IAC 5-6.1-127; filed Oct 29, 1993, 5:00 p.m.: 17 IR 389; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA)