Authority: IC 16-41-35-26; IC 16-41-35-29
Affected: IC 16-41-35
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
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
successfully completed or taught a minimum of fifteen (15) hours of
postgraduate work in mammography interpretation every thirty-six (36)
(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
(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.
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.
name of the facility providing the mammography procedure.
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.
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
shall assure that all operators of mammographic x-ray equipment:
have a general diagnostic x-ray machine
operator's certificate in accordance with 410 IAC 5
(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.
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.
For xeroradiography, the target shall be constructed of tungsten with aluminum
(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
(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.
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.
For all mammographic x-ray equipment:
(1) the kVp shall be accurate within two (2)
kV, plus or minus; and
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)
Mammographic x-ray equipment shall have automatic exposure control, including
(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.
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
(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
(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.
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
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.
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
(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.
All quality assurance records shall be maintained for at least three (3) years
and shall be readily available for inspection by the commissioner.
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:
| Darkroom cleanliness
| Processor performance
| Screen cleanliness
| View boxes and viewing conditions
| Image quality (phantom images)
| Repeat analysis
| Analysis of fixer retention in film
| Darkroom fog
| Screen-film contact
| AEC density control function
|| diagnostic imaging physicist
| Star pattern focal spot size test
|| diagnostic imaging physicist
| Uniformity of screen speed
|| diagnostic imaging physicist
| Assembly physical evaluation
|| diagnostic imaging physicist
performance shall be monitored daily before the first patient
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.
Speck groups of thirty-two hundredths
(0.32) mm, forty-hundredths (0.40) mm, and fifty-hundredths (0.50) mm shall be
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