Ill. Admin. Code tit. 32, § 370.70 - Personnel Requirements
Personnel. The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities:
a) Interpreting
physicians. All physicians interpreting mammograms shall meet the following
qualifications:
1) Initial qualifications.
Unless the exemption in subsection (a)(3) of this Section applies, before
beginning to interpret mammograms independently, the interpreting physician
shall:
A) Be a physician licensed under the
Medical Practice Act of 1987 to practice medicine in all its branches [225 ILCS
60 ];
B) Be certified in diagnostic
radiology by either the American Board of Radiology, the American Osteopathic
Board of Radiology, or Royal College of Physicians and Surgeons of Canada or
have had at least 3 months of documented formal training in the interpretation
of mammograms and in topics related to mammography. The training shall include
instruction in radiation physics, including radiation physics specific to
mammography, radiation effects and radiation protection. The mammographic
interpretation component shall be under the direct supervision of a physician
who meets the requirements of subsection (a) of this Section;
C) Have a minimum of 60 hours of documented
medical education in mammography, which shall include instruction in the
interpretation of mammograms and education in basic breast anatomy, pathology,
physiology, technical aspects of mammography and quality assurance and quality
control in mammography. All 60 of these hours shall be Category I and at least
15 of the Category I hours shall have been acquired within the 3 years
immediately prior to the date that the physician qualifies as an interpreting
physician. Hours spent in residency specifically devoted to mammography will be
considered as equivalent to Category I continuing medical education credits and
will be accepted if documented in writing by the appropriate representative of
the training institution; and
D)
Unless the exemption in subsection (a)(3) of this Section applies, have
interpreted or multi-read at least 240 mammographic examinations within the 6
month period immediately prior to the date that the physician qualifies as an
interpreting physician. This interpretation or multi-reading shall be under the
direct supervision of an interpreting physician.
2) Continuing experience and education. All
interpreting physicians shall maintain their qualifications by meeting the
following requirements:
A) Following the
second anniversary date of the end of the calendar quarter in which the
requirements of subsection (a)(1) of this Section were completed, the
interpreting physician shall have interpreted or multi-read at least 960
mammographic examinations during the 24 months immediately preceding the date
of the facility's annual MQSA inspection, or the last day of the calendar
quarter preceding the inspection or any date in between the two. The facility
will choose one of these dates to determine the 24 month period.
B) Following the third anniversary date of
the end of the calendar quarter in which the requirements of subsection (a)(1)
of this Section were completed, the interpreting physician shall have taught or
completed at least 15 Category I continuing medical education units in
mammography during the 36 months immediately preceding the date of the
facility's annual MQSA inspection, or the last day of the calendar quarter
preceding the inspection or any date in between the two. The facility will
choose one of these dates to determine the 36 month period. This training shall
include at least 6 Category I continuing medical education credits in each
mammographic modality used by the interpreting physician in his or her
practice.
C) Before an interpreting
physician may begin independently interpreting mammograms produced by a new
mammographic modality, that is, a mammographic modality in which the physician
has not previously been trained, the interpreting physician shall have at least
8 hours of training in the new mammographic modality.
D) Units earned through teaching a specific
course can be counted only once towards the 15 units required by subsection
(a)(2) of this Section, even if the course is taught multiple times during the
previous 36 months.
3)
Exemptions.
A) Those physicians who qualified
as interpreting physicians under FDA's interim regulations prior to April 28,
1999, are considered to have met the initial requirements of subsection (a)(1)
of this Section. These physicians may continue to interpret mammograms provided
they continue to meet the requirements of subsection (a)(1) of this Section and
the continuing experience and education requirements of subsection (a)(2) of
this Section.
B) Physicians who
have interpreted or multi-read at least 240 mammographic examinations under the
direct supervision of an interpreting physician in any 6 month period during
the last 2 years of a diagnostic radiology residency and who become
appropriately board certified at the first allowable time, as defined by an
eligible certifying body, are otherwise exempt from subsection (a)(1)(D) of
this Section.
4)
Reestablishing qualifications. Interpreting physicians who fail to maintain the
required continuing experience or continuing education requirements of
subsection (a)(2) of this Section, shall reestablish their qualifications
before resuming the independent interpretation of mammograms as follows:
A) Interpret or multi-read at least 240
mammographic examinations under the direct supervision of an interpreting
physician, or interpret or multi-read a sufficient number of mammographic
examinations, under the direct supervision of an interpreting physician, to
bring the physician's total up to 960 examinations for the prior 24 months,
whichever is less.
B) Interpreting
physicians who fail to meet the continuing education requirements of subsection
(a)(2)(B) of this Section shall obtain a sufficient number of additional
Category I continuing medical education credits in mammography to bring their
total up to the required 15 credits in the previous 36 months before resuming
independent interpretation.
C) The
interpretations required under this Section shall be done within the 6 months
immediately prior to resuming independent interpretation.
b) Radiologic technologists who
perform mammographic examinations shall be accredited by the Agency and shall
meet the following:
1) Training requirements.
A) Have, prior to April 28, 1999, qualified
as a radiologic technologist under FDA's interim regulations; or
B) Complete at least 40 contact hours of
documented training specific to mammography under the supervision of a
qualified instructor. The hours of documented training shall include, but not
necessarily be limited to:
i) Training in
breast anatomy and physiology, positioning and compression, quality
assurance/quality control techniques and imaging of patients with breast
implants;
ii) The performance of a
minimum of 25 examinations under the direct supervision of an individual
qualified under subsection (b) of this Section; and
iii) At least 8 hours of training in each
mammography modality to be used by the technologist in performing mammography
exams.
2)
Continuing education requirements.
A)
Following the third anniversary date of the end of the calendar quarter in
which the requirements of subsection (b)(1) of this Section were completed, the
radiologic technologist who performs mammography shall have taught or completed
at least 15 continuing education units in mammography during the 36 months
immediately preceding the date of the facility's annual MQSA inspection, or the
last day of the calendar quarter preceding the inspection or any date in
between the two. The facility will choose one of these dates to determine the
36 month period.
B) Units earned
through teaching a specific course can be counted only once towards the 15
hours of continuing education requirements required in subsection (b)(2) of
this Section, even if the course is taught multiple times during the previous
36 months.
C) At least 6 of the
continuing education units required in subsection (b)(2) of this Section shall
be related to each mammographic modality used by the technologist.
D) Requalification. Radiologic technologists
who fail to meet the continuing education requirements of subsection (b)(2)(A)
of this Section shall obtain a sufficient number of continuing education units
in mammography to bring their total up to at least 15 in the previous 3 years,
at least 6 of which shall be related to each modality used by the technologist
in mammography. The technologist shall not resume performing unsupervised
mammography examinations until the continuing education requirements are
completed.
E) Before a radiologic
technologist may begin independently performing mammography examinations using
a mammographic modality other than one of those for which the technologist
received training under subsection (b)(1)(B)(iii) of this Section, the
technologist shall have at least 8 hours of continuing education units in the
new modality.
3)
Continuing experience requirements.
A)
Following the second anniversary date of the end of the calendar quarter in
which the requirements of subsection (b)(1) of this Section were completed or
of April 28, 1999, whichever is later, the radiologic technologist shall have
performed a minimum of 200 mammography examinations during the 24 months
immediately preceding the date of the facility's annual MQSA inspection, or the
last day of the calendar quarter preceding the inspection or any date in
between the two. The facility will choose one of these dates to determine the
24 month period.
B)
Requalification. Radiologic technologists who fail to meet the continuing
experience requirements of subsection (b)(3)(A) of this Section shall perform a
minimum of 25 mammography examinations under the direct supervision of a
qualified radiologic technologist before resuming the performance of
unsupervised mammography.
C)
Programs, courses or other activities intended to meet the requirement for
initial, or requalification, mammography training or continuing education in
mammography shall be approved by the Agency.
D) Completion of initial, or requalification,
mammography training and continuing education in mammography shall be verified
to the Agency.
c) Medical physicists. All medical physicists
conducting surveys of mammography facilities and providing oversight of the
facility quality assurance program shall be approved by the Agency as
diagnostic imaging specialists pursuant to 32 Ill. Adm. Code 410, and meet the
following:
1) Initial qualifications.
A) Be certified in diagnostic radiological
physics or radiological physics by either the American Board of Radiology (ABR)
or the American Board of Medical Physics (ABMP);
B) Have a masters degree or higher in a
physical science from an accredited institution, with no less than 20 semester
hours or equivalent (e.g., 30 quarter hours) of college undergraduate or
graduate level physics;
C) Have 20
contact hours of documented specialized training in conducting surveys of
mammography facilities; and
D) Have
the experience of conducting surveys of at least 1 mammography facility and a
total of at least 10 mammography units. No more than one survey of a specific
unit within a period of 60 days can be counted towards the total mammography
unit survey requirement. After April 28, 1999, experience conducting surveys
shall be acquired under the direct supervision of a medical physicist who meets
all the requirements of subsections (c)(1), (c)(2) and (c)(3) of this
Section.
2) Alternative
initial qualifications.
A) Have qualified as a
medical physicist under FDA's interim regulations and retained that
qualification by maintenance of the active status of any licensure, approval or
certification required;
B) Have,
prior to April 28, 1999, obtained a bachelor's degree or higher in a physical
science from an accredited institution with no less than 10 semester hours or
equivalent of college undergraduate or graduate level physics;
C) Have 40 contact hours of documented
specialized training in conducting surveys of mammography facilities;
and
D) Have the experience of
conducting surveys of at least 1 mammography facility and a total of at least
20 mammography units. No more than one survey of a specific unit within a
period of 60 days can be counted towards the total mammography unit survey
requirement. The training and experience requirements shall be met after
fulfilling the degree requirement.
3) Continuing education and experience. All
medical physicists shall maintain their qualifications by meeting the following
requirements:
A) Continuing education.
Beginning 3 years after the end of the calendar quarter in which the
requirements of subsection (c)(1) or (c)(2) of this Section were completed, the
medical physicist shall have taught, or completed, at least 15 continuing
education units in mammography during the 36 months immediately preceding the
date of the facility's annual inspection, or the last day of the calendar
quarter preceding the inspection or any date in between the two. The facility
shall choose one of these dates to determine the 36 month period. This
continuing education shall include hours of training appropriate to each
mammographic modality evaluated by the medical physicist during his or her
surveys or oversight of quality assurance programs. Units earned through
teaching a specific course can be counted only once towards the required 15
continuing education units in a 36 month period, even if the course is taught
multiple times during the 36 months.
B) Continuing experience. Beginning 2 years
after the end of the calendar quarter in which the requirements of subsection
(c)(1) or (c)(2) of this Section were completed or of April 28, 1999, whichever
is later, the medical physicist shall have surveyed at least 2 mammography
facilities and a total of at least 6 mammography units during the 24 months
immediately preceding the date of the facility's annual MQSA inspection, or the
last day of the calendar quarter preceding the inspection or any date in
between the two. The facility shall choose one of these dates to determine the
24 month period. No more than one survey of a specific facility within a 10
month period or a specific unit within a period of 60 days can be counted
towards the total mammography unit survey requirement.
C) Before a medical physicist may begin
independently performing mammographic surveys of a new mammographic modality,
that is, a mammographic modality other than one for which the physicist
received training to qualify under subsection (c)(1) or (c)(2) of this Section,
the physicist shall receive at least 8 hours of training in surveying units of
the new mammographic modality.
4) Reestablishing qualifications. Medical
physicists who fail to maintain the required continuing education and
experience qualifications of subsection (c)(3) of this Section may not perform
the MQSA surveys without the supervision of a qualified medical physicist.
Before independently surveying another facility, medical physicists shall
reestablish their qualifications, as follows:
A) Medical physicists who fail to meet the
continuing educational requirements of subsection (c)(3)(A) of this Section
shall obtain a sufficient number of continuing education units to bring their
total units up to the required 15 units in the previous 3 years.
B) Medical physicists who fail to meet the
continuing experience requirement of subsection (c)(3)(B) of this Section shall
complete a sufficient number of surveys under the direct supervision of a
medical physicist who meets the qualifications of subsection (c)(1) or (c)(2)
of this Section, to bring their total surveys up to the required 2 facilities
and 6 units in the previous 24 months. No more than one survey of a specific
unit within a period of 60 days can be counted towards the total mammography
unit survey requirement.
d) Retention of personnel records. Facilities
shall maintain records to document the qualifications of all personnel who
worked at the facility as interpreting physicians, radiologic technologists or
medical physicists. These records shall be available for review by the Agency.
Records of personnel no longer employed by the facility shall not be discarded
until the next annual inspection has been completed and the Agency has
determined that the facility is in compliance with the personnel requirements
of this Section.
Notes
Amended at 29 Ill. Reg. 20963, effective December 16, 2005
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