South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-64 - X-Rays (Title B)
Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY
Section 61-64.V.RHB 5.9 - Personnel Requirements
Universal Citation: SC Code Regs 61-64.V.RHB 5.9
Current through Register Vol. 48, No. 9, September 27, 2024
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:
5.9.1 Interpreting physicians. All physicians interpreting mammograms shall meet the following qualifications:
5.9.1.1 Initial qualifications. Unless the
exemption in
RHB 5.9.1.3 applies, before
beginning to interpret mammograms independently, the interpreting physician
shall:
5.9.1.1.1 Be a licensed physician to
practice medicine in this state;
5.9.1.1.2 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 three (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 RHB 5.9.1 of this Part.
5.9.1.1.3 Have a minimum of sixty (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 sixty (60) of these hours shall be
Category I and have at least fifteen (15) hours of the Category I hours shall
have been acquired within three (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
5.9.1.1.4 Unless
the exemption in
RHB 5.9.1.3.2 applies, have
interpreted or multi-read at least two hundred forty (240) mammograms
examinations within the six (6)-month period immediately prior to the date that
the physician qualifies as an interpreting physician. The interpretation or
multi-reading shall be under direct supervision of a qualified interpreting
physician.
5.9.1.2
Continuing experience and education. All interpreting physicians shall maintain
their qualifications by meeting the following requirements:
5.9.1.2.1 Following the second anniversary
date of the end of the calendar quarter in which the requirements of
RHB 5.9.1.1 of this Part were
completed, the interpreting physician shall have interpreted or multi-read at
least nine hundred sixty (960) mammographic examinations during the twenty-four
(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 twenty-four (24)-month period.
5.9.1.2.2 Following the third anniversary of
the end of the calendar quarter in which the requirements of
RHB 5.9.1.1 of this Part
were completed, the interpreting physician shall have taught or completed at
least fifteen (15) Category I continuing medical education units in mammography
during the thirty-six (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 shall
choose one of these dates to determine the thirty-six (36)-month period. This
training shall include at least six (6) Category I continuing medical education
credits in each mammographic modality used by the interpreting physician in his
or her practice.
5.9.1.2.3 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 eight (8) hours of training in the new mammographic
modality.
5.9.1.2.4 Units earned
through teaching a specific course can be counted only once towards the fifteen
(15) units required by
RHB 5.9.1.2.2, even if the
course is taught multiple times during the previous thirty-six (36)
months.
5.9.1.3
Exemptions
5.9.1.3.1 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
RHB 5.9.1.1 of this Part.
These physicians may continue to interpret mammograms provided they continue to
meet the requirement of RHB 5.9.1 and the continuing experience and education
requirements of
RHB 5.9.1.2. Any physician
added to a facility after April 28, 1999, must provide documentation of initial
qualifications. This documentation must be maintained by the facility for
Departmental review.
5.9.1.3.2
Physicians who have interpreted or multi-read at least two hundred forty (240)
mammographic examinations under the direct supervision of an interpreting
physician in any six (6)-month period during the last two (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 exempt
from RHB
5.9.1.1.4.
5.9.1.4 Reestablishing qualifications.
Interpreting physicians who fail to maintain the required continuing experience
or continuing education requirements shall reestablish their qualifications
before resuming the independent interpretation of mammograms as follows:
5.9.1.4.1 Interpreting physicians who fail to
meet the continuing experience requirements of RHB
5.9.1.2.1 shall interpret or multi-read at
least two hundred forty (240) mammographic examinations within six (6) months
or less 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 nine hundred sixty (960) examinations from the prior twenty-four (24)
months, whichever is less. The interpretations required shall be done within
the six (6) months immediately prior to resuming independent
interpretation.
5.9.1.4.2
Interpreting physicians who fail to meet the continuing education requirements
of RHB
5.9.1.2.2 shall obtain a
sufficient number of additional Category I continuing medical education credits
in mammography to bring their total up to the required fifteen (15) credits in
the previous thirty-six (36) months before resuming independent
interpretation.
5.9.2 Radiologic technologists. All mammographic examinations shall be performed by radiologic technologists who meet the following general requirements, mammography requirements, and continuing education requirements:
5.9.2.1
Initial Qualifications
5.9.2.1.1 Be
registered in active status with the American Registry of Radiologic
Technologists in the field of radiography; and
5.9.2.1.2 All provisions of
RHB 4.2.2 apply to the
operators of mammography equipment.
5.9.2.2 Mammography requirements. Have, prior
to April 28, 1999, qualified as a radiologic technologist under FDA's interim
regulations or completed at least forty (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:
5.9.2.2.1 Training in breast
anatomy and physiology, positioning and compression, quality assurance/quality
control techniques, imaging of patients with breast implants;
5.9.2.2.2 The performance of a minimum of
twenty-five (25) examinations under the direct supervision of an individual
qualified under
RHB 5.9.2; and
5.9.2.2.3 At least eight (8) hours of
training in each mammography modality to be used by the technologist in
performing mammography exams.
5.9.2.3 Continuing education requirements
5.9.2.3.1 Following the third anniversary
date of the end of the calendar quarter in which the requirements of
RHB 5.9.2.1 and RHB 5.9.2.2
were completed, the radiologic technologist who performs mammography shall have
taught or completed at least fifteen (15) continuing education units in
mammography during the thirty-six (36) months immediately preceding the date of
the facility's annual mammography inspection, or the last day of the calendar
quarter preceding the inspection or any day in between the two. The facility
will choose one of these dates to determine the thirty-six (36)- month
period.
5.9.2.3.2 Units earned
through teaching a specific course can be counted only once towards the fifteen
(15) hours of continuing education requirements required in
RHB 5.9.2.3.1, even if the
course is taught multiple times during the previous thirty-six (36)
months.
5.9.2.3.3 At least six (6)
of the continuing education units required in
RHB 5.9.2.3.1 shall be
related to each mammographic modality used by the technologist.
5.9.2.3.4 Requalification. Radiologic
technologists who fail to meet the continuing education requirements of
RHB 5.9.2.3.1, shall
obtain a sufficient number of continuing education units in mammography to
bring their total up to at least fifteen (15) in the previous three (3) years,
at least six (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.
5.9.2.3.5 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
RHB 5.9.2.3.3, the
technologist shall have at least eight (8) hours of continuing education units
in the new modality.
5.9.2.3.6
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 Department.
5.9.2.3.7 Completion of initial or
requalification mammography training and continuing education in mammography
shall be verified to the Department.
5.9.2.4 Continuing experience requirements.
5.9.2.4.1 Following the second anniversary
date of the end of the calendar quarter in which the requirements of
RHB 5.9.2.1 and 5.9.2.2 were
completed or as of April 28, 1999, whichever is later, the radiologic
technologist shall have performed a minimum of two hundred (200) mammography
examinations during the twenty-four (24) months immediately preceding the date
of the facility's annual mammography 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 twenty-four (24)-month
period.
5.9.2.4.2 Requalification.
Radiologic technologists who fail to meet the continuing experience
requirements of
RHB 5.9.2.4.1 shall
perform a minimum of twenty-five mammography examinations under the direct
supervision of a qualified radiologic technologist before resuming the
performance of unsupervised mammography.
5.9.3 Medical Physicists. All medical physicists conducting surveys of mammography facilities and providing oversight of the facility quality assurance program shall meet the following:
5.9.3.1 Initial Qualifications. The medical
physicist must be approved by the Department as a Class IX vendor, prior to
providing or offering to provide services, as required in
RHB 2.7.1. Unless the
alternative initial qualifications in
RHB 5.9.3.2 apply, the
medical physicist must:
5.9.3.1.1 Have a
master's degree or higher in a physical science from an accredited institution,
with no less than twenty (20) semester hours or equivalent (e.g., thirty (30)
quarter hours) of college undergraduate or graduate level physics;
5.9.3.1.2 Have twenty (20) contact hours of
documented specialized training in conducting surveys of mammography
facilities; and
5.9.3.1.3 Have the
experience of conducting surveys of at least one (1) mammography facility and a
total of at least ten (10) mammography units. No more than one (1) survey of a
specific unit within a period of sixty (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
RHB 5.9.3.1 and
5.9.3.3.
5.9.3.2
Alternative initial qualifications.
5.9.3.2.1
Have qualified as a medical physicist under the FDA's interim-regulations and
retained that qualification by maintenance of the active status of any
licensure, approval, or certification required;
5.9.3.2.2 Prior to April 28, 1999, obtained a
bachelor's degree or higher in a physical science from an accredited
institution with no less than ten (10) semester hours or equivalent of college
undergraduate or graduate level physics;
5.9.3.2.3 Prior to April 28, 1999, have forty
(40) contact hours of documented specialized training in conducting surveys of
mammography facilities; and
5.9.3.2.4 Prior to April 28, 1999, have the
experience of conducting surveys of at least one (1) mammography facility and a
total of at least twenty (20) mammography units. No more than one (1) survey of
a specific unit within a period of sixty (60) days can be counted towards the
total mammography survey requirement. The training and experience requirements
shall be met after fulfilling the degree requirement.
5.9.3.3 Continuing education and experience.
5.9.3.3.1 Continuing education. Following the
third anniversary date of the end of the calendar quarter in which the
requirements of
RHB 5.9.3.1 and 5.9.3.2 were
completed, the medical physicist shall have taught, or completed, at least
fifteen (15) continuing education units in mammography during the thirty-six
(36)-months immediately preceding the date of the facility 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
thirty-six (36)-month period. This continuing education shall include hours of
training appropriate to each mammography 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 fifteen (15) continuing education units in a thirty-six
(36)-month period, even if the course is taught multiple times during the
thirty-six (36) months.
5.9.3.3.2
Continuing experience. Following the second anniversary date of the end of the
calendar quarter in which the requirements of
RHB 5.9.3.1 and 5.9.3.2 were
completed or as of April 28, 1999, whichever is later, the medical physicist
shall have surveyed at least two (2) mammography facilities and a total of at
least six (6) mammography units during the twenty-four (24) months immediately
preceding the date of the facility's annual mammography 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 twenty-four
(24)-month period. No more than one (1) survey of a specific facility within a
ten (10)-month period or a specific unit within a period of sixty (60) days can
be counted towards the total mammography unit survey requirement.
5.9.3.3.3 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
RHB 5.9.3.1 and 5.9.3.2, the
physicist shall receive at least eight (8) hours of training in surveying units
of the new mammographic modality.
5.9.3.4 Reestablishing qualifications.
Medical physicists who fail to maintain the required continuing qualifications
of RHB
5.9.3.3 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:
5.9.3.4.1 Medical physicists who
fail to meet the continuing educational requirements of 5.9.3.3.1 shall obtain
a sufficient number of continuing education units to bring their total units up
to the required fifteen (15) in the previous three (3) years.
5.9.3.4.2 Medical physicists who fail to meet
the continuing experience requirement of
RHB 5.9.3.3.2 shall
complete a sufficient number of surveys under the direct supervision of a
medical physicist who meets the qualification of
RHB 5.9.3.1 and 5.9.3.3 to
bring their total surveys up to the required two (2) facilities and six (6)
units in the previous twenty-four (24) months. No more than one (1) survey of a
specific unit within a period of sixty (60) days can be counted towards the
total mammography unit survey requirement.
5.9.4 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 must be available for review by the Department. Records of personnel no longer employed by the facility should not be discarded until the next annual inspection has been completed and the Department has determined that the facility is in compliance with the MQSA/State personnel requirements of this Part.
Disclaimer: These regulations may not be the most recent version. South Carolina may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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