| (I) include a minimum of 1 hour fluoroscopic machine
training demonstrating application of clause (i)(I), and (IV) - (VII)
of this subparagraph; and
(II) be provided by a radiologist, licensed medical
physicist, or a physician that meets the requirements of this subparagraph.
(iii) The registrant shall ensure that radiation safety
awareness training be completed within 2 years from the effective
date of this rule for each physician, "as well as individuals to whom
a physician has delegated authority pursuant to the Occupations Code,
Chapter 601, and the applicable rules of the Texas Medical Board,"
performing FGI procedures.
(iv) Two years after the effective date of this rule,
the registrant shall ensure that prior to performing FGI procedures
each physician, "as well as individuals to whom a physician has delegated
authority pursuant to the Occupations Code, Chapter 601, and the applicable
rules of the Texas Medical Board," shall complete the radiation safety
awareness training.
(v) The 8 hours of Category 1 CMEU in radiation safety
awareness training required by this subsection may be obtained by
web-based online training.
(vi) The registrant shall maintain radiation safety
awareness training records for the 8 hours Category 1 CMEU and the
1 hour fluoroscopic machine training required in this subparagraph
in accordance with subsection (s)(1) of this section for inspection
by the agency.
(n) CT systems.
(1) CT system requirements shall include the following.
(A) Warning label. The warning label will meet the
requirements of §289.231(z) of this title.
(B) Visual indication. The CT control panel shall provide
visual indication of the production of x-rays.
(C) Indicated technique factors. The indicated technique
factors shall be accurate to meet manufacturer's specifications. If
these specifications are not available from the manufacturer, the
factors shall be accurate to within plus or minus 10% of the indicated
setting.
(D) Tomographic plane indication and alignment.
(i) For any single tomogram system, means shall be
provided to permit visual determination of the tomographic plane or
a reference plane offset from the tomographic plane.
(ii) For any multiple slice tomogram system, means
shall be provided to permit visual determination of the location of
a reference plane. The reference plane can be offset from the location
of the tomographic planes.
(iii) If a device using a light source is used to satisfy
the requirements of clause (i) or (ii) of this subparagraph, the light
source shall provide illumination levels sufficient to permit visual
determination of the location of the tomographic plane or reference
plane under ambient light conditions of up to 500 lux.
(E) Indication of CT conditions of operation. The CT
system shall be designed such that the CT conditions of operation
to be used during a scan or a scan sequence are indicated prior to
the initiation of a scan or a scan sequence. On CT systems having
all or some of these conditions of operation at fixed values, this
requirement may be met by permanent markings. Indication of CT conditions
of operation shall be visible from any position from which scan initiation
is possible.
(F) Initiation of operation.
(i) The CT control panel and gantry shall provide visual
indication whenever x rays are produced and, if applicable, whether
the shutter is open or closed.
(ii) Means shall be provided to require operator initiation
of each individual scan or series of scans.
(iii) All emergency buttons/switches shall be clearly
labeled as to their functions.
(G) Termination of exposure.
(i) Means shall be provided to terminate the x-ray
exposure automatically by either de-energizing the x-ray source or
shuttering the x-ray beam in the event of equipment failure affecting
data collection. Such termination shall occur within an interval that
limits the total scan time to no more than 110% of its preset value
through the use of either a backup timer or devices that monitor equipment
function.
(ii) A signal visible to the operator shall indicate
when the x-ray exposure has been terminated through the means required
by clause (i) of this subparagraph.
(iii) The operator shall be able to terminate the x-ray
exposure at any time during a scan or series of scans under CT system
control, of greater than 0.5 seconds duration. Termination of the
x-ray exposure shall necessitate resetting of the CT conditions of
operation prior to initiation of another scan.
(H) Additional requirements applicable to CT systems.
Additional requirements applicable to CT systems containing a gantry
manufactured after September 3, 1985, are as follows.
(i) The total error in the indicated location of the
tomographic plane or reference plane shall not exceed 5 mm.
(ii) If the x-ray production period is less than 0.5
seconds, the indication of x-ray production shall be actuated for
at least 0.5 seconds. Indicators at or near the gantry shall be discernible
from any point external to the patient opening where insertion of
any part of the human body into the primary beam is possible.
(iii) The deviation of indicated scan increment versus
actual increment shall not exceed plus or minus 1 mm with any mass
from 0 to 100 kilograms (kg) resting on the support device. The patient
support device shall be incremented from a typical starting position
to the maximum incremented distance or 30 cm, whichever is less, and
then returned to the starting position. Measurement of actual versus
indicated scan increment can be taken anywhere along this travel.
(2) Facility design requirements shall include the
following.
(A) Provision shall be made for two-way aural communication
between the patient and the operator at the control panel.
(B) Windows, mirrors, closed-circuit television, or
an equivalent shall be provided to permit continuous observation of
the patient during irradiation and shall be so located that the operator
can observe the patient from the control panel.
(i) Should the viewing system described in subparagraph
(B) of this paragraph fail or be inoperative, treatment shall not
be performed with the unit until the system is restored.
(ii) In a facility that has a primary viewing system
by electronic means and an alternate viewing system, should the viewing
system described in subparagraph (B) of this paragraph fail or be
inoperative, treatment shall not be performed with the unit until
one of the systems is restored.
(3) Measurements of the radiation output of the CT
system, using the computed tomography dose index (CTDI) as recommended
by the American Association of Physicists in Medicine (AAPM) and the
International Council on Radiation Protection (ICRP), shall be performed
by a licensed medical physicist.
(A) Performance of the radiation output measurements
shall be:
(i) within 30 days after initial installation;
(ii) thereafter annually or at intervals not to exceed
14 months from the date of the prior radiation output measurements;
(iii) within 30 days of any major maintenance, that
could affect radiation output; and
(iv) within 30 days of any major change in equipment
operation for example, introduction of a new software package.
(B) The registrant shall ensure that radiation output
measurements of a CT system are performed with a calibrated dosimetry
system in accordance with subsection (i)(14) of this section.
(4) A maintenance schedule shall be developed and followed.
This schedule shall be in writing or documented in an electronic reporting
system and shall be included in the registrant's operating and safety
procedures. The maintenance schedule shall include but not be limited
to the following:
(A) radiation output measurements required by paragraph
(3)(A) of this subsection;
(B) acquisition of images by a licensed medical physicist
obtained with phantoms and using the same processing mode and CT conditions
of operation as are used to perform radiation output measurements
required by paragraph (3)(A) of this subsection; and
(C) acquisition of images by the registrant for quality
control purposes obtained with phantoms and using protocol and intervals
recommended by the manufacturer or the licensed medical physicist.
(5) The registrant shall maintain the images specified
in paragraph (4)(B) and (C) of this subsection in accordance with
subsection (s)(1) of this section for inspection by the agency. The
images may be maintained by either of the following methods:
(A) photographic copies of the images obtained from
the image display device; or
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