Current through Register Vol. 54, No. 44, November 2, 2024
(a)
General requirements. Fluoroscopic X-ray systems shall use an
image intensifier and, in addition to the requirements of §§
221.1-221.34a, shall meet the
requirements of §§
221.36a-221.38a (relating to limitation of
useful beam of fluoroscopic equipment; activation of fluoroscopic tube; and
entrance exposure rate).
(b)
Operator qualifications. In addition to the applicable
sections of these regulations, the operation of a fluoroscopic X-ray system for
clinical purposes is limited to:
(1) A
licensed practitioner working within his scope of practice.
(2) A Department-recognized radiologist
assistant working within his scope of practice and under the direct supervision
of a licensed practitioner working within his scope of practice.
(3) An individual who passed the American
Registry of Radiologic Technologists exam or equivalent, holds a valid
certification and is under the personal supervision of a licensed practitioner
working within his scope of practice.
(4) A medical resident, radiologist assistant
or radiologic technology student in training who is under the personal
supervision of a licensed practitioner working within his scope of
practice.
(c)
QMP
evaluations. Fluoroscopic equipment shall be evaluated by or under the
direction of a QMP within 30 days after installation and after any maintenance
of the system that may affect the exposure rate. Thereafter, evaluations shall
be made at intervals not to exceed 14 months from the date of the prior
evaluation by or under the direction of a QMP. At a minimum, evaluations shall
include all of the following:
(1) A
measurement of entrance exposure rates over a representative range of
attenuating materials in all modes clinically used, including fluoroscopy,
high-level control, acquisition and CINE, when available. Measurements shall be
performed with a dosimetry system calibrated within 2 years preceding the
measurements. Records of these output measurements shall be maintained for 5
years for inspection by the Department. Measurements shall be made as follows:
(i) For systems without automatic exposure
control, by utilizing an mA and kVp typical of the clinical use of the
fluoroscopic system.
(ii) For
systems with automatic exposure control, by utilizing sufficient attenuating
material in the useful beam to produce an mA and kVp typical of the clinical
use of the fluoroscopic system.
(2) A measurement and verification of
compliance with maximum air kerma rate for fluoroscopy and high-level control,
if available.
(3) An evaluation of
high-contrast resolution and low-contrast resolution in both fluoroscopic and
spot-film or digital acquisition modes.
(4) An evaluation of the operation of the
5-minute timer, warning lights, interlocks and collision sensors.
(5) An evaluation of the beam
quality.
(6) An evaluation of the
collimation in the fluoroscopy and spot-film or digital acquisition
modes.
(7) An evaluation of the
availability and accuracy of technique indicators and integrated radiation dose
displays.
(8) An evaluation of any
changes that may impact patient and personnel exposure.
(d)
Additional requirements for
facilities performing FGI.
(1) The
registrant utilizing FGI studies shall establish and implement written
procedures, or procedures documented in an electronic reporting system, that
include all of the following:
(i)
Identification of individuals who are authorized to use fluoroscopic systems
for interventional purposes.
(ii) A
method to be used to monitor patient radiation dose during FGI.
(iii) Dose notification levels, as
appropriate, at which the physician is notified for actions that may be taken
for patient safety.
(iv) SRDL
values referencing or consistent with nationally-recognized
standards.
(v) Actions to be taken
for cases when an SRDL is exceeded, which may include patient
follow-up.
(vi) A review of the
established procedures at an interval not to exceed 12 months.
(2) Records of policies and
procedures shall be maintained for inspection by the Department. If the
registrant revises a policy or procedure, documentation shall be maintained
that includes the justification for the revision.
(3) A record of radiation output information
shall be maintained so the radiation dose to the skin may be estimated in
accordance with established protocols. The record must include all of the
following:
(i) Patient
identification.
(ii) Type and date
of examination.
(iii)
Identification of the fluoroscopic system used.
(iv) Peak skin dose, cumulative air kerma or
dose area product used if the information is available on the fluoroscopic
system.
(4) If the peak
skin dose, cumulative air kerma or dose area product is not displayed on the
fluoroscopic system, records must include other information necessary to
estimate the radiation dose to the skin in accordance with established protocol
or one or more of the following:
(i)
Fluoroscopic mode, such as high-level or pulsed mode of operation.
(ii) Cumulative fluoroscopic exposure
time.
(iii) Number of films or
recorded exposures.
(5)
The registrant shall maintain records for 5 years for inspection by the
Department.
The provisions of this §221.35a issued and amended under
sections 301 and 302 of the Radiation Protection Act (31 P.S.
§§ 7110.301 and
7110.302); and section 1920-A
of The Administrative Code of 1929 (71 P.S. §
510-20).
This section cited in 25 Pa. Code §
221.43a (relating to mobile
fluoroscopes); and 25 Pa. Code §
221.61 (relating to radiation
therapy simulation systems).
