| (XVII) Capabilities shall be provided so that all radiation
safety interlocks can be checked for correct operation.
(ii) Facility and shielding requirements.
(I) Each installation shall be provided with primary
and secondary barriers as are necessary to assure compliance with §289.231(m)
of this title.
(II) All protective barriers shall be fixed except
for entrance doors or beam interceptors.
(III) The console shall be located outside the treatment
room and all emergency buttons/switches shall be clearly labeled as
to their functions.
(IV) Treatment room entrances shall be provided with
a warning light in a readily observable position near the outside
of all access doors to indicate when the useful beam is "on."
(V) Interlocks shall be provided such that all entrance
doors shall be closed before treatment can be initiated or continued.
If the radiation beam is interrupted by any door opening, it shall
not be possible to restore the machine to operation without closing
the door and reinitiating irradiation by manual action at the console.
(iii) Surveys, calibrations, spot checks, and operational
requirements.
(I) Surveys shall be performed as follows.
(-a-) All new and existing facilities not previously
surveyed shall have an initial survey made by a licensed medical physicist
with a specialty in therapeutic radiological physics, who shall provide
a written report of the survey to the registrant. In addition, such
surveys shall be done after any change in the facility or equipment
that might cause a significant increase in radiation hazard.
(-b-) The survey report shall include the following:
(-1-) a diagram of the facility that details building
structures and the position of the console, therapeutic radiation
machine, and associated equipment;
(-2-) a description of the therapeutic radiation system,
including the manufacturer, model and serial number, beam type, and
beam energy;
(-3-) a description of the instrumentation used to
determine radiation measurements, including the date and source of
the most recent calibration for each instrument used;
(-4-) conditions under which radiation measurements
were taken;
(-5-) projected annual TEDE in areas adjacent to the
therapy room; and
(-6-) a description of workload, use, and occupancy
factors employed in determining the projected annual TEDE.
(-c-) The registrant shall maintain a copy of the survey
report and a copy of the survey report shall be provided to the agency
within 30 days of completion of the survey. Records of the survey
report shall be maintained in accordance with subsection (k)(2) of
this section for inspection by the agency.
(-d-) The survey report shall include documentation
of all instances where the installation is in violation of applicable
regulations. Any deficiencies detected during the survey shall be
corrected before using the machine.
(II) Calibrations of therapeutic systems shall be performed
as follows.
(-a-) The calibration of systems subject to this subsection
shall be performed in accordance with an established calibration protocol
before the system is first used for irradiation of an animal and thereafter
at time intervals that do not exceed 12 months and after any change
that might significantly alter the calibration, spatial distribution,
or other characteristics of the therapy beam. The calibration procedures
shall be in writing, or documented in an electronic reporting system,
and shall have been developed by a licensed medical physicist with
a specialty in therapeutic radiological physics.
(-b-) The calibration shall be performed by a licensed
medical physicist with a specialty in therapeutic radiological physics
who is physically present at the facility during the calibration.
(-c-) The calibration shall include verification that
the equipment is operating in compliance with the design specifications
concerning the light field, animal positioning lasers, and back-pointer
lights with the isocenter when applicable, variation in the axis of
rotation for the table, gantry, and collimator system, and beam flatness
and symmetry at the specified depth.
(-d-) Records of calibration measurements shall be
maintained according to subsection (k)(2) of this section for inspection
by the agency.
(III) The spot check procedures shall be performed
in accordance with established protocol, shall be in writing, or documented
in an electronic reporting system, and shall have been developed by
a licensed medical physicist with a specialty in therapeutic radiological
physics.
(-a-) The written spot check procedures shall specify
the frequency at which tests or measurements are to be performed and
the acceptable tolerance for each parameter measured in the spot check
when compared to the value for that parameter determined in the calibration.
(-b-) Records of spot check measurements and any necessary
corrective actions shall be maintained by the registrant in accordance
with subsection (k) of this section for inspection by the agency.
(D) General requirements for simulators in radiation
therapy.
(i) A technique chart relevant to the particular radiation
machine shall be provided or electronically displayed in the vicinity
of the console and used by all operators.
(ii) Each registrant shall have and implement written
operating and safety procedures in accordance with paragraph (2) of
this subsection.
(iii) When utilized, protective devices shall follow
the requirements of paragraph (3)(H) of this subsection.
(iv) The operator's position during the exposure shall
follow the requirements of paragraph (3)(K) of this subsection.
(v) No individuals other than the animal and the operators
shall be in the treatment room during operation of the simulator.
(9) Educational facilities. Facilities conducting training
using live animals are held to the requirements of this section except
for paragraphs (10) - (12) of this subsection concerning film processing.
(10) Automatic and manual film processing for veterinary
facilities and mobile veterinary services.
(A) Films shall be developed in accordance with the
time-temperature relationships recommended by the film manufacturer.
The specified developer temperature for automatic processing and the
time-temperature chart for manual processing shall be posted in the
processing area. If the registrant determines an alternate time-temperature
relationship is more appropriate for a specific facility, that time-temperature
relationship shall be documented and posted.
(B) Chemicals shall be replaced according to the chemical
manufacturer's or supplier's recommendations or at an interval not
to exceed three months.
(C) Darkroom light leak tests shall be performed at
intervals not to exceed six months.
(D) Lighting in the film processing/loading area shall
be maintained with the filter, bulb wattage, and distances recommended
by the film manufacturer for that film emulsion or with products that
provide an equivalent level of protection against fogging.
(E) Corrections or repairs of the light leaks or other
deficiencies in subparagraphs (B) - (D) of this paragraph shall be
initiated within 72 hours of discovery and completed no longer than
15 days from detection of the deficiency unless a longer time is authorized
by the agency.
(F) Documentation of the items in subparagraphs (B),
(C), and (E) of this paragraph shall be maintained at the site where
performed and shall include the date and initials of the individual
completing these items. These records shall be made and maintained
in accordance with subsection (k)(2) of this section for inspection
by the agency.
(11) Alternative processing systems. Users of daylight
processing systems, laser processors, self-processing film units,
or other alternative processing systems shall follow manufacturer's
recommendations for image processing. Documentation that the registrant
is following manufacturer's recommendations shall include the date
and initials of the individual completing the document and shall be
made and maintained at the site where performed in accordance with
subsection (k)(2) of this section for inspection by the agency.
(12) Digital imaging acquisition systems.
(A) Users of digital imaging acquisition systems shall
follow quality assurance/quality control (QA/QC) protocol for digital
imaging established by the manufacturer.
(i) The registrant shall include the protocols established
in subparagraph (B) of this paragraph in its operating and safety
procedures.
(ii) The registrant shall document the frequency at
which the QA/QC protocol is performed. Documentation shall:
Cont'd... |
