| (II) radiation oncology by the American Osteopathic
Board of Radiology;
(E) Operators of the electronic brachytherapy device
shall complete device-specific training as follows:
(i) completion of a training program provided by the
manufacturer; or
(ii) training received that is substantially equivalent
to the manufacturer's training program from a certified physician
or a licensed medical physicist who is trained to use the device.
(iii) The registrant shall retain a record of each
individual's device-specific training in accordance with subsection
(l) of this section for inspection by the agency.
(F) Each facility, including facilities using electronic
brachytherapy devices, shall develop a quality assurance program in
writing or in an electronic reporting system. The quality assurance
program shall be implemented as a method of minimizing deviations
from facility procedures and to document preventative measures taken
prior to serious patient injury or therapeutic misadministration.
(i) The quality assurance program shall include but
not be limited to the following topics:
(I) treatment planning and patient simulation;
(II) charting and documenting treatment field parameters;
(III) dose calculation and review procedures;
(IV) review of daily treatment records; and
(V) for electronic brachytherapy, verification of catheter
placement and device exchange procedures;
(ii) A written directive shall be prepared prior to
administration of a therapeutic radiation dose except where a delay
to provide a written directive would jeopardize the patient's health.
The information contained in the oral directive shall be documented
immediately in the patient's record and a written directive prepared
within 24 hours of the oral directive.
(iii) A written directive that changes an existing
written directive for any therapeutic radiation procedure is only
acceptable if the revision is dated and signed by a certified physician
prior to the administration of the therapeutic dose, or the next fractional
dose.
(iv) Deviations from the prescribed treatment, from
the facilities quality assurance program, and from the operating and
safety procedures shall be investigated and brought to the attention
of the certified physician or licensed medical physicist, and the
radiation safety officer (RSO).
(v) The patient's identity shall be verified by more
than one method as the individual named in the written directive prior
to administration.
(vi) The discovery of each medical event or misadministration
shall be reported in accordance with subsection (i) or (j) of this
section.
(vii) The review of the quality assurance program shall
include all the deviations from the prescribed treatment and shall
be conducted at intervals not to exceed 14 months. A signed record
of each dated review shall be maintained for inspection by the agency
in accordance with subsection (l) of this section and shall include
evaluations and findings of the review.
(G) Written operating and safety procedures shall be
developed by a licensed medical physicist with a specialty in therapeutic
radiological physics and shall include any restrictions required for
the safe operation of the particular therapeutic radiation machine.
These procedures shall be available in the control area of the therapeutic
radiation machine and an electronic brachytherapy device. The operator(s)
shall be able to demonstrate familiarity with these procedures. These
procedures shall include, but are not limited to the following:
(i) therapeutic radiation machines shall not be used
for irradiation of patients unless full calibration measurements and
quality assurance checks have been completed;
(ii) therapeutic radiation machines shall not be used
in the administration of radiation therapy if a spot check indicates
a significant change in the operating characteristics of a system
as specified in the written procedures;
(iii) therapeutic radiation machines shall not be left
unattended unless secured by a locking device which will prevent unauthorized
use (A computerized pass-word system would also constitute a locking
device);
(iv) when there is a need to immobilize a patient or
port film for radiation therapy, mechanical supporting or restraining
devices shall be used;
(v) no individual, other than the patient, shall be
in the treatment room during exposures from therapeutic radiation
machines operating above 150 kV;
(vi) at energies less than or equal to 150 kV, any
individual, other than the patient, in the treatment room shall be
protected by a barrier sufficient to meet the requirements of §289.231(m)
and (o) of this title;
(vii) use of a technique chart for simulators in accordance
with paragraph (4)(A)(i) of this subsection;
(viii) radiation dose requirements in accordance with
§289.231(m) and (o) of this title;
(ix) personnel monitoring requirements in accordance
with §289.231(n) of this title;
(x) use of protective devices for simulators in accordance
with paragraph (4)(A)(iii) of this subsection;
(xi) credentialing requirements for individuals operating
radiation machines in accordance with subparagraph (C) of this paragraph;
(xii) film processing program for simulators in accordance
with paragraph (4)(A)(viii) of this subsection; and
(xiii) procedures for restriction and alignment of
beam for simulators in accordance with paragraph (4)(B)(iii) of this
subsection.
(H) Registrants with equipment that has been issued
variances by the United States Food and Drug Administration (FDA)
to Title 21, CFR Part 1020 shall maintain copies of those variances
at authorized use locations in accordance with subsection (l) of this
section.
(I) The registrant shall perform radiation surveys
and contamination smears prior to the transfer or disposal of an accelerator
operating at or above 10 MeV. Such survey(s) shall be documented and
maintained by the registrant for inspection by the agency in accordance
with subsection (l) of this section.
(J) Where applicable, the licensed medical physicist
shall perform acceptance testing on the treatment planning system
of therapy-related computer systems in accordance with published protocols
accepted by nationally recognized bodies. In the absence of such a
published protocol, the manufacturer's current protocol shall be followed.
(2) Therapeutic radiation machines capable of operating
at energies below 1 MeV.
(A) Equipment requirements.
(i) When the tube is operated at its leakage technique
factors, the leakage radiation shall not exceed the values specified
at the distance stated for the classification of that radiation machine
system shown in the following Table I. The leakage technique factors
are the maximum-rated peak tube potential and the maximum-rated continuous
tube current for the maximum-rated peak tube potential.
Attached Graphic
(ii) Permanent fixed diaphragms or cones used for limiting
the useful beam shall provide the same or a higher degree of protection
as required for the tube housing assembly.
(iii) Removable and adjustable beam-limiting devices
shall meet the following requirements.
(I) Removable beam-limiting devices shall, for the
portion of the useful beam to be blocked by these devices, transmit
not more than 1.0% of the useful beam at the maximum kVp and maximum
treatment filter. This requirement does not apply to auxiliary blocks
or materials placed in the x-ray field to shape the useful beam to
the individual patient.
(II) Adjustable beam-limiting devices installed before
March 1, 1989, shall, for the portion of the x-ray beam to be blocked
by these devices, transmit not more than 5.0% of the useful beam at
the maximum kVp and maximum treatment filter.
(III) Adjustable beam-limiting devices installed after
March 1, 1989, shall meet the requirements of subclause (I) of this
clause.
(iv) The filter system shall be so designed that:
(I) the filters cannot be accidentally displaced at
any possible tube orientation;
(II) for equipment installed after March 1, 1989, an
interlock system prevents irradiation if the proper filter is not
in place;
(III) the radiation at 5 centimeters (cm) from the
filter insertion slot opening does not exceed 30 roentgens per hour
(R/hr) (300 mGy/hr) under any operating conditions; and
Cont'd... |
