| (viii) procedures for necessary area surveys and time
intervals.
(C) The registrant shall ensure that radiation measurements
are performed with a calibrated dosimetry system. The dosimetry system
calibration shall be traceable to a national standard. The calibration
interval shall not exceed 24 months. There shall be available at each
accelerator facility, appropriate portable monitoring equipment that
is operable and has been calibrated for the appropriate radiations
being produced at the facility.
(D) A radiation protection survey shall be performed
and the results recorded when changes have been made in shielding,
operation, equipment, or occupancy of adjacent areas.
(E) For portable or mobile accelerators, such as neutron
generators that are used at temporary job sites where permanent shielding
is not available, radiation protection shall be provided by temporary
shielding or by providing an adequate exclusion area around the accelerator
while it is in use.
(F) Records of calibration and survey results made
in accordance with subparagraphs (C) and (D) of this paragraph shall
be maintained in accordance with subsection (l) of this section.
(G) 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.
(H) The registrant shall retain records of receipt,
transfer, and disposal of all radiation machines specific to each
authorized use location. The records shall include the date, manufacturer
name, model and serial number from the control panel or console of
the radiation machine and identification of the person making the
record.
(4) Training requirements for operators.
(A) No person shall be permitted to operate an accelerator
unless such person has received instruction in and demonstrated competence
with the following:
(i) operating and safety procedures in accordance with
paragraph (3)(B) of this subsection;
(ii) radiation warning and safety devices incorporated
into the equipment and in the room;
(iii) identification of radiation hazards associated
with the use of the equipment; and
(iv) procedures for reporting an actual or suspected
exposure.
(B) Records of the training specified in subparagraph
(A) of this paragraph shall be made and maintained for agency inspection
in accordance with subsection (l) of this section.
(g) Requirements for accelerator(s) used in industrial
radiography. In addition to the requirements in subsections (f)(1),
(2), and (3)(C) - (H) of this section, accelerators used for industrial
radiography shall meet the applicable requirements of §289.255
of this title.
(h) Therapeutic radiation machines, simulators used
in the healing arts, veterinary medicine, and electronic brachytherapy
devices.
(1) General requirements.
(A) Each person possessing a therapeutic radiation
machine capable of operating at or above 1 million electron volts
(MeV) shall apply for and receive a certificate of registration from
the agency before using the accelerator for human use. A person may
energize the accelerator for purposes of installation and acceptance
testing before receiving a certificate of registration from the agency.
(B) Each person possessing a simulator, a therapeutic
radiation machine capable of operating below 1 MeV, and/or an electronic
brachytherapy device, shall apply for a certificate of registration
within 30 days after energizing the equipment.
(C) Individuals who operate radiation machines for
human use shall meet the appropriate credentialing requirements issued
in accordance with the Medical Radiologic Technologist Certification
Act, Texas Occupations Code, Chapter 601. Copies of the credentialing
document shall be maintained at the locations(s) where the individual
is working.
(D) The electronic brachytherapy registrant shall require
the physician to be:
(i) licensed by the Texas Medical Board; and
(ii) certified in:
(I) radiation oncology or therapeutic radiology by
the American Board of Radiology; or
(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;
Cont'd... |
