Current through Register Vol. 48, No. 52, December 27, 2024
a) A licensee using sealed sources in remote
afterloader units, teletherapy units or gamma stereotactic radiosurgery units
for therapeutic medical uses shall:
1) Secure
the unit, the console, the console keys and the treatment room when not in use
or unattended, if applicable;
2)
Permit only individuals approved by the authorized user, Radiation Safety
Officer or authorized medical physicist to be present in the treatment room
during treatment or emergencies with the sources;
3) Prevent dual operation of more than one
radiation producing device in a treatment room, if applicable; and
4) Develop, implement and maintain written
procedures for responding to an abnormal situation when the operator is unable
to place the sources in the shielded position, or remove the patient or human
research subject from the radiation field with controls from outside the
treatment room. These procedures shall include:
A) Instructions for responding to equipment
failures and the names of the individuals responsible for implementing
corrective actions;
B) The process
for restricting access to and posting of the treatment area to minimize the
risk of inadvertent exposure; and
C) The names and telephone numbers of the
authorized users, the authorized medical physicist and the Radiation Safety
Officer to be contacted if the unit or console operates abnormally.
b) A copy of the
procedures required by subsection (a)(4) and the manufacturer's instruction
manual shall be physically located at the unit console.
c) A licensee shall post instructions at the
unit console to inform the operator of:
1) The
procedures located there as required by subsection (b); and
2) The names and telephone numbers of the
authorized users, the authorized medical physicist and the Radiation Safety
Officer to be contacted if the unit or console operates abnormally.
d) Operational and Safety Training
1) Prior to the first use for patient
treatment of a new unit or an existing unit with a manufacturer upgrade that
affects the operation and safety of the unit, the licensee shall ensure that
vendor operational and safety training is provided to all individuals who will
operate the unit. The vendor operational and safety training must be provided
by the device manufacturer or by an individual certified by the device
manufacturer to provide the operational and safety training.
2) Initially and at least annually, the
licensee shall provide operational and safety instructions to all individuals
who operate the unit at the facility, as appropriate to the individual's
assigned duties, in:
A) The procedures
identified in subsection (a)(4); and
B) The operating procedures for the
unit.
e) A
licensee shall ensure that operators, authorized medical physicists and
authorized users participate in drills of the emergency procedures, initially
and at least annually.
f) A
licensee shall retain a record of the instruction required by subsection (d).
The record shall be retained for five years and include a list of the topics
covered, the date of the instruction, the names of the attendees and the names
of the individuals who provided instruction.
g) A licensee shall retain a copy of the
procedures required by subsections (a)(4) and (d)(2)(B) until the licensee no
longer possesses the remote afterloader, teletherapy unit or gamma stereotactic
radiosurgery unit.
h) A licensee
shall maintain a copy of the record documenting results of the drills of
emergency procedures required by subsection (e) for five years.
