Current through Register Vol. 48, No. 9, September 27, 2024
4.61.1 A licensee
shall--
4.61.1.1 Secure the unit, the console, the
console keys, and the treatment room when not in use or unattended;
4.61.1.2 Permit only individuals approved by the
authorized user, Radiation Safety Officer, or authorized medical physicist to be
present in the treatment room during treatment with the source(s);
4.61.1.3 Prevent dual operation of more than one
radiation producing device in a treatment room if applicable; and
4.61.1.4 Develop, implement, and maintain written
procedures for responding to an abnormal situation when the operator is unable to
place the source(s) 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 must include--
4.61.1.4.1
Instructions for responding to equipment failures and the names of the individuals
responsible for implementing corrective actions;
4.61.1.4.2 The process for restricting access to
and posting of the treatment area to minimize the risk of inadvertent exposure;
and
4.61.1.4.3 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.
4.61.2
A copy of the procedures required by RHA 4.61.1.4 must be physically located at the
unit console.
4.61.3 A licensee shall
post instructions at the unit console to inform the operator of--
4.61.3.1 The location of the procedures required
by RHA 4.61.1.4; and
4.61.3.2 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.
4.61.4 Training
and Instructions.
4.61.4.1 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, a 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.
4.61.4.2 A licensee shall provide operational and
safety instructions initially and at least annually to all individuals who operate
the unit at the facility, as appropriate to the individual's assigned duties. The
instructions shall include instruction in-
4.61.4.2.1 The procedures identified in paragraph
4.61.1.4 of this section; and
4.61.4.2.2
The operating procedures for the unit.
4.61.5 A licensee shall ensure that operators,
authorized medical physicists, and authorized users participate in drills of the
emergency procedures, initially and at least annually.
4.61.6 A licensee shall retain a record of
individuals receiving instruction required by RHA 4.61.4, in accordance with RHA
4.102.
4.61.7 A licensee shall retain a
copy of the procedures required by RHA 4.61.1.4 and 4.61.4.2.2 of this section in
accordance with RHA 4.108.
