Virginia Law

A. Safety procedures and instructions.

1. Licensees shall:

a. Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

b. Permit only individuals approved by the authorized user (AU), the authorized medical physicist (AMP), or the RSO to be present in the treatment room during treatment with sources;

c. Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

d. Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source in the shielded position, or remove the patient or human research subject from the radiation field with controls from the outside the treatment room. These procedures shall include:

(1) Instructions for responding to equipment failure and the names of the individuals responsible for implementing corrective actions;

(2) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

(3) The names and telephone numbers of the authorized user (AU), the authorized medical physicist (AMP), and the RSO to be contacted if the unit or the console operates abnormally.

2. A copy of the procedures required by subdivision 1 d of this subsection shall be physically located at the unit console.

3. Licensees shall post instructions at the unit console to inform the operator of:

a. The location of the procedures required by subdivision 1 d of this subsection; and

b. The names and telephone numbers of the AU, the AMP, and the RSO to be contacted if the unit or console operates abnormally.

4. Safety instruction and training.

a. Prior to the first use of 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.

b. Licensees shall provide instruction initially and at least annually to all individuals who operate the unit, as appropriate to the individual's assigned duties, in the procedures identified in subdivision 1 d of this subsection and the operating procedures for the unit.

5. Licensees shall ensure that operators, authorized users, and authorized medical physicists participate in drills of the emergency procedures initially and at least annually and document the exercise.

6. Licensees shall retain a record of individuals receiving instruction required by subdivision 4 of this subsection in accordance with 12VAC5-481-2070 L.

7. Licensees shall retain a copy of the procedures required by subdivisions 1 d and 4 b of this subsection in accordance with 12VAC5-481-2070 R.

B. Safety procedures for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

1. Licensees shall control access to the treatment room by a door at each entrance.

2. Licensees shall equip each entrance to the treatment room with an electrical interlock system that will:

a. Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

b. Cause the source to be shielded when an entrance door is opened; and

c. Prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off console is reset at the console.

3. Licensees shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

4. Except for low-dose remote afterloader units, licensees shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

5. For licensed activities where sources are placed within the patient's or human research subject's body, licensees shall only conduct treatments that allow for expeditious removal of a decoupled or jammed source.

6. In addition to the requirements specified in subdivisions 1 through 5 of this subsection, licensees shall:

a. For medium dose-rate and pulsed dose-rate remote afterloader units, require:

(1) An AMP and either an AU or an physician under the supervision of an AU who has been trained to the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the units; and

(2) An AMP and either an AU or an individual under the supervision of an AU who has been trained to remove the source applicators in the event of an emergency involving the unit to be immediately available during the continuation of all patient treatments involving the unit.

b. For high dose-rate remote afterloader units, require:

(1) An AU and an AMP to be physically present during the initiation of all patient treatments involving the unit; and

(2) An AMP and either an AU or a physician under the supervision of an AU who has been trained in the operation and emergency response for the unit to be physically present during continuation of all patient treatments involving the unit.

c. For gamma stereotactic radiosurgery units, require an AU and an AMP to be physically present throughout all patient treatments involving the unit.

d. Notify the RSO, or his designee, and the authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

7. Licensees shall have applicable emergency response equipment available near each treatment room to respond to a source that:

a. Remains in the unshielded position; or

b. Lodges within the patient following completion of the treatment.