N.J. Admin. Code § 7:28-15.6

Current through Register Vol. 56, No. 24, December 18, 2024

Section 7:28-15.6 - Radiation therapy simulators

(a) No person shall operate or permit the operation of a radiation therapy simulator system unless it meets the requirements of this section and complies with all applicable requirements of this subchapter, unless otherwise exempted.

(b) Operation of a radiation therapy simulator system on a patient shall be performed only by a licensed practitioner, a licensed radiation therapy technologist, or a licensed diagnostic x-ray technologist, as prescribed in N.J.A.C. 7:28-19.

(c) No person shall operate or permit the operation of a radiation therapy simulator system unless it meets the following requirements:

1. A quality assurance program has been established in collaboration with a qualified medical physicist for the supervision of quality assurance programs for therapy simulator systems, and implemented by the registrant to ensure congruence of the position and size of the simulated field with the position and size of the irradiation field.

i. The quality assurance program is consistent with, but not limited to, the guidelines established by the American Association of Physicists in Medicine, (AAPM) Report Number 13;

ii. The quality assurance program is documented by the registrant; and

iii. The quality assurance program records are maintained by the registrant for at least 36 months, and are available for review at the facility by the department during any inspection;

2. Any radiation therapy simulator system, which uses a gantry rotation system when performing radiographic examinations, shall be equipped with a sensor mechanism that shall stop the gantry motion if necessary to prevent collision. This requirement shall take effect October 18, 1994.

i. Restarting the unit shall only be possible when the cause of the termination has been determined and corrected and the sensor mechanism is satisfied that a collision reoccurrence is not possible.

ii. Tests of the operation of the anti-collision sensor mechanism are performed and results are documented by those individuals listed in (b) above or by a qualified medical physicist for the supervision of quality assurance programs for therapy simulator systems at intervals not to exceed 12 months. The records shall be maintained for at least 36 months, and shall be available at the facility for review by the department during any inspection. A true copy of these records shall be sent to the department upon request;

3. A dead-man switch and/or an emergency "off" control shall be located on the remote control console and also at all places in the simulator room from which motions are controlled;

4. A radiation therapy simulator system attached to a megavoltage radiation therapy x-ray system shall meet the following requirements:

i. Exposure controls shall be located outside the therapy room;

ii. The operator shall be able to view the patient from the control panel at all times during the procedure. The viewing system may consist of, but is not limited to, a window, mirror, or closed circuit television; and

iii. A method for two-way aural communication between the patient and the operator shall be provided at the control panel and shall be operable at all times when the system is in operation;

5. A superficial or orthovoltage therapy x-ray system shall not be used for radiation therapy simulation except for treatments given on this system; and

6. Protective aprons of at least 0.25 millimeters lead equivalent shall be worn by the operator or therapy physician during every instance in which entry into the simulator room is necessary while the patient exposure is in progress. Protective gloves of at least 0.25 millimeters lead equivalent shall be worn by the operator or therapy physician during every instance when the hands must be in the primary beam while the patient exposure is in progress. The exposure of such individuals shall be controlled by the use of shielding and protective clothing as necessary to ensure that they are not exposed to radiation doses in excess of those permitted by N.J.A.C. 7:28-6.

N.J. Admin. Code § 7:28-15.6