N.J. Admin. Code § 7:28-15.7

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

Section 7:28-15.7 - Computed tomography equipment

(a) The provisions of this section are in addition to and not in substitution for the applicable sections of this subchapter.

(b) No person shall operate or permit the operation of computed tomography equipment used in the healing arts unless the equipment meets the following requirements:

1. The registrant shall maintain the technical and safety information supplied by the manufacturer as required by the Code of Federal Regulations at 21 C.F.R. 1020.33(c) near the control panel and produce it to the department during any inspection;

2. A visual indication of the conditions of operation to be used during a scan or scan sequence shall be indicated prior to initiation of a scan or scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions shall be visible from any position from which the scan can be initiated;

3. A means shall be provided to terminate the exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. A visible signal shall indicate when the x-ray exposure has been terminated by this means. Such termination shall occur within an interval that limits the total scan time to no more than 110 percent of the preset value through the use of either a backup timer or devices which monitor equipment function. Means shall be provided such that the exposure from the system does not exceed 100 mR/scan except when x-ray transmission data are being collected for use in image production or technique factor selection;

4. The operator shall be able to terminate the x-ray exposure at any time during a scan or during a series of scans under the x-ray system control of greater than one-half second exposure. Termination of the x-ray exposure shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan;

5. A means shall be provided to permit visual determination of the location of the tomographic plane or a reference plane offset from the tomographic plane;

6. If a device using a light source, including a laser source, is used to determine the location of the tomographic plane, this source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux;

7. The x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed. If the x-ray production period is less than one-half second, the indication of x-ray production shall be actuated for one-half second. Indicators at or near the housing of the scanning mechanism shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible;

8. For systems that allow high voltage to be applied to the x-ray tube continuously and that control the emission of x-rays with a shutter, the radiation emitted shall not exceed 100 milliroentgens (2.6 E-2 Coulombs per kilogram) in one hour at any point five centimeters (two inches) outside the external surface of the housing of the scanning mechanism when the shutter is closed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters (15.5 square inches) with no linear dimensions greater than 20 centimeters (eight inches);

9. The deviation of indicated scan increment from actual scan increment shall not exceed 1 millimeter. Compliance shall be measured as follows: The determination of the deviation of indicated versus actual scan increment shall be based on measurements taken with a mass of 100 kilograms or less on the patient support. The patient support shall be incremented from a typical starting position to the maximum incremented distance or 30 centimeters (12 inches), whichever is less, and then returned to the starting position;

10. The distance between the indicated location of the tomograhic plane or reference plane and its actual location may not exceed five millimeters; and

11. An emergency off switch shall be available at the control panel and in the CT room.

(c) No person shall operate or permit the operation of computed tomographic equipment unless the facility meets the following:

1. Provision shall be made for two-way aural communication between the patient and the operator at the control panel; and

2. Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel. When the primary viewing system is by electronic means, such as a closed-circuit television, an alternate viewing system, which may also be electronic, shall be provided to permit continuous observation of the patient during irradiation in the event of failure of the primary viewing system.

(d) No person shall operate or permit the operation of computed tomography equipment used in the healing arts unless the following operating conditions are met:

1. The CT system shall not be operated except by a licensed individual who has been specifically trained in its operation;

2. Information shall be available near the control panel regarding the operation and calibration of the system. That information shall contain:

i. Dates of the latest calibration and spot checks and the location within the facility where the results of these tests may be obtained;

ii. Instructions on the use of the phantom(s), including a schedule of testing appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent tests conducted on the system; and

iii. A technique chart for each predetermined scan protocol shall be available at the control panel; and

iv. No person shall operate or permit the operation of computed tomography equipment used in the healing arts unless the registrant has developed and continuously implements a quality assurance program that meets the applicable requirements of N.J.A.C. 7:28-22, Quality Assurance Programs for Medical Diagnostic X-ray Installations.

N.J. Admin. Code § 7:28-15.7

Amended by R.2001 d.37, effective 1/16/2001.
See: 32 New Jersey Register 1459(a), 33 New Jersey Register 292(b).
Rewrote the section.