Cal. Code Regs. Tit. 17, § 30307 - Fluoroscopic Installations

(a) The user shall ensure fluoroscopic equipment meets the following:

(1) The tube housing shall be of diagnostic type.

(2) The target-to-panel or target-to-table top distance should not be less than 18 inches and shall not be less than 12 inches.

(3) The total filtration permanently in the useful beam shall not be less than 2.5 millimeters aluminum equivalent. This requirement may be assumed to have been met if the half-value layer is not less than 2.5 millimeters aluminum at normal operating voltages.

(4) The equipment shall be so constructed that the entire cross-section of the useful beam is attenuated by a primary protective barrier. This barrier is usually the viewing device, either a conventional fluoroscopic screen or an image intensification mechanism.

(A) The lead equivalent of the barrier of conventional fluoroscopes shall be at least 1.5 millimeters for equipment capable of operating up to 100 kVp, at least 1.8 millimeters for equipment whose maximum operating potential is greater than 100 kVp and less than 125 kVp, and at least 2.0 millimeters for equipment whose maximum operating potential is 125 kVp or greater. Special attention must be paid to the shielding of image intensifiers so that neither the useful beam nor scattered radiation from the intensifier can produce a radiation hazard to the operator or personnel. With the fluorescent screen 14 inches (35 cm) from the panel or table top, the exposure rate 2 inches (5 cm) beyond the viewing surface of the screen shall not exceed 30 mR/hr for each R per minute at the table top with the screen in the useful beam without a patient and with the fluoroscope operating at the highest potential employed.

(B) Collimators shall be provided to restrict the size of the useful beam to less than the area of the barrier. For conventional fluoroscopes this requirement is met if, when the adjustable diaphragm is opened to its fullest extent, an unilluminated margin is left at all edges of the fluorescent screen with the screen centered in the beam at a distance of 35 cm (14 inches) from the panel or table top.

For image intensified fluoroscopy, shutters shall be provided which can be adjusted to restrict the X-ray field to the visible portion of the image receptor during fluoroscopy. For systems employing rectangular X-ray fields and circular image receptors, this requirement is met if the collimated beam forms a square which circumscribes, and is tangent to, the circular margin of the image receptor.

(C) The tube mounting and the carrier shall be so linked together that the carrier always intercepts the entire useful beam. The X-ray exposure shall automatically terminate when the carrier is removed from the useful beam.

(D) Collimators and adjustable diaphragms or shutters to restrict the size of the useful beam shall provide the same degree of protection as is required of the tube housing.

(5) The exposure switch shall be of the dead-man type.

(6) Each fluoroscopic unit shall be equipped with a manual-reset cumulative timing device, activated by the exposure switch, which will either indicate elapsed exposure time by a signal audible to the fluorocopist or turn off the apparatus when the total exposure exceeds a predetermined limit not exceeding five minutes in one or a series of exposures.

(7) Useful beam exposure rate.

(A) All fluoroscopic equipment. For routine fluoroscopy, the exposure rate measured at the point where the center of the useful beam enters a typical patient shall be as low as is practicable and shall not exceed 5 roentgens per minute under the conditions specified herein. This limit shall not apply during magnification procedures or the recording of fluoroscopic images where higher exposure rates are required. Compliance with this paragraph shall be determined using the measuring specifications of subsection (a)(7)(D), plus the following procedures when the automatic exposure rate control is used:

1. The useful beam exposure rate shall be measured with a phantom equivalent to 9 inches of water or 7 7/8 inches of lucite, intercepting the entire useful beam.

2. If the X-ray source is below the table, the X-ray exposure rate shall be measured with the nearest part of the imaging assembly located at 14 inches above the table top.

3. The field size at the point of exposure rate measurement shall be at least 6 1/4 square inches in area in the plane perpendicular to the central ray.

(B) Fluoroscopic equipment manufactured after August 1, 1974, and equipped with automatic exposure rate controls. Fluoroscopic equipment which is provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 10 roentgens per minute at the point where the center of the useful beam enters the patient, except during recording of fluoroscopicimages, or when an optional high level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute at the point where the center of the useful beam enters the patient unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.

(C) Fluoroscopic equipment manufactured after August 1, 1974, without automatic exposure rate controls. Fluoroscopic equipment which is not provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute at the point where the center of the useful beam enters the patient, except during recording of fluoroscopic images, or when an optional high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.

(D) Measuring useful beam exposure rate compliance.

1. If the X-ray tube is below the table, the exposure rate shall be measured 1 centimeter above the tabletop or cradle.

2. If the X-ray tube is above the table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

3. In a C-arm type of fluoroscope, the exposure rate shall be measured at 30 centimeters from the input surface of the fluoroscopic imaging assembly.

(8) Mobile fluoroscopic equipment shall meet the requirements of this section where applicable, except that:

(A) Inherent provisions shall be made so that the machine is not operated at a source-skin distance of less than 30 cm (12 inches).

(B) Image intensification shall always be provided. Conventional fluoroscopic screens shall not be used.

(C) It shall be impossible to operate a machine when the collimating cone or diaphragm is not in place.

(D) It shall be impossible to energize the useful beam of a mobile fluoroscope unless the entire useful beam is intercepted by the image receptor.

(9) Devices which indicate the X-ray tube potential and current shall be provided, and should be located in such a manner that the operator may monitor the tube potential and current during fluoroscopy.

(10) A shielding device of at least 0.25 millimeters lead equivalent shall be provided for covering the bucky-slot during fluoroscopy.

(11) Whenever practicable, protective drapes, or hinged or sliding panels, of at least 0.25 millimeters lead equivalent shall be provided between the patient and the fluoroscopist to intercept scattered radiation which would otherwise reach the fluoroscopist and others near the machine. Such devices shall not substitute for wearing of a protective apron.

(b) The user shall ensure the following:

(1) Protective aprons of at least 0.25 mm lead equivalent shall be worn in the fluoroscopy room by each person, except the patient, whose body is likely to be exposed to 5 mR/hr or more.

(2) On fluoroscopes with automatic exposure controls the operator shall monitor the tube current and potential at least once each week to ascertain that they are in their usual ranges for a given set of operating parameters. This requirement may be met by adjusting the controls to usual settings for fluoroscoping an average patient, and using a phantom of any suitable material with attenuation roughly equivalent to six to ten inches of water. Whenever the monitored tube current or potential vary in a way which could increase the patient X-ray exposure rate by more than 25% over the latest exposure rate measurement required by subsection (b)(3), the cause(s) for the change shall be determined promptly and the patient exposure rate shall be remeasured. On fluoroscopes with manual exposure control only, the operator shall monitor the tube current and potential at least once each day during use to ascertain that they are within the normal ranges used by the facility. A written log shall be kept of all monitored readings and shall include at least the tube current and potential, the date, identification of the fluoroscope, and name of the person who did the monitoring. Records of all monitored readings shall be preserved at the facility for at least three years.

(3) Measurements of the table top or patient exposure rate shall be made at least once each year for units with automatic exposure control, and at least once each 3 years for units without automatic exposure control, and immediately following alteration or replacement of a major component, such as the X-ray tube, the exposure controls, the imaging assembly, and the power source.

(4) On the cineradiography equipment, the exposure rates to which patients are normally subjected shall be determined at least once each year, and immediately following alterations or replacement of a major component, such as the X-ray tube, the exposure controls, the imaging assembly, and the power source.

(c) The user shall record for each patient the cumulative air kerma, if provided by the equipment, or, if it is not provided, the total fluoroscopic irradiation time. The terms "cumulative air kerma" and "fluoroscopic irradiation time" are as defined in title 21, Code of Federal Regulations, Part 1020.30(b) referenced in section 30305(a)(4). This record shall be maintained for three years and made available for inspection by the Department. The recorded value shall be trackable to the particular patient but need not be retained in the patient's medical record.

Notes

Cal. Code Regs. Tit. 17, § 30307

1. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.
2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).
3. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).
4. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).
5. Amendment of subsections (a), (a)(4), (a)(7)(A), (b) and (b)(2) and amendment of NOTE filed 5-13-2020; operative 10-1-2020 pursuant to Government Code section 11343.4(b)(2) (Register 2020, No. 20).
6. New subsection (c) filed 8-18-2020; operative 10-1-2020 (Register 2020, No. 34).

Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060, 131050, 131051 and 131052, Health and Safety Code.

1. Renumbering and amendment filed 9-4-73 as an emergency; effective upon filing (Register 73, No. 36). Approved by State Building Standards Commission 11-30-73.
2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).
3. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No. 26).
4. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).
5. Amendment of subsections (a), (a)(4), (a)(7)(A), (b) and (b)(2) and amendment of Note filed 5-13-2020; operative 10/1/2020 pursuant to Government Code section 11343.4(b)(2) (Register 2020, No. 20).
6. New subsection (c) filed 8-18-2020; operative 10/1/2020 (Register 2020, No. 34).