S.C. Code Regs. § § 61-64.VI.RHB 6.4

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-64.VI.RHB 6.4 - Therapeutic X-ray Systems of Less than 1 MeV

6.4.1 Equipment requirements.

6.4.1.1 Leakage radiation. When the tube is operated at its leakage technique factors, the leakage radiation shall not exceed the values specified at the distance stated for the classification of that x-ray system shown in Table 1.

TABLE 1. LEAKAGE LIMITS FOR THERAPEUTIC X-RAY SYSTEMS OF LESS THAN 1 MeV.

System Contact Therapy 0-150 kVp (manufactured or installed prior to January 1, 1994)	Leakage Limit 100 mR/hr 1 R in 1 hr.	Measurement Location 5 cm from surface of tube housing 1 m from source
0-150 kVp (manufactured on or after January 1, 1994)	100 mR in 1 hr	1 m from source
151-500 kVp 500-999 kVp	1 R in 1 hr 0.1 percent of 1 R in 1 hr.	1 m from source 1 m from source useful beam

6.4.1.2 Permanent Beam-Limiting Devices. Permanent fixed diaphragms or cones used for limiting the useful beam shall provide the same or a higher degree of protection as required for the tube housing assembly.

6.4.1.3 Removable and Adjustable Beam-Limiting Device.

6.4.1.3.1 Removable beam-limiting devices shall, for the portion of the useful beam to be blocked by these devices, transmit not more than one percent (1%) of the useful beam at the maximum kV and maximum treatment filter. This requirement does not apply to auxiliary blocks or materials placed in the useful beam to shape the useful beam to the individual patient.

6.4.1.3.2 Adjustable beam-limiting devices shall, for the portion of the x-ray beam to be blocked by these devices, transmit not more than five percent (5%) of the useful beam at the maximum kV and maximum treatment filter.

6.4.1.3.3 Adjustable beam-limiting devices installed after May 25, 2001, shall meet the requirements of RHB 6.4.1.3.

6.4.1.4 The filter system shall be so designed that:

6.4.1.4.1 The filters cannot be accidentally displaced at any possible tube orientation;

6.4.1.4.2 For equipment installed after January 1, 1994, an interlock system prevents irradiation if the proper filter is not in place;

6.4.1.4.3 The radiation at five centimeters (5 cm) from the filter insertion slot opening does not exceed thirty Roentgens (30 R)(7.74 mC/kg) per hour under any operating conditions; and

6.4.1.4.4 Each filter is marked as to its material of construction and its thickness. For wedge filters, the wedge angle shall appear on the wedge or wedge tray.

6.4.1.5 Tube Immobilization. The tube housing assembly shall be capable of being immobilized for stationary treatments.

6.4.1.6 Focal Spot Marking. The tube housing assembly shall be so marked that it is possible to determine the location of the focal spot to within five millimeters (5 mm), and such markings shall be readily accessible for use during calibration procedures.

6.4.1.7 Beam Block. Contact therapy tube housing assemblies shall have a removable shield of at least 0.5 millimeter lead equivalency at one hundred kilovoltage peak (100 kVp) that can be positioned over the entire useful beam exit port during periods when the beam is not in use.

6.4.1.8 Beam Monitoring System. Systems of greater than one hundred fifty (150 kVp) manufactured after January 1, 1994, shall be provided with a beam monitoring system which:

6.4.1.8.1 Shall have the detector of the monitor system interlocked to prevent incorrect positioning;

6.4.1.8.2 Shall not allow irradiation until a preselected value of exposure has been made at the treatment control panel;

6.4.1.8.3 Shall independently terminate irradiation when the preselected exposure has been reached;

6.4.1.8.4 Shall be so designed that, in the event of a system malfunction or electrical power failure, the dose administered to a patient prior to the system malfunction or power failure can be accurately determined;

6.4.1.8.5 Shall have a display at the control panel from which the dose at a reference point in soft tissue can be calculated;

6.4.1.8.6 Shall have a control panel display which maintains the administered dose reading until intentionally reset to zero (0); and

6.4.1.8.7 Shall have a control panel display which does not have scale multiplying factors and utilizes a design such that increasing dose is displayed by increasing numbers.

6.4.1.9 Timer.

6.4.1.9.1 A timer which has a display shall be provided at the treatment control panel. The timer shall have a preset time selector.

6.4.1.9.2 The timer shall activate with the production of radiation and retain its reading after irradiation is interrupted. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator to zero (0).

6.4.1.9.3 The timer shall terminate irradiation when a preselected time has elapsed, if any dose monitoring system present has not previously terminated irradiation.

6.4.1.9.4 The timer shall permit accurate presetting and determination of exposure times as short as one (1) second.

6.4.1.9.5 The timer shall not permit an exposure if set at zero (0).

6.4.1.9.6 The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer factor to compensate for mechanical lag.

6.4.1.9.7 Timers shall be accurate to within one percent (1%) of the selected value or one (1) second, whichever is greater.

6.4.1.10 Control Panel Functions. The control panel, in addition to the displays required in other provisions of this Part, shall have:

6.4.1.10.1 An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;

6.4.1.10.2 An indication of whether x-rays are being produced;

6.4.1.10.3 Means for indicating x-ray tube potential and current;

6.4.1.10.4 Means for terminating an exposure at any time;

6.4.1.10.5 A locking device which will prevent unauthorized use of the x-ray system; and

6.4.1.10.6 For x-ray systems manufactured after May 25, 2001, a positive display of specific filters in the beam.

6.4.1.11 Multiple Tubes. When a control panel may energize more than one (1) x-ray tube:

6.4.1.11.1 It shall be possible to activate only one (1) x-ray tube at any time;

6.4.1.11.2 There shall be an indication at the control panel identifying which x-ray tube is activated; and

6.4.1.11.3 There shall be an indication at the tube housing assembly when that tube is energized.

6.4.1.12 Source-to-Skin Distance (SSD). There shall be means of determining initially the SSD to within one centimeter (1 cm) and of producing this measurement to within two millimeters (2 mm) thereafter.

6.4.1.13 Shutters. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five (5) seconds, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly.

6.4.1.13.1 After the unit is at operating parameters, the shutter shall be controlled electrically by the operator from the control panel.

6.4.1.13.2 An indication of shutter position shall appear on the control panel.

6.4.2 Facility Design Requirements for Therapy X-ray Systems Capable of Operating Above 50 kVp.

6.4.2.1 Aural Communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel. However, where excessive noise levels or treatment requirements make aural communication impractical, other methods of communication shall be used.

6.4.2.2 Viewing Systems.

6.4.2.2.1 Windows, mirrors, closed circuit television, or an equivalent system 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.

6.4.2.2.2 When the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, shall be available for use in the event of failure of the primary viewing system.

6.4.2.2.3 Should both systems described in RHB 6.4.2.2.2 above fail or be inoperative, treatment shall not be performed with the unit until one of the systems is restored.

6.4.2.3 Barriers. With equipment operating at voltages above fifty kilovoltage peak (50 kVp), the required barriers shall be an integral part of the building.

6.4.2.4 Multiple Access. Treatment rooms to which access is possible through more than one entrance shall be provided with flashing warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "on." Interlocks shall be provided such that all entrance doors must be closed, including doors to any interior booths, before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel.

6.4.3 Additional Requirements for X-ray Systems Capable of Operating Above 150 kVp.

6.4.3.1 All protective barriers shall be fixed except for entrance doors or beam interceptors.

6.4.3.2 The control panel shall be within a protective booth equipped with an interlocked door or located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room.

6.4.3.3 Interlocks shall be provided such that all entrance doors must be closed, including doors to any interior booth, before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel.

6.4.3.4 When any door referred to in RHB 6.4.3.3 is opened while the x-ray tube is activated, the exposure at a distance of one meter (1 m) from the source shall be reduced to less than one hundred milliroentgen (100 mR) per hour.

6.4.3.5 A scram button or other emergency power cut-off switch shall be located and easily identifiable in all accessible high radiation areas.

6.4.3.6 All safety and warning devices, including interlocks, shall be tested and appropriately serviced after each five hundred (500) hours of operation or at intervals not to exceed six (6) months, whichever comes first. Documentation shall be kept and available for review of all testing and servicing.

6.4.4 Surveys, Calibrations, and Spot Checks.

6.4.4.1 Surveys.

6.4.4.1.1 All new facilities, and existing facilities not previously surveyed shall have a survey made by or under the direction of a qualified expert who is authorized by the Department to perform such surveys. Such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard. A record shall be made of the therapeutic operating conditions and radiation levels measured at specific control points. One (1) of these control points must be at the normal work station of the operator.

6.4.4.1.2 The registrant shall obtain a written report of the survey from the qualified expert. A copy of the initial report shall be transmitted by the registrant to the Department within thirty (30) calendar days of the first patient treatment following the survey. The registrant shall maintain all subsequent reports for inspection by the Department.

6.4.4.1.3 The survey and report shall indicate all instances where the installation, in the opinion of the qualified expert, is in violation of applicable rules or regulations.

6.4.4.1.4 The registrant shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by this regulation. Each radiation survey instrument shall meet the requirements of RHB 1.4.4.

6.4.4.2 Calibrations. Calibrations of x-ray systems subject to the requirements of this Part shall meet the following requirements:

6.4.4.2.1 The calibration of an x-ray system shall be performed at intervals not to exceed one (1) year and after any change or replacement of components which could cause a change in the radiation output on output.

6.4.4.2.2 The calibration of the radiation output of the x-ray system shall be performed by or under the direction of a radiological physicist who is physically present at the facility during such calibration.

6.4.4.2.3 Calibration of the radiation output of an x-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall meet the requirements of RHB 1.4.4.

6.4.4.2.4 The calibration shall be such that the dose at a reference point in a water or tissue equivalent phantom can be calculated to within an uncertainty of five percent (5%). For superficial units, free-in-air calibrations are acceptable.

6.4.4.2.5 The calibration of the x-ray system shall include, but not be limited to, the following determinations:

6.4.4.2.5.1 Verification that the x-ray system is operating in compliance with the design specifications;

6.4.4.2.5.2 Half-value layer for each kV setting and filter combination used;

6.4.4.2.5.3 The exposure rates as a function of field size, technique factors, filter, and treatment distance used; and

6.4.4.2.5.4 The degree of congruence between the radiation field and the field indicated by the localizing device if such device is present, which shall be within five millimeters (5 mm) for any field edge.

6.4.4.2.6 Records of calibrations shall be maintained by the registrant for five (5) years after completion of the calibration. The records shall be available for review.

6.4.4.2.7 A copy of the most recent x-ray system calibration shall be available at or in the general area of the control panel.

6.4.4.2.8 A copy of the most recent x-ray system calibration shall be submitted to the Department upon request.

6.4.4.3 Spot Checks. Spot checks shall be performed on x-ray systems capable of operation at greater than one hundred fifty kilovoltage peak (150 kVp). Such spot checks shall meet the following requirements:

6.4.4.3.1 The spot check procedures shall be in writing and shall have been developed by a radiological physicist. A copy of the procedures shall be submitted to the Department upon request.

6.4.4.3.2 If the radiological physicist does not perform the spot check measurement, the results of the spot check measurements shall be reviewed by the radiological physicist within seven (7) treatment days and a record made of the review.

6.4.4.3.3 The spot check procedures shall specify the frequency at which tests or measurements are to be performed. The spot check procedures shall specify that the spot check shall be performed during the calibration specified in RHB 6.4.4.2. The acceptable tolerance for each parameter measured in the spot check when compared to the value for that parameter determined in the calibration specified in RHB 6.4.4.2 shall be stated.

6.4.4.3.4 The written spot check procedures shall include special operating instructions which shall be carried out whenever a parameter in RHB 6.4.4.2 exceeds an acceptable tolerance.

6.4.4.3.5 Whenever a spot check indicates a significant change in the operating characteristics of a system, as specified in the spot check procedures, the system shall be recalibrated, as required in RHB 6.4.4.2.

6.4.4.3.6 Records of spot check measurements and any necessary corrective actions shall be maintained by the registrant for two (2) years after completion of the spot check measurements. A copy of the most recent spot check shall be available at or in the area of the control panel.

6.4.4.3.7 Where a spot check involves a radiation measurement, such measurement shall be obtained using a system satisfying the requirements of RHB 6.4.4.2.3 or which has been intercompared with a system meeting those requirements within the previous year.

6.4.4.4 Prohibited use. The x-ray system shall not be used in the administration of radiation therapy unless the requirements of RHB 6.4.4.2 and 6.4.4.3 have been met.

S.C. Code Regs. § 61-64.VI.RHB 6.4

Replaced and amended by State Register Volume 40, Issue No. 06, eff. 6/24/2016; State Register Volume 47, Issue No. 05, eff. 5/26/2023.