Section 410IAC5-6.1-124. Therapeutic x-ray systems operating at less than one MeV

 

                                (a) This section and 410 IAC 5-9, excluding 410 IAC 5-9-8(a), 410 IAC 5-9-10(a), 410 IAC 5-9-10(c), and 410 IAC 5-9-10(d), shall apply to medical facilities using therapeutic x-ray systems capable of operating at less than one (1) MeV.

                                (b) When the tube is operated at its leakage technique factors, leakage radiation shall not exceed the following:

(1) For contact therapy systems, one hundred (100) mR per hour at five (5) cm from the surface of the tube housing assembly.

(2) For systems capable of operating from zero (0) to one hundred fifty (150) kVp which are manufactured prior to June 25, 1978, one (1) roentgen per hour at one (1) meter from the source.

(3) For systems capable of operating from zero (0) to one hundred fifty (150) kVp which were manufactured on or after June 25, 1978, one hundred (100) mR per hour at one (1) meter from the source.

(4) For systems capable of operating from greater than one hundred fifty (150) to five hundred (500) kVp, one (1) roentgen per hour at one (1) meter from the source.

(5) For systems capable of operating in excess of five hundred (500) kVp, no more than one-tenth of one percent (0.1%) of the useful beam at one (1) meter from the source.

                                (c) 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.

                                (d) 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 original x-ray beam at the maximum kilovoltage 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 patient.

                                (e) Adjustable beam-limiting devices installed after June 25, 1978, shall comply with subsection (d). Adjustable beam-limiting devices installed before June 25, 1978, shall, for the portion of the x-ray beam to be blocked by such devices, transmit no more than five percent (5%) of the useful beam at the maximum kilovoltage and maximum treatment filter.

                                (f) The filter system shall be such that filters cannot be accidentally displaced from the useful beam at any possible tube orientation. Each filter shall be marked to identify its thickness and material of which it is constructed. For wedge filters, the wedge angle shall appear on the wedge or wedge tray. The radiation at five (5) cm from the filter insertion slot opening shall not exceed thirty (30) roentgens per hour at any operating condition.

                                (g) The tube housing assembly shall be capable of immobilization for stationary treatment. It shall be marked so that it is possible to determine the location of the focal spot to within five (5) mm. The marking shall be readily accessible for use during calibration procedures.

                                (h) Contact therapy system tube housing assemblies shall have a removable shield of at least five-tenths (0.5) mm lead equivalency at one hundred (100) kVp which can be positioned over the entire useful beam exit port during periods when the beam is not in use.

                                (i) Therapeutic x-ray systems capable of operating at greater than one hundred fifty (150) kVp, which were manufactured after June 25, 1978, shall be provided with a beam monitor system having the following capabilities:

(1) The system shall have the radiation detector of the monitoring system interlocked to prevent incorrect positioning.

(2) The system shall not allow irradiation until a value for exposure has been selected at the x-ray control panel.

(3) The system shall independently terminate irradiation when the selected exposure has been reached.

(4) The system shall be so designed that the dose administered to a patient prior to any system malfunction or power failure can be accurately determined.

(5) The system shall have a display at the x-ray control panel from which the dose at a reference point in the soft tissue can be calculated. This display must be intentionally reset to the zero (0) position.

(6) The system shall have a display at the x-ray control panel which does not have scale multiplying factors and utilizes a design such that increasing dose is displayed by increasing numbers.

                                (j) A timer shall be provided with a display at the x-ray control panel. The timer shall have a preset time selector and an elapsed time indicator. The timer shall be a cumulative timer which activates with the production of radiation and retains its readings after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator to the zero (0) position. The timer shall terminate irradiation when a preselected time has elapsed if any dose monitoring system present has not previously terminated irradiation. The timer shall permit accurate presetting and determination of exposure times as short as one (1) second. The timer shall not permit an exposure if set at the zero (0) position. When irradiation is controlled by a shutter mechanism, the timer shall not activate until the shutter is opened.

                                (k) The x-ray control panel shall be fitted with a device to terminate exposure at any time. In addition to displays required by other provisions of this section, the x-ray control panel shall indicate the following:

(1) When electrical power is available at the x-ray control panel.

(2) If activation of the x-ray tube is possible.

(3) When x-rays are being produced.

(4) kV and x-ray tube current.

For x-ray equipment manufactured after June 25, 1978, the x-ray control panel shall display specific filters in the beam.

                                (l) When an x-ray control panel may energize more than one (1) x-ray tube, it shall be possible to activate only one (1) x-ray tube at a time. The x-ray control panel shall identify which x-ray tube is energized, and the tube housing assembly shall also indicate when that tube is energized.

                                (m) There shall be means of determining the SSD to within one (1) cm.

                                (n) Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five (5) seconds, the beam shall be automatically attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. After the system is at operating parameters, the shutter shall be controlled electrically by the operator from the x-ray control panel. The x-ray control panel shall indicate the shutter position.

                                (o) Each x-ray system equipped with a beryllium or other low filtration window shall be clearly labeled as such upon the tube housing assembly and at the x-ray control panel.

                                (p) Facilities which will house therapeutic x-ray systems capable of operating at fifty (50) kVp or more shall comply with the following:

(1) Provision shall be made for verbal communication between the patient and the operator at the x-ray control panel. However, where treatment requirements or excessive noise levels make verbal communication impractical, other effective methods of communication shall be utilized.

(2) 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 x-ray control panel.

(3) When the primary viewing system is electronic, an alternate viewing system shall be available for use in the event of failure of the primary viewing system. The alternate viewing system may also be electronic. In the event of failure of both viewing systems, the therapeutic x-ray system shall not be used to irradiate patients until one (1) of the viewing systems is again fully operational.

                                (q) Facilities which will house therapeutic x-ray systems capable of operating at one hundred fifty (150) kVp or more shall comply with subsection (o) and the following:

(1) All protective barriers shall be fixed, except for entrance doors or beam interceptors.

(2) The x-ray control panel shall be located outside the treatment room.

(3) Interlocks shall be provided such that all treatment room entrances must be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to continue irradiation without closing all entrance doors and manually reinitiating irradiation at the x-ray control panel.

(4) When any door referred to in subdivision (3) is opened while the x-ray tube is activated, the exposure one (1) meter from the source shall be reduced to less than one hundred (100) mR per hour.

                                (r) Registrants shall have all new therapeutic x-ray facilities, and existing facilities not previously surveyed, surveyed by a radiation oncology physicist approved by the department. Such surveys shall also be performed after any change in the facility or equipment which might cause a significant increase in radiation hazard. The survey shall be done before the therapeutic x-ray system is used for therapeutic purposes, and an evaluation report, including all violations of this rule on a form acceptable to the commissioner, must be completed by the radiation oncology physicist and a copy forwarded to the registrant and to the commissioner within thirty (30) days of receipt of the completion of the survey. The survey and report shall indicate all locations where the dose equivalent rate exceeds the limits specified in this rule.

                                (s) The registrant shall establish procedures to check all timer calculations by an independent method or by a second individual before administering thirty percent (30%) of the prescribed total dose, to assure that the given dose agrees with the manual or computer generated dose calculation, and with the written order of a practitioner of the healing arts. Additionally, the registrant shall verify that the correct beam filtration and cone factors are used and documented.

                                (t) Calibration of therapeutic x-ray systems subject to this section shall be performed before the system is first used for irradiation of an individual and thereafter at time intervals not to exceed twelve (12) months. Calibrations shall be also be performed after any change which might significantly alter the beam energy, spatial distribution, or other output characteristics of the therapy beam. Calibration shall be performed by a radiation oncology physicist approved by the department, who is physically present at the facility. Radiation measurements conducted during calibrations required by this subsection shall be performed using a dosimetry system which complies with the following:

(1) The dosimetry system shall have an air-kerma or exposure calibration factor traceable to the National Institute for Standards and Technology.

(2) The dosimetry system shall have been calibrated within the previous two (2) years and after any servicing that may have affected its calibration. The system shall have been calibrated in such a fashion that an uncertainty can be stated for the radiation output measured by the system. The dosimetry system shall have had constancy checks performed on the system as specified by a radiation oncology physicist. Calibration shall be in sufficient detail that the dose at a reference point in soft tissue may be calculated with a maximum uncertainty of five percent (5%).

(3) Calibration of each therapy beam shall include, but not be limited to, the output, half-value layer, and cone factors. Records of calibration measurements and dosimetry system calibrations conducted in accordance with this subsection shall be maintained by the registrant for at least five (5) years after completion of such calibration.

                                (u) An independent check of the output of a therapeutic x-ray system shall be performed annually. The check shall be performed by either of the following:

(1) A radiation oncology physicist approved by the department, other than the one who performed the annual output calibration, using a dosimetry system other than the one that was used during said annual calibration. The dosimetry system must also comply with subsection (t).

(2) A thermoluminescence dosimetry service capable of measuring doses with an accuracy of five percent (5%) or less.

                                (v) Output spot checks shall be performed on therapeutic x-ray systems during spot checks conducted in accordance with subsection (t), and thereafter at intervals not to exceed one (1) month, by a radiation oncology physicist approved by the department. Output spot check procedures shall be in writing and shall have been developed by a radiation oncology physicist approved by the department. Output spot check procedures shall specify:

(1) which tests or measurements are to be performed;

(2) the frequency the tests or measurements are to be performed;

(3) the acceptable tolerance for each parameter measured compared to the value for that parameter as determined in the last calibration conducted in accordance with subsection (t); and

(4) the action to be taken if a tolerance has been exceeded for any test or measurement required by the written output spot check procedures.

If an output spot check conducted in accordance with this subsection indicates a variance of more than five percent (5%) in output per timer unit compared to the value determined in the last spot check conducted under this subsection, the radiation oncology physicist shall calibrate the therapeutic x-ray system. Records of each output spot check measurement conducted in accordance with this subsection shall be maintained by the registrant for a minimum of five (5) years from the date the output calibration was performed.

                                (w) The registrant shall perform weekly output constancy checks on each of their therapeutic x-ray systems in accordance with written output constancy check procedures developed by a radiation oncology physicist approved by the department. The output constancy check procedures shall specify:

(1) the tests or measurements to be performed;

(2) the acceptable tolerance for each parameter measured compared to the value for that parameter as determined in the last calibration conducted in accordance with subsection (t); and

(3) the action to be taken if a tolerance has been exceeded for a test or measurement required by the written output constancy check procedures.

At least monthly, a radiation oncology physicist approved by the department shall review the results of all required output constancy checks performed since his or her last such review. If an output constancy check conducted in accordance with this subsection indicates a variance of more than five percent (5%) in output per timer unit compared to the value determined in the last calibration conducted in accordance with subsection (t), the registrant shall repair the therapeutic x-ray system or undertake other corrective action before the equipment is again used to irradiate patients. The registrant shall also perform an output constancy check to determine whether or not the therapeutic x-ray system is again in compliance with this subsection prior to utilizing the equipment to irradiate patients. A record of each output constancy check performed in accordance with this subsection, and any repairs or corrective action undertaken in compliance with this subsection, shall be maintained by the registrant for a minimum of two (2) years from the date the output constancy check, repair, or corrective action was performed.

                                (x) The registrant shall perform checks on treatment planning computers and dose calculation algorithms in accordance with written quality assurance procedures developed by a radiation oncology physicist approved by the department. At a minimum, the written quality assurance procedures shall require that the registrant do the following:

(1) Ensure that any computer software changes, including beam data files, have been correctly implemented without corrupting beam data.

(2) Verify that all users of treatment planning computers have been trained in the use of the computers.

                                (y) The registrant shall establish and maintain a written quality management plan to assure that radiation from an x-ray therapy system is administered as ordered by a practitioner of the healing arts. At a minimum, a quality management plan must assure all of the following:

(1) Prior to administration, a written order for therapeutic radiation must be prepared by a practitioner of the healing arts. The order shall specify, at a minimum, the following:

(A) The patient's name.

(B) The anatomical treatment site or sites.

(C) For each treatment site, the following:

(i) Beam energy.

(ii) HVL.

(iii) The dose per fraction.

(iv) The number of fractions.

(v) The total dose.

If, in the opinion of a practitioner of the healing arts, any delay could jeopardize the health of a patient, the practitioner may verbally order therapeutic radiation, as long as the practitioner prepares a written order in accordance with this subdivision, to confirm his or her verbal orders, within seventy-two (72) hours of issuing the verbal order.

(2) Treatment plans and related calculations for radiation are in accordance with the written order of a practitioner of the healing arts.

(3) Each administration of therapeutic radiation is in accordance with a written order of a practitioner of the healing arts.

(4) Any deviation from the written order of a practitioner of the healing arts in excess of ten percent (10%) of the daily prescribed dose is identified, evaluated, and the findings communicated to the practitioner of the healing arts.

                                (z) The registrant shall review the radiation oncology chart of patients subjected to irradiation from a therapeutic x-ray system in accordance with written quality assurance procedures developed by a radiation oncology physicist approved by the department. At a minimum, the written quality assurance procedures shall require the following:

(1) The documented timer settings used for each field is [sic., are] in conformance with the calculations.

(2) The therapeutic x-ray system operator initials the treatment documentation for each patient he or she treats, each day.

(3) The daily radiation dose and the cumulative radiation dose are recorded.

(4) Each written order for therapy treatment is being followed.

(5) The total prescribed dose for each treatment site is appropriately indicated.

                                (aa) The registrant shall submit a written report to the commissioner of any misadministration within fifteen (15) days of discovery of the misadministration. The report shall:

(1) state the name and address of the registrant;

(2) state the name of the practitioner of the healing arts who prescribed the x-ray therapy at issue;

(3) state the name of the individual who was improperly irradiated or the name of that individual's parent or guardian, if applicable;

(4) briefly describe the nature of the misadministration and any resultant effect on the individual who was improperly irradiated;

(5) describe the actions taken by the registrant to prevent a recurrence of similar misadministrations; and

(6) state what information has been presented to the individual who was improperly irradiated, or to that individual's parent or guardian, if applicable.

A copy of the report shall be maintained by the registrant for at least five (5) years after the date of the misadministration.

                                (bb) If possible, within twenty-four (24) hours of discovery of a misadministration, the registrant shall notify the individual who has been improperly irradiated, or that individual's parent or guardian, if applicable, about the misadministration, unless, in the opinion of a practitioner of the healing arts, such notification would be harmful to that individual. Also, within twenty-four (24) hours of discovery of a misadministration, the registrant shall notify the referring practitioner of the healing arts about the misadministration. At a minimum, the notification shall briefly describe the nature of the misadministration and any resultant effect on the individual who was improperly irradiated.

                                (cc) Therapeutic x-ray systems shall not be left unattended unless the system or the treatment room door is secured against unauthorized use.

                                (dd) When a patient must be held in position for radiation therapy, mechanical supports or restraining devices shall be used.

                                (ee) The tube housing assembly shall not be held by hand during operation unless the system is designed to require holding and the kVp of the system does not exceed fifty (50) kVp. In such cases, the holder shall wear protective gloves and an apron of not less than five-tenths (0.5) mm lead equivalency at one hundred (100) kVp.

                                (ff) No individual other than the patient shall be in the treatment room during exposures from therapeutic x-ray systems unless such individual is shielded by protective barriers sufficient to reduce their exposure to no more than that allowed by 410 IAC 5-4-2. No individual other than the patient shall be in the treatment room during exposures from therapeutic x-ray systems operating above one hundred fifty (150) kVp.

                                (gg) A therapeutic x-ray system shall not be used to administer radiation therapy unless it complies with subsections (t), (v), and (w). (Indiana State Department of Health; 410 IAC 5-6.1-124; filed Oct 29, 1993, 5:00 p.m.: 17 IR 379; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA)