Iowa Admin. Code r. 641-41.3

Current through Regsiter Vol. 46, No. 26, June 12, 2024

Rule 641-41.3 - Therapeutic use of radiation machines

(1) Scope and applicability.

a. This subrule establishes requirements, for which the registrant is responsible, for use of therapeutic radiation machines.

b. The use of therapeutic radiation machines shall be by, or under the supervision of, a physician who meets the training/experience criteria established by 41.3(5).

c. Unless specifically required otherwise by 641-41.3 (136C), all registrants are subject to the requirements of 641-Chapters 38 to 40.

(2) Definitions. In addition to the definitions provided in 641-38.2 (136C) and 641-40.2 (136C), the following definitions are specific to 641-41.3 (136C).

"Accessible surface " means surface of equipment or of an equipment part that can be easily or accidentally touched by persons without the use of a tool.

Added filtration" means any filtration which is in addition to the inherent filtration.

"Beam-limiting device" means a field defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimensions of the useful beam.

"Beam-scattering foil" means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

"Bent beam linear accelerator" means a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.

"Contact therapy system " means a therapeutic radiation machine with a short target-to-skin distance (TSD), usually less than 5 centimeters.

"Dose monitor unit (DMU) " means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

"External beam radiation therapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

"Field flattening filter " means a filter used to homogenize the absorbed dose rate over the radiation field.

"Filter " means material placed in the useful beam to change beam quality or its intensity profile in therapeutic radiation machines.

"Gantry " means that part of a radiation therapy system supporting and allowing movements of the radiation head around a center of rotation.

"Interruption of irradiation" means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

"Isocenter" means the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.

"Megavolt (MV) (mega electron volt (MeV)) " means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of 1 million volts in a vacuum. (Note: Current convention is to use MV for photons and MeV for electrons.)

"Monitor unit (MU). " See "Dose monitor unit."

"Moving beam radiation therapy " means radiation therapy with continuous displacement of one or more mechanical axes relative to the patient during irradiation. It includes arc therapy, skip therapy, conformal therapy, intensity modulation, and rotational therapy.

"Nominal treatment distance" means:

1. For electron irradiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.

2. For X-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For nonisocentric equipment, this distance shall be that specified by the manufacturer.

"Periodic quality assurance check" means a procedure which is performed to ensure that a previous calibration continues to be valid.

"Practical range of electrons" corresponds to classical electron range where the only remaining contribution to dose is from bremsstrahlung X-rays. A further explanation may be found in "Clinical Electron Beam Dosimetry: Report of AAPM Radiation Therapy Committee Task Group 25" (Medical Physics 18(1): 73-109, Jan/Feb 1991) and ICRU Report 35, "Radiation Dosimetry: Electron Beams with Energies Between 1 and 50 MeV," International Agency on Radiation Units and Measurements, September 15, 1984.

"Radiation field. " See "Useful beam."

"Radiation head" means the structure from which the useful beam emerges.

"Radiation therapy physicist" means an individual qualified in accordance with 41.3(6).

"Redundant beam monitoring system " means a combination of two dose monitoring systems in which each system is designed to terminate irradiation in accordance with a preselected number of dose monitor units.

"Shadow tray" means a device attached to the radiation head to support auxiliary beam blocking material.

"Stationary beam radiation therapy " means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.

"Target" means that part of an X-ray tube or accelerator onto which is directed a beam of accelerated particles to produce ionizing radiation or other particles.

"Tenth-value layer (TVL) " means the thickness of a specified material which attenuates X-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point.

"Therapeutic radiation machine " means X-ray or electron-producing equipment designed and used for external beam radiation therapy.

"Virtual source " means a point from which radiation appears to originate.

(3) Registration or license requirements. No person shall receive, possess, use, transfer, own, or acquire therapeutic radiation machines except as authorized in a registration issued pursuant to 641-39.1 (136C) to 39.4(136C).

(4) General administrative requirements for facilities using therapeutic radiation machines.

a. Administrative controls. The registrant shall be responsible for directing the operation of the therapeutic radiation machines which have been registered with the agency. The registrant or the registrant's agent shall ensure that the requirements of 41.3(136C) are met in the operation of the therapeutic radiation machine(s).

b. A therapeutic radiation machine which does not meet the provisions of these regulations shall not be used for irradiation of patients unless authorized by the agency.

(5) Training for external beam radiation therapy authorized users. The registrant for any therapeutic radiation machine subject to 41.3(17) or 41.3(18) shall require the authorized user to be a physician who:

a. Is certified in:

(1) Radiology or therapeutic radiology by the American Board of Radiology; or

(2) Radiation oncology by the American Osteopathic Board of Radiology; or

(3) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

(4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

b. Is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, 500 hours of supervised work experience, and a minimum of three years of supervised clinical experience.

c. To satisfy the requirement for instruction in 41.3(5)"b " above, the classroom and laboratory training shall include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of ionization radiation; and

(4) Radiation biology.

d. To satisfy the requirement for supervised work experience in 41.3(4)"b " above, training shall be under the supervision of an authorized user and shall include:

(1) Reviewing the full calibration measurements and periodic quality assurance checks;

(2) Evaluating prepared treatment plans and calculation of treatment times/patient treatment settings;

(3) Using administrative controls to prevent misadministrations;

(4) Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and

(5) Checking and using radiation survey meters.

e. To satisfy the requirement for a period of supervised clinical experience, training shall include one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include:

(1) Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications;

(2) Selecting proper dose and how it is to be administered;

(3) Calculating the external beam radiation therapy doses and collaborating with the authorized user in the review of patients' progress; consideration of the need to modify originally prescribed doses or treatment plans as warranted by patients' reaction to radiation; and

(4) Postadministration follow-up and review of case histories.

f. Notwithstanding the requirements of 41.3(5)"b, " the registrant for any therapeutic radiation machine subject to 41.3(17) and 41.3(18) may also submit the training of the prospective authorized user physician for agency review.

g. A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician's training has been reviewed and approved by the registrant.

(6) Training for radiation therapy physicist. The registrant for any therapeutic radiation machine subject to 41.3(17) or (18) shall require the radiation therapy physicist to:

a. Be registered with the agency, under the provisions of 641-subrule 39.3(3) of these regulations, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and

b. Be certified by the American Board of Radiology in:

(1) Therapeutic radiological physics; or

(2) Roentgen-ray and gamma-ray physics; or

(3) X-ray and radium physics; or

(4) Radiological physics; or

(5) Therapeutic medical physics; or

c. Be certified by the American Board of Medical Physics in radiation oncology physics; or

d. Be certified by the Canadian College of Physicists in Medicine; or

e. Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full-time training in therapeutic radiological physics and also one year of full-time work experience under the supervision of a radiation therapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in 41.3(16)"a, "41.3(17)"c" and"d, " and 41.3(18)"e" and"f" under the supervision of a radiation therapy physicist during the year of work experience.

f. Rescinded IAB 4/3/02, effective 5/8/02.

(7) Qualifications of operators. Individuals who will be operating a therapeutic radiation machine for medical use shall be adequately instructed in the safe operating procedures and hold a current permit to practice in radiation therapy as a radiation therapist under the provisions of 641-Chapter 42. The permit holder shall make the permit available at the individual's place of employment. If the permit holder works at more than one facility, a duplicate of the permit shall be kept at each facility.

(8) Written safety procedures and rules shall be developed by a radiation therapy physicist and shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules. All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with procedures for maintaining written directives.

(9) Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a physician. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing arts purposes.

(10) Records of visiting authorized users. Notwithstanding the provisions of 41.3(5), a registrant may permit any physician to act as a visiting authorized user for up to 60 days per calendar year under the following conditions:

a. The visiting authorized user has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's radiation safety committee;

b. The visiting authorized user meets the requirements of 41.3(5); and

c. The registrant maintains copies of all records specified in 41.3(5) for five years from the date of the last visit.

(11) Information and maintenance record and associated information. The registrant shall maintain the following information in a separate file or package for each therapeutic radiation machine for inspection by the agency:

a. Report of acceptance testing;

b. Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by 41.3(136C), as well as the name(s) of person(s) who performed such activities;

c. Records of maintenance or modifications, or both, performed on the therapeutic radiation machine after July 9, 1997, as well as the name(s) of person(s) who performed such services;

d. Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.

e. Records of training specified in 41.3(5) and 41.3(6).

(12) Records retention. All records required by 641-41.3 (136C) shall be retained until disposal is authorized by the agency unless another retention period is specifically authorized in 41.3(136C). All required records shall be retained in an active file from at least the time of generation until the next agency inspection. Any required record generated before the last agency inspection may be microfilmed or otherwise archived as long as a complete copy can be retrieved until such time the agency authorizes final disposal.

(13) Form of records. Rescinded IAB 4/5/00, effective 5/10/00.

(14) Written directives. Each registrant shall meet the following:

a. A written directive must be dated and signed by an authorized user prior to the administration of radiation.

(1) If, because of the patient's condition, a delay in the order to provide a written revision to an existing directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in writing in the patient's record and a revised written directive is signed by an authorized user within 48 hours of the oral revision.

(2) The written directive must contain the patient or human research subject's name, the type and energy of the beam, the total dose, dose per fraction, treatment site, and number of fractions.

(3) A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the external beam dose, or the next fractional dose.

(4) The registrant shall retain a copy of the written directive for three years.

b. Procedures for administration. The registrant shall have written procedures that provide the following information:

(1) Prior to the administration of each course of radiation treatment, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive;

(2) Each administration is in accordance with the written directive;

(3) External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written directives by:

1. Checking both manual and computer-generated dose calculations to verify that they are correct and in accordance with the written directive; and

2. Verifying that any computer-generated calculations are correctly transferred into the consoles of authorized therapeutic medical units;

(4) Any unintended deviation from the written directive is identified, evaluated and appropriate action is taken; and

(5) The registrant retains a copy of the procedures for administrations for the duration of the registration.

(15) Reports and notifications of misadministrations.

a. A registrant shall report any event resulting from intervention of a patient or human research subject in which the administration of external beam radiation results, or will result, in unintended permanent functional damage to an organ or a physiological system as determined by a physician.

b. Other than events that result from intervention by a patient or human research subject, a registrant shall report any event in which the administration of an external beam radiation therapy dose results in:

(1) A dose that differs from the prescribed dose by more than 5 rem (0.05 sievert) effective dose equivalent, 50 rem (0.5 sievert) to an organ or tissue, or 50 rem (0.5 sievert) shallow dose equivalent to the skin, and either:

1. The total dose delivered differs from the prescribed dose by 20 percent or more; or

2. The fractionated dose delivered differs from the prescribed dose for a single fraction by 50 percent or more.

(2) A dose that exceeds 5 rem (0.05 sievert) effective dose equivalent, 50 rem (0.5 sievert) to an organ or tissue, or 50 rem (0.5 sievert) shallow dose equivalent to the skin from either of the following:

1. An administration of the wrong treatment modality;

2. An administration to the wrong individual or human research subject.

(3) A dose to the skin or an organ or tissue other than the treatment site that exceeds by 50 rem (0.5 sievert) to an organ or tissue and 50 percent or more of the dose expected from the administration defined in the written directive.

c. The registrant shall notify the agency by telephone no later than the next calendar day after the discovery of a misadministration.

d. The registrant shall submit a written report to the agency within 15 days after the discovery of a misadministration. The written report shall include:

(1) The registrant's name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect, if any, on the individual or individuals who received the misadministration;

(6) Actions, if any, that have been taken, or are planned, to prevent recurrence;

(7) Certification that the registrant notified the individual or the individual's responsible relative or guardian, and if not, why not.

e. The report to the agency shall not contain the individual's name or any other information that could lead to the identification of the individual.

f. The registrant shall provide notification of the event to the referring physician and also notify the individual who is the subject of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that the referring physician will inform the individual or that, based on medical judgment, the physician's telling the individual would be harmful. The registrant is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the registrant shall notify the individual as soon as possible thereafter. The registrant may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the misadministration may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the registrant shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event may be obtained from the registrant upon request. The registrant shall provide such a written description if requested.

g. Aside from the notification requirement, nothing in this subrule affects any rights or duties of registrants and physicians in relation to each other, to individuals affected by the misadministration, or to individuals' responsible relatives or guardians.

h. A copy of the record required in this subrule shall be provided to the referring physician, if other than the registrant, within 15 days after discovery of the misadministration.

i. Records of misadministrations. A registrant shall retain a record of misadministrations reported in this subrule for three years. The record must contain the following:

(1) The registrant's name and the names of the individuals involved;

(2) The social security number or other identification number, if one has been assigned, of the individual who is the subject of the misadministration;

(3) A brief description of the event; why it occurred; and the effect, if any, on the individual;

(4) The actions, if any, taken or planned to prevent recurrence; and

(5) Whether the registrant notified the individual or the individual's responsible relative or guardian, and, if not, whether such failure to notify was based on guidance from the referring physician.

(16) General technical requirements for facilities using therapeutic radiation machines.

a. Protection surveys.

(1) The registrant shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed, are performed with an operable radiation measurement survey instrument calibrated within the past 12 months. The radiation protection survey shall be performed by, or under the direction of, a radiation therapy physicist or a certified health physicist and shall verify that, with the therapeutic radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation:

1. Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in 641-subrule 40.15(1); and

2. Radiation levels in unrestricted areas do not exceed the limits specified in 641-paragraphs 40.26(1)"a" and"b."

(2) In addition to the requirements of 41.3(16)"a"(1), a radiation protection survey shall also be performed prior to any subsequent medical use and:

1. After making any change in the treatment room shielding;

2. After making any change in the location of the therapeutic radiation machine within the treatment room;

3. After relocating the therapeutic radiation machine; or

4. Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.

(3) The survey record shall indicate all instances where the facility, in the opinion of the radiation therapy physicist or a certified health physicist, is in violation of applicable regulations. The survey record shall also include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the therapeutic radiation machine, the instrument(s) used to measure radiation levels, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in microsieverts or millirems per hour, the calculated maximum level of radiation over a period of one week for each restricted and unrestricted area, and the signature of the individual responsible for conducting the survey.

(4) If the results of the surveys required by 41.3(16)"a "(1) or (2) indicate any radiation levels in excess of the respective limit specified in 41.3(16)"a"(1), the registrant shall lock the control in the "OFF" position and not use the unit:

1. Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or

2. Until the registrant has received a specific exemption in writing from the agency.

b. Modification of radiation therapy unit or room before beginning a treatment program. If the survey required by 41.3(16)"a" indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 641-paragraphs 40.26(1) "a" and"b, " before beginning the treatment program the registrant shall:

(1) Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 641-paragraphs 40.26(1)"a" and"b";

(2) Perform the survey required by 41.3(16)"a" again; and

(3) Include in the report required by 41.3(16)"d" the results of the initial survey, a description of the modification made to comply with 41.3(5)"b "(1), and the results of the second survey; or

(4) Request and receive written authorization from the agency that authorizes radiation levels in unrestricted areas greater than those permitted by 641-paragraphs 40.26(1)"a" and"b. "

c. Dosimetry equipment.

(1) The registrant shall have a calibrated dosimetry system available for use. The system shall have been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL). The calibration shall have been performed within the previous 24 months and after any servicing that may have affected system calibration.

1. For beams with energies greater than 1 MV (1 MeV), the dosimetry system shall have been calibrated for Cobalt-60.

2. For beams with energies equal to or less than 1 MV (1 MeV), the dosimetry system shall have been calibrated at an energy (energy range) appropriate for the radiation being measured.

(2) The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with 41.3(16)"c"(1). This comparison shall have been performed within the previous 12 months and after each servicing that may have affected system calibration. The quality assurance check system maybe the same system used to meet the requirement in 41.3(16)"c"(1).

(3) The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the license or registration. For each calibration, intercomparison, or comparison, the record shall include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 41.3(16)"c"(1) and (2), the correction factors that were determined, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a radiation therapy physicist.

d. Reports of external beam radiation therapy surveys and measurements. The registrant for any therapeutic radiation machine subject to 41.3(17) or 41.3(18) shall furnish a copy of the records required in 41.3(16) "a" and"b" to the agency within 30 days following completion of the action that initiated the record requirement.

(17) Therapeutic radiation machines of less than 500 kV.

a. Equipment requirements.

(1) Leakage radiation. When the X-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapeutic radiation machine:

1. 5-50 kV systems. The leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly shall not exceed 100 mrad (1 mGy) in any one hour.

2. >50 and <500 kV systems. The leakage air kerma rate measured at a distance of one meter from the target in any direction shall not exceed 1 rad (1 cGy) in any one hour. This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters. In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly shall not exceed 30 rad (30 cGy) per hour.

3. For each therapeutic machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at positions specified in 41.3(17) "a"(1)"1" and 41.3(17) "a"(1)"2"for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the facility for inspection by the agency.

(2) Permanent beam-limiting devices. Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.

(3) Adjustable or removable beam-limiting devices.

1. All adjustable or removable beam-limiting devices, diaphragms, cones or blocks shall not transmit more than 5 percent of the useful beam for the most penetrating beam used;

2. When adjustable beam-limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.

(4) Filter system. The filter system shall be so designed that:

1. Filters cannot be accidentally displaced at any possible tube orientation;

2. For equipment installed after July 9,1997, an interlock system prevents irradiation if the proper filter is not in place;

3. The air kerma rate escaping from the filter slot shall not exceed 1 rad (1 cGy) per hour at one meter under any operating conditions; and

4. Each filter shall be marked as to its material of construction and its thickness.

(5) Tube immobilization.

1. The X-ray tube shall be so mounted that it cannot accidentally turn or slide with respect to the housing aperture; and

2. The tube housing assembly shall be capable of being immobilized for stationary portal treatments.

(6) Source marking. The tube housing assembly shall be so marked that it is possible to determine the location of the source to within 5 millimeters, and such marking shall be readily accessible for use during calibration procedures.

(7) Beam block. Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.

(8) Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a preset time interval.

1. A timer which has a display shall be provided at the treatment control panel. The timer shall have a preset time selector and an elapsed time or time remaining indicator;

2. The timer shall be a cumulative timer which activates with an indication of "BEAM-ON" and retains its reading 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;

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

4. The timer shall permit accurate presetting and determination of exposure times as short as one second;

5. The timer shall not permit an exposure if set at zero;

6. The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and

7. Timer shall be accurate to within 1 percent of the selected value or one second, whichever is greater.

(9) Control panel functions. The control panel, in addition to the displays required by other provisions in 41.3(6), shall have:

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

2. An indication of whether X-rays are being produced;

3. Means for indicating X-ray tube potential and current;

4. The means for terminating an exposure at any time;

5. A locking device which will prevent unauthorized use of the therapeutic radiation machine; and

6. For therapeutic radiation machines manufactured after July 9, 1997, a positive display of specific filter(s) in the beam.

(10) Multiple tubes. When a control panel may energize more than one X-ray tube:

1. It shall be possible to activate only one X-ray tube at any time;

2. There shall be an indication at the control panel identifying which X-ray tube is activated; and

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

(11)Target-to-skin distance (TSD). There shall be a means of determining the central axis TSD to within one centimeter and of reproducing this measurement to within two millimeters thereafter.

(12)Shutters. Unless it is possible to bring the X-ray output to the prescribed exposure parameters within five seconds after the X-ray "ON" switch is energized, the beam shall be attenuated by a shutter(s) having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter(s) shall be controlled by the operator from the control panel. An indication of shutter position shall appear at the control panel.

(13) Low filtration X-ray tubes. Each therapeutic radiation machine equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.

b. Facility design requirements for therapeutic radiation machines capable of operating in the range 50 kV to 500 kV. In addition to shielding adequate to meet requirements of 41.3(19), the treatment room shall meet the following design requirements:

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

(2) Viewing systems. Provision shall be made to permit continuous observation of the patient during irradiation and the viewing system shall be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational.

(3) Additional requirements. Treatment rooms which contain a therapeutic radiation machine capable of operating above 150 kV shall meet the following additional requirements:

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

2. The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room;

3. Interlocks shall be provided such that all entrance doors, including doors to any interior booths, shall 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 restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and

4. When any door referred to in 41.3(17) "b"(3)"3" is opened while the radiation machine is activated, the air kerma rate at a distance of one meter from the source shall be reduced to less than 1 mGy (100 mrad) per hour.

c. Full calibration measurements.

(1) Full calibration of a therapeutic radiation machine subject to 41.3(17) shall be performed by, or under the direct supervision of, a radiation therapy physicist:

1. Before the first medical use following installation or reinstallation of the therapeutic radiation machine;

2. At intervals not exceeding one year; and

3. Before medical use under the following conditions:

* Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled; and

* Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.

4. Notwithstanding the requirements of 41.3 (17)"c "( 1):

* Full calibration of therapeutic radiation machines with multienergy capabilities is required only for those modes or energies that are not within their acceptable range; and

* If the repair, replacement or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in 41.3(17)"b "(3).

(2) To satisfy the requirement of 41.3(17)"c"(1), full calibration shall include all measurements recommended for annual calibration by NCRP Report 69, "Dosimetry of X-ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV" (1981).

(3) The registrant shall maintain a record of each calibration for the duration of the registration. The record shall include the date of the calibration, the manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the X-ray tube, the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine, and the signature of the radiation therapy physicist responsible for performing the calibration.

d. Periodic quality assurance checks.

(1) Periodic quality assurance checks shall be performed on therapeutic radiation machines, subject to 41.3(17), which are capable of operation at greater than or equal to 50 kV.

(2) To satisfy the requirement of 41.3(17)"d"(1), quality assurance checks shall meet the following requirements:

1. The registrant shall perform quality assurance checks in accordance with written procedures established by the radiation therapy physicist; and

2. The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in 41.3(17)"c"(1). The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in 41.3(17)"c"(1), shall be stated.

(3) The cause for a parameter exceeding a tolerance set by the radiation therapy physicist shall be investigated and corrected before the system is used for patient or human research subject irradiation;

(4) Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the radiation therapy physicist's quality assurance check procedures, the system shall be recalibrated as required in 41.3(17)"c"(1);

(5) The registrant shall use the dosimetry system described in 41.3(16)"c"(2) to make the quality assurance check required in 41.3(17) "d";

(6) The registrant shall have the radiation therapy physicist review and sign the results of each radiation output quality assurance check within one month of test completion;

(7) The registrant shall ensure that safety quality assurance checks of therapeutic radiation machines subject to 41.3(17) are performed at intervals not to exceed one month;

(8) Notwithstanding the requirements of 41.3(17)"d"(6) and (7), the registrant shall ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by 41.3(17)"d"(6) and (7) have been performed within the 30 days prior to administration;

(9) To satisfy the requirement of 41.3(17)"d"(7), safety quality assurance checks shall ensure proper operation of:

1. Electrical interlocks at each external beam radiation therapy room entrance;

2. The "BEAM-ON" and termination switches;

3. Beam condition indicator lights on the access door(s), control console, and in the radiation therapy room;

4. Viewing systems;

5. If applicable, electrically operated treatment room doors from inside and outside the treatment room.

(10) The registrant shall maintain a record of each quality assurance check required by 41.3(17)"d"(1) and (7) for three years. The record shall include the date of the quality assurance check, the manufacturer's name, model number, and serial number for the therapeutic radiation machine, the manufacturer's name, model number and serial number of the instrument(s) used to measure the radiation output of the therapeutic radiation machine, and the signature of the individual who performed the periodic quality assurance check.

e. Operating procedures.

(1) Therapeutic radiation machines shall not be left unattended unless secured by means identified in 41.3(17) "a"(9)"5";

(2) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;

(3) The tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed 50 kV. In such cases, the holder shall wear protective gloves and apron of not less than 0.5 millimeters lead equivalency at 100 kV;

(4) A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and

(5) No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV. At energies less than or equal to 150 kV, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of 641-40.26 (136C).

(6) The therapeutic radiation machine shall not be used for irradiation of patients unless the requirements of 41.3(17)"c" and"d" have been met.

f. Possession of survey instrument(s). Each facility location authorized to use a therapeutic radiation machine in accordance with 41.3(17) shall have at its disposal appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 mrem (10 µSv) per hour to 1000 mrem (10 mSv) per hour. The survey instrument(s) shall be operable and calibrated at intervals not to exceed 12 months for the radiation measured.

(18) Therapeutic radiation machines-photon therapy systems (500 kV and above) and electron therapy systems (500 keV and above).

a. Equipment requirements.

(1) Leakage radiation outside the maximum useful beam in photon and electron modes.

1. The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum-sized useful beam, but within a circular plane of radius two meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e., patient plane), shall not exceed a maximum of 0.2 percent and an average of 0.1 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane;

2. Except for the area defined in 41.3(18) "a"(1)"1," the absorbed dose due to leakage radiation (excluding neutrons) at one meter from the electron path between the electron source and the target or electron window shall not exceed 0.5 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding 100 square centimeters;

3. For equipment manufactured after July 9, 1997, the neutron absorbed dose outside the useful beam shall be in compliance with International Electrotechnical Agency (IEC) Document 601-2-1 (most current revision); and

4. For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in 41.3(18) "a"(1)"1" to "3" for the specified operating conditions. Records of leakage radiation measurements shall be maintained for inspection by the agency.

(2) Leakage radiation through beam-limiting devices.

1. Photon radiation. All adjustable or interchangeable beam-limiting devices shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam-limiting device(s) shall not exceed 2 percent of the maximum absorbed dose on the central axis of the useful beam measured in a 10-centimeter by 10-centimeter radiation field;

2. Electron radiation. All adjustable or interchangeable electron applicators shall attenuate the radiation including, but not limited to, photon radiation generated by electrons incident on the beam-limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance shall not exceed:

* A maximum of 2 percent and average of 0.5 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line seven centimeters outside the periphery of the useful beam; and

* A maximum of 10 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line two centimeters outside the periphery of the useful beam.

(3) Measurement of leakage radiation.

1. Photon radiation. Measurements of leakage radiation through the beam-limiting devices shall be made with the beam-limiting devices closed and any residual aperture blocked by at least two-tenth value layers of suitable absorbing material. In the case of overlapping beam-limiting devices, the leakage radiation through each set shall be measured independently at the depth of maximum dose. Measurements shall be made using a radiation detector with an area not exceeding ten square centimeters;

2. Electron radiation. Measurements of leakage radiation through the electron applicators shall be made with the electron beam directed into the air and using a radiation detector with an area up to but not exceeding one square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements shall be made using one centimeter of water equivalent buildup material.

(4) Filters/wedges.

1. Each wedge filter which is removable from the system shall be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be redetermined;

2. If the absorbed dose rate information required by 41.3(18)"a"(9) relates exclusively to operation with a field-flattening filter or beam-scattering foil in place, such filter or foil shall be removable only by the use of tools;

3. For equipment manufactured after July 9, 1997, which utilizes a system of wedge filters, interchangeable field-flattening filters, or interchangeable beam-scattering foils:

* Irradiation shall not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment control panel, either manually or automatically;

* An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position;

* A display shall be provided at the treatment control panel showing the wedge filter(s), interchangeable field-flattening filter(s), and interchangeable beam-scattering foil(s) in use; and

* An interlock shall be provided to prevent irradiation if any filter or be am-scattering foil selection operation carried out in the treatment room does not agree with the filter or beam-scattering foil selection operation carried out at the treatment control panel.

(5) Stray radiation in the useful beam. For equipment manufactured after July 9, 1997, the registrant shall determine during acceptance testing, or obtain from the manufacturer, data sufficient to ensure that X-ray stray radiation in the useful electron beam, absorbed dose at the surface during X-ray irradiation and stray neutron radiation in the useful X-ray beam are in compliance with International Electrotechnical Agency (IEC) Document 601-2-1 (most current revision).

(6) Beam monitors. All therapeutic radiation machines subject to 41.3(18) shall be provided with redundant beam monitoring systems. The sensors for these systems shall be fixed in the useful beam during treatment to indicate the dose monitor unit rate.

1. Equipment manufactured after July 9, 1997, shall be provided with at least two independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.

2. Equipment manufactured on or before July 9,1997, shall be provided with at least one radiation detector. This detector shall be incorporated into a useful beam monitoring system. The detector and the system into which that detector is incorporated shall meet the following requirements:

* Each detector shall be removable only with tools and, if movable, shall be interlocked to prevent incorrect positioning;

* Each detector shall form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated;

* Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation; and

3. For equipment manufactured after July 9, 1997, the design of the beam monitoring systems shall ensure that the:

* Malfunctioning of one system shall not affect the correct functioning of the other system(s); and

* Failure of any element common to both systems which could affect the correct function of both systems shall terminate irradiation or prevent the initiation of radiation.

4. Each beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after July 9, 1997, each display shall:

* Maintain a reading until intentionally reset;

* Have only one scale and no electrical or mechanical scale multiplying factors;

* Utilize a design such that increasing dose is displayed by increasing numbers; and

* In the event of power failure, the beam monitoring information required in 41.3(18) "a"(6)"4" displayed at the control panel at the time of failure shall be retrievable in at least one system for a 20-minute period of time.

(7) Beam symmetry.

1. Bent-beam linear accelerators with beam-flattening filter(s) subject to 41.3(18) shall be provided with auxiliary device(s) to monitor beam symmetry;

2. The device(s) referenced in 41.3(18) "a"(7)"1" shall be able to detect field asymmetry greater than 10 percent, and shall be configured to terminate irradiation if field asymmetry cannot be maintained at 10 percent or less.

(8) Selection and display of dose monitor units.

1. The preselected number of dose monitor units shall be displayed at the treatment control panel until reset manually;

2. After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and

3. For equipment manufactured after July 9, 1997, after termination of irradiation, it shall be necessary for the operator to reset the preselected dose monitor units before irradiation can be initiated.

4. Irradiation shall not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel.

(9) Air kerma rate/absorbed dose rate. For equipment manufactured after July 9, 1997, a system shall be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. (The radiation detectors specified in 41.3(18)"a"(6) may form part of this system.) In addition:

1. The dose monitor unit rate shall be displayed at the treatment control panel;

2. If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device shall be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated shall be a record maintained by the registrant;

3. If the equipment can deliver under any fault condition(s) an air kerma rate or absorbed dose rate at the nominal treatment distance more than ten times the maximum value specified by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds 400 rad (4 Gy); and

4. For each therapeutic radiation machine, the registrant shall determine, or obtain from the manufacturer, the maximum value(s) specified in 41.3(18) "a"(7)"2" and "3" for the specified operating conditions. Records of these maximum value(s) shall be maintained at the installation for inspection by the agency.

(10)Termination of irradiation by the beam monitoring system or systems during stationary beam radiation therapy.

1. Each primary system shall terminate irradiation when the preselected number of dose monitor units has been detected by the system;

2. If the original design of the equipment included a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than 15 percent or 40 dose monitor units above the preselected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and

3. For equipment manufactured after July 9, 1997, an indicator on the control panel shall show which monitoring system has terminated irradiation.

(11) Termination switches. It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel.

(12) Interruption switches. If a therapeutic radiation machine has an interrupt mode, it shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change of a preselected value is made during an interruption, irradiation and equipment movements shall be automatically terminated.

(13) Timer. A suitable irradiation control device shall be provided to terminate the irradiation after a preset time interval.

1. A timer shall be provided which has a display at the treatment control panel. The timer shall have a preset time selector and an elapsed time indicator;

2. The timer shall be a cumulative timer which activates with an indication of "BEAM-ON" and retains its reading 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;

3. The timer shall terminate irradiation when a preselected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.

(14) Selection of radiation type. Equipment capable of both X-ray therapy and electron therapy shall meet the following additional requirements:

1. Irradiation shall not be possible until a selection of radiation type (X-rays or electrons) has been made at the treatment control panel;

2. The radiation type selected shall be displayed at the treatment control panel before and during irradiation;

3. An interlock system shall be provided to ensure that the equipment can principally emit only the radiation type which has been selected;

4. An interlock system shall be provided to prevent irradiation with X-rays, except to obtain a verification image, when electron applicators are fitted;

5. An interlock system shall be provided to prevent irradiation with electrons when accessories specific for X-ray therapy are fitted; and

6. An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.

(15) Selection of energy. Equipment capable of generating radiation beams of different energies shall meet the following requirements:

1. Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;

2. The nominal energy value selected shall be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated; and

3. Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location.

4. For equipment manufactured after July 9, 1997, the selection of energy shall be in compliance with International Electrotechnical Commission (IEC) Document 60601-2-1.

(16) Selection of stationary beam radiation therapy or moving beam radiation therapy. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:

1. Irradiation shall not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel;

2. The mode of operation shall be displayed at the treatment control panel;

3. An interlock system shall be provided to ensure that the equipment can operate only in the mode which has been selected;

4. An interlock system shall be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel;

5. Moving beam radiation therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment manufactured after July 9, 1997:

* An interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any ten degrees of rotation or one centimeter of linear motion differs by more than 20 percent from the selected value;

* Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered shall differ by less than 5 percent from the dose monitor unit value selected;

* An interlock shall be provided to prevent motion of more than five degrees or one centimeter beyond the selected limits during moving beam radiation therapy;

* An interlock shall be provided to require that a selection of direction be made at the treatment control panel in all units which are capable of both clockwise and counterclockwise moving beam radiation therapy.

* Moving beam radiation therapy shall be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement.

6. Where the beam monitoring system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by 41.3(18)"a "(10); and

7. For equipment manufactured after July 9, 1997, an interlock system shall be provided to terminate irradiation if movement:

* Occurs during stationary beam radiation therapy; or

* Does not start or stops during moving beam radiation therapy unless such stoppage is a preplanned function.

b. Facility design requirements for therapeutic radiation machines operating above 500 kV. In addition to shielding adequate to meet requirements of 41.3(19), the following design requirements are made:

(1) Protective barriers. All protective barriers shall be fixed, except for access doors to the treatment room or movable beam interceptors.

(2) Control panel. In addition to other requirements specified in 41.3(136C), the control panel shall also:

1. Be located outside the treatment room;

2. Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;

3. Provide an indication of whether radiation is being produced; and

4. Include an access control (locking) device which will prevent unauthorized use of the therapeutic radiation machine.

(3) Viewing systems. Windows, mirrors, closed-circuit television or an equivalent viewing system shall be provided to permit continuous observation of the patient following positioning and during irradiation and shall be so located that the operator may observe the patient from the treatment control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational.

(4) Aural communications. Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine shall not be used for irradiation of patients unless continuous two-way aural communication is possible.

(5) Room entrances. Treatment room entrances shall be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "ON" and when it is "OFF".

(6) Entrance interlocks. Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it shall not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel.

(7) Beam interceptor interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with 641-paragraphs 40.26(1)"a" and"b," interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s).

(8) Emergency cutoff switches. At least one emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by 41.3(18)"a "(11). All emergency power cutoff switches shall include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch.

(9) Safety interlocks. All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine.

(10) Surveys for residual radiation. Surveys for residual activity shall be conducted on all therapeutic radiation machines capable of generating photon and electron energies above 10 MV prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photoneutron production.

(11) Possession of survey instrument(s). Each facility location authorized to use a therapeutic radiation machine in accordance with 41.3(18) shall have at its disposal appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 mrem (10 µSv) per hour to 1000 mrem (10 mSv) per hour. The survey instrument(s) shall be operable and calibrated at intervals not to exceed 12 months for the radiation measured.

c. Radiation therapy physicist support.

(1) The services of a radiation therapy physicist shall be required in facilities having therapeutic radiation machines with energies of 500 kV and above. The radiation therapy physicist shall be responsible for:

1. Full calibration(s) required by 41.3(18)"e" and protection surveys required by 41.3(16)"a";

2. Supervision and review of dosimetry;

3. Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;

4. Quality assurance, including quality assurance check review required by 41.3(18)"f"(5) of these regulations;

5. Consultation with the authorized user in treatment planning, as needed; and

6. Performing calculations/assessments regarding misadministrations.

(2) If the radiation therapy physicist is not a full-time employee of the registrant, the operating procedures required by 41.3(18)"d" shall also specifically address how the radiation therapy physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the radiation therapy physicist can be contacted.

d. Operating procedures.

(1) No individual, other than the patient, shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes;

(2) Therapeutic radiation machines shall not be made available for medical use unless the requirements of 41.3(16) "a, "41.3(18)"e, " and 41.3(18)'f" have been met;

(3) Therapeutic radiation machines, when not in operation, shall be secured to prevent unauthorized use;

(4) When adjustable beam-limiting devices are used, the position and shape of the radiation field shall be indicated by a light field;

(5) If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used; and

(6) A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console.

e. Acceptance testing, commissioning, and full calibration measurements.

(1) Acceptance testing, commissioning, and full calibration of a therapeutic radiation machine subject to 41.3(18) shall be performed by, or under the direct supervision of, a radiation therapy physicist:

1. Acceptance testing and commissioning shall be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47," prepared by Radiation Therapy Task Group 45, and the manufacturer's contractual specifications and shall be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine;

2. Full calibration shall include measurement of all parameters listed in Appendix D of 641-Chapter 41 and shall be performed in accordance with "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47," prepared by Radiation Therapy Task Group 45. Although it shall not be necessary to complete all elements of a full calibration at the same time, all parameters (for all energies) shall be completed at intervals not to exceed 12 calendar months, unless a more frequent interval is required by this agency.

3. The radiation therapy physicist shall perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits:

* Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multienergy or multimode capabilities or both shall only require measurements for those modes or energies that are not within their acceptable range; and

* Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes or energies, measurements shall be performed on the affected mode/energy that is in most frequent clinical use at the facility. The remaining energies/modes may be validated with quality assurance check procedures against the criteria in 41.3(18)"e "(1)"3."

(2) The registrant shall use the dosimetry system described in 41.3(16)"c " to measure the radiation output for one set of exposure conditions.

(3) The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include the date of the calibration, the manufacturer's name, model number, and serial number for the therapeutic radiation machine, the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine, and the signature of the radiation therapy physicist responsible for performing the calibration.

f. Periodic quality assurance checks.

(1) Periodic quality assurance checks shall be performed on all therapeutic radiation machines subject to 41.3(18) at intervals as specified in Appendix D of 641-Chapter 41;

(2) To satisfy the requirement of 41.3(18)'f"(1), quality assurance checks shall include determination of central axis radiation output and a representative sampling of periodic quality assurance checks contained in Appendix D of 641-Chapter 41. Representative sampling shall include all referenced periodic quality assurance checks at intervals not to exceed 12 consecutive calendar months;

(3) The registrant shall use a dosimetry system which has been intercompared within the previous 12 months with the dosimetry system described in 41.3(16)"c"(1) to make the periodic quality assurance checks required in 41.3(18)"f'(2)',

(4) The registrant shall perform periodic quality assurance checks required by 41.3(18)"f'(1) in accordance with procedures established by the radiation therapy physicist;

(5) The registrant shall review the results of each periodic radiation output check according to the following procedures:

1. The authorized user and radiation therapy physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine shall not be made available for subsequent medical use until the radiation therapy physicist has determined that all parameters are within their acceptable tolerances;

2. If all quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either the authorized user or radiation therapy physicist within three treatment days; and

3. The radiation therapy physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed one month.

(6) Therapeutic radiation machines subject to 41.3(18) shall have safety quality assurance checks of each external beam radiation therapy machine performed at intervals not to exceed one week or at longer intervals as recommended by the manufacturer;

(7) To satisfy the requirement of 41.3(18)"f'(6), safety quality assurance checks shall ensure proper operation of:

1. Electrical interlocks at each external beam radiation therapy room entrance;

2. Proper operation of the "BEAM-ON," interrupt and termination switches;

3. Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;

4. Viewing systems;

5. Aural systems;

6. Electrically operated treatment room door(s) from inside and outside the treatment room;

7. At least one emergency power cutoff switch. If more than one emergency power cutoff switch is installed and not all switches are tested at once, each switch shall be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted at the end of the treatment day in order to minimize possible stability problems with the therapeutic radiation machine;

(8) Rescinded IAB 4/11/07, effective 5/16/07.

(9) The registrant shall promptly repair any system identified in 41.3(18)"f'(7) that is not operating properly; and

(10) The registrant shall maintain a record of each quality assurance check required by 41.3(18)"f"(1) and 41.3(18)"f'(7) for three years. The record shall include the date of the quality assurance check, the manufacturer's name, model number, and serial number for the therapeutic radiation machine, the manufacturer's name, model number and serial number of the instrument(s) used to measure the radiation output of the therapeutic radiation machine, and the signature of the individual who performed the periodic quality assurance check.

(19) Shielding and safety design requirements.

a. Each therapeutic radiation machine subject to 41.3(17) or 41.3(18) shall be provided with such primary or secondary barriers as are necessary to ensure compliance with 641-40.15 (136C) and 641-40.26 (136C).

b. Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy shall be submitted for agency approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in Appendix E of 641-Chapter 41.

(20) Calibration of survey instruments.

a. The registrant shall ensure that the survey instruments used to show compliance with 645-41.3 (136C) have been calibrated before first use, at intervals not to exceed 12 months, and following repair.

b. To satisfy the requirements of 41.3(20), the registrant shall:

(1) Calibrate all required scale readings up to 1000 mrem (10 mSv) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST);

(2) Calibrate at least two points on each scale to be calibrated. These points should be at approximately 1/3 and 2/3 of full scale;

(3) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 10 percent; and

(4) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 20 percent if a correction factor or graph is conspicuously attached to the instrument.

c. The registrant shall retain a record of each calibration required in 41.3(20) for three years. The record shall include:

(1) A description of the calibration procedure; and

(2) A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.

d. The registrant may obtain the services of individuals licensed by this agency, the U.S. Nuclear Regulatory Commission, an agreement state, or a licensing state to perform calibrations of survey instruments. Records of calibrations that contain information required in 41.3(20) shall be maintained by the registrant.

Iowa Admin. Code r. 641-41.3

Amended by IAB October 1, 2014/Volume XXXVII, Number 7, effective 11/5/2014