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Environmental Quality - Waste Management and Radiation Control, Radiation - Therapeutic Radiation Machines


Published: 2013-03-19

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R313. Environmental Quality, Waste Management and Radiation Control, Radiation.
R313-30. Therapeutic Radiation Machines.
R313-30-1. Scope and Applicability.
(1) R313-30 establishes requirements, for which the registrant is responsible, for use of therapeutic radiation machines. The provisions of R313-30 are in addition to, and not in substitution for, other applicable provisions of these rules.
(2) The use of therapeutic radiation machines shall be by, or under the supervision of, a licensed practitioner of the healing arts who meets the training and experience criteria established by R313-30-3(3).
(3) R313-30 shall only apply to therapeutic radiation machines which accelerate electrons into a target to produce bremsstrahlung or which accelerate electrons to produce a clinically useful electron beam.
R313-30-2. Definitions.
As used in R313-30, the following definitions apply:
"Absorbed dose (D)" means the mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by ionizing radiation to matter of mass dM. The SI unit of absorbed dose is joule per kilogram and the special name of the unit of absorbed dose is the gray (Gy). The previously used special unit of absorbed dose (rad) is being replaced by the gray.
"Absorbed dose rate" means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.
"Accessible surfaces" means surface of equipment or of an equipment part that can be easily or accidentally touched by persons without the use of a tool, or without opening an access panel or door.
"Added filtration" means filtration which is in addition to the inherent filtration.
"Air kerma (K)" means the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy).
"Barrier" See "Protective barrier."
"Beam axis" means the axis of rotation of the radiation head.
"Beam-limiting device" means a field defining collimator which provides a means to restrict the dimensions of the useful beam.
"Beam monitoring system" means a system designed and installed in the radiation head to detect and measure the radiation present in 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.
"Changeable filters" means filters, exclusive of inherent filtration, which can be removed from the useful beam through electronic, mechanical, or physical processes.
"Contact therapy system" means a therapeutic radiation machine with a short target to skin distance (TSD), usually less than five centimeters.
"Detector" See "Radiation detector."
"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 in therapeutic radiation machines subject to R313-30-6.
"Gantry" means that part of a therapeutic radiation machine supporting and allowing movements of the radiation head about a center of rotation.
"Gray (Gy)" means the SI unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. The previous unit of absorbed dose (rad) is being replaced by the gray. Note that 1 Gy equals 100 rad.
"Half-value layer (HVL)" means the thickness of a specified material which attenuates x-radiation or gamma radiation to the extent that the air kerma rate, exposure rate or absorbed dose rate is reduced to one-half of the value measured without the material at the same point.
"Interlock" means a device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.
"Interruption of irradiation" means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.
"Irradiation" means the exposure of a living being or matter to ionizing radiation.
"Isocenter" means the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.
"Kilovolt (kV) or kilo electron volt (keV)" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand volts in a vacuum. Current convention is to use kV for photons and keV for electrons.
"Lead equivalent" means the thickness of the material in question affording the same attenuation, under specified conditions, as lead.
"Leakage radiation" means radiation emanating from the therapeutic radiation machine except for the useful beam.
"Light field" means the area illuminated by light, simulating the radiation field.
"mA" means milliampere.
"Megavolt (MV) or 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 one million volts in a vacuum. 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 and rotational therapy.
"Nominal treatment distance" means:
(a) 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.
(b) For x-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For non-isocentric equipment, this distance shall be that specified by the manufacturer.
"Patient" means an individual subjected to machine produced external beam radiation for the purposes of medical therapy.
"Peak tube potential" means the maximum value of the potential difference across the x-ray tube during an exposure.
"Periodic quality assurance check" means a procedure which is performed to ensure that a previous calibration continues to be valid.
"Phantom" means an object which attenuates, absorbs, and scatters ionizing radiation in the same quantitative manner as tissue.
"Practical range of electrons" corresponds to classical electron range where the only remaining contribution to dose is from bremsstrahlung x-rays.
"Primary dose monitoring system" means a system which will monitor the useful beam during irradiation and which will terminate irradiation when a pre-selected number of dose monitor units have been delivered.
"Primary protective barrier" See "Protective barrier."
"Protective barrier" means a barrier of radiation absorbing materials used to reduce radiation exposure. The types of protective barriers are as follows:
(a) "Primary protective barrier" means the material, excluding filters, placed in the useful beam or a barrier which attenuates the primary beam.
(b) "Secondary protective barrier" means the material which attenuates stray radiation.
"Radiation detector" means a device which, in the presence of radiation provides, by either direct or indirect means a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
"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 R313-30-3(4).
"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 pre-selected number of dose monitor units.
"Scattered radiation" means ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation.
"Secondary dose monitoring system" means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.
"Secondary protective barrier" See "Protective barrier."
"Shadow tray" means a device attached to the radiation head to support auxiliary beam blocking material.
"Shutter" means a device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
"Sievert (Sv)" means the SI unit of dose equivalent. The unit of dose equivalent is the joule per kilogram. The previous unit of dose equivalent (rem) is being replaced by the sievert. Note that 1 Sv equals 100 rem.
"Simulator, or radiation therapy simulation system" means an x-ray system intended for localizing the volume to be exposed during radiation therapy and reproducing the position and size of the therapeutic irradiation field.
"Source" means the region or material from which the radiation emanates.
"Source-skin distance (SSD)" See "Target-skin distance."
"Stationary beam radiation therapy" means radiation therapy without displacement of the radiation source relative to the patient during irradiation.
"Stray radiation" means the sum of leakage and scattered radiation.
"Target" means that part of an x-ray tube or particle accelerator onto which is directed a beam of accelerated particles to produce ionizing radiation or other particles.
"Target-skin distance (TSD)" means the distance measured along the beam axis from the center of the front surface of the x-ray target or electron virtual source to the surface of the irradiated object or patient.
"Tenth-value layer (TVL)" means the thickness of a specified material which, x-radiation or gamma radiation to the extent 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.
"Termination of irradiation" means the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.
"Therapeutic radiation machine" means x-ray or electron-producing equipment designed and used for external beam radiation therapy.
"Tube" means an x-ray tube, unless otherwise specified.
"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and filament transformers and other appropriate elements that are contained within the tube housing.
"Useful beam" means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the therapeutic radiation machine to produce radiation.
"Virtual source" means a point from which radiation appears to originate.
"Wedge filter" means a filter which effects continuous change in transmission over all or a part of the radiation field.
"X-ray tube" means an electron tube which is designed to be used primarily for the production of x-rays.
R313-30-3. General Administrative Requirements for Facilities Using Therapeutic Radiation Machines.
(1) Administrative Controls. The registrant shall be responsible for directing the operation of the therapeutic radiation machines which have been registered with the Director. The registrant or the registrant's agent shall ensure that the requirements of R313-30 are met in the operation of the therapeutic radiation machines.
(2) A therapeutic radiation machine which does not meet the provisions of these rules shall not be used for irradiation of patients.
(3) Training for External Beam Radiation Therapy Authorized Users. The registrant for a therapeutic radiation machine subject to R313-30-6 or R313-30-7 shall require the authorized user to be a physician who:
(a) Is certified in:
(i) Radiology or therapeutic radiology by the American Board of Radiology; or
(ii) Radiation oncology by the American Osteopathic Board of Radiology; or
(iii) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or
(iv) 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.
(i) To satisfy the requirement for instruction, the classroom and laboratory training shall include:
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity; and
(D) Radiation biology.
(ii) To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include:
(A) Review of the full calibration measurements and periodic quality assurance checks;
(B) Preparing treatment plans and calculating treatment times;
(C) Using administrative controls to prevent misadministrations;
(D) Implementing emergency procedures to be followed in the event of the abnormal operation of a external beam radiation therapy unit or console; and
(E) Checking and using radiation survey meters.
(iii) 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:
(A) Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and limitations and contraindications;
(B) Selecting proper dose and how it is to be administered;
(C) Calculating the external beam radiation therapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses as warranted by patients' reaction to radiation; and
(D) Post-administration follow-up and review of case histories.
(iv) An individual who satisfies the requirements in R313-30-3(b), but not R313-30-3(a), must submit an application to the Director and must satisfy the requirements in R313-30-3(a) within one year of initial application to the Director.
(c) After December 31, 1994, a physician shall not act as an authorized user for a therapeutic radiation machine until the physician's training has been reviewed and approved by the Director.
(4) Training for Radiation Therapy Physicist. The registrant for a therapeutic radiation machine subject to R313-30-6 or R313-30-7 shall require the Radiation Therapy Physicist to:
(a) Satisfy the provisions of R313-16, 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:
(i) Therapeutic radiological physics; or
(ii) Roentgen-ray and gamma-ray physics; or
(iii) X-ray and radium physics; or
(iv) Radiological 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 Medical Physics; 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 R313-30-4(1), R313-30-6(16), R313-30-7(19), R313-30-6(17), and R313-30-7(20) under the supervision of a Radiation Therapy Physicist during the year of work experience.
(f) Notwithstanding the provisions of R313-30-3(4)(e), certification pursuant to R313-30-3(4)(b), (c) or (d) shall be required on or before December 31, 1999 for all persons currently qualifying as a Radiation Therapy Physicist pursuant to R313-30-3(4)(e).
(5) Qualifications of Operators.
(a) Individuals who will be operating a therapeutic radiation machine for medical use shall be American Registry of Radiologic Technologists (ARRT) Registered Radiation Therapy Technologists.
(b) The names and training of personnel currently operating a therapeutic radiation machine shall be kept on file at the facility. Information on former operators shall be retained for a period of at least two years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.
(6) 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 restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be familiar with these rules as required in R313-18-12(1)(c).
(7) Individuals shall not be exposed to the useful beam except for medical therapy purposes. Exposure for medical therapy purposes shall be ordered in writing by an authorized user who is specifically identified on the Certificate of Registration. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes.
(8) Visiting Authorized User. Notwithstanding the provisions of R313-30-3(7), a registrant may permit a physician to act as a visiting authorized user under the term of the registrant's Certificate of Registration 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; and
(b) The visiting authorized user meets the requirements established for authorized users in R313-30-3(3)(a) and R313-30-3(3)(b); and
(c) The registrant maintains copies of records specified by R313-30-3(8) for five years from the date of the last visit.
(9) Individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's quality management program. In addition to the requirements of R313-30, these individuals are also subject to the requirements of R313-15-201, R313-15-202, R313-15-205 and R313-15-502.
(10) Information and Maintenance Record and Associated Information. The registrant shall maintain the following information in a separate file or package for therapeutic radiation machines, for inspection by the representatives of the Director:
(a) Report of acceptance testing;
(b) Records of surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by R313-30, as well as the names of persons who performed the activities;
(c) Records of major maintenance and modifications performed on the therapeutic radiation machine after the effective date of these rules, as well as the names of persons who performed the services; and
(d) Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.
(11) Records Retention. Records required by R313-30 shall be retained until disposal is authorized by the Director unless another retention period is specifically authorized in R313-30. Required records shall be retained in an active file from at least the time of generation until the next inspection by a representative of the Director. A required record generated prior to the last inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until the Director authorizes final disposal.
R313-30-4. General Technical Requirements for Facilities Using Therapeutic Radiation Machines.
(1) Protection Surveys.
(a) The registrant shall ensure that radiation protection surveys of new facilities, and existing facilities not previously surveyed are performed with an operable radiation measurement survey instrument calibrated in accordance with R313-30-8. 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:
(i) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in R313-15-201(1); and
(ii) Radiation levels in unrestricted areas do not exceed the limits specified in R313-15-301(1).
(b) In addition to the requirements of R313-30-4(1)(a), a radiation protection survey shall also be performed prior to subsequent medical use and:
(i) After making changes in the treatment room shielding;
(ii) After making changes in the location of the therapeutic radiation machine within the treatment room;
(iii) After relocation of, or modification of, the therapeutic radiation machine; or
(iv) 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.
(c) The survey record shall indicate instances where the facility, in the opinion of the Radiation Therapy Physicist or a Certified Health Physicist, is in violation of applicable radiation protection rules. 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 instruments 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 areas expressed in microsieverts, millirems, per hour, the calculated maximum level of radiation over a period of one week for restricted and unrestricted areas, and the signature of the individual responsible for conducting the survey;
(d) If the results of the surveys required by R313-30-4(1)(a) or R313-30-4(1)(b) indicate radiation levels in excess of the respective limit specified in R313-30-4(1)(a), the registrant shall lock the control in the "OFF" position and not use the unit:
(i) 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
(ii) Until the registrant has received a written approval from the Director.
(2) Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program. If the survey required by R313-30-4(1) indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by R313-15-301(1) of these rules, before beginning the treatment program the registrant shall:
(a) Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with R313-15-301(1) of these rules;
(b) Perform the survey required by R313-30-4(1) again; and
(c) Include in the report required by R313-30-4(4) the results of the initial survey, a description of the modification made to comply with R313-30-4(2)(a), and the results of the second survey; or
(d) Request and receive a registration amendment under R313-15-301(3) of these rules that authorizes radiation levels in unrestricted areas greater than those permitted by R313-15-301(1) of these rules.
(3) Possession of Survey Instruments. Facility locations authorized to use a therapeutic radiation machine in accordance with R313-30-6 and R313-30-7 shall possess appropriately calibrated portable monitoring equipment. As a minimum, the equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 uSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instruments shall be operable and calibrated in accordance with R313-30-8.
(4) Reports of External Beam Radiation Therapy Surveys and Measurements. The registrant for a therapeutic radiation machine subject to R313-30-6 or R313-30-7 shall furnish a copy of the records required in R313-30-4(1) and R313-30-4(2) to the Director within 30 days following completion of the action that initiated the record requirement.
R313-30-5. Quality Management Program.
(1) In addition to the definitions in R313-30-2, the following definitions are applicable to a quality management program:
"Course" means the entire treatment consisting of multiple fractions as prescribed in the written directive.
"Misadministration" means the administration of an external beam radiation therapy dose:
(a) Involving the wrong patient, wrong treatment modality, or wrong treatment site;
(b) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose;
(c) When the calculated weekly administered dose differs from the weekly prescribed dose by more than 30 percent; or
(d) When the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose;
"Prescribed dose" means the total dose and dose per fraction as documented in the written directive.
"Recordable event" means the administration of an external beam radiation therapy dose when the calculated weekly administered dose differs by 15 percent or more from the weekly prescribed dose;
"Written directive" means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of radiation, containing the following information: total dose, dose per fraction, treatment site and overall treatment period.
(2) Scope and Applicability. Applicants or registrants subject to R313-30-6 or R313-30-7 shall establish and maintain a written quality management program to provide high confidence that radiation will be administered as directed by the authorized user. The quality management program shall include written policies and procedures to meet the following specific objectives:
(a) Prior to administration, a written directive is prepared for an external beam radiation therapy dose;
(i) Notwithstanding R313-30-5(2)(a), 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 administration of the external beam radiation therapy dose or the next external beam radiation therapy fractional dose;
(ii) Notwithstanding R313-30-5(2)(a), if, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive shall be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by an authorized user within 48 hours of the oral revision;
(iii) Notwithstanding R313-30-5(2)(a), if, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive shall be acceptable, provided that the information
contained in the oral directive is documented immediately in the patient's record and a written directive is prepared and signed by an authorized user within 24 hours of the oral directive.
(b) Prior to the administration of a course of radiation treatments, the patient's identity is verified, by more than one method, as the individual named in the written directive;
(c) External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written directives;
(d) An administration is in accordance with the written directive; and
(e) Unintended deviations from the written directive is identified and evaluated, and appropriate action are taken.
(3) Development of Quality Management Program.
(a) An application for registration subject to R313-30-6 or R313-30-7 shall include a quality management program that specifies staff, duties and responsibilities, and equipment and procedures as part of the application required by R313-16 of these rules. The registrant shall implement the program upon issuance of a Certificate of Registration by the Director;
(b) Existing registrants subject to R313-30-6 or R313-30-7 shall submit to the Director a written certification that a quality management program has been implemented by December 31, 1994.
(4) As a part of the quality management program, the registrant shall:
(a) Develop procedures for, and conduct a review of, the quality management program including, since the last review, an evaluation of a representative sample of patient administrations, recordable events, and misadministrations to verify compliance with the quality management program;
(b) Conduct these reviews annually. The intervals should not exceed 12 months and shall not exceed 13 months;
(c) Evaluate these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the requirements of R313-30-5(2); and
(d) Maintain records of these reviews, including the evaluations and findings of the reviews, in a form that can be readily audited, for three years.
(5) The registrant shall evaluate and respond, within 30 days after discovery of the recordable event, to recordable events by:
(a) Assembling the relevant facts including the cause;
(b) Identifying what corrective actions are required to prevent recurrence; and
(c) Retaining a record, in a form that can be readily audited, for three years, of the relevant facts and what corrective actions were taken.
(6) The registrant shall retain:
(a) Written directives; and
(b) A record of administered radiation doses, in a form that can be readily audited, for three years after the date of administration.
(7) The registrant may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased.
(8) The registrant shall evaluate misadministrations and shall take the following actions in response to a misadministration:
(a) Notify the Director by telephone no later than the next calendar day after discovery of the misadministration;
(b) Submit a written report to the Director within 15 days after discovery of the misadministration. The written report shall include: the registrant's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the registrant notified the patient or the patient's responsible relative or guardian, this person will subsequently be referred to as "the patient," and if not, why not; and if the patient was notified, what information was provided to the patient. The report shall not include the patient's name or other information that could lead to identification of the patient;
(c) Notify the referring physician and also notify the patient of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that the physician will inform the patient, or that, based on medical judgment, telling the patient would be harmful. The registrant is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within 24 hours, the registrant shall notify the patient as soon as possible thereafter. The registrant shall not delay appropriate medical care for the patient, including necessary remedial care as a result of the misadministration, because of a delay in notification;
(d) Retain a record of misadministrations for five years. The record shall contain the names of individuals involved; including the prescribing physician, allied health personnel, the patient, and the patient's referring physician; the patient's social security number or identification number if one has been assigned; a brief description of the event; why it occurred; the effect on the patient; what improvements are needed to prevent recurrence; and the actions taken to prevent recurrence; and
(e) If the patient was notified, furnish, within 15 days after discovery of the misadministration, a written report to the patient by sending either a copy of the report that was submitted to the Director, or a brief description of both the event and the consequences as they may effect the patient, provided a statement is included that the report submitted to the Director can be obtained from the registrant;
(9) Aside from the notification requirement, nothing in R313-30-5(8) affects the rights or duties of registrants and physicians in relation to patients, the patient's responsible relatives or guardians, or to others.
R313-30-6. Therapeutic Radiation Machines of Less Than 500 kV.
(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:
(a) Systems 5-50 kV. The leakage air kerma rate measured at a position five centimeters from the tube housing assembly shall not exceed 1 mGy (100 mrad) in one hour.
(b) Systems greater than 50 and less than 500 kV. The leakage air kerma rate measured at a distance of one meter from the source in every direction shall not exceed 1 cGy (1 rad) in 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 five centimeters from the surface of the tube housing assembly shall not exceed 30 cGy (30 rad) per hour.
(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.
(a) Adjustable or removable beam limiting devices, diaphragms, cones or blocks shall not transmit more than five percent of the useful beam for the most penetrating beam used;
(b) 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:
(a) Filters can not be accidentally displaced at every possible tube orientation;
(b) For equipment installed after the effective date of these rules, an interlock system prevents irradiation if the proper filter is not in place;
(c) The air kerma rate escaping from the filter slot shall not exceed 1 cGy (1 rad) per hour at one meter under operating conditions; and
(d) Filters shall be marked as to its material of construction and its thickness.
(5) Tube Immobilization.
(a) The x-ray tube shall be so mounted that it can not accidentally turn or slide with respect to the housing aperture; and
(b) 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 five millimeters, and the 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 pre-set time interval.
(a) A timer which has a display shall be provided at the treatment control panel. The timer shall have a pre-set time selector. The timer shall activate with an indication of "BEAM-ON" and retain 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 timer;
(b) For equipment manufactured after the effective date of these rules, the timer shall be a cumulative timer with an elapsed time indicator. Otherwise, the timer may be a countdown timer;
(c) The timer shall terminate irradiation when a pre-selected time has elapsed, if the dose monitoring system present has not previously terminated irradiation;
(d) The timer shall permit pre-setting and determination of exposure times as short as one second;
(e) The timer shall not permit an exposure if set at zero;
(f) 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
(g) Timer shall be accurate to within one percent of the selected value or to within one second, whichever is greater.
(9) Control Panel Functions. The control panel, in addition to the displays required by other provisions in R313-30-6, shall have:
(a) An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;
(b) An indication of whether x-rays are being produced;
(c) Means for indicating x-ray tube potential and current;
(d) The means for terminating an exposure at any time;
(e) A locking device which will prevent unauthorized use of the therapeutic radiation machine; and
(f) For therapeutic radiation machines manufactured after the effective date of these rules, a positive display of specific filters in the beam.
(10) Multiple Tubes. When a control panel may energize more than one x-ray tube:
(a) It shall be possible to activate only one x-ray tube at a time;
(b) There shall be an indication at the control panel identifying which x-ray tube is activated; and
(c) 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 having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter shall be controlled electrically by the operator from the control panel. An indication of shutter position shall appear at the control panel.
(13) Low Filtration X-ray Tubes. Therapeutic radiation machines equipped with a beryllium or other low-filtration window shall have a label clearly marked on 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.
(14) 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 R313-30-9, the treatment room shall meet the following design requirements:
(a) Aural Communication. Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel;
(b) 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.
(15) Additional Requirements. Treatment rooms which contain a therapeutic radiation machine capable of operating above 150 kV shall meet the following additional requirements:
(a) Protective barriers shall be fixed except for entrance doors or beam interceptors;
(b) The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room;
(c) Interlocks shall be provided so that entrance doors, including doors to interior booths, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by a 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
(d) When a door referred to in R313-30-6(15)(c) is opened while the x-ray tube is activated, the irradiation shall be interrupted either electrically or by the closure of the shutter.
(16) Full Calibration Measurements.
(a) Full calibration of a therapeutic radiation machine subject to R313-30-6 shall be performed by, or under the direct supervision of, a Radiation Therapy Physicist:
(i) Before the first medical use following installation or reinstallation of the therapeutic radiation machine;
(ii) Annually. The intervals should not exceed 12 months and shall not exceed 13 months; and
(iii) Before medical use under the following conditions:
(A) Whenever quality assurance check measurements indicate that the radiation output differs by more than five percent from the value obtained at the last full calibration and the difference cannot be reconciled; and
(B) Following a component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
(iv) Notwithstanding the requirements of R313-30-6(16)(a)(iii):
(A) Full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes and energies that are not within their acceptable range; and
(B) 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 R313-30-6(16)(a)(iii)(A).
(v) The registrant shall use the dosimetry system described in R313-30-8(6)(a) to perform the full calibration required in R313-30-6(16)(b);
(b) To satisfy the requirement of R313-30-6(16)(a), full calibration shall include 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 ed., which is adopted and incorporated by reference.
(c) The registrant shall maintain a record of calibrations 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.
(17) Periodic Quality Assurance Checks.
(a) Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to R313-30-6, which are capable of operation at greater than 50 kV.
(b) To satisfy the requirement of R313-30-6(17)(a), quality assurance checks shall meet the following requirements:
(i) The registrant shall perform quality assurance checks in accordance with written procedures established by the Radiation Therapy Physicist; and
(ii) The quality <