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 105 CMR 120.430 are met in the operation of the therapeutic radiation machine(s). (B) Prohibition A therapeutic radiation machine which does not meet the provisions of 105 CMR 120.000 shall not be used for irradiation of patients. (C) Training for Therapeutic Radiation Machine Authorized Users The registrant for any therapeutic radiation machine subject to 105 CMR 120.436 or 120.437 shall require the authorized user to be a physician who: (1) Is certified in: (a) Radiology or therapeutic radiology by the American Board of Radiology; or (b) Radiation oncology by the American Osteopathic Board of Radiology; or (c) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or (d) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons. (2) 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. (a) To satisfy the requirement for instruction in 105 CMR 120.433(C)(2), 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. (b) To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include: 1. Review of the full calibration measurements and periodic quality assurance checks; 2. Evaluation of 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 a external beam radiation therapy unit or console; and, 5. Checking and using radiation survey meters. (c) 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 year 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 thetherapeutic radiation machine doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses and/or treatment plans as warranted by patients' reaction to radiation; and, 4. Post administration follow up and review of case histories. (d) Notwithstanding the requirements of 105 CMR 120.433(C)(1) and (2), the registrant for any therapeutic radiation machine subject to 105 CMR 120.436 may also submit the training of the prospective authorized user physician for Agency review on a case by case basis. (e) 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 Agency. (D) Training for Qualified Medical Physicist for Radiation Therapy. The registrant for any therapeutic radiation machine subject to 105 CMR 120.436 or 120.437 shall require the Qualified Medical Physicist to: (1) Be registered with the Agency, under the provisions of 105 CMR 120.026, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and, (2) Be certified by the American Board of Radiology in: (a) Therapeutic radiological physics; or (b) Roentgen-ray and gamma-ray physics; or (c) X-ray and radium physics; or (d) Radiological physics; or, (3) Be certified by the American Board of Medical Physics in Radiation Oncology Physics; or, (4) Be certified by the Canadian College of Medical Physics. (E) Qualifications of Operators. (1) Individuals who will be operating a therapeutic radiation machine for medical use shall possess a valid Massachusetts License as a Radiologic Technologists in Radiation Therapy. (2) The names and the respective training records of all 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. (F) Written safety procedures and rules shall be developed by a Qualified Medical 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. (G) Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by an authorized user meeting the requirements of 105 CMR 120.433(C) who is specifically identified on the Certificate of Registration. 105 CMR 120.433(G) specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes. (H) Visiting Authorized User. Notwithstanding the provisions of 105 CMR 120.433(G), a registrant may permit any 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: (1) 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 (2) The visiting authorized user meets the requirements established for authorized user(s) in 105 CMR 120.433(C)(1) and (2); and (3) The registrant maintains copies of all records specified by 105 CMR 120.433(H) for five years from the date of the last visit. (I) All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's written directive program. In addition to the requirements of 105 CMR 120.430, these individuals are also subject to the requirements of 105 CMR 120.201 and 120.205. (J) 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: (1) Report of acceptance testing; (2) Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by 105 CMR 120.430, as well as the name(s) of person(s) who performed such activities; (3) Records of maintenance and/or modifications performed on the therapeutic radiation machine after July 9, 1999, as well as the name(s) of person(s) who performed such services; (4) Signature of the Radiation therapy Physicist or Authorized User authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade. (K) Records Retention. All records required by 105 CMR 120.430 shall be retained until disposal is authorized by the Agency unless another retention period is specifically authorized in 105 CMR 120.430. 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 prior to the last Agency inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the Agency authorizes final disposal. 120.434 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 in accordance with 105 CMR 120.438. The radiation protection survey shall be performed by, or under the direction of, a Qualified Medical 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. The following standards must be met and recorded: (a) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in 105 CMR 120.211(A); and, (b) Radiation levels in unrestricted areas do not exceed the limits specified in 105 CMR 120.221(A) and (B). (2) In addition to the requirements of 105 CMR 120.434(A)(1), a radiation protection survey shall also be performed prior to any subsequent medical use and: (a) After making any structural or composite modifications to the treatment room shielding; (b) After making any changes in the location of the therapeutic radiation machine within the treatment room; (c) After relocating the therapeutic radiation machine; or (d) 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 Qualified Medical 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 105 CMR 120.434(A)(1) or (2) indicate any radiation levels in excess of the respective limit specified in 105 CMR 120.434(A)(1), the registrant shall lock the control in the "OFF" position and not use the unit: (a) 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 (b) Until the registrant has received a specific exemption from the Agency. (B) Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program. If the survey required by 105 CMR 120.434(A) indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 105 CMR 120.221(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 105 CMR 120.221(A) and (B); (2) Perform the survey required by 105 CMR 120.434(A) again; and, (3) Include in the report required by 105 CMR 120.434(D) the results of the initial survey, a description of the modification made to comply with 105 CMR 120.434(B)(1), and the results of the second survey; or, (4) Request and receive a registration amendment under 105 CMR 120.221(C). that authorizes radiation levels in unrestricted areas greater than those permitted by 105 CMR 120.221(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. (a) For beams with energies greater than one MV (one MeV), the dosimetry system shall have been calibrated for Cobalt-60; (b) For beams with energies equal to or less than one MV (one 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 105 CMR 120.434(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 may be the same system used to meet the requirement in 105 CMR 120.434(C)(1); (3) The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the license and/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, inter-compared, or compared as required by 105 CMR 120.434(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 Qualified Medical Physicist. (D) Reports of External Beam Radiation Therapy Surveys and Measurements. The registrant for any therapeutic radiation machine subject to 105 CMR 120.436 or 120.437 shall furnish a copy of the records required in 105 CMR 120.434(A) and (B) to the Agency within 30 days following completion of the action that initiated the record requirement.