General Requirements, Operating Procedures, Surveys, Dosimetry, and Instrument Calibration for Facilities Using Therapeutic Radiation Machines
(1)Administrative Controls. The registrant is responsible for directing the operation of the therapeutic radiation machines that they have registered with the Authority. The registrant or the registrant’s agent must ensure that the requirements of this Division are met in the operation of the therapeutic radiation machine(s) and:
(a)A therapeutic radiation machine that does not meet the requirements of these rules must not be used for irradiation of patients; and
(b)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/experience criteria established by 333-123-0015 (Training and Qualification Requirements for Individuals in the External Beam Radiation Therapy Area)(1).
(2)Operating Procedures. A copy of the current operating and emergency procedures must be available at each therapeutic radiation authority or clinic and at the therapeutic radiation machine control console; and
(a)Any alterations or changes to existing procedures and new radiation therapy treatment protocols must be approved by the Chief Medical Physicist and the Senior Radiation Therapy Physician or designee; and
(b)The date of the approval and the appropriate signatures must be placed on the first page of each radiation therapy procedure; and
(c)The registrant must retain a copy of all versions of the procedures for 5 years; and
(d)If the Qualified Medical Physicist is not a full-time employee of the registrant, the operating procedures must specify how to contact the Physicist. The procedures must list specific actions to be initiated until the Physicist assumes personal control.
(e)The therapeutic radiation machine must not be used for irradiation of patients unless the requirements of sections (1) and (2) have been met.
(f)Individuals must not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing or electronically by a qualified radiation therapy physician.
(g)This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing arts purposes.
(h)Therapeutic radiation machines, when not in operation, must be secured to prevent unauthorized use.
(i)When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices must be used.
(j)No individual other than the patient must 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 must be protected by a barrier sufficient to meet the requirements of 333-120-0100 (Radiation Dose Limits: Occupational Dose Limits For Adults).
(k)When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light field.
(l)Written safety procedures and rules must be developed by a Qualified Medical Physicist and must 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 must be able to demonstrate familiarity with these rules.
(m)All individuals associated with the operation of a therapeutic radiation machine must be instructed in and must comply with the provisions of the registrant’s quality assurance program. In addition to the requirements of 333-123-0015 (Training and Qualification Requirements for Individuals in the External Beam Radiation Therapy Area), these individuals are also subject to the requirements of divisions 111 and 120.
(3)Calibration Of Radiation Survey Instruments. Radiation Survey Instrument(s) for Photon and Electron Beam Therapy Systems 1 MV and Above. Each facility location authorized to use a therapeutic radiation machine in accordance with these rules must possess appropriately calibrated portable radiation monitoring equipment. As a minimum, such equipment must include a portable radiation survey instrument capable of measuring dose rates over the range 10 µSv/hr (1 mrem/hr) to 10 mSv/hr (1000 mrem/hr) with an energy response appropriate to the system being surveyed.
(a)The registrant must ensure that the survey instruments, which are used to show compliance with this Division, have been calibrated before first use, at intervals not to exceed 12 months, and following repair; and
(b)To satisfy the requirements of this rule, the registrant must:
(A)Calibrate all required scale readings up to 10 mSv (1000 mrem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST); and
(B)The calibration must include at least 2 points on each scale tested. These points should be at approximately 1⁄3 and 2⁄3 of full-scale.
(c)To satisfy the requirements of section (3)(b)(B) of this rule, the registrant must:
(A)Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 10 percent; and
(B)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.
(d)The registrant must retain a record of each calibration required in section (3)(a) of this rule for 3 years. The record must include:
(A)A description of the instrument and the calibration procedure; and
(B)A description of the radiation 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.
(e)The registrant may obtain the services of individuals licensed by the Authority, the US Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform calibrations of survey instruments. Records of calibrations must contain information required by section (3)(d) of this rule and be maintained by the registrant.
(4)Radiation Protection Surveys. The registrant must ensure that radiation protection surveys are performed at new facilities, and existing facilities not previously surveyed. Surveys must be conducted with an operable radiation survey instrument calibrated in accordance with of section (3) of this rule. In new facilities, a radiation protection survey must be completed prior to the first clinical use of a therapeutic radiation machine following installation.
(a)For machines capable of photon output at 10MV or above, registrants must perform or arrange to have performed a radiation survey to monitor neutron dose rates. The radiation survey instrument(s) used must be capable of measuring neutron dose rates over the range of 10 µSv/hr (1 mrem/hr) to 10 mSv/hr (1000 mrem/hr). The radiation survey instrument(s) used to measure must be operable and calibrated in accordance with section (3) of this rule. Neutron monitoring must be done prior to first patient treatment; and
(b)The survey must be performed 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; and
(c)The radiation protection survey must be performed by, or under the direction of, a Qualified Medical Physicist or a Qualified Expert as defined in 333-100-0005 (Definitions).
(d)The Qualified Medical Physicist or Qualified Expert must verify that:
(A)Radiation levels in restricted areas are not likely to cause personnel to receive exposures in excess of the limits specified in 333-120-0100 (Radiation Dose Limits: Occupational Dose Limits For Adults)(1); and
(B)Radiation levels in unrestricted areas do not exceed the limits specified in 333-120-0180 (Radiation Dose Limits: Dose Limits for Individual Members of the Public) and 333-120-0190 (Radiation Dose Limits: Compliance with Dose Limits for Individual Members of the Public).
(e)In addition, a radiation protection survey must also be performed:
(A)Prior to any subsequent medical use; and
(B)After making any change in the treatment room shielding; and
(C)After making any change in the location of the therapeutic radiation machine within the treatment room; and
(D)After relocating the therapeutic radiation machine; or
(E)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.
(f)The radiation protection survey record must indicate all instances where the facility, in the opinion of the Qualified Medical Physicist or a Qualified Expert, is in violation of applicable regulations. The survey record must also include the:
(A)Date of the measurements; and
(B)Reason the survey is required; and
(C)Manufacturer’s name, model number and serial number of the therapeutic radiation machine; and
(D)Manufacturer and model of the instrument(s) used to measure radiation levels and date last calibrated; and
(E)A floor plan of the areas surrounding the treatment room that were surveyed; and
(F)Measured dose rate at several points in each area expressed in mSv/hr or mrems/hr; and
(G)Calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area; and
(H)Signature of the individual responsible for conducting the survey.
(g)If the results of the radiation protection survey indicate any radiation levels in excess of the respective limit specified in 333-120-0180 (Radiation Dose Limits: Dose Limits for Individual Members of the Public), the registrant must lock the control in the “OFF” position and not use the unit. The control must remain locked:
(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 Authority.
(h)If the radiation protection survey, indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 333-120-0180 (Radiation Dose Limits: Dose Limits for Individual Members of the Public)(1) and (2), before beginning the treatment program the registrant must:
(A)Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 333-120-0180 (Radiation Dose Limits: Dose Limits for Individual Members of the Public)(1) and (2); and
(B)Perform the survey required by these rules again; and
(C)Include in the report required by section (4)(f) of this rule the results of the initial survey, a description of the modification made to comply with section (4)(g)(A) of this rule, and the results of the second survey; or
(D)Request and receive a registration amendment under 333-120-0180 (Radiation Dose Limits: Dose Limits for Individual Members of the Public)(3) that authorizes radiation levels in unrestricted areas greater than those permitted by 333-120-0180 (Radiation Dose Limits: Dose Limits for Individual Members of the Public)(1) and (2).
(5)Dosimetry Equipment. The registrant must have a calibrated dosimetry system available for use. The calibration must be traceable to the appropriate national standard. The calibration must have been performed within the previous 24 months and after any servicing that may have affected system calibration and:
(a)The dosimetry system must have been calibrated at an energy appropriate for the radiation being measured.
(b)The registrant must 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 section (5)(a) of this rule. This comparison must have been performed within the previous 12 months and after each servicing that may have affected system calibration. The quality assurance system may be the same system used to meet the requirement in section (5)(a) of this rule.
(c)The registrant must 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 must include:
(B)The model numbers and serial numbers of the instruments that were calibrated, inter-compared, or compared as required by sections (5)(a) and (b) of this rule;
(C)The correction factors that were determined;
(D)The names of the individuals who performed the calibration, intercomparison, or comparison; and
(E)Evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a Qualified Medical Physicist.
(6)Reports Of External Beam Radiation Therapy Surveys And Measurements. The registrant for any therapeutic radiation machine subject to 333-123-0025 (Requirements for Therapeutic Radiation Machines) must furnish a copy of the records required in section (5)(c) of this rule to the Authority within 30 days following completion of the action that initiated the record requirement.
(7)Records Retention. All records required in this Division must be retained until disposal is authorized by the Authority unless another retention period is specifically authorized in the rule in this Division.
(a)All required records must be retained in an active file from at least the time of generation until the next Authority inspection.
(b)Any required record generated before the last Authority inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the Authority authorizes final disposal.
(c)The registrant must maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the Authority:
(A)Report of acceptance testing; and
(B)Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by 333-123-0040 (Quality Assurance And Safety Checks), as well as the name(s) and business addresses of person(s) who performed such activities; and
(C)Records of maintenance and/or modifications performed on the therapeutic radiation machine after January 30, 2007, as well as the name(s) of person(s) who performed such services; and
(D)Signature of the Qualified Medical Physicist or service engineer authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.
Rule 333-123-0010 — General Requirements, Operating Procedures, Surveys, Dosimetry, and Instrument Calibration for Facilities Using Therapeutic Radiation Machines,