Chapter 3701:1-58 | Medical Use of Radioactive Materials

(A) Before the first medical use of a brachytherapy source, a licensee shall have:(1) Determined the source output or activity using a dosimetry system that meets the requirements of paragraph (A) of rule 3701:1-58-60 of the Administrative Code;(2) Determined source positioning a…

(A) Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in paragraph (B) of this rule are performed by either:(1) An authorized medical physicist; or(2) An individual who:(a) Is identified as an ophthalmic physicist on a speci…

The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:(A…

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under rule 3701:1-58-43 of the Administrative Code to be a physician who:(A) Is certified by a medical specia…

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who:(A) Is an authorized user under rule 3701:1-58-51 of the Administrative Code, or equivalent United …

(A) A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the sealed source and device registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not exp…

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require the authorized user of a diagnostic sealed source or a device authorized under rule 3701:1-58-53 of the Administrative Code to be a physician, dentist, or podiatrist who:(A) Is certifie…

(A) A licensee must only use sealed sources:(1) Approved and as provided for in the sealed source and device registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses; or(2) In r…

(A) Before releasing a patient or a human research subject from licensee control, a licensee shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed…

(A) Only a person specifically licensed by the director, the United States nuclear regulatory commission, or an agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on th…

(A) A licensee shall:(1) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;(2) Permit only individuals approved by the authorized user, radiation safety officer, or authorized medical physicist to be present in the treatment room…

(A) A licensee shall control access to the treatment room by a door at each entrance.(B) A licensee shall equip each entrance to the treatment room with an electrical interlock system that will:(1) Prevent the operator from initiating the treatment cycle unless each treatment roo…

(A) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met:(1) T…

(A) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:(1) Before the first medical use of the unit;(2) Before medical use under the following conditions:(a) Whenever spot-check measurements, as des…

(A) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:(1) Before the first medical use of the unit;(2) Before medical use under the following conditions:(a) Following replacement of the source or follow…

(A) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:(1) Before the first medical use of the unit;(2) Before medical use under the following conditions:(a) Whenever spot-check measurements…

(A) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:(1) Timer accuracy, and timer linearity over the range of use;(2) On-off error;(3) The coincidenc…

(A) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:(1) Before the first use on any given day that a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader is i…

(A) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:(1) Monthly;(2) Before the first use of the unit on a given day; and(3) After each source installati…

(A) A licensee providing mobile remote afterloader service shall:(1) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and(2) Account for all sources before departure from a client's address of use.(B) In additio…

(A) In addition to the survey requirement in rule 3701:1-38-14 of the Administrative Code, a person subject to rules 3701:1-58-55 to 3701:1-58-71 of the Administrative Code shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surfac…

(A) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement, to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full-inspection se…

The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:(A…

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user of a sealed source for a use authorized under rule 3701:1-58-55 of the Administrative Code to be a physician who:(A) Is certified by a medical specialty board whose c…

A licensee may use radioactive material or a radiation source approved for medical use which is not specifically addressed in rules 3701:1-58-32, 3701:1-58-34, 3701:1-58-37, 3701:1-58-43, 3701:1-58-53 and 3701:1-58-55 of the Administrative Code if:(A) The applicant or licensee ha…

(A) A licensee shall retain a record of actions taken by the licensee's management in accordance with paragraph (A) of rule 3701:1-58-12 of the Administrative Code for five years. The record must include a summary of the actions taken and a signature of licensee management.(B) Th…

A licensee shall retain a record of each radiation protection program change made in accordance with paragraph (A) of rule 3701:1-58-13 of the Administrative Code for five years. The record must include a copy of the old and new procedures, the effective date of the change, and t…

For purposes of this chapter, a licensee shall retain a copy of each written directive as required by rule 3701:1-58-15 of the Administrative Code for three years. Last updated November 18, 2022 at 8:39 AM Authorized By: 3748.02, 3748.04 Amplifies: 3748.04 Five Year Review Date: …

For purposes of this chapter, a licensee shall retain a copy of the procedures required by paragraph (A) of rule 3701:1-58-16 of the Administrative Code for the duration of the license. Last updated November 18, 2022 at 8:39 AM Authorized By: 3748.02, 3748.04 Amplifies: 3748.04 F…

A licensee shall maintain a record of instrument calibrations required by rule 3701:1-58-23 of the Administrative Code for three years. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the nam…

A licensee shall maintain a record of radiation survey instrument calibrations required by rule 3701:1-58-24 of the Administrative Code for three years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibrat…

(A) For purposes of this chapter, a licensee shall maintain a record of dosage determinations required by rule 3701:1-58-25 of the Administrative Code for three years.(B) The record must contain:(1) The radiopharmaceutical;(2) The patient's or human research subject's name, or id…

(A) A licensee shall retain records of leak tests required by paragraph (B) of rule 3701:1-58-27 of the Administrative Code for three years. The records must include the model number, and serial number if one has been assigned, of each source tested; the identity of each source b…

A licensee shall retain a record of each survey required by rule 3701:1-58-29 of the Administrative Code for three years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performe…

(A) A licensee shall retain a record of the basis for authorizing the release of an individual in accordance with rule 3701:1-58-30 of the Administrative Code, if the total effective dose equivalent is calculated by:(1) Using the retained activity rather than the activity adminis…

(A) A licensee shall retain a copy of each letter that permits the use of radioactive material at a client's address, as required by paragraph (A)(1) of rule 3701:1-58-31 of the Administrative Code. Each letter must clearly delineate the authority and responsibility of the licens…

A licensee shall maintain records of the disposal of licensed materials, as required by rule 3701:1-38-19 of the Administrative Code, for three years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level…

A licensee shall maintain a record of the molybdenum-99 concentration or strontium-82 and strontium-85 concentration tests required by paragraph (B) of rule 3701:1-58-35 of the Administrative Code for three years. The record must include:(A) For each measured elution of technetiu…

A licensee shall maintain a record of safety instructions required by rules 3701:1-58-38, 3701:1-58-46 of the Administrative Code, and the operational and safety instructions required by rule 3701:1-58-58 of the Administrative Code, for three years. The record must include a list…

For purposes of this chapter, a licensee shall maintain a record of the surveys required by rules 3701:1-58-44 and 3701:1-58-56 of the Administrative Code for three years. Each record must include the date and results of the survey, the survey instrument used, and the name of the…

(A) A licensee shall maintain a record of brachytherapy source accountability required by rule 3701:1-58-45 of the Administrative Code for three years.(B) For temporary implants, the record must include:(1) The number and activity of sources removed from storage, the time and dat…

(A) A licensee shall maintain a record of the calibrations of brachytherapy sources required by rule 3701:1-58-48 of the Administrative Code for three years after the last use of the source.(B) The record must include:(1) The date of the calibration;(2) The manufacturer's name, m…

(A) A licensee shall maintain a record of the activity of a strontium-90 source required by rule 3701:1-58-49 of the Administrative Code for the life of the source.(B) The record must include:(1) The date and initial activity of the source as determined under rule 3701:1-58-48 of…

A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by rule 3701:1-58-57 of the Administrative Code for three years. For each installation, …

A licensee shall retain a copy of the procedures required by paragraphs (A)(4) and (D)(2) of rule 3701:1-58-58 of the Administrative Code until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit. Last updated Novembe…

(A) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with rule 3701:1-58-60 of the Administrative Code for the duration of the license.(B) For each calibration, intercomparison, or comparison, the …

(A) A licensee shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by rules 3701:1-58-61 to 3701:1-58-63 of the Administrative Code for three years.(B) The record must include:(1) The date o…