Ohio Administrative Code Search

...Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user for the oral administration of sodium iodide iodine-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (thirty-three millicuries) to be a physician who: (A) Is certified by a medical specialty board whose certification process includes all of the requirements in ...

...A licensee shall use only brachytherapy sources for therapeutic medical uses: (A) As approved in the sealed source and device registry; or (B) In research in accordance with an active investigational device exemption application accepted by the United States food and drug administration provided the requirements of rule 3701:1-58-17 of the Administrative Code are met.

...A licensee shall use only brachytherapy sources: (A) As approved in the sealed source and device registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the sealed source and device registry, but must be used in accordance with the radiation safety conditions and limitations described in the sealed s...

...(A) The licensee shall make a survey to locate and account for all sources that have not been implanted immediately after implanting sources in a patient or a human research subject. (B) The licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed immediately after removing the last temporary implant source fr...

...(A) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use. (B) As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area. (C) A licensee shall maintain a record of the brachytherapy source accountability in accordance with rule 3701:1-58-88 of the Administrative Code.

...In addition to the requirements of rule 3701:1-38-10 of the Administrative Code: (A) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under rule 3701:1-58-30 of the Administrative Code. To satisfy this requirement, the instruction must be commensurate with the du...

...(A) For each patient or human research subject who is receiving brachytherapy and cannot be released under rule 3701:1-58-30 of the Administrative Code, a licensee shall: (1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy; (2) Visibly post the patient's or human research subject's room with a "radioactive materials" sign; and (3) Note on t...

...(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 accuracy within applicators; and (3) Used published protocols currently accepted by nationally recognized bodies to meet the requirement...

...(A) Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under rule 3701:1-58-48 of the Administrative Code. (B) A licensee shall retain a record of the activity of each strontium-90 source in accordance with rule 3701:1-58-90 of the Administrative Code...

...(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 specific medical use license issued by the director, United States nuclear regulatory commission or an agreement state; per...

...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 specialty board whose certification process has been recognized by the director, United States nuclear regulatory commission, or an agreement st...

...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 specialty board whose certification process has been recognized by the director, the United States nuclear regulatory commission, ...

...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 specialty board whose certification process has been recognized by the director, the United States nuclear regulatory commission, ...

...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 States nuclear regulatory commission or agreement state requirements; or (B) Has achieved the following requirements: (1) Has completed...

...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 States nuclear regulatory commission or agreement state requirements; or (B) Has achieved the following requirements: (1...

...(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 explicitly listed in the sealed source and device registry but must be used in accordance with the radiation safety con...

...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 for use in a device authorized under rule 3701:1-58-53 of the Administrative Code to be a physician, dentist, or podiatrist who: (A) Is certified by a specialty board whose certification process includes all of the requirements in paragraphs (B) and (C) of this rule and who...

...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 certified by a specialty board whose certification process includes all of the requirements in paragraphs (C) and (D) of this rule a...

...A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses: (A) As approved in the sealed source and device registry; or (B) In research in accordance with an active investigational device exemption application accepted by the United States food and drug administration provided the requirements of paragrap...

...(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 research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurger...

...(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 from the patient or human research subject and returned to the safe shielded position. (B) A licensee shall retain a record of these surve...

...(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 the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the s...

...(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 during treatment with the source(s); (3) Prevent dual operation of more than one radiation producing device in a treatment room if app...

...(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 during treatment with the source(s); (3) Prevent dual operation of more than one radiation producing device in...

...(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) The system must have been calibrated using a system or source traceable to the "National Institute of Standards and Technology" (NIST) and...