reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-41 - Training for the oral administration of sodium iodide iodine-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (thirty-three millicuries)

Current through all regulations passed and filed through July 1, 2024
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 less than or equal to
				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 paragraphs
			 (C)(1) and (C)(2) of this rule and whose certification process has been
			 recognized by the director, the United States
			 nuclear regulatory commission, or an agreement state . The names of board certifications which have been recognized by
			 the director, the United States nuclear
			 regulatory commission, or an agreement state will be posted on the United
			 States nuclear regulatory commission's "Medical Uses
			 Licensee Toolkit" web page at
www.nrc.gov
; or
(B) Is an authorized user under rule
			 3701:1-58-40
			 of the Administrative Code for uses listed in paragraph (B)(1)(b)(vi)(a) or
			 (B)(1)(b)(vi)(b) of rule
			 3701:1-58-40
			 of the Administrative Code, rule
			 3701:1-58-42
			 of the Administrative Code, or equivalent United States nuclear regulatory
			 commission or agreement state requirements; or
(C) Has achieved the following requirements:
(1) Has successfully completed eighty hours
			 of classroom and laboratory training, applicable to the medical use of sodium
			 iodide iodine-131 for procedures requiring a written directive. The training
			 must include:
(a) Radiation physics and
			 instrumentation;
(b) Radiation
			 protection;
(c) Mathematics
			 pertaining to the use and measurement of radioactivity;
(d) Chemistry of radioactive material for
			 medical use; and
(e) Radiation
			 biology;
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-42 - Training for the oral administration of sodium iodide iodine-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (thirty-three millicuries)

Current through all regulations passed and filed through July 1, 2024
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 paragraphs
			 (C)(1) and (C)(2) of this rule, and whose certification has been recognized by
			 the director, the United States nuclear
			 regulatory commission, or an agreement state. The names
			 of board certifications which have been recognized by the director,
			 the United States nuclear regulatory commission,
			 or an agreement state will be posted on the United States nuclear regulatory
			 commission's "Medical Uses Licensee Toolkit" web
			 page at
www.nrc.gov
.; or
(B) Is an authorized user under rule
			 3701:1-58-40
			 of the Administrative Code, for uses listed in paragraph (B)(1)(b)(vi)(b) of
			 rule
			 3701:1-58-40
			 of the Administrative Code, or equivalent United States nuclear regulatory
			 commission or agreement state requirements; or
(C) Has achieved the following requirements:
(1) Has successfully completed eighty hours
			 of classroom and laboratory training, applicable to the medical use of sodium
			 iodide iodine-131 for procedures requiring a written directive. The training
			 must include:
(a) Radiation physics and
			 instrumentation;
(b) Radiation
			 protection;
(c) Mathematics
			 pertaining to the use and measurement of radioactivity;
(d) Chemistry of radioactive material for
			 medical use; and
(e) Radiation
			 biology;
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-43 - Use of sources for manual brachytherapy

Current through all regulations passed and filed through July 1, 2024
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 source and device
			 registry; or
(B)
								In research to deliver therapeutic doses for medical
			 use in accordance with an active investigational device exemption application
			 accepted by the United States food and drug administration provided the
			 requirements of paragraph (A) of rule
			 3701:1-58-17
			 of the Administrative Code are met.
Replaces: 3701:1-58-43
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-44 - Surveys after source implant and removal

Current through all regulations passed and filed through July 1, 2024
(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 from a patient or a human research
			 subject.
(C) A licensee shall
			 retain a record of the surveys required by paragraphs (A) and (B) of this rule
			 in accordance with rule
			 3701:1-58-87
			 of the Administrative Code.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-45 - Brachytherapy sources accountability

Current through all regulations passed and filed through July 1, 2024
(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.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-46 - Safety instruction for manual brachytherapy

Current through all regulations passed and filed through July 1, 2024
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 duties of the personnel and include the:
(1) Size and appearance of the brachytherapy
			 sources;
(2) Safe handling and
			 shielding instructions;
(3) Patient
			 or human research subject control;
(4) Visitor control, including both:
(a) Routine visitation of hospitalized
			 individuals in accordance with paragraph (A)(1) of rule
			 3701:1-38-13
			 of the Administrative Code; and
(b)
			 Visitation authorized in accordance with paragraph (C) of rule
			 3701:1-38-13
			 of the Administrative Code; and
(5) Notification of the radiation safety
			 officer, or his or her designee, and an authorized user if the patient or the
			 human research subject has a medical emergency or dies.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-47 - Safety precautions for manual brachytherapy

Current through all regulations passed and filed through July 1, 2024
(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 the door or in the
			 patient's or human research subject's chart where and how long visitors may
			 stay in the patient's or human research subject's room.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-48 - Calibration measurements of brachytherapy sources

Current through all regulations passed and filed through July 1, 2024
(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 requirements of paragraphs
			 (A)(1) and (A)(2) of this rule.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-49 - Strontium-90 sources for ophthalmic treatments

Current through all regulations passed and filed through July 1, 2024
(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;
			 permit issued by a United States nuclear regulatory commission or an agreement
			 state broad scope medical use licensee; medical use permit issued by a United
			 States nuclear regulatory commission master material licensee; or permit issued
			 by a United States nuclear regulatory commission master material licensee broad
			 scope medical use permittee; and
(b)
										Holds a master's
			 or doctor's degree in physics, medical physics, other physical sciences,
			 engineering, or applied mathematics from an accredited college or university;
			 and
(c)
										Has successfully completed one year of full-time
			 training in medical physics and an additional year of full-time work experience
			 under the supervision of a medical physicist; and
(d)
										Has documented
			 training in:
(i)
											The creation, modification, and completion of written
			 directives;
(ii)
											Procedures for administrations requiring a written
			 directive; and
(iii)
											Performing the calibration measurements of
			 brachytherapy sources as detailed in rule
			 3701:1-58-48
			 of the Administrative Code.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-50 - Therapy-related computer systems for manual brachytherapy

Current through all regulations passed and filed through July 1, 2024
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) The source-specific input parameters
			 required by the dose calculation algorithm;
(B) The accuracy of dose, dwell time, and
			 treatment time calculations at representative points;
(C) The accuracy of isodose plots and graphic
			 displays; and
(D) The accuracy of
			 the software used to determine sealed source positions from radiographic
			 images.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-51 - Training for use of manual brachytherapy sources

Current through all regulations passed and filed through July 1, 2024
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, or an agreement state. The names of board
			 certifications which have been recognized by the director, the United States
			 nuclear regulatory commission, or an agreement state will be posted on the
			 United States nuclear regulatory commission's "Medical Uses Licensee Toolkit"
			 web page at
www.nrc.gov
. To have its
			 certification process recognized, a specialty board shall require all
			 candidates for certification to:
(1)
			 Successfully complete a minimum of three years of residency training in a
			 radiation oncology program approved by the "Residency Review Committee of the
			 Accreditation Council for Graduate Medical Education" or the "Royal College of
			 Physicians and Surgeons of Canada" or the "
									Council on Postdoctoral
			 Training of the American Osteopathic Association"; and
(2) Pass an examination, administered by
			 diplomats of the specialty board, that tests knowledge and competence in
			 radiation safety, radionuclide handling, treatment planning, quality assurance,
			 and clinical use of manual brachytherapy; or
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-52 - Training for ophthalmic use of strontium-90

Current through all regulations passed and filed through July 1, 2024
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 twenty-four hours of
			 classroom and laboratory training applicable to the medical use of strontium-90
			 for ophthalmic radiotherapy. The training must include:
(a) Radiation physics and
			 instrumentation;
(b) Radiation
			 protection;
(c) Mathematics
			 pertaining to the use and measurement of radioactivity; and
(d) Radiation biology;
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-53 - Use of sealed sources and medical devices for diagnosis

Current through all regulations passed and filed through July 1, 2024
(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 conditions and limitations described in the sealed source
			 and device registry.
(B)
								A licensee must only use medical devices containing
			 sealed sources for diagnostic medical uses if both the sealed sources and
			 medical devices are approved in the sealed source and device registry for
			 diagnostic medical uses. The diagnostic medical devices 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
			 conditions and limitations described in the sealed source and device
			 registry.
(C)
								Sealed sources and devices for diagnostic medical uses
			 may be used in research in accordance with an active investigational device
			 exemption (IDE) application accepted by the United States food and drug
			 administration provided the requirements of paragraph (A) of rule
			 3701:1-58-17
			 of the Administrative Code are met.
Replaces: 3701:1-58-53
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-54 - Training for use of sealed sources and medical devices for diagnosis

Current through all regulations passed and filed through July 1, 2024
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 and whose certification has
			 been recognized by the director, United States nuclear regulatory commission,
			 or an agreement state. The names of board certifications which have been
			 recognized by the director, the United States
			 nuclear regulatory commission, or an agreement state will be posted on the
			 United States nuclear regulatory commission's "Medical
			 Uses Licensee Toolkit" web page at
www.nrc.gov
; or
(B)
								Is an authorized
			 user for uses listed in rule
			 3701:1-58-34
			 of the Administrative Code, or equivalent United States nuclear regulatory
			 commission or agreement state requirements; or
(C) Has completed
			 eight hours of classroom and laboratory training in basic radionuclide handling
			 techniques specifically applicable to the use of the device. The training must
			 include:
(1) Radiation physics and
			 instrumentation;
(2) Radiation
			 protection;
(3) Mathematics
			 pertaining to the use and measurement of radioactivity; and
(4) Radiation biology; and
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-55 - Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit

Current through all regulations passed and filed through July 1, 2024
(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 radiosurgery units
			 in accordance with an active investigational device exemption (IDE) application
			 accepted by the United States food and drug administration provided the
			 requirements of paragraph (A) of rule
			 3701:1-58-17
			 of the Administrative Code are met.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-56 - Surveys of patients and human research subjects treated with a remote afterloader unit

Current through all regulations passed and filed through July 1, 2024
(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 surveys in accordance with rule
			 3701:1-58-87
			 of the Administrative Code.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-57 - Installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
(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 shielding around the
			 source(s), or compromise the radiation safety of the unit or the
			 source(s).
(B) Except for low
			 dose-rate remote afterloader units, only a person specifically licensed by the
			 director, United States nuclear regulatory commission, or an agreement state
			 shall install, replace, relocate, or remove a sealed source or source contained
			 in other remote afterloader units, teletherapy units, or gamma stereotactic
			 radiosurgery units.
(C) For a low
			 dose-rate remote afterloader unit, only a person specifically licensed by the
			 director, United States nuclear regulatory commission, or an agreement state,
			 or an authorized medical physicist shall install, replace, relocate, or remove
			 a sealed source(s) contained in the unit.
(D) A licensee shall retain a record of the
			 installation, maintenance, adjustment, and repair of remote afterloader units,
			 teletherapy units, and gamma stereotactic radiosurgery units in accordance with
			 rule
			 3701:1-58-91
			 of the Administrative Code.
Effective: 8/10/2015
Five Year
				Review (FYR) Dates: 05/26/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005, 10/4/10
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-58 - Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
(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 applicable; and
(4) Develop, implement, and maintain written
			 procedures for responding to an abnormal situation when the operator is unable
			 to place the source(s) in the shielded position, or remove the patient or human
			 research subject from the radiation field with controls from outside the
			 treatment room. These procedures must include:
(a) Instructions for responding to equipment
			 failures and the names of the individuals responsible for implementing
			 corrective actions;
(b) The process
			 for restricting access to and posting of the treatment area to minimize the
			 risk of inadvertent exposure; and
(c) The names and telephone numbers of the
			 authorized users, the authorized medical physicist, and the radiation safety
			 officer to be contacted if the unit or console operates abnormally.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-59 - Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
(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 room entrance door is closed;
(2) Cause the source(s) to be shielded when
			 an entrance door is opened; and
(3) Prevent the source(s) from being exposed
			 following an interlock interruption until all treatment room entrance doors are
			 closed and the source(s) on-off control is reset at the console.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-60 - Dosimetry equipment

Current through all regulations passed and filed through July 1, 2024
(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 published protocols
			 accepted by nationally recognized bodies; or by a calibration laboratory
			 accredited by the "American Association of Physicists
			 in Medicine" (AAPM). The calibration must have been performed within the
			 previous two years and after any servicing that may have affected system
			 calibration; or
(2) The system
			 must have been calibrated within the previous four years. Eighteen to thirty
			 months after that calibration, the system must have been intercompared with
			 another dosimetry system that was calibrated within the past twenty-four months
			 by NIST or by a calibration laboratory accredited by the AAPM. The results of
			 the intercomparison must indicate that the calibration factor of the licensee's
			 system had not changed by more than two per cent. The
			 licensee may not use the intercomparison result to change the calibration
			 factor. When intercomparing dosimetry systems to be used for calibrating sealed
			 sources for therapeutic units, the licensee shall use a comparable unit with
			 beam attenuators or collimators, as applicable, and sources of the same
			 radionuclide as the source used at the licensee's facility.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-61 - Full calibration measurements on teletherapy units

Current through all regulations passed and filed through July 1, 2024
(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 described in rule
			 3701:1-58-64
			 of the Administrative Code, indicate that the output differs by more than five
			 per
			 cent from the output obtained at the last full calibration corrected
			 mathematically for radioactive decay;
(b) Following replacement of the source or
			 following reinstallation of the teletherapy unit in a new location;
(c) Following any repair of the teletherapy
			 unit that includes removal of the source or major repair of the components
			 associated with the source exposure assembly; and
(3) At intervals not exceeding one year.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-62 - Full calibration measurements on remote afterloader units

Current through all regulations passed and filed through July 1, 2024
(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 following reinstallation of the unit in a new location outside the
			 facility; and
(b) Following any
			 repair of the unit that includes removal of the source or major repair of the
			 components associated with the source exposure assembly;
(3) At intervals not exceeding one quarter
			 for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader
			 units with sources whose half-life exceeds seventy-five days; and
(4) At intervals not exceeding one year for
			 low dose-rate remote afterloader units.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-63 - Full calibration measurements on gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
(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, as
			 described in rule
			 3701:1-58-66
			 of the Administrative Code, indicate that the output differs by more than five
			 per
			 cent from the output obtained at the last full calibration corrected
			 mathematically for radioactive decay;
(b) Following replacement of the sources or
			 following reinstallation of the gamma stereotactic radiosurgery unit in a new
			 location; and
(c) Following any
			 repair of the gamma stereotactic radiosurgery unit that includes removal of the
			 sources or major repair of the components associated with the source assembly;
			 and
(3) At intervals
			 not exceeding one year, with the exception that relative helmet factors need
			 only be determined before the first medical use of a helmet and following any
			 damage to a helmet.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-64 - Periodic spot-checks for teletherapy units

Current through all regulations passed and filed through July 1, 2024
(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 coincidence of the
			 radiation field and the field indicated by the light beam localizing device;
(4) The accuracy of all distance
			 measuring and localization devices used for medical use;
(5) The output for one typical set of
			 operating conditions measured with the dosimetry system described in paragraph
			 (B) of rule
			 3701:1-58-60;
			 and
(6) The difference between the
			 measurement made in paragraph (A)(5) of this rule and the anticipated output,
			 expressed as a percentage of the anticipated output (i.e., the value obtained
			 at last full calibration corrected mathematically for radioactive decay).
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-65 - Periodic spot-checks for remote afterloader units

Current through all regulations passed and filed through July 1, 2024
(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 in operation;
(2) Before each
			 patient treatment with a low dose-rate remote afterloader unit; and
(3) After each source installation.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-66 - Periodic spot-checks for gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
(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 installation.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-67 - Additional technical requirements for mobile remote afterloader units

Current through all regulations passed and filed through July 1, 2024
(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.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-68 - Radiation surveys for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
(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 surface of the main
			 source safe with the source(s) in the shielded position do not exceed the
			 levels stated in the sealed source and device registry.
(B) The licensee shall make the survey
			 required by paragraph (A) of this rule at installation of a new source and
			 following repairs to the source(s) shielding, the source(s) driving unit, or
			 other electronic or mechanical component that could expose the source, reduce
			 the shielding around the source(s), or compromise the radiation safety of the
			 unit or the source(s).
(C) A
			 licensee shall retain a record of the radiation surveys required by paragraph
			 (A) of this rule in accordance with rule
			 3701:1-58-99
			 of the Administrative Code.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005, 10/4/10
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-69 - Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
(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 servicing shall not
			 exceed five years for each teletherapy unit and shall not exceed seven years
			 for each gamma stereotactic radiosurgery unit.
(B) This inspection and servicing may only be
			 performed by persons specifically licensed to do so by the director, the United
			 States nuclear regulatory commission, or an agreement state.
(C) A licensee shall keep a record of the
			 inspection and servicing in accordance with rule
			 3701:1-58-100
			 of the Administrative Code.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-70 - Therapy-related computer systems for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
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) The source-specific input parameters
			 required by the dose calculation algorithm;
(B) The accuracy of dose, dwell time, and
			 treatment time calculations at representative points;
(C) The accuracy of isodose plots and graphic
			 displays;
(D) The accuracy of the
			 software used to determine sealed source positions from radiographic images;
			 and
(E) The accuracy of electronic
			 transfer of the treatment delivery parameters to the treatment delivery unit
			 from the treatment planning system.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-71 - Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
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 certification process has been recognized by the director, the United
			 States nuclear regulatory commission, or an agreement state and who meets the
			 requirements in paragraph (C) of this rule. The names of board certifications
			 which have been recognized by the director, the United States nuclear
			 regulatory commission, or an agreement state will be posted on the United
			 States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page
			 at
www.nrc.gov
. To have its certification
			 process recognized, a specialty board shall require all candidates for
			 certification to:
(1) Successfully complete a
			 minimum of three years of residency training in a radiation therapy program
			 approved by the "Residency Review Committee of the Accreditation Council for
			 Graduate Medical Education" or the "Royal College of Physicians and Surgeons of
			 Canada" or the "
									Council on Postdoctoral Training of the American
			 Osteopathic Association"; and
(2)
			 Pass an examination, administered by diplomats of the specialty board, which
			 tests knowledge and competence in radiation safety, radionuclide handling,
			 treatment planning, quality assurance, and clinical use of stereotactic
			 radiosurgery, remote afterloaders and external beam therapy; or
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-72 - Other medical uses of radioactive material or radiation from radioactive material

Current through all regulations passed and filed through July 1, 2024
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 has submitted the information required by paragraphs
			 (B) to (D) of rule
			 3701:1-58-07
			 of the Administrative Code; and
(B) The applicant or licensee has received
			 written approval from the director in a license or license amendment and uses
			 the material in accordance with the regulations and specific conditions the
			 director considers necessary for the medical use of the material.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748 .02, 3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-73 - Records of authority and responsibilities for radiation protection programs

Current through all regulations passed and filed through July 1, 2024
(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) The licensee shall retain
			 a
			 record of the authority, duties, and responsibilities of the radiation
			 safety officer as required by paragraph (E) of rule
			 3701:1-58-12
			 of the Administrative Code, and a signed copy of each radiation safety
			 officer's agreement to be responsible for implementing the radiation safety
			 program, as required by paragraph (B) of rule
			 3701:1-58-12
			 of the Administrative Code, for the duration of the license. The records must
			 include the signature of the radiation safety officer and licensee
			 management.
(C)
								For each associate radiation safety officer appointed
			 under paragraph (B) of rule
			 3701:1-58-12
			 of the Administrative Code, the licensee shall retain, for five years after the
			 associate radiation safety officer is removed from the license, a copy of the
			 written document appointing the associate radiation safety officer signed by
			 the licensee's management.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-74 - Records of radiation protection program changes

Current through all regulations passed and filed through July 1, 2024
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 the signature of the licensee management that
				reviewed and approved the change.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3748.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005, 10/4/10
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-75 - Records of written directives

Current through all regulations passed and filed through July 1, 2024
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.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3743.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-76 - Records for procedures for administrations requiring a written directive

Current through all regulations passed and filed through July 1, 2024
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.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3743.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-77 - Records of calibrations of instruments used to measure the activity of unsealed radioactive material

Current through all regulations passed and filed through July 1, 2024
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 name of the individual who performed the
				calibration.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3743.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-78 - Records of radiation survey instrument calibrations

Current through all regulations passed and filed through July 1, 2024
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 calibration, and the name of the individual who performed the
				calibration.
Five Year Review (FYR) Dates:
				06/12/2015 and
				06/01/2020
Promulgated
				Under: 119.03
Statutory
				Authority: 3743.02,
				3748.04
Rule
				Amplifies: 3748.04
Prior
				Effective Dates: 8/15/2005
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-79 - Records of dosages of unsealed radioactive material for medical use

Current through all regulations passed and filed through July 1, 2024
(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 identification number if one has been assigned;
(3) The prescribed dosage, the determined
			 dosage, or a notation that the total activity is less than 1.1
			 megabecquerels
									(thirty microcuries);
(4) The date and time of the
			 dosage determination; and
(5) The
			 name of the individual who determined the dosage.