reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-80 - Records of leaks tests and inventory of sealed sources and brachytherapy sources

Current through all regulations passed and filed through July 1, 2024
(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 by radionuclide and its estimated activity; the results
			 of the test; the date of the test; and the name of the individual who performed
			 the test.
(B) A licensee shall
			 retain records of the semi-annual physical inventory of sealed sources and
			 brachytherapy sources required by paragraph (G) of rule
			 3701:1-58-27
			 of the Administrative Code for three years. The inventory records must contain
			 the model number of each source, and serial number if one has been assigned,
			 the identity of each source by radionuclide and its nominal activity, the
			 location of each source, and the name of the individual who performed the
			 inventory.
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 3701:1-58-81 - Records of surveys for ambient radiation exposure rate

Current through all regulations passed and filed through July 1, 2024
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 performed the survey.
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 3701:1-58-82 - Records of the release of individuals containing unsealed radioactive material or implants containing radioactive material

Current through all regulations passed and filed through July 1, 2024
(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 administered;
(2) Using an occupancy factor less than 0.25
			 at one meter;
(3) Using the
			 biological or effective half-life; or
(4) Considering the shielding by tissue.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-83 - Records of mobile medical services

Current through all regulations passed and filed through July 1, 2024
(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 licensee and the client and must be retained for
			 three years after the last provision of service.
(B) A licensee shall retain the record of
			 each survey required by paragraph (A)(4) of rule
			 3701:1-58-31
			 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 performed the survey.
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 3701:1-58-84 - Records of decay-in-storage

Current through all regulations passed and filed through July 1, 2024
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 measured at the surface of each waste container, and the name
				of the individual who performed the survey.
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 3701:1-58-85 - Records of molybdenum-99, strontium-82, and strontium-85 concentrations

Current through all regulations passed and filed through July 1, 2024
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 technetium-99m, the ratio of the measures expressed as
			 kilobecquerel (microcuries) of molybdenum-99 per megabecquerel (millicurie) of
			 technetium-99m, the time and date of the measurement, and the name of the
			 individual who made the measurement; or
(B)
								 For each
			 measured elution of rubidium-82, the ratio of the measures expressed as
			 kilobecquerel (microcuries) of strontium-82 per megabecquerel (millicurie) of
			 rubidium-82, kilobecquerel (microcuries) of strontium-85 per megabecquerel
			 (millicurie) of rubidium-82, the time and date of the measurement, and the name
			 of the individual who made the measurement.
Replaces: 3701:1-58-85
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 3701:1-58-86 - Records of safety instruction

Current through all regulations passed and filed through July 1, 2024
A licensee shall maintain a record of safety instructions
				required by rules
				3701:1-58-38,
				3701:1-58-46of 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 of
				the topics covered, the date of the instruction, the name(s) of the
				attendee(s), and the name(s) of the individual(s) who provided the
				instruction.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-87 - Records of surveys after source implant and removal

Current through all regulations passed and filed through July 1, 2024
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
				individual who made the survey.
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 3701:1-58-88 - Records of brachytherapy source accountability

Current through all regulations passed and filed through July 1, 2024
(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 date they were removed from storage,
			 the name of the individual who removed them from storage, and the location of
			 use; and
(2) The number and
			 activity of sources returned to storage, the time and date they were returned
			 to storage, and the name of the individual who returned them to storage.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-89 - Records of calibration measurements of brachytherapy sources

Current through all regulations passed and filed through July 1, 2024
(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, model number,
			 and serial number for the source and the instruments used to calibrate the
			 source;
(3) The source output or
			 activity;
(4) The source
			 positioning accuracy within the applicators; and
(5) The name of the individual, the source
			 manufacturer, or the calibration laboratory that performed the calibration.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-90 - Records of decay of strontium-90 sources for ophthalmic treatments

Current through all regulations passed and filed through July 1, 2024
(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 the Administrative Code; and
(2) For each decay calculation, the date and
			 the source activity as determined under rule
			 3701:1-58-49
			 of the Administrative Code.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-91 - Records of 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 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, maintenance,
				adjustment and repair, the record must include the date, description of the
				service, and name(s) of the individual(s) who performed the work.
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 3701:1-58-92 - Records of safety procedures for remote afterloaders, teletherapy units, or gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
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.
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, 10/4/10
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-93 - Records of dosimetry equipment used with 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 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 record must include:
(1) The
			 date;
(2) The manufacturer's name,
			 model numbers and serial numbers of the instruments that were calibrated,
			 intercompared, or compared as required by paragraphs (A) and (B) of rule
			 3701:1-58-60
			 of the Administrative Code;
(3)
			 The correction factor that was determined from the calibration or comparison or
			 the apparent correction factor that was determined from an intercomparison; and
(4) The names of the individuals
			 who performed the calibration, intercomparison, or comparison.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-94 - Records of full calibrations for teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
(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 of the calibration;
(2) The manufacturer's name, model number,
			 and serial number of the teletherapy, remote afterloader, and gamma
			 stereotactic radiosurgery unit(s), the source(s), and the instruments used to
			 calibrate the unit(s);
(3) The
			 results and an assessment of the full calibrations;
(4) The results of the autoradiograph
			 required for low dose-rate remote afterloader units; and
(5) The signature of the authorized medical
			 physicist who performed the full calibration.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-95 - Records of periodic spot-checks for teletherapy units

Current through all regulations passed and filed through July 1, 2024
(A) A licensee
			 shall retain a record of each periodic spot-check for teletherapy units
			 required by rule
			 3701:1-58-64
			 of the Administrative Code for three years.
(B) The record must include:
(1) The date of the spot-check;
(2) The manufacturer's name, model number,
			 and serial number of the teletherapy unit, source and instrument used to
			 measure the output of the teletherapy unit;
(3) An assessment of timer linearity and
			 constancy;
(4) The calculated
			 on-off error;
(5) A determination
			 of the coincidence of the radiation field and the field indicated by the light
			 beam localizing device;
(6) The
			 determined accuracy of each distance measuring and localization device;
(7) The difference between the
			 anticipated output and the measured output;
(8) Notations indicating the operability of
			 each entrance door electrical interlock, each electrical or mechanical stop,
			 each source exposure indicator light, and the viewing and intercom system and
			 doors; and
(9) The name of the
			 individual who performed the periodic spot-check and the signature of the
			 authorized medical physicist who reviewed the record of the spot-check.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-96 - Records of periodic spot-checks for remote afterloader units

Current through all regulations passed and filed through July 1, 2024
(A) A licensee
			 shall retain a record of each spot-check for remote afterloader units required
			 by rule
			 3701:1-58-65
			 of the Administrative Code for three years.
(B) The record must include, as applicable:
(1) The date of the spot-check;
(2) The manufacturer's name, model number,
			 and serial number for the remote afterloader unit and source;
(3) An assessment of timer accuracy;
(4) Notations indicating the
			 operability of each entrance door electrical interlock, radiation monitors,
			 source exposure indicator lights, viewing and intercom systems, and clock and
			 decayed source activity in the unit's computer; and
(5) The name of the individual who performed
			 the periodic spot-check and the signature of the authorized medical physicist
			 who reviewed the record of the spot-check.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-97 - Records of periodic spot-checks for gamma stereotactic radiosurgery units

Current through all regulations passed and filed through July 1, 2024
(A) A licensee shall retain a record of each
			 spot-check for gamma stereotactic radiosurgery units required by rule
			 3701:1-58-66
			 of the Administrative Code for three years.
(B) The record must include:
(1) The date of the spot-check;
(2) The manufacturer's name, model number,
			 and serial number for the gamma stereotactic radiosurgery unit and the
			 instrument used to measure the output of the unit;
(3) An assessment of timer linearity and
			 accuracy;
(4) The calculated
			 on-off error;
(5) A determination
			 of trunnion centricity;
(6) The
			 difference between the anticipated output and the measured output;
(7) An assessment of source output against
			 computer calculations;
(8)
			 Notations indicating the operability of radiation monitors, helmet
			 microswitches, emergency timing circuits, emergency off buttons, electrical
			 interlocks, source exposure indicator lights, viewing and intercom systems,
			 timer termination, treatment table retraction mechanism, and stereotactic
			 frames and localizing devices (trunnions); and
(9) The name of the individual who performed
			 the periodic spot-check and the signature of the authorized medical physicist
			 who reviewed the record of the spot-check.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-98 - Records of additional technical requirements for mobile remote afterloader units

Current through all regulations passed and filed through July 1, 2024
(A) A licensee shall retain a record of each
			 check for mobile remote afterloader units required by rule
			 3701:1-58-67
			 of the Administrative Code for three years.
(B) The record must include:
(1) The date of the check;
(2) The manufacturer's name, model number,
			 and serial number of the remote afterloader unit;
(3) Notations accounting for all sources
			 before the licensee departs from a facility;
(4) Notations indicating the operability of
			 each entrance door electrical interlock, radiation monitors, source exposure
			 indicator lights, viewing and intercom system, applicators, source transfer
			 tubes, and transfer tube applicator interfaces, and source positioning
			 accuracy; and
(5) The signature of
			 the individual who performed the check.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-99 - Records of surveys of therapeutic treatment units

Current through all regulations passed and filed through July 1, 2024
(A) A licensee
			 shall maintain a record of radiation surveys of treatment units made in
			 accordance with rule
			 3701:1-58-68
			 of the Administrative Code for the duration of use of the unit.
(B) The record must include:
(1) The date of the measurements;
(2) The manufacturer's name, model number and
			 serial number of the treatment unit, source, and instrument used to measure
			 radiation levels;
(3) Each dose
			 rate measured around the source while the unit is in the off position and the
			 average of all measurements; and
(4) The signature of the individual who
			 performed the test.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-100 - Records of 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 maintain a record of the
			 full-inspection servicing for teletherapy and gamma
			 stereotactic radiosurgery units required by rule
			 3701:1-58-69
			 of the Administrative Code for the duration of use of the unit.
(B) The record must contain:
(1) The inspector's radioactive materials
			 license number;
(2) The date of
			 inspection;
(3) The manufacturer's
			 name and model number and the serial number of
			 both the treatment unit and source;
(4) A list of components inspected and
			 serviced, and the type of service; and
(5) The signature of the inspector.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-101 - Report and notification of a medical event

Current through all regulations passed and filed through July 1, 2024
(A) A licensee shall report any event as a
			 medical event, except for an event that results from patient intervention, in
			 which:
(1) The administration of radioactive
			 material or radiation from radioactive material, except permanent implant
			 brachytherapy, results in:
(a) A dose that
			 differs from the prescribed dose or dose that would have resulted from the
			 prescribed dosage by more than
			 0.05 sievert (five rem)
			 effective dose equivalent,
			 0.5 sievert (fifty rem) to an
			 organ or tissue, or 0.5 sievert (fifty rem) shallow
			 dose equivalent to the skin; and
(i) The
			 total dose delivered differs from the prescribed dose by twenty per cent or
			 more;
(ii) The total dosage
			 delivered differs from the prescribed dosage by twenty per cent or more or
			 falls outside the prescribed dosage range; or
(iii) The fractionated dose delivered differs
			 from the prescribed dose for a single fraction, by fifty per cent or
			 more.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-102 - Report and notification of a dose to an embryo/fetus or a nursing child

Current through all regulations passed and filed through July 1, 2024
(A) A licensee shall report any dose to an
			 embryo/fetus that is greater than fifty millisievert (five rem) dose equivalent
			 that is a result of an administration of radioactive material or radiation from
			 radioactive material to a pregnant individual unless the dose to the
			 embryo/fetus was specifically approved, in advance, by the authorized
			 user.
(B) A licensee shall report
			 any dose to a nursing child that is a result of an administration of
			 radioactive material to a breast-feeding individual that:
(1) Is greater than fifty millisievert (five
			 rem) total effective dose equivalent; or
(2) Has resulted in unintended permanent
			 functional damage to an organ or a physiological system of the child, as
			 determined by a physician.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-103 - Report of a leaking source

Current through all regulations passed and filed through July 1, 2024
A licensee shall file a report within five days if a leak test
				required by rule
				3701:1-58-27
				of the Administrative Code reveals the presence of one hundred eighty-five
				becquerels
								(0.005microcurie) or more of removable contamination. The
				report must be filed with the address listed in rule
				3701:1-40-04 of
				the Administrative Code. The written report must include the model number and
				serial number if assigned, of the leaking source; the radionuclide and its
				estimated activity; the results of the test; the date of the test; and the
				action taken.
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, 10/4/10
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-104 - Training for the parenteral administration of unsealed radioactive material requiring a written directive

Current through all regulations passed and filed through July 1, 2024
(A)
								Except as
			 provided in rule
			 3701:1-58-21
			 of the Administrative Code, the licensee shall require an authorized user for
			 the parenteral administration of unsealed radioactive material requiring a
			 written directive, to be a physician who:
(1)
									Is an authorized
			 user under rule
			 3701:1-58-40
			 of the Administrative Code for uses listed in paragraph (B)(1)(b)(vi)(c) of
			 rule
			 3701:1-58-40
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission or agreement state requirements; or
(2)
									Is an authorized
			 user under rule
			 3701:1-58-51
			 or
			 3701:1-58-71
			 of the Administrative code, or equivalent United States nuclear regulatory
			 commission or agreement state requirements and who meets the requirements in
			 paragraph (B) of this rule; or
(3)
									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 under rule
			 3701:1-58-51
			 or
			 3701:1-58-71
			 of the Administrative Code, and who meets the requirements in paragraph (B) of
			 this rule.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-58 - Medical Use of Radioactive Materials › Section 3701:1-58-105 - Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations

Current through all regulations passed and filed through July 1, 2024
(A)
								The licensee
			 shall notify by telephone the department at 614-644-2727 and the distributor of
			 the generator within seven calendar days after discovery that an eluate
			 exceeded the permissible concentration listed in paragraph (A) of rule
			 3701:1-58-35
			 of the Administrative Code at the time of generator elution. The telephone
			 report to the department must include the manufacturer, model number, and
			 serial number (or lot number) of the generator; the results of the measurement;
			 the date of the measurement; whether dosages were administered to patients or
			 human research subjects, when the distributor was notified, and the action
			 taken.
(B)
								By an appropriate method listed in rule
			 3701:1-40-04 of
			 the Administrative Code, the licensee shall submit a written report to the
			 department within thirty calendar days after discovery of an eluate exceeding
			 the permissible concentration at the time of generator elution. The written
			 report must include the action taken by the licensee; the patient dose
			 assessment; the methodology used to make this dose assessment if the eluate was
			 administered to patients or human research subjects; and the probable cause and
			 an assessment of failure in the licensee's equipment, procedures or training
			 that contributed to the excessive readings if an error occurred in the
			 licensee's breakthrough determination; and the information in the telephone
			 report as required by paragraph (A) of this rule.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-02 - General administration requirements for medical radiation-generating equipment

Current through all regulations passed and filed through July 1, 2024
As used in this rule, "radiation-generating equipment" means
				radiation-generating equipment used for dental,
				veterinary, or medical purpose but does not include
				therapeutic radiation-generating equipment.
(A) The director
			 may, upon application thereof or upon his or her own initiative, grant a
			 variance to the requirements of rules in this chapter as he or she determines
			 is authorized by law, provided that the registrant shows to the satisfaction of
			 the director that there is good cause for the variance, and that the variance
			 will not result in any undue hazard or effect on the public health and safety
			 or environment. The terms, conditions, and expiration of the variance shall be
			 set forth in writing by the director. Failure to comply with the terms of the
			 variance may result in immediate revocation of the variance.
(B) Except as specified in rule
			 3701:1-66-17
			 of the Administrative Code, no individual shall be exposed to the useful beam
			 except a patient for dental or medical radiologic procedures and unless such
			 exposure has been authorized by a licensed practitioner within his or her scope
			 of practice. This provision specifically prohibits deliberate exposure for the
			 following purposes:
(1) Exposure of an
			 individual for training, demonstration, or any
			 other non-medical purpose; and
(2)
			 Exposure of an individual for the purpose of self-referred screening except as
			 authorized by the department in accordance with paragraph (A) of rule
			 3701:1-66-17
			 of the Administrative Code.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-03 - Certification of radiation experts

Current through all regulations passed and filed through July 1, 2024
(A) An individual may seek certification from
			 the Ohio department of health as a radiation expert in one or more of the
			 following categories of radiation-generating equipment:
(1) Therapeutic;
(2) Diagnostic other than mammography;
			 or
(3) Mammography.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-06 - Dental radiation-generating equipment

Current through all regulations passed and filed through July 1, 2024
(A) Dental equipment
			  shall meet the following
			 equipment standards:
(1)
									For dental
			 intraoral equipment, a means shall be provided to limit the source-
			 to-skin distance (SSD) to not less than eighteen
			 centimeters;
(2)
									For dental
			 intraoral equipment, the x-ray field at the minimum SSD shall be
			 containable in a circle having a diameter of no more than seven
			 centimeters;
(3) A
			 means shall be provided to terminate the exposure at a preset time interval, a
			 preset product of current and time, a preset number of pulses, or a preset
			 radiation exposure to the image receptor;
(4) The exposure control switch shall meet
			 the following requirements:
(a) The switch
			 shall be of the "dead-man" type;
(b) The
			 operator shall be able to terminate the exposure at any time during an exposure
			 of greater than one-half second. Except during panoramic radiography,
			 termination of the exposure shall cause automatic resetting of the timer to its
			 initial setting or to zero; and
(c) It shall not be possible to make an
			 exposure when the timer is set to "zero" or "off" position if either position
			 is provided;
(5) The kVp accuracy shall be within plus or
			 minus ten per cent of the indicated value;
(6) For manual exposures, the accuracy of the
			 timing device shall be within plus or minus ten per cent of the indicated
			 setting. The timing device shall be tested at a minimum of two settings within
			 the operative range of fifty milliseconds to one thousand milliseconds;
(7) Visual indication shall be provided
			 whenever x-rays are produced. Certified equipment also shall provide audible
			 indication to the operator while x-rays are produced or on termination of the
			 exposure;
			 and
(8) The coefficient of
			 variation for reproducibility of kVp, timing, and radiation exposure shall not
			 exceed 0.05 for four consecutive exposures.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-07 - Medical fluoroscopic equipment

Current through all regulations passed and filed through July 1, 2024
(A) Fluoroscopic
			 equipment shall meet the following standards:
(1) Unless the United States food and drug
			 administration (FDA) has granted a variance for  specific fluoroscopic equipment, the
			 source-to-skin distance (SSD) for fluoroscopy
			 equipment shall not be less than:
(a)
			 Thirty-eight centimeters on stationary fluoroscopic equipment unless a
			 particular procedure application prohibits that distance, in which case the SSD
			 shall not be less than twenty centimeters;
(b) Thirty centimeters on mobile fluoroscopic
			 equipment unless a particular procedure prohibits that distance, in which case
			 it shall not be less than twenty centimeters; and
(c) Nineteen centimeters for c-arm type
			 fluoroscopic equipment having a maximum source-to-image distance (SID) less
			 than forty-five centimeters unless a particular procedure prohibits that
			 distance, in which case it shall not be less than ten centimeters. Such systems
			 shall be used for extremity or dental purposes only;
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-08 - Mammography radiation-generating equipment

Current through all regulations passed and filed through July 1, 2024
This rule provides standards for radiation-generating equipment
				used for screening and diagnostic mammography, and mammography equipment used
				for invasive localization and stereotactically guided breast biopsy purposes,
				except as provided by paragraphs (E) and (F) of this rule. In addition
				, a handler of mammography radiation-generating
				equipment that uses either stationary or mobile installations, shall comply
				with all applicable standards in 21 C.F.R. part
				1020 (as effective on the effective
				date of this rule) .
(A) In addition to meeting the applicable
			 equipment standards in rule
			 3701:1-66-02
			 of the Administrative Code, a handler performing screening or diagnostic mammography
			 shall have a valid certificate issued by the U.S. department of health and
			 human services, pursuant to the Mammography Quality Standards Reauthorization
			 Act of 1998,
			 Public
			 Law 105-248, and 21 C.F.R. Part 900(as effective on the effective date of this
			 rule).
(B) A handler of all
			 types of mammography radiation-generating equipment shall comply with the
			 shielding requirements in paragraphs (H)(2) to
			 (H)(4)
			 of rule
			 3701:1-66-02
			 of the Administrative Code.
(C) In
			 addition to applicable radiation safety requirements in rules adopted pursuant
			 to Chapter 3748. of the Revised Code and rule
			 3701:1-66-02
			 of the Administrative Code, a handler of all types of screening and diagnostic
			 mammography radiation-generating equipment shall comply with the following:
(1) When a film/screen mammography system is
			 used, clinical films shall be processed as soon as possible, but not to exceed
			 twenty-four hours from the time the first clinical image is taken. Facilities
			 utilizing batch processing shall:
(a) Use a
			 container to transport clinical films that will protect the film from exposure
			 to light, excessive heat and radiation; and
(b) Maintain a log to include date and
			 identification of each patient, time of first exposure of each batch, and date
			 and time of each batch processing;
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-10 - Medical computed tomography radiation-generating equipment

Current through all regulations passed and filed through July 1, 2024
This ruleapplies to mobile and stationary computed tomography
				(CT) radiation-generating equipment, except for
				fluoroscopy units with CT capability, CT units used exclusively for
				radiotherapy simulation, and CT units integrated
				with linear accelerators.
(A) CT radiation-generating equipment shall
			 be maintained to meet the following equipment standards:
(1) The operator shall be able to terminate
			 x-ray exposure at any time during a scan
			 or series of scans  of greater than 0.5 second duration;
(2) In the case of premature termination of
			 the x-ray exposure by the operator, the CT radiation-generating equipment shall
			 require the operator to reset CT conditions of operation prior to the
			 initiation of another scan;
(3) The CT x-ray control and gantry shall
			 provide visual indication whenever x-rays are produced;
(4) If the x-ray production period is less
			 than 0.5 second, the indication of x-ray production shall be actuated for at
			 least 0.5 second. Visual indicators at or near the gantry shall be discernible
			 from any point external to the patient opening where insertion of any part of
			 the human body into the primary beam is possible;
(5) Each emergency button or switch shall be
			 clearly labeled as to its function;
(6) The
			 CT radiation-generating equipment shall be designed such that the CT conditions
			 of operation are indicated prior to the initiation of a scan or a scan
			 sequence;
(7) The indicated table increment
			 shall not deviate from the actual table increment by more than one
			 millimeter;
(8)
			 Means shall be provided to permit visual determination of the location of the
			 tomographic plane or a reference plane. A reference plane may be offset from
			 the location of the tomographic plane(s);
(9) If a device using a light source is used
			 to satisfy paragraph (A)(8) of this rule, the light source shall provide
			 illumination levels sufficient to permit visual determination of the location
			 of the tomographic plane or reference plane under ambient light conditions of
			 up to five hundred lux; and
(10)
			 The total error in the indicated location of the tomographic plane or reference
			 plane shall not exceed five millimeters.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-11 - Medical bone densitometry radiation-generating equipment

Current through all regulations passed and filed through July 1, 2024
(A) Handlers of
			 bone densitometry equipment shall assure that the equipment is certified by the
			 manufacturer in accordance with the requirements of 21 C.F.R.
			 part1010.2, ( as
			 effective on the effective date of
			 this rule), and maintained in accordance with the manufacturer's
			 specifications.
(B) In addition to
			 other applicable radiation safety requirements in Chapters 3701:1-38 and
			 3701:1-66 of the Administrative Code, the operator of bone densitometry equipment shall be
			 positioned at least one meter ( 3.3 feet) from the primary beam or behind a
			 protective barrier containing a minimum of 0.25 millimeter of lead equivalent
			 materials.
(C) In addition to other applicable quality
			 assurance requirements in rules
			 3701:1-66-02
			 and
			 3701:1-66-04
			 of the Administrative Code, handlers of bone densitometry equipment shall
			 comply with the following:
(1) The quality
			 assurance program shall include quality control test records which shall be
			 maintained between inspections and shall include the following:
(a) A list of the tests to be performed as
			 specified by the manufacturer;
(b)
			 The frequency of performance as specified by the manufacturer;
(c) The acceptability limits for each test as
			 specified by the manufacturer; and
(d) A brief description of the procedures and
			 test equipment to be used for each test;
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-16 - Security screening systems

Current through all regulations passed and filed through July 1, 2024
(A) Definitions for the purpose of this rule:
(1) "Ambient dose equivalent area product
			 (ADAP)" shall be determined using the american
									national
									standards
									institute
			  publication "ANSI/HPS N 43.17 -2009 Radiation Safety for Personnel
			 Security Screening Systems Using X-Ray or Gamma Radiation."
(2) "Interlock" means a device preventing the
			 start or continued operation of equipment that could cause a radiation
			 hazard.
(3) "Mode of operation"
			 means a selectable set of technique factors or machine settings that is
			 pre-determined by the manufacturer for a specific purpose.
(4) "Scan" means the operation necessary to
			 produce one image (e.g., front view) from one radiation source. One radiation
			 source simultaneously producing multiple images also constitutes one scan. Two
			 sources simultaneously producing two images constitute two scans. In some cases
			 several scans may be required for a single screening of the subject.
(5) "Screening" means the sum of radiation
			 exposures or scans necessary to image objects concealed on all sides of the
			 body as intended by the system design under normal conditions:
(a) For backscatter systems a screening
			 typically consists of four scans, one from each side.
(b) For transmission systems a screening
			 typically consists of one scan.
(c)
			 For portal systems a screening consists of a complete pass through the
			 inspection zone.
(6)
			 "Security screening system" means radiation-generating equipment used for the
			 sole purpose of screening an individual who is in custody of a law enforcement
			 agency to identify contraband items that would present a security threat within
			 a secured facility perimeter.
(7)
			 "Technique factors" means the x-ray settings including:
(a) The peak kilovoltage applied to the x-ray
			 tube;
(b) The electric current
			 passing through the x-ray tube; and
(c) The scan time.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-17 - Medical screening and research

Current through all regulations passed and filed through July 1, 2024
This rule provides standards for self-referral screening and
				medical research. Notwithstanding paragraph (B) of rule
				3701:1-66-02
				of the Administrative Code:
(A) Any
			 person proposing to conduct a self-referral screening program using radiation
			 generating equipment shall not initiate such a program without prior approval
			 by the department. When requesting such approval, that person shall submit
			 information on a form prescribed by the department. If any information
			 submitted to the department becomes invalid or not current, the department
			 shall be immediately notified in writing.
(B)
								No person shall
			 use radiation-generating equipment to conduct
								 research  on human beings
			 unless the research has been approved by an
			 institutional review board (IRB) as required by  45 CFR Part 46 (as effective on
			 the effective date of this rule and  21 CFR Part 56 (as effective on
			 the effective date of this rule).
(C) Nothing in this rule relieves registrants
			 from complying with the other requirements of this chapter.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-67 - External Beam Radiation Therapy Equipment › Section 3701:1-67-01 - Definitions

Current through all regulations passed and filed through July 1, 2024
(A) Terms defined
			 in rule
			 3701:1-38-01 of the
			 Administrative Code shall have the same meaning when used in Chapter 3701:1-67
			 of the Administrative Code except for:
(1)
			 Terms redefined within this rule which shall be used within Chapter 3701:1-67
			 of the Administrative Code; and
(2)
			 Terms redefined in specific rules in Chapter 3701:1-67 of the Administrative
			 Code, are for use within that specific rule only.
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-67 - External Beam Radiation Therapy Equipment › Section 3701:1-67-02 - General administrative requirements

Current through all regulations passed and filed through July 1, 2024
(A) The handler shall be responsible for
			 directing the operation of the therapy equipmentto ensure that the
			 requirements of Chapter 3701:1-67 of the Administrative Code are met
			 .
(B)
								The handler
			 shall not use therapy equipment that does not meet the provisions of
			  Chapter 3701:1-67 of the
			 Administrative Code to irradiate
			 patients.
(C) For any therapy
			 equipment subject to Chapter 3701:1-67 of the Administrative Code, the handler
			 shall require the physician or veterinarian who authorizes use of the therapy
			 equipment to be:
(1) Certified in one of the
			 following:
(a) Radiation oncology or
			 therapeutic radiology by the "American Board of Radiology" or combined
			 diagnostic and therapeutic radiology program by the "American Board of
			 Radiology" prior to 1976; 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"; or
(e) Radiation oncology by the "American
			 College of Veterinary Radiology"; or
Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-67 - External Beam Radiation Therapy Equipment › Section 3701:1-67-04 - Quality management program

Current through all regulations passed and filed through July 1, 2024
(A) Each  handler of therapy equipment subject
			 to the requirements of Chapter 3701:1-67 of the Administrative Code, shall
			 develop, implement, and maintain a quality management program to provide high
			 confidence that radiation will be administered as directed by the physician or
			 veterinarian authorizing its use.
(B) The quality management program shall
			 address, as a minimum, the following specific objectives regarding written
			 directives:
(1) A written directive must be
			 dated and signed by a physician or veterinarian authorizing its use prior to
			 the administration of radiation. If because of the patient's condition, a delay
			 in the order to provide a written revision to an existing written directive
			 would jeopardize the patient's health, an oral revision to an existing written
			 directive will be acceptable, provided that the oral revision is documented as
			 soon as possible in the patient's record and a revised written directive is
			 signed by an authorized user within forty-eight hours of the oral
			 revision;
(2) The written directive
			 must contain the patient or human research subject's name, the type and energy
			 of the beam, the total dose, dose per fraction, treatment site, and number of
			 fractions;
(3) A written revision
			 to an existing written directive may be made provided that the revision is
			 dated and signed by an authorized user prior to the administration of the
			 therapy equipment dose, or the next fractional dose; and
(4) The handler shall retain a copy of the
			 written directive for seven years.