reglab/statecodes huggingface dataset:
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 335.2080 - Monitoring for Contamination and Ambient Radiation Dose Rate

Current through Register Vol. 48, No. 28, July 12, 2024
a) In addition to
				the monitoring required by 32 Ill. Adm. Code 340, the licensee shall measure
				with a radiation detection survey instrument all areas where unsealed
				radioactive material was prepared for use or administered at the end of use
				each day. However, the licensee does not need to perform the monitoring
				required by this Section in areas where patients or human research subjects are
				confined until release under Section
				335.2110.
				The instrument shall be operable and calibrated in accordance with the
				requirements of 32 Ill. Adm. Code
				340.510(b) and
				(c).
b) At least once each week, a licensee shall
				measure with a radiation detection survey instrument all areas where
				radiopharmaceuticals or radioactive wastes are stored to ensure compliance with
				32 Ill. Adm. Code
				340.210
				and
				340.310.
				The instrument shall be operable and calibrated in accordance with the
				requirements of 32 Ill. Adm. Code
				340.510(b) and
				(c).
c) At least once each week, a licensee shall
				measure for removable contamination in all areas where unsealed radioactive
				materials are prepared for use, administered or stored.
d) A licensee shall conduct the measurements
				required by subsections (b) and (c) in a manner that permits detection of both
				external exposure rates and removable contamination that would give rise to
				exposures in excess of the limits specified in 32 Ill. Adm. Code
				340.210
				and 340.310.
e) A licensee shall
				retain a record of each survey required by this Section for 5 years. The record
				shall include the monitoring date, a description of each area monitored, the
				measurement results, the manufacturer, model and serial number of the
				instruments, and the identity of the individual who performed the
				monitoring.
AGENCY NOTE: For the purposes of this Section, 2000 dpm
					 (disintegrations per minute) per 100 square centimeters of surface area may be
					 utilized as a sufficiently sensitive detection limit for removable
					 contamination unless the licensee has developed alternate removable
					 contamination limits which take into consideration the unsealed radionuclides
					 in use, their respective contribution to the dose limits in 32 Ill. Adm. Code
					 340.210
					 and
					 340.310,
					 and the detection capability of the radiation detection survey instruments in
					 use. Measurement of removable contamination shall only be performed with a
					 survey instrument, in lieu of wipes, if the instrument is sufficiently
					 sensitive to detect the contamination at the limits specified in this
					 Section.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 335.2090 - Safety Instructions for Patients Not Hospitalized and Containing Therapeutic Doses of Radiopharmaceuticals or Permanent Implants (Repealed)

Current through Register Vol. 48, No. 28, July 12, 2024
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 335.2110 - Release of Individuals Containing Unsealed Radioactive Material or Implants Containing Radioactive Material

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				A licensee may authorize the release from its control of any individual who has
				been administered unsealed radioactive material or implants containing
				radioactive material if the total effective dose equivalent to any other
				individual from exposure to the released individual is not likely to exceed 5
				mSv (0.5 rem) following assessment of the patient's medical, living and working
				conditions.
AGENCY NOTE: NUREG-1556, Vol. 9, "Consolidated Guidance About
				  Materials Licenses: Program-Specific Guidance About Medical Licenses,"
				  published September 2019, exclusive of subsequent amendments or editions,
				  describes methods for calculating doses to other individuals and contains
				  tables of activities not likely to cause doses exceeding 5 mSv (0.5
				  rem).
b) If the total
				effective dose equivalent to any other individual is likely to exceed 1 mSv
				(0.1 rem), the licensee shall provide the released individual and, as
				determined appropriate by the authorized physician user, the individual's
				spouse, parent, guardian or other primary caregiver with verbal and written
				instructions on actions recommended to maintain doses to other individuals as
				low as is reasonably achievable. If the total effective dose equivalent to a
				minor, pregnant individual or nursing infant or child could exceed 1 mSv (0.1
				rem), assuming there were no interruptions of breast-feeding, the instructions
				shall also include:
1) Guidance on the
				interruption or discontinuation of breast-feeding;
2) Guidance on minimizing close or extended
				contact; and
3) Information on the
				potential consequences, if any, of failure to follow the guidance.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 335.2140 - Other Medical Uses of Radioactive Material or Radiation from Radioactive Material (Emerging Technologies)

Current through Register Vol. 48, No. 28, July 12, 2024
A licensee may use radioactive material or a radiation source
				  that is not specifically addressed in Subparts D through I, or if the use is
				  inconsistent with those Subparts, if:
a) The licensee has submitted the information
				required by 32 Ill. Adm. Code
				330.250
				and any other necessary information consistent with 32 Ill. Adm. Code
				330;
b) The application contains at
				least the following:
1) A request signed by
				management that is consistent with the requirements of 32 Ill. Adm. Code
				340.310(b);
2) A description of:
A) The facilities, with a diagram;
B) The necessary equipment and its
				calibration or maintenance; and
C)
				Training and experience qualifications of the Radiation Safety Officer,
				Associate Radiation Safety Officers, authorized users, authorized medical
				physicists, and ophthalmic physicists, if not already previously
				submitted;
3)
				Procedures, as applicable, that describe:
A)
				The radionuclide, form and activity;
B) The expected levels of contamination and
				the procedures to control them;
C)
				The general safety precautions;
D)
				The safety instructions to be provided to staff that are specific to the
				proposed use; and
E) The
				methodology for measurement of dosages or doses to be administered to patients
				or human research subjects;
4) If applicable, a description of the sealed
				source and/or device as per 32 Ill. Adm. Code
				330.280(i)
				and (k), as applicable, or, alternately,
				identification of the product in the Sealed Source and Device
				Registry.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart D - UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION AND EXCRETION STUDIES - WRITTEN DIRECTIVE NOT REQUIRED › Section 335.3010 - Use of Unsealed Radioactive Material for Uptake, Dilution and Excretion Studies for Which a Written Directive is Not Required

Current through Register Vol. 48, No. 28, July 12, 2024
Except for quantities that require a written directive under
				  subsection
				  335.1110(a),
				  a licensee may use any unsealed radioactive material prepared for medical use
				  for uptake, dilution or excretion studies that is:
a) Obtained from a person specified in
				Section
				335.30, or
				equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;
				or
b) Excluding production of PET
				radionuclides, prepared by an authorized nuclear pharmacist, a physician who is
				an authorized user and who meets the requirements in Section
				335.9040,
				or a combination of Section
				335.9050
				and subsection
				335.9040(c)(1)(B)(vii)
				or an individual under the supervision of either as specified in Section
				335.1050;
				or
c) Obtained from and prepared by
				an Agency, U.S. Nuclear Regulatory Commission or Agreement State licensee for
				use in research in accordance with a Radioactive Drug Research
				Committee-approved protocol or an application or protocol accepted by the FDA;
				or
d) Prepared by the licensee for
				use in research in accordance with a Radioactive Drug Research
				Committee-approved application or an application or a protocol accepted by the
				FDA.
AGENCY NOTE: Participation in FDA research trials involving
					 human subjects does not relieve the licensee from following all Agency
					 regulations, whether or not they are included in the trial protocols. This
					 includes participation in trials using "blind" research
					 protocols.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED › Section 335.4010 - Use of Unsealed Radioactive Material for Imaging and Localization Studies for Which a Written Directive is Not Required

Current through Register Vol. 48, No. 28, July 12, 2024
Except for quantities that require a written directive under
				  subsection
				  335.1110(a),
				  a licensee may use any unsealed radioactive material prepared for medical use
				  for imaging and localization studies that is:
a) Obtained from a person specified in
				Section
				335.30 of this
				Part, or equivalent U.S. Nuclear Regulatory Commission or Agreement State
				requirements; or
b) Excluding
				production of PET radionuclides, prepared by an authorized nuclear pharmacist,
				a physician who is an authorized user and who meets the requirements specified
				in Section
				335.9040
				or a combination of Section
				335.9050
				and subsection
				335.9040(c)(1)(B)(vii)
				or an individual under the supervision of either as specified in Section
				335.1050;
				or
c) Obtained from and prepared by
				an Agency, U.S. Nuclear Regulatory Commission or Agreement State licensee for
				use in research in accordance with a Radioactive Drug Research
				Committee-approved protocol or an application or protocol accepted by the FDA;
				or
d) Prepared by the licensee for
				use in research in accordance with a Radioactive Drug Research
				Committee-approved application or an application or a protocol accepted by the
				FDA.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED › Section 335.4020 - Permissible Concentrations of Molybdenum-99, Strontium-82 and Strontium-85

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee shall
				not administer to humans a radiopharmaceutical that contains more than:
1)0.15 kBq of molybdenum-99 per MBq of
				technetium-99m (0.15µCi of molybdenum-99 per mCi of
				technetium-99m);
2)0.02 kBq of
				strontium-82 per MBq of rubidium-82 chloride injection (0.02 µCi of
				strontium-82 per mCi of rubidium-82); or
3)0.2 kBq of strontium-85 per MBq of
				rubidium-82 chloride injection (0.2 µCi of strontium-85 per mCi of
				rubidium-82.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED › Section 335.4030 - Control of Aerosols and Gases (Repealed)

Current through Register Vol. 48, No. 28, July 12, 2024
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE REQUIRED › Section 335.5010 - Use of Unsealed Radioactive Material for Which a Written Directive is Required

Current through Register Vol. 48, No. 28, July 12, 2024
a) A
				licensee may use any unsealed radioactive material identified in subsection
				335.9050(b)(2)(F)
				prepared for medical use and for which a written directive is required that is:
1) Obtained from a person specified in
				Section
				335.30 or
				equivalent U.S. Nuclear Regulatory Commission or Agreement State
				requirements;
2) Excluding
				production of PET radionuclides, prepared by an authorized nuclear pharmacist,
				a physician who is an authorized user and who meets the requirements specified
				in Section
				335.9040,
				335.9050, or an individual under the supervision of either as specified in
				Section
				335.1050;
				or
3) Obtained from and prepared by
				an Agency, U.S. Nuclear Regulatory Commission or Agreement State licensee for
				use in research in accordance with a protocol accepted by FDA; or
4) Prepared by the licensee for use in
				research in accordance with an application or a protocol accepted by
				FDA.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE REQUIRED › Section 335.5020 - Safety Instruction

Current through Register Vol. 48, No. 28, July 12, 2024
In addition to the requirements of 32 Ill. Adm. Code
				  400.120:
a) A licensee shall provide radiation safety
				instruction, prior to beginning work and at least annually, to personnel caring
				for patients or human research subjects who have been administered radioactive
				materials requiring a written directive. To satisfy this requirement, the
				instructions shall be commensurate with the duties of the personnel and shall
				include:
1) Patient or human research subject
				control;
2) Visitor control,
				including:
A) Routine visitation to
				hospitalized individuals in accordance with 32 Ill. Adm. Code
				340.310(a)(1);
				and
B) Visitation authorized in
				accordance with 32 Ill. Adm. Code
				340.310(c);
3) Contamination
				control;
4) Waste control;
				and
5) Notification of the
				Radiation Safety Officer or his or her designee and the authorized user if the
				patient or the human research subject has a medical emergency or
				dies.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE REQUIRED › Section 335.5030 - Safety Precautions

Current through Register Vol. 48, No. 28, July 12, 2024
a) For
				each patient or human research subject who cannot be released under Section
				335.2110
				of this Part, the licensee shall:
1) Perform
				radiation monitoring as required by 32 Ill. Adm. Code
				340.510 for use in
				determining when the licensee shall supply appropriate personnel with
				individual monitoring devices as required by 32 Ill. Adm. Code
				340.520.
				Records of the radiation monitoring indicating the date and time of the
				monitoring, an annotated diagram of the area and a list of points monitored,
				the measured dose rate, the manufacturer, model and serial number of the
				instrument used to perform the monitoring and the identity of the individual
				who performed the monitoring shall be maintained for 5 years. This radiation
				monitoring shall include, as a minimum, the dose rate in units, multiples or
				subunits of Sieverts or rem per hour at:
A)
				The patient's bedside;
B) 1 meter
				from the patient;
C) The patient's
				hospital room door; and
D)
				Contiguous restricted and unrestricted areas. However, radiation monitoring of
				adjoining rooms is not required if a calculation of the dose rate to a patient
				in the adjoining room is made based on measurements obtained pursuant to
				subsection (a)(1)(A) or (B) of this Section.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart G - SEALED SOURCES FOR DIAGNOSIS › Section 335.6010 - Use of Sealed Sources for Diagnosis

Current through Register Vol. 48, No. 28, July 12, 2024
A licensee shall use only sealed sources for diagnostic
				  medical uses that are:
a) Obtained from
				a person specified in Section 335.35, or equivalent U.S. Nuclear Regulatory
				Commission or Agreement State requirements; or
b) 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 shall be used in accordance with the radiation safety conditions
				and limitations described in the Sealed Source and Device Registry.
c) A licensee shall 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 shall be used in accordance with the radiation
				safety conditions and limitations described in the Sealed Source and Device
				Registry.
d) 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
				U.S. Food and Drug Administration provided the requirements of Section 335.35
				are met.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - MANUAL BRACHYTHERAPY › Section 335.7010 - Use of Sealed Sources for Brachytherapy

Current through Register Vol. 48, No. 28, July 12, 2024
A licensee shall use only brachytherapy sources for
				  therapeutic medical uses:
a) That are:
1) Obtained from a person specified in
				Section 335.35, or equivalent U.S. Nuclear Regulatory Commission or Agreement
				State requirements; and
2) 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
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - MANUAL BRACHYTHERAPY › Section 335.7020 - Safety Instruction

Current through Register Vol. 48, No. 28, July 12, 2024
In addition to the requirements of 32 Ill. Adm. Code
				  400.120:
a) The licensee shall provide radiation
				safety instruction, prior to their assuming duties and at least annually, to
				personnel caring for patients or human research subjects who are receiving
				brachytherapy and cannot be released under Section
				335.2110
				of this Part. To satisfy this requirement, the instructions 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 32 Ill. Adm. Code
				340.310(a)(1);
				and
B) Visitation authorized in
				accordance with 32 Ill. Adm. Code
				340.310(c);
				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.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - MANUAL BRACHYTHERAPY › Section 335.7030 - Safety Precautions

Current through Register Vol. 48, No. 28, July 12, 2024
a) For
				each patient or human research subject who is receiving brachytherapy and
				cannot be released under Section
				335.2110
				of this Part, 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)
				Authorize visits by individuals under age 18 only on a patient-by-patient basis
				with the approval of the authorized user after consultation with the Radiation
				Safety Officer;
3) Conspicuously
				post the patient's or human research subject's room with a "Caution -
				Radioactive Materials" sign bearing the radiation symbol;
4) 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; and
5) Note on the door or in the patient's or
				human research subject's chart safety instruction noted in Section
				335.7020 of
				this Part.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - MANUAL BRACHYTHERAPY › Section 335.7040 - Accountability and Security of Brachytherapy Sources

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee shall maintain security and
				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
				brachytherapy source accountability required by this Section for 5 years. The
				record must include:
1) For temporary
				implants:
A) 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
B) 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.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - MANUAL BRACHYTHERAPY › Section 335.7060 - Surveys After Source Implant and Removal

Current through Register Vol. 48, No. 28, July 12, 2024
a) Immediately after implanting sources in a
				patient or a human research subject, the licensee shall monitor the area to
				locate and account for all sources that have not been implanted.
b) Immediately after removing the last
				temporary implant source from a patient or a human research subject, the
				licensee shall monitor the patient or the human research subject with a
				radiation detection survey instrument to confirm that all sources have been
				removed.
c) A licensee shall
				maintain a record of the monitoring required by this Section for 5 years. The
				record shall include the monitoring date, the measured dose rate at several
				points in each area, expressed in units, multiples or subunits of Sieverts or
				rem per hour, the manufacturer, model and serial number of the survey
				instrument used to perform the monitoring, and the identity of the person who
				performed the monitoring.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - MANUAL BRACHYTHERAPY › Section 335.7070 - Calibration Measurements of Brachytherapy Sources

Current through Register Vol. 48, No. 28, July 12, 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 subsection
				335.8080(a);
2) Determined source positioning accuracy
				within applicators; and
3) Used
				published protocols currently accepted by nationally recognized bodies to meet
				the requirements of subsections (a)(1) and (a)(2). Copies of these protocols
				shall be maintained on file by the licensee for 5 years after the
				discontinuation of use of brachytherapy sources.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - MANUAL BRACHYTHERAPY › Section 335.7080 - Decay of Brachytherapy Sources

Current through Register Vol. 48, No. 28, July 12, 2024
a) Only an authorized medical physicist or
				physician-authorized user shall calculate the activity of each brachytherapy
				source that is used to determine the treatment times for brachytherapy
				treatments. The decay must be based on the activity determined under Section
				335.7070
				of this Part.
b) A licensee shall
				maintain a record of the activity of all brachytherapy sources required by this
				Section for the life of the source. The record must include:
1) The manufacturer, model and serial number
				(or lot number for permanent implants) of the sources;
2) The date and initial activity of the
				source as determined under Section
				335.7070
				of this Part; and
3) For each decay
				calculation, the date and the source activity as determined under this
				Section.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - MANUAL BRACHYTHERAPY › Section 335.7090 - Therapy-related Computer Systems for Manual Brachytherapy

Current through Register Vol. 48, No. 28, July 12, 2024
The licensee shall:
a) 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:
1) The source-specific input parameters
				required by the dose calculation algorithm;
2) The accuracy of dose, dwell time, and
				treatment time calculations at representative points;
3) The accuracy of isodose plots and graphic
				displays; and
4) The accuracy of
				the software used to determine sealed source positions from radiographic
				images.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - MANUAL BRACHYTHERAPY › Section 335.7100 - Strontium-90 Sources for Ophthalmic Treatments

Current through Register Vol. 48, No. 28, July 12, 2024
Licensees who use strontium-90 for ophthalmic treatments must
				  ensure that certain activities as specified in subsection (c) are performed by
				  either:
a) An authorized medical
				physicist; or
b) An individual who:
1) is identified as an ophthalmic physicist
				on a specific medical use license issued by the Agency, U.S. Nuclear Regulatory
				Commission, or Agreement State; a permit issued by the Agency, U.S. Nuclear
				Regulatory Commission, or Agreement State broad scope medical use licensee; a
				medical use permit issued by a U.S. Nuclear Regulatory Commission master
				material licensee; or permit issued by a U.S. Nuclear Regulatory Commission
				master material licensee broad scope medical use permittee; and
2) 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
3) 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
4) Has documented training in:
A) The creation, modification, and completion
				of written directives;
B)
				Procedures for administrations requiring a written directive; and
C) Performing the calibration measurements of
				brachytherapy sources as detailed in Section
				335.7070.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8010 - Use of a Sealed Source in Remote Afterloader Units, Teletherapy Units or Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee shall only use sealed sources:
1) Obtained from a person specified in
				Section 335.35, or equivalent U.S. Nuclear Regulatory Commission or Agreement
				State requirements; or
2) 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
3) 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 U.S. Food and Drug
				Administration, provided the requirements of Section 335.35 are met.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8020 - Installation, Maintenance, Adjustment and Repair Restrictions

Current through Register Vol. 48, No. 28, July 12, 2024
a) Only a person
				specifically licensed by the Agency, the U.S. Nuclear Regulatory Commission, an
				Agreement State or a Licensing State shall install, maintain, adjust or repair
				a remote afterloader unit, intravascular brachytherapy unit, teletherapy unit
				or gamma stereotactic radiosurgery unit that involves work on the sources
				shielding, the sources driving unit or other electronic or mechanical component
				that could expose the sources, reduce the shielding around the sources, or
				compromise the radiation safety of the unit or the sources.
b) Except for a low dose-rate remote
				afterloader unit and intravascular brachytherapy unit, only a person
				specifically licensed by the Agency, the U.S. Nuclear Regulatory Commission, an
				Agreement State or a Licensing State shall install, replace, relocate, or
				remove a sealed source or source contained in other remote afterloader units,
				intravascular brachytherapy units, teletherapy units or gamma stereotactic
				radiosurgery units.
c) For a low
				dose-rate remote afterloader unit and intravascular brachytherapy unit, only a
				person specifically licensed by the Agency, the U.S. Nuclear Regulatory
				Commission, an Agreement State or a Licensing State or an authorized medical
				physicist shall install, replace, relocate or remove a sealed source contained
				in the unit.
d) A licensee shall
				retain a record of the installation, maintenance, adjustment and repair of
				remote afterloader units, intravascular brachytherapy units, teletherapy units
				and gamma stereotactic radiosurgery units as required by this Section for 5
				years. For each installation, maintenance, adjustment and repair, the record
				must include the date, description of the service, names of the individuals who
				performed the work, and a copy of the specific license authorizing the
				service.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8030 - Amendments to Teletherapy Licenses (Repealed)

Current through Register Vol. 48, No. 28, July 12, 2024
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8040 - Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee using sealed sources in remote
				afterloader units, teletherapy units or gamma stereotactic radiosurgery units
				for therapeutic medical uses shall:
1) Secure
				the unit, the console, the console keys and the treatment room when not in use
				or unattended, if applicable;
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 or emergencies with the sources;
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 sources 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 shall 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.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8050 - Safety Precautions for Remote Afterloader Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 28, July 12, 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 shall:
1) Prevent the operator from initiating the
				treatment cycle unless each treatment room entrance door is closed;
2) Cause the sources to be shielded when an
				entrance door is opened; and
3)
				Prevent the sources from being exposed following an interlock interruption
				until all treatment room entrance doors are closed and the sources on-off
				control is reset at the console.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8060 - Radiation Monitoring Device for Teletherapy Units and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee
				shall have in each teletherapy or gamma stereotactic radiosurgery room a
				permanent radiation monitor capable of continuously monitoring the status of
				the beam.
b) Each radiation monitor
				shall be capable of providing visible indication of a teletherapy or gamma
				stereotactic radiosurgery unit malfunction that results in an exposed or
				partially exposed source. The visible indicator of high radiation levels shall
				be observable by an individual entering the teletherapy or gamma stereotactic
				radiosurgery room.
c) Each
				radiation monitor shall be equipped with an auxiliary power supply separate
				from the power supply to the teletherapy or gamma stereotactic radiosurgery
				unit. This auxiliary power supply may be a battery system.
d) The radiation monitor shall be checked
				with a dedicated check source for proper operation each day before the
				teletherapy or gamma stereotactic radiosurgery unit is used for treatment of
				patients.
AGENCY NOTE: Exposing the source and remotely viewing the
				  instrument response is an acceptable method for checking the monitor with a
				  "dedicated check source".
e) A licensee shall maintain a record of the
				check required by subsection (d) of this Section for 5 years. The record shall
				include the date of the check, a notation that the monitor indicated when the
				source was exposed and the identity of the individual who performed the
				check.
f) If the radiation monitor
				is inoperable, the licensee shall require any individual entering the
				teletherapy or gamma stereotactic radiosurgery room to use either a survey
				instrument or a personal dosimeter with an audible alarm to monitor for any
				malfunction of the source exposure mechanism that may result in an exposed or
				partially exposed source. The instrument or dosimeter shall be checked with a
				dedicated check source for proper operation at the beginning of each day of
				use. The licensee shall keep a record as described in subsection (e) of this
				Section.
g) If the radiation
				monitor is inoperable, the licensee shall take action within 24 hours to repair
				or replace the radiation monitor. At a minimum, such action shall include the
				scheduling for the repair or replacement of the inoperable monitor.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8070 - Viewing System for Teletherapy (Repealed)

Current through Register Vol. 48, No. 28, July 12, 2024
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8080 - Dosimetry Equipment

Current through Register Vol. 48, No. 28, July 12, 2024
a) A
				licensee shall have a calibrated dosimetry system available for use. To satisfy
				this requirement, one of the following two conditions shall be met:
1) The system shall have been calibrated by
				the National Bureau of Standards, by the National Institute of Standards and
				Technology or by a calibration laboratory accredited by the American
				Association of Physicists in Medicine (AAPM). The calibration shall have been
				performed within the previous 2 years and after any servicing that may have
				affected system calibration; or
2)
				The system shall have been calibrated within the previous 4 years; 18 to 30
				months after that calibration, the system shall have been compared with another
				dosimetry system that was calibrated within the past 24 months by the National
				Bureau of Standards, by the National Institute of Standards and Technology or
				by a calibration laboratory accredited by the AAPM. The dosimetry system shall
				be considered calibrated if a comparison is performed at a meeting sanctioned
				by a calibration laboratory or radiological physics center accredited by the
				AAPM and the results of the comparison indicate that the calibration factor of
				the licensee's system has not changed by more than two percent. The licensee
				shall not use the comparison result to change the calibration factor. When
				comparing dosimetry systems to be used for calibrating cobalt-60 teletherapy
				units, the licensee shall use a teletherapy unit with a cobalt-60 source. 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.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8090 - Full Calibration Measurements for Teletherapy

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee authorized to use a teletherapy
				unit for medical use shall perform full calibration measurements as described
				in subsection (b) of this Section, on each teletherapy unit:
1) Before the first medical use of the unit;
				and
2) Before medical use under the
				following conditions:
A) Whenever spot-check
				measurements indicate that the output differs by more than five percent 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 1 year.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8100 - Periodic Spot-Checks for Teletherapy

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee authorized to use teletherapy
				units for medical use shall perform spot-checks on each teletherapy unit at
				intervals not to exceed 1 month.
b)
				To satisfy the requirement of subsection (a) of this Section, spot-checks shall
				include the taking of measurements that permit the determination of:
1) Timer constancy and 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 localization
				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; and
6) The
				difference between the measurement made in subsection (b)(5) of this Section
				and the anticipated output, expressed as a percentage of the anticipated value
				obtained at the last full calibration corrected mathematically for physical
				decay.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8110 - Radiation Monitoring

Current through Register Vol. 48, No. 28, July 12, 2024
a) In
				addition to the monitoring requirements in 32 Ill. Adm. Code
				340.510, a person
				licensed under this Subpart shall monitor to ensure that the maximum radiation
				levels and average radiation levels from the surface of the main source safe
				with the sources in the shielded position do not exceed the levels stated in
				the Sealed Source and Device Registry.
b) The licensee shall monitor, as required by
				subsection (a) of this Section, at installations 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, or compromise the radiation safety of the unit or
				the source.
c) A licensee shall
				maintain a record of the radiation monitoring of treatment units made in
				accordance with this Section for the duration of use of the unit. The record
				must include:
1) The date of the
				measurement;
2) The manufacturer's
				name, model 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.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8120 - Safety Checks for Teletherapy Facilities (Repealed)

Current through Register Vol. 48, No. 28, July 12, 2024
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8130 - Modification of Teletherapy Unit or Room Before Beginning a Treatment Program (Repealed)

Current through Register Vol. 48, No. 28, July 12, 2024
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8140 - Reports of Teletherapy Monitoring, Checks, Tests and Measurements (Repealed)

Current through Register Vol. 48, No. 28, July 12, 2024
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8150 - Full-Inspection Servicing for Teletherapy and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee
				shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully
				inspected and serviced during each 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 5 years for
				each teletherapy unit and shall not exceed 7 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 Agency, the U.S. Nuclear Regulatory Commission, or an Agreement
				State.
c) A licensee shall maintain
				a record of the inspection and servicing for teletherapy and gamma stereotactic
				radiosurgery units required by this Section for the duration of use of the
				unit.
d) The record shall contain:
1) The inspector's radioactive materials
				license number;
2) The date of the
				inspection;
3) The manufacturer's
				name and model number and 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.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8160 - Full Calibration Measurements on Remote Afterloader Units

Current through Register Vol. 48, No. 28, July 12, 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;
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 1 quarter for
				high dose-rate, medium dose-rate and pulsed dose-rate remote afterloader units
				with sources whose half-life exceeds 75 days; and
4) At intervals not exceeding 1 year for low
				dose-rate remote afterloader units.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart I - REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 335.8170 - Periodic Spot-Checks for Remote Afterloader Units

Current through Register Vol. 48, No. 28, July 12, 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 of a high dose-rate, medium dose-rate or pulsed dose-rate
				remote afterloader unit on a given day;
2) Before each patient treatment with a low
				dose-rate remote afterloader unit; and
3) After each source installation.