reglab/statecodes huggingface dataset:
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 144-220-G-E-392 - Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 Millicuries)

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require an
						authorized user for the oral administration of sodium iodide I-131 requiring a
						written directive in quantities less than or equal to 1.22 gigabecquerels (33
						millicuries), to be a physician who:
A. Is certified by a medical specialty board
					 whose certification process includes all of the requirements in G.392.C(1) and
					 C(2) and whose certification has been recognized by the Agency, the Nuclear
					 Regulatory Commission or an Agreement State Specialty Boards whose
					 certification processes have been recognized by the Agency, Nuclear Regulatory
					 Commission, or Agreement state will be posted on the NRC's Medical Uses
					 Licensee Toolkit Web page; or
B. Is
					 an authorized user under G.390.A and G.390.B, for uses listed in
					 G.390.B(1)(b)(vii)(a) or (b), G.394 or equivalent Nuclear Regulatory Commission
					 or Agreement State requirements; or
C.
(1) Has
					 successfully completed 80 hours of classroom and laboratory training,
					 applicable to the medical use of sodium iodide I-131 for procedures requiring a
					 written directive. The training must include:
(a) Radiation physics and instrumentation;
(b) Radiation
					 protection;
(c) Mathematics
					 pertaining to the use and measurement of radioactivity;
(d) Chemistry of radioactive material for
					 medical use; and
(e) Radiation
					 biology; and
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 144-220-G-E-394 - Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 Millicuries)

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require an
						authorized user for the oral administration of sodium iodide I-131 requiring a
						written directive in quantities greater than 1.22 gigabecquerels (33
						millicuries), to be a physician who:
A. Is certified by a medical specialty board
					 whose certification process includes all of the requirements in G.394.C(1) and
					 (2) and whose certification has been recognized by the Agency, the Nuclear
					 Regulatory Commission or an Agreement State. The names of board certifications
					 which have been recognized by the Agency, the NRC, or an Agreement State will
					 be posted on the NRC's Medical Uses Licensee Toolkit Web page; or
B. Is an authorized user under G.390.A and
					 G.390.B for uses listed in G.390 B(1)(b)(vii)(b), or equivalent Nuclear
					 Regulatory Commission or Agreement State requirements; or
C.
(1) Has
					 successfully completed 80 hours of classroom and laboratory training,
					 applicable to the medical use of sodium iodide I-131 for procedures requiring a
					 written directive. The training must include:
(a) Radiation physics and
					 instrumentation;
(b) Radiation
					 protection;
(c) Mathematics
					 pertaining to the use and measurement of radioactivity;
(d) Chemistry of radioactive material for
					 medical use; and
(e) Radiation
					 biology; and
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 144-220-G-E-396 - Training for the parenteral administration of unsealed byproduct material requiring a written directive

Current through 2024-29, July 17, 2024
A. Except as
					 provided in G.57, the licensee shall require an authorized user for the
					 parenteral administration requiring a written directive, to be a physician who:
(1) Is an authorized user under G.390 for
					 uses listed in G.390.B.(1)(b)(vii)(c) and G.390.B.(1)(b)(vii)(d) or equivalent
					 NRC or Agreement State requirements; or
(2) Is an authorized user under G.490, G.690,
					 or equivalent NRC or Agreement State requirements and who meets the
					 requirements in G.396.D; or G.396.C
(3) Is certified by a medical specialty board
					 whose certification process has been recognized by the Agency, the NRC or an
					 Agreement State under G.490 or G.690, and who meets the requirements in
					 G.396.D.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-400 - Use of Sources for manual brachytherapy

Current through 2024-29, July 17, 2024
A licensee shall use only brachytherapy sources for
						therapeutic medical uses:
A. Approved
					 in the Sealed Source and Device Registry for manual brachytherapy medical use.
					 The manual brachytherapy sources may be used for manual brachytherapy uses that
					 are not explicitly listed in the Sealed Source and Device Registry, but must be
					 used in accordance with the radiation safety conditions and limitations
					 described in the Sealed Source and Device Registry; or
B. In research to deliver therapeutic does
					 for medical use in accordance with an active Investigational Device Exemption
					 (IDE) application accepted by the U.S. Food and Drug Administration provided
					 the requirements of G.49 are met.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-404 - Surveys after source implant and removal

Current through 2024-29, July 17, 2024
A. Immediately after implanting sources in a
					 patient or a human research subject, the licensee shall make a survey 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 make a survey of the patient or the human research subject with
					 a radiation detection survey instrument to confirm that all sources have been
					 removed.
C. A licensee shall retain
					 a record of the surveys required by G.404.A and G.404.B in accordance with
					 G.2404.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-406 - Brachytherapy sources accountability

Current through 2024-29, July 17, 2024
A. A
					 licensee shall maintain accountability at all times for all brachytherapy
					 sources in storage or use.
B. As
					 soon as possible after removing sources from a patient or a human research
					 subject, a licensee shall return brachytherapy sources to a secure storage
					 area.
C. A licensee shall maintain
					 a record of the brachytherapy source accountability in accordance with G.2406.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-410 - Safety instruction

Current through 2024-29, July 17, 2024
In addition to the requirements of Part J:
A. The licensee shall provide radiation
					 safety instruction initially and at least annually, to personnel caring for
					 patients or human research subjects who are receiving brachytherapy and cannot
					 be released under G.75. To satisfy this requirement, the instruction must be
					 commensurate with the duties of the personnel and include:
(1) Size and appearance of the brachytherapy
					 sources;
(2) Safe handling and
					 shielding instructions;
(3) Patient
					 and human research subject control;
(4) Visitor control, including both:
(a) Routine visitation of hospitalized
					 individuals in accordance with Part D.1301.A(1); and
(b) Visitation authorized in accordance with
					 Part D.1301.C; and
(5)
					 Notification of the radiation safety officer, or his or her designee, and an
					 authorized user if the patient or human research subject has a medical
					 emergency or dies. The licensee shall also notify the Agency in accordance with
					 G.3068 if it is possible that any individual could receive exposures in excess
					 of Part D.301 of this rule as a result from exposure to the deceased
					 body.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-415 - Safety precautions

Current through 2024-29, July 17, 2024
A. For each patient
					 or human research subject who is receiving brachytherapy and cannot be release
					 under G.75, a licensee shall:
(1) Not quarter
					 the patient or human research subject in the same room as an individual who is
					 not receiving brachytherapy;
(2)
					 Visibly post the patient's or human research subject's room with a Radioactive
					 Materials sign; and
(3) Note on the
					 door or 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;
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-420 - Possession of survey instrument

Current through 2024-29, July 17, 2024
A licensee authorized to use manual brachytherapy sources
						shall possess a portable radiation detection survey instrument capable of
						detecting dose rates over the range of 1 microsievert (0.1 mrem) per hour to
						500 microsieverts (50 mrems) per hour, and a portable survey instrument capable
						of measuring dose rates over the range of 10 microsieverts (1 mrem) per hour to
						10 microsieverts (1000 mrems) per hour. The instrument shall be operable and
						calibrated in accordance with G.61.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-432 - Calibration measurements of brachytherapy sources

Current through 2024-29, July 17, 2024
A. Before the first medical use of a
					 brachytherapy source on or after December 1, 2003, a licensee shall have:
(1) Determined the source output or activity
					 using a dosimetry system that meets the requirements of G.630.A;
(2) Determined source positioning accuracy
					 within applicators; and
(3) Used
					 published protocols currently accepted by nationally recognized bodies to meet
					 the requirements of G.432.A.(1) and G.432.A.(2).
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-433 - Strontium-90 sources for ophthalmic treatments

Current through 2024-29, July 17, 2024
A. Licensees who use strontium-90 for
					 ophthalmic treatments must ensure that certain activities as specified in
					 paragraph (b) of this section are performed by either:
(1) An authorized medical physicist;
					 or
(2) An individual who:
(a) Is identified as an ophthalmic physicist
					 on a specific medical use license issued by the Agency, Nuclear Regulatory
					 Commission or an Agreement State; permit issued by the Agency, Nuclear
					 Regulatory Commission or Agreement State broad scope medical use licensee;
					 medical use permit issued by a Nuclear Regulatory Commission master material
					 licensee; or permit issued by a Nuclear Regulatory Commission master material
					 licensee broad scope medical use permittee; and
(b) Holds a master's or doctor's degree in
					 physics, medical physics, other physical sciences, engineering, or applied
					 mathematics from an accredited college or university; and
(c) Has successfully completed one year of
					 full-time training in medical physics and an additional year of full-time work
					 experience under the supervision of a medical physicist; and
(d) Has documented training in:
(i) The creation, modification, and
					 completion of written directives;
(ii) Procedures for administrations requiring
					 a written directive; and
(iii)
					 Performing the calibration measurements of brachytherapy sources as detailed in
					 G.432.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-457 - Therapy-related computer systems

Current through 2024-29, July 17, 2024
The licensee shall perform acceptance testing on the
						treatment planning system of therapy-related computer systems in accordance
						with published protocols accepted by nationally recognized bodies. At a
						minimum, the acceptance testing must include, as applicable, verification
						of:
A. The source-specific input
					 parameters required by the dose calculation algorithm;
B. The accuracy of dose, dwell time, and
					 treatment time calculations at representative points;
C. The accuracy of isodose plots and graphic
					 displays; and
D. The accuracy of
					 the software used to determine sealed source positions from radiographic
					 images.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-490 - Training for Use of manual brachytherapy sources

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require an
						authorized user of a manual brachytherapy source for the uses authorized under
						G.400 to be a physician who:
A. Is
					 certified by a medical specialty board whose certification process has been
					 recognized by the Agency, the Nuclear Regulatory Commission, or an Agreement
					 State. The names of board certifications which have been recognized by the
					 Agency, the NRC, or an Agreement State will be posted on the NRC's Medical Uses
					 Licensee Toolkit Web page. To have its certification process recognized, a
					 specialty board shall require all candidates for certification to:
(1) Successfully complete a minimum of three
					 years of residency training in a radiation oncology program approved by the
					 Residency Review Committee of the Accreditation Council for Graduate Medical
					 Education or Royal College of Physicians and Surgeons of Canada or the Council
					 on Postdoctoral Training of the American Osteopathic Association; and
(2) Pass an examination, administered by
					 diplomates of the specialty board, which tests knowledge and competence in
					 radiation safety, radionuclide handling, treatment planning, quality assurance,
					 and clinical use of manual brachytherapy; or
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart F - MANUAL BRACHYTHERAPY › Section 144-220-G-F-491 - Training for ophthalmic use of strontium-90

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require
						the authorized user of strontium-90 for ophthalmic radiotherapy to be a
						physician who:
A. Is an authorized
					 user under G.490 or equivalent Nuclear Regulatory Commission, or Agreement
					 State requirements; or
B.
(1) Has completed 24 hours of classroom and
					 laboratory training applicable to the medical use of strontium-90 for
					 ophthalmic radiotherapy. The training must include:
(a) Radiation physics and
					 instrumentation;
(b) Radiation
					 protection;
(c) Mathematics
					 pertaining to the use and measurement of radioactivity; and
(d) Radiation biology; and
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart G - SEALED SOURCES FOR DIAGNOSIS › Section 144-220-G-G-500 - Use of sealed sources and medical devices for diagnosis

Current through 2024-29, July 17, 2024
A. A licensee must use only sealed sources
					 that are not in medical devices for diagnostic medical uses if the sealed
					 sources are approved in the Sealed Source and Device Registry for diagnostic
					 medicine. The sealed sources may be used for diagnostic medical uses that are
					 not explicitly listed in the Sealed Source and Device Registry but must be used
					 in accordance with the radiation safety conditions and limitations described in
					 the Sealed Source and Device Registry.
B. A licensee must only use medical devices
					 containing sealed sources for diagnostic medical uses if both the sealed
					 sources and medical devices are approved in the Sealed Source and Device
					 Registry for diagnostic medical uses. The diagnostic medical devices may be
					 used for diagnostic medical uses that are not explicitly listed in the Sealed
					 Source and Device Registry but must be used in accordance with the radiation
					 safety conditions and limitations described in the Sealed Source and Device
					 Registry.
C. Sealed sources and
					 devices for diagnostic medical uses may be used in research in accordance with
					 an active Investigational Device Exemption (IDE) application accepted by the
					 U.S. Food and Drug Administration provided the requirements of G.49.A are
					 met.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart G - SEALED SOURCES FOR DIAGNOSIS › Section 144-220-G-G-590 - Training for use of sealed sources and medical devices for diagnosis

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require
						the authorized user of a diagnostic sealed source for use in a device
						authorized under G.500 to be a physician, dentist, or podiatrist who:
A. Is certified by a specialty board whose
					 certification process includes all of the requirements in G.590.C and D and
					 whose certification has been recognized by the Agency, the Nuclear Regulatory
					 Commission, or an Agreement State The names of board certifications which have
					 been recognized by the Agency, the NRC, or an Agreement State will be posted on
					 the NRC's Medical Users Licensee Toolkit Web page; or
B. Is an authorized user for uses listed in
					 G.200 or equivalent Nuclear Regulatory Commission or Agreement State
					 requirements:
C. Has had completed
					 eight hours of classroom and laboratory training in basic radionuclide handling
					 techniques specifically applicable to the use of the device. The training must
					 include:
(1) Radiation physics and
					 instrumentation;
(2) Radiation
					 protection;
(3) Mathematics
					 pertaining to the use and measurement of radioactivity;
(4) Radiation biology; and
(5) Has completed training in the use of the
					 device for the uses requested.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-600 - Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit

Current through 2024-29, July 17, 2024
A. A licensee must only use sealed sources:
(1) Approved and as provided for in the
					 Sealed Source and Device Registry in photon emitting remote afterloader units,
					 teletherapy units, or gamma stereotactic radiosurgery units to deliver
					 therapeutic doses for medical uses; or
(2) In research involving photon-emitting
					 remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
					 units in accordance with an active Investigational Device Exemption (IDE)
					 application accepted by the U.S. Food and Drug Administration provided the
					 requirements of G.49.A are met.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-604 - Surveys of patients and human research subjects treated with a remote afterloader unit

Current through 2024-29, July 17, 2024
A. Before releasing
					 a patient or a human research subject from licensee control, a licensee shall
					 survey the patient or the human research subject and the remote afterloader
					 unit with a portable radiation detection survey instrument to confirm that the
					 source(s) has been removed from the patient or human research subject and
					 returned to the safe shielded position.
B. A licensee shall retain a record of these
					 surveys in accordance with G.2404.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-605 - Installation, maintenance, adjustment and repair

Current through 2024-29, July 17, 2024
A. Only a person specifically licensed by the
					 Agency, the Nuclear Regulatory Commission or an Agreement State shall install,
					 maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or
					 gamma stereotactic radiosurgery unit that involves work on the source(s)
					 shielding, the source(s) driving unit, or other electronic or mechanical
					 component that could expose the source(s), reduce the shielding around the
					 source(s), or compromise the radiation safety of the unit or the
					 source(s).
B. Except for low
					 dose-rate remote afterloader units, only a person specifically licensed by the
					 Agency, the Nuclear Regulatory Commission or an Agreement State shall install,
					 replace, relocate, or remove a sealed source or source contained in other
					 remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
					 units.
C. For a low dose-rate
					 remote afterloader unit, only a person specifically licensed by the Agency, the
					 Nuclear Regulatory Commission or an Agreement State or an authorized medical
					 physicist shall install, replace, relocate, or remove a sealed source(s)
					 contained in the unit.
D. A
					 licensee shall retain a record of the installation, maintenance, adjustment,
					 and repair of remote afterloader units, teletherapy units, and gamma
					 stereotactic radiosurgery units in accordance with G.2605.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-610 - Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Current through 2024-29, July 17, 2024
A. A licensee shall:
(1) Secure the unit, the console, the console
					 keys, and the treatment room when not in use or unattended;
(2) Permit only individuals approved by the
					 authorized user, radiation safety officer, or authorized medical physicist to
					 be present in the treatment room during treatment with the source(s);
(3) Prevent dual operation of more than one
					 radiation producing device in a treatment room if applicable; and
(4) Develop, implement, and maintain written
					 procedures for responding to an abnormal situation when the operator is unable
					 to place the source(s) in the shielded position, or remove the patient or human
					 research subject from the radiation field with controls from outside the
					 treatment room. These procedures must include:
(a) Instructions for responding to equipment
					 failures and the names of the individuals responsible for implementing
					 corrective actions;
(b) The process
					 for restricting access to and posting of the treatment area to minimize the
					 risk of inadvertent exposure; and
(c) The names and telephone numbers of the
					 authorized users, the authorized medical physicist, and the Radiation Safety
					 Officer to be contacted if the unit or console operates abnormally.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-615 - Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Current through 2024-29, July 17, 2024
A. A licensee shall control access to the
					 treatment room by a door at each entrance.
B. A licensee shall equip each entrance to
					 the treatment room with an electrical interlock system that will:
(1) Prevent the operator from initiating the
					 treatment cycle unless each treatment room entrance door is closed;
(2) Cause the source(s) to be shielded when
					 an entrance door is opened; and
(3)
					 Prevent the source(s) from being exposed following an interlock interruption
					 until all treatment room entrance doors are closed and the source(s) on-off
					 control is reset at the console.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-630 - Dosimetry equipment

Current through 2024-29, July 17, 2024
A. Except for low
					 dose-rate remote afterloader sources where the source output or activity is
					 determined by the manufacturer, a licensee shall have a calibrated dosimetry
					 system available for use. To satisfy this requirement, one of the following two
					 conditions shall be met:
(1) The system must
					 have been calibrated using a system or source traceable to the National
					 Institute of Standards and Technology (NIST) and published protocols accepted
					 by nationally recognized bodies; or by a calibration laboratory accredited by
					 the American Association of Physicists in Medicine (AAPM). The calibration must
					 have been performed within the previous two years and after any servicing that
					 may have affected system calibration; or
(2) The system must have been calibrated
					 within the previous four years. Eighteen to thirty months after that
					 calibration, the system must have been intercompared with another dosimetry
					 system that was calibrated within the past 24 months by NIST or by a
					 calibration laboratory accredited by the AAPM. The results of the
					 intercomparison must indicate that the calibration factor of the licensee's
					 system had not changed by more than two percent. The licensee may not use the
					 intercomparison result to change the calibration factor. When intercomparing
					 dosimetry systems to be used for calibrating sealed sources for therapeutic
					 units, the licensee shall use a comparable unit with beam attenuators or
					 collimators, as applicable, and sources of the same radionuclide as the source
					 used at the licensee's facility.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-632 - Full calibration measurements on teletherapy units

Current through 2024-29, July 17, 2024
A. A licensee authorized to use a teletherapy
					 unit for medical use shall perform full calibration measurements on each
					 teletherapy unit:
(1) Before the first
					 medical use of the unit; and
(2)
					 Before medical use under the following conditions:
(a) Whenever spot-check measurements indicate
					 that the output differs by more than 5 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 one
					 year.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-633 - Full calibration measurements on remote afterloader units

Current through 2024-29, July 17, 2024
A. A licensee authorized to use a remote
					 afterloader unit for medical use shall perform full calibration measurements on
					 each unit:
(1) Before the first medical use
					 of the unit;
(2) Before medical use
					 under the following conditions:
(a) Following
					 replacement of the source or following reinstallation of the unit in a new
					 location outside the facility; and
(b) Following any repair of the unit that
					 includes removal of the source or major repair of the components associated
					 with the source exposure assembly; and
(3) At intervals not exceeding one quarter
					 for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader
					 units with sources whose half-life exceeds 75 days; and
(4) At intervals not exceeding one year for
					 low dose-rate remote afterloader units.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-635 - Full calibration measurements on gamma stereotactic radiosurgery units

Current through 2024-29, July 17, 2024
A. A licensee
					 authorized to use a gamma stereotactic radiosurgery unit for medical use shall
					 perform full calibration measurements on each unit:
(1) Before the first medical use of the
					 unit;
(2) Before medical use under
					 the following conditions:
(a) Whenever
					 spot-check measurements indicate that the output differs by more than 5 percent
					 from the output obtained at the last full calibration corrected mathematically
					 for radioactive decay;
(b)
					 Following replacement of the sources or following reinstallation of the gamma
					 stereotactic radiosurgery unit in a new location; and
(c) Following any repair of the gamma
					 stereotactic radiosurgery unit that includes removal of the sources or major
					 repair of the components associated with the source assembly;
					 and
(3) At intervals not
					 exceeding one year, with the exception that relative helmet factors need only
					 be determined before the first medical use of a helmet and following any damage
					 to a helmet.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-642 - Periodic spot checks for teletherapy units

Current through 2024-29, July 17, 2024
A. A licensee authorized to use teletherapy
					 units for medical use shall perform output spot checks on each teletherapy unit
					 once in each calendar month that include determination of:
(1) Timer accuracy, and timer linearity over
					 the range of use;
(2) On-off
					 error;
(3) The coincidence of the
					 radiation field and the field indicated by the light beam localizing
					 device;
(4) The accuracy of all
					 distance measuring and localization devices used for medical use;
(5) The output for one typical set of
					 operating conditions measured with the dosimetry system described in G.630.A;
					 and
(6) The difference between the
					 measurement made in G.642.B(5) and the anticipated output, expressed as a
					 percentage of the anticipated output (i.e., the value obtained at last full
					 calibration corrected mathematically for physical decay).
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-643 - Periodic spot-checks for remote afterloader units

Current through 2024-29, July 17, 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.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-645 - Periodic spot-checks for gamma stereotactic radiosurgery units

Current through 2024-29, July 17, 2024
A. A licensee authorized to use a gamma
					 stereotactic radiosurgery unit for medical use shall perform spot-checks of
					 each gamma stereotactic radiosurgery facility and on each unit --
(1) Monthly;
(2) Before the first use of the unit on a
					 given day; and
(3) After each
					 source installation.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-647 - Additional technical requirements for mobile remote afterloader units

Current through 2024-29, July 17, 2024
A. A licensee providing mobile remote
					 afterloader service shall:
(1) Check survey
					 instruments before medical use at each address of use or on each day of use,
					 whichever is more frequent; and
(2)
					 Account for all sources before departure from a client's address of
					 use.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-652 - Radiation surveys

Current through 2024-29, July 17, 2024
A. In addition to
					 the survey requirement in Part D.1501, a person licensed under Part G shall
					 make surveys to ensure that the maximum radiation levels and average radiation
					 levels from the surface of the main source safe with the source(s) in the
					 shielded position do not exceed the levels stated in the Sealed Source and
					 Device Registry.
B. The licensee
					 shall make the survey required by G.652.A at installation of a new source and
					 following repairs to the source(s) shielding, the source(s) driving unit, or
					 other electronic or mechanical component that could expose the source, reduce
					 the shielding around the source(s), or compromise the radiation safety of the
					 unit or the source(s).
C. A
					 licensee shall retain a record of the radiation surveys required by G.652.A in
					 accordance with G.2652.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-655 - Full-Inspection Service for teletherapy and gamma stereotactic radiosurgery units

Current through 2024-29, July 17, 2024
A. A licensee shall
					 have each teletherapy unit and gamma stereotactic radiosurgery unit fully
					 inspected and serviced during source replacement to assure proper functioning
					 of the source exposure mechanism and other safety components. The interval
					 between each full inspection shall not exceed five years for each teletherapy
					 unit and shall not exceed seven years for each gamma stereotactic radiosurgery
					 unit.
B. This inspection and
					 servicing may only be performed by persons specifically licensed to do so by
					 the Agency, the Nuclear Regulatory Commission, or an Agreement State.
C. A licensee shall keep a record of the
					 inspection and servicing in accordance with G.2655.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-657 - Therapy-related computer systems

Current through 2024-29, July 17, 2024
The licensee shall perform acceptance testing on the
						treatment planning system of therapy-related computer systems in accordance
						with published protocols accepted by nationally recognized bodies. At a
						minimum, the acceptance testing must include, as applicable, verification
						of:
A. The source-specific input
					 parameters required by the dose calculation algorithm;
B. The accuracy of dose, dwell time, and
					 treatment time calculations at representative points;
C. The accuracy of isodose plots and graphic
					 displays;
D. The accuracy of the
					 software used to determine sealed source positions from radiographic images;
					 and
E. The accuracy of electronic
					 transfer of the treatment delivery parameters to the treatment delivery unit
					 from the treatment planning system.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 144-220-G-H-690 - Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require an
						authorized user of a sealed source for a use authorized under G.600 to be a
						physician who:
A. Is certified by a
					 medical specialty board whose certification process has been recognized by the
					 Agency, the Nuclear Regulatory Commission, or an Agreement State and who meets
					 the requirements in G.690.C. The names of board certifications which have been
					 recognized by the Agency, the NRC, or an Agreement State will be posted on the
					 NRC's Medical Uses Licensee Toolkit Web page. To be recognized, a specialty
					 board shall require all candidates for certification to:
(1) Successfully complete a minimum of three
					 years of residency training in a radiation therapy program approved by the
					 Residency Review Committee of the Accreditation Council for Graduate Medical
					 Education or Royal College of Physicians and Surgeons of Canada or the Council
					 on Postdoctoral Training of the American Osteopathic Association; and
(2) Pass an examination, administered by
					 diplomates of the specialty board, which tests knowledge and competence in
					 radiation safety, radionuclide handling, treatment planning, quality assurance,
					 and clinical use of stereotactic radiosurgery, remote afterloaders and external
					 beam therapy; or
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart K - OTHER MEDICAL USES OF RADIOACTIVE MATERIAL OR RADIATION FROM RADIOACTIVE MATERIAL › Section 144-220-G-K-1000 - Other medical uses of radioactive material or radiation from radioactive material

Current through 2024-29, July 17, 2024
A licensee may use radioactive material or a radiation
						source approved for medical use which is not specifically addressed in subparts
						D through H of Part G if:
A. The
					 applicant or licensee has submitted the information required by G.12.B through
					 G.12.D; and B. The applicant or licensee has received written approval from the
					 Agency in a license or license amendment and uses the material in accordance
					 with the regulations and specific conditions the Agency considers necessary for
					 the medical use of the material.
C.
					 There are three modalities currently authorized by the Agency, the U.S. Nuclear
					 Regulatory Commission or an Agreement State:
(1) Yttrium-90 (Y-90) Microspheres (e.g., MDS
					 Nordion Y-90 TheraSphere®).
(2)
					 Liquid Brachytherapy (e.g., Proxima Therapeutics' GilaSite® Radiation
					 Therapy System).
(3) Intravascular
					 Brachytherapy (e.g., Cordis CheckmateTM System,
					 Novoste Beta-CathTM System, and Guidant
					 GalileoTM Intravascular Radiotherapy
					 System).
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart L - RECORDS › Section 144-220-G-L-2024 - Records of authority and responsibilities for radiation protection programs

Current through 2024-29, July 17, 2024
A. A licensee shall
					 retain a record of actions taken by the licensee's management in accordance
					 with G.24.A for five years. The record must include a summary of the actions
					 taken and a signature of licensee management.
B. The licensee shall retain a copy of both
					 authority, duties, and responsibilities of the Radiation Safety Officer as
					 required by G.24.E, and a signed copy of each radiation safety officer's
					 agreement to be responsible for implementing the radiation safety program, as
					 required by G.24.B, for the duration of the license. The records must include
					 the signature of the radiation safety officer and licensee
					 management.
C. For each associate
					 radiation safety officer appointed under G.24.B, the licensee shall retain, for
					 5 years after the associate radiation safety officer is removed from the
					 license, a copy of the written document appointing the associate radiation
					 safety officer signed by the licensee's management.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart L - RECORDS › Section 144-220-G-L-2026 - Records of radiation protection program changes

Current through 2024-29, July 17, 2024
A licensee shall retain a record of each radiation
						protection program change made in accordance with G.26.A for five years. The
						record must include a copy of the old and new procedures, the effective date of
						the change, and the signature of the licensee management that reviewed and
						approved the change.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart L - RECORDS › Section 144-220-G-L-2031 - Records of mobile nuclear medicine services

Current through 2024-29, July 17, 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 G.80.A(1). 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 G.80.A.4 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.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart L - RECORDS › Section 144-220-G-L-2040 - Records of written directives

Current through 2024-29, July 17, 2024
A licensee shall retain a copy of each written directive
						as required by G.40 for three years.