reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 120.553 - Safety Instruction

Current through Register 1525, July 5, 2024
In addition to the requirements of
				  105 CMR
				  120.753:
(A) A licensee shall provide radiation safety
				instruction, initially and at least annually, to personnel caring for patients
				or human research subjects who have received therapy with with a radioactive
				drug, and cannot be released in accordance with
				105
				CMR 120.540. To satisfy the requirement in
				105 CMR 120.553(A), the instruction must be commensurate with the duties of the
				personnel and include:
(1) Patient or human
				research subject control;
(2)
				Visitor control to include the following:
(a)
				Routine visitation to hospitalized individuals in accordance with
				105 CMR
				120.221(A)(1) and
				(C);
(b) Contamination control;
(c) Waste control; and
(d) Notification of the RSO, or his or her
				designee, and the authorized user if the patient or the human research subject
				has a medical emergency or dies.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 120.554 - Safety Precautions

Current through Register 1525, July 5, 2024
(A) For each patient
				or human research subject receiving radiopharmaceutical therapy and
				hospitalized for compliance with
				105
				CMR 120.540, a licensee shall:
(1) Quarter the patient or the human research
				subject either in:
(a) A private room with a
				private sanitary facility; or
(b) A
				room, with a private sanitary facility, with another individual who also has
				received similar radiopharmaceutical therapy and who cannot be released in
				accordance with
				105
				CMR 120.540; and
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 120.556 - Training for Use of Unsealed Byproduct Material for Which a Written Directive Is Required

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  authorized user of radioactive material for the uses authorized under
				  105
				  CMR 120.552 to be a physician who:
(A) Is certified by a medical specialty board
				whose certification process has been recognized by the Agency, Nuclear
				Regulatory Commission or an Agreement State and who meets the requirements in
				105 CMR 120.556(B)(1)(b)6. The names of board certifications that have been
				recognized by the Agency, Nuclear Regulatory Commission or an Agreement State
				are 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 residency
				training in a radiation therapy or nuclear medicine training program or a
				program in a related medical specialty. These residency training programs must
				include 700 hours of training and experience as described in 105 CMR
				120.556(B)(1)(a) through (b)5. Eligible training programs must be approved by
				the Residency Review Committee of the Accreditation Council for Graduate
				Medical Education, the Royal College of Physicians and Surgeons of Canada, or
				the Committee on Post-graduate 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, quality
				assurance, and clinical use of unsealed byproduct material for which a written
				directive is required; or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 120.557 - Training for the Oral Administration of Sodium Iodide I-131 in Quantities Less than or Equal to 1.22 Gigabequerels (33 millicurie) for Which a Written Directive Is Required

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  authorized user for the oral administration of sodium iodide I-131 in
				  quantities less than or equal to 1.22 gigabecquerels (33 millicuries), for
				  which a written directive is required, to be a physician who:
(A) Is certified by a medical specialty board
				whose certification process includes all of the requirements in 105 CMR
				120.557(C)(1) and (2) and whose certification process has been recognized by
				the Agency, an Agreement State or the Nuclear Regulatory Commission. The names
				of board certifications that have been recognized by the Agency, Nuclear
				Regulatory Commission or an Agreement State are posted on the NRC's Medical
				Uses Licensee Toolkit Web page; or
(B) Is an authorized user under
				105
				CMR 120.556, for uses listed in
				105
				CMR 120.556(B)(1)(b)6.a. or
				b., 120.558, or equivalent Agreement State or Nuclear Regulatory Commission
				requirements; or
(C)
(1) Has successfully completed 80 hours
				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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 120.558 - Training for the Oral Administration of Sodium Iodide I-131 in Quantities Greater than 1.22 Gigabequerels (33 millicurie) for Which a Written Directive Is Required

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  authorized user for the oral administration of sodium iodide I-131 in
				  quantities greater than 1.22 gigabecquerels (33 millicuries), for which a
				  written directive is required, to be a physician who:
(A) Is certified by a medical specialty board
				whose certification process includes all of the requirements in 105 CMR
				120.558(C)(1) and (2) and whose certification has been recognized by the
				Agency, an Agreement State or the Nuclear Regulatory Commission. The names of
				board certifications that have been recognized by the Agency, Nuclear
				Regulatory Commission or an Agreement State are posted on the NRC's Medical
				Uses License Toolkit Web page; or
(B) Is an authorized user under
				105
				CMR 120.556, for uses listed in
				105
				CMR 120.556(B)(1)(b)6.b. or
				equivalent Agreement State, or Nuclear Regulatory Commission requirements;
				or
(C)
(1) Has successfully completed 80 hours
				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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 120.558A - Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive

Current through Register 1525, July 5, 2024
(A) Except as
				provided in
				105
				CMR 120.528, 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
				105
				CMR 120.556 for uses listed in
				105
				CMR 120.556(B)(1)(b)6.c., or
				equivalent Nuclear Regulatory Commission or Agreement State requirements;
				or
(2) Is an authorized user under
				105 CMR
				120.566,
				120.587,
				or equivalent Nuclear Regulatory Commission or Agreement State requirements,
				and who meets the requirements in 105 CMR 120.558A(B); or
(3) Is certified by a medical specialty board
				whose certification process has been recognized by the Agency, Nuclear
				Regulatory Commission or an Agreement State under
				105 CMR
				120.566 or
				120.587,
				and who meets the requirements in 105 CMR 120.558A(B).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.559 - Use of Sealed Sources for Manual Brachytherapy

Current through Register 1525, July 5, 2024
A licensee must use only brachytherapy sources:
(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 doses 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
				105
				CMR 120.523(A)  are
				met.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.560 - Surveys After Source Implant and Removal

Current through Register 1525, July 5, 2024
(A)
				Immediately after implanting sources in a patient or a human research subject,
				the licensee shall perform 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 in accordance with
				105 CMR
				120.590(Q).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.561 - Brachytherapy Sources Accountability

Current through Register 1525, July 5, 2024
(A) A
				licensee shall maintain accountability at all times for all brachytherapy
				sources in storage or use.
(B)
				Promptly 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
				105
				CMR 120.592(A).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.562 - Safety Instruction

Current through Register 1525, July 5, 2024
In addition to the requirements of
				  105 CMR
				  120.753:
(A) The licensee shall provide radiation
				safety instruction, initially and at least annually, to personnel caring for
				patients or human research subject that are undergoing brachytherapy and cannot
				be released in accordance with 105 CMR 120 540. Instruction must be
				commensurate with the duties of the personnel and shall include the following:
(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
				105 CMR
				120.221(A)(1);
(b) Visitation authorized in accordance with
				105 CMR
				120.221(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 dies or has a medical emergency.
(6) A licensee shall retain a record of
				individuals receiving instruction in accordance with
				105 CMR
				120.590(P).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.563 - Safety Precautions for Patients or Human Research Subjects Receiving Brachytherapy

Current through Register 1525, July 5, 2024
(A) For each patient
				or human research subject receiving brachytherapy and cannot be released in
				accordance with
				105
				CMR 120.540, a licensee shall:
(1) Not place the patient or human research
				subject in the same room as an individual who is not receiving brachytherapy;
				and
(2) Visibly post the patient's
				or human research subject's door with a "Radioactive Materials" sign and 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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.564 - Calibration Measurement of Brachytherapy Sealed Sources

Current through Register 1525, July 5, 2024
(A) Prior to the first medical use of a
				brachytherapy sealed source on or after October 6, 2006, a licensee shall
				perform the following:
(1) Determine the
				source output or activity using a dosimetry system that meets the requirements
				of
				105 CMR
				120.575(A);
(2) Determine source positioning accuracy
				within applicators; and
(3) Use
				published protocols accepted by nationally recognized bodies to meet the
				requirements of 105 CMR 120.564(A)(1) and (2).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.564A - Strontium-90 Sources for Ophthalmic Treatments

Current through Register 1525, July 5, 2024
(A) Licensees who use strontium-90 for
				ophthalmic treatments must ensure that certain activities as specified in 105
				CMR 120.564A(B) 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:
1. The creation, modification, and completion
				of written directives;
2.
				Procedures for administrations requiring a written directive; and
3. Performing the calibration measurements of
				brachytherapy sources as detailed in
				105 CMR
				120.564.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.565 - Therapy-related Computer Systems

Current through Register 1525, July 5, 2024
The licensee shall perform acceptance testing on the
				  treatment planning system 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. The licensee shall
				perform regular quality assurance testing on the treatment planning computer.
				Said testing shall be in accordance with TG40 or current AAPM
				recommendation.
(C) The accuracy of
				isodose plots and graphic displays; and
(D) The accuracy of the software used to
				determine radioactive source positions from radiographic images.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.566 - Training for Use of Manual Brachytherapy Sources

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  authorized user of a manual brachytherapy source for the uses authorized under
				  105 CMR
				  120.559 to be a physician who:
(A) Is certified by a medical specialty board
				whose certification process has been recognized by the Agency, an Agreement
				State or the Nuclear Regulatory Commission. The names of board certifications
				that have been recognized by the Agency, Nuclear Regulatory Commission or an
				Agreement State are 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 the Royal College of
				Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of
				the American Osteopathic Association; and
(2) Pass an examination, administered by
				diplomates of the specialty board, that tests knowledge and competence in
				radiation safety, radionuclide handling, treatment planning, quality assurance,
				and clinical use of manual brachytherapy; or
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › MANUAL BRACHYTHERAPY › Section 120.567 - Training for Ophthalmic Use of Strontium-90

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  authorized user of a strontium-90 source for ophthalmic uses authorized under
				  105 CMR
				  120.559 to be a physician who:
(A) Is an authorized user under
				105 CMR
				120.566 or equivalent Agreement State or
				Nuclear Regulatory Commission 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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SEALED SOURCES FOR DIAGNOSIS › Section 120.568 - Use of Sealed Sources and Medical Devices for Diagnosis

Current through Register 1525, July 5, 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
				105
				CMR 120.523(A)  are
				met.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › SEALED SOURCES FOR DIAGNOSIS › Section 120.569 - Training for Use of Sealed Sources and Medical Devices for Diagnosis

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  authorized user of a diagnostic sealed source or a device authorized under
				  105 CMR
				  120.568 to be a physician, dentist, or
				  podiatrist who:
(A) Is certified by a
				medical specialty board whose certification process includes all of the
				requirements in 105 CMR 120.569(C) and (D) and whose certification has been
				recognized by the Agency, an Agreement State or the Nuclear Regulatory
				Commission. The names of board certifications that have been recognized by the
				Agency, Nuclear Regulatory Commission or an Agreement State are posted on the
				NRC's Medical Uses Licensee Toolkit Web page; or
(B) Is an authorized user for uses listed in
				105
				CMR 120.547 or equivalent Nuclear Regulatory
				Commission or Agreement State requirements; or
(C) Has completed eight hours of classroom
				and laboratory training in basic radionuclide handling techniques specifically
				applicable to the use of the device that includes:
(1) Radiation physics and
				instrumentation;
(2) Radiation
				protection;
(3) Mathematics
				pertaining to the use and measurement of radioactivity; and
(4) Radiation biology; and
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.570 - Use of Sealed Sources in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit

Current through Register 1525, July 5, 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
				105
				CMR 120.523(A)  are
				met.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.571 - Surveys of Patients and Human Research Subjects Treated with Remote Afterloader Unit

Current through Register 1525, July 5, 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 the
				surveys in accordance with
				105 CMR
				120.590(Q).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.572 - Installation, Maintenance, Adjustment, and Repair

Current through Register 1525, July 5, 2024
(A) Only a person specifically licensed by
				the Agency, the U.S. 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) drive 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, an Agreement State, or the Nuclear Regulatory Commission 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, an
				Agreement State, or the Nuclear Regulatory Commission, 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 done on remote afterloader units, teletherapy units, and gamma
				stereotactic radiosurgery units in accordance with
				105
				CMR 120.592(D).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.573 - Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register 1525, July 5, 2024
(A) A licensee shall:
(1) Secure the unit, the console, the console
				keys, and the treatment room when not in use or is unattended;
(2) Permit only individuals approved by
				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. This procedure 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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.574 - Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register 1525, July 5, 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
				promptly 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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.575 - Dosimetry Equipment

Current through Register 1525, July 5, 2024
(A) Except for low
				dose-rate remote afterloader sources where the source output or activity is
				determined by the manufacturer, a licensee shall have a calibrated dosimetry
				system available for use. To satisfy this requirement, one of the following two
				conditions must be met.
(1) The system must
				have been calibrated using a system or source traceable to the National
				Institute of Standards and Technology (NIST) and published protocols accepted
				by nationally recognized bodies; or by a calibration laboratory accredited by
				the American Association of Physicists in Medicine (AAPM). The calibration must
				have been performed within the previous two years and after any servicing that
				may have affected system calibration; or
(2) The system must have been calibrated
				within the previous four years; 18 to 30 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 have indicated
				that the calibration factor of the licensee's system had not changed by more
				than 2%. 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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.576 - Full Calibration Measurements on Teletherapy Units

Current through Register 1525, July 5, 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% 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;
				and
(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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.577 - Full Calibration Measurements on Remote Afterloader Units

Current through Register 1525, July 5, 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; and
(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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.578 - Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units

Current through Register 1525, July 5, 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;
				and
(2) Before medical use under
				the following conditions:
(a) Whenever
				spot-check measurements indicate that the output differs by more than 5 % 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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.579 - Periodic Spot-checks for Teletherapy Units

Current through Register 1525, July 5, 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
				105 CmR
				120.575(B); and
(6) The difference between the measurement
				made in 105 CMR 120.579(A)(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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.580 - Periodic Spot-checks for Remote Afterloader Units

Current through Register 1525, July 5, 2024
(A) A licensee authorized to use remote
				afterloader units for medical use shall perform spot-checks on each remote
				afterloader facility and on each unit:
(1) At
				the beginning of each day of use of a high dose-rate, medium dose-rate or
				pulsed dose-rate remote afterloader unit;
(2) Prior to each patient treatment with a
				low dose-rate remote afterloader unit; and
(3) After each source installation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.581 - Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units

Current through Register 1525, July 5, 2024
(A) A licensee authorized to use a gamma
				stereotactic radiosurgery unit for medical use shall perform spot-checks on
				each gamma stereotactic radiosurgery facility and on each unit:
(1) Monthly;
(2) At the beginning of each day of use;
				and
(3) After each source
				installation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.582 - Additional Technical Requirements for Mobile Remote Afterloader Units

Current through Register 1525, July 5, 2024
(A) A licensee providing mobile remote
				afterloader service shall:
(1) Check survey
				instruments for consistent response 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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.583 - Radiation Surveys

Current through Register 1525, July 5, 2024
(A) In addition to
				the survey requirements in
				105 CMR 120.225, a person
				licensed pursuant to
				105 CMR
				120.500 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 does not exceed
				the levels stated in the Sealed Source and Device Registry.
(B) The licensee shall make the survey
				required by 105 CMR 120.583(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 in 105 CMR 120.583(A)
				in accordance with
				105
				CMR 120.592(K).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.584 - Full Inspection Servicing for Teletherapy and Gamma Stereotactic Radiosurgery Units

Current through Register 1525, July 5, 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 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, an Agreement State, or the U.S. Nuclear
				Regulatory Commission.
(C) A
				licensee shall maintain a record of the inspection and servicing in accordance
				with
				105
				CMR 120.592(L).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.585 - Therapy-related Computer Systems

Current through Register 1525, July 5, 2024
The licensee shall perform acceptance testing on the
				  treatment planning system 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. The licensee shall
				perform regular quality assurance testing on the treatment planning computer.
				Said testing shall be in accordance with TG40 or current AAPM
				recommendation.
(C) The accuracy of
				isodose plots and graphic displays;
(D) The accuracy of the software used to
				determine radioactive 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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 120.587 - Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register 1525, July 5, 2024
Except as provided in
				  105
				  CMR 120.528, the licensee shall require an
				  authorized user of a sealed source for a use authorized under
				  105
				  CMR 120.570 to be a physician who:
(A) Is certified by a medical specialty board
				whose certification process has been recognized by the Agency, an Agreement
				State or the Nuclear Regulatory Commission and who meets the requirements in
				105 CMR 120.587(C). The names of board certifications that have been recognized
				by the Agency, Nuclear Regulatory Commission 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 therapy program approved by the Residency Review Committee of the
				Accreditation Council for Graduate Medical Education or the Royal College of
				Physicians and Surgeons of Canada or the Committee on Post-graduate 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 Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › OTHER MEDICAL USES OF RADIOACTIVE MATERIAL OR RADIATION FROM RADIOACTIVE MATERIAL › Section 120.589 - Other Medical Uses of Radioactive Material or Radiation from Radioactive Material

Current through Register 1525, July 5, 2024
A licensee may use radioactive material or a radiation source
				  approved for medical use that is not specifically addressed in
				  105 CMR
				  120.500 if:
(A) The applicant or licensee has submitted
				the information required by
				105 CMR
				120.507(B) through (D);
				and
(B) The applicant or licensee
				has received written approval from the Agency in a license and uses the
				material in accordance with
				105
				CMR 120.000 and specific conditions the agency
				considers necessary for the medical use of the material.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDS › Section 120.590 - Requirements for Recordkeeping

Current through Register 1525, July 5, 2024
(A)
Records of Authority and Responsibilities for Radiation Protection
				Programs
.
(1) A licensee shall
				retain a record of actions taken by the licensee's management in accordance
				with
				105
				CMR 120.515(A)  for five
				years. The record must include a summary of the actions taken and a signature
				of licensee management.
(2) The
				licensee shall retain a current copy of the authorities, duties and
				responsibilities of the Radiation Safety Officer as required by
				105
				CMR 120.515(E), and a signed
				copy of the Radiation Safety Officer's agreement to be responsible for
				implementing the radiation safety program, as required by
				105
				CMR 120.515(B). The record
				must include the signature of the Radiation Safety Officer and licensee
				management.
(3) For each Associate
				Radiation Safety Officer appointed under
				105
				CMR 120.515(B), the licensee
				shall retain, for five years after the Associate Radiation Safety Officer is
				removed from the license, a copy of the written document appointing the
				Associate Radiation Safety Officer signed by the licensee's
				management.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDS › Section 120.592 - Requirements for Recordkeeping Pertaining to the Use of Sealed Sources

Current through Register 1525, July 5, 2024
(A)
Records of Brachytherapy
				Source Inventory
.
(1) A licensee
				shall maintain a record of brachytherapy source accountability required by
				105 CMR
				120.561 for three years.
(2) For temporary implants, the record must
				include:
(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 not implanted, the time and date they were returned to
				storage, and the name of the individual who returned them from
				storage.
(3) For
				permanent implants, the record must include:
(a) The number and activity of sources
				removed from storage, the date they were removed from storage, and the name of
				the individual who removed them from storage;
(b) The number and activity of sources
				returned to storage, the date they were returned to storage, and the name of
				the individual who returned them to storage; and
(c) The number and activity of sources
				permanently implanted in the patient or human research subject.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › REPORTS › Section 120.594 - Reports and Notifications

Current through Register 1525, July 5, 2024
(A)
Report and Notification of a Medical Event
.
(1) A licensee shall report any event as a
				medical event, except for an event that results from patient intervention, in
				which:
(a) The administration of byproduct
				material or radiation from byproduct material, except permanent implant
				brachytherapy, results in:
1. A dose that
				differs from the prescribed dose or dose that would have resulted from the
				prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5
				Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent
				to the skin; and
a. The total dose delivered
				differs from the prescribed dose by 20% or more;
b. The total dosage delivered differs from
				the prescribed dosage by 20% or more or falls outside the prescribed dosage
				range; or
c. The fractionated dose
				delivered differs from the prescribed dose for a single fraction, by 50% or
				more.