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DHS 157.65(8)(b)2.f. f. Using emergency procedures to control radioactive material.
DHS 157.65(8)(b)3. 3. Three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in this subsection, s. DHS 157.61 (10), or equivalent agreement state requirements, as part of a formal training program approved by the residency review committee for radiation oncology of the accreditation council for graduate medical education or the royal college of physicians and surgeons of Canada or the committee on postdoctoral training of the American osteopathic association. The experience may be obtained concurrently with the supervised work experience required by subd. 2.
DHS 157.65(9) (9)Training for ophthalmic use of strontium-90. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user of strontium-90 for ophthalmic radiotherapy to have obtained written attestation under sub. (10) (b) and be a physician who has had classroom and laboratory training applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy that meets all of the following criteria:
DHS 157.65(9)(a) (a) Twenty-four hours of classroom and laboratory training that includes all of the following:
DHS 157.65(9)(a)1. 1. Radiation physics and instrumentation.
DHS 157.65(9)(a)2. 2. Radiation protection.
DHS 157.65(9)(a)3. 3. Mathematics pertaining to the use and measurement of radioactivity.
DHS 157.65(9)(a)4. 4. Radiation biology.
DHS 157.65(9)(b) (b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of 5 individuals. The supervised clinical training shall include all of the following:
DHS 157.65(9)(b)1. 1. Examination of each person to be treated.
DHS 157.65(9)(b)2. 2. Calculation of the dose to be administered.
DHS 157.65(9)(b)3. 3. Administration of the dose.
DHS 157.65(9)(b)4. 4. Follow up and review of each individual's case history.
DHS 157.65(10) (10)Written attestation.
DHS 157.65(10)(a) (a) Manual brachytherapy sources. A licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under sub. (1) to have obtained written attestation, signed by a preceptor authorized user who meets the requirements in sub. (8), s. DHS 157.61 (10), or equivalent agreement state requirements, that the individual has satisfactorily completed the requirements in sub. (8) (a) 1. or (b) and has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized under sub. (8).
DHS 157.65(10)(b) (b) Ophthalmic use of strontium-90. A licensee shall require an authorized user for ophthalmic use of strontium-90 to have obtained written attestation, signed by a preceptor authorized user who meets the requirements in sub. (8) or (9), s. DHS 157.61 (10), or equivalent agreement state requirements, that the individual has satisfactorily completed the requirements in sub. (9) (a) and (b) and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use.
DHS 157.65 History History: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: am. (1) (intro.) and (6) (a) (intro.), r. and recr. (8) and (9), cr. (10) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (8) (b) 2. (intro.), 3., and (10) Register April 2010 No. 652, eff. 5-1-10.
DHS 157.66 DHS 157.66Sealed sources for diagnosis.
DHS 157.66(1)(1)Use of sealed sources for diagnosis. A licensee shall use only sealed sources for diagnostic medical uses as approved in the sealed source and device registry.
DHS 157.66 Note Note: The sealed source and device registrations may be obtained from the manufacturer or by writing the department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.
DHS 157.66(2) (2)Training for use of sealed sources for diagnosis. Except as provided in s. DHS 157.61 (10), a licensee shall require the authorized user of a diagnostic sealed source for use in a device authorized under sub. (1) to have received training in the use of the device for the uses requested. The licensee shall also require the authorized user to be a physician, dentist or podiatrist who meets either of the following requirements:
DHS 157.66(2)(a) (a) Is certified by a specialty board whose certification process includes all of the requirements in par. (b) and whose certification is recognized by the department, the NRC or an agreement state.
DHS 157.66 Note Note: Specialty boards whose certification processes have been recognized by the department, the NRC or an agreement state will be posted on the NRC's web site at www.nrc.gov.
DHS 157.66(2)(b) (b) Has completed 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device that includes all of the following:
DHS 157.66(2)(b)1. 1. Radiation physics and instrumentation.
DHS 157.66(2)(b)2. 2. Radiation protection.
DHS 157.66(2)(b)3. 3. Mathematics pertaining to the use and measurement of radioactivity.
DHS 157.66(2)(b)4. 4. Radiation biology.
DHS 157.66 History History: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: r. and recr. (2) Register October 2006 No. 610, eff. 11-1-06.
DHS 157.67 DHS 157.67Photon emitting remote afterloader, teletherapy and gamma stereotactic radiosurgery units.
DHS 157.67(1)(1)Use of a sealed source in a remote afterloader, teletherapy or gamma stereotactic radiosurgery unit. A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units or gamma stereotactic units for therapeutic medical uses that meet one of the following criteria:
DHS 157.67(1)(a) (a) Is approved in the sealed source and device registry.
DHS 157.67 Note Note: The sealed source and device registrations may be obtained from the manufacturer or by writing the department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.
DHS 157.67(1)(b) (b) In research under an effective investigational device exemption application accepted by the FDA, provided the requirements of s. DHS 157.61 (6) (a) are met.
DHS 157.67 Note Note: The FDA requirements for investigational devices may be found at: http://www.fda.gov/Radiation-EmittingProducts/default.htm.
DHS 157.67(2) (2)Surveys of patients and human research subjects treated with a remote afterloader unit.
DHS 157.67(2)(a) (a) Before releasing a patient or a human research subject from licensee control, a licensee shall make a survey of the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source has been removed from the patient or human research subject and returned to the safe shielded position.
DHS 157.67(2)(b) (b) A licensee shall retain a record of the surveys under s. DHS 157.71 (16).
DHS 157.67(3) (3)Installation, maintenance, adjustment and repair.
DHS 157.67(3)(a)(a) A person shall be specifically licensed by the department, NRC or another agreement state to install, maintain, adjust or repair a remote afterloader unit, teletherapy unit or gamma stereotactic radiosurgery unit that involves work on the source shielding, the source driving unit used to move the source or other electronic or mechanical component that could expose the source, reduce the shielding around the source or compromise the radiation safety of the unit or the source.
DHS 157.67(3)(b) (b) Except for low dose-rate remote afterloader units, only a person specifically licensed by the department, NRC or another agreement state may install, replace, relocate or remove a sealed source or source contained in other remote afterloader units, teletherapy units or gamma stereotactic units.
DHS 157.67(3)(c) (c) For a low dose-rate remote afterloader unit, only a person specifically licensed by the department, NRC or another agreement state, or an authorized medical physicist, shall install, replace, relocate or remove a sealed source contained in the unit.
DHS 157.67(3)(d) (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 under s. DHS 157.71 (19).
DHS 157.67(4) (4)Safety procedures and instructions for remote afterloader, teletherapy and gamma stereotactic radiosurgery units.
DHS 157.67(4)(a)(a) A licensee shall do all of the following:
DHS 157.67(4)(a)1. 1. Secure the unit, console, console keys and the treatment room when unattended or not in use.
DHS 157.67(4)(a)2. 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.
DHS 157.67(4)(a)3. 3. Prevent dual operation of more than one radiation producing device in a treatment room, if applicable.
DHS 157.67(4)(a)4. 4. Develop, implement and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source in the shielded position or remove the patient or human research subject from the radiation field with controls from outside the treatment room. The procedure shall include all the following:
DHS 157.67(4)(a)4.a. a. Instructions for responding to equipment failures and the names of the persons responsible for implementing corrective actions.
DHS 157.67(4)(a)4.b. b. The process for restricting access to and posting signs in the proximity of the treatment area to minimize the risk of inadvertent exposure.
DHS 157.67(4)(a)4.c. 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.
DHS 157.67(4)(b) (b) A copy of the procedures required by par. (a) 4. shall be physically located at the unit console.
DHS 157.67(4)(c) (c) A licensee shall post instructions at the unit console to inform the operator of both of the following:
DHS 157.67(4)(c)1. 1. The location of the procedures required by par. (a) 4.
DHS 157.67(4)(c)2. 2. 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.
DHS 157.67(4)(d) (d) A licensee shall provide instruction, initially and at least annually, to all persons who operate the unit, as appropriate to the person's assigned duties, in all the following:
DHS 157.67(4)(d)1. 1. The procedures identified in par. (a) 4.
DHS 157.67(4)(d)2. 2. The operating procedures for the unit.
DHS 157.67(4)(e) (e) A licensee shall ensure that operators, authorized medical physicists and authorized users participate in drills of the emergency procedures, initially and at least annually thereafter.
DHS 157.67(4)(f) (f) A licensee shall retain a record of individuals receiving instruction required under s. DHS 157.71 (15).
DHS 157.67(5) (5)Safety precautions for remote afterloader, teletherapy and gamma stereotactic radiosurgery units.
DHS 157.67(5)(a)(a) A licensee shall control access to the treatment room by a door at each entrance.
DHS 157.67(5)(b) (b) A licensee shall equip each entrance to the treatment room with an electrical interlock system that accomplishes all the following:
DHS 157.67(5)(b)1. 1. Prevents the operator from initiating the treatment cycle unless each treatment room entrance door is closed.
DHS 157.67(5)(b)2. 2. Causes the source to be shielded promptly when an entrance door is opened.
DHS 157.67(5)(b)3. 3. Prevents the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.
DHS 157.67(5)(c) (c) A licensee shall require any person entering the treatment room to assure, via appropriate radiation monitors, that radiation levels have returned to ambient levels.
DHS 157.67(5)(d) (d) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.
DHS 157.67(5)(e) (e) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments that allow for expeditious removal of a decoupled or jammed source.
DHS 157.67(5)(f) (f) A licensee shall do all the following:
DHS 157.67(5)(f)1. 1. For medium dose-rate and pulsed dose-rate remote afterloader units, require all the following:
DHS 157.67(5)(f)1.a. a. An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit.
DHS 157.67(5)(f)1.b. b. An authorized medical physicist and either an authorized user or a person under the supervision of an authorized user who has been trained to remove the source applicator in the event of an emergency involving the unit to be immediately available during continuation of all patient treatments involving the unit.
DHS 157.67(5)(f)2. 2. For high dose-rate remote afterloader units, require all the following:
DHS 157.67(5)(f)2.a. a. An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit.
DHS 157.67(5)(f)2.b. b. An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during continuation of all patient treatments involving the unit.
DHS 157.67(5)(f)3. 3. For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.
DHS 157.67(5)(f)4. 4. Notify the radiation safety officer or his or her designee and an authorized user immediately if the patient or human research subject has a medical emergency or if the patient dies.
DHS 157.67(5)(g) (g) A licensee shall have available near each treatment room, emergency response equipment, as applicable, to respond to all of the following:
DHS 157.67(5)(g)1. 1. A source inadvertently remaining in the unshielded position.
DHS 157.67(5)(g)2. 2. A source inadvertently lodged within the patient following completion of the treatment.
DHS 157.67(6) (6)Dosimetry equipment.
DHS 157.67(6)(a) (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 conditions shall be met:
DHS 157.67(6)(a)1. 1. The system shall have been calibrated using a system or source traceable to the national institute of standards and technology and published protocols accepted by nationally recognized bodies, or by a calibration laboratory accredited by the American association of physicists in medicine. The calibration shall have been performed within the previous 2 years and after any servicing that may have affected system calibration.
DHS 157.67 Note Note: An example of a nationally recognized body is the American Association of Physicists in Medicine.
DHS 157.67(6)(a)2. 2. The system shall have been calibrated within the previous 4 years. Eighteen to 30 months after that calibration, the system shall have been compared to another dosimetry system that was calibrated within the past 24 months by the national institute of standards and technology or by a calibration laboratory accredited by the American association of physicists in medicine. The results of the comparison shall have indicated that the calibration factor of the licensee's system had not changed by more than 2%. A licensee may not use the intercomparison result to change the calibration factor. When comparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, a 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.
DHS 157.67(6)(b) (b) A licensee shall have available for use a dosimetry system for spot-check output measurements to periodically measure the radiation output of the device for consistency, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated under par. (a). The comparison shall have been performed within the previous 12 months and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in par. (a).
DHS 157.67(6)(c) (c) A licensee shall retain a record of each calibration and comparison under s. DHS 157.71 (20).
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.