DHS 157.65(6m)(a)(a) Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in par. (b) of this section are performed by either of the following: DHS 157.65(6m)(a)2.a.a. Is identified as an ophthalmic physicist on a specific medical use license issued by the department, the NRC or an agreement state, or permit issued by the NRC or an agreement state broad scope medical use licensee, medical use permit issued by an NRC master material licensee, or permit issued by an NRC master material licensee broad scope medical use permittee. DHS 157.65(6m)(a)2.b.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. DHS 157.65(6m)(a)2.c.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. DHS 157.65(6m)(a)2.d.d. Has documented training in the creation, modification, and completion of written directives. DHS 157.65(6m)(a)2.e.e. Has documented training in procedures for administrations requiring a written directive. DHS 157.65(6m)(a)2.f.f. Has documented training in performing the calibration measurements of brachytherapy sources as detailed in sub. (6). DHS 157.65(6m)(b)1.1. Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under sub. (6). DHS 157.65(6m)(b)2.2. Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures shall include the frequencies that the individual meeting the requirements in par. (a) will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives. DHS 157.65(7)(7) Therapy-related computer systems. A licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems under published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing shall include, as applicable, verification of all of the following: DHS 157.65(7)(a)(a) Source-specific input parameters required by the dose calculation algorithm. DHS 157.65(7)(b)(b) Accuracy of dose, dwell time and treatment time calculations at representative points. DHS 157.65(7)(d)(d) Accuracy of the software used to determine radioactive source positions from radiographic images. DHS 157.65 NoteNote: An example of a nationally recognized body is the American Association of Physicists in Medicine.
DHS 157.65(8)(8) Training for use of manual brachytherapy sources. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under sub. (1) to be a physician who meets any of the following requirements: DHS 157.65(8)(a)(a) Is certified by a medical specialty board whose certification process has been recognized by the department, the NRC or an agreement state. To have its certification process recognized, a specialty board shall require all candidates for certification to do all of the following: DHS 157.65(8)(a)1.1. Successfully complete a minimum of 3 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. DHS 157.65(8)(a)2.2. 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. DHS 157.65 NoteNote: 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 157.65(8)(b)(b) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes all of the following: DHS 157.65(8)(b)1.1. Two hundred hours of classroom and laboratory training in all of the following areas: DHS 157.65(8)(b)2.2. Five hundred hours of work experience, under the supervision of an authorized user who meets the requirements in this subsection, s. DHS 157.61 (10), or equivalent NRC or agreement state requirements at a medical facility authorized to use byproduct materials under sub. (1), involving all of the following: DHS 157.65(8)(b)2.a.a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys. DHS 157.65(8)(b)2.e.e. Using administrative controls to prevent a medical event involving the use of 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 NRC or 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 Council 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 be a physician who meets any of the following requirements: DHS 157.65(9)(a)(a) Is an authorized user under sub. (8) or equivalent NRC or agreement state requirement. DHS 157.65(9)(b)(b) 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 includes all of the following: DHS 157.65(9)(b)1.1. Twenty-four hours of classroom and laboratory training that includes all of the following: DHS 157.65(9)(b)2.2. 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(10)(a)(a) Manual brachytherapy sources. As required by sub. (8) (b) 4., 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 NRC or agreement state requirements, that the individual has successfully completed the requirements in sub. (8) (b) and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under sub. (1). The attestation must be obtained from any of the following: DHS 157.65(10)(a)2.2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (8), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements and concurs with the attestation provided by the residency program director. The residency training program must be 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 Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (8) (b). DHS 157.65(10)(b)(b) Ophthalmic use of strontium-90. As required by sub. (9) (b) 3., 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 NRC or agreement state requirements, that the individual has successfully completed the requirements in sub. (9) (b) and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use. DHS 157.65 HistoryHistory: 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; CR 22-015: am. (1) (a), (b), r and recr. (6), cr. (6m), am. (8) (intro.), (a) (intro.), 1., (b) 2. (intro.), 3., cr. (8) (b) 4., r. and recr. (9), renum. (10) (a) to (10) (a) (intro.) and am., cr. (10) (a) 1., 2., am. (10) (b) Register June 2023 No. 810, eff. 7-1-23; correction in (6m) (b) 2. made under ss. 13.92 (4) (b) 4. and 35.17, Stats., Register June 2023 No. 810. DHS 157.66DHS 157.66 Sealed sources for diagnosis. DHS 157.66(1)(a)(a) A licensee may use sealed sources that are not in medical devices for diagnostic medical uses if all of the following are met: DHS 157.66(1)(a)1.1. The sealed sources are approved in the sealed source and device registry for diagnostic medicine. DHS 157.66(1)(a)2.2. If the diagnostic medical uses are not explicitly listed in the sealed source and device registry, the sealed sources are used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry. DHS 157.66(1)(b)(b) A licensee may use medical devices containing sealed sources for diagnostic medical uses if all the following are met: DHS 157.66(1)(b)1.1. Both the sealed sources and medical devices are approved in the sealed source and device registry for diagnostic medical uses. DHS 157.66(1)(b)2.2. If the diagnostic medical uses are not explicitly listed in the sealed source and device registry, the diagnostic medical devices are used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry. DHS 157.66(1)(c)(c) Sealed sources and devices for diagnostic medical uses may be used for research in accordance with an active investigational device exemption application accepted by the U.S. Food and Drug Administration, and provided the requirements of s. DHS 157.61 (6) are met. 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 any 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 NoteNote: 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 HistoryHistory: 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; CR 22-015: r. and recr. (1), am. (2) (intro.) cr. (2) (c) Register June 2023 No. 810, eff. 7-1-23. DHS 157.67DHS 157.67 Photon 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. DHS 157.67(1)(a)(a) A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units or gamma stereotactic units for therapeutic medical uses that meet any of the following criteria: DHS 157.67 NoteNote: 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)(a)2.2. In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active effective investigational device exemption application accepted by the FDA provided the requirements of s. DHS 157.61 (6) (a) are met. DHS 157.67(1)(b)(b) A licensee shall use photon-emitting remote afterloader units, teletherapy units, or gammastereotactic radiosurgery units that meet any of the following criteria: DHS 157.67(1)(b)1.1. Is approved in the sealed source and device registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the sealed source and device registry, but must be used in accordance with radiation safety conditions and limitations described in the sealed source and device registry. DHS 157.67(1)(b)2.2. In research in accordance with an active investigational device exemption application accepted by the FDA and provided the requirements of s. DHS 157.61 (6) are met. DHS 157.67(2)(2) Surveys of patients and human research subjects treated with a remote afterloader unit.
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