Chapter DHS 157

DHS 157.61(7)(b)3. 3. Has obtained written attestation under sub. (12) (a).

DHS 157.61(7)(c) (c) Is any one of the following:

DHS 157.61(7)(c)1. 1. A medical physicist who has been certified by a specialty board whose certification process has been recognized by the department, NRC, or another agreement state under sub. (8) (a), and has experience in radiation safety aspects of similar types of use of radioactive material for which the licensee seeks the approval of the individual as the radiation safety officer or an associate radiation safety officer.

DHS 157.61(7)(c)2. 2. An authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on a department, NRC, or an agreement state license, or medical use permit issued by an NRC master material licensee, and has experience with the radiation safety aspects of similar types of use of radioactive material for which the licensee seeks the approval of the individual as the radiation safety officer or associate radiation safety officer.

DHS 157.61(7)(c)3. 3. An individual who has experience with the radiation safety aspects of the types of use of radioactive material for which the individual is seeking simultaneous approval both as the radiation safety officer and the authorized user on the same new medical use license.

DHS 157.61(8) (8) Training for an authorized medical physicist. Except as provided in sub. (10), a licensee shall require the authorized medical physicist to have training for the type of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by successfully completing either a training program provided by the vendor of the applicable system or device, or by training supervised by an authorized medical physicist authorized for the type of use for which the individual is seeking authorization. A licensee shall also require the authorized medical physicist to be an individual who meets either of the following requirements:

DHS 157.61(8)(a) (a) Is certified by a 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 have all of the following:

DHS 157.61(8)(a)1. 1. A master’s or doctor’s degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university.

DHS 157.61(8)(a)2. 2. Attained two years full-time practical training or supervised experience in medical physics that meets either of the following requirements:

DHS 157.61(8)(a)2.a. a. Completed under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized under this section by the department, the NRC, or an agreement state.

DHS 157.61(8)(a)2.b. b. Completed in clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements for authorized users in sub. (10) or s. DHS 157.65 (8) or 157.67 (17).

DHS 157.61(8)(a)3. 3. Passed an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery.

DHS 157.61 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 157.61(8)(b) (b)

DHS 157.61(8)(b)1. 1. Holds a master’s or doctorate degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university and completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type of use for which the individual is seeking authorization. This training and work experience shall be conducted in clinical radiation facilities that provide high energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services and shall include all of the following:

DHS 157.61(8)(b)1.a. a. Performing sealed source leak tests and inventories.

DHS 157.61(8)(b)1.b. b. Performing decay corrections.

DHS 157.61(8)(b)1.c. c. Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.

DHS 157.61(8)(b)1.d. d. Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.

DHS 157.61(8)(b)2. 2. Has obtained written attestation under sub. (12) (b).

DHS 157.61(9) (9) Training for an authorized nuclear pharmacist. Except as provided in sub. (10), the licensee shall require the authorized nuclear pharmacist to be a pharmacist who meets either of the following requirements:

DHS 157.61(9)(a) (a) Is certified by a 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 have all of the following:

DHS 157.61(9)(a)1. 1. Graduated from a pharmacy program accredited by the Accreditation Council for Pharmacy Education or have passed the foreign pharmacy graduate examination committee examination.

DHS 157.61(9)(a)2. 2. A current, active license to practice pharmacy.

DHS 157.61(9)(a)3. 3. Evidence of having acquired at least 4000 hours of training and experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience.

DHS 157.61(9)(a)4. 4. Evidence of having passed an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in the procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development.

DHS 157.61 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 157.61(9)(b) (b) Has completed 700 hours in a structured educational program including all of the following requirements:

DHS 157.61(9)(b)1. 1. Two hundred hours of classroom and laboratory training covering all of the following areas:

DHS 157.61(9)(b)1.a. a. Radiation physics and instrumentation.

DHS 157.61(9)(b)1.b. b. Radiation protection.

DHS 157.61(9)(b)1.c. c. Mathematics pertaining to the use and measurement of radioactivity.

DHS 157.61(9)(b)1.d. d. Chemistry of radioactive material for medical use.

DHS 157.61(9)(b)1.e. e. Radiation biology.

DHS 157.61(9)(b)2. 2. Supervised practical experience in a nuclear pharmacy involving all the following:

DHS 157.61(9)(b)2.a. a. Shipping, receiving and performing related radiation surveys.

DHS 157.61(9)(b)2.b. b. Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and if appropriate, instruments used to measure alpha-emitting or beta-emitting radionuclides.

DHS 157.61(9)(b)2.c. c. Calculating, assaying and safely preparing dosages for patients or human research subjects.

DHS 157.61(9)(b)2.d. d. Using administrative controls to avoid medical events in the administration of radioactive material.

DHS 157.61(9)(b)2.e. e. Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures.

DHS 157.61(9)(b)3. 3. Has obtained written attestation under sub. (12) (c).

DHS 157.61(10) (10) Training for experienced radiation safety officer, teletherapy or medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

DHS 157.61(10)(a) (a)

DHS 157.61(10)(a)1. 1. An individual identified as a radiation safety officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist, or an authorized nuclear pharmacist on a department, NRC or another agreement state license, or permit issued by a NRC or agreement state broad scope licensee or master material license permit or by a master material license permittee of broad scope on or before January 14, 2019, is exempt from the training requirements of subs. (7) to (9), respectively, except the radiation safety officers and authorized medical physicists identified in this paragraph must meet the training requirements of sub. (7) or (8), as appropriate, for any material uses for which they were not authorized prior to this date.

DHS 157.61(10)(a)2. 2. Any individual certified by the American Board of Health Physics in Comprehensive Health Physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, is exempt from the training requirements of sub. (7) to be identified as a radiation safety officer or as an associate radiation safety officer on a department, NRC, or an agreement state license or NRC master material license permit for those materials and uses that these individuals performed on or before October 24, 2005.

DHS 157.61(10)(a)3. 3. Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, is exempt from the training requirements for an authorized medical physicist described in sub. (8), for those materials and uses that these individuals performed on or before October 24, 2005.

DHS 157.61(10)(a)4. 4. A radiation safety officer, a medical physicist, or a nuclear pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the department, is exempt from the training requirements of subs. (7) to (9), respectively, when performing the same uses. A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and during the time period identified in this paragraph, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for the purposes of this chapter.

DHS 157.61(10)(b) (b) An individual identified as a radiation safety officer, an authorized medical physicist, or an authorized nuclear pharmacist on a department, NRC or another agreement state license, the permit issued by a licensee of broad scope or the permit issued by NRC master material licensee between October 24, 2002 and April 29, 2005 is exempt from the training requirements of sub. (7), (8) or (9).

DHS 157.61(10)(c) (c)

DHS 157.61(10)(c)1. 1. Physicians, dentists, or podiatrists who are identified as authorized users for the medical use of radioactive material on a license issued by the department, the NRC, an agreement state, a permit issued by a NRC master material licensee, a permit issued by a NRC or an agreement state broad scope licensee, or a permit issued by a NRC master material license broad scope permittee on or before January 14, 2019, who perform only those medical uses for which they were authorized on or before that date is exempt from the training requirements of ss. DHS 157.63 to 157.67.

DHS 157.61(10)(c)2. 2. Physicians, dentists, or podiatrists not identified as authorized users for the medical use of radioactive material on a license issued by the department, the NRC, an agreement state, a permit issued by a NRC master material licensee, a permit issued by a NRC or an agreement a state broad scope licensee, or a permit issued in accordance with a NRC master material broad scope license on or before October 24, 2005, is exempt from the training requirements of ss. DHS 157.63 to 157.67 for any of the following materials and uses that these individuals performed on or before October 24, 2005:

DHS 157.61(10)(c)2.a. a. For uses authorized under s. DHS 157.63 (1) or (2), or oral administration of sodium iodide I–131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine in nuclear medicine, the American Board of Radiology in diagnostic radiology, the American Osteopathic Board of Radiology in diagnostic radiology or radiology the Royal College of Physicians and Surgeons of Canada in nuclear medicine, or American Osteopathic Board of Nuclear Medicine in nuclear medicine.

DHS 157.61(10)(c)2.b. b. For uses authorized under s. DHS 157.64 (1), a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine, the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology, the Royal College of Physicians and Surgeons of Canada in nuclear medicine, or the American Osteopathic Board of Radiology after 1984.

DHS 157.61(10)(c)2.c. c. For uses authorized under s. DHS 157.65 (1) or 157.67 (1), a physician who was certified on or before October 24, 2005, by the American Board of Radiology in radiology, therapeutic radiology or radiation oncology, the American Osteopathic Board of Radiology in radiation oncology, or the Canadian Royal College of Physicians and Surgeons in therapeutic radiology, or as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology” in radiology, with specialization in radiotherapy.

DHS 157.61(10)(c)2.d. d. For uses authorized under s. DHS 157.66 (1), a physician who was certified on or before October 24, 2005, by the American Board of Radiology, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology, the American Board of Nuclear Medicine in nuclear medicine, the American Osteopathic Board of Radiology in diagnostic radiology or radiology, or the Royal College of Physicians and Surgeons of Canada in nuclear medicine.

DHS 157.61(10)(c)3. 3. Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the department, are exempt from the training requirements of ss. DHS 157.63 to 157.67 when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for the purposes of this chapter.

DHS 157.61(10)(d) (d) Individuals who are not required to comply with the training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on department licenses for the same uses for which these individuals are authorized.

DHS 157.61(11) (11) Recentness of training. The training and experience specified in this section and ss. DHS 157.63 to 157.67 shall have been completed within 7 years preceding the date of license application. If the training and experience specified in this section and ss. DHS 157.63 to 157.67 have not been completed within 7 years preceding the date of license application, additional related continuing education and experience shall be required.

DHS 157.61(12) (12) Written attestation.

DHS 157.61(12)(a) (a) Radiation safety officer or associate radiation safety officer. As required by sub. (7) (b) 3., the licensee shall ensure that an individual fulfilling the responsibilities of the radiation safety officer or associate radiation safety officer has obtained written attestation, signed by a preceptor radiation safety officer or associate radiation safety officer who has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking approval as a radiation safety officer or an associate radiation safety officer. The written attestation must state that the individual has successfully completed the requirements in sub. (7) (b) , has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval and is able to independently fulfill the radiation safety-related duties as a radiation safety officer or as an associate radiation safety officer for a medical use license.

DHS 157.61(12)(b) (b) Authorized medical physicist. As required by sub. (8) (b) 2., the licensee shall ensure that the individual has obtained written attestation that the individual has successfully completed the requirements in sub. (8) (b) 1., has training for the type of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system, and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation shall be signed by a preceptor authorized medical physicist who meets the requirements in sub. (8) or (10), or equivalent NRC or agreement state requirements, for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.

DHS 157.61(12)(c) (c) Authorized nuclear pharmacist. As required by sub. (9) (b) 3., the licensee shall ensure that the individual has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, 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 nuclear pharmacist.

DHS 157.61 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) (g), r. and recr. (7) to (10), cr. (12) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (10) (a) and (12) (b), renum. (10) (b) to be (10) (c), cr. (10) (b) Register April 2010 No. 652, eff. 5-1-10; CR 16-078: am. (7) (a) 2. b., (8) (a) 1. b., (10) (a), (c), cr. (10) (d) Register January 2018 No. 745, eff. 2-1-18; CR 22-015: am. (1) (b), (c), (4) (a) 1., r. and recr. (4) (b), am. (5) (b) 3., 4., cr. (5) (b) 5., 6., am. (7) (intro.), (a) (intro.), (b) 2. (intro.), cr. (7) (b) 3., am. (7) (c) 1., 2., cr. (7) (c) 3., r. and recr. (8), am. (9) (intro.), (a) (intro.), 1., cr. (9) (b) 3., r. and recr. (10), am. (12) Register June 2023 No. 810, eff. 7-1-23; correction in (5) (b) 4., 5., (7) (intro.), (8) (a) 2. b., (10) (a) 1. to 3., (b), (c) 2. a., c., 3. made under s. 35.17, Stats., Register June 2023 No. 810.

DHS 157.62 DHS 157.62 Technical requirements.

DHS 157.62(1) (1) Possession, use and calibration of instruments to measure the activity of unsealed radioactive materials.

DHS 157.62(1)(a) (a) For direct measurements performed under sub. (3), a licensee shall possess and use instrumentation to measure the activity of unsealed radioactive materials prior to administration of unsealed radioactive materials to each patient or human research subject.

DHS 157.62(1)(b) (b) A licensee shall calibrate the instrumentation required in par. (a) according to nationally recognized standards or the manufacturer’s instructions.

DHS 157.62(1)(c) (c) A licensee shall retain a record of each instrument calibration required by this subsection under s. DHS 157.71 (6).

DHS 157.62(2) (2) Calibration of survey instruments.

DHS 157.62(2)(a) (a) A licensee shall calibrate the survey instruments used to show compliance with this subchapter and subch. III before first use, at a frequency not to exceed 13 months and following any repair that will affect the calibration.

DHS 157.62(2)(b) (b) A licensee shall do all the following:

DHS 157.62(2)(b)1. 1. Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source.

DHS 157.62(2)(b)2. 2. Calibrate each scale used to show compliance at a sufficient number of readings to determine the response characteristics of the instrument.

DHS 157.62(2)(b)3. 3. Conspicuously note on the instrument the date of calibration.

DHS 157.62 Note Note: Two separated readings on each scale or decade are typically used for linear scale instruments.

DHS 157.62(2)(c) (c) A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20%.

DHS 157.62(2)(d) (d) A licensee shall retain a record of each survey instrument calibration under s. DHS 157.71 (7).

DHS 157.62(3) (3) Determination of dosages of unsealed radioactive material for medical use.

DHS 157.62(3)(a) (a) A licensee shall determine and record the activity of each dosage prior to medical use.

DHS 157.62(3)(b) (b) For a unit dosage, this determination shall be made by using one of the following methods:

DHS 157.62(3)(b)1. 1. Direct measurement of radioactivity.

DHS 157.62(3)(b)2. 2. A decay correction, based on the measurement made by either of the following:

DHS 157.62(3)(b)2.a. a. A manufacturer or preparer licensed under s. DHS 157.13 (4) (i) or by NRC or another agreement state.

DHS 157.62(3)(b)2.b. b. An NRC or other agreement state licensee only for use in research in accordance with an RDRC protocol or and IND protocol accepted by FDA.

DHS 157.62(3)(b)2.c. c. A PET radioactive drug producer licensed under s. DHS 157.13 (1) (j) or by NRC or another agreement state.

DHS 157.62(3)(c) (c) For other than unit dosages, the determination of dosages of unsealed radioactive material shall be made through one of the following methods:

DHS 157.62(3)(c)1. 1. Direct measurement of radioactivity.

DHS 157.62(3)(c)2. 2. A combination of direct measurements of radioactivity and mathematical calculations.

DHS 157.62(3)(c)3. 3. A combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed under s. DHS 157.13 (4) (i), a PET radioactive drug producer licensed under s. DHS 157.13 (1) (j), or equivalent NRC or other agreement state requirements.