DHS 157.61(9)(b)2.
2. Supervised practical experience in a nuclear pharmacy involving all the following:
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(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)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)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)(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(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(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)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 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(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)2.
2. A decay correction, based on the measurement made by either of the following:
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)(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)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.
DHS 157.62(3)(d)
(d) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage differs from the prescribed dosage by more than 20% or if the dosage does not fall within the prescribed dosage range.
DHS 157.62(4)
(4)
Authorization for calibration, transmission and reference sources. DHS 157.62(4)(a)
(a) Any person authorized by s.
DHS 157.13 (5) for medical use of radioactive material may receive, possess and use any of the following radioactive material for check, calibration, transmission and reference use:
DHS 157.62(4)(a)1.
1. A sealed source that does not exceed 1.11 GBq (30 mCi) that is manufactured and distributed by a person licensed under s.
DHS 157.13 (4) (j) or equivalent NRC or agreement state regulations or redistributed by a person authorized to redistribute sealed sources, provided that the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.
DHS 157.62(4)(a)2.
2. Any radioactive material with a half-life not longer than 120 days in individual amounts not to exceed 0.555 GBq (15 mCi).
DHS 157.62(4)(a)3.
3. Any radioactive material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 microcuries) or 1000 times the quantities in ch.
DHS 157 Appendix F.
DHS 157.62(4)(b)
(b) Radioactive material in sealed sources authorized by this subsection shall not be used in either of the following:
DHS 157.62(4)(b)2.
2. Bundled or aggregated to create activity greater than the maximum activity of any single sealed source authorization under this section.
DHS 157.62(4)(c)
(c) A licensee using calibration, transmission, and reference sources in accordance with the requirements in this subsection need not list these sources on a specific medical use license.
DHS 157.62(5)
(5)
Requirements for possession of sealed sources and brachytherapy sources. DHS 157.62(5)(a)
(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.
DHS 157.62(5)(b)
(b) A licensee in possession of a sealed source shall do both the following:
DHS 157.62(5)(b)1.
1. Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee.
DHS 157.62(5)(b)2.
2. Test the source for leakage at intervals not to exceed 6 months or at other intervals approved by the department, NRC or another agreement state in the sealed source and device registry.
DHS 157.62(5)(b)3.
3. Test the source for leakage at any time there is reason to suspect that the sealed source might have been damaged or might be leaking.
DHS 157.62(5)(c)
(c) To satisfy the leak test requirements of this section, a licensee shall measure the sample so that the leakage test may detect the presence of 185 Bq (0.005
µCi) of radioactive material on the sample.
DHS 157.62(5)(e)
(e) If the leakage test reveals the presence of 185 Bq (0.005
µCi) or more of removable contamination, a licensee shall do both the following:
DHS 157.62(5)(e)1.
1. Immediately withdraw the sealed source from use and store, dispose or cause it to be repaired under the requirements in subchs.
II and
III.
DHS 157.62(5)(f)
(f) A licensee need not perform a leakage test on any of the following sources:
DHS 157.62(5)(f)1.
1. A source containing only radioactive material with a half-life of less than 30 days.
DHS 157.62(5)(f)3.
3. A source containing 3.7 MBq (100
µCi) or less of beta or gamma-emitting material or 0.37 MBq (10
µCi) or less of alpha-emitting material.
DHS 157.62(5)(f)4.
4. A source stored and not being used. A licensee shall, however, test each source for leakage before any use or transfer unless it has been leakage-tested within 6 months before the date of use or transfer.
DHS 157.62(5)(g)
(g) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. A licensee shall retain each inventory record under s.
DHS 157.71 (9).
DHS 157.62(6)
(6)
Labelling of vials and syringes. Each syringe and vial that contains a radioactive drug containing radioactive material shall be labeled to identify the radioactive drug.
Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded.
DHS 157.62(7)(a)
(a) Except as provided in par.
(b), a licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radioactive drugs containing radioactive material requiring a written directive were prepared for use or administered.
