DHS 157.63(3)(a)(a) A licensee may not administer to humans a radioactive drug containing more than the following:
DHS 157.63(3)(a)1.1. 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per 1 millicurie of technetium 99m).
DHS 157.63(3)(a)2.2. 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per 1 millicurie of rubidium-82 chloride injection).
DHS 157.63(3)(a)3.3. 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per 1 millicurie of rubidium-82 chloride injection).
DHS 157.63(3)(b)(b) A licensee that prepares radioactive drugs from radionuclide generators shall do all the following:
DHS 157.63(3)(b)1.1. If using a molybdenum-99/technetium-99m generator for preparing a technetium-99m radiopharmaceutical, measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with par. (a).
DHS 157.63(3)(b)2.2. Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems.
DHS 157.63(3)(b)3.3. If using a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with par. (a).
DHS 157.63(3)(c)(c) A licensee that must measure radionuclide contaminant concentration shall retain a record of each measurement under s. DHS 157.71 (14).
DHS 157.63(3)(d)(d) The licensee shall report any measurement that exceeds the limits in par. (a) at the time of generator elution, in accordance with s. DHS 157.72 (4).
DHS 157.63(4)(4)Training for uptake, dilution and excretion studies. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user of unsealed radioactive material for the uses authorized under sub. (1) to be a physician who meets any of the following requirements:
DHS 157.63(4)(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 157.63(4)(a)1.1. Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies that includes the topics listed in par. (c).
DHS 157.63(4)(a)2.2. Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control.
DHS 157.63 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 157.63(4)(b)(b) Is an authorized user under sub. (5), s. DHS 157.64 (4), or equivalent NRC or agreement state requirements.
DHS 157.63(4)(c)(c) Has completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution and excretion studies that includes all the following:
DHS 157.63(4)(c)1.1. Classroom and laboratory training in all the following areas:
DHS 157.63(4)(c)1.a.a. Radiation physics and instrumentation.
DHS 157.63(4)(c)1.b.b. Radiation protection.
DHS 157.63(4)(c)1.c.c. Mathematics pertaining to the use and measurement of radioactivity.
DHS 157.63(4)(c)1.d.d. Chemistry of radioactive material for medical use.
DHS 157.63(4)(c)1.e.e. Radiation biology.
DHS 157.63(4)(c)2.2. Work experience, under the supervision of an authorized user who meets the requirements in this subsection, sub. (4) or (5), s. DHS 157.61 (10) or 157.64 (4), or equivalent NRC or agreement state requirements, involving all the following:
DHS 157.63(4)(c)2.a.a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys.
DHS 157.63(4)(c)2.b.b. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters.
DHS 157.63(4)(c)2.c.c. Calculating, measuring and safely preparing patient or human research subject dosages.
DHS 157.63(4)(c)2.d.d. Using administrative controls to prevent a medical event involving the use of unsealed radioactive material.
DHS 157.63(4)(c)2.e.e. Using procedures to contain spilled radioactive material safely and using proper decontamination procedures.