Chapter DHS 157

DHS 157.62(9)(a)1. 1. Obtain a letter signed by the management of each client for which services are rendered by the licensee that permits the use of radioactive material at the client’s address and clearly delineates the authority and responsibility of the licensee and the client.

DHS 157.62(9)(a)2. 2. Check instruments used to measure the activity of unsealed radioactive materials for proper function before medical use at each client’s address or on each day of use, whichever is more frequent. The check for proper function shall include a test to verify accurate calibration using a known radioactive source.

DHS 157.62(9)(a)3. 3. Check survey instruments for proper operation with a dedicated check source before use at each client’s address.

DHS 157.62(9)(a)4. 4. Before leaving a client’s address, survey all areas of use to ensure compliance with the requirements in subch. III.

DHS 157.62(9)(b) (b) A mobile medical service may not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client’s license.

DHS 157.62(9)(c) (c) A licensee providing mobile medical services shall retain the letter required in par. (a) 1. and the record of each survey required in s. DHS 157.71 (12) (b).

DHS 157.62(10) (10) Decay-in-storage.

DHS 157.62(10)(a) (a) A licensee may hold radioactive material with a physical half-life of less than 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee does both the following:

DHS 157.62(10)(a)1. 1. Monitors radioactive material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding.

DHS 157.62(10)(a)2. 2. Removes or obliterates all radiation labels except for material that will be handled as biomedical waste after it has been released.

DHS 157.62(10)(b) (b) A licensee shall retain a record of each disposal permitted under s. DHS 157.71 (13).

DHS 157.62 History History: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; corrections in (9) (c) and (10) (b) made under s. 13.93 (2m) (b) 7., Stats., Register July 2002 No. 559; CR 06-021: am. (2) (a), (3) (b) 2. a., (4) (intro.) and (8) (d) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (1) (b) and (3) (c) 3., cr. (3) (b) 2. c. Register April 2010 No. 652, eff. 5-1-10; correction in (4) (b) made under s. 35.17, Stats., Register January 2018 No. 745; CR 22-015: r. and recr. (4), cr. (5) (b) 3. Register June 2023 No. 810, eff. 7-1-23.

DHS 157.63 DHS 157.63 Unsealed radioactive material — written directive not required.

DHS 157.63(1) (1) Use of unsealed radioactive material for uptake, dilution and excretion studies for which a written directive is not required. A licensee may use for uptake, dilution or excretion studies any unsealed radioactive material, except in quantities that require a written directive under s. DHS 157.61 (4), prepared for medical use that meets any of the following requirements:

DHS 157.63 Note Note: Uptake, dilution and excretion studies determine the amount of radioactive material absorbed by a patient and the patient’s ability to excrete the remainder of the radioactive material.

DHS 157.63(1)(a) (a) Is obtained from any of the following:

DHS 157.63(1)(a)1. 1. A manufacturer or preparer licensed under s. DHS 157.13 (4) (i), or equivalent NRC or other agreement state requirements.

DHS 157.63(1)(a)2. 2. A PET radioactive drug producer licensed under s. DHS 157.13 (1) (j), or equivalent NRC or other agreement state requirements.

DHS 157.63(1)(b) (b) Excluding production of PET radionuclides, is prepared by any of the following:

DHS 157.63(1)(b)1. 1. An authorized nuclear pharmacist.

DHS 157.63(1)(b)2. 2. A physician who is an authorized user and who meets the requirements in sub. (5), or sub. (5) (c) 2. g. and s. DHS 157.64 (4).

DHS 157.63(1)(b)3. 3. An individual under the supervision, as specified in s. DHS 157.61 (10), of the authorized nuclear pharmacist in subd.1. or the physician in subd. 2.

DHS 157.63(1)(c) (c) Is obtained from an NRC or agreement state licensee for use in research under a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by the FDA.

DHS 157.63(1)(d) (d) Is prepared by the licensee for use in research under a radioactive drug research committee-approved application or an investigational new drug protocol accepted by the FDA.

DHS 157.63 Note Note: Information on radioactive drugs or investigational new drug protocols may be obtained from the following FDA website: http://www.fda.gov/Radiation-EmittingProducts/default.htm.

DHS 157.63(2) (2) Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required. A licensee may use for imaging and localization studies any unsealed radioactive material, except in quantities that require a written directive under s. DHS 157.61 (4), prepared for medical use that meets any of the following requirements:

DHS 157.63(2)(a) (a) Is obtained from any of the following:

DHS 157.63(2)(a)1. 1. A manufacturer or preparer licensed under s. DHS 157.13 (4) (i), or equivalent NRC or other agreement state requirements.

DHS 157.63(2)(a)2. 2. A PET radioactive drug producer licensed under s. DHS 157.13 (1) (j), or equivalent NRC or other agreement state requirements.

DHS 157.63(2)(b) (b) Is prepared by, excluding production of PET radionuclides, any of the following:

DHS 157.63(2)(b)1. 1. An authorized nuclear pharmacist.

DHS 157.63(2)(b)2. 2. A physician who is an authorized user and who meets the requirements in sub. (5), or s. DHS 157.64 (4) and sub. (5) (c) 2. g.

DHS 157.63(2)(b)3. 3. An individual under the supervision, as specified in s. DHS 157.61 (3), of the authorized nuclear pharmacist in subd.1., or the physician in subd. 2.

DHS 157.63(2)(c) (c) Is obtained from a NRC or agreement state licensee for use in research under a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by the FDA.

DHS 157.63(2)(d) (d) Is prepared by the licensee for use in research under a radioactive drug research committee-approved application or an investigational new drug protocol accepted by the FDA.

DHS 157.63(3) (3) Permissible radionuclide contaminants.

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 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 157.63(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.

DHS 157.63(4)(c)2.f. f. Administering dosages of radioactive drugs to patients or human research subjects.

DHS 157.63(4)(c)3. 3. A written attestation under sub. (6) (a).

DHS 157.63(5) (5) Training for imaging and localization 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. (2) to be a physician who meets any of the following requirements:

DHS 157.63(5)(a) (a) Is certified by a medical special 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 both of the following:

DHS 157.63(5)(a)1. 1. Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for imaging and localization studies that includes the topics listed in par. (c) 1. and 2.

DHS 157.63(5)(a)2. 2. Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control.

DHS 157.63 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 157.63(5)(b) (b) Is an authorized user under s. DHS 157.64 (4) and meets the requirements in par. (c) 2. g., or equivalent NRC or agreement state requirements.

DHS 157.63(5)(c) (c) Has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies that includes, at a minimum, all the following:

DHS 157.63(5)(c)1. 1. Classroom and laboratory training in all the following areas:

DHS 157.63(5)(c)1.a. a. Radiation physics and instrumentation.

DHS 157.63(5)(c)1.b. b. Radiation protection.

DHS 157.63(5)(c)1.c. c. Mathematics pertaining to the use and measurement of radioactivity.

DHS 157.63(5)(c)1.d. d. Chemistry of radioactive material for medical use.

DHS 157.63(5)(c)1.e. e. Radiation biology.

DHS 157.63(5)(c)2. 2. Work experience, under the supervision of an authorized user, who meets the requirements in this subsection, s. DHS 157.61 (10), or subd. 2. g. and s. DHS 157.64 (4), or equivalent NRC or agreement state requirements. An authorized nuclear pharmacist who meets the requirements in s. DHS 157.61 (9) or (10) may provide the supervised work experience under subd. 2. g. Work experience must include all of the following:

DHS 157.63(5)(c)2.a. a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys.

DHS 157.63(5)(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(5)(c)2.c. c. Calculating, measuring and safely preparing patient or human research subject dosages.

DHS 157.63(5)(c)2.d. d. Using administrative controls to prevent a medical event involving the use of unsealed radioactive material.

DHS 157.63(5)(c)2.e. e. Using procedures to safely contain spilled radioactive material and using proper decontamination procedures.

DHS 157.63(5)(c)2.f. f. Administering dosages of radioactive drugs to patients or human research subjects.

DHS 157.63(5)(c)2.g. g. Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs.

DHS 157.63 Note Note: Eluting generator systems are a family of radioactive material devices used to extract useful radioactive materials by passing sterile fluid through a column of the parent material. The resulting mixture of fluid and radioactive material, known as the eluate, is used in the diagnostic procedures. These generators are used to produce Tc-99m, Ga-67 or Rb-82.