Chapter DHS 157

DHS 157.62(4)(a)4. 4. Technetium-99m in amounts as needed.

DHS 157.62(4)(a)5. 5. Flourine-18 in amounts as needed.

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)1. 1. For medical use as defined in s. DHS 157.03 (211), except in accordance with the requirements in s. DHS 157.66 (1).

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 mCi) of radioactive material on the sample.

DHS 157.62(5)(d) (d) A licensee shall retain leakage test records under s. DHS 157.71 (9).

DHS 157.62(5)(e) (e) If the leakage test reveals the presence of 185 Bq (0.005 mCi) 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)(e)2. 2. File a report to the department within 5 working days of the leakage test as specified under s. DHS 157.72 (3).

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)2. 2. A source containing only radioactive material as a gas.

DHS 157.62(5)(f)3. 3. A source containing 3.7 MBq (100 mCi) or less of beta or gamma-emitting material or 0.37 MBq (10 mCi) 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)(f)5. 5. Seeds of iridium-192 encased in intact nylon ribbon.

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) (7) Surveys for ambient radiation exposure rate.

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.

DHS 157.62(7)(b) (b) A licensee need not perform the surveys required under par. (a) in an area where patients or human research subjects are confined when the patients or human research subjects cannot be released under sub. (8).

DHS 157.62(7)(c) (c) A licensee shall retain a record of each survey under s. DHS 157.71 (10).

DHS 157.62(8) (8) Release of individuals containing radioactive drugs or implants containing radioactive material.

DHS 157.62(8)(a) (a) A licensee may authorize the release from its control of any person who has been administered radioactive drugs or implants containing radioactive material if the total effective dose equivalent to any other person from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).

DHS 157.62 Note Note: WISREG 1556, Vol. 9, Guidance for Medical Use of Radioactive Material describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 Rem).  It is available from the following website: http://dhs.wisconsin.gov/radiation/radioactivematerials/index.htm.

DHS 157.62(8)(b) (b) A licensee shall provide the released person or the person’s parent or guardian with instructions, including written instructions, on actions recommended to maintain doses to other persons as low as is reasonably achievable if the total effective dose equivalent to any other person is likely to exceed one mSv (0.1 rem). If the total effective dose equivalent to a breast-feeding infant or child could exceed one mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include all the following:

DHS 157.62(8)(b)1. 1. Guidance on the interruption or discontinuation of breast-feeding.

DHS 157.62(8)(b)2. 2. Any information on the potential consequences of failure to follow the guidance.

DHS 157.62(8)(c) (c) A licensee shall maintain a record, as required by s. DHS 157.71 (11), of the basis for authorizing the release of an individual, under par. (a).

DHS 157.62(8)(d) (d) A licensee shall maintain a record of instructions provided to breast-feeding women under par. (b) according to record retention requirements of s. DHS 157.71 (11) (b).

DHS 157.62(9) (9) Provision of mobile medical service.

DHS 157.62(9)(a) (a) A licensee providing mobile medical service shall do all of the following:

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.