DHS 157.64(7)(c)2.2. Has work experience with any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV for which a written directive is required. This work experience shall be under the supervision of an authorized user with experience in parenteral administration under sub. (4) (b) 2. g., for which a written directive is required, and who meets the requirements in sub. (4), s. DHS 157.61 (10), this subsection, or equivalent NRC or agreement state requirements. The supervising authorized user who meets the requirements in sub. (4), this subsection, or equivalent NRC or agreement state requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience shall involve all the following: DHS 157.64(7)(c)2.a.a. Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys. DHS 157.64(7)(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 157.64(7)(c)2.c.c. Calculating, measuring, and safely preparing patient or human research subject dosages. DHS 157.64(7)(c)2.d.d. Using administrative controls to prevent a medical event involving the use of unsealed radioactive material. DHS 157.64(7)(c)2.e.e. Using procedures to contain spilled radioactive material safely, and using proper decontamination procedures. DHS 157.64(7)(c)2.f.f. Administering dosages to patients or human research subjects, that include at least 3 cases involving the parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required. DHS 157.64(8)(a)(a) Unsealed radioactive material for which a written directive is required. As required by sub. (4) (b) 3., the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under sub. (1) to have obtained written attestation that the individual has successfully completed the requirements in sub. (4) (b) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under sub. (1) for which the individual is requesting authorized user status. The attestation must be obtained from either of the following: DHS 157.64(8)(a)1.1. A preceptor authorized user who meets the requirements in sub. (4), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status. DHS 157.64(8)(a)2.2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (4), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (4) (b). DHS 157.64(8)(b)(b) Oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries). As required by sub. (5) (c) 3., the licensee shall require an authorized user of sodium iodide I-131 for oral administration to have obtained written attestation that the individual has successfully completed the requirements in sub. (5) (c), and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under sub. (1). The attestation must be obtained from either of the following: DHS 157.64(8)(b)2.2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (4), (5) or (6), s. DHS 157.61 (10). or equivalent NRC or agreement state requirements, has experience in administering sodium iodide I-131 dosages as specified in sub. (4) (b) 2. g., and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (5) (c). DHS 157.64(8)(c)(c) Oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries). As required by sub. (6) (c) 3., a licensee shall require an authorized user of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) to have obtained written attestation that the individual has successfully completed the requirements in sub. (6) (c), and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131 under sub. (1). The attestation must be obtained from either of the following: DHS 157.64(8)(c)1.1. A preceptor authorized user who meets the requirements in sub. (4) or (6), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements and has experience in administering dosages of I-131 greater than 1.22 Gigabecquerels (33 millicuries) as specified in sub. (4) (b) 2. g. DHS 157.64(8)(c)2.2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (4) or (6), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements, has experience in administering dosages of I-131 greater than 1.22 Gigabecquerels (33 millicuries) as specified in sub. (4) (b) 2. g. and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (6) (c). DHS 157.64(8)(d)(d) Parenteral administration of unsealed radioactive material requiring a written directive. As required by sub. (7) (c) 3., the licensee shall require a user for the parenteral administration of unsealed radioactive material requiring a written directive to have obtained written attestation that the individual has successfully completed the requirements in sub. (7) (c), and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive as specified in sub. (4) (b) 2. g. The attestation must be obtained from either of the following: DHS 157.64(8)(d)1.1. A preceptor authorized user who meets the requirements in sub. (4) or (7), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements. A preceptor authorized user who meets the requirements in sub. (4) or (7), or equivalent NRC or agreement state requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. DHS 157.64(8)(d)2.2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (4) or (7), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements, has experience in administering parenteral dosages as specified in sub. (4) (b) 2. g., and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (7) (c). DHS 157.64 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: r. and recr. (4) to (6), cr. (7) and (8) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (1) (a), (b) (intro.), (4) (b) 2. (intro.), (5) (b), (c) 2. (intro.), (6) (c) 2. (intro.), (7) (c) 2. (intro.), (8) (a) to (d) Register April 2010 No. 652, eff. 5-1-10; CR 22-015: am. (1) (intro.), (4) (intro.), (a) 1., (b) 2. (intro.), g., 3., cr. (4) (b) 3., am. (5) (intro.), (b), (c) (intro.), 2., 3., (6) (intro.), (b), (c) (intro.), 2. (intro.), cr. (6) (c) 3., am. (7) (intro.), (a), (b), (c) (intro.), (c) 1. (intro.), 2. (intro.), f., cr. (7) (c) 3., r. and recr. (8) Register June 2023 No. 810, eff. 7-1-23; correction in (7) (c) 2. (intro.) made under s. 35.17, Stats., Register June 2023 No. 810. DHS 157.65(1)(1) Use of sources for manual brachytherapy. A licensee shall use only brachytherapy sources for therapeutic medical uses under either of the following criteria: DHS 157.65(1)(a)(a) As approved in the sealed source and device registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the SSDR. DHS 157.65(1)(b)(b) In research to deliver therapeutic doses for medical use in accordance with an active investigational device exemption application accepted by the FDA, provided the requirements of s. DHS 157.61 (6) (a) are met.