DHS 157.64(1)(d)(d) Prepared by the licensee for use under an investigational new drug protocol accepted by FDA. DHS 157.64(2)(2) Safety instruction. In addition to the requirements of subch. X, a licensee shall do all the following: DHS 157.64(2)(a)(a) Provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who have received therapy with a drug containing radioactive material and cannot be released under s. DHS 157.62 (8). The instruction shall be commensurate with the duties of the personnel and include all the following: DHS 157.64(2)(a)5.5. Notification of the radiation safety officer or his or her designee and the authorized user if the patient or the human research subject dies or has a medical emergency. DHS 157.64(3)(a)1.1. Quarter the patient or the human research subject in one of the following: DHS 157.64(3)(a)1.b.b. A room, with a bathroom, with another person who also has received therapy with a radioactive drug containing radioactive material and who cannot be released under s. DHS 157.62 (8). DHS 157.64(3)(a)2.2. Visibly post a “Radioactive Materials” sign on the door of a patient’s or the human research subject’s room and note on the door or in the patient’s or human research subject’s chart where and how long visitors may stay in the patient’s or the human research subject’s room. DHS 157.64(3)(a)3.3. Either monitor material and items removed from the patient’s or the human research subject’s room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding or handle such material and items as radioactive waste. DHS 157.64(3)(b)(b) A licensee shall notify the radiation safety officer or his or her designee and the authorized user as soon as possible if the patient or human research subject has a medical emergency and immediately if the patient dies. DHS 157.64(4)(4) Training for use of unsealed radioactive material for which a written directive is required. 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 either of the following requirements: DHS 157.64(4)(a)(a) Is certified by a medical specialty board whose certification process is recognized by the department, the NRC or an agreement state and who meets the requirements of par. (b) 2. g. To be recognized, a specialty board shall require all candidates for certification to do all of the following: DHS 157.64(4)(a)1.1. Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs shall include 700 hours of training and experience as described in par. (b) 1. and (b) 2. a., b., c., d., and e. Eligible training programs shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association. DHS 157.64(4)(a)2.2. Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed radioactive material for which a written directive is required. DHS 157.64 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 157.64(4)(b)(b) Has completed 700 hours of certified training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive that includes all the following: DHS 157.64(4)(b)2.2. Work experience under the supervision of an authorized user who meets the requirements in this subsection, s. DHS 157.61 (10), or equivalent NRC or agreement state requirements. A supervising authorized user who meets the requirements of this paragraph shall also have experience under subd. 2. g. in administering dosages in the same dosage category or categories as the individual requesting authorized user status. The work experience shall involve all of the following: DHS 157.64(4)(b)2.a.a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys. DHS 157.64(4)(b)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(4)(b)2.c.c. Calculating, measuring, and safely preparing patient or human research subject dosages. DHS 157.64(4)(b)2.d.d. Using administrative controls to prevent a medical event involving the use of unsealed radioactive material. DHS 157.64(4)(b)2.g.g. Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of 3 cases in each of the following categories for which the individual is requesting authorized user status: oral administration of less than or equal to 1.22 GBq (33 millicurie) of sodium iodide I-131 for which a written directive is required; oral administration of greater than 1.22 GBq (33 millicuries) of sodium iodide I-131; and 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. Experience with at least 3 cases of oral administration of greater than 1.22 GBq (33 millicuries) of I-131 also satisfies the requirement for experience with 3 cases of oral administration of less than or equal to 1.22 GBq (33 millicuries) of I-131. DHS 157.64(5)(5) Training for the oral administration of sodium iodide i-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries). Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who meets any of the following requirements: DHS 157.64(5)(a)(a) Is certified by a medical specialty board whose certification process includes all of the requirements in par. (c) and whose certification process has been recognized by the department, the NRC or an agreement state. DHS 157.64 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 157.64(5)(c)(c) Has successfully completed training and work experience, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive that includes all of the following: DHS 157.64(5)(c)1.1. Eighty hours of classroom and laboratory training in all of the following areas: DHS 157.64(5)(c)2.2. Work experience, under the supervision of an authorized user who meets the requirements in sub. (4) (a) or (b), (5) or (6), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements. A supervising authorized user who meets the requirements in sub. (4) (b) or s. DHS 157.61 (10), shall also have experience in administering the same category of sodium iodide I-131 use as specified in sub. (4) (b) 2. g. The work experience shall involve all of the following: DHS 157.64(5)(c)2.a.a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys. DHS 157.64(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 157.64(5)(c)2.c.c. Calculating, measuring, and safely preparing patient or human research subject dosages. DHS 157.64(5)(c)2.d.d. Using administrative controls to prevent a medical event involving the use of radioactive material. DHS 157.64(5)(c)2.e.e. Using procedures to contain spilled radioactive material safely and using proper decontamination procedures. DHS 157.64(5)(c)2.f.f. Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131. DHS 157.64(6)(6) Training for the oral administration of sodium iodide i-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries). Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) to be a physician who meets any of the following requirements: DHS 157.64(6)(a)(a) Is certified by a medical specialty board whose certification process includes all of the requirements in par. (c) and whose certification has been recognized by the department, the NRC or agreement state. DHS 157.64 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 157.64(6)(b)(b) Is an authorized user under sub. (4) (a) or (b) for use of I-131 greater than 1.22 Gigabecquerel (33 millicuries) under sub. (4) (b) 2. g., or equivalent NRC or agreement state requirements. DHS 157.64(6)(c)(c) Has successfully completed training and experience, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive, that includes all of the following: DHS 157.64(6)(c)1.1. Eighty hours of classroom and laboratory training in all of the following areas: DHS 157.64(6)(c)2.2. Work experience, under the supervision of an authorized user who meets the requirements in sub. (4) (a) or (b), this subsection, s. DHS 157.61 (10), or equivalent NRC agreement state requirements. A supervising authorized user, who meets the requirements in sub. (4) (b), or s. DHS 157.61 (10), shall also have experience in administering dosages of I-131 greater than 1.22 Gigabecquerels (33 millicuries) as specified in sub. (4) (b) 2. g. The work experience shall involve all the following: DHS 157.64(6)(c)2.a.a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys. DHS 157.64(6)(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(6)(c)2.c.c. Calculating, measuring and safely preparing patient or human research subject dosages. DHS 157.64(6)(c)2.d.d. Using administrative controls to prevent a medical event involving the use of radioactive material. DHS 157.64(6)(c)2.e.e. Using procedures to contain spilled radioactive material safely and using proper decontamination procedures. DHS 157.64(6)(c)2.f.f. Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131. DHS 157.64(7)(7) Training for the parenteral administration of unsealed radioactive material requiring a written directive. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user for the parenteral administration requiring a written directive to be a physician who meets any of the following requirements: DHS 157.64(7)(a)(a) Is an authorized user under sub. (4) for the specific parenteral uses listed in sub. (4) (b) 2. g., or equivalent NRC or agreement state requirements. DHS 157.64(7)(c)(c) Is certified by a medical specialty board whose certification process has been recognized by the department under s. DHS 157.65 (8) or 157.67 (17) or equivalent NRC or agreement state requirements; and who meets the following requirements: DHS 157.64(7)(c)1.1. Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations 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. The training shall include all of the following: 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:
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Department of Health Services (DHS)
Chs. DHS 110-199; Health
administrativecode/DHS 157.64(4)(b)1.d.
administrativecode/DHS 157.64(4)(b)1.d.
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