DHS 157.64(1)(c)(c) Obtained from an NRC or agreement state licensee for use in research under an investigational new drug application accepted by FDA. 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: