DHS 157.70(1)(1)Application. The applicant or licensee has submitted the information required by s. DHS 157.59 (2) (b) and (c).
DHS 157.70(2)(2)Approval. The applicant or licensee has received written approval from the department in a license and uses the material under this chapter and specific conditions the department considers necessary for the medical use of the material.
DHS 157.70 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter.
DHS 157.71DHS 157.71Records.
DHS 157.71(1)(1)Records of authority and responsibilities for radiation protection programs.
DHS 157.71(1)(a)(a) A licensee shall retain a record of actions taken by the licensee’s management under s. DHS 157.61 (1) (a) for 5 years. The record shall include a summary of the actions taken and a signature of licensee management.
DHS 157.71(1)(b)(b) A licensee shall retain a current copy of the authorities, duties and responsibilities of the radiation safety officer as required by s. DHS 157.61 (1) (d). The record shall include the signature of the radiation safety officer and licensee management.
DHS 157.71(1)(c)(c) For each Associate Radiation Safety Officer appointed under s. DHS 157.61 (1) (b), the licensee shall retain, for 5 years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensee’s management.
DHS 157.71(2)(2)Records of radiation protection program safety changes. A licensee shall retain a record of each radiation protection program change made under s. DHS 157.61 (2) (a) for 5 years. The record shall include a copy of the old and new procedures, the effective date of the change and the signature of the licensee management that reviewed and approved the change.
DHS 157.71(3)(3)Records of written directives. A licensee shall retain a copy of each written directive as required by s. DHS 157.61 (4) for 3 years.
DHS 157.71(4)(4)Records of medical events.
DHS 157.71(4)(a)(a) A licensee shall retain a record of medical events reported under s. DHS 157.72 (1) for 3 years.
DHS 157.71(4)(b)(b) The record shall contain all of the following:
DHS 157.71(4)(b)1.1. The licensee’s name.
DHS 157.71(4)(b)2.2. Names of the persons involved.
DHS 157.71(4)(b)3.3. An identification number assigned by the licensee or, if no other identification number is available, the social security number of any person who is the subject of a medical event.
DHS 157.71(4)(b)4.4. A brief description of the event and why it occurred.
DHS 157.71(4)(b)5.5. The effect, if any, on any individual.
DHS 157.71(4)(b)6.6. The actions, if any, taken or planned to prevent recurrence.
DHS 157.71(4)(b)7.7. Whether the licensee notified the affected individual or the affected individual’s responsible relative or guardian and, if not, whether the failure to notify was based on guidance from the referring physician.
DHS 157.71(5)(5)Record of a dose to an embryo or fetus or a nursing child. A licensee shall retain a record of a dose to an embryo or fetus or a nursing child reported under s. DHS 157.72 (2) for 3 years. The record shall contain all of the following:
DHS 157.71(5)(a)(a) The licensee’s name.
DHS 157.71(5)(b)(b) The names of all the individuals involved.
DHS 157.71(5)(c)(c) An identification number assigned by the licensee or, if no other identification number is available, the social security number of the pregnant individual or nursing child who is the subject of the event.
DHS 157.71(5)(d)(d) A brief description of the event, why it occurred, any effect on the embryo or fetus or nursing child and any actions taken or planned to prevent recurrence.
DHS 157.71(5)(e)(e) Whether the licensee notified the pregnant individual or mother, or the mother’s or child’s responsible relative or guardian, and if the licensee did not, whether such failure to notify was based on guidance from the referring physician.
DHS 157.71(6)(6)Records of instrument calibrations. A licensee shall maintain a record of instrument calibrations required by s. DHS 157.62 (1) for 3 years. The record shall include the model and serial number of the instrument, the date of the calibration, the results of the calibration and the name of the individual who performed the calibration.
DHS 157.71(7)(7)Records of radiation survey instrument calibrations. A licensee shall maintain a record of radiation survey instrument calibrations required by s. DHS 157.62 (2) for 3 years. The record shall include the date of the calibration, the results of the calibration, the name of the person who performed the calibration, and the model and serial number of the instrument.
DHS 157.71(8)(8)Records of dosages of unsealed radioactive material for medical use. A licensee shall maintain a record of dosage determinations required by s. DHS 157.62 (3) for 3 years. The record shall contain the radiopharmaceutical, patient’s or human research subject’s name or identification number if one has been assigned, the prescribed dosage, the determined dosage or a notation that the total activity is less than 1.1 MBq (30 microcuries), the date and time of the dosage determination and the name of the individual who determined the dosage.