DHS 157.65DHS 157.65Manual brachytherapy.
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.
DHS 157.65(2)(2)Source implant and removal requirements.
DHS 157.65(2)(a)(a) Immediately after implanting sources in a patient or a human research subject, a licensee shall make a survey to locate and account for all sources that have not been implanted.
DHS 157.65(2)(b)(b) Immediately after removing the last temporary implant source from a patient or a human research subject, a licensee shall conduct a survey of the patient or the human research subject with a radiation detection survey instrument, with the sources shielded and outside the room, to confirm that all sources have been removed from the patient.
DHS 157.65(2)(c)(c) A licensee shall retain a record of the surveys under s. DHS 157.71 (16).
DHS 157.65(3)(3)Brachytherapy sources inventory.
DHS 157.65(3)(a)(a) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use.
DHS 157.65(3)(b)(b) Promptly after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.
DHS 157.65(3)(c)(c) A licensee shall maintain a record of the brachytherapy source accountability under s. DHS 157.71 (17).
DHS 157.65(4)(4)Safety instruction. In addition to the requirements of subch. X, a licensee shall do both of the following:
DHS 157.65(4)(a)(a) Provide radiation safety instruction, initially and at least once in each year, at intervals no greater than 13 months, to personnel caring for patients or human research subjects undergoing implant therapy and cannot be released under s. DHS 157.62 (8). To satisfy this requirement, the instruction shall be commensurate with the duties of the personnel and include all of the following:
DHS 157.65(4)(a)1.1. Size and appearance of the brachytherapy sources.
DHS 157.65(4)(a)2.2. Safe handling and shielding instructions.
DHS 157.65(4)(a)3.3. Patient or human research subject control.
DHS 157.65(4)(a)4.4. Visitor control, including both of the following:
DHS 157.65(4)(a)4.a.a. Routine visitation of hospitalized individuals under s. DHS 157.23 (1) (a) 1.
DHS 157.65(4)(a)4.b.b. Visitation authorized under s. DHS 157.23 (1) (b).
DHS 157.65(4)(a)5.5. Notification of the radiation safety officer or his or her designee and an authorized user if the patient or the human research subject dies or has a medical emergency that causes the patient’s condition to suddenly deteriorate.
DHS 157.65(4)(b)(b) Retain a record under s. DHS 157.71 (15) of individuals receiving instruction.
DHS 157.65(5)(5)Safety precautions.
DHS 157.65(5)(a)(a) For each patient or human research subject receiving brachytherapy who may not be released under s. DHS 157.62 (8), a licensee shall do both the following:
DHS 157.65(5)(a)1.1. Not quarter the patient or the human research subject in the same room as a person who is not receiving brachytherapy.
DHS 157.65(5)(a)2.2. Visibly post a “Radioactive Materials” sign on the door of the patient’s or 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 human research subject’s room.
DHS 157.65(5)(b)(b) A licensee shall have available, near each treatment room, emergency response equipment to respond to a source that is any of the following:
DHS 157.65(5)(b)1.1. Inadvertently dislodged from the patient.
DHS 157.65(5)(b)2.2. Inadvertently lodged within the patient following removal of the source applicators.