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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 have obtained written attestation under sub. (8) (d) and 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 agreement state requirements.
DHS 157.64(7)(b) (b) Is an authorized user under s. DHS 157.65 (8) or 157.67 (17), or equivalent agreement state requirements and who meets the requirements in par. (c) 1. and 2.
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 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, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. The training shall include all of the following:
DHS 157.64(7)(c)1.a. a. Radiation physics and instrumentation.
DHS 157.64(7)(c)1.b. b. Radiation protection.
DHS 157.64(7)(c)1.c. c. Mathematics pertaining to the use and measurement of radioactivity.
DHS 157.64(7)(c)1.d. d. Chemistry of radioactive material for medical use.
DHS 157.64(7)(c)1.e. e. Radiation biology.
DHS 157.64(7)(c)2. 2. Has work experience with any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide 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 agreement state requirements. 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, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV and/or at least 3 cases involving the parenteral administration of any other radionuclide, for which a written directive is required.
DHS 157.64(8) (8)Written attestation.
DHS 157.64(8)(a) (a) Unsealed radioactive material for which a written directive is required. A 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 satisfactorily completed the requirements in sub. (4) (a) 1. and (b) 2. g., or sub. (4) (b) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under sub. (1). The written attestation shall be signed by a preceptor authorized user who meets the requirements in this subsection, s. DHS 157.61 (10), or equivalent agreement state requirements. The preceptor authorized user, who meets the requirements in sub. (4) (b) or s. DHS 157.61 (10) shall have experience under sub. (4) (b) 2. g. in administering dosages in the same dosage category or categories as the individual requesting authorized user status.
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). A licensee shall require an authorized user of sodium iodide I-131 for oral administration to have obtained written attestation that the individual has satisfactorily completed the requirements in sub. (5) (c) and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under sub. (1). The written attestation shall be signed by a preceptor authorized user who meets the requirements in sub. (4), (5) or (6), s. DHS 157.61 (10), or equivalent agreement state requirements. A preceptor authorized user, who meets the requirements of sub. (4) (b) or s. DHS 157.61 (10), shall have experience in administering I -131 dosage less than 1.22 Gigabecquerels (33 millicuries) under sub. (4) (b) 2. g.
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). A licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than Gigabecquerels (33 millicuries) to have obtained written attestation that the individual has satisfactorily completed the requirements in sub. (6) (c) and has achieved a level of competency sufficient to function independently as an authorized user under sub. (1). The written attestation shall be signed by a preceptor authorized user who meets the requirements in sub. (4) or (6), s. DHS 157.61 (10), or equivalent agreement state requirements. A preceptor authorized user, who meets the requirements of sub. (4) (b) or s. DHS 157.61 (10), shall have 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)(d) (d) Parenteral administration of unsealed radioactive material requiring a written directive. A licensee shall require an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive to have obtained written attestation that the individual has satisfactorily completed the requirements in sub. (7) (b) or (c) and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The written attestation shall be signed by a preceptor authorized user who meets the requirements in sub. (4), s. DHS 157.61 (10), or equivalent agreement state requirements. A preceptor authorized user, who meets the requirements in sub. (4) or s. DHS 157.61 (10) shall have experience in administering parenteral dosages as specified in sub. (4) (b) 2. g.
DHS 157.64 History History: 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.
DHS 157.65 DHS 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.
DHS 157.65(1)(b) (b) In research under an effective 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.
DHS 157.65(5)(c) (c) A licensee shall notify the radiation safety officer or his or her designee and an authorized user as soon as possible if the patient or human research subject has a medical emergency, and immediately if the patient dies.
DHS 157.65(6) (6)Calibration measurements of brachytherapy sources.
DHS 157.65(6)(a)(a) Prior to the first medical use of brachytherapy sources, a licensee shall do all the following:
DHS 157.65(6)(a)1. 1. Determine the source output or activity using a dosimetry system that meets the requirements of s. DHS 157.67 (6).
DHS 157.65(6)(a)2. 2. Determine source positioning accuracy within applicators.
DHS 157.65(6)(a)3. 3. Use published protocols accepted by nationally recognized bodies to meet the requirements of subds. 1. and 2.
DHS 157.65 Note Note: A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with par. (a).
DHS 157.65(6)(b) (b) A licensee shall mathematically correct the outputs or activities determined in par. (a) for physical decay at intervals consistent with one percent physical decay.
DHS 157.65(6)(b)1. 1. For strontium-90 sources for ophthalmic treatments, only an authorized medical physicist may calculate the activity of each source used to determine the treatment times for ophthalmic treatments. The decay shall be based on the activity determined under par. (a).
DHS 157.65(6)(b)2. 2. A licensee shall retain a record of the activity of each strontium-90 source under s. DHS 157.71 (28).
DHS 157.65(6)(c) (c) A licensee shall retain a record of each calibration under s. DHS 157.71 (18).
DHS 157.65(7) (7)Therapy-related computer systems. A licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems under published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing shall include, as applicable, verification of all of the following:
DHS 157.65(7)(a) (a) Source-specific input parameters required by the dose calculation algorithm.
DHS 157.65(7)(b) (b) Accuracy of dose, dwell time and treatment time calculations at representative points.
DHS 157.65(7)(c) (c) Accuracy of isodose plots and graphic displays.
DHS 157.65(7)(d) (d) Accuracy of the software used to determine radioactive source positions from radiographic images.
DHS 157.65 Note Note: An example of a nationally recognized body is the American Association of Physicists in Medicine.
DHS 157.65(8) (8)Training for use of manual brachytherapy sources. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under sub. (1) to have obtained written attestation under sub. (10) (a) and to be a physician who meets either of the following requirements:
DHS 157.65(8)(a) (a) Is certified by a medical specialty board whose certification process has been recognized by the department, the NRC or an agreement state. To be recognized, a specialty board shall require all candidates for certification to do all of the following:
DHS 157.65(8)(a)1. 1. Successfully complete a minimum of 3 years of residency training in a radiation oncology program approved by the residency review committee of the accreditation council for graduate medical education or royal college of physicians and surgeons of Canada or the committee on post-graduate training of the American osteopathic association.
DHS 157.65(8)(a)2. 2. Pass an examination, administered by diplomates of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy.
DHS 157.65 Note Note: 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 157.65(8)(b) (b) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes all of the following:
DHS 157.65(8)(b)1. 1. Two hundred hours of classroom and laboratory training in all of the following areas:
DHS 157.65(8)(b)1.a. a. Radiation physics and instrumentation.
DHS 157.65(8)(b)1.b. b. Radiation protection.
DHS 157.65(8)(b)1.c. c. Mathematics pertaining to the use and measurement of radioactivity.
DHS 157.65(8)(b)1.d. d. Radiation biology.
DHS 157.65(8)(b)2. 2. Five hundred hours of work experience, under the supervision of an authorized user who meets the requirements in this subsection, s. DHS 157.61 (10), or equivalent agreement state requirements at a medical institution, involving all of the following:
DHS 157.65(8)(b)2.a. a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys.
DHS 157.65(8)(b)2.b. b. Checking survey meters for proper operation.
DHS 157.65(8)(b)2.c. c. Preparing, implanting and removing brachytherapy sources.
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.