Chapter DHS 157

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(6)(c)3. 3. A written attestation under sub. (8) (c).

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)(b) (b) Is an authorized user under s. DHS 157.65 (8) or 157.67 (17), or equivalent NRC or 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 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)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 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:

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 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.

DHS 157.64(7)(c)3. 3. Has obtained written attestation under sub. (8) (d).

DHS 157.64(8) (8) Written attestation.

DHS 157.64(8)(a) (a) Unsealed radioactive material for which a written directive is required. As required by sub. (4) (b) 3., the 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 successfully completed the requirements in sub. (4) (b) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under sub. (1) for which the individual is requesting authorized user status. The attestation must be obtained from either of the following:

DHS 157.64(8)(a)1. 1. A preceptor authorized user who meets the requirements in sub. (4), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status.

DHS 157.64(8)(a)2. 2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (4), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (4) (b).

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). As required by sub. (5) (c) 3., the licensee shall require an authorized user of sodium iodide I-131 for oral administration to have obtained written attestation that the individual has successfully completed the requirements in sub. (5) (c), and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under sub. (1). The attestation must be obtained from either of the following:

DHS 157.64(8)(b)1. 1. A preceptor authorized user who meets the requirements in sub. (4), (5) or (6), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements and has experience in administering sodium iodide I-131 dosages as specified in sub. (4) (b) 2. g.

DHS 157.64(8)(b)2. 2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (4), (5) or (6), s. DHS 157.61 (10). or equivalent NRC or agreement state requirements, has experience in administering sodium iodide I-131 dosages as specified in sub. (4) (b) 2. g., and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (5) (c).

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). As required by sub. (6) (c) 3., a licensee shall require an authorized user of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) to have obtained written attestation that the individual has successfully completed the requirements in sub. (6) (c), and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131 under sub. (1). The attestation must be obtained from either of the following:

DHS 157.64(8)(c)1. 1. A preceptor authorized user who meets the requirements in sub. (4) or (6), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements and has 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)(c)2. 2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (4) or (6), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements, has experience in administering dosages of I-131 greater than 1.22 Gigabecquerels (33 millicuries) as specified in sub. (4) (b) 2. g. and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (6) (c).

DHS 157.64(8)(d) (d) Parenteral administration of unsealed radioactive material requiring a written directive. As required by sub. (7) (c) 3., the licensee shall require a user for the parenteral administration of unsealed radioactive material requiring a written directive to have obtained written attestation that the individual has successfully completed the requirements in sub. (7) (c), and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive as specified in sub. (4) (b) 2. g. The attestation must be obtained from either of the following:

DHS 157.64(8)(d)1. 1. A preceptor authorized user who meets the requirements in sub. (4) or (7), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements. A preceptor authorized user who meets the requirements in sub. (4) or (7), 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.

DHS 157.64(8)(d)2. 2. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (4) or (7), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements, has experience in administering parenteral dosages as specified in sub. (4) (b) 2. g., and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (7) (c).

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; CR 22-015: am. (1) (intro.), (4) (intro.), (a) 1., (b) 2. (intro.), g., 3., cr. (4) (b) 3., am. (5) (intro.), (b), (c) (intro.), 2., 3., (6) (intro.), (b), (c) (intro.), 2. (intro.), cr. (6) (c) 3., am. (7) (intro.), (a), (b), (c) (intro.), (c) 1. (intro.), 2. (intro.), f., cr. (7) (c) 3., r. and recr. (8) Register June 2023 No. 810, eff. 7-1-23; correction in (7) (c) 2. (intro.) made under s. 35.17, Stats., Register June 2023 No. 810.

DHS 157.65 DHS 157.65 Manual 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.

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 either comply with par. (b) or do all of 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(6)(b) (b) Instead of a licensee making its own measurements as required in par. (a), the 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)(c) (c) 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)(d) (d) A license shall retain a record of each calibration under s. DHS 157.71 (18).

DHS 157.65(6m) (6m) Strontium-90 sources for ophthalmic treatments.

DHS 157.65(6m)(a) (a) Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in par. (b) of this section are performed by either of the following:

DHS 157.65(6m)(a)1. 1. An authorized medical physicist.

DHS 157.65(6m)(a)2. 2. An individual who meets all of the following:

DHS 157.65(6m)(a)2.a. a. Is identified as an ophthalmic physicist on a specific medical use license issued by the department, the NRC or an agreement state, or permit issued by the NRC or an agreement state broad scope medical use licensee, medical use permit issued by an NRC master material licensee, or permit issued by an NRC master material licensee broad scope medical use permittee.

DHS 157.65(6m)(a)2.b. b. Holds a master’s or doctor’s degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university.

DHS 157.65(6m)(a)2.c. c. Has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist.

DHS 157.65(6m)(a)2.d. d. Has documented training in the creation, modification, and completion of written directives.

DHS 157.65(6m)(a)2.e. e. Has documented training in procedures for administrations requiring a written directive.

DHS 157.65(6m)(a)2.f. f. Has documented training in performing the calibration measurements of brachytherapy sources as detailed in sub. (6).

DHS 157.65(6m)(b) (b) The individuals who are identified in par. (a) 1. or 2. shall do all of the following:

DHS 157.65(6m)(b)1. 1. Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under sub. (6).

DHS 157.65(6m)(b)2. 2. Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures shall include the frequencies that the individual meeting the requirements in par. (a) will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives.

DHS 157.65(6m)(c) (c) Licensees shall retain a record of the activity of each strontium-90 source in accordance with 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.