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)(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(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(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)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(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)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)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(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)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)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(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)(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 be a physician who meets any 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 have its certification process 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 council on postdoctoral 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)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 NRC or agreement state requirements at a medical facility authorized to use byproduct materials under sub.
(1), 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.e.
e. Using administrative controls to prevent a medical event involving the use of radioactive material.
DHS 157.65(8)(b)3.
3. Three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in this subsection, s.
DHS 157.61 (10), or equivalent NRC or agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology 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. The experience may be obtained concurrently with the supervised work experience required by subd.
2. DHS 157.65(9)
(9)
Training for ophthalmic use of strontium-90. Except as provided in s.
DHS 157.61 (10), a licensee shall require an authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who meets any of the following requirements:
DHS 157.65(9)(a)
(a) Is an authorized user under sub.
(8) or equivalent NRC or agreement state requirement.
DHS 157.65(9)(b)
(b) Has had classroom and laboratory training applicable to the use of strontium-90 for ophthalmic radiotherapy and a period of supervised clinical training in ophthalmic radiotherapy that includes all of the following:
DHS 157.65(9)(b)1.
1. Twenty-four hours of classroom and laboratory training that includes all of the following:
DHS 157.65(9)(b)2.
2. Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of 5 individuals. The supervised clinical training shall include all of the following:
