DHS 157.59(2)
(2)
Provisions for research involving human subjects. A licensee may conduct research involving human subjects using radioactive material provided all of the following requirements are met:
DHS 157.59(2)(a)
(a) A licensee shall apply for and receive approval of a specific amendment to its radioactive materials license before conducting the research. A licensee shall obtain informed consent from the human subjects and obtain prior review and approval of the research activities by an “Institutional Review Board" or equivalent under the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.
DHS 157.59(2)(b)
(b) The research involving human subjects authorized in par.
(a) shall be conducted using radioactive material authorized for medical use in the license.
DHS 157.59(2)(c)
(c) Nothing in this subsection relieves a licensee from complying with the other requirements in this subchapter or from complying with applicable FDA or other federal requirements governing radioactive drugs or devices.
DHS 157.59(3)(a)(a) If the requirements of this subchapter are more restrictive than the existing license condition, a licensee shall comply with this subchapter unless exempted by par.
(c).
DHS 157.59(3)(b)
(b) Any existing license condition that is not affected by a requirement in this subchapter remains in effect until there is a license amendment or license renewal.
DHS 157.59(3)(c)
(c) If a license condition exempted a licensee from a provision of this subchapter on the effective date of August 1, 2002, the exemption shall continue until the department amends, suspends or revokes the license.
DHS 157.59(3)(d)
(d) If a license condition cites provisions in this subchapter that are later deleted, the license condition remains in effect until a license amendment or renewal modifies or removes the license condition.
DHS 157.59 History
History: CR 01-108: cr.
Register July 2002 No. 559, eff. — see Note at the start of the chapter.
DHS 157.61
DHS 157.61 Administrative requirements. DHS 157.61(1)(1)
Authority and responsibilities for the radiation protection program. DHS 157.61(1)(a)(a) In addition to the radiation protection program requirements of s.
DHS 157.21, a licensee's management shall approve in writing any of the following:
DHS 157.61(1)(a)1.
1. A request for license application, renewal or amendment before submittal to the department.
DHS 157.61(1)(a)2.
2. Authorization prior to using licensed materials for any individual to work as an authorized user, authorized nuclear pharmacist or authorized medical physicist.
DHS 157.61(1)(a)3.
3. A radiation protection program change that does not require a license amendment and is permitted under sub.
(2).
DHS 157.61(1)(b)
(b) A licensee's management shall appoint a radiation safety officer who agrees in writing to be responsible for implementing the radiation protection program. A licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed under licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more associate radiation safety officers to support the radiation safety officer. The radiation safety officer, with written agreement of the licensee's management, must assign the specific duties and tasks to each associate radiation safety officer. These duties and tasks are restricted to the types of use for which the associate radiation safety officer is listed on a license. The radiation safety officer may delegate duties and tasks to the associate radiation safety officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.
DHS 157.61(1)(c)
(c) For up to 60 days each year, a licensee may permit an individual qualified to be a radiation safety officer to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer, as provided in par.
(f), provided the licensee takes the actions required in pars.
(b),
(d),
(f), and
(g) and notifies the department in accordance with s.
DHS 157.13 (5) (c) 2. e. A licensee may simultaneously appoint more than one temporary radiation safety officer if needed to ensure that the licensee has a temporary radiation safety officer that satisfies the requirements to be a radiation safety officer for each of the different uses of radioactive material permitted by the license.
DHS 157.61(1)(d)
(d) A licensee shall establish in writing the authority, duties and responsibilities of the radiation safety officer.
DHS 157.61(1)(e)
(e) A licensee that is authorized for 2 or more different types of uses of radioactive material under ss.
DHS 157.64,
157.65 and
157.67 or 2 or more types of units under s.
DHS 157.67 shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license. The committee shall include an authorized user of each type of use permitted by the license, the radiation safety officer, a representative of the nursing service and a representative of management who is neither an authorized user nor a radiation safety officer, and may include other members as the licensee deems appropriate.
DHS 157.61(1)(f)
(f) A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources and management prerogative to perform all the following functions:
DHS 157.61(2)(a)
(a) A licensee may revise its radiation protection program without department approval if the revision meets all the following criteria:
DHS 157.61(2)(a)2.
2. The revision complies with the requirements of this chapter and the license.
DHS 157.61(2)(a)3.
3. The revision has been reviewed and approved by the radiation safety officer and licensee management.
DHS 157.61(2)(a)4.
4. The affected individuals are instructed on the revised program before the changes are implemented.
DHS 157.61(3)(a)(a) A licensee who permits the receipt, possession, use or transfer of radioactive material by an individual under the supervision of an authorized user shall do all the following:
DHS 157.61(3)(a)1.
1. Instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, requirements of this chapter and license conditions regarding the use of radioactive material.
DHS 157.61(3)(a)2.
2. Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, requirements of this chapter and license conditions regarding the medical use of radioactive material.
DHS 157.61(3)(b)
(b) A licensee who permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user shall do all of the following:
DHS 157.61(3)(b)1.
1. Instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material.
DHS 157.61(3)(b)2.
2. Require the supervised person to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, the written radiation protection procedures established by the licensee and the regulations of this chapter, and license conditions.
DHS 157.61(3)(c)
(c) A licensee who permits supervised activities under pars.
(a) and
(b) is responsible for the acts and omissions of the supervised individual.
DHS 157.61(4)(a)1.1. A written directive must be dated and signed by an authorized user prior to administration of I-131 sodium iodide greater than 1.11 Megabecquerels (30 microcuries), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material.
DHS 157.61(4)(a)2.
2. If, because of the emergent nature of the patient's condition, a delay in providing a written directive would jeopardize the patient's health, an oral directive from an authorized user is acceptable provided the information contained in the oral directive is documented immediately in writing in the patient's record and a written directive is prepared within 48 hours of the oral directive.
DHS 157.61(4)(a)3.
3. A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose or the next fractional dose.
DHS 157.61(4)(a)4.
4. If, because of the patient's condition, a delay to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision.
DHS 157.61(4)(b)
(b) The written directive shall contain the patient or human research subject's name and all of the following information:
DHS 157.61(4)(b)1.
1. For the administration of a dosage of a radioactive drug, the name, dosage and administration route of the radioactive drug.
DHS 157.61(4)(b)2.
2. For each anatomically distinct treatment site exposed to gamma stereotactic radiosurgery, total dose, treatment site and number of target settings per treatment.
DHS 157.61(4)(b)3.
3. For teletherapy, the total dose, dose per fraction, number of fractions, treatment site and overall treatment period.
DHS 157.61(4)(b)4.
4. For high dose rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions and total dose.
DHS 157.61(4)(b)5.a.
a. Before implantation, the written directive shall include the treatment site, the radionuclide, and the total source strength.
DHS 157.61(4)(b)5.b.
b. After implantation but before the patient leaves the post-treatment recovery area, the written directive shall include the treatment site, the number of sources implanted, the total source strength implanted, and the date.
DHS 157.61(4)(b)6.
6. For all other brachytherapy including low dose rate, medium dose rate and pulsed dose rate afterloaders:
DHS 157.61(4)(b)6.a.
a. Before implantation, the written directive shall include the treatment site, radionuclide, and dose.
DHS 157.61(4)(b)6.b.
b. After implantation but before completion of the procedure, the written directive shall include the radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose), and date.
DHS 157.61(5)
(5)
Procedures for administrations requiring a written directive. DHS 157.61(5)(a)(a) For any administration requiring a written directive, a licensee shall develop, implement and maintain written procedures to help ensure both of the following:
DHS 157.61(5)(a)1.
1. The patient's or human research subject's identity is verified by more than one method before each administration.
DHS 157.61(5)(a)2.
2. Each administration is performed according to the provisions of a written directive.
DHS 157.61(5)(b)
(b) The procedures required by par.
(a) shall address all of the following items that are applicable for the licensee's use of radioactive material:
DHS 157.61(5)(b)1.
1. Verifying the identity by more than one method of the patient or human research subject.
DHS 157.61(5)(b)2.
2. Verifying that the specific details of the administration are under the treatment plan, if applicable, and the written directive.
DHS 157.61(5)(b)4.
4. Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by s.
DHS 157.67 or
157.70.
DHS 157.61(5)(b)6.
6. Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.
DHS 157.61(6)
(6)
Suppliers for sealed sources or devices for medical use. For medical use, a licensee may only use the following:
DHS 157.61(6)(a)
(a) Sealed sources or devices manufactured, labeled, packaged and distributed under a license issued under subch.
II or the equivalent requirements of the NRC or another agreement state.
DHS 157.61(6)(b)
(b) Teletherapy sources manufactured and distributed under a license issued under subch.
II or the equivalent requirements of the NRC or another agreement state.
DHS 157.61(6)(c)
(c) Sealed sources or devices non-commercially transferred from a medical licensee.
DHS 157.61(7)
(7)
Training for radiation safety officer and associate radiation safety officer.. Except as provided in sub.
(10), a licensee shall ensure that an individual fulfilling the responsibilities of the radiation safety officer, or an individual assigned duties and tasks as an associate radiation safety officer as provided in this section, is an individual who has training in radiation safety, regulatory issues and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a radiation safety officer, associate radiation safety officer, authorized medical physicist, authorized nuclear pharmacist or authorized user, as appropriate, who is authorized for the type of use for which the licensee is seeking approval. A licensee shall also require the radiation safety officer or an associate radiation safety officer to be a person who meets any of the following requirements:
DHS 157.61(7)(a)
(a) Is certified by a specialty board whose certification process has been recognized by the department, the NRC or another agreement state. To have its certification process recognized, a specialty board shall require all candidates for certification to have either of the following:
DHS 157.61(7)(a)1.a.a. A bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science.
DHS 157.61(7)(a)1.b.
b. Five or more years of professional experience in health physics (graduate training may be substituted for no more than 2 years of the required experience) including at least 3 years in applied health physics.
DHS 157.61(7)(a)1.c.
c. Passed an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry.
DHS 157.61(7)(a)2.a.a. Master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university.
DHS 157.61(7)(a)2.b.
b. Two years of full-time practical training and/or supervised experience in medical physics either under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the department, the NRC, or another agreement state or in clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users in s.
DHS 157.61 (10),
157.63 (5) or
157.64 (4).
DHS 157.61(7)(a)2.c.
c. Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety.
DHS 157.61 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 157.61(7)(b)
(b) Has completed a structured educational program consisting of all the following:
DHS 157.61(7)(b)1.
1. 200 hours of classroom and laboratory training in all the following areas:
