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:
DHS 157.61(7)(b)2.
2. One year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on a department, NRC or another agreement state license, or a permit issued by a NRC master material licensee that authorizes similar types of uses of radioactive material. An associate radiation safety officer may provide supervision for those areas for which the associate radiation safety officer is authorized on a department, NRC, or an agreement state license or permit issued by a NRC master material licensee. The full-time radiation safety experience must involve all of the following:
DHS 157.61(7)(b)2.b.
b. Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters and instruments used to measure radionuclides.
DHS 157.61(7)(b)2.d.
d. Using administrative controls to avoid mistakes in the administration of radioactive material.
DHS 157.61(7)(b)2.e.
e. Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures.
DHS 157.61(7)(c)1.
1. A medical physicist who has been certified by a specialty board whose certification process has been recognized by the department, NRC, or another agreement state under sub.
(8) (a), and has experience in radiation safety aspects of similar types of use of radioactive material for which the licensee seeks the approval of the individual as the radiation safety officer or an associate radiation safety officer.
DHS 157.61(7)(c)2.
2. An authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on a department, NRC, or an agreement state license, or medical use permit issued by an NRC master material licensee, and has experience with the radiation safety aspects of similar types of use of radioactive material for which the licensee seeks the approval of the individual as the radiation safety officer or associate radiation safety officer.
DHS 157.61(7)(c)3.
3. An individual who has experience with the radiation safety aspects of the types of use of radioactive material for which the individual is seeking simultaneous approval both as the radiation safety officer and the authorized user on the same new medical use license.
DHS 157.61(8)
(8)
Training for an authorized medical physicist. Except as provided in sub.
(10), a licensee shall require the authorized medical physicist to have training for the type of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by successfully completing either a training program provided by the vendor of the applicable system or device, or by training supervised by an authorized medical physicist authorized for the type of use for which the individual is seeking authorization. A licensee shall also require the authorized medical physicist to be an individual who meets either of the following requirements:
DHS 157.61(8)(a)
(a) Is certified by a 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 have all of the following:
DHS 157.61(8)(a)1.
1. 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(8)(a)2.
2. Attained two years full-time practical training or supervised experience in medical physics that meets either of the following requirements:
DHS 157.61(8)(a)2.a.
a. Completed under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized under this section by the department, the NRC, or an agreement state.
DHS 157.61(8)(a)2.b.
b. Completed in clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements for authorized users in sub.
(10) or s.
DHS 157.65 (8) or
157.67 (17).
DHS 157.61(8)(a)3.
3. Passed an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery.
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(8)(b)1.1. Holds a master's or doctorate degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university and completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type of use for which the individual is seeking authorization. This training and work experience shall be conducted in clinical radiation facilities that provide high energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services and shall include all of the following:
DHS 157.61(8)(b)1.c.
c. Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.
DHS 157.61(8)(b)1.d.
d. Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.
DHS 157.61(9)
(9)
Training for an authorized nuclear pharmacist. Except as provided in sub.
(10), the licensee shall require the authorized nuclear pharmacist to be a pharmacist who meets either of the following requirements:
DHS 157.61(9)(a)
(a) Is certified by a 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 have all of the following:
DHS 157.61(9)(a)1.
1. Graduated from a pharmacy program accredited by the Accreditation Council for Pharmacy Education or have passed the foreign pharmacy graduate examination committee examination.
DHS 157.61(9)(a)3.
3. Evidence of having acquired at least 4000 hours of training and experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience.
DHS 157.61(9)(a)4.
4. Evidence of having passed an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in the procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development.
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(9)(b)
(b) Has completed 700 hours in a structured educational program including all of the following requirements:
DHS 157.61(9)(b)1.
1. Two hundred hours of classroom and laboratory training covering all of the following areas:
