DHS 157.61 (4) (b) The written directive shall contain the patient or human research subject’s name and all of the following information:
1. For the administration of a dosage of a radioactive drug, the name, dosage and administration route of the radioactive drug.
2. For each anatomically distinct treatment site exposed to gamma stereotactic radiosurgery, total dose, treatment site and number of target settings per treatment.
3. For teletherapy, the total dose, dose per fraction, number of fractions, treatment site and overall treatment period.
4. For high dose rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions and total dose.
5. For permanent implant brachytherapy:
a. Before implantation, the written directive shall include the treatment site, the radionuclide, and the total source strength.
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.
6. For all other brachytherapy including low dose rate, medium dose rate and pulsed dose rate afterloaders:
a. Before implantation, written directive shall include the treatment site, radionuclide, and dose.
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.
SECTION 42.
DHS 157.61 (5) (b) 3. and 4. are amended to read:DHS 157.61 (5) (b) 3. Checking both manual and computer-generated dose calculations, if performed.
DHS 157.61 (5) (b) 4. Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic remote afterloader, teletherapy or gamma stereotactic radiosurgery units medical units authorized by s. DHS 157.67 or 70. SECTION 43.
DHS 157.61 (5) (b) 5. and 6. are created to read:DHS 157.61 (5) (b) 5. Determining if a medical event, as defined in s. DHS 157.72 (1), has occurred. DHS 157.61 (5) (b) 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.
SECTION 44.
DHS 157.61 (7) (intro.), (7) (a), and (7) (b) 2. are amended to read:DHS 157.61 (7) (intro.) 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 s. DHS 157.61 to be 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, an 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 has obtained written attestation under sub. (12) (a) and meets any of the following requirements: DHS 157.61 (7) (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 be recognized, a specialty board shall require all candidates for certification to have either of the following:
DHS 157.61 (7) (b) 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 involving all the following:
SECTION 45.
DHS 157.61 (7) (b) 3. is created to read:DHS 157.61 (7) (b) 3. Has obtained written attestation under sub. (12) (a).
SECTION 46.
DHS 157.61 (7) (c) 1., and 2., are repealed and recreated to read:DHS 157.61 (7) (c) 1. A medical physicist who has been certified by a specialty board whose certification process has been recognized by the department, the NRC or another agreement state under sub. (8) (a), 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. An authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on a department, NRC, or an agreement state license, or other equivalent permit or license, has experience with the radiation safety aspects of similar types of use of radioactive material for which the licensee is seeks the approval of the individual as the radiation safety officer or associate radiation safety officer.
SECTION 47.
DHS 157.61 (7) (c) 3. is created to read:DHS 157.61 (7) (c) 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.
SECTION 48.
DHS 157.61 (8) is repealed and recreated to read:DHS 157.61 (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:
(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:
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.
2. Attained two years full-time practical training or supervised experience in medical physics that meets either of the following requirements:
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.
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 s. DHS 157.61 (10), 157.65 (8) or 157.67 (17). 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.
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. (b) 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:
a. Performing sealed source leak tests and inventories.
b. Performing decay corrections.
c. Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.
d. Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.
2. Has obtained written attestation under sub. (12) (b).
SECTION 49.
DHS 157.61 (9) (intro.) is amended to read:DHS 157.61 (9) (intro.) 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 has obtained written attestation under sub. (12) (c) and meets either of the following requirements:
SECTION 50.
DHS 157.61 (9) (a) and (9) (a) 1. are amended to read:DHS 157.61 (9) (a) Is certified by a specialty board whose certification process has been recognized by the department, the NRC, or an agreement state. and who has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in sub. (12) (c) and has achieved a level of competency sufficient to independently operate a nuclear pharmacy. To have its certification process be recognized, a specialty board shall require all candidates for certification to have all of the following:
DHS 157.61 (9) (a) 1. Graduated from a pharmacy program accredited by the American council on pharmaceutical education Accreditation Council for Pharmacy Education or have passed the foreign pharmacy graduate examination committee examination
SECTION 51.
DHS 157.61 (9) (b) 3. is created to read:DHS 157.61 (9) (b) 3. Has obtained written attestation under sub. (12) (c).
SECTION 52.
DHS 157.61 (10) is repealed and recreated to read:DHS 157.61 (10) Training for experienced radiation safety officer, teletherapy or medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
(a) 1. An individual identified as a radiation safety officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist, or an authorized nuclear pharmacist on a department, NRC or another agreement state license, or other equivalent permit on or before January 14, 2019, is exempt from the training requirements of subs. (7) to (9), respectively, except the radiation safety officers and authorized medical physicists identified in this paragraph must meet the training requirements of subs. (7) or (8), as appropriate, for any material uses for which they were not authorized prior to this date.
2. Any individual certified by the American Board of Health Physics in Comprehensive Health Physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, is exempt from the training requirements of subs. (7) to be identified as a radiation safety officer or as an associate radiation safety officer on a department, NRC, or an agreement state license or NRC master material license permit for those materials and uses that these individuals performed on or before October 24, 2005.
3. Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, is exempt from the training requirements for an authorized medical physicist described in subs. (8), for those materials and uses that these individuals performed on or before October 24, 2005.
4. A radiation safety officer, a medical physicist, or a nuclear pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the department, is exempt from the training requirements of subs. (7) to (9), respectively, when performing the same uses. A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and during the time period identified in this paragraph, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for the purposes of this chapter.
(b) An individual identified as a radiation safety officer, an authorized medical physicist, or an authorized nuclear pharmacist on a department, NRC or another agreement state license, the permit issued by a licensee of broad scope or the permit issued by NRC master material licensee between October 24, 2002 and April 29, 2005 is exempt from the training requirements of s. DHS 157.61 (7), (8) or (9). (c) 1. Physicians, dentists, or podiatrists who are identified as authorized users for the medical use of radioactive material on a license issued by the department, the NRC, an agreement state, a permit issued by a NRC master material licensee, a permit issued by a NRC or an agreement state broad scope licensee, or a permit issued by a NRC master material license broad scope permittee on or before January 14, 2019, who perform only those medical uses for which they were authorized on or before that date is exempt from the training requirements of ss. DHS 157.63 to 157.67. 2. Physicians, dentists, or podiatrists not identified as authorized users for the medical use of radioactive material on a license issued by the department, the NRC, an agreement state, a permit issued by a NRC master material licensee, a permit issued by a NRC or an agreement a state broad scope licensee, or a permit issued in accordance with a NRC master material broad scope license on or before October 24, 2005, is exempt from the training requirements of ss. DHS 157.63 to 157.67 for any of the following materials and uses that these individuals performed on or before October 24, 2005: a. For uses authorized under ss. DHS 157.63 (1) or DHS 157.63 (2), or oral administration of sodium iodide I–131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine in nuclear medicine, the American Board of Radiology in diagnostic radiology, the American Osteopathic Board of Radiology in diagnostic radiology or radiology the Royal College of Physicians and Surgeons of Canada in nuclear medicine, or American Osteopathic Board of Nuclear Medicine in nuclear medicine. b. For uses authorized under s. DHS 157.64 (1), a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine, the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology, the Royal College of Physicians and Surgeons of Canada in nuclear medicine, or the American Osteopathic Board of Radiology after 1984. c. For uses authorized under ss. DHS 157.65 (1) or DHS 157.67 (1), a physician who was certified on or before October 24, 2005, by the American Board of Radiology in radiology, therapeutic radiology or radiation oncology, the American Osteopathic Board of Radiology in radiation oncology;, by the Canadian Royal College of Physicians and Surgeons in therapeutic radiology, or as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology" in radiology, with specialization in radiotherapy. d. For uses authorized under s. DHS 157.66 (1), a physician who was certified on or before October 24, 2005, by the American Board of Radiology, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology, the American Board of Nuclear Medicine in nuclear medicine, the American Osteopathic Board of Radiology in diagnostic radiology or radiology, or the Royal College of Physicians and Surgeons of Canada in nuclear medicine. 3. Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the department, is exempt from the training requirements of ss. DHS 157.63 to 157.67 when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for the purposes of this chapter. (d) Individuals who are not required to comply with the training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on department licenses for the same uses for which these individuals are authorized.
SECTION 53.
DHS 157.61 (12) (a) to (c) are amended to read:DHS 157.61 (12) (a) Radiation safety officer or associate radiation safety officer. As required by sub. (7) (b) 3., the The licensee shall ensure that an individual fulfilling the responsibilities of the radiation safety officer or associate radiation safety officer has obtained written attestation, signed by a preceptor radiation safety officer or associate radiation safety officer who has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking approval as a radiation safety officer or an associate radiation safety officer. , The written attestation must state that the individual has satisfactorilysuccessfully completed the requirements in sub. (7) (b) (a) 1. a. and b., 2. a. and b., (b), or (c), has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to independently function as a radiation safety officer for a medical use of radioactive material is able to independently fulfill the radiation safety-related duties as a radiation safety officer or as an associate radiation safety officer for a medical use license.
DHS 157.61 (12) (b) Authorized medical physicist. As required by sub. (8) (b) 2., the A licensee shall ensure that the individual has obtained written attestation that the individual has satisfactorilysuccessfully completed the requirements in sub. (8) (b) 1. (a) 1. a. and b. or (b), has 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, and is able to independently fulfill the radiation safety-related duties has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation shall be signed by a preceptor authorized medical physicist who meets the requirements in sub. (8) or (10), or equivalent NRC or agreement state requirements, for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.
DHS 157.61 (12) (c) Authorized nuclear pharmacist. As required by sub. (9) (b) 3., the A licensee shall ensure that the individual has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorilysuccessfully completed the requirements in sub. (9) (a) or (b) and is able to independently fulfill the radiation safety-related duties has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.
SECTION 54.
DHS 157.62 (2) (b) 3. (Note) is amended to read:DHS 157.62 (2) (b) 3. (Note) Two separated readings on each scale or decade are typically used used for linear scale instruments.
SECTION 55.
DHS 157.62 (4) is repealed and recreated to read:DHS 157.62 (4) Authorization for calibration, transmission and reference sources. (a) Any person authorized by s. DHS 157.13 (5) for medical use of radioactive material may receive, possess and use any of the following radioactive material for check, calibration, transmission and reference use: 1. A sealed source that does not exceed 1.11 GBq (30 mCi) that is manufactured and distributed by a person licensed under s. DHS 157.13 (4) (j) or equivalent NRC or agreement state regulations or redistributed by a person authorized to redistribute sealed sources, provided that the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer’s approved instructions. 2. Any radioactive material with a half-life not longer than 120 days in individual amounts not to exceed 0.555 GBq (15 mCi).
3. Any radioactive material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 microcuries) or 1000 times the quantities in ch. DHS 157 Appendix F. 4. Technetium-99m in amounts as needed.
5. Flourine-18 in amounts as needed.
(b) Radioactive material in sealed sources authorized by this subsection shall not be used in either of the following:
2. Bundled or aggregated to create activity greater than the maximum activity of any single sealed source authorization under this section.
(c) A licensee using calibration, transmission, and reference sources in accordance with the requirements in this subsection need not list these sources on a specific medical use license.
SECTION 56.
DHS 157.62 (5) (b) 3. is created to read:DHS 157.62 (5) (b) 3. Test the source for leakage at any time there is reason to suspect that the sealed source might have been damaged or might be leaking.
SECTION 57.
DHS 157.63 (3) (b) 1. is repealed and recreated to read:DHS 157.63 (3) (b) 1. If using a molybdenum-99/technetium-99m generator for preparing a technetium-99m radiopharmaceutical, measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with par. (a).
SECTION 58.
DHS 157.63 (4) (intro.), (a), (b), and (c) 2. are amended to read:DHS 157.63 (4) (intro.) Training for uptake, dilution and excretion studies. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user of unsealed radioactive material for the uses authorized under sub. (1) to have obtained written attestation under sub. (6) (a) and to be a physician who meets any of the following requirements: DHS 157.63 (4) (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 be recognized, a specialty board shall require all candidates for certification to do all of the following:
