DHS 157.67(16)
(16)
Therapy-related computer systems. A licensee shall perform acceptance testing on the treatment planning system under published protocols accepted by nationally recognized bodies. The acceptance testing shall include, as applicable, verification of all of the following:
DHS 157.67(16)(a)
(a) Source-specific input parameters required by the dose calculation algorithm used to calculate the dose to the patient.
DHS 157.67(16)(b)
(b) Accuracy of dose, dwell time of the radioactive source at a particular location and treatment time calculations at representative points.
DHS 157.67(16)(c)
(c) Accuracy of isodose graphic plots on paper and graphic displays.
DHS 157.67(16)(d)
(d) Accuracy of the software used to determine radioactive source positions from radiographic images.
DHS 157.67(16)(e)
(e) Accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system that was used to calculate the patient dose and radioactive source dwell times.
DHS 157.67 Note
Note: An example of such a nationally recognized body is the American Association of Physicists in Medicine.
DHS 157.67(17)
(17)
Training for use of remote afterloader, teletherapy and gamma stereotactic radiosurgery units. A licensee shall require an authorized user of a sealed source for a use authorized under sub.
(1) to have received training in device operation, safety procedures, and clinical use for the type of use for which authorization is sought. This training requirement may be satisfied by successful completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type of use for which the individual is seeking authorization. Except as provided in s.
DHS 157.61 (10), a licensee shall require an authorized user of a sealed source for a use authorized under sub.
(1) to be a physician who meets any of the following requirements:
DHS 157.67(17)(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 157.67(17)(a)1.
1. Successfully complete a minimum of 3 years of residency training in a radiation therapy program 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 of Postdoctoral Training of the American Osteopathic Association.
DHS 157.67(17)(a)2.
2. Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy.
DHS 157.67 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 157.67(17)(b)
(b) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes all of the following:
DHS 157.67(17)(b)1.
1. Two hundred hours of classroom and laboratory training in all the following areas:
DHS 157.67(17)(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 157.67(17)(b)2.c.
c. Using administrative controls to prevent a medical event involving the use of radioactive material.
DHS 157.67(17)(b)2.d.
d. Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console.
DHS 157.67(17)(b)3.
3. Three years of supervised clinical experience in radiation therapy 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 Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subd.
2. DHS 157.67(18)
(18)
Written attestation. A licensee shall require an authorized user of a sealed source for a use authorized under sub.
(17) to have obtained written attestation that the individual has successfully completed the requirements in sub.
(17) (b), and has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The attestation must be obtained from either of the following:
DHS 157.67(18)(a)
(a) A preceptor authorized user who meets the requirements in sub.
(17), s.
DHS 157.61 (10), or equivalent NRC or agreement state requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status.
DHS 157.67(18)(b)
(b) . 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.
(17), s.
DHS 157.61 (10), or equivalent NRC or agreement state requirements user for each type of therapeutic medical unit for which the individual is requesting authorized user status. 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.
(17) (b).
DHS 157.67 History
History: CR 01-108: cr.
Register July 2002 No. 559, eff. — see Note at the start of the chapter; correction in (4) (f) made under s. 13.93 (2m) (b) 7., Stats.,
Register July 2002 No. 559;
CR 06-021: am. (9) (b) 2., 3., 6., 8. and 10., r. and recr. (17), cr. (18)
Register September 2006, No. 609, eff. 10-1-06;
CR 09-062: am. (8) (b) 1., (17) (b) 2. (intro.), 3. and (18)
Register April 2010 No. 652, eff. 5-1-10;
CR 16-078: am. (11) (f), (12) (b) 3.
Register January 2018 No. 745, eff. 2-1-18;
CR 22-015: r. (1) (intro.), renum. (1) (a) to (1) (a) (intro.) and am., cr. (1) (a) 1., renum. (1) (b) to (1) (a) 2. and am., cr. (1) (b), am. (4) (d) (intro.), (e), cr. (4) (g), (h), am. (15) (title), (a), (17) (intro.), (a) (intro.), 1., (b) 2. (intro.), 3., cr. (17) (b) 4., renum. (18) to (18) (intro.) and am., cr. (18) (a), (b) Register June 2023 No. 810, eff. 7-1-23; correction in numbering of (4) (h) made under s. 13.92 (4) (b) 1., Stats., Register June 2023 No. 810. DHS 157.68
DHS 157.68 Radioactive drugs for medical use. DHS 157.68(1)(1)
Preparation. A licensee authorized to manufacture, prepare or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium radioactive drugs shall ensure that any individual preparing the drugs is one of the following:
DHS 157.68(1)(b)
(b) An individual under the supervision of an authorized nuclear pharmacist.
DHS 157.68(1)(c)2.
2. Is identified as an authorized nuclear pharmacist on a license issued by the department, an agreement state or the NRC.
DHS 157.68(1)(c)3.
3. Is identified as an authorized nuclear pharmacist by a licensee who is authorized by the department, an agreement state or the NRC to designate authorized nuclear pharmacists operating under their license.
DHS 157.68(1)(c)4.
4. Functioned as a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and practiced at a 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.
DHS 157.68(2)
(2)
Documentation. A licensee shall provide to the department a copy of all the following, as appropriate:
DHS 157.68(2)(a)
(a) A copy of each individual's certification by a specialty board whose certification process has been recognized by the department, the NRC, or an agreement state as specified in s.
DHS 157.61 (9).
DHS 157.68(2)(e)
(e) The state pharmacist licensure, no later than 30 days after the date that the licensee allows, under sub.
(1) (c) 1. and
2., the individual to work as an authorized nuclear pharmacist.
DHS 157.68(2)(f)
(f) Documentation that only accelerator-produced radioactive materials were used 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.
DHS 157.68 History
History: CR 06-021: cr.
Register October 2006 No. 610, eff. 11-1-06;
CR 09-062: am. (1) (intro.) and (2) (e), cr. (1) (c) 4. and (2) (f)
Register April 2010 No. 652, eff. 5-1-10;
CR 22-015: am. (2) (a) Register June 2023 No. 810, eff. 7-1-23. DHS 157.70
DHS 157.70 Other medical uses of radioactive material or radiation from radioactive material. A licensee may use radioactive material or a radiation source approved for medical use that is not specifically addressed in ss.
DHS 157.63 to
157.67 if all of the following criteria are met:
DHS 157.70(2)
(2)
Approval. The applicant or licensee has received written approval from the department in a license and uses the material under this chapter and specific conditions the department considers necessary for the medical use of the material.
DHS 157.70 History
History: CR 01-108: cr.
Register July 2002 No. 559, eff. — see Note at the start of the chapter.
DHS 157.71(1)(1)
Records of authority and responsibilities for radiation protection programs. DHS 157.71(1)(a)(a) A licensee shall retain a record of actions taken by the licensee's management under s.
DHS 157.61 (1) (a) for 5 years. The record shall include a summary of the actions taken and a signature of licensee management.
DHS 157.71(1)(b)
(b) A licensee shall retain a current copy of the authorities, duties and responsibilities of the radiation safety officer as required by s.
DHS 157.61 (1) (d). The record shall include the signature of the radiation safety officer and licensee management.
DHS 157.71(1)(c)
(c) For each Associate Radiation Safety Officer appointed under s.
DHS 157.61 (1) (b), the licensee shall retain, for 5 years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensee's management.
DHS 157.71(2)
(2)
Records of radiation protection program safety changes. A licensee shall retain a record of each radiation protection program change made under s.
DHS 157.61 (2) (a) for 5 years. The record shall include a copy of the old and new procedures, the effective date of the change and the signature of the licensee management that reviewed and approved the change.
DHS 157.71(3)
(3)
Records of written directives. A licensee shall retain a copy of each written directive as required by s.
DHS 157.61 (4) for 3 years.
DHS 157.71(4)(b)3.
3. An identification number assigned by the licensee or, if no other identification number is available, the social security number of any person who is the subject of a medical event.
DHS 157.71(4)(b)7.
7. Whether the licensee notified the affected individual or the affected individual's responsible relative or guardian and, if not, whether the failure to notify was based on guidance from the referring physician.
DHS 157.71(5)
(5)
Record of a dose to an embryo or fetus or a nursing child. A licensee shall retain a record of a dose to an embryo or fetus or a nursing child reported under s.
DHS 157.72 (2) for 3 years. The record shall contain all of the following:
DHS 157.71(5)(c)
(c) An identification number assigned by the licensee or, if no other identification number is available, the social security number of the pregnant individual or nursing child who is the subject of the event.
DHS 157.71(5)(d)
(d) A brief description of the event, why it occurred, any effect on the embryo or fetus or nursing child and any actions taken or planned to prevent recurrence.
DHS 157.71(5)(e)
(e) Whether the licensee notified the pregnant individual or mother, or the mother's or child's responsible relative or guardian, and if the licensee did not, whether such failure to notify was based on guidance from the referring physician.
DHS 157.71(6)
(6)
Records of instrument calibrations. A licensee shall maintain a record of instrument calibrations required by s.
DHS 157.62 (1) for 3 years. The record shall include the model and serial number of the instrument, the date of the calibration, the results of the calibration and the name of the individual who performed the calibration.
DHS 157.71(7)
(7)
Records of radiation survey instrument calibrations. A licensee shall maintain a record of radiation survey instrument calibrations required by s.
DHS 157.62 (2) for 3 years. The record shall include the date of the calibration, the results of the calibration, the name of the person who performed the calibration, and the model and serial number of the instrument.
DHS 157.71(8)
(8)
Records of dosages of unsealed radioactive material for medical use. A licensee shall maintain a record of dosage determinations required by s.
DHS 157.62 (3) for 3 years. The record shall contain the radiopharmaceutical, patient's or human research subject's name or identification number if one has been assigned, the prescribed dosage, the determined dosage or a notation that the total activity is less than 1.1 MBq (30 microcuries), the date and time of the dosage determination and the name of the individual who determined the dosage.
DHS 157.71(9)
(9)
Records of possession of sealed sources and brachytherapy sources. DHS 157.71(9)(a)
(a) A licensee shall retain a record of leak tests required by s.
DHS 157.62 (5) (b) for 3 years. The record shall contain the model number and serial number if one has been assigned of each source tested, the identity of each source radionuclide and its estimated activity, the results of the test, the date of the test and the name of the person who performed the test.
DHS 157.71(9)(b)
(b) A licensee shall retain a record of the semi-annual physical inventory of sealed sources and brachytherapy sources required by s.
DHS 157.62 (5) (g) for 3 years. The inventory record shall contain the model number of each source and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source and the name of the person who performed the inventory.
DHS 157.71(10)
(10)
Records of surveys for ambient radiation exposure rate. A licensee shall retain a record of each survey required by s.
DHS 157.62 (7) for 3 years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey and the name of the person who performed the survey.
DHS 157.71(11)
(11)
Records of the release of persons containing radioactive drugs or implants containing radioactive material. DHS 157.71(11)(a)(a) A licensee shall retain a record of the basis for authorizing the release of a person for 3 years after the date of release if the total effective dose equivalent is calculated by any of the following methods:
DHS 157.71(11)(a)1.
1. Using the retained radioactivity in the body rather than the radioactivity administered.
DHS 157.71(11)(a)2.
2. Using an occupancy factor less than 0.25 at one meter to determine radiation exposure to persons physically near the patient.
DHS 157.71(11)(a)3.
3. Using the biological or effective half-life of the radioactive material retained in the body.
DHS 157.71(11)(a)4.
4. Considering the shielding by tissue to calculate the exposure to persons physically near the patient.
DHS 157.71(11)(b)
(b) A licensee shall retain a record for 3 years after the date of release that the instructions required by s.
DHS 157.62 (8) (b) were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem).
