d. Permits anyone to work as an associate radiation safety officer, or before the radiation safety officer assigns duties and tasks to an associate radiation safety officer that differ from those for which this individual is authorized on the license.
e. Receives radioactive material in excess of the amount or in a different form or receives a different radionuclide than is authorized on the license
f. Adds to or changes the areas identified in the application or on the license, except for areas where radioactive material is used only under ss. DHS 157.63 (1) and (2). g. Changes the address of use identified on the application or on the license.
h. Revises procedures required by ss. DHS 157.67 (4) and (10) to (12), as applicable, where such revision reduces radiation safety. i. Receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.
2. An application for a license amendment shall include procedures required by s. DHS 157.67, as applicable. (c) Notifications. A licensee shall make all of the following notifications:
1. Provide to the department a copy of the board certification, the NRC or agreement state license, or other equivalent permit or license for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, an ophthalmic physicist, or an authorized medical physicist under par. (b) 1. b. For individuals permitted to work under par. (b) 1. b., within the same 30 day time frame, the licensee shall also provide, as appropriate, verification of completion of all the following: b. 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 satisfactory 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 as an authorized user under s. DHS 157.67 (1). c. 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 satisfactorily successfully completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type of use for which the individual is seeking authorization as an authorized medical physicist.
2. Notify the department in writing no later than 30 days after any of the following occurs:
a. An authorized user, an authorized nuclear pharmacist, a radiation safety officer, an associate radiation safety officer, an authorized medical physicist, or an ophthalmic physicist permanently discontinues performance of duties under the license or has a name change.
b. The licensee’s mailing address changes.
c. The licensee’s name changes but the name change does not constitute a transfer of control of the license.
d. The licensee has added to or changed the areas where radioactive material is used under ss. DHS 157.63 (1) or (2) if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from a PET radionuclide/PET radioactive drug production area. e. The licensee permits an individual qualified to be a radiation safety officer under ss. DHS 157.61 (7) and (11) to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer in accordance with s. DHS 157.61 (1) (c). f. The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in par. (b) 1. i. The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.
(d) Exemptions for Type A broad scope licensees. A licensee possessing a Type A specific license of broad scope for medical use is exempt from all of the following requirements:
1. The provisions of par. (a) 3. regarding the need to file an amendment to the license for medical uses of radioactive material as described in s. DHS 157.70. 2. The provisions of par. (b) 1. b.
3. The provisions of par. (b) 1. f. regarding additions to or changes in the areas of use only at the addresses identified in the application or on the license.
4. The provisions of par. (c) 1.
5. The provisions of par. (c) 2. a. for an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist.
SECTION 28.
DHS 157.13 (8) (d) is amended to read:DHS 157.13 (8) (d) The applicant establishes and submits to the department the applicant’s program for annual inspections, at intervals not to exceed 13 months, of the job performance of each well logging supervisor to ensure that the department’s rules, license requirements, and the applicant’s operating and emergency procedures are followed. The applicant’s inspection records shall be retained for 3 years after each annual internal inspection.
SECTION 29.
DHS 157.15 (3) (d) is amended to read:DHS 157.15 (3) (d) A licensee’s financial assurance arrangements may be reviewed annually by the department to recognize any increases or decreases resulting from inflation or deflation, changes in engineering plans, activities performed or any other condition affecting costs for decommissioning to ensure that sufficient funding is available to cover liability that remains until license termination.
SECTION 30.
DHS 157.21(3) is amended to read:DHS 157.21 (3) A licensee or registrant shall, at intervals not to exceed 12 13 months, review the radiation protection program content and implementation.
SECTION 31.
DHS 157.35 is amended to read:DHS 157.35 Exemptions. Industrial uses of hand-held imaging intensification devices are exempt from the requirements of this subchapter if the dose rate 0.45 meters (18 inches) from the source of radiation to any individual does not exceed .02 mSv mGy(2.0 mR) per hour. Industrial x-ray tubes are exempt from the inventory, leak testing and materials labeling requirements of this subchapter. All other requirements apply.
SECTION 32.
DHS 157.44 (6) (a) and (a) 3. are amended to read:DHS 157.44 (6) (a) A licensee or registrant may not permit any individual to act as a radiographer or a radiographer’s assistant unless, at all times during radiographic operations, each individual wears on the trunk of his or her body a combination of direct reading dosimeter, an alarming ratemeter and a personnel dosimeter that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program processor. At permanent radiographic installations where other appropriate alarming or warning devices are in routine use or during radiographic operations using radiation machines, the use of an alarming ratemeter is not required. Dosimeters shall comply with all of the following conditions:
DHS 157.44 (6) (a) 3. Personnel dosimeters shall be exchanged at periods not to exceed one month.Film badges shall be replaced at least monthly and all other personnel dosimeters that require replacement must be replaced at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent.
SECTION 33.
DHS 157.44 (6) (a) 4. is repealed.SECTION 34.
DHS 157.44 (6) (d) and (f) are amended to read:DHS 157.44 (6) (d) If an individual’s pocket dosimeter is determined found to be off-scale, or if the electronic personal dosimeter reads greater than 2 millisieverts (200 mrem), and the possibility of radiation exposure cannot be ruled out as the cause, the individual’s film badge, TLD or similar approved device shallpersonnel dosimeter that require processing shall be sent for processing and evaluation within 24 hours. For personnel dosimeters that do not require processing, evaluation of the dosimeter shall be started within 24 hours. In addition, the individual may not resume work associated with the use of sources of radiation until a determination of the individual’s radiation exposure dose has been made. The determination shall be made by the radiation safety officer or the radiation safety officer’s designee. The results of the determination shall be included in the records maintained under s. DHS 157.45 (11). DHS 157.44 (6) (f) Dosimetry reports received from the accredited National Voluntary Laboratory Accreditation Program personnel dosimeter processor shall be retained as specified under s. DHS 157.45 (11). SECTION 35.
DHS 157.45 (11) (c) is amended to read:DHS 157.45 (11) (c) Personnel dosimeter results received from the accredited National Voluntary Laboratory Accreditation Program processor until the department terminates the license or registration
SECTION 36.
DHS 157.51 (1) (a) 2. is amended to read:
DHS 157.51 (1) (a) 2. If a decision is made to abandon the sealed source in the well, the licensee shall meet the requirements of s. DHS 157.56 (3) and any requirements of the department of natural resources under chs. NR 141, 500 to 555 544, and 812. SECTION 37.
DHS 157.52 (4) (a) is amended to read:DHS 157.52 (4) (a) A licensee or registrant shall maintain sufficient calibrated and operable radiation survey instruments at each field station and temporary job site to make physical radiation surveys as required by this subchapter and by s. DHS 157.25 (1). Instrumentation shall be capable of measuring one uSvmicrosieverts (0.1 milliroentgenmillirem) per hour through at least 0.5 mSvmillisieverts (50 milliroentgenmillirem) per hour. SECTION 38.
DHS 157.53 (3) (a) is amended to read:DHS 157.53 (3) (a) A licensee or registrant may not permit an individual to act as a well logging supervisor or to assit logging assistant in the handling of sources of radiation unless the individual wears either a film badge or a thermoluminescent dosimeter or similar approved devicea personnel dosimeter at all times during the handling of licensed radioactive materials. Each film badge or TLD personnel dosimeter shall be assigned to and worn by only one individual. Film badges shall be replaced at least monthly and TLDs all other personnel dosimeters that require replacement shall be replaced at least quarterly. After replacement, each film badge or TLD shall be promptly processed.All personnel dosimeters shall be evaluated at least quarterly or promptly after replacement, whichever is more frequent.
SECTION 39.
DHS 157.61 (1) (b) and (c) are repealed and recreated to read:DHS 157.61 (1) (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) 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. SECTION 40.
DHS 157.61 (4) (a) 1. is amended to read:DHS 157.61 (4) Written directives. (a) 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 Megabequerels Megabecquerels (30 microcuries), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material.
SECTION 41.
DHS 157.61 (4) (b) is repealed and recreated to read: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:
