DHS 157.13(5)(a)(a) License application. The department shall approve an application for a specific license for medical use of radioactive material if all of the following conditions are satisfied: DHS 157.13(5)(a)3.3. In addition to the requirements in this paragraph and par. (b), an application for a license or amendment for medical use of radioactive material as described in s. DHS 157.70 shall also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in ss. DHS 157.59 to 157.62, identification of and commitment to follow the applicable radiation safety program requirements in ss. DHS 157.63 (1) to 157.67 (1) that are appropriate for the specific s. DHS 157.70 medical use, as well as any specific information on each of the following: DHS 157.13(5)(a)3.c.c. Methodology for measurement of dosages or doses to be administered to patients or human research subjects. DHS 157.13(5)(a)3.d.d. Calibration, maintenance and repair of instruments and equipment necessary for radiation safety. DHS 157.13(5)(a)4.4. An applicant for a license for mobile services shall assure that release of individuals or human research subjects to whom radioactive drugs or implants containing radioactive material are administered will be released under s. DHS 157.62 (8). DHS 157.13(5)(a)5.5. The applicant or licensee shall provide any other information requested by the department in its review of the application. DHS 157.13(5)(b)(b) License amendment. An application for a license amendment shall meet all of the following requirements: DHS 157.13(5)(b)1.1. A licensee shall apply for and must receive a license amendment before the licensee does any of the following: DHS 157.13(5)(b)1.a.a. Receives or uses radioactive material for a type of use that is permitted under this subchapter, but that is not authorized on the licensee’s current license issued under this subchapter. DHS 157.13(5)(b)1.b.b. Permits anyone to work as an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist under the license, except an individual who is certified by a specialty board appropriate to the intended use of radioactive material and recognized by the NRC; or is named as an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist on a department, NRC or other agreement state license, or on a permit issued by a licensee who is authorized by a Type A license of broad scope to permit the medical use of radioactive material. DHS 157.13(5)(b)1.d.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 the associate radiation safety officer is authorized on the license. DHS 157.13(5)(b)1.e.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 DHS 157.13(5)(b)1.f.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). DHS 157.13(5)(b)1.i.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. DHS 157.13(5)(c)(c) Notifications. A licensee shall make all of the following notifications: DHS 157.13(5)(c)1.1. 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: DHS 157.13(5)(c)1.b.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). DHS 157.13(5)(c)1.c.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. DHS 157.13(5)(c)2.2. Notify the department in writing no later than 30 days after any of the following occurs: DHS 157.13(5)(c)2.a.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. DHS 157.13(5)(c)2.c.c. The licensee’s name changes but the name change does not constitute a transfer of control of the license. DHS 157.13(5)(c)2.d.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. DHS 157.13(5)(c)2.e.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). DHS 157.13(5)(c)2.f.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. DHS 157.13(5)(d)(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: DHS 157.13(5)(d)1.1. 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. DHS 157.13(5)(d)3.3. 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. DHS 157.13(5)(d)5.5. The provisions of par. (c) 2. a. for an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist. DHS 157.13(6)(6) Special requirements for a specific license to conduct industrial radiography operations. The department shall approve an application for a specific license to conduct radiography using radioactive materials if all the following conditions are satisfied: DHS 157.13(6)(b)(b) The applicant has an adequate program for training radiographers and radiographer’s assistants that meets the requirements of s. DHS 157.44 (3). DHS 157.13(6)(c)(c) The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid. DHS 157.13(6)(e)(e) The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographer’s assistant at intervals not to exceed 6 months that meets the requirements of s. DHS 157.44 (3) (e). DHS 157.13(6)(f)(f) The applicant submits a description of the applicant’s overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility. DHS 157.13(6)(g)(g) The applicant submits the qualifications of the individual designated as the radiation safety officer. DHS 157.13(6)(h)(h) If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium shielding, the applicant shall describe the procedures for performing the test. The description shall include all of the following: DHS 157.13(6)(j)(j) The applicant identifies and describes the location or locations of all field stations and permanent radiographic installations. DHS 157.13(6)(k)(k) The applicant identifies the location or locations where all records required by this and other subchapters will be maintained. DHS 157.13(6)(L)(L) If a license application includes underwater radiography, a description of all of the following: DHS 157.13(6)(L)1.1. Radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography. DHS 157.13(6)(L)2.2. Radiographic equipment and radiation safety equipment unique to underwater radiography. DHS 157.13(6)(m)(m) If an application includes offshore platform or lay-barge radiography, a description of all of the following: DHS 157.13(6)(m)1.1. Transport procedures for radioactive material to be used in industrial radiographic operations. DHS 157.13(6)(n)(n) The applicant describes the program for inspection and maintenance of radiographic exposure devices and storage containers to ensure proper functioning of components important to safety. DHS 157.13(7)(7) Special requirements for a specific license to conduct irradiator operations. DHS 157.13(7)(a)(a) The department shall approve an application for a specific license for the use of radioactive material in an irradiator if all the following conditions are satisfied: DHS 157.13(7)(a)2.2. The applicant submits an adequate program for training irradiator operators that includes all of the following: DHS 157.13(7)(a)2.d.d. The method employed by the applicant to test each operator’s understanding of the department’s regulations and licensing requirements and the irradiator operating, safety and emergency procedures. DHS 157.13(7)(a)3.3. The applicant submits an outline of the written operating and emergency procedures that describes the radiation safety aspects of the procedures. DHS 157.13(7)(a)4.4. The applicant submits a description of the overall organizational structure for managing the irradiator, including the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have radiation safety responsibilities or authorities, and who within the management structure has the authority to stop unsafe operations. The applicant shall also describe the training and experience required for the position of radiation safety officer. DHS 157.13(7)(a)5.5. The applicant includes a description of the access control systems required by s. DHS 157.73 (2), radiation monitors required by s. DHS 157.73 (5), the method of detecting leaking sources required by s. DHS 157.73 (16) including the sensitivity of the method and a diagram of the facility showing the locations of all required interlocks and radiation monitors. DHS 157.13(7)(a)6.6. If the applicant intends to perform leak testing, the applicant shall establish procedures for performing leak testing of dry-source-storage sealed sources and submit a description of these procedures to the department. The description shall include all the following: DHS 157.13(7)(a)7.7. If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading shall only be done by a person specifically authorized by the department, the NRC or another agreement state to load or unload irradiator sources. The information in this subdivision shall also be indicated on the application. DHS 157.13(7)(b)(b) A license issued under par. (a) is subject to all of the following conditions: DHS 157.13(7)(b)1.1. The applicant may not begin construction of a new irradiator prior to the submission to the department of both an application for a specific license for the irradiator and the fee required by s. DHS 157.10 (3). As used in this section, the term “construction” includes the construction of any portion of the permanent irradiator structure on the site, but does not include engineering and other design work, purchase of a site, site surveys or soil testing, site preparation, site excavation, construction of warehouse or auxiliary structures, and other similar tasks. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license by the department. DHS 157.13(7)(b)2.2. Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this subsection. The department shall approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates the likely provision of an adequate level of safety for workers and the public. DHS 157.13(7)(b)3.3. Each license will be issued with the condition that the licensee will, at any time before expiration of the license, upon the department’s request, submit a written statement to enable the department to determine whether the license should be modified, suspended or revoked.
/exec_review/admin_code/dhs/110/157
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administrativecode
/exec_review/admin_code/dhs/110/157/ii/13/5/c/2/b
Department of Health Services (DHS)
Chs. DHS 110-199; Health
administrativecode/DHS 157.13(5)(c)2.b.
administrativecode/DHS 157.13(5)(c)2.b.
section
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