ML18212A330
| ML18212A330 | |
| Person / Time | |
|---|---|
| Site: | 03002269 |
| Issue date: | 07/31/2018 |
| From: | Frazier C F NRC/RGN-III |
| To: | Saint Francis Medical Center |
| References | |
| 609227 | |
| Download: ML18212A330 (5) | |
Text
NRC FORM 374 U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE PAGE 1 OF 5 PAGES Amendment No. 76 Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 70 and 71, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose(s) and at the place(s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. Licensee 1. Saint Francis Medical Center 2. 211 Saint Francis Dr. Cape Girardeau, MO 63703 6. Byproduct, source, 7. and/or special nuclear material A. Any byproduct material A. permitted by 10 CFR 35.100 B. Any byproduct material B. permitted by 10 CFR 35.200 C. Any byproduct material C. permitted by 10 CFR 35.300 D. Any byproduct material D. permitted by 1 O CFR 35.500 E. Any byproduct material E. permitted by 10 CFR 31.11 In accordance with letter dated 4. Expiration Date: March 31, 2026 June r-----------
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- 5. Docket No.: 030-02269 Reference No.: Chemical a~r ohvsical f~\:11 Maxillllllllli:lunt that licebiee 9. Authorized use Any A. For use in uptake, dilution and excretion studies permitted by 10 CFR 35.100. Any B. For use in imaging and localization studies permitted by 10 CFR 35.200. Any C. 1 curie total C. For any use permitted by *10 CFR )'/: 35.300. Sealed Sources (DuPont D. 600 millicuries total D. For diagnostic medical use of sealed Pharma , Model NES 8412; sources permitted by 10 CFR 35.500 in North American Scientific, Model compatible devices registered in 3601) accordance with 10 CFR ~10.32(9).
Prepackaged Kits E. 2 millicuries total E. For use in in-vitro studies.
NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 OF 5 PAGES 6. F. G. MATERIALS LICENSE SUPPLEMENTARY SHEET License Number 24-00158-03 Amendment No. 76 Byproduct, source, 7. Chemical and/or physical form and/or special nuclear material Microspheres (Nord ion f,f 1/;,P.!t, p. Yttrium-90 permitted by F. 10 CFR 35.1000 Inc., Model TheraSple MicrospherlJirte~
Yttrium-90 permitted by G. 10 CFR 35.1000 SIR-Spher elivery s . ,._ ,. . 10. Licensed material may be used or stored 11. The Radiation Safety Officer (RSO) for this 8. G. Docket or Reference Number 030-02269 Maximum amount that licensee 9. Authorized use may possess at any one time E~ft'" 54 r~per vial; 3 F. For use in permanent manual curies tota '\.. brachytherapy using Nordi,on (Canada), Inc. TheraSphere yttrium-90 microspheres delivery system as permitted by 10 CFR 35.1000. G. For use in permanent manual brachytherapy using Sirtex Model SIR-Spheres yttrium-90 microspheres delivery system as permitted by 10 CFR 35.1000.
NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License Number 24-00158-03 Amendment No. 76 Docket or Reference Number 030-02269 PAGE 3 OF 5 PAGES 12. Licensed material shall only be used by, or under the supervision of: A. Individuals permitted to work as authorized usersi!,~~ar8E&)l{9r 35.13 and 10 CFR 35.14. B. The following individuals are authorized
~"tor the material and medical u:?~dicated:
Authorized User(M.D.,D.0
.. etc.) Matthew Bekerman, M.D. James Borders, M.D. Jeffrey W. Boss, M.D. Tom B. Brumitt, D.O. Todd Michael Buersmeyer, M.D. Terrence Michael Chambers, M.D. Derek L. Fimmen, M.D. MarkL Gates, M.D. Benjamin D. Goodman, M.D. Rajinder M. Gulati, M.D. Michael C. Muzinich, M.D. Shanaree M. Muzinich, M.D. Huan Nguyen, M.D. mited to the oral administration of sodium millicuries), 10 CFR 35.1000 (limited to (limited to the oral administration of sodium 10 CFR 35.300 (limited to the oral administration of sodium iodide 1-131 and the parenteral administration of any beta emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV) 10 CFR 31.11, 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.500 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300 (limited to the oral administration of sodium iodide 1-131) 10 CFR 35.200 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.500 NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET Authorized User(M.D.,0.0.,etc.)
Richard Lyle Ogles, M.D. William Michael Pelton, M.D. Mark Lewis Pfautsch, 0.0. George A. Pjura, M.D. Tappan Roy, M.D. Christopher Russell, M.D. Ryan Siebert, M.D. Willeford J. Stoecker, M.D. Cedric Strange, M.D. Theodore R. Swartz, M.D. Michael Thomas, M.D. Adam Ross Todd, M.D. Andrew E. West, M.D. Jeffrey Wichman, M.D. U.S. NUCLEAR REGULATORY COMMISSION PAGE 4 OF 5 PAGES License Number 24-00158-03 Amendment No. 76 Material and Use Docket or Reference Number 030-02269 10 CFR 35.100,10 Cff 35.200 10CFR~~fl KE /J 1 O QfE~~rno, 1 O CFR 35.200, 1t~~5.300 (limited to the oral administration of sodium io<:t~-131 in quantities less than or e,ffi"~to 33 millicuries), 10 CFR 35.500 FR 35.100, 10 CFR 35.200, 10 CFR ~O, 10 CFR 35.500 0,10 CFR 35.200 5. ited to the oral administration of sodium illicuries), 1 O CFR 35.500 (limited to the oral administration of sodium 1000 (limited to yttrium-90 as TheraSpheres and as 13. The licensee shall conduct a physical inventory every 6 months, or at other intervals approved by the U.S. Nuclear Regulatory Commission, to account for all glass microspheres received and possessed under the license. Records of inventories shall be maintained for 3 years from the date of each inventory, and shall include the radionuclides, quantities, manufacturer's name and model numbers, and the date of the inventory.
- 14. In accordance with letter dated March 7, 2017 (ML 17068A355), the licensee may make changes to its radiation safety program, as it relates to the use of yttrium-90 microspheres as permitted by 10 CFR 35.1000.
- NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License Number 24-00158-03 Amendment No. 76 Docket or Reference Number 030-02269 PAGE 5 OF 5 PAGES 15. Except as specifically provided otherwise in this license, the licen~e~hall conduct its program in accordance with the statements, representations, and procedure~
contained in the doc~t!ltf'iic~lrt10¥r9Jlilosures, listed below. This license condition applies only to those procedures that are required to be submitt~~rdance with the ~"l~ns. Additionally, this license condition does not limit the licensee's ability to make changes to the radia~"Jrotection program as provide'cM~
10 CFR 35.26. The U.S. Nuclear Regulatory Commission's regulations shall govern unle~~ statements, representations, and p~dures in the licensee's application and correspondence are more restrictive than tl1\treQulations. " A. Application dated September 8, 20rL 1525 B. Letter dated March 1, 2016 (ML16 6 A327) C. Letter dated March 7, 2017 (ML 17~A355) D. Letter dated July 27, 2017 (ML 172U,831)
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- 3-1 20.18 FOR ~S. NUCL 7LATO Y COMMISSION Cassandra F. Frazier Region Ill