ML18191B082

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608561 Outgoing Amendment No. 34 for St. Mary Medical Center - Hobart to License No. 13-03459-03
ML18191B082
Person / Time
Site: 03031379
Issue date: 07/09/2018
From: Frazier C F
NRC/RGN-III
To:
St. Mary Medical Ctr, Hobart, IN
References
608561
Download: ML18191B082 (5)
v • d • e


Text

NRC FORM374 U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE PAGE 1 OF 5 PAGES Amendment No. 34 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 In accordance with letter dated 4. Expiration Date: January 31, 2026 1. St. Mary Medical Center -Hobart April 1 2. 1500 S Lake Park Ave. t----------"-.;:,.....---1

5. Docket No.: 030-31379 Reference No.: Hobart, IN 46342 6. Byproduct, source, 7. Chemical a~r physical Maxll~unt that lice*e 9. Authorized use and/or special nuclear material A. Any byproduct material A. Any A. For use in uptake, dilution and permitted by 10 CFR excretion studies permitted by 10 CFR 35.100 35.100. 8. Any byproduct material B. Any B. For use in imaging and localization permitted by 10 CFR studies permitted by 10 CFR 35.200. 35.200 '% C. Any byproduct material C. Any C. 500 millicurie'tl~tal C. For any use permitted by 10 CFR permitted by 10 CFR :'"'""'" 35.300. 35.300 D. Any byproduct material D. Prepackaged Kits D. 3 millicuries total D. For use in in-vitro studies. permitted by 10 CFR 31.11 NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 OF 5 PAGES License Number 13-03459-03 MATERIALS LICENSE SUPPLEMENTARY SHEET Amendment No. 34 6. Byproduct, source, and/or special nuclear material E. Yttrium-90 permitted by 10 CFR 35.1000 7. Chemical and/or physical form E. Microspheres SIR-Spheres)
10. A. Licensed material listed in Subiterrti(os.

6.A. thr, Ave., Hobart, Indiana. 1-8. Licensed material listed in Subitemfns.

6 Ave., Hobart, Indiana. C. Licensed material listed in Subitem Blvd., Portage, Indiana. D. Licensed material listed in Subitem Nos. Drive, Valparaiso, Indiana. Docket or Reference Number 030-31379

8. Maximum amount that licensee may possess at any one time e~ ~is license 1 s'!f nf.1/clrie~per vial; 2 9. Authorized use curies tot1it E. For use in permanent manual brachytherapy using Sirtex Model SIR-Spheres yttrium-90 microspheres delivery system as permitted by 10 CFR 35.1000. 8nsee's facilities located at 1500 S Lake Park e licensee's facilities located at 300 W 61st e licensee's facilities located at 3545 Arbors at the licensee's facilities located at 3800 St. Mary 11. The Radiation Safety Officer (RSO) for this license is S~sJ:~. ~A fvl'..§'.

1 ,, 12. Licensed material shall only be used by, or under the supervision of: A. Individuals permitted to work as authorized users in accordance with 1 O CFR 35.13 and 1 O CFR 35.14.

NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License Number 13-03459-03 Amendment No. 34 Docket or Reference Number 030-31379 PAGE 3 OF 5 PAGES B. The following individuals are authorized users for the material and medical uses as in.dicated:

Authorized User(M.D.,D.O.,etc.)

Samer Ajam, M.D. Keith Atassi, M.D. Cam Long Choji, D.O. John W. Gustaitis, Jr., M.D. Thomas M. Hoess, M.D. Mikhail Jeha, M.D. Abdul Kawamleh, M.D. Shawn R. Kenney, M.D. A. Arif Khalil, M.D. Akram Knoloki, M.D. Sorin Lazar, M.D. Jonathon T. Lee, M.D. Mary Nicholson, M.D. Charles-Lauwanga Okoro, D.O. Jeffery Jon Quackenbush, M.D. Anas Hakam Safadi, M.D. Koppolu P. Sarma, M.D. Harish Shah, M.D. Vijah P. Shah, M.D. Thomas Shin, M.D. Justin Spackey, M.D. Hussam Suradi, M.D. 10 CFR 35~'"~'~ ) *"' 10 CFR 35.200 .t**! 10 CFR 35.300 (limited to the parenteral administration of strontium-89 for palliative treatment of bone pain) 10 CFR 35.100,10 CFR 35.200 10 CFR 35.100, 10 CFR 35.200 10 CFR 35.100,10 CFR 35.200 10 CFR 35.100,10 CFR 35.200 10 CFR 35.100,10 CFR 35.200 NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 4 OF 5 PAGES MATERIALS LICENSE SUPPLEMENTARY SHEET Authorized User(M.D.,D.0.,etc.)

Ramana Yedavalli, M.D. Kais J. Yehyawi, M.D. Feng Zhang, M.D. Jack Ziegler, M.D. 13. The licensee shall conduct a physical in

  • License Number 13-03459-03 Amendment No. 34 Material and Use Docket or Reference Number 030-31379 10 CFR 35.100,10 C~R 35.200; 10 CFR 35.1000 (limited to yttrium-90 as SIR-Spheres) 10 CFR 1PQJi\ ~fuG'ofJ't 1 a' (lfl"~~1 o_~. 1 O CFR 3~.~00j 1',Q~35.300 (limited to oral administration of sodium iodide I:;; 'Ni 1"fn quant1t1es of 33 m1lhcunes or 1es~ FR 35.200 tJ to account for all glass microspheres r~ed and p from the date of each inventory, and s~include th the inventory.

l-appro~ by the U.S. Nuclear Regulatory Commission, ecords IV inventories shall be maintained for 3 years anufacturE) name and model numbers, and the date of 14. In accordance with letter dated DecemW 19, relates to the use of yttrium-90 microsph 15. Except as specifically provided otherwise in'f\).: license, the gram in accordance with the statements, representations, and procedures contained in ~ocuments, any enclos , listed below. This license condition applies only to those procedures that are required to be submitted}

accordance with the reSJulat1

s. Additionally, this license condition does not limit the licensee's ability to make changes to the radiation prote~$1\Pt2~~

~reyied for in 10 CFR 35.26. The U.S. Nuclear Regulatory Commission's regulations shall govern unless the statements~epr,esentalions, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A. Application dated July 28, 2015 (ML 15218A568)

B. Letter dated January 6, 2016 (ML 16007A727)

C. Letter dated January 5, 2017 (ML 17018A414)

D. Letter dated May 22, 2017 (ML 171468324)

E. Letter dated June 20, 2017 (ML 17172A121)

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 5 OF 5 PAGES MATERIALS LICENSE SUPPLEMENTARY SHEET License Number 13-03459-03 Amendment No. 34 F. Letter dated September 28, 2017 (ML 172768167)

G. Letter dated December 19, 2017 (ML17354A646)

H. Letter dated December 19, 2017 (ML 17353A894)~

I. Letter dated February 26, 2018 (ML 18057A,_..,..,'\

-* Date: JUL 9 2018 Docket or Reference Number 030-31379 R REGULATORY COMMISSION B'V ef :t::'4&"=

Cassandra F. Frazier Region 3

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