ML18233A364
| ML18233A364 | |
| Person / Time | |
|---|---|
| Site: | 03009486 |
| Issue date: | 08/16/2018 |
| From: | Simmons M R NRC Region 4 |
| To: | Avera Queen of Peace Health Services |
| References | |
| 609327 | |
| Download: ML18233A364 (6) | |
Text
U.S. NUCLEAR REGULATORY COMMISSIONMATERIALS LICENSE NRC FORM 374PAGE OF16 Amendment No. 42 P AGESPursuant 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 Mitchell, SD 57301-2000 2.525 North Foster 1.Avera Queen of Peace Health Services 4.Expiration Date:
October 31, 2023 Docket No.:
5.030-09486 License number: 40-15633-01 is amended in its entirety to read as
follows: Reference No.:
3.In accordance with application
dated June 20, 2018.
6.7.8.Byproduct, source, and/or special nuclear material Chemical and/or physical form Maximum amount that licensee
may possess at any one time
under this license 9.Authorized use A.A.A.A.For use in uptake, dilution and excretion studies permitted by 10 CFR
35.100.Any As Needed Any byproduct material
permitted by 10 CFR
35.100 B.B.B.B.For use in imaging and localization
studies permitted by 10 CFR 35.200.
Any As Needed Any byproduct material
permitted by 10 CFR
35.200 C.C.C.C.For any use permitted by 10 CFR
35.300.Any 900 millicuries total Any byproduct material
permitted by 10 CFR 35.300 License Number Docket or Reference NumberU.S. NUCLEAR REGULATORY COMMISSION NRC FORM 374AMATERIALS LICENSESUPPLEMENTARY SHEETPAGES OFPAGE62 40-15633-01 030-09486 Amendment No. 42 6.7.8.Byproduct, source, and/or special nuclear
material Chemical and/or physical form Maximum amount that licensee
may possess at any one time
under this license 9.Authorized use D.D.D.D.For any manual brachytherapy procedure permitted by 10 CFR 35.400.
Sealed Sources (Bard
Brachytherapy, Inc., Model
STM-1251; Best Medical
International, Inc., Model 2300
Series; Core Oncology, Inc.,
Model I125SH; I125SL;
International Brachytherapy, Inc., Model 1251L; IsoAid, LLC, Model IAI-125A; Medi-Physics, Inc., Model 6711; 6733; North American Scientific, Inc., Model
MED 3631 SurTRAK Strand;
Theragenics Corporation, Model
I25.S06)4 curies total Iodine-125 permitted by
10 CFR 35.400 E.E.E.E.For any manual brachytherapy
procedure permitted by 10 CFR 35.400.
Sealed Sources (International
Brachytherapy, Inc., Model
1032P; IsoAid, LLC, Model IAPd-103A; North American
Scientific, Inc., Model MED 3633
SurTRAK Strand; Theragenics
Corporation, Model 200) 4 curies total Palladium-103 permitted
by 10 CFR 35.400 F.F.F.F.For use in in-vitro studies.
Prepackaged Kits 50 millicuries total Any byproduct material
permitted by 10 CFR31.11 CONDITIONS 10.A.Licensed material in Items 6.A. through 6.F. may be used or stored only at the licensee's facilities located at 525 North Foster, Mitchell, South Dakota.
License Number Docket or Reference NumberU.S. NUCLEAR REGULATORY COMMISSION NRC FORM 374AMATERIALS LICENSESUPPLEMENTARY SHEETPAGES OFPAGE63 40-15633-01 030-09486 Amendment No. 42 B.Licensed material in Items 6.D. and 6.E. may be used or stored at Avera Cancer Institute Mitchell, 605 North Foster, Mitchell, South Dakota.C.Licensed material in Items 6.D. and 6.E. may be used or stored at Avera St. Mary's d/b/a Avera Medical Group Pierre, 100 MAC Lane, Pierre, South Dakota.11.The Radiation Safety Officer (RSO) for this license is Michelle White, BA, CNMT.
12.Licensed material shall only be used by, or under the supervision of:
A.Individuals permitted to work as authorized users, authorized nuclear pharmacists, and/or authorized medical physicists in accordance with 10 CFR 35.13 and 10 CFR 35.14.
B.The following individuals are authorized users for the material and medical uses as indicated:
Authorized Users Material and Use Carey C. Buhler, M.D.
35.100; 35.200; 35.300; 31.11 Stephen J. Dick, M.D.
35.300; 35.400Brad Alan Paulson, M.D.35.100; 35.200; 35.300; 31.11 Daryl C. Rife, M.D.35.100; 35.200; 35.300; 31.11Kathleen L. Schneekloth, M.D.35.400 Kelly Don Smith, M.D.35.100; 35.200; 31.11Kevin J. Turneau, M.D.
35.100; 35.200; Oral administration of sodium iodide I-131 in quantities less than or equal to 33 millicuriesTamara Sue Wendt Wheeler, M.D.35.100; 35.200; 35.300; 31.11 13.For sealed sources not associated with 10 CFR Part 35 use, the following conditions apply:
License Number Docket or Reference Number U.S. NUCLEAR REGULATORY COMMISSION NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEETPAGES OFPAGE 6 4 40-15633-01 030-09486 Amendment No. 42 A.Sealed sources shall be tested for leakage and/or contamination at intervals not to exceed the intervals specified in the certificate of registration issued by the U.S. Nuclear Regulatory Commission under 10 CFR 32.210 or under equivalent regulations of an Agreement State.B.Notwithstanding Paragraph A of this Condition , sealed sources designed to primarily emit alpha particles shall be tested for leakage and/or contamination at intervals not to exceed 3 months.
C.In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the U.S. Nuclear Regulatory Commission under 10 CFR 32.210 or under equivalent regulations of an Agreement State, prior to the transfer, a sealed source received from another person shall not be put into use until tested and the test results received.D.Sealed sources need not be tested if they contain only hydrogen 3; or they contain only a radioactive gas; or the half-life of the isotope is 30 days or less; or they contain not more than 100 microcuries of beta- and/or gamma-emitting material or not more than 10 microcuries of alpha emitting material.
E.Sealed sources need not be tested if they are in storage and are not being used; however, when they are removed from storage for use or transferred to another person and have not been tested within the required leak test interval, they shall be tested before use or transfer. No sealed source shall be stored for a period of more than 10 years without being tested for leakage and/or contamination.
F.The leak test shall be capable of detecting the presence of 185 becquerels (0.005 microcuries) of radioactive material on the test sample. If the test reveals the presence of 185 becquerels (0.005 microcuries) or more of removable contamination, a report shall be filed with the U.S. Nuclear Regulatory Commission in accordance with 10 CFR 30.50(c)(2), and the source shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations.
G.Tests for leakage and
/or contamination, including leak test sample collection and analysis, shall be performed by the licensee or by other persons specifically licensed by the U.S.
Nuclear Regulatory Commission or an Agreement State to perform such services
.
License Number Docket or Reference Number U.S. NUCLEAR REGULATORY COMMISSION NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEETPAGES OFPAGE 6 5 40-15633-01 030-09486 Amendment No. 42 H.Records of leak test results shall be kept in units of microcuries and shall be maintained for 3 years.
14.Sealed sources containing licensed material shall not be opened or sources removed from source holders by the licensee, except as specifically authorized.
15.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 sources and/or devices 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.
License Number Docket or Reference NumberU.S. NUCLEAR REGULATORY COMMISSION NRC FORM 374AMATERIALS LICENSESUPPLEMENTARY SHEETPAGES OFPAGE66 40-15633-01 030-09486 Amendment No. 42 16.Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. This license condition applies only to
those procedures that are required to be submitted in accordance with the regulations. Additionally, this license condition does not limit the
licensee's ability to make changes to the radiation protection program as provided for in 10 CFR 35.26. The U.S. Nuclear Regulatory
Commission's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.A.Application dated April 24, 2013 (ML13127A338)B.Letter dated April 28, 2014 (ML14140A555)C.Letter dated July 10, 2015 (ML15191A484)
D.Application dated June 20, 2018, (ML18198A455)FOR THE U.S. NUCLEAR REGULATORY COMMISSION By: Date: Region 4 Michelle R. Simmons August 16, 2018