ML18212A156
| ML18212A156 | |
| Person / Time | |
|---|---|
| Site: | 03003509 |
| Issue date: | 07/30/2018 |
| From: | Cook J D NRC Region 4 |
| To: | Fairbanks Memorial Hosp, Foundation Health |
| References | |
| 608674, 609312 | |
| Download: ML18212A156 (5) | |
Text
U.S. NUCLEAR REGULATORY COMMISSIONMATERIALS LICENSE NRC FORM 374PAGE OF15 Amendment No. 58 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 Fairbanks, AK 99701 2.1650 Cowles Street d/b/a Fairbanks Memorial Hospital 1.Foundation Health LLC 4.Expiration Date:
April 30, 2022 Docket No.:
5.030-03509 License number: 50-13648-01 is amended in its entirety to read as
follows: Reference No.:
3.In accordance with letters dated April 19, 2018, and July 06, 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 3.2 curies total Any byproduct material
permitted by 10 CFR 35.300 D.D.D.D.For any manual brachytherapy procedure permitted by 10 CFR 35.400.
Sealed Sources (Bard
Brachytherapy, Inc., Model STM
1251)1.5 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 (Theragenics
Corporation, Model TheraSeed 200)500 millicuries total Palladium-103 permitted
by 10 CFR 35.400 License Number Docket or Reference NumberU.S. NUCLEAR REGULATORY COMMISSION NRC FORM 374AMATERIALS LICENSESUPPLEMENTARY SHEETPAGES OFPAGE52 50-13648-01 030-03509 Amendment No. 58 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 F.F.F.F.For use in attenuation correction of gamma camera imaging systems.
Sealed Sources (Eckert &
Ziegler Isotope Products, Model NES-8412 or A3410; North American Scientific, Inc., Model
MED 3601)300 millicuries per source
and 1.2 curies total Gadolinium-153 CONDITIONS 10.Licensed material may be used or stored at the licensee's facilities located at 1650 Cowles Street, Fairbanks, Alaska, 99701 1 1.The Radiation Safety Officer for this license is Mark Burton, M.D.
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 User(M.D.,D.O.,etc.)
Material and Use Mark Burton, M.D.
35.100; 35.200; 35.300; Gadolinium-153 for attenuation correction in imaging systems Janice Chen, M.D.
35.100; 35.200; 35.300; Gadolinium-153 for attenuation correction in imaging systems David L. Evans, M.D.
35.100; 35.200; oral administration of sodium iodide I-131; parenteral administration of any beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV for which
a written directive is required Keir Fowler, M.D.
35.100; 35.200; 35.300; Gadolinium-153 for attenuation correction in imaging systems License Number Docket or Reference Number U.S. NUCLEAR REGULATORY COMMISSION NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEETPAGES OFPAGE 5 3 50-13648-01 030-03509 Amendment No. 58 Authorized User(M.D.,D.O.,etc.)
Material and Use Richard A. Hattan, M.D.
35.100; 35.200; oral administration of sodium iodide I-131 in quantities less than or equal to 33 millicuries; Gadolinium-153 for attenuation correction in imaging systems Joel S. Marquess, M.D.
35.100; 35.200; oral administration of sodium iodide I-131 Jessica E. Panko, M.D.
35.100, 35.200; oral administration of sodium iodide I-131 Essam Shihadeh, M.D.
35.400 Claire M. Waite, M.D.
35.100; 35.200; oral administration of sodium iodide I-131 in quantities less than or equal to 33 millicuries Gregory James Wood, D.O.
35.100; 35.200 Romel Wrenn, M.D.
35.100; 35.200 13.For sealed sources not associated with 10 CFR Part 35 use, the following conditions apply:
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 by an Agreement State. In the absence of a registration certificate, sealed sources shall be tested for leakage and/or contamination at intervals not to exceed 6 months, or at such other intervals as specified.
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.
License Number Docket or Reference NumberU.S. NUCLEAR REGULATORY COMMISSION NRC FORM 374AMATERIALS LICENSESUPPLEMENTARY SHEETPAGES OFPAGE54 50-13648-01 030-03509 Amendment No. 58 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 0.005 microcurie (185 becquerels) of radioactive material on the test sample.
If the test reveals the presence of 0.005 microcurie (185 becquerels) 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 otherpersons specifically licensed by the U.S. Nuclear Regulatory Commission or an Agreement State to perform such services.
H.Records of leak test results shall be kept in units of microcuries (becquerels) 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.
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.
16.In addition to the possession limits in Item 8, the licensee shall further restrict the possession of licensed material to quantities below the
minimum limit specified in 10 CFR 30.35(d) for establishing financial assurance for decommissioning.
License Number Docket or Reference NumberU.S. NUCLEAR REGULATORY COMMISSION NRC FORM 374AMATERIALS LICENSESUPPLEMENTARY SHEETPAGES OFPAGE55 50-13648-01 030-03509 Amendment No. 58 17.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 October 20, 2011 (ML11314A028)B.Letter dated April 10, 2012 with attachments (ML121080398)C.Letter dated October 26, 2016 (ML16313A129)
D.Change of control form dated November 22, 2016 (ML16340A720)FOR THE U.S. NUCLEAR REGULATORY COMMISSION By: Date: Jacqueline D. CookRegion July 30, 2018