-
DEC 8 2011
THE QUEEN'S MEDICAL CENTER
1301 Punchbowl Street • Honolulu, Hawaii 96813 • Phone (808)
538-9011 • FAX: (808) 547-4646 • www.queens.org
~December 22, 2011
USNRC Region IV 1600 E. Lamar Blvd Arlington, TX 76011-4511
Docket: License:
030-14522 53-16533-02
RE: Notification of New AU pursuant to 10 CFR 35.14
Greetings:
Pursuant to 10 CFR 35.14, The Queen's Medical Center submits
notification of a new Authorized User and requests amendment of our
materials license:
1. Shay J. Lee, M.D. was approved as Authorized User for
35.100,35.200, and 35.300 by the Radiation Safety Committee upon
demonstrating the qualifications required by 10 CFR 35.13(b )(1).
Specifically, Dr. Lee is certified by the American Board of Nuclear
Medicine and is also listed as an Authorized User for 35.100,
35.200, and 35.300 on a NRC license (#53-11966-01).
Please find enclosed copies of the necessary documentation to
demonstrate that Dr. Shay J. Lee meets requirements stated in 10
CFR 35.13(b )(1).
Please contact the RSO, Brian Oyadomari, at (808) 691-4884 or
email at [email protected] for further information. Thank you.
q;~ =-------
Darlena Chadwick VP Patient Care
Attached: 1. Dr. Shay Lee ABNP certificate 2. Dr. Shay Lee NRC
license no. 53-11966-01
Founded in 1859 by Queen Emma and King Kamehameha IV
t/n576615
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NRC FORM 374
u.s. NUCLEAR REGULATORY COMMISSION
MATERIALS LICENSE
PAGE __ 1 _ OF _4_ PAGES
Amendment No. 69
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, 39, 40, and 70, 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. Hawaii Medical Center
2. 2230 Liliha Street
Honolulu, Hawaii 96817
In accordance with letter dated
February 9, 2011
3. License number 53-11966-01 is amended in
its entirety to read as follows:
4. Expiration date October 31 , 2015
5. Docket No. 030-03557 Reference No.
6. Byproduct, source, and/or special nuclear material
7. Chemical and/or physical form 8. Maximum amount that licensee
may possess at anyone time under this license
A.
B.
C.
9.
Any byproduct material A. Any permitted by 10 CFR 35.100
Any byproduct material B. Any permitted by 10 CFR 35.200
Any byproduct material C. Any permitted by 10 CFR 35.300
Authorized use:
A. Any uptake, dilution and excretion study permitted by 10 CFR
35.100.
B. Any imaging and localization study permitted by 10 CFR
35.200.
C. Any use permitted by 10 CFR 35.300.
CONDITIONS
A. As needed
B. As needed
C. 3.3 curies total (no single container to exceed 200
millicuries)
10. Licensed material may be used or stored only at the
licensee's facilities located at:
A. 2230 Liliha Street, Honolulu, Hawaii, and
B. 91-2141 Fort Weaver Road, Ewa Beach, Hawaii
11. The Radiation Safety Officer (RSO) for this license is
Ronald W. Frick, M.S.
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NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 of 4
PAGES
MATERIALS LICENSE SUPPLEMENTARY SHEET
License Number
53-11966-01 Docket or Reference Number
030-03557
Amendment No. 69
12. Licensed material is only authorized for use by, or under
the supervision of:
A. Individuals permitted to work as an authorized user,
authorized nuclear pharmacist, and/or authorized medical physicist
in accordance with 10 CFR 35.13 and 35.14.
B. The following individuals are authorized users for the
material and medical uses indicated:
Authorized User
Bryan J. Gushiken, M.D.
Kevin N. Kon, M.D.
Van An Le, M.D.
Chuong Nguyen, M.D.
Ann Asako Ohata, M.D.
Jerel K. Saito, M.D.
Ryan L. Albritton, M.D.
Venerando Seguritan, M.D.
Robert M. Dimauro, M.D.
Dennis H. Kumura, M.D.
Shay J. Lee, M.D.
Joel R. Okazaki, M.D.
Kim Mika Fujinaga, M.D.
Landsdale Lau, M.D.
Norman O. Polk, M.D.
Material and Use
35.100; 35.200
35.100; 35.200
35.100; 35.200
35.100; 35.200
35.100; 35.200
35: 1 00; 35.200
35.100; 35.200
35.100; 35.200
35.100; 35.200; 35.300
35.100; 35.200; 35.300
35.100; 35.200; 35.300
35.100; 35.200; 35.300
35.100; 35.200; 35.300 oral administration of sodium iodide
1-131 in quantities less than or equal to 33 millicuries
35.100; 35.200; 35.300 oral administration of sodium iodide
1-131 in quantities less than or equal to 33 millicuries
35.100; 35.200; 35.300 oral administration of sodium iodide
1-131 in quantities less than or equal to 33 millicuries; P-32 for
treatment of polycythemia vera leukemia and bone metastases
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NRC FORM 374A u.s. NUCLEAR REGULATORY COMMISSION
MATERIALS LICENSE SUPPLEMENTARY SHEET
PAGE 3 of 4 PAGES
License Number
53-11966-01 Docket or Reference Number
030-03557
Amendment No. 69
13. 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 decommissioning financial assurance.
14. 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 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 by 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
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. The report shall be
filed within 5 days of the date the leak test result is known with
the U.S. Nuclear Regulatory Commission, Region IV, 612 East Lamar
Boulevard, Suite 400, Arlington, Texas 76011-4125, ATTN: Director,
Division of Nuclear Materials Safety. The report shall specify the
source involved, the test results, and corrective action taken.
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.
H. Records of leak test results shall be kept in units of
microcuries and shall be maintained for 3 years.
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NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION
MATERIALS LICENSE SUPPLEMENTARY SHEET
PAGE 4 of 4 PAGES
License Number
53-11966-01 Docket or Reference Number
030-03557
Amendment No. 69
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 sealed 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. Sealed sources containing licensed material shall not be
opened or sources removed from source holders by the licensee,
except as specifically authorized.
17. The licensee is authorized to transport licensed material in
accordance with the provisions of 10 CFR Part 71, "Packaging and
Transportation of Radioactive Material."
18. 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 July 22, 2005 (ML05231 061 0) B. E-mail
dated September 26, 2005 (ML052700071 ) C. E-mail dated September
27, 2005 (ML05271 0249) D. Letter dated October 27,2006
(ML063240545) E. Letter dated December 1, 2006 (ML063550350) F.
Letter dated September 8, 2010 (ML 103220089) G. Letter dated
February 9, 2011 (ML 11 060A002)
FOR THE U.S. NUCLEAR REGULATORY COMMISSION
Date: March 29, 2011 IRA!
By: __________________________ __ Michelle Simmons, Health
Physicist Nuclear Materials Safety Branch B Region IV Arlington,
Texas 76011
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1'10.516615
ORIGIN ID: HIKA (808) 547-4348 RECEIVING DEPT QUEENS MEDICAL
CENTER 1301 PUNCHBOWL ST HONOLULU, HI 86813 UNITED STATES US
TO NRC - REGION IV US NUCLEAR REGULATORY 1600 E. LAMAR BLVD
ARLINGTON TX 760114511 REF: CC:2413
SHIP DATE: 23DECll ACTWGT: 0.1 LB CAD: 0751243/CAFE2508
BILL THIRD PARTY
···PO: SNDR: BRIAN OYADO 808-547-4884 DEPT: RADIATION THERAPY
1111111111111111111111111111111111111111111111111111111111111111111
~ 4636 4598 5056
SE 'FWHA
~ 1, I, TUE - 27 DEC A1
STANDARD OVERNIGHT
-
DEC 2 9 2011 This is to acknowledge the receipt of your
letter/application dated
DEC 2 ~ 2011 , and to inform you that the initial processing,
DATE
which includes an administrative review, has been performed.
[E'(' There were no administrative omissions. Your application
will be assigned to a technical reviewer. Please note that the
technical review may identify additional omissions or require
additional information.
D Please provide to this office within 30 days of your receipt
of this card:
The action you requested is normally processed within () 0 days.
D A copy of your action has been forwarded to our License Fee &
Accounts Receivable
Branch, who will contact you separately if there is a feet~So
inrlVef' 6 '\ 5 Your action has been assiqned Mail Control Number
-:--_~_--:"_--:-__ When calling to inquire about this action,
please refer to this mail control number. You may call me at
817-860-8103.
NRC FORM 532 (RIV) (10-2006)
Sin} relY"
~(~j) "----Licensing Assistant
-
BETWEEN:
Accounts Receivable/Payable and
Regional Licensing Branches
[ FOR ARPB USE 1 INFORMATION FROM L TS
Program Code: 02230 Status Code: Pending Amendment Fee Category:
3E 7C Exp. Date: Fee Comments: CODE 23 Decom Fin Assur Reqd: N
License Fee Worksheet - License Fee Transmittal
A. REGION
1. APPLICATION ATIACHED
Applicant/Licensee: QUEEN'S MEDICAL CENTER, THE
Received Date: 12/28/2011 Docket Number: 3014522
Mail Control Number: 576615
License Number: 53-16533-02
Action Type: Amendment
2. FEE ATIACHED
Amount:
Check No.: _.,.1_' ___ _
( 3. COMMENTS
Signed:
Date:
B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03 is
entered 1 1
1. Fee Category and Amount:
2. Correct Fee Paid. Application may be processed for:
Amendment:
Renewal:
License:
3. OTHER _______________________ ___
Signed:
Date:
