ML20140G260
| ML20140G260 | |
| Person / Time | |
|---|---|
| Site: | 07001331 |
| Issue date: | 02/12/1997 |
| From: | Tara Weidner NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| References | |
| 124101, NUDOCS 9706160092 | |
| Download: ML20140G260 (9) | |
Text
._Wwwwwwwwww w w w w w w.w w w w Ts w w ist 4 w veryan737 w wyunner w w w veiy g,RC FORM 374 U.S. NUCLEAR REGULATORY COMMIESION 8
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M ATERIALS LICENSE Amendment No. I1
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Pl Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganifation Act of 1974 (Public Law 93-438). and Title 10, Code of h
-g[lf ederal Regulations, Chapter I Parts 30,31,32,33,34,35,36,39. 40, and 70, and in reliance on statements and representations heretofore ma by the licensee, a hcense is hereby issued authori/ing the licensee to recris e, acquire, possess, and transfer byproduct, source, and special nuclear l2!
material designated below; to use such material for the purpose (s) and at the placets) designated below; to deliver or tran*fer su.h material to i3 q persons authorized to receis e it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions y f specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, segulations, and orders of the j
S Nuclear Regulatory Commission now or hereaf ter in ef fect and to any conditions specified below.
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?y Licensee In accordance with the letter dated j"l December 27, 1996,
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Y L Veterans Administration Medical Center
- 3. License Number SNM-1305 is amended in its 9
I entirety to read as follows:
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- 2. 3495 Bailey Avenue E!
Buffalo, New York 14215
- 4. Expiration Date October 31, 2002 E
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- 5. Docket or g
Reference No.
070-01331 l 'l h
- 7. Chemical and/or Physical
- 8. Maximum Amount that Licensee gl
- 6. Byproduct. Source, and/or Special Nuclear Material Fonn May Possess at Any One Time h
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Under This License g
J Sj A. Plutonium (principal A. Sealed source A. Not to exceed 210
$m
(;l Bi radionuclide Pu-238) milligrams per source and f
0.62 grams total 4.,
9 B
- 8. Plutonium (principal B. Sealed Source B. Not to exceed 250 2
milligramspersourceand-f s
radionuclide Pu-238) is; 0.25 grams total
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i Authorized use h
s Follow-up, recovery and disposal of Medtronic Model 9000 nuclear-powered cardiac l.fll s
9llA.
pacemakers previously implanted in humans.
B.
Follow-up, recovery and disposal of Coratomic Model C-101 nuclear-powered cardiac
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pacemakers previously implanted in humans.
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g' CONDITIONS E@
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10.
Licensed material may be used only at the licensee's facilities located at 3495 lij l
g Bailey Avenue, Buffalo, New York.
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A.
The physicians responsible for implantation, follow-up, explanation, and return li l
of nuclear-powered pacemakers to the manufacturer for proper disposal are 1;l g!
Jacob Bergsland, M.D. and Anthony Panos, M.D.
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The Radiation Safety Officer for this license is Jayakumari M. Gona, M.D.
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The specified possession limit includes all licensed material possessed by the
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in use.
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FORM 374A U.S.
LEAR REGULATORY COMMCSION PAGE 2
or 2
PAGES g
g License Number g
i SNM-1305 g
W MATERIALS LICENSE Docket or Reference Number g
g SUPPLEMENTARY SHEET 070-01331 g
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q Amendment No. 11 g
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13.
The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN: !
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Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, j
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Pennsylvania 19406, ATTN: Chief, Nuclear Materials Safety Branch, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of g
g occurrence, the death of any nuclear pacemaker patient, and any adverse reaction E
N and/or malfunction involving a pacemaker system, including the leads. A written report giving details of the adverse reaction and/or malfenction shall be submitted E
l within 30 days.
E 14.
A.
The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, I
ATTN: Chief, Nuclear Materials Safet'y Branch, 475 Allendale Road, King of E
5 Prussia, Pennsylvania 19406, within 10~ days of loss of contact with a nuclear E
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pacemaker patient.
E 1
E 4
E B.
The licensee shal_1 not receive or transfer in any single transaction one (1)
E N
gram or more ofcplutonium 238 contained in a nuclear-poi,ered pacemakers without E
notifying the. Division of Safeguards, U.S. Nuclear Regulatory Commission, E
R Washington, D..C'. 20555,.and, in addition, completing and distributing Form E
NRC-741 as required by Section 70.54 of 10 CFR170.
E B
/4 E
N 15.
The licensee shall continue ~ patient follow-up Jand replacement' procedures for the E
R nuclear pacemaker:during the life tr the patient.. Procedures for recovery and E
N authorized disposal of the nucle ~ar pacemaker.by.~ return to the manufacturer shall be E
N followed upon the death of the. patient.
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16.
Sealed sources or detector cells containing' licensed material;shall not be opened or y y
sources removed from source. holders;by the licensee.
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- 17. The licensee is authorized'to transport licensed material in accordance with the g
g provisions of 10 CFR,Part 71, " Packaging and' Transportation" of Radioactive Material." g m-g y
Except as specifically"yprovided otherwise in this license; the licensee shall conduct g y
18.
y its program in accordance'with the statements, representations, and procedures y
y contained in the documents, including any enclosures, listed below.
The Nuclear g
g Regulatory Commission's regulations shall govern unless the statements, g
g representations, and procedures in the licensee's application and correspondence are g
g more restrictive than the regulations.
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A.
Letter dated August 13, 1971 g
g B.
Letter dated April 30, 1987 g
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Letter dated May 4, 1992 g
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For the U.S. Nuclear Regulatory Commission Original Signed By-E plDate M
I S97 By Tara Weidner l
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Division of Nuclear Materials Safety E
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Region I fl King of Prussia, Pennsylvania 19406 s
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9 FEB l 21997 Richard S. Droske Director l
Veterans Administration Medical Center
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l 3495 Bailey Avenue j
l Buffalo, NY 14215
Dear Mr. Droske:
This refers to your license amendment request. Enclosed with this letter is the amended license. Please note that as part of this amendment, in accordance with 10 CFR 30.36, effective February 15,1996, the expiration date of your license has been extended by a i
period of five years. Your new expiration date is stated in item 4 of the license.
Please review the enclosed document carefully and be sure that you understand and fully I
implement all the conditions incorporated into the amended license. If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region i Office, Licensing Assistance Team, (610) 337-5093 or 5239, so that we can provide appropriate corrections and answers.
l Thank you for your cooperation.
Sincerely, Tara L. Weidner Division of Nuclear Matarials Safety License No. SNM-1305 Docket No. 070-01331 Control No. 124101
Enclosure:
Amendment No.11 l
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OFFICIAL RECORD COPY
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l R. Droske l Veterans Administration Medical Center i
DOCUMENT NAME: R:\\WPS\\MLTR\\SNM-1305 l
To receive a copy of this document. Indicate in the box:
"C" = Copy w/o attach /enci "E" = Copy w/ attach /enci
- N" = No copy l
OFFICE DNMS/RI
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NAME TWeidner fi f" DATE 02/04/97 02/ /97 02/ /97 02/ /97 l
l OFFICIAL RECORD COPY
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DEPARTMENT OF VETERANS AFFAIRS Medical Center St Louis MO 63125 0AY
'" "*P' V " * I January 8,1997 U.S. Nuclear Regulatory Commission Region I 475 Allendale Rd.
King of Prussia, PA 19406-1415
SUBJECT:
NRC License No. SNM-1305/070-01331 The enclosed correspondence from the Buffalo, New York VA Medical Center has been received and is forwarded to your office for processing. If there are questions, please contact the facility.
Please provide a copy of any correspondence relative to licensing actions for this Medical Center to:
Department of Veterans Affairs Health Physics Programs (115 iip) 915 North Grand Blvd.
St. Louis, MO 63106 Sincerely, 0/nf 0U tGADL Francis K. Herbig IIcalth Physics Programs v
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i 124101 m;0rl i::CCT_ !.'.. l.
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JAN 131997
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,g UNITED STATES 8
NUCLEAR REGULATORY COMMISSION o
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- y REGION I 5
475 ALLENDALE ROAD j
g*g KING OF PRUSSIA, PENNSYLVANIA 194 5 1415 Jul -2 Egr Department of Veterans Affairs ATfN: Francis K. Herbig Health Physics Programs (115HP) 915 North Grand Blvd.
St. Louis, MO 63106
Dear Mr. Herbig:
We are referring a request for an Ainendment to NRC License No. SNM-1305/070-01331 from Veterans Administration Central Office Buffalo, New York
, dated December 27, 1996
, to your office for your concurrence.
Please return all documents to the above address for NRC review and action.
If there are any questions, please call (FTS) 610/337-5239.
Sincerely, l$ butd' N
She 1 Villar, Chief Licensing Assistance Section Nuclear Materials Safety Branch Division of Radiation Safety and Safeguards I
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'q SNm-1305 DEPARTMENT OF VETERANS AFFAIRS Medical Center 3495 Bailey Avenue Buffalo NY 14215 l
December 27, 1996 in Reply Ref" k 528/112
' Nuclear Regulatory Commission Region 1 475 Allendale Rd.
King of Prussia, PA 19406-1415 l
Re:
Nuclear License Please be advised that Dr. Leon Levinsky has left.the VA Western New York Healthcare System.
Dr. Anthony Panos has been recently appointed Chief of Cardiothoracic Surgery.
It is recommended that his name be placed on the Nuclear License.
trf a
RICHARD S.
DROSKE Director, VA Western New York Healthcare System cc:
Radiation Safety Officer Chief, Nuclear Medicine i
l OED 31 996
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INFORMATION FROM LTS SETWEEN:
.LICENS E FEE M AN AGEMENT BRANCHr ARM PROGRAM CODE: 22160 AND STATUS CODE: 0 REGION AL - LIC ENSING SEC TION S FEE CATEGORY: EX 7C l
r EXP. DATE: 20021031 FEE COMMENTS: PACEMAKER I
DECOM FIN ASSUR REQD: N LICENSE FEE TRANSMITTAL A.
R E GIO N
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APPLICATION ATTACHED 4
APPLICANT / LICENSEE:
V.
A.
MEDICAL CENTER RECEIVED DATE:
970113 DOCKET NO:
7001331
. CONTROL NO.:
1 24101 LICENSE NO. :
S NM-1305 i
ACTION TYPE:
AMEN 0 MENT
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FEE ATTACHED AMOUNT:
CHECK No.:
c l-3.' COMMENTS SIGNED _
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LICENS E FEE MANAGEMENT BRANCH (CHECF WHEN MILESTONE 03 IS ENTERED /__/)
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FEE C ATEGORY AND AMOUNT:
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CORRECT FEE PAIO.
APPLIC ATION M AY BE-PROCESSED F04:
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