ML20204H189
| ML20204H189 | |
| Person / Time | |
|---|---|
| Site: | 07001397 |
| Issue date: | 06/03/1988 |
| From: | Connell C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML20204H194 | List: |
| References | |
| NUDOCS 8810240353 | |
| Download: ML20204H189 (2) | |
Text
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W Nnc Form 374
'3"Ent3MWEw'mwwA mp -------
1 PAGE 1 g
ts.e 3) U.S. NUCLiiAR RE!ULATORY COMMISSION OF FAGES 3
l l MATERIALS LICENSE Amendment No. 06 i Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, E y Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations 1 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct.
f
[
] source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to I J deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This !
I license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is I subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any f
1, e nditions specined below. ,
In accordance with letter dated l
April 26, 1988, l!l '
l l l St. Mary's Hospital 3. Ucense number SNM-1375 is amended in its
] entirety to read as follows: }i 1 5801 Breco Road b8 Y Gp ti h e,f June 30, 1993 t
1 Richmond, Virginia 23226 4. I l Neren$ No -01397 l 6. Byproduct, source, and/or 7, Chemical and/or physical O Maximum amount that licensee I l special nuc, car material n form ay posuss at any one time 1 l h / % der this license f l
1 D h- t I
/ t gw t C t l j A. Plutonium (Princ . j ale d oyrce h j A. .63 gram (3 E a radionuclide Pu- ) V: rw^ #S,4 dividual sources (
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/ ot to exceed 210 D(
g 1 (f) A,w % e 1111 grams each) 1 5' y -
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j 9. Authorized use p ng g y V <
l A. As a component Medfo'n NUbue; ower cemakers for clinical 1 evaluation in a jn}s-Ale Model 9000 Isotopic I
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1 Pulse Generator Ptor ance ol," withdated ffp4ttp(W Mrc 21, L' 1973. license authorizes I 1 possession of these makers for explantation, overy and disposal, but t I not for implantation. I j, 4 _1_ k >
o n n l CONDITIONS i@
1 It 1 10. Licensed material shall be used only at St. Mary's Hospital, 5801 Bremo Road, Richmond, Virginia. lt j
- 11. The specified possession limit includes all licensed material possessed by the I l
l licensee under this license whether in storage, implanted in patients, or otherwise 1 in use. 4, 1 I i 12. The licensee shall report to the U. S. Nuclear Regulatory Commission, Region II lt t
I Division of Radiation Safety and Safeguards NuclearMaterialSafetySection,101 ;l l MariettaStreet, Suite 2900, Atlanta, Georgia 30323, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any nuclear pacemaker patient and any adverse reaction and/or j
i 1 Includingtheleads. A written report I, malfunction involving a pacemaker giving details of the adverse reaction and system, /or malfunction shall be submitted within I
l 30 days.
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. jt l se.10240353 000603 lI I
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r-,.---------------------- a------aa l 88'8 0 NRC Form 374A U.S. NUCLEA3 REf.ULATORY COMMISSION pggg 2 g, 2 pgggg l l
Licente number I l MATERIALS LICENSE Docket or werence number SUPPLEMEP'TARY SH E ET g7 I Amendment No. 06 I ,
I I i I
l (cont'd) CONDITIONS !
l . i q I i 13. The licensee shall report to the U. S. Nuclear Regulatory Commission, Region II, I ,
1 Division of Radiation Safety and Safeguards, Nuclear Material Safety Section,101 1 '
Marietta Street, Suite 2900, Atlanta, Georgia 30323, within 10 days of loss of l l contact with a nuclear pacemaker patient. g I
- 14. The licensee shall ,:ontinue patient. follow-up and replacement procedures for the I I
nuclear pacemaker during the life of the' pat,ient. , Procedures for recovery and i I authorized disposal of the nuclea~r~ pacemaker >y return,to the manufacturer shall be I followed upon the death of ;the patient. 1, s
- y. s y l l 15. Except as specifica11yJprovided otherwise in this license,'the licensee shall i i e conduct its program in accordance with the statements, representations, and 1 I procedures contained in the documents including any enclosures, listed below. The I I Nuclear Regulatory Commission's regulations shall govern unless the ste:ements, 3 I representations and procedures in tne licensee's application and correspondence are more restrictive'than the regulations.' l l
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! A. Letter dated May 17, 1973 Withattachedapplication l i ~ r -y I I 8. Letters dated: June 19 I I I August February , 1974 2$}1973s 1973.
l l l April 19 1983 '
l l . April 26,19.88 -
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c l 101 H vietta Street, Suite 2900 I '
Atlanta, GA 30323 l l l '
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