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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1 Nnc Form 374 1
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PAGE OF FAGES 3
U.S. NUCLiiAR RE!ULATORY COMMISSION 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 f
1 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct.
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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.
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In accordance with letter dated l
April 26, 1988, l
l l St. Mary's Hospital
- 3. Ucense number SNM-1375 is amended in its l
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entirety to read as follows:
b8 Y h e, June
- t 1 5801 Breco Road 1
Richmond, Virginia 23226
- 4. Gp ti f
30, 1993 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 form ay posuss at any one time 1
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% der this license f
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Plutonium (Princ ale d oyrce h j A.
.63 gram (3 E
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a radionuclide Pu-
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ot to exceed 210 1
6/w#$d-1111 grams each) lt g
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Authorized use p
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As a component Medfo'n NUbue; jn}s-Ale ower cemakers for clinical
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1 evaluation in a or ance with ffp4ttp(W L' Model 9000 Isotopic I
1 Pulse Generator Pt ol," dated Mrc 21, 1973.
license authorizes I
1 possession of these makers for explantation, overy and disposal, but t
I not for implantation.
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CONDITIONS 1
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10.
Licensed material shall be used only at St. Mary's Hospital, 5801 Bremo Road, lt j
Richmond, Virginia.
l 11.
The specified possession limit includes all licensed material possessed by the I
l licensee under this license whether in storage, implanted in patients, or otherwise 1
in use.
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12.
The licensee shall report to the U. S. Nuclear Regulatory Commission, Region II t
Division of Radiation Safety and Safeguards NuclearMaterialSafetySection,101
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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, j i
the death of any nuclear pacemaker patient and any adverse reaction and/or Includingtheleads.
A written report I,
malfunction involving a pacemaker system, /or malfunction shall be submitted within 1
lt giving details of the adverse reaction and I
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30 days.
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se.10240353 000603 lI I
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NRC Form 374A U.S. NUCLEA3 REf.ULATORY COMMISSION pggg 2 g,
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88'8 0 l
Licente number I
l MATERIALS LICENSE Docket or werence number SUPPLEMEP'TARY SH E ET g7 I
Amendment No. 06 I
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I (cont'd)
CONDITIONS l
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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
contact with a nuclear pacemaker patient.
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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.
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l 15.
Except as specifica11yJprovided otherwise in this license,'the licensee shall i
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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 l
l more restrictive'than the regulations.'
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Letter dated May 17, 1973 Withattachedapplication l
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8.
Letters dated:
June 19 August 2$}1973s I
1973.
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l February, 1974 l
April 19 1983 l
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. April 26,19.88 -
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i FOR THE U.S. NUCLEAR REGULATORY COMISSION i
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h Date 03198g sy 8
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ton II Re0afcty$ection i
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l 101 H vietta Street, Suite 2900 I
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Atlanta, GA 30323 l
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