ML20248A616
| ML20248A616 | |
| Person / Time | |
|---|---|
| Site: | 07001388 |
| Issue date: | 07/26/1988 |
| From: | Vacherlon P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20248A621 | List: |
| References | |
| 0273, 22326, 273, 2778, 385692, 85692, NUDOCS 8906080166 | |
| Download: ML20248A616 (5) | |
Text
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l NIC Fum 374 l 1
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U.Sf NUCLEAR REGULATORY COMMISSION e
g Amendment No. 04 I
MATERIALS LICENSE Pursuant ta the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, E
l Code of Federal Regulations, Chapter'I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations - l 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 l
Ie l deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This b
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license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is I
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subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any I
conditions specified below.
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I In accordance with application' dated June 23, 1988
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Mount Carmel Mercy Hospital
- 3. License number SNM-1374 is amended 1n its il entirety to read as follows:
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,,,, bQ 2-6071 West Guter Drive
- 4. bpir August 31, 1993 f
Detroit, MI 48235 d
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- 5. Docket or 070-01388 gI di Reference No.
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- 6. flyproduct, source, and/or M
- 7. Chemical and/or physical L 8., Maximum amount that licensee l
$may possess at any one time I
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special nuclear material form 3
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Plutonium (PrincipY,h)
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NAYSealed_ Sources
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A.h<3.15 grams A.
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Authorized use gj g y'
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As a component of Ms.hitronic'Model 9000Tnuclear-p#owered pacem)akers for y
pacemakers for purpos'es'/pf explantation,urecovery and d.osi;ession of thes clinicalevaluation1urposes. TheTicuse?abthohizesp p
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for implantation or reimpipntation.
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-CONDITIONS y -
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- 10. Licensed material shall be used only at Mount Carmel Mercy Hospital, 6071 l
West Outer Drive, Detroit, Michigan.
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- 11. The specified possession limit includes all licensed material possessed by the licensee under the license whether in storage, implanted in patients or otherwise in use.
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- 12. The licensee shall not receive or transfer in any single transaction, I g
gram or more of plutonium 238 contained in nuclear-powered pacemakers N
without notifying the Division of Safeguards, U.S. Nuclear Regulatory Conrnission, Washington, D.C. 20555, and, in addition, completing and 3
distributing Form NRC-741 as required by Section 70.54 of 10 CFR Part 70.
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REG 3 LIC70 E
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NRC Form 374A U.S. NUCLEAR REGULATORY COMMISSION 2
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pace oF ucense number i
N SNM-1374 l
MATERIALS LICENSE l
SUPPLEMENTARY SHEET R
070-1388 i
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Amendment No. 04 p
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- 13. The licensee shall report to the Material Licensing Branch, U.S. Nuclear Regulatory 1
l Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of g
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occurrence, the death of any nuclear pacemaker patient, and any adverse reaction E
I and/or malfunction involving a pacemaker system, including the leads. A written M
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report written report giving details of the adverse reaction and/or malfunction shall malfunction shall be submitted within 30 days.
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14.
The licensee shall report to the Material Licensing Branch, U.S. Nuclear Regulatory gl Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of p
I contact with a nuclear pacemaker patient.
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- 15. The licensee shall continue patient?folNvPup$n"dtreplacement procedures I
for the nuclear pacemaker dur.ing'the life of the patient; and procedures y
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for recovery and author.iied " disposal of the nuclear" pacemaker by return g
to the manufacturer shal1 be followed upon the death oflhe patient.
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Except as specifically provided otherwise in this license;"the licensee l
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shall possess and,use licensed material described,inlltems%7, and 8 of g
i thelicenseinaccordance'with]thestatements, representations,and g
I procedures containe'd in the11etters dat;ed; April.23',11973, Fetifbary 8, g
1 1974, June 9,1983 and lette'r dated June 23,19887The Nuclear Regulatory P
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Commission's regulations shallhgovernitheJicensee's unless the' statements, in applications :or lette's, UnlesPth'e~ statements: are more re'strictive l
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For the U.S. Nuclear Regulatory Commission t
Original Signed MI 4
Date: July 26, 1988 By Patricia M. Vacherlon hl f
Materials Licensing Section, Region III i
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-Mount Carmel Mercy Hospital 14.
ATTN:.. L. D. Fakle, President' b
Chief Executive Officer-h 6071 West ~ 0 uter Drive '
l Detroit, MI. 48235 Gentiemen:-
A
. Enclosed is Amendment.No. 04 renewing.your NRC License No. SNM-1374 in accordance with your request.
Please review the enclosed document _ carefully and be sure that you understand all conditions. You must conduct your program involving radioactive materials.
in accordance with the conditions of your NRC license, representations made in-your license application, and NRC regulations.
In particular, note that you-j must:
l-1.
Operate in accordance with NRC regulations 10 CFR Part 19, " Notices, Instructions and Reports to Workers; Inspections," 10 CFR Part 20,
" Standards for Protection'Against Radiation," and other applicable
-regulations.
2.
Possess radioactive material only in the quantity and form indicated in -
your license.
3.
Use radioactive material only for the purpose (s) indicated in your license.
4.
Notify NRC in writing of any change in mailing address.
5.
Request and obtain appropriate amendment if you plan to change ownership of your organization, change locations of. radioactive material, or make any other changes in your facility or program which are contrary to your license conditions or representations made in your license application and any. supplemental correspondence with NRC. Any amendment request should be accompanied by the appropriate fee specified in 10 CFR Part 170.
6.
Submit a complete renewal application with proper fee or termination request at least 30 days before the expiration date on your license. You will-receive a reminder notice approximately 90' days before the expiration date. Possession of radioactive material after your license expires is a violation of NRC regulations.
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Mount Carmel Mercy Hospital 2
I 7.
Request termination of your -license if you plan to permanently discontinue activities involving radioactive material prior to your expiration date-.
You will be periodically inspected by NRC.
Failure to conduct your program in accordance with NRC regulations, license conditions and representations in your
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license application will result in enforcement action against you in accordance
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with the General Policy and Procedures for NRC Enforcement Actions,10 CFR l
Part 2, Appendix C.
l If you have any questions or require clarification of any of the above stated j
information, contact us at (312) 790-5625.
i Sincerely, Patricia M. Vacherlon I
Materials Licensing Section
.l
Enclosure:
Amendment No. 04 RIII Vacherlon/crr
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(FOR LFMS USE) t INFORMATION FROM LITS Q-BETWEENS 8
Q LICENSE FEE MANAGEMENT BRANCH, ARM PR001AM CODE 22160 AND STAVOS CDDE 2
REGIONAL LICENSING SECTIONS FEE CATE30RY: Ex 7C t
EXP. DATE: 19BBOT31 Q
FEE: COMMENTS:
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LICENSE FEE TRANSMITTAL O
A.
REGION 1
APPLICATION ATTACHED =
Q APPLICANT /LICENSEEt MT. CARMEL MERCY HOSPIT alt RECEIVED DATE:
880701 i
f/" O DOCKET ND 7001388 Q
CONTROL NO.
385692 LICENSE NO.!
SNM-13T4 ACTION TYPE:
RENEWAL O
2 FEE ATTACHED AMOUNT M
Q CHECK NO.I
- 3. COMMENTS M* O '
SIGNED DATE 7///f#
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LICENSE FEE MANAGEMENT 3 RANCH (CHECK WHEN] CESM 9
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/T Q-1 FEE CATEGORY AND AMDJNT 2.
CORRECT FEE FAID.
A DP L.I C ION MAY dE PR CE O
AMENDMENT
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RENEWAL V
LICENSE O
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SIGNED SIS DATE
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