ML20134B959
| ML20134B959 | |
| Person / Time | |
|---|---|
| Site: | 07003083 |
| Issue date: | 06/13/1996 |
| From: | Thompson T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| References | |
| 123175, NUDOCS 9609240157 | |
| Download: ML20134B959 (7) | |
Text
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,N,RC, FORM 374.
h U.S. NUCLEAR REOULATORY COMMisslON PAGE OF PAGES f
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M ATERI ALS I.ICENSE Amendment No. 01 g
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g Pursuant to the Atomic Energy Act of 1954 as amended, the EnerFy Reorganization Act of 1974 (Pubh g
Federal RcFulations. Chapter 1. parts 30,31,32,33,34,35,36. 39. 40, and 70, and in reliance on statements and repr l
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by the htensee, a license is hereby suued authorizing the licensee to receive, acquire, pouess, and transfer byproduct, source, and I
7 m:terial desi nated below; to use such material for the purposeN and at the placeN designated below; to deliver or transfer such material to F
E persons authoriecd to receive it in accordance with the regul.itions of the applicable PartN. This hcense shall be deemed to contain the conditions N N
specified in Section lH3 of the Atomic Energy Act of 1954, as amended, and is subject to all applicab N
dndo d *fi f the Nuclear Regulatory Comminion now or hereafter in ef fect and to any conditions specified below.
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In accordance with the letter dated E
March 29, 1996, 5
L Brockton Hospital
- 3. License Number SNM-2000 is amended in N
b its entirety to read as follows:
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2.
680 Centre Street d
I Brockton, Massachusetts 02402
- 4. Expiration Date February 28, 2003 6
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- 5. Docket or B
Reference No.
070-03083/SNM-1973
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- 6. Byproduct, Source, and/or
- 7. Chemical and/or Physical
- 8. Maximum Amount that Licensee g
g Specia! Nuclear Material Form May Possess at Any One Time (6
g Under This License
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B A. Plutonium (principal A. Sealed sources A. 7.5 grams (individual 0
9 radionuclide Pu-238) sources not to exceed 250 0 4
milligrams each) b b
9.
Authorized use 6
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B A.
As a component of Cordis 0 mini-Stanicor Model 184A nuclear-powered cardiac pacemakers 0 9
for clinical evaluation in accordance with manufacturer's protocol dated November 1, 6
B 1975, this authorization includes: follow-up, explantation, recovery disposal, but 0
B not implantation.
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CONDITIONS 6
5 6
9' 10.
Licensed material may be used only at the licensee's facilities at 680 Centre Street, 6 b
Brockton, Massachusetts.
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11.
A.
The physician responsible for follow-up, explantation, and return to the s
3 manufacturer for proper disposal is Dr. Burton J. Polansky.
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B B.
The Radiation Safety Officer for this license is Charles E. Taylor, M.D.
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6 3
12.
The specified possession limit includes all licensed material possessed by the g
y licensee under this license whether in storage, implanted in patients, or otherwise e
p in use.
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p 13.
The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, g
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ATTN: Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, g
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Pennsylvania 19406 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 s l
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patient, and any adverse reaction and/or malfunction involving a pacemaker system, e
l pI including the leads. A written report giving details of the adverse reaction and/or.e p
malfunction shall be submitted within 30 days.
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F,ORW374A U.S EAR REOULATOR'Y COMMISSION NR PAGE 7
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SNM-2000 F
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MATERIALS LICENSE th Let or Reference Number E
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l SUPPLEMENTARY SHEET 070-03083/SNM-1973 5
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l Amendment No. 01 E
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y 14. 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, F
g Pennsylvania 19406 within 10 days of loss of contact with a nuclear pacemaker p
4 patient.
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The licensee shall continue patient follow-up and replacement procedures for the E
y nuclear pacemaker during the life of the patient.
Procedures for recovery and y
y authorized disposal of the nuclear pacemaker by return to the manufacturer shall be p
j followed upon the death of the patient.
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16.
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Sealed sources or detector cells containing licensed material shall not be opened __or g
y sources removed from source holders or detector cells by the licensee.
g I 17. The licensee may transport licensed material in accordance with the provisions of f!
10 CFR 71, " Packaging and Transportation of Radioactive Material."
g 3 18.
The licensee shall not receive or transfer in any single transaction one (1) gram or f
I more of plutonium 238 contained in nuclear-powered pacemakers without notifying the 1
Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C.
- 20555, E
1 and, in addition, completing and distributing Form NRC-741 as required by p
Section 70.54 of 10 CFR 70.
I 19.
Except as specifically provided otherwise in this license, the licensee shall conduct E
1 its program in accordance with the statements, representations, and procedures 3
contained in the documents, including any enclosures, listed below. The Nuclear E
1 Regulatory Commission's regulations shall govern unless the statements, E
a representations, and procedures in the licensee's application and correspondence are E
1 more restrictive than the regulations.
E y
E 1
A.
Letter dated July 16, 1976 E
1 B.
Letter dated April 22, 1980 E
1 C.
Letter dated August 3, 1981 E
1 D.
Letter dated September 2, 1986 E
1 E.
Letter dated December 14, 1992
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F.
Letter dated February 17, 1993 E
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For the U.S. Nuclear Regulatory Commission E
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JUN l 31996 ORIGINAL SIGNED BY:
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THOMAS K. THOMPSON g Date By i
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Nuclear Materials Safety Branch i
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Region I E
g King of Prussia, Pennsylvania 19406 E
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JUN I 3 1996 l
Mr. Norman B. Goodman President Brockton liospital 680 Centre Street Brockton, MA 02402
Dear Mr. Goodman:
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 70.38, effective February 15, 1996, the expiration date of your license has been extended by a 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 implement all the conditions incorporated into the amended license.
If there are any errors or questions, please notify the U.S. Nuclear i
I Regulatory Commission, Region I Office, Licensing Assistance Team, (610) 337-5093 or 5239, so that we can provide appropriate corrections and answers.
Thank you for your cooperation.
Sincerely, ORIGINAL 8IGNED BY:
THOMAS K. THOMPSON Thomas K. Thompson Division of Nuclear Materials Safety License No. SNM-2000 Docket No.
070-03083 Control No. 123175
Enclosure:
Amendment No. 01 DOCUMENT NAME:
R:\\WPS\\MLTR\\LSNM2000 To,eceive a copy of this document, Indicate in the bos: 'C' = Copy w/o attach /enct
- E' - Copy w/ attach /enct "N" = No copy 0FFICE DNMS/RI N
DNMS/RI N
NAME Stambaugh/jys ThompsonfM DATE 06/13/96 CA.
06/ l3 /96 06/
/96 06/
/96 0FFICIAL RECORD COPY
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March 29,1996 U.S. Nuclear Regulatory Commission - Region I 475 Allendale Road i
King of Prussia, PA 19406 Attn: Licensing Assistance Section
Dear Sir:
This letter is to request the following physicians be added to the NRC license #20-03333-02 as follows:
1.
Add the following individuals as authorized users for Groups I, II, III and Xenon:
James L. Hayes, M.D.
Margo M. Moskos, M.D.
Daryl R. Parker, M.D.
2.
Delete the following as authorized users for Groups I, II, III and Xenon Nassar Tehranian, M.D.
Edward P. O'Brien, M.D.
Training and experience forms and preceptor statements are submitted for each individual.
3.
Error Correction:
License #SNM-2000 with an expiration date of February 28,1998 and docket or reference
- 70-03083/SNM-1973 shows Dr. Barton J. Polansky as Radiation Safety Officer. Dr.
Polansky's correct spelling of his first name is Burton. Also, Dr. Charles E. Taylor is Brockton Hospital's Radiation Safety Officer.
Should you require further information on this request, please contact Dr. Charles E. Taylor, Radiation Safety Officer or John E. Reilly, R.T., C.N.M.T., at 508-941-7228.
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k' pulled o<d op 123070 President 123175 OhlCIAl. RECORD COPY ML 10 2AL 10 MY I 3 m s
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(FOR LFMS USE)
INFORMATION FROM-LTS
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' LICENSE-F EE M AN AGEMENT BR ANCH, ARM PROGRAM C00E: 22160 AND-
- ^ STATUS CODE: 0 REGIONAL LIC ENSING - SECTIONS FEE CATEGORY: EX 7C 6
EXP. DATE: 20030228 i
FEE COMMENTS: P ACEM AK E R/2 0-03 333-02 l
DECOM FIN ASSUR REQD: N l
- LICENSE FEE TRANSMITTAL-A.
REGION M
1.
APPLIC AT ION ATT ACH ED
' APPLICANT / LICENSEE:
8ROCKTON HOSPITAL
' R ECEIVED - D ATE:
960513 OOCKET NO:
7003083 i
CONTROL NO.:
123175 l
LICENSE NO.:
S NM-2000 i
ACTION TYPE:
AMENOMENT I
2 FEE ATTACHED AMOUNT:'
CHECK NO.:
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FEE C ATEGORY AND AMOUNT:
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CORRECT FEE P AIDy APPLIC ATION M AY BE PROCESSED FOR:-
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RENEWAL LICENSE 3.
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SIGNED DATe
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