ML20135B752
| ML20135B752 | |
| Person / Time | |
|---|---|
| Site: | 070*****, 07003092 |
| Issue date: | 02/05/1997 |
| From: | Michelle Beardsley NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| References | |
| 124116, NUDOCS 9703030186 | |
| Download: ML20135B752 (11) | |
Text
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i Ot0Rf4/'*f1f4r$fWWin- si irWirtrfWgrGrrarWgAirWirWiririrgrWrgrirqAirgririrgrgrgrgrgrgrgrgF FORM 374
- U.S. NUCLEAR REGULATORY COMMLSI NE I & 2 EE
%, MATERI AI.S I.lCENSE g
Is jgl Pursuant to the Atomie Encry> Act of 1954. as amended, the Energy Reorganuat it g) Federal Regulations. Chapter 1. Parts 30. 31. 3133. 34,35. R 39. 40, and 70. and in reliance on statements gand hj by the hcensee, a litense is bereby iwued authoruing the licensee to receive, acquire. possess, and transfer byp material designated below: to use sush material for the purposeh) and at the placcul designated below, to deliser or transfer such m
$ persons authorized to receise it in accordance w uh the regulanons of the applisable Partm This license shall be deeme l
% specified in Section IM3 of the AtomicinEnergy effect andAct of cenditions 1954,Uhasspecified amended, rgg ngydcryf thesubje and is I
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Nuclear Regulatory Commission now or hereafter to any .. 6 below.ub"g Wiiw j j;g Q ;
lh! Licensee i
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Pl1 3. License Number SNM-2003
,E Crozer-Chester Medical Center j$
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r l j 2.0ne Medical Center Boulevard Upland, Pennsylvania 19013-3995 in lL3 4. Expiration Date February 28, 2002 j.
- 5. Docket or LlE Reference No. 070-03092/ SNM-1691 e
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3l 6.13yproduct. Source, and/or 7. Chemical and/or Physical 8. Maximum Amount that Licensee g Special Nuclear Material Form q May Possess at Any One Time g d
s- Under This License 1 tj ls5- A. Plutonium (principal
' A. Sealed sourc.e A. 250 milligrams E l radionuclide Pu-238) E 5
6 5 9. Authorized use i !s s
l lA. As a component of a Coratomic Model C-101 nuclear-powered cardiac pacemakers for 5 l clinical evaluation in accordance with manufacturer's protocol dated November 1, (
- $ 1975, this authorization includes
- follow-up, explanation, recovery, disposal, but not implantation. (
l5 4 1
- )5 CONDITIONS di i
3 I(g I3 10. Licensed material may be used only at the licensee's facilities located at One I n
l g Medical Center Boulevard, Upland, Pennsylvania.
. (
is 11. The physician responsible for follow-up, explanation, and return of nuclear-powered i
- t pacemaker to the manufacturer for proper disposal is Howard P. Rothenberg, M.D. k
- 12. q The Radiation Safety Officer for this license is Diana Stockdale, M.S. gi s
,II 13. The specified possession limit for cardiac pacemakers includes all licensed material i possessed by the licensee under this license whether in storage, implanted in patients, or otherwise in use. j la g' s
$ 14. The licensee shall continue patient follow-up and replacement procedures for the i
$ nuclear pacemaker during the life of the patient. Procedures for recovery and i
$ authorized disposal of the nuclear pacemaker by return to the manufacturer shall b l t followed upon the death of the patient. 4
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,1 1 15 . Sealed sources or detector cells containing licensed material shall not be openedfo,r s h sources removed from source holders by the licensee. j j 16. The licensee is authorized to transport licensed material in accordance with the E g
provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material." g 9703030186 970205 lElE%EElhIhN m PDR ADOCK 070***** Jgj * ..
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- FORM 374A 'u- _2 CLEAR REOULATORY COMMISslON - PAGE OF PAGES B "*""**
N SNM-2003 I i i p MATERIALS LICENSE g SUPPLEMENTARY SHEET Docket or Reference Ngygr 03092/ SNM-1691 B
E N
N N 17. Except as specifically provided otherwise in this license, the licensee shall conduct N jE N
its program in accordance with the statements, representations, and procedures jN contained in the documents, including any enclosures, listed below. The Nuclear ;E N
Regulatory Commission's regulations shall govern unless the statements, ;E N
representations, and procedures in the licensee's application and correspondence are jE N more restrictive than the regulations, E I N
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9 A. Letter dated January 9, 1997 E E
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For the U.S. Nuclear Regulatory Commission E N
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~ Original Signed By: E js Michelle Beardsley Nj Date By E N
Division of Nuclear Materials Safety E Region I E!
LN King of Prussia, Pennsylvania 19406 h N
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FEB - 51997 j
.I License No. SNM-2OO3
- Docket No. 070-03092 i l
Control No. 124116 Joseph Saunders !
Vice President, Support Services l Crozer-Chester Medical Center One Medical Center Boulevard !
Upland, PA 19013-3995 .i i
Dear Mr. Saunders:
l
' Please review the enclosed document carefully and be sure that you understand all ;
conditions. 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 15239, so that we can provide appropriate corrections and answers. {,
Please be advised that your license expires at the end of the day, in the month,'and year stated in the license. Until your license is terminated, you must conduct your program ,
. involving byproduct materials in accordance with the conditions of your NRC license, I representations made in your license application, and NRC regulations. In particular, !
note that you must:
- 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," 10 CFR Part 35, " Medical Use of Byproduct j Material," and other applicable regulations.
l
- 2. Not possess and use materials authorized in items 6,7, and 8, on the license until: l l
- a. you have constructed the facilities and obtained the equipment described in the license application and supporting documentation; and
- b. you have notified the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials Safety Branch,475 Allendale Road, i King of Prussia, Pennsylvania 19406 in writing, that activities authorized by i the license will be initiated.
- 3. Notify NRC,in accordance with 10 CFR 35.14, no later than 30 days after: l 4
- a. the date that you permit any individual to work as an Authorized User or an Authorized Nuclear Pharmacist pursuant to 10 CFR 35.13(b)(1 through (4), 3 and provide to the Commission a copy of the board certificaticn, the OFFICIAL RECORD COPY P
.. - .._ --.. . - - - - . . . - - - . - - . - - - - . - . . - - - - - - . ~
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-J. Saunders - i Crozer-Chester Medical Center i
- Commission or Agreement State license, or the Permit issued by a licensee of broad l scope identifying the individual; I
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- b. an Authorized User, Authorized Nuclear Pharmacist, Radiation Safety. ;
Officer, Teletherapy Physicist, or Medical Physicist permanently ;
discontinues performance of duties under the license or has a name change; !
or l1 1
! c. when the mailing address on the license changes (no fee is required if the .j location of byproduct material remains the same). !
l
- 4. In accordance with 10 CFR 30.36(b) and/or license condition, notify NRC, ;
, promptly, in writing, and request termination of the license
- a. when you decide to terminate all activities involving materials authorized )
- under the license; or ;j i 1 a-
- b. if you decide not to complete the facility, acquire equipment, or possess and use authorized material.
- 5. -In accordance with 10 CFR 35.13, request and obtain a license amendment before
, you: I
) a. receive or use byproduct material for a clinical procedure permitted under j- Part 35 but not permitted by your license issued pursuant to this Part;
- b. permit an individual, except as specified in 10 CFR 35.14(b)(1) through (4),
j- to work as an Authorized User or Authorized Nuclear Pharmac 8.,t under the license; j c. change Radiation Safety Officer, Teletherapy Physicist or Medical Physicist;
- d. order byproduct materialin excess of the amount, or radionuclide, or form g
different than authorized on the license; or
- e. add or change the areas of use, or address or addresses of use identified in the license application or on the license.
t
)' 6. Receive written approval from the NRC prior to any change in ownership of your i organization, in accordance with 10 CFR 30.34(b).
i j 7. Submit a complete renewal application with proper fee or termination request at
- . least 30 days before the expiration date of your license. You will receive a j reminder notice approximately 90 days before the expiration date. Possession of J- byproduct material after your license expires is a violation of NRC regulations. A license _will not normally be renewed, except on a case-by-case basis, in instances OFFICIAL RECORD COPY 1 1
1 l
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2- . .
i J. Saunders Crozer-Chester Medical Center )
where licensed material has never been possessed or used.
. In addition, please note that NRC Form 313 requires the applicant, by his/her signature, to verify that the applicant understands that all statements contained in the application i
are true and correct to the best of the applicant's knowledge. The signatory for the application should be the licensee or a certifying official of the licensee rather than the
, Radiation Safety Officer or a consultant.
, You will be periodically inspected by the NRC. Failure to conduct your program in j accordance with NRC regulations, license conditions, and representations made in your !
license application and supplemental correspondence with NRC will result in enforcement action against you. This could include issuance of a notice of violation, or imposition of l .
a civil penalty, or an order suspending, modifying or revoking your license as specified in
- . the " General Statement of Policy and Procedure for NRC Enforcement Actions,"
(Enforcement Policy), NUREG 1600.
.Since serious consequences to employees and the public can result from failure to comply with NRC requirements, prompt and vigorous enforcement actions will be taken when dealing with licensees who do not achieve the necessary meticulous attention to detail and the high standard of compliance which NRC expects of its licensees.
Thank you for your cooperation.
Sincerely, OrlDinal Sioned By:
Michelie seerdeley :
Michelle R. Beardsley Division of Nuclear Materials Safety License No. SNM-2OO3 Docket No. 070-03092 Control No. 124116
Enclosures:
- 1. License No. SNM-2OO3
- 2. 10 CFR Pads 2,19, 20, 30, 31, 35, and 170 OFFICIAL RECORD COPY
.O .O i
J. Saunders I Crozer-Chester Medical Center ;
DOCUMENT NAME: R:\WPS\MLTR\LSNM2003
- To receive e copy of this document, Indicato in the box: 'C' = Copy w/o attach /enci "E' = Copy w/ ettach/enci *N" = No copy OFFICE DNMS/RI q lN DNMS/RI l l l .
NAME Beardsley 1\pA <
DATE 01/17/97 l '.M 01/ /97 01/ /97 01/ /97 ;
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OFFICIAL RECORD COPY l
. :- - <o, ROZER -YF" CROZER-CHESTER KEYSTO It s A L T H SYFTEM um- ct-One Medical Center Bh d.
UplanJ, PA 19013 3995 t Tel 610.447.2000 j
{ /21V0 090* o3dL St/6 0 i l
January 9,1997 '
i U.S. Nuclear Regulatory Commission Region 1 475 Allendale Road King of Prussia PA 19406 ATTN: Michelle Beardsley
Dear Michelle:
We would like to apply for a Special NL.5:.r Material License to permit the follow-up of one (1) Colatomic Model C-101 nuclear-powered cardiac pacemaker containing 250 milligrams of Plutonium. (Previous license SNM-1691).
The pacemaker was implanted in 1977 at Cro7er Chester Medical Center. We will contact the physician group following the patient every six months to ensure that our information concerning her address and phone number remains current. We will continue follow-up for the life of the patient or until the pacemaker is recovered and returned to BioControl Technology, Inc This license request is for one patient follow-up only. Crozer Chester Medical Center does not intend to porsess or implant other nuclear-powered pacemakers.
The authorized user for this license is Howard P. Rothenbeig M D who is curiently an authorized user under our NRC License (37-12240-01) ;
The radiation safety ofEcer for this license is Diana L. Stockdale, M.S. who is currently RSO under our NRC License (37-12240-01)
The application fee of $1400 00 for a class 7C Special Nuclear Material License for human use is enclosed
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OFFICir.L RECORD 00F( FEB - 31997 l
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f if you have any questions concerning this request you may contact our Radiation Safety Otlicer, Diana l Stockdale at 610-447-2549. Thank you for your attention to this matter.
l Sincerely, f
/
1 c15 e President, Support Senices Crozer-Chester Medical Center One Medical Center floulevard Upland, PA 19013 use, ,,spu ,s,,,,,
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NRC FOPM 637 - *
' S. NUCLEAR REcuLATORY COMMISSION (14s) -
LMNSE FEE AND DEBT COLLECTION BRANCH DIVISION OF ACCOUNTINB AND FINANCE i LICENSE FEE REQUIREMENTS OFFICE OF THE CONTROLLER
. U.S. NUCLEAR REGULATORY COMMISSION WASHINGTON, DC 20555 0001 TYPE OF ACTION
- NEW LICENSE RENEWAL OF LICENSE ,
CROZER-CHESTER MEDICAL CENTER AMENDMENT TO LICENSE ATTN: DIANE L. STOCKDALE, M.S.
REQ'UESTECID TE RADIATION SAFETY OFFICER ONE MEDICAL CENTER BOULEVARD 1-9-97
~
UPLAND,PA 19013-3995 LICEN5I'NijldBER~ >
h6 PER OUR TELEPHONE CONVERSATION OF FEBRUARY 3,1997, SINCE YOU ALREADY HAVE A NRC LICENSE, THE PACEMAKER CONMOL NUMBER ~
REQUEST DATED 1/9/97 IS FEE EXEMPT. NO FEE IS DUE. 124116 ,
- l. APPLICATION FEE DUE 11. FEE NOT REQUIRED Your request for a hcensing action is subject to the fee (s) in the category (ies) noted below in accordance with Section 170.31 of the =yJ . Enclosed is Check No. 228861 73 We .#
- I which socompanied your ,
enclosed Federal Register notice. Payment of the fee is required prior to the issuance of the hcense, renewal, or amendment. request. The fee is not required beWse:g j
_ . _ We received your Check afb APPLICATION ._ RENEWAL ! AMENDMENT _ _ . _ _ _ q l No in payment of ,
jg g ,g h the fee
$ $ :$ i
- s s ,s - The Licensing staff has informed us that your request is to be I
. ,- p --
q, L.J < considered as a continuation of your request dated !
$ : $ , Control No.
3 5 8 5 5 .$ _-
l Your request was combined, prior to review, with your
$ 5 $
request, Control Ill. CHECK RETURNED ~
FEE (s) DUE 5 I
PAYMENT RECEIVED S ~
by e o AMOUNT DUE 3 j
j
_7 INSUFFICIENT FUNDS {
! l Your request was received without the prescribed application i
l he. . . ACCOUNT CLOSED l
T ,
- received your Check -
O 'OTHER
] No. , in the amount of >
$_, _ . Payment of the additional fee noted above is required 1
--- I MAIL THE REPLACEMENT CHECK TO THE ADDRESS LISTED AT THE 0 Your request willincrease the scope of your license program.
Therefore your request is subject to the apphcation fee (s) noted TOP OF THIS FORM AND REFERENCE THE ABOVE CONTROL NUMBER.
l above. Refer to Section 170 31 and Footnote 1(d)(2).
~
IV. LICENSE ISSUED WITHOUT THE REQUIRED FEE i Your heense expired pnor to the receipt of your appli5 tion for - ~ License , Amendment renewal Therefore, your request is subject to the application fee (s) -
- No. No. _ _ ,lasued on noted above Refer to Section 170 31 and Footnote 1(a). was ssued without the mquired fee being collected. The fee required is noted ;n Section I of this MAKE PAYMENT OF THE FEE (S) TO THE U S. NUCLEAR - Nsc~o'pe of your heenied proghm was increased. The ofore, your REGULATORY COMMISSION AND MAIL THE PAYMENT TO THE request is subject to the appacc.t on fee (s) noted in Section 1 of this ADDRESS LISTED AT THE TOP OF THIS FORM. IF WE DO NOT form. Refer to Section 170 31 and Footnote 1(d)(2).
RECEIVE A REPLY FROM YOU WITHIN 30 CALENDAR DAYS FROM THE DATE LISTED BELOW. WE SHALL ASSUME THAT YOU DO NOT ;
WISH TO PURSUE YOUR APPLICATION AND WILL VOID THIS Be'cause of the urgency of your requed,lhe license was issued ACTION - without remittance of the prescribed fee noted in Section 1 of this form.
SIGNATURE - LICEN5E F EE ANAL.YST i.FDCB ! LFDCB Dietribution: DATE r Ragion I
- Odd Pending taFAAS R/F oc/DAF R/F BRENDA BROWN 301-415-6055 ' 2/7/97 , narown oc/nAF s/r u .3.2.7) -
2-7-97 wic rom su n. N -n .=ciridiOMuceny EMo Federal Form, inc i
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- (FOR LFMS USE)
- INFORMATION FROM LTS
- -BETWEEN. .
-- LICENSE FEE M AN AGEMENT BR ANCH, ARM = PROGRAM CODE: 22160
- AND : STATUS'CDDE: 3
- REGIONAL: LICENSING SECTIONS : FEE CATEGORY:_ ,,________ .... ____c
& : EXP. DATE: O r .: FEE COMMENTS:
e : ' D E C O M F IN A S S UI IH57 _-~ ~------
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.A. REGION [
r 1,- - APPLIC ATION ATTACHED r APPLICANT / LICENSEE:' C R0Z ER-CHESTER MEDIC AL CENTER RECEIVED-DATE: 970113
- DOCKET NO:. 7003092 CONTROL NO.: 124116 e LICENSE NO. :
- ACTION TYPE: NEW LICENSE
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w r, m 2. CORRECT FEE PAID. APPLIC ATION M AY BE PROCESSED FOR: 'S r AMENDMENT _........_____
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