Matls licensing package for amend 45 to license 21-04177-01 for ...

21
* e _ _ _ _ _ - __ _-____ ______-_-__mwwwwwwmmmwwwmm- wwwawwwwwwwwww_____----- ._ mw m w WA w_wiga w w m- g , NR FORM 374 " U.S. NUCLEAR REGULATORY COMMISSION " i g MATERIALS LICENSE g W E g Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of g Federal Regulations. Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations heretofore made g | g by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear g material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to g N persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions - N specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the N % Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. N | 3 9f/ kN | | '*"*** In accordance with letters dated 1 3.{.ecembgrg,21-04177-011995 and February 1, 19 g | | l- Lakeland Medical Center, St. Joseph cense m is amended g j in its entirety to read as follows: g N 8 2. 1234 Napier Avenue ' 4 Expn.ation Date | St. Joseph, MI 49085 January 31, 2000 5. Docket or f , 030-02049 ~ g g Reference No.M - $ E ' W 6. Byproduct. Source, and/or 7. Chemical and/or Physical 8. Maximum Amount that Lic:nsee g g Special Nuclear Material Form May Possess at Any One Time g Under This License g N H A. Any byproduct material A. Any radiopharmaceutical A. As needed 5 identified in 10_CFR identified in 10 CFR E E 3 35.100 35.100 M E < N 5 B. Any byproduct material B. Any radiopharmaceutical B. As needed 5 identified in 10 CFR identified in'10 CFR E E | N 35.200 35.200:(excluding i X s E ' ~ Tc-99m aerosols)' / T ' 1 y E ! , . , $ C. Any byproduct matsrial .C. Any radiopharmaceutical C. As needed E M identified in 10 CFR identified in'10 CFR E . 5 35.300 35.300 - E y 4 g W D. Any byproduct material D. Any brachytherapy source D. As needed E $ identified in 10 CFR. identified in 10 CFR E I I M 35.400 35.400 E . 5 E $ 9. Authorized Use: E N N W E W A. Medical use described in 10 CFR 35.100. W W E $ B. Medical use described in 10 CFR 35.200 (excluding Tc-99m aerosols). E N N g C. Medical use described in 10 CFR 35.300. E M N i N D. Medical use described in 10 CFR 35.400. E N $ M CONDITIONS E i W N E ! g 10. Location of use: 1234 Napier Avenue, St. Joseph, Michigan. 0 E h \ E M 9602280108 960214 d '' 1 g PDR ADOCK 03002049 Y g 'l C PDR Y h---mmm_mm=_==mmm__m__m_mmmmm_m__=__=__=====_=__m__m__m_m u - - - - -

Transcript of Matls licensing package for amend 45 to license 21-04177-01 for ...

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_-____ ______-_-__mwwwwwwmmmwwwmm- wwwawwwwwwwwww_____-----._

mw m w WA w_wiga w w m-g ,

NR FORM 374 " U.S. NUCLEAR REGULATORY COMMISSION " i

g MATERIALS LICENSE g

W E

g Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of gFederal Regulations. Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations heretofore made g |gby the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear

gmaterial designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to g

N persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions -

N specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the N

% Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. N

| 3 9f/ kN ||

'*"*** In accordance with letters dated 1

3.{.ecembgrg,21-04177-011995 and February 1, 1996g || l- Lakeland Medical Center, St. Joseph cense m is amended gj in its entirety to read as follows: g

N8 2. 1234 Napier Avenue' 4 Expn.ation Date

| St. Joseph, MI 49085 January 31, 2000

5. Docket or f, 030-02049

~

ggReference No.M-

$ E'

W 6. Byproduct. Source, and/or 7. Chemical and/or Physical 8. Maximum Amount that Lic:nsee g

g Special Nuclear Material Form May Possess at Any One Time gUnder This License

g

NH A. Any byproduct material A. Any radiopharmaceutical A. As needed5 identified in 10_CFR identified in 10 CFR E

E3 35.100 35.100M E <

N5 B. Any byproduct material B. Any radiopharmaceutical B. As needed5 identified in 10 CFR identified in'10 CFR E

E|N 35.200 35.200:(excluding i Xs

E'

~ Tc-99m aerosols)' / T '

1 y E !, . ,

$ C. Any byproduct matsrial .C. Any radiopharmaceutical C. As needed E

M identified in 10 CFR identified in'10 CFR E.

5 35.300 35.300 - E

y 4 g

W D. Any byproduct material D. Any brachytherapy source D. As needed E

$ identified in 10 CFR. identified in 10 CFR E I

IM 35.400 35.400 E.

5 E

$ 9. Authorized Use: E

N N

W E

W A. Medical use described in 10 CFR 35.100. WW E

$ B. Medical use described in 10 CFR 35.200 (excluding Tc-99m aerosols). E

N Ng C. Medical use described in 10 CFR 35.300. E

M N i

N D. Medical use described in 10 CFR 35.400. E'

N $M CONDITIONS E i

W N E !g 10. Location of use: 1234 Napier Avenue, St. Joseph, Michigan. 0 Eh \E

M 9602280108 960214 d''1

g PDR ADOCK 03002049 Y g 'lC PDR

Y

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e WA U. . LEAR GEIULATORY COMMISSION 2 3 iI N ',C ", PAGE or pactsI License rumber W

! MATERIALS LICENSE 21-04177-01 1,** * * * " * " " "4 SUPPLEMENTARY SHEET |i 030-02049I pI Amendment No. 45 iI il ii Ii pI ii 11. Radiation Safety Officer: Alexander Bogda, M.S. II

Ii 12. Authorized Users: I#

1

! A. Gene E. Maddock, M.D., for material in 10 CFR 35.100, 35.200 (excluding Tc-99m I

I aerosols) and 35.300. i,

I i

William F. Leahey, M.D., 1.orrma[d,ri R E g JFRI B. f 35.100, 35.200 (excluding iI ;-99fn aerosols), ind 35.300 |

| a(htlyroid carcinoma therapyh (excluding Iodine-131 forj

I

, v ,I C. Walter M. Decker g.D., for material in 10 CFR 35.100]and 35.200 (excludingg i

| Tc-99m aerosols).s >p p,

|ce ~,4 ,

D. Anwar Ahmad, M.D., for;ma'terial in 10 CFR 35.400,- ^ l! s: ~.g% ' ..gs 1 |.

| E. Muhammad Z. Iqbal, for m' ate'rj Al in;10'CFR/35[400. |' n fa/~

\Wi 'T iiRoman Hyszczak~, M.D., for material:2ind0 c 235.100 and 35.200 (excluding ii F.

8r'"

"Tc-99' ? aerosol s)im .P E 's 1

8 W 1,JW p p . A c., -

C~ l(f)! Daniel F. Kreider, MM (for Inater;ial )ls)tand 35!300.35.100',435'.200($cluding|G.,

Q 'i ;Ic-99fni aer'osy Cqy

I p yrQ u'N,%g Q f (r p

Kent T. LancasAer, M.D.i f'or material ^1n 35v100 and 35.200 (excludingd H. e i

|!s"

^/ Tc-99ni'aeroiol's) sid/35.300.i i;, Wp p-

i I. Kathleen Gafarian, M.D'', for material in 35.100,t35.'200 (excludingy

4 Tc-99maerosols)anf35.300.i 4 & g., e "P g#8 J. . Brad Bastow, M.D., for material''in 35.100 and 35.200 (excluding Tc-99m W

| aerosols) |<>) K. Don F. Brooks, M.D., for material in 10 CFR 35.200 (excluding generators y

4 and reagent kits) limited to cardiovascular clinical y

|- procedures only. F

>| L. Dilip Arora, M.D., for material in 10 CFR 35.100 and 35.200 (excluding Tc-99m

|q aerosols and generators) limited to cardiovascular clinical ,4 procedures only.i p

.

>! M. J. Christian Higgins, M.D., for material in 10 CFR 35.100 and 35.200 (excluding ij Tc-99m aerosols and generators) limited to P

) cardiovascular clinical procedures only. || >

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p======.-=.----- m--.____...._____, ,___ ,,___ _ _ m| N C Fum 374A U. . LEA % cE2ULATORY COMMISSION - PAGE 3 3 ior ,3ces4

License number i! MATERIALS LICENSE 21-04177-01 1

" " * * " " " " ' "I SUPPLEMENTARY SHEET || 030-02049 ,I

ilI Amendment No. 45 iIi'

||

1 iip

IIi 12. Authorized Users (Continued) iI iI N. John F. Fiederlein, M.D., for material in 10 CFR 35.100, 35.200 (excluding |

| Tc-99m aerosols) 35.300. |i,

i 13. A. The licensee may use the Calicheck device for doing linearity tests of its dose,

gI calibrator provided it follows the goc _edures in the Calcorp, Inc., Manual ij dated March 2, 1982. 8 HEG I

The licensee may use(t follows the procedures in tl}e\ Atomic Productsfktineator device for d ins linearity tests of its dose| B. I

calibratorprovidesMf |i1 Corporation LinegY Instructions Manual dated June 23 1983. ii N 4 Ii 14. The licensee may transpoit' licensed material in accordance with the provisions of i| 10CFRPart71,"Pa,cfaging?a%nd?Transportationof. Radioactive ^ Material."

I

gf Ig4

! s

The licensee will require the'l5uthorized| user perfbrhing an iodine procedure to .cign |i 15.

awrittenrequest;thatwillindi{dsthesupplierpriortoorderingthedose,at'e thi name'ofgthejpatient,sisotope, i|i

radiopharmaceutical, activity,g'an ii y g 44{ .q yr

| 16. In addition to th'ePpossession limits in i,

h

restrict the possession 'ofdlicense'djiate(Coiidition''8, the :licens6e shall furtherrjiki o quantities belo' the minimum limit ii w

ww yshih ?decommissioningTfinancial assurance. |fpr es' tabi specified in 10 CFR,30.35(dmier c- , i

n

Except as specifically provi ed'other%'efinsthisflicense,-the licensee shalla ,

d 17. wis k! conduct its program in,accordance~ with/the' stat'ements, repfesentations, and i[ procedures contained in''ithe documents',Miricluding any enclosures, listed below, iq except for minor changes iiQthe medical use radiationJsafety procedures as provided |4 in 10 CFR 35.31. The Nuclear Regula. tory Commission's' regulations shall govern g .

! unless the statements, represent ~ations,_and.proce~dures in the licensee's application p |

| and correspondence are more restric'tive than' the regulations. Eh

F i

| A. Application dated June 20, 1994; and ii h

4 B. Letter dated June 20, 1990 (excluding the requests to change Items 7., 9.2,b

! and 10.14), I'i,e

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4 'FOR THE U.S. NUCLEAR REGULATORY COMMISSION |

., - |~

! >

N [d oq Date 2//4/96 By w' '

Nu ear Materials (icensing Braqth, Region III, ,I DV l

L------__..._....__ _ ._.-__-_ _ ___a|*. __________ -

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .___

O O |^

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(FOR LFMS USE),

,O : INFORMATION FROM LTS |EETWEEN: : --------------------

:LICENSE FEE MANACEMENT ERANCH, AFM : PROGRAM CODE: 02120

O AnD : STATUS CcDE: OP.EGIONAL LICENSING SECTIONS FEE CATECORY: 7C 2B*

: EXP. DATE: 200001312 FEE COMMENTS: CODE 23

O DECOM FIN ASSUR REOD: N: : .::: ::::,:r::::::::::::::::::::::::

LICENSE FEE TRANSMITTALO

A. REGION

1. APPLICATION ATTACHED$ APPLICANT / LICENSEE: LAKELAND MEDICAL CENTER

RECEIVED DATE: 960116DOCKET NO: 3002049,

CONTROL f40.: 399874O LICENSE NO.: 21-04177-01

ACTION TYPE: AMENDMENT -

!vd #2. FEE ATTACHED

H f40.: :~ dff/Md ~ E

3. COMMENTS /dO /J ' ,,/ -

i--

SIGNEDDATE ::~g-J f__ ,,,,,_,,

'~,t o' '

|O! E. LICENSE FEE MANAGEPENT ERANCH ( C H E >"" W W Ea' M o ~ S"* r " " * CRED / '

1. FEE CATECORY AND AMOUNT: ,., _ _ _ . ____,

O 2. CORRECT FEE FAID/ APPLICAT]DN MAY EE PROCESSED FOR:AMENDMENT /

---.. -- ..---

LICENSE ~ . ~ . " . ~ ~ ~ ~ . ~ - ~ ~ ~ -. . ... -

3. OTHER

gg:::::::::::::::::::::::::::::: :::d::6, f 4:::::::::::: 0g s'O SIGNED

44 g__ :::uTe

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q@ \p \Y0gS$b1RNFCD fly LFDCB

'O (v" .pqg[ d~ ~ ~ y~_ ~ a _=

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Date Completed,

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Lakeland Regional j|g Health SystemL 4

.

l

'

December 13,1995'

:

James Mullauer'

: United States Nuclear Regulatory Commission' i

- Region III, Materials Licensing Section801 Lisle, IL 60532-4351

RE: License Number 21-04177-01 :

Control Number 399146,

'

'

Dear Mr. Mullauer:

This letter is in follow up to the phone conversation you had earlier today with Cheryl Weise'

,

|

regarding the license amendment request to include Dr. J. Christian Higgins as an authorized useron our license. The original amendment was requested in August,1995. We then sent an j

additional amendment request for the name change at our facility. The amendment was granted |for the name change, amendment number 43.'

.

|

You indicated that Dr. Higgins would not be added to the license at the time the amendment was |

granted due to an incomplete preceptorship form (he was missing part A). Upon completion of ithis form, we were to resubmit the entire preceptorship form for a new amendment to include Dr.Higgins as an authorized user on the license. Enclosed you will find the completed preceptorshipform for Dr. J. Christian Higgins.

Thank you for your patience in this matter. If you have any additional questions or require ,

'

additional information, please do not hesitate to contact Cheryl at (616) 983-8868.'

%ely,i

J.

6d/VIWWobert P. Ham. on

. ChiefOperating Officer

RPH:nhEnci~ 'd 4 ~

8 g7 g RECEIVED/

Jg ' ggREGION III |'

1234 Nap;er Avenue, St. Joseph. MI 49085-2158 616/985-0999 {

37'NN.

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) n} 1 DATES AND TOTAL NUMBER OF HOURS RECElVED IN Cl.INICAL RADIDISOTOPE TRAINING l' i

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I ! NAME OF SUPERVtSon

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tb NAME OF INSiliUTION 7. PRECEPTOR'S NAME iPtesse type orptint).

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'Kenneth A. Brown. HD i I' . .-DirectorsNucledr,DerdiOlogy[^ [ |I ,I|

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oi : J. Christian Higgins, MD has successfully completed a cardiology |! ' ~ fellowship program at' Fletcher Allen Healthcare / University of ! ,

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Dr. Higgins is fully trained in nuclear cardiology procedured and |i,,; interpretation including; radionuclide ventriculography, exercise i 7

', and pharmaceutical stress testing with SPECT'and planar perfusion q!,

1maging using sestamibi and 2 T1. Dr. Higgins has speht a total of *

7 months of dedicated time in our high volume nuclear cardiology i ;. .

t ,-( laboratory 4 Dr. Higgins has met the clinical'irequirements i ;j p ; ];,3, bpecified in 10 CFR Part 35.920.

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a~ 1aw. If the reader of this massage is not the intended recipient, you ane lereby notified that any disocmination,

d bution or copying of this facsimDe irmwMa is strictly prohibited.If you have recehwi this communication in error,please notify us immediately by telephone, and return the original message tu us at the above address via the U.S. PostalServie.*lhank you.

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~&ansmission

Date / // / 94 Pagm(includmg cover 6 {By d , gp 4'

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ete-el-i m 12:24 Phu1 PVTIC HEART CENTER TO 917085151259 P.02'

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{WLakelandMedical Center

February 1,1996

| James MullauerUnited States Nuclear Regulatory CommissionRegion III, Materials Licensing Section801 Lisle, IL 60532-4351

RE: License Number 21-04177-01ControlNumber 399146

i DearMr. Mullauer:

This letter is in accordance with the discussion we had earlier today regarding adding anadditional authorized user to our Materials License while we currently have an amendmentrequest open. Since the individual this regards has previously been an authorized user on a licenseund we were not requesting additional materials or use for this indMdual, you stated that it wouldnot be a problem to include him in the open amendment request. g

,

Please include John F. Flederlein, M.D. to Materials License Number 21-04177-01 under 10 CFR

35.100,35.200 and 35.300. Enclosed is a copy ofthe Materials License were he was previouslyan authorized user.

Once again, thank you for your helpfulness in this matter. Please do not hesitate to call me at(616) 983-8868 ifyou have any questions or require additional information.

4

i Sincerely,

Ch eise, CNMT.

.

I

0e !W*

ChiefOperating Officer

O,

6d18 Doors 4|| Rnnr1. Rntric n Coniet MI 49102 . Phone 616/471-776131 Nor1h $t, Joseph Avenue e NUes. Mf 49120 Phone 616/6834101234 Napier Avenue . St, Joseph, M:49085 Phone 616/983-8300

.

1cco ui-i no Ae.ea t-mun mt McHki Lt:ril t-R TO 917085151259 P.03 '

g.rar r,rraLEw_w w wwww wwwww=w=====w=_I' fg FORM $74

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U.S. NUCt. EAR REW!LATORY COMMt&SiONAR)endmen ho. 26 | \i MATERIALS LICENSE se

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g Pursuant to the Atomic Encrgy Act of 1954, as amenJed. the Energy Reorganit.ation Act of 1974 (Public Law 93 438).and Titic 10. Code |

; Federal Regulations, Chapter I. Parts .to,31, 32. D. 34, 33,36, 39,40, and 70, and in reliance on statements and representations heretofore ma ) !g by the licensee, a license is hereby issued authorizin g the beensee to receive. acquire, possess, and transfer byproduct. source, and special nuclear

Imaterial designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver of transfer such material to NI

persons authorized to reselve is in assordanse with the regwlations of the appil54 tile Part(s).*This licerise s!6411 be deemed to contain the conditions5IspecinId in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of theENuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

E

l- E

Ei UC8n5"In accordance with letter dated E

June 29, 1995 EI. Lafayette Home Hospital3. Ucense Nurnber 13-09788-01'is amended in i

! its entirety to read as follows: > E

E2. 2400 South Street . .

Elafayette, IN 47904-3027 4. Expustion Date September 30, 1998 E

N '

5. Docket orReference No. .: 030-01642 E

i|

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4. Byproduct. Source. and/or 7. Chemical and/or Physica! ' .. a. Maximum Arnount that Licertsee (,

Special Nuclear Material Form '' / May Possess at Any One'Ihne+ UnderThis License

g~. .

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-..

A. Any byproduct A. Any A. As neededE

material identified radiopharmaceutical q

in 10 CFR 35.100 identified.in 10 CFR q

g~. 35.100 ( c -

: : .: . , e:ni | |. . . . . . .B. Any byproduct J B, Any B;' As needed

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indterial identified 'radiopharmaceutical Nin 10 CFR 35.200 identified in 10 CFR'

.

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35.200 > E

(-. .,

C. Any byproduct C. Any ' :' EC. As needed (not to g'

material identified radiopharmaceutical exceed I curie of..

in 10 CFR 35.300 identified in 10 CFR NT-!.31 ) -

35.300g

MN

9. Authorized Use: 5E

A. Medical use described.in 10 CFR 35.100.

B. M: dical uso described in 10 CFR 35.200. 1C. Medical use described in 10 CFR 35.300.4

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MATERIAL 5 LICENSE 3-09 m -01 | |U**""""* Is SUPPt.EMENTARY SHE ET i'

030-01642

Amendment No. 26 i

|-

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| CONDITIONS |;

E10. Licensed material shall be used only at the licensee's facilities located at i

I2400 South Street, Lafayette, Indiana. I |

'

11. Radiation Safety Officer: John A. Knote, M.D. '

j12. Licensed material listed in Item 6;ahoYetIsf.~onTy' authorized for use by, or under the |

| supervision of, the following iddiv'iduals for 'the, mate als and uses indicated: |(' N I

g* V ', -| ,

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,I Authorized Users ''

Material and use Q'

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| A, William J. Miller, M.D. ;, 10CFR35.10,0r35.20D}and35.300~

I,

''B. John A. Knott M.D. FR 5'35.200(and35.300 ,

1 C. JohnW.RemoTdM.D. :; . /. 10 CFR.3 00,35.200$d35.3003j

s. N -s.> r- -

i s. ey D. Glen A. Tuckm_a..n, M.D. -;< 10 CFJt 100,35.200) iodine-131 for P

'

ilijr.Q',%'jtWatme,i. N g'.i >

f,)y,perthyrj dism and thyroid {|g

5@Mc8'4fa}*8Jg4 A|n p

E. DavidR.Schm6bM.D.?jisF J0ilimitaidYto cardiovascular !i h' C[b Fdb5I$i,c'h/pceduny

1

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F. Phyllis Martin-Simerman M.D. 10CFR35.100,,3C200and35.300.

| N $10 CFR 35100,' 35.200 aE 05.300 gr G. Jeffry S. Cahoon, M.D. -

4, % -4 ok Y gH. Mark C. Arvin, M.D. 70 CFR 35.100, 35.200 and 35.300 1

3fla T. Knroon Kay Ra11hagen.pnth. N.D. 10 CFR M.100. M.2nn anti 15.300' ,

IIJ. John F. Fiederlein, H.O. 10 CFR 35.100, 35.200 and 35.300

j X. Joseph C. George, M.D. 10 CFR 35.100, 35.200 and 35.300 .I

! L. Collan Ismail, M.D. Io CFR 35.200 limited to cardiovascular

;$gclinical procedures a

.

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4 MATERTALS LICENSE 13-09768-01-

d SUPPLEMENTAR Y $HEET --Mn er Merme number-

1:030-01642

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I Amendr i.t'No. 26.

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'A 13.

conduct its program in accordance with the statementsExcept as specifically provided otherwise in this license, the licensee shall8

}| procedures contained in the documents, including any e,nclosures, listed belowrepresentations. and

except for minor changes in the medical use radiation safety procedures as pro,vided3ynin 10 CFR 35.31.1

The U.S. Nuclear Regulatory Commission's regulations shall governgt

unless the statements, representations, and procedures in the licensee's applicationI0and correspondence are more restrictive than the reguistions. jr

I :: ~., ,-

A.| Application dated August 20, .1993; and - ' ? (/ < ,

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i-LettersdatedMarch;2'2;#.-1994anjdMay2,1994.Y

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FOR THE U.S. NUCLEAR REGULATORY c0MMISSION),

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late fBy _ . ' wy h,,,a'

1Na 131: Licensin Secton, Reg [cnIII y%m . ,,rwmmw, g. n . . . -,. . ... . (_ b'

TOTAL P.05,

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FEB 2 01996 :1

!

'|

Robert P.' Harrison |

Chief 0perating Officer ;

Lakeland Medical Center, St. Joseph '

1234 Napier Avenue !St. Joseph, MI 49085

Dear Mr. Harrison: ;

'

Enclosed is your Amendment No. 45 to your NRC Material License No. 21-04177-01in'accordance with your request. -

i

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 III office at (708) 829-9887 so that we can provideappropriate 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. Unless your license has been terminated, youmust conduct your program involving byproduct materials in accordance with theconditions of your NRC license, 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," and other applicableregulations.

2. Notify NRC, in writing, within 30 days:i

a. When an authorized user or Radiation Safety Officer permanentlydiscontinues performance of duties under the license or has a namechange; or

b. When the licensee's mailing address changes (no fee is required ifthe location of byproduct material remains the same).

3. In accordance with 10 CFR 30.36(b) and/or license condition, notify NRC, ;

promptly, in writing, and request termination of the license when you !

decide to terminate all activities involving materials authorized under :

the license, f

4. Request and obtain a license amendment before you: |1

a. Receive or use byproduct material for a clinical procedure permitted junder Part 35 but not permitted by your license issued pursuant to ithis Part;

3@O 4i,

_ _ _ _ _ _ . _ _ _ _ _ _ _ _

, . . . . . _-

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.

<

Robert P. Harrison -2- !

b. Permit anyone, enc;;t individuals described in 10 CFR 35.13(b), towork as an authorized user under the license;

,:

c. Change Radiation Safety Officers;

d. Order byproduct material in excess of the amount, or radionuclide,or form different than authorized on the license;

,

!

e. Add or change the areas of use or address or addresses of use ;

identified in the license application or on the license; or

f. Change ownership of your organization.,

5. Submit a complete renewal application with proper fee or terminationrequest at least 30 days before the expiration date of your license. Youwill receive a reminder notice approximately 90 days before the expirationdate. Possession of 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 where licensed material has :

never been possessed or used.

In addition, please note that NRC Form 313 requires the applicant, by his/hersignature, to verify that the applicant understands that all statements contained i

in the application are true and correct to the best of the applicant's knowledge.The signatory for the application should be the licensee or certifying officialrather than a consultant.

You will be periodically inspected by NRC. Failure to conduct your program inaccordance with NRC regulations, license conditions, and representations made inyour license application and supplemental correspondence with NRC will result inenforcement action against you. This could include issuance of a notice ofviolation, or imposition of a civil penalty, or an order suspending, modifyingor revoking your license as specified in the General Policy and Procedures forNRC Enforcement Actions. Since serious consequences to employees and the publiccan result from failure to comply with NRC requirements, prompt and vigorousenforcement action will be taken when dealing with licensees who do not achievethe necessary meticulous attention to detail and the high standard of compliancewhich NRC expects of its licensees.

Sincerely,James R. Mullauer, M.H.S. ,Health PhysicistNuclear Materials Licensing Branch

License No.: 21-04177-01Docket No.: 030-02049

Enclosures: Amendment No. 45

v. 1.i, . ..p, ., thi. 4..um.\ 03 0 0 2 0 4 9 . C L 6DOCUMENT NAME: M: int. inai.. . in th. 6..: c . copy without .it. chm nii.ncio.ur. t . copy with .et.chment/.ne:oeure N - No copy

0FFICE DKM9Rlli |NAME Mhjl)hte'r)/sjdDATE 2708/96(

OFFICIAL RECORD COPY !!

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.

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E Lakeland !Medical Center

,

,

February 1,1996

James MullauerUnited States Nuclear Regulatory Commission4

Region III, Materials Licensing Section80l Lisle, IL 60532-4351.

,

RE: License Number 21-04177-01Control Number 399146

,

1

|- Dear Mr. Mullauer:|

This letter is in accordance with the discussion we had earlier today regarding adding anadditional authorized user to our Materials License while we currently have an amendment

.,

!request open. Since the individual this regards has previously been an authorized user on a licenseand we were not requesting additional materials or use for this individual, you stated that it wouldnot be ' ' problem to include him in the open amendment request.a

IPlease include John F. Fiederlein, M.D. to Materials License Number 21-04177-01 under 10 CFR

'

35.100,35.200 and 35.300. Enclosed is a copy of the Materials License were he was previously-

an authorized user.

Once again, thank you for your helpfulness in this matter. Please do not hesitate to call me at(616) 983-8868 if you have any questions or require additional information.

i

Sincerely,

|

Che 1 eise, CNMT. , .

|

ei d- .- - RECEIVEDs

Chief Operating Officerm . ~ r- - - -- < ,n -

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;FEB.O 61996- n -

:Rf@,hy#51116418 Deans Hill Road . Berrion Centet MI 49102 = Phone 616/4717761

31 North St. Joseph Avenue e Nilos. MI 49120 = Fhone 616/683-55101234 Napier Avenue . St. Joseph. MI 49085 . Phone 616/983-83f10

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AmendmenYNo.26U.S. NUCLEAR REIULATORY COMMISSION

g MATERIALS LICENSE _ qId Pursuant to the Atomic Energy Act of 1954, as amended. the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 1o. Code of Iy Federal Regulations. Chapter I. Parts 3o. 31,32. 33. 34. 33,36. 39. 4o. and 70. and m reliance on statements and representations heretofore made

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g by the licensee .t license is hereby issued authorizing the licensee to receive acquire. possess. and transfer byproduct. source. and special nuclear1

material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to I

persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions kspecified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicabic rules, regulations. and orders of the kNuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. E

IE

l-i Ei Licensee In accordance with letter dated E1 June 29, 1995 EI 1. Lafayette Home Hospital 3. License Number 13-09788-01 is amended in EI

Eits entirety to read as follows: *

I Ei 2. 2400 South Street EI Lafayette, IN 47904-3027 4. Expiration Date September 30, 1998 EF

E

e7e 030-01642 Ee No. .

| 6. Byproduct. Source, and/or 7. Chemical and/or Physical 8. Maximum Amount that Licensee ( jj Special Nuclear Material Form / May Possess at Any One Time g 4

Under This License Ig

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J A. Any byproduct A. Any A. As needed g imaterial identified radiopharmaceutical g )i in 10 CFR 35.100 identified in 10 CFR g

35.100 ,.

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material identified radiopharmaceutical,

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in 10 CFR 35.200 identified in 10 CFR35.200 - E,

YC. Any byproduct C. Any 'C. As needed (not to p'

material identified radiopharmaceutical exceed I curie of E -

in 10 CFR 35.300 identified in 10 CFR T-131)'

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E35.300 g I

|9. Authorized J:a:

A. Medical use described .in 10 CFR 35.100. g

B. Medical use described in 10 CFR 35.200. |C. Medical use described in 10 CFR 35.300.

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MATERIALS LICENSE .3-09788-01 1 ;

SUPPLEMENTARY SHEET Den or warme nuber --

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030-01642|

Amendment No. 26 | |

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CONDITIONS !I I

10. Licensed material shall be used only at the licensee's facilities located at i l

2400 South Street, Lafayette, Indiana. N |p ..

11. Radiation Safety Officer: John A. Knote, M.D. ||. . . . . . p |

12. Licensed material listed in Item 6 abovelis'.only, authorized for use by, or under the isupervision of, the following<iridiv'iduals for 'the-materials and uses indicated: i

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,'Authorized Users z?;U Material and Use Q i'"

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'- O IWilliam J. Mille,r, M.D. ,i . 10CFR35.100,35.200}and35.300A.

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JohnA.Knote[,H.D. . f.:'.

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C. John W. RemoTJ,M.D. - 32 y &~^**% )e. 10 CFRs300,35.200$d35.300 g i

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5.- 10 CFR 100, 35.200 $ ,pd iodine-131 for P j_ , . .

QW;.. , '%'"-{tpht'm.'3D. Glen A. Tuckman, M.D.

jq e.ntJof, hyp,erthyr idism and thyroid |f -Q1 g l1 -

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18 E. David R. Schmid,t'; M.D.7 Sr#AlhCFR:35:200 limite'd.to cardiovascular p 1

I . ini,cag ocedurer ~ g'.g

/|F. Phyllis Martin-Simmerman, M.D. ' 10 CFR 35.100, 35.200 and 35.300 )

ec10 CFR 35 100,' 35.200 a X 05.300 p |G. Jeffry S. Cahoon, M.D. .-

4 Y gj V % .A'10 CFR 35.100, 35.200 and 35.300.

;q H. Mark C. Arvin, M.D. -

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I. Koreen Kay Ballhagen-Potts, M.D. 10 CFR 35.100, 35.200 and 35.300 f )A ,,[di J.ri

.. John F. Fiederlein','N.D. 10 CFR 35.100, 35.200 and 35.300 + '

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>j K. Joseph C. George, M.D. 10 CFR 35.100, 35.200 and 35.300 N1

4 i jL. Gellan Ismail, M.D. 10 CFR 35.200 limited to cardiovascular 3

J,a clinical procedures'a.i P

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MATERIALS LICENSE 13-09788-01 i

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030-01642 F

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Amendment' No. 26 ,

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13. Except as specifically provided otherwise in this license, the licensee shall |) conduct its program in accordance with the statements, representations, and pLi procedures contained in the documents, including any enclosures, listed below, i5 except for minor changes in the medical use radiation safety procedures as provided R

| in 10 CFR 35.31. The U.S. Nuclear Regulatory Commission'c regulations shall govern E

|$ unless the statements, representations, and procedures in the licensee's application jr1 and correspondence are more restrictive than.th6 regulations. ,

A. Application dated August,,20,.199 ; and ' - L/

| B. Letters dated March 22,'1994 and May 2, 1994. f--

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