_ _---____ -___ _ - ______- - ______- _ _ _ _ - _ _ - - - - _ _ - - - - _ _ - - - - - _ _ _ _ _ ------.
.
u.S. NUCLEAR REGULATORY Commission g g MATERIALS LICENSE 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 Fed:ral Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations 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 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license
, sh:ll be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all I applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specif'e d
c.
Ucensee In accordance with the letter dated May 19,1998, and fax transmittal dated June 2,1998 1. St. Joseph's Community Hospital 3. Ucense number 48-16117-01 is amended in of West Bend, Inc. Its entirety as follows: 2. 551 S. Silverbrook Drive g R le. gpiration date January 31,2002 W st Bend, WI 53095 Y- b 5. Dock"et 1(o 30-10451 Q Reference { v v 6. Byproduct, source, and/or special @ 7. Chemical and/or physical form ' , 0. ximum amount that licensee may nuclear material 7 ess at any one time under this O g a, 4 li nse A. Any byproduct materi I Nh adiopharpiaceu ~ ! A. ks needed identified in 10 CFR 100 Tidentified in 10 CFR 35.100 0 ' c,:n ( ( A u.4 ._7 - B. Any byproduct materW BCAny. ceutical B. s needed identified in 10 CFR 3g200 : # Tident FR 35.200 3|* O ' f %g N' ?, C. Any byproduct ma'erial S Afu1yfac i talTlaceuticalG C.[As needed (not to exceed 1 identified in 10 CFR 35. : identifit .11) CFR 35.300 o, curie of I-131) ,; ~, .;.3y y D. Any byproduct material h D. P packaged Mts ' 9) O.D As needed identified in 10 CFR 31.11 4 Q' 4 Q a v h
9. Authorized Use:
A. Medical use described in 10 CFR 35.100.
B. Medical use described in 10 CFR 35.200.
C. Medical use described in 10 CFR 35.300.
D. In vitro studies.
CONDITIONS
10. Licensed material shall be used only at the licensee's facilities located at 551 S. Silverbrook Drive, West Bend, Wisconsin,1700 W. Paradise, West Bend, Wisconsin, and 205 Valley Avenue, West Bend, Wisconsin. t g y j ,ng , , " 7' 9807080191 980604 ( .I b '\/ PDR ADOCK 03010451 d b W'' II C PDR _ 's
NRC FORM 374A u.s. NUCLEAR RE!uLAToRY Commission PAGE 2 of 2 PAGES Ucense Number 48-16117-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-10451 Amendment No.12
11. Radiation Safety Officer: Robert L. Meredith, M.L.
12. Licensed material listed in item 6 above is only authorized for use by, or under the supervision of, the ! following individuals for the materials and uses indicated:
Authorized Users Material and Use j
Robert L Meredith, M.D. 10 CFR 35.100,35.200,35.300 and 31.11
Patrick M. Gardner, M.D. g R idfft 35.19,35.200,35.300 and 31.11
William J. Pier, M.D. O 10 CFR 35.100,3h,35.300 and 31.11 D G John G. Fink, M.D. Y 10 CFR 35.100,35.200,3$.300 (excluding 1-131 for g k, m, thyroid carcinoma)'and 31.14
13. The licensee is auth ek to trans m'Eiirlal oni rdance Oh the provisions of 10 CFR Part 71, " Packaging an transportation"of' R$dioactivd Mdtsrisf.st O , /k 4"44 ,,MM E 14. Except as specifically provided se in- the lice 6see shall cogduct its program in accordance with the sta$pment rocedures contained Irf'the documents, including " any enclosures, listed below, ex'q' 'lM i the medicil use rgBlation safety procedures as provided in 10 CFR 35.31RThe b asion'*9egulations shall govem unless the . m
statements, representation, and . Econsee's application (Ad correspondence are more ' restrictive than the regulatio(s f5) " A. Application dated July 24,1"999,
B. Letters received October 17,1991 d ru 2 996 with enclosures);
C. Letters dated December 18,1991, January 16,1992, and June 19,1996; and
D. Close-out survey results dated August 13,1996.
' FOR THE U.S. NUCLEAR REGULATORY COMMISSION
JUN 0 41998 Dats By Vw 0$ 1 - - a Jam 4pf R. Mullau'er, M.(.S. Nuclear Materials Licensing Branch Region lli ______- _ _.. . ) ' f e -
: (FOR LFMS USE) ) : , INFORMATION FROM LTS BETWEEN: : ______License Fee Management Branch ARM Progran Code: 02120 ) and Status Code: 0 Regional Licensing Sections : Fee Category: 7C * Exp. Date: 20020131 * Fee Comments: ) : Decon Fin Assur~ Req 8T~R~~~~~~~~~~~~ :::::::::::::::::::::::::::::::::::::: ) LICENSE FEE TRANSMITTAL I A. REGION $ j
- 1. APPLICATION ATTACHED ) | Applicant / Licensee ST. JOSEPH'S COMM. HOSP.0F WEST BEND | Received Date 980528 1 Docket No: 3010451 '' Control No.: 303999 0 3 e ) License No.: 48-16117-01 .;; Action Type Amendment V6 Q gg, 2. FEE ATTACHED 8 , ) Anount d k Check No.: ' ~2,, : 3. COMMENTS Si D.knede :::NOZ''f~~~~_~::::,~~ , ) 'B. LICENSE FEE MANAGEMENT BRANCH (Check Whe flestone 03 is entered /__/)
1. Fee Category and Anount: ,, __,,_____y,___f______,,______' 2. Correct Fee Paid. ./pplicationnaybeprocessedfor: Amendnent V Rcnewd ~~~~~~~~~~~~~'
License ::~~,, :~~ _~::~:
3. OTHER _ _ _ , , _ _ _ _ , _ _ _ _ , , _ _ _ , , _ , , , , , , , _ _ _ _ , , , , , , , _ _ _
______
oate ::::::_. _ ff:::::::::::::::::::
~ tse wie H 27.L______' nanient.. checkNo.J _2. ______- __ _. _ - ! Amount __ cd____ _-__.' Fee Category _,._7_d_____ . _ _ Typo of Fee ____AG2.b_ _ -- --
) - Date Check Rec'd ______. Dasey _ sy._____.______g ______;|
_ - __ - _ - , - _ __ __ .. ______- _ _ - _ _ _ - ______-______-__ - - aii
' M $1 JOSEPH'S ' COMMUNITY HOSPITAL . OF WESTIHND y Yoca Tausno Praimafur IJfEIDNG ntAIDL i [|ig May 19,1998 .. gp|a Op: U.S. Nuclear Regulatoly Commission O* 801 Warrenville Road Lisle, Illinois 60532
1 | Subject: By-Product Material License #48-16117-01
P
, Dear Sir or Madam: ?.+ #! We request that you amend our by-product material license to show the following i changes:
M 1. Please delete Roland Brown, M.D. as the Radiation Safety Officer. ypj 7l 2. Please add Robert L. Meredith, M.D. as the new Radiation Safety Officer. kk 'd 3. Please add Patrick M. Gardner, M.D. and Robert L. Meredith, M.D. as authorized users of by-product on our licence. Copies of training and preceptor statements are enclosed for your review. [Qm
4. We request these individuals be added for all materials that we are currently authorized for. W:q d 5. Enclosed please find our check for $460.00 to cover the appropriate amendment I#** g( . Should you have any questions or require additional information regarding this 3 matter, we authorize Mr. Ronald D. Edwards, Radiation Physicist, Radiation $f Protection Services, Ltd.,800 W. 5* Ave. Suite 103E, Naperville Illinois 60563 d (630) 309-6493 to answer any questions or provide any additional information you ] may require. p g Sincerely, Aadutd 7t&' ($) Barbara L. Knutzen RECEIVED vi Director of Professional and Support Services
, MAY 2 81998 , " * d"" h REGION III Enclosures: 1. Training and Preceptor Statements M1 2. Check for Amendment Fees MAY 2 8 R8
BOARD OF DIRECrORS Wmm W. Kieckhafer, Ih/mau.umwn h nusR.Bei Rohen D. Gilmon, M D Barbra T. Manm Rnden J. khnald Gregory T. Burns Rohen J. Swiner. Er Acadms Mx!wel F. Bk=xk,rn Amirew J Gurnm Mark A. Nrhen Rita B Scpenky Emwnw thw Rxhard A.14rwn. Tmuner Paul S. Christemen TmL! J. Hamner. M D. George L Preami Arty. ILine A. Shanchnmk Gre5or, T. Burns, hwirr Charles 5. Gnger, M.11 Allen C. IGepke Jean M Rngic Sbmn S. Zryler 551 S. Silverbrmk Drive, Wen Bend. WI 53095 3898 (414) 334-5533 Fax (414) 334-8484 ]Q - - ______. _ _ _ _ _
* ' ' - . , 0 0 .. .
t
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..
Date April 23,1998
| Ms. Michelle Uecker ' Nuclear Medicine Supervisor St. Joseph Community Hospital 551 Silverbook Dr West Bend, WI 53095 . ! Dear Ms. Uecker:
This letter is to verify that Robert L. Meredith MD. is in the process of completing his residency and will complete his residency by June 30,1998. Dr. Meredith has completed greater than the required amount of(500) five hundred hours of clinical and gmater than (500) hours of work experience, as well as two hundred (200) hours of didactic training.
I have completed and returned the preceptor forms to you along with this letter. If you have further questions or concerns regarding Dr. Memdith's training, feel free to contact me by phone at (608) 263-5306 or by fax at (608) 262-0907. i , !
' | l Sincerely,
b | Michael A. Wilson, MD. Chief, Nuclear Medicine Section | Chairman , University Hospital and Clinics | -. Radiation Safety Committee
| |
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' - ' '
exa1811 2 - . O o , SUPPLEMENT A
U.L NUCLEAR REGULATORY COMMi$$lON SLFPLEMENT TRAINING AND EXPERIENCE AUTHORIZED USER OR RADIATlDN SAFETY OFFICER . 2. R IC T 0 1 . MAME OF PROPOSED AUTHORIZED USER OR RADIATION SAFETY OFFICER .. MererH t h I?obe rt i 1 CERTIFICATION B00 NTH AND YE AR CE RTIFIED CATEGORY c SPECIALTY SOARD e ^ , I
4. TRAINING RECEIVED IN BASIC RAD 10lSO10PE HANDLING TECHfilOUES TYPE AND LENGTH OF TRAINING
CLOCK HOURS IN CLOCK HOURS OF SUPERVISED LOCAtl0N ANO DATW B) OP TRAINING LECTURE OR PIELD OF TRAINING 5 LABORATORY ON THE-JOB A EXPERIENCE
= 100 e. RAot AvtoM Physics ANo INST RUMENT ATION
University of Wisconsin 30 A RAoiATiOM PROTECTION Hospital and Clinics June 1, 1996 thru s. MATHEMATIC $ PERTAINING TO 20 THE USE AND MEASUREMENT Jul7 30' 1998 OF RA0lOACTIVITY
20 d. RADt Att0N 810 LOGY
e. RADIOPHARMACEUTICAL 30 CHEMISTRY -
5. EKFtRIENCE viliH R ADt ATION. (ActWan of nogetsotopes or Equirenent Experlence) TYPE OF USE CLOCK HOURS LOCATION ISOTOPE mC1 USED AT ONE TIME Jniversity of Wisconsin July 1, 1996 - fc~hm 330h ECi June 30,1998 250 mci lospital & Clinics I-131 indison, WI 53792-3252 s I-125 1 mci greater than 500 h 1-123 2 mci T1-201 15 mci Cr-51 1 mci Ja-67 20 mci _ _ . _ _ _ In-111 10 mci _. Cs-137 1 mci Co-57 10 mC1 EXH-5 f ko~-h 330$ @
i - . __ .
- ...... o . EXHIBIT 3 < . \ SUPPLEMENT B | O SUPPLEMENT U. 8. NUCLE AR REGULATORY COMMISSION
~ * PRECEFTOR STATEMENT l I .* Sunotement 3 must be carnpieud by me solicantphysicien'spoeceptor. Itmore nart useprecapnorin neonaery no anocument | esperoence,06 min a aspereer earament each.
O PRDPOSED PHYSICIAN USER'S MAME AND ADDRESS KEY TO COLUMN C | PULL w Anag PS ISON AL P ARYlCIPAfl0N 340WLD C0800187 OF | t swervened eneminsi6en et estiona to sostems.= ww susiamme, ser redometeos sharests and/or treatmens and resowenenseselon f or 4nhoPf I. Mevnd4tb Fr4Eerl%88 88891 8 * " # D " 88 24elleboretten la efuse entierstion and eseust eeninistreelen of aless to the patient includng eseculation of the rasket6en close.related - - - _ ta and stett6ag of abste, ~ iisty l g7 A ra Izarcopa SAdesweee perted et ereialas to enstae phys 6cten es me.ege resoect.w set 6ents end femow painsais through eherenas and/or eewse et trase sent.
2. CLINICAL TRAINING AND EXPERIENCF OF ABOVE NAMED PHYSICIAN IeLastEP OF CASES trov0LVl800 Cash 0$NTS 980 TOPE CONDefl0886 DIAONOSED 04 TRE ATED PE M AL (Asensaanst eniennet.as er remmene mer PARTICIPATION 88 as awwtere we shephces es asperee shoe e.J A 3 C D '' Ttyroid span ' ' /sD Thyroid uptake See attached sheets that ' - '& document training in therapies Lung perfusion scan $., "6,"'v g using radioactive meterials. ' ''.'/,, Xenon ventilation stud / ,s. ' '.f,,,- ' , , Aerosol ventilation scan O .r ; , ,, # ;,p /j,"rf, Renal flow scan !*' , , Brain scan >rh"V . ~' . # ,//' . Liver / spleen scan 2y ,. , f(>' Bone scan ' fj , ; Gastroesophageal study 4 fy,32,, "riz. ' Leveen shunt study .pp O' * Cys togram 7 ' Decryocystogram *I Cardiac perfusion s:an. . f '/ k Cardiac stress vent.riculogram . .J, . /.,,;, , Cardiac rest ventriculogram p'ge.',' , /,;d Gallium scan
0 0
EXH-6 _ ------_
* - - EXHIBIT 3 (Continubd) , Q
Y PROPOSED PHYSIC 1??.'JSf*. Robert L. Movedith M n PRECEPTOR STATEMENT (Continued) , 2. CLINICAL TAAINING AND EXPERIENCE OF ASOVE NAMED PHYSICIAN (Ccrithued) f numenn or ' ,y CAass sNvoLvlNo c0MMENTs (Aaffitietaf Wwmee,an er renmsee mar to is PE RSON AL suenuteaf da dehsee an esparaar sheeaf | 000 TOPE CONDITSONS DIAOseOSED OR TRE ATED PARTICIPATION | ,. C D 2 A B P*32 TRE ATMENT OF POLYCYTHEMIA VE R al. h e*1 LEuxEMiA. AND 80NE METASTASES , , , , , j n 3 See attached sheets that documeat training in therapies using { g,'1, istTRACAVITARY TREATWENT radioactive materials. t greater than 'C TRE ATMENT OF THY ROID CARCINOMA p . :: greater tha:t10 TREATMENT OF HYPERTHYROIDISM 9 Ai>190 INTRACAVIT ARY TREATMENT
g CW INTE RSTITI AL TRE ATME NT * C+137 INTRACAVITARY TREATMENT
4 sNTE RSTITIAL TRE ATMENT 3. T TELETHE RAPY TRE ATMENT C>137 8690 1RE ATMENT OF EYE DISE ASE R ADIOPH ARMACEUTICAL PREPARATION
f, GE NER ATOR GENERATOR
, Te40m RE AGENT KITS cowe Sm-153 1 mci per kilograr
i Sr-89 4 mci )
I I
i 3. DATES AND TOTAL NUMBER OF HOURS RECEIVED IN CLINICA LCLOCK RADIOL HOURS OF&OTOPE EIFERJENCE TRAINING LOCATION DATEC University of Wisconsin Hosp. & Clinics 6/1/96-7/30/98 greater than 500 hrs
E PRECEFTOR154GNATURE l'"TIII TiiAINING AND EXPERIENCE INDICATED ABOVE WAS OsTAINED UNDER THE SUPE RVISION OF: a maus or avranvason V n Md_cbnel A. Wilrnn r a haus OP INSTITUTION 7. PRECEPTOR'S NAME Pmme a ee arenatt Univ. of WT Henn & c14 nice e. MAILING ADDatBS Viebnn' A V41cna Y h .s.A a 6(in if e ,L '- - u.DATE Maddenn. WT M702 Up . s. mATa ntAbs uGEN5t, NUMSF MlU UW 48-008M-18 EXH-7 - :: . _ _ _ _ _ - _ - _ . _ - _ _ _ - _ _ _ - _ - _ _ _ _ _ - _ _ _ &/ ... * * ** . ' . EXHIBIT'( ' RESIDENT'S SUPPORT TECHNOLOGY TRAINING TASK LOG 1 ' , , nameh+ L. PerwMb H b. Supervising . Task Date Technologist's Perfomed Initials 1. Hot lab. a. Log and monitor incoming packages. b. Elute generator. ___ - - c. Measure and record Mo and Al ~~~ concentrations in eluate. - - d. - ~ ~ ~ ' Prepare each radiophamaceutical kit used. Measure taggin'g efficiency. e. Calculate volume of radiopharmaceutical ___ needed for prescribed dosage. Draw and measure dosage. - - - f. Perform constancy. accuracy. linearity. ~ ~ ~ ~ and geometry tests on dose calibrator. 9 _ _ , _ _ h. 2. Camera. a. Center photopeak, focus lens and dot. - - b. Perform and evaluate extrinsic and ~ ~ ~ ~ ~ intrinsic field uniformity checks. - - c. Perfom and evaluate spatial resolution ~~~ checks. ~ d. Check motion switches for safe - ~ ~ ~ operation. e. ___ . f. i 3. Processor and dark room. a. Operate processor. - - b. Prepare fresh chemistry. --~ c. - - Clean transport and crossover. racks.- - - - ' 7 ' ' - ~~ E 'd. Check safelight; ' ' e. [ ~_ ~_~ i f. . i .. 4. Safety surveys. a. ' Perform dose rate survey of clinic. - - b. Perfom removable contamination surysy ~~~ of clinic. c. _ Survey and log decayed waste. ~~ [,~ ~ d. - _ ,_ e. . - , M s' Preceptor 4 EXH-8 --______c .. ~;:- . . o O #. EXHIBIT 5 RESIDENT'S CLINICAL PROCEDURES TRAINING LOG - - Na&%& L. MecorYAb H.h . . Supervising Clinical Procedure Date Technologist's Performed Initials Thyroid scan - - - - . _ _ Thyroid uptake - - . . . _ - Lung perfusion scan - - . - . _ _ Xenon ventilation study ~ - - _ Aerosol ventilation scan - - _ , , _ _ _ Renal flow scan : Brain scan : : -. Liver / spleen scan . . ___ Bone scan \ - - __ Gastroesophageal study - - _- Leveen shunt study _ - - __ Cystogram - . _.__ . . Dacryocystogram - ~ _ Cardiac perfusion scan. - - __ - Cardiac stress ventriculogram - _ ___ " Cardiac rest ventriculogram -- Gallium scan :- - .. 6 p - _. - ee O _h Preceptor i EXH-9 m,. - - - - . - - - . - . , - - - . - - . - - , ------. - - . - - - - - . , - - - - . - . - - - - , - . - - - - - , - - . - - - - - . - - - - - . - - , ------. - - - . - - - - , - . . - - - . ------. . - . . - - - - - , , ------, . . ------, - - - . - - - . . - - : O . 4 0 ' S e $ ' Q C4i27/H - ' fr& L eb., e s . ._t.a ~ .,.h, aun...,. .w . A . . o.n- O-- '2 ' U ~ n, n we rv dih usu.m. us> u l l.s ,u m. s wi.m aaw+A s1' inN 4ae * T W ;a *l . rss h g.gq',:M.. Js s .aj re y a O A. m.m- .j . tygm.u.ab . . .p 4.-* ;q . .fra v m 1* as p(dAwd ! dp V " .t .py,w * rAhwg r ne -eg ?* ! L5?_G..~y.1.T. F.g t. U..tt. 3.j b". ' *N)u *C . .. . O 07d236 'EU u UF: Ass :r>S 0% W P2fEAEC H N D B 128 00003 Im0!DSCAN !!! . Q 0%f.011 70 RE LA!E!E Mi 0000017 T!!iRC;D EI Ki.YEY 113 OE030- TE?rl; EMION OF 3) ' - Q 00M95 *!YDie: E*.IFEAf! ,19 4 GDPs . OEXE 5:6 00)9Eb fAINISSA?Y $ - Q 00%00 FARATEYDID L'JCLIZ M XM FOLICTIEENIA TEEAEY l 0 % 0:22 k /?LA!FA Wi"E 16 - , - Q OM0175 _ A01EXE ECG X:SG 13 MM191 ELA"?2 SCG 2 OM0!M 6: (ASEE55) 5:6 E M21% LES03'I!3EA?ff 174 Q - , , . , . ~ ',J e.W ,e ui V!,A yAh... D. . * ' f * * h.vW,M. .i g, .u "ItZ.t.*r a* r?.,h' +(LO- .( hbMb [.!YN !0AN k 9 $ . u ww}.w .6 m$m...1 .. An... . e. ..n .v h , 4i . Q 00075 GE EFQ 3:n M . | n:34 9 ; GA m :". .E .E m e . a~ u,,, ....m. m.i wv, ,a u ) kb O! b!.b) bh b$h b) | M I" . kliES SCG 17 . msg .w& Tnumw .,s e A r , ,;s .. 6 ;wvwt J O M f.- I .% S. ${.!. #. '2 . f.P[(f.. . L$ i. k. * b.^tXI' ER5N. MINIM N ~n m ; mA , # my. v. Ar.F.m.a . m. $u. v n altf ^ 3at3'AN3F~^53- 3i O' r c; e.n,-y v Ps e n0.i. .csf tn e , ,c w- v 0Ih} j)$$ 3'.N E 'qq r s. h krr .,wa r u.w wa r, p...e} s O s . . k w 0:E157 E E S*E M S:S 2 | .e m n.wsd pn .c.- .A . bn n.0 - gs..t. , . **v 0, e - . 4 MW3 SBC WD FElf D',Nr ES Q_ ~ 70472 ~ RES D:A 5:8 MI N0iG E!*-W33 0:A 347 . * tmv snmI .e.. mf t;.e.g . L .m.... . gen. 4 h b0.h9 $.E ?N S'b'M b[A5 b U2Cf!?' . LT EETILAIi3 IIi DJ 0M27 SPET HA:h SJJ U i ; Q~ Mi$ CEEUi EU: ICE) 35 r- w n wvn n. vta . ut k .em.yi . su ' (-?;645 CSF SE; r EV ELAHi.! 16 ' Q' oms 50 CffLfAi37CY ' 0%C701 FINC. ELOS Gi - H E;4 ' 1EA*iVE HIF 15 0 . _ - _ ___ O ^ **t*. ~.. I| '~ * O .4. 9. n /,. ,- ' i #4 + , N'" ...T. .. ..,, 4. i O , .. ..4.e4hb, , . _ N. .. . , ...,L & . 1 . , i.e.a; r .; 2 -.5 i .' i r- .' - a .,. . , h o. g. . .. O s s... * f 99i, .*cp ? f es Fy 1 44 *p9 94 m% is | 'ss% e a.!|Ir.) .L ' 6.'. , l.....t., < 7....- t e. p p p .,; ,7ufi.;p.., **h Q* *C .- ut.^ \.;' .. ,,.s O ' 'f?"*1 y .J/* y . t. g ' '; j ..i,-g + !. .i w.j f' ,i M ::Li d' OJ.V P s y. p q .c..y. O n r..f t!.m um .e .'t, . i . 3 {. .s..,am..i..,. sb ., ._ O kP ' b N' Yl*' j.4 4s..<. 5 4 . s t- 0 J . N'. , . ., , . . .g ' I g 'J., J sw ) . .. - gm., g i * g- L .a ,.'s' , sg? I O ; ! l O , O , | ' , O | ! | O i O O O O ; 1 | 1 0 1. . O 1 | | | O 1 O .. O - . . O e e . - - - . . . . -- - --m-- nea a s . . ,* - ' ' EXHIBIT d ' , RESIDENT'S SUPPORT TECHNOLOGY TRAINING TASK LOG 1' ," namehA L. Henah H.b. Supervising Task Date Technologist's .- Perfomed Initials 1. Hot lab. a. Log and monitor incoming packages. ' b. Elute generator. ._l-g-3 tenu L.gz-AR t# M c. Measure and record No and Al concentrations in eluate. ,g,dZ,-91 t&M ' d. Prepare each radiophamacentfcal kit used. Measure tagging efficiency. e. Calculate volume of radiopharsaceutical 1 - { 7_ d W W needed for prescribed dosage. Draw and measure dosage. , g_-g1-91 W f. Perfom constancy, accuracy, linearity, and geometry tests on dose calibrator. ,g,, g2;g, N 9 ~ i h. i 2. Camera. a. Center photopeak, focus lens and dot. - b. Perfom and evaluate extrinsic and I.9-$~ ~ ~ ~ 4/ intrinsic fleid unifomity checks. T 9 b 4# c. Perfom and evaluate spatial resolution !. checks. 3 1 76 O /7 d. Check motion switches for safe operation. e. 8 -7 -%. Q# , f. 3. Processor ahd dark mom. ' a. Operate processor. b. Prepare fresh chemistry. O/AL $_.-R$ M_ _ _ c. Clean transport and cmssover racks.:. . .. L- .o rt ' G 'd . Check safelight. ** ' ~ L- & .g,- _ _ , _ - dv e. . ' f. . .. 4. Safety surveys. a. Perform dose rate survey of clinic. d t b. //,,, Q-f/ W) Perfom removable contamination survey / of clinic. - Survey and log decayed waste. //- M , E. 7N .. . | ' - W. I s Preceptor < ; ' ' . EXH-8 . .- _ _ . - _ . - __ ------. - - . - . - _ ~ ~ . -- _ ~ . :. O O . MEDICAL ' COLLEGE * - OFWISCONSIN *, Departmentof Radiology 3 Section of Nucieer Medicine FAX:414 771 3400 9200 W. Wisconsin Ave. Wauwatosa, WI 53226 11 May, 1998 . St. Joseph's Community Hospital Radiation Safety Officer 551 S. Silverbrook Dr. West Bend, WI 53095 To Whom it May Concern, I This letter accompanies the application for Nuclear Regulatory Commission authorized user status for Dr. Patrick Gardner. Dr. Gardner is currently completing one year of dedicated training in clinical Nuclear Medicine. During this period, he has completed the required clinical experience hours and didactic training in radiation biology / physics and radiopharmacy. Accompanying this letter are the cummulative summaries of clinical procedures performed over six of the preceding twelve month corresponding to Dr. Gardner's experience at these sites. I may be reached for any > further required comments at the Medical College of WI, Dept of Nuclear Medicine (414) 777-3771. 1 i Yours, ' " O-JS Arthur Z. Krasnow, MD Residency Directory , ; Assoc Prof Radiology i " I's.1*1"u"*oOn*J7# (414) 777 3771 ! 1 L. M2 98 16:20 f1CW ta) CLEAR l'EDICitE * 4143348497 tO.466 003 - - - . . . . O I. e EXHIBIT 2 . ~ SUPPLEMENT A f SUPPLEMENT | l U.S. NUCLE AR REGULATORY COMMassioN , , ' , TRAINING AND EXPERIENCE | AUTHDRIZED USER OR RADIATION SAFETY OFFICER | 1. HAME OF PROF 0 SED AUTHORIZED USER OR RA0rAfl0N SAFEi! MFICER 2. FOR PHYSICIANS. STATE OR Patrick M. Gardner, M.D. TERRITORY llHERE LICENSED Wisconsin 1 CERTIF: CATION SPtcl ALTY DOARO A CAff00RY B MONTH AND YtAR CfRflFIED C PAT 110 LOGY 5/98 . 4. TR AINING RECEIVED IN EASIC RADIOISOTOPE HANDLING TECHNf 00E8 TYTE AND LSNOTH OF TRAINING F888.0 0P TRAINING # LOCAT10N AND OATId510P TRAINING 8 y g r[ g 1A80RATORY ON-TifE-J08 EXPERIENCE s Medical College of Wisconsir ** "u*g"'n'u[seNT T y ANo From: July 1997 to June 199E 50 100 5. RAosttiow PROTECTION ,, ,, " 30 100 - e. MATHEMATICS PERTAINING TO THE USE AND MEASUREMENT e. " " OF RA080ACTIV87Y 40 100 . W. ftADIAfs0N 8tOLOGY " " " 40 100 e. RActoPHARuActuTacAL cHEumTRY ,, ,, o 40 100 EL EXPERIENCE WITH RADI ATION. (Actuef uer of Aadb/sotoper ar feulewAmt feerArnor/ ISOTDPE mCf USED AT ONE TIME LOCATION 99m-Tc 1000 CLOCK it0VP.S Medical Go11ege 01 40 TYPE OF USE 131-1 100 Winconsin, Froedtert citnical 125-1 * 0.1 10 , Memorial Lutheran 40 67-Ga 7 Hospital, VA Medical In-Vitro 201-Tl 4 20 Clinical Center, Milw., UI " 32-P 10 " 40 " 111-In 10 " 10 20 " .. | EXH-5 - ______. . . . . . !' - EXilIBIT 3 SUPPLEMENT B | | SUPPLEMENT * I . U. 5. NUCLE AH REGULATORY COMMissitw PRECEPTOR STATEMENT . SuWF ;t 8 must be costplesedby the vpliemt exponence, obsoln a supsreer earsemertt istun occh. phys!cim*epreceptor. !Ireswa 86m erne preceptoris pseceesaryoevment 00 en 1. _ PROPOSED PHYSIC 1M USER'S R#fE AND ADDRESS KEY TO COLUMN C PULLesAwe PEN 6cN AL PARTICleAfloN SHOULD CoNetst ora i4 cvs.ed.=mia.iion of petwave se seiermiae the weisbaney to, Patrick M. Gardner, M.D. ree.i.cione sseresis ead/or rmin.ai end ree .eneneni se, pe= crit e esee. stater Aoomass 3Cettatuoretion in does enlitration end setvel odmlatetretten of seis le the patient inedddag peleulsflog of the redetten goes,gelsted 7002 W. Wisconsin Ave. ==ewww.au sas pienias e' aim. ciit v -- ,er,,, ,,,,eoo, s.ne e ..e ,,ie, c ...i.i., io vew. ,nymes.. .e me ,e ,pois,,,,,e Mi1waukee WI 53213 C'.',"*''"*"'""'*"''''"'"**""''"''''"*'"'' e 2. CLINICAL TRAINING AND EXPERIENCE OF A80VE NAMED PHY$lCIAN NURASER OF isorors casas swvotvino ecmanatwTs coNotisons osAanosto oR intArto essesowAt 44.w. ore.n.e.e. Or ,- = ..y A rAaricerAwon as ., wire,,u e,,isee , en 0,,e,s. ee,e; o e p - g ,/ Thyroid span 34 di;'. * * 'i thyroid optd e f . , 19 {'/ Lung perfusion scan 97 M3'*,,- , .' '',' Xenon ventilation study . 4 -' , , ' ' ' , , Aerosol ventilation scan 3 4 'eg ' Renal flow scan 25 / ' k,rv 'h Brain scan -24 - *? . k' . / . Liver / spleen scan , ' } 'q.4.-fg sone' scan 326 fp Castroesophapeal study g ['k , 'h' Leveen shunt study .. f 0 * */ ' .% Cys togran U a; f I'h / -. ,_ - 4e- Dacryocys togram f.' ..i- ,; M' y g 0 * -Q Cardiac perfusion scan. 380 . . , * , x., , '4/g. Cardf ac stress ventriculogram #'' .i 9 . . Cardf ac rest ventriculogram 'Q;s. - 60 i j,M',, (h' Gallium scan 32 C5,sternogram o r:Anoy run,rinn 24 blood volume 7 . in- 111 WBC 76 ' schilling 11 C-14 Urea Breath J _. EXH-6 I ______... _ _ ._ _ _ _ _ . __ _ - . , 4_ . _ . \ * o O . EXHIBIT 3,(C:ntino6d) - PROPOSED PHY31CIM USER .ick H. Gardner, M.D. . PRECEPTOR STATEMENT (Continued / ( 2. C8.INICAL TRAINfNG AND EXPERIENCE OF ABDVE NAMED PHY$1CIAN (Cottinued/ - NUREBER OF ' - #90f0PE CASES INVOLVING COMMENTS CCMOITIONS CHAONOSEDOR TREATED PE RSONAL PARTICIPAfl0N (Amelosof infamiesten ar rowwse nner er A subeneredm Aqplicae en aspwee mal A e C A32 D 85 M *I TREATMENT OF PDLYCYTHEM1A VERA. t.EUKEMIA. ANO 90NE METASTASES > I fe,Q eNTRACAv TART TREATMENT * f.131 TRE ATMENT OF THYROIO CARCtNoMA 7 > TREATMENT OF HYPERTHYROIDISM 97 Aw195 INTR ACAVi!AR Y T'RE ATMENT 0 Ca>40 INTER $TITI AL TREATMEidi * C 137 n k INTRACAVITARY TRE ATMENT O 6 ,125, , .., $NTE RSTITI AL TREATMENT , e' WLETHERAPY TRE ATMENT 5+00 0 TMEATMENT CF E YE Of te ASE O R ADIOPH ARMACEUTICAL PREPARATION 40 "fg cENERAToR nn N$ oENERAToR 0 , Yeoom REAcENTrrn ovwe 40 . In-111 WBC 10 ! TL-20] *Hyocardial 380 * | 3 | . DATES ANDLO TOTAL M NUMBER OF HOURS RECEIVED IN CLINICAL RADIOISOTOPE TRAINING DAfts CLOCK HOURS OF EXPERJDICE Froedtert Memorial Lutheran Hospital August Thru October 1997 VA Medicial Center (Milwaukee, WI) July, Nov. 1997 Total: 1001 4. Jan. Thru Narch 1998 THE TRAINING AND EXPERIENCE li4DICATEDE PREGEFTOR151GNATURE ADDVE WA8 OSTAlWED UNDER THE SUPERVitt0N OFa a wAus or avreRvrooR B. David Collier, M.D. % NAWS OP SNST87VTION - FMLu/VAMC 7. PRECEPTOR *8 NAME paw arpe orpfar/ iMAsumo ApoRees . 5000 unst National Ave B. David Collier, M.D. " " " Milwaukee, WI 53295 s. DATE ** "*M'-li.I$51","T5%2130-02 | i EXH-7 | | . _ _ . ______. . . ______. . _ - - ~ - ~ . -- ~ m - - [ ,_ . O ygpJn , >>>>> PROCEDURE /CPT STATISTICS REPORT (INPATIENT) <<<<< Paga 1 Division: MILWAUKEE, WI Im:ging Type: NUCLEAR MEDICINE . For period: 01/01/98 to Run Date: MAY 12,1998 13:39 03/31/98 , ,# of Procedures selected: All CPT CODE PROCEDURE # OF OCCURRENCES ,y...me== ...... =m...... 78223 HEPATOBILIARY EXCRETION 2 78262 GASTROESOPHAGEAL REFLUX 9 78270 SCHILLING'S TEST PART I W/O INTRINSIC FACTOR 1 78271 SCHILLING'S TEST PART II W/ INTRINSIC FACTOR 1 70278 GI BLEED SCAN- 4 i 78306 * BONE SCAN (WHOLE BODY) 31 78315- BONE SCAN (THREE PHASE) 28 78320 BONE SCAN (SPECT) 2 '78465 MYOCARDIAL VIABILITY 2 78465 MYOCARDIAL PERFUSION-PERSANT. 39 78465 MYOCARDIAL PERFUSION-EXER. 19 78472 RESTING VENTRICULOGRAM 2 1 78478 . MYOCARDIAL WALL MOTION 58 78480 MYOCARDIAL EJECTION FRACTION 58 .78585 LUNG SCAN (VENT /PERF) 24 78596 LUNG SCAN (QUANTITATIVE) 1 I 78601' BRAIN SCAN (VASCULAR FLOW) 1 78607 BRAIN SCAN (SPECT) 1 78701 RENAL SCAN (DTPA) 3 78704 RENOGRAM-(HIPPURAN) 3 75805 GALLIUM SCAN 14 70805 LABELED WBC SCAN (LIMITED AREA) 2 78806 GALLIUM SCAN (WHOLE BODY) 5 78806 LABELED WBC SCAN (WHOLE BODY) 2 79400 SAMARIUM-153 THERAPY 1 93015 STRESS MONITORING (PERSANTINE) 39 i i !' I | i | | c 1 E______.______. . _ _ . _ _ . . _ _ _.______. . . ______~ _ ~ ~ . -- - , ' - - ,. O O >>>>> PROCEDURE /CPT STATISTICS REPORT (OUTPATIENT) au< Pcga: 2 Division: MILWAUKEE, WI Imiging Type: NUCLEAR MEDICINE For period: 01/01/98 to Run Dater MAY 12,1998 13:39 03/31/98 , ,# of Procedures selected: All CPT CODE PROCEDURE # OF OCCURRENCES , p83ummmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmma 78007 THROID (SCAN + UPTAKE) 1 78007 IM THYROID SCAN 4 78007 THYROID (SCAN + UPTAKE) 2 78018 WHOLE BODY IODINE SCAN 1 78122 BLOOD VOLUME (COMBINED) 2 78215 IM LIVER / SPLEEN 5 i 73223 IM HEPATOBILIARY EXCREATION 2 78262 GASTROESOPHAGEAL REFLUX 3 78264 GASTRIC EMPTYING SCAN 1 78290 IM MECKELS 1 78299 HELICOBACTER PYLORI TBST 4 I 78306 BONE SCAN (WHOLE BODY) 68 78306 IM BONE SCAN (WHOLE BODY) 63 { 78315 BONE SCAN (THREE PHASE) 31 j 13 78320 BONE SCAN (SPECT) 1 ; 78320 IM BONE SCAN (SPECT) 2 j 78465 MYOCARDIAL VIABILITY 1 78465 IM MYOCARDIAL PERFUSION (SPECT) 106 78465 MYOCARDIAL PERFUSION-PERSANT. 111 78465 MYOCARDIAL PERFUSION-EXER. 51 78472 RESTING VENTRICULOGRAM 14 78472 IM RESTING VENTRICULOGRAM 17 78478 MYOCARDIAL WALL MOTION 161 78480 MYOCARDIAL EJECTION FRACTION 161 78585 LUNG SCAN (VENT /PERF) 8 | 78585 IM LUNG SCAN 9 78596 LUNG SCAN (QUANTITATIVE) 1 ! 78607 BRAIN SCAN (SPECT) 1 ) 78707 IM RENAL SCAN 5 1 ! 78726 RENAL SCAN (LASIX) 1 78726 RENOGRAM (ENALA-BASELINE) 1 78726 RENOGRAM (ENALA) 2 78801 MONOCLONAL ANTIBODY (PLANAR) 4 78802 OCTREOTIDE SCAN 1 78803 MONOCLONAL ANTIBODY (SPECT) 4 78805 GALLIUM SCAN 6 78805 LABELED WBC BCAN (LIMITED AREA) 2 '78805 IM GALLIUM SCAN 4 78806 GALLIUM SCAN (WHOLE BODY) 1 78806 LABELED WBC SCAN (WHOLE BODY) 2 79400 SAMARIUM-153 THERAPY 3 93015 STRESS MONITORING (PERSANTINE) 110 ' i ______- - -_ . .- ~ _ ~ ~ . __ _ . - ,. ,. /7 . O . q)['i MTim ctm i w 1 5t m T8 LINITED (g, g 5 g a v m isi ;" E x3 *Ew"7[M"f"[ FGS MMO-ML@n+D&W NM p..In1CS Spsteihns wr-=*a. w===+Pmbm Orde r Da t e = ' 01 - OCT- 9 7 ' , " " " " " Thru Order Date='31-OCT-97' , ' Include Exam Modifiers ='N', Include Credited Exams ='N' Final Reports Only='N', Include Cancelled Procedures ='N' Include Rescheduled Exams ='N' 'Sacrch Conditions: IF: DEPT IS EQUAL TO NM (Dept Is Equal To NM) & STATUS (Current Status Is not In List SCHEDULE, RESCHED, CANCEL, ORDER) i NUMBER OF Exam Records Exam Name # M' ABSCESS /INFLAM LTD AREA 13 ABSCESS /INFLAM WHOLE BODY 6 84M BONE DENSITY DEXA 70 /NM BONE DENSITY DEXA W WRIST 4 VNM BONE MINERAL (XC 73) 42 #NM BONE MULT AREA W/O F 5 | VNM BONE SPECT 42 ' VNM BONE THREE PHASE 33 VNM BONE WHOLE BODY 56 BRAIN TOMOGRAPHY (ECT) 5 JM BRAIN W/ CEREBRAL ANG. 3 C-14 UREA BREATH TEST 6 v4TM CAPTO/ENAL/ LASIX RENAL 5 l .41M CSF SHUNT 3 i /NM CISTERNOGRAPHY 2 ATM DOUBLE BLOOD VOLUME 1 VNM EXER MYOCARDIAL PERF 42 vNM GALLBLADDER (HEPATOB . ) 3 /NM GASTRIC EMPTYING B p/NM I-131 THYROID THPY ABLA 5 VNM I-131 THYROID THPY HYPER 8 IM I-131 WHOLE BODY 5 /)NMV LABEL PLATELET 1 i/NM LUNG PERF W QUANT 32 /NM LUNG RADIO AEROSOL 7 vNM LYMPHOSCINTIGRAPHY 7 y"NM MYOCARD PERSANT SINGLE 2 VNM MYOCARD WALL MOTION (GATED) 93 /NM NO SHOW/RADIONUC CHARGE 4 /NM PARATHYROID 1 /NM PERSANTINE MYOCARDIAL 49 /EM PROCEDURE MONITOR 47 g NM RENOGRAM 4 ,vNM SCHILLING DUAL LABEL 2 vHM SPECT E.F. 93 WNM THYROID IMAGE 1-123 1 /NM THYROID IMAGE TC99M 3 y/NM THYROID UPTAKE I-131 5 | /NM TL201 REST MYOC PERP 2 | VNM TUMOR LIMITED AREA 1 ' VNM TUMOR SPECT 17 | RADIOLOGY REPORT . ______--- -- , ~- . - . w o m o v m ~ ~ 3,s- > , nu, a m - _ , n. , . ..n - U V . -- HPJGLEUEITU43Cc~fisiH (Pri U 1 13A) "*",ff.,%""I'"," , FGS MMe=Nt44Pi+.rY NM ..lUlCS M M=*jyyg ma NUMBER OF ' Exam Records Exam Name /NM VENT GATED HEART MUGA 27 Total 765 A Anini OAV AFPGAT - ______- - ______* - . [ 9 ,. Q . - mamaawma | LN11ED (P ,1^og g i + win,ai ;" g 3,A) "W[,7d$,7,, [,;," FGS Mue-Mt44pbW NM ggs.teihns um w.==Parom Ord er Da t e = ' 01 -SEP- 97 ' , InlCS R """"" Include Exam Modifiers = ' N' , Thru Order Date='30-SEP-97' ' Include Credited Exams ='N' Final Reports Onl ='N', Include Cancelled Procedures ='N' Inc ude Rescheduled Exams ='N' 'Snarch Coniitions: I IF: DEPT IS EQUAL TO NM (Dept Is Equal To NM) l & STATUS (Current Status Io not In List: SCHEDULE, RESCHED, CANCEL, ORDER) NUMBER OF Exam Records ! Exam Name i V NM ABSCESS /INFLAM LTD AREA 21 /NM ABSCESS /INFLAM WHOLE BODY 7 /NM BONE DENSITY DEXA 63 /NM BONE DENSITY DEXA W WRIST 2 I /NM BONE MINERAL (XC 73) 40 { VNM BONE MULT AREA W/O F 1 | /NM DONE SPECT 42 I /NM BONE THREE PHASE 44 / IM BONE WHOLE BODY 57 v'NM BRAIN TOMOGRAPHY (ECT) 6 /NM BRAIN W/ CEREBRAL ANG. 5 /NM CAPTO/ENAL/ LASIX RENAL 5 /NM CSF LEAK DETECTION 1 i /NM CSF SHUNT 3 I / NM CISTERNOGRAPHY 5 / NM DOUBLE BLOOD VOLUME 3 /'NM EXER MYOCARDIAL PERF 33 | 4 / NM GALLBLADDER (HEPATOB . ) i V NM GASTRIC EMPTYING 3 | 2 /g NM I-131 THYROIDTHYROID THPYTHPY HYPER ABLA 4 / NM I-131 WHOLE BODY 4 , V NM LIVER / SPLEEN SPECT 1 / NM LUNG PERF W QUANT 29 VNM LUNG PERFUSION MAA 1 i / NM LUNG RADIO AEROSOL 12 vNM LUNG VENTILATION XE133 2 | / NM LYMPHOSCINTIGRAPHY 6 | p/NM MYOCARD PERSANT SINGLE 3 | / NM MYOCARD WALL MOTION (GATED) 74 | VNM NO SHOW/RADIONUC CHARGE 6 ' /NM PARATHYROID 1 /NM PERSANTINE MYOCARDIAL 38 . 40 l /NM PROCEDURE MONITOR / NM RENOGRAM 6 ./NM SCHILLING DUAL LABEL 4 yNM SPECT E.F. 74 yIm SPLEEN IMAGE 1 / NM SR-89 OR SM-153 THERAPY 1 /NM THYROID IMAGE 1-123 2 p/NM THYROID IMAGE TC99M 6 RADIOL OGY RFPORT ______. . _ . _ . _ _ ___. __ ,,, , .- , f- y n . - .. U U - unucuwunalmw N1b (PribSId$ !O38A) t nS "",*"ff,", .;w^==*n,',"m"esen,,'"f - ras Mus Ni4 4P4eY NM .In1CS S ww.m e NUMBER OF (4:4> rns" * Exam * Records Extm Name Yi?M THYROID UPTAKE I-131 8 v NM TL201 MYOC PERSANTINE 1 y NM TL201 REST MYOC PERF 3 vNM TUMOR LIMITED AREA 1 / NM TUMOR SPECT 9 prNM TUMOR WHOLE BODY 2 / NM VENT GATED HEART MUGA 14 l Total 700 l I 1 I i ! ! 1 RAOlOI OGY RFPORT | ' ______- 771~2 % - 16i24 F1CiiTiUd.EnKEfflCiRE L 4143348497 NO.466 D12 - - - . , . - _ 9 9 -" FWXI wtm,Lpthwn%IN " ,, (Pri 0 29A) 3. em w . . n. FGS MM&ML@@+a1Y NM ..lUlCS M **m" w=aa*Ptmm " " " Order Da t e = ' 01 - AUG - 9 7 ' , Thru Order Date='31-AUG-97' Include Exam Modifiers ='N', Include Credited Exams ='N' * - Final Reports Only='N', Include Cancelled Procedures ='N' Include Rescheduled Exams ='N' ' Search Conditions: IF: DEPT IS EQUAL TO NM (Dept Is Equal To NM) & STATUS (Current Status Is not In List: SCHEDULE, RESCHED, CANCEL, ORDER) NUMBER Ol' Exam Records Exam Name VfiM ABSCESS /INFLAM LTD AREA 23 VNM ABSCESS /INFLAM SPECT 1 pfiM ABSCESS /INFLAM WHOLE BODY 6 edfM BONE DENSITY DEXA 41 WiM BONE DENSITY DEXA W WRIST 4 vhM BONE MINERAL (XC 73) 35 vWM BONE SPECT 35 VNM BONE THREE PHASE 40 t/NM BONE WHOLE BODY 54 vhM BRAIN TOMOGRAPHY (ECT) 1 VTM BRAIN W/ CEREBRAL ANG. 4 v^7M CAPTO/ENAL/ LASIX RENAL 2 dim CISTERNOGRAPHY 1 VNM DOUBLE BLOOD VOLUME 3 /NM EXER MYOCARDIAL PERF 30 s/NM GALLBLADDER (HEPATOB.) 1 VNM GASTRIC EMPTYING 5 VNM GFR (FK506) 1 .VNM I-131 THYROID THPY HYPER 5 /NM I-131 WHOLE BODY 1 VNM IV THERAPY P-32 1 VNM LUNG PERF W QUANT 34 vNM LUNG PERFUSION MAA 1 VNM LUNG RADIO AEROSOL 9 , A m LUNG VENTILATION XE133 2 ; vtm LYMPHOSCINTIGRAPHY 3 p fM MYOCARD WALL MOTION (GATED) 75 VJM NO SHOW/PADIONUC CHARGE 3 VNM PERSANTINE MYOCARDIAL 46 :VNM PROCEDURE MONITOR 45 utM RENOGRAM 3 /NM SCHILLING DUAL LABEL 5 v NM SPECT E.F. 74 yNM S.R-89 OR SM-153 THERAPY 1 ytm THYROID IMAGE TC99M 2 VNM THYROID UPTAKC I-13' 6 edfM TL201 REST MYOC PERF 1 ,VNM TUMOR LIMITED AREA 1 VNM TUMOR SPECT 10 V NM URINARY EXCRETION 1 v NM VENT GATED HEART MUGA 19 Total 635 AAnlOI OAV AFPGAT __ _ . - _ _ _ .___ ~ _ _ _ . _ _ . . _ . . - . 1 . . . . . o o . EXHIBIT 3.,(Continutd) - PROP 0stD PittstCthe Usta Patr ick M. Gardner, M.D. - j . PRECEPTOR STATEMENT (Continued / 2. CLINICAL TRAINfNG AND EXPERIENCE OF ABOVE NAMED PHYSICIAN Kontinued) . Nuusen sw 880 TOPE cAstsiNvolv No couMENT: CONDITSONS 08AOWOSEO OR TRE ATEO PER$0NAL PARilC1f ATION twitaaMenneum a emanien m wir er A edanirs#Ja abadices e asperem steeaLJ e C P.32 0 85a&**) TRE ATMENT OF POLYCYTHEMIA VERA. LEuxEM:A, ANo sowE METASTASES I g,',', fj INTR ACAVITARY TRE ATWENT 0 * 113t TRE ATMENT OF THYRolo CARCINOMA 7 TRE ATMENT OF HYPERTHYRolplST j7 Au 190 INf'RACAVITARY TRE AWAENT 0 C640 INTE RsTITI AL TRE ATMENT * er n Cot 37 INTR ACAVITAR Y TRE A THENT 4 125 0 e, ' le tti INTERSTITIAL TRE ATMENT n TEtaf ME RAPY TRE ATMENT , sm TRE ATMENT O F E Y[ DISE AllE O RADt0FHARM'ACEUT8 CAL PREPARAT106 40 I",*,T/( cENEi4AfoR m (, OENERATOR 0 Tesem RE AGENT Ksts I , oe.or 49 . In-111 WBC , 10 TL-20) ' Myocardial 380 ( 3. DATES ANDLOCATION TOTAL NUMBER OF HOURS RECElVED IN CLINICAL MADIOl50 TOPE TRAINING (Afts CLOCK HOURS OF EXPERJENCE Yroedtert Memorial Lutheran Hospital August Thru October 1997 VA Medicial Center (Milwaukee, WI) July, Nov. 1997 Total: 1000 Jan. Thru March 1998 4. THE TRAINING AND EXPERithCE INOlCATEDu. AROVE PREcemR mNATVME WAS OSTAINED UNDER THE SUPERVIBfDN OF e. NAus or surf Rvneon - Arthur Krasnow, M.D. y i nAuf or sNev TvTeoN " () FMLH/VAMC T. FREcarToR s NAME #waar empe eranast en uAILtNO t.00RE04 * 5000 Wat National Ave Arthur Krasnow, M.D,. " Milwaukee, WI 53295 ' DATE '' "^ T.^.oh@l",95'50 2130-0 2 EXH-7 | ______- __ __ _ ._ _ _ ._ _ ~ - ~. -.c - 3 ~ ' ' '' - . O :- , O ' 'EXH'IBIT 4 * _, RESIDENT'S SUPPORT TECHN01.0GY TRAINING TASK LOG i i - i . Name: M4CK [MDN@ M. Supervising Date Technologist's ,', Task Perfomed Initials 1. Hot lab. a. | Log and monitor incoming packages. (_-2-3 b. Elute generator. - ,' 3,_,-Ji>_-g M c. Measure and record Ho and Al ' concentrations in eluate. J_,F__-ff ,! d. I ' Prepare each radiophamaceutical kit | used. Measure taggin'g efficiency. i e. Calculate volume of radiopharmaceutical 2_-h.ff needed for prescribed dos 6pe. Draw and : i measure dosage. [email protected] I . f. Perfonn constancy, accuracy, ifnearity, and ge:ometry tests on dose calibrator. 3,_-&,.n.a_ _ , , h. enter photopeak, focus lens and dot. J_-JJ J[ F# b. Perfom and evaluate extrinsic and intrinsic field uniformity checks. 3 -p,g - c. Perfom and evaluate spatial- resolution ' checks. 1-Hjf.. ' ~| d. Check motion switches for safe \ operation. ,$_-p}}[ EdtAPg e. * i f. 3. Processor ahd dark room. a. Operate processor. . b. Prepare fresh chemistry. 4rA EIN#"d ! ' ' c. Clean transport and crossover. racks.2, - ## d. Check safelight. '' ~ #d/ e. , p_- ) - f. , | 4. Safety surveys. a. Perfonn dose rate survey of clinic. - b. Perfom removable contamination survey 11-h , | of clinic. f-])_- , Survey and log decayed waste. - , y . e. . ! | 78 II Preceptor ~ /I EXH-8- | ISI _ - _ - _ _ _ i! > . . , 0 O . . . . S * Y " A D 0 0 2 9 0 2 N I 3 " 3 H 0 _2 - 1 TI Tw 6 ,- - -. 1 7 W u 4 - 0 D os * 7 E n " 1 H a * S * 0 A u * . C ce * 1 ~" T H * ?' 8 N O c * * 9 F -- * / D * 4 o s * 1 v * r\ * . ' - 5 \ . 5"/ _ , -_ _ - n '.' =a -. */. =m 1e. =mr 0 =s 1 =M S _ E _ c L - ._ 0 _ _ - 7WD 0 - - 6 __ _ C _ M3 _ : - 1 -_. _ 2 -. - _ 2 _ . " . - " M[* s 7 - * N -. _ r O 2 _ a I __ - l S 0 - " " - 3 l __ _- S '= ' 3 9 _ I . . *5 o . 5 5 .. = - D M 4 . 3 M 7 _ - "5 0 3 O . - " -_ ) 5 0 C 0 . 4 _ - 1 1 : _ ' " a 3 t / Y ._ 5 " ( . _ 0 R . 0 O e T 2 d A . n L 3 a U - G L - SL y E 7 t R - TA x 0 . IT i R 1 -. PI S A EP E e S S d L e C r U OO d N JH n T u S S Y H U T I D r u NNE b UB _ , F ' _. ]g: M t U- e.~,.f : Y .4 |,' t A P COOF ' - - | |, | 1ii p o O b , . , . - . h _ S Y " A " D0 's 0 9 f. 0 2 " " 2 M 3 " 3 H s 0 : " T T - * 1 N 6 - 1 7 NU 4 . 0 D O * 7 " E M 1 H A * 0 S K * CA C * E * .. 1 ' .. ~- T H O C * - * 8 N * " 9 F - * /D + * I " 4 O * \ 1 V * " / * " 5 \ . ~ a " m a =S "n =W ~a =D, N E e. B t =iT O u L =M = G G L O O G : 8 2 2 . " s N 7 m 5' r O 2 a I " l S 0 3 l S 9 w*'35 o I 5 5 - D M a 4 3 M 7 s. 3 0 O s " ) 0 C 0 "41 1 : 5 / Y a i5 ** (4 0 R 0 O T r d A 2 n L 3 a U G 1 y E 7 S L t R A x 0 HPI T i R 1 - . S A 't EP E i S S d L e C _ OO r U d N JH n T, Y u S S T H U I D r - NN u E . , ' b - - F - UB . - 3 ' l 7; 's . Y i ' ,. 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O , . .Q..>% m., - . ., . s. .w. . .s.i H .a w. , , . . r. f. ., d %...... ~ . , . s ~ , ,...L. N +,q %. m , *** ^ k ssNd I O'] s .Ms I 7' . .**Y E'''*7 [ ' 'fo A i. O I M 'sak *O N_N * .%'t.@ 'Y D_YMN 8" 'tM YMk 'b H W W|rLN W :.v '.h.Q . :C.c. q. Xp/%E,s.L m . ~ s.. QL &,s r% M W5, ', 'c & , . . . g w y.;, *,y: ., n.. . m;.;, .u. wA *;. A w %q.ew u%.,Q. w v %.L.s? Q kd$??r.htQt.e s. p;w<.y u;s.c ww t m . m , #.c%.n., . Mm z 2 .;.o , e,4 I Q W IC.4 .rr%m;, Oyn,w w swem m w n.Nrmm.mns m.n%.ws.n w rmu 3.w 9 94 * - th ' ( *Qr - KW : QhSWNit'9;CG'WWW+A;%heD.p.7.?!.Q.a mw L~tn M k,r- w a r gm emM& ie~%n a m y@~F,. '%w)&.%,~S,%m .L 1:aE%.y Co m.% s&4 m:,4w. : q. * w p #w c w' A. e& 'fr. p* t. .h~ q%UfJ b%.y WW-M.,4 e+t $j.w.hd*M h.m 4. >w.,j [email protected],.. w, w. p '.a. 4 * o s. % .n~ a> a ,m . .+..n...M. ,. +.. M. .. Mih %M.6 O . .C .h'g n ,c.a f.4-G t4. . 'm/ bA.L.4,p. rXMw 3% % ,y 2 %., g ; %g& hy%q s ..q'W M.CYW41* W ?M*3&p% ',yn[ O 8 :f n ,no - m a,i a. w . . rw . . .. 4 .&..,nw. . - .. m +.r w o.w. w.v.~ ..s D.yn. .>.- : 6 - 4 . - . . , . _m 1 _ _ _ . _ . _ _ _ _ _ . _ - - _ - - . ______- - ______- _ - _ - - _ _ _ __-- - ______- _ _ - | < !' Barbara L Knutzzn ~j | r Director of Prof:ssionil gnd Support Services JUN 0 41998 551 S. Silverbrook Drive West Bend, WI 53095-3898 I Dear Ms. Knutzen: | Enclosed is Amendment No.~ 12 to your NRC Material License No. 48-16117-01 in accordance ! with your request. Please note that the changes made to your license are printed in bold font. Please review the enclosed document carefully and be sure that you understand all conditions. If I there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region til office at (630) 829-9887 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; Unless your license has been terminated, you must conduct your program involving byproduct materials in accordance with the conditions 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 applicable regulations. 2. Notify NRC, in writing, within 30 days: a. When an authorized user or Radiation Safety Officer permanently discontinues performance of duties under the license or has a name change; or b. When the mailing address listed on the license changes. (No fee is required if the location of byproduct material remains the same.) ; 3. ' In accordance with 10 CFR 30.36(b) and/or license condition, notify NRC, promptly, in a writing, and request termination of the license when you decide to terminate all activities . ' i involving materials authorized under the license. , 4. Request and obtain a license amendment before you: . a. Receive or use byproduct material for a clinical procedure permitted under Part 35 but not permitted by your license issued pursuant to this Part; b. Permit anyone, except individuals described in 10 CFR 35.13(b), to work as an authorized user under the license; j c. Change Radiation Safety Officers; d. Order byproduct material in excess of the amount, or radionuclides, or form different than authorized on the license; e. Add or change the areas of use or address or addresses of use identifwxt in the license application or on the license; or ! !' p L ] - - _ _ _ - ______- _ - _ - ____ _- -- _ - -- - - , ,f.- - B. Knutzen 2 L | ! ! | f. Change ownership of your organization. 5.- Submit a complete renewal application with proper fee or termination request at least 30 , days before th s expiration date of your license. You will receive a reminder notice | approximately 90 days before the expiration date. 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. . L . 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 are true and [ correct to the best of the applicant's knowledge.- The signatory for the application should be the L licensee or certifying official rather than a consultant. | i ! You will be periodically inspected by NRC. Failure to conduct your program in accordance with j 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 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. Since serious consequences to employees and the public can result from failure to comply with NRC requirements, prompt and vigorous enforcement action 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. L Sincerely, c i Original signed by ' James R. Mullauer, M.H.S. | Health Physicist Materials Licensing Branch . License No. 48-16117-01 Docket No. 030-10451 Enclosure: Amendment No.12 To receive a oopy of this document, Indicate in the box: "C" = Copy without attachment /encio.ure "E" = Copy with e een u.e r s uo , OFFICE DpM@l | DNMS/ Rill | | { NAME JWlwMueg DATE (o /3 /98' OFFICIAL RECORD COPY t . . _ . . . . _ _ . . . ____ - - _ - _ _ _ _ . _ _ _ _ _ - - _ - _ _ _ _ _ . _ . _ _ - _ _ _ - _ _ _ _ - _ _ _ _ - - - _ _ _ - _ _ - _ . . _ _ _ _ - _ - _ _ _ - _ _ _ _ _ - _ _ - _ - - ______- - ______- _ _ _ _ _ - _ _ _ - - - _ _ _ _ - _ _ _ - _ - _ - - _ _ - _ _ - _ _ _ _ - _ _ _ _ UNITED STATES # p aCarog4 NUCLEAR REGULATORY COMMISSION 8 $ REGION lli g g 801 WARRENVILLE ROAD e LISLE. ILLINOIS 605324351 k...../ June 1,1998 Barbara L. Knutzen Director of Professional and Support Services St. Joseph's Community Hospital of West Bend 551 S. Silverbrook Drive West Bend, WI 53095 SUBJECT: ACKNOWLEDGEMENT OF CORRESPONDENCE (Letter Dated 05/19/98) Dear Licensee: In response to your request, we have completed the initial processing, which is an administrative review of your application for a(n): New License X Amendment Renewal Termination Auth User (Amendment not required) Other No administrative deficiencies were identified during this initial review. However, it should be noted that a technical review may identify omissions in the submitted information. It appears that your request is routine (see 1-3 below, as applicable). 1. New and amendment actions are normally completed within 90 days, unless we find major deficiencies, or policy issues requiring central program office assistance. 2. Renewal actions are normally completed within 180 days, however, under timely filing (before expiration), you may continue to opuate under your existing license. 3. Termination actions are normally completed within 90 days, unless confirmatory surveys following decontamination / decommissioning activities are involved. A copy of your correspondence has been forwarded to our Licensing Fee and Debt Collection Branch (301/415-6097) for approval of the fee category and amount, if required. We will try to complete your request as soon as practicable. Any correspondence about this request should reference the control number. Please direct any questions conceming your request to the Materials Licensing Branch at (630) 829-9887. Materials Licensing Branch Mail Control No. 303999 l License No. 48-16117-01 : I , l | --.----______j .- . - _ - ______. -- Laboratory fcx 414-334-8497 Sr. JOSEPHS - ;OMMUNITY HOSPITAL ,: v. n i m 3n foesTaustw twtTNcaf , Lat4xuac Hw.ni. TO: kb 616 - ja69 FAX: bo30 h - FROM NcAdc M u- ATTN: . Jo % Mw\\ %e c * * I nge,j,LE th O RE: _ % Core *& & * DATE: lo k h.l%3 , This transmission is from the Laboratory at St. Joseph's Community Hospital of You should receive this page and an additional 1 page (s). ] Want send, WI. ( If you do not receive the correct number of pages, please call the Laboratory at (414-334-8215) immediately and report the discrepancy. This transmission is intended only for the use of the individual or entity to which it is addressed and may contain information that is privileged, confidential and exempt from disclosure under applicable law. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering the message to the intended recipient, you are hereby notified that any dissemination, distribution i or copy of this communication is strictly prohibited. If you have received this transmission'in error, please notify us immediately at t": a above telephone number and arrange for return of this transaction to us. ADDITIONAL COMMENTS: . . __.__ Operator's Name ab l_# [h_ ! . | 7 M g,,,,,,,,,, BOARD OF DIREcroR$ hhv. p. camen, MD 3.la.se T. Mein kwbc= 1. WaN W Tk.-es w.gG M g., su,g,.e4.h th.smas 2. 6.mu M,k A N i.e. un et 5,r.Af M dw t p. sa A A.J J.c S.A etJ.5 ; r.t<.,r 6. G wp F, Per Aery,h A9 W P.J 1.Owisie.w a b Li).Han== M D. 9*=a 5 7*W W A.Larmen. 6n A8 = C G,Ln W M. Reigir _ C g=y T. 5 $ , ChaAs 5. Cape. M.0 SSI S, Sitw,Ince& Dr; v.h bd.WI 53095 3s9s . (414). 334 5533 Fax (414) 3344484 g -~- - - ,,m,g,u y _ _o ,_ , q m fg g gggy - ' \ / * - | EXHIBIT 2 ; SUPPLEMENT A ._ 2r-'-?tm W.L "*>"_" &R RteubATORY SWPLEeENT !, TRAINING AND EXPERIENCE ,. ! AUTHORIESO USER OR RADIATION SAFETY OFFKER ! 2. Pon PHistc1Aus. 5Tmt OR TEIRITOM te4ERE tlCENEG , 5. ItsME Of PRorosu AlffMORIZtn testa oft RADIAfl0K 5AFETT OFFICER 1 Wisconsin Rahet t 1. W4 A4+h - 1 maTiriMTrent i toGNTN 4800 V8&R 'bl ATff tfD EATEGORY 8 pSS6ALTv98489 O A ! t | ' ' : . 4. TRAlWINC NECEtVED 190 B&WC MADecl80f0PE MANDUNG TSCHNIOWES! TDP4 ASID LBusGE OF Tmaesswee 4 CLOCet isouns tia clock ovovas Or $UPERVISCO tetATest.nnS Dais elof Tsancessee LECT M 08 PW4D or famosusse 8 N TORT OsHTHE. Joe A tsPEUEMCE ! > 100 100 ! | s. mApiAview enveies Aeso 'sanetsuessavalion - University of Wisconsiin 100 n naciattostrootscTiou 30 _- Hospital and clinics ., asATwouAvecs PeetAiwiwo To June 1, 1996 thru 20 100 Tusuns Anointesvnessam July 30, 1998 ~ or maaesoActivrry . I 20 100 * d. RA0aAtleef 990 LOGY . e. mAsierseAmancewecAL 30 100 casessesTmf _ s. ExpEntssecs WITH R AtHAft0N. (Aspastser of AsseWunspas or AevisadentTvrk or vst fausrdnesel ) c d c nouRs is0 Tert act unto AT out tisit! 00cAtsom 5 mC1 | $r-89 Jniversity of Wisconsin July 1, 1996 - Tc-99m 3300 mC1 June 30,1998 250 mC1 despital L Clinica I-131 Sadison, WI 53792-32E2 e 1-125 1 mci greater than 500 d 1-123 2 mci T1-201 15 mci Cr-51 1 mci ;a-67 20 mC1 . ,_ L k rn-iis to mes _ Cs-137 1 mci Co-37 10 mci I EXH-5 koh 330[ ${ ! l ! l i | | _ . _ _ _ __ - _ _ . - - - - _ -_ ~ _ _ __~_ .__ ...... ' . - EXHIBIT 3,,(C2ntinu6d) ' | - Pforesto rinsEtN: vssa ' ich M. Gardner, M.D. | Patr PRRCEFTOR STATEMENT (conrinued) ! 2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSIC 8AN /Cartehest/ - . "" _ . WP casts MrVOLwtf00 comedENTS 800 TOPE C04087908s8 98A0880000 DR TRE ATSO PEASONAL M/medh wdesessuwe easy'he PAnfacerATsDat memitesm anommee ssi senesar senestJ A 8 W c _ D TREATMENT OF POLYCYTH8W4A VERA.~_ SW LSUstStelA AhoSope anETASTASES q g 98ffAACAVf7ARY 781EATWENT 0 * t.131 TREAftaf887 0F TMYAot0 CAnciosoMA 7 TREAT 8sE*fT OF NYP98tTHVpO60t97 37 Aarits 8MTRAcAVITAftY TRSAThaeNr 0 coep pet 75fesTITRAl.TREAftaEAff * er ^ Co531 tWTRAcAvrTAny THEAftetNT ! g b t38 88f75 RSTITIAL TmEATh8ENT r_ w- gg, TELETME8tAPY TAE ATMfafT 3*00 TME AThe4NT OF E YE DISE ASE O RaoioenAnuacturicAL enErARATiow .40 7 OtseEAATOst e - Q oEwen4 ton 'o vese== msAceNrxTs **" 40 . In-111 WBC 10 , TL-201 ' Myocardial 380 . . % 3. DAfts AseO707AL OF NOUR$ RECSIVfD IN CLf800 CAL RAOf 088070PE TilAlffspit = om u.s , i Troedtert Heinorial Lutheran Hospital August Thru October 1997 VA Medicial Center (Hilwaukee, WI) July, Nov. 1997 Total: 1000 Jan. Thru March 1998 4 , THE TRAIN 4NC AND EXPE ::"F- BheDICATED A90VE *- ~ - autena m nt WA8 ceTAINED UpsoGR THE suPEnvis ON OFs , . m or sursavseon __ Arthur Krasnow, M.D. ] y . , t --- : or sessisTVTG, ff , T. P p cerTo n t s AnsE pas,aurseses'renk e FML11/VAMC , e. asAatmo -- -- * Anna v,me National Ave Arthur Krasnow, M.D. * ' Milwaukee, WI 53295 m. navu di'05 Mff T5'"62130-02 78 - EXH-7 i i . - _ _ - _ _ _ - ______- _ _ _ . l | | CONVERSATION RECORD |Tiue |DATE | | ! l 6/2/98 1 ' O viSrr O CONFERENCE x retEpsONe | O iNCOuiNG xOUTGOING NAME OF PERSON (S) CONTACTED OR IN CONTACT ORGANIZATION (OFFICE, DEPT.ETC.) TELEPHONE NO. Michelle Uecker, Chief Tech. St. Joseph's Comm. Hosp. 414-334-3451 x866 'll4-344-/(,4 / x wGG SUBJECT cmendment request dated 5/19/98 : SUMMARY I spoke to Michelle for the following information: j 1. Dr. Meredith's preceptor Supp. A needs the state where he is licensed to practice and clarify the 200 hours of c!assroom and hands-on. 2. Dr. Gardners preceptor is not signed by Dr. Collier. ' This action is certified by bh Od .. . s Gd [9[ yc e ?'i- ACTION REQUIRED 1 | Response due in 20 days. 1 1e ** f f P |v f f On f f (t} m 5 l' f/|$P ( - 1 fj; ; g "C ------