GUTHRIE" May 21, 2002

Ms. Theresa Hall-Darden United States Nuclear Regulatory Commission Region 1 475 Allendale Rd. King of Prussia, PA 19406-1415

ECE IVED REGION 1

Robert Packer Hospital 128 p i q 2: One Guthrie Square

Sayre, PA 18840-1698 Tel 570.888.6666

0 3 6- 6 30 ) -

Re: Amendment of Materials License 37-01893-01

Dear Ms. Hall-Darden:

This letter is to request an amendment to our above referenced materials license. We have recently added a permanent medical physicist to our medical staff and request the following changes:

Addition of Joon Ho Park, MMSc as Medical Physicist and Radiation Safety Officer. Delete Thomas Padikal, PhD, on our license as Medical Physicist. Addition of Raymond Perez, DO as an authorized user of licensed materials. Delete Lanny Chuang, DO as Radiation Safety Officer.

I have attached a copy of materials license 45-09207-01 demonstrating Mr. Park's previous privileges as medical physicist on an NRC license. I have also included Mr. Park's resume. I believe Mr. Park meets the criteria for Radiation Safety Officer as defined by the NRC under Standard 35.900 part b, meeting both the educational requirements, as well as supervision under a Radiation Safety Officer identified as such on a Commission or Agreement State license that authorizes the medical use of byproduct material. Mr. Park is also eligible to complete the ABR therapeutic radiation physicist certification process this year.

I have also attached a copy of Radioactive Materials License 2989-1 from the State of Florida demonstrating privileges for Raymond Perez on a materials license in an agreement state.

Please note that Thomas Padikal, PhD has finished his temporary assignment at our institution and is no longer working here. Also, Dr. Chuang will continue to work at our organization and will remain an authorized user on our license, but will relinquish responsibility as Radiation Safety Officer to Mr. Park when our license is amended.

All proposed changes to our license have been reviewed by our Radiation Safety Committee. If you have any questions or comments, please do not hesitate to contact me directly at 570-8825197.

Sincerely,

Jeff B. McBee

Administrative Director 1 3 156 1

cc: Lanny Chuang, DO NMSSIRGNI MATERIALS-002

www.guthrie.org AIM 53 I

0

0

0

JOON HO PARK

OBJECTIVE

Employment as a medical physicist.

EDUCATION

1997 - 1999 University of Flonida Gainesville, FL.

Ph.D. candidate (discontmbv.d)/Medical Physics

m Research assistant at the Shands Cancer Center.

a Completion of Ph.D. preliminary examination requirement.

x Co-authoring of two poster presentations for the 1999 AAPM annual meeting.

m Monte Carlo techniques for radiation transport (MCNP4b).

n Graduate level analytical radiation transport methods.

u Graduate level radiation interaction fundamentals.

m Preliminary works on automation of DMLC leafnotion generation.

1995 - 1997 EmoryUniversity Atlanta, GA

M. MSc./Radiation Oncolog Physics

"* A one-year of clinical experience.

"* Dosimetry, Radiation oncology, Oncology, Radiation Biology, Diagnostic imaging,

Nuclear Medicine, Health physics, Radiation shielding, Nuclear physics, Anatomy, and

BioStatistics.

1992 - 1995 Georgia Institute of Technology Atlanta, GA

B.S./Physics

"a Graduate level fundamental physics courses.

"* Teaching assistant for the sophomore level physics curriculum.

"* Induction to Sigma Pi Sigma.

PUBLICATIONS

Abstracts and poster presentation for the 1999 AAPM annual meeting

Use of dynamic multileaf collimator as dose compensator, Joon Ho Park, Cody Chen,

Chihray Liu, Jarinder Palta.

Generation of EDW profile with dynamic multileaf collimator using se.smented treatment

table, Cody Chen, Joon Ho Park, Chihray Liu, Jatinder Palta.

5624 STARKEY RD 0 ROANOKE, VA 24014

HOME: (540) 769-6159 WORK: (540) 776-4162 E-MAIL joonpark@msn.com

PROFESSIONAL EXPERIENCE

2000 - Present CPRS, ltd. VA

Medical Physicist (Regional Cooirda&tor)

"u On-site consulting•t the HCA Lewis-Gale Medical Center (Salem, VA)

"* Commissioning and implementation of ADAC Pinnacle RTP systems.

"* Varian 2100 C/D with 80 leaf MLC with EPID, VARIS R&V system, Varian Ximatron simulator, microSelctron HDR remote afterloader with Plato BPS.

"* Prostate seed implants.

"* Radiation Safety.

"* Management of all aspects of equipment and dosimetry QAN

"* Development of in-house software for the routine monitor unit calculations and other relevant clinical functions.

n Implementation and education of staff on the conformal radiation therapy and the basic

concepts on radiation interactions pertaining to radiation therapy.

"• Experiences with MultiData dosimetry system.

1999 - 2000 Baptist Health System of South Florida Miami, FL Medical Physicist (contracted consdtant,)

"* Commissioning and implementation of ADAC Pinnacle KIT systems (photon, electron and brachy modules) at both Baptist affiliated hospitals (Baptist hospital and SouthMiami hospital).

"* Commissioning and implementation of STP3 (Leibinger) based SRS at Baptist hospital.

"- Implementation and education of staff on the conformal radiation therapy and the basic concepts on radiation interactions pertaining to radiation therapy (BAT ultrasound localization system).

"• Experiences with MultiData dosimetry system.

"* Cinical involvement in treatment planning in both extemal and brachy therapy programs.

"* Commissioning and implementation of interfacing between ADAC Pinnacle RTP and Varian Vans R&V system.

"* Commissioning of Varian 2100EX linear accelerator with Enhanced dynamic wedge and Millennium DMLC.

1999 RTSI Ft. Myers Ft. Lauderdale, FL

Medical Physicist

"* Involvement in commissioning of Varian 2100EX and ADAC Pinnacle RTP.

"* 1-125 and Pd-103 prostate seed implants (both real-time and pre-plan), T&O, Sr-89 injection, Sr-90 Pterygiumn eye applicator.

" HDR procedures (micro selectron with plato treatment planning software).

"* Treatment planning experience with ROCs, GAS focus and Prowess prostate treatment planning systems.

" Experiences with CRS dosimetry system.

"• Clinical routine tasks including morning daily QA, chart checks, chart rounds and

monthly and annual QA.

n Experience with IMPAC record and verify system.

1997- 1999 University of Florida Gainesville, FL

Research assistant

"N Monthly and yearly QA program involving Varian 600 and 2100 C/D (EDW and

DMLC), Phillips SL25 and SL75, Theratron 1000 Co-60 unit (external beam units).

"* Treatment planning,-experience with ROCs and ADAC pinnacle treatment planning systems (both extemal beams and brachytherapy).

"N Experiences with Wellhofer dosimetry system (WP600 and WP700 and film scanning

system) and Sun Nudear diode array profiler.

"* Limited experience with Varian Ximatron simulator and Picker AcQsimn.

"N Limited experience with IDPAC record and verify system.

1996 - 1997 Emory University Atlanta, GA

Radiation Oncology PAysics resident

"N Monthly and yearly QA program involving Varian 600 and 2300 C/D, (extemal beam

units).

"N QA experiences with nudetron HDR unit and Emory X-knife.

"N Treatment planning experience in extemal beam radiation therapy using Emory

implemented 3D treatment planning system and Render Plan 3D.

"* Treatment planning experience with the SRS procedure.

N Treatment planning expenrence with brachytherapy procedures (excluding permanent

implants).

"• Limited experience with stereotactic interstitial implant therapy.

"N Limited experience with Weflhofer dosimetry system (WP600)

"N Limited experience with VARIS record and verify system.

PROFESSIONAL MEMBERSHIPS

Sigma Pi Sigma

American Association of Physicists in Medicine

ACCREDITATIONS

Completed written exam part of the ABR therapeutic radiation physics (10/2001). Eligible to complete the certification process in 2002.

Virginia department of health certified private investigator.

PROGRAMMING EXPERIENCE (PCS AND UNIX/LINUX BASED PLATFORMS)

"* Visual Basic (implementation of site-specific Win32 based physics tools, including

Monitor unit calculation and diode dosimerty tools with goal of developinig an integrated

system that will assist in the department daily routines and special procedures.)

"* MatLab & IDL

"* Fortran

"* Visual C/C+ +

REFERENCES

William J. Walker

jatinder Palta

Patton McGinley

President/medical physicist CPRS, ltd. (VA)

Chief Physicist Shands Cancer Center (UF)

Former Director of graduate program EmoryUniversity

I!-.!?2 1;i AM{ FROM; Fax TO: 1S70-i&254..2 PA'GE; )C- ).- C07

NRC FORM 37AU.S, NUCLEAR REULATr0RY O0MMISSMO

PAGE 1 OF 8 PAGES Amendment No. 52

MATER1IALS UCENSE Purauas4 to the Atomic Energy Aci of 1964., as amxenderd, fte Energy Reorganiza~an Act of '1974 (PL61c Law 03-4385), and TiMl 10, Codfe of Federof Refgoltions Chapter 1. Pwt 20. 31, 32Z 23, 34,35., 36, 39,40, and TD, and in relianý on vatemenb a nd rMprseratlione her~oto~re made byj fth Reenfte, a lkense Is hereby iesued aattlouzig the r1censee to recei'e. acquire, possme and Iransfer byproduoct.

aeand speclal nuctar rnatdal designate below. to u.se such materiW for fthpurpasefs) anid al 1N. place(s) designated. below, to dolWvetor tesauh etlotoprnsihiztoreceiveit in accordance with the Ww~iatons ofthe appfrcAble Pat(s). Thia Bcensa shal be deemed to contain the condaltons specifled In Secfton 183 of the Atomi Eniergy Act of 1954, as amended, and Is eizbjec- io all appkac~e niles, tegula*Uns, and orders of %ae N'uciear Rogulatoiy Comnwissice now or hereafter in effect and to any comdltmr speciid below.

In accodancea with the lettw daled ISeptetber 26, 2001

i.Ley4s-Gate Medeca] Center~c a License No. 45-0e2Q7-01 is amended in its entirety to read as foflows:

2. 1q00 EectriC ROad }4 Expi ratfori Date: Novemnber.30, 2005 Salemmu amountl th13-49 Ncsoema

1& Byroduct. scurce, andlor special 7. Chemical wndor Physical komt

A, Any byproduct mate~al idenfified in 10 CFRý 4 .100

8, Any byproduct matIeiW Identified in 10 CFRý4200

C. Iodine 131-t

D. Any byproduct matefWisi ýý

a half-life less then 120 days, except iodine 131

E, Any byproduct matorWe idenfifled in 10 CFR 36A40

F. Any byproduct materia kfentliled in 10 GFR 35.600

8. Strontium 90

H, Id id~us 192

A. y radophwarma'CettoCal A.identf -fied i C F-R'3S. 100

B. Any radiopharmaceutical idenithd hnA0~ C; 35-200

C. Ary t.;nsoealed fbnrn fo'r p repraiaiorl and

)0. Any for M identified In 10 k

1091 tp ý32 or a equivalent Agreement State regulatin.

E. Any brachytherapy sources Identirled In 10 CFRl 35.400

F. Any diagnostic source registered pursunt to 10 CFR 32.210 and identitied in 10 CFR 35-.00

G, Seated source regitered pursuant to 10 CFR 32.2 10

K~ Seated Source (Byk Malinckrodt. Model CI-L-BV)

'0*e"s at ary one trow under Whs

A.. A4s needed

a- 0. neededt

C 5..5 gigabeoquerels (G~q)

0.As needed

F- As needed

F. See Item S.F.

Cu 33.33 tnegabecquerels (9W0 mtcrocrles)

K. 8114 G Bq (22 Qi) tetal (see ftem 9.H)

5/1/'2G02 11:13 AM FR~OM: Fax TO: 15708825422 PAGE: 003 OF 007

NP ORM~ 314A UB. HUCLEM PFEGULAOfiY COMMSB$O PAGE 2 of 6 PAGES License No. 45-09207-01

MATERIALS LICENSE Docket No. SUPPLIE1AENARY SHEET03-33

AmnendmTent No. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 52

9, Authorized Uw.:

A. Medical use described In 10 COF1 35.100.

B. Medica) use described in 10 CFRt 36.200.

C. and D, Any radlopharrraceutlc pi4.4p§5.0

Medical use d~v~din 10 OFR 35.400. ý

F~. Sealed s&~e contained In a compatible dVice jre4aredp:ursuant to 10 GFR 32210 to-or an eQ*ialerf Agreement State regulation) for medical use Identiflld In '10 GFR

~35.00.Theioene~emay also possess on~e addifiona1 stiurce in iAs shipping container for use irncident, to sourceý exchange.

G.Insta~nt 0afimrn 14. Qneq#uwce net to exceud3701 cGlq 00O Gi) in Nucietron-Oldeft Corporation Model icro

Setetrc-HDRS0.00~rerotre afterloading bracthytherepyi irradiator for treatment of cancr~aiena~n o~wso-rcenotto zxrefod 444 GBq ( 12 0) for storage In its

shippinq 2'Contaia for decay to- 370 GBq (lOI a 0 k, cidaA M, source replacement.

CONDITION8

10. lcenad materWa shall be used only at the NcenaIes factlfties located at Lewis-Gale Medical Center, 1900 Etectrlc Soad, Salem, Virginia, except th~at the M4DR device identified in, Subiterm ,s H, 7-H, 8.1-1 and 9.H shall be used only in the licensee's Clinic linear accelerator treatment room.

11. A. The Radiation Safety Officer (RSO) for this license Is David fi.4.Randolph.4 M.D.,or In his absente, John M. Mathis, M.D.

8. The Bradiyherapy Physicist for ths ficense is Joon Ho Park.

5/1/2002 11:13 AM FROM: Fax To: 15-08325422 ?AGE: 004 OF 00O

WtC POW 374A u.S. UAUM REGULATORY CO4AM1ON PAGE 3 of 6 PAGES

Lircese No. 45-09207-01

MATERIALS LICENSE Docket No. SUPPLEMENTARY SHEET 0300333M

Amendmern No.

52

12. Licensed material listed in Item 8 above is only authorized for use by, or under the supervision of, the

followin indivduals for the materials and uses indicated

Authorized User A

A- Ptacine H. OeGuzmran, M.D. uSIBeI usedecrbed in 10 CFR 35.100, 35.200, and 35&500.

S. David M. Randolph, M.D •.W Medical use described in 1•0 CFR 35.400, and for strontium 89 therapy identified in 10 CoF t35.300. Subitemn H. for intersa, intracavitary, inraaluminal or topic,~ -.tretent of cancer,

C.Eraly 14. Lewis, MR

D. Robert F. aBdrien'.D.

E. John M. MWthis, M.D.

FR Robert G, Ze-ler, Kit

G. Richard A. Smith, M,.D.

H. Naiyer Imam, M.D.

L James D. Matthews, M.D.

J. Neil F. O'Donohue, Mn.

K. Debra Ann Chiarefla, M.D.

L Brardon W. Chan, M.D.

M. Patrick T. Rucker, M.D.

Medical use described in: 1:.•61CFR 3. 100, 35200, 35.300, and "35. .C

Medica. use desced iý and35.

in 10 CFR 35-100 and 35.200.

Medical Lis de=ibed in 10 OFR 35.100, 35.200, 35.300, and 35.500.

Medical use described in 10 CFR 35.100 and 35.200.

Medical use described in 10 CR 35,100 and 36.200.

Medical use described in 10 CFR 35,100 and 35.200,.

Medical use described in 10 CFR 35.100 and 36.200.

13. Sealed sources conaining ficensed material shaH not be opened by the licensee.

14. In addition to the possession imits in Item 8, the licensee shal further restrict the possession of licensed

materia; to quantities below the minimum limit specified In 10 CFR 30.35 for establishing decommissioning financial assurance.

;If

3/1/2002 11;13 •i2 FROM; Fax T': `5708e25122 PAG-E: D05 OF 107

2) unrestricted areas do not exceed the fimits Specified in 10 CFR 20.130, .

r .. . . ... . . .

11t= FORM 374A U,S. NUCLEAR Re.ULATORY COQMSSI PAGE 4 of 6 PAGES

License No. 46-0920.7-01

MATERIALS LICENSE Docket No. SUPPLEMENTARY SHEET

Amendment No.

CONDITION NUMBERS 15 THROUGH 19 ARE APPUCABLE ONLY TO HIGH DOSE RATE (HDR) REMOTE AFTERLOADiNG BRACHYTHERAPY UNIT(S)

15. In lieu of 10 CMR 35.404(a), immediately after retracting the source from fhe patient into ibt shielded position in the HDR remote afterloading bractytherapy unit, a radiation survey shall be made of the patient and the HMR remote aftertoad hythapy unit with a portabie radiation detection survey kistrument to confirm that the souoe* been removed from.the p*atent. Records of the survey shall be maintained In lieu of the reomrd4cpred in 10 CFR 35404(b). ' ,

1t0 lieu of the source inveotey required in 10 GEM 35.406, the licensee 1.:

A. Promptly detemine•hiat ali ou.itbLshave returned tD t•he af•ý shielded..osition at the conclusio of each HOP remote eiftertoac~ng b-achrythperepy poroc~edure.

B. Promptly make a~vey of the area, iuse IacIntimi -that no sources iAe been misplaced.

0.. Make a record of the urvev iitkrg.til~e swve-,y ýnstumernetusad. d"' rate expressed in millirem per hour (mremihr) TIIicosievws1 p6c: r 0cyWv/k 4ira, date ar4nne of the individual making the swavy.

0. Retain the record of the survey inwi-u tthe record re4red In 10 CFR 36.406(d).

17. Prior to initiation oe a treatment program, and subsequent to each source exchange, using the HDR remote afterfoading brachytherapy unit(s), a radiation survey shag be made of:

A. The itrradiator source housing, with the source in the shielded position. The maximum radiation levels at 10 centimeters from the surface of the main source safe shall not exceed I mremfhr (uSv/hr).

&L All areas adjacent to the treatment room with the source in the "irradiation" position. The survey shall clearly establish -that radiation levels in:

1): restricted areas are not likely to cause personnel exposure in excess of the limits specified in 10 CFR 20.1201; and

5/1/2002 11:13 AJs FROM; Fax rO: 15708325492 PAGE: 006 OF 007

I

WRC FOsM 374A U.S. NUCWM REWLATORV COMMS9KM PAGE 5 of 6 PAGES

License No. 4502oM7-01

MATERIALS UCENSE Docket No. SUPPLELENTARY SHEET 030=333

Amendment No.

82

lM The following sheM be performed only by manufacturer's representatives or persons specificaily aufthrized by the Commission or an Agreement State to perform such services:

A. Installalion and replacement of the sealed sources contained in the HDIM remote afterloading bracthytherapy unit(s).

8. Any maintenance or repair oqpe.t-n on the HOR r ,tAfterloadlrg brachytherapy unit(s) risted in Item 9, Subitem(s) H involpwork on the source safe, thi #rpe drive unit, or other meahairsm that could expose the seg&, reduce the shelding aound the or comomise the safety of the Lit* and resuft in Inbased rmaiationr levels.

19. A, Access to the roomar housing +1h9 HDR remote aftefloacirg b hyer~apy unit shahl be controlled by

a dox at each aietrance.

B. The entrance 'o the irradis locroo shalt be equipped ith an a~sctrcaf intedock system that wi4 cause the source to return to the shielded posftiorn immedfiatefy Upon r 9 ing of the entrance door. The intedoc.i syszrem shall be pdinnctud in .uch a w& nner•fti! the squde cannot be placed In the irradkn position until the erl.c door is closed . id th*•i.source Woff* control is reset at the contro panel. ,

Ca Electrical interlocks on thel atmnce door to the adfator ro1lhalf be tested for proper operatim at

0. In the event of malfunction of the door interlock, the irradiation device shall be klcked in the 'otf position and not used, except as may be necessary for rpair or replacement of the interlock system, until the interlock system is shown to be functioning properly.

20. Except as specifically provided otherwise in this license, the licensee shalg conduct its program in accordance with the statements, representations, and procedures contained in the documents, inLuding any enclosures, listed below, except for minor changes in the medical use radiation safety procedures as provided in 10 CFR -35.31. The U. S. Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A. Apprications dated:

1) Aprit 30, 1990 2) May 16, 1995 [renewal]

5/:/20C2 11:13 AM FROM: Fa, T,: 15703525422 FAGE: C0? OF 0,)7

NRC P04OfM WS. JCLEA EGULATORY COMMISSMN PAGE 6 of 6 PAGES

Uce•se No. 45-00207-01

MATERIALS LICENSE Qocket No. SUPPLEMENTARY SHEET 030-03333

AMeck'ne No.

52

20. B. Letters dated:

1) September 7, 1990 jad'l Info re: bioassay program, hoods, dosimetry and actin levels]

2) March 3, 1994 [procedures for use of strontium 89] 3) November 7, 1995 [fax re: quatlication of new RSO *v1tr drd 1031i95 providing add' into re:

sScuity and exposure contrnl.for. seale.sources} 4) January 23, 1996 [name chan•id HOR 6•:s and. procedures] 5). February 21, 1996 [ad-n&r#: NOR use arid precq~duresI 6) August 12, 1996 [ac4Wcal treaement of cancer with~t1. (See TAR dated June 21, 1996)] 7) October 20. 1907 -•dldelete authorzed users] 8) May 13, 1990 [aC 72 users (R. OTBrien, J. Mathis); delete u&s.ur. Bassignani)]

Vt9) July 1, 1998 1qafne (change (d/bt'a Lewis-Gate Medica Centelt) 10) January 14, 1999 .- nanme. .ange] 11) March 9, 19$& :delete? users(t.Zeinik, B. Baning. . Fergu.pn, N. Adamson, J. Buer, R,

Broadwe. t I sr. and add 4-users (R• Zek,.er R -Smith. N. lm J.(- Matthews)] 12) March 198, 2909 [change AIS(Y (D: Rsndclphfl,. 13) April 14, iaOe flax re: ch angeaAs ?A, (A- arkus~l ft 14) Apr~l 15, 1999; flax?-e a~dd Iinfoi'fpropos-ed RaO'e training and dwePrience~l 15) June 1, 19099 [change 304. Randoiph>A4i. RSY (J. Marthis), and Brachytherapy Physicist

(Ft. Olossnetj;, add on6 tsar (W. OtDonchue; -and exanud, use of one. user (R.L O'Brien)) 10) Augus~t 13, 1999q {die$Oac:kilnaI qualdficafiphs for Mai*sws arid O'Brien) 17) August 19, 1999 NUoLf)R U f&TRw RSO aOpeMencj 18) September 20, 19609 -fadd3- users (0.- C-hiam~dia4 B-Char, P. Fiuckerhý 19) July 11, 2000 [ctan-ga Brachytherapy Physiist (S. Darwist--ff 20) August 17, 2000 Jiaxc re' change'in Bra hyitherepy hysicist (J.. Perk)] 21) June 18,2001 [new lay~out for Nu-dear Med: Dept.

ý.~~~ ~ ,/ /i; -..... -. . IMQ

22) Sepember 25,2-001 [add1At $150 afp) oretphscst ae

FOR THE U. &. NUCLEAR REGULATORY COMMItSSION

DEC 0 7.3)0k DATE - BY Dryan a;: rker

Region Division of Nuclear Materials Safety

60 Forsyth Street, S.W., Suite 23T85 Atlanta, Georgia 30303-8931

AMVMCTf4*WO-0t M"2Awd

In -

U_ýUJ 41 L.UU

RADIOACTIVE MATERIALS LICENSE

Pursuant to Chapter 404, Florlds Statutes, ind Chnptnr 64E-6. FlOrldm Admnlistraflvs Code (FA..C.), nrld In rellince on etmlanlons end

rep..e.nt.t.on .heretoore mods by Rim .. cen.se dsign•-,d below, a ,lee, Is hereby Issued liAboe1zI1g nuch lcelnsee to rLeeive,

acqutire. possee sand transfer the rdo~oetive, mq,•-_.• ,, designated b",,w and to ,,, such rudloactOr mntodeIl fo the i, purpoFo(s)

anid at the place(s) designated below. Thirs Wlense It aubject to @4l ipplicabla n'os, regvatlons end ois of the i,-e,- of Forld..

Ueparbn~t of Health now or hereafte In effect and to any oondlUos polfmoel below.

LAonT A A

NAVIX - M30 - PUNTA GORDA, INC.

,.Addreus: t- 2601 S. Bayshore Drive, # 500 - Coconut Grove, FL 33133

2. L.,--g Nmber: 2989-1

Is hereby amended in its entirely, with reference to correspondence dated 02106/02.

4.Expwt m a,, 02128/2004

Ic.Congoy: 5C

,. ' . . " .4' ,I I_ 1, , .I 2.._,,,• ,,. • ,, . .. . ,:'- , ' • •, ,:,. .. . .. :. ' " : ... ' ' .r• :'' ".'' '';• " •' ! '

A. Any radioactive material described In section 64E-5.626, F.A.C.

B. Any radioactive material described in section 64E-5.627, F.A.C.

C. Any radioactive maledal described in sectin 64E-6.630, F.A.C.

A. Any radlophormaceutical for diagnostio use Involving measurements of uptake, dilution or excretion as described In section 64E-6.626, F.A.C.

B. Any radiopharmaceutlcal for diagnostic use Involving Imaging and localization as described In section 64E-5,627, F.A.C., except gases and aerosols

C. Any radiopharmaceutical for therapeutic use as described In section 04E-5.630, F.A.C., except gold 198, andiodine 131 for the treatment of thyroid carcinoma

, i• ." PA, , T 1 ' • •

'PBM '�. I 'o) 'tr ,n , .' , .

A. As necessary

B. As necessary

C. As necessary

* , 9,

W: ZY U-,,P I U.• H'H.L I H

p .I

L un. b;rq., . .' : '• 'I "":,• J~ 206202114,1."

1 850 1,,i bJb4

A. Any medical use described In eescion 64E-5.626, FA.C.

B. Any medical use described In section 64E-5.627, F.A.C., except gases and aerosols.

C. Any medical use described In secton 64E-5,630, F.A,C,,except gold 198, and Iodine 131 for the trasviment of thyroid carcinoma.

10. The authorized place of use Is the licensee's facility located at 329 East Olympia Avenue, Punts Gorda, Florida 33950.

11. Failure to comply with the provisions of this license is a felony of the third degree pursuanI to seclion 404.101, Florida Statutes. Also, violatiuns may warrant sn administrative fine of up to $1,000.00 per violation per day, pursuant to section 404.102, Florkia Statutes.

12. A. The following Individuals are authorized for the materials and uses as Indicated:

64E-6.626, 64E-6,627, and 64E-5.630 (except gold 198 Melvyn J. Katzen, .D

and Iodine 131 for the treatment of thyroid carcinoma)

04E-5.626, 04E-6,627, and 64E-5.630 (except gold 198, Margo H. Roca, MID, phosphorus 32, strontium 89, samarium 103, and Iodine Alberto Rlghl, M.D. 131 for the treatment of thyroid carcinoma)

64E-5.026 and 64E-5.627 Raymond J. Perez, U.O,

B. The radiation safety officer Is Aiberto Righi, M.D.

C. Radlologic technologists who use and administer radioactive materials or perform bmchytherepy or teletherapy procedures under the general supervision of an authorized user shall hold a valid certificate as required by Chapter 468, F.S.

13. Radioactive material transported on public thoroughfares shall be packaged, prepared for shipment, and transported in accordance with Tidte 49, Code of Federal Regulations and Chapter 64E-5, FA.C.

I~Tl I ,

•, 'c•Itmt.}"Nwber: .2UQ0 1+-o. .O.

* fl'J R' J ~." .7; .' I.' " "*,'* ', "••'a nP !,•: ." •" '" • U j " Pm" ,gp• ;' 'of.3•• ' •"4' , ,"1. " . e~m• Pagm(q). .;. ",:-,. -,' pn -e . 1 2/---.

11-0, Or......"•• V•W WI IF'+ at.

bLEP I LIF HLý- I H P. 0j

14. Sealed sources containing licensed material shall not be opened.

15.

16.

17.

The licensee shall not authorize release from confinement for medical care any patient

administered a radlopharmacautical until:

A. The dose rate is less than 5 millirem (50 microsieverds) per hour at a distance of

1 meter; or

B. The amount of rdoactive materlal In the patient is less tharn 30 millicurles.

Any therapeutic dose of iodine 131 shall be recelved In capsule form only,

Phosphorus 32, strontium 89 or any other pure beta-emitting radiopharmaoeutkuals shall be

received In single dose aliquots only.

18. The licensee shall Implement the quality management program (QMP) as stated In Condition

19 and section 64E-5.611, F.A.C.

19. A. Except as specifically provided otherwise by this lisense, the licensee shall possess arid

use licensed material described In Items 6. 7, 8, and 9 of this license in accordance with statements, repFesentations and procedures contained In the licensee's application dated October 13, 1G98, signed by Miles E, Gilman, and correspondence dated:

November 10, 1998, signed by Melvyn J. Katzen, M.D., F.A.C.R.; December 16, 1998, January 28, 1999, and June 13, 2001 (delegation of authority - Alberto Righl, M.D.), all signed by Miles E. Gilman, President.

B. The licensee shall comply with all applicable requirements of Rule 04E-5, Florida Administrative Code, and these regulaOons shall supersede the licensee's statements in applications or correspondence, unless the statements are more restrictive than the regulations.

For the Bureau of Radiation Control:

Issuanc. Data: FEB 22 mw11? Qrlqina~l ftned Ely LIBBY MITCHELI

Libby Mitchell Environmental Specililst II Bin C2a1 40t2 Bold Cypress Way Tallahassee, FL 32399-1741 Iiill/t @AIIU.l AEA

T0TRL P.Od

1 31561

This is to acknowledge the receipt of your letter/application dated

2.,f/.-? t/- _'A, , and to inform you that the initial processing which includes an administrative review has been performed. /• 4i' . ? 7-co/Sq•7-..o/

LE' There were no administrative omissions. Your application was assigned to a technical reviewer. Please note that the technical review may identify additional omissions or require additional information.

Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee & Accounts Receivable Branch, who will contact you separately if there is a fee issue involved.

Your action has been assigned Mail Control Number 1 3 1 5 6 When calling to inquire about this action, please refer to this control number. You may call us on (610) 337-5398, or 337-5260.

NRC FORM 532 (RI) Sincerely, (6-96) Licensing Assistance Team Leader

BETWEEN:

License Fee Management Branch, ARM and

Regional Licensing Sections

LICENSE FEE TRANSMITTAL

A. REGION

1. APPLICATION ATTACHED

Applicant/Licensee: Received Date: Docket No:

Control No.: License No.: Action Type:

* (FOR LFMS USE) : INFORMATION FROM LTS

Program Code: 02230 Status Code: 0 Fee Category: 7C_3M :Exp. Date: 20110930 Fee Comments: CODE 23 Decom Fin Assur Reqd: N

GUTHRIE HEALTHCARE SYSTEM & 20020528

3003013

131561 37-01893-01 Amendment

2. FEE ATTACHED Amount: Check No.:

3. COMMENTS

Signed Date

B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03 is entered //)

1. Fee Category and Amount:

2. Correct Fee Paid. Application may be processed for: Amendment Renewal License

3. OTHER

Signed Date