plateau medical center, amendment request nrc form 313 ...nuclear regulatory commission, washington,...

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PLATEAU MEDICAL CENTER QUALXTY CARE. RIGHT HERE, Division of Nuclear Materials Safety US Nuclear Regulatory Commission, Region I 475 Allendale Road King of Prussia, PA 19406-1415 Q 00 0 License Number 47-25469-01 8 3%lhd To Whom It May Concern:, Please amend our byproduct materials license as follows: 1. Add the following two physicians to our license as authorized users for materials identified in 10 CFR 25.100 and 35.200. Verification of these physicians training and experience is attached. a. Gary L. Dier, MD b. Clinton E. Curtis, MD c. Andrew McDonnell, MD d. Ralph J. Perrico, 111, MD Thank you for your attention to this matter. Administration l3q to7 430 Main Street, Oak Hill, West Virginia 25901 (304)469-8600 ~;q~~;r~~;;! M.ATEW!ALSCO%

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Page 1: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

PLATEAU MEDICAL CENTER QUALXTY CARE. RIGHT HERE,

Division of Nuclear Materials Safety US Nuclear Regulatory Commission, Region I 475 Allendale Road King of Prussia, PA 19406-1415

Q 00

0 License Number 47-25469-01 8 3%lhd To Whom It May Concern:,

Please amend our byproduct materials license as follows:

1. Add the following two physicians to our license as authorized users for materials identified in 10 CFR 25.100 and 35.200. Verification of these physicians training and experience is attached.

a. Gary L. Dier, MD b. Clinton E. Curtis, MD c. Andrew McDonnell, MD d. Ralph J. Perrico, 111, MD

Thank you for your attention to this matter.

Administration

l3q to7 430 Main Street, Oak Hill, West Virginia 25901 (304)469-8600

~ ; q ~ ~ ; r ~ ~ ; ; ! M.ATEW!ALSCO%

Page 2: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

RC FORM 313 ,2004) CFR 30.32,33. ,35,36,39, and 40

U.S. NUCLEAR REGULATORY COMMISSION

APPLICATION FOR MATERIAL LICENSE .

ply with this mandatory EXPIRES: collection lOl311200 hours. Submittal of the a plication is necessary to detennine that the a z s ' i ylifiad and that ad uak pmcedums exist to protect the public health and safet %Q burden eatimate to the Records and FOWPriva Setvice Bm& (T-5 F52)YS. Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer Office c lnfonnah and Regulatory Affairs N&B-i6202. (3150-0120), Office of &nagem and Budget Washington, DC 26503. if a means used to impose an lnformatio collection ddes not display a currently valid OMB control number, the NRC may nc conduct or sponsor, and a person is not required to respond to, the informatio collection.

end comments

DIVISION OF INDUSTRIAL AN0 MEDICAL NUCLEAR SAFETY OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS US. NUCLEAR REGULATORY COMMlSSfON WASHINGTON, OC 205556001

'PLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WllH:

.L OTHER PERSONS FILE APPLICATIONS AS FOLLOWS:

IF you ARE LOCAED IN:

ILLINOIS. INDIANA, IOWA, MICHIGAN, MINNESOTA, MISSOURI, OHIO, OR WISCONSIN. SElO APPLICATIONS T O

MATERIALS LICENSING BRANCH US. NUCLEAR REGULATORY COMMISSION, REGION 111 2443 WARRENVILLE ROAD, SUITE 210 LISLE, IL 80532.4352

YOU ARE LOCATED IN:

ABAMA. CONNECTICUT. DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, WUCKY, MAINE. MARYLAND. MASSACHUSETTS, MISSISSIPPI, NEW HAMPSHIRE, NEW RSEY, NEW YORK, NORTH CAROLINA, PENNSYLVANIA, PUERTO REO, RHODE AND, SOUTH CAROLINA. TENNESSEE, VERMONT, VIRGINIA, VIRGIN ISLANDS, OR :ST VIRGINIA. SEND APPLICATIONS TO

ALASKA, ARIZONA, ARKANSAS, CALIFORNIA. COLORADO. HAWAII, IDAHO, KANSAS, LOUISIANA, MONTANA, NEBRASKA. NEVADA, NEW MEXICO, NORTH DAKOTA, OKLAHOMA OREGON. PACIFIC TRUST TERRITORIES, SOUTH DAKOTA, TEXAS. UTAH, WASHINGTON, OR WYOMING, SEND APPLICATIONS T O

LICENSING ASSISTANCE TEAM DIVISION OF NUCLEAR MATERMS SAFETY U S . NUCLEAR REGULATORY COMMISSION, REGION I 475 ALLENDALE ROAD KING OF PRUSSM, PA 194051415

THIS IS AN APPLICATION FOR (Check approprlafe @em)

NUCLEAR MATERIALS LICENSING BRANCH U.S. NUCLEAR REGULATORY COMMISSION, REGION N 611 RYAN PLAZA DRIVE, SUITE 400 ARLINGTON. TX 7601 1-4005

c3 M

2. NAME AND MAILING ADORESS OF APPLICANT ( fdude UP d e ]

Plateau Medical Center c)

RADIOACTIVE MATERIAL a. Element and mass nurnbsr; b. chemlcal andlor physlcal form; and c. malxlmum amwnt

INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM ANOTHEIR TRAINING EXPERIENCE

whlch mll be possesbed at any one Ume.

FACILITIES AND EQUIPMENT.

U 430 Main Street East 8. AMENDMENT TO LICENSE NUMBER 47-25469-01 1 Oak Hill, West Virginia 25901-2136

6. PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED.

8. TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS.

10. RADlATlON SAFETY PROGRAM.

c. RENEWAL OF LICENSE NUMBER

ADDRESS WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED 4. NAME OF PERSON TO BE CONTACTED ABOUTTHIS APPLICATION c

Same .* Q ' Sharon L. Long, NPC

TELEPHONE NUMBER

12. LICENSE FEES (See 10CFR 170andSeection 170.31) AMOUNT

FEE CATEGORY 7c 1 ENCLOSED $ O.Oo . WASTE MANAGEMENT.

. CERTIFICATION. (Musf be complefedby eppucanfl THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING 'ON THE APPLICANT.

THE APRICANT AND ANY OFFICIAL MECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT NAMED IN ITEM 2, CERTIN THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10. CODE OF FEDERAL REGULATIONS. PARTS 30.32.33.34.35,36,39. ANDh, AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AN0 BELIEF.

I 'PROVED BY DATE

PRINTED ON RECYCLED PAPE ?C FORM 313 (4-2004)

Page 3: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FFlX NO. z3045982293 act. 24 2006 03: 56PM p2 FROM : RMER I RD 87/86/2086 09:25 18775253761 LAKES RADIOLOGY P A E t BZ

- STATE OF NEW YORK DOH DE.PARTMENT OF HEALTH Flanlgan Square, 541 River Strwt. Troy, New York 12186-2216

Antonb C. Novella, M.D,, M.P.H., Dr.P,H. Camisdloner

Lakes Rediology, PLLC 450 Canifita Street Hornell, New York 14843 n A Y 1 6 r n

Attention: tddo Netenyahy M.D. Radiation Safety Officer

Re: N Y S Dcpt. of Health Radioactive ht#ials License No. 5 140 DH NO. 06-189

Dear Liceneee:

Emlaecd is Ammdment No. 1 to New York State DqwOneut ofHedth Radioactive Materials License NO. 51 40, which incorporates the following ckges:

1.

2.

3.

Names K m e t h Nalaboff, M.D., aa an authorized user for nuclesr diagnostic mdicine.

Removes Andrew Rabin, MB., as ~ l t l autharhd ueer.

chsnges the name of the facility to Lakes Radiology, PLLC,

If I can be of further assistance to you, please, contact me at 518-402-7590, or at:

New York State Deparbnmt ofI3edt.h Bureau of Envimnmentd Radiation Pmtuction Radioactive Materials Section $47 Rivet Street, Flanigan Square - Raom 530 Troy, New York 12180-2216

Alaxhdcr H. bemid, M.S., M.P.H. Associate Radiological Health Specialist

I?ED/AHD; gsd

Euclomre: Amendment No, 1

Page 4: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

Contra1 Field Office 21 7 Solrth Salina Street Syracuse, New York 13202

Antonla C. Novelo, M.D., M,P.H., 01’. P.H. Commissimer

Dennlr P. Whalsn Exmurive Oepury Cammissioner

October 24,2005

Lakes Radiology, PC 450 Canistea St. Hornell, NY 14843

Attn: Dr. Iddo Netanyahu

Re: Inspection o f Radioactive Materials License No. 5140

Dear Dr. Netanyahu:

This letter refers to the ins ctjon conducted by this writer an-october 20, 2005, of activities authorized by the New York !r tare Department of Health Radioactive Materials and to the discussion of finding8 held with you and othef members of your staff: at the conclusion OF the inspection.

The inspection was an examination of activities conducted under your license a6 they relate to radiation safety and to compliance with the requirements of the State Sanitary Code, Chapter 1, Part 16, “Ionizing Radiation,” and the conditions of your license(s). The inspection consisted of selective examinations of procedures and represantative records, interviews with personnel and observations by this writer.

During the inspection, no ‘it0ns of noncompliance with the requirements of Part 16 and the license were noted. It was noted, however, that you had not begun to use radioactive materials under this license. You are requested to notify this office at the time you commence use so that I more detailed inspection may be performed.

I wish to thank yau for the cooperation and assistance given to m during the Inspection. Please feel free to contact me at (315)- 477-8448 or by email at ghbOl~herrlth.state.ny-us.

Sincerely,

CC: BERP License

Page 5: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FROM L: FlMER I RD FQX NO. Z3045982293 Oct. 24 2006 0 3 : 5 6 P M P4 LAKES RADIOLOGY rHUC VLt

07/06/2006 08: 25 18775253701

NEW YORK STATE DEPARTMENT OF HEALX'H RADIOACTM MATERIALS LICENBE

License Number 51 40

DH. NO. 06-189 Lakee Radiology, PLLC 450 Cdsteo Street Hornell, New York 14843

Attention: Idda Netanyah, M.D. Radiation Safety Officer

Dear Licensee:

In accordance with the request dated April 19,2006, signed by iddo Netanyahu, M.D., New

k a c Conditioti No. 1 to R ead:

1. Name;

York State Department of Health Radioactive Materhls License No. 5 140 is amended as follows:

Lakcs Radiology, PLLC.

Change Cm& 'tion No, 10 to Read:

10. A. Radioactive materia1 listed in Etm 6 shall only be used by the following individuals:

Andrew McDonnell, M.D.

Kenneth Nalaboff, M,D.

Iddo Netanyahu, MD,

B. Radioactive material listed in Item 6 shall be used by Iddo Netanyahu, M.D., M appropriate to fidfill the responsibilities of the Radiation Safety Officor.

FOR THE NEW YQRK STATE DEPARTMENT QP HEALTH

Radioactive Materials Section Bureau of Envimmental ~adiation Rotcction

Page 6: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FRX NO. :3045982293 act . 24 2006 03: 5 6 p M p5 FROM : FlMER I FID r m u L w e 07/06/2006 68: 25 18775253761 LAKES RADIOLOGY

J

NEW YORK STATE DEPARTMENT OF HEALTH RADIOACTIVE MAlX3UGLS LICENSE

Pursuant to the Public Health Law and Part 16 of the New York State Sanitary Code, .and in reliance on statements and repretientations heretofore rnade by the licensee desipted below, a Iicmse is hereby issued authorizing radioactive material@) for the purpose(s), and at tbe place@) desigmted beIow. The l h e is subject to aU appliwble rub, regulations, and orders now or hereafter In effect ofi all appropriate regulatary agencies and to any conditions specified below.

1. Name

Lakes Radiology, f .

3. License Number

5140

2. Address 4. a. Bffective Rate

450 Canistw Street Hornell, New York 14843

Attention: Iddo Netanyahu, M.D. Radiation Safety Officer

June 18,2004

b. Expiration Date

Juae 30,2014

5 . Reference Number DH No. 03-445

6 I Radioactive Materials 7. Chemical and/or 8. Maximum quantity (element & mass no.) Physical. Form licensee may possess

at one time

A. Fluorine 18 A. Fluorodeoxyglucose A. 300 millicuries (FDO)

9. Authorized use (unless othcnvi$e described, the authorized place af use i s the licensee’s address stated in Item 2, above).

A. For any diagnostic procedure involving imaging and localization studies as described in 10 NYCM 16.123 (b) (2). Radioactive materials m y not be delivered directly to the

. ghrc-lt3

Doc:BOIUPETPX (52400) Rev. 01/03

Page 7: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

NEW YORK STATE DEPARTMENT OF mALTH ’RADIOACTIVE MATERLALS LICENSE

CONDITIONS License No. 5140

10. A. Radioactive material listed in Item 6 shall only be used by the following individuals:

Andrew MCDQIUICI~, M.D.

Iddo Netanyahu, M.D.

-DD. MiCcbdf ’ €3, Radioactive material listad in Item 6 shall be used by Iddo Netanyahu, M.D.,

appropriate to fulfill the responsibilities af the Radiation safety Officer.

I 1. Except as specifically provided otherwise by this licenge, the Licensee shall possess and we licensed material described in Item3 6, 7, and 8 o f this license, in accordance with statements, representations, and procedures contained in the docummta (including any enclosures) listed below:

A. Applicatfon far New York State Department of Health Radioactive Materials License dated August 12, 2003, signed by Iddo Netanyahu, M. D. Letter datd July 22,2003, signed by Iddo Netany&u, M,D.

Letter dated Decsrnbcr 4,2003, signed by Iddo Netanyahu, M.D.

Lcttcr dated Match 18, 2004, signed by Iddo net any ah^, M.D.

E.

C.

P.

E. Facshdle June 4, 2004, signed by Iddo Netayahu, M.D.

The New York State Department of Health’ s regulations shall, govern the licemee’ B statements in applications or letters ynless the statements lare mwe restrictive than the regulations.

12. A. RadioMve material shall be stored in a locked facility in the original. shipping container, or a container providing equivalent radiation protection. Such a facility may be a cabinet, a safe, as a room, providing the facility is locked at all times when no activities aru in progress relating to the U B ~ afrhs radioactive material. This includes periods of brief absence of personnel fiom a nuclear medicine department, laboratory, etc., where radioactive materials are used or stored.

Kadioacttive m e a l s shall not be stored in the same facilities with materials which might 8ubstantidly increw the fie or explosion hazard ofthe starage space and its radioactive contents.

B.

Page 8: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FROM : RMER I AD FAX NO. :3045982293 O c t . 24 2006 03:57PM P7 LAKES RADIOLOGY PAGE 87

0 7 / 0 6 / 2 0 0 6 09: 25 la775253701

NEW YORK STATE DEPARTMENT OF HEALTH RAPIOACTIVE MATERIALS LICENSE

~

13.

14.

15.

16,

17.

CONDITIONS License No. 5140

A. Tmportation of l i m e d radioactive &rial shall be subject to all reguladonra of the U.S. Pepartrnent of Trmsportatian and other agencies of the United States bavhg jurisdiction insofar a8 B U C ~ regulations relate to the packaging of radioactive material, marking and labeling of the packages, loading and storage of packages, rnonitoriq requiTements, accident reporting, and shipping papas,

TranaI>ortation of low level radioactive waste shall be in accordance with the regulatlom of the New York State Department of Environmental Consmation as contained in 6 NYCRR Part 381.

E.

The licensee &all have available an appropriate survey meter which shall be maintained operational and shall be calibrated boforc initial use and at subsuquent intervals not Rtceeding twelve mntha by p e r ~ m specifically authorized by the U,S, Nuclear Regulatory Commission or an Agreement State to perfarm such services. Recards of all calibrations shall be kept a minimum of five years.

Le& tests of seated so1ur;es shall be perfom4 in accordance with Section 16.10 (a) (4), New Yak State Sanitary Code (1 0 NYCRR 16). Off-site analysis of leak test samples shall be performed by persons spacifically autharizad by the U.S. Nuclear lbgulatory Commission or wn Agrement State to perf- such services. On-site U y g i e of leak test samples shall be in accordance with procedures appxwved by the Department.

The iicensee ie anhrized to holdjadioactive material with a physical half-life of less tban 65 days far dwy-in-storage before disposal ordinary trash, provided:

A. Affected radioactive waste shall be heid for decay a minimum of ten half-lives.

B. Prior to disposal a8 nom& waste, radhxtive waste shall be surveyed to detemdnc that i ts radioactivity cannot be didnguiahed from background. All radiation labels will be removed or obliterated.

A. The licensee shall not release any licensed radioactive materials into the environment except as allowed by the New York State Dqzirtmmt of Environmental Conaervation.

Before use or disposal of any licensed radioactive mate&l in a manner that oould result in discharge or release to the environment, the licensee shall obtain from the New York State Deperunent of Envkonmentd Cons~tvation either:

B.

i) A valjd permit, or

ii) A letter stating that no pennit is required.

Page 9: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FROM . : QMER I QD FRX NO. z3045982293 O c t . 24 2006 03: 57PM p8 LAKES RADIOLOGY PAGE BB 07/06/2086 08: 25 18775253701

m W YORK STATE DEPARTMENT OF RGDIOACTXVE MATERIAL8 LICENSE

CONDI'ITONS License No. 5140

17.

18.

19.

20.

21,

22.

C. The licensee ahall maintain the letter or valid permit required in paragraphB of Ehls codtion on file for the duration of the license and make such letter or permit available for inspection by the Department upon request,

The kxwee shall submit complete decontamination procedures to the Department for approval inety (90) days prior to the tr;mination of operations involving radioactive materials in my r e s t x i d wee.

~ 1 a . m of fwilities which ths licensee Intends to dedicate to operations invalving the use of radioactive material shall be .submitted to the Department for review and approval pdor to any such use.

The licensee shall maintain records of infomation imparum to safe and effective decommhsioning at Lakes Radiology, F.C., 450 Canisteo Street, Homell, New York, and at other locatians as the licensee chooses. The records shall be maintained until this license is terminated by tbc Department and shalll indude;

A. Records of spills or other unuaual occumnccs involving the spread of contaminatiou in md mound the facility, equipment, or site;

B. As-built drawings and modifications of structures and equipment in E S t n G t e d weas where radioactive materials are wed and/or stored, and locations of possible inaccessible contamination such ae buried pips which may be subject to contamination;

Records of the cost estimate performed for the decommissioning funding plan or the mount certifred for decommissioning, and records of the h d h g method wed for meuring funds if either a funcling plan or certificstian ia used.

C.

for E8ehlg Radiation safety may be delegated to qualified entities, however I . I

that thew tseks have been completed rceta with the licensee named in-o. 1, and appropriate record^ must be mhmined at the address shown in Condition No. 2.

Radioactive materials may be used in the Medical Consultants haging Company, B subsidiary of AIlianca Imaging, Inc., coach located autside of the Lskss Radiology, P.C., ofices BS described in the Application for New York State Department of Hea1t.h Radiomave Mat&& Licstlloe dated Angust 12,2003, Signad by Tddo Netanyahu, M.D.

Page 10: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FQX NO. z3045982293 O c t . 24 2006 03:58PM P9 FROM : 9MER I QD 07/06/208~ 08: 25 18775253701 LAKES RADIOLOGY PAbt U Y

NEW yam STATE DEPARTMENT OF HEALTH RADIOACTWE MATERIALS LICENSE

CONDITIONS License No, 5140

23. The licensee shdl mahtdn doses to menabem o f the public hrn licensed activities such that the total &%&ve doee equivalent to an individual shall not exceed 100 mitm in one year. The total effective close equivdemt to an individual member of the public shall include doses resulting fkom exposure to patienta adminiatad radioactive materials while those patients m a i n on the licmeee’s premises.

24. Nuclear Medicine Technologhits who meet the criteria of 10 NYCRR 16.123(a)(3)(i) may perform parexlteral injections of radioactive materials for diagnostic purposes under the supervisktn of a physician on the premises. Prior to allowing parenteral administration by a nuclear medicine technolagist,: the Radiation Safety QMicer ahall insure that the technologiirt is competent in the performance ofparsnterral adminimation. Record8 of th is approval must ba retaimd a6 long as the Nuclear Mcdicine ~echakogist is working under the license.

25. D e licensee shdl follow the camqa manufactura’e recommendations fgr d a t i o n safety and quality amuancc. I

26. Sesled sources containing radiaative material shall not bc opened or removed from their respective source holders by the licensee.

FOR THE NEW YORK STATE DEPARTMENT OF HEALTH

~adiaaaive ~ateriats Section Burcau of EnviEommtal Radiation Protecrion

Page 11: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FRX NO. :3045982293 Oct. 24 2006 03:58PM P I 0 FROM . :,QMER I QD 06/13/2086 20: 21 6879628228 AMCWNNELL PAGE 81/02

Nap 11 03 a i l a a p P - 2

1, Name 3. License Number 421

i s a d @ & in Its eniirety * l

to mad as fpilows:

2. Ad&& 4, a. Effective Paca

176 Dmlaon Pdcway &st - Coming, New Yo& 14830

A t t e n t h Pew NicholBon, M.D. b. Expiration Data , - Radiation Safety Officer

5. Reference Numbers DH NO. 00-380 DH NO. 01-16

6. Radioacthe Mamiah 7. Chemical and/or 8. Maximumquantity (ekment & ma93 no.) . Physical Form . licenoee may possless

at om time

A. Any rdloactlve mdrarhl A. Any radiopharmaceutbnl A. Aa3necessary for uses in as described la a9 deacribcd in h'hltam 9A\, 10 WCWI t6,123(b)(l), e x w t alpha or positron ernitling Isotopes

10 WCRR 16.123@)(1)

B. Any radtaactIve mstaidl B. Any ndlophamaceutlcal 8, Aa MW6BaV for uses in a8 deacribcd in qr re@w Ut m SublCarn 9Y) 10 NYCRR 16.323@)42), derrcribtSil In axcagt alpb or positron LO N'YCRR X6.123@)(2) amitring l e o t o p

Doc:ROIL\C3RCOMBQ (32230\52200)

I . . ., . I I .̂--..a,,,- ,-.. c

REV, 4/00

Page 12: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FBX NO. :3045982293 Oct. 24 2006 03:58PM Pi1 FROM . : QMER I Rp

A M C M L L PAGE 02/82 06/ 131 2006 20: 21 6079620229 M e r 11 U3 OltOBp p . 3

W YORK STATE D B P A R W W OF HEALTH RADIOACTXVIS: MATERIALS FlCBNSE

C ONDITIQNS yuu - --

LiOXse NO- 421 Amendment No. a0

6 . Radioacthe MateriaIS 7, Cbmical and/or 8. Maaimm quantity (element & mass no.) Physicbt Form licensee may possess

at m e time .

C. lodine I25

D. Pmlladium 103 ID. Sealed murcas b. 1 curie

E. Tactwetiurn 99m E, Diethyknetriamiw= E. lOQ millicuries ptntaacetic add OTPA)

A. and F. Any dfagnostlc procedure involving mcasurment o f uptake, ditqtian, or excrctjm, a$ described in 18 NYCRR 16.123 (b) (1).

Any diagnostic procedure involving imging an4 localization studio&, aa dp;scr~W in 10NYCRR 16.123 @)(2).

B- and F.

]E. Evaluatian of pulmaary ventilation.

10. PI.. Radioactive mateti.at tisred in Iiem 6 6 h d be us& by, or under the tutelage of rhg following indlviduah, with the r r p a i f i llmltatlans:

Peter La’Nasa , M .D.

D. &gene Martin, M.D.

Andrew J. McDonne11, M.D.

Peter 1. NichoIson. M .D.

Sublwms C and D

Subilems A, B, E, and F

Sab’lterns A, B, E. and P

Wbitenrs A, H, E, and F

- -

Page 13: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

3045980517 To:304 929 2470 P. 4/16

Page 14: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

P.5'16 SEp-@1-2006 13:46 From:RMERIRRD To:304 929 2470

Page 15: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

3045980517 To:304 929 2470 P.6'16

004

111

111 M4TERIALS LICENSE

SUPPLEMENTARY SHEET endmsnt No. 02

m I Ill

c Sealed snrtrces need not be &tad if bey are in storage and are nm k n g used. tiowever, when they atv removed from storage for use cy hJnsfwmd to analhet parman. and have mi been basred within the rquirea leak test inlwal, Vmy shall be tested bekre use or transkr. No setalad sours ahdl be stdced for a period of more than 10 year6 without being tested for leakage andlw contaminutlm.

I

8, Lener dated August 11,2000 ( with attachmente),

' FOR THE U.S. NUCLEAR REGULATORY COMMISSION

U Materials Limsing Branch Reglbn 111

Page 16: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FQX NO. :3045982293 Oct. 25 2006 12:08PM P2 FROM :RMERIQD

D. CobRlt-57 D. SaplcrlSaUm

C. hNNmkd

Page 17: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FFlX NO. :3045982293 Oct. 25 2006 12:08PM P3 FROM ZFIMERIFID

Page 18: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

FFIX NO. :3045982293 Oct. 25 2006 12:88PM P4 FROM TFIMERIFID

OHIO DE~AUTMENT OF ~ A L T H

LICENSE FOR RADI6ACTIVE MATERIALS

SwPL6MENTARY SmmT

1

B. PamChmfhM.ID 8.

b. RabcrtSmiih,M.D. b.

Q. willsnn, L n N n b k , M.D. G.

Page 19: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

Charleston Area Medical Center

MEDICAL IMAGING

3200 MacCorkle Ave. SE Charleston, WV 25304

Fax: (304) 388-8922 (304) 388-5474

July 13 , 2006

Dear Colleague,

I am an authorized user listed on the Radioactive Material License of NRC, license number 47-15473-01. This communication is to confirm that Clinton E. Curtis, MD has successfully completed all training requirements set forth by the Nuclear Regulatory Commission guidelines section 35.290, paragraph c (1). Dr. Curtis has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under the NRC guidelines 35.100 and 35.200. Dr. Curtis has completed 700 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies. This training and experience include a minimum of the following:

A. 1) Classroom and laboratory training in the following areas: a. radiation physics and instrumentation b. radiation protection c. mathematics pertaining to the use and measuring of radioactivity d. chemistry of byproduct material for medical use e. radiation biology f. generator elution

2) Work experience under the supervision of Steven w. Walter, MD (Corscan Plus Inc.),. which meet the requirements under 3 5.290, involving: a.

b.

C.

d.

e.

f.

g.

ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys calibrating instruments used to determine the activity of dosages and performing checks for proper operation of survey meters calculating, measuring, and safely preparing patient or human research subject dosages using administrative controls to prevent a medical event involving the use of unsealed byproduct material using procedures to safely contain spilled radioactive material and using proper decontamination procedures administering dosages of radioactive drugs to patients or human research subjects eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radioactive purity and processing the eluate with reagent kits to prepare labeled radioactive drugs.

Page 20: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

I am pleased to confirm that Dr. Curtis has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under NRC guidelines 35.100 and 35.200.

Page 21: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

* I

CharlestofiArea Medical Center _. --.

Clinton E. ctrttis 305 O'Dd Fann Lane Oak Hill, West Virginirr 2590 i

RE; Clinton Curtis, MD

To Whom It May Coneem

Dr. Cliutoa CtPti5's training was equivalent to Level 2 training in nuclear cardiolo~ ss outlsned in &e ACCI'ASNC CQCATS Guideliner (revised 2000).

Page 22: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

--.

Cor sc ZW~TM

The Nuclear Imaging Csmpany www.oorscannlusus.#m

(910) 246-0434

Quality Control Procedures Worksheet

J 3S.290 Training for imaglng and localization studies

Please complete the following acthrities and have them attested by the nuclear medicine technologist in the laboratory and fax to 703-995-4433.

(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(1) Ordering, recelving, and unpacking radioactive materials Safely and performing the related radiatlon surveys;

Date Completed &pq(w Attestation Signatu 42pvPn.Amw (2) Calibrating instruments and performing quality control pmcedures used to determine the actlvity of dosages and performing checks

Date Completed @~V!OS (3) Calculating, measuring, and safe4 preparing patient or human research subject dosages;

Dab Completed bbq! 6 (4) Using administrative controls to prevent a medlcal event Involving the use of unsealed byproduct ma teriaf;

Attestation Signature

Date Completed !&q 1 'h6 Attestation Slgnatur 20- &I y-+T

Date Completed IplNlau Attstation Signature 0. ( 5 ) Using procedures to safely contain spllled radioactive material and using proper decontamination procedures;

(6) Administering dosages of radioactive drugs to patients or human research subjects;

Date Completed Lt p405' Attestation Signature &*

Page 23: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer
Page 24: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

Attended the foilowing Contlnudng Medicni Education aciivity

Myocardial P erJirsion Scintigruphy: Tricks ojtfae Trade June 30,2001-June 30,2002

Univ. 111n & Con$ Cir. Amherst, NY And has earszed thefoitowimg:

Cat 1 AMACredlt 7.0. hours Washingbn HaspiW Center is accfeuiteu by lhe Accledifation Council for Continuing Medical Education to sponscr

continuing medical eUuCatii for physidans.

Washingtcn Hospital Center has designated this educallonal activity tot cam 1 credit towwds the AMA Physidan's Reccgnilion Award.

.C' .

' Senior Vi@l?resident B Medicd Director

Page 25: Plateau Medical Center, Amendment Request NRC Form 313 ...Nuclear Regulatory Commission, Washington, DC 2%55000' or by internet e-mail to infocollects nrc ov, and to the Desk Officer

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

11 1 6 I @a b , and to inform you that the initial processing which includes an administrative review has been performed.

El was assigned to a I

i 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.

,

\Jc/ro7 . Your action has been assigned Mail Control Number 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)

(6-96)

Sincerely, Licensing Assistance Team Leader