o#ieial 911ly united states nuclear regulatory commission

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O#ieial Yee 911ly 8eettrity Relateel lnfennation

UNITED STATES NUCLEAR REGULATORY COMMISSION

REGION I 475 ALLENDALE ROAD

KING OF PRUSSIA, PENNSYLVANIA 19406-1415

Docket No. 03033297 Control No. 140454

Robert Luthmann, Ph.D. Radiation Safety Officer Capital Area R.T. Associates Oakwood Center Radiation Oncology 880 Century Drive Mechanicsburg, PA 17055

I

May 17, 2007

License No. 37-30075-01

SUBJECT: CAPITAL AREA R.T. ASSOCIATES, LICENSE AMENDMENT, CONTROL NO. 140454 .

Dear Dr. Luthmann:

This refers to your license amendment request. Enclosed with this letter is the amended license reducing the possession limits for your high dose-rate remote afterloader, In addition, pursuant to discussions with Varian Medical Systems and our Sealed Source and Device Registry office, we understand that Varian currently supplies the sources for your device that are constructed equivalent to those previously supplied for use in your (levice. The license has been updated to reflect this change. )

Please review the ericloseq document carefully and be sure that you understand and fully implement all the conditions incorporated Into the amended license. If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region I Office, Licensing Assistance Team, (61 O) 337-5239, so that we can provide appropriate corrections and answers.

An environmental assessment for this action Is not required, since this action is categorically excluded under 1 O CFR 51.22(c){14).

Current NRC regulations and guidance,are included on the NRC's website at www.nrc.gov: select Nuclear Materials; Medical, Academic, and Industrial Uses of Nuclear Material; then Regulations, Guidance, and Communications. You may also obtain these documents by contacting the Government Printing Office {GPO) toll-free at 1-888-293-6498. The GPO is open from 7:00 a.m. to 8:00 p.m. EST, Monday through Friday (except Federal holidays).

Cffi:::: Use C11l, Cuua,:lj Rulatod ! .. fs .... uHu ..

R. Ll!thmann Capital Area R.T. Asse>ciates

Thank you for your cooperation.

Enclosure: Amendment No. 12

2

Sincerely,

Qrig{ilal signed by Penny La_nzise~

Penny Lanzisera Senior Health Physicist Medical Branch Division of ·Nuclear Materials Safety

Offit:ia1' '•se Ooly -Sem•nt:1(-Be!ateci •otormatjan

R. Luthmann 3 Capital Area FtT. Associates

DOCUMENT NAME: C:\FileNet\ML071380342.wpd

SUNSI Review Complete: PLanzisera_

To recell!o a cop of this document, Indicate In the box: 'C' • Copy .w/o ettach/encL 'E~ = Copv_w/_ettaervene1 'N~ = No COPY'- -- . -OFFICE DNMS/RI I N DNMSIRI -. DNMSIRI I I

: NAME Planzlsera /PAN! - i : ! - --

DATE 5117/07 - - --' ( : -

OFFICIAL RECORD COPY

NRC FORM 37~

8fficiaUlse 8nly &ee11ritJ A1lal1el l11feM1atl111

U.S. NUCLEAR REGULATORY COMMISSION

MATERIALS LICENSI:

PAGE __ 1_ 0F _a_ PAGES

Amendment No. 12

Pursuant tq the Atomic Energy Act of 1954, as amen~ed, the Energy _Reorganization Act of 1974 {Publlc Law 93-438), an~ Trtle 1 o, Code of Federal Regulations; Chapter I, Parts 30, 31, 32, 33, 34, 35, 36, 39, 40, and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear materiai 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 regulation.s of the applicable Part(!$). This license shall be deemed to contain the conditions i,pecified in section 183 of the Atpmic Energy Act of 1954. as amended, and is subject~ all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified ' below. , - -

1 1. Capital Area R. T. Associates

9. Authorized use: '-,

In accordance with the letter dated . April 24, 2007,

; , ·t fu~n'se number 37-30075-01 is amended in

its enti;;fyto"read as f~llows:' I}'', .

· -rt"":.\.

A. One source for medical use permitted by 10 CFR 35.600, l(b)(?)(F) I _ ICbU7l(Fl l(b)(7)(F) IOne source in its shipping container as necessary ror replacement or me source m me

remote atterloader unit. B. Shielding in a remote afterloader unit.

CONDITIONS

10. Licensed mi3terial may be used or stored only at the licensee's facilities located at 880 Century Drive, Mechanicsburg, Pennsylvania.

Qf:Aaial Uia 0Aly Sasmrity Related IAfnrmatinr

-- - ----11

I

. . . i

I

. :

I .

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE -z-- of-

11.

12.

Ucense·Number _3Z-300_75-01

MATERIALS LICENSE SUPPLEMENTARY SHE~

Docket or Reference Nuniber 030-33297

Amendment No. 12

The Radiation Safety Officer for this Hcense is Robert W. Luthmann, Ph.D.~

Licensed material is only auJhorized for use by, or under the supervision of:

.... -·

- '

- -

' -

-·-· -

-- . .,..-__ u,_ •

A. .Individuals permitted to work as an authorized user and/or authorized medical physicist in accordance with 1 O CFR 35.13 a~~ a~\ 11?.\ f=i /~: ,,..-_\.

-~ ·\·~·-... ~ ·r - ·~ _, \ -.: ,.~ / .:.: .

B. The following individuals ~~~~~i:rthorized users for medical·:i•~-F~ indicated: .·,· - .

Authorized Users Material and Use < )·

3 PAGES

--- ----·

' - -

I Stephen J. Milito, .~;~; S.:\. _ . ~:. ·,. l(b lC7lCE)

. . ' (~_--t: :·-:i'\ '·.\ ......,.,,.,_ ......... _--«·;-; -,'"" .. : ."""·~'!.,..·' --,.:-,, .... , --~,-, ."'."'. ---------

c. The following indiviauals are agtho.iit~ meff.ii:aJ~hysic.Jst~;~s lndicatect:_ ,~ f_ : " f, -: (.:'.t _ _/kg.,,t. /} / :j' --

I

Authorized MedicalPhvsicl~ts· ,\·- '· :-· Material:ana Use· '" · A,. I~;:~.',_:.'~;. ',.i:"!7 ., 1; ·} :..;' ';-:...:,;-r·:,:;_:li.;,;··~-'..;.:·:i..;;;;,:J...:· •;...·•..:,i.:,.:,f:4

;...'' _ _,;;.'.:::;.._; __________ ill Donald E. Velkley;_·P:~-D. ,\:' ~· · .. '._ :··-;-<'..,,(1 . (b)(7)(E)

,- '.. \''.: ,,\.!(t ;.-Robert W. Luthmanri, Ph.D. ';;,. ·<, . ,,~.(

., \.:: ' r..., •,;{:_,-::

13. The licensee is authorized to transport !!~'!S.ed m~teri~J _in ~C9Qrdance with the provisions of 1 10 CFR Part 71, "Packaging and Transportation]>fRadioactive Material."

NRC FORM 374A

. U.S. NUCLEAR REGULATORY COMl't'IISSION

MATERIALS LICENSE SUPPLEMENTARY SHEET

l,.iceitse Number 31-30015-01 Qocket or ReferenceNum))er 030-33297

Amendment No. 12

14. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance wjth the statements; representations, and procedures contained in the documents, inclu.ding any enc!osur~. listed below. This license condition applies only to those-procedures that are required to be submitted in accordance with the regulations. Additionally, this licerise condition does not limit the licensee's ability to make changes fo th~ radiation protection program as provided for in 10 CFR35.26. The U.S. Nuclear Regulatory Commission~s l'.~ulatio.n§ §h!;lll govern unle~ the staJements; repr~ent~tions!,and procedures inJh(!tcb'n~ee's ~~pliciitio([pQ.d correspondence are more restrictive than the regulations. l"''' <:,,o . ,( ,./•

(;.,''\), .,.., "··.:!~ ~\

A. Application dated Octo~er'h, 2004 [ML042930132l ;, i:·) B. Letter dated March.~.O. 2005 [ML05115055J «<t

Date · May 17 2DCZ

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q:s ~-'t.-)~·) ·:f~·~ /}:\Vf () V, ' • J,,,l <, j ( ;, I' ..•. >:, •;;.::.;

,;~- t~If ;!~j'.[Jt;J1t ,;l •1 "':)r. i I:.:.. {:,'«'·:h,;s, ,. i;,.1, ·""'·

t. .. t. l\· \:,·_'.,· __ }_~:.5L. -~ ·; ~-A t<~;);. ~ .

For the U.S. Nuclear Regulatory Commission

By Original signed by Penny Lanzlsera

Penny Lanzisera Medical Branch Dlvit?ion of Nuclear Materials Safety Region I King of Prussia, Pennsylvania 19406

··-· ... • .·1

April 24, 2007

United States Nuclear Regul~tory Commission Region 1 Division of Nuclear Materials Safety 4 75 Allendale Road · King of Prussia, Pennsylvania 1940~1415

To Whom It May Concern:

This letteris a request for an amendment for License No. 37-30075-0L Capital Area R.T. Associates 're nes · ossession oft (b)(?)(F)

If you have any questions please feel free to contact me at 717-691-3235.

Sincerely,

~ ..

' ' '· ' : . :' . ~- . ,

..•. - . -. ' ~ ' 't . .

:, ._·" ' ' '. '; ·_. '. : :·. :' .. ~

· Robert W, Luthmann, Ph.D. Radiation Safety Officer , ... :,)

f3 -.I

-.:-. -0 :::,

t..J ~

55 9 VI .....

,~ r:S"f· NMSS/RGN1 MATERIALS-002

·;;o;:tJ rt1m r:nn -m o< z. .... a

This ·1s to acknowledge the ~ceipt of yourJetteriappUcatlon dated

.- .... .. :,'fr(¥-f.._;d7. __ . .,_ and to lnfolll'! you thatthe Initial processing whl~h li'lcludeun administrative ra\llew tias been performed.

. ,,,.,_&,.di_ 11 .. ~,7~-;,o( @' There were no admin_istratlve omissions. Your application was as$1gned to a

technl~I reviewer. Please.note .that the technlcatreview may Identify addit!onal onil!lsiriruror r~uire additional information. .

D Please provide to this o~ce Yi!lthll'I 30 day_s Df yoi,ir ~lpt of this card

A copy. of your.action has been forwarded to-our License Fee & Accounts Receivable Branch, who:wiil contact you s~arately if there is a fee Issue Involved.

Your action has been assigned Mall Control Number l<r~-V-'zi,· ---, Wheii calling f9 Inquire a.bout this action, please refer to t,hls contror number. You may <:BIi.us on (610) 337-53~8. or337-5260.

NRC.FORM 632 (RI)

lll-l)e)

Sincerely, Licensing Asslstanoo Team Leader

OAI,WOODCENTER Radiation Oncology

December 6, 2005

Director Office of Nuclear Material Safety aruJ Safeguards Attn: Ernesto Quinones, USNRC, MS TBF3

· United States Nuclear Regulatory Agency Washington. D.C. 20SSS..0001

Dear Mr. Quinones.

Stt'phen J. Milito. /11.D .. :\k:dkal t>irL"<.'tor Rohen W. Luthmann. Ph.D .. Physidst

Linnie P. Cough. Adr11inistmtln: Din:ctor

lam writing in regards to the NRC Order EA-05.090, ISSUANCE OF ORDER FOR JNCREASED CONTROLS FOR CERTAIN RADIOACTIVE MATERIALS LICENSEES. We are licensed with the NRC as:

License No. 37-30075-0l · Docket No. 030-33297 Capital Area R.T. Associates 8SO Century Drive : -· . Mecbanicsb · PA 17050 . . ' urg, . .. , .. · .

Compliance _(or our ~cility, Oak:Wood Center Radiation Oncology, is unn

. '

' ~ ... '

· ·, '.· ~bert w;):.µ ,Physicist Oak.Wood Center Radiation Oncology 0soc~~Drilie': -·._: . Y .• , ... -~-~J •.. " . Mecbmics'l>m ·:·pi\ 17050 . .... \!'"!::::-~ ;.:.-:.:.: tf;_· · .. -:-~(;~:•: ... ~.:.. ..

• .. , I \• , • , I' ., ... 'l\'\\W.wk.\oodr.tdooc.oom

AA{) Ccnnuy Driw, Me,:h;1°nkihurg: PA 17055 •.7J7/69J.:32.,-lc; • Fax: 717/691-324.3 A PinrucleHealth l!lld Holy Spirit Health S~·stcms Seivkc

"-',

UNITED STATES NUCl.,EAR REGULATORY COMMISSION

REGION I . 475 ALLENDALE ROAD

Kl~G OF PRUSSIA, PENNSYLVANIA 19406-1415

Docket No. 03033297 Control No. 1 ;37821

Stephen J. Milito, M.D. Medical Director Capital Area RT. Associate~ Oakwood Center _Radiation Oncology 880 Century Drive Mechanicsburg, PA 17055

December 6, _2005

License No. 37-30075-01

SUBJECT: yAPITAL AREA R.T. ASSOCIATES, LICENSE AMENDMENT, CONTROL NO. 137821

Dear Dr. Milito:

This refers to your license amendment requel?t. Enclosed with this letter is-the amended license naming Dr. Luthmann the Radiation Safety Officer.

Please review the enclosed document carefully and be sure that you understand and fully implement all the conditions ln~rporated into the a.mended license. If there are ariy errors or questions, please notify the U.S. Nuclear Regulatory Commh;slon, Region I Office, Licensing Assistance Team, (610) 337;.5239, so that we can provide appropriate corrections and answers,

An environmental assessment for this action is not required, since this action Is categorically excluded under 10 CFR 51.22(c){14). ·

Current NRC regulations and guidance are included on the NRC'~ website atwww.nrc:·aov,:. selept Nuclear Materials; Medical, industrial, and academic uses of nuclear materialj then toolkit index page. Or you may obtain these documents by contacting· the Government Printing O~ce (GPO) toll-free at 1-888-293-_6498. The GPO Is open from 7:00 a.m. to 9:00 p.m. EST, Monday th.rough Friday (except Federal holidays).



Sincerely,

, Original signed by Penny Lanzlsera

Penny Lanzisera Senior Health Physicist Medical Branch Division of Nuclear Materials Safety

S.Milito 2 Capital Area R.T. Associates

cc: Robert W. Luthmann, Ph.D., Radiation Safety Officer

S. Milito 3 Capital Area R.T. Associates

DOCUMENT NAME: G:\Docs\Mailed\Uc Cvr Letter\137-30075-01.137821.12122005.wpd

SISP Review Complete:.'PU:1rizisera . After declaring this document ~Ail Offlclal Agency Record" ll w

. To rocolvo o coi:' ~ or this documont. .tndlcato In tho box: ·c·." Conu w/o attech/onct ·1:~ • Cooii w/. attach/encl 'N' = No coriil ', . OFFICE · DNMSJRI I N ,ONMSIRI .I DNMS/R! I .1 NAME PLenzlsera/PL ,. DATE- : 12/6/2005 _ - _ -- --


NRCFORM374 U.S. NUCLEAR REGULATORY COMMISSION

PAGE 1 OF 3 PAGES

Amendment No. 11

MATERIALS LICENSE Pursuant to the Atomic Energy Act cif 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 34, 35, 36, 39, 40, and 70, and in reliance on statements and· representations heretofore made 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 shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, anr;I is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Licensee In accordance with the letter dated

October 6, 2005,

1. Capital Area R. T. Associates

Oakwood Center Radiation Oncology

3. License number 37-30075-01 is amended in

i~ en..tirety to read as follows: !. ·i c:· t" •. ~. 'e .~

··, \ .. ,· ./

4. Expiration d~t~ ~pril 30, 2015 .2. 880 Century Drive . 1-· · ····

Mechanicsburg, Pennsylvania. :1'ids5 , .. ,'

.. : )

6. Byproduct, source, and/or sp'ecial nuclei:ir material

(b)(7)(F) A. ,.

~·-

5. Docket No. 03073~297 Reference No. . .. : ,

·ts thetnical and/or physical,fo'm,. . ~-'\<....:'4 - ;:'·; ~:/ :,~ -:.1:.3~;-~· \:,": ?· ; ("' '"

·,,,. · ·1. -~ ,:·. r' , :. ··., i",.: , ~· • r " , ~ . . -

( ~-: (b)(7)(F)

', • 'r,,,. ~-\'.:

(.: ",

>··

8. ~aximum amount that licensee may po;;sess at any one time under this li~~se

A. Jb)(7)(F) I F>·-:i

B. r)(7)(F) . < ·{ .. _s:;:;,(b::;:)(;;::;;7):::;:;(F:;::) ::;".j;:-:='.',i'-:./~.(.'\..--,"'7,.-;:-:-:,: !-: __,

•• ./ • ·,.,.:r'"

· .. ·:, B~ rb )(7)(F)

1 s·. Authorized use:

A. One source for medical use perm.itted by 10.CF~i35.sbo,..)(b __ ) .... (7 .... )( __ F) _____ ....... _____ __,

One source in its shipping container as necessary for replacement of the source in the '-'loz:!ffl'l'nzr!!lffl!'lfflader unit.

B. Shielding in a remote afterloader unit.

CONDITIONS

10. Licensed material may be used or stored only at the licensee's facilities located at 880 Century Drive, Mechanicsburg, Pennsylvania.

11. The Radiation Safety Officer for this licen·se is Robert W. Luthmann, Ph.D.

NRC FORM 3?4A U.S. NUCL.EAR REGULATORY COMMISSION P/\GE 2 of 3 PA~ES ii-'------------------------__,.-___;,__, MATERIALS LICENSE SUPPLEMENTARY SHEET

License Number 37~30075-01 Doci<et or Reference Number

, 030-33297

Amendment No. 11

12. Licensed material is only authorized for use ~y, or under the supervision of:

A. Individuals permitted to work ·as an authorized user and/or ~uthorized medical physicist in accordance with to CFR 35. 13 an('.135.14.

B. The following individuals are authoriz~d .. ~~e~.Jpr.OJ~~ical use as indicated:

,Authorized Users \:, f r_~,,_ f\

1

~:~~;; i~~f:use . ,_ ~~~~~--------.

Slephen J. Miltto, M:~;c:-',) rb)(7J(F)

- C. The following :individuals at~authorized meL.di_ca_l_p_h_y_s-ic-is-ts-f""'a..,.s·-in-d-ica--,.te.,.d""':---------___,J

. ~~:·- '_ei~~:_::',i!'~-~-,,, ,"fs:"_-. _/;;i{;/' < )' A~~orized_-~-E3~i~l~~hy~lclstsk,c-~¥i,) z:. Mate~"'~r.~~~l~~~ {) Donald E. Velkle;}~h.D. ,. (/::-~- \} .. ~. ~(b-:-)(=7)~(F=-).....;;.:.:.....;;..:.:;. ___ ....;;;;;.. _________ """"

"~-/.,. i.D\:~?r~,:::,~\::!,. . Robert w. Luthma'nr{Ph,b.':, · ,,t,'), '"C,'J::1t,:.

- · - ,,.:·>. ;\;t_Jfsi1::ff,,~ . ..,.·,;..-~~:.1,~:":~ .... :-.--~,·~.~·-~"~·.·~~.,_-.-....... --.~-----.... J~-____________ ...,..,..

13. The licensee is authorized t~;fransiir1~~nsJdffi'.iirt~h~1 irlgc~rdance:,~1~ the provisions of . • . , .;.. . .... . - -y ·!f-,,-!f.}'.'- ..... ff ·'"" i-....

10 CFR Part 71, "Packaging anq;::rransportationiof/Radioacthie Material."·

NRC FORM 374A. U.S. NUCLEAR REGULATORY COMMISSION


P~~E 3 of 3 PAGES

License Number

37-30075-01 Docket or Reference Number

- 030-33297 .

i Amendment. No. 11

14. Except as specifically provided otherwise in this license, the licensee shall conduct its program in ~ccordance with the statements, representations, and procedures contained in the documents, including any ~nclo~µres, listed below. This license condition applies only to those procedure_s that are required to be submitted in accordance with the regulations. Additionally, this license condition doe~ not limit the licensee's ability to make changes to the radiation protection program as provided for in 10 CFR 35.26. The U.S. Nuclear Regul~tory Commission's regulations shall govern unless the statements, representations, and procedures in the licen~~l3'.s cilRPlica~on and correspondence are more restriptive than the regulations. !,\ f~ !·"; t:· (;! .I' " .

• '· .t. • ·, \:~.,. t ,/ .('-, ·tf-

A. Application dated Octobe,r-,f~,,.,2_004 [ML042930132] B. Letter dated March 30,,_?9..05 [Ml05115055]

}·.

,.

' ' ;f

D~te Oecerobec 6 2QQ5

,'

. .t\ ~ ' }'

,~.::c" .l ·

• .. ..,.


By Original signed by Penny Lanzlsera

Pellny Lanzisera Medical Branch Division of Nuclear Materials Safety Region I King of Prussia, Pennsylvania 19406





Stev,en J. Milito, M.D. Medical Director Capital Area R.T. Associates Oakwood Center Radiation Oncology 880 Century Drive Mechanicsburg, PA 17055

August 5, 2005

License No. 37-30075-01

SUBJECT: CAPITAL AREA R.T. ASSOCIATES, LICENSE AMENDMENT, CONTROL NO. 137441

Dear Dr. MIiito:

This refers to your license.amendment request dated August 2, ioo5. Enclosed.with this letter is the amended license adding RobertW. Luthmann, Ph.D. as Authorized Medical Physicist. As requested by Linnie Cough· of your staff In a telephone conversation on Augm,t 5, 2005, David J. Salinger; M.D. and Robert J. Baker, Ph.D. have been removed from your license.

Please review the enclosed document carefully and be sure that you understand and fully implement all the conditions incorporated into the amended license. If there are any errors or questions, please notify the U'._S. Nuclear Regulatory Commission, Region I Office, Licensing Assistance Team, (610) 337-5239, so that we can provide appropriate corrections .and answers.

An environmental assessment for this action is not required, since this.action is categorically excluded under 10 CFR 51.22©)(14). ·

Current NRC regulations and guidance are included oh the NRC'.sWebsite atwww.nrc.qov; select Nuclear Materials; Medical, industrial, and academic uses of nuclear material; then toolkit Index page. Or you m1:1y obtain these documents by contacting the Government Printing Office (GPO) toll-free at 1-888-293-6498. The GPO Is open from 7:00 a.m. to 9:00 p.m. EST, Monday through Friday (except Federal holidays).


Enclosure: Amendment No. 1 O

Sincerely,

Original signed by Sandra Gabriel

Sandra Gabriel Senior Health Physicist Medical Branch Division of N~clear Materials Safety


DOCUMENT NAME: E:\Filenet\ML052230132.wpd

SISP Review Complete: (R~viewer's Initials) slg2 After declaring this document "An Official Agency

To receive a cop of this document, Indicate iii 1he box:.·c· = Copy w/o attach/encl ·E· = CollV w/ attach/encl "N" = No copy

· OFFICE _ , DNMS/RI - -- .~ --- ',l:N DNMS/RI I DNMS/RI !I I

. NAME SGabriel/SLG : DATE 8/5/05 '


I

NRC FORM374 U.S. NUCLEAR REGULATORY COMMISSION

PAGE _1_0F _3_PAGES Amendment No. 10

MATERIALS LICENSE Pursuanno the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 3·4, 35, 36, 39, 40, and 70, and In reliance on statements and representations heretofore rriade 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 sueh material for the purpose(s) and at the place(s) designated below; to deliver or tran~fer such material to persons authorized to receive it in a~corcfance with the regulations of the applicable Part(s). This fk:ense i;hall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable niles, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Licensee

. 1. Capital Area R. T. Associates


. 2. eao Century Drive r . ' •',

Mechanicsburg, Pennsylvania_: 17055

' 6. Byproduct, source, and/or special nuclear material

.........

In accordance with the letter dated

: August 2, 2005,

i 3. License number 37-30075-01 is amended in

. ·, '. !~ ~ntirety to read as follows: i' ',' : .. 1 ,:.· /'

• ·'f ;.i.,;:.1, •

'?· Docket No. 030~33297 Reference No.

_,.··.

8. fylax_imum arnount that licensee may possess at any one time under this lice6se ·

A. (!) )(7)(F) ' A (b)(7)(F) I:, .· . A. r )(7)(F)

,_ -: ~: l(b )(7)(F) B. r(1)(F)

9. Authorized use:

. ~}~;·:: ·, 1_ t ·';:~ ~·~.- :;

. .., ~ -·

A. · One source for medical use p0

ermitted by 10 CFR 35.60·d~(b:::;:);:;;(?;::;)(::;;F)===========---....il.L... !{b)(7}(F) ! l.._(b .. >)(._7 ... )(F_.:) _____________ __.I

l<b)(7)(F) I- One source in its shipping container as necessary for replacement of the source in the remote afterloader unit.


CONDITIONS


11. The Radiation Safety Officer for this license is Stephen J. Milito, M.D.

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION


· °License Number . 37-30075-01 ; . --- - - - -

i Docket or Reference Number 030-33297

PAGE 2 of 3 PAGES

'1-------------------: Amendment No. 10

12. Licensed material is only authorized for use by, or under the supervision of:

A. Individuals permitted to work as an authorized user and/or authorized medical physicist in accordance with 10 CFR 35.13 and 35.14.

B. The following individuals are authorized;users for- medical use as indicated: ,, ~ .-· ', '··, :·~. ,· .. :··:· .;-· ·'.' / / .1:'

Authorized Users .Material and: Use.,

Stephen J. Milito, M.o .. ' · '· ·

C. The following indiyi.clJals ~re;"at.ithqrized medical physicist~-:~s indicated: ~ ""··· ~: .... ' ~--:... • J. .,' .,,.,_:i. > ·.~'

:.· _1· -

Authorized Medic~i'Physicists~: -~~ .i .. · · fViaterial·an&Use .. /,

. '\ ....... _,..,.,.(b.,..,)(=7)-.:(F,,..) ----------------, David E. Cunning_l:lam, Ph.D. • .. -.

,, . .. . ~

\! t ... '··,, ..

Donald E. Velkley, Ph.D. . .. · •I",. 1

1 °r

' .. IL Robert W. Luthmann, ·Ph.D. ;' '

'· .. , •'.l

13. The licensee is authorized to transport licensed material in accordance with the provisions of 1 O CFR Part 71, "Packaging and Transportation of Radioactive Materi~I."

NRC FO~M 374A U.S. NUCLEAR REGULATORY CQMMISSIO~ PAGE 3 6r 3 PAGES '1

I 14,


~:------:------....;...--..;._-~--'-----'-Li cien s e NLimber

3?-:300?~-01_ DoekefofReference Number 030-33297

Amendment No. 10

Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. This license condition applies only to those procedures that are required to be submitted in accordance with th~ reg!:J!ations. Additionally, this license condition does n·ot limit th_e license.e's ability to make changes fo the radiation protection program a~ provided for in 10 CFR 35.26. 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. Application dat~d Oc;tobe,fJ1: '2004 [ML042930132] B. Letter dated March 30, 2005 [ML05115055] .

-.

) . : 1,,:,,.

,,.-;

··:I

For· the U.S. Nuclear Regulatory Commission

Original signed by Sandra Gabriel Date August 5, 2005 By

••••••••••••••••••••••••.••••••••••••••• •SaABre·@·abriel Medical Branc~ Division of Nuclear Materials Safety Region I King of Prussia, Pennsylvania 19406



KING OF PRUSSIA. PENNSYLVANIA 19406-1415


Stephen J. Milito, M.D. Medical Director Capital Area R.T. Associates Oakwood Center Radiation Oncology 880 Century Drive, Mechanicsburg, PA 17055

July 14, 2005

License No. 37-30075-01

SUBJECT: CAPITAL AREA R.T. ASSOCIATES, CORRECTED.COPY OF LICENSE, CONTROL NO. 137172 .

· Dear Dr. Milito:

Enclosed is the Corrected Copy of Amendment No: 9 for License No. 37-30075-01. As discussed with Linnie Cough of your staff on July 13, 2005, NRC administrative review identified minor typographical errors in Condition Nos. 3 and 12C of your license. These conditions have been updated fo correct the errors.

We apologize for any inconvenience these errors may have caused.

Enclosure: Corrected Copy of Amendment No. 9

Sincerely,

Original signed by Pamela ·J. Henderson

Pameia J. Henderson, Chief Medical Branch Division of Nuclear Materials Safety


DOCUMENT NAME: E:\Filenet\ML051990499.wpd

SISP Review Complete: (PJH). After declaring this document "An Official Agency Record" it

:To receive.a coD' of.this document. Indicate iri the box:~ C" = Copywto attac encl "I:= CoDVw/.attachfencJ._ 'N~= No copy

OFFICE DNMS/RI rN DNMS/RJ ·1 N DNMS/RJ ti: NAME SGabrlel/SLG PHendersontPJH

- ---

DATE 7/14/05 - 7/14/05 --

--


-- .

'I - ..

NRCFORM374 U.S. NUCLEAR REGULATORY COMMISSION

PAGE 1 OF 3 PAGES

Amendment No. 9

CORRECTED COPY 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 Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 34, 35, 36, 39, 40, and 70, and in reliance on statements and representations heretofore ·made 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; lo use such material for thEl 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 applicabie Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. ·

Licensee



2. 880 Century Drive

Mechanicsburg! Pennsylvania· 17055

i.

In accordance with the letter dated

· June 3, 2005,


. Its ~ntirety to read as follows: "l :• t •, .

5. Docket No. 030-33297 Reference No.

6. Byproduct, source, and/or special nuclear material

:7. Chemical and/or physical fomi • ,.... ' ' • 1· • - .~~ _.... ,. ' •

8. Maximum amount that licensee may possess at any one time under this llce~se

f•.

A. (b)(7)(F) A. (b)(7)(F)

l :/.

B.1(b)(7)(F) B. (b)(7)(F)

9. -Authorized use:

A. One source for medical use permitted by 10 CFR 35.60Q'fo!l,J,.,.(b;.:=)(7.,..;,),;,,.(F __ ) __________ ,__ _ _,

l(b)(llCFl il~Jib_)(_7)_(F_) _ _._ __ ~-~---~~--' (b)(7)(F) 1- One source in its shipping container as necessary for replacement of the source in the remote anenoader unit.


CONDITIONS

1 O. Licensed material may be used or stored only at the licensee's facilities located at 880 Century Drive, Mechanicsburg, Pennsylvania.

11. The Radiation Safety Officer for this licen_se is Stephen J. Milito, M.D.

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION

MATERIALS LICENSE SUPPLEMENTARY SHEET.

CORRECTED COPY

_ -~AGE 2 of 3 PAGES --License Number

3'7-30075-01 "oockel or Reference Number

030-33297_

Amendment No. 9

I -....a-----------------....:....-------...L:.---------------....:....----

i

i

! :

12. Licensed material is only authorized for use by, or under-the supervision of:

A.

B.

Individuals permitted to work as an authorized user and/or authorized medical physicist in accordance with 1 o GFR 35.13 and 35.14.

The following individuals are auth_9r~:~r,!:11~e1ff~r:--."1e:9i~al use as indicated:

r- ·.,. ' ·"

Authorized Users _:,}:/ .. ,: · ~'M:-:a~t:':'er~ia~l-~-~_&_~u_-~_:e __ .. __ ·-------------...... David J. Salinger, M.D/;- (b)(7)(F)

.r'

Stephen J. Milito, lv1:_D. ·-- -·-~ ' ' ..

,_ ,_ ;,_- . ''·:,!;_:'~·\ _,.~ ...... "'"'")--:,--:-:· -.,,,...~~~r-~---:,,~~-,,...-_ ----------..i :1

C. The following lndlylr:Juals are a_Clthoriz~d mE!dicaJ physiclsts<:as indicated~· ;· ~ .n· , . 5> , \}>:· ce:;,_y:~t . _: i .,~- . , ;. ,

Authorized Medlcal.Physidsts,. c.- , ... :-~ -- · - ·:Material and.Use ,-- - - - i,--·-~. - 1~. • I ".-c~ !, ..,...,.....,..,.,,,;.'1."...,._,,,_"'--' -•""'::,~;_,' ;_;•;-,,·_,, ____________ _

David E. Cunningha·m, Ph;:C~.:}: . (b)(7)(F) \ •1. > 1,~ ,...· : i,

I..-. t~'· .. ·i('" i

! • :;.· •:. ~-

Donald E. Velkley, Ph;b~:·.. ·· I·'

Robert J. Baker, Ph.D;

13. The lic_ensee is au~horized to transport licensed material in accordance with the provisions of 10 CFR Part 71, "Packaging and Transportation of Radioactive Material."

N_RC FORM ;J74A U.S. NUCLEAR REGULATORY COMMISSION PAGE 3 of 3 PAGES . 1~l-l~-~---N-um-b-~~·---~~,.....,,-,---~


C.

CORRECTED COPY

. :37-30075-01 Docket or Reference Number

, 030-33297

Amendment No. e

14. Except as specifically provided otherwise In this license, the licensee shall conduct Its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. This license condition applies only to those procedures that are required to be submitted in accordance with the regulations. Additionally, this license condition does not limit the licensee's ability to make changes to the radiation protectlqn program as provided for in 10 CFR 35.26. The U.S. Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the lic.:~n~~e's,,c1ppUcatjon and correspondence are more restrictive than the regulations. , ' · ·

' A. Application dated Octobef 11; 2004 [ML042930'132] B. Letter dated March 30; ~(}05 [ML05115055]

• ;,1

.:..,,!_

.... (,

Date July 14, 2005 .

:,·,. ',.


(?riginal signed by Sandra Gabriel By

• • • • • • • )• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •Sar,drs•Ge.briel Medical Branch Division of Nuclear Materials Safety Region I King of Prussia, Pennsylvania 19406

UNITEl:l STATES NUCLEAR REGULATORY COMMISSION

. . . REGION! . 475 ALLB-mALE ROAD

KING OF PRUSSIA, PENNSYLVANIA 1840.6-1415

D<>ckeJ No, 030.33297 Control No. 137172

Stephen .J .. MIiito, M. D. Medical Director · Capital_Atea RT:-Asso9iate_s, Oakvifood Center Radiation Oncology 880 Century Driv~ . Mechanicsburg, PA 17055

July 12, 2005

License No. 37~30075-01

SUBJECT: · CAPITAL AREA R.T. ASSOCIATES, LICENSE AMENDMENT, CONTROL.NO. 137172

Dear Dr. Milito:

ttiis refers to your license amendment request. Enclosed with this letter is the amended license adding Robert J. Baker; Ph.[). as Authorize~ Medical Physicist_ for yoµr high dose rate ~mote afterloader unit: As discu~seci with Linnie Cough of your st~ff_on.July 11, 2005, Dr,, Baker will receive. device-specifiq training from Varian before participating in any clinical treatments.

Please review the enclosed document carefully and be sure that you understand and fully implement all.the conditions. in~orporated· into the amencjed license. If 'there are ·any errors or questions, please notify the U.S. Nµclear.Regulatory Qommission, Rt:igion I Office, Ucerising Assistance Team, (610) 337-523$, so that we can provide appropriate corrections and answers.

An environmental assessment for this action is· not required, since this action is categorically · exclLideci under 10 CFR 51.22©)(14).

Cµrrent NRC regulations and guid::mc_e are available at the NRCweb site at http://www.nrc:gov/materials/niiau/rriat-toolkits.htnil ~rid http://www.nrc,gov/who-weareiqoveniincFlaWs:html or oy contacting the Government Printing Office (GPO) loll-free at 1-1:faa~293:54.9a_·-·rh'e GPO is open from 7:00 a.m. to 9:00 p.m. EST, Monday t~rough ·Friday (except !federal holidays). . .

Thank you for your cooperation. Sincerely,

· ()riginal signed by Sandra Gabriel

Sandra Gabriel Senior Health Physicist Medical Branch Division of Nuclear Materials Safety


DOCUMENT NAME: E:\Filenet\ML0519~0284.wpd

SISP Review Complete: (SL<32)

, To receive a cop ofthls document, Indicate In the bQx:•c• = Copyw/o attach/encl . 'E" =Copy w/attachlencl. 'N" = No copy · PFFICE _ -_ DNMS/Rl -- IN DNMS/81 - . _- --~ I . ,DNMS/RI- -·.· -- I .

NAML . SGaliriel /SLG2/ .DATE . 7112105


r

NRC FQRM 374 U.S. NUCLEAR.REGULATORY COMMISSION

PAGE 1. OF 3 PAGES Amendment No. 9

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 Federal Regulation:;;, chapter I, Parts 30, 31, 32, ~3. 34, 35, 36, 39, 40, and 70, and in reliance on statements.and representations heretofore made by the licensee, a license Is hereby issued au1horizing the iicensee 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 p!ace(s) designated below; to deliver or transfer such material to persons authorized to receive ifin accordance with the regulations of the applicable Part(s). This license shall be deemed· to contain the conditions specified in Section 183 of 1he Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and o"rders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Licensee

· 1. Capital Area R. T. Associates

Oakwood Cente.r Radiation Oncology

I ' . 2. 880 Century Dnve ,I

Mech~nicsburg, Pennsylvania_ .17055

I

In. application with the· 1etter dated

June 3, 2005,


f _; ~ ,~~irety to read as follows: ' '! - • : I:"'/.

; 4. Expiration diif April 30, 2015

' 5. Docket No. 030;:33297 ',.. .)

Reference No.

-- - ·i-· -- ~ ~ rM

6. Byproduct, source, and/or spilclal : nuclear materia)

. 7. Chemical and/or physical form e •,.:< '•·, I ~.t •>~ -~-~~-'-}. F ~:

8. ry'la~imum amountthat licensee may poisess at any one time under this

1,· :·: li~~se

l:A:: ... (b ...... )(""'7) .... (F ... ) ........... -------.... A-_r ........ )( ..... 7) ...... (F .... ) -----------1 -.~ ;..,.: .

A. l(b)(7)(F)

B. ,(b )(7)(F} . :~: l(b)(7)(F)

-:.(-~ !

9. Authorized use:

A. One source for medical use permitted by 1 O CFR 35.600.l(b)(?)(F) I · l(b)(7)(F) U(b)(7)(F)

l(b)(7)(F) 1 une source in its srnppmg comainer as necessary tor replacement of tne source In the remote afterloader unit.


CONDITIONS

1 o. Licensed material may be used or stored only at the licensee's facilities located at880 Century Drive, Mechanicsburg, Pennsylvania.


I

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION! Pf.GI;:_ .·. _2 of 3 PAGES i ""'L-ic'""-en=se"""N'-i.J..;..mber-=---"'---,--"==--'"'-'-......:...--.......... -----...;....._.....

! 37~30075,-01 MATERIALS LICENSE SUPPLEMENTARY SHEET

·~D-ock..,.,. __ ;,..~..,.or.,...R_efi....,.ere""'"ri,..ce-.N-.u-mb_e_r------------,· i

i 030-33297 ' Aryiendrnent No. 9.

12. ~icensed material i1:; only authorized for use l?Y, or under the supervision of:

A. Individuals p~nnitt~d to work as an authorized _user and/or authorized medical physicist in accordance with 10 CFR 35.13 and 35.14 •.

B. The following individuals are authorjzed;:~~ers:for::m1;idical use ·as indicated: . 1 r\ ,;y-, c·"'1 '-;- ~ { .,...'T .,i y 1 .

, . ~ r* Material and Use ... Authorized Users

David J. Salinger, M.D,;: (b)(7)(F)

Stephen J. Milito,_ M:J~. \ ... ' "t,,.~ •:, il :;"',,

C. )'he followiil"g indtl!J'~tipls are a~~i>rj~ea me~ica'.,f ph~l~i~,(as indicate'f[; i . ·•· ·.;,·r·. . v.,:\ r.~ .. ~h-:.:G:}-~~-\. -- ,:~ .. ~ .. /.. ,. ; i:',·i ,.

,Authorized .MedicMPMsici~s;_,,''<: . ' ,~'~ ~' ;·: •. M~ieriatahil Use: :, ·-- ·~~ t-"'/;},:-., .., ___ ,;.,... ··...,;' i:: ... ~i_' _i.\ .... )·r._i,..·;;, _______________ _

David E. Cunningh~m,. Phi@t: .. ti' \ (b)(7)(F) ' ~~·,i· -· >. ;_

bon~ld E. Velkleyi P~1pi . '

R,obert J. Baker, Ph.b,

13. The licensee is authoi:ized to transport _licensed material in accordance with·the provisions of 10 ·cFR Part 71, "Packaging and T~nsportation of Radioactive Material.", .

)

1 NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION', _. _PAGE 3. of 3 _F'~G_E~-i1-L--l~---n~se .... N-u-mber---------'---=....;;;;...;=---;.;:..;_-'-'------------


. 37-30075-01

. Docket or Reference Number

'030-33297

Amendmenl-No. ·g

14. Except as specifically provided otheiwise in this license, the licensee shall conduct Its program in accordance with the statements, representations, and procedures contained In the documents, including ' any enclosures, listed below. This license condition applies only to those procedures that are required to be submitted in accordance with the regulations. Additionally, this license condition does not limit the licensee's ability to make changes to the radiation protection program as provided for in 10 CFR 35.26. The U.S. Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the licen~~e'S(clP,P,.liCf,!tion and correspondence are mc;>re restrictive than the regulations. . : ; . · · -· - ': ,.. :

\ / . l ~ •.

A. Application dated Octo~~d 1"[2004 [ML042930132] B. Letter dated March 30,-2005 [ML051-15055]

,; .,._ ... , "·. ;, \,. :1 •,-::

f i.

'I ·,· •,.,,.:1 ,'

' . ,,

~. ' / '· -;_ .. ,·: ,t·· ~ ,- "

~: t·).'~~r: · ,.•.

For the U.'S. Nuclear Regulatory Commission

Original signed by Sandra Gabriel Date July 12, 2005 By

• • • • • • • • • • • • • • • • • •-• • • • • • • • • • • • • • • • • • • • • •Sar,dre•Gribriel· Medical Branch Division of Nuclear Materials Safety Region I King of Prussia, Pennsylvania 19406

FAX

Re:

717 691 3243 _,...._ --,.---.,--'-,-,..._ __ .....,,.,,, ____ __, __ .0.AKW'QODCENTER

BBD Century Drive MechaniC$burg, PA 170$5 PI\One: 1•717~91-:3235 Ftx: '1·717-691·3243'

Rndfafioa Onc:ology

- WEBSITE: W)A'Vi•.OaHwoocirndonc.r.om ~-mail: ,..,..,ii~o®iiiitwo11draelf!nc:m·

. ~ilillcwopdiju:atj{r.nm ~

Stephen ~- Milito, M.D., '4edical Pirec;tQr Unrue P. c;augh, 1.idmln,l~,rstlve:Dlrectpr ~ean M; Weiner, Frpnt omce Man(#g_er Osvld E. C11nnirigham, Ph.D. OlrectororPlrysics

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CJ Ureicnt CJ For R.saview Cl .fllea-!! Cwninerit [J Please Reply

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717 691 32.43

et10a12ees .ae:19 ss1~2s,~1ea1 ,, sir"' Gf Cillfamia-tt111i1n,ane1 N&lniin. ,,nism' A11eiu:, -., .... . ~ . .. ,· .. ' . . . ,.

RADIOACTIVE MATijRIAl LICENSE

- -- ·- - .'-~.:--.::·.

• ':I.: •lJOe/lSe! M/JITbV. . ~56-tL

2. ArJdfriiil:

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Page 1 of 5 ,page;

.ro. SS2Z Sepwveda B9~1ivjird Van.Niays, CA 91~11 Rob~l't ).·:awr. h:J>, Radiation Safety, Officer

1· '9/'lnlpe,:tlon!A,.,,~ ·:- J.os AnBeles·C:01111.t:Y ~ -.- c. ···

· _ _ . . _ ......... , D1mar1mentotP.ealt1i.Sc;,.ices

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I B. l.i'roup 9 as ilpecifi1d in Item 9 .. i8·

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717 691 $.243

B7/l!lB/20B.S 1)0!19 .6,6~-~5,-103i SANTA QJIRITA PAGE as ~,aitmeri\ ot Netlldl $~iee,

Page 2 of 5 p&get

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Mletidlliirit NUIIIIJ!i!t: f!

~-9' C:.tlrornll-tlftlth.•ild Humi!I S•M~ Apnq . " •'

Ml)JQACTlVE W.TERrAl. _LICENSE

9. AY~bm~~

A. ~P 6 •111cb,tten,py_ and Op~ic ~-ts utiliziiag ,ui~ er solid so.uri:es ffllUlufe.cblrcd; J11~Jecf.. package~ iiicl rli'1n~lild in. ~~with ll SP=if,i~ license.·~ JIW'IU~ \'C! T°Jtle 10• «;:ode ori:eimra1 ~-w~ P11t 32.14, or a iJ>ecific uce~e i.mied by an Agre,ma11t st~ or i. Licming State pursuant to equivalent wits regillaticns (except rot IOU~., mR!luf'acturad l'Wiorto Augutt 1~ '1974). · · · ·· r.··

l. 2.

A ii;awr . pp . . . . . . ' . ' .. ,· ' . ' To bo used in a Nuclltnm)l'.dd,1 Micn,Sel~n-HDR. Classic Aflerlo11dir fot , biach1&hirapy~e1rib (10 C:I mQimum ~~ ~e4 ~ ~~vie,). .,

To ise ~.scd iD a-Nucl~ Colporadoa:Modcl 105~999 KPR Afte,Jcadet for biai=h)'lhliltilP)' ~•nts CU Ci ~mum.so~ lnstelled ia de~jc:e).

· 8; ~up 9 l. Marktr ancl celi~f.!n ~rces.

L,qRlfSet;QNDqioNS.

l O. Radioactive materiel sha1J bt n,,:1 only at die fc)Uowing lo,ca\jons: (9? 5522 Sepulvedal3ou1evan1, V~NU)'J. CA,. ... (b-)("""I .... )(F"'". ) ....... _____________ _

.(b) 23023.Sll•nnen Way, West Hills, CA. (b)_(?)(F).

Ce:) 2!751 McBcan P11rkway. Val•ncia,CA. (b)(7)(F)

.11. 'This license ~ subj~fki an wual fee for sources c;tive matar Allt oraze to po , , at any one ti~e as spe~ed lo I~ 6; 7, ·s ani:19 uf'~ license. The .iimual f•• for this tiw.ue is required b>.' aod computed In ac:cord""ce with Title 17, California Cado or_Rlgulatlons. Si,;tions 3.~230-30l32 mid is.also subject to an annual ccst-of•IMn8- adJ"5Tfflent plll'Suac,co Section 100425 l){the Califbniil.Hn.lth 1111d S~ Code. ·

J2, (a) the individual• Mined hlow are autho'ri28d the spei:itilfuses ofndioactive mat«'iiil dmn'bed in Items 6, 7, .8, · · and ~ of d)is Ut:11J1se as follows: .

(I) Bemud S. Lewilll'io', M.1', (2} · Ro~ert Paul Z-unmerman, MD. (3) Wilijam J. Jlo"11ello, M.t>. '(4) Gary A. lhfar, M.D.

Otoilp, 6 and 9 Groups hnO Oro&aps 6 ud 9

· Groups , and 9 . ' . .

(b} Ra.dioaciivc material may !,e used byth~ followm, indMduals for physical measmements oply:

Ol David R. Metcalt Ph;D~ . (2) Randy K.apla..ram*S, M.S~ DABR (.3) Robert j, B:aker; :Ph.D.

·,,

/

717 691 3243 07/1 l/200S 08:53 ,(8C ? ,J04!005.

El7le18/2e1e1S i,e,; 19 S61-2S9-l8!ll SANTA Cl.MITA

RAD.IOA~TIVE MATERIAL LICENSE

PAIS£ .BIi

D•,artni•l'II of Health Servi""

Paga 3 of 5 ~es

Ucense Number. ~

Alftllnd!IMnt Nllftlber. il

13. Except as s~ifil.ally provided otherwise by this lic:CJ1Se. the licensee !hall pNsess an!i ura ,adlo~ive material dos~ribed m· 1teins 6, 7, 1 .llnd 9 ~ thi:i lictilsc in accordance with the mtaments, · repr.scntations. !Ind proceduras c:onuiiled in the docllfflenb listed below, Thi Dep~ent•s reiulations shall 2ovcm ·unless the statements, repMClZltations, and procedmes jn th= li~'s e.pplica1ion and correspandericl! ~. aiote re,.rrictm, th.Ail· the ~lati~. ,. ·

(a) 'Ibe letters, both ~itll snac:bm1pts, dated Octobci 12,. 1g51'° and October ll, 1998; as supplemcntwd by the letter dated Octob!i'r 22, J 998, all signed by David IL M~t Ph.D., Radiation Safety Officer, r~lng die addhiori of a RDR. for physical qi.easwem~u only. ·

(b) The l.etter dated November 17. 1998, signed by David It M•ra::alf. Ph.D., Radiation Safety Officar, reg~ng 11. •

c:oi:rection rar the use toc:ati~ of th11 HnRAfti:zlodcr. .

(c) The Jetter, with attachment, dated Janua,y 10. 1!195J, signed by pavid R.. Metcalf. Ph.D .. regarding the shlelcling verificatiori measuremenu fbr the HDlt troatml!lnt roam. ·

(d) The' letwrs, both .w11h urachments, diitsd :March. 27, 2000, end J'wie ~. :zooo. both-,igced by lwid;y Kaplan• 1~es, MS, DABR, Medical Ph}'3ic:isf. lilld David ll M~ l'h.D.. DABR. Jladiation Sllicty Officer, repnlin; 1hc additi1n1 of an HDR ·for ph)'Sical measuremenu onl;y.

(e) The letter. with .RtW:1unent$; dated Cktober 30, 2000, b01h signed by Randy Kaplm-Iaxnes, M.S., DABR. Medical Physicist, and David R.Metcalf, Ph.D •• DASI'., Radiation Safety Officer. tega.rdingthepedormance of ph)'Glctl measurements for an ,HDR Afterloader.

Cf) The liceni;a renewal applicatlcn, with attachments. dated April ~o. 1998, signe~ by David lt. Metcal( Ph.D., lladiatiou S11fct.y Offic:w, and Bernard Lewinslcy, MD., President. Chiof&el:utiva Officer, and the letters. both with attachments. dated Oc:tober 8, 2001, and Oc:.tober :n, 2001, both signed by D:ivid R.. MetoaJf, Ph.D., Radiation Safety Officer.

Cg) Tin: letter, wtth 11tt11cllmezat. dated No,.-embel' 13, :Z.003~ r•eardint 11te duties, respou:5ibilitiaa and authortcy oftha Radla~o11 Safety Officer, ~igneil by BGrnard Lew~ld, Pre5ident and Robr.::rt J, Beker, Ph~».

14. (a) The Ra&:JJatlon San:iy om~ in ibis proil'Qm i;hall be Robert J, 'Baker. Pb.I),

Cb) The Custodian of seated sources- slwl bo Oa.vid R. Metc11lf, PhD.

(c:) the Alremate Radiation Safety Offi~r in this program shaU be Randy Kaplan·Jam:s, Ph.n., DABlt

1i Sea.Jed sou~ pds:ics~ed under thjs license shall be 1eSted for leakage andfor contamination as nquired by Title 17, Califomia Code.of Regulations, Section 30275 (c):

16. In lieu of the h:ak 1=st irm:rvals Rltluis-ed b)' California Codo of luigulations, Title 17. Section 3027S (c), .s8alad sa~ can be tested for IAlcago and/or contamination m lonicr inteiva.~ when !bey ~re specified m a certificate cf registration iss·ued by the U.S. ·Nuclear R.egulat.ory Coqimiuion, a.n Agreement Stata or"' Licensi::ig State. When a longv interVai s~pulated in 1. ce~cate of registraticn is used. the cartificate must be maintained 011 file and availabh: fo'r ln:spectiol\ for iu lofts as the assoi:iated leak teat ..-;.ords a:e reb.ined. ·

17. The foll~wing individual; are authorized to r::oll~ wip• test semples of sealed sources possess11d under this licenH using leak tl!St kits a.ccepta'ble to the Califorrua D1partmimt ofHeahh SeNi1:e5;

(:,,) The F.adialion. Sar~ty Officer · (b) Qulllifled lndMduals designatfld in writins by the Radiation Safety Officu

717 691 3243 0- 1120""' ...... ,.. •. $'.;..,"' G""' ".-v::. II I Li..;:'I ...o: ::,,,. ; . ..,.,..1 ,., • · .,;:,/ ..,uu

ei7/ !l~/21!1£15 ea: 1, 661-259-lEl:31 S~A CL.AlilTA

· RADIOACTIVE lll!AT#:RIAL Ll~NSE

PAGE EIS

l:lep;,M11111t Df HQIDI Svvlces

Pag& 4 Df 5 paga

Llculso Number: ZU§:12

Am1ndinen1 N11111Der: !!

ia. lbc licensee s&an conduct a physical inve1110ry every six monthg ~ account for ull ·G1111.lod .aourccs andfor devices rece.i~d and_ pcsses~d Wlder the li~ansc. R=onls. gf the invc.11.torie$ sbaJl be mamtainad fer mspection, and may be disposed of'f'ollowing Departmentinspection. · · ·

19. Treatment and DWlliement of patients undiqoing braehytbenipy shall be in accordance with the guidance from any a!tha fo~owinJ: . . ·

(a) Chapter 5, ~~af•ty frecautfons in Cllnical Application'.', Natiom.l Counc:U on Radiation Protection and Measuremen~ (.NCRP) ~ort No. 4'!, ~mtion As~in$t ~iaticn From Bracb.)'thenipy Sourcu,. (NCRP Publications, P .0. Box 3017$, Wash~n; D.C. 20014). • ·

(b) Appen~ N in lh• "Guide for the .Preparation of Appliali~ fbr Medical Prcsrams". Srata of Califctnia, . DepllJtfflen.t of Health Services, Radiological Health Branch. . · . .

(~) ·oocum~ted t"Ationale or p&.~ent:-11Pei:lfic C!.~onsdemO!)mlll~that member& of the gu.ual public wi.11 br: limited ta SOD mrc:rn tobil 11.fli=ctivn dose equivalent :from patienu. wli.c?·Jiave been relea.s6!1

20. Rl!lllobe afierloadias device f'aciJi~g shell be ~c, conS!nlctff. as to permit continuous o'l:J5ervatit'n of patient:. fi'orn 011tsidr: the tffatmcnt room(s)'. ·

21. Written emergency instructions· ,baU be posted c:olisplcuously at the 111mote 11flerl~di11J: devic11 conb'ol(s). Instructions wU inc:.lude direction.a for mmuaUy iumfng off'th~ rrqnoce mterlcmliag device(s), removing the patlcnt, securing 1he ro:0m(1) apiost imautltori:r:ed ently, and nalif)'ing lh• HSJ'ODSible authorized ll!ltf or Zh• Radlatii:m Safety Officer. · · ·

22. EJei;trlcal interloclc(s) on en~ door{s} to 'the remote •fterioading dmce room(s) shat! be t.ster:1 for. FOPet <1pcmtlori ai l~t ones eYCJY. raooth er prior tG use (if 1.111ccl ll!Ss mquentl)'). Records gf ten mults shall be maintained available for inspection. · ·

23. lfthere ls " ri:ason to su.~pect that thuource po~ition in_dicator or entrer.c. dccr(s) interlock(s) Ware acit functioning properly, use of 'tlte remote atbsr~oading dt'Vice(s.) shall be diJcorit.iruzed until tb~ co11didon ?199 been coJTeCted, A ~ord of U)' ,uch mal~~tmn .matl be aw:le and maintained aYalJabJu for inz;p,ction.

24. Specbl Rc:qulremants for Remote Afterloading Device Spot Che:ks a.-id Calibration'.

(a) . At intervals not to ~eaed daily or prior tc use (if med Jw frequently), the follo~ MSU shall be ptrformed:

(l) Sol.lf'CB pt>aition indicatot(s}. ~) Source posltionlna reproduclbiliey. ,o within ±Imm. · (3) .hlsp~tion ::,f guide 1:1,1bei for kinks and other impcrftcticns.

(b) Timinl davicc ac;urac:y shall be pnrfonn.ed at intervals not to CX~lld monthl::, or prior to 8ilql u:;c (If Used les5 ·frequently). ·1

(c) Sow-c:e travel time error shall bci JJerlonned at each so\lJ'ce loading,

(d) At eac:h $0\lrce loading al'ld then at intBrv.al5 not to e~d thtee mcntlu, atie month for Ir·192, or prior·1e us• (lr · usiBd less frcquantl)'~ the licensee :mall determine the dose ~ur.c:.y ta within ::1:5 percent.

25. ltemote afurloa.ding devices authcrJz11d by rhis Ii~ slwl not be operated unless the licensee: has in his p1:11ssession detailed writttn instructions specific. for the make and model ofthc n:mote efterloading device.

717 53: 32!3 : .-.-:. ~ 1"' .. .:.. ·- ~ ... , ..........

~7/BB/2BB5 aa:19 661-25'3-lfJl SANTA CLAF.ITA

RADIOACTIVE MATERIAL l,.ICENSE

PAGE. 06

.OepllftrMnl of Health ~r,,icu

Pciga 5 of 5 pages

l.ii:aN.• Nllnlbe,: ~

Amendment NIITll!er. S2

Z6. Eac:h remote afterJCiding davice shall be ui&peCU?d and serviced in accordance with the -man~ctu.rer's recommeruiat[ons.

27. For remoto after1oading device', specifically a~thorized per90nncl st.A.II:

(a) Install, n:iocate, mainrain and repair devices containing radica;tlve nwicr.ial. {b) Laak test, l'llpi11C1: 1md dispose ofsca1cd sources c.onta!Dlng radloactlve material usnd in d~ice;.

lB. Sul:!equent to eacb 50lffl:e loading, r~iation SIUVDY=i shall ba pimonned prior to human 11S1 as tbJJows:

(a) A radiation survay shllll be made of the unit scutc:e housing. wJth the sourcu(s) in th• shielded p~sJtlon. The maximum r"di&iiQn levels at 20 . c:cntimetm from the su~;e of lhe sourt.e bousJn3 shall noi exce&d 3 millito•ntgeni. per hour,

(b) P.ccorda of survey results sball be maintained fer inspectiim.

Z9, Imi:nediately «fter mraeting th111 :;ou.-ce ftom the pat~· into itG shielded p0$iticm in the r:mote a.flerloading device. a radiation survey sJi.all be made ofthe patient with a pott.a~le radiation detection survey illlllrument to confirm that th• sourca has been removed from th, patient Aecords of each ,urvcy shall be inaintsin.td,

30. Trl!atment tim• c:alculations and data er.ti)" for rem.o~e afterlaaden; shall be Individually verified by the re,sponsible authorized user physfc:ian immediately prior to treotment.

31. At Jeast 30 days prier tD vacatine an)' addrass of use listed in Condition 1 Q of this Uc:ense, the llcemoe shell provide ~an notification thereof to th• I)epartfnent or Health S0rvicc111, in nccordanc:c: with Titie 17, Cafiforttia Ced• of Re~Jations, Section ?0256. ·

n. A !:QI))' cf this lieen,e and a copy of ali r.ecord, and dccumen~ pennining to rhis license· shall be maintained ~va.ilabl.e for inspection at 5S22 Sepulveda Bauleva.rd, V1U1 Nuy.i, CA- ·

Printe· Nsrne: Heidi S. O'Conn•IJ I

~It: Marc:h 22, 2004

t of He.alt?,

Radiologic Hesltl; Branch MS 7610, P.O. Bex 597414 Sac:ramianto. CA 9589~·1414.

. . UNITED STATES. 'NUCLEAR REGULATORY COMMISSION

REGION I . 475 ALLENDALE ROAD



Stephen J. Milito, M.D. Medical Director & RS0 Capital Area R~T. ('ssoclates Oakwood Cente~ Radiation OncQlogy 880 Century Drive

. Mechanicsburg, PA.17055

April6, 2005

License No. 37.:.30075-01

SUBJECT: . CAPITAL AREA R.T. ASSOCIATES, ISSUANCE OF LICENSE RENEWAL, CONTROL NO. 1_35812 . . .

Dear Dr. MIiito:

This refers to your request for renewal of your NRC license. Enclosed with this letter Is the renewec! license. Please note that your license was written .In a format comRatible with the revls~d 10 CFR-Part 35, dated April 24, 2002. Please review the enclosed docµnient carefully and be sure that you understand all c·ondit_ions. If there ar!9 any errors or questions; please notify the U.S. Nuclear Regulatory Commission, Region I .Office, Licensing Assistance Team, (610) 337-5239, so that we can provide appropriate corrections and answers.

The NRG expects licensees.to conduct their.program·s with ,rietlculous attention to detail and high standards of cprnplianc_e. B~cause of the ·serious consequences to employees and th~ public that can result from failure to comply with NRC requirements, you m_ust conduct.your program according to NRC regulations, the conditions of your NRC license, an~ the representations made In your application. Please note that th_e last condition on your license indicates that "This licens·e condition applies only to those procedures that are required to be submitted in 1;1ccordance with. the regulations." Therefore, any procedures submitted that were. not required by regulation to be submitted, e.g., full calibration ·procedures, will n·ot.be qonsidered a part of your license and were not reviewed during the licensing process. T~ese procedures will be reviewed during inspections, as necessary.

Please note that you must:

1, Op~rate _in accordance with NRG regulations 10 CFR P~rt 19, "Notices, Instructions and Reports to Workers; lnspections.U 10 CFR part 20, "Standa'rds; for Protection Against Radiation," and other applicable regulations.

2. Notify the NRC in writing when:

a) an authorized user, authorized medical physicist or Radiation Safety Officer . permanently discontinues performance of duties under the license or has a name change;


b) the mailing address changes;

c) the naine on the license changes; or

d) permitting an lntjividual to. function as a temporary Radiation· Safety Officer In accordance with 10 CFR 35.24(c).

3. In accordance with 10 CFR 30.36(d), notify the NRC, promptly, in writing, ahd request termination·ofthe license

a) when yoµ decide to. terminate all activities involving materials authorized Under the license; or

b) if you decide not to acquire or possess and use authorized material;

4. Request and obtain a license Amendment before you:

a)

b)

c)

d)

e)

f)

g)

h)

permanently change Radiation Safety Officers;

receive byproduct material in excess of the amount, or radionuclide, or form different than l;IU\horized on the license; or

add pr change the areas of !.!Se, except as allowed by 10 CFR 35.13(e) and with the appropriate notification described in 10 CFR 35.14(b)(4);

change the name or ownership of your organization;·

change the address(es) of use identified on the license;

receive, prepare, or use byproduct material for a type of use thaf is not authorized on the license;

permit anyone to work as an authorized user or authorized medical ptwsicist, except as allowed by 10 CFR 35.13(b) and with the appropriate notification described in 10 CFR 35.14(a); or

revise procedures required by 10 CFR 35.610, 35.642, 35.643, or 35.645, as applicable, where such revision reduces radiation safety.

5. Submit a complete renewal application or termination request at least 30 days before the 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.

In addition, please note that NRC Form 313 requires the applicant, by 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 appliqation should be the lic.ensee or a certifying official of the licensee rather than a consultant.

S. Milito 3 Capital Area R 1' .. Associates

You will be periodically inspected by the NRC. Failure to.conduct.your program in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspon~eilce with N~C win result in enforceril~nt action ag~instJ~u. This could include iss1,1ance of. a notiqe of violation, or irilpositio,n of ct civil pen~lty, Qf ~n or~er susperidio·g, modifyjng,orJevoking your license ~s specified in ~UREG 1600, "General Policy and Procedure for NRC Enforcement Actionsp (EnforcelT)erit Policy}. ·

An enVironmentafa$sessment for this action is not required, s;nce this action is categorically excluded undet10.CFR 51.22(0)(14).

Current. NRC regulations and guid1;1nce. ate ayailable at the NRC w~~ sites liste(:I below or by · ~ontactl~g, the Gov~rnm.('}nt PHntlng Office (GPO) toll.:.free at 1-888-,29~-6498. ih~ GPO i.s open from 7:00 a.m..to 9:00 p.m; E:ST, Monday through Frid~y (('}xcept Federal hi:>lidays).

• I . .

Thank you for·your cooperation.

Enclosure: Amendment Nb. 8

NRC Web site addresses

Sincere.ly,

Original signe,d by Pame/c1 J. Henders.o.n

Pamela J. Henderson, Chief Medi~! Brancb Division of Nuclear Materials Safety

NRC regulations ·· , http:i/www.nrc:gov/reading~rm/doc.,.collections/cfr/ .

LicenSlflQ guidance . .. ---· htfp:l/www .nrc:gov/read1ng·,.rm1doc~collections/nuregs/staff /sr1 556/

General Polio{ and Procedure for.NRC Enforcement Actions - ~· · · Http://www. nrc,gov/what-we-do/regu latofyJenforcement/eriforc-poLj)df

206 of the l;riergy Reorganization Act of 1974 . . . . ... . , . -.. . . -' http://www.nrc.gov/who~we-are/governing~laws.t\tml.

s .. Milito 4 Capital Area R.T. Associates

DOCUMENT NAME: G:\Oocs\Mailed\Lic Cvr Letter\137-30075-01.135812.04072005.wpd "

To receive a c:011 of this documenL imficate In the box: "C" = Coov:w/o attach/end "E" = Coov w/ et12ch/end "'N' :a No cool! _ _ _ ''

OFFICE DNMS/RI IN DNM$1Rf-- -- I.N DNMS!RI Ii I I

L

NAME WLee/WJL1 PHeriderson/PJH1 - - ---

--i DATE ___ . 4/6/2005 4/6/2005 r_


NRC FORM374 U.S. NUCLEAR REGULATORY COMMISSION

PAGE _1_0F _3_ PAGES : Amendment No. 8

MATERIALS LICENSE Pursuant to the Atomic. Energy Act of 1954, as amended, the Energy Reorganization ~ct or 197 4 (Public Law 93-438), and Title 1 o, Code

'of Federal Regulations, Chapter I, Parts _30, 31, 32, 33,.34, 35, 36, 39, '10, and 70, and In reliance on statements and representations '. heretofore made by the 11,;:ensee, a Ucense 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 Parl(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of- 1954, as amended, and Is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter In effect arid to any conditions specified below.

LiC8nsee - - ..,


Oakw~od Center Radiation Oncology

: In· appiication ·with the applicati'on d·afed ---

1 October 11, 2004, • 3. license number 37-30075-01 is amended in

., . Ii., I?; {',;'. i!§ ~n,,tirety to read as.follows: \(../• ,\-i•.: < ~ t-~,· t?· [/.:·."·

.,.,,,...,......,.....,.........,.,--...,,...__,...,....,,.,._--.--.--------,--. 4. exp1raiio'n daj~-~pril 30, 201 s 2. 880 Ceritury Drive . _ '\ 5. Docket No. 030;S3297

•,; 11'

~<!. ·.J,:

Mechanicsburg, Pennsylvania,,,;:h705!j

(,- ! Refe~nce No. - ·

, A. (b )(7)(F)

I

9.

,_. ./J !~ -·

,::--,; · .. _._ ..

·~--:---~:"'-,,,. -·--- •• -- 1 -----

. . ·;~ ,.,,. ~· ... -,._ - .ft ,./.." ::".;

a. M~lmum amount th_at licensee may possess at any one time under this li6ense

..,,-:_~;,

A. One source for medical use permitted .by 16 CFFlss.sb 11,.,,.,b.,..,,lc=1i"""cF,,...l--------...... l l(h){7lfFl' ' (b)(7)(F)'

1.._(b""',w .... 7_.,'UI._F ... :l __ ,.• one source m its snipping contameras n ~· V IUI 1-• -· ....... UI LIIC: ;:,uu, 1.,0 In LIIO

remote afterloader unit. B. Shielding in a remote afterloader unit.

CONDITIONS



I

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION P"GE 2 of ~ PAGES 1,-L_ii:e_n-se_N_u_m-be_r ___ ...;..;.. ____ ___:. __ _


37-30075-Q1 ·ooclief or Reference Number ,030-33297

Amendment No. 8

12. Licensed material is only authorized for use by, or under the supervision of:

A. Individuals permitted to work as ari authorized user and/or authorized medical physjcist in accordance with 10 CFR 35.13 and 35.14.

8. The following individuals are authoriz~d 1!,.i.~e~7fpr;m~~ical use as indicated: ',. 1(. p. (~\ I_ -.t (~ t_) / J: ,·. ,

Authorized Users C. \ ... · ·Material and.Use '" \, ·,." .¢.(b~)(~7)~(F~) :::::::::::::::::::..... ________ __,

David J. Salinger, M.D. ::-.-.''· · ·,.

13. The licensee is authorized to transport, 1!t:en,se.9 ~aterj~_l,in ~c:cordance with _the provisions of 1 O CFR Part 71, "Packaging and Transportation pf1Radioactive MateriaL"

PA~E 3 of 3 PAGES NRC FORM ~74A U.S. NI/CLEAR REGULATORY COMMISSION 1--------------------------Li cen s e. Number

MATERIALS LICENSE -SUPPLEMENTARY SHE!=T

37-30075-01 ·oockefofReference Numtier -030-33297 .

IAmendment No. 8 I • •

I

- .•• ,I

14. Except as specifically provi9ed otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the dQcuments,. including any enclosur~s. listed below. This. license condition applies only to those procedures that are required to be submitted in accordance with the regulations. Additionally, this license condition does not limit the licensee's ability to make changes to the radiation protection program as provided fur in 1 ff CFR 35.26. The U.S. Nuclear Regulatory Con;imission's regulations shall govern unle.ss the statements, representations, and procedures in the ljt:~n~efs ~RP}ipa_!ton and correspondence are more restrictive than the regulations. : :. P. ,r, n t:: .t -: ; .

' f. '1: <. t ~ ·~~ :~ i .

A. Application dated.-Octol;>~r'.,1{,2\cfo4 [ML042930132] . ,,:; c~t.). B. Letter dated March 30,Jqos

D.ate April 6 2QQ5 -

''?:" ! . ..,;·


By Original signed by Pamela J. Henderson

Pamela J. Henderson, Chief Medical Branch Division of Nuclear Materials Safety Region I King of Prussia, Pennsylvania 19406

j

--·,.-.-

RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION LICENSE RENEWAL APPLICATfON

TO: Wi.11,le J. !,:.ee, Health Physicist · U.S. Nuclear Regulatory Coinn:iission Region 1. . 475 Allendale.Road Kiog-of Prussia, PA 19406 (610)337-5090

RE: . License Number 37;30075--01 Docket ·Number 030332~7

bATE: March 30, 2005 .

··:GEIVED· .GION r

"05 APR -4 ·AB :41

Gapltol Area Rad.latlon Therapy (CART) Associates response to the NRC letter of Inquiries dated March 22, 2005 · ·

Question 1.

sxour renew.al application (ltei(> 5.1~urce De~tiptlon} requests_ ailthotization for several differenrsealect sources, ·/rictuding those manutact(!red by RTS TeChnofogy, Byk Mallincpodt, c,s-u.s; Inc., an.d MOS Nordion. Please.note that the Sealed .. Source and Dovice Regfsl,y .

. ~rrently approyf!S the fp/fo'l(ing seated sourc~ for:your G.~miiMed f!DR. unit:

aJl(b_)(7)(F) l .

-~=,(b=)(7;)(;F)::=::=::=::=::=::=:::::::;;--~~~~--

Onfy. these sources will be listed on yaur NRC license .. In ackiition, Item 9.A (Authorized Use . wlll be changecfto t(b)(7)(F) . !(distributed as (b)(7)(F) !(b)(7)(FJ -!· »

CART Associates response: CART Associates requests a renewal for the following sources: .................... -----------------

a) !(b)(?J(F)

Question 2.

b) rb)(7)(FJ

(b}(7)(F)

r,"5" .<t' ~- . NMSS/RGNI MATERIALS·002

(b)(7)(F)

Quest!on3.

"Your renewal .applicat(ory (lt~m 9,2. MndiiP!Jnder,t Monlt~r) ~escrlbes the t,estment ~m area 111diation monii,or: and bac!«Jp bat;tery supply. Conflnn that this .mon/(or and baqktlp ~ttery supply wm be piDvld"'- In_ ,sch 0{"'9 two tre.atmenfvautts. Confirm tlUJt HDR iemote ~ftertpader use w,1/ be suspended If the siea monitor tans/' ·

9ART 'Associates response: CART ~oclates confi.nns that b:oth ~atment rooms have the follow1n·g area radiation monitor with battery ba¢kui> supply; · ·

Nucl~r Associates Pr;malerrt 1 o ·

CARJ MsQCl~tes confinns that HOR aftertoaci~r use wiil be suspended If the area monitor fails; ·

Question 4.

Your nmewal apptlt:atl~n . .{lfem 9.1.6:-Vlsuill and Audio .Patlent~urvelllanoe) ctesc~s ,tie patient '(lewing and communication systems and ths backup·ctosed circuit television (CO'n'} monitor. Confirm that prl,nsry and backup CCTV~ are provided for both tre{Jtment rooms. Also descnbe the backup systems orproce.dures to be .u$8d In case of failure of the two-:way audio communication sysfem. ·· ·

CART Associates response: CART Associates ~nfirms thatthe primary and backup patient viewing systems (CC7V) are provided for both treatment rooms. CART · Associates confirms that In the .ewnt of failure· of the two-way audio communication system the tteatment shall riot be' Initiated and an on-going· treatment shall be tennlnated · until the primary system Is cotrec~ed or the backup system Is Installed. CART Associates ,confirms ~t It.will purcha~ and maintain on' site a backup audio S)$1em to, be used in the evjant of failure of the primary system In e.ither treatment rQOm.

. Question 5. ·

"Please. confirm thal the locks, warning sig,w, and warning /lglJts desprlbed In Items 9.1.3, 9.1. 7, and 9.1,8 of your renewal applicatio,, apply to both treatment rooms."

Cf\RT Assa.dates response: C~RT Associates co~flrm~ that th~ locks, v.aming signs,· and warning lights described In Items 9.1.3, 9.1. 7, and 9.1.8 of your renewal application applY'to both treatment rooms.

Question 6.

Please prpvide additional Information about the Interlocks dt:$Crlbed in Item 9. 1.5 of your application. Confirm that these interlock systems (1) am provided for both treatment moms, (2)

cause the source to retract If the room door is open_ed, and (3) prevent initlat{on of the ~atment cycle if the door ls not closed.

CART Associa~s ,asponse: CART Associates confinns that.the ~oorintertock &)"Stems are completely Independent and are provided for both rooms. Both door interlock systems cause the source to retract if the door Is opened. Both door interlock systems prevent initiation of the treatment cycle if the door Is not closed.

Question 7.

Your renewal appllcatiOn (Item 10. 8-Daily Quality Assurance and Addendum K) descn"bss checks to be perfonned each day ofpatisnt treatment. Please update these procedures to comply with all of the requirements of10 CFR 35.643, Including verlncatlon of proper operation of(1) source eKposure indicator lights on the remote. sttertoade,: unit, on the control console, and fn the faclllty; (2) emergency response equipment,· (3) clock (date and time} In il,e HOR un;tt computer; and (4) decayed source activity In the unit •s comp¢er. Describe your method for checking proper operation of the area radiation monitor. Describe your method for checking timer ~ccuracy and range of acceptable results •

. CART Associates response: CART Associates updated the HOR treatment procedures to include proper operation of ( 1) source exposure Indicator lights on the remote after1oader unit, on the control console, and In the facility; (2) emergency response equipment; (3) clock (date and time) In the HOR unlfs computer; and (4) decayed source activity In the collSole computer. Documentation for the completion of the procedures Is included on the Patient Treatment Qu~llty Assurance fonn. This fonn Is appended to this response.

The following. methoc;I is used for checking proper operation of the area radiation monitor. Nuclear Associates Primalert 10.

a.) Disconnect the detectorfrom the primary power source. b.) Place a 1 O mlcroCurie Cesium 137 source on the .face of the unit.

Proper operation is Indicated by a flashing red light.

The following method is used for checking proper operation of the console timer. The treatment delivery unit is connected lo an optical sowce viewing system and positioned in a ·manner to pennlt visualization with a remote CCTV (see attached photographs). The delivery console unit is programmed to position the source at an appropriate dweU position for a preset time. The observer initiates a digital timerwhen the source reaches the dwell position and terminates the timer when the source leaves the position. The digital measuring device has an accuracy of .01 sec. However the technique accuracy is l!mlted by the response.tim~ of the observer, which Is known to be less than 0.5.seconds. The technique is used for a minimum of two times on every treatment day. The times are seiected to be less than and greater than the actual clinical treatment time. The accuracy of this technique of timer accuracy determination is less than 0.5 seconds. The measurement for a setting of 100 seconds must be betvi.een 99.5 and 100.5 seconds.

Question 8.

--'---- ·---

Confinn tl)at 19u wl1I post~ the HDR unit~ the eme,r,ency pTDCedures submitted as 1t11m 10'.13 of your renewal application. Please 11pdate these.~ures ~ add the follO.wing: (1) lnc/.Ufle 'cc?ndltlons for performing a. patient su~y: (2) ~s¢n"bfil wording on ,tie $lgn used to prr,hibif ~dmlllance by una,utl}c,,rized Pl!.;sonn_el, $UCh. as ·No lfnlry".; (3) .iflc/ude t/le names ant! telephone niimb&ls of~ authoiized use~.auth¢ze~ med_lc!il physic/$ts; end RS0to be conlacted if the unit or cdMole operates abnormal/Y; (4) ilddress maintenance and catlbratlon _prior to -,esumlnr, 'HOR use. · · ' ·

CART AssQcl~tes confirms that_th~ywill post atthe tieatmerat console the er,ietgency pl'C)Cedures. attached to this. !85ponse. These procedures have been upda~ to Include tt,e following: (1 ) conditions for perfonning a patient survey; (2) pl"Dhibitio!'I of a~mittance by unauth9nzed personnel; _(3) names ~nd telephone numl;>ers of the authorized users, authorized medical physicists, arid RSO to be cxmtacted if th~ unit or c;:onsole operates abnorm_ally;_(4) maintenance and calibration ~uirements pri~r to $Umptton of HD_R operation; A copy of the revi~ed Emergency Procedures ls atlache~I: -

Question 9;

Please confirm that ~u res_efV!j the. right to 11pgrade your survey lnst/Uments-as necii~ry ~s _ lorn, ~S they ~lf)"adequate to "19BSUt'e the type find leve_J Of $:flation foi wt,fch they !'f8 ~~.

CART As,ociates_ ~~'the right tp ~pgrade Olir surv~y instruments as ne~sary as 10,:ig ~ ~Y are .at;iequate to 111easure tije ~ ~nd leveJ of radl~oi, (Qr whictl they are used. ·

,Question 10.

Please confirm that you-wn1 provide dosimetry tht.lt meets the 'requirements listed under ACrilena@ in NUREG 1S56; yo/ .. 9 A Consolidated Guidance itboilf M!Jterials. Licenffl: Program Specffic Guidance About Medit:al Use Ucenses,@dated October 2002.

. CART Associates confirms that M. will p,:ovide .dosimetry. thEil meets the ,equire_ments listed ·under ACriteria@ in NUREG 1556, Vo[ 9 A. Consolidated ~~!dance About Materials Licenses: Program Specific Guidance About Medical Use Licenses,@ dated October 2002. - ·

Question 11.

· Please conflim that you haviJ develo;,ed. arid will Implement and maintain written procedures for area surveys in accordance with 10 CFR 20.1101 that meetlhe requirements of 10 CFR 20.150t

CART As!!oclated confirms that we h~ve developed and wlU Implement and maintain -written-procedures for area surveys in accordance with 10 CFR 20.1101 that meet the requirements of 10 CFR 20.1501.

Question 12.

Please conflim that you have developed and will Implement and maint~in written waste disposal procedures for licensed materiel if'! accon1ance with 10 CFR 20.1101. that also meet the · requirements of. the applies~ section of Subpad K to 10 CFR Pa_,t 20.

CART Associates confinns that \\e have developed and will maintain written waste

~-~c:~=~~~pa~:~~-~20~at-$ept,en J. MIiito, M.D. ~apltoJ Area R. T. Associates Oakwood Center Radiation Onoology 880 Century Dril/6 Mechan/c8burg, PA 17055

OAKWOOD CENTER RADIATI:ON O~COLO~Y

Imrt EMERGENCY INTERVENTION.PROCEDURES -· ... -~· . . - ,\.. . .. . . ' .. . . ' . . .

GammaMed 12i AFrERLOADER

Hi~chy ofititerhlpt Actions in case Emergency Retract is.necessary. Each step a:ss\11*1es the fail~ of the previous step(s). ·

1. Press the·. Interrupt Bu~o:q on ~he .Console Unit. 2. Press the Emergency. Button on the Console Unit. . _ 3. Open th~ Tr~ent Room D<>or to allow Console Uiµt to Indica~ "Door

Open." 4. Enter the Treatin~t Room with s.urvey ~eter and pr¢ss Em~rgency Button on

JJDil'Unit Qfily the authorized emergency trained pe(sonnel l.isted below ~Y enter the room. ·

S. Turn·the Emergency Hand Crank in.th~ditection of the am,>w~ 6. If radiation survey shc,ws source is still in patient remoye ~e ilpplicator from

the patient and, msert the applicator contaimpg th~ stuck or brok<m $0W'Ce'into the Emergency Con~ner. 00 NOT cut~ cable or gµid~ tube; or disconp.ect guide tube ·from applicator or HOR unit · - · ·

7. Remove patient from treatment and re-s~y patien~~ ·seal Trea~ent Room door with radioactivity warning label and a sign stating the following: "DANGER ADMITTANCE PROHIBITED." Notify the RSO, Physician and VARIAN MEDCAt SYSTEMS.

8. Subsequent to .corrective measures or repairs, do not initiate treatments until the licensed medical radiation physicist has completed an evaluation and calibration of the treatment unit and the RSO has aJJproved the unit for use.

VARIAN EMERGENCY TELEPHONE: 1.800.864.1672

My DoanncmlSIForm.'Clfnical/OammaMcd 12i Aftmoadcr

PERSONAL INFORMATION WAS REMOVED BY NRC. NO COPY OF THIS INFORMATION

WAS RETAINED BY lHE URC.

HDR PHYSICS CONSULT

Patient: .,_,. ---'-""'"-'---=---'----=-~'---.. ID No.: "--.. -__________ _

Unit: .,_. ------------"------=-----____;;;.a..:::::..-- Serial No.:. ____________ _

Source:.._. ----------------- Model No.:-----............ ==· -=·-:a..;-·-;.;;...·- Serial No.:. ___ . ----'"----

Survey meter:-------- Serial No.:. ________ Cali. Date:,_. ___ -~

The following checks must be perfonned each day the unit is used for patient m,atment.

1. Source position accuracy: . Criterion;a...· -----,-,----- mm

3

I .f

1, 5

I. Door Interlock: Satisfactozy

0 UnsatisfacJ()ry

D 2. Catheter Disconnect Interlock: D 3. Source Exposure Indicator Lights-Console D 4. Source Exposure Indicator Lights-HOR Uliit D s. . Source Exposµre Indicator Lights-Facility D 6. Source Retraction: q 1. Audio and Visual Equipment: 0 8. Radiation Wall Monitor (with check source): 0 9. Timer Accuracy: 0 10. Radiation survey meter operation: D 11. Emergency Response Equipment: D 12. Console Computer Date and Time: D 13. Radiation survey meter operation: D 14. Meter Reading of patients Tx. Area D

Before treatment: After treatment:

DOSIMETRY: ;'

I :

' . S~urce installed on:._· ________ ,_ Activity A0 = _______ Ci

Calibration date:: ______ J ____ ,-'Measured Activity:. ____ -----,,'Ci

Decayed Activity on treatment Dld~: ______ _

D D 0 D D 0 D D D D 0 D D

I

Calculated Decay Factor: _ __;;, __ _ HOR Console Decay Factor. ____ _

Physicist: _________ _ Date:. ___ _

' ' ....

..... '\

\,

REQUEST FOR ADDITIONAL INFORMATION LICENS~ RENEWAL APPLICATION

TO: Stephen J. Milito, M.D. Capitol Area R T; Associates Oakwooq Center Radiation Oncology 880 C~ntury Drive Mec;:hanicsburg, PA 17055

RE: License Number 37-30075-01 Docket Number 03033297 Mail Control Number 135812

PATE: March 22, 2005

Please respond to the following items:

1. Your renewal application,(ltem 5.1-Source D~scription) req4ests authorizati.ori for sev~ral different sealed sources, inqluding those manufactured by RTS Teghnology, Byk Mallinckrodt, CIS-US, Inc., and MDS Nordion. Please note that the Sealed Source and Device Registry currently approves the following sealed sources for your Gamm~Med HOR unit:

2.

3.

a) (b)(7)(F)

b) (b)(7)(F)

RC license. In .addition, Item 9.A (Authorized Sa.1;.W11WW12DJ:iaal.l0.111.12.ll.L.llJ:L _____________ .llC. llStributed

Your renewal application (Item 9~2.1-lndependent Monitor) describes the treatment room area radiation monitor and backup battery supply. Confirm that this monitor and backup battery supply will be provided in each of the two treatm.ent vaults. Confirm that HOR remote afterloader use will be suspended if the area monitor fails.

4. Your renewal application (Item 9.1.6-Visual and Audio Patient Surveillance) describes the patient viewing and communication systems and the backup closed circuit television (CCTV) monitor. Confirm that primary and backup CCTV's are provided for both treatment rooms. Also describe the backup systems or procedures to be used in c~se of failure of the two-way audio communication system.

5. Please confirm that the locks, warning signs, and warning lights described In Items 9.1.3, 9.1.7, and 9.1.8 of your renewal application apply to both treatment rooms.

6. Please provide additional information about the interlocks described in Item 9.1.5 bf your application. Confirm that these Interlock systems (1) are provided for both treatment rooms, (2) cause the source to retract if the room door is opened, and (3) prevent initiation of the treatment cycle if the door is not closed.

7. Your renewal application (Item 10.8-Daily Quality Assurance and Addendum K) describes checks to be performed each day of patient treatment. Please update these procedures to comply with all of the requirements of 10 CFR 35.643, including verification of proper operation of (1) source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (2) emergency response equipment; (3) clock (date and time) in the HOR unit's computer; and (4) decayed source activity in the unit's computer. Describe your method for checking proper operation of the area radiation monitor. Describe your method for checking timer accuracy and range of acceptable results.

8. Confirm that you will post at the HDR unit console the emergency procedures submitted as Item 10.13 of your renewal application. Please update these procedures to add the following: ( 1) include· conditions to,r performin·g a patient ~urvey; (2) describe wording on . the sign used to prohibit admittance by unauthorized personnel, such as "No Entry".; (3} include the names and telephone numbers of the authorized users, authorized medical physicists, and RSO to be contacted if the unit or console operates abnormally; (4) address maintenance and calibration prior to resuming HDR use.

(

9. Please confinn that you reserve the right to upgrade your su1'(ey instruments as necessary as long as they are adeql,late to measure the type and level of radiation for which they are used.

10. Please confirm that you will provide dosimetry that meets the requirements listed under "Criteria" in NUREG 1556, Vol. 9."Consolidated Guidan9e About Materials Licenses: Program Specific Guidance About Medical Use Licenses," dated October 2002.

11. Please confirm that you have developed and will implement and maintain written procedures for area surveys in accordance with 10 CFR 20; 1101 that meet the requirements of 10 CFR20.1501.

12. Please confirm that you have developed and will implement and maintain written waste disposal procedures for licensed material in accordance With 10 CFR 20.1101, that also meet the requirements of the applicable section of Subpart K to 1 O CFR Part 20.

Please note that procedures submitted tor ALARA Program, HDR Souroe exchange Quality Assurance; Sburte Inventory, Quality Management of Brachytherapy Procedures, and Sourte Cal~bration Were not ~qui~d for Uce(1S,~ re~ewal and_ we~ not ri>viewed. These items will be acldressed during the next inspection, as required.

Willie J. Lee, Health Physicist .. U.S. Nuclear Regulatory Commission· Region 1 · · 475 Allendale Road King of-Prussia·, PA 19406 (610) 337-5090

NRC FORM 591M PART 1 (10-2003)

U.S. NUCLEAR REGULATORY COMMISSION .

1CCFR2.201

SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTiON

1. L!G.1?:JE>Ep'LQ~6 TIQN IN~PECIED.: 2. 'NRC/REGIONAL,QFFIGE• - - · Capital Area R. T. Associates Oakwood Center Radiation Oncology 880 Century Dr. Mechanicsburg, PA 17055

U.S. Nuclear Regulatory Commission Region I, 475 Allendale Road King of Prussia, Pennsylvania 1940~-1415

REPORT 3. DOCKET-NUMBER(S) ~ ·-14: LICENSEE NUMB_ER{S)

-_ 37-30075-01 I 5. DATE(S) OF INSPECTION

3/10/2005 0303329_7 -· LICENSEE:

The Inspection was an examination of the actilri!les conducted under your Ecense as they relate to radiaUon safety and to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the condlfions of your license. The inspection consisted of selective examlnaUons of procedures and representative records, Interviews with personnel, and observalions by the inspector. The Inspection findings are as follows:

IBJ D

D

D

1. Based on the inspection findings, no violations were identified.

2. Previous violation(s) closed.

3. The violaUon(s), specifically described to you by the inspector as non-;eited violations, are not being cited because they were self-identified, non-repetitive, and corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy, NUREG-1600, to exercise discretion, were satisfied.

___ Non.Cited Violation(s) was/were discussed Involving the following requlrement(s) arid Corrective Actlon(s):

4. During this Inspection ~rtaln of your activities, as described below and/or attached, were In violation of NRC requirements and are being cited. This fonn isa NOTICE OFVIPLATlON, which may be subject to posting In accordance with 10 CFR 19.11.

(Violations and Corrective Actions)

Licensee's Statement of Corrective Actions for Item 4, ·above.

I hereby state that, within 30 days, tho actions described by me to the inspector will be taken to correct the violations Identified. This statement of corrective actions Is made In accordance with the requirements of 10 CFR 2,201 (corrective steps already taken, corrective steps which wfll be taken, data when full compliance will be achieved). I understand that no further written response to NRC will be required, unless apeclflcally requested, I

Title Printed Name Slgnaturo Dato : LICENSEE'S REPRESENTATIVE

NRC INSPECTOR

J Penny Lanzlsera

NRC FORM 591M _"ART 1 (10-2003)

IRA/ 3/10/2005 - I

E:\FDenot\ML051080266.wpd

rNRC-FORM~S91M PART 3 : (10,2003) · 10 CFR 2.201 Docket FIie lnforml!tion

U.S. NUCL~ REGUL:ATORY'COMMISSIO~ 1

I•

i' . i

SAFETY iNSPECTION REPORT AND COMPLIANCE INSPECTION

1. LICENSEE , 2. NRC/REGIONAL OFFICE

. ' · , Capital Area R.T .. Associates l.J.S. Nuclear Regulatory Commission

Region I, 476 Allendale Road MeQhanlcsburg, PA 17055

REPORT NOS 2005-001 -·

3. DOCKET NUMBER(S)

03033297 6. INSPECTION PROCEDURES USED

87132 -·

Main Office Inspection

, King of Prussia, Pennsylvania 19406-1415

' 4. llCENSE NUMBER(S)' - __ - - -- --- ·15·-_·3-o_ A1:r0-E(OSS)_OF IN_S.PECTION

37~30075-01

SUPPLEMENTALiN~PECTION--INFORMATIO~ - ...

3. LICENSEE CONTACT

37-30075-01 1

4. TELEPHONE N\JMBER 7-17-691-3235

·-- . ·- ·- ~ ,.

Next lnspectlon Date: $107_ _ ____________ ..;._ ___ . ~

D D

Fleld Office ____ _ _ .;;;;;.;.;;..;.;;;.;_-,' __ ;.,,_ ,-__ ,--.,.._-_ -.,_...,....--,_,-, --,--.----,,..,........-,--,.--.,...---,.~-=""'--··-

Temporary Job Stte - ---

PROGRAM SCOPE

This Was a routine, unannounced Inspection of the licensee. This is a freestanding clinic performing· cancer treatments using a high dose-rate remote afterloader. The·llcensee treats approximately.25 patients per year for breast and gynecological cancers. For treatments using the mammosite device, the licensee uses ultrasound prior t.o each fractionated treatment to verify proper inflation of the balloon. Two authorized medical physicists and one authorized user are primarily involved in the treatments. The source is replaced approximately every · four months, with the most recerit source received January 2005. Dose rates around the new area of use were 'measured, and no con~ms were noted. In addition, the inspectors verified that treatments were conducted with sources of less thari 10 curies of 1:1ctivity.

'

·,

The subjects in Tl 2800-032 were reviewed during the inspection, 1:1nd no concerns were identified. :

,·_.

NRC rvt<M 591Mt'III'( I 3 (10-2003) E:\Fileneiuvi~v" ,v8v~,.,.wpo

', I - --- - - - - - -- - .

U.S. NUCLEAR REGULATORY COMMISSION Convers·ation Date: 06/27/05

TELEPHONE_CONVERSATION RECORD ·' Time: 3:30.p,m. -- -

' --- -,· -- - -

1

: .' Docket No.: : Mail Control No.: I License No.:

a·1.711:ir . ·:.17~::l'fl075i0.1 11

--r:1~n~·::i:1f:i7· i I; . '., • • -----

-- ---

Licensee!Applicant Participant(s): Organization: Telephone No.:

Linnie Cough, Administrator Capital Area R.T. 717-691-3235 _ RoQert J. Baker,-l?h._D'.., Physicist__ -- - - -- Associates

-- - •::..,-- --- -- --

Person{s) .Cailing: SGabriel, RI 1 -- - --

'Subiect: Amendment request - . - - ..

I

,summary:

NRC received the fax of the front page of a California radioactive materials license listing Dr. Baker as RSO and listing HDR as an authorized use. This license does

r not, however, show Dr. Baker as AMP for HOR. I asked Or; Baker to provide either a

I copy of a license listing him as AMP for HOR within the past 7 years or a statement l signed by another authorized individual, documenting_ Dr. Baker's recent HOR

experience.

Dr. Baker's first day of work is today. I asked Linnie whether any patients are ! scheduled for HDR treatments and how urgent the need is to add Dr. Baker to the license. She said she does not anticipate any HOR treatments until August.

- -- ~--- -·-- - -· - - ---- --· - -

, Action Required!Taken:_ Await response frorn licensee . "

- -- - -- - -~- - - -- - - - -----

, Preoared By: SGabriel Date: 7/1105

Page 1 of 1 Document Name:E:\Filenet\ML051870449. wpd

Blank Form: G:\Reference\Blank Fonns\telcon1.wpd

·-I I 'I Initial -- -1 · f Announced

··-- I x I Unannounbed lx I Routine !ii, I Special '' 'I

NRC FO'™ 591M PART3 -------··- -- ·-- -·----- -- d.s;-f.n.icLEAR REGULATORY COMMISSION-· I (10®03) 10CFR2.201 Dot:Jmt Fite lnionnatlon ' SAFETY INSPECTION REPORT

i - AND COMPLIANCE INSPECTION --·-- - - -·- - .. - - -· - --· - -

·. 1. LICENSEE - . -- ----- -- -- ---- --· ~- i 2'. NRCIREGIONALOFFICE-- --- - - - - --I.

I Ii C~pltal Area R._ T. Associates I U.S. Nuclear Regulatory Commission I 880 Ceniury Drlv~

' Region I, 475 Allendal~ Road . . -I' Mechanicsburg, PA i King of Prussia, Peim~ylvanla 1940,6°1415 ! REPORT NOS 2007-001 ' .•• ·:1' - ··-·· -··--·- --- -- ·--- ----- - --·--·---- - - --

. ~: DOCKET NUMBER(S) - . . , 4.- t:ICENSE N(!MBER(Sf

-- - .... --· - - 5. -oATE(S)OF INSPECTION I 03033297 I 37-30075-01 March 21, 2007 I! : - - -·-- -- -· - - - - - - - ·----- ---6. INSPECTION PROCEDURES USE~ 7. INSPECTION FOCUS AREAS r INSPECTOR- - - -- -- . - - -

8713~ All R; McKinley ' . ·- - --· . -- - ---

--

SUPPLEMENTAL INSPECTION INFORMATION . I -· .. .... ,.

~. PROGRAM COOE(S) _, 2_. PRIO~ITY~-- --

. 3. LICENSEE CONTACT 4. TELEPHONE NUMBER ''

Stephen Milito, M.D. (717)691-3235 1• ~2~0 - - : ' -- - ·- r-• ·-

i 00 M~ln Office Inspection Next Inspection Date: Mal'Ch-2009 --- ·-··-· --- - -~- -I

D 'i Fieltf Office -: r D

- . .-.. ---· ·- --

! Tefnj)ormy Job Site ·--- - --- ·• -··· - . . -------·-- - .... .. - -

- -- a --~' ----- -·- -··-,·

PROGRAM SCOPE ;

The licensee is a free-standing c~ncer 9linic. They_ treat about 28 patients per year, almost all C>f which are mammosites. There is 1. authoriz~ user and 2:medica) plwsicjsc. Orie of 1he latter is the RSO. There is'atso a I

therapist'invcilved in treatments. The HDR is al(b (7)(F s.specifled on the license. All QA has been performed as required.

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NRC Fur<r.i 591M PART 3 (Rev. by RI 07/06) C:11"uer1elW)I.Or!!•ou11l7.wpd

SUNSI Review Completed By: / RA I -,,.._--~----,-----.,-.... [!] Non-Public 0 Non-Sensitive

o#ieial 911ly united states nuclear regulatory commission

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