Canonsburg General Hospital, Amendment Request Letter dtd ... · ALLEGHENY GENERAL HOSPITAL...

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November 16.2005 U.S. Regulatory Commission Materials Licensing Branch 475 Allendale Road King of Prussia, PA 19406 RE: Amendment to Radioactive Materials License NcSUWWUr \3 Region I 0 3 7- {71;’g8-0I Canonsburg General Hospital ,w cn W Gentlemen : Please add authorization for use of materials in 10 CFR 35.400 for use in manual brachytherap y . Please add Russel Fuhrer, M.D., David Parda, M.D., Stephen Michael Karlovitis, M.D., Athanasios Colonias, M.D., Steven Lee Anolik, M.D., Youssef Arshoun, M.D., Vinod Shaw, M.D., and Mark Trombetta, M.D., as authorized users under 10 CFR 35.400. Training and experience for the above referenced physicians can be found on license number 37- 1 8 104-0 1 (Forbes Regional Hospital) or through authorization by Allegheny General Hospital ( Broadscope license). Specific authorization are included with this amendment. If you have any questions or require additional clarification, please do not hesitate to contact the undersigned. Sincerely, Kim Malinky, CEO

Transcript of Canonsburg General Hospital, Amendment Request Letter dtd ... · ALLEGHENY GENERAL HOSPITAL...

Page 1: Canonsburg General Hospital, Amendment Request Letter dtd ... · ALLEGHENY GENERAL HOSPITAL RADIOACTIVE MATERIAL USE PERMIT This permit grant Russell Fuhrer. MD. Authorized User status

November 16.2005

U.S. Regulatory Commission Materials Licensing Branch

475 Allendale Road King of Prussia, PA 19406

RE: Amendment to Radioactive Materials License N c S U W W U r

\ 3 Region I 0

3 7- {71;’g8-0I

Canonsburg General Hospital ,w

cn W

Gentlemen :

Please add authorization for use of materials in 10 CFR 35.400 for use in manual brach ytherap y .

Please add Russel Fuhrer, M.D., David Parda, M.D., Stephen Michael Karlovitis, M.D., Athanasios Colonias, M.D., Steven Lee Anolik, M.D., Youssef Arshoun, M.D., Vinod Shaw, M.D., and Mark Trombetta, M.D., as authorized users under 10 CFR 35.400.

Training and experience for the above referenced physicians can be found on license number 37- 1 8 104-0 1 (Forbes Regional Hospital) or through authorization by Allegheny General Hospital ( Broadscope license). Specific authorization are included with this amendment.

If you have any questions or require additional clarification, please do not hesitate to contact the undersigned.

Sincerely,

Kim Malinky, CEO

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ALLEGHENY GENERAL HOSPITAL RADIOACTIVE MATERIAL USE PERMIT

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This permit grant Russell Fuhrer. MD. Authorized User status and is authorized to receive, possess, transfer, and ship radioactive material of the type@ listed below. The Authorized User is expected to comply with 1) the Authorized User Reqxmsibilities andfitia Form, 2) applicable sections fiom Title 10, Code of Federal Regulations, 3) applicable sections fkom Title 25, Pennsylvania Code, and 4) any additional requirements mandated by the Radiation Safety Committee. Radioactive isotopes stated below may only be used at 320 East North Ave., Pittsburgh, PA 15212 or 3290 William Pitt Way, Building 9, Pittsburgh, PA 15238. Any reason to use or transfer radioactive material to a location other than those listed must be approved by theRadiation Safety Committee.

( - I

1. Russell Fuhrer. M.D. Authorized User

3. Radiation Oncoloqyl Department or Section

2. 58 Permit Number

4. Auwst22.2000 Approval Date

5. Human Use Isotope &OUD 35.400 and dedeted U-235 shieldinp Authorized Use

6. - Group 111 - Group 11: - Group I

Group IU isotopes (low radiotoxicity): beta < 100 keV E 4 gamma 100 keV I H-3, G14, S-35, Ca-45, Ru-103

Group II isotopes (medium radiotoxicity): beta 300 keV E& gamma 300 keV Cr-51, co-57, 1-123,1-125, Xe-133, -141, T1-201

Group I isotopes (high radiotoxicity): beta 1.3 00 keV E 4 gamma 2 3 00 keV P-32, Ga-67, -86, Sr-89,1-131 * *

!

Date Chairman, Qdiation Safety Committee

JOS& G. 0 ~ 4 M.S. Date' ' Radiation Safety Officer Allegheny General. Hospital

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ALLEGHENY GENERAL HOSPITAL RADIOACTIVE MATERIAL USE PERMIT

I

This permit grants authorized to receive, possess, tran&er, and ship radioactive material of the types) listed below. The.Authorized User is expected to comply with 1) the Authorized User Responsibilities and Duties Form, 2) applicable sections fiom Title 10, Code of Federal Regulations, 3) applicable sections fkom Title 25, Pennsylvania Code, and 4) any additional requirements mandated by the Radizjtion Saf;eety Committee. Radioactive isotopes stated below may only be wed at 320 East North, Ave., Phsburgh, PA 15212. Any reason to use or transfer radi&ctive & t d to a locatibn other:& thke listed must be approved by the Radiation Saf6ty Coe t t ee . '

Stephen Michael Rarlovitis. M.D. Authorized User status and is

1. SteDhen Michael Rarlovitis. M.D. Authorized User

3. Radiation Oncolom Department or Section

2. 60 Permit Number

4. Julv 10. 2001 Approval Date

5. Human Use IsotoDe Grow 35.400 and dedeted U-235 shieldina Authorized Use

Group II - Group I 6. - Group III - Group JII isotopes (low radiotoxicity): beta < 100 keV Ed gamma c 100 keV

Group h1IiSO toxicity): beta 300 keVE4 gamma < 300 keV

I ' a-3, C-14, S-35, Ca-45, Ru-103

L . S O I .cr.+-n .. .In*- ,*-.*,, * - "Tk-5 123;'T=125, Xs133, Ce-141, T1-20'1-'Lm.'- . , M

Group I isotopes (high radiotoxicity): beta 2 300 keV ENB; gamma 2 300 keV P-32, Ga-67, Rb-86, Sr-89,1-131 , I

- ' .: , : r g *ar$ , * - t I I.,

J u l y I ' 1 7 , ~ d p j , Date

Allegheny General Hospital

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. ALLEGHENY GENERAL HOSPITAL

RADIOACTIVE MATERIAL USE PERMIT

This permit grants Authorized User status and is authorized to receive, possess, transfer, and ship radioactive mated of the type@) listed below. The Authorized User is expected to comply with 1) the Authorized User Responsibilities andDuties Form, 2) applicable sections fiom Title 10, Code of Federal Regulations, 3) applicable sections fiom Title 25, Pennsylvania Code, and 4) any additional requirements mandated by the Radiation Safetn Committee. Radioactive isotopes stated below may only be use$ at 320 East North Ave., Pitt&$rgh, PA 15212. Any reason to use or transfer radioade matehh 4 , to a location other than those%ted must be approved by the Radiation Safety Com.mi&e.

Athanasios Colonias. M.D.

:!.

1. Athanasios Colonias. M.D. 2. 59 Authorized User Permit Number

3. Radiation Oncoloau, 4. Julv 10.2001 Department or Section Approval Date

5. Human Use IsotoDe Group 35.400 and depleted U-235 shieldinn Authorized Use

Group II - Group I 6. - Group In -

Group III isotopes flow radiotoxicity): beta < 100 keVEd gamma 100 keV ! H-3, C-14, S-35, ca-45, Ru-103

Group I][ isotopes (medium radiotoxicity): beta 300 keV E 4 gamma 300 keV

Group I isotopes (high radiotoxicity): beta 2 300 k e V E 4 gamma 2 300 keV

--.ccI. . -bud-- -'-"~r~5l~~O~s7f"g9~.~-l23; 1-125, Xe-133, &.14i;fl22()1- '+- -- - ----

P-32, Ga-67, Rb-86, Sr-89,1-131 . .

JdIY/1, z k l Date

Allegheny General Hospital

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ALLEGHEIW GENEW HOSPITAL RADIOACTIVE MATERIAL USE PERMIT

This permit grants receive, possess, trans€& and ship radioactive material of the type(s) listed below. The Authorized User is expected to comply with 1) the Authonied W w m 5 i Z i t i a dWa Form, 2) applicable d o n s fiom Title 10, Code of Federal Regulations, 3) applicable sections hrn Tide 25, Pennsyhgnia Code, and 4) any additional requirements mandated by the Radiation Safety Committee. Radioactive isotopes stated below may only be used at 320 East North Ave., P@bu@, PA 15212. Any reason to use or d e r radio* material to a location other than &se listed must be approved by the Radiation Safety Cow. 5

Steven Lee AnoE M.D. Authorized User status and is authorized to

1. Steven Lee Anolik. M.D. Authorized User

3. lo Department or Section

2. 52 Permit Number

4. Juhr 10. 2001 Appmd Date

5. Hiunan Use Isotope Gm UD 35.400 and deDIeted U-235 shieldinq, Authorized Use

6, GroupIII - Group II -Group1

Group III isotopes (low radiotoxicity): beta 100 k e V G gamma < 100 keV 1 8-3, C-14, S-35, Ca-45, Ru-103

Group I isotopes-(high radiotoxicity): beta 2 300 keV &8mma 5 300 b V P-32, Ga-67, -86, Sr-89,1-131

i i I t i

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I

1 i

Allegheny General Hospital

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* * ALLEGHENY GENERAL HOSPITAL RADIOACTIVE MATERIAL USE PERMIT

This pennit grants Vmod Shah MD. and PA license PA-003 1 and is authorized to receive, possess, transfer, and ship radioactive material of the type@) listed below. The Authorized User is expected to comply with 1) the Authorized User ResponsibiZities andDuties Form, 2) applicable sections fiom Title 10, Code of Federal Regulations, 3) applicable sections ftom Title 25, Pennsylvania Code, and 4) any additional requirements mandated by the Radiation Safkty Committee. Radioactive isotopes stated below may only be used at 320 East North Ave., Pittsburgh, PA 15212. Any reason to use or transfer radioactive m a t e d to a location other than those listed must be approved by the Radiation Safety Committee.

Authorized User status under NRC license 37-013 17-01

1. &i&&-d: user

3. Radiation O n c o l o c Department or Section

5. Human Use hotope Group

2. 63 Permit Number

4. February 11.2003 Approval Date

- 35.100 35.200 35.300 X 35.400 35.500 X 35.600 X 35.1000 Qbdovascular) - depleted U-235 shielding

6. Authorized Use

- Group1 - Group II - Group m

Group II isotope? (medium radiotoxicity): beta < 300 keVE4 gamma\< 300 keV

7. Restrictions: NONE . . . . . ...... .. . . . . . . : '! c, ._ .f ,. 'X' . . *.:&: '..,.!

. . . . . . . . .

I , ..r.. .-

. . . . . . . . . _ . . , . L

. . . . . . . . . . .

- - . I'. . . . .

Approvd Si atures:

** .%L Ad& SodRehder, M.D. Chairman, Radiation Safety Compittee

Josep6G. Och, M.S. Radiation Safety O f i e r Allegheny General Hospital

. _. --. i ......... .- . . ; d . . .

, . . . . . . , .., - ..

. . . . . . . .

Date

2- Date

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ALLEGHENY GENEMIL HOSPITAL RADIOACTIVE MATERIAL, USE PERMIT

This permit grants Youssef Arshoun M.D. 013 17-01 and PA license PA-003 1 and is authorized to receive, possess, trader, and ship radioactive material of the type@) listed below. The Authorized User is expected to comply with 1) the Authorized User RepnsiMizYes &Duties Form, 2) applicable sections &om Title 10, Code of Federal Regulations, 3) applicable sections from Title 25, Pennsylvania Code, and 4) any additional requirements mandated by the Radiation Safety Committee. Radioactive isotopes stated below may only be used at 320 East North Ave., Pittsburgh, PA 15212. Any reason to use or transfk rdokt ive material to a location other than those listed must be approved by the Radiation Safety Committee. I

Authorized User status under NRC license 37-

1. Youssef Arshoun . M.D. Authorized User

3. Radiation OncoIom Department or Section

2. 64 Permit Number

4. March 11.2003 Approval Date

5. Human Use Isotope Group

35.100 3 5.200 35.300 X 35.400 35.500 X 35.600 - X 35.1000 (ENDOVASCULAR THERAPY) - depleted U-23 5 shieIding -

6. Authorized Use

- Group I - Group II - Group m 1 3

Group I isotopes (high radiotoxicity): beta '2 300 keV E,; gamma 2 300 keV P-32, Ga-67, Rb-86, SrW89,1-131

Group II isotopes (medium radiotoxicity): beta 300 keV E 4 gamma 300 keV Cr-51, co-57, TC-99~1, b123,1-125, Xe-133, Ce-141, TI-201

Group III isotopes (low radiotoxicity): beta 100 keVE4 gamma < 100 keV H-3, C-14, S-35, Ca-45, Ru-103

7. Restrictions: NONE

JogRehder, M.D. .f I Date Chairman, RadiatiodSafeW Committee

Joseph G.Dch, M.S. Dafe

Allegheny General Hospital a Radiation Safety Officer

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ll/U'L/2005 12: 62 412359455748 AGGRADWN 05.ICOLOGY PAGE 82

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ALLEGEENY G W W HOSPnfi RADIOACTlvE mERIAL USE PE-

3- MarkTmmbettaM. D: Authorized user

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PAGE 81/84 8C/ 32/2885 15: 49 412-856-8899 INTERCOMM CANCER CTR x Q '. --

712 -77 V -22 2 2 5'

' pursuant fo the Atdrnic Energy Act of 1954, as amended, the En& Reorganization Act of 1974 (Public Law 93-48), and Title 10, &de of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statQment8 and representations hemtofore made by the licehsea, a license is hereby issued authorizing the licensee to recdve, acquire, possess, and transfer bproduor, 6 o u ~ e m and special nuclear material designated below; to use such material for the pu'poss(s) and at the plece(s) dWgnated below; to

, deliver or transfer such material to persons authorized to rocelve R in accordance kith the regulations of fhe applicable Part@). This liceme be deemed io contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and Is subject to dl

applicable rules, regufatlons, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. I

I

Lice ns 88 In accordance with the application dated May27,ZOW 3. Ucense numbs: 37-181 04-01 is amended In 1. Forbes Regional Hospbl

ty to read as follows: I Z. 2570 Haymaker Road '

Monroevifle, Pennsyfvania 1

A. Any byproduct materi permitted by 10 CFR

3. A n y byproduct materid permitted by 10 CFR 35

;. Any byproduct maferial permitted by 10 CFR 35.30

1. Any byproduct material . D. permitted by IO- CFR 35.400

Biop h armace uticals Inc., Models 125SL and 125Sf4, Medi-Physk hc. Model 671 1, In ternation a-1 I3 rach yth 8 ra-py, SA Model 1251L, Drm'mstge Model LS-1, Best Medicaf I n2e ma tio-haf Model 230 'I, Bard ~ B rac h y tbe rapy,- I-nc. Model STM7 251)

Any by@duct mqterjd permittqd by 10 CFR 31 .I I

E. Prepackaged .Kits I

I

nc:

E. 5 millicuries

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--

Pr /8212885 15: 49 412-856-8899

___ -

INTERCOf~lM CANCER CTR PAGE 82/84

'I NRC FORM 374A US. N U C L M REGULATORY COMMISSION PAGE 2 of 4 PAGES

ff cenm Number'

MATERfALS LICENSE . SUPPLEMENTARY SHEET

I

/Amendment No. 21 I

9, Authorized use:

A. Any uptake, dilution and excretion study permitted by 10 CFR 35.100. 5. Any imaging and iocalizatlon study permitted by I O CFR 35.200. C. Any diagnostic study or therapy procedure permitted by 10 CFR 35.300, D Any manual brachytberapy procedure permitted by 70 CFR 35.400.

Frank G. Diettinget-, M.D. --

Ave M. Bacher, M.D;

Eric W. Flint, M.D. ,

David F. Lacknw, M.D.

35.1 00; 35.200 L- In vitro studies

35.7 OO; 35.200; oyal ,administratioh of sqdiuh :

iodide-iodine4 31 fdmaging and locafization studies -- In vitro studies

35.1 00; 35.200; oral administration of sodium iodide iodine4 31 for im.aghg and localization studies

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BL 2885 15: 49 412-856-8899

5' t I

IMERcOMM CANCER CTR PAGE 83/84

. - -. NRC FORM 374A U.S, NUCLEAR REGULATORY COMMfSSlON

MATERIALS LICENSE SUPPLEMENTAKY SHEm

111 I - I JAmendment No. 21

Carol L. Seifert, M.D. 35.1 00; 35.200; oral administration of sodium iodide iodine-131 for imaging and localkation studies In vitro studies

35.1 00; 35.200; oral administration of sodium I Vera R. Sperling, M,D. e iodine-131 for Imaging and focalization

histration of sodium lodid and localization studies

Steven LeeAn

Russeil Fuhrer, Mi

Steven Michael Karlovitis,

1

13. In addition to the possession limits in kern 8, the licensee shall further restrict tbe poiseasion of licensed material-to quantities below the minimum limit specified in 10 CFR 30.35(d) for establishing decommissioning financial assurance.

. I

14. The licensee is authorized tortransport licensed material in accordance with the provisions of 10 CFR Part . 71, "Packaging and Transportation of Radioactive Material:"

Duplicate ill Duslicate I

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BEIJ82!2885 15: 49 412-856-8899

15. Except as specifically provided ofhewise In this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contahed In the documents, including any enclosures, Ilsted below. This license condition applies only to those procedures that are required to be submitted in accbrdance 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 IO CFR 35.26. The US. bfuclear Regulatory Commission's re em unfess the statements, representations, and procedures in th correspondence are more restria've than the regufations.

: A. Application dated M B. Letter dated June Jun

I

IMERCOFZM CANCER CTR

I

PAGE 84/84

For the U.S. Nuclear Regulatory Commissicin

I

Original signed by James P, Pwyw

James P. Dwycr 'Nuclear Materials Safety Branch I Division of Nuclear Materials Safetv

. * BY _ _

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

i i , h fidv(- , and to inform you that the initial processing which includes an administrative review has been performed.

dwl6PDO 3 7 - / ? 6 % g - d d T h e r e were no administrative omissions. Your application was assigned to a

technical reviewer. Please note that the technical review may identify additional omissions or require additional information.

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

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

Your action has been assigned Mail Control Number 13 ‘r! o+ 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)

Sin cere1 y , Licensing Assistance Team Leader