MOBE RLY REGIONAL M E D I C A L C E N T E R

04/2 5/20O 7 U.S. Nuclear Regulatory Commission Region I11 Materials Licensing Section 2443 Warrenville Road, Suite 2 10 Lisle, Illinois 60532-435 1

License # 24- 18695-0 1

Re: Request Addition of Authorized User

Dear reviewer:

This is an amendment to notify NRC that we are requesting a modification of our license to include 10 CFR 35.300 materials authorization for Dr. Neal Richard Meyer, M.D. Evidence of training for this physician is included.

No other changes are requested at this time

Thank you for your prompt attention to this amendment. Please contact our facility at (660) 269-3 169, if you have further questions.

Sincerely,

151 5 Union Wnue Moberly MO 65270 Phone 660 263 8400 Fax 660 269 3091

N o . 0 1 4 9 P. 2

NRC FORM 313A U.S, NUCLEAR REGUUTORY COMMISSION (462002)

TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT '

APPENDIX B

APPROVED BY OME: NO. 31so61za EXPIRES: l0/31/2005

Description of Training

Radiation Physics and Inslrumentalion

- Radiafion Protection

tJeC\ \q&f&f m a 2. For Physicians, Podiarrisls, Dentists, Pharmacists - State or Territory Where Licensed

Locatlon Clock Hours Dates of Training

ST. L h C Q 4 5 6 :zL. A+L I

w i A , c c \ c e ,k ' 7 1 ~ 1 , - c : / ? c ~ ? d \ 2 ( k ( k L-r &&& ~ C p C L d i

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3. CERTIFICATION

Month and Year Cerllfled Specialty Board Category

Radiatlon Biology

Chemistry of Byproduct Material for Medical Use

1 1 1 ' ( r

i( ' \ I t

1 Methernatlcs Pertaining to the Use and Measurement of Radioactivity I ( ' ' I ' \

OTHER

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NRC FORM 3fW (10-20021 PRINTED ON RECVClEO PAPER C A E f

E-l NUREG - 1556, 1'01. 9

APPENDIX B

Name of

I"J"ld"d(S) Su ervising Descriptlon of Experience

Location and - Dates and Correspondlng Clock Hourrs

Materials Llcenee of Number Experience

B-2

N o . 0149 P. 4 ._

Degree, Area of Study or

Residency Program

v i rn

APPENDIX B

Name of Organization that Approved the Program

(e.g., Accreditation Counctl for Graduate Medical Education) and fhe Applicable Regulatlon

(e& 10 CFR 35.490)

Name of Program and Location with

Corresponding Dates Materials

Llcense Numbers

PAGE 3

NRC FORM S13A ( 102002)

U S , NUCLEAR REGULATORY COMMISSION

TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

6. FORMAL TRAINING (applies to Medical Physicists and Therapy Physicians)

NUREG - 15SG, VOI. 9

PAGf 4

NRC FORM 3lSA U.S. NUCLEAR REGULATORY COMM19510f (razooq I TRAINING AND EXPERIENCE AND PRECEPTOR STATEMENT (continued)

PART II - PRECEPTOR STATEMENT

Note: This part must be completed by the lndivldual's preceptor. If more than one precepfor is necessary to document experience, obtain a separate preceptor statement from each. This pert is not required lo meet the hlning requirements In 10 C f R 35.590.

Item 10 must be completed for Nuclear Pharmacists meeling the requirements of 10 CFR Part 35, Subpart J. Preceptors do not have to complete items 1 la, 11 b, or the certifying statements for other individuals meeting the requirements of 10 CFR Part 35, Subpart J .

13 YES I O . The individual named in item 1 has sarlefactarily carnpleted the treinlng requirements in

10 CFR 35.980 and is competent to Independently operate a nuclear pharmacy.

YES 1 la. The individual named in Item 1 has satisfactorily completed the requirements in Part 35, Seclion(s)

NIA and Paregraph(s) 3 / . I C @ C.) .".A 3 <.lGG ( L ) -&. 3f. 3 $ 0 &) - ~ ~ - ~ - - ~ - -

@-YES 1 1 b. The individual named in Item 1. is competent to independently function as an authorized Io NIA vs 'uf for I 0 C ~ R I": 'WLuses . L G C *& 3Q"

7 2. PRECEPTOR APPROVAL AND CERTlflCATlON

17 1 certify the approval of item 10 and certify I am an Authorized Nuclear Phanaclsf; I or

0 I certify the approval of items 11 a and 11 b and certify I am an Authorized Nuclear Pharmacist I or ~.

pt certify the approval of Items 1 la and 11 b, and I certify that I meet lhe requirements of '3 f- '; *' ' ' cu

or equivalent Agreement State requirements lo be a preceptor authorized J e A \

for the following uses of byproduct material: $ f a / "U --& 3 r - n 7 0 0

NUREG - 1556, VOI. 9 8-4

NRC FORM 374 U S . NUCLEAR REGULATORY COMMISSION

w MATERIALS LICENSE Pursuant lo the Atomic Energy Act of 1954, as amended. the Energy Reorganization Act of 1974 (Public Law of Federal Regulations. Chapler I. Pans 30, 31, 32, 33. 34, 35, 36, 39, 40. and 70. and in reliance on statements and represenra::ons heretofore made by the licensee. a license is hereby issued authorizing the licensee lo receive. acquire. possess, and transfer byproducf. source, and special nuclear material designated below to use such material for lhe purpose(s) and at the place(s) deslgnared belo-: to deliver or transfer such malerial to persons authorized to receive i t in accordancewith the regulattons of theapplicable Pan(s). This license shall be deemed to contain Ihe conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended. and is subject IO ai' applicable rules, regulations. and orders of the Nuclear Regulatory Commission now or hereafler in effect and to any condiflons s p e c ~ f i e ~ below.

Licensm

I . St. Vincent's Medical Center

2. 2800 Main Street Bridgeport, Connecticut 06606

6. Byproduct, source. andlor special nuclear material

A. Any byproduct material identified in I O CFR 35.100

6. Any byproduct material identified in 10 CFR'35.200

1

C. Any byproduct material identified in 10 CFR 35.300

D. Any byproduct material identified in 10 CFR 35.400

E. Uranium depleted in Uranium 235

F. Iridium 192

G. Strontium SOlYttrium 90

In accordance with the letter dated December 19,2001 3. License number 06-00843-03 is amended in its entirely to read as follows:

4. Expiration date April 30. 2003 5. Docker No. 030-0 1245

Reference No.

7.- Chemical andlor physical form 8. Maximum amount that licensee may possess at any one time under (his license

A. As needed

B. Asneeded

L I ; .'. 1 --.Lv\. .\.. .\ AT- .Any radiopharmaceutical

identified . . in 10 CFR 35.100

8. .. Any radiopharmaceutical '-::identified in 10 CFR 35.200 . . 'I.. iixcept gj&&'itors . -' ;,

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C. Any radiopharmaceutical C. Asneeded

D. Any brachytherapy source 0. Asnkeded

- ___. . - . .'I ' "

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identified in 10 CFR 35.300

identified in 10 CFR 35.400

E. Cadmium plated metal E. 160 kilograms

F. Sealed sources (Mallinckrodt F. 2 sources, 1 source not to Medical B.V.DRN 07735) exceed 12 curies and 1 source

not to exceed 10 curies

G. 12 sources per source train; no to exceed 4.2 millicuries mean activity per source; 51 millicuries total per train; 4 train total

G. Sealed Sources (BEBIG Model SrO. S03)

~

Amendment No. 38

6. Byproduct, source. andlor special 7. Chemical andlor physical form 8. Maximum amount that licensee may nuclear material possess at any one time under this

license

H. 16 sources per source train; no to exceed 4.2 millicuries mean activity per source: 68 millicuries total per train; 4 train total

assembly; 2 source assemblies

H. Strontium SO/Yttrium 90 H. Sealed Sources (BEBIG Model SrO.SO3)

I. Phosphorus 32 I. Sealed Sources (Guidant I. 600 millicuries per source Corporation VI Model GDT P - 32 Series) total

111 CI a.

A. B. C. 0. E. F.

G.

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. . # . - . . . Authorized use:

Any uptake, dilution and excretion ptocedure approved in 40 CCR 35.100. Any imaging and localization procedure approved ..-.-. in ' I O CCR 35.200. Any radiopharmaceutical therapy procedure approved% '1'0 CFR 35.300. Any brachytherapy procedure approved in 10 CFR 35.40p- \

One source to be used in a Nucletrdn Corporation Micro&ele&& HDR remote afterloading brachytherapy device for inJerstitia1, intraluminal and intracavitary radiotC5yby in humans. The source activity may not exceed 10 curies at the time of instahation. One source in Rsf shipping container for source replacement. Notwithstanding the requirements of 10 CFR 35:400,'two source trains, one each to be used in two Novoste Beta-Cath System Models A1 732 (30 millimeter source train) for intravascular brachytherapy and, four source trains in a shipping container for source train replacement. Notwithstanding the requirements of 10 CFR 35.400, two source trains, one each to be used in two Novoste Beta-Cath System Models A1 733 (40 millimeter source train) for intravascular brachytherapy and, four source trains in a shipping container for source train replacement. Notwithstanding the requirements of 10 CFR 35.400, for use in Guidant Corporation VI Model GALILEO

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Shielding in a linear accelerator:,$%:.. +?j h..

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Intravascular Brachytherapy High Dose Rate Afterloader devices for intravascular brachytherapy

CONDITIONS

10. Licensed material may be used only at the licensee's facilities located at 2800 Main Street, Bridgeport, Connecticut.

11, The Radiation Safety Officer for this license is Tatiana S. Kain, M.D.

12. A. Licensed material listed in Item 6 above is only authorized for use by, or under the supervision of, the following individuais for the materials and uses indicated:

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION

MAT E R I AL S LICENSE SUPPLEMENTARY SHEET

Authorized Users

Gioia J. Riccio, M.O.

Robert 0. Russo, Jr., M.0,

Thomas D. Olsavsky, M.D.

Ralph W. Romano, M.D.

- ..

PAGE 3 d 6 PAC;%

License Number 06-00843-03 Docket or Reference Numbec 030-0 124 5

~~- ~~

Amendment No. 38 ,

Material and Use

35.100; 35.200

35.100; 35.200; 35.300

35.100; 35.200; 35.300

35.400; Strontium 89 and Phosphorus 32 for radiopharmaceutical procedures approved in 35.300; Iridium 192 in a high dose rate remote afterloading device for the treatment of humans; Strontium 9ONttrium 90 in a Novoste Beta-Cath System Phosphorus 32 for use in Guidant Corporation VI Mode! GALILEO Intravascular Brachytherapy High Oose Rate Afterloader 9evices

A 5 1- I { , , I . .-,,--35; 100; ,35.200; .35 I 300 .-

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

Bernard S. Jay, M.D.

Barbi L. Kaplan-Frenkel, D.0: ..

_- . ... .. , ,. . . . . . . ; . I

--L-. . . . . ; 35.300; 35.400; Iridium 192 in a high dose rate remote -_: ..

. .+. .! i" I

, ,.:: .' . ~. :..,.-90/Yttriump90 in a Novoste Beta-Cath System . . I L+) ...

.i afterloading device for the treatment of humans: Strontiurr:

4.. Pht&phorus 4 -; . 32 for use in Guidant Corporation VI Model GALILEO Intravascular Brachytherapy High Dose Rate Aftedoader devices

7

Joseph A. Gagliardi, M.D. 35,100; 35.200; 35.300 \

Tatiana S. Kain, M.D. 35.100; 35.200; 35.300

Lesley Snelling, M.D. 35.400

6. The Medical Physicists for this license are Jerome A. Meli, Ph.0 and Vas Krithivas, Ph.D

C. Licensed materials in Subitems 6.G. , 6 . H . and 6.1. shall be used by or under the supervision of an authorized user, who will consult with the interventional cardiofogistlphysician and medical physicist prior to initiating treatment, The procedures will be conducted in the physical presence of the authorized user or medical physicist, whom is specificafly named on the license.

13. In addition to the possession limits in Item 8, the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 30.35(d). 40,36(b), and 70.25(d) for establishing financial assurance for decommissioning.

NRC FORM 37AA U.S. NUCLEAR REGULATORY COMMISSION

MATERIALS LICENSE SUPPLEMENTARYSHEET

PAGE 4 of 6 PAGES

L i s e Number 06-00843-03 W e 1 or Rderence Number 030-0 1245

1

Amendment No, 38 I

14. In addition to the possession limits in Item 8, the licensee shall further restrict the possession of licensed material at a single location to quantities below the limits specified in 10 CFR 30.72 which require consideration of the need for an emergency plan for responding to a release of licensed material.

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

16. A, Access to the treatment room housing each high dose rate remote afterloading brachytherapy unit shall be controlled by a door at each entrance.

8. Each entrance to the treatment room shall be equipped with an electrical interlock system that will cause the source to return to the shielded position immediately upon opening of the entrance door. The interlock system shall be connected in such a manner that the source cannot be placed in the irradiation position until the entrance door is closed and the source "on-off" control is reset at the control panel.

Electrical interlocks on each enkance door to the treaiment room shall be tested for proper operation at leasf once each day of use. G..' :.

In the event of malfunction'of the door interlock. the unit shall be locked in the "off" position and not used, except as may be nec&&ary fo igpair or replacement of the interlock system, until the interlock system is shown to be functioning properly.,,

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17. Prior to initiation of a treatment program. and subsequent to each source exchange for each high dose rate remote afterloading brachytherapy unit, a radiation survey shall be made of:

A. The source housing, with the source in the shiejded position. The maximum Zadiation levels at 10 centimeters from the surface of the main source safe shall not exceed 1 millirem per hour.

8. All areas adjacent to the treatment room with the source in the exposed position. The survey shall clearly establish:

(1) That radiation doses to occupationally exposed individuals do not exceed the limits specified in 10 CFR 20.1201 (a), 20.1207 and 20.1208.

(2) That radiation doses to individual members of the public do not exceed the limits specified in 10 CFR 20.1301 (a).

18. The following shall be performed only By persons specifically authorized by the Commission or an Agreement State 10 perform such service:

A. Installation, and replacement of the sealed sources contained in each high dose rate remote

MATERIALS LICENSE SUPPLEMENTARY SHEET

Wet CY Refemr~ce Number 030-01245 I

IAmendment No. 38

afterloading brachytherapy unit.

8. Maintenance or repair operations on any high dose rate remote afterloading brachytherapy unit and associated equipment involving work on the source safe, the source driving unit, or other mechanism that could expose the source, reduce the shielding around ihe source, or compromise the safety of the unit and result in increased radiation levels.

19. In lieu of the source inventory described in 10 CFR 35.406, the licensee shall:

A. Promptly determine that all sources have returned to the safe. shielded position at the conclusion of each high dose remote brachytherapy procedure or at the conclusion of each intravascular bra c h yt h era p y procedure.

8. Promptly make a survey of the area of use to confirm that . , no sources have been misplaced.

C. Make a record of the survey including survey instrument used, dose rate, time, date and name of the

D. Retain the record of the suri/ey’,in , .. lieu of the record required in 10 CFR 35.406(d).

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A individual making the survey. < . ! ’ < ii ‘‘L . *,~L”-.is.2..+.<:~ ’ d- ,

.-$JS:;,; ,, 4 + \ . ’ ’ t’. 20. In lieu of 10 CFR 35.404(a), immediately after retracting the sour& from the patient into its shielded

position in the remote afterloading device or ,jntravascular..b$achytherapy .d .; _. device, a radiation survey shall be made ofithe patient and the remoth afterloading &-I device oF,intravascular brachytherapy device with a portable radiation detection survey instru6enl to c6nh;rn that the source has been removed from the patient. Records of the survey shall be maintained in lieu of the record required in 10 CFR 35.404(b).

21, Except as specifically provided otherwise in this license, the licensee shall conduut its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below, except for minor changes in the medical use radiation safety procedures as provided in t O CFR 35.31. The U.S. Nuclear Regulatory Commission’s regulations shall govern unless the statements, representations, and procedures in the licensee‘s application and correspondence are more restrictive than the regulations.

A. 0. C. D. E. F. G. H. I.

Application dated June 25. 1992 Letter dated March 2, 1993 Letter dated March 5, 1993 Letter dated May 6, 1996 Letter dated July 29, 1996 Letter received August 12, 1996 ~

Letter dated July 28, 1999 Letter dated April 5, 2001 Letter dated June 13,2001

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NRC FORM 374A U.S. NUCL€4R REGULATORY COMMfSSlON PAGE 6 d 6 PAGES c.

Limae Number

Docket o( Adecenco Number

06-00843-03

030-01 245 MATERIALS LICENSE SUPPLEMENTARY SHEET

Amendment No. 38

J. K. Letter dated December 19,2001 C. Letter received February 1.2002 M. Letter received February 20, 2002

Letter dated October 18, 2001

Date Ah-:

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For the U.S. Nuclear Regulatory Commission

Original signed by Thomas K. Thompson BY

Thomas K. Thompson Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety Region I '

Klng of Prussia, Pennsylvania 19406 900348 10

. .