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Danbury Hospital

March 10,2006

Shirley Xu Nuclear Materials Safety Branch United States Nuclear Regulatory Commission, Region 1 475 Allendale Road King of Prussia, Pennsylvania 19406-1415

Re: NRC License No. 06-08544-01 Control # 138427

Dear Ms. Xu:

In response to your inquiry from 3/8/06 regarding our NRC license amendment proposal of 2/2/06:

1.

2.

3.

The area adjacent to the hot lab at the proposed Southbury, CT cardiology site is an exam roomlECH0 room that is part of the cardiology facility. Routine area surveys will be performed in this area as per our usual protocols. I am forwarding a copy of Dr. Mani‘s official ASNC certificate (she had received a copy since we sent t h e original proposal) along with preceptorship statements from Dr. Jonathan Alexander & myself who are both licensed users here at Danbury Hospital. I have corrected the information (10 CFR 35 numbers) on Dr. Savino’s paperwork to correspond with your current system.

Please inform me if you require any further information.

Sincerely,

William 0. Johns, MD Radiation Safety Officer Danbury Hospital 24 Hospital Avenue Danbury, CT 06810

Tel: 203-797-7222 Fax: 203-739-6473

WDJ:wdj 3/10/06

24 Hospital Avenue Danbury, Connecticut 06810 - Phone (203) 797-7000 www.danhosp.org

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Danbury Hospital

February 2, 2006 (corrections February 8, 2006- WJ)

Licensing Assistant Section Nuclear Materials Safety Branch U. S. Nuclear Regulatory Commission, Region 1 475 Allendale Road King of Prussia, PA 19406-1415

RE: NRC License No. 06-08544-01 (Danbury Hospital) Amendment Request

To Whom It May Concern:

Enclosed you will find an application and supporting information for an amendment lo the Danbury Hospital material license. We recently completed our 1 0-year renewal process. Included in this proposed amendment will be:

1. Addition of a satellite facility (owned and operated by Danbury Hospital) for nuclear cardiology diagnostic imaging located in Southbury, Connecticut. The address of the facility will be:

Cardiovascular Diagnostic Center (Danbury Hospital) 22 Old Waterbury Road, Suite 106 Southbury, CT 06488 Tel: 203-262-4270

The facility will be staffed by Danbury Hospital employees and will include 1 gamma camera and other equipment required for operation. Tc-99m and TI-201 will be used for diagnostic imaging and other sealed sources will be required for instrument calibration, etc. We will have a hot lab and on-site radioactive waste storage. No therapeutic modalities using isotopes will be performed at this site. Diagrams of the planned facility and hot lab are enclosed.

The facility will be under the supervision of the Radiation Safety Officer (Or. William Johns) and our medical physics staff at Danbury Hospital, with activities being overseen by the Radiation Safety Committee at Danbury Hospital. All hospital policies and procedures will be followed at the satellite facility for compliance with NRC and State of Connecticut regulations .

2. We would like to add 2 physicians to our NRC license:

a. Robert Savino, OD: Dr. Savino is Chief of Endocrinology at Danbury Hospital. He is board certified in Endocrinology and has completed an 80-hour course in radiation physicshuclear

24 Hospital Avenue - Danhury. Connecticut. 06810 Phone (203) 797-7000 www.danhosp.org

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endocrinology (certificate enclosed). He has been supervised here at Danbury Hospital in the administration of 1-131 therapies to 10 patients with hyperthyroidism and 3 patients with thyroid cancer. We is applying for privileges under 10 CFR 35.392 (treatment of hyperthyroidism) and 35.394 (treatment of thyroid cancer). Preceptorship statements are also attached.

b. Susan Mani, MD: Dr. Mani is a staff Cardiologist here at Danbury Hospital. She is board certified in Cardiology and Nuclear Cardiology. Here certifications are enclosed. She is applying. for privileges for Nuclear Cardiology diagnostic imaging under 1 0 CFR 35.100 and 35.200.

Please inform us if you require any further information. Inquiries may be directed to the Radiation Safety Officer (Dr, William Johns).

Sincerely, A '

Patricia O'Connor Senior Vice President, Operations Danbury Hospital 24 Hospital Avenue Danbury, CT 06810

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Nuclear Materials Safety Branch United States Nuclear Regulatory Commission, Region 1 475 Allendale Road King of Prussia, Pennsylvania 19406-1415

Re: NRC License No. 06-08544-01

Subject: Addition of Robert Savino, D.O. to Hospital License

To Whom It May Concern:

We request the addition of Dr. Robert Savino to the Danbury Hospital N R C license as an authorized user for treatment of hyperthyroidism (35.392) and thyroid carcinoma (35.394). Dr. Savino is currently t he Chief of Endocrinology here at the hospital. He completed his fellowship training in endocrinology in 1994 and coursework in radiological physics in 2003 (certificate attached).

We has completed 80 hours of classroom and laboratory training that includes radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, and radiation biology. Dr. Joseph Belsky who is currently a-licensed user has supervised him in treatment of hyperthyroidism in 10 individuals here at Danbury Hospital. Drs. Gupta and Johns who are currently licensed users have also supervised him in treatment of thyroid cancer in 3 individuals here at Danbury Hospital. We certify that he has successfully completed training and is competent in the use of 1-131 to treat both hyperthyroidism and thyroid cancer.

S ince-ly,

ShivGupta, MD (F . . Chief of ‘Nuclear Medicine Chairman, Radiation Safety Committee, Danbury Hospital

William Johns, bfb (Preceptor) Nuclear Medicine Rad9tion Safety Officer, Danbury Hospital

J o s M Bekky, MD (hecsptor) ’ Endocrinology, Danbury Hospital

r WDJ:wdj 1/19/06 0

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2037396473 TO:215 337 5269 P. 7/15 MRR-10-2006 14:20 FR0M:DQNEURY HOSPITQL

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I lb. Sekdone In r] 3S.We) 0 35.51 (e) r] 36.WbK1 flM0) 0 s.W@ f o ~ 1

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TO:215 337 5259 P. 8/15 MRR-10-2005 14:20 FR0M:DQNBURY HOSPITRL 2037396473

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or~Agmammtstatmmquimmmtsto~apreoeptor e p p U w DM kathefkllhhg b v p r o d u G t ~ ~ ( o r u n i t s ) : z- 0 ) 7?le+pp k 4 + f W ~

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MRR-10-2006 14:21 FR0M:DRNBURY HOSPITRL 2037396473 TO:215 337 5269 P. 9'15

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IRC FORM 313A U.8. NUCLEAR REGUUYORY COQRWS8EBIO)

?'OO5' M E W X . USE TRAINING AND EXPERIENCE AND PRECEPTOR A'ITESTATION (cantlnued) 10. SUPERVISING lNDlVlDUAL - IDENTIF ICAVON AND QUALIFICATIONS

'he training and ex erience indicated above wae obtained under the supervislon of (irmore than one supefvislng 7dlVidud IS need J to meet mquimmennls in 70 CFR Part 36, pmvide the fullobdng lnformeban for each) :

A. Name of Supervisor 8. Superviaor is:

Tosee h S k,r, Authariied User Authorized Medlcal Physicist --.. .... a Radiation Safely Officer Authorized Nuclear Pharmacist

PART )I - PRECEPYOR APTESTATION Vote: This prt must be completed by the individU8I'S preceptor. if mom Lhan one preceptor is necessary lo document

experiOnce, obtain 8 separate m e tor sfelement from each. This p&f? Is notregulred 10 meet tdnjng quimmenfs In 35.590 or PaZ36, .&bpiwf J (except 36.980).

I attest the individual named In item 1: KO 6 vT suc/k73 b U I

has sati9factorlly completed the requirements In Part 35, Sectlon(s) and Paragmph(8) 3 as documented In sedion(s) C- of his knn.

- ...................................................................................................................... 1 Ib. Select one

meets the mqulrements In 35.50(4 35.51 (c) 35.390(b)(l)(ii)(G) [rl35.6QO(c) for --- * N/A types of use, as documented in section(6) or this fom.

...................................................................................................................... 5 H 0

he8 achieved a level of competency sufficient to independently operate @I nucha pharmacy (for 35.980): Of

has achieved a level of competency sufficient to functlon lnbependmtly as an arthorized

he6 achieved a level of radiation safety knowledge &&~&&%n%~&ently BS a Radlallon Safety ORtcer for a medical use licensee ; or

tcscr for -r \ ? I uses (or units); Or

NIA 1 id .

I am an Authofized Nudear Pharmacist; Or

imeettherequlrementsof 3 s 392 sodion(8) of 10 CFR Pert 35

or equivalent Agreement state requirements to be a preceptor

I am a Radiation Safety OtlFcer, Or

_L-

HAU or CJ AMP

for the follawlng byproduct meterial use8 (or units): z- 13 1 (tfufb-h&-t K& ...................................................................................................................... A. Address B. Malerlds License Number

DAfia- byih ' &'I l-bqi-bl ~ C ~ l l c c C :

D a e b w y , C T 0 6 P l D 06- 0 9 C Y ' / - O

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Danbury Hospital

March 9,2006

Nuclear Materials Safety Branch United States Nuclear Regulatory Commission, Region 1 475 Allendale Road King of Prussia, Pennsylvania 19406-1 41 5

Re: NRC License No. 06-08544-01 Control #: 138427

Subject: Addition of Susan Mani, MD to Hospital License

To Whom It May Concern:

We request the addition of Dr. Susan Mani to the Danbury Hospital NRC license as an authorized user for diagnostic Nuclear Cardiology (35.1 00, 35.200). She completed her training in Nuclear Cardiology and is board certified by the American Society of Nuclear Cardiology.

She has been employed at Danbury Hospital since June 2005 and has been precepted here by Dr. Jonathan Alexander and Dr. William Johns. She is familiar with all procedures using isotopes in Nuclear Cardiology, as well as having demonstrated good knowledge regarding radiation safety procedures and isotope handling. We certify that she is competent to be placedon our license.

Sincerely,

nathan Alexander, MD uclear Cardiology

%?z& &. W i I I iarn Jo h n s m 0 Nuclear Medicine/Radiation Safety Officer

WDJwdj 3/9/06

24 Hospital Avenue Danbuty, Connecticut 068'10 Phone (203) 797-7000 www.danhosp.org

HAYTNG MET THE REQUIREMENTS PRESCRIBED BY THIS BOARD FOR PHYSICIANS RESIDING

IN THE UNITED STATES AND H A W G SATTSFACTOEULY PASSED THE REQUIRED EXAMINATION,

IS HEREBY DESIGNATED

A DIPLOMATE CERTIFLED IN THE SUBSPECIALTY OF

NUCLEAR CARDIOLQGY FOR THE PERIOD 2005 THROUGH 2015

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2037396473 TO:215 337 5269 P. 1 2 / 1 5 M R R - I ~ - E J ~ S 1 4 : ~ FROM:DRNBURY HOSPITRL

3. CERTIFICATION hem Mepp&ing under 70 CFR Pert 35, Subpad J or 35.590(s);

b. Provide docurnentation In ep 35.51 c : 35.290 c 1) i)(G)

tiate items 4 through 10 oftfaiilng or clinlcel c01be work m q u M by 35.60 a - 6eddng 35.200 authorizatian; 35.390(b)(lXU)(G); 35.3W(d)(l) and 35.&d)(2); I 3S.€&k or 35.&S.

c. Provide complsted Part 1) Preceptor Attestation, Items 1 l a through 1 ld. Stop twm der completing items 3a, 3b, and X when uslng board cartHlcatlon to moat 10 CFR Part 35 Wdng and I w=hm-.

t 4. MDMDUALS IDENTIFIED ON A LICENSE OR PERMIT AS RADIATION SAFETY OFFICERS @SO),

AU?HORQW USERS AU), AUTHOFUZED MEDICAL PHYSICISTS AMP Off

8. Provide a copy of the license or broadscape pennit listing the current authorhation and (b) or (c) b. Carprplete items Bc (and 10 when training Is provided by an Rso, AMP, ANP, or AU) and pmceptor items l l b through

Zld to meet requirements for. RSO in 35.50(~)(2) or 3!3SO(e); or AtJ in 35,29O(c)(l)(li)(G) or 35.390@)(1)(iI)(G) or 35.590(c) or 35.6W(c): or AMP under %.Sl(c).

AUTHOREED NUCLEAR PH Ak MACISTS (ANP) SEEMNQ ADblTlOKAL AhklkKATlONI

c. CompBCate items 5,8a, 6b, 10, and Preceptor lterna l l a through 1 I d to meet AU requlrpwnem In 35.398(a). I 5. OlDACTlC OR CLASSROOM AND LABORATORY TRAJNINQ (optlone1 For Medlcal Phyelckt8)

De6Crlflon of Tralnlng L o d m Clock Mourn Daosa Of TmIIIUW I I

I I I I

Radlatlon Protection I

MQR-10-2006 14:22 FR0M:DQNBURY HOSPITAL 2037396473 TO:215 337 5269 P . 13/15 Q/&7 m.40,- m

I US, NUCLEAR RWUUTORY -OX IRC FoRly S l S A '-) MEDICAL USE TRAlNlNC AND EXPERIENCE AND PRECEPTOR ATESTATION fconthrued)

6a. WORK OR PRACTICAL EXPERIENCE WlTH RADIATlOP4

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PART U - PRECEPTOR ATTESTATION M d : This pert must be amplefed by the lnc#vidds peceptor. I f mom than one pmepturls n

icqbwienct?, o w n B separate mquhrnents in 35.590 or PF&??&b$mrt J (except 35.980).

to document tor atatwnenr fvm e&. Thls pert is notlequhad lb ?%I&

31Cf 113 I a&& Lhe individual named tn Item 1: *

35': 2 , d J $& l ib . Selectone

has satisladorlly campleted the requiremen$ in Part 36, Sedion(s) auld Paragmph(8) asdoarrnentedinsection(e) I I ofthisfom.

meets the mqulrementa in a %.We) r] 35.61 (c) a 35.3QO(b)(WW)

I

.......................................................................................................................... S.WC) for

13 N/A types of uw, douunentod in seetlon(s) of this form.

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- WEOlCAL USE TRAlNIMG AND EXPERWCE AND PRECEPTOR ATTESTATION (-}

10. SUPERVlSlNO VlOlVlDUAL - IDENTIFICATlON AND QUAUFICATIONS

of this form. ....................................................................................................................... Ilb. Selectone

3 3 WA

5 ?6

meab the requirements in 35.50(8) 0 35.51 (c) 0 35.380(b)(l)(UXGJ a s.Wc) for. types Of use, as documented in mdon(s) of this forin.

....................................................................................................................... has acttievd a level &competency sufficient to independently operate a n u b pharnracy (for 35.m); O t

has scclieved a levd of oompdency suffldent to f u d o n Independently e8 an atbdmd J C r for 3J-, jd3 3,,-. tu? u s c n ~ i ~ uhw or

L i L c 3 has 8 level ol radiation mbv knowledge e A e n t l ~ ( c i i i~e- a wty m w f w e m e d l = i u s e m ; o r

1 id. -J iamunk4umnmd * ~uciew phanna~lst; or xi em a Radiation ot~cer; or

lmgetthereqrrltemen@pd 3T' , JT, L-J eedlpn(e)aflOCFRPaR35

or s q ~ l ~ a l e n t w e n t stab requimnto to be a preceptor WU or a AMP foz fhe Wowing bvproduct meteria! uses (or units): NM 6 & C A r /dG< L a// /J&t .....................................................................................................................

AAddt%SS B. Mattwkds ur;Bslea Number