When Heart Health Counts CARDIOLOGY ASSOCIATES OF SOMERSET COUNTY, P.A. MARK LEBENTEAL, MD, FACC

STEPHEN OCKEN, MD, FACC

JEFP Tirnon, MD, PACC, PSCAI ALEXANDER IVANOV, YD, FACC

RANJITA S E N G U P T A , M D

cEUiDRE!jHWAll SEAHI, MD, FACC -- m7 - -7 F=

July 30, 2008

Licensing Assistant Section Nuclear Materials Safety Branch U.S. Nuclear Regulatory Commission, Region 1 475 Allendale Road King of Prussia, PA 19405- 14 15

Dear Sir or Madam:

This is to inform you that effective 12:Olam, Saturday August 2nd, 2008 I resigned from Cardiology Associates of Somerset County. I also resign as Radiation Safety Officer, Administrator and Authorized User on their license. This should be noted in their records.

Interventional Cardiology In-Office Comprehensive Cardiac Testing Electrophysiology Vascular Studies 745 Route 202/206, Bridgewater, NJ 08807 Tel 908-722-641 0 Fax 908-722-4638 wwwMyHeartDocs.com

J u l 05 08 0 4 : 2 9 p John Gochoco choco 973 322 2479 P . 3

Cardiology Associates of Somerset County, P.A. 745 Route 202-206 South

Bridgewater, NJ 08807

Licensing Assistant Section Nuclear Materials Safety Branch U.S. Nuclear Regulatory Commission, Region I 475 Allendale Road King of Prussia, PA 19405-1415

Re: Amendment NRC License # 29-30572-01

July 28, 2008

Dear Sir/ Madam,

Please amend our license to:

1) AddElaine Rovazzi, M.S., DABR as Radiation Safety Officer. Enclosed for your review is Ms. Rovazzi's ABR certificate in medical nuclear physics and preceptorship papers signed by John M. Gochoco, M.S., DABR.

2) Shivang Trivedi, M.D. as an authorized user for 35.200 for cardiovascular clinical procedures , and as the management representative for our license.

Enclosed for your review regarding Dr. Shivang Trivedi :

a) Curriculum vitae b) c) d)

CBNC Nuclear Cardiology board certification for the period 2004-2014 Institute for Nuclear Medical Education certificates of 200 didactic hours. Preceptorship letter dated May 6,2002 signed by Perty Gerard, M.D. and Alvin Greengart, M.D. of Maimonides Medical Center in Brooklyn, NY (NYS license # 91-2844-01)

If you have any questions regarding this amendment, kindly contact our physicist, Elaine Rovaui @ 973- 322-5 1 18.

Thank you for your assistance. We look forward to receiving our amendment.

Sincerely, .

Management

f l & @ v 7 J ' * , m 4 Elaine Rovazzi. M.S.. DABR Physicist

Jul 05 08 04:29p John Gochoco choco 973 322 2479

Cardiology Associates of Somerset County Division of Nuclear Medicine

745 Route 202-206 Bridgewater, NJ 08807

DELEGATION OF AUTHORITY

To: All Employees

From: Shivang Trivedi, M.D.

Subject: Delegation of Authority

Elaine Rovazzi, M.S. has been appointed Radiation Safety Officer and is responsible for ensuring the safe use of radiation. The Radiation Safety Officer is responsible for managing the radiation safety program; identifying radiation safety problems; initiating, recommending, or providing corrective actions; verifying implementation of corrective actions; and ensuring compliance with regulations. The Radiation Safety Officer is hereby delegated the unrestricted authority necessary to meet those responsibilities.

Adequate funding is authorized for all expenditures related to recommendations made by the Radiation Safety Officer in order to facilitate the objectives of the radiation safety program and related regulatory requirements.

Management

l.(&(+ Shivang Trivedi, M.D. Management

Julv 29. 2008 Date

Jul 05

08

0

4:2

9p

John

Go

ch

oc

o

ch

oc

o

973 322 2479

P. 5

Jul 05 08 04:29p John Gochoco choco

IRC FORM 313A (RSO) !-Zoo 7)

US. NUCLEAR REGULATORY COMMISSION

RADIATION SAFEW OFFICER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

rio CFR 35.501

973 322 2479

~~~E~~~~~~ No* 315041;

P - 6

lame of Proposed Radiation Safety Officer 5 LA /dUF/ @.ov A a.zz ~ ___ -- ... tequested Authorization(s) The license authorizes the following medical uses (check all that apply):

@ 35.100 @ 35.200 c) 35.300 0 35.400 0 35.500 0 35.600 (remote afterloader)

0 35.600 (teletherapy) n 35.600 (gamma stereotactic radiosurgery) 0 35.1000 ( - 1

PART I -TRAINING AND EXPERIENCE (Select one of the four methods below)

Training and Experience, including board certification, must have been obtained within the 7 years preceding the date 01 pplication or the individual must have obtained related continuing education and experience since the required training nd experience was completed. Provide dates, duration, and description of con6nuing education and experience related 1 the uses checked above.

a 1. Board Certification

a. Provide a copy of the board certification.

b. Use Table 3.c. to describe training in radiation safety, regulatory issues, and emergency procedures for all types of medical use on the license.

c. Skip to and complete Part II Preceptor Attestation.

OR [I3 2. Current Radiation Safety Officer Seekim Authorization to Be Recoanized as a Radiation Safety

Officer for the Additional Medical Uses Checked Above

a. Use the table in section 3.c. to describe training in radiation safety, regulabry issues, and emergency procedures for the additional types of medical use for which recognition as RSO is sought.

b. Skip to and complete Part II Preceptor Attestation.

OR ] 3. Structured Educational Proaram for Proposed Radiation Safety Officer

a. Classroom and Laboratory Training ......... ....... ..., .......... ~

Clock Location of Training .__- ~ ..

...................... .I.-----__._ ................ _^,_ .

instrumentation

- - -- ........

.. ......................

.... ...... ---i ... - - .

Total Hours of Training: ... .... ~ ........................

C FORM 313A (RSO) (2-2007) PRINTEDON RECYCLED PAPER PAGE 1

. . . . . . . ~ __ .- . .

Jul 05 08 04:29p John Gochoco choco 973 322 2479 P . 7

b. Supervised Radiation Safety Experience ( I f more than one supervising individual is necessary to document supervised wcrk experience, provide multiple copies of this section.)

Description of Experience __. --

Shipping, receiving, and performing related radiation surveys

- -. . . - -- Using and perfdrming checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides

- - Securing and controlling byproduct material

__ I .______- Using administrative controls to avoid pnistakes in administration of byproduct material

-- Using procedures to prevent or minimize sdioactive contamination and using proper jecontamination procedures

Jsing emergency procedures to control ,yproduct material

~

)isposing of byproduct material

-- . - .- - .icensed Ma iza l Used (e.9.. 35.100. i5.200, etc.)+

._ ._

NRC FORM 313A (RSO) (2-2007)

U.S. NUCLEAR REGULATORY COMMISSIOb

RADIATION SAFETY OFFICER TRAINING AND EXPERIENCE AND PRECEPTOR ATESTATION (continued)

3. Structured Educational Proqram for Proposed Radiation Safety Officer (continued)

PAC1

Location of Training/ License or Permit Number of Facility __ - .. . . . - - - . ___ .- --

- .

Dates of Training'

Choose all applicable sections of 10 CFR Pad 35 lo describe radioisolopes and quantities used: 35.100, 35.200.35.300,35.400.35.500. 35.600 rernole afterloader units. 35.600 teletherapy units, 35,600 gamma stereotactic radiosurgery units, emerging technologies (provide list of devices). -_-- --..I- ~ - - - .I__. .

973 322 2479 Jul 05 08 0 4 : 3 0 p John Gochoco choco P - 8

IRC FORM 313A (RSO) US. NUCLEAR REGULATORY COMMISSK !-2007)

RADIATION SAFETY OFFICER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3. Structured Educational Proqram for Proposed Radiation Safety Officer (continued)

b. Supervised Radiation Safety Experience (continued)

(If more than one supervising individual is necessary to document supervised wcrk experience, provide multiple copies of fhis section.)

.. -. . ---__ - . -. . . . iLicenselPermit Number listing supervising individual as a !Radiation Safety Officer

................................................................ ......................................................................................................... This license authorizes the following medical uses:

c] 35.500 [I 35.600 (remote afterloader) 13 35.600 (teletherapy) c] 35.600 (gamma stereotactic radiosurgery)

1-J 35.100 c.1 35.200 r - 35.300 I.. l 35.400

1 ~ _ _ - .- ... ...... /-I 35.1000 (

. . . . . . ... ..... ----__I._ __ c. Describe training in radiation safety, regulatory issues, and emergency procedues for all types of medical

use on the license. ..... ....... ~ -.-.-...----____II___._.. __.. -- .............. .............

Description of Training Training Provided By ....................... ..........................

---_.___ ___ Radiation safety, regulatory issues, and

and 35.500 uses T~ M 60 C I ~ O C c 3 emergency procedures for 35.100, 35.200,

Radiation safety, regulatory issues, and emergency procedures for 35.300 uses

...................... ......

.............. __ - __ - Radiation safely, regulatory issues, and emergency procedures for 35.400 uses

-_ - . .... .-....I---. ~ - - - _ . Radiation safety, regulatory issues, and emergency procedures for 35.600 - teletherapy uses

Radiation safely, regulatory issues, and emergency procedures for 35.600 - remote afterloader uses

...... ...... ___-__

_ ... ... .. ________- ~ ._ . t Radiation safety, regulatory issues, and ?mergency procedures for 35.600 - gamma stereotactic radiosurgery uses

................. -- .... ..................... ..... . . . ........

.. .I I ~ _ _ .

3adiation safety, regulatory issues, and ?mergency procedures for 35.1000, specify ae( s):

Jul 05 08 04:30p John Gochoco choco 973 322 2479 P. 9

NRC FORM 313A (RSO) (2-2007)

U.S. NUCLEAR REGULATORY COMMtSSIOI

RADIATION SAFETY OFFICER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION [continued) _ _ _ _ _ _ ~ ~ ~ ~~ ~ ~~ ~

3. Structured Educational Program for ProDosed Radiation Safetv Officer (continued)

c. Training in radiation safety, regulatory issues, and emergency procedures f i r all types of medical use on the license (continued)

-~ ______--_-._- Individual If training was provided by S~PeWising Licenselpermit Number listing supervising individual

RSO, AU, AMP, or ANP. (If more than one supervising individual is necessary lo documenl supervised hlning, provide mu/liple copies of this page)

!

___. ~ ~ ~ ~ ~ ._____.. ~ _._..__.__ ~ ~

LicensePermit lists supervising individual as:

n Radiation Safety OHcer

111 Authorized Medical Physicist

Authorized as RSO, AU. ANP. or AMP for the following medical uses:

L1 Authorized User n Authorized Nuclear Pharmacist

CJ 35.100 u 35.200 [lrJ 35.300 0 35.400

0 35.500 r-1 35.600 (remote afterloader) [x 35.600 (teletherapy)

I

) -- 35.600 (gamma stereotactic radiosurgery) []35.1000 (

. . . . __ .. ,. . - .._. __ -. .. - . . - d. Skip to and complete Part II Preceptor Attestation. Ii OR

4. Authorized User, Authorized Medical Physicist, or Authorized Nuclear Pharmacist identified on the licensee's license

a. Provide license number.

b. Use the table in section 3.c. to describe training in radiation safety, regulatory issues, and emergency procedures for all types of medical use on the license.

c. Skip to and complete Part II Preceptor Attestation.

PART II - PRECEPTOR AlTESTATION

Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each.

First Section Check one of the following:

I. Board Certification

@ I attest that F-L/) i d & @& U/t 2:z'L has satisfactorily completed the requirements in _- - .- Name of Proposed Radiation Safely Officer

10 CFR 35.50(a)(l)(i) and (a)(l)(ii); or 35.50 (a)(2)(i) and (a)(2)(ii); or 35.!X(c)( I ) .

OR 2. Structured Educational Proqrarn for Proposed Radiation Safety Officers

has satisfactorily completed a structural educational ~- I attest that

program consisting of both 200 hours of classroom and laboratory training and one year of full-time radiation safety experience as required by 10 CFR 35.50(b)( 1).

Name of Proposed Radiation Safely Oficer p. I OR

Jul 05 08 0 4 : 3 0 p John Gochoco choco 973 322 2479 p. 10

NRC FORM 313A (RSO) U.S. NUCLEAR REGULATORY COMMISSION (2-2007)

RADIATION SAFETY OFFICER TRAINING AND EXPERIENCE AND PRECEPTOR AlTESTATlON (continued)

'receptor Attestation (continued)

Wit Section (continued) :heck one of the following:

u 3. Additional Authorization as Radiation Safety Officer

IS an - -. .. -- I attest that Name of PmposedRadiil& Safety Offcer

Authorized User n Authorized Nuclear Pharmacist

n Authorized Medical Physicist

identified on the Licensees license and has experience with the radiation safety aspects of similar type of use of byproduct material for which the individual has Radiation Safety Officer responsibilities

AND iecond Section iomplete for al l (check all that apply):

@ I attest that dp). ~4.2 f&OLI/$-2-LJ-Jhas training in the radiation safety, regulatory issues, and . ~

Name of PmpasedRadiation Safely Officer

emergency procedures for the following types of use:

m35.100

p 3 5 . 2 0 0 -.

n 35.300

0 35.300

35.300

0 35.300

tg 35.400

L] 35.500

n 35,600

0 35.600

n 35.600

ci 35.1000

oral administration of less than or equal to 33 millicuries of sodium iodide 1-131, for which a written directive is required

oral administration of greater than 33 millicuries of sodium iodide 1-131

parenteral administration of any beta-emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required

parenteral administration of any other radionuclide for which a written directive is required

remote afterloader units

teletherapy units

gamma stereotactic radiosurgery units

J u l 05 08 0 4 : 3 0 p

NRC FORM 313A (RSO) U.S. NUCLEAR REGULATORY COMMISSIOI (2-2M7)

RADIATION SAFETY OFFICER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

AND Third Section Complete for ALL

HI attest that r&&//3 e- b u * q 2 Z I has achieved a level of radiation safety knowledge - -_ ._ - - - - ___ Name af Proposed Radialion Safety Offlcer

sufficient to function independently as a Radiation Safely Officer for a medical use licensee

. ~ 1 1 1 1 1 1 1 1 9 1 ~ 1 1 u 1 1 9 m m m m 1 ~ 1 u D 1 1 m ~ u u 9 9 9 ~ ~ 9 9 9 9 ~ 1 m m ~ 1 m m D m m m m 1 ~ 1 9 .

John G o c h o c o choco 973 322 2479 p. 1 1

\ re 0 0 00

Is? 0 0 0 P \ 0 0 0 4

0 -J \ N 8 \ N

- 0 0 c4

N N

cn 01

..

E

m 0 0 0 01 \ 0 0 b, 4

0 0 \ (D 0 0 0

f3

x 4 L

(D In e4 01

8 0 0‘ 01

..

\ m e4 \ t- 0

m 2

fi

f

4 i

0 7 / 2 8 / 2 0 0 8 2 2 : 5 7 FAX @0008 /0034

* May 6,2002 Msirnonidee

Rs: Di. Shivang Tdvedl

To Wham It May Concwn:

This letles is to dum that Dr. Shivmg Mvedl pined alinical slqwience during him aardiology fellowhip rt out institution in Nwlaar Cardiology. The procewrship period incldes the fbllowing datas: September 1 t031,1999; May 1 tb 31, u)oO; A M I 1 U) 302001; 80brUary 1-28zOO2, d h g w h k h h s wasassignadto tho nucloar stress test lab, as wdl as other timw durintg the fellowship that he M Y ~ other fallows in thaw rotation iiOm July 1999 through April 2002, Dr. 'Ifivedi actively participated in the following number of procedures:

1.

2. 3, 4. 5. 6.

tion on O f 400 cases of my0cat~Il.l perfusion imaging using Technetium and Thallium radionuclide agents for rest and sues (exercise or phannrcalogic) ptocsle . 10 PYPrnC multi-gated acquisition StIess p d u r e s 10 EJection fraction calcul&m p d u r a e 50 Wall mtion evduotioa studies 20 myocudial viability sssessmont studles IntarpratatiOn. 30 C- of &sting cathttulalid@opphk data with radionuclide derivsd dpta

Our Institutid license number is: 91-2844-01.

Dr. Shivmg Trivedi'e formal Sollowship training mmm in nuclear cardiology meets ths rsquirements I outlined in tbe American College of CsrdiologylAmerioan Society of Nuclear Cardiology COCATS Ouidelines fbr training in Nuclear Cardiolo~ 2000 revision.

Dt. Shivang Trivcdi has achieved a level ofcmpetenp uufnduat to function independently as M authorized user for the medical we aulhorizsd under NRC r u m E- imaging and looalizarlon.

Tha hours of nuclear cardiology clinical and work experieacc m c d duriag this period total lo00 hours.

SinCcrtlY,

9B/ZO 3 W d

n .

OCrOeeR 24,2004

07/28/2008 2 2 : 5 8 FAX 1

\

cv PERSONAL ANU CONFlDENTfAL

ET/!X 3 V d

Shivrnm IH. Trivedi. MD. FACC

Board CertMed In Intemal Medicine 1999) Board Ccrtifted in Cardiovascular Diseases ( 2002) Board Certified in Nuclear Cardiology (2004)

Medical ltainina and Profess1 anal experlence-

@0010/0034

July 2004 onwards July 2002- June 2004

July 1999- JUM 2002

July 1996- June 1999

July 1984- Juno 1996

AUguat 1990- July 1994

July 1984- March 1990

Researc h-

Praetlcing Cardlologkt in New Jerssy Practiced as Cadiohgist In Pennsylvenla

Fellowship in Cardiovascular Dkcrses Maimonfdets Medical Center, Brooklyn, NY . Resldenoy in lrrtrernal Medicine MaCmonldas Medlcal Center, BrtwKlyn. NY Remarch Associate Maimonldes Medlcal Csnbrr, Brooklyn , NY M.S. (Master of Surgery) Residency in General Surgery 1111.5. University, Vadodan, Gujaat, India M.B.B.S. Government Medical College M.6. University, Vadodara, Gujaw India

1. Bkedfng compllcetlocl( fhbl intracranial hemvrrhage ) of platelet GP 2- inhlbfbor- abciximab. A case report srifh review of Iibraturr, pubilshed in The Journal of lmaslve Cardlalogyduly 2002

2. Clarithromycine irnd digoxlne toxicity - A case report letter to editor published in the Annals af Internal Medicine, 41111998 issue.

3. Numerous artlcler and abstracts published in different ]ournals end presented at mUngs of eneshesiologisb as research associate between July 1984 and June 1996.

Members hip- 1 American College of Cardiology ( ACC ) 2. American Society of Nuclemr Cardiology ( ASNC )

State Medical hence - New Jersey, Pennsylvania Citizenship- USA

BY NRC. NO CQPY OF THIS INFORMATION WAS RETAINED BY THE NRC.