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QUALITY CARDIOVASCULAR CARE, LLC 1389 West Main Street Tower One, Suite 106 Waterbury, CT 06708

203-591-1 998 Fax 203-591-8163

Nuclear Regulatory Commission Region 1 475 Allendale Road King of Prussia, PA 19406-1415

April 12, 2009

RE: License No. 06-30966-01

To Whom It May Concern:

Iwould like to add myself as an authorized user to the Materials License (No. 30966-01) for Quality Cardiovascular Care, LLC.

Enclosed please find Form 313A (AUD) and a copy of my board certification (certificate number 6602) issued by the

The following is a summary of my continuing education and experience related to uses 35.100 and 35.200:

of

Course Title Basic Radioisotope Handling Course Nuclear Cardiology Board Exam Preparation Course Nuclear Cardiology Assessment Program

Date November 2005 July 2008

September 2008

Ithank you in advance for

Sincerely,

Location Chicago, I L

Chicago, I L

Internet-Based

Credits 100

15.75

7

Sponsor Consultants in Nuclear Medicine

American Society of Nuclear Cardiology American Society of Nuclear Cardiology

attention to this matter.

UMark Rosenberg, MD Managing Partner Quality Cardiovascular Care, LLC 1389 West Main Street Tower One, Suite 106, Waterbury, 06708 Voice: 203-591-1998 Fax: 203-591-8163

35.100,35.200, 110 90,35.290, 35.5901

)

OMB: 10/31/2008

RAINING thme

indiv~dual

Marie S. R o ~ k l h [ d ,

II

State Territory

Cc,,tns /i c u t

Authorization(s) thadpply)

supelvising wcwk

ExperienceILicense 1 1 j

drugs

radionuclidic

I j LicenselPermit

I supervisor requiremnts I

32.290(c)(l)(ii)(G)

I NRC FORM 31% (AUD) (102007) PRINTED ON RECYCLE0 PAPER PAGE 1

NRC FORM 313A (AUD) U.S. NUCLEAR REGULATORY COMMISSION

35.1 00 Uptake, dilution, and excretion studies

35.200 Imaging and localization studies

lo 35.500 Sealed sources for diagnosis (specify device

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

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

1. Board Certification

a. Provide a copy of the board certification.

I b. If using only 35.500 materials, stop here. If using 35.100 and 35.200 materials, skip to and complete Part Preceptor Attestation.

a. Authorized user on Materials License meeting 10 CFR 35.390 or equivalent Agreement

State requirements seeking authorization for 35.290.

b. Supervised Work Experience. (If more than one individual is necessary to document supervised experience, provide multiple copies of this section.)

Description of Experience Location of or Clock Dates of Permit Number of Facility Hours Experience*

Total Hours of Experience:

Supervising Individual Number listing supervising individual as an /authorized user

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

(for uses defined under and 35.500) CFR 35.1 and

APPROVED BY NO. 3150-01 EXPIRES:

Name of Proposed Authorized User or Where Licensed

Requested (check all

Eluting generator systems appropriate for the preparation of radioactive for imaging and localization studies, measuring and testing the eluate for purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs

meets the requirements below, or equivalent Agreement State (check all that apply).

35.290 35.390 + generator experience in

FORN 313A COMMISSI( "- Trainina Ex~erience P r o m e d

1 ( of Training 1 1 1 Hours Training* t - 1

I

required

1

wcrk

1

1 I TOW Hours : 1

performing

activity

No

No

i ExperiendLicense I ~xperienced

(AUD) U.S. NUCLEAR REGULATORY NRC

AUTHORIZED USER TRAINING AND EXPERIENCEAND PRECEPTOR ATTESTATION (continued)

3. and for Authorized User

a. Classroom and Laboratory Training.

Description of Training Location Clock Dates of I

Radiation physics and instrumentation

Radiation protection

Mathematics pertaining to the use and measurement of radioactivity

Chemistry of byproduct material for medical use (not for 35.590)

Radiation biology

Total Hours of Training:

b. Supervised Work Experience (completion of this table is not required for 35.590). (Ifmore than one supervising individual is necessary to document supervised experience, provide multiple copies of this section.)

Supervised Work Experience of

Ordering, receiving, and unpacking radioactive materials safely and

the related radiation surveys

Performing quality control procedures on instruments used to determine the of dosages and performing checks for proper operation of survey meters

Experience:

Yes

Yes

Description of Experience Must Include: ConfirmLocation of or

Permit Number of Facility Dates of

3 1 3 ~ (AUD) COMMISS~~N 'lOm ~

Ex~erlence Pro~osed ! ! - 1 -

~ ~

I -

-

!

I

i- I ~

-- - I

I

I I

i 1 1

radionuclidic

dw gs

ExperienceILicense Facility

1 LicenseIPermit 1

I

I I--..' 1

C] C] 35.290(c)(l)(ii)(G) I

, I I

No

No

No

No

No

.I I I 1 I

I

I

- 1 I

II !

NRC FORM U.S. NUCLEARREGULATORY

AUTHORIZED USER TRAININGAND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3. Trainina and for Authorized User (continued)

b. Supervised Work Experience. (continued)

Dates of Experience'

--

I

,-

-,

i

I

i i

individualas an

Description of Experience Must Include:

Calculating, measuring, and safely preparing patient or human research subject dosages

Using administrative controls to prevent a medical event involving the use of unsealed byproduct material

Using procedures to contain spilled byproduct material safely and using proper decontaminationprocedures

Administering dosages of radioactive drugs to patients or human research subjects

Eluting generator systems appropriate for the preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for purity, and processing the eluate with reagent kits to preparelabeled radioactive

SupervisingIndividual

Location of or Permit Number of

Number listing authorized user I

I

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

Supervisor meets the requirementsbelow, or equivalent Agreement State requirements (check one).

i35.190 35.290 35.390 35.390 + generator experience in

c. For 35.590 only, provide documentationof training on use of the device.

Yes

Yes

Yes

Yes

Yes

supervising

ii

Device

i

i

d. For 35.500 uses only, stop here. For 35.100 and 35.200 uses, skip to and completePart Preceptor Attestation.

Type of Training Location and Dates

~ u ~ m u m m m ~ u m m m m ~ ~ m m m m ~ ~ ~ m m ~ ~ ~ ~ m ~ ~ m ~ ~ m ~ ~ m

313A COMMISSI~~N "- AllESTATION v

II AllESTATlON superv~sing

)

tke

1 I

I I

attest IRl k - RKv, I

I NarneofP~~pedAuthonzedUaer J

35.190(a)(l) 1

I

Exweriencq

I -

Name Propod AuUwkod Uwr I

10 35.190(c)(l), competency ~

I

1 -n I

& l /L1 k $ I

of Pmpo& Authonrd UM A I 35.290(a)(l) I

Exwerienq I

Name P m p e d AuthorLed

classroom 35.290(~)(1),

~ u u l n ~ ~ ~ l u m u ~ ~ u u ~ ~ ~ ~ ~ ~ ~ ~ ~ u ~ ~ l i l ~ ~ ~ ~ ~ ~ ~ u ~ m m ~ ~

HI EYI 1

~ 1 ~ 2 $1 N EH N I ~ A N O J ] p.ij ~ 3 - S ~ I - - 1-

LicenselPermlt NumberIFacility

0 6 317 L,b- 0 1 I L 4

NRC FORN (AUD) U.S. NUCLEAR REGULATORY

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR (continued)

PART -PRECEPTOR I

Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the individual as long as the preceptor provides, directs, or verities training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptorstatement from each. (Not required to meet training requirements in 35.590) I

By checking the boxes below, the preceptor is attesting that the individual has knowledge to fulfill the duties of position sought and not attesting to the individual's "general clinical competency."

First Section Check one of the following for each use requested:

For 35.1 90 I

Board Certification

that has satisfactorily completed the requirements in I

10 CFR and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100.

OR Trainina and I

I attest that has satisfactorily completed the 60 hours of training and of

experience, including a minimum of 8 hours of classroom and laboratory training, required by CFR and has achieved a level of sufficient to function independently as an

authorized user for the medical uses authorized under 10 CFR 35.100.

For 35.290 I

attest that . , , has satisfactorily completed the requirements in Name

10 CFR and has achieved a level of competency sufficient to function independently as an I

authorized user for the medical uses authorized under 10 CFR 35.100 and 35.200.

OR Trainina and

Iattest that has satisfactorily completed the 700 hours of training i

d Uwr

and experience, including a minimum of 80 hours of and laboratory training, required by 10 CFR and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.1 00 and 35.200.

Second Section Complete the following for preceptor attestation and signature:

meet the requirements below, or equivalent Agreement State requirements, as authorized user for: , 35.190 35.290 35.390 35.390 + generator experience I

Name of Preceptor elephone Number

-Name

PAGE

~.~

tifiCation ~ o a r d of Nuclear C w i o l o gb

HAVING

IN UNITED

A

Incorporated 1996

Certifies that

Mark S. Rosenberg, MD MET THE REQUIREMENTS PRESCRIBED BY THIS BOARD

FOR PHYSICIANS TRAINED THE STATES

AND HAVING SATISFACTORILY PASSED THE REQUIRED EXAMINATION,

IS HEREBY DESIGNATED

DIPLOMATE CERTIFIED IN THE SUBSPECIALTYOF

NUCLEAR CARDIOLOGY

Secretary

CERTIFICATE NUMBER: 6602

Consukants nliLch?ar 3Mediczne w. Estes

IL 60645

certqicate verqies that Novew~ber

Nark ~ o s e n 6 e r g

comp le t ed~oo l i a~ r r tlie ~ d i o i s o t H a n d i n g

covering the

Radiioy liarmac ~ a d i a t i o n ~ i o l o g y , Ffiysics ~ a d i a t i o n P ~ o t e c t th,

Nathernatics dssociatedwitl i

a d r e c e i v e d a y a s s i n g q u a h i apliysician Cardiology Boarc

a d f i i authorzz radiopliarmaceutica6, generatms, a d r e a g e n t 1

a d m e e t s aCCrequirements fwtfi by tlie 'US nliLclea 2&?guCatmy Commission a n d a l C ~ g r e e m ~ n t

in ~ederaC~gznhtions.

in 2910 Avenue

Chicago,

This on 6,2005

Dr. SS # 124-36-6302

of Basic ope Course,

topics of

y, an Instrumentation, ion, and

Radioactivity

grade. This course is designed t for the Nuclear

Examination to qua aphysic ian as an user of

set States as

out fined the Code of

Course Director

R Credit(sJ TM. only

-. I I

ASNL' i

This Statement is for Enrollee's Records

Mark Rosenberg, MD

attended a continuing medical education program entitled

2008 Nuclear Cardiology Board Exam Preparation Course

from July 19-20, 2008 in Chicago

The American Society of Nuclear Cardiology is accredited by the Accreditation Council for Continuing Medical Education to

sponsor continuing medical education for physicians.

The American Society of Nuclear Cardiolo y designates this educational activity for a maximum of 15.75 AMA P Category I

Physicians should claim credit commensurate with the extent of their particination in the activity.

James A. Arrighi. MD Chairman. Education Committee

Cardioloa: https://www.asnc.org~edu~aKi0nln~ksap~4/~ertifi~ate/cn /ecertificate.c..

20814-3304 FAX(301)215-7113

info@asnc.orq www.asnc.orq

corrlpleted Program"

Category ~ r e d i t ( s ) ~ ~ .

J a m Arrighl, ASNC Cmnninee

(PDF)]

American Society of Nuclear NCKSAP

American Society of Nuclear Cardiology 4550 Montgomery Ave., Suite 780 North Bethesda, Maryland

(301)215-7575

This Statement is for Enrollee's Records

Mark S. Rosenberg, MD a continuing medical education activity entitled

"Nuclear Cardiology Knowledge Self Assessment on Saturday, September 13, 2008

The American Society of Nuclear Cardiology is accredited by the Accreditation Council for Continuing Medical Education to sponsor

continuing medical education for physicians.

The American Society of Nuclear Cardiology designates this educational

activity for a maximum of 7AMA PRA Physicians should only claim credit commensurate with the extent

of their participation in the activity.

1

A. MD Chairman. Education

[Close Window] I[Download Printer-friendly version

-

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FORM 374 PAGE OF 2U.S. NUCLEAR REGULATORY COMMISSION Amendment No. 2

MATERIALS LICENSE Pursuant to the Atomic Energy Act of as amended, the Energy Reorganization Act of 1974 (Public Law and Title 10, of Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 34, 35, 36, 39, 40, and 70, and in reliance on statements and heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer source, and special nuclear material designated below; to use such material for the and at the designated

or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable This shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions /?d below. I

Licensee

I. Quality Cardiovascular Care,

2. 1389 West Main Street

Tower Suite 106

Waterbury, Connecticut

-In accordance with letter dated

June 12, 2007 I

License number 06-30966-01 is amended in

its entirety to read as follows: I

I -

Expiration date November 30, 201 4 I

Docket No. 030-36684 Reference No.

i--I

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

license

A. Any byproduct material A. Any A. As needed permitted by 10 CFR 35.100 i

Any byproduct material Any B. As needed permitted by 10 CFR 35.200

! I I

i.-9. Authorized use: i A. Any uptake, dilution and excretion study permitted by CFR 35.100.

I

Any imaging and localization study permitted by 10 CFR 35.200.

CONDITIONS

Waterbury, Connecticut.

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

10. Licensed may be used or stored only at the licensee's facilities located at 1389 West Main

i

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

!

I

of PAGE;

-I- I-

l-

1- I

(I( B. 1 L~ ly

Item 30.35(d) 1

I

14. I CFR 71, 'Packaging Material.'' I '

3 - othe'rwise 1 includin,~

conditidn.&pplies /o with,the reguladons. Additionally,'this 1

35.26.l regulationhshall

app~icatlon~and .,: ! .!,, !

1,

, '

, : +! ,.,.... ... : ., .,., * ' , I

[~~0428203??]

I [ML043200749]

i I

BY ~ g p h e n

26. 9:51:32(AM I

U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 2

License Number

06-30966-01

MATERIALS LICENSE Docket or Reference Number -SUPPLEMENTARY SHEET 030-36684 I

-Amendment No. 2

The following individuals are authorized users for medical use as indicated:

Authorized Users Material and Use

Singhaviranon, M.D. 35.100, 35.200

12. The Radiation Safety Officer for this license is Lily Singhaviranon, M.D.

13. In addition to the possession limits in 8, the licensee shall further restrict the possession of license, material to quantities below the minimum limit specified in 10 CFR for establishing I

decommissioning financial assurance. I

The licensee is authorized to transport licensed material in accordance with the provisions of 10 Part and Transportation of Radioactive

. i 15. Except as specifically provided in this license, the licensee shall conduct its program in

accordance with the statements, representations, and procedures contained in the documents, any enclosures, listed below. This license only to those procedures that are required be submitted in accordance license condition does not limit the licensee's ability to make changes to the radiation protection program as provided for in 10 CFR The U.S. Nuclear Regulatory Commission's

.

govern unless the statements, representations, and procedures in the licensee's correspondence are more restrictive

. ,than the regulations. ,

A. Letter dated September 30,2004 B. Facsimile dated November 5, 2004

I

For the U.S. Nuclear Regulatory Cornmission I

Date June 26, 2007 Hammann

Commercial and R&D Branch Division of Nuclear Materials Safety Region I King of Prussia, Pennsylvania 19406

Tuesday, June 2007

letterlapplication

~ / ; v / - ~ O&-TQ%~-C>I

@There

/y?b *J

(Rl)

(6-96)

This is to acknowledge the receipt of your dated

, and to inform you that the initial processing which includes an administrative review has been performed.

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 .

When calling to inquire about this action, please refer to this control number. You may call us on (610) 337-5398, or 337-5260.

Sincerely, Licensing Assistance Team Leader

NRC FORM 532