w southbendcl lnic.com

Main Campus at 211 Norlh Eddy SI. South Bend, IN 46617

Fax 5741237-9329 5741234-8161

The South Bend Clinic at Family Care Associates

720 E Cedar SI Suite 320 South Bend, IN 46617

Fax 5741288-1426 5741288-1200

The South Bend Clinic at Granger

14950 State Road 23 Granger. IN 46530 Eye Center 5741247-3937 Urology (L OBGYN 5741243-4450 Fax 5741243-4405

The South Bend Clinic at Granger Family Medicine

52500 Fir Road Granger IN 46530 5741271-0700 Fax 5741273-5648

The South Bend Clinic at Ironwood Medical Group

2102 E inwood Road South Bend. IN 46614

Fax 5741299-2410 5141299-2400

The South Bend Clinic at Michiana Pediatrics

837 E Cedar SI , Suite 350 South Bend, IN 4661 7 5741234-9555 Fax 5741287-9137

The South Bend Clinic at Skyway Primary Care

610 N Michigan SI Suite 400 South Bend IN 46601

Fax 5741239-1520 5741239-1420

The South Bend Clinic at South Bend Internal Medicine

720 E Cedar St Suite 400 South Bend IN 46617

Fax 574/232-3369 574/232-3327

The South Bend Clinic at New Carlisle 8984 East U S 20 New Carlisle. IN 46552

Fax 5741654.3643 57416544490

November 14,2007

US Nuclear Regulatory Commission Region 3 Materials Licensing Branch 2443 Warrenville Road, Ste 2 10 Lisle, IL 60532-4352

To Whom This May Concern:

Please make an amendment to The South Bend Clinic’s Materials License. We would like to add Dr. Naseer H. Nasser as an authorized user for 35.100 and 35.200 limited to cardiology only.

Please see the attached Attestation form, current Materials License, a former Materials License Dr. Nasser used to be on, and a copy of Dr. Nasser’s Board Certification.

Please contact me if you should need anything further.

Sincerely, 1

U Crystal Andrews Credentialing Coordinator South Bend Clinic & Surgicenter LLP 2 1 1 North Eddy Street South Bend, IN 466 17 574-239-1567 574-239-1458 f a candrews@southbendclinic.com

RECEIVEDNDV 19m? Allergy & Clinical Immunology Audiology m Cardiology a Dermatology a Nutrition Servlces a Endocrinology a Family Practice a Gastroenterology a General & Vascular Surgery

Internal Medicine Laboratory a Neurology a Obstetrics & Gynecology a Oncology-Hematology a Ophthalmology a Optometry a Orthopedic Surgery Otolaryngology-Ear-Nose-Throat Ambulatory Surgery Center a Pediatrics a Pharmacy a Physical Medicine 8 Rehabilitation a Radiology Clinical Research a Rheumatology a Urology

RC FORM 313A (AUD) -2007)

US. NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

(for uses defined under 35.100, 35.200, and 35.500) [ I O CFR 35.190, 35.290, and 35.5901

APPROVED BY OMB: NO. 315041: EXPIRES : 10131 ROO 8

lame of Proposed Authorized User ,State or Territory Where Licensed

. .

35.100 Uptake, dilution, and excretion studies

@ 35.200 Imaging and localization studies

1 _ - _ _ - - - - - - - 1 35.500 Sealed sources for diagnosis (specify device

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

' Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of application or the individual 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.

a 1. Board Certification

a. Provide a copy of the board certification.

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

3 2. Current 35.390 Authorized User Seekina Additional 35.290 Authorization

a. Authorized user on Materials License State requirements seeking authorization for 35.290.

(If more than one supervising individual is necessary to document supervised work experience, provide murtiple copies of this section.)

meeting 10 CFR 35.390 or equivalent Agreement

b. Supervised Work Experience.

_____.___-- __ - - - - _ _ _ _ -

I I Location of ExperiencelLicense or 1 Clock I Datesof Description of Experience Permit Number of Facility i Hours 1 Expeience'

- ---- __ - - - - - - - ~ ~ - - - - Eluting generator systems appropriate for the preparation of radioactive drugs for imaging and ~

localization studies, measuring and ' testing the eluate for radionuclidic I I

I

purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs

I 1

I I i ____--,---I ___ __-__---.- --

I

Total Hours of Experience: I______-.__ _----- ~ ____ _ _ _ - Supervising Individual LicenselPermit Number listing supervising individual as an

authorized user

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

0 35.290 0 35.390 + generator experience in 32.290(c)(l)(ii)(G)

~ - IRC FORM 313A (AVD) (3-2007) PRINTEDONRECYCLEOPAPER PAGE

C FORM 313A (AUD) U.S. NUCLEAR REGULATORY COMMISSION w7) AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

Description of Training Location of Training Dates of

Hours I Training*

Radiation physics and instrumentation

Mathematics pertaining to the use and measurement of radioactivity

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

I Radiation biology

Total Hours of Training:

Radiation protection

Supervised Work Experience

I

Total Hours of Experience:

Location of Experience/License or Description of Experience Must Include: Permit Number of Facility Confirm

Dates of Experience'

Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation

PAGE :

0 Yes

surveys

Performing quality control procedures on instruments used to determine the activity of dosages and Derforming checks for proper

0 Yes

0 No I

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

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued) -2007)

I

Description of Experience Location of Experience/License or Dates of Must Include: Permit Number of Facility Experience' 1 1

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 decontamination procedures 0 No

Yes 1

Administering dosages of radioactive drugs to patients or human research subjects

0 Yes

I I D N O I

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

Supervising Individual I I I I

1 License/Permit Number listing supervising individual as an 'authorized user

I Supervisor meets the requirements below, or equivalent Agreement State requirements (check one). i 0 35.190 35.290 0 35.390 0 35.390 + generator experience in 35.290(c)(l)(ii)(G) 1 c. For 35.590 only, provide documentation of training on use of the device.

Device Type of Training Location and Dates I I I

d. For 35.500 uses only, stop here. For 35.100 and 35.200 uses, skip to and complete Part II Preceptor Attesta ti on.

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

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued) 5-2007)

PART II - PRECEPTOR AlTESTATlON

dote: 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. (Not required to meet training requirements in 35.590)

7rst Section :heck one of the followinn for each use reauested:

For 35.190

Board Certification

I attest that has satisfactorily completed the requirements in Name of Proposed Authorized User

I O CFR 35.190(a)(l) 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 Experience

0 I attest that has satisfactorily completed the 60 hours of training and Name of Proposed Authorized User

experience, including a minimum of 8 hours of classroom and laboratory training, required by 10 CFR 35.190(~)(1), and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under I O CFR 35.100.

For 35.290

Board Certification

I attest that 6 has satisfactorily completed the requirements in

10 CFR 35.290(a)(1) 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 and 35.200.

Name of Proposed Authorized User

OR Traininq and Experience

c) I attest that has satisfactorily completed the 700 hours of training

and experience, including a minimum of 80 hours of classroom and laboratory t r~ning, required by I O CFR 35.290(~)(1), 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 and 35.200.

Name of Proposed Authorized User

iecond Section :omplete the following for preceptor attestation and signature:

p] I meet the requirements below, or equivalent Agreement State requirements, as ZI authorized user for:

.icense/Permit NumberlFacility Name

PAGE 4

Ill NRC 374

U.S. NUCLEAR REGULATORY COMMISSION PAGE 1 OF 3 PAGES

Amendment No. 01 MATERIALS LICENSE

7ursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code Jf Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 34. 35, 36, 39, 40, and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose(s) and at the place(s) design 3ted below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Paft(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified

II

below.

Licensee In accordance with the letter dated I June 23,2003,

its entirety to read as follows: 4. Expiration date May 31, 2012

I. The South Bend Clinic 3. License number 13-32393-01 is amended in

2. 211 N Eddy Street South Bend, IN 46634-1755 E ,@cPtNo 030-36006

\. $ 9 fl Refd+ NA 6 Byproduct, source, and/or special Qi' Chemical andlor physical form

nuclear matenal

A. Any byproduct materig?: permitted by 10 C F e 35.100

B. Any byproduct materkl

I

Q

35.200 lii permitted by 10 CFR

C. Any byproduct materia9 permitted by 10 CFR 35.300

I

A. Any uptake, dilution and excretion study permitted by 10 CFR 35.100.

6. Any imaging and localization study permitted by 10 CFR 35.200.

C. Any therapy procedure permitted by 10 CFR 35.300 (limited to out-patient procedures cnly). m 111

CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at 21 1 N. Eddy Street, South Bend, Indiana .

111

Pats 1 ( 4 - 3 - 0 2 1

Amount Purpose . i )

Bvproduct Material 5.a Material in #35.100 As Needed 6.a Medical C'se

5 . b Material in #35.200 As Needed 6.b Medical Use (Excluding Generators and xenon)

5.c Material in #35.300 As Needed 6.c Medical Use

- It- - INDIVIDUALS RESPONSIBLE RAD IATION QAF'ETY PROGRAM -- THBIR TRAINING ANI) EXPERIW-

- 7.1 Authorized Users for Medical Use. Listed User on NRC License

7.1.a Thomas Bowers, M.D. 2 1 - 04 177-0 1 35.100, 35.200 (excluding generators and xenon), 35 .300 .

35.100, 35.200 (excluding generators and xenon), 35 .300 .

35.100, 35.200 (excluding generators and xenon)

7.1.b Robert Slabaugh, M.D. 2 1 - 0 4 1 7 7 -0 1

7.l.c Donald W. Gindelberger, M.D. 2 1 - 3 2 2 8 7-0 1

See Att 7.1.d 7.1.d Ahmed Abdel-Latief, M.D. - - -- 35.100, 35.200 limited to cardiovascular clinical procedures (excluding generators and xenon)

35.100, 35.200 limited to cardiovascular clinical procedures (excluding generators and xenon)

7.1.e Abul W. Basher, M.D. See Att 7.1.e

L_ 7.2 Authorized User for Nonmedical Use

Deparunent of State Health Scrviccs

RADIOACTIVE MATERIAL LICENSE

1. Name METHODIST HEALTH CENTERS DBA METHODIST WILLOWBROOK

ATTN THOMAS L DUMLER MD

HOUSTON TX 77070

HOSPITAL

2. Address 18220 TOMBALL PARKWAY

RADIOACTIVE MATERIAL AUTHORIZED _ , _ __.------------..I . 5. Radioisotope 6 . Form of Material 5 . Maximum A c t ; q *

A. Any radio- active material ceutical, except gas diagnostic purposes witb a half-life and aerosol < 120 days, except positron emitters

B. Tc-9h

A. Any radiopharma- A . As needed for

B. Bulk liquid elution B . As needed for from a generator diagnoaic purposes authorized in 25 TAC 5289.2% ( 2 )

C. Xe-133 C. Anyradiophanna- C. 100mCi ccutical

D. 1 - w D. Sodiumiodide D. 120mCi (in capsules only)

Q C u k mCi-Mllicuries pCi-Mrrocunes - Teus Admimsfrrtivc Codc (TAC)

Dated: July 3. 2007

Sigoed by: 3. License Number Amendment Number

Thomas L. Dumlcr, M.D.

LO5472 25 PREVIOUS AMENDMENTS ARE V O X D c

4. Expiration Date

_,.-___ December --- 31,2010 -_L_-.--.

8. Autborued bse A. Any diagnostic use indicated in Title 25 TACO 8289.25qy) and ( 2 ) .

B. Preparation and use of radiopbannaccutical reagent kits authorized in 25 TAC 8289.256 (W).

C. Pulmonary function studies and lung imaging.

D. Treatment of hyperthyroidism. rn accordance with 25 TAC 8289.25qaa). -

9. Radioactive material shall only be stored and used at:

Sire Number Location OOO Houston - Methodist Willowbrook Hospital - 18220 Tomball Parkway

10. Each site shall maintain documents and records pertinent to the operations at that site. Copies of 4 1 documents and records required by this license shall be mmtained for Agency review at Site OOO

1. The licensee shall compIy witb the provisions (as amended) of Title 25 Texas Administrative Code (TAC) $289 201, 9289.202. $289.203, 5289.204, 4289.205, $289 251, 8289.252. 9289.256 auld 6289.257.

D e p m i of Sure Health Services

RADIOACTIVE MATERIAL LICENSE

12.

13.

14.

15.

16.

Radioactive material may be used only by the individuals listed below for tbe uses specified. The use of PET radionuclides is authorized only when specified:

A. All diagnostic uses aulhorized by the license; therapy with 1-131 for hypMthyroidism.

Jett R. Brady, M.D. Sofia N. Chatziiannou, M.D.

StephenB Chiang, M D Thomas L. M e r , M.D

Ronald E Fisher. M.D Tbomas P Haynte, M D

B. All diagnostic uses authorized by the license.

Rajesh S. Amin, M.D. Davld S. Conrow, M.D.

Lisa K. Minckley, M.D. Jonathan N. Levine, M.D.

James F. Wiilis, M.D.

C. Diagnostic nuclear cardiology.

Maged Amine, M.D. John C. Isaac, M.D. Sandy Shah, D . 0 Ahmad Adnan Aslam, M.D. Mukarram A. Baig. M.D. Ismail T. Dairywala, M.D. Stanley M. Duchman, M.D. Subroto Gangopadhyay, M.D.

Waqar A . Khan, M.D Kevin A. Lisman, M.D. Daljit S. Muttiana, M.D. Naseer Hasan Nasser, M.D. Aditya K. Samal, M.D.

Kamran K. Sherwani, M.D Cyril B. Tawa, M.D David Turbay. M D. Annie Varughese, M.D Krishnamoorthy Vivckananthao, h4 D.

The individual designated to perform the functions of Radiation Safety Officer (RSO) for activities covered by chis license is Thomas L. M e r , M.D.

The licensee sball not open sealed sources containing radioacuve material.

AI1 radiophannaceutids to be used io humans must be from suppliers approved for distribution by the Unitcd Stam Food and Drug Administration (FDA), prepared from reagent kits fim suppliers approved for distribution by the FDA, or obtained from a licensed nuclear pharmacy

The liccastt shall maintain a current copy of the safety evaluation from "The Registry of Radioactive Sealed Sources and Devices" for each sealed source received under authority of ais license, in exass of 100 pCi of p/y-cmitting material or 10 pCi of a-emitting material.

LICENSE WUMRER

17. Except as specifically provided otbenvise by this license. the licensee shall possess and use the radioactive material authorized by this license in accordance with statements, representations, and procedures contained in the following:

MFNDWENT NUMBER

application dated July 24, 2001, letters dated November 5 , 2001, December 5. 2001, December 19. 2002, and March 19, 2003.

Title 25 TAC $289 shall prevail over statements conrained in rhe above documents unless such statements are more restrictive than the regulations.

SRU: m FOR THE DEPARTMENT OF STATE HEALTH SERVICES

?ate July 11, 2007 - J . don KW, Chief Medical and Academic Licensing Branch

HAVING MET THE KEQUIREMEN'I'S PKESCRIBkD RY 'ItilS BOARD FOR PHYSICIANS RESIDING

IN THE UNITED STATES AND HAVING SA'~ISFACTORllaY PASSED TIW KEQIJIRED EXAMINATLON,

IS HEREBY DESIGNATED

A DIPLOMATE CERTIFIED IN THE SUBSPECIALTY OF

NUCLEAR CARDIOLOGY FOR THE PERIOD 2005 TIIKOUGH 2015

(hToHbH 23. 2005