CARDIOSPECIALISTS GROUP, LTD. 801 MacArthur Boulevard, Suite 203

Munster, IN 46321

June 11,201 1

Radioactive Materials Licensing Section US. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352

Re: Amendment to License No. 13-32400-01 :

To Whom It May Concern:

Please add the names of Joaquin Bernard0 Gonzalez, M.D., as an authorized user for 1 OCFR35.200 procedures, limited to cardiovascular clinical procedures.

To support this request, we have attached a copy of Dr. Gonzalez's Certification Board of Nuclear Cardiology certificate, documentation of his safe use of radioactive materials training, a completed NRC Form 31 3A form, including signed preceptor attestation, and copy of his State of Indiana physician's license.

If you need additional information to process this request, please contact Margie Biltgen, CNMT at 21 9-jH6-9390.

Sincerely, 83d

Radiation Safety Officerv

Copy: Margie Biltgen, CNMT

IRC FORM 313A (AUD) US. NUCLEAR REGULATORY COMMISSION 1-2009)

Jame of Proposed Authorized User

~

r0AQLcIhj &WARbo GO#zAhTAfi.h.

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

State or Territory Where Licensed

- - ..

193b rAdA

APPROVED BY OMB: NO. 3150-01 I EXPIRES: 3/31/2012

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.

1. Board Certification

a. Provide a copy of the board certification.( % A b. If using only 35.500 materials, stop here. If using 35.100 and 35.200 materials, skip to and complete Part I1

1 2. Current 35.390 Authorized User Seekinq 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 multiple copies of this section.)

U Re)

Preceptor Attestation. -1

meeting 10 CFR 35.390 or equivalent Agreement __ -

b. Supervised Work Experience.

I Location of ExperienceILicense or Clock I Hours Permit Number of Facility Description of Experience

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 --___ __

Total Hours of Experience:

Dates of Experience*

~ _ - - - - - - - Supervising Individual LicenseIPermit Number listing supervising individual as an

authorized user

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

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

- - . - - . . . - . . .._ _ _ - . - - _ _ ~

RC FORM 313A (AUD) (3-2009) PRINTED ON RECYCLED PAPER PAGE 1

V.U. I V U U L C M K KCUU

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAT'^"' ' J-LUUY J

- 1 - ~

LATORY COMMlSSlO JRC FORM 313A (AUD)

I I C LIIIPI crnnrrram ... ^^^_.

I IUIY [continued)

Description of Training __ - _..

3. Traininq and Experience for Proposed Authorized User

7-

Dates of Training *

-. -

Location of Training

performing the related radiation surveys

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

__ --. _. ~- - -

--_

Radiatibn physics and instrumentation

Radiation protection

Wathematics pertaining to the use and measurement of radioactivity

:hemistry of byproduct material or medical use (not required for E. 590)

ladiation biology

_ _ - - - - -- - - _- Total Hours of Training:

.. . . ._.

..

b. Supervised Work Experience (completion of this table is not required for 35.590). (If more than one supervising individual is necessary fo document supervised work experience, provide mulfiple copies of this section.)

-- - - _. - - __ _ _ __ - -

I Supervised Work Experience Total Hours of Experience:

-- - . __ - - - - ---- - .. -_ - Location of ExperienceILicense or

Permit Number of Facility Dates of

i U N o i

PAGE

IRC FORM 313A (AUD) US. NUCLEAR REGULATORY COMMlSSlC AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3-2009)

___.___.

Device

3. Trainina and Experience for Proposed Authorized User (continued)

Type of Training Location and Dates

b. Supervised Work Experience. (continued) - ~ ~ __

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 decontamination procedures

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

Location of ExperiencelLicense or Permit Number of Facility Confirm Dates of

Experience*

Supervising Individual ; License/Permit Number listing supervising individual as an i authorized user

-..-----..---...--- ................................................................................................ ...,- .... ~ ..................................................................................................... ~ .......

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

35.190 H 3 5 . 2 9 0 n 35.390 n 35.390 + generator experience in 35,29O(c)(l)(ii)(G)

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

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

PAGE 3

IRC FORM 313A (AUD) 1-2009)

U.S. NUCLEAR REGULATORY COMMlSSlOb

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

PART I I - PRECEPTOR ATTESTATION 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)

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

:irst Section :heck one of the following for each use requested:

For 35.190

Board Certification

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

10 CFR 35.190(a)(I) 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 Traininq and Experience

17 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 IO 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 10 CFR 35.100.

For 35.290

Board Certification

@ I attest that 50AGkUN i 3 a W A R b 0

Go r32ALE t , N , b, has satisfactorily completed the requirements i'n Name of Proposed Authorized User

10 CFR 35.290(a)(I) 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.

OR Trainina and Experience

-. 1 I attest that has satisfactorily completed the 700 hours of training

and experience, including a minimum of 80 hours of classroom and laboratory training, required by 10 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

i m m ~ m ~ m ~ ~ m ~ m ~ m m m m m m m m ~ m m ~ m m m m m m m ~ ~ m m m m m m m m m ~ m m m ~ m m m ~ m . m m m m m m ~ m m m m m ~ ~ m ~ ~ m m ~ ~ ~ m m m m ~ ~ ~ m ~ m ~ ~ m ~ m m ~ m m m m m m m ~ ~ m m m m ~ ~

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

HI meet the requirements below, or equivalent Agreement State requirements, as an authorized user for:

0 35.190 a 3 5 . 2 9 0 n 35.390 n 35.390 + generator experience rate Telephone Number lame of Preceptor

icense/Permit Number/Facility Name

13- 3 2 4 O O - O l PAGE 4

JRC FORM 313A (AUD) 3-2009)

U.S. NUCLEAR REGULATORY COMMISSION

appropriate for the preparation of radioactive drugs for imaging and localization studies, measuring and

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. 3150-01 I EXPl RES : 3/31 1201 2

dame of Proposed Authorized User 1 State or Territory Where Licensed

mb rAAJ4 - __ - - __ -.

. T Q A Q L ( / ~ _ . - . &iWAARbo G O ~ z A ~ ~ / r - f L iequested Authorrzation(s) (check all that apply)

3 35.100 Uptake, dilution, and excretion studies

a 3 5 . 2 0 0 Imaging and localization studies &I/- W c A A b / w B Y

I] 35.500 Sealed sources for diagnosis (specify device 1 ~ ~~~

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.( $k€ 4 U B t )

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

-1

1 2. - 1

Current 35.390 Authorized User Seeking Additional 35.290 Authorization

meeting 10 CFR 35.390 or equivalent Agreement __ - a. Authorized user on Materials License State requirements seeking authorization for 35.290.

(If more than one supervising individual is necessary to documenf supervised work experience, provide mulfiple copies of this secfion.)

b. Supervised Work Experience.

1 Location of ExperiencelLicense or Clock 1 Hours Permit Number of Facility 1 Description of Experience

Total Hours of Experience:

Dates of Experience*

. . . . . -- . ~- .... .- ____. ..

Supervising Individual j License/Permit Number listing supervising individual as an ! authorized user

i I

1 Supervisor meets the requirements below, or equivalent Agreement State requirements (check all that apply). I n 35.290 35.390 .t generator experience in 32,29O(c)(l)(ii)(G)

I . . . _ ~ _ . . . . . . . . . . .... ........ -

RC FORM 313A (AUD) (3-2009) PRINTED ON RECYCLED PAPER PAGE

iRC FORM 313A (AUD) >-2009)

U.S. NUCLEAR REGULATORY COMMlSSlC

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

‘Onfirm - . __

Yes

0 No

0 Yes

__- .

n No

1 3. Traininq and Experience for Proposed Authorized User

a. Classroom and Laboratory Training.

Dates of Experience*

- - .- . - -

- -

Description of Training

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

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

-. ._ - - - - - . __.

--_

Radiation physics and instrumentation

. .- __

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

Radiation protection

Mathematics pertaining to the use and measurement of radioactivity

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

~

Radiation biology

. .. . . - - .

Location of Training

- ~ ~ ~ - .. .. ... ~

Total Hours of Training:

___ - .... . -

Dates of Training *

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

Supervised Work Experience Total Hours of Experience:

PAGE 2

IRC FORM 313A (AUD) 1-2009)

U.S. NUCLEAR REGULATORY COMMlSSlO

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

Device

3. Training and Experience for Proposed Authorized User (continued)

b. Supervised Work Experience. (continued)

Type of Training Location and Dates

i 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 decontamination procedures

I Administering dosages of radioactive 'drugs to patients or human research b subjects 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

I

Location of ExperiencelLicense or Permit Number of Facility Confirm Dates of

Experience*

n Yes

n NO

n NO

0 Yes

___--

authorized user

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

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

El 35.190 *5.290 n 35.390 n 35.390 + generator experience in 35.290(c)(l)(ii)(G)

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

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 Attestation.

PAGE 3

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

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued) (3-2009)

PART I1 - PRECEPTOR ATTESTATION 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. (Not required to meet training requirements in 35.590)

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

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

For 35.190

Board Certification

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

10 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 Traininq and Experience

has satisfactorily completed the 60 hours of training and _____ -

I attest that

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 functi'on independently as an authorized user for the medical uses authorized under 10 CFR 35.100.

Name of Proposed Authorized User

For 35.290

Board Certification

I attest that 3 0 A Q U I Q RFnNARo

Go r32ALE 2, 5 , b. has satisfactorily completed the requirements i'n Name of Proposed Authorized User

10 CFR 35.290(a)(I) 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.

OR Traininq and Experience

1 - 1 I attest that has satisfactorily completed the 700 hours of training

and experience, including a minimum of 80 hours of classroom and laboratory training, required by 10 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 Authortzed User *I -

. ~ ~ g m g g g ~ ~ ~ m ~ m - ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ g ~ ~ ~ ~ g ~ g ~ ~ ~ ~ ~ ~ g g ~ ~ ~ ~ m ~ ~ ~ ~ ~ m ~ ~ g g ~ g ~ ~ ~ g ~ ~ m g ~ ~ ~ ~ m g ~ ~ ~ g ~ g ~ ~ m ~ ~ ~ ~ ~ ~ m ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ r n ~ - ~ ~ r n ~ -

Second Section Complete the following for preceptor attestation and signature:

I meet the requirements below, or equivalent Agreement State requirements, as an authorized user for:

n 35.190 H 3 5 . 2 9 0 0 35.390 n 35.390 + generator experience

Name of Preceptor Signature Telephone Number Date

X / K % License/Permit Number/Facility Name

i

- _. 3 has cu:

mity of Arkansas for Medical Sciences

y of New Mexica Health Science Center and the

certify that

September 11,2008

4 ? 2008

F;;MD

nz;n\ss,

pns on your wmpletion of Nudear Education Wine tducatian prctgmm for Authorized User training. We you have gained the fundamental knowledge of the on which tu build experience and expertise in this Biz.

arm.D, BCNP If Arkansas for Medical Scienms

I