Millennium Diagnostic Center Millennium CT/MRI/MRA Imaging Division of Millennium Medical Group, P.C.

28625 Northwestern Hwy, Suite 120-150 Phone: (248) 945-0000 Southfield, MI 48034 Fax: (248) 945-1819

November 16,2011

U.S. Nuclear Regulatory Commission Materials Licensing Section Region III 2443 Warrenville Road Ste 210 Lisle, IL 60532~4352 Licensing

Dear Sir:

Please amend Byproduct Material License No: 21-32035-01 for the following changes:

1. Add Justin Trivax, M.D. as an authorized user for 35.100 and 35.200

Attached is the Authorized user training and experience and preceptor attestation.

If there are any questions, please call our physics consultant Ray A. Carlson, M.S. at (734) 455-4730, or me at 248-945-0000.

Sincerely

&­Manager

RECEIVED DEC 212m

NRC FORM 313A (AVO) u.s. NUCLEAR REGULATORY COMMISSION (30-2009)

AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMS: NO. 3150-0120 AND PRECEPTOR A TIESTATION EXPIRES: 313112012

(for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.190. 35.290, and 35.590]

Name of Proposed Authorized User lState or Territory Where Ucensed 1

Justin Trivax. MD i L "

Requested Authorization(s) (check aI/ that apply)

:-i] 35.100 Uptake, dilution, and excretion studies

II! 35.200 Imaging"and localization studies

) 35.500 Sealed sources for diagnosis (specify device

PART I - TRAINING AND EXPERIENCE (Select one of the three methods be/ow)

.. 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.

I : 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 It Preceptor Attestation.

!. 1 j 2. Current 35.390 Authorized User Seeking Additional 35.290 Authorization

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 supervising individual is necessary to document supervised work experience, provide multiple copies of this section.)

r Clock Dates oflocation of Experience/license orDescription of Experience Experience"Permit Number of Facility HoursI

IEluting generator systems ,appropriate for the preparation ofIi radioactive drugs for imaging and ilocalization studies, measuring and !testing the eluate for radionuclidicIpurity, and processing the eluate iwith reagent kits to prepare labeled 1radioactive drugs f ~" . I

Total Hours of Experience:! I"iSupervising Individual !License/Permit Number listing supervising individual as an

iauthorized user 1

."" .. "".

rSupervisor meets the requirements below, or equivalent Agreement State requirements (check al/ that apply).

35.290 ! "j 35.390 + generator experience in 32.290(c)(1 )(jj)(G)

i

NRC FORM 313A (AU()) l$-2OO9) PRINTED ON RECYCLED PAPER PAGel

NRC FORM 3i3A (AU D) U.s. NUCLEAR REGULATORY COMMISSION

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

1-113. Training and Experience for Proposed Authorized User

a. Classroom and Laboratory Training.

Description of Training

1

IiRadiation physics and ! instrumentation

. IiRadiation protection

I

r !Mathematics pertaining to the use!and measurement of radioactivity

I. i I iChemistry of byproduct material ifor medical use (not required for 135.590)

I I

!Radiation biology !

Location of Training

Total Hours of Training:

Clock: Hours

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.)

iSupervised Work Experience

Description of Experience Must Include:

!Ordering. receiving, and unpacking!radioactive materials safely and 1performing the related radiation isurveys

il

Performing quality control tprocedures on instruments used to ; determine the activity of dosages : and performing checks for proper i?peration of survey meters

,. t .

!Total Hours of 16 !Experience:

Location of Experience/license or Permit Number of Facility

~t. John Hospital, 2201 Moross, Detroit. Mi USNRC ~l-0321~1 i

~ 1st. John Hospital, 2261 Morass, Detroit. Mi USNRC ~21-032JO-01

Confirm

[Ii Yes

i No

l/J Yes

Dates of Training*

Dates of Experience'"

Marcil 7-8, 2009 aud March 14-15, 2009

March 7-8,2009 IIJldMarcb 14-15,2009

PAGE 2

NRC fORM 313A (AUOI U.S. NUCLEAR REGUlATORY COMMISSION

(3-2iJ09) AUTHORJZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

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

b. Supervised Work Experience. (continued) , ..- --._.- , .. " ...

Description of Experience Location of Experience/License or II Must Inclucle: Penni! Number of Facility ~. . .~.

: Calculating. measuring. and safely j Sf. Joha Hospital, nOl Moross. Detroit, Mi :preparing patient or human research IUSNRC #21-4)3210-01 . Iisubject dosages I .' ' ..., .. --.--.-.... --.-- .. -- ..... ~"'. . .1 I iiUsing administrative controls to !St. John Hospital,nOI Moross, Detroit, Mi Iprevent a medical event involving the IUSNRC #21..03210-01Iuse of unsealed byproduct material j

Dates ofConfirm

Experience*t-. , .....

!ji Yes iMarcb 7-8, 2009 land March 14-15,

No IzOO9I

...J I

il'brch 7-8., 2009l71 Yes ~::'March 14-15, r !No

j~~jng procedures to contain spilled .. !~t John Hospital,2201 Moross, Detroit, Mi US~~J-Iyll Yes .. ~farch 7-8, 2009 Ibyproduct material safely and using 1#21-03210-01 I land March 14-15,Iproper decontamination procedures ! i No 12009

IAdministering dosages of radioactive -'Ii St. John Ifospitlll, 2201 Moross, Detroit, Mi .... It-'ll ~~~-'.iMa·-D·ad"rcMha~~ 21~15. ; drugs to patients or human research ! USNRC #21-63210-01 . n ....

1subjects i r· No 12009

IEi~ting"~~~~~ator sy~~~~ ap~;~ri~~~rs~ J~ba Hospital, nOI 'Mol"Oss, ~etroit, Mi rIll YesI~an:h 7-8, 200'),for the preparation of radioactive IUSNRC #21-63210-01 i land Mareh 14-15,

! ~ I ! r Iidrugs lor imaging and localization . . L. J No 12009 Istudies, measuring and testing the i i teluate for radionuclidic purity, and I !processing the eluate with reagent I

Ikits to prepare labeled radioactive !drugs i _________-1.1 ..L,..I____________. __._,~.____~!Supervising Individual iLicenselPermi! Number listing supervising individual as an

!authorized user

; ~.. __ L.--.........e_ ~ 121.oJ2I0-01

ru~~:~~~ ~e~premenlsv.;;. ~;~~;:";;t ~greem~~ ,;.~ ~qU~;"'~ r;;'.ck one}.

i l ~5.190 Iv(35.290 IX35.390 35.390 + generator experience in 35.290(c)(1)(ij)(G)

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

Location and DatesDevice Type of Training

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 3ilA (AUO) u.s. NUCLEAR REGULATORY COMMISSION

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

PART 11- 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

l . I attest that has satisfactorily completed the requirements in

Name of Proposed Au!horized User

10 CFR 35.190(13)(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.

OR

Training and Experience

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

Name of Proposed Authorized u-experience, including a minimum of B hours of classroom and laboratory training, required by 10 CFR 35.190(c)(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 has satisfactorily completed the requirements in ..."., ........ ..~., '""~

Name of Proposed Authorized U­

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.

OR Training and Experience

i ]1 attest that has satisfactorily completed the 700 hours of training

Name of Proposed Au!horized u-and experience, including a minimum of 80 hours of classroom and laboratory training, required by 10 CFR 35.290{c)(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.

~~~~~~.............-................--.-..-.....-----..--..--.-.-....---.._----_._--_._........-.... Complete the following for preceptor attestation and signature:

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

;35.190 135.290 35.390 , 35.390 + generator experience

Name of Preceptor

. - ­license/Permit Number/Facility Name

PAGE.

Medical Physics Training Certifies that

Justin Trivax, MD Has satisfactorily completed 80 hours of required training that meets the requirements of CBNC (Certification Board of Nuclear Cardiology including all topic areas required by the United States Nuclear Regulatory Commission. Training occurred March 2, 2009 thru June 13, 2009. This training includes the following subjects: PHYSICS AND INSTRUMENTATION: Basic physics (atomic structures), Basic physics as applied to clinical imaging (e.g., nuclides, isotopes and decay) Electromagnetic Properties of Radiation (Background Radiation, wavelength formulas), Basic physics as applied to clinical imaging (decay modes (Alpha, Beta, Gamma), high energy imaging). Gamma cameras, collimation, and equipment quality control procedures, Nuclear Generators, Interactions of radiation with matter, Radiation Units, Attenuation correction, including transmission and CT methods. RADIOPHARMACEUTICALS: Radiotracer kinetics and characteristics (e.g., thallium~201 and technetium-99m), PET agents, Red blood cell tagging. RADIATION SAFETY: Radiopharmaceutical receiving, handling. monitoring, and containment, Hazmat. Handling radiopharmaceutical spillS and waste, Storage and calibration of radiopharmaceuticals, Dosimetry and MIRD, Radiation Safety Concepts and Training. Radiation exposure and ALARA, Governmental regulations, Radiation Exposure monitors and limits. RADIATION BIOLOGY. MATHEMATICS. Wave Formula, Inverse Square Law, Radiation Decay, Shielding (Half-Value Layer). NUCLEAR CARDIOLOGY DIAGNOSTIC TESTS AND PROCEDURES/PROTOCOLS: Image acquisition, Image processing

/)

Cv (r?? f2Ci?1 7Cuu~ Date ature of Instructor- Laura T. Smith, MS, DABR

·.

5upport@MedicaIPhysicsTraining.com

Laura T. Smitb. M.8. Cheskriidd. MI (586) 215-5947 (3lJ) 609-2038 Ismitb@medic:alplrysicstraitliq.cum American Board ofRadiology Certified Nuclear Physicist (1'2390)

linda S. PoweU. M.S. Medical Physicist

Dear Justin E. Trivax, MD,

Congratulations on the completion of your 80 hours of Nuclear Medical Physics Training.

Medical Physics Training Certifies that Dr. Justin E. Trivax has satisfactorily completed 80 hours of required training that meets the requirements of CBNC (Certification Board of Nuclear Cardiology) as outlined in the ACCF/ASNC COCATS guideline for training in Nuclear Cardiology, including all topic areas required by the United States Nuclear Regulatory Commission. This training was presented from March 2, 2009 through June 13, 2009. This training includes the following subjects: PHYSICS AND INSTRUMENTATION: Basic physics (atomic structures), Basic physics as applied to clinical imaging (e.g., nuclides, isotopes and decay) Electromagnetic Properties of Radiation (Background Radiation, wavelength formulas), Basic physics as applied to clinical imaging (decay modes (Alpha, Beta, Gamma), high energy imaging), Gamma cameras, collimation, and equipment quality control procedures, Nuclear Generators, Interactions of radiation with matter, Radiation Units, Attenuation correction, including transmission and CT methods. RADIOPHARMACEUTICALS: Radiotracer kinetics and characteristics (e.g., thallium-201 and technetium-99m), PET agents, Red blood cell tagging. RADIATION SAFETY: Radiopharmaceutical receiving, handling, monitoring, and containment, Hazmat, Handling radiopharmaceutical spills and waste, Storage and calibration of radiopharmaceuticals, Dosimetry and MIRD, Radiation Safety Concepts and Training, Radiation exposure and ALARA, Governmental regulations, Radiation Exposure monitors and limits. RADIATION BIOLOGY. MATHEMATICS. Wave Formula, Inverse Square Law, Radiation Decay, Shielding (Half-Value Layer). NUCLEAR CARDIOLOGY DIAGNOSTIC TESTS AND PROCEDURES/PROTOCOLS: Image acquiSition, Image processing.

ore Iy, 7~ ura T. Smith, MS, DABR

Certified Medical Physicist

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