N 0 R THSTAR~ health system

May 20,2013

United States Nuclear Regulatory Commission Region III Materials Licensing Section 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352

RE: NRC License #21-18586-01

Subject: Authorized User

Dear Sir or Madame:

This is to notify you that on April30, 2013 our Radiation Safety Committee granted the following doctor authorized user status on our NRC license #21-1856-0 1 for the materials and uses indicated.

John F. Maesaka, M.D.: 10 CFR 35.100 and 10 CFR 35.200

Since that meeting I had the opportunity to speak with Toye Simmons of your Materials Licensing Branch regarding Dr. Maesaka's recentness of training. She noted that the prior NRC license he was named as an authorized user was not within 7 years. Please find enclosed his board certification, the prior NRC license where he was named an authorized user, and the Preceptor Attestations for three of the facilities he has worked at consistently for the past 7 years as a locum radiologist.

Contact me with any questions. Thank you.

Sincerely,

/!1;'---tVzALcfL.-.U, IJS,~/lJmT; 12-f)fYl s (rt~ o

Sharon Dedo, BS, CNMT, RDMS Radiation Safety Officer 906-265-0429 Sharon.dedo@northstarhs.org

. -. RECElVEO MAY 3 0 2013

Hospital 1 1400 West Ice Lake Road 1 Iron River; Ml 49935 I P. 906.265.6121 F. 906.265.6372 I www.northstarhs.org

NRC FORM 313A (AUD) (05-2012)

U.S. NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

APPROVED BYOMB: NO. 3150-0120 EXPIRES: (05/31/2015)

(for uses defined under 35.1 00, 35.200, and 35.500) [10 CFR 35.190, 35.290, and 35.590]

Name of Proposed Authorized User

Jt)i\.,J ~- M AE:SA!::A-Requested Authorization(s) (check all that apply)

[Yf35.1 00 Uptake, dilution, and excretion studies

~5.200 Imaging and localization studies

D 35.500 Sealed sources for diagnosis (specify device)

State or Territory Where Licensed

--------------------------

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.

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.

D 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.)

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

Supervising Individual

f-

Location of Experience/License or Permit Number of Facility

Total Hours of Experience:

Clock Hours

Dates of Experience*

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

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

D 35.29o D 35.390 +generator experience in 32.290(c)(1)(ii)(G)

NRC FORM 313A (AUD) (05-2012) PAGE1

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

(os.-2012

l AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

0 3. Training and Experience for Proposed Authorized User

a. Classroom and Laboratory Training.

Description of Training

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:

b. Supervised Work Experience (completion of this table is not required for 35.590).

Clock Hours

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

Supervised Work Experience

Description of Experience Must Include:

Total Hours of Experience:

Location of Experience/License or Permit Number of Facility Confirm

Dates of Training*

Dates of Experience*

"'''''''''

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

NRC FORM 313A (AUD) (05-2012)

DYes

DNo

DYes

D No

PAGE2

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

(o5-2012

l AUTHORIZED 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 Must Include:

Location of Experience/License or Permit Number of Facility

Confirm Dates of

Experience*

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

Supervising Individual

DYes

DNo

DYes

DNo

DYes

ONo

DYes

DNo

DYes

ONo

!License/Permit Number listing supervising individual as an ;authorized user

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

D 35.19o D 35.29o D 35.39o D 35.390 +generator experience in 35.290(c)(1 )(ii)(G)

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

Device Type of Training Location and Dates

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

NRC FORM 313A (AUD) (05-2012) PAGE3

05/15/2013 WED 16:30 FAX 906 265 3593 ICGH RADIOLOGY ~002/002

NRC FORM 313A (AUO) U.S. NUCLEAR REGULATORY COMLWSSION

(05o20l2l AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

PART II- 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:

For35.190

Board Certification

~ I attest that .:bhn ( l{,q (!.Ct;jl? ... has satisfactorily completed the requirements in Name Of PtopOScd AUinOtlzecl User

10 CFR 35.190(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.

Training and Experience

O I attest that Name of P~ AuUlcliWid User

OR

has satisfactorily completed the 60 hours of training and

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

For35.290

Board Certification

9(11 attest that ;J;/,11 t &?ofs.a. has satisfactorily completed the requirements in Name or PIOpOSed Authorized User

10 CFR 35.290(a)(1) and has achieved a leyel of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100 and 35.200.

Training and Experience

0 I attest that Name ot PropoSed Aulllorlzed User

OR

has satisfactorily completed the 700 hours of training

and experience, including a minimum of 80 hours of cl.assroom 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.

~~··············~·~····--·····R·-~~----~--~----••••••••••••••••••••••••••••••·----····----······M•--•--•--•••-Second Section Complete the following for preceptor attestation and signature:

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

~ 35.190 [&135.290 0 35.390 0 35.390 + generator experience

Name of Preceptor Sig~ture 1(\ _ 0 fielephone Number Date

fVYJ"YYc.. b1Pov11o Jvt~ ~ ~~ (qa)lff2-~5oo 5~15-13 1---------!....------L---=--~:........L..--=:...;::::ill-____ .l.....-.• ----····-·---·- ·····-·

License/Permit Number/Facility NarJ:Je

NRC.. -IJ;'ll- I fS" fG, ... D I NRC FORM 313A (1\UD) (05o2012) PAGE'!

May 15 2013 12:43PM SMH 9063413214 page 2

05/15/2013 WED 12:35 FAX 906 265 3593 ICGH RADIOLOGY ~ 002/002

NRC FOR;M 313A. (AUD) ·U.S. NUCLEAR REGULATORY COMMISSION

(os-20121 AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATICSTATtON (contlnuedt

PART II- PRECEPTOR ATTeSTATION

Note: This part must be completed by the individuars preceptor. The preceptor do~s not haV(! to be the supeNising 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 meeUraining 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 ind.iViduars •general Clinical competency."

First Section Check one of the following for ea~h use requested:

For35.190

Board Certlftcatlon

~ I attest that J)6" . [ k(11...e,~r< ~~ •. has satisfactorily completed the requlraments in · NBme ot PropoHd Authorii:ed ~'"'- -

10 CFR 35.190(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.

OR

Training and Experience

0 J attest tha1 has satisfactorily completed the 60 hO\n of training and

experience, including a minimum of a hours of classroom and laboratoty 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 1 o CFR 35.100.

For 35.290

Boarct Cea!ncatlon

~ l attest that :};4!1 F)dq~.f.t;i<..~~- has satisfactorily completed the requirements in Name of PfOPOsed Authorized u.er

10 CFR 35.29_0(a)(1) and has achieved a level of competency sufficient to function independently as an a~.tthoriZed userfor.the medical uses authorized under 10 CFR 35.100 and 35.20.0.

OR Training and Experience

D I attest that has satisfactorily completed the 700 hours of training _.:....;.N.meotPniPosed~ed uw--

ar.d experience, including a mlnimu~ of 80 hours of cl_assroom and laboratory training, required by 1 0 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 1 o CFR 35.100 and 35.200.

~--·----·-.·----·----.... ·--··----····----·--··-·············-···-~·····-~--·-----------------···· ..... Second Section · Complete the following for preceptor attestation and signature:

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

[E 35.190 _l}g 35.:290 D 3s.ago D 35.390 + generator experience ........,. _______ - "• '----------r::-:-------:----------r.::-:----:---:-:----:---~=-------1 Name of Preceptor Signatu-:.:..re::-----.~ 7 elephone Numb,er Date

r-:-:-~-~_tO_m-=--R-~ _.m_I_L_~..,....s~_1J_._CJ_. --...J~ .. --~ ~-~---..;-~ __ -=> ___ ___..~_9._~_-_~_li'_'_R_'2_~_!>....~...-~...:..-~-z_lf/4-./_~_~_-----1

License/Permit NumberJFadlity Name ~ \ _ J6 54~ - o 3

05/15/2013 14:12 8128853662 NUCLEAR MEDICINE

05/14/2013 TL~ 13:53 FAX 906 265 3593 ICGH RADIOLOGY PAGE 02/03

~002/002

NRC FORM 313A (AUO) U.S. NUCLEAR R!iiGUJ..ATORY COMMISSION

(IJ$o~~ AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

PART II ...... PRECEPTOR ATTt:;STATION

Note: This: part rn1.1st be completed by the indiVidUtil'~ preceptor, Th@ preceptor does not have to be the supervising Individual as long as thE!! prec:E!ptor provides, directs, or verifies training and experience required. Jf more than one preceptor Is necessary to doCument experience, obtain a separate preceptor statement from eac:h. (Not required to rneet training requirements In 35.590)

By checking the boxes below, tht:~ p~eceptor is attesting that the individual has knowledge to fulfill the duties of the position sought and not attesting to the individuars "general clinical competency," ·

Flr$t Section Check one of the following for each use requested;

For36.190

Board Certification .

~ 1 attest that ~£. fk.~>..l;, L,.,~ has &l!iltisfactorlly completed the requirements In Name of Propoiled Authcriud \e.;

1 a CFR 35.190(a)(1) and has achieved a level of competency sufficient to function independently aa an authori2ed user for the medical uses authorized une1er 10 CFR 35.100.

OR

Training and Experience

Jil.l atteSt that _ .. _...... has satisfactorily completed tn~ 60 hours of training a.nd NIH'I'IO Of P~ Aulhorlzed User '

experience, ihcluding a minimum of 8 hours of classroom and laboratory training, raqulred by 10 CFR 35.190(c){1), and has achieved a .lever of ccmpetency suf(icient to function Independently as an authorized user for the medical uses authorized under 10 CFR 35.100.

For35.290

Board Certification

!Xl I attest that ~ [" ~~~ has satisfactorily completed the requirements in ~'!arne ot PropOQCd AU~ User

10 CFR :36.290(aX 1} and has achieved a level of competency sllffieient to function independently as an authorized UGer for the medical uaes authorized under 10 CFR 35.100 and 35.200.

OR Trainjog apd.Ex~ru~nce

~ I attest that . has satisfactorily completed the 700 hours of training --~--~--~~~~---Name tJf Proposed AulholllOd U~l!t

a11d ~perlence, including a minimum of SO hours of classroom and laboratory training, required by 10 CFR 35.290(c)(1), and r.as ac:hleved a Tellel ofcompet&nc:y sl.lffJCient to ft.lnction independently as an authorized user for the medical uses authorized under 10 CFR 35,100 and 35.200.

••-•••--IIIHIIIIIIIIIII • ....,_~Illlltll!lill"'----•~~------lllllll.-.,,....,.,......., ............. _ ........ _ ..... ___ ....._111 .. _•......_~ Second SQcti<)n Complete the following fot preceptor attlistation and signature:

~ I meet the requirements below, or equivalent Agreement State requirements, as an authoriZed user for.

~ 35.190 ~ 35.290 0 35.390 0 35.390 + generator experience

NRC I'ORI.! 313A !AUD) (O!«P1:!)

'2-oo1 -Htru... 2-0t 3

04/11/2013 THU 12:58 FAX 574 535 2843 ~003/004

NRC FOAM 374 U-S. NUCLEAR REGULATORY COMMISSION

PAGE 1 OF _2_ PAGES Amendment No. 17

) MATERIALS LICENSE

Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and lltle 10, Code of 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) designated below; to deliver or transfer such material to persons authorized to receive it In accordance with the regulations of the applicable Pan(s). This license shall be deemed to contain the conditions specified in Section 183 of tl'le 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 below.

Licensee

1. Goshen General Hospital

2. 200 High Park Avenue

Goshen, IN 46526 R

~ ......,

In accordance with letter dated

February 8, 2002,

3. License number 13-18845-01 is amended

in its entirety to read as follows:

4. Expiration date February 28, 2011

-5. 50cer ~o- 030-14254 Referen6e No.

-" " ;-6. Byproduct, source, and/or special

nuclear material ...) 7. Chemical and/or physical form ., SC-Maximum amount that licensee may

p.e,ssess at any one time under this license """

A. Any byproduct material: identified in 1 0 CFA 35~ 1 00 ,--....,.

8. Any byproduct material identified in 1 0 CFA 35.200 ....

C. Any byproduct materfai identified in 1 0 CFR 35:~00

9. Authorized Use:

A. Medical use described in 1 0 CFR_ 35.1 00 . .. ,· .. -

B. Medical use described in 10 CFR 35.2oo:· --··.

C. Medical use described in 1 0 CFR 35.300.

CONDITIONS

. ·-

A. . -As needed

B. -~~needed

s; C. --As needed (not to exceed 1

~-',curie of 1-131) ... ~·'

Licensed material shall be used only at the licensee's facilities located at 200 High Park Avenue, Goshen, Indiana.

11. The Radiation Safety Officer for this license is, Jaime M. Sheperd, M.D.

04/11/2013 THU 12!58 FAX 574 535 2843

. '

NRC FORM 374A

·)

U.S. NUCLEAR REGULATOFIY COMMISSION

MATERIALS LICENSE SUPPLEMENTARY SHEET

~004/004

PAGE 2 of 2 PAGES

Ucense Number

13-18845-01 Docket or Reference Number

030-14254

Amendment No. 17

12. Licensed material listed in Item 6 above is only authorized for use by, or under the supeJVision of, the following individuals for the materials and uses indicated:

Authorized Users

A. John F. Maesaka, M.D.

B. Jaime M. Sheperd, M.D.

13.

14 .

. )

A. Applications datect_Septe

APR 16 2002 .Jate _______ _

Material and Uses

10 CFR 35.100, 35.200, and 35.300

10 CFR 35.100, 35.200 and 35.300.

.... ... ,.,

-~.

FOR THE U.S. NUCLEAR REGULATORY COMMISSION

ayZ,~?_~~ William P. Reichhold Materials Licensing Branch Region Ill

-:----------------~-------~-----------------------------------~~---~

4-~F'Os]-~ ~.l~~ ~ (t.( ~-, .

~ ~ ,.._.... pnN£Y aow~s

2 1P $ 004.82° 004484161 MAY 21 2013

-lr.AILED FROM ZIPCODE49935