received averai jan 3 0 2013 mckennanaverai mckennan january 21, 2013 u.s. nuclear regulatory...

Averai McKennan

January 21, 2013

U.S. Nuclear Regulatory Commission, Region IV Nuclear Material Safety Branch 1600 E. Lamar Blvd. Arlington, TX 76011 ·4511

DcaI' Sir or Madam:

RECEIVED

JAN 3 0 2013

DNMS

We would like to amend our NRC License #40-16571-01 (Docket Number 030-11252) to add James H. Simon, M.D., as an Author~zcd User for IOCFR35.400 and J OCFR35.600 Iridium- 192 for uses in High Dose Rate Remote Afterloading unit.

James H. Simon, M.D., is certified by the American Board of Radiology (ARR) and is licensed to practice medicine in the Slate of South Dakota; a copy oflhe ABR certification and South Dakota license is attached .

.. _- Jamcs-H. -Simon, M.D. is currently -listed <1:, un Authorized USCI' for I OCFR35.400 use on Iowa Department of Public Health license number 0073-1-17-Ml. There is a mi::;::;pt:lling of Dr. Simon's middle initial. The license lists the initial as a "K" when it should he listed as an "H" . A copy of this license is attached.

NRC Form 313A (AUD) fol' James H. S imon, M.D., signed by preceptors Kathleen Schneckloth, M.D., Barbara Schlager, M.D, and Jamic Harris, M$. are also attached.

Thank you for your attention to this malter. If you have questions or need additional information please contact Traci Hollingshead, Radiation Safety Officer at (605) 310-0916 or by email at [email protected].

Sincerely,

D£c:!~(J President/CEO Avera McKennan

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Iowa Departm!!nt of Public Health PromolhlLt I;lnd Protecllng the Ueallh of Iowans

Mariannette MlIre(-Moeks, a.S.N., M.Ed., M.D. DIrector

January 13, 2012

Terry E. 8ranstad Govefllor

, '.

JAr.t "9 KIm Revnolds 1I. Governor

James Finpabick, President and CEO Mcroy Medical Center-North Iowa 1000 4th Street Southwest

License No.: 0073-1-17~Ml

Mason Cit)', Iowa 50401

Dear Mr. Fitzpatrick:

Enclosed is your renewed Iowa Rudioactive MalMols Licenso No. 0073-1-l7-MI.

Pleaso review the enclosed document carefully to be sure that YOlI understand all conditions. You must conduct your program involving radiouctivo materi~ls in accord8nc~ wj.th the conditions of your Iowa Jicenso, representations made in your licenso application, and Iowa's RAdiation Machines nnd Radioactive Materials Rulc:"!. [nparticular, note that you must:

1. Operate in accordance with Chapter 40 Rltd othcr applicable niles of Iho Iowa Administrative Code.

2. Possess radioactive material only in tbe quanlily aDd fOfID indicated in your IIcense~

3. Use Il!dioilCliv6 materitll only for the pUlpOSe{S) indicated in your license.

4. Notity Ule Iowa Department of Public Health (IDPH) in writing of any chnnge in mailing addrcss.

5. Request aud obtain appropriate amendment if you plan to change Qwncrship of your organization, chango locations of radioactive material, or make any other cI\auges in your facility or p1'Ogram which are contrary to your license conditiong 01' representations J",ade in your license application find any suppiemoolni cOlTcspondence with IDPH. Any amendment request should be accompanied by the appropriate fee speeHicd ill 641-38.8(2).

6, Submit a complete renewal application or termination request at lenst 30 days bofore the expiration date on your licOllse. You will recoivo a reminder notice approximately 90 days bcfol"c the expiration dale. Possession ofradioaciive material nOel' your license expires is n violation of state law.

7. Request tenninatiol1 of your licen:", if you plrut to Jlenna.nently discontinue activities involving mdioaclivo matcliAI prior to your expil'llliOi\ dalo.

lucas 81ale Office Buldlng, 321 E. 12fh Sireet, Des MoInes, IA 50319-0075.515-281-7689. www.klph.slale.la.u8 DEAF RELAY (Hearing or Speech Impaired) 711 oc 1-800-735-2942

Pogo 2 Mr. James Fitz.patrick Mercy Medical Center~North Towa Jatluary 13, 2012

You will be periodically inspected hy the IDPH. Failure to conduct YOllr program in accordance wilh IDPH rules, licenso conditions, and representations in YOllr licellso applicatioll will result in enforcement notion against you in accordanco wilh 136C.s of Chapter 136C. the Iowa Code.

If you have any queslions or require clarification of any of lhe above stated infomlatioll, pleaso conlact me.

Sincerely,

Randal S. Dahlin Bureau ofRndioiogicol HeaLih (515) 281-0419 taluJal,[email protected],gov

MD/tio

cc: Jwnes 1(. Simon, MD, RSO

Enclosure

Official Use Only-Seclll'ity Reh,ted Infol'mution

IOWA DEPARTMENT OF PUBLIC HEALTH

MATERIALS LICENSE

Paga 1 of 3 Pages

P~fSUilnt 10 Chapler 1JOC of \he Iowa Code and 841-38 Ihrough 42 (f38C) 01 rho Iowa J\dmlnlslfa~yo Code and HI rl!lillroc'.II on slillemeAle and represeolallOl'l9 hmelolote made by U.e lloensoo. a Nconsa Is heleby luuod ;JulhorizillO Iha 1100(1$(18 Co receive. acquire. ~ess. and IrilMlcr IWloacUve JOilh"lills doslgn!lted below; 10 USB RUch material lot the ptH'pose(s) and al Iho plooo(s) dosl(lootetJ bfJIow; to defiwr 01 Ir.msfer sud. ma1el1al InpPflIQnS aull'lori'!ed 10 reu/Ye Uln IfCC;Ojd.moo wlth Uu:! wku; oIlhu 3pplicabJI:I ooilp(er(s). 1h1s 110005918 slIbfed 10 all applicable n~8$ a.ld OMMII of the Iowa Departmenl of public Hoarl" Including Ih& Iowa Rules fOl RadIslllon Machlnos aiM! RaoJloar.INe Ma1erials (64I-38I11(ooOh 421 nlNt ornell~lIll~rlo effecl. aoo to any condillons spe<:mod below.

1. Merey Medicol Conter - North lown

2. 1000 4th Sirecl, Soulhwest Mason City, Iowa 50401

December 30, 2011, License No.: 0073 -1-17-MI is renewed to read as follows:

3. License Number: 0073-1-17-MI

4. E.xpiration Dnte: Feblllruy 1,2011

5. Byproduct. Source, Special 6. __ Chem~cal . al).#oT Phxsical 7. Mtudmum Amount that Nuclear andlor'Nahu'af . J/0rm Licensee May Possess At Occurring or Aecelerutor Any One Time Under This Produced Radioaclive License Material

A,. Any I"udionclive lllaterial A. Ally fOim authorized by A. As needed authOl;zed by 64l~ 641 -41.2(31) 41.2(31)

B. Any radioactive mHtcrial B. Any [onn authorized by B. As needed authorized by 641- 641~41.2(33), including 41.2(33) including DPTA Tc99m/Mo99 generators aerosol <lnd Xenon-133

C. Any radioactiv~ malerial C. Any f01m authorized by C. As needed authollzed by 641- 641-41.2(37) 41.2(37)

D. Any radioactive mutoriul D. Any se:tled source D. 1 curie total for 1111 nuthodzed by 641- authorized by 641- sources 41.2(43) 41.2(43)

E. Any radioactive malerilll E. Prepllckaged kils. E. As needed authorized by 641-3I)A(2~) coi"

Offi<:faJ' l1se Only-Sccurity Related InfOl'mlllioll

/ Official Use ODly~Secur!ty Related Information

Iowa Department of Public Health

MATERIALS LICENSE

Supplementary Sheet

8. AUTHORIZED USE

A. Medical use described in 641·4t.2(31).

B. Medical use de.';crihed in 641·41.2(33).

C. Medical use described in 641·41.2(37).

D. Medical use dc.'\cribed in 641-41.2(43).

n. In vitro studies.

CONDITIONS

Page 2 of 3 Pages

License No.: 0073-1-17-M1

9. Licensed material ShAll be used at the licensee's facilities located at 1000 4th Street Suuthwest, Milson Cily, Iowa; Mason City Clinic facHities locnted at 250 Soulh Crescent Drive, Mason City. Iowa; Mason City Surgery Center, 990 41h Street Southwest. Mason City, Iowa; Mitchell COlmty HospitaJ facilities located at 616 N. glh Street, 080g0, Iowa; Kossuth Regional Health Cep.ler facilities Jocnted at 1515 South Ilhillips, Algona, IowA; Palo Alto Conummity H;C3lth Center fllcilJlies locllted at 3201 First SltCtlt, Emmetsburg, Iowa; Mercy Medical Center facilities Jocuted at 308 Maple Avenue, New Hampton, Iowa; Wright Medical Center [acilities locatcd lit 1316 Sonth Mllin Street, Clarion, Iowa, and BJlSWOl1h Mnnicipul Hospital, J 10 Rocksylvania Avenue, Iowa Falls, Iowa.

10. Licensed material shaH only bc m;ed by or under tho supervision of:

Robelt E, RCI'!h MD, fOl' material~ described in 641-.41.2(31); (33). (37) rodine-131 only; lind (41).

Ryan M. Hollhaus, MD, for materillls described in 641·41.2(31). (33); (37) lodine-131 only; and (41).

Brad Janson, MD, [01' malcrials described in 641-41.2(31); (33); (37) Jodine·131 only; and (41).

Timothy 10hn LucRs, MD, for materials described in 641-41.2(31); (33); (37) Iodine-13I only; and (41).

William D. MnUhews, MD, for materials described in 641-41.2(31); (33); (37) Iodine-i31 only; lind (41).

Joseph J. Ocel, MD, for materials described ill 641 -41.2(31); (33); and (31) Iodine-131 only.

Jeana L. Pelree, MD, fol' materia's described irt 641-41.2(31); (33); (37) Iodine-131 only; tmd (41).

Travis J. Petree, MD, for materiAls described in 641-41.2(31); (33); (31) Iodine-131 only; und (41).

JRmes K. Simoll, MD, for materinls described in 641-41.2(31) Rnd (43).

Officii. 1 Use Only-Security Relaled JufOJ'lIllttion

Official Use Only-SecurUy Related Infornm tloll

Iowa Department of Public Health

MATERIALS LICENSE

Page 3 of 3 Pages

Supplementary Sheet License No.: 0073-1 -17-M1 8lATE CAI'frol..OI"IOWA 01:8 MOINES. IOWA

Ryan L. Smilh, MD, fol'malerials dcscribcd in 64 1-41.2(31); (33); UlIO (37) lodint}-131 only.

Gary W. Swenson, MD, fo r materials described in 641-41.2(Jl); (33); (37) Iodine-131 for thyroid carcinoma only; and (41).

James B. Talkon-Coker, MD, for materials described in 641 -41.2(33) for cardiov8scillar studies only.

Kristin C. White, MD, for materials descl'ibed in 641-41.2 (31); (33); (37) Iodine-I31 only; and (41).

Gholam Zadeii, MD, for materials described in 641-41.2(33) far cardiavtlscular studies only.

11. The Radiation Safety Officer for licensed activities is James K. Simon, MD.

12. The Authorized Medical Physic;:ist for this license is aUlhorized for the following activities:

Frank P. Bolin, MS, brachytherapy.

·Shawn D. Moorehead, MS, braehylherapy

13. In addition to the possession limits in Hem 7, the licenscc shall furlher restrict the possession of licensed malerial to quantili~ below the minimum limit spccified in 641-39.4(26)"d" for establishing decommissioning fi nancifll assul"fI.nce.

14, Except as specifically provided otherwise in this liccnse, the liccnsee shall conduct its program in accordance with the slatcmcnls, representations, and procedures contained ill the documents, including any enclosures, listed bcIqw. The Dcpurlmellt of Public Health's rules silRn govern unless Ihe statements, representations, and procedures in Ihe licensee's application and cOlTespondeuce fire more restrictive than the mles,

A. Application received DecembeL' 30, 201 1 (with atlaehmcJlts);

B, Lctlel' dated January 12, 2012,

Dato \- 1:\-;)" ,:>.

VOl" the Iowa Department of Pub lie Hcallh

B \2. ~i fI. -S, D ..... '----' y--=-~~~~--------~

Randal S. Dahlin Radioactive Materials Program

Official Use Ollly-Secl1l"ity Related ]nfol'matJon

NRC fORM l13A (AUS} U.S. NUCLEAR REGULATORY COMMtSSION !O$-lOI!)

AUTHORIZED USER TRAINING AND EXPERIENCE APPROVEO BYOMB: NO. 3150.0120

AND PRECEPTOR ATTESTATION EXPIRES; (O6l3112016)

(for uses defined under 35.400 and 35.600) [10 CFR 35.490, 35.491, and 35.690)

Name of Proposed Aulhorized User State or Territory Vv11ere l icensed

James H. Simon, M.D. South Dakota

Requested o 35.400 Manual brachylherapy sources 035.600 Telelherapy unit(s)

Authorlzatlon{s) o 35.400 Ophthalmic use of strontium-90 035.600 Gamma stereotactic radiosurgery unit(s) (check all 'tla! apply) o 35.600 Remole afterloader lHlil(s)

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 Ihe date of applicali.on or the Individual must have oblained related conllnulng education and experience since the required training and experience was completed. Provide dates, duraUon, and description of conlinuing education and experience related to the uses checked above.

0 1. Board Certlf[S:l!tI20

a. PrOlllde a copy of the board certification.

b. For 35.600, go to the table in 3.e. and describe training provider and dates of training for each type of use for which authorization is sought.

c. Skip to and complete Part n Preceptor Attestation.

o 2. Current ~~,§QQ 6uthorlzed User Reguestlng Additional Authorlzatron for 35.600 Use'sl Checked Above

a. Go 10 the table in section 3.e. to documentlraining for new device.

b. Skip to and complete Part II Preceptor Atteslation .

0 3. I[lloln9 !nd EXl!:erle[]c~ for Pro(!:osed Authorl"!i!:d !Jur

a. Classroom and Laboratory Training 035.490 0 35.491 0 35.690 -- Dates of- -

Description of Training Location of Training Clock Hours Training·

- -

Radiation physics and instrumentation

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

Radiation protection

.. .. _-

Mathematics pertaining to the use and measurement of radioaclillity

-- .

Radiation biology I - - --.. - ... I _ .. - ..... .. -. . _- - -_ .. . . _ .

Total Hours ofTralntng! D NR(;fORM 313A.(AUS) (~ZG I2) .'" ,

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

AUTHORIZED USER TRAINING AN D EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3. Training and Exeerlence for Proeosed Authorized User ,contlnu~dl

b. Supervised Work and Clinical Experience for 10 CFR 35.490 (ff more thall one suporvising indivIDual is necessary to documellt sup8rvised work 8xperience, provide multiple copies of this page.)

--_. _--Supervised Work Experience

Total Hours of Experience!

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

Description of Experience location of Experience/License or Confirm

Dates of Must Inctude: Permit Number of Facili ty Experience· --_._.

Ordering, receiving, and D Yes unpacking radioactive malerials

safely and performing the retaled ONo radiation surveys

- --

Checking survey meters for DYes

proper operation ONo . _. . -

Preparing, implanting, and safely DYes

removing brachytherapy sources O No _ .. _._ .... _----._--_._- --- - -.~ - _.- -

Mainlaining running inventories DYes

of male rial on hand ONo --- - .--. _ - - -

Using administrative controls to DYes prevent a medical event involving the use of byproduct ONo material - - --_. -- . ..

Using emergency procedures to D Yes

control byproduct material ONo

-

f linlcal experience In radlal ion

.. ...

location of ExperlencefUcense or Dates of loncology as part of an approved Permit Number of Facility Experience· formal training program

-_ ... . _- --- - --[Approved by:

o Residency Review Committee for Radiation Oncology of the ACGME o Royal College of PhysIcians and Surgeons of Canada

o Committee on Postdoctoral Training or tile American Osteopathic Association

1~lcense/Penllll Number Ilsllng supervising indIVidual as an - - --~-- .

Supervising Individual r UlhOfized User

-,~ ,

NRC FORM 313A{AUS) U.S. NUCLEAR REGULATORY COMMISSION ~\l'

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3. Training and E)(~arlance for Pro~osed Authorized User 'continued}

c. Supervised Clinical ElCperience for 10 CFR 35.491

Descriplion of ElCperlence location of ElCperience/Ucense or Clock Dales of

Permi! Number of Facility Hours Experience*

Use of stronlium-gO for ophthalmic trealment, Including: examinalion of each individual to be treated; calculation of the dose to be administered; admlnlstratton of the dose; and follow up and review of each Individual's case history

". - -----Supervising Individual license/Permil Number lisling supervising individual as an

Authorized User

- ---- --- -d_ Supervised Work and Clinical Experience fOl10 CFR 35.690

[ZJ Remote afterloader unit(s) o Teletherapy unit(s) o Gamma stereotactic radiosurgery unit(s)

Supervised Work EICperlence . _ __ _ , __ _ . _ __ =:J_~otal Hours of Expurlunce:

Oescriplion of EICperience localion of Experience/license or Confirm

Dates of Musllnclude: Permit Number of Facilily Experience·

-----Reviewing fuU calibration DYes measurements and periodic

ONo spol-checks

._ - ~

Preparing treatment plans and DYes calculating treatment doses and limes ONo

. - - ~ - ,,-- ---Using administrative controls 10 Avera McKclllHUl [Z] Yes 12110112 prevent a medical event Sioux Falls, SO involving the use of byprodll{;t RML# 40-16571-01 ONo malerial

-.---- _. Implementing emergency Avem McKennAn IZ] Ye, 1211 1112 procedures 10 be followed in the Sioux Falls, SO event of the abnormal operation of the medical unit or console

RML# 40-16511 -01 O No

_._. -

Checking and using survey Avera McKennan [ZJVes 12111 / 12

meters Sioux Falls, SO U No RMLII40- IM71-01

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

Selecting the proper dose and DYe, how it is to be administered ONo

...

,~,

NRC FORM 313A IAUS) U.S. NUCLEAR REGULATORY COMMISSION (OS.20I2)


3. Training and EX~Qrlence for Pro~osed Authorized User (continued)

d. Supervised Work and Clinical Experience for 10 CFR 35.690 (continued) -

Clinical experience in radiation Location of Experience/License or Dales of

oncology as part of an approved Permit Number of Facilily Experience" rOl'ffial training program - '-" -'-_ .--- -- -- -- - -+- - - _. - -- - - - --._--_.-Approved by:

o Residency Review Committee for Radiation Oncology of the ACGME

o Royal College of Physicians and Surgeons of Canada

o Committee on Postdoctoral Training of the American Osteopalhic Association

--- - ----- - .. _--_ . .. _._-Supervising Individual license/Permil Numb.er listing ~pervising individual as an

Authorized User

-- --_ .. . _-. - ._ ..... --_ . -- ,--- -- - .. - ----- --- -

•• For 35.600, describe training provider and dates of Iraining for each type of use for which authorizallon is sought.

- - - - -- - -- - _._-- ---- -, -- - - .. - -.. . _ .. - --_.-- ---. --- - _ .. _-Description

Training Provider and Dates of Training

Remote Afterloader Te;etherapy Gamma Stereotaclic Radiosurgery

12/111t2

DevIce opera lion 12/ 10/ 12

--

12111112 Safety procedures 12/10/12 for Ihe device use

Clinical use of the device

Supervising Individual. ("'milling provided by Supervis;ng LicensefPermit Number listing supervising Individual as an iIIdMdl/8J ("mont/hall 0fI8 6upetvlsing ifldfvldua/ is necessary Authorized User

/0 doctJrrum/ supervised WO/I{ 6/CperifJrrc8. provide mulriple oopias of Ihls page.)

Jamie Harris, MS Medical Physicist Avem McKennlln Sioux Flllls, SO RMU 40-16571--01 ._-- -_. -_. ------- ---- --- -- --- ---- --- ----- - -- ---- ---- -- --------- ----------- --- ----- --- --- --- -- -- - ---

Authorized for the following types of use:

[(] Remote afterloader unil(s) o Teletherapy unites) o Gamma slcrcotacllc radiosurgel)' unites)

-----f. Provide completed Part It Preceptor Attestation.

NRC FCR\I31V1 tAUS) (05-2012) PAGE~

NRC FORM 313A (AUSI (0).:1012]

U.S. NUCLEAR REGULATORY COMMISSION


PART 11- PRECEPTOR ATTESTATION

Note: This part must be completed by the individual's preceplor. 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, oblain a separate preceptor statement from each.

By checking the boxes below, Ihe preceptor is altestlng lhatthe individual has knowledge to fullill the duties of the position sought and not attesting to the Individual's "general clinical compettmcy .~

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

For 35.490:

Board Certification

o I attest Ihal has satisfactorily completed the requirements in

--·N~_='~';;;"'="'=A~"""""=="u..=, --35.490(a)(1) and has achieved a level of competency sufficient to flJllct/on Independenlly as an authorized user of manual brachytherapy sources for the medical uses authorized under 10 CFR 35.400.

OR Training and EXperience

o I aUest that has satisfactorily completed the 200 hours of

--'N~_= 'CiPrOpo$=""A"""""=~"="'~'~'--

classroom and laboratory training, 500 hours of supervised work experience, and 3 years of supervised clinical experience In radiation oncology, as requIred by 10 CFR 35.4QO(b)(1) and (b)(2), and has achieved a level of competency sulflCi~nl lo function Independently as an authorized user of manual brachytherapy sources for the medical uses authorized under 10 CFR 35.400.

For 35.491:

o I allest thai has satisfactorily completed the 24 hours of

--·N~_;;;:.~';;;"=""''''''''A;:_;;;;:~·'''=u...~--classroom and laboratory training applicable 10 the medical use of strontium-90 for ophthalmiC radiotherapy, has used strontlum-90 for ophthalmic treatment of 5 individuals, as required by 10 CFR 35.491(b), and has achieved a level 01 competency sufficient 10 funclioll independently as an authorized user of strontium·gO (0( ophthalmic use.

Second Section

for 35.690:

Board Certification

[(] I allestlhal Jnmes II. Simon, M.D.

35.690(.)(1). Nama '" Proposed AulhOllud Uler

has satisfactorily completed the requirements in

OR Training and Exporlonce

o I attesllhat has satisfactorily completed 200 hours of classroom

N_ of Proposed AuChorir:;;· = .. """,=--and laboralOry training, 500 hours of supervised work experience, and 3 years of supervIsed clinical experience In radiation Iherapy, as required by 10 CFR 35.690(bX1) and (b)(2).

AND ..............•••• -. __ •................. . _ ....... __ ... ----- _. NRC fORJ,llllA ("US) [OS-:!1I12) I'lGE 5

NRC FORM 313A IAUSI U.S. NUCLEAR REGUlATORYCOMMISSLON ~2012)


Preceptor Attestation (continued)

Third SectIon

For 35.690: (continued)

({] I allest Ihal James H. Simon, M.D. has received training required in 3S.690{c) lot device

N ..... 01 Ptcpo$ed AU\horiI'" Us«

operation, safely procedures, and cUnical use for the type{s) of use fOf which aulhorization is sought, as checked below.

o Remote after loader unit(s) o Teletherapy unil(s) o Gamma slercolaclic radiosurgery unit(s)

----- ... _------_._---- ---- ._ --------------------.---_.-------AND

Fourth Section

o I sUest thai J~me! H. Simon, M.D. has achieved a level of competency sufficienllo

N . .... 01 Prq><><H AuUIoriz ... UH'

achieve a level of competency sufficient to funclion independenlly as an authorized user for:

III Remote afterloader unit{s) o Teletherapy unll(s) o Gamma stereotactic radiosurgery unit(s)

-------------------_._--_ .. _-------- -------- ---- ----_.-_ .. _--Fifth Section

Complete the following for preceptor attestation and Signature:

[{] I meet the requiremenls in 10 CFR 35.490. 35.491, 35.690, or equivalent Agreement Stale requirements, as all aulhorized user for:

o 35.400 Manual bracnylnerapy sOLKces 035.600 Telelherapy unll{s)

0 35.400 Ophthalmic use of strontium·90 0 35.600 Gamma stereotactic radiosurgery unit(s)

[{] 35.600 Remote aflerloader unites)

. .... - --Name of Preceplor

L6:~~ Telephone Number Oat.

JlImie Hllffis, MS (60S) 322·1625 011211201) ._ .. LlQenselPermi! NumberlFaCllIty Name

RMLN 40-16571 -0IlAvcra McKenn:an Siou:\ l-'alls, SO -.. _ ..... --- ---

, PAGEl!

NRC FORM 3UA IAUSI U.S. NUCLEAR REGULATORY COMMISSION ~10111

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

APPROVED BY OMS: NO. 3160.0120

(for uses defined under 35.400 and 35.600) EXPIRES: (0513112016)

[10 CFR 35.490, 35.491 , and 35.6901

Name of Proposed Authorized User State Of Territory Where licensed

JOInes H. Simon, M.D. South Dakota

Requested ill 35.400 Manual bl<lchylherapy sources 0 35.600 Teletherapy uoll(s)

Authorlzatlon(s) o 35.400 Ophthatmic use of slfOntium-90 035.600 Gamma stereotactic I<ldiosurgery unit(s) (check all that apply) o 35.600 Remote anerloader unil{s)

PART I _. TRAINING AND EXPERIENCE (Select one of the three methods befow) . Training and Experience, Including Board Certification, must have been obtained within the 7 years preceding the

dale of appllcalion or the individuat must have obtaIned re tated continuing education and experience sInce Ihe required training and experience was completed. Provide dates, duration, and description of continuing education and experience (elated to the uses checked above.

I{] 1. Board Certlflcatfon

a. Provide a copy of the board certifical ion.

b. For 35.600, go to the table in 3.e. and describe training provider and dates of training for each type of use fO( which authorization is sought.

c. Skip to and complete Part If Preceptor Attestation.

o 2. Current 35.61)0 A uthorized Use r Reguestlng Ad dilional Authorization for 35.600 Use[s l Checked Above

a. Go to tile lable in section 3.e. to document training tor new device.

b. Skip to and complete Part II Preceptor Attestation.

0 3. Training and Ex(!erience for PrOl2osed Aulhor lzed User

a. Classroom and laboratory Training 0 35.490 035.491 035.690 . - - Clock - - -- .

Descripllon of Training Location of Training Dales of Hours Training·

. - - .- . _.


-- -- -- - .. ,----

Radialion protection

- .. .. -

Mathematics pertaining to the use and measurement of radioactivity

- ... .. .-

Radiation biology

I - . . . - - . Tol al Hours of Training: I I

HAC FOR M3tM(AUSII05-lO tll .'" ,

NRC FORM 313A (AUS) U.S. NUCLEAR REGULATORY COMMISSION {O!>20lll

AUTHORIZED USER TRAINING AND EXPERIENCE ANO PRECEPTOR ATTESTATION (continued)

,. Tralnln9 and Exeerlence for Pro~osed Authorized User {contlnuedl

b. Supervised Worn and Clinical ElCpcrience for 10 CFR 35.490 (II more than one supelVising individual Is necessaty to document sllpetvlsed work oxperience. provide multiple copies of this page.)

_. Isupervlsed Work Experience

Total Hours of Experience:

Description of Experience Lacallon of Expertence/Ucense or Confirm

Dates of Must Include: Permit Number of Facility Experience"

_.- .. ----.. - -Ordering, receiving. and

DYes unpacking radioaclive materials safely and performing the related ONo radiallon surveys _. .-- -- -

Chocking survey meters for DYes

proper operation ONo _. - ---- - - -

Preparing, implanting, and safely DYes

removing brachytherapy sources ONo

.- - -- -- -

Maintaining running inventories DYes

of malerial on hand ONo -- -- ,- _ .. .. - -

UsIng administrative controls to o V., prevent a medical event involving the use of byproduct ONo malerial

. - --- _.

Using emergency procedures to DYes

control byproduct malerial O No

E linicat experience in radialion Location of Experience/License or Dates of oncology as part of an approved Permit Number of Faci1ily Experience' ormaltrainJng program

. _ . . _._- ---- ---- -

Approved by:

D Residency Review Commitlee for Radiation Oncology of the ACGME


o Committee on Postdoctoral Trail\ing of the American Osteopathic AS!iociation

SupelVis!ng Individual iLrcensefPermli Number ~sUng supervising Individual asan--rUlhOriZed User

.. .

PAGEl

·0-_ .. m .... n ... • ... ....... 0 .................. '-A .......... a .. _ ... _._ ..

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTQRATTE$TATION (continued)

3. Training and E"l!!rlence for Pro[!osed Authorized User {continued}

c. Supervised Clinical Experience for 10 CFR 35.491 --- -- :-

DeSCription of Experience Location of E):perience/license or Crock Dates of

Permit Number of Facility Hours Experience'

Use ot strontium-90 fO( ophthalmic treatment, including: examination of each individual to be treated; calculation of the dose to be administered; administralioo of the dose; and follow up and review of each Individual's ease history

"."--.-Supervising Individual lic:ellselPenull Number listing supervising individual as an

Authorized User

- -- -- - - --- -d, Supervised Work and Clinical Experience for 10 CFR 35.690

[Z] Remote afterloader unit(s) o Teletherapy unit(s) o Gamma stereotactic radiosurgery unit(s)

---- - -- ---Supervised Work Exporlence ! Tolal ~ou~ of ExperIence:

--------- -Descripl!on of Experience location of ExperiencelLicense or

Confirm Dates of

Must Include: Permit Number of Facility ExperIence-- - ---- -

Reviewing fu ll calibration DYes measurements and periodic

DNa spot-checks

-,-.- -Preparing treatment plans and A vera McKconrlll

[Zj Yes 10/10,11/27-23

calculating ' reatment doses and Sioux 1'alls, SO 12fJ,12f7 limes RMLJi 40-16511-01 D Na 12117,1213 1112

.-. - --- -.-.---- - - - - --Using administrative controls to Avera McKClioiln [Z]Yes 10I IO,lln1-2S prevent a medical event Sioux falls, SD 1213,1 211 involving the use of byproduct ){MLU 40-16511 -01 DNa 12/ 17,1 2131112 malerial

-- -- -Implemenling emergency Avera McKcnnan o Yes 12110112 procedures to be followed In the Sioux I'alls, SD event of the abnormal operation of the medical unit or console

RML# 40-1657[ -01 DNa

--Checking and using survey DYes

meters DNa --.~. -

Selecting the proper dose and Avera McKennan [Z]Yes 10110,11127·28

how it is 10 be administered Sioux Fillls, SIJ DNa

12/3,1217 RMLII <10-16571-01 12117,12/311 12

--- --

NRC FORM SUA lAOS) u.s. NUCLEAR REGULATORY COMMISSION \OS-XII1J

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ArrESTATION (continued)

3. training and EXl1erience for ~roRosed Authorized Uger (continued)

d. Supervised Work and Clinical Experience for 10 CFR 35.690 (conllnued)

Clinical experience in radiation Location 01 ExperienceJUcense Of Dates of

oncology as part of an approved formal lraining program

Permit Number of Facility Experience·

Approved by:

o Residency Review Committee for Radiation Oncology of Ihe ACGME


o Committee on Postdoctoral Training of the American Osteopathic Association ..

SupelVising Individual UcenseJPermit Number lis ling supervising individual as an Authoriled User

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

a. For 35.600, describe training provider and dales of training for each Iype of use for which authorization is sought

p. _._-Description

Training Provider and Dates of Training

_ .. -._-_._. ------Remote Afterfoader Teletherapy

Gamma Stereotactic Radiosurgef)' -_ .. -.- ... ~

101 10/ 12, 11127112, 11128/12

Device operation 1213112,1217f12,&' 12/1711 2,12/31/12

------- .~- -'-"-'--10110112,10/11112,11127112,

Safely proceduros 11128112,1213112,12/7112, & fOf the device use 12/11112, 12/31112

.- .-.-.. 10"0112, 101 11 / 12, 11127112.

Clinical use of the 1 I12Kl12,1213112, 12n/ 12, & device 12117/12, 12/31112

_ ...•. . _. ----Supervising Individual. {lftre~!ftl9 plOvidQri by SUpmvlslng llcenseIPermil Number listing supervising Individual as an Individual (If lJIO(8/hlJfl OM $uptJr'VisJng IrKlividulJlls n6C&SSo1I)' Aulhorized User

/0 document SlJptlrvised II'(!rl( O:(pOriflnc6, provld9 mu/tipl9 vopiflSQ/ /h lsp9!J9.J

K31hleen Schnt':ekl01h, M.D. Avera MtKcnmm Sioult Falls, SO RML# 40·16511-01 ........ _ ............. ..... ........... ........ , ... , ......... . .... , ..... .... . ... ......... ,., .................. ............ , , ...... . .. " .. , ................. __ ..... _ .. _. ........ . __ .. Authorized for the following types of use:

lZ1 Remote after10ader unlt(s) o Tetetherapy unlt(s) o Gamma stereotactic radiosurgery unites)

---.~--.-. --' f. Provide completed Par111 Preceptor Allestation.

HRCfOOM 31lAlAUS) 100020lll I'AGE4

NRC FORM 313A (AUS) (11&-20121

U.S. NUCLEAR REGULATORY COMMISSION

AUTHORiZED USER TRAINING AND EXPERIENC;:E 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 Ihe supervising individual as long as the preceptor provides. directs, or verifies training and experience required. If more than one preceptor is necessary 10 document experience, oblain a separate preceptor statement from each.

By checking the boxes below, the preceptor is attesting that the individual has kno'NIedge to fulfill the dulies of the position sought and not 811eslln910 the individual's ~general clinical compelency.~


For 35.490:

Board Certification

[7J I attest that Jame.~ H. Simon, M.D. has satisfactorily completed the requirements In

= =--N_ of PfOPO$<'d AuIl'IootIr .... UsN

35.490(a)(1) and has achieved a level of competency sufficient to function Independently as an authorized user of manual brachytherapy sources for the medical uses authorized under 10 CFR 35.400.

Training and Experience

o I altest that

Q.R

has satisfactorily completed the 200 hours of

classroom and laboratory training. 500 hours of supervised work experience, and 3 years of supervised clinkal experience In radiation onco.logy, as required by 10 CFR 35.490(b)(1} and (b)(2). and has achieved a level of competency sufficient to function independenlly as an authorized user of manual brachytherapy sources for the medical uses authorized undel 10 CFR 35.400.

For 35.491:

o I allest that has satisfactorily compleied the 24 hours of - - t«.-me ~ Pmpml!d Aulhi:lfil. d lJu< .--

classroom and laboratory training appl1cable to the mt!!dical use of strontlum-90 for ophlhalmic radiotherapy, has used strontium-90 for ,ophlhalmic treatment of 5 individuals, as required by 10 CFR 3'5.491(b), and has achieved a level of competency sufficient to flmcllon independently as an authorized user of strontium·90 for ophthalmic use.

Second Section

For 35.690:

Board Certification

01 aUest that James II. Simon, M.D. has satisfactorily completed the requirements In

35.690(a}(1). N_ rJ PropoIiO<l AC_=",.,=u .. ~o,~-

Q.R Training and Exporlence

D I attest that has satisfactori ly completed 200 hours of classroom ---'NO_=~."_;;;=;::OA·_""O·,.,=-·u.=.o---

and laboralory Iralnlng, 500 hours of supervised wolk experience, and 3 years of supervised clinical experience In radiation therapy, as required by 10 CFR 35.690(b)(1) and (b)(2) .

AND ------- ----- -_ .... ------------_ .. _----------_ .. _------- -- -- --

NRC FORM 313A (AUSj U.S. NUCLEAR REGULATORY COMMISSION ~~121



Third Section


[(] I allesllhal JDmcs H. Simon, M.D. has received training required in 35 .690(c) for de\lice

N' ..... cI p,~ AtAhori2"" u .... operation, safety procedures, and clinical use for the type(s) of use for which aulhorizatlon Is sought, as checked below.

I{} Remote aflerloader unil(s) o Teletherapy unites} o Gamma stereotactic radiosurgery unites) • ___________________________ ____ __________________________ MM.

AND Fourth Section

[{] 1 attest that JOines H. Simon, M.D. has achieved a le\lel of competency suffICient to --tot_ 01 Propo&ed AutlIortled User

achieve a level of competency sufficient to function Independently as an authorized user for:

I{} Remote aflerloador unlt(s) o Teletherapy unites) o Gamma stereotactic radiosurgery unites)

----------------------------. __ .------------------_._- ____ MM.

Fifth Section

Complete the following for preceptor attestation and signature:

o I meel the requirements in 10 CFR 35.490, 35.491, 35.690, or equivalent Agreement State reqwements, as an authorized user for:

[{] 35.400 Manual brachytherapy sources 035.600 Teletherapy unites)

D 35.400 Ophthalmic use of stronlJum-90 0 35.600 Gamma stereotactic radIosurgery unites)

[(] 35.600 Remote afterloader unit{s)

-- ~

Name of Preceptor is;'':; 1 I )f-{ J'''Ph~;. Numbo, Date

KOlhle<:fl Schnccktolh, M.D. i . F, ,'u- ();; jI-1{)i (60')J2!: '~_" _ 0112212013 < -

llcenselPermil NumbcrlFacllily Name

RMLN 40-J6571-01/Avcm McKeornm Sioux Falls, SO ----- -.-

NRC rooM JIJ,o,(AUSI (GS-20 121 PAG(6

NRC FORM 313A(AUS) U.S. NUCLEAR REGULATORY COMMISSION 1~""11J

AUTHORIZED USER TRAINING AND EXPERIENCE Af'f'ROVl:O BY OMB: NO. 31&0.0120

AND PRECEPTOR ATTESTATION EXPIRES: (0!fl11201&)

(for uses defined under 35.400 and 35.600) [10 CFR 35.490, 35.491, and 35.690)

Name 01 Proposed Authorized User Stale Of Terrilory Where Licensed

Jamcs II. Simon, M.D. South Dakota

Requested o 35.400 Manual brachytherapy sources 0 35.600 Teletherapy unites)

Authorb:atlon(s) o 35.400 Ophthalmic use of strontium·gO 035.600 Gamma stereolaclic radiosurgery unit(s) (check all that apply)

[(] 35.600 Remote afterloader unit(s)

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 applicaHon or the individual must have obtained related continuing education and experience since the requIred training and experience was completed. Provide dates, duration, and description 01 continuing education and experience related to the uses checked above.

0 1. Board Certification

a. Provide a copy of the board certification.

b. for 35.600, go to the table in 3.e. and describe training provider and dates of training for each type of use for which authorizatIon Is sought.

c. Skip to and complete Part II Preceptor Attestation.

o 2, C~rrent 35.600 Authorlz!i!d User Reguestlng AddltlO!li!1 A~thorlzatlon for 35.600 !.!sil_) Cb!!i:ked Above

3. Go to the lable in section 3.e. to document training for new device.

b. Skip to and complete Part II Preceptor Allesta\ion..

0 3. Training and Ex(!erlem,!t;!2[ eroeosed Authorlzed·Ussr

3. Classroom and laboratory Training 035.490 n 35.491 [J 35.690 ... . . . .... - .... _ .

Dates'or-Descripllon of Training Localion of TraIning Clock

Hours Training· f-. -- -. - ..


. - ... . . - ..

Radialion protection

.. .. ..

Mathematics pertaining to the use and measurement of radioactivity

.. .. -

Radiation biology

- - . .. Total Hours of Training: D .. , ., , c OR 3 3A(AUS) (1)>.20 2) PAGE 1

NRC FORM 313A (AUS) U.S. NUCLEAR REGUlATORY COMMISSION ~~)I012J

AUTHORIZED USER TRAINING AND EXPERIENc,E AND PRECEPTOR ATTESTATION (continued)

3. Training and EX2erience for Prol2osed Authorized ~ser ,conllnued}

b. Supervised Work and Clinical Experie[lCe tor 10 CFR 35.490 (If more than one supervising individual is nocessary to docum~nt supervised work oxperlonce, provide multiple copies of this page.)

-- . .-

!supervlsed Work Experience Total Hours of Experience:

... _ .. Description of Experience Location of ExperiencelLicense or

Confirm Oates of

Musllnclude: Permit Number of Facility Experience· ._. . . .

Ordering, receiving, and DYes unpacking radioactlve materials

safely and performing the related oNo radial ion surveys - - ---_ ._- - - -_._-- .. -- -,.-

Checking survey meters for DYes

proper operation o No

- ' -

Preparing, implanting. and safely DYes

removing brachytherapy sources o No

---- ----- - , - _ .. -

Maintaining running Inventories DYes

of material on hand ONo . - - - - ---,._ - ,- ..

Using administrative controls 10 DYes prevent a medical event involving the use ot byproduct ONo malerial

---- --_. - --

Using emergency procedures to DYes

control byproduct material ONo

- ... -

:Clinical experience In radialion .. ..

Locallon of ExperiencelLicense or Oates of pncology as part ot an approved Permit Number of Facility Experience" formal training program

.. ... _--~pproved by:

o Residency Review Committee for RadiatlOIl Oncology of the ACGME


o Committee on Postdoctoral Training of the American osteopathic Association -.- _.

upervising Indiyidual LicenselPermit Number listing supervIsing individual 35 an iAuthorized User

. . _--- _ ... HRC 'OII.nl~f.ws) ~2011) PACI;2

NRC FORM 313A (AUS) U.S. NUCLEAR REGULATORY COMMISSION jOS-20I!)


3. Training and EXl!:erlence for Prol!:osed Authorized User {continued)

c. Supervised Clinical Experience for 10 CFR 35.491

- .. -- ... _--- ---- --. __ .. Description of Experience

Location of Experience/License or Clock Dates at Permit Number of Facilily Hours Experience-

- - - -Use of sllonlium-90 for ophthalmic trealmenl, including: examination of each indlvlduat to be treated; calculat ion of the dose to be administered; administration of the dose; and follow up and review of each Individuat's case hislOI)'

Supervising tlldividval license/Permit Number listing supervising individual as an ~ulhori.;:ed User

-·_· 0-0;:- - - -d. Supervised WorK and Clinical Experience for 10 CFR 35.690

({] Remole afterloader unit(s) o Teletherapy unit(s) o Gamma stereotactic radiosurgery unil(s)

,--._- .. .... - - - . --- ---·r---_ ... _ .. -Supervised Work Experlonce Total Hours of Experience:

Descri~ion of Experience Localion of Experlence/License or Confirm

Dates of Must Include: Permll Number of Facility Experience·

Reviewing fult calibration D Yes measurements and periodic

O No spot-checks

--~~ .- - ----Preparing treatment plans and A v..:ra McKennan

{{]Ves 10/10112

calculating treatmenl doses and Sioux Falls, SD 12/26112

limes RMLII <10-16571·01 ONo

- - - .. - .... _ ....... -. Using administrative conlrols to Avern McKt:nmm [{] Ves 10/10112 prevent a medical event Siou.\( Flllls, SO 12126112

l ~nvolving lhe use of byproduct RML# 40·16S71-0 1 O No malerial

.- . Ilmplementing emergency Avera MI;Ktnnun [{]Yes 10110112 procedures to be followed In the SiollX Falls, SD 12126/12 event of the abf"lormal operation of the medical unit or console

RML# 40-IM71·01 O No

-- - . .- ~ .

CheckIng and using survey DYes meters ONo

--- - -Selecting the proper dose and Avera McKcnn~n [{] Yes 10110112

how It Is to be administered Sioux Falls, SD O No

12126/ t2 RMLII 40·t6571..Q1

- .-NRC FORM UI.O \/IUS] (1IS-2"01!) ,.,.,

NRC fORM 313A tAUS) U.S. NUCLEAR REGULATORY COMMISSION (OS-201:/t


3. Training and EIC(!erlence for Pro(!osed Authorized User (continued)

d . Supervised Work and Clinical Experience for 10 CFR 35.690 (continued) --~-- -- -- - --- --- - -- - . --_ ... _- - -- -. - -. - -

Clinical experience In radiation Location of Experience/license or Dates of oncology as part of an approved Permit Number of Facility Experience" formal Iraining pro9ram

---Approved by:

o Residency Review Committee for Radiation Oncology of the ACGME


o Committee on Postdoctoral Training of the American OsleopathJc Association

Supervising Individual License/Permil Number ~sting supervising individual as an AUlhorized User

-- -----

e. For 35.600, describe training provider and dales of training lor each type of use for which authorization is sought.

--- -

Description Training Provider alld Dates

of Training ----

Remole AHerloader Telelherapy Gamma Slereolactic

Radiosurgery

101[0112

Device operation 12126/12

10110/12 Sarety procedures 12/26/12 ror!he devloo use

- -- - - , -- .-10110112

Clinical use of the 12/26112 device

--------

Supervising Individual. (1/ training provKJed by SupoNlsJng UcensefPermit Number listing supervising Individual as an Individual (If tIJO($ /han Qflb supervising individual is rJocessary Au!horized User

/0 doctImlm/ tlupervisaci woffl OlCperianoa, provide multiple r;op/$sollNspaga.)

Barbara Schlager, M.D. A\'crn McKcnnan Sioux Falls, SO RMLU 40-16571-01 . . .. , _ . ... - -.. _ ... -- - ------- ---- -------------------- ------- --.-.. - --- - ------- ------------ - ---

Authorized for Ihe following Iypes of use:

o Remote aftertoader unit(s) o Te[etherapy unlt(s) 0 Gamma stereotactic radiosurgery unil(S)

- - _. f. Provide compleled Part" Preceptor Attestation .

NRC FORIU':lA (MIS) (OS-2012) PAGE~

NRC FORM S13AIAUSI U.S. NUCLEAR REGUlATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (conllnued)

PART 11- PRECEPTOR ATTeSTATION

Nole: This part musI be compleled by the individual's preceplor. The preceptor does not have to be the supervising individual as long as the preceplor provides, directs, or verifies Iralning and experience required. If more than one preceptor Is necessary to document experience, obtain a separate preceptor statemenl from each.

By checking the boxes betow, the preceptor Is altesling that the individual has knowledge to fulfllt the dulles of the position sought and not aUesting to the individual's "general clinical competency."


For 35.490:

Boa rd CertlflcaUon

o I atiestlhat has satisfactorily completed the requirements in NatM of Plopos;;;;;"OO"A"~"".· O~"""O;;;.;_--

35.490(a)(1) and tlas achieved a level of competency sufficient to function independently as an authorized user of manual brachylherapy sources lor the medical uses authorized under 10 CFR 35.400.

Training and Experl@nco

o J allest Ihat

OR

has satisfactorily completed the 200 hours of Namu of Proposed Authooi .... ""'"W.--

classroom and laboratory training, 500 hours of supervised wor1t experience, and 3 yeCirs of supervised clinical experience In radiation oncology, as required by 10 CFR J5.490(b)(1) and (b)(2), and has achieved a level of competency sufficient to function independenlly as an authorized user of manual brachytherapv sources for the medical uses aulhorized under 10 CFR 35.400.

For36.491:

o I attest Ihal has satisfactorily completed the 24 hours of

-'N.~;;;;;;~.",C_;;;"""'A",~;;;;;;;· ,;",,,,,,,,,,;_-classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy, has used strontium-gO for ophthalmic trealment of 5 il1dividuals, as required by 10 CFR 35.491(b), and hilS achieved a level of competency sufficlenllo function Independently as an authorized user of stronHum-90 for ophthalmic use . ••.. . ....... - ..... _--_ .. _----._ .... _-------_ .. _ ... __ ....... _-

Second Section

for 35.690:

Board Certification

o I aUest Ihat James H. Simon, M.D. has satisfactorily completed the requicements in

35.690(a)(1). N_ of P(Of'O'ed'-A.: ..... ;;;:;.,o"' .. u."-~;---

OR Training and Experience

o I attest that has satisfactorily completed 200 hours of classroom

N~.~;;;; •• ~o;;;""';;;;;" .. A" .... ;;;o;O' .. "" .... ;:;--

and laboratory training, 500 hours of supervised wof1c:: experience, and 3 years of supervised clinical experience In radiation therapy, as required by 10 CFR 35.690(b)(1) and (b)(2).

AND ...... _ .. __ ..... -_ . .. _--- .. __ ...... _ ...... _- ...... _.--------. ''''' 5

NRC FORM 313A IAUS) U.S. NUCLEAR REGULAlORY COMMISSION !0S-20'2)



Third Section


[(] I aUest Ihal Janles I-I. Simon, M.D. has received Iraining required In 35.690(c) for device

Hime 01 Propoud AuO>orU-.:I UHt

operation, safely procedures, and dinical use for the type(s) of use for which authorization is sought, as checked below.

IZI Remote aftetloader unites) o Teletherapy unites) o Gamma stereotactic radiosurgery unil(s) ~_~.~ __ ~_.M ... __ . ___ ._._._ •• __ . ___ ~ __ •• _._. ______ . ____ _______

AND Fourth Section

o I allesllhal James H. Simon, M.D. has achIeved a level of competency sufficient to

H'ITI$ 01 Proposad Authorlzad Us.,

achieve a level of compelencv sufficient to ftJncUon Independently as an authorized user for:

[(] Remote afterloader uoil{S) o Teletherapv unit{s) o Gamma stereotactic radiosurgery unites)

._. _-_ .. _._-_._._--_._--_ ... ---_ ... _- .. _-_._._._._ .. _-----_.-Fifth Section

Complete the following for preceptor atte~tatlon and sl~natur9:

[{] I mael Ihe requirements In 10 CFR 35.490, 35.491, 35.690, or equivalent Agreement Slale requirements, as an authorized user for:

o 35.400 Manual brachytherapv sources 035.600 Teletherapy unil(s)

035.400 Ophthalmic use of strontium·90 035.600 Gamma stereotactic radiosurgery unites)

[2] 35.600 Remote afterloader unil(s)

.. ..... , iTelephone Number

... _ .. . Name of Preceptor ;Signatl,lre

Ai!.j Date

1\&..1,.,. I Barbam Schlager, M.D. (60j) 322·1625 01/2112013 l i_

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NRC FORM 532 U. S. NUCLEAR REGULATORY COMMISSION (1-2012)

DATE

02/0112013

NAME AND ADDRESS OF APPLICANT AND/OR LICENSEE LICENSE NUM8ER

A vera McKennan ATr N: Nuclear Medicine Department

Tracy Hollingshead Radiation Safety Officer

1325 South Cl ifT A venue Sioux Fa lls, South Dakota 57 117-5045

This is to acknowledge the receipt of your:

o LETTER and/or 0 APPLICATION

40- 16571 -01

MAIL CONTROL NUMBER

579912

LICENSING AND/OR TECHNICAL ReVIE'lv'ER

eh

DATED: 01 12 112.013

The initial processing, which included an administrative review, has been performed.

o AMENDMENT 0 TERMINATION 0 NEW LICENSE 0 RENEWAL

o There were no administrative omissions identified during our initial review.

o This is to acknowledge receipt of your application for renewal of the material(s) license identified above. Your application is deemed timely filed , and accordingly , the license will not expire until final action has been taken by th is office.

o Vour application for a new NRC license did not include your taxpayer identification number. Please fin out NRC Form 531 , located at the following link:

http:lLwww.n rc ,gov Iread ing:.rm/doc-collectionsiformsin rc531 . P_d.f

Send the completed NRC Form 531 , by facsimile, to the following number: (301 ) 415-5387

A copy of your action has been emailed to our License Fee and Accounts Receivable Branch, in our Headquarters office in Rockville, MD. You will be contacted separately if there is a fee issue involved.

Your application has been assigned the above listed MAIL CONTROL NUMBER. When calling to inquire about this action, please refer to this control number. Your application has been forwarded to a techn ical reviewer. Please note that the technical review, which is normally completed within 180 days for a renewal application (90 days for all other requests), may identify additional omissions or require additional information. If you have any questions concerning the processing of your application, our contact information is listed below:

NRC FORM 532 (1 -2012)

Region IV U. S. Nuclear Regulatory Commission DNMS/NMSB - B 1600 E. Lamar Boulevard Arl ington, TX 76011-451 1 (817) 200-1103 or (817) 200-1140

BETWEEN:

Accounts Receivablo/Payable

,,' Regional licensing Branches

I FOR ARPB USE I INFORMATION FROM WBL

Program Code: 02230 Status Code: Pending Amendment

Fee Category: 2B 7C

Exp. Date: Fee Comments: CODE 21

Oecom Fin Assur Reqd : N

License Fee Worksheet - License Fee Transmittal

A. REGION

1. APPLICATION ATTACHED ApplicanVUcensee: AVERA MCKENNAN

Received Date: 0113012013 DocIIet Number: 3011252 Mail Control Number: 579912 License Number: 40-16571-01

Action Type: Amendment

2~:::TTACH+ED

Check No.:

( 3. COMMENTS

Signed:

Date:

B. lICENSE FEE MANAGEMENT BRANCH (Check when mllostone 03 is entered I I

1. Fee Category and Amount:

2. Coned Fee Paid. Application may be pmcessed for:

Amendment:

Renewal:

License:

3. OTHER ___ ______ _ ___ _

Signed:

Date:

received averai jan 3 0 2013 mckennanaverai mckennan january 21, 2013 u.s. nuclear regulatory...

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