Averal ij!EtG[UWIE~ ~ MAR O 4 2019 ~

McKennan DNMS PUBLIC

March 4, 2019

U.S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511

RE: License number 40-16571-01

Dear Sir or Madam:

o Immediate Release ,a:.Normal Release

NON-PUBLIC 0 A.3 sensitive-Security Related o A.7 Sensitive Internal 0 Other:'--____ _

Reviewer: ~ Date: 3-ft,-\ q,

I request an amendment to our radioactive material license to add Liviu Adrian Anton, MS, as and Authorized Medical Physicist for Gamma Knife use under 10 CFR 35.1000.

Attached is NRC Form 313AMP and Mr. Anton's training certificate from Cleveland Clinic dated February 1, 2019.

If you have any questions or need additional information please contact me at 605-310-0916 or by email at Traci_.Hollingshead@avera.org.

Sincerely,

~~("'~~f Traci Hollingshead Radiation Safety Officer

th6115 10

NRC FORM313 (10-2017) 10 CFR 30, 32, 33, 34, 35, 36, 37, 39. and 40

U;S. NUCLEAR REGULATORY C.OMMISSION

APPLICATION FOR MATERIALS LICENSE

APPROVED BY 0MB: NO. 3~50-0120 EXPIRES: 06/3012019 Estimalod biJrdan per response lo cO!l'Plr wllh this mandatory conoction request 4.3 hours. Submillal of the application Is nocessary to dollllmino lhat lhe awl~t Is qualified and·lhal adequato prllOOdures e,isl lo prolecl Iha public hoallh and saJoty •. Send commo.nts regarding bUldon cstimato lo tho Information Serv~os Br1JOch (T-2 F43), U.S.' Nuclear Rogulatol)' Commrssron, Washington, DC 20555-000.1, or by o-mall to lnlocolleets.Resourco@nrc.gov. and to the Dosk omcer, Office of lnJormaUon ,nd Regulalory Affal,s, NEOB-10202, (3150-0120), Office of Management and Budget, WashlnglOn,, DC 20503. If a moans usod lo Impose an inlormaUon collection does nol display a curranUy valid 0MB control number, tho NllC may not conduct or sponsor, and a person Is not required to respond IO, tho lnformaUon.colloclion.

INSTRUCTIONS; SEE THE CURRENT VOLUMES OF THE NUREG-1566 TECHNICAL REPORT SERIES ("CONSOLIDATED GUll;>ANCE AB()UT MATERIALS LIC.ENSES"J FOR DETAILED INSTRUCTIONS FOR COMPLETING THIS FORM: lll1ii;//.WWW.OC~!l.'l.VlJ'.9!l!IO!l:Oillll.2Ji:£21Jgg(j)Jl.ilOY~QSl6tafl/sd5~ SEND TWO COPl!;S OF THE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW. .

APPLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH;

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ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS:

IF YOU ARE LOCATED IN;

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SEND APPLfCATIONS)'9:

NUCLEAR MATERIALS LICENSING BRANCH U.S. NUCLEAR REGULATORY COMMISSION, llEGION IV 1600 E. I.AMAR DOUI.EVARO ARLINGTON, TX 76011-4511

PERSONS LOC/ITEO IN AGREEMENT STATES SEND APPLICATIONS TO THE U.S. NUCLEAR REGULATORY COMM\SSION OlolLY ff THEY WISH TO POSSES.SAND USE LICENSED MATERIAL IN STATES SUBJECT TO U.S. NUCLEAR REGULATORY COMMISSION JURISDICTIONS.

1 THIS IS AN APPLICATION FOR /Check appropriate item)

D A. NEW LICENSE

[Z] B. AMENDMENTTOLICENSENUMBER 40-16571-01

D C. RENEWAL OFLICENSE NUMBER

3. ADDRESS WHERE LICENSED MATERIALS WLL BE USED OR POSSESSED

2. NAME AND MAILING ADDRESS OF APPLICANT (Include zip code)

Avera McKenr;ian 1325 S. Cliff Ayenue Sioux Falls, SD 57117

4. NAME OF PERSON.TO BE CONTACTED AIJOUT THIS APPLICATION

Traci Hollingshead

BUSINESS TELEPHONE NUMDEH ,

6053100916 I BUSINESS CELLUlAR TELEPHONE NUMBER

6053100916

BUSINESS E-MAIL AODllESS

traci. holli ngs head@avera.org SUBMIT ITEMS 5 THROUGH 11 ON 0·1/2 X 11" PAPER. THE TYPE AND SCOPE OF INFORMATION TOBE PROVIDED IS OESCflltlEO IN THE LICENSE APPLICATION GUIDE. 5. RADIOACTIVE MATERIAL 6. PURPOSE(S) FOR.IMilCH LIC£,NSED MATERIAL WILL BE USED.

a. Element and mass number; b. chemical ondlor physical form; and c. maximum amount 7. INDIVIOUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND which will be possessed at any .one tfmo. EXPERIENCE.

8. mAINfNG FOR INDIVIOUALS 'M:lRKfNG IN OR FREQUENTING RESTRICTED AREAS. 9. FACILITIES ANO EQUIPMENT. 10. RAl)fATION SAFETY PROGRAM. 11: WASTE MANAGEMl:NT.

l2. LICENSE FEES (Foes required only for now applications, with fow oxcoptions·) · FEE I I I (Seo 10 CFR 170and Soclion 170.JIJ CATEGORY F.~~~,;:;ro $ • AmondmentslRcnow•I• that lncroaso lho acopo or the o,lsUng license to·• new or higher rec category will require a Ice. . .

PER THE DEBT COLLECTION IMPROVEMENT ACT OF 1996 (PUBLIC LAW 104-134), YOU ARE REQUIRED TO PROVIDE YOUR TAXPAYElt IDENTIFICATION NUMBER, PROVIDE THIS INFORMATION BY COMPLETING NRC FORM 01: IJtlp_a;Uwww.nr~~log,llllllml;,<;oHecUpo•l[prm•lorc631fnfo Mm)

13. CERTIFICATION. (Must be complolfJ<f by opp/leant) THE APl'LICANT UNDERSTANDS THAT ALL STATEMENTS AND.Rf:PRf.iSENTA T/ONS MADE IN TfllS APPLICATION ARE BINDING UPON THE APPLICANT.

THE APPLICANT ANO ANY OFFICIAL EXECUTING THIS CEffflflCATION ON BEHALF Of THE APPLICANT, NAMED IN ITEM 2. CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10, CODE Of FEDERAL REGULATIONS, PARTS 30, 32, 33, 34, 35, 36, 37, 39, AND 40, AND THAT Al.I. INFORMATION CONTAINED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNO'M.EDGE AND B1lL1¢F. WARNING; 18 U.S.C. SECTION 1001 ACT OF JUNE 26, 1848 62 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKEA WILLFULLY FALSE STATEMENT OR REPRESENT.ATION TO ANY OEPAfffMENT OR AGENCY OF HIE UNITED STATES AS TO ANY MATTER WITHIN ITS JURIS.DICTION.

CERTIFYING OFFICER •• 1YPEO/PRINTED NAME AND TITLE

Traci Hollingshead/Radiation Safety Officer

'tV,i>E 0~ .:El,. I APl'R0VEOBY

NllC FORM 313 (10-2017)

''i ..

SIGNATURE

i::oR NRC ·use ONL v · ~ • 1 • • • •

DAYE

' . .

1·

I . i ;

th 6

DATE

J <,i j ' • t '· . f"' .

' ,,

• -

1 1 5 1 0

U.S. NUCLEAR REGULATORY COMMISSION

AUTHORIZED/MEDICAL PHYSICIST TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

[10 CFR 35.51]

APPROVED BY 0MB: NO. 3150-0120 EXPIRES: 06/30/2019

Name of Proposed Authorized Medical Physicist

Liviu Adrian Anton, MS

Requested D 35.400 Ophthalmic use of strontium-90 D 35.600 T,eletherapy unit(s) Authorization(s)

(check all that apply) D 35.600 Remote afterloader unit(s) [Z] 36.600 Gamma stereotactic radiosurgery 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 application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and oescription of continuing education and experience related to the uses checked above. ·

D 1. Board Certification

a. Provide a copy of the board certification.

b. Go to the table in 3.c. 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.

[Z] 2. Current Authorized Medical Physicist Seeking Additional Authorization for use(s) checked above

a. Go to the table in section 3.c. to document training for new device.

b. Skip to and complete Part II Preceptor Attestation

D 3. Education, Training, and Experience for Proposed Authorized Medical Physicist

a. Education: Document master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university.

Degree

' ,.,,,.,,,,,, ____ _, ______________ _ I Majoc Field

College or University

- --------- --·---·- ---

b. Supervised Full-Time Medical Physics Training and Work Experience in clinical radiation facilities that provide high-energy external beam therapy (photons and electrons with energies,greater than or equal to 1 million electron volts) and brachytherapy services. · ·

0 Yes. Completed 1 year of full-time training in medical physics (for are.as identified below) under the

supervision of who rneets the requirements for an

Authorized Medical Physicist.

AND

D Yes. Completed 1 year of full-time work experience in medical physics (for areas identified below)

under the supervision of -----· ··-··---·-·----··-- who meets the requirements for

an Authorized Medical Physicist.

NRC FORM 313A (AMP) (06-2016) PAGE1

NRC FORM 313A (AMP) U.S. NUCLEAR REGULATORY COMMISSION l00.2016)

AUTHORIZED MEDICAL PHYSICIST rRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3. Education , Training, and Experience for Proposed Authorized Medical Physicist (continued)

b. Supervised Full-Time Medical Physics Training and Work Experience (continued) If more than one supervfsing individual is necessary to document ,supeNised training, provide multiple copies of this page.

Description of Training/ Experience

Location of Training/License or P~rmit Number of Training Facility/Medical Devices Used+

Dates of Training*

Dates of Work Experience*

Medical Physics

Performing sealed source leak tests and inventories

Performing decay corrections

Performing full calibration and periodic spot checks of external beam treatment unit(s)

Performing full calibration and periodic spot checks of stereotactic radiosurgery unit(s)

Performing full calibration and periodic spot checks of remote afterloading unit(s) ,

Conducting radiation surveys around external beam treatment unit(s), stereotactic radiosurgery unit(s), remote after loading unit(s)

Supervising Individual**

for the following types of use:

D Remote afterloader unit(s)

License/Permit Number listing supervising individual as an authorized Medical Physicist

D Teletherapy unit(s) D Gamma stereotactic radiosurgery unit(s)

+ Training and work experience must be conducted In clinical radiation facilities that provide high-energy external beam therapy (photons and electrons with energies greater than or equal lo 1 million electron volts) and brachytherapy services.

• 1 year of Full-lime medical physics training and 1 year of full time work experience cannot be concurrent.

" If the supervising medical physicist is not an authorized medical physicist, the licensee must submit evidence that the supervising medical physicist meets the training and experience requirements in 1 O CFR 35.51 and 35.59 for the types of use for which the individual Is seeking authorization.

NRC FORM 313A (AMP) (06-2016) PAGE2

NRC FORM 313A (AMP) U.S. NUCLEAR REGULATORY COMMISSION (06-2016)

AUTHORIZED MEDICAL PHYSICIST TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3. Education. Training. and Experience for Proposed Authorized Medical Physicist (continued)

c. Describe training provider and dates of training for each type of use for which authorization is sought.

~------~----·----------------------····--····-··---------------~ Description ofTraining

Training Provider and Dates

f-------·-·"·-··-·-+---------------- ~------- --- - - -·-----------~-- ~~-----

Remote Afterloader Teletherapy Gamma Stereotactic

Radiosurgery

r-·----.. ·-·------- - •------------+- -.. -·----·----~--·-·------L--,---- ________ ,.

Hands-on device operation

January 28-February I, 2019

- ~-----·------+------- .. ··"·~---.. ~--·--- -------------l----·---·-·--·-·- --------l

Safety procedures for the device use

January 28-Febrnary 1, 2019

f---------··-··--- ----·--·---------·----.. -·--·-·----·---·-----·-·-·--·-----·--· ------·-·---------------·--.. ·---·-·-·-.. ·-·-···-···--·--- ·-·· -·· ··· - --··----------1

Clinical use of the device

January 28-February 1, 2019

____ _,_ ___________ ..,_ ___ ____ ,_ .. _, __ ,u, .. --·-- - -------------1

Treatment planning system operation

January 28-February I, 2019

>-------->-----------& .... -,-~ .. - .. - ---··-·----------~-------- -----! Supervising Individual , L' /P ·t N b 1· t· · · · ct· 'd I h · Jftralning is provided oy supervising Modica! Physicist, /I/more 1han one supervising ; 1cense erm_1 .. um er IS 1ng supervising 1n IVI ua as an au! onzed individual is necessary lo document supervised training, provide muNiple copies of , Medical Phys1c1st !his page.) '

Jamie Harris, MS

tor'flie ·tc,now,rig· types of use:· D Remote afterloader unit(s)

40-16571-0 l

D Teletherapy unit{s) 0 Gamma stereotactic radiosurgery unit{s)

.................. - -------------- --·----·-...... _, ........... _._ ... _____________ ______ ___J

If Applicable:

·-·-.............. _ ............................ ----~--------~ '--·-·---.. ---···---·-·"""'"""-----·--···- - - -~--- ------Authorization Sought Device Training Provided By Dates of Training

1--·--·-"'·'----------i---------~···-.,-.... ~ ........ ._ .... _, ____ ··-·--··--····-·--·--------------···----···-·-·-·-· --······---·----· ······-·---- " __ ,, ____________ ...... ..

35.400 Ophthalmic Use of strontium-90

I >-----·- ---·----~------ ·-,-~- ___________________ L ___ ~ -·------'

d. Sklp to and complete Part II Preceptor Attestation.

NRC FORM 313A (AMP) (06-2016) PAGE3

NRC FORM 313A (AMP) U.S. NUCLEAR REGULATORY COMMISSION (06-2016)

AUTHORIZED MEDICAL PHYSICIST 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 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.

First Section Check one of the following:

1. Board Certification

[ZJ I attest that Uviu Adrian Anton, MS Name of Proposed Authorized Medical Physicist

10 CFR 35.51(a)(1) and (a)(2).

2. Education , Training, and Experience

D I attest that

OR

Name of Proposed Authorized Medical Physicist

has satisfactorily completed the requirements in

has satisfactorily completed the 1-year of full-time

training in medical physics and an additional year of full-time work experience as required by 10 CFR 35.51 (b}(1 ).

--------------·····-------------------------······----········ Second Section Complete the following:

AND

[ZJ I attest that Liviu Adrian Anton, MS has training for the types of use for which authorization

Name of Proposed Authorized Medical Physicist

is sought that include hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system.

------------------------------------·········---------·-··---· AND Third Section Complete the following:

[ZJ I attest that Liviu Adrian Anton, MS has achieved a level of competency sufficient to -------·~ ---~-----------

Nama of Proposed Authorized Medical Physicist

function independently as an Authorized Medical Physicist for the following:

0 35.400 Ophthalmic use of strontium-90 D 35.600 Teletherapy unit(s)

D 35.600 Remote afterloader unit(s) [ZJ 35.600 Gamma stereotactic radiosurgery unit(s)

----~~-M•••••····----------------------·-·······-----········· AND Fourth Section Complete the following for preceptor attestation and signature:

[Z) t meet the requirements in 10 CFR 35.51, or equivalent Agreement State requirements for Authorized Medical Physicist for the following:

D 35.400 Ophthalmic use of strontium-90 D 35.600 Teletherapy unit(s)

D 35.600 Remote afterloader unit(s) [Z] 35.600 Gamma stereotactic radiosurgery unit(s)

~=1::-tt-:.;t~~r -~\~--~--:·--·-------····----··--- ,Telep(::~ ~~:~~~9 1

Data

03/04/2019 ·Licens'e/Permit Number/Facility Name-·--- - - ' '( -

40-16571-01/Avera McKennan

NRG FORM 313A (AMP) (00-2016)

l 6 1

PAGE4

1.'510

[ J Cleveland Clinic

February 1, 2019

Uviu Adrian Anton, MS Avera Cancer Institute

Dear Liviu Adrian Anton,

This is to confirm that during the January 28-February 1, 2019 Gamma l\nife Perfexion Intro training course that you attended at the Cleveland Clin_ic, the course involved participan,ts planning at least one single metastasis case, at-least two multiple metastasis cases, at least one AVM case, at least one Pituitary tumor case, at least two Trigeminal Neuralgia cases, at least one Meningioma case and at least two Vestibular Schwannoma cases. In addition, the full process of planning, CBCTJocalization and treatment was demonstrated on at least one mask case.

Sincerely,

A~-1/fi:if c( ~4-- u"~Ji ~~ Gene Barnett, MD Lilyana Angelov, MD Gennady Neyman, PhD

W:100 Euclid /.\vonu~i ,) Ctevelanrl, ('l·l 44"1!")6

t\,.611510

NRC FORM 532 U.S. NUCLEAR REGULATORY COMMISSION (05-2016) aY'P.IIECJQ,t,,

•• f ~ ACKNOWLEDGEMENT - RECEIPT OF CORRESPONDENCE ' • \; .l ... * .......

Name and Address of Applicant and/or Licensee Date

I 03/05/2019 I Traci Hollingshead License Number(s} Radiation Safety Officer I 40-16571-01 I Nuclear Medicine Department

Mail Control Number{s } Avera McKennan 1325 S Cliff Ave I 611510 I Sioux Falls, SD 57117-5045 Licensing and/or Technical Reviewer or Branch

IC.Hill I

This is to acknowledge receipt of your: 0 Letter and/or D Application Dated: 03/04/2019

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

0 Amendment D Termination D New License D Renewal

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

D 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 this office.

D Your application for a new NRC license did not include your taxpayer identification number. Please complete and submit NRC Form 531, Request for Taxpayer Identification Number, located at the following link: htto ://www. n rc.aov/read i na-rm/doc-collections/f orms/n rc531. odf

Follow the instructions on the form for submission.

D The following administrative omissions have been identified:

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 technical 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:

Region IV U. S. Nuclear Regulatory Commission DNMS/NMSB - B 1600 E. Lamar Boulevard Arlington, TX 76011-4511 (817) 200-1103 or (817) 200-1140

NRC FORM 532 (05-2016)

BETWEEN:

Accounts Receivable/Payable and

Regional Licensing Branches

[ FOR ARPS USE ] INFORMATION FROM WBL .. . ..... . . .. . ---- ·····

Program Code: 02310 Status Code: Pending Amendment Fee Category:7A 7C Exp. Date: 03/31/2024 Fee Comments: CODE 21 Decom Fin Assur Reqd: N

License Fee Worksheet - License Fee Transmittal A. REGION

1. APPLICATION ATIACHED ApplicanULicensee: Avera McKennan

Received Date: 03/04/2019 Docket Number: 3011252 Mail Control Number: 611510 License Number: 40-16571-01

Action Type: Amendment

2. FEE ATTACHED

Amount:

Check No.:

3. COMMENTS

Signed:

Date:

B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03 is entered / /

1. Fee Category and Amount: ------------------2. Correct Fee Paid. Application may be processed for:

Amendment:

Renewal:

License:

Signed:

Date: