Hill. Carol

From: Sent: To: Subject: Attachments:

Chris Fitz <chrisfitz65@hotmail.com> Wednesday, February 17, 201611:47 AM Torres, RobertoJ; Hill, Carol [External_Sender] Amendment Request for Billings Clinic 25-01051-01 signed_Dan_lewis.pdf; Daniellewis_313AMP GammaKnife (l).pdf

Please find attached an amendment request for the above referenced license.

Thank you

Chris

1 1h5 902 12

Billings Clinic ..

February 17, 2016

Roberto J. Torres, Senior Health Physicist U.S. Nuclear Regulatory Commission, Region IV 612 East Larmar Blvd. Suite 400 Arlington, TX 76011-4125

· Re: Amendment Request for Billings Clinic, NRC License Number 25~01051-01

Dear Mr. Torres:

Please amend the above referenced license to indude the following: 1. Please add Daniel J. Lewis, MS, as an authorized medical physicist for gamma stereotactic

, device (Gamma Knife).

If you have questions or require additional information, please contact me at 925-550-7720. Thank you for your assistance with this request.

Christopher Fitz, JD, MS, ABSNM Radiation Safety Officer Billings Clinic

2800 Tenth Avenue North - P.O. Box 37000 Bl/Ongs, Montana 59107-7000 Biiiings Clinic Hospital (406) 65l-4000 .Billings Clink; (406) 238 2500 www.billingsclinic.com · -

rNRC FORM 313A (AMP) U.S. NUCLEAR REGULATORY COMMISSION 1~1~111 •• .,,

!><JI" ~i..

/~. ~· °\ AUTHORIZED MEDICAL PHYS. ICIST TRAINING AND ~ ~ ·, . : EXPERIENCE AND PRECEPTOR ATTESTATION

APPROVED BY OMB: NO. 31IO-Cl120 EXPIRES: (0113112016)

~, · r_/ [10 CFR 35.51) .. ....... Name of Proposed Authorized Medical Physicist

Doniel J LL"WiS

• Requested O 35.400 Ophthalmic use ofstrontium-90 0 35.600 Teletherapy unit(s) Authorization{s)

(check all that apply) 0 35.600 Remote afterloader unit(s) f.Z] 35.600 Gamma stereotactlc radiosurgery unit(s)

PART 1-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.

0 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.

0 2. Current Authorized Medical Phvslclst 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, · Educatlol'l.Traln!Oq.and Experience for Proposed Authorized MedicalPhvslcist

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 r~-- ·-College or UnlversiiY -- · ·-·"

-- -- - -- -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.

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

supervision of who meets the requirements for an

Authorized Medical Physicist.

AND

0 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.

I

1

NRC FORM 31~ tAMPI (01·20161 PAGE1

NRC FORM 313A (AMPt U.S. NUCLEAR REGULATORY COMMISSION I~ 1.Mlil

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

3. Educatlon1 Tralaiog1 and Exeeritnce for Proeosed Autho[jzed Medical Ph:aicist (continued)

b. Supervised Full-Time Medical Physics Training and Work Experience (continued} If more than one supervising individual is necessaty to document supervised training, provide multiple CQpies of this page.

Description of Training/ Location of Training/License or Permit Number Dates·of Dates of Work Experience of Training Facility/Medical Devices Used+ Training* Experience* I

Medical Physics

Performing sealed source leak tests and Inventories

Performing decay correclions

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

Pelforming 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 unlt(s), stereotactlc radlosurgery unlt(s), remote after loading unit(s)

Supervising Individual*" License/Pennit Number listing supervising individilal as an authorized Medical Physicist

tor the following types of use:

D Remote afterloader unlt(s) D Teletherapy unlt(s) D Gamma stereotactlc radiosurgery unit(s)

+ Training and wor1c experience.must be conducted In dlnlcal radiation facilities Ulat provide high-energy ex1emal beam the1apy (photons and electrons with energies greater than or equal to 1 miUlon eleciron volts) and brachytherapy seivlces. . 1 year or Ful-llme medical physics training and 1 year of full time work experience cannot be concurrent .. If the supervising medleal physicist Is not an au1hotlzed medical physicist, the licensee must submit evidence that the supervising medical physicist meets the trairiing and experience requirements In 10 CFR 35.51 and 35.59 for the types or use for which the Individual Is seeking authorization.

NRC FORM 313A (AMP} (01·2018) PAGE2

NRC FORM 313A (AMP) U.S. NUCLEAR REGULATORY COMMISSION ~1~181

AUTHORIZED MEDICAL PHYSICIST TRAINING.AND EXl'ERIENCE AND PRECEPTOR ATIESTATION (continued)

3. Education. Training. and Experience for Proposed Authorized Medical Phvs!c;lst lcontlnued)

c. Describe training provider and dates of tr:alning for each type c:if use for which authorization is soughL

Description of Training

Hands-on device operation

Safety procedures for the device use

- .. _.:-_._ .

Clinical use of the device

Remote Afterloader

-t I

I i .

I

Training Provider and Oates

Teletherapy I Gamma Stereotactic Radiosurgery

- 1-

------··-

01/15-06/15 University of Kentucky - Lexington, KY 07115-01116 Billings Clinic -Billings, MT

01115-06/15 University of , Kl.-ntucky • Lexington; KY 07/15-01/16 Billings Clinic -Billings, MT

01/ts - 06115 University of Kentucky • Lexington, KY 07/lS-01/16 Billings Clinic -Billings. MT

01/15-06/15 University of

Treatment planning Kentucky- Lexington. KY sy&tem operatiOn 07/15-01/16 Billings Clinic·

l

. 1 1 Billings. MT

~=l~!iv~C~ ~~ "'-~-~:'Z1censeJPermit.Number UstingsupeMsing individual as an authorized1· ~ •-uaiy ro ........,.nr 1upen,/11dfl9/n*'IJ, pmid• mulllpl• copes ol , MedicaLPhyslast lllir,.,../

z.S-6\oS I -o\

I for the following types of use:

0 Remote afterloader unit(s) l . . 0 Teletherapy unlt(s) 0 Gamma stereotactlc radlosurgery unit(s)

If Applicable:

I ·· A~thorl~a-uo_n_~ .. -u_gh_r_ j __

i 35.400 Ophthalmic Use lof strontium-90

I

Device

d. Skip to and complete Part II Preceptor Attestation.

NRC FORM 31:i.t. (AMP) · IOl•ZOUSI

f Training Provided By Dates of Training

l _J

i I

l ' _____ f

PAGE3

NRC FORM 313A (AMP) U.S. NUCLEAR REGULATORY COMr.tSSION (01-2018)

AUTHORIZED r.!EDICAL PHYSICIST 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 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.

Rrst Section Check one of the.following:

1. Board Certification

0 1· attest that - N...n;Di Prapoaed Ailtii'Difiiidu9ciciiiP'1ysidSI

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

OR 2. Education. Tralnina, and Experience

has satisfactorily completed the requirements in

i;tJ I attest that ~~~el J L~~~~--~~ ·--- .. - . - ---- . - -~·- has satisfactorily completed the 1-year of full-time Name or Proposed Authorized Medical Phyllidst

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

•• os •••••••••••••••~••••••••••••••••• a ••••••••••••••••••••••••

Second Section Complete the following:

AND

~ I attest that ~~!.~~~~~ .. _ ·--···---·-·- __ ... __ has training for the types of use for which authorization Name af Pniposed Aulhorized Medical Phylic:iSI

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:

ps1 I attest that .Daniel J Lewis has achieved a level of competency sufficient to '""'Ni.nttr pmpo&eciAui.;.;zeci-Mi ltiGiifiit."Ya1ciat

function independently as an Authorized Medical Physicist for the following:

D 35.400 Ophthalmic use of str'ontium-90 0 35.600 Teletherapy unit(s)

D 35.600 Remote afterloader unlt(s) [t] 35.600 Gamma stereolactic radiosurgery unll(s)

~--····--·-··--~---·······-·····-······--······---·-·········· AND Fourth Section Complete the followlng for preceptor attestation and signature:

~ I meet the requirements In 1 D CFR 35.51, or equivalent Agreement State requirements for Authorized Medical Physicist for the following:

D 35,400 Ophthalmic use of strontium-90 0 35.600 Teletherapy unit(s}

'l2SI 35.600 Remote afterloader unit(s) l2J. 35.600 Gamma stereotactic radiosurgery unit(s)

Nam& of Preceptor rsi~-;J/~ !Telephone Number··-·t0ate ..

THOW1iq.5 -~· ~LQ_~J~ .. I Kl ~--~O(f-'Hf- 1112-£11 /16 LicenseJPennlt Number/Facility Name

1. S- o' o')' 1 - o 1 s, JI h-,s C/:'lt\'-<-NRC FORM 313A(AMPI {01-20181 PAGE~

th 5 9 0 2 1 2

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

DATE

02/22/2016

NAME AND ADDRESS OF APPLICANT AND/OR LICENSEE LICENSE NUMBER

Mr. Christopher K. Fitz, J.D., M.S. Radiation Safety Officer Billings Clinic Department of Nuclear Medicine P.O. Box 37000 Billings, MT 59107

This is to acknowledge the receipt of your:

[{]LETTER and/or 0 APPLICATION

25-01051-01

MAIL CONTROL NUMBER

590212

LICENSING AND/OR TECHNICAL REVIEWER

CH

DATED: 02/17/2016

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

[Z] AMENDMENT D TERMINATION D NEWLICENSE D RENEWAL

D D

There were no administrative omissions identified during our initial review.

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 fill out NRC Form 531, located at the following link:

http://www.nrc.gov/reading-rm/doc-col lections/forms/n rc531. pdf

Send the completed NRG 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 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 - 8 1600 E. Lamar Boulevard Arlington, TX 76011-4511 (817) 200-1140

NRC FORM 532

(1-201~.;r

BElWEEN:

Accounts Receivable/Payable and

Regional Licensing Branches

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

Program Code: 02230 Status Code: Pending Amendment Fee Category:7A 7C Exp. Date: Fee Comments: CODE 23 Decom Fin Assur Reqd: N

License Fee Worksheet - License Fee Transmittal A.REGION

1. APPLICATION ATTACHED Applicant/Licensee: BILLINGS CLINIC

Received Date: 02/17/2016 Docket Number: 3002389 Mail Control Number: 590212 License Number: 25-01051-01 Action Type: Amendment

2. FEE ATTACHED

Amount:

Check No.:

3. COMMENTS

Signed:

Date:

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

1. Fee Category and Amount: ---~~~~~~~~~~~~~~~---

2. Correct Fee Paid. Application may be processed for:

Amendment:

Renewal:

License:

Signed:

Date:

1