HEADQUARTERS, US ARMY MEDICAL …The Radiation Safety Officer (RSO) for this license is 1 LT Luis A Huitron. 2. The Radiation Safety Committee has reviewed and approved these actions

DEPARTMENT OF THE ARMY HEADQUARTERS, US ARMY MEDICAL DEPARTMENT ACTIVITY

REYNOLDS ARMY HEAL TH CLINIC 4301 WILSON STREET

FORT SILL, OK 73502-9042

REPLY TO ATTENTION OF

RECEIVED

JUN 1 4 2018 MCUA-PMR

DNMS 11 June 2018

MEMORANDUM FOR U. S. Nuclear Regulatory Commission, Region IV, 1600 E. Lamar Blvd, Arlington, Texas 76011-4511

SUBJECT: Amendment Request for US Nuclear Regulatory Commission (NRG) Byproduct Material License Number 35-10202-01

1. Request NRG License No. 35-10202-01 is amended with the following change:

a. Add Dr. Howard Harper MD, as an authorized user to prescribe, prepare and administer radiopharmaceuticals for medical diagnosis and therapy in accordance with 10 CFR 35.100 and 35.200. Enclosure 1 contains Dr. Harpers's supporting documents for addition as an authorized user.

b. Delete CPT William C. House, as Radiation Safety Officer.

c. The Radiation Safety Officer (RSO) for this license is 1 LT Luis A Huitron.

2. The Radiation Safety Committee has reviewed and approved these actions.

3. The point of contact for this memorandum is 1 LT Luis Huitron at (580) 704-6118 [email protected].

2 Enclosures

CF:

,? ,1-r-LU IS A HUITRON 1LT, MS Radiation SPllat.¥cOfficer

C Immediate R11e1N J'l NOffllll Rtleau

RAHC Radiation Safety Committee Members RMC-C Command Radiation Safety Officer

NON-PUBLIC 0 A.3 Senaftlve-Stcurlty ~ C A.7 Senaltfva Internal Q othlr::--:.-----

Revltwlr:'l<n, \\

NRC FORM 313A (AUD) (06-2016)

U.S. NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION APPROVED BY 0MB: NO. 3150-0120

EXPIRES: 06/30/2019 (for uses defined under 35.100, 35.200, and 35.500)

[10 CFR 35.190, 35.290, and 35.590]

Name of Proposed Authorized User

Howard Harper

Requested Authorization(s) (check all that apply)

[{] 35.100 Uptake, dilution, and excretion studies

[{] 35.200 Imaging and localization studies

D 35.500 Sealed sources for diagnosis (specify device}

State or Territory Where Licensed

Oklahoma

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.

D 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

1 testing the eluate for radionuciidic

· purity, and processing the eluate 'with reagent kits to prepare labeled : radioactive drugs f-

Supervising Individual

Location of Experience/License or Permit Number of Facility

Total Hours of Experience: •. .. ---·- -· ·-·· ·· - ·-- ·- . -

Clock Dates of Hours Experience*

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

-· - -NRC FORM 313A (AUD) (06-2016) PAGE1

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

(oe-2016

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

[l] 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

Reynolds Army Health Clinic/License Number: 35-10202-01





Total Hours of Training: 440

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

Clock Hours

120

120

80

40

80

(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:

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) (06-2016)

1000 Total Hours of Experience:




1440

Confirm

[{]Yes

ONo

[Z] Yes

D No

Dates of Training*

March 2018 -May2018

March2018-May 2018

March 2018 -May2018

March 2018-May 2018

March2018 -May2018

Dates of Experience*

March2018-May2018

March2018 -May 2018

PAGE2

lh609099


coe-2015

> 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:

Calculating, measuring, and safely preparing patient or human research subject dosages



Using administrative controls to Reynolds Army Health Clinic/License Number: prevent a medical event involving the 35-10202-01 use of unsealed byproduct material

. Using procedures to contain spilled byproduct material safel:.' nnd using proper decontamination procedures


· Administering dosages of radioactive Reynolds Anny Health Clinic/License Number: drugs to patients or human research 35_10202_0 1 subjects

Eluting generator systems appropriate · Reynolds Army Health Clinic/License Number: for the preparation of radioactive 35_10202_01 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

Confirm

[Z) Yes

ONo

[Z] Yes

0No

[Z) Yes

O No

[Z) Yes

D No

[{]Yes

O No

Dates of Experience"'

March 2018 -May 2018


March 2018 -

. May 2018


March 2018-May2018

Supervising Individual License/Permit Number listing supervising individual as an authorized user

• Randall Behrmann Reynolds Army Health Clinic/License Number: 35-10202-01

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

D 35.190 D 35.290 [Z] 35.390 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) (06-2016) PAGE3


(00-2016

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

PART 11- PRECEPTOR ATTESTATION

Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each. (Not required to meet training requirements in 35.590)

By checking the boxes below, the preceptor is attesting that the individual has knowledge to fulfill the duties of the position sought and not attesting to the individual's "general clinical competency."

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

For 35.190

Board Certification

D I attest that --- -····


has satisfactorily completed the requirements in

1 O 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

[lJ I attest that Howard Harper 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 competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100.

For 35.290

Board Certification

D I attest that has satisfactorily completed the requirements in - . -


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

OR Training and Experience

[lJ I attest that Howard Haper has satisfac:.torily completed the 700 hours of training - -·-·


and experience, including a minimum of 80 hours of classroom and laboratory training, required by 10 CFR 35.290(c)(1 ), and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100 and 35.200 .

•.................................•............•.............•............•.............•........•...•........•. Second Section Complete the following for preceptor attestation and signature:

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

[lJ 35.190

Name of Preceptor

Randall Behrmann

[lj 35.290

License/Permit Number/Facility Name

35-10202-01/Reynolds Army Health Clinic

NRC FORM 313A (AUD) (06-2016)

D 35.390 D 35.390 + generator experience

PAGE4

tS = -

\ ..

DEQ FORM #410-374 (07/14)

OKLAHOMA DEPARTMENT OF ENVIRONMENTAL QUALITY

MATERIALS LICENSE

' PAGE _1_ OF __L PA~ES

A nendment No. 135

I I

,uant to the Oklahoma Radiation Management Act (27A 0.S. §2-9-101, et seq.) and the Oklahoma Radi~tlon Managerr ent Rules (Rules) at Oklahoma Administrative Code (OAC) 252:410, Including rules incorporated by reference from Trtle 10 of the Code of Federal Regulations, and In reliance on statements and representations heretofore made by the licensee, a license Is hereby issued authorizjng the license):! to receive, acquire, possess, and transfer the source(s) of radiation (byproduct, source and special nuclear material, accelerator produced material, r 1dium sealed sourpes and/or radiation machines) designated below; to use such source(s) for the purpose(s) and at the place(s) design~ted below; anc to deliver or tranSfer such material to persons authorized to receive It in accordance with applicable rules. This license is subject to a,1 applicable nltes and orders of the Oklahoma Department of Environmental Quality (DEQ) now or hereafter in effect and to any conditions specified below. 1

i i Licensee

1. Southwestern Medical Center, LLC

I

In accordance with applica~ion material dated

Apni2a,201e I 3. License number OK-10p69-02 is amended in

its entirety to read as follows:

2. 5602 Southwest Lee Boulevard

Lawton, Oklahoma 73505

4. Expiration date May_31j 2026

5. DEQ Login No.

22.83.86 I 6. Byproduct Material· as defined in OAC 7. Chemical and/or physical form

252 :410-10-2(b )(1 }, soutce or special nuclear material

A. Any byproduct material identified in OAC,252:410-10-35(a)(4)(A) (10 CFR 35 .. 100)

B. Any byproduct material identified in OAC 252:410-10-35(a)(4)(C) (10 CFR 3.5.200)

C. Any byproduct material identified in OAC 252:410-10-35(a)(5)(A) (10 CFR 35.300)

D. Any byproduct material identified in OAC 252:410-10-31 (2)(H) {10 CFR 31.11)

A.

B.

C.

D.

Any radiopharmaceutical identified in OAC 252:410-10-35( a)( 4 )(A) {10 CFR 35.100)

Any radiopharmaceutical identified in OAC 252:410-10-35(a)(4)(C) {10 CFR 35'.200), except gases.

Any radiopharmaceutical identified in OAC 252:410-10-35(a)(5)(A) {10 CFR 35.300)

Prepackaged Kits

I 8. Maximum amount th1 t licensee may

possesJ at any one time under this license i

A As lneeded

I

I

I I B. Aj needed

I C. 5qo milliquriE s

I

D. As !needed I

i !

I I I

116090 39

.. ! I

DEQ FORM #410-374A (07/14) OK DEPT OF ENVIRONMENTAL QUALITY PAGE 2 OF 3 PAGes

MATERIALS LICENSE SUPPLEMENTARY SHEET

License Number OK-10669-02 DEQ Login No. 228386

Amendment No.

35

9. Authorized use I A. Medical use described in OAC 252:410-10-35(a)(4)(A) {10 CFR 35.100). \ B. Medical use described in OAC 252:410-10-35(a}(4}(C} {10 CFR 35.200). C. Medical use described in OAC 252:410-10-35(a)(5)(A) (10 CFR 35.300). I D. In vitro studies.

I

CONDITIONS

10. Locations of use: A. 5602 Southwest Lee Boulevard, Lawton, Oklahoma.

11. Radiation Safety Officer: Nathan Elfrink, M.D.

'

I

I 12. Authorized Users: I i

A. Byron H. Christie, M.D;, for material identified in 10 CFR 35.100, 35.2ooj 31.11, as adopted by reference in OAC 252:410-10-31 and 35, and for 1-131 for diagnqsis and treatment of hyperthyroidism and cardiac dysfunction.

B. Richard F. Gastello, M.D., for material identified in 10 CFR 35.100, 35.20C, 31.11, as adopted by I reference in OAC 252:410-10-31 and 35, and oral administration of sodiun iodide 1-1 !1.

C. John T. Doan, M.D., for material identified in 10 CFR 35.300 limited tol oral admi,istration of I sodium iodide 1-131 and parenteral administration of any radionuclide othef' than beta emitters, or photon-emitting radlonuclides with a photon energy less than 150 keV as dopted b) reference in OAC 252:410-10-31 and 35.

1

D. Nathan D. Elfrink, M.D., for material identified in 10 CFR 35.100, 35.200; /and 31.11 as adopted i by reference in OAC 252:410-10-31 and 35 and for oral administration of spdium iodlc le 1-131. !

. . I I

E. Thomas S. Griggs, M.D., for material identified in 10 CFR 35.100, 35.200, !and 31.11 as adopted ! by reference in OAC 252:410~10-31 and 35 and for oral administration of spdium iodic e 1-131. i

I I i

F. HO'Ward Harper, M.D., for material identified in 10 CFR 35.100, 35.200, 135.300, a1 d 31 .11 as adopted by reference in OAC 252:410-10-31 and 35. j l

G. Vaughn G. Marshall, M. D., for material identified in 10 CFR 35.100, 35.2PO, 35.300 and 31.11 I as adopted by reference in OAC 252:410-10-31 and 35. I

I

H. Bassam Saliba, M.D., for material identified in 10 CFR 35.100 and 3p.200 as ::1dopted by 1

reference in OAC 252:410-10-35 limited to nuclear cardiology.

.. I !

DEQ FORM #410-374A(07/14) OK DEPT OF ENVIRONMENTAL QUALITY I PAG I: 3 OF 3 PAG~S

MATERIALS LICENSE SUPPLEMENTARY SHEET

License Number OK-10669-02 DEQ Login No. 228386

Amendment No.

35

I i I I

I

I I I

I I '

I. Robert F. Sweeney, M.D., for material identified in 10 CFR 35.100 andl 35.200 a~ adopted by

1

reference in OAC 252:410-10-35 limited to nuclear cardiology. I J. Vijay Velury, M.D., for material identified in 10 CFR 35.100 and 35.200 a$ adopted by reference

in OAC 252:410-10-35 limited to nuclear cardiology. I I

K. Mark E. Whitley, M.D., for material identified in 10 CFR 35.100, 35.200, ~nd 35.3011 as adopted

L.

by reference in OAC 252:410-10-35. I

Ronald G. Woodson, M.D., for material identified in 10 CFR 35.100, 135.200 ard 31.11, as adopted by reference in OAC 252:410-10-31 and 35.

13. In addition to the possession limits in Item 8, the licensee shall further re,rict the p )ssession of : licensed material to quantities below the minimum limit specified in OA 252:410 10-30-(3)(E) : {10 CFR 30,35(d)} for establishing decommissioning financial assurance.

I 14. Except as specifically provided ·.otherwise in this license, the licensee shall !conduct itu program in

accordance with the statements, representations, and_ procedures contai~ed in the documents, including any enclosures, listed b~low, except for minor changes in the medical use rac iation safety procedures as proyided in OAC 252:410-10-35{a)(2)(B) {10 CFR 35.26}. The lRadiation Vlanagement Rules shall govern unless the statements, representations, and proced~res in tti e licensee's application and correspondence are more restrictive than the Rules. I

I I A. Application dated April 26, 2016 [

FOR THE DEPARTMENT OF ENVl~ONMENT~L QUALITY 1

By 111.~ {)9 w Mike· Broderi~k- · i Environmental Programs Manager Radiation Management Section Land Protection Division

... '"'" "'

' j

LU > 1.LJ

LU a::

N

8 D

.,

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11609099

NRC FORM532 U.S. NUCLEAR REGULATORY COMMISSION (05-2016) ~~-..;\ !¥~ ACKNOWLEDGEMENT - RECEIPT OF CORRESPONDENCE ; .

\ r/ .......

Name and Address of Applicant and/or Licensee Date

I 06/18/2018 I 1 Lt Luis A. Huitron License Number{s}

I Radiation Safety Officer I 35-102102-01 Department of the Army

Mail Control Number~s~ Reynolds Army Health Clinic I 4301 Wilson Street I 609099

Ft Sill, OK 73503-9042 Licensina and/or Technical Reviewer or Branch

C. Hill

This is to acknowledge receipt of your: 0 Letter and/or D Application Dated: 06/11/2018

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: httg://www.nrc.gov/reading-rm/doc-collections/forms/nrc531.gdf

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: 02120 Status Code: Pending Amendment Fee Category: 7C Exp. Date: 01/31/2023 Fee Comments: Decom Fin Assur Reqd: N

License Fee Worksheet - License Fee Transmittal A. REGION

1. APPLICATION ATIACHED Applicant/Licensee: Department of the Army

Received Date: 06/14/2018 Docket Number: 3002902 Mail Control Number: 609099 License Number: 35-10202-01

Action Type: Amendment

2. FEE ATIACHED

Amount:

Check No.:

3. COMMENTS

I

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

Documents

HEADQUARTERS, US ARMY MEDICAL …The Radiation Safety Officer (RSO) for this license is 1 LT Luis A Huitron. 2. The Radiation Safety Committee has reviewed and approved these actions