st. alphonsus regional medical center; amendment request ...f,u~:hrmc cardio & resp care 541 881...

12SEPII

Saint Alphonsus St Alphonsus RMC 1055 N Curtis Rd BoisR 10 83706 208-367-3124

St. Alphonsus Regional Medical Center 1055 N. Curtis Rd. Boise, ID 83706

NRC Region IV 611 Ryan Plaza Dr., Suite 400 Arlington, TX 76011 Fax: 817-860-8263

RE: Amendment to License Number # 11-27306-01

Item I.B Item :2

Item 3 Item 4

Item 12.B

Amendment to License number 11-27306-01 St. Alphonsus Regional Medical Center 1055 N. Cmiis Rd. Boise, ID 83706 Same as Item 2 Timothy B. Stack, MS, DABR, Medical Physicist 208-367-3124

Authorized Users Materials and Use

Add Benjamin K. I-lOIn, MD 35.100 35.200 35.300

Mark R. Papenfuss, MD 35.100 35.200 35.300

Janet M. Cegnar, MD sub items 9A and 9B

S[p 11201/

(see previous NRC License #ORE-90367, attached with Oregon equivalence)

Remove

Sincerely,

Joseph Brooks, MD sub items 12 A. Radioactive material for the therapeutic use of sealed radioactive sources in manual brachytherapy 1 OCFR35 .400. 12 B. Radioactive material for the therapeutic use of ophthalmic devices containing Sr-90 10CFR35.400. 12 C. Radioactive material for therapeutic use of sealed sources in a HDR Remote Afterloading Brachytherapy Unit. Subpart H of I OCFR35. (See previous NC Materials Licence attached)

N/A

Timothy B. Stack, MS ,RSO, SARMC, 208-367-3124

1h575992

F,u~:HRMC CARDIO & RESP CARE 541 881 7174 07/07/2011 14:03 #302 P.002/004

STATE OF OREGON DEPARTMENT OF HUMAN SERVICES.

PUBLIC HEALTH DIVISION

RADIOACTIVE MATERIALS LICENSE

Page 1 of 3 Pages License No. ORE-90367 Amendment Number 25

ursuanl to Section 274 of the Atomic Energy Act of 1954 as amended, Oregon Administrative Rules for the Control of Radiation and in reliance on statements and representations made by the Licensee referred to below_ This license is hereby issued authorizing the LiceDSee to transfer, receive, possess and use radioactive material(s) designated below_ This license is subject to all applicable rules, regulations, and orders now in effect by the DHS PUBUC HEALTH DIVISION and all conditions ~l'ccified below.

In accordance with renewal application dated December 28, 2010, Oregon Radioactive Materials License Number ORE-90367 is amended in its entirety to read as follows:

1. Name Saint Alphonsus Medical Center-Ontario, Inc.

2_ Address 351 SW 9th Street Ontario, Oregon 97914

6_ Radioactive materials (element imd mass number)

A. Any radioactive A.

'I. Chemical and/or physical fonn

Any radiopharmaceutical

3. license Number

ORE-9ci367

4. Expiration Date

~1:-F:¢Sfillli¥~~V4D'rp'c '1

5_ License Type

Medical Diagnosticffherapy Q1vfP

8. Maximum quantity licensee may possess at any one time

A. As needed. material identified in identified in OAR 333-116-OAR 333-116-0300 0300

B. Any radioactive B. Any radiopharmaceutical B. As needed. material identifi ed in identified in OAR 333-116-OAR 333-116-0320 0320

C. Any radioactive C. Any brachytherapy source C. 29.6 GBq (800 millicuries). material identified in identified in OAR 333-116-OAR 333-116-0420. 0420

9. Authorized usc.

A. Medical use as described in OAR 333-] 16-0300.

B. Medical use as described in OAR 333-116-0320.

C. Medical use as described in OAR 333-116-0420.

CONDITIONS

10. Licensed radioactive material shaH be used only at the licensee's facilities stated in Item 2 above.

1 L Thislicense is s.ubject to and void without an annual validation certificate. Insofar as the licensee has submitted the proper fee prior to the expiration of a validation certificate, such existing validation certificate shall not expire until the issuance of a new validation certificate for the then current fiscal year.

ih57599

Fr""l:HRMC CARDIO & RESP CARE 541 881 7174 07/07/2011 14:03 #302 P.003/004

STArn OF OREGON DEPARTMENT OF HUMAN SERVICES

PUBLIC HEALTH DIVISION


Page 2 of 3 Pages License No. ORE-90367 Amendment Number 25

Continued from Page 1

12.

13.

14.

A.

'CONDITIONS (cont.)

The Radiation Safety Officer for the activities a~thorized by this license is Robert T. Yeager, M.D.

B. ' The Assistant Radiation Safety Officers for the activities authonzed by this license are Janet

A.

B.

A.

Cegnar, M.D., John GambiI;o, M.D., and David O. Wood, M.D. ; . " .. -.'~

" ,< Licensed radioactive materia11isted in Item 6 above is authorized for use by, or lUlder the supervision of, the following individuals for the materials and uses indicated:

NAME

Janet M. Cegnar, M.D. Subitems A and B John Gambino, M.D. Subitems A and B Robert T. Yeager, M.D. Subitems A and B David O. Wood, M.D. ., ,Sgbit~p!~. A and B

Chadcs E. SOOth, MD. . • ." ·':;i~t~~·,;.;~ . .; .. The Medical Physicist to~:w.~~ ~QtiYities;,aqtli61':iz~d~f:fui'rli~;ense is:

• /~,:,:: ••• ,7 /,;;,' ":;':; :"i(;~~;:r.::~:::· i ';,:;:r?<c, Rodney J. Wnnmer: Ph,D.,'~' ." ~, ~- ""':"'.:" ~.

; ~~".' ~';:: J~l ,-:.:~,. " • ,\, ,', ';:"';~ t',::' Notwithstanding the;!~quk¢Pient tQ;pr~p<d~·an~it~i~·iIttigs p:t1I990rdance with the package insert,

'~"'-"-':' ".,', ;:'~_ .. t'I,_::~~O""'~~'.~_"':'!:?...;·.~\l:·':" .~-:.<

if, in the judgemenfof tp.~ pliysician as:~ 'ap~oriZ;~EJ¥;t{r, 4ep~es from the package insert, or ~e ofunapprove~·:~g~?'is.~~~~~~~~ m~~~f§f~~~ir,lll~(i<Hfn such procedures consistent WIth goodprofesslO.na1lI,ledl~1 pr.~YU~~ ~t~9-~~~'bfttle,~Ore~~nBoard ofPhannacy, ilie Oregon Board of Medical ExaPri.ners;, aQgz6Filie'Qf~gqn Ra41ation Advisory Board, as appropriate. " ..>. ~:,.'V "",c" '/,' ,;;

, B. Procedures shall be done by 91." und~r the s}tpci;ryisiOIl of persons whose training meets the requirements in OAR 333-116 and' ~h:aIl. p~lli'~~Gdrdance with safe radiation safety procedures and ALARA in OAR 333-120. Radi~phannaceuticals shall not be used in humans until their ,pharmaceutical quality and assay have been established. Records documenting radioactive material use described in A. of this condition shall be kept by the licensee until inspection by the Agency.

15. Insofar a~ the licensee restricts the possession of unsealed byproduct material or readily dispensable source to quantities less than] 04 or 105 of the applicable limits in AppendL"{ Bof 1 0 CFR Part 30, as specified in 10 CPR 3035(d), or 40.36(b), or 70.25(d), the licensee is not required to provide financial assurance pursuant to OAR 333-102-0200(6).

Frolll:HRMC CARDIO & RESP CARE 541 881 7174 07/07/2011 14:03 #302 P.004/004

STATE OF OREGON DEPARTMENT OFHUMAN SERVICES

PUBLIC HEALTH DNISION


Page 3 of3 Pag~s License No. ORE-90367 Amendment Number 25

Continued from Page 2 CONDITIONS (cont.)

16. Notwithstanding the requirements in OAR 333-120-0180 and 333-116-0260, the licensee is authorized to release a patient who has been administered therapeutic radiopharmaceuticals or permanent implants containing radioactive material if the total effective does equivalent (TEDE) to any other individual is not likely to exceed 500 mrem. Upon release, the licensee shall:

17.

(l) Provide the patient with written instructions to maintain doses to other individuals as low as reasonably achievable jf the TEDE to any other individual is likely to exceed 5 millisieverts (0.5 rem);

(2) Maintain, for three years after date of release, a record of the basis for authorizing patient release if the TEDE is calculated:

A. using the retained activity rather than the activity administered B. using an o~cupancy factor less than 0.25 at 1 meter C. using the biological or efff;\ctiv¢:]jij]f.1ife"Qr D. considering shield4lg'hy-ti~§,~~,t ,_. ., .

• ,..- ._r • -.~' ,,-.. • - •• ' ;'~:, l~ <::.I~~ _<,.', ~':'~'" ..... ~:-~ .:;" .. ".. ~'. .,~.~'.;~~;~»\. ..

(3) Maintain a record, fOI:Jbi'~§'yemiaft~t"th{f~~~te.O;f:(eI@e, 'showing that instructions were provided to a breast;f~~ij~i~~~~m~;~PJitiQJiA.~·s~:t(f~.~ infant or child from continued breast-feeding coulq 'f~~WidJ1··iCrED~exEgelling'S.IDilJisj~y,~r.(s (0_5 rem).

. (.1 '.;;~~ri,<:' /;:'-~\~,,:~t:~,·,,<~; .. li:';<:~'}i~ \~~ '~\~~;"~.\ . . Except as specifically proNiJ~~d' Qth~~$e..c:ijr~s:ijge~£}~t.!i~.\licenS~~fo,E1l;!.aI1 conduct its program in

l . ,.!,fj_~r-!; " ',:' •.•. .: _, .:. - .' "-:--- t:~l'--' ..,.-" ..... ""~_,.".~.;,.".: .. : ~,._~~,:' . ~.' "'::"11";; -..it:

accordance with the statements, tep:resentatI()ri~,·an<;i:pi6Ced].te~ f:Q~taiJ:).ed in the documents, including • ~' '.'" ~k_ • ~ '*.~ ·;:,..;,-i" ,'~ ''';'''' '. ~.;>"",,,'i"~""''; ....... ~ .• ....;--! ~."- .. ~ iT 1: ~'~.,,-! I r .

any ~nclo~ures listed beloW .. ~XRepr{9E:'~~r!~~~~~:#tw:~4i~al;t~~);?clia~o~ safety procedures as proVided m OAR 333-116-",0370;: 1J1~ ()~ego~Rill:~s:f9Ftl1e,CJjntrol ofRadiallon shall govern, unless the statements, representations "twd ptQ~e4l:l.r.~Si,ffi:;1h~;~j~i':l~e~s'J,pp;licati.9h and correspondence are more restrictive than the rules. I, '" . - .•• ':; :'n2~;'" /'" ',e,' .. ,?

A. Renewal application dat~d D~~embet>cf.8,:'~Ql{tf .. sign~~Fls~ Robert Yeager, M.D., RSO, & Richard L. Palagi, CEO, submitted under cQy.~r-)~~er cl?tedlanuary 28, 2011.

Date: February 11, 2011

Todd Carpenter, geT Radioactive Materials Licensing Program

Oregon Equivalence

333-116-0300

Use of Unsealed Radioactive Material for Uptake, Dilution or Excretion Studies for Which a Written Directive Is Not Required

(I) A licensce may use any unsealed radioactive material for a diagnostic use involving measurements of uptake, dilution or excretion that:

(a) The Food and Drug Administration (FDA) has accepted a "Notice of Claimed Investigational Exemption for a New Drug" (lND) or approved a "New Drug Application" (NDA); and

(b) Is obtained from a manufacturer or preparer licensed under 333-102-0285 or equivalent Nuclear Regulatory Commission or Agreement State requirements; or

(c) Is prepared and compounded by an authorized nuclear phal111acist, a physician who is an authorized user, or an individual under the supervision of either as specified in OAR 333-116-0100; or

(d) Is prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (lND) protocol accepted by FDA.

(2) A licensee using a radiophan11aceutical specified in section (1) ofthis rule for a clinical procedure other than one specified in the product label or package inseli instructions t()r use must comply with the product label or package insert instructions regarding physical 1'01111, route of administration and dosage range.

Stat. Auth.: ORS 453.635 Stats. Implemented: ORS 453.605 - 453.807 Hist.: HD 1-1991, f. & celio ef. 1-8-91; PH 3-2003, f. & celio ef. 3-27-03; PH 31-2004(Temp), f. & celio ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & celio ef. 12-1-04; PH 12-2006, f. & celio ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07

Imaging and Localization

333-116-0320

Use of Radiopharmaceuticals, Generators and Reagents Kits for Imaging and Localization Studies for Which a Written Directive Is Not Required

1

(1) A licensee may use any radioactive matelial in a diagnostic radiopharmaceutical, except aerosol or gaseous f01111, or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing radioactive material for:

(a) Which the Food and DlUg Administration has accepted a "Notice of Claimed Investigational Exemption for a New DlUg" (IND) or approved a "New Drug Application" (NDA); or

(b) Which is prepared and compounded by an authorized nuclear phan11acist, a physician who is an authorized user, or an individual under the supervision of either as specified in OAR 333-116-0100; or

(c) Obtained from a manufacturer or preparer licensed under 333-102 and 333-116 or equivalent Nuclear Regulatory Commission or Agreement State requirements.

(2) A licensee using radiopharmaceuticals specified in section (1) of this lUle for clinical procedures other than one specifIed in the product label or package insert instlUctions must comply with the product label or package insert regarding physical f01111 and dosage range.

(3) A licensee must elute generators in compliance with OAR 333-116-0330 and prepare radiophall11aceutica1s from kits in accordance with the manufacturer's instructions.

(4) Technetium-99m pentetate as an aerosol for lung function studies is not subject to the restrictions in section (1) of this rule. Provided the conditions of OAR 333-116-0340 are met, a licensee must use radioactive aerosols or gases only if specific application is made to and approved by the Agency.

Stat. Auth.: ORS 453.635 Stats. Implemented: ORS 453.605 - 453.807 Hist.: HD 1-1991, f & celio ef 1-8-91; HD 1-1995, f & cert. ef 4-26-95; PH 3-2003, f & celio ef 3-27-03; PH 31-2004(Temp), f & celio ef 10-8-04 thru 4-5-05; PH 36-2004, f & cert. ef. 12-1-04; PH 36-2004, f & cert. ef. 12-1-04; PH 12-2006, f & cert. ef 6-16-06; PH 4-2007, f & cert. ef 3-1-07

333-116-0360

Use of Unsealed Radioactive Materials or Radiopharmaceuticals for Which a V/ritten Directive is Required

A licensee may use for therapeutic administration any unsealed radioactive material or radiopha1111aceutical prepared for medical use that:

(1) Has been granted acceptance or approval by the Food and Drug Administration; and

2

(2) Has been prepared by an authorized nuclear phal1TIacist, a physician who is an authorized user on a license from the Agency, other Agreement State, or the U.S. Nuclear Regulatory Commission; or

(3) Has been manufactured and distributed under a license from the Agency, other Agreement State, or the U.S. Nuclear Regulatory Commission; or

(4) Obtained from and prepared by an Agency or Nuclear Regulatory Commission or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or

(5) Prepared by the licensee for use in research in accordance with an Investigational New Drug (lND) protocol accepted by FDA.

Stat. Auth.: ORS 453.635 Stats. Implemented: ORS 453.605 - 453.807 !-list.:!-lD 1-1991, f. & cert. ef. 1-8-91; PH 3-2003, f & cert. ef. 3-27-03; PH 31-2004(Temp), f & celio ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & celio ef 12-1-04; PH 12-2006, f & celio ef. 6-16-06; PH 4-2007, f. & celio ef. 3-1-07

3

AVA MCDEMR

RADIOACTIVE MATji;RIALSBRANCH

RADIATION PROTECTION SECTION .. .

N. C. DEPARTMENT OF ENViRONMENT AND NATURAL RESOURCES

Page 1 of6

. .


Pursuant to North Carolina Regulations for Protection Against RadhltiQnami in reliance on statements and representations

heretofore made by the licensee, a license is .hereby issued anthorizing the!icenseeto receive, acquire, own, possess, trailsfer, and

import radioactive materials ]istedbelo'W; and use such radioactive material forthepurpose(s) andatthe place(s) designated below.

This License is subject to all applicable rules and regulations of the North Carolina Department of Environment and Natural

Resources now and hereafter in effect and to any conditions specified below. .

1. Licensee Name:

2a. Mailing Address:

b. Physical Address:

c. Radiation . Safety Officer:

Moses Cone Regional Cancer Center

Radiation Oncology Department

50 1 North Elam Avenue . .

Greensboro, NC 27403-1199

501 North ElamAvenue Greensboro, NC 27403-1199

Elroy J. Friesen, PhD

3. License No: 041-0021-3 .·.··.·.~i~~II~cT)'(;~2.·

· .• ··· ... ·· .••. :· ..•. ~l~~i.·.···,> 4. Expiration Date: May 31,2012

_J New License W Routine H Corrected Copy

I Renewal I ~l Administrative . Termination

5.a. Amendment No.: 18

b. Issuance Date: June 15,2011

6. . Radioactive Material (element alld mass no.)

7. Chemical alld/orPhysical 8.

Form

Maxiillnm Amount of Radioactivity and/or

Quantity of Radioactive Material which

Licensee May Possess at Any One Time.

A. Gold 198 A. Sealed Source A. No single source to exceed 10 millicuries

B. Iridium 192 B. Sealed Source B. No single source to exceed 4 millicllries

c. Cesium 137 C. Sealed Source C. No single soui'ce to exceed 70 millicllries

D. Palladium 103 D. Sealed Source D. No single source to exceed 7 millicu~ies

E. Iodine 125 E. Sealed Source E. No single source to exceed 2 miUicuries

F. Strontium 90 F. Sealed Source F. No single source to exceed 100 millicuries

G. Iridium 192 G. Sealed Source G. No single source to exceed 12 curies

H. Iodine 125 H. Sealed Sources H. No single cartridge to exceed 110 millicuries

9. AuthOflzed Use:

A.-F. To be used for interstitial, intercavity; or surface treatment of malignant . and some non-malignant diseases in humans in

accordance with a written directive from an authorized user identified by this license

G. To be USed for bronchial, intraluminal, intercavitmy, and interstitial treatment of cancer in humans in a Nucletron microSelectron

. HDR (105.999) Remote Afterloading Brachytherapy Unit in accordance with a written directive from an authorized user identified

by this license.

H. To be used for bronchial, intraluminal, intercavitary, and interstitial treatment Of cancer in humans in a Nucletron Model

seedSeJectron 130.001 Brachytherapy Unit in accordance with a written directive from an authorized user identified by this

license.. . . .

CONDITIONS

10. The authorized place of receipt and use of radioactive material is the licensee's address stated in item 2.b. above

11. The licensee shall comply with the provisions of 15A NCAC 11 .1600 "Standards for Protection Against Radiation," 15A

NCAC 11 .1000 "Notices, Instructions, Reports and Inspections.", and 15A NCAC 11 .0700, "Use of Sealed Radioactive

Sources in the Healing Arts". (The North Carolina Regulations for Protection Against Radiation are contained in 15A NCAC

11.)

RADIOACTIVE. MATERIALS BRANCH RADIATION PROTECTION SECTION

N. C. DEP ARTMENTOF ENVIRONMENT AND NATURAL RESOURCES


Page 2 of6 License No.: 041-0021-3

CONDITIONS (continued):

12. . Radioactive material for the thl.::rapeutic use of sealed radioactive sources in manual brachytherapy (15A NCAC 11. 0117(a) and 10 CFR 35AOO) shall only be used by:

Nancy McBryde Bednarz; MD Joseph P. Brooks, MD Matthew A. Manning, MD John S. Moody, MD . Sarah Elizabeth Squire, MD Stacy WentwOlih, MD

James D. Kinard, PhD, MD Robert J. Mun'ay, MD

B. Radioactive material for the therapeutic use of ophthalmic devices containing S1'"90 (15A NCAC 11. 0 117(a) and 10 CFR 35.400) shall only be used by: .

Nancy McBryde Bednarz, MD Joseph P. Brooks, MD James D. Kinard, PhD, MD Matthew A. Manning, MD John S. Moody, MD Robeli J. Murray, MD Stacy Wentworth, MD

C. Radioactive material for therapeutic use of sealed sources in a HDR Remote Aftel'ioading Bl'achytherapy Unit (l5A NCAC II. bl17(a) and Subpart H 000 CFR 35 uses) shall only be used by:

Nancy McBlyde Bednarz, MD Joseph P. Brooks, MD James D. Kinard, PhD, MD Matthew A. Maiming, MD Jolm S. Moody, MD Robert LMunay, MD Sarah Elizabeth Squire, MD Stacy Wentworth, MD

D. The Authorized Medical Physicist [l5A NCAC 11. 0318(a)] for activities authorized under this license shall be Elizabeth Carey, MS Eh'oy 1. Friesen, Ph.D. Shirley S. Hagemann, MS Vicky L. Howard, MS Benjamin JeremiahSintay, PhD Benjamin Smith, MS Gabrielle Rumley-Smith, MS Jonathan A. Ten-ell, MS David Wiant, PhD

E. The Radiation Safety Officer for the activities authorized by this license shall be Elroy J. Friesen, PhD.

13. For a period not to exceed 60 days in any calendar year, a visiting physician or authorized medical physicist (AMP) is authorized to use the radioactive material under the terms of this license provided the physician or physicist:

A. Has prior written permission ofthe hospital administrator and its Radiation Safety Committee; and

B. Is specifically named as a user or AMP on a N.C. Department of Environment and Natural Resources license, another Agreement State license, US NRC license authorizing use, or is registered as a Qualified Expert with the State of North Carolina pursuahtto ISA NCAC 11 .0205; and

C. Performs only those procedures for which specifically authorized by a license listed in 13. B. above.

14. Radioactive materials shall not be used on humans without the prior approval (if applicable), in accordance with the provisioris of 15A NCAC 11 .. 0356fi·om an authorized user who is either listed in or satisfies the requirements of Condition No. 15. above, or by a visiting physician who satisfies the requirements of Condition No. 16. above.

15. The licensee is authorized to conduct a decay-in-storage program for sealed sources used for therapy in accordance with 15A NCAC 11 .0362 if the licensee:

16. A.

A. stores the sources in such a manner that radiation doses to individual members of the public do not exceed the limits specified in 15A NCAC 11 .l611(a);

B. will not use the sources for any other patient treatment;

Sealed radioactive sources owned orpossessed for calibration and reference standards shall be tested for leakage and/or contamination in accordance with 15A NCAC 11 .0321(c).

RADIOACTIVE MATERIALS BRANCH RADIATlor~ PROTECTION SECTION

N. C. DEPARTMENT OF ENVIRONMENT AND NATURAL RESOURCES

RADIOACTIVE MATERIALS LlCENSE



16. B. Sealed radioactive sources owned or possessed for therapy with a half-life greater than thirty (30) days, other than Hydrogen 3, and in any form other than gas, shall be tested for leakagealld/or contamination prior to initial use and at intervals notto exceed six (6) months, or at other intervals approved by the US Nuclear Regulatory Commission or an Agreement State iii. the Sealed Source and Device Registry. In the absence of a certificate from a transferor indicating that a test has been made within six (6) months prior to the transfer, the sealed source shall not be put into use until tested. .

C. Notwithstanding License Condition 16.A., above, brachytherapy implaJit seeds that are being held in storage before being returned to the distributor or disposed of are required to be tested for leakageaildlor contamination at intervals not to exceed three (3) years. If the interval since the last leak test and the date the seeds are to be returned to the distributor, or disposed of exceeds six (6) months, the seeds must be tested for leakage andlorcontamination prior to shipment back to the distributor or disposal and the leak test certificate must accompany the shipment.

D. . The test shall be capabJeof detecting the presellce of 0.005 micl'ocurie of radioactive material on the test sample, or in the case of radium, the escape of radon at a rate of 0.001 microcurie per 24 hours. The test sample shall be taken fi'om the sealed source or from the sUlfaces of the device in Which the sealed source is permanently mounted or stored on which one might expect contamination to accumulate. Records of leak test results shall be kept in units of microcuries and maintained

. for inspection by the agency.· .

E. If the test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shaH immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with agency regulations. A tepOlt shall be filed within five (5) days of the test with the Radioactive Materials Branch, Radiation Protection Section, Depattment of Environment and Natural Resources, 1645 Mail Service Center,Raleigh, NC 27699-1645, describing the equipment involved, the test results, and the corrective action taken.

F. Tests for leakage andlor contamination shall be performed by the licensee or by persons specifically authorized by the agency to perform such services. . .

17. Sealed sources containing radioactive material shall not be opened.

18. The licensee shall not open needles or standard medical applicator cells containing Cobalt 60 as wire, unless specifically authorized by a condition in this license.

19. The. licensee shall conduct a physical inventory every three (3) months to account for.a11 sealed sources received and possessed under the license. The records of the inventories shall be maintained for two (2) years from the date of the inventory for inspection by the agency and shall include the quantities and kinds of radioactive material, location of sealed sources, and the date of the inventory. .

20. The licensee shall maintain accountability for all brachytherapy sources in storage or in use. Records of source accountability

21.

shall be maintained in accordance with the applicable provisions of 15A NCAC 11 .0702(e) & (t). .

A. Patients administered either diagnostic or therapeutic quantities of unsealed radioactive material, or therapeutic quantities of pennanently implanted sealed radioactive materials may be released in accordance with the provisions of 15A NCAC II .0358.

B. The licensee shall retain all records associated with the release of patients containing radioactive materials, when applicable, for a minimum ofthree (3) years following the administration.

22. The licensee shall perform and document radiation surveys. of patients receiving implants in accordance with the applicable provisions oflSA NCAC 11 .0702(c).

23. Patients containing implants shall remain hospitalized until the implants are removed, except that patients containing Iridium 192, Palladium 103, or Iodine 125 seeds may be released from the hospital provided:

A. the attending physician has determined the seeds are secured and are not likely to be lost by the patient; and

RADIOACTIVE MATERIALS BRANCH RADIATION PROTECTION SECTION


RADIOACTIVE MATERiALS LICENSE



23. The patient has heenreleased in accordance with lSA NCAC 11 .0358.

C. The licensee· shall retain all records associated with the release Of patients containing radioactive nlaterials, when applicable, for a minimum ofthi'ee (3) years following the administration.

24. In lieu of 15A NCAC 11 .0702(c), immediately after retracting the source from the patient into its shielded position in the remote afterloading device, radiation survey shall be made of the patient and the remote afterloadlng device with a calibrated portable radiation detection survey instrument to confirm that the source has been removed from the patient. Records of the survey shall be maintained in lieu of the record required in lSA NCAC II .0702(c).

25. In Ileuofthe sourceillventory described in lSA NCAC 11 .0702(a)(1), the licensee shall:

A. Promptly determine that all sources have returned to the safe, shielded position at the conclusion of each HDR remote brachytherapy procedure.

B. Promptly make a slU'vey of the area of use to corifinn that no sources have been misplaced.

C. Make a record of the survey including survey instrument used, dose rate, time, date and name of the individual making the survey.

D. Retain the record of the survey in lieu of the record required in 15A NCAC I I .0702(a)(1).

26. Prior to initiation of a U'eatment program, and subsequent to each source exchange for each HDR Remote Afterloading Bnichytherapy Unit, a radiation survey shall be made of all areas adjacent to the treatment room with the source in the exposed position. The survey shall clearly establish:

A. That radiation doses to occupationally exposed individuals do not exceed the limits specified in lSA NCAC 11 .1604, .1609, and .1610.

B. That radiation doses to individual members of the public do not exceed the limits specified in 15A NCAC 11 .l611(a).

27. The following shallbe perfonned only by persons specifically authorized by an Agreement State or the NRC to perform such service:

28.

A. Installation, and replacement ofthe sealed sources contained in each HDR Remote Afterloading Bl'achytherapy Unit.

B. Maintenance or repair operations on any HDR remote afterloading brachytherapy unit and associated equipment involving work on the source safe, the source driving unit, 01' other mechanism that could expose the SOlU'ce, reduce the shieldingarouild the source, or compromise the safety of the unit and result in increased radiation levels.

A. Access to the treatment room housing each HDRremote afterloading brachytherapy unit shall be controlled by a door at each entrance.

B. Each entrance to the treatment room shall be equipped with an electrical interlock system that will cause the SOlU'ce to retum to the shielded position immediately upon opening of the entrance door. The interlock system shall be connected in such a manner that the source caMot be placed in the irradiation position until the entrance door is closed and the source "on-off" control is reset at the control panel.

C. Electrica.1 interlocks on each enu'ancedoor to the treatment room shall be tested for proper operation at least once each day of use.

D. In the event of malfunction of the door interlock, the unit shall be locked in the "off' position and not used, except as may be necessary for repair orl'eplacement of the interlock system, until the interlock system is shown to be functioning properly.

RADIOACTIVE· MATERIALS BRANCH RADIATION PROTECTION SECTION





28. E. If the HDR remote afterloadingbrachytherapyunit is used in an accelerator treatment room, it shall not be possible to energize the accelerator and deliver beam intothe treatment room while the remote afterloading device is in use.

29. In addition to the possession limits referenced in Item 8. above, the licensee shall further restrict possession of licensed material to quantities below the minimum limit specified in 15A NCAC 11.0353 for establishing decommissioning financial assurance.

30. The licensee may transport licensed material or deliver licensed material to a calTier for transport, in accordance with the provisions of Section 71.5, Title 10, Code of Federal Regu lations, Part 71, "Packaging of Radioactive Material For Transport. "

31. The licensee shall annually review its Radiation Protection Program for content and implementation [Ref. 15A NCAC 11 .l603(c)]. Documentation of the Radiation Protection program reviews shall be retained for inspection by the agency [Ref. 15A NCAC 11 .1636].

32. The licensee shall institute the provisions of 15A NCAC 11 .1610 when an occupationally exposed woman voluntarily informs her supervisor; in writing, of her pregnancy and the estimated date of conception.·

33. The licensee shall ensure that no individual"member of the public" [Reference: 15A NCAC 11 .0104(81») receives a radiation dose in excess of the limits specified in 15A NCAC 11.1611(a) while conducting licensed operations.

34. Neither this license nor any subsequent amendments shall be deemed to constitute compliance with the requil'ements for health planning review contained in the Certificate of Need Statute, G.S. 131-175 et seq., and regulations promulgated pursuant to that statute. Inquiries concerniilg the Certificate of Need Statute should be addressed to the Certificate of Need Section of the Division of Health Service Regulatioil at (919) 855-3883.

35. . In addition to the possession limits referenced in Item 8. above, the licensee shall fUliher restrict possession of radionuclides listed in the table below to the quantities noted within the table. Sum of fractions for the radionuclides listed below shall not exceed unity: . .

Quantity Quantity Radionuclide (curies) Radionuclide (curies)

Am-241 .................................... 16 Pm-147 ............................ 10,800 Aln~241:Be ........................... ; .. 16 Pu-238 ............................ , 16 Cf-252 ...................................... 5.4 Pu-239:Be ........................ 16 Cm-244 .................................... 13.5 Ra-226 ............................. 10.8 Co-60 ............ ~ ............................ 8.1 Se~75 ................................ 54 Cs-137 ..................................... 27 Sr-90 (Y -90) .................... 270 Gd·153 ..................................... 270 Tm-170 ............................ 5,400 Ir-192 .................. ~ .................... 2L6 Yb-169 ............................. 81

36. This license may be subject to amendment, revision, modification, suspension, or revocation in accordance with the provisions of 15A NCAC 11 .0344.

RADIOACTIVE MATERIALS BRANCH RADIATION PROTECTION SECTION




Page 6of6 License No.: 041·0021·3

37. Except as specifically provided otherwise by this license, the licellseeshall possess and use radioactive material described in Items 6., 7., and 8. of this license in accordaiicewith statements, representations and procedures and attachments listed below. The North Carolina Regulations fa!' Protection Against Radiation shaHgovem unless the statements, representations, and procedures il;l the licensee's application and conespondence are more restrictive than the regulations.

A. Application with attachments dated April 29, 2007,signed by Jim Whiting, Vice President, Oncology Services.

B. Corrected Copy as indicated in Application for Amendment dated December 12,2007, signed by Elroy 1. Frieson, PhD, RSO.

C. Application for Amendment with attachments dated October 24,2008, signed by ElroyJ. Friesen, Ph.D., RSO.

D. Application for Amendment with attachments dated October 31, 2008, signed by Elroy 1. Friesen, Ph.D., RSO.

E. Application for Amendment with attachmel1ts dated December 03, 2008, signed by Elroy J.Friesen, Ph.D., RSO.

F. Application for Amendment with attachments dated August 10, 2009, signed by Elroy 1. Friesen, Ph.D., RSO, and an Administrative amendment to put the license in a neW format and to implement several minor updates.

G. Application for Amendment with attachments dated August 12, 2009, signed by Elroy J. Friesen, Ph.D., RSO.

H. Application for Amendment with attachments dated May 4,2010, signed by Elroy J. Friesen, Ph.D.,RSO.

1. Letter with attachments dated September 13, 2010, signed by Eh'oy 1. Friesen, Ph.D., RSO.

J. Letter with attachments dated January 7, 201 I, signed by Elroy J. Friesen, Ph.D., RSO.

K. Application for amendment with attachments dated March 24, 20n, signed by Elroy J. Friesen, Ph.D., RSO, and an Administrative Amendment to put the license in our latest format.

L. Application Jor amendment with attachments dated June 8, 2011, signed by Elroy J. Friesen, Ph.D~, RSO.

For: W. Lee Cox, III ef, Radiation Protection Section

137,'J 5/21311 15: 31 4349248598 RESIDENCV PAGE 02/05

Jul. 8, 201112:41PM

NRO F'ORJ'JI 313A (AUD) 13-2(01)

WO, 10~O p, 2

U.S. NUCLEAR ~EQUl.ATORY COMMISSION

AUTHORlZec USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION APP~OVED BY OM6: NO. 3150-0120

EXPIRES: 313112012 (fOr uses defined under 35.10D, 35.200, and 35.500) [10 CFR 35.190, 36.290, and 35.590]

Name of Pro~ol§ed Authorized User Benjall2iQ K. Hom, M.D.

Requested Allthori%:ation(s) (check all that apply) 035,100 Uptake. dilution, and excretion studies [l] 36,200 Imaging and IO~lgation studies

State or Tenitory VVhern Licensed Vi~Qia

LA ~.500 Sealed sources for diagnosis (specify device A.J .D '" ~ ) I • ~,~~~~--------------

PART I - TRAINING AND EXPERIENCE (Select on~ of the three methods below)

• Training and Experience. in eluding board certIfication, must have been obtained within the 7 years precE!ding the date of Gpplication or the individual must have obtained related oontinuing education and expEll'iance since the required training and experience was completed. Provide dates, duration. and descriptIon Of continuing education and experience related to the uses checked abQVe.

[!J 1. Board Certi1icatigo

a, Provide a copy Of the board certification. b. If usfng onry M.sOO materials. stop here. If using 35.100 and 35.200 materials, skip to and complete Part II Preceptor Attl?st;rtion.

p 2. gurrent 35.390 Autbori;ed User Seeking Additional 35.290 Al:!thOri&ttion a. Author'i'!ed user on Materials License meeting 10 CFR 35.390 or equivalent Agreement

Slate reCluirements seeking authori:rotion for 35.290.

b. Supervised Work Experience. (If more than One supeNisifl{J individual is necessary to document supervised war/( eXJ'erience, provk1e murtfple copies of thIs section.)

Description of Experience

Eluting generator system; appropriate for the preparation of radioactive drugs for imaging and I localization studIes, mealMing and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs

SuperviSing Individual

Location of Experience/L1cens~ or Permit Number of Facility

Total Hours of Experience:

Clock Hours

Dates of Experience"

: License/Perm ~ Number listing supl!!~ising Ind!victual as an ! authori,-ed user

! Virginia 540-248-1 ........ --... ~ ........ -......... -.. "'-.. -.. , .......... --.........••.. -...... -.. -... -.-.-........ -... ~.~ ... : .... -.--.-.-.... -.... ,.~ ...... --.. -.. -.-....... -.-.. ,." .. ' ............ _ .................................... _ .... . Supervisor meets the requiremenu below, or equivalent Agreement State requirements (check 8/1 that apply).

[Z] 35.290 fZ]36.390 +- gen&l'IiItor expenenee in 32.290(C)(1 )(ji)(G)

NRC ~ORM 313A (AWl) (~O~ PR'NT'!II:I ON RECYCLl!IlI'''I'~R I'AGE,

07/15/2011 15:31 4349248598 RESIDENCY PAGE 03/05

J u 1. 8. 2011 12: 41 PM No. 1090 P. 3

NRC FOM'l :l13A (AUO) U.S. NUCL~ IU;GUI.ATORV COMMISSION (3o&!QlltIl

AUTHORIZED USER TRAINrNG AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

o 3. Training ailS! ~eerience fOr e!:2l:losed Authorlz9d y~er a. Classroom and Laboratory Training.

Description of Training LOcQtlon of Training Clock Dates of Hour~ Trainlng~

Radiatlon phYSics and I instrumentation

Radlation protection

Mathematics pertaining to the yse and measurement of radioactivity

Chemistry of byproduct material for medical use (not required fOr 35.590)

~adI6tiof) biology

Total Hours of Training:

b. Supervised Work Experience (completion of this table Is not required for 35.590). (If mora than one supervising individual is necessary to document supervised work experfe,nc~ •

. provide multiple copies of thi~ secr.ion.)

Supervised Work expari@nce ! Total Hours e~ 5xperiel\ce:

Description of Experience Location of e)(periencelLi~nse Or Confirm Dates of

Must Inelude: Pennit Number Of Facility Experlen~·

Orderfng. receiving, and unpacking DYes radioaclive materials ~afely and

performing the related radiation ONO surveys

Performing quality contrOl DYes procedures on instruments used to

determine the actiVity of dosages DNo end performing checks for proper

operation Of &urvey meters

th575992

07/15/2011 15:31 4349248598 RESIDENCY PAGE 04/05

Jul, S, 201112:41PM No, 1090 p, 4

NR,C FORM 313,\ (AUO) U,s, NUCLEAIt Rt:GUl.AiORY COMMISSION I3-.%!109)

AUTHO~ZED USER 'T'RAINING AND EXPERIENCE AND PRECEPTORATTESiAnON (continuod)

3, lraining and ElCge!:i~ce for Prol22l!1!lS AYlbolized Usef (contil'luea)

b, Supervised Wor\( Experience. (continusd) I

DeGcription of Experience Locetion of t;xperienceJUcense or Dates of Must (nelude: Permit Number of Facility Confirm 8q:Ierience-

Calculating. measuring, and safely DYes I

prel:l~ring patient or human research ONO SUbject dosages

Using administrative oontrols to DYes prevent a medical ev~nt involving the use of unsealed byproduct materil/ll ONo

Using procedures to contain spHJed DYes byproduct material safely and USing

ONo proper decontamination proOGdures

Administenns do~ges of radioact(v~ DYes qrugs to patients or human rasa~arch

DNa subjects

Eluting generator systems appropriate DYes for t/'le preparntion of radioactive drugs for Imagll'\g and localization DNo studies. measuring anc! testing the eluate fOT radionuclidic purity, ~nd processing the eluate with reagent kfts to prepare labeled radioactive drugs

Supervising Individual i l.icense/Permlt Number liBt;ing supervising Individual as an

Patrife RebID, MD i authorlZM user ; Virginia 541)·1.48-1 i ............................. _ ............................ __ ..... -............. , ....................... -...... -.. -.. ~ ... -................. ····-· .. ··.·· ______ · __ ··_·· __ ····· .... ·~ .. I.-........... , ... _.- ............................

Supervisor meets the requirements below, or equivalent Agra~ment State requirements (check onfJ),

035.190 035,290 035.390 [Z) 35.390'" generator experience in 3Ei.290(c)(1)(Ii)(G)

c, For 35.5130 only. provide documentation of training on use of the device.

Ceyjc;e Type of Training location anC! Oates

Nf'q,.-€.

d, For 35,500 uses only, stop here, For 35.100 and 35,200 uses, skip to aM complete Part II Flreceptor AttestaUon.

PMlliia

07/15/2011 15:31 4349248598 RESIDENCY PAGE 05/135

J u l. g, ~ 0 11 12: 41 PM No, 1090 p, 5

NRC fORM 31M lAUD) U.S. NUCLEAR Ft!OUt.ATORY COMMISSION

lM>OC~ AUTHORIZED USER. TRAINING AND EXPERIENCE AND PRECEPTOR A lTESTATION (caMtinued)

PART 11- PRECEPTOR ATTESTATION Note: This part must be completed by the Individual's preceptor, The preceptor dOes net have to be the supervising

individual as; long as the preeep10T provides, directs, or verifies training and experience required. If more than one I'l~ceptor is necessary to document experf9"~, obtain a separate preceptor statement from ~ch. (Not re~Uired tcJ 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 ettesting to the individual's "general clinical competency."

First Section Cheek one of the follOwing for each use requested:

Eor 35.190

E!oard Certlfleatio[J

~ r attest that BIlI'I.i!lllDiQ K.. 110m, M.D. has satisfactorily completed the requirements in

Name at ProllOSe<l Al<tI1oriz4!cl UIl(!'

10 Cf:R 35.190(a)(1) a"d has achieved a lever of competency sufficient to function independently file an authorized user for the medical uses aulhorized under 1 a CF~ 35,100.

Im,jniog and ExperieQ~e

o I attest that

OR

has satisfactorily compl8l:ed the 60 hours of training and

experience, including a miniml.Jm of 8 heul'S Of classroom and labonatory training, required by 10 CFR 35.190(c)(1), and has achieved a level of competency suffiejMt to func;tlon Independently as an authortzed uaer for the medical uses authorized under 10 CFR 35.100.

For35290

Bo.ard Certification

~ I attest that Benj.llDlill K. Hom, M.D. has satietactorily completed the requirements in N~II\I'! 0\' PlQPowd AUOIolUe<I U~r

10 CFR 3S.290(a}(1) and has achieved a level of eompetency suffjcie~t tel fundion lndependently as an authorized user for the medical uses authorized under 10 CFR 35.100 and 35.200.

Training and Experience

o I attest that Na1!18 QI Proposed Au~ US41r

OR

nas ~isfactorlly complli\ted the iOO hours oftr-ainlng

and experience. including a minimum of 80 noul'S Of classroom and laboratory tf1\it'ling, required by 10 CFR 35.290(c)(1), and has achieved a level Of competency sufficient to fundion independently as an authorfz:ed user for the medrOJi!I uses authorized under 10 CFR 35.100 and 35.200 .

•• __ ..... q.b.w •• _._ •• ~ ••••••• _ ........ _~ ........ ___ •• __ ......... ____ ._N __ •••••• ___ ••• _ .. ~ ••••••••. ____ .q ••••

Second ~ectlon Complete the fOllowing for preceptor attestation ~nd signature;

o I meet the requlr~ments below, or equIvalent Agreement State reqUirements, as an authoriZed user for:

0 35.190

Nam~ of Preceptor

P"lTlcEI Rehm, MD

0 35.290

llc&)nseIPermi! Number/Facility Name

035.390

Virginia 540..24-] UDivmiry o{VlrgiBio Medin! Ceuter

!Zl 35.990 + generator experience

Telephon~ NUfTlCQr

(434) 982-9391

Date,

071l111J2nu

· ...... ,urtritttn lI}llarn nf ~nn +

.... '.i·4t ~ .... > • t1f'\.lu )' .& .•• '" \.U )' I ","". I h !, '. tJ"rn~ thM~ .tk <=jw><altcn 0/ th6 ~ ~

~VAU' 'it'~ 0/ ~)" I/u dne,,,,,,,,,, L r , iZ1'",,), '~""'7' tk sfrM7}(.tfX.M~ {!lladt:.tMtz, Yoct"et;y, de. (flcu/iol()jical !/oCfhty 0/ ,-A~?'~{i s..dnte4f.4,ca,

-tlu !/ectr~/[ gn .?Jl,(ulioio/!;'ip 0/ de, JtZlneJc#;rvn ,/(t,tI,;rxp! "yf;UCCt!valvJl"

l~e dJtlR/}l.ifXl/Jr Yoa'e~ foc £lladt{V/io;JZ f!hu.olon .. lie. sd'aW{)(:a£uw// oj' °/tfu/umtdiCtb [!)l.a4iolor;it.4, (Mu/ M~ S1m,f?/)lic(ld~ ~Cl,a/a~1t 0/ 9?,tMA1.Cf&ta Vn uIt~{Ir;ct;ne

J ? '~~. 'lIP / 1...J d[e~o:t c/{!'}c,£ijit'4Ylai

iBeuj&lutll il\arl Jintn, !III £a6!W/J{MtU! £(/l'I. (UX'~fz·hj c{Ut/)!,!e <ltua<i«de tJludy

(,/ (J

a/lui oit,:nic-alwm(i;, ~'?llR-t C(Ml.lr.u//[ !J,~M{d:t (uu/. ttttdijicaiwnJ;, inc.itt<knt

IUlJ!J{'~'!f de {'/.r .. (uni'J'Ul,t,:O·'J'l4 ('.M'l.dt.t{'..k4 umde4(,ti.e a,ttthfo}td/!/ 0/(/

[, !!1k ... eZnw;j{iccuz f!iJNMfd 0/ fliacftll/Iry:" '

,J\~~ lEIisihle tt,YI'/IAJltuJi;;(aivl't;f 10 i/u da/¥oUCb'Jr o/'de 88o(V)cd Ihq"t!i.e t4 '!4.tt-".ltled io !l/}l.ac,uCe,

(Mzd {J tk,.;'1~le IUl<{l1J1ded .th~ fj{)(urC/j cel)/¥cal;.o/l't in. .tk ¥ea~zitJ' 17

JP i&i'lW~tic ~ab-illlllgll ~~?i . (if .. (o/fec./i,lte dJ{{;JW 30, 2(11{/

I, ~~,~ ~WiJu~ ~fmrur1!-'Qlrt!lSUl'er

~~ illedlfir.ah' ~ 0. 58942 tJalii) H1Hl1.lHl! 2112D

NRC FORM 313A (AUT) (3-2009)

U.S. NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

(for uses defined under 35.300) APPROVED BY OMB: NO. 3150·0120

EXPIRES: 3/31/2012

[10 CFR 35.390, 35.392, 35.394, and 35.396]

Name of Proposed Authorized User

Benjamin Hom, MD

Requested Authorization(s) (check all that apply):

State or Territory Where Licensed

Idaho

o 35.300 Use of unsealed byproduct material for which a written directive is required

OR

[{] 35.300 Oral administration of sodium iodide 1-131 requiring a written dIrective in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

[{] 35.300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries)

D 35.300 Parenteral administration of any beta-emitter, or photon-emitting radionuclide with a photon energy less that 150 keV for which a written directive is required

035.300 Parenteral administration of any other radionuclide for which a written directive is required

PART I .- TRAINING AND EXPERIENCE (Se/ect one of the three methods be/ow)

* Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of application or the individual must have related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the uses checked above.

[{] 1. Board Certification

a. Provide a copy of the board certification.

b. For 35.390, provide documentation on supervised clinical case experience. The table in section 3.c. may be used to document this experience.

c. For 35.396, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.e. may be used to document this experience.

d. Skip to and complete Part II Preceptor Attestation.

o 2. Current 35.300, 35.400, or 36.600 Authorized User Seeking Additional Authorization a. Authorized User on Materials License under the requirements below or

equivalent Agreement State requirements (check all that apply):

035.390 035.392 035.394 0 35.490 035.690

. ~.-__ --b_ILcllrrently...autbOIjze.cLfoLa.S.ubs.e1..of.clinicaLu.s.e~:iQ..o .... p-rovide documentation on additional required supervised case experience. The table In section 3.c. may be used to document this experience. Also provide completed Part II Preceptor Attestation.

c. If currently authorized under 35.490 or 35.690 and requesting authorization for 35.396, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this experience. Also provide completed Part II Preceptor Attestation.

NRC FORM 313A (AUT) (3·2009) PAGEl

NRC FORM 313A (AUT) U.S. NUCLEAR REGULATORY COMMISSION (3.2009)

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

D 3. Training and EXQerience for ProQosed Authorized User

a. Classroom and Laboratory Training D 35.390 D 35.392 D 35.394 D 35.396

Description of Training Location of Training Clock Dates of Hours Training*

Radiation physics and instrumentation

Radiation protection

Mathematics pertaining to the use and measurement of radioactivity

Chemistry of byproduct material for medical use

Radiation biology

Total Hours of Training:

b. Supervised Work Experience D 35.390 D 35.392 D 35.394 D 35.396 If more than one supervising individual is necessary to document supervised training, 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 Include: Permit Number of Facility Experience*

Ordering, receiving, and DYes unpacking radioactive

materials safely and performing DNo the related radiation surveys

Performing quality control DYes procedures on instruments used to determine the activity

DNo of dosages and performing checks for proper operation of sUivey meters

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

Using administrative controls to DYes prevent a medical event

- lnvolvirrg-the-use-orunsealed - Ul'Jo -byproduct material

Using procedures to contain DYes spilled byproduct material safely and using proper DNo decontamination procedures

PAGE 2

, th575992

NRC FORM 313A (AUT) (3-2009)

u.s. NUCLEAR REGULATORY COMMISSION


3. Training and Experience for Proposed Authorized User (continued)

b_ Supervised Work Experience (continued)

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

Patrice Rehm, 1vID :Virginia 540-248-1

Supervising individual meets the requirements below, or equivalent Agreement State requirements (check all that apply)*": -------- .. --,.------- .. ----._----.------ .. _--------- ........... -----------_.------- ....... -- .-----_. __ ....... -----[{] 35.390 With experience administering dosages of:

[{] 35.392 [{] Oral Nal-131 requiring a written directive in quantities less than or equal to 1.22 [{] 35.394 gigabecquerels (33 millicuries)

[{] Oral Nal-131 in quantities greater than 1.22 gigabecquerels (33 millicuries) [{] 35.396

[{] Parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required

o Parenteral administration of any other radionuclide requiring a written directive -----------_:._-----_ .. _-_ .... _-----_ .. - ...... _-_ ................. --_ ...... - ..... _---_ ............... -....... _._._. •• Supervising Authorized User must have experience In administering dosages in the same dosage category or categories as Ihe individual

requesting authorized user status.

c. Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience, provide mul/iple copies of this page.


Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 1.22 gigabecq uerels (33 millicuries)

Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries)

Parenteral administration of any beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV for which a written

"---1- direetive-is-required

Parenteral administration of any other radionuclide for which a written directive is required

(List radlonuclides)

Number of Cases Involving Personal

Participation

Location of Experience/License or Permit Number of Facility

(JL,6tff£ $£.£ A~J /IU- ---Itf!.E11'rl.GNT.J ?oOiC- f~t&

Dates of Experience*

117 U NI ,;t,:a O·r' t)~V!/{£1 #III ~~'lJ/ .\I-I\fd1

---------+----------------------l------i-ll---i_

PAGE 3

NRC FORM 313A (AUT) (3-2009)




c. Supervised Clinical Case Experience (continued)


Patrice RelulI, lYID : Virginia 540-248-1

S"upervlsirlg lriCilvfduai mi:iels" the' requlremenis 'bei6w," or 'equlvaienf Agreeme"rif State" requirements (cheek ali that' " apply)**:

035.390

[{] 35.392

[{] 35.394

[Z] 35.396

With experience administering dosages of:

[2] Oral Nal-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

[2] Oral Nal-131 in quantities greater than 1.22 gigabecquerels (33 millicuries) [2] Parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon

energy less than 150 keV requiring a written directive is required

[2] Parenteral administration of any other radionuclide requiring a written directive

.. Supervising AuthOrized User must have experience In administering dosages In the same dosage category or categories as the Individual requesting authorized user status.

d. Provide completed Part II Preceptor Attestation.

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.

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 requested authorization:

For 35.390:

Board Certification

[2] I attest that Benjamin Hom, MD has satisfactorily completed the training and experience ----~N~am-e-o~fP~ro-p-cs-ed~A~u~th-cm~·e~d~U~$e-r----

requirements in 35.390(a)(1).

---I------------------------0R'--------------------------,I----l-,

Training and Exps;ience

o I attest that has satisfactorily completed the 700 hours of training


and experience, including a minimum of 200 hours of classroom and laboratory training, as required by 10 CFR 35.390 (b)(1).

PAGE 4

NRC FORM 313A (AUT) (3<2009)



Preceptor Attestation (continued)

First Saction (continued)

For 35.392 (Identical Attestation Statement Regardless of Training and Experience Pathway):

D I attest that has satisfactorily completed the 80 hours of classroom

Name of Proposed AuthOrized User

and laboratory training, as required by 10 CFR 35.392(c)(1), and the supervised work and clinical case experience required in 35.392(c)(2}.

For 35.394 (Identical Attestation Statement Regardless of Training and Experience Pathway):

D I attest that has satisfactorily completed the 80 hours of classroom


and laboratory training, as required by 10 CFR 35.394 (c}(1), and the supervised work and clinical case experience required in 35.394(c)(2) .

•••••••••• _ •••••••••••••••••• __ ••••••••••••••••••••••••• ____ 1

Second Section

[l] I attest that Benjamin Hom, MD has satisfactorily completed the required clinical case ----~N~am-e-o~fP~r-op-os-ed7A~u~th-on~·ze~d~U~se-r----

experience required in 35.390(b)(1)(il)G listed below:

[l] Oral Nal-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

[l] Oral Nal-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

D Parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required

D Parenteral administration of any other radionuclide requiring a written directive

_ ••••• _._ ••• __ ••••••• ~. ____ ._._ ••••••••• _ •• ___ ._ •••••• ••• ___ 1

Third Section

[l] I attest that Benjamin Hom, :NID has satisfactorily achieved a level of competency to -----N~am-e-o~fP~r-op-os-ed7A-u~fu-o~~·e~d~U-se-r----

function independently as an authorized user for:

[l] Oral Nal-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

[{] Oral Nal-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

D Parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required

D Parenteral administration of any other radionuc!ide requiring a written directive

PAGES

NRC FORM 313A (AUT) (3·2009)



Fourth Section

For 35.396:

Current 35.490 or 35.690 authorized user:

o I attest that is an authorized user under 10 CFR 35.490 Of 35.690 Name 01 Proposed Authorized User

or equivalent Agreement State requirements, has satisfactorily completed the 80 hours of classroom and laboratory training, as required by 10 CFR 35.396 (d)(1), and the supervised work and clinical case experience required by 35.396(d)(2), and has achieved a level of competency sufficient to function independently as an authorized user for:

o Parenteral administration of any beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required

o Parenteral administration of any other radionuclide for which a written directive is required

OR Board Certification:

o I attest that has satisfactorily completed the board certification Name of Proposed Authorized User

requirements of 35.396(c), has satisfactorily completed the 80 hours of classroom and laboratory training required by 10 CFR 35.396 (d)(1) and the supervised work and clinical case experience required by 35.396(d)(2), and has achieved a level of competency sufficient to function independently as an authorized user for:

o Parenteral administration of any beta-emitter, or photon-emitting radionuclidewith a photon energy less than 150 keY fOf which a written directive is required

D Parenteral adminstration of any other radionuclide for which a written directive is required

.. -------------- .. - .... _- ......... -.- .. _-------._._---.-._ .. Fifth Section Complete the following for preceptor attestation and signature:

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

[Z] 35.390 [l] 35.392 [{] 35.394 IlJ 35.396

III I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization.

[Z] Oral Nal-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

III Oral Nal-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

[{] Parenteral aoi'i'iifiiStration ofl5eta-emmef,(5l'plYOton-emlttlflgl'adtt51'lUCIIClewltl'raplmtlll"l'1fl'rnlgy-le'S"!rthan 150 keY requiring a written directive Is required

IlJ Parenteral administration of any other radionuclide requiring a written directive

Name of Preceptor Patrice Rehm, MD

License/Permit Number/Facility Name Virginia 540-248-1 University of Virginia

I

I Telephone Number I Date

I 434-924-9363 I

PAGE 6

Date Treatment 12/1/2006 15 mCi mCi of 1-131 sodium iodide in capsule form was given orally. 12/7/2006 150 mCi 1-131 sodium iodide was given orally as therapy

11/30/2006 "18.6 mCi 1-131 sodium iodide was given orally as therapy for Graves' disease Ben" 12/112006 15.1 mCi 1-131 sodium iodide was given orally

11/21/2006 28.6 mCII-131 sodium iodide was given orally as therapy 6/1312008 "100 mCi 1-131 sodium iodide was given orally as therapy for papillary thyroid ca" 6129/2009 "100 mCi 1-131 as therapy for thyroid cancer. 1/14/2010 "25.2 mCI 1-131 as therapy for hyperthyroidism. 7/2/2009 "28.5 mCi 1~131 sodium iodide was given orally as therapy for Benjamin K. Hom M.O" 7/1/2009 "188.8 mCi 1-131 as therapy for thyroid cancer.

7/22/2009 "29.6 mCi 1-131 sodium iodide was given orally as therapy for hyperthyroidism

..... ---...... ----..----' ..... -m'---""""""""' ....................... ----..... -"""II' ...... -----.............................. "I NRC FORM 313A (AUD) (3-2009)


AUTHORIZED USER TRAINING AND EXPERiENCE AND PRECEPTOR ATTESTATION

(for uses defined under ~~5.1 00, 35.200, and 35.5DD) [1D CFR 35.190,35.290, and 35.590]

APPROVED BY OMB: NO. 3150·0120 EXPIRES: 313112012

Name of Proposed Authorizeci User ______ ...... _""""""'1; or Territory Where Licensed

fA () r_~_~_'[~ ~ __ p,::~&-_~£ I _ (_~!'-~ ___ ~~. ____ .. Requested Authorization(s) (check all that apply)

835.100 Uptake, dilution, and excretion studies

l~5.200 Imaging and 10Gcilization studies

35.500 Sealed sources for diagnosis (specify device

PART i -- TRAih1iNG A~\lD EXPERIENCE (Select one o{ 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 indiviclual must have obtained related continuing education and experience since the required training and ,expel'ience was completed. F rovide dates, duration, and description of continuing

. ~cation and experience related to the uses checked above.

~ 1. Board Certnfi(~atio!l 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.

a. Authorized user on iVlaterials License meeting 10 CFR 35.390 or equivalent Agreement

State requil"ements seeking authorization for :35.2~0.

b. Supervised Work E)'perience. (If more than one supe/vising individual is necessalY to document supervised work experience, provide multiple copies of this section.)

[~~~cr;Ption~xper;e,~e _ •.

I Eluting generator systems I appropriate for the preparatk;n Of

I radioactive drugs. for irr:aginu anej illocalization studies, measuring and testing the eluatE' for :-adionLicliclic purity, and processing the eluate

I with reagent kits to prepare labeled

I radio~~i~=--clru~E ..... .... _ _ ...

Location of Experience/License or Permit r'~Llrnber of Facility

.. - ..... ----. +---··-----1--------1

Total I·-Iours of Experience:

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

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

35.290 35.390 -I- generator experience in 32.290(c)(1 )(ii)(G)

---._. -- - lIIIII3lmlll8l11ltJ'~~ ~::~DWlZ!lllwmllllltltJllCIEm:lIIZlnrut;,.;;;,;;.;.;,;;,.:;;;;:;;;;.;;,;;;;;.;;::;;;;;;;;;;;,;;.;,;;;;:;;,;;;;:;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;:;;;;;;;;:.:;;;;:;;;;:;;;;:;;;;:;;;;~1 NRC FORM 313A (AUD) (3-2009) PRINTeD ON RECYCLED PAPER PAGE 1

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

(3·2009) AUTHORIZED USER TRAINING AND EXPERIENCE Aim PRECEPTOR ATTESTATION (continued)

ID 3. Training and t:y!erience for Proposed AuthorizHd Usel:

a. Classroom and Laboratoi-Y Training.

Description of Training

Radiation physics and instrumentation

---~--- - --------


Location of Training Clock Hours

------I~----I

Dates of Training*

- - --···-----~------~-I----~~~-I--·~·--~~-I

Mathematics pertaining to the use and measurement of radioactivity

Chemistry of byproduct material for medical use (not requireej for 35.590)

Radiation biology

I----- ----~-

L

--- -------·-·-·--I--·--------I~-~-~---1

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

"trotal Hours of Training: ._----_.--------_.- - -~.--.~--~---------'

b. Supervised Work E)(perience (completion of this table is not required for 35.590). (If more than one supelvising individual is /lecess"l)' to document supervised work experience, provide multiple copies of this section.)

,--Supervised Wor!< Experience

[---------- ---_. - ----- - -

Description of Experience Must Include:

Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys I---~--~~ ------------- - - .--. -- --

Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for pmper operation of survey meters ~-.-.----. ------------_.

Total Hours of Experience:

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


--.-------------- ----.- i-----

Confirm

Yes

No

Yes

No


.... _______ Io'UmlIIIIlJIrumm:tIE3IIIIIiWlDmmr-ml.,.......~m:t'lnaamn:unmu::tR!lllU.l!~"mm ______ ............ _ ...... __ ...................... ___ """!I


(3·2009) AUTHORIZED IJSER TRAINiNG AND EXPERiENCE AND PRECEPTOR ATTESTATION (continued)

3_ Training and EXQgJ-ience for Proposed Authorized User (continued)

b. Supervised Work Experience. (continued)

I cal~:t~:~r:~~:~~:~~::::e; ""--'-L--o-c--a~-i~~~~: ~~~:~;:~~~_~ .... ~i.~ .. Y .. s_, e ... o __ r ~~i ____ y_e'_s~+--_E_~_p~_tr_~: __ n .. ~.f .. e'_*---j

preparing patient or human research subject dosages

Using administrative controls to prevent a medicEIl el/ent involving the use of unsealed byprocluct material

I I

Using procedures to contain spilled I, -. .....

byproduct material safely and using proper decontamination procedures I

Adm~~~t~~ng ~~s~~~~ of r~i;~o-;ctive 1-

~~~T:c\~ patients or hur~~n:~~~~~Ch 1_. Eluting genera~;r systems a:Jpropriate I for the preparation of radioactive II

drugs for imagin~1 and IDcalization studies, measuring and testing the I eluate for radionuclidic puritj', and . processing the eluate with reagent kits to prepare labeled radioactive drugs

Supervising Individual

No

Yes

Yes

No

Yes

Yes

License/Permit Number listing supervising individual as an authorized user

Supervisor meets t~e requirements .. be I. OIN , or eqUiValel~t A_greenient State reqUire~ents .(CheCk one). ..J I I 35.190 II 35.290 I I 35.390 II 3::1.390 + generator experience In 35.290(c)(1 )(II)(G) --- - -~- ---- ---_. --------------- ,- ------ - -- --.- ------- -----"" -----------------"

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

DeviGe Type o'Y Training Location and Dates .----.-----.. - ..... --~~~--.----_i

·--~--.. ~--~~--~--~~I

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

.;y

1I"""' ___ ................. _1UIiIlIII1111:t:!tm:I~1tm!1IJIiUOIIlUl~1IIIIEIZlJUmIRilIID:II::t!:EI~""""''''''''''''''''' __________ ....... ________ '''''''iI


(3-2009) AUTHORIZED IJSER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

PART U - PRECEPTOR ATTESTATION Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising

individual as 10nrJ as the .)receptor 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 tile boxes below, tile preceptor is attE!sting tr,at the individual has knowledge to fulfill the duties of the position SOUgilt Clnd not attesting to the individual's "general clinical competency."

First Section Check one of the foillowin~l for each use l"I:!que~5ted:

For 35.190

Board Certification

[~ attest that M~((c: __ ~Yt{A.P-tf(Al-SJ has satisfactorily completed the requirements in Naln:; of pr0p~sed Authorized US!::f'

10 CFR 3!5.190(a)(1) ancillas achieved a level of competency sufficient to function independently as an authorizecl user for the Ilieciicaluses authorized under 10 CFR 35.100.

Training and E:xperir:mce

[] I attest that ~ ---- ----

Name, of Proposed Autll0rized 'Js8r

OR

has satisfactorily completed the 60 hours of training and

experience, i'lcluding a minimum of 8 hours of classroom and laboratory training, required by 10 CFR 35. 190(c)('1 ), 2nd has achieved a level of competency sufficient to function inclependently as an authorized user for the medical uses authorized under 10 CFR 35.100.

For 35.290

Board Certification

[~I attest that NNlf-~-I!., tt/l _~p0j;fJhas satisfactorily completed the requirements in Name of Propo's-el.'-,\utI10riZed User

10 CFR 3!5.290(a)(1) ancll1as achieved a level of competency sufficient to function independently as an authorized w;er for the medical uses authorized Llnde;- ., 0 CFR 35.100 and 35.200.

(lR Training and r::xpHience

_ j i attest that i'1;', :', :~8Usf2Ci.Ofiiy C'JIT;p!eted the 700 hours of training

I-Jani''= of Pmposr::d AUt:l0nzed USEJ I

and experience, including a minimum of 80 hours of classroom and laboratory training, required by 10 I CFR 35.290(c)(1), and has achieved ;3 level of competency sufficient to function independently as an , authorized user for the medical uses authoriZEd under 10 CFR 35.100 and 35.200. 1

S;~~"';d.S;~ti~ID~I!II= •• 'mlllllrlm'f!lnllDlZlrtl!m!.aJtilIl.rl;U::DlIn:rlllt:l.l:Ullllm(lll~rusnr.u:IHtmi1lilmt:!I~EJIlilu:t:JII!il"'IiDEllmdtl!llJlmIllI:lBllm£BIIIElI!lIIIiIDlDI.lIIIlIlaIllDlra.I!Il!ilm"I!IJ"" ••• " .......... 11111111111

comPle;;t:0!iOWin9 for preGeptor attestation and signature: .

[j I meet!!J.e requiremellts ~ovv, or equivalent f',g!'eement State requirements, as an authorized user for: I [~90 i~90 [~390 : 35.390 + generator experience I

Name of Preceptor " /J A

~rii>r. C/, ~b.vtf --~--.. -.----- - -----l¥--

License/Permit Number/Faciiity 1\lame

NRC FORM 313A (AUT) (3-2009)


AUTHORIZED USER TRAINiNG AND EXPERIENCE AND PRECEPTOR ATTESTATION

APPROVED BY OMB: NO. 3150-0120 EXPIRES: 3/31/2012

(folr USl~S defined !.mclelr 35.300) [10 CFR :~5.3:90, 35.392, 35.394, and 35.396]

N,me of Pcop"ed Aotho,;zed u,e~ ---,st;le 0' Te"lIoey Whe,e L1co"e'

Mdt t<.. __ ~~~ ... _._~~~£~~ D:~·.I Ik~LO .. _~ ___ .. _._._. ______ I Requested Authorization(s) (check al/ that apply):

35.300 Use of unsealed byproduct material for wr~ich a written directive is required

OR

~5.300

~5.300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 1.22 gigahecquerels (33 !Ttillicuries)


35.300 Parenteral administration of any beta·-emitter, or photon-emitting radionuclide with a photon energy less than '150 keV for which a written directive is required

D 35.300 Parenteral administration of any other radionuclide for which a written directive is required

PART i -- TRAINING AND EXPERIENCE (Select' one IOf the three methods be/ow)

* Training and Experience, incuding board certification, must have been obtained within the 7 years preceding the date of application or the ind'viduHI mList haVE related continuing education and experience since the required training and experience was completed. Provide elates, duration, and description of continuing education and experience related to the uses checked above.

1if1. Board CelinficatrcI!

a. Provide a copy of the board certification.

b. For 35.390, pmvide documentation on supervised clinical case experience. The table in section 3.c. may be used to document thiE experience.

c. For 35.396, provide documentation O~ clas::,room and laboratory training, supervised work experience, and supervised clinical case experi';:!nce. The tables if' sections 3.a., 3.b" and 3.c. may be used to document this e>:perienw.

d. Skip to and complete Part II F'rE~c:ptor Attestation.

D 2. Current 35.30Q.....35.400, Il[ 35"60.Q./\uthorl~~ Us~r Seeking Additional Authorization

a. Authorized User on Materials License under the requirements below or equivalent Agreement St;3te requirernents (check all that apply):

[] 35.390 35.392 35.394 ; 35.490 35.690

b. If currently authorized for a subset of clinicalusss uncler 35.300, provide documentation on additional required supervised caSE experience The table i'l section 3.c, may be used to document this experience. /\Iso providE! completed Part II PI"eceptor Attestation.

c. If currently authorized under 35.490 or 35.690 and requesting authorization for 35.396, provide documentation on classroom aile! laboratory training, supervised work experience, and supervised clinical case E!xperience. The tables in sections 3.a., 3.D., and 3.c. may be used to document this experience. J\lso provide completed Part II Preceptor Attestation .

...... __ ...... _ ..... _"""""'l!lIIl:IIISllIS!Im!I.IJIZIIII:l:!IID!IIIl£lI~~=IlEmnWliImIl.lI'ImIIi~'~~ __ ....... ______ ............ ____ ....... _ ..... .....I1

NRC FORM 313A (AUT) (3-2009) PR'i'·lTED ON R ,CYCLED PAPER PAGE 1

!h 5 7 5 9

..... _ ............ _ .......... _IIISI2IWltllDI~II!Ila!II!Ca:e:~i:llil!l~~I?'~.IIUlFi"""""""' __ """" ________ ..... _______ ........

NRC FORM 313A (AUT) (3-2009)


AUTHORIZED USI::R T~AINiNG Aim EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

D 3. Training am!...~~ien<CH for ProRosed}\utl)oriz~tUlser a. Classroom and Laboratol}l Training 35.390 35.392 [J 35.394 35.396 r-----.---

Description of Traii1ing 1--------- ---..

Radiation physics ai1d instrumentation


Mathematics pen:aining to the use and measurement of radioactivity

Chemistry of byprociuct material for medical US(~

Radiation biology

---- --- - -

b. Supervised Work ExperiEmce

Location of Training Clock Hours

Dates of Training*

. --.... ------- .. - - - - .... -. -- .... -.------.---- ·----+--·----------I-------------i

Total Homs <Oil Training: ------ ---- ------- ---- ---- -------------------'

35.390 I 35.392 35.394 [J 35.396 If more than one supervi;;ing ino'jviclua/ is necessuy to cfocLiment supervised training, provide multiple copies of this page.

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

Supervised Wori< E?:xperience

_.

Description of Experience Must Inclucle:

Ordering, receiving, and unpacking radioacti\fe 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 propel- opel-ation of survey meters _ .. _---_ .. - -------- ------------

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

Using administrativE: controh to prevent a medicctl event involving the use of unsealed byproduct material

_ ..

Using procedures to contain spilled byproduct material safely and using proper decontamination procedures

L...... _________ _


Confirm

Yes

No

Yes

No

[] Yes

No

Yes

No

Yes

No


NRC FORM 313A (AUT) (3-2009)




b. Supervised Work Experience (continued)


Supervising individual meets the requirements below, or equivalent Agreement State requirements (check all that apply)**:

35.390

35.392

35.394

35.396

With experience administering dosages of:

, VDral Nal-131 requiring a written directive in quantities less than or equal to 1.22 -~abecquerels (33 millicuries)

~ Oral Nal-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

Parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon ~- energy less than 150 keV requiring a written directive is required

Parenteral administration of any other radionuclide requiring a written directive --_. - - - - - - - - - - -- - - - - - - - ---

** Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status.

c. Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this page.


Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)


Parenteral administration of any beta-emitter, or photon-emitting radionuclide with a photon energy less than '150 keV for which a written directive is required

- ------ ------------------~----~--------i

Parenteral administration of any other radionuclide for which a written directive is required

(List radionuclides)

Number of Cases Involving Personal. Location of Experience/License or Permit

Participation Number of Facility

! 0,>+ {~- .- Fv-s.nci ;

~--'Z-e (,?C, ( Ce..,.'{ k- _ I

__ LCp_tJ\~t_< __ 1 c --r i Os.f- 5:1 _- Frq/L~.s

~{/_.( ~.k.J

.


- -- -------------------!

------~~~ ----------------- ----------~----------- ----------~~---------~------- ----- -----------~~~--

PAGE 3

1I""" ........ _ ..... __ """"' ... lI'UHiJUlmm.Jll~~liI:-~~i1l.mrmiiEli!lJln!mlOm:ten"""' ____ ..... ~ ____ ..... __ ...... _ ............... _ ..... ....,

NRC FORM 313A (AUT) U.S. NUCLEAR REGULATORY COMMISSION (3-2009)

AUTHORIZED USER TRAINIiIAG Mm EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3. Training and EXlli!!:ience for Pro!;!osed Aut!"]orized Use..!: (continued)

c. Supervised Clinical Case Experience (continued)

suP;rvisi;;glndiVidual~~e~'~-~;P;~jt-Number listing supervising individual as an

, (' ~ ~. t. authorized user

.. Dr. VQf' ~/l .Af ~{.. \H'''r~~hJ Lt-r/\{i&~/-0('1 ............... ,. Supervising individual rneets the requirernents below. or equivalent Agreement State requirements (check all that app/y)**:

D 35.390

D 35.392

With eXDerience administering closalJes of:

-~Oral Nal- 'i 31 requiring a written directive in quantities less than or equal to 1.22 gig,;;becquerels (33 n:illicu;'jes)

:0 Oral Nal< 31 in quantities grC"c:ter ':han 1.22 gigabecquerels (33 millicuries) ILJ 35.394

D 35.396

I

..: P3 -enteral acirninistratior' ,:;f beta-emIHe'f. or photon-emitting radionuclide with a photon el1er~y le!;s than '15J keV requiring a wntten directive is required

Parenteral aciministration of any other radionuclide requiring a written ciirective

** Supervising Authorize' i User n1 JST have exper'ence In admirilslellng rjosages In th e same dosage category or categories as the individual requesling authOrized USc'lr statlJS

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

d, Provide cornpleteci Part Ii Preceptor ,."tte:otcl:ion.

PART 1:1- P~1!EGEPTOR ATTESTATION

Note:,o This part rnust be comolE,ted by the individual's preceptor, The preceptor does not have to be the supervising r individual as lonn a::; the oreceptor provides, c:lirec~f:. or verifies training and experience required. If more than

one preceptor is necess2ry to document experience, obtain a separate preceptor statement from each.

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 indiviciual',; "qeneral clinical competency,"

First Section Check one of the folilo\illin~1 for each \'lel{lJuesteoi <'1utholri<:ation:

For 35.390:

Soard Certiftfai;bm

l~attest that ILL 1M IlL .. ~..I .... J": I ~./'A--/~SJ _ has satisfactorily completed the training and experience Nsme of ;rdosec] Authori::ed User

requirements in 35.3SI0(a)(1),

or~

has satisfactorily completed the 700 hours of training - ..

N3me of PrcpcSed Authorizec U~£r

and experience, including a minimum of 200 h'Jurs of classroom and laboratory training, as required by 10 CFR 35.390 (b)(1),

NRC FORM 313A (AUT) (3-2009)


AUTHORIZED USER TRAINING Aim IEXPER~ENCE AND PRECEPTOR ATTESTATION (continued)

Preceptor Attestatio[!} (continued)

First Section (continued)

For 35.392 (ldentica.L8Jtestation StatemenLReqm:,9Jes§...pf Training and Experience Pathway):

~attest that j~~~._fl-il1 .. f(,'t""'~S> has satisfactorily completed the 80 hours of classroom • Narle of propo~ed Aut[lori"e~ User

and laboratory training, as requi[-ed by -10 CFR 35.3~;2(c)(1), and the supervised work and clinical case experience required in 35.392(c)(2).

For 35.394 (ldentica.L.!.~ttest'!!ion Sl~3t{imel1t 8.S(lill·diess of Training and Experience Pathway):

~attest that _ M&'lL.. (Lt,h.1\. J~~ '<> ~ has s8tisfactori!y completed the 80 hours of classroom Nar,le of Propoled Authorized User

and laboratory training, as required by '10 CFF\ 35.394 (c)(1), and the supervised work and clinical case experience required in 35.394(c)(2).

___ • ____ • __ ••• _____ ~ ___ ._~m ___ rn __ m ___ ••• ___ • ___ ••• ___ ••• __ _

Second Section

[.:.:yi attest thatjVltA ! l R fI L1 I,V\. Iv.;; !las satisfactorily completed the required clinical case ~\!ar,~e of FroDt)~C: /\.ltilOli.::J~\_!:_l3r

experience required in 35.390(b)( 1 )(ii)G listed below

Ii Oral Nal-1 ~11 requil-ing a written directive in ouantities less than or equal to 1.22 gigabecquE~rel:; (33 millicLiries)

[Yoral 1'Jal-n 1 in quantities greater than 1.22 ~1igabecquerels (33 millicuries)

D Parenteral administration of beta-emitter, 0[- photon-emitting radionuclide with a photon energy Iless than 150 keV requiring a IJvi"itten directive is required

11 Parenteral administration of all)1 other fc:dionuGlic1e requiring a written directive ____________________ a ______ • ____ m _________________ • ____ • __ _

Third Section

c:11 attest that JM-tAr It- ~.~lti1. e"-'dA..t~J lias satisfactorily achieved a level of competency to

Name ~F¢;.o)osed P,.uth~riz~d User

function indepE:ndently as all authorized user for:

[ZJ Oral Nal-13'1 requiring a written direclive in qci31'Hiiies less than or equal to 1.22 gigabecquE~rels (33 millicuries)

II] Oral 1'Jal-1 ~j 1 in quantities weater than 1.22 qigabecquerels (33 millicuries)

I Parenteral administration of betEl-emitte,', or ~hotoi1-emitting radionuclide with a photon energy leSE: than 150 ke\f requirin~1 a written dii'edive is required

Parenteral aciminist(ation :)f any other rc[dionuclide requiring a written directive

5:7 5 9 9 2

NRC FORM 313A (AUT) (3-2009)


AUTHORIZED USE::R r~AINlr'!G AND EXPERiENCE AND PRECEPTOR ATTESTATION (continued)

Fourth Section 1\,," For 35.396: I"

Current 35.490 or 35.690 au!hQl:LIf'dlJ!?~r..;.

I attest that is an authorized user under 10 CFR 35.490 or 35.690 -----

t'·Jane of ProPOS6C; Autllorized Usar

or equivalent Agreement State requirements, has satisfactorily completed the 80 hours of classroom and laboratory training as required by 10 CFP :'\5.30 6 (dI(1), and the supervised work and clinical case experience recuired by 35.396(d)(2), and has achieved a level of competency sufficient to function independently as an authorized user fix:

Parenteral 3clministratiol1 of an}1 bE~ta.-emitter, or pllcton-emitting radionuclide with a photon energy less than 150 keV for which a written dh~cti\le is required

[J Parenteral 3cininistration of anv other radionuclide fOi which a written directive is required

OR Board Certification:

I attest that 118S satisfactorily completed the board certification

Name of Pro;)()s(:d }\uthorize,j U.:ier

requirements of 35.396(c), heS, :;;:;t'f,factorily corrlDleted the 80 hours of classroom and laboratory training required by '10 CFR 35.3913 ) Emci thf! supervised work and clinical case experience required by 35,396(d)(2), and has Clcllievr:d a level of con- peten,,) sufficient to function independently as an authorized user for:

D Parenteral aciministration c/ env beta-emiti:el'. or photon-emitting radionuclide with a photon energy less than 15Cl ke\l for which a written ciirective is required

fJ Parenteral aciminstration of any other radionuclicle for '1vhich a written directive is required ... ______ ._._ ... _ .... ~.~.w. ___ m _______ • __ ••••• _ ••••••• _ ••••

.f( Fifth Section f'\ comple~he following for preG8ptor aites.t3!t~on and Sn!f::lllature:

[g1 meet the requirem8'lts b,:!low, or equivalent /I.gmernent State requirements, as an authorized user for:

~ r~'J2 1~ 135396

~ave experience cldministering Cios5ges ill lhe lollowing categories for which the proposed Authorized User is reque ng authorization.

[-- Oral Nal-131 requiring a written ciirectlve in quantities less than or equal to 1,22 gigabecquerels (33 , ~uries)

[i2(Oral Nal-13 'I in qllar. 'it e~ grF'r IE ,- ria'] , '2;; ~'g 1_ ~K :"Jerels (33 rnillicunes)

Parenteral adr:linistrclti·)n of bela-E'rnitter. N phol:c,.l,ernittilg radionuclide with a photon energy less than 150 l<eV requiring a Vir,tten dit:,cU'J8 !~:

Parenteral administration of arry OUl8r raclionuclide n;:quiring a written directive

Telephone Number Date ----~ --- ~ ~-.- ~··~-·-~-l--·----·-

:3 D"tT ~ ,/, -6-S-5---77@-S~7- )t;JL

FonnA

American Board of Radiology - Program Director Attestation

COMPLIANCE WITH NRC TRAINING AND EXPERIENCE REQUIREMENTS

More infonnation can be found at the following link: http://www.nrc.qov/reading-rm/doc-collections/cfr/part035/part035-0290.html

(Y\~rk. P ar-e" tvs 5 U of IL ColI of Med at Peoria 14-08-18-2 Resident Name Program Program #

By the time of the ABR oral examination, this applicant will have successfully completed the hours of training and experience as outlined in 10 CFR 35.290 and 35.392 ............................................ ..

This applicant has taken part in ~ 3 cases of oral administration ofI-131 therapy (:S 33mCi) ............ ..

The resident's logbook ofthese therapy experiences (date, dose, and preceptor) is attached .............. .

The work and experience cited above for § 35.290 was obtained under the supervision of an Authorized User (AU) who meets the requirements under relevant sections of § 35.290 or equivalent Agreement State requirements ........................................................................................................... .

The work and experience cited above for § 35.392 was obtained under the supervision of an Authorized User (AU) who meets the requirements under § 35.390, 35.392 or 35.394 or equivalent Agreement State requirements ......................................................................... .

Terry M. Brady, M.D. Residency Program Director

(Print Name)

T H.~ Program~ (Signature)

YES NO

FormB

Date

1. 5~

2. ~

3. z&f-z

4. 5 /21JLo'g

5~ £/27/Bg

cPo r~1/D7

1-131 Therapy Experience

Dose Administered

17> M~I T-(3/

L 7 r; (hei r'i? (

~() MuI'-fII

10 tv..{( I '-is I

21 /lItC; j:.<-( s (

14 jVl(; J;-/Jf

.

bvt~"'Ul'~ o{ !({(vW~ {p~ 0.( ~,d- fc.orty

~O(F (".f-J/2<41d1 AeJ~~\~) -#:14-08-18-2 Program & Number

Preceptor (AU) Print & Si{!D Name

~v.h~ C4-=rt,~ Print Name

~)...--<:"~~ jjglI"Name

~v~ ~h,J1 Print Name

~~ S~me

G~ -JJ ~~ pl'intN~~~~ SjgwN'ame

v

Gt>v'"j 0",. C~.~ fa fl print~~;_~/~ SigtfName

~v-~",- c~ 104 1',-1"-<- tv "'-"-C.

~=~ -:>ii?S ...... N~~

~ ~"'- ~~ fa.J} '-rC';-+~...--~ :2

>" ~ :;- ..... fu ... .-......e

J\Jl:t ~ligiblr

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I';'

" I, ifdck1dl }t(o.w;v

/;t"Tch:r~-'\jjrc:Hinn r

tifica±r l'J n _ 5814 Z llalib tlrnm£ll: ZU2D

ih575992

TRUSTEES

Bruce G, Haffty,

Radia:ion Oncolc\]y'

Radiologic Physics

ileai'Dr P

~:Ij I n b\ tin: Al1k!'ic:;[1

Ililier lucu! c1I1ti;I:!IC or niillonal

1\',"0011:,11\ .

inc. to lhe uboyc ! r

. 1 wish \cl

Sail1t Alphc)nsus Regional Medical Center 1055 North Curtis Road· Boise, Idaho 83706

RETURN SERVICE REQUESTED

ldio {O~L-J

:RCHANDISE, MAY BE OPENED FOR POSTAL INSPECTION IF NECESSARY.

LL Reject 00-81

FIRST-CLASS flAIL

US POSTAGE PAID

Boise, 10

PERMIT" 679

11111111111111111111111111111111111111111111111111111111111111I1 RE C E iVE 0 4112110912-160515

NRC REGION IV 611 RYAN PLAZA DR. STE 400 ARLINGTON, TX 76011

SEP 1 4 2011

SEP 14 Z011

TlJJs is to acknowledge the receipt of your letter/application dated

~EP "1 2 2011 , and to inform you that the initial processing,

DATE

which includes an administrative review, has been performed.

i There were no administrative omissions. Your application will be assigned to a technical

reviewer. Please note that the technical review may identify additional omissions or

require additional information.

o Please provide to this office within 30 days of your receipt of this card:

The action you requested is normally processed withi~ days.

o A copy of your action has been forwarded to our License Fee & Accounts Receivable

Branch, who will contact you separately if there is a fee issue involved.

Your action has been assiqned Mail Control Number th 5 7 5 9 9. 2 When calling to inquire about this action, please refer to this mail control number.

You may call me at 817 -860-8103. I}:relY, () i 0 . J~/

l ~~ J<! (j) I~/ NRC FORM 532 (RIV)

(10-2006)

Licensing Assistant

BElWEEN:

Accounts Receivable/Payable and

Regional Licensing Branches

License Fee Worksheet - License Fee Transmittal

A. REGION

1. APPLICATION ATTACHED

ApplicanULicensee: ST. ALPHONSUS REGIONAL MEDICAL CENTER

Received Date: 09/14/2011 Docket Number: 3032263

Mail Control Number: 575992

License Number: 11-27306-01

Action Type: Amendment

2. FEE ATTACHED L Amount:

Check No.: L 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:

3. OTHER ______________ _

Signed:

Date:

[ FOR ARPB USE 1 INFORMATION FROM LTS

Program Code: 02240 Status Code: Pending Amendment Fee Category: 7C Exp. Date: Fee Comments: Decom Fin Assur Reqd: N

st. alphonsus regional medical center; amendment request ...f,u~:hrmc cardio & resp care 541 881...

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