Text

Matls Licensing Package for Amend 3 to License 50-29096-01MD for Alaska Radiological Pharmacy Ltd. Control:466920
	ML20198B618
Person / Time
Site:	03034015
Issue date:	12/01/1998
From:	Jonathan Montgomery; NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:	;
References
	466920, 50-29096-01MD, 50-29096-1MD, NUDOCS 9812210038
	Download: ML20198B618 (80)
	v • d • e

{{#Wiki_filter:.. . _ _ _ _ - _ _ _ _ _ _ - _ _ _ _ _ _ _ - _ _ _ _ -_ _ _ _ _ _ _ - . _ _ _ _ _ _ _ _ _ _ t u.S. NUCLEAR REGULATORY CoMMISSloN m ent o MATERIALS UCENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code cf Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliaries on statements and representations heretofore made by the licensee, a license is hereby issued authortang the hcensee to receive, acquire. possess, and transfer byproduct, sourco, and special nuclear material designated below, to use such material for the purpose (s) and at the place (s) designated below, to deirver or transfer such material to persons authorized to receive it in ttccordance with the regulations of the applicable Part(s). This license sh ll be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicible rules, regulations, and orders of ths Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. Ucensae in accordance with letter dated September 1,1998, 1. Al:ska Radiological Pharmacy Ltd. 3. Ucense number 50-29096-01MD is amended in its entirety to read as follows: 2. 4201 Lake Otis Parkway 4. Expiration date April 30,2001 Anchorage, Alaska 99508 5. Docket No. 030-34015 Reference No. 6. Byproduct, source, and/or special 7. Chembat and/or physical form 8. Maximum amount that licensee may nuclear matenal possess at any one time under this license A. Any byproduct material A. Unsoaled A. Molybdenum 99 35.0 Ci listed in 8.A. which is initially -Technicium-99m 35.0C1 , distributed in accordance , s Xenon-133 1.0 Ci ' O with a specific license issued Strontium-89 495.0 mci pursuant to 10 CFR 32.72 or'c fw ; N Phosphorus-32 50.0 mCl equivalent Agreement State C, Rhenium-186 500.0 mci regulations +n( lodine-131 1.0 Ci g , B. Technetium-99m B. UbsealebS B. 35 curies C. Strontium-89 C. Unsealed C. 50 millicuries D. Phosphorus-32 D. Unsealed D. 50 millicuries E. Rhenium-186 E. Unsealed E.100 millicuries F. Any byproduct material F. Prepackaged units forin F. 50 millicuries listed in 10 CFR 31.11(a) vitro diagnostic tests G. Any byproduct material G. Any sealed source listed in G. 50 millicuries g authorized under 10 CFR 35.57(a) that has 10 CFR 35.57(a) been manufactured, / labeled, packaged, and distributed in accordance with a specific license issued pursuant to 10 CFR 32.74 or equivalent regulations of any Agreement State 9012210030 901201 PDR ADOCK 03034015 C PDR j' ~ gg ~ 0FFICIAL RECORD COPY

. e . NRC FORM 374A u.S. NUCt. EAR REG ulAToRY coM MisSloN PAGE 2 of 5 PAGEs ucen.e number 50-29096-01MD MATERIALS LICENSE oocket or Reference Number 030-34015 SUPPLEMENTARY SHEET Amendment No. 3 6. Dyproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear materia? possess at any o.ie time under this license H. Any byproduct material H. Any sealed source that has H. 500 millicuries listed in Sections 35.400 been manufactured, and 35.500 of labeled, packaged, and 10 CFR Part 35 distributed in accordance with a specific license issued pursuant to 10 CFR 32.74 or equivalent Agreement State regulations I. Uranium (Depleted in the 1. Metal encased in stainless 1. 180 kilograms isotope Uranium-235) steel 9. Authorized use: ' . , A. through E. Preparintion and distribution 6f radioactive drugs and redistribution of ~ Mo09/Tc09m generators to atittiorized recipients.- e . s F. Redistribution to specific licensees or general,licen'see' pursuant to 10 CFR 31.11 provided the ~ '" packaging and labeling remain unchanged.; G. Instrument calibration. Redistribution of sources to specifically authorized recipients. Pursuant to 10 CFR 32.74, the licensee is authorized to redistribute sources to persons licensed punsuant to 10 CFR 35.57(a) or under equivalent licenses of Agreement States. H. Redistribution of sealed sources as received from the manufacturer in the manufacturers original packaging and shielding and accompanied by the manufacturers approved instructions to authorized recipients for use and storage. l. As shielding for molybdenum-99/ technetium-99m generators. Pursuant to 10 CFR 32.71, 32.72, 32.74, the licensee is authoriz,9d to distribute the byproduct material described in items 6 and 7 and prepared in accordance with this ll cense to persons licensed pursuant to Section 10 CFR 31.11, or Sections 35.57,35.100,35.200,35.300, 35.400, and 35.500 of 10 CFR l Part 35, or under equivalent Agreement State licenses. CONDITIONS 10. Licensed material shall be used only at the licensee's facility located at 4201 Lake Otis Parkway, i Anchorage, Alaska. ! _

. . . _ - , . - . . . . . . . , . . . esec poRM mA u.s. NUCLEAR REGULATORY COMMISSION PAGE 3 of 5 PAGES Lkenee Number 2- 50-29096-01MD MATERIALS LICENSE " " * " " " ' OEMS

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SUPPt.EMENTARY SHEET j', Amendment No. 3 1 1 !- 11. A Licensed material shall be used by, or under the supervision of: ,- i l 1). authorized nuclear pharmacists: Peter C. lverslie, R.Ph.; Cheryl Fowler; Daniel Cariddi; . l Steven C. Dragotakes, R.Ph.; Jeffery S. Cone, R.Ph.; L, . Kathleen M. Taylor, R.Ph.; or Ronald J. Callahan, R.Ph.; Yunga Vercelline, R.Ph. 2) a pharmacist working or designated as an authorized nuclear pharmacist in accordance with

' 10 CFR 32.72(b)(2) and (4). ' ' B. The Radiation Safety Officer for this license is Peter lverslie, R.Ph. ' 12.- Sealed sources containing licensed material shall not be opened or sources removed from source

j holders by the licensee.

s< s. j 13. A. Sealed sources shall be $$sted'for leakage and/or contamination at intervals not to exceed 6 months or at such other int'ervaliasi specifiq by the' certificate of registration referred to in 10 a j CFR 32.210. ( /,' ! r - , ,

, _ s An, - , 4 B. Notwithstanding ParagraSh~A of this dondition,! sealed sources designed to emit alpha particles ' shall be tested for leakage and/or< contamination at intervals not b exceed 3 months. ,

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d% ^ $. N ll ' ' + . C. In the absence of a~ certificate from a transferor ihdicatin'g that a leak test has been made within i 8 months prior to the transfer,'a seIiseil so0rce 'r65ked from an6ther person shall not be put into use until tested. 1Gl" " C " y % ! D. Sealed sources need not be leak tested if: l j- (i) they contain only hydrogen-3; or ! ,' (ii) they contain only a radioactive gas; or i.

(iii) the half-life of the isotope is 30 days or less; or i (iv) they contain not more than 100 microcunes of beta and/or gamma emitting material or not " 1- more than 10 microcuries of alpha emitting material; or I (v) they are not designed to emit alpha particles, are in storage, and are not being used. j However, when they are removed from storage for use or transferred to another person, and have not been tested within the required leak test interval, they shall be tested before use or i transfer. No sealed source shall be stored for a period of more than 10 years without being ' i tested for leakage and/or contamination. b i , iL !'

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_ _ _ _ E NRC FORM 374A U.S. NUCLEAR rUGULATORY commission PAGE 4 of G PAGEs ucense Number 50-29096-01MD MATERIALS LICENSE oxket or Reference Number 030-34015 SUPPLEMENTARY SHEET Amendment No. 3 . 13. (Continued) , E. The leak test shall be capable of cutecting the presence of 0.005 microcurie of radioactive material on the test sample. If the test reveals the presence of 0.005 microcurie or more of removable contamination, a report thall be filed with the U.S. Nuclear Regulatory Commission in accordance with 10 CFR 30(b)(2), end the source shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report J shall be filed within 5 days of the dato the leak test result is known with the U.S. Nuclear Regulatory Commission, Region IV,011 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, ATTN: Director, Division of Nuclear Materials Safety. The report shall specify the source j involved, the test results, and corrective action taken. i F. Tests for leakage and/or contamination shall be performed by the licensee or by other persons i specifically licensed by the Commission or an Agreement State to perform such services. ~ 14. The licensee shall conduct a physical . inventory every 6 months to accoun: for all sources and/or devices received and possessed 'under the license. 15. The licensee is authorized to ' transport licensett material only in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation cf Radioactive Material." i 16. Radioactive waste may be picked'up from the lizensee's customers and disposed of in accordance with the procedures, statements, and repr'esen6itionslrPa'pplication dated March 14,1996. e, - 17. The licensee is authorized to hold radioactive material with a physical haF-life of less than 65 days for decay-in-storage before disposal in ordinary trash provided: i A. Radioactive waste to be disposed of in this manner shall be held for decay a minimum of 10 half-lives. B. Before disposal as ordinary trash, byproduct material shall be surve: red at the container surface with the appropriate meter set on its most sensitive scale and with no interposed shielding to determine that its radioactivity cannot be distinguished from background. All radiation labels shall be removed or obliterated. C. Generator columns shall be segregated so that they may be monitcred separately to ensure decay to background levels prior to disposal. D. A record of each disposal parmitted under this License Condition shall be retained for 3 years. The record must include the date of disposal, the date on which tho byproduct material was placed in storage, the radionuclides disposed, the survey instrume:1t used, the background dose rate, the dose rate measured at the surface of each waste contairur, and the name of the individual who performed the disposal. .

- . . .. _=. - _ _ . - . .__ . , , , NRC FORM 374A U.S. NUCLEAR REGULATORY coMMISSloN PAGE 5 of 5 PAGEs L. cense Numbw 50-29096-01MD MATERIALS LICENSE oa*dw W m eNumbw 030-34015 SUPPLEMENTARY SHEET Amendment No. 3 18. In addition to the possession limits in Item 8, the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 30.35(d) and 40.36(b) for establishing decommissioning financial assurance. 19. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and_ procedures contained in the documents, including any enclosures, listed below. The U.S. Nuclear Regulatory Commission's regulations shall govem unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations. A. Product labels submitted with application dated November 21,1995 B. Application dated March 14,1996 C. Letter dated March 25,1996 , D. Telefacsimile received March 29,' 1996 E. Facility diagram received April 2,(1996 , F. Letter dated November 21,1996 ; , t G. Telefacsimile dated Februari 10,1997 " H. Telefacsimile dated April \\1.1,~ 1997 1. Telefacsimile dated July;25,1997; , , , , J. Letter dated September 1[1998 ], K. Letter dated September 23l1998 - .. . ~ Letter dated November 17,11996I, a! " - <C: ^ L. . FOR THE U.S. NUCLEAR REGULATORY COMMISSION ey hAfg kkwc DEC 1 1!58 Date ~ U g/ - giriies L. Montgomery Nuclear Materials Ucensing Branch Region IV Arlington, Texas 76011

.4. 4t>8 "'4Q UNITED STATES I*g . NUCLEAR REGULATORY COMMISSION 3- REGION IV k+,, * s a #,C[' 611 RYAN PLAZA DRIVE, SUITE 400 AR LINGTON, TEXAS 760118064 December 1,1998 Alaska Radiological Pharmacy Ltd. ATTN: Peter C. lverslie, R.Ph. 4201 Lake Otis Parkway Anchorage, Alaska 99508 SUBJECT: LICENSE AMENDMENT Please find enclosed amendment 3 to License No. 50-29096-01MD. You should review this license carefully and be sure that you understand all conditions. If you have any questions, you may contact the reviewer who signed your license at 925-673-0112. NRC expects licensees to conduct their programs with meticulous attention to detail and a high . standard of compliance. Because of the serious consequences to employees and the public which can result from failure to comply with NRC requirements, you must conduct your . program involving radioactive materials in accordance with the conditions of your NRC license, representations made in your license application, and NRC regulations. In particular, note that you must: 1. Operate in accordance with NRC regulations 10 CFR Part 19, " Notices, Instructions and Reports to Workers: Inspection and Investigations," 10 CFR Part 20, " Standards for Protection Against Radiation," and other applicable regulations. 2. Possess radioactive material only in the quantity and form indicated in your license. 3. Use radioactive material only for the purpose (s) indicated in your license. 4. Notify NRC in writing of. .ny change in mailing address (no fee required if the location of radioactive material rt mains the same). 5. Request and obtain written NRC consent before transferring your license or any right thereunder, either voluntarily or involuntarily, directly or indirectly, through transfer of control of your license to any person or entity. A transfer of control of your license includes not only a total cha_nge of ownership, but also a change in the controlling interest in your company whether it is a corporation, partnership, or other entity. In - addition, appropriate license amendments must be requested and obtained for any other planned changes in yoGr facility or program that are contrary to your license or contrary to representations made in your license application, as well as supplemental correspondence thereto, which are incorporated into your license. A license fee may be charged for the amendments if you are not in a fee-exempt category. - . - . .. - - .- . .- - - - - - - ,

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' Alaska Radiological Pharmacy, Ltd. 2 6. Maintain in a single document decommissioning records that have been certified for completeness and accuracy listing all the following items applicable to the license: Onsite areas designated or formerly designated as restricted areas as defined - - in 10 CFR 20.3(a)(14) or 20.1003. ) Onsite areas, other than restricted areas, where radioactive materials in - quantities greater than amounts listed in Appendix C to 10 CFR ) 20.1001-20.2401 have been used, possessed, or stored. Onsite areas, other than restricted areas, where spills or other unusual - occurrences involving the spread of contamination in and around the facility, equipment, or site have occurred that required reporting pursuant to 10 CFR 30.50(b)(1) or (b)(4), including areas where subsequent cleanup procedures - have removed the contamination. Specific locations and radionuclide contents of previous and current burial areas - within the site, excl ?ng radioactive material with half-lives of 10 days or less, depleted uranium used only for shielding or as penetrators in unused munitions, or sealed sources authorized for use at temporary job sites. Location and description of all contaminated equipment involved 'in licensed

operations that is to remain onsite after license termination. 7. Submit a complete renewal application with proper fee, or termination request at least 30 days before the expiration date on your license. You will receive a reminder notice approximately 90 days before the expiration date. Possession of radioactive material after your license expires is a violation of NRC regulations. 8. Request termination of your license if you plan to permanently discontinue activities involving radioactive material. You will be periodically inspected by NRC. Failure to conduct your program in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in enforcement action against you. This could include issuance of a notice of violation; imposition of a civil penalty; or an order

. . Alaska Radiological Pharmacy, Ltd. 3 i suspending, modifying, or revoking your license as specified in the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG 1600, Rev.1. J Thank you for your cooperation. Sincerely, p@ , . James L. Montgo ery Senior Health Physicist Nuclear Materials Licensing Branch Docket: 030-3401S License: 50-29096-01MD Control: 466920 Enclosures: As stated 1

. _ _ _ _ . . . _ _ _ . _ _ _. . . _ , .. _._. _. i . . .. ' Alaska Radiological Pharmacy, Ltd. 4 i p . bec w/ enclosure: LFARB, T-9, E10 ' inspection File Docket File State of Alaska (License Only) DOCUMENT NAME: C:W66920 To receive copy of document. Indicate in box: "C" = Copy without enclosures "E" = Copy with enclosures "N" = No copy RIV:NMSB1 JLMontgomery b /1/ //98 OFFICIAL RECORD COPY - -

. . .. _ .. -- . - - - ._ -. . .- - 11./23/1998 14:05 9072434570 ARP PAGE 01 , - g . . . J ." ALASKA RADIOLOGICAL PHARMACY, LTip. . ,. 3 -% . . . - _ _ . _ . . _ _ . [ ' ' > A.p 4201 Lake Otis Parkway, Anchorage, AK,99508 . ! - , s <'i (907) 561-7375 * Fax (907) 561-7380 - - M r , ' r,p i

.s. j . j November 17,1998

i Dear James Montgomery, This letter is in regard to pharmacist Cheryl Fowler, She received her 200 hrs. of Nuclear Pharmacy course work at the University of Oklahoma during the 1997- 1996 school year. Her piogram director was Garo Basmedjian, Ph.D., This covers the course requirements set by the college and the NRC. She also received 1112 hours of training in Nuclear Pharmacy at OUHSC Nuclear , Pharmacy under her preceptor Adam Malak. Her training at this pharmacy were under compliance with state board of pharmacy and NRC regulations. The i director of the Nucieer Pharmacy is Dr. Stanly Mills and he can be reached at (405) 271-6264. If there are any questions, please let me know. Sincerely, s Peter Iverslie, R.Ph. . . . b & P

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. _ _ _ _ _ _ . _ _ -. ._ _ ' 11/23/1998 14:05 9072434570 W PAGE 02 \\ _ - 1 I m.1258 STATE OF ALASKA - FEective' .10/21/1998 ExWee; 06/30/2000 DEPARTMENT OF COMMERCE & ECONOMIC DEVELOPMENT pi,i, ion or occupauonal Lic.neine P.O.Bos 110606, Juneau. Alaska se8114006 i B'OARD OF PHARMACY Certifies that

' CHERYL ' A FOWLER - ,? - is a Licensed . , ' 7, . : PHARMACIST , , . Commissioner: Deborah B. Sedwick .. e l ? ' ) ' , - e t . t . l t

, e s b g I .' e , y e at a 9 . _ .-n _ _ , ,

. . . . . - . - - I '. 11/23/1990 14:05 ~9072434570 ARP PAGE 03 , Nav 23 CS 03 21p Dan Ccridgi C78-433-5134 p.3 l COMPLY: V1.5d. 7.1/23/98 2:28 40 CFR Part 61 National Emission Standards for Hazardous Air Pollutants REPORT ON COMPLIANCE WITH THE CLEAN AIR ACT LIMIT 8 FOR RADIONUCLIDE EMISSIONS FRCM THE COMPLY CODB, VERSION 1.5d 1 l Prepared by: Alaska Radiological Pharinacy Ltd N.R.C. License number 030-34015 4201 Lake Otis Parkway. Anchorage. AK. 99508 Peter Iverslei. RPh. 907-561-7375 Prepared for; U.S. Environmental Protection Agency Office of Radiation Programe Washington, D.C. 20460

_- . -- 11/23/1990 14:05 9072434570 W PAGE 04 I ' Nr.v 23 SD 03:21p Dan Cer ics1 C73-436-3134 p.3 COMPLY: V1.5d, 11/23/98 2:28 i Demonstration of Compliance with Public Dose Limit using COMPLY ................. SCRBENING I.BVBL.1- i ................. DATA JDfTERED: ......... ... Annual possession limits used. \\ I Annual Amount Physical l ' Nuclide (ci/ year) Fozu ........ ............. ........ I.13 1 2.085+01 Liquid XR.133 4.16E+00 Gaseous NOTES: ...... Input parameters outside the " normal' range: None. RESULTS: ........ You possess 3.2 cimes the allowao'le amount given in the possession table. ~You possess 10.3 tintes the allowable amount of Iodine.

- - Failed at level 1.

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~_ _ _ . - . . _ . . . _ . . . . . .._. _ __ _ _ _ _ _ 11/23/1998 14:05 9872434570 ARA PAGE 05 - ' '

M:V 23 CG 03:01P

Dan certegg 878-436-0134 p , c, COMPLY: V1.5d. 11/23/98 2:28 Demonstration of Compliance with Public Dose Limit using COMPLY ................. SCREIDt!NG LEVRL 2 . . . . . . . . . . . . . . . . . , DATA ENTERED: ............. . . ) 1 1 i ) i i )

'~ ' ,11 23 19 8 14:05 9072434570 ARP PAGE 05 / / 9 N3v 23 88 03:21r Dsn Cce1Cdi 978-438-9134 p.E Release Rate Nuclide (curies / YEAR) ... ......... .......... I-131 D 2.0805-03 XB-133 4.240E+00 Release height 4 meters. Building height 4 meters. The source and receptor are not on the came building. Distance from the source to the receptor is 402 meters. Building width 14 meters. . Default mean wind speed used (2.0 m/sec). lEmtS: ...... Input paraineters outside the " normal" range: None. RESULTS: . ...... Effective dose equivalent: 0.1 mresi/yr. Effective dose equivalent: 0.1 mrem /yr due to Iodine.

- - Comply at level 2.

This facility is in COMPLIANCE. It may or may not be EXEMPT from reporting to the EPA. You may contact your regional EPA office for more information. t END OF COMPLIANCB REPORT * *"* * *" *

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1. APPLTCATION ATTACHED M Applicant / Licensee: ALASKA RADIOLOGICAL PHARMACY LTD. f- I, - 0 i n ;1 Yr^ r~ sl]0 b - - --- 7 ,i i: Q

',, , - , , ' Received Date: 980908 Docket No: ~ 3034015 1.UI P ~ L, ^ ~ " -- Centrol No.: 466920 l {#If.1 -- C#1 , b . Lic9nse No.: 50-29096-01MD , i- i, Action Type: Amendment ! SEP 18 - .a m , e"' sL i -:

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2. FEE ATTACHED d M ,OO 'I ' t ' Amount: 2doo i -/ ' Check No.: - "WI i 3. COMMENTS .. 'CW xy

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i ALASKA RADIOLOGICAL FilARMACY, LTD. .. . .* ' " ,l0.l . 4201 Lake Otis Parkway, Anchorage, AK,99508 ' - .- . g. , (907)561-7375 * Fax (907) 561-7380 o . ... a a . .y. !. . O l g 8 F* - .. September 1,1998 - -. Dear Nuclear Materials Licensing Branch, I would like to amendment my license as follows: 1. Add Cheryl Fowler and Daniel Cariddi as authorized users. Both will work under this license only while they hold a current Alaska Pharrracist License. Supporting documents follow. 2. Use I-131 in the pharmacy. Supporting documents follow. 1 lithere are any questions please da not hesitate to call me at (907) 561-7375. 1 Since.el , Pet Iverslic . O r ! - 4 . Y e a f k 466920 . F

p----------------,---s g ,,, .,,,. .. s .. . ,,, ,,,,....,,,...,,,,,, s . ,.. ......,, ,,,,,,, l NAC FORM 374 1 U' 6 l I EO g 60-se) U.S. NUCl.EA3 Recut.ATcRY COMMIS310N [ N i il MATERIALS LICENSE i j '1 y ' [' Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title to, y j Code of Federal Regulations, Cnapter I, Pans 30,31, 32,33,34, 35, 39, do and 70, and in reliance on statements and representations heretofore p ' - ide by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special l uclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver of transfer such material l to persons authorized to receive it in accordance with the regulations of the applicable Pan (s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable ru!cs, regulations and orders of the Nuclear g Regulatory Commission now or hereafter in effect and to any conditions specified below. l 1 l Licensee l ' 1. Medi-Physics, Incorporated 3. Ucense number 20-30176-01MD , N W 2 25 Olympia Avenue, Suite D < . . , l > Woburn, Massachusetts 01801 > O. c 4.iExpiration date January 31, 2000 8 ,. ?* > ' ' ~ .* , 5. Docket or ' .f Reference No. f030-33662 g 6. Byproduct, source, and/or 7. Chemical and/or physical ~ #8. Maximum amount that licensee special nuclear material

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form 4, may possess at any one time . under this license - A. Molybdenum 99 A. Any Molybdenum 99/ @ A. 200 curies I

J Jtechnetium 99m generittor l " -- ympiufactu!rM, Iabe16di y f; packaged and distr t 2in'accordancewithj}buted , ," ac I N "JM,, w?isgec,ific licenseQisued , 4 l P~ a.3 NpdfstattTTTQ'tkR'32,73/ ,' cf' -Sic.r. . oriequivalent' reg 61at'idns;

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any W eement. State 7 s SB.f';Prepackagediln VitroF)P n B.50 millicuries i B. Any byproduct materitil. listed in paragraph 9 . d.iagnostic-test kits- W - . 4d 2 31.11(a) of 10 CFR Part 31 " ' U 9 > C. Any byproduct material * C. Any sealed 's'ource "' ~ C. 50 millicuries [ identified in 10 CFR / p- identified in d' g , ~ 35.57(a) 10 CFR 35.57(a) that hits i , 4'been manufacturedJ!.

labeled, packaged and W distributed in accordance l with a specific licence lli issued pursuant to , 10 CFR 32.74 or - g - equivalent regulations of ,1 any Agreement State } f f kl - . ____________~___________----------- -- ---------- "

~ WWiafWWuter ununununur- my l FORM 374A U.S. NUCLEAR RE!ULATORY COMMISSION P,*.GE p OF g* PAGES g License Number g 20-30176-01MD 'E MATERIALS LICENSE Docket or Reference Number g , SUPPLEMENTARY SHEET 030-33662 E 's [D. Xenon 133 D. Unit dose containers of D. I curie E g gas or gas in solution h p that is the subject of an E p active (i.e., not h p withdrawn or terminated) W p "New Drug Application" h a (NDA) approved by FDA or ) p an active (i.e., not W g withdrawn, terminated or E g on " clinical hold") i g " Notice of Claimed E y , Investigational Exemption W g for a New Drug" (IND) W g that has been accepted by k p FDA h y E. Iodine 131 E. Any form identified in E. 300 millicuries W 10 CFR 35.100, 35.200 or g y 35.300 g g g F. Technetium 99m F. Any form identified in F. 200 curies y 10 CFR 35.100 and 35.200 y g y G. Any byproduct material, G. Any form identified in G. 50 millicuries y > except-iodine 131 and 10 CFR 35.100 'g technetium 99m, identified p W in 10 CFR 35.100 g [ 't. Any byproduct material, H. Any' form identified in H. 200 millicuries y except iodine 131 and 10 CFR 35.200 g y technetium 99m, identified y g in 10 CFR 35.200 , g I. Any byproduct material, I. Any form identified in I. 100 millicuries i g except iodine 131, 10 CFR 35.300 g g identified in 10 CFR 35.300 , g J. Any byproduct material J. Any sealed source that J. 4000 millicuries j g identified in 10 CFR 35.400 has been manufactured, g 1 and 35.500 ' labeled, packaged and y g distributed in accordance f with a specific license [ ' issued pursuant to

g 10 CFR 32.74 or ^ l equivalent regulations of l any Agreement State K. Metal K. 400 kilograms l lK.Uraniumdepletedin ' isotope U-235 W , I . 9, Authorized use A. Production of technetium 99m pertechnetate. Redistribution of unused generators to f , authorized recipients in accordance with statements, representations and procedures , . contained in application dated September 2, 1994. g f . Redistribution to general and specific licensees in accordance with statements, B h representations and procedures contained in application dated September 2, 1994. , > e .s g - --mma==========mmmammmammmammmmmmmmmmammaammmmial Prmied on recycled papr s

pirJIuuw msung:Lwaw mm wmm w w w wm ammmm wmm mmwe_amm am musumq NR FORM 374A U.S. NUCLEAR REGULATORY CoMMISSloN PAGE 3 OF f' PQGES g g License Number g g . N 20-30176-01MD E . ! y MATERIALS LICENSE ooctei or aererence Number [ , SUPPLEMENTARY SHEET 030-33662 i I .' P I ! - N C. Instrument calibration. Redistribution of sources to specifically authorized h N recipients. Pursuant to 10 CFR 32.74, the licensee is authorized to redistribute i N sources to persons licensed pursuant to 10 CFR 35.14 and 35.100 of 10 CFR Part 35 E B (superceded) and 10 CFR 35.57(a) of 10 CFR Part 35 (effective April 1,1987) or under ! N equivalent licenses of any Agreement State. k p D. Redistribution as received from the manufacturer in the manufacturer's original t y packaging and shielding to authorized recipients. ) g E. Redistribution of prepared radiopharmaceuticals as received from the manufacturer in s y the manufacturer's original packaging and shielding to authorized recipients. p y F. Dispensing and/or distribution of prepared radiopharmaceuticals to authorized a y recipients. Use of technetium 99m pertechnetate for processing with reagent kits in ! y preparing radiopharmaceuticals. g g G. through I. Dispensing and/or distribution of prepared radiopharmaceuticals to y a authorized recipients. k j J. Redistribution of sealed sources as received from the ma..ufacturer in the i g manufacturer's original packaging and shielding and accompanied by the manufacturer's g y approved instructions to authorized recipients for use and storage. g y K. Shielding for Mo99/Tc99m generators.

9 2 g Pursuant to 10 CFR 32.72, 32.73 and 32.74 of 10 CFR Part 32, the licensee is authorized to E y distribute the byproduct material described in Items 6 and 7 of this license to persons g licensed pursuant to 10 CFR 35.14 and 35.100 of 10 CFR Part 35 (superceded), 10 CFR y a i 35.100, 35.200, 35,300, 35.400 and 35.500 of 10 CFR Part 35 (effective April 1,1987) or - g gi under equivalent licenses of Agreement States, for the Groups or Sections indicated below: 3 A. Unused molybdenum 99/ technetium 99m generators may be redistributed to persons f g licensed pursuant to Group III or 10 CFR 35.200. , D. Gas or gas in saline may be distributed to persons licensed pursuant to 10 CFR 35.200 j y (effective April 1, 1987). E y E. through I. Any form listed in each group, Groups I, II, IV and V of Schedule A, g y 10 CFR 35.100 of 10 CFR Part 35 (superseded) or authorized by g g 10 CFR 35.100, 35.200, and 35.300 (effective April 1, 1987), may be y y distributed to persons licensed pursuant to 10 CFR Part 35 or under g y equivalent licenses of any Agreement State. Sealed sources may be redistributed to persons licensed pursuant to Group VI uf I y l J. l Schedule A or 10 CFR 35.400 and 35.500. l CONDITIONS E E A. Licensed material may be used only at the licensee's facilities located at l10. 25 Olympia Avenue, Suite D, Woburn, Massachusetts. l , E B. The licensee may not possess and use materials authorized in Items 6, 7, and 8, I until: (1) the licensee has constructed the facilities and obtained the l equipment described in the application and supporting documentation; and (2) the l U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials g g Safety Branch, 475 Allendale Road, King of Prussia, Pennsylvania 19406 has been , notified in writing that activities authetized by the license will be initiated. y, l In accordance with the requirements set forth in 10 CFR 30.36(b), 40.42(b), and f ' p 70.38(b), the licensee shall promptly notify the Nuclear Regulatory Commission, g in writing, of a decision not to complete the facility, acquire equipment, or j y possess and use authorized material. 3 ,nm==mmamm==mmmmmmmmmmmmmmmmmmmmm====mmmm====mmmm Prmted on recycled pupr _ - - _ _ _ _ _ _ _ . _ _ . 2

, N,R- - - - - _ _ _ _ _, _ __ FORM 374A U.S. NUCLEAR REoVLAToRY COMMISSloN PCGE 4 OF (;* PAGES g Lkense Number g $*

20-30176-01MD W

R, MATERIALS LICENSE cocket er Referaice Number g ' i SUPPLEMENTARY SHEET 030-33662 E

E il g E . N 11. A. Licensed material shall be used by, or under the supervision of, Daniel Cariddi, E N Walter Adicche, Ross Strauss, Jill Twehues, Janet Reuther, James Pancy, E N John Carr, Clyde Cole or John Marzocca. E N t N B. At least one individual named in Paragraph A of this Condition shall be ( N physically present at the authorized place of use whenever licensed material is E , l N being used. E ' I N E 3 C. The Radiation Safety Officer for this license is Daniel Cariddi. E 3 E \\ N 12. A. Sealed sources and detector cells containing licensed material shall be tested ( l N for leakage and/or contamination at intervals not to exceed six months or at E ' y such other intervals as are specified by the certificate of registration f y referred to in 10 CFR 32.210, not to exceed three years. p; E N ' y B. Notwithstanding Paragraph A of this Condition, sealed sources designed to emit ( y alpha particles shall be tested for leakage and/or contamination at intervals g y not to exceed three months. gl = 1 y C. In the absence of a certificate from a transferor indicating that a leak test j has been made within six months prior to the transfer, a sealed source or g y detector cell received from another person shall not be put into use until g > tested. g . y f ' ^ D. Each sealed source fabricated by the licensee shall be inspected and tested for g construction defects, leakage, and contamination prior to ny use or transfer as g y a sealed source. y g E. Sealed sources and detector cells,need not be leak tested if: l l E 4 4 (i) they contain only hydrogen-3; or g l (ii) they contain only a radioactive gas;.or l l (iii) the half-life of the isotope is 30' days or less; or f " l (iv) they contain not more than 100 microcuries of beta and/or gamma emitting l material or not more than 10 microcuries of alpha emitting material; or y 4 N l (v) they are not designed to emit alpha particles, are in storage, and are not E being used. However, when they are removed from storage for use or N 3 transfer to another person, and have not been tested within the required f j leak test interval, they shall be tested before use or transfer. No sealed 4 source or detector cell shall be stored for a period of more than 10 years j without being tested for leakage and/or contamination, f

g > ( 1 E i s W ! n g i r...............................................! i Prmmd on recycled pape

p umum.m a v n a o o osm9 to o o o o o 9.mm.----- .-

- NR FOnM 374A U.S. NUCLEAR REGULATORY COMMISOON PAGE g OF g* PAGES g License Number g. N 20-30176-0lMD ' M N MATERIALS LICENSE oocket or nererence Number r* SUPPLEMENYARY SilEET 030-33662 Nf

ul $ li~ F. The test shall be capable of detecting the presence of 0.005 microcurie of E N radioactive material on the test sample. If the test reveals the presence of E N 0.005 microcurie or more of removable contamination, a report shall be filed )E ! N with the U.S. Nuclear Regulatory Comission and the source or detector cell p shall be removed immediately from service and decontaminated, repaired, or E N disposed of in accordance with Commission regulations. The report shall be E N filed within five days of the date the leak test result is known with the W p U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials W g Safety Branch, 475 Allondale Road, King of Prussia, Pennsylvania 19406. The E g report shall specify the source or detector cell involved, the test results, and n .g corrective action taken. W . . g ,\\ W W . p G. The licensee is authoriz'ed,to collect leak test samples for analysis by the W y licensee. Alternatively, ' tests for leakage and/or contamination may be )E ! y performed by persons specifically licensed by the Commission or an Agreement y State to perform,such services. g w , . y ' y 13. Sealed sources orOfstecto'r cells containing licensed material shall not be opened or y y suurces removed from source holders by the licensee, g N N h 14. The licensee shall conduct a p$ysical inventory every six months to account for all y sealed sources and devices containing licensed material received and possessed under y y Q.;- g the license. t ,,,, . w, y .. 15. The licensee is authorized to transport licensed material in accordance with the y provisions of 10 CFR Part 71',f"Packa,ging and Transportation of Radioactive Haterial." g 8 . .6

.u

y 16. A. Radiopharmaceuticals dispensed,and/or distributed for human use shall be either: , we n , , , , , (1) repackagedafrom prepared h diopharmaceuticals that are the subject of U.S. g Food and DrugcAdministration-(FDA)-approved "New Drug Application" (NDA) or j for which FDA has accepted a " Notice of Claimed Investigational Exemption g foraNewDrug"(IND};or y (ii) preparedfromgeneratorbandreagentkitsthatarethesubjectofanFDA- l approved NDA or for which FDA has accepted an IND. g B. Prepared radiopharmaceuticals for which FDA has accepted an IND and l radiopharmaceuticals prepared from generators or reagent kits for which FDA has y accepted an IND shall be dispensed and/or distributed: y (i) in accordance with the directions provided by the sponsor of the IND; and (ii) only to physicians who have been accepted by the sponsor of the IND to l participate in clinical evaluation of the drug. g 17. The licensee shall elute generators and process radioactive material with reagent f kits in accordance with instructions furnished by the manufacturer on the label y attached to or in the leaflet or brochure that accompanies the generator or reagent y f kit. y s E . w nummmmmmmmmmmmmmimmmmmmmmmmmar Prmted an recycled papet _ _ _ _ . _ . _ _ . _ . _ _ . . _

NR FORM 374A U.S. NUCLEAR REGULATORY COMMISSION P E g OF g PAGES LKense f: umber

" . MATERIALS LICENSE ooc w . w m nce so me, GUPPt.EMENTARY SHEET 030-33662 '

k jl E'd 1 18. The licensee is authorized to hold radioactive material with a physical half-life of g ' 1 less than 65 days for decay-in-storage before disposal in ordinary trash, provided: E 1gl, 1 , 1 A. Waste to be disposed of in this manner shall be held for decay a minimum of ten t 1 hal f-lives. p 4 g I B. Before disposal as ordinary trash, the waste shall be surveyed a( the container )fl ' I surface with the appropriate survey instrument set on its most seitsdtive scale E I and with no interposed shielding to determine that its radioactivity cannot be g(! 1 distinguished from background. All radiation labels shall be removed or 1 1 obliterated. / g l , ' $ 1 1 C. A record of each such disposal hermitted under this License condition shall be gi i ' retained for three years. ' The record must include the date of disposal, the gl 4 date on which the byproduct material was placed in storage, the radionuclides g a disposed, the survey instrument used, the background dose rate, the dose rate gl ! 1 measured at the' surface of each waste container, and the name of the individual g 1 who performed;the disposal. g: t , g 1 ! 19. Reagent kits may be redistributed to persons licensed pursuant to 10 CFR 35.200 or y g under equivalent 1.icenses of Agreement States. g j g 20. Radioactive wast may be pick d up from the licensee's customers and disposed of in fi l ' accordance with'the statements, Nrepresentations and procedures- in the application g " g ! dated September 2, 1994. - $ 21. In addition to the possession limits in Item 8, the licensee shall further restrict g the possession of licensed material'to quantities below the minimum limit specified g ~ in 10 CFR 30.35(d),,40.36(b), and 70;25(d) for establishing financial assurance for g j . decommissioning. ', R y 7 W, g 22. The licensee shall not acquire licensed material in a sealed source or device unless y the source or device has been registered with the U.S. Nuclear Regulatory Comission g

pursuant to 10 CFR 32.210 or equivalent regulations of an Agreement State, i 23. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures f The Nuclear contained in the documents, including any enclosures, listed below. y - Regulatory Commission's regulations shall govern unless the statements, g representations, and procedures in the licensee's application and correspondence are , more restrictive than the regulations. g A. Application dated September 2, 1994 f B. Letter dated November 16, 1994 [ C. Letter dated December 28, 1994 For .S. Nuclear Regulatory Commission g , m-3E g (. % , Date % Nuclear Mat a s Safety Branch g Region I g ' King of Prus a, Pennsylvania 19406 _...................... ...--------..----.--- g . . .. -- _. .- _.

. . _ TRAINING RECEIVED IN BASIC RADIOISOTOPE ifANDLI, ! TECili! UES Student' Cheryl Fowler Program Director Garo Basmadiian.Ph D. Signature ~ u N Date 5/1/98 Breakdown of Course Content in Clock liours Total Clock Course Title if flours if Radiation Math Location of Date(s) of Applicable Applicable Pysics & Pertaining Radiopharma. Training Attendance Instrumen. Radiation to Radio- Radiation ceutical tation Protection activity liiology Chemistry A B A B A B A B A B University of Fall 1997 pilar 5324- 44/48 48 22 8 4 10 Oklahoma Radionuclide flealth Sciences Methodology Center Lecture / Lab Spring 1998 pilar 5334- 41/50 37 10 8 16 20 Nuclear Pharmacy Lecture / Lab May 1998 pilar 5001 17 Intersession Lit Phar Sci 10 7 Column "A" refers to Lecture / Laboratory Ccu e [200 85 10 32 7 16 20 30 Column "B" refers to Supervised Lab Experience 'TOTIL 95 39 16 20 30 HOURS Scheda.97 ) ~~ ____.

_.__ _ _ _ _ _ _ __ _ _ _ _ - - _ _ _ _ _ _ _ - . . . . Oddk8,dh9(5[ COREGEOFPHARECY Add [Md[8) h MM. (Last name, first name) b (section)

, (month) . WEEK BEGNMNG SUNDA'Y: SUNDAY MONDAY ' TUESDAY WEDNESDAY THURSDAY FHDAY SATURDAY TOTAL PA!DLEAVE OTHERHOLF1S dids6tXvns4%MJMMMhanMNfmL _

"r ~24' ~ c%ah. + .w yss W2 Np Fimt ilAR HDURSUSED tr m .- 4/1/93 a bd 5 - ' ' .. O d F 8 .h b &

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TOTALHOURS BALANCE CARR:EDFORWARD + TOTALHOUR',, T, RUED N + TOTALPA!D LEAVE HOURS M - BALANCE END OF MON'IH = RJEGll/RHOURS H HOUDAY REGULARHOURS EMPLMEE V-VACATION-PA:D LEAVE HOURS S-SICK HOURS-PAD LEAVE HOURS OT-OVERTNE4THERHOLRS - . STD-SHORTTERM DISABLRY-OTHER HOURS alBElhT50R ~ e . . . . - m . m

- _ - - _ . . . _ - _ . - hk [D(dffI $(/U\\ ! fUl' [/)} d4/[ MAY Lkd # COLLEGE OF PHARMACY (Last_ name, stret name) V , (section) (month) r WEEK BEGINNING SUNDAY: . SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY TOTAL PAID LEAVE OTHERFOURS

M hilE#RnSte@4MULn9Ein4MWEst*W;4? N M N E*;.;uM @ W #%

~*E NGt1AR HOURSUSED LEED I .n, , n. 5/2/93 I $5 b bh$ h b.h$ lYs h ci e 5/9/93 .h behI dhb - 5/16/93 i . a 5as 5 M# ao.E & + & & 5/23/93 h. - 5 ~ AIP 31 ?@$*Nsf b Wu); ^ rw 9o ^ '< - ~ , Ct; ' .,M 5/20/93 M E) 4" < - 4 W . - < .

ss

_- <. - < , . - . . TOTAL HOURS he BALANCE CARRIEDFORWARE + . TOTALHOURSACCRUED + TOTAL PAID LEAVE HOURS - BALANCE END OFMONTH = a . [ R REGULARHOURS EWLOYEE (j H-HOLIDAY-REGULAR HOURS ' ' V-VACATION-PAID LEAVE HOURS ' S-SICK HOURS-PAID LEAVE HOURS < .omeR- STD-SHORTTERM DISABLRY-OTHER HOURS huPERVISOR .

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

-

---- -- -

- - - - - - ~ . - 1-i <,s q Fouhr, Cha 1 Nr MaA.r? <T a t /M3 mLtEoEc PHARMicY e (Last name, First'name) (section) (month) / WEEK BEGNNN".NG SUNM TOTAL PAID LEAVE OTHER SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY REGULAR HOURS USED (OT/STD) b/1/9 3 $ 0* - s s' 6/6/93 . e

^ 8 , __ sh h s0 9:13t93 - 6/20/93 .? 45 k !1 , 6127/93 E ~ l TOTAL HOURS em,u CARaEDFORoum . TOTAL FOURS ACCRUED + TOTAL PA!D LEAVE HOURS USED - BALANCE END OF fCNTH l- l remumem --ww w- -=xmemaammmunasymemamanera-memimwem ' 8R -REGULAR HOURS / 6H- HOUDAY HOURS -REGUtAR HOURS . _ EWLOYEESIGr$ NRE Q 8V - VACATON HOURS - PAID LEAVE HOURS USED s 8S - SICK LEAVE HOURS - PAID LEAVE HOURS USED OT-8 HOURS OVERTIME-OTHER HOURS A STD - SHORT TERM DISABluTY HOURS - OTHER HOURS SUPEih SIGtMTURE - - - - - - - . - - . . .

h3 , COLLEGE OF PHARMACY h(ldf/L ' LOA [/NOU JULY OlM\\ b^\\Qh_g{ (month) (last name, first name) d (section) WEEK BEGINNING SUNDAY: SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY TOTAL PA!DLEAVE OnERHOURS - , g g g yjgg g g g g , W s RN N USED USB

7.g ... p;.ps:- -mmu+n - mnwa sm-x-m- -nan., m,:w. m-ww mum +y pansue IL h.h b - k 2h. 7/1/93 @$

55 9 7.35 S$!N[3 22.77 . 7/4/93 R &N '!.a'5 9.5 '7.a 3 L'75 M@S! 56.'If - 7/11193 MF 5 5 5 5 Miss SD 7/18/93 O + . 7/25/93 r m . .. .s -e m, . : sm.ce wu. iaamwan% m mmum. < TOTALHOURS N, BALANCE CARR:EDFCmVARD + TOTALHOURSACCRUED + TOTAL PAID LEAVE HOURS - DALANCE ENDOF MONTH = l1/01 . M) ' EMPt.OYEEy R-FEGULFaHOURS H-HOUDAY-REGULARtOURS s V. VACATION. PAD LEAVE HOURS jf[/j)-' S-SICKHOURS-PAD LEAVE HOURS / /bf/W/ ,, OT. OVERTIME CTHERh00RS STD.SHORTTERM DISABLITY-OTHER HOURS . _ . _ . _ _ _ _ . . ._. - _ _ _ _ . . ____--_____.___..m_- m - d

- . - . . . - . . . . . _ . _ . - - - . _ . . . . _ _ _ . -f0 i ap,Ie . i t - COLLEGE OF PHARMACY-TIMESHEET Au0ust kk j . i SeQon ' Week Beginni Su MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY TOTAL PAID LEAVE OTHERHOlflS l FEGUUV1 HOURSUSED USED l __ 8/1/93 I 9. b ~Y 7 Yh __ 8/8/93 b 7. $ d ' __ 7 7,$ h, I __ j 8/15 . 81_22193 _ h.5 Y Ys Eb h?05 h- lN . pmxwww wam wwww.ww . sumwaaw ua.mewa+ a emmmaw mewwam } . TOTALHOURS /M.[ ~b~ ~b~ ' [ BALANCE CARRIEDFORWARD + ' l ! TOTALHOURSACCRUED + j TOTALPAID LEAVE HOURS - BALANCE END CF MOtHH - i r ' l / 3 -o -- H.HOUDAY-REGlfJJ1 HOURS I V-VACATION-PAID LEAVE HOURS ! S-SICK HOURS-PAD LEAVE HOUR 3 / i OT.OVERTNE OTHERHOURS

/

l STD-SHORTTERM DISABUTY.OTHER HOURS l , e

. _ _ . _ _ . _ - - . - . _ . . . - _ . _ . _ . . _ _ _ _ . . _ _ _ . . . _ . _ . , _ _ _ _ _ _ - . Y M t) i COLLEGE OF PHRRMRCY - .E SHEET SEPTEMBER / F6v3/e/2, C- t tzst Nr.me. First kame f Ib b Ssetion I I WEEK BEGINNNG SUNDAY: I SATURDAY I EGULAR TOTAL PA!D LEAVE OTHERHOURS j MONDAY TUESDAY WEDNESDAY THURSDAY FRDAY KJURSUSED USED j i 9/1/93 b b d O 4 t / 5 .$ &.5 h. 5 Y hb / 'l. 0 ( 0 S 91519 3 9/12/93 ) h* $ h Y M . k __ .. [ .. O [- 30. [ &___ . N 9/19/93 . _ . _ _ . _ _ j i ! .

.O TOTAL HOURS f 1 BALANCE CARRIEDFORWARD + l TOTALHOURS ACCRUED + l I TOTAL PAID LEAVE HOURS - t E ! BALANCE END OF MONTH _

hfit b b 91)) -- - ,

. H.HOLDAY-REGULAR HOURS

l l V-VACATON-PAID LEAVE HOURS < Sr-SICK HOURS. PAD LEAVE HOURS tJT-OVERTNE.OTHER HOURS A / ,. , STD-SHORTTERM DtSABUIY-OTHER HOURS SUPERVISOR [ l ,

i ! i 2

. _ _ _ . - - - __ _ _ _ . _ _ COLLEGE OF PHARMACY-TIME SHEET VDG)lbYn0]u)Lv$ 92l Y& Last Name First Name 0 octob. N\\u- Qt w m . Section WEEK SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY TOTAL PA!D LEAVE - C~r2RHOURS BEGNaNG FEG1AR HO R UBED UED SUNDAY i 48)# ^

sM O o

r ? - 10/3/93 kt 7 [ hd IE $ N.j[ b O quesa - ... < , ne 10/10/93 O Y, Oh _b d h -' ' 'hk M. M[ O O - seg um . O ?Y . 3 .g t $ h_ kj e $ h,0 $ b]f (O Yh5 N[ Q

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' 10/17193 y vnygg 99mgg 10/24/93 [WP5$1N O Y. N k, /. 7 M /$,3 [ ^ ' s $??si... ,ikgf#, , -w f bb BALANCE CARRED FORWARD + TOTALHOURS TOTAL HOURS ACCRUED + TOTAL PAID LEAVE HOURS - BALANCE END OF MOffni = lj j( R-REGULAR HOURS / H440LDAY-REGULAR HOURS EMPLQYEE-( V-VACATION-PAID LEAVE HOURS ' S-SICKHOURS-PAD LEAVE HOURS OT. OVERTIME.OTHER HOURS a ), , STD-SHORTTERM DISABLITY.OTHER HOURS ( \\. , ! .u ,3;, v

.-. - _ - _ - _ . _ _ _ _ _ . . _ _ __ _ _ - - _ _ _ _ _ _ . _ _ _ - - - _ _ _ _ - _ _ _ f b ' l ! COLLEGE C. AARMACY -TIME SHEET Last Name, First Name V November 00 W b$N Section Week SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FR1 DAY SATURDAY TOTAL PA!D LEAVE OTHERHOURS Beginning REGLAM HOURSUSED UEED Sunday %50h$ 6. 'X 6 5 a.3 5 (o.3( ' ' ^ ' ar.oS h - / .h 11/7/93 4 um Eh A$ h. I [.Oh ~ /h,d ' ' 11/14193 d% 11/21/93 ! i < , v4 enW; 7 ML +

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> - Carried Forward + TOTAL HOURS

Total Hours Accrued + Total Paid Leave Hours - " .;.nce Ena or Month = J h) R. Regular Hours _ / H.Ho!! day-Regular Hours , EMPLOYEE d ' V-Vacation. Paid Leave Hours .- g/ S. Sick Hours. Paid Leave Hours e OT= Overtime-Other Hours y STD.Short Term Disability-Other Hours _ ,. . , Wf

' / l

- _ _ _ _ _ _ _ _ _ _ _ _ ts'fpf CC' ' c4E GF F .MACY -TIME SHEET i Foa)leci eheen} /99 8 ~ Last Name. First Name December Aelear Phanimau Section i Week SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRDAY SATURDAY TOTAL PA!DLEAVE OTHERHOURS Beginning FEGJLAR HOURSUSED -UED Sunday ' 12f1193 ! .b . d6 e

s- ff$$$$ /,95~ SS 5 &aT /M5' ME4! 46.af # & i2isi.3 12112/93 - y,s wa nn n bI f88 Nih @ i s e l$$$$$ 5 3 3 & .-Py %$$$ M & 9- ,2n ere3 YNNN 3, % 93 4M S & %$$R3) Jr D ~ ,,,,,,,, 'TOTALHOURS,//M,9 b^ -& O Carried Fcrward + Total Hours Accrued + . Total Paid Leave Hours - Balance End of Month = l ) R RegularHours / _, H.Honday-Regular Hours EMPLOYEE (/ V-Vacation-Pald Leave Hours , S-Sick Hours-Paid Leave Hours OT-Overtime-Other Hours fj L STD-Short Term Disability-Other Hours _ //. z .

_ _ _ _ _ _ _ __ _ _ _ _ . _ _ _ _ _ _ /Jd+yi f P* cou EGE OF f 3MACY-TIME SHEET ' Last Name. First flame V Janusty - U i s.cuon Week SUMDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY TOTAL PAIDLEAVE OTHERHOURS Beginning REGULAR HOURSUSED LEED Sunday i ' 1/2/94 - C+ N 1/9/94 ,

, _ 5': ' ' ' ' ' s 1/16/94 _ t - ' 't 1/23/94 1/30/94 _ h ' l - Carried Forward + TOTAL HO' CSr'e ,b Tota! Hours Accrued + Total Pald Leave Hours _ , - Balance End of Month = ./ . ) R-Regular Hours ) . , H-Hdiday-Regular Hours BELOYEE Q V-Vacadon-Pald Leave Hours

. S-Sick Hours-Paid Leave Hours ,' ' OT-Overtime-Other Hours . . ' STD-Short Term Disabiltty-Other Hours SUPEFMST . - - . -

. _ _ . . _ _ _ _ - - - - - . . . _ _ _ . _ _ . / g./-h4j . I ' COLLEGE OF PHARMACY -TIME SHEET ' Last Name. First Name V February IUur(par Phauhacu Sect!on / IO

3ppy Week SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY TOTAL PAIDLEAVE ORERHOURS Beginning FEGULAR HOURSUSED LED Sursday pyg fyqqp y 9 o 4

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._ _ _ - _ _ _ _ _ ._ . _ - _ _ - _ _ _ _ _ _ . _ . _ _ . _ _ - _ - _ _ _ _ _ _ _ _ _ _ _ . _ _ _ - _ _ _ _ - . COLLEGE OF PHART.iACY-TIME SHEET / & . Name. First Name MAY 11NM14 24 - - Week SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRDAY SATURDAY TOTAL PAfDLEAVE ODERHOURS Beginning FEGLIAR HOURSUED UED sunday b '. b' ' 511/94 - 518194 '? '< ' I 5115/94 l' ' hb* 5122194 -' l . < f f o r f ^~ 'n92iGi'M AYf4GssE yghjpgjg % 9 M {$y 5129194 ' ^' ' %N$N9 I $$N N

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HAZMAT EMPLOYEE TRAINING E Univ. of Oklahoma llealth [piQ_ ~ . i L**Q A N@ldjg Sciences Center Nuclear Pharmacy 1110 N. Stonewall ski ( h f .k3 TF{4T5Ef1 ADDRESS $h{/.jf [ yy$ M < g/8 Oklahnma City. OK 73117 5

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I .vg%. _ I _ ( .,. . , %gk' d cQ*'# 0 D NA 2 g.;7 Y- Ne N6# NQu~:,07 V' .g V 4.1992 J.J. RELLER & ASSOCIATES.INC.Neonsh WI $49$74368 2WS-A2 ' , - - _ - . . . _ _ _ b e.. , g . " tAm, s t$It . . . . . . . . . . .. . . .

HAZMAT EMPLOYEE TRAINING M' RECORD AND CERTIFICATION 3- '"'*' ^ **'*a*5 $ -L S*r T'*iaias X Function Specific X Dnver Training l Recurrent Training Date l EMPtOYEE NAME LAST FIRST MIDDLE EMPLOYER NAME Fowler. Cheryl OUHSC Nuclear Pharmacy i EMPLOYEE 10ENTIFICATION NUMBER LOCATION STREET l 478-32-3878 1110 N. Stonewall l POSITION /JOO DESCRIPTION CITY STATE ZIP CODE Siudent Anninenne Otel n hnm n Cirv O k' 71117 i REGULATIONS $172.704(d) Recordkeeping. A record of current training, inclusive of the preceding two years,in accordance with this subpart shall be created and retained by each hazmat employer for each hazmat employee for as long as that employee is employed by that employer as a hazmat employee and for 90 days thereafter. The record shall include: (1) The hazmat employee's name; (2) The rnost recent training compleuon date of the hazmat employee's training: (3) A desenption copy, or the location of the training matenals used to meet the requirements in paragraph (a) of this section; (4) The name and address of the person providing the training; and (5) Certificaton that the hazmat employee has been trained and tested as reqJered by this subpart $172.704(e) Limitation. A hazmat employee who repairs, modifies, recondiDons, or tests packagings as qualified for use in the transportation of hazardous matenals, and who does not perform any other function subject to the requirements of this subchapter,is not subject to the safety training requirements of paragraph (a)(3) of this section. INSTRUCTIONS The trairnng requirements in $172.704 and 177.816 cover four areas of training for hazmat employees. Based on the training required for the above named hazmat emp^oyee, provide the training and testing for comphance. Satisfy the recordkeeping requirements in 172.704(d) by completing the information on this form. MeH[eHE Kell : : !NT TRA 2 M "*Sr'E tecIriE[oNR$NENEEU$Eo TRAINER / ADDRESS "^7'$$$o7'"G DATE " o 1000 S.L. Young 9/10/93 ' See attached Subhash Danak, RSO 11/1/93 .- . _ . . . - _ - . - - - . - . - . . . . . .-- _ ..- _. - .- . -- . . - . _ . --__- --. _ .. . - . . . . -- , - .. -- -. . - - . . - - --... - . _ _ - . _ _ _ _ . . . . . .- _ _. .___._ _ _ _ _ . _ _ _ _ _ _ _ . . _ _ . . _ _ . _ . . _ . _ _ MkHoHE ' ELEVANT TRA 1 M

Provide information from previous Hazmat emplov"7nt training Attach aopropnate current records from the previous employer. l _. . _ _ _ _ .- oggJguER & AS'AciATES,iNc. 3%f h*aaan. W8 505N88 SUBSTANTIATE THE ABOVE TRAINING REQUIREMENTS

. - _. . . - _ - .-. - __. - ""8

STATE OF ALASKA Effectivi: 08/27/1998 DEPARTMENT OF COMMERCE & ECONOMIC DEVELOPMENT Expires: 11/15/1998 Division of occupational Licensing P.O. Box 110806, Juneau, Alaska 998110806 , BOARD OF PHARMACY Certifies that - I CHERYL A FOWLER is a Tealporarily Licensed PHARMACIST PER AS 08.80.150 PMR 12AAC52.075(C) A TEMPORARY PERMIT IS VALID FOR THREE MONfHS OR (JHTIL THE NEXT REGULAR MEETING OF THE BOARD Commissioner: Deborah B. Sedwick , a Wallet Card 1 No.9 State Of Alaska Department of Commerce and Economic Development < Division of occupational Licensing This Certifies that cusaYL A PatsA le a tesporarily Licensed PHARMACIFF Pam AS 04.80.150 J 01f16Y ol/20Y958 1 T 5 f1 5 8 1 fel*M!.*d' Anal %"u5 U""rAl EIS"" ' " "" """' " i i sto.s.r. 1 i . VHd ' ' P0566 MV 3DVHOHONY EAY HIEI ISYS EP65 ] H37MO3 V 1AH3HD 2 a e

__ _ - _ _ ._ _. . _ . . 15

lt:m 9. Facilities and Eq ilpme:t . 9.4 Adequacy of Facility for llandling Volatile Materials that are Radioactive II. Iodine-131 A. Handling and storage 1. All liquid iodine-131 will be stored in the manufacturer's shielding in sealed plastic bags in the main fume hood. 2. All liquid iodine-131 will be opened and handled in the radiciodine fume hood. 3. Special equipment for handling iodine-131 B. Procedures for the Receipt and Use ofI-131 Therapeutic Solutions Discussion: I-131 solution is a very high concentration material. If any contammation exists as a result of handling this material, the contanunation can contribute to volatile iodine levels. The diagnostic capsules are also shipped in sealed containers. If any volatilization occurs in shipping (capsules do volatilize), then you may find sonu volatile iodine escaping when you open the container, and you nmy find < some contamination on the shielding material. Because of all of the above, steps must be taken to prevent or limit the amount of volatile 1-131 that is released into our pharmacy or to the environment. The following precautions must be taken for receipt and handling of this material. , , 1. Check-in Procedure Follow the routine procedures for receipt of radioactive material. a. l b. When performing the wipe test on the inner source container, thoroughly wipe test the sealed tin can. l Use an alcohol moistened 1" x 1" swipe and wipe the entire surface c. f . of the can. ^ l d. Count it in (not on) your well counter. If no contamination is found on the sealed tin can > < c. 0.0luCl(22,000 DPM), place it in storage until it becomes necessary to use it. If significant is . +

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

Item 9. Facilities and Eq:ipme:t ( cont.) 9.4 Adeauncy of Facility for Handline Volatile Materials that are Radioactive cont. contamination is found, report your findings to the RSO and double seal the container and place it in storage. (Zip lock or heavy plastic bags are recommended.) NOTE: If the tin can is not contaminated and remains sealed, it should be stored sealed until ready to use'. All 1-131, regardless of whether it is sealed or unsealed, must be stored j in accordance with the conditions stated in your NRC/ Agreement State License , application. l 2. Preparation for use l For both therapy solutions and diagnostic capsules, open the sealed tin can in your l a. i charcoal filtered fume hood or charcoal filtered I-131 glove box.

L b. Remove the lead shield and perform a wipe test on it. If significant contamination is found, then replace this shieki with an uncontaminated shield. The contaminated shield should be double sealed and placed in waste storage along with the tin can ' since it will also be contaminated. _ Store your diagnostic capsules in the standard laboratory fume hood. c. d. To prevent the possibility of volatile I-131 escaping from the therapy solution; and as a precaution to prevent contamination, release the partial pressure over the liquid 1-131 by venting it through a 10 cc or larger charcoal filled syringe barrel. To prepare this syringe, add a cotton pledget to the syrmge, fill with charcoal and add a cotton pledget to the top of the charcoal. If you do not require a high concentration of 1-131, you may wish to buffer the e. solution or use a buffer as a diluent when preparing liquid 1 131 therapy doses. .. . ! l _ . _ _

_ m _ . . _ .. _ ._ __ _ _ _ __ _. _ _ _ .. _ _ _ _ __ _ _ . _ 17 Item 9. Facilities czd Equipment ( c:ct,) 9.4 Adeauncy of Facility for Handlier Volatile Materials that are Radioactive cont. 1 3. Contamination Control l a. After each day's use of 1-131 solution, the area where this material was handled must be cleaned up and decontaminated immediately. Since we are deahng with a highly concentrated 1-131 solution, contamination l significantly contributes to volatile 1-131 levels. Attached are ! procedures for use with an 1 131 fume hood. b. After use, make sure you clean the vial septum thoroughly with an alcohol swab. Place the swab, syringe, and any sahne or buffer used which might be contaminated into a sealed container prior to storing this ' material. 1 C. Liquid I 131 shall be handled in a double charcoal filtered glove box which is located outside of your standard laboratory fume hood. The effluent from this glove box will be piped to the standard laboratory fume hood, thereby ensuring the MPC levels are not exceeded and contamination is isolated to the glove box area. This prevents cross contamination between volatile materials handling and storage areas. 4. Procedures for Contaminated Sources In case of a contaminated 1-131 shipment, you must make a decision a. whether you wish to use the material or place it in storage for decay. If you choose to use the material, you must proceed through steps La. and M. and subsequently make it available for use. b. Any regulatory requirements with respect to incident or package opening procedures reporting must be implemented. C. Use and Maintenance of the I-131 Glove Box NOTE: Prior to use, at installation, the linear flow across each armport of the hood will be nwasured with an anemometer under conditions of. normal operation, i.e., turned on with negative air flow speed at maximum, with both charcoal filters in place, and the standard laboratory fume hood on. Quarterly measurements will be obained to ensure that the unit continues to operate at this base line level determination with respect A to negative linear flow. i t l t _ . _ . . _ _. . __ _

.- . - _ .. - .- -- . . . _ . - . . . . _ _ - . _ - . - _ _ - _ , r 18 l Item 9. Fccilities c d Equipm2nt ( coit.) t 9.4 Adeauncy of Facility for Handline Volatile Materials that are Radioactive cont. Procedures for Use a. Put on disposable gloves. b. Turn on glove box exhaust fan to ensure negative pressure in the , @m Set up the apparatus, vials, shields, etc., in the hood behind the c. L-block shield to be ready for the 1131 transfer to ensure that the transfer time is minimal. d. Place the sealed stock solution ofI-131 in the hood behind the < L-block shield and on the absorbent pad. The air sampling system must be on during this procedure. e. f Transfer the 1-131 from the stock solution to the prescribed unit dose form. Make sure to recap or seal vials immediately ' after transfer. g. Using forceps or a remote handling device, assay the unit dose in the dose cahhator. Prepare for shipping. h. Replace the stock I-131 in storage. i. With a low level survey meter ara pancake probe, survey the 1-131 glove box and record the results on the form provided. j. Clean up and change the absorbent pad, if necessary (survey meter readings will indicate if the pad is contaminated). k. After glove box clean up, survey again, and record the results on the form provided. NOTE: Liquid 1-131 is obtained from a scaled system (similar to a multidose vial for parenteral use). 2. Maintenance Procedures Note: Very little maintenance is necessary on this unit since it has only a UL , approved induction type motor and switch. I , . - . . . - - _.

__ ___ ._ . . _ . _ . . __ ___ - _. _._. _. _ _ ___ __. _ _ . , , 19 Item 9. F cilities ced Equipme2t ( csst.) i 9.4 Adeauscy of Facility for Handlina Volatile Materials that are Radioactive cont. j When performing charcoal filter surveys, observe the fan motor. j a. If dusty or dirty, clean with a dry cloth. ' b. To insure that the system is operating properly, a determination oflinear flow at the armports will be taken quarterly using an anemometer. If flow decreases

below 50 Ifm, the filter (s) will be changed to ensure proper operation. . ' 3. I'rocedure for Surveying and Changing the Filters a. Put on disposable gloves. b. Disconnect the exhaust pipe connector to the fume hood. . c. Lift the filter housing lid. - d. Remove the top filter and survey with a low level survey meter and pancake probe, and record mr/hr or CPM on the form provided. l ~ e. Set the filter on the absorbent pad provided in the standard laboratory fume hood. i f. Remove the bottom filter and survey with a low level survey meter and pancake probe. Record mR/hr or CPM on the form provided.

- i g. Calculate the ratio of the radiation level on the top filter to the radiation level on

i the bottom filter and express it as a percentage. l EXAMPLE: , . mr/hr tco filter . X 100 = % mr/hr bottom filter 4 b When the top filter radiation level is equal to or greater than 10% cf the bottom filter's radiation level, then the bottom filter should be discarded into RAM

waste storap (make sure you seal the charcoal filter in a plastic bag before discardinginto RAM waste). h. Replace the top charcoal filter in the unit. This filter now becomes the bottom filter, d ) i ' 4 d w

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.. _ . . . . - . .. - . .- . . .. - . . - - - . . . ._. . 0 Item 9. Ferilities ctd Eqripart ( cont.) 9.4 Adeousev of Facility for Handline Volatile Materials that are Radioactive cont. . i. Insert a new (unused) Ster into the unit as the top Ster, close the baffle housing lid and reconnect the unit to the fume hood. NOTE: The charcoal Sters in this device are surveyed weekly; however, the bottom filter is replaced as necessary only when the top Ster indicates that the bottom fiher allows greater than 10% of the I-131 to pass through it. k ( I . 4 .sm*,

. _. ._ _ ._. . _. . . . _ . -_ _- . _ _ . _ . . ~ .. l 21 Item 9. Fce'" ties cad Eq:ipment ( cort.) 9.4 A3eauscv of Facility for Handline Volatile Materials that are Radioactive cont. Sodium Iodide-13 I s'apsule Preparation l ! MATERIALS NEEDED: 1. CIS I-131 Tx Solution in Scaled Vial 2. Sodium Phosphate Size #1 Capsules 3. B-D LO Dose (0.5 CC Insulin) Synnges 4. Dispensing Container 5. Lead Dispensing / Shipping Container 6. Lead " Capsule Holder" or equivalent shielding (see diagram "A") 7. I cc Tuberculin Syringe Shield 8. Tongs 9. Latex Gloves,2 pairs . . --

___ . _ _ _ . _ _ . . . _ . . . _ . . _ . . _ . _ ... _ ._ . _ _ . _ ._ _ _ _ . ._. _ . _ . ..._. _ . ._ _ - _ .._.. __._ 22 . Itama 9. Facilities and Equdpuneet ( coat.) . .i 9A Adeauncy of FacGity for Handian Velatse Materials that are Radioecdve coat. j E. Imed Capsule Holder

.-

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MATERIALS NEEDED:

1 One (1) orange 3/8' NEN Imed enmeh (NEN Ger 67 lead aa=*h) ! One (1) Medi Physics 1/** Xenom land Container .I One (1) Squibb 1/r ' Generator Lead Pleod j (Scamaged lead ph front the Sqath gamerators needle i adeptor aseseNy)

) Insert the Medilead zeeen e=emi=r isso the arenge NEN lead > h bM k & shb . j way into the aramed one. Place the Squth 'gaaerator need piece", i as top arche orange need ensuimer. s , i '

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.-. - - _ . - . _ _ . - - . _ - . _. -. -- 23 Item 9. Facilities aid Eqripment ( cort.) 9.4 Adeauscy of Facility for Handlinst Volatile Materials that are Radioactive cont. F. Sodium Iodide 1-131 Capsule Preparation (Compound Procedure) 1. Turn on the fume hood and the 1-131 glove box, if not already operating. Check to make sure the equipment is operating properly. 2. Turn on the vacuum pump for air monitoring, if not already operating. Check to make sure the gauges and vacuum pump are operating properly. 3. Perform an area survey of the 1-131 glove box and work area to assure that it is contamination free. If not, decontammate the work area before you start. Always use ALARA principles!! 4. Calculate the amount of 1-131 solution needed to fill the prescription. Remember to take into consideration " decay", if the therapy dose is for the next day. Also, the residual volume left in the Lo-Dose syringe will be approximately 200-400 uCi. This must also be taken into consideration, especially when very low activity capsules are made. 5. Wear two (2) pair (s) of gloves. First, put on a pair of gloves. Next, put on a pair of latex gloves over the first pair of gloves you are wearing. 6. Place the shielded I-131 Lo-Dose syringe in the funw hood so it is out of the way. 7. Set up the orange NEN lead vial with the Squibb generator lead piece on top. This set-up will be referred to as the " Lead Capsule Holder." 8. Take a small piece of saran wrap (approx. 3" x 3"), and place it on top of the lead capsule holder. I 9. Separate a size "O" gelatin capsule. Take the long end and push the plastic wrap into the lead capsule holder. 10. Place a sodium phosphate capsule (from de freezer) into the shielded size "O" capsule. i l 11. Take anempty Lo-Dose syringe and bore a pilot hole through the center top of the sodium phosphate capsule. Special Note: This procedure will prevent coring, which could clog the needle.

i l

- _ _ ,_ _ . _ _ _ . _ _ _ _ __._____---._ _ _.___ _ . 24 ItIm 9. Facilities and EquipmeIt ( ent.) 9.4 Adeausev of Facility for Handlisa Volatile Materials that are Radioactive cont. - 12. Transfer the sealed stock solution from the fume hood to the 1-131 glove box type fume hood, and place it behind the L-block shield on the absorbent pad. j 13. In the iodine glove box, draw up the activity needed in a shielded Lo-Dose syringe. Place the shielded Lo-Dose syrmge into a NEN orange shield for transfer (if necessary) to the dose calibrator. Replace lid on stock solution shield. Remove the syringe from ' shields, and assay. Replace the syringe into the syringe shield and NEN orange shield, and return to iodine-131 glove box type fume hood. Special Note: Do not exceed 0.20 c:: volume. This volume appears to be the capsule's holding capacity. If a greater volume than 0.20 cc is needed, a second capsule should be made. In ' l addition, only fill the syringe with that amount of solution to be injected into a single capsule. 14. Insert the needle of the shielded 1-131 dose into the hole as far as it will go. Inject the capsule with a slow but constant injection. Special Note: Ifyour injection is made too slowly, you increase the chances that the sodium phosphate powder will harden prematurely before you are able to make the entire injection. If your injection is made too quickly, the sodium phosphate's ability to absorb the solution will be exceeded. This will be obvious by the distorted appearance of the finished capsule. 15. Once the injection is complete, remove the needle from the capsule and cover with a lead top. Rinse out the empty syringe into the sealed saline vial provided. Place the rinsed syringe into a sealed plastic bag (zip lock bag) for transfer to I-131 waste bin. 16. Using tongs, pick up the size "O" capsule half, and place it on the capsule in the lead capsule hokier. Tap it down tightly. 17. Remove the capsule by inverting the Squibb generator lead piece onto a second orange lead container that has a " Dispensing Container" within. With an empty Lo-Dose synnge, push the capsule through the Squibb generator lead piece, so it drops into the dispensing containet. I 8. Remove the Squibb generator lead piece and cap the dispensing container inside. Cover the orange lead contamer with its lead top. - . . _ , . 4 i . _ , _. _ . . . - _ . _ _ _

. . . . 25 It:m 9. Fccilities czd Eqripmezt ( cat.) 9.4 Adeauscy of Facility for Handline Volatile Materials that are Radioactive cont. 19. Remove your latex gloves and replace with new ones. (Make sure this step is a part of your normal routine.) Special Note: If, for any reason, your outer gloves are contaminated, it is important to change them now to assure that you don't contanunate the lead shipping container. 20. Assay the I-131 therapy capsule. Account for decay, and assure that the finished capsule strength is not greater than 10% of which was ordered. 21. Dispense the I-131 therapy capsule in a heavy lead container. Special Note: Perform a wet smear on the lead container to assure that there is no removable contamination. , 22. Remove the lid from-the sealed stock I-131 solution, and with tongs wipe the vial septums with an alcohol swab to remove possible contamination. Place this swab in a sealed plastic bag (zip lock bag) for transfer to 1-131 waste. With tongs, wipe the septum of the stock solution with a dry cotton swab, and perform 'the wipe sample procedure. If the wipe sample is equal to or less than 2200 DPM, place the stock solution into the shield, and into a sealed plastic bag, and transfer back to the fume hood , for storage. If the wipe sample exceeds 2200 DPM, con:inue decontammation with alcohol swabs until the wipe sample is less than 2200 DPM. Document all wipe sample information. 23. All contaminated material, cotton swabs, saran wrap, etc., shall be scaled in plastic bags and transferred to 1-131 waste storage. 24 Perform an area survey of the 1-131 glove box and other immediate work areas to assure it is contamination free. Decontaminate, if necessary, and store contaminated material in sealed plastic containers, i 25. Follow the air monitoring procedure as outlined in your NRC or Agreement State license. 26. Follow the thyroid bioassay procedure as outlined in your NRC or Agreement State license. _

. - . _ _ _ _ _ __ _ . . _ _ _ _ _ _ _ _ _ _ _. _ ._ . . _ _ _ . . _ . . _ _ . _ . . . ._ _ _ _ . . _ ._ 26 It:m 9. Facilities and Equipmezt ( cort.) 9.5 SDecial Eautoment for Handline Millicurie Ouanties of Radiciodine Special Equioment for Handlino Mdlicurie Ouantities of Liquid Radioiodine l i l A radioiodine fume hood will be utilized for dispensing liquid sodium iodidel31. The efHuent from this fume hoed will be connected directly into the standard laboratoy fume hood or MERV fume hood. Two charcoal filters will be used in the iodine-131 fume hood. Each filter is one foot square and one inch thick. One filter will be stacked on top of the other so that the iodine-131 will be exhausted through two inches of charcoal. This ensures a trapping efficiency of at least 90%. Measurements with an anemometer of air flow at the arm ports for the iodine-131 fume hood l show a linear air flow of 50 to 70 ft/ min, or greater, vith a total exhaust of 20 to 25 CFM or i greater. ! The efBeiency of this trapping system is checked weekly using a survey meter. The filters are removed and the radiation level at their surfaces is measured with a pancake probe type survey meter. When the radiation level of the top fiher is equal to or greater than 10% of the radiation level of the bottom fiher, the bottom fiher will be replaced. Air sampling for volatile iodine-131 will be performed in conjunction with the use of the radiciodine fume hood. Please see the enclosed air sampling procedure. , ! i l ! . t 1 ! i .

. _ _ . _ __ _ . _ . _ _ _ . . - _ . . . . _ . _ _ . _ . _ _ . . _ . _ _ . _ _ . _ _ . . _ _ . _ _ _ _ . _ _ _ _ _ _ . . _ . . . _ . _ _ . _ . _ 27 ! Item 9 Adequacy of Facility for Handling Volatile Materials that l that are Radioactive, l Item 9.5 Special Equipment for Handling Radiciodine. 1 cont. . i

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. - . . . . . . - . .. . .-. . . - . .- _ . . 28 Item 9. Faciliti:s sad Equipment ( cost.) l ~ 9.5 Special Euulpment for llandling Millicurie Ouantitles of Radiolodine cont. EOUIPMENT AND STANDARDS A TEDA-hnpregnated carbon cartridge 21/4" in diameter and I" Idgh-(Ill-Q Environmental Products Co., La Jolla, CA,619/549-2820, Catalog #TC-12) will be used with no pre-fdter. The nmnufacturer's ' stated efliciency factor is 99% at 0.35 CFM or 10 liters per minute Ibr worst case, i.e., for methyl iodide. Please see the attacheu graph. . - Item 2 , ALASKA RADIOLOGICAL PHARMACY,INc confirms that sampling will be done on a continual basis. ' a. b. Air sampling cartridges will be exchanged every 7 days. For outer dimensions of 21/4" diameter by 1" inch, the volume of the TEDA carbon c. , ' 1- is calculated using a 3/4" radius with a 3/4" thickness: , RESIDENCE TIME = Volume of Absorber (f t ') i Sample rate (fl'/ min) 4 RESIDENCE 1.36x10-3 n' = 3.9 x 10 min = 0.23 seconds TIME 0.35 R'/ min d. Please see the attached example of the geometrical relationship between the sample cartridge / standard cartridge and the scintillation detector. A barium-133 standard will be placed on the scintillation probe in the same geometrical e. configuration as the sample cartridge. The analyzer transmission wi2 be set between 300 kev and_430 kev (or in equivalent channels if an MCA is used), and the instrument will be peaked to obtain the maximum count rate for the standard. The standard will be counted for a minimum of 10,000 net epm to insure an accuracy of 2% at 95% confidence level, i.e., two (2) standard deviations. This calibration will be performed each time the sample cartridge is counted and the activity of the standard in net cpm wid be used in the determination of sample cartridge iodine-131 activity. The following calibration sources will be available. An LLD and an MDA will be determined for the standards. . . .. .*

. . _ __ --_. _ _ _ . . _ . . . _ _ . _ _ _ . _ . ~ . _ .-. _ .__ _ '29 ' Item 9. Fccilities c d Eq:ipment (est.) 9.5 Special Eautoment for Handline Millicurie Ouantities of Radiolodine cut. Isotope Products Laboratories (IPL) 1800 N. Keystone Street Burbank, CA 91504 818/843 *1000 IPL P/N EG-133-CH: Barium-133 0.5 uCi in Charcoal Cartndge. Calibrated & NIST traceable. Item 3 The equipment will be checked prior to use (every 7 days) with the barium-133 standard to ensure a. i accuracy of the system. b. The air flow measuring equipment will be calibrated annually using a mass flow calibrator which l is calibrated annually for NIST traceability. l i l I. i ! l t . , L , 4 - --

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31 . Item 9. Facilities and Equipment cont. l 9.5 Special Equipment for Handling Millicurie Quantities of ' Radiciodine, a O Diagram of counting geometry of cartridge and well b ! O l m, i E I o ' -- em T Z m ' o a 3 X - $ NH D . N Q 3: I 1 o = 3 < 3 4 T j e

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_. . ,. __ _- - . - - . ._ .~. . . - . - . . - - . . . - - - ~ 32 - Item 9. Fccilities at:d Equipment (cost.) 9.5 Special Eaulpinent for llandling Millicurie Ouantitles oflladiolodine cont. ! ' Frocedures for Completion of1-131 Air Monitoring [ The following pages give detailed hutructions for performing iodine-131 air nenitorhig including operating procedures for cartridges. This is followed by installation instructions. Procedures for lodine-131 Air Mquitoring A. Discussion 1. The handling ofcertain volatile radioactive materials nmy require that air sampling be performed to document that Derived Air Concentration (DAC) are not exceeded , in either the restricted or unrestricted areas. 2. Acceptable methods include: (1) air sampling data and/or (2) ' calculations, if those calculations can demonstrate that the DAC for a particular substance is not exceeded. 3. For volatile iodine-131, ALASKA RADIOLOGICAL PRARMACY. Inc. facilities are required to use air sampling data ny the conditions of their license or license application. The following procedure is provided and is to be used with Form RS- 55, or an equivalent computer generated form. B. Eauioment 1. Vacuum pump with air flow gauge,(rotanxter) 1 Because we will operate our air sampling equipment continually, evaluation of the ellluent 1 concentration will be done every 7 days. , 2. Appropriate teflon tubing 3. Charcoal Cartridge holder 4. TEDA-impregnated charcoal cartridge 5. Scintillation counting assembly and barium-133 cartridge standard .. l l ! l l l ,. - __ .- - , --.-

..- - .- - ..- -. - - . . .._-. - . - . - . - - - . . _. - 33 i Item 9. Fcellities ced Equipment (ent.) - 9.5 Soeelal Eauipment for Handlina Millieurie Ouantitles of Radi) iodine cont. j C. Ooerating Procedure for Air Cartridnes Y ' 1. Mount the air sampling apparatus in a manner which will ens are that effluent being ' released to both the restricted and unrestricted areas will be sampled. Sampling must be done in the exhaust vent pipe on the down stream side ofiny addhional air filtering system. Be sure that the starviard laboratory fume hood sash opening is positioned to - optimize the face velocity across the fume hood opening. This decreases the amount ' of volatile I-131 that will escape into the restricted area. ,

2. The charcoal cartridge will be counted every 7 days. ' 1

NOTE: IN THE EVENT OF A SPILL THE CHARCOAL CARTRIDGE WILL BE COUNTED IMMEDIATELY. ' O i 3. To obtain the data necessary to determine the activity in the cartridge: a. Put on disposable gloves. i

b. Calibrate the counting system by placing the barium-133 eirtridge standard

directly on the scintillation probe housing. Set the analyze r transmission with the lower discriminator at 300 kev and the upper discriminato e at 430 kev and peak the instrument by adjusting the high voltage potentiometer or gain control. Obtain a count on the standard. Remove the standard and obtain a background 1 ' count. Record the background and standard counts on the RS-55 form or enter 1 this data into the RS-55 computer program

Place the cartridge on the scintillation probe in tie same geometrical c. , j configuration as the standard source; and, ) d. Obtain a count on it. Make sure that an efficiency factor (1:.) for the barium-133 . standard with the I-131 correction factor has been calculated for the analyzer ' . setting in b. above. d Record the iodine-131 count on Form RS-55 or enter ut data into the RS-55 e. j computer program. { 4. Recoril the sampling pump air flow in ml from the measured flow of the vacuum i. pump.

t 5. Record the activity of the barium-133 standard. . r 4 ' 4 . , , . . - - , , - - . . ...--,-c .. - . ,, , , .e,-.- - - - , - + -.,.,,.. -.- s

. . _ _ _ . _ _ ~ . __ _ . _ _ _ _. _ __ _ __ - ._ . _ _ - 34

Item 9. Iacilities and Eqzipment (cont.) 9.5 Special Eauloment for Handlina Millicurie Ouantities of Radiolodine cont. , D. he:edure for Calculating the Concentration of Volatile Iodine i The following calculations may be used to determine the concentration of volatile iodine in uCi/ml in the restricted and unrestricted areas. (Please see the attached worksheet). 1. Calculate the " pump on duration" from pump on and off times. . 2. Determine uCi of 131-iodine present on the cartridge using: iodine-131 (uCi) Net com e4 (cartridae) where (CF) CF = the Ba-133 standard in cpm /uCi corrected for photon yield, and " is the correction factor for decay. , i ' 3. Determine the air flow through the sampling pump in ml from: i i a. Direct pump flow data x time ' b. Pump flow data converted to ml/ min x time . 4. Calculate the 131-iodine concentration in uCi/mi using the formula below. 4 uCi I-131 = I-131 concentration (uCi/ml)

i mlof flow through pump

' E. hocedures for Installation 4 1. Cartridge Holder #1 should be mounted on the OUTSIDE of the 131-iodine hood above the area where an individual would be working. This cartridge monitors the

air in a RESTRICTED area at the level of the operators breathing zone. ' 2. Cartridge Holder #2 should be positioned with the sampling probe mounted in the vent stack. This cartridge monitors the air to the UNRESTRICTED area, i.e., the air being vented to the environment.

If a barium-133 standard is used, CF may be corrected for photon yield, however, the actual correction factor is dependent on the equipment used to obtain your data. e* is the correction for decay of the 1-131 trapped in the cartridge. i ~ -- , , , ,

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' l ^ ~ Item 9. Facilities and Equipment (cont.)- 9.5 Special Eauloment for llandling Millicurie Ouantitles of Radiolodine cont.

[ - l EXAMPLE of"I-131 AIR MONITORING RECORD"(RS 55) f _ . 1-131 Air Monitoring Worksheet ] Location Id: Sample Date: WC Serial Make: Desc: Well Counter Bkg cpm Unrestr Sample Count: cpm Net Unrestr Sample Count: cpm Restr Sample Count: cpm Net Restr Sample Count epm Bal33 Src Count: cpm 1131 Cap Count: cpm Net Count: cpm Net Count: cpm Bal33 Src Lot # : 1131 Cap Lot: 1131 Cap Actv: uCi Bal33 Src Actv: uCl Mens Pump Flow: ml/ min Pump Flow mi Pump 'ON' Time: min Fume Hood Flow Rate : cf/ min (unrestricted area) (restricted area) uCi uCi Total uCiof1131 uCl/ml uCi/ml ' Air Conc' of 1131: % % DAC% Test Performed By . 4,4 I O 6 ene, 0 I e l ! . . . " - - r

- ~ . - . .. 36 Item 9. Facilities and Equipment cont. 9.5 Special Equipment for Handling Millicurie Quantities of Radiciodine cont. VOLATILE SU8 STANCE HANDLING AND SAMPLING SYSTEM NOTE: :UME HOOD MOTOR IS LOCATED ON THE ROOF. " 1. .I l~ l f (Ni o k (Al S _l MERV) .: - Jar oal filters . , N, . O tcD,i ni] I" ("I 6* Olameter \\ \\ / I \\,/ I 50 to 70 f t/ min negative flow ^N VAO U U M P 'J M P (El A. 1/2' TEFLON SEMI RIGIO TUBING B. FILTEft HOLDER (CONTAINS CHARCOAL CARTRIDGE) C. L-5 A ACK E T D. ROTOMETER (OWYER CATALOG NO. RM A 24SSV) E. WCUUM PUMP (G AST MODEL DOL-101-AA) F. GLOVE 90X l-131 HOOD G. SIANDARD L ADOR ATORY FUME '4000 H. SAMPLlHG 3 ROBE I. 'T' CONNER TION i I W ) . .

- _ . _ . _ _ _ . . . . . _ . . _ . _ __ _ _ _ T1 . . Itaan 9. Facilities and Equipment ( cont.) , 9.5 Se=+1=1 Ee=tamient for Han Rino Millicurie Ouantities of Radioladine cont. O EXAMPLE of 111-131 AIR MONITORING RECORD" (RS-55) I l-131 Air Monitoring Worksheet . . 1 I Location Id: Sample Date- ! ! l WC Serial Make: Desc:

WellCounter Bk CPM j

Unrestr Sample mat: CPM Net Unrestr Sample Count: CPM j J Restr Sample u at: CPM Net Restr Sample Count CPM l . 1131 Cap Count: CPM Ba-33 Src Count: CPM . , Net Count: CPM Net Count: CPM !

, l - Ba-133 SrcLot#: 1131 CapLot: i 1131 Cap Acty: uCi Ba-133 Src Actv uCi , ? l ml ' Mens Pump Mow: ml/ min Pump Mow Fume Hood Flow Rate: CFmin l ,;l Pump 'ON Time: 1 (unrestricted area) (restricted are

uci ut j TotaluCiof1131 uCih > uci/mi ' Air Conc' of1131: - ' % ~DAC% . .. Test Performed By

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. _ . . . - - . . . . . _ . - . . . - .- - - . . - _ .. - . . i 38 ! Item 9. Facilities ced Eq:ipm2:t (c::t,) 9.5 Special Eauipment for Handlina Millicurie Ouantities of Radiolodine cont. , ! . ' l EXAMPLE of"I-131 RELEASED YTD" (RS-55A) l l , l ' I-131 Released (YTD) . Location Id : ! Year-to-Date : t TotalI-131 ' Collected'(YTD): uCi Total Air Flow Sampled (YTD): ml ' Average' I-131 Concentration (YTD): uCi/mi ' Average' Fume Hood Flow (YTD). cfm Total Milliliters of Fume Hood Flow (YTD): ml TotalI-131 Released to Environment (YTD) uCi . % . V l t , _ _ _ _ _. .---

- _ - - - = _ . . -.- -- _ - . - . . - . . _-. ..--..-.-.-..- -. 43 Item 10,10 Precautia==ry M*=== es for Handline-Minicurie Ousatities of Mggid ' Radiolodine.Le Bioassay Procedures ,' Personnel dispensing therapeutic quantities ofliquid iodine-131 will be instructed to wear gloves and to perform this operation in the 1-131 fume hood. There will be an leblock drawing station in the fume hood with 1/2" or greater ofleaded glass and 1/2" or greater oflead. The iodine will be drawn behind h. Discussion: Bioassay shall be performed in accordance with Regulatory Guide 8.20, Interim Bioassay Guide. A copy of this guide should be filed with bionssay resuks so that it may be used as a reference should thyroid burden action levels be exceeded. 4 In Vivo Thyroid Bioassay 1. Equipment necessary: n - a. Scintillation counting systemwith b. Thyroid neck phantom c. Ba-133 sealed rod source 2. Procedure: I-131 energy = 364 KEV Analyzer window = 100 KEV ' ! With the 1-131 capsule, p;sk the analyzer by adjusting the detector vokage until maximum count rate is achieved. i a. Obtain the background of the counting system. ! 1 $ b. Obtain the standard count by placing the neck phantom containing capsule centered on the detector face. Obtain counts over the thyroid. Place the detector against the front of the neck ' c. at midline in three vertical positions. For your calculations, use the positions which give you the highest count rate. , ' . , f . . -. . . - . - - . . -- . - -

_ . . - . _ - . _ . . - _ . - ...-- . - - . -_- .. 44 Item 10 Radiation Safoty Progra.n cont. 10.10 Precautionary Measures for Mandling mci Quantities of Liquid Radiciodine., ie Bioassay PIocedures d. Calculate thyroid activity from: 131-1 thyroid activity - (neck com - 8ko com) (uC1 of caosule) = aCl in thyroid Capsule cpm - Skg cpe l 3. Conenent: Since NRC Guide 8.20 specifies an action level with respect to l thyroid burden of 0.04 uti, it will be necessary fer you to determine the sensitivity of your equipment, and the thyroid t.ounting time l necessary to demonstrate a level of 0.04 uCl in the thyroid. This may be done in the following manner: From the data obtained when counting the I-131 cap.tule for thyroid a. bloassay, express the sensitivity of your counting .'ystem in cpm . per uti. Example: a 5.0 uti 1-131 capsule is counted in the , ' thyroid neck phantom on the detector face and counts ?.0,000 cps, then: CF - 20.000 com - 4000 cpW uCi 5 uCi b. Sample calculations: Minimum detectable activity Prior to any thyroid bioassay procedure, it is necessary to verify that the requisite ISA can be achieved. The M)A is given by: 5 '* MDA=3.3 CF R, - the background counting rate t, = time taken to count the background CF = calibration factor, i.e., the counts per minute per uCi of a standard source In the above example, CF = 4000 cps /uct. If background was counted for i minute and yielded 290 total counts, then the PGA is detemined to be: ( 2 x 2 40 cpm /16. ) * = 0. 018 microcurles ' g ,3,3 y 4000 cpm / UCl . . . _ - -_ _ - - .-,._ --

__ __ . _ . . . . . . _ _._ _ _ _ _ ._ .._._ _ . _._. ..- _ _.__ _ __ Item 10.10 Pree:utionary Measures for Hadling mci Quantities cf Uquid Radiciodine ie, Bionssay Procedures 1 which satisfies the requisite sensitivity. It is apparent th.:t this thyroid counting system would be capable of detecting quantities of 1-131 below that required for adequate monitoring of heahh and safety. The quantity of radioactive material (Q) deposited in the thyroid is simply: " 1 Q= Net thyroid com 4. For our bionssay programs, action levels, frequency ofbioassay, and actions to be taken if those levels are =cMM will be in accordance whh Regulatory Guide 8.20 for I-125

and I-131. Bionssays for thyroid uptake will be obtained with a Single Channel Analyzer Ludhun Model 2200 and SAtm**ian Probe. - Measurements of the thyroid will be compared to a Ba-133 rod source housed in an appropriate thyroid phantom to take into account tissue attenuation from the employee's neck. A record ofbionssay resuhs of the above test will be maintained. Records will contain the name of the individual, resuhs of testing, and date. All positive bioassay resuhs will be investigated. Corrective actions taken to prevent further uptake will be documented. _ -. k A66920 . . . _ . _ _ _ }}

ML20198B618

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