ML20141M774
| ML20141M774 | |
| Person / Time | |
|---|---|
| Site: | 03019521 |
| Issue date: | 10/28/1985 |
| From: | Rielinger B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | |
| Shared Package | |
| ML20141M775 | List: |
| References | |
| 50-19913-01, 50-19913-1, NUDOCS 8602280178 | |
| Download: ML20141M774 (4) | |
See also: IR 05000199/2013001
Text
{{#Wiki_filter:7-ur==mmmm====== = m mmmm mm mmm m m m m m mm m mm m m m m m m m m m mm m m mm m m m my I l NOC Form 3M 1 4 g ., PAGE OF PAGES ta an U.S. NUCLEAR REGULATORY COMMISSloN a . , , Amendment No. 8 j MATERIALS LICENSE . Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93 -438), and Title 10, q Code of Federal Regulations, Chapter I. Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations l 1 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and trans j !p 1 source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to N , l deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This !> l license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is lN subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any z conditions specified below. l I Licensee ! l In accordance with letter 'l 1 dated October 16, 1985 lN j itsentiretytoreadasfollowsj l. Ketchikan Cencral Hospital 3. License number 50-19913-01 is amended in y 1 1 'li 1 2. 3100 Tongass Avenue t .' . . ll , l Ketchikan, Alaska 99901 4. Eipiratida date January 31, 1987 h , 1 .h - 1 - 5. Docket or j j r j Reference No. 030-19521 g ' * 1 6. Byproduct, source, and/or 7. Chemical and/or physical ' 8. Maximum amount that licensee j) ,. 1 special nuclear material ~, form ' may possess at any one time il @h 1 ' ' under this license - 1 w ' j A. Any byproduct material A. =Any,radiopharmaceutical- A., As necessary for uses j listed in Groups ;1-and listed in Groups l1 and II L " authorized in p ) II of Schedule A,, of Schedule A, Section " Subitem 9.A. f jk ] Section 35.100 of .35.100 of'.10.CFR 35 ~ , l 10 CFR 35 ,- ( J , 1
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byproduct material _ !j of 10-CFR 35 . authorized in ' . 1 of Schedule A, 4 k .- l } Section 35.100 of - ' ~ J Subitem 6.B. lI k ' c, i l 10 CFR 35 i. J fi ! ] i; 3 ' - ! C. Any byproduct material 'C_ Any J C. 3 mil 11 curies of each ! listed in Section 31.11(a)^ byproduct material f I ) - authorized in ) ' ] of 10 CFR 31 , , Subitem 6.C. lk ] -- ' , , ) M ' f ! 1 D. Xenon 133 D. Gas or gas in solution that D. 50 mil 11 curies is the subject of an active g$ ' , l ) (i.e., not withdrawn or l ) terminated) "New Drug % l } Application" (NDA) approved lR l by FDA or an active (i.e., lF ' 1 not withdrawn, terminated or j> l on " clinical hold") " Notice of Claimed Investigational Exemption !p
j l } for a New Drug" (I!!D) that has y ! ] been accepted by FDA j >> ! l ] E. Phosphorus 32 E. Soluble phosphate E. 10 mil 11 curies 4 i. . ! J '> l M > E f 8602280178 851028 \\ I
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50-19913-01 5 MATERIALS LICENSE p ' ' '
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SUPPLEMENTARY SHEET h 030-19521 g I Amendment No. 8 l 'h l>N b 9. Authorized use l5 A. Any diagnostic procedure listed Groups I and II of Schedule A, Section 35.100 ly of Title 10, Code of Federal Regulations, llN B. Preparation and use of radiopharmaceuticals for any diagnostic procedure listed l in Group III of Schedule A Section 35.100 of Title 10, Code of Federal } Regulations. l \\ ,- ~ l\\ C. h vitro studies. p
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1 il - E. For treatment of polySythemia vera, leukemia and bone m'tastases. h e 6 . ) CONDITIONS . - , . I. 't _- ., . l> Qj ( ' s 10. Licensed material shall be used.only at.Ketchikan Ceneral lloshical, 3100 ^ Tongass Avenue, Ketchikan, Alaska.I \\ ) fg , %, ' ig 11. The licensee shall comply with"the provisions [of Title 10, Chapter 1, Code of Ip Federal Regulations, Part :19, Notices ; Instructions and Reports to Workers; lh Inspections" and-Part 20, '.' Standards lfer Protection 'Against Radiation". il . , , . . ,
,m -. . f. , % p 12. Licensed materialilisted in Item 6 above.is= authorized for use'by, or under the , supervision of, the' following individual (s). for the materials 7nnd uses indicated: ' 's l9 ' l 1- < s, , , John C. Jowett, M.D.D /:Grcups I,'II, and.III lM u 4e -I Enon 133 k In vitro studies. j x - , l' Rush A. Youngberg, M.D. Groups I,~ II, and III l ' In vitro studies j Xenon 133 in Phosphorus 32 as soluble phosphate for if treatment of polycythenia vera, f leukemia, and bone metastases y P Michael Z. Sedlovsky, M.D. Groups I, II, and III l In vitro studies W Enon 133 I B !> isp !> 9Il $I E WF= = * - = = = =w#mm2rmra.sms9rshmwezamwramwsmsura .
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U.S. NUCLEAR REGULATORY COMMISSION 3 4 {p C Form 374A . o, ,,o Licenw number jN
'N 50-19913-01 'g MATERIALS LICENSE ' h5b " SUPPLEMENTARY SHEET 30 l, Amendment No. 8 [p !b 'P k, CONDITIONS h g 13. For a period not to exceed s'.xty (60) days in any calendar year, a visiting g physician is authorized to use licensed material for human use under the terms % ef this license, provided the visiting physician: h l>. (a) Has the prior written permission of the hospital's Administrator and its k Medical isotopes Committee, and , i i (b) Is specifically named as_a user (on a Nucicar_ Regulatory Commission license authorizing human use, and. U, , j > - ,i !- (c) Performs only those' procedures for which he is specifically authorized by a j Nuclear Regulatory Commission license. Q gl> -13 , The licensee shall maintain for inspection by the Commission; copies of the p' written permission specified in subitem (a) above-and of the' license (s) A specified in subitems (b) and' (c) above. These records shall,be maintained for f ^ five (5) years from the time the licensee. grants its' permission!under I subitem (a) above. ( ' ; () f ' ' - + * '- , .. A
14. The licensee is! authorized to hold radioactive-material'with a: physical ,pj half-life of less-than'65, days-for decay-in-storage before disposal in ordinary lWi ,;! ,' - - z' O f trash provided: ' ' - ? ~ , ' - h . - A. RadioactivevastetobedisposedoflinLthismannershal1[beheldfordecay h> ~ a minimum of ten (10) half-lives.- ' s ip , I i M !, Prior to disposa1las normal waste,, radioactive waste adall be monitored to lh B. I determine that irr.Lradioactivity cannot bc distinguished from background ! with typical low-level laboratory survey instruments. All radiation labels !f will be removed or obliterated. < l> " ' C. Generator columns shall be segregated s'o that they may be monitored j) separately to ensure decay to background 1cvels prior to dispocal, jb k ! 15. Effluent from the xenon 133 charcoal trap shall be tested for the presence of I xenon 133 after every ten patient procedures, in order to assure that the device y l is functioning properly and that filter saturation has not occurred. p , i i > ~ l 16. The license shall include the reference standards described below when i performing dose calibrator accuracy tests: , Dose Calibrator Reference Standards y ') Radionuclide Activity Calibration Accuracy Ip !) Cesium 137 90 microcuries or more Within 1 5% lI ) Cobalt 57 One millicurie or more Within ! 5% , I, in 1 - - - - -x- - - . . . .--_--__,--m_. 4 - . . . _ - . .. -. . -
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C Form 374A e U.S. NUCLEAR REGULATORY COMMISSION 4 4 g PAGE o, ,,cg3 License number 1
50-19913-01 I MATERIALS LICENSE g Docket or Reference number SUPPLEMENTARY SHEET 030-19521 II I Amendment No. 8 l l 1 CONDITIONS I h 1 17. Except as specifically provided otherwise by this license, the licensee shall y possess and use licensed material described in Items 6, 7, and 8 of this licent.e g in accordance with statements, representations, and procedures contained in ,1 application dated October 27, 1981; Model ALARA Program contained in Appendix 0 jI of Regulatory Guide 10.8 (Rev. 1), " Guide for the Preparation of Applications il for Medical Programs", October 1980 and letters dated July 28, 1983, September h 29, 1983, March 13, 1984, telegram dated, July 5, 1984 from Sister Barbara j l Haase, Administrator,and letter dated OctoberT16,,1985. The Nuclear Regulatory !g l Commission's regulations shall g'overn the licendce's statements in applications I . or letters, unless the statements are more restrictive?than the regulations. I l s e N I , 4,v ,y y , l 18. The Radiation Protection Officer for the activities authorized by this license y i is Dr. Michael Z. Sedlovsky. ' , , y ,1 ~ r, . - i
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