Text

Corrected Amend 10 to License 50-19913-01 for Ketchikan General Hosp,Amending License in Entirety
	ML20210R065
Person / Time
Site:	03019521
Issue date:	01/09/1987
From:	Riedlinger B; NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V)
To:	;
Shared Package
ML20210R071	List: ML20210R065; ML20210R108;
References
	50-19913-01, 50-19913-1, NUDOCS 8702170313
	Download: ML20210R065 (4)
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u.s. NUCLEAR REIULATO?.Y COMMISSION

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MATERIALS LICENSE

Amendment No. 10

Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10,

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Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations

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heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer bypraduct, j

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source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to r

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deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This L

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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 rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any

( conditions specified below.

CORPECTED COPY

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In accordance with letter

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dated March 4, 1986

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Ketchikan General llospital

3. Ucense number 50-19913-01 is maended in

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its entirety to read as follows:g

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3100 Tongass Avenue

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Ketchikan, Alaska 99901

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4. Expiration date January 31, 1987

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5. Docket or

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Reference No.

30-19521

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6. Bypioduct, source, and/or

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7. Chemical and/or physical

8. Maximum amount that licensee

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special nuclear material

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under thislicense

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Anybyproductmatebal

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Any radtopharmaceutical

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listed in Groups I and

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II of Schedule A, f

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Xenon 133

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50 millicuries

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terminated) "New Drug

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Application" (NDA) approved

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by FDA or an active (i.e.,

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not withdrawn, terminated or

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on "cifnical hold") " Notice of

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for a New Drug" (IND) that has

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been accepted by FDA

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Amendment No. 10

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6. BYPRODUCT, SOURCE, AND/0R

7. CHEMICAL AND/OR PMYSICAL

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SPECIAL NUCLEAR MATERIAL

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UNDER Tl!IS LICENSE

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Phosphorus 32

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Any soluble phosphate

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10 millicurfes

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that has been manufactured,

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labeled, packaged, and

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distributed in accordance

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Authorized use

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Preparation and use of radiopharmaceuticals- for any diagnostic procedure listed

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CONDITIONS

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Licensed material shall be used only at Ketchikan General !!ospital, 3100

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Tongass Avenue, Ketchikan, Alaska.

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The licensee shall comply with the provisions of Title 10, Chapter 1, Code of

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Federal Regulations, Part 19, " Notices, Instructions and Reports to Workers;

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Inspections" and Part 20, " Standards for Protection Against Radiation".

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12. Licensed materf al listed in Item 6 above is authorized for use by, or under the

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supervision of, the following individual (s) for the materials and uses indicated

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Zeke L. llendricks, M.D.

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In vitro studies

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Xenon 133

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Phosphorus 32 as soluble phosphate for

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treatment of polycythemia vera,

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1eukemia, and bone metastases

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CONDITIONS

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Arthur K. liarris, M.D.

Groups I, II, and III

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In vitro studies

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Xenon 133

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treatment of polycythemia vera,

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leukemia, and bone metastases

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13. For a period not to exceed sixty ,(60)$ days in$ny/ calendar year, a visiting

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physician is authorized to uschlice'n'ed material'fsr' human use under the terms

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of this license, providedQhe' visiting physician:

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(a) lias the prior written permission of the hospital's Administrator and its

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The licensee shall' main'tain for inspectioniby[tlie"Commis'sion, c'6[les of the

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written permissio'ri"specifled;in, subites (s) above 'and' of Jthe license (s)

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specified in subitems (b) and. (c) abovel.] jThese, records :shall.be' maintained for

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five (5) years from'the time: the licenseesgrants'.its? permission'under

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14. The licensee is authorized to hold radis 6tive mate'ial with a physical

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half-life of less than'65' days for decay;fn-storage befote/ disposal in ordinary

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Radioactive waste to be disposed ~of in this manner shall be held for decay

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a minimum of ten (10) half-lives.

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Prior to disposal as normal waste, radioactive waste shall be monitored to

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determine that its radjoactivity cannot be distinguished from background

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with typical low-level laboratory survey instruments. All radiation labels

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will be removed or obliterated.

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Generator columns shall be segregated so that they may be monitored

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separateJy to ensure decay to background levels prior to disposal.

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15. Effluent from the xenon 133 charcoal trap shall be tested for the presence of

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xenon 133 af ter every ten patient procedures, in order to assure that the device

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is functioning properly and that filter saturation has not occurred.

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CONDITIONS

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16. The license shall include the reference standards described below when

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performing dose calibrator accuracy tests:

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Dose Calibrator Reference Standards

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Radionuclide

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Calibration Accuracy

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17. Except as specifically provided otherwise in this license,fthe licensee shall

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conduct its program in,accordance with the statements, representations, and

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procedures contained.,in the documents including any enclosures, listed below.

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The Nuclear Regulatory Commission's regulations shall govern unless the

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statements, representations'and. procedures in the' licensee's application and

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correspondence are more restrictive than the re'gu1'ations.

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A. Appifcation dat'd October 27',(1981, ' , ;(

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B. Model ALARA Piogram contained.In' Appendix

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11. Letter dated November;20,1985

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The Radiation Protection 0$ficer'for,the activities authorized by this if cense

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is Dr. Zeke L. IIendricks.

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FOR TIIE U.S. NUCLEAR REGULATORY COMMISSION

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original signed by B. A. Ried11nger

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D;te July 9, 1986

By

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Deth A. Riedlinger

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IIcalth Physicist (Licensing)

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Nuclear Materfalo Safety Section

Region V

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JuuRwaam1MukTaram' ALT.TmT;suavaraT.truraT;nvemaameras.vaJawmT;swar;sirar;sLT;

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