ML20137W943

Amend 9 to License 50-19913-01 for Ketchikan General Hosp, Amending License in Entirety

ML20137W943
Person / Time
Site:	03019521
Issue date:	02/02/1986
From:	Thomas R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V)
To:
Shared Package
ML20137W946	List: ML20137W943 ML20137W950 ML20137W971
References
50-19913-01, 50-19913-1, NUDOCS 8603040026
Download: ML20137W943 (4)

See also: IR 05000199/2013001

Text

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j NRC Fo,m 374 1 4 g

ta sU PACE oF PACES

) u.s. NUCLE A~l REIULATZRY COMMISSloN

MATERIALS LICENSE Amendment No. 9

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j 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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q Code of Federal RegGlations, Chapter 1, Parts 30. 31,32,33,34,35,40 and 70, and in reliance on statements and representations y

] heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, y

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

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

I license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is f

f subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effe

11 e nditi ns specified below h-

In accordance with letters

dated November 19, 1985 andDecember20,198l

]1. Ketchikan General Hospital 3. License number 50-19913-01 is amended in

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itsentiretytoreadasfollows:g,

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l 2. 3100 Tongass Avenue I

llj Ketchikan, Alaska 99901 4. Expiration date January 31, 1987 I

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J 5. Docket or I

j Reference No. 030-19521 g

1l 6. Byproduct, source, and/or

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7. Chemical and/or physical 8. Maximum amount that licensee I

1 special nuclear material form may possess at any one time I

under this license

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A. Any byproduct material A. Any radiopharmaceutical A. As necessary for uses'l

f listed in Groups I and

II of Schedule A,

listed in Groups I and II

of Schedule A. Section

authorized in

Subitem 9.A. fp

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Section 35.100 of 35.100 of 10 CFR 35

1l i 10 CFR 35

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Any byproduct material B. Any form listed in Group III B. 2 curies of each

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listed in Group III

af Schedule A,

of Schedule A, Section 35.100

of 10 CFR 35

byproduct material

authorized in

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1 Section 35.100 of ,

Subitem 6.B. b

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C. Any byproduct material C., Any C. 3 millicuries of each N

] listed in Section 31.11(a) byproduct material E

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]! of 10 CFR 31 authorized in i

Subitem 6.C. (/ fg;

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1 D. Xenon 133 D. Gas or gas in solution that D. 50 millicuries b

I is the subject of an active E

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(i.e., not withdrawn or

j terminated) "New Drug

1 Application" (NDA) approved g

1 by FDA or an active (i.e., g

not withdrawn, terminated or

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on " clinical hold") " Notice of N

Claimed Investigat.icnal Exemption

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for a New Drug" (IND) that has

been accepted by FDA

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1 E. Phosphorus 32 E. Soluble phosphate E. 10 millicuries

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8603040026 860202 g

REG 5 LIC30 PDR p.

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} 50-19913-01 y\ g

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i NRC Form 374A U.S. NUCLEA'l CEIULATO2Y COMMISSION PAGE 2 o, 4 ,,ogs l

l Licznse number l

1 50-19913-01 N

l MATERIALS LICENSE pocket or nererence number I

I SUPPLEMENTARY SHEET 030-19521 I

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Amendment No. 9 l

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Authorized use

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g A. Any diagnostic procedure listed Groups I and II of Schedule A, Section 35.100 g

of Title 10, Code of Federal Regulations. [

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ll B. Preparation and use of radiopharmaceuticals for any diagnostic procedure listed Ii

in Group III of Schedule A, Section 35.100 of Title 10, Code of Federal

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gj Regulations. b f

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ll C. -In vitro studies. I!

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ll D. For blood flow and pulmonary function studies. l~

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I'g! E. For treatment of polycythemia vera, leukemia and bone metastases.  ![=

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ll CONDITIONS [j

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Licensed materisi shall be used only at Ketchikan General Hospital, 3100 h

f 10. Tongass Avenue, Ketchikan, Alaska.

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

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ill 11. Federal Regulations, Part 19, " Notices, Instructions and Reports to Workers- 7

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

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Licensed material listed in Item 6 above is authorized for use by, or under the R

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g supervision of, the followips individual (s) for the materials and uses indicated:

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i; John C. Jowett, M.D. Groups I, II, and III h[I

f' h vitro studies y

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Xenon 133

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g; Rush A. Youngberg, M.D. Groups I, II, and III i

$ In vitro studies [l

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Hl Xenon 133 il

Il Phosphorus 32 as soluble phosphate for 4

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treatment of polycythemia vera,

leukemia, and bone metastases

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N, Michael Z. Sedlovsky, M.D. Groups I, II, and III

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3l In vitro studies U

li Xenon 133 I

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g. Arthur K. Harris, M.D. Groups I, II, and III

In vitro studies

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l Xenon 133 I;

I Phosphorus 32 as soluble phosphate for I-

I treatment of polycythemia vera, I

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leukemia, and bone metastases

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L_____________m..._______________________

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] N!C Form 374A U.S. NUCLEAFt RESULATCRY COMMISSloN p,cc oy 4 ,,og, p

3 Lscense number l

h 50-19913-01 I

lj MAT.ERIALS LICENSE Docket or neference number

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lj SUPPLEMENTARY SHE ET 030-19521 I

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1 Amendment No. 9 l

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CONDITIONS

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For a period not to exceed sixty (60) days in nny calendar year, a visiting g

physician is authorized to use licensed material for human use under the terms l

3{ 13.

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of this license, provided the visiting physician: ll

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

Medical Isotopes Comittee, and g

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1 (b) Is specifically named as a user on a Nuclear Regulatory Comission license 3

{1 authorizing human use, and I

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f (c) Performs only those procedures for which he is specifically authorized by a

Nuclear Regulatory Commission license.

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1! The licensee shall maintain for inspection by the Commission, copies of the ,

l written permission specified in subitem (a) above and of the license (s)  ;

1 specified in subitems (b) and (c) above. These records shall be maintained for i

7

five (5) years from the time the licensee grants its permission under

subitem (a) above.

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1 14. The licensee is authorized to hold radioactive material with a physical lE

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l half-life of less than 65 days for decay-in-storage before disposal in ordinary iR

3 trash provided: !E

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fy A. Radioactive vaste to be disposed of in this manner shall be held for decay

a minimum of ten (10) half-lives.

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i! B. Prior to disposal as normal waste, radioactive waste shall be monitored to ll

l determine that its radioactivity cannot be distinguished from background  %

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

will be removed or obliterated.

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] C. Generator columns shall be segregated so that they may be monitored ;R

1, separately to ensure decay to background levels prior to disposal. il

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

j!1 xen n 133 after every ten patient procedures, in order to assure that the device

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f is functioning properly and that filter saturation has not occurred. p

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

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performing dose calibrator accuracy tests: N I

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Dose Calibrator Reference Standards f

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ll Radionuclide Activity Calibration Accuracy l l

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l Cesium 137 90 microcuries or more Within 1 5%

Cobalt 57 One millicurie or more Within 5% l '

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N! C' Form 374A U.S. NUCLEAR REGULATO;Y COMMISSION

PACE

4 OF

4 PAGES I

License number jl

50-19913-01 ll,

MATERIALS LICENSE 3,,,,,,,,,f,,,,,,,,,,,, y

GUPPLEMENTARY SHEET 030-19521

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Amendment No. 9 (

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h CONDITIONS

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17. Except as specifically provided otherwise by this license, the licensee shall

! possess and use licensed material described in Items 6, 7, and 8 of this license  !

in accordance with statements, representations, and procedures contained in l

j application dated October 27, 1981; Model ALARA Program contained in Appendix 0

h of Regulatory Guide 10.8 (Rev. 1), " Guide for the Preparation of Applications

for Medical Programs", October 1980 and letters dated July 28, 1903, September j

[jj 29, 1983, March 13, 1984, telegram dated July 5,1984 from Sister Barbara !g

i Haase, Administrator, and letters dated October 16, 1985, November 19, 1985 and !g

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y December 20, 1985. The Nuclear Regulatory Commission's regulations shall govern lR:

h the licensee's statements in applications or letters, unless the statements are jE;

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more restrictive than the regulations.

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{ 18. The Radiation Protection Officer for the activities authorized by this license gj

lj is Dr. Arthur K. Harris. j[:

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'l FOR THE U.S. 'ECLEAR REGULATORY COMMISSION @:

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fj! Date 'f aNE2 By

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R. D. Thomas, Chief g:

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