ML20137W943
| 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: |
| References | |
| 50-19913-01, 50-19913-1, NUDOCS 8603040026 | |
| Download: ML20137W943 (4) | |
See also: IR 05000199/2013001
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NRC Fo,m 374
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u.s. NUCLE A~l REIULATZRY COMMISSloN
Amendment No. 9
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MATERIALS LICENSE
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Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438),and Title 10, f
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Code of Federal RegGlations, Chapter 1, 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 byproduct,
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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
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deliver or transfer such material to persons authorized to receive it in accordance with the regulations df the applicable Part(s). This
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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 f
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In accordance with letters
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dated November 19, 1985 andDecember20,198l
Ketchikan General Hospital
3. License number
50-19913-01 is amended in
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3100 Tongass Avenue
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Ketchikan, Alaska 99901
4. Expiration date January 31, 1987
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5. Docket or
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030-19521
Reference No.
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1l 6. Byproduct, source, and/or
7. Chemical and/or physical
8. Maximum amount that licensee
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may possess at any one time
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under this license
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Any radiopharmaceutical
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As necessary for uses'l
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Any byproduct material
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listed in Groups I and
listed in Groups I and II
authorized in
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II of Schedule A,
of Schedule A. Section
Subitem 9.A.
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Section 35.100 of
35.100 of 10 CFR 35
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Any byproduct material
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Any form listed in Group III
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2 curies of each
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listed in Group III
of Schedule A, Section 35.100
byproduct material
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af Schedule A,
of 10 CFR 35
authorized in
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Section 35.100 of
Subitem 6.B.
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Any byproduct material
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Any
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3 millicuries of each N
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listed in Section 31.11(a)
byproduct material
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of 10 CFR 31
authorized in i
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Subitem 6.C.
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Xenon 133
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Gas or gas in solution that
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50 millicuries
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is the subject of an active
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(i.e., not withdrawn or
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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 " clinical hold") " Notice of
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Claimed Investigat.icnal Exemption
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for a New Drug" (IND) that has
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been accepted by FDA
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Phosphorus 32
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Soluble phosphate
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10 millicuries
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U.S. NUCLEA'l CEIULATO2Y COMMISSION
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Licznse number
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50-19913-01
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MATERIALS LICENSE
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pocket or nererence number
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SUPPLEMENTARY SHEET
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030-19521
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Amendment No. 9
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Authorized use
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Any diagnostic procedure listed Groups I and II of Schedule A, Section 35.100
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of Title 10, Code of Federal Regulations.
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Preparation and use of radiopharmaceuticals for any diagnostic procedure listed
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in Group III of Schedule A, Section 35.100 of Title 10, Code of Federal
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Regulations.
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-In vitro studies.
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For blood flow and pulmonary function studies.
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For treatment of polycythemia vera, leukemia and bone metastases.
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CONDITIONS
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Licensed materisi shall be used only at Ketchikan General Hospital, 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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Licensed material listed in Item 6 above is authorized for use by, or under the
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supervision of, the followips individual (s) for the materials and uses indicated:
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John C. Jowett, M.D.
Groups I, II, and III
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h vitro studies
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Xenon 133
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Rush A. Youngberg, M.D.
Groups I, II, and III
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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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leukemia, and bone metastases
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Michael Z. Sedlovsky, M.D.
Groups I, II, and III
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In vitro studies
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Xenon 133
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Arthur K. Harris, M.D.
Groups I, II, and III
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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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leukemia, and bone metastases
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N!C Form 374A
U.S. NUCLEAFt RESULATCRY COMMISSloN
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Lscense number
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50-19913-01
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MAT.ERIALS LICENSE
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Docket or neference number
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SUPPLEMENTARY SHE ET
030-19521
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Amendment No. 9
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CONDITIONS
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For a period not to exceed sixty (60) days in nny calendar year, a visiting
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physician is authorized to use licensed material for human use under the terms
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of this license, provided the visiting physician:
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(a) Has the prior written permission of the hospital's Administrator and its
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Medical Isotopes Comittee, and
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(b) Is specifically named as a user on a Nuclear Regulatory Comission license
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authorizing human use, and
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(c) Performs only those procedures for which he is specifically authorized by a
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Nuclear Regulatory Commission license.
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The licensee shall maintain for inspection by the Commission, copies of the
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written permission specified in subitem (a) above and of the license (s)
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specified in subitems (b) and (c) above. These records shall be maintained for
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five (5) years from the time the licensee grants its permission under
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subitem (a) above.
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The licensee is authorized to hold radioactive material with a physical
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half-life of less than 65 days for decay-in-storage before disposal in ordinary
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trash provided:
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A.
Radioactive vaste 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 radioactivity 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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separately to ensure decay to background levels prior to disposal.
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15.
Ef fluent from the xenon 133 charcoal trap shall be tested for the presence of
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xen n 133 after 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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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
Activity
Calibration Accuracy
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90 microcuries or more
Within 1 5%
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Cobalt 57
One millicurie or more
Within
5%
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N! C' Form 374A
U.S. NUCLEAR REGULATO;Y COMMISSION
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PACE
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License number
50-19913-01
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MATERIALS LICENSE
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GUPPLEMENTARY SHEET
030-19521
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Amendment No. 9
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CONDITIONS
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Except as specifically provided otherwise by this license, the licensee shall
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possess and use licensed material described in Items 6, 7, and 8 of this license
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in accordance with statements, representations, and procedures contained in
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application dated October 27, 1981; Model ALARA Program contained in Appendix 0
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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
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29, 1983, March 13, 1984, telegram dated July 5,1984 from Sister Barbara
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Haase, Administrator, and letters dated October 16, 1985, November 19, 1985 and
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December 20, 1985. The Nuclear Regulatory Commission's regulations shall govern
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the licensee's statements in applications or letters, unless the statements are
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more restrictive than the regulations.
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The Radiation Protection Officer for the activities authorized by this license
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is Dr. Arthur K. Harris.
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FOR THE U.S. 'ECLEAR REGULATORY COMMISSION
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IS. W 3
By
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R. D. Thomas, Chief
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Nuclear Materials Safety Section
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Region V
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