ML20031A033

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Notice of Violation from Insp on 810723,24 & 27. Noncompliance Noted:Four Patients Received Doses of Tc-99m Which Contained More than 5 Uci of Mo-99 Per Dose & Lung Function Unit Not Used When Xe-133 Gas Administered
ML20031A033
Person / Time
Issue date: 08/28/1981
From: Riedlinger B
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML20031A032 List:
References
NUDOCS 8109180316
Download: ML20031A033 (2)


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APPENDIX A NOTICE OF VIOLAT_I_0N Department of the Amy License No. 5'-00458-04 U. S. Army Tripler Amy tiedical Center Oahu, Hawaii 96819 As a result of the inspection conducted on July 23, 24 and 27,1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:

A.

An Order modifying all medical licenses on Pfarch 12, 1979 states that by March 22, 1979, technetium 49n containing more than one microcurie of molybdenum-9 per millicurie of technetium-99m or more than five microcuries of molybdenum-99 per dose of technetium-59m shall not be administered to patients.

Contrary to this requirement, on August 6,1979, four patients were administered doses of technetium-99m which contained more than five nicrocuries of nolybdenum-99 per dose. One patient's dose contained 19.85 microcuries of molybdenun-99. Three pailents' doses contained 11.85 microcuries of molybdenum-99.

This is a Severity Level IV Violation (Supplement VII).

B.

License Condition 23. states that the licensee shall possess and use licensed material in accordance with statements, representations, and procedures contained in application dated October 11, 1978; letter dated October 9,1979; and letter dated January 3,1979 (received January 18,1980).

Item 21, " Procedures and Precautions for Use of Radioactive Cases (e.g., Xenon-133)," of the application dated October 1,1978, states that xenon-133 gas is administered to the patient using a xenon lung function unit and that the system exhaust is expelled through a "NONEX" xenon gas trap.

Contrary to these requirements, at the time of the inspection, no lung function unit was being used when xenon-133 gas was administered to patients. A NONEX gas trap was in use. Licensee personnel stated that a lung function unit had been ordered but had not been received.

This is a Severity Level V Violation (Supplement VII).

Pursuant to the provisicas of 10 CFR 2.201, Tripbr Army Medical Center, i

is hereby required to submit to this office within thirty days of the date of this Notice, a written statement or explanation in reply, including:

(1) the corrective steps which have been taken and the results achieved; 8109180316 810828 NMS LIC30 53-00458-04 PDR

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. (2) corrective steps which will bo taken to avoid further items of noncompliance _;

and (3) the date when full compliance will be achieved. Under the authority of bection 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitt'ad under oath or affimation. Consideration may be given to extending your response time for good cause shown.

The resp 4ases directed by this Notice are not subject to the clearance procedures of the Office of Minagement and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.

h dated C A. Rigdlinger, Gadiation Specialist i

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