ML20031H295

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Notice of Violation from Insp on 810831 & 0901.Noncompliance Noted:Patient Surveys Re Cs-137 Brachytherapy Implants Not Performed,Radiation Levels in Unrestricted Area Exceeded Limit & Linearity Checks Not Performed Quarterly
ML20031H295
Person / Time
Issue date: 10/15/1981
From: Greger L
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20031H279 List:
References
NUDOCS 8110270335
Download: ML20031H295 (2)


Text

e Appendix A NOTICE OF VIOLATION St. Elizabeth Hospital License No. 13-08615-04 Medical Center As a result of the inspection conducted on August 31 and September 1, 1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following v4olations were identified:

1.

10 CFR 35.14(b)(S)(vii) states (for Group VI) that any licensee who possesses and uses sources or devices containing byproduct material shall assure that patients treated with cesium-137 implants remain hospitalized until a source count and a radiation survey of the patient, confirms that all implants have been removed.

Contrary to the above requirement, it was determined through state-ments by licensee representatives that this condition is not being met.

Specifically, a licensee representative stated cesium-137 brachytherapy implants are counted when removed from the patient; however, patient surveys are not performed.

This is a repeat item of noncompliance.

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

2.

10 CFR 20.105(b)(1) requires that radiation levels in unrestricted areas be limited so that if an individual were continuously present in the area, he could not receive a dose in excess of 2 millirems in any one hour.

Contrary to the above requirement, on the day of this inspection, September 1, 1981, radiation levels in an unrestricted area exceeded the 2 millirem per hour limit.

Specifically, the NRC inspector and a licensee representative measured 4 millitem per hour in a patient's room which was adjacent to a room where a octient was being treated with cesium-13/ implant sources.

This is a Severity Level IV violation (Supplement IV).

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Appendix A 3.

License Condition No.18 states the dose calibrator shall be calibrated in accordance with the procedures set forth in Appendix D, Section 2 of Regulatory Guide 10.8, " Guide for the Preparation of Applications for Medical Programs," dated January 1979.

Appendix D, Section 2 requires the dose calibrator to be checked quarterly for linearity.

Contrary to the above requirement, it was determined through state-ments by licensee representatives and the NRC inspector's review of records that this condition is not being met.

Specifically, linearity checks were performed on January 15,1979, March 8,1980, and January 26, 1981, periods of uore than three months.

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

Pursuant to the provisions of 10 CFR 2.201, you are required to submit to this office within thirty days of the date of this Notice a written statement or explanation in reply, including for each item of noncompliance:

(1) cor-rective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full compliance will be achieved. Under the authority of Section 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitted under oath or affirmation. Consideration may be given to extending your response time for good cause shown.

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Date L. R. Greger, Acting Chief Technical Inspection Branch

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