ML20009B341

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Notice of Violation from Insp on 810624.Noncompliance Noted: Leakage Test for Calibr Source Not Performed Every 6 Months, Therapeutic Doses of I-131 Administered in Liquid Form & Licensed Matl Not Secured
ML20009B341
Person / Time
Issue date: 07/09/1981
From: Sreniawski D
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20009B340 List:
References
NUDOCS 8107150299
Download: ML20009B341 (2)


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Appendix A NOTICE OF__ VIOLATION St. Mary's Hospital License No. 21-03646-03 License No. 21-03646-04 As a result of the inspection conducted on June 24, 1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the f;11owing violations were identified:

License No. 21-03646-03 1.

10 CFR 35.14(e)(1)(i) requires each licensee who possesses sealed sources as calibration or reference sources shall perform tests for leakage and/or contamination at intervals not to exceed six months.

Contrary to this requirement, the 168 microcurie ~ cesium-137 calibration source was last tested for leakage on October 28, 1980, an interval of more than six months.

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

2.

License Condition No. 19 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated July 31, 1978.

Appendix K in the application dated July 31, 1978, states therapeutic doses of iodine-131 will be in the form of capsules.

Contrary to the above, it was determined through statements by licensee representatives that therapeutic quantities of iodine-131 have been administered to patients in liquid form.

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

3.

10 CFR 20.207(a) requires that licensed materials stored in an unre-stricted area be secured against unauthorized removal from the place of storage.

Contrary to the above, the entrance to the area where spent technetium generators are stored was not secured, on the day of inspection, to prevent unauthorized removal of Byproduct Material.

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

8107150299 810710 NMS LIC30 21-03646-03 PDR

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V Appendix A License No. 21-03646-04 4.

License Condition No. 14(a) requires teletherapy sources to be tested for leakage at intervals not to exceed six months.

Contrary to the above, a licensee representative stated a leak tent had not been performed since the date of his employment, January 3, 1981.

Furthermore, previous leak test records were not available for review.

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

5.

10 CFR 35.21(b)(3) requires full calibration measurements to inclade determination of the uniformity of the radiation field.

Contrary to _the above, the full calibration performed on January 16, 1981, did not include the determination of beam uniformity.

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

6.

10 CFR 35.22(b) requires spot-check measurements to include determina-tion of the congruence between the radiation field and the field indi-cated by the light beam localizing device.

10 CFR 35.22(b)(5) requires spot-check measurements to include the determination of the difference between the expected output and the measured output expressed as a percentage of the anticipated output.

Contrary to the above, spot-check measurements performed since January, 1981, did not include the above required measurements.

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 l

or affirmation.

Consideration may be given to extending your response time for good cause shown.

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l Dated

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D. J. Sr niawski, Chief Mate'ial Radiation Protection r

Sec ici 2

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