ML20005A635

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Notice of Violation from Insp on 810603.Noncompliance Noted: Daily/Weekly Area Surveys Not Performed,Failure to Perform Daily Review of Dose Calibrator Records & Leak Test Documentation
ML20005A635
Person / Time
Issue date: 06/18/1981
From: Sreniawski D
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20005A628 List:
References
NUDOCS 8106300523
Download: ML20005A635 (2)


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h Appendix A NOTICE OF VIOLATION Drs. Kellam and Klein P.C.

License No. 21-12716-01 As a: result of the inspection conducted on June 3,1981, and in accordance with the Interi.m Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:

1.

License Condition No. 15 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated August 2, 1976.

Item No. 14 of the above referenced application states areas used for preparation of radiopharmaceuticals from reagent kits, and for pre-paration of individual patient doses will be surveyed for contamination after each procedure and/or at the end of each working day.

In addition, a routine weekly area survey of all possible areas of radioisotope usage will be performed.

Contrary to the above requirement, it was determined through statements by licensee representatives that this condition is not being met. Spec-ifically, a licensee representative stated daily and weekly surveys have not been performed since April 1981.

This is a repeat of item of noncompliance.

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

2.

License Condition No. 15 requires that licensed material be possessed and used in accordance with statements, representation, and procedures contained in application dated August 1, 1976.

Item No. 11(A)(2) of the above referenced application states a daily accuracy and a daily constancy will be performed on the Capintec CRC-4 dose calibrator.

Contrary to the above requirement, it was determined through statements by licensee representatives and the NRC inspector. review of dose cali-brator records that this :ondition is not being met.

Specifically, a licensee representative stited the last accuracy and constancy check was performed on April 17, 1981. This exceeds the daily requirement.

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

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O Appendix A,

3.

10 CFR 35.14(e)(1)(1) 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 the above requirement, it was determined through statements by licensee representatives and the NRC inspectors review of leak test records that th'.s condition is not being met.

Specifically, as of the date of-this inspection, the nominal 197 microcurie cesium 137 reference source was. tested for leakage on August 3, 1980. This interval exceeds six monthc-

'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 orLexplanation in reply, including for each item of noncompliance:

(1) cor-rective action taken and the results achieved; (2) corrective action to be taken to avotd further noncomp.ance; 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 oe given to extending your response time for good cause shown.

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Dated D. J.

eniawski, Chief Hateri s Radiation Protection Section 2 9

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