ML19345H051

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Notice of Violation from Insp on 801219.Noncompliance Noted: Sodium Phosphate Prepared & Administered W/O Verifying Activity of Dose W/Scintillation Detector
ML19345H051
Person / Time
Issue date: 04/27/1981
From: Stello V
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE)
To:
Shared Package
ML19345H049 List:
References
EA-81-020, EA-81-20, NUDOCS 8104300167
Download: ML19345H051 (1)


Text

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Appendix A NOTICE OF VIOLATION Mayo Clinic License No. 22-00519-03 Roct. ester, MN EA 81-20 As a result of the investigation conducted on December 19, 1980, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980),

tne following violation was identified:

License Condition 24 states, in part, the licensee shall possess and use licensed material in accordance with statements, representations and procedures listed in the letter dated March 15, 1979.

Item 4.a. of that letter requires each radiciodide therapy dose to be counted in a sodium iodide scintillation detector (" cup counter").

Contrary to the above, on December 18, 1980, what was intended to be a radio-iodide therapy dose, turned out to be a dose of approximately 9.85 millicuries of phosphorus-32 as sodium phosphate that was prepared and administered to a patient without first verifying the activity of the dose with the scintillation detector.

This is a Severity Level III violation (Supplement VII. C.6.).

(Civil Penalty - $1,500)

Pursuant to the provisiuns of 10 CFR 2.201, Mayo Clinic would ordinarily be required to submit to this office within twenty-five days of the date of this Notice, a written statement or explanation in reply, including:

(1) admission or denial of the alleged violation; (2) the reasons for the violation if admitted; (3) the corrective steps which have been taken and the results achieved; (4) corrective steps which will be taken to avoid further noncom-pliance; and (5) the date when full compliance will be achieved.

However, since Mayo Clinic has already submitted the corrective actions taken or planned, no response is necessary.

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/d Victor Stello, Jr.

Director Office of Inspection and Enforcement Dated at Bethesda, Maryland this 27th day of April 1981 P00R ORIGINAL sl o4 aon l67

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