ML19345H048
| ML19345H048 | |
| Person / Time | |
|---|---|
| Issue date: | 04/27/1981 |
| From: | Stello V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Michael Brown MAYO CLINIC, ROCHESTER, MN |
| Shared Package | |
| ML19345H049 | List: |
| References | |
| EA-81-020, EA-81-20, NUDOCS 8104300161 | |
| Download: ML19345H048 (2) | |
Text
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UNITED STATES NUCLEAR REGULATORY COMMISSION g
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License No. 22-00519-03 2Ll p '
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4 Mayo Clinic 4
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ATTN:
Dr. Manuel L. Brown C'
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Chairman, Committee on O
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Rochester, MN 55901
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Gentlemen:
This refers to the investigation conducted by Mr. R. M. Burton and Dr. W. J.
Adam of our Region III office (Chicago) on December 19, 1980.
The investi-gation was conducted to determine the circumstances surrounding the misadminis-tration of a therapeutic radiopharmaceutical at the Mayo Clinic which occurred on December 18, 1980.
The results of this investigation were discussed during a meeting held on February 4,1981, between you and James G. Keppler, Director, Region.III, and members of his staff.
Further discussions were held with members of your staff by the Director, Enforcement and Investigations, and members of the NRC staff at our Bethesda, Maryland headquarters office on March 10, 1981.
The invest.gation showed that the label on the radiopharmaceutical container was not properly read and that the procedure requiring assaying of the radio-pharmaceutical prior to administration was not followed.
The violation set forth in Appencix A has been categorized at Severity Level III in accordance with the Interim Enforcement Policy as published in the Federal, Register October 7, 1980.
The amount of civil penalty normally imposed for a-Severity Level III event is Four Thousand Dollars.
However, in view of the fact that the Mayo Foundation identified the problem, immediately took all necessary measures available to mitigate the effects of the misadministration and notified the NRC in a 'tery timely manner, we have determined that a fifty percent (50%) reduction in the penalty, which would ordinarily be imposed, is appropriate.
- Further, Mayo Foundation has shown good faith, not only by self-identification of the problem, but by implementation of extraordinarily prompt and effective corrective actions.
Because of these actions, an additional twenty-five percent (25%)
reduction of the adjusted value in the amount of civil penalty assee nd has been made.
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CERTIFIED MAIL RETURN RECEIPT REQUESTED P00R~0RIGINAL 8104 300lQ
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Mayo Clinic In light of the above considerations, we propose to impose a civil penalty in the amount of One Thousand Five Hundred Dollars for the violation set forth in Appendix A to this letter.
Since you have already submitted the corrective actions taken or planned, no response to Appendix A is necessary.
Appendix B to this letter is the Notice of Proposed Imposition of a Civil Penalty.
You are required to respond to Appendix B, and in preparing your response, you should follow the instructions in Appendix B.
In accordance with Section.2.790 of the NRC's " Rules of Practice, " Part 2, Title 10, Code of Federal Regulations, a copy of this letter ar.d the enclosures l
will be placed in the Commission's Public Document Room.
V ctor Stello, r.
Director Office of Irspection and Enforcement Attachments:
1.
Appendix A, Notice of Violation 2.
Appendix B, Notice of Proposed Imposition of a Civil Penalty l
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P00R BRIGINAl.
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