ML20155C126
| ML20155C126 | |
| Person / Time | |
|---|---|
| Site: | 07001397 |
| Issue date: | 09/19/1988 |
| From: | Stohr J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML20155C116 | List: |
| References | |
| 70-1397-88-01, 70-1397-88-1, NUDOCS 8810070248 | |
| Download: ML20155C126 (2) | |
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ENCLOSURE NOTICE OF VIOLATION St. Mary's Hospital Docket No. 070-01397 Richmond, VA License No. SNM-1375 During the Nuclear Regulatory Commission (NRC) inspection conducted on August 4, 1988, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1988), the violations are listed below:
A. Condition 14 of License No SNM-1375 requires that during the lifetime of any patient implanted with a nuclear pacemaker, the licensee sha!!
continue patient follow-up and replacement procedures for each nuclest pacemaker, including adherence to procedures for recovery and authorized disposal of the nuclear pacemaker by return to the manufacturer upon the death of the patient. Further, 10 CFR 20.301 requires that the licensee .
dispose of licensed material only by certain specified procedures set l forth therein.
Contrary to the above, upon the death on March 3,1988, of a patient previously implanted with a nuclear pacemaker, the pacemaker, which contained milligram quantities of plutonium-238, was not recovered and returned to the manufacturer for authorized disposal and was buried with the individual, a method of disposal not authorized by 10 CFR 20.301.
This is a Severity Level IV violation (Supplement IV and VI).
B. Condition 12 requires the licensee to report to the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the death of any nuclear pacemaker patient.
Contrary to the above, the death of a nuclear pacemaker patient on March 3,1988, was not reported to the NRC until June 28, 1988.
This is a Severity Level IV violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, St. Mary's Hospital is hereby required to submit a written statement or explabation to the Nuclear Regulatory Comission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Adninistrator, Region II, within 30 days of the date of the letter transmitting this Notice. This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) admission or denial of the violation, (2) the reason for the violation if admitted, (3) the j corrective steps which have been taken and the results achieved, (4)the l
' corrective steps which will be taken to avoid further violations, and (5) the date when full compliance will be achieved. Where good cause is shown, SNM-1373 PDC
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Notice of Violation 2 consideration will be given to extending the response time. If an adequate reply is not received within the time specified in this Notice, an order may be issued to show cause why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken.
l FOR THE NUCLEAR REGULATORY COMMISSION
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, ohr, Direc or vision o Radiation Safety Di'and Safeguards Dated at Atlanta, Georgia this /7/fday of September 1988 I
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