ML19276F008

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Notice of Violation from Insp on 790131.Noncompliance Noted: Appropriate Rept Not Made After Death of Pacemaker Patient & Loss of Contact W/Other Pacemaker Patient
ML19276F008
Person / Time
Site: 07001430
Issue date: 02/07/1979
From:
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML19276F007 List:
References
NUDOCS 7903260383
Download: ML19276F008 (1)


Text

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A.-

Appendix A NOTICE OF VIOLATION Mt. Sinai Hospital License No. SNM-1387 Medical Center Based on the inspection conducted on January 31, 1979, it appears that certain of your activities were in concompliance with NRC requirements, as noted below.

Items 1 and 2 are deficiencies.

1.

Condition 13 of your license requires that yod report to the Materials Branch, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any nuclear pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads. Also required is that a written report giving details of the adverse reaction and/or malfunction be submitted within 30 days.

Contrary to the above, from statements of licensee repre-sentatives and the absence of records, no appropriate notifications were made following the death of one of your nuclear pacemaker patients in November, 1977.

2.

Condition 14 of your license requires that a report be submitted to the Fbterials Branch, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, within 10 days, of loss of contact with a nuclear pacemaker patient.

Contrary to the above, from statements of licensee repre-sentatives and the absence of records, no such report was ever made for a nuclear pacemaker patient who has been out of contact since June, 1974.

7903260SF3