ML20023B509

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Notice of Violation from Insp on 830315.Noncompliance Noted: One Patient Implanted W/Pacemaker Did Not Have Required 6-month Followup Exam,Per Condition 16 (10CFR2,App C).Reply Expected within 30 Days
ML20023B509
Person / Time
Site: 07001402
Issue date: 04/21/1983
From:
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20023B505 List:
References
70-1402-83-01, 70-1402-83-1, NUDOCS 8305050140
Download: ML20023B509 (1)


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APR 21 1983 APPENDIX A NOTICE OF VIOLATION Abington Memorial Hospital Docket No.

70-01402 Abington, Pennsylvania 19001 License No. SNM-1412 As a result of the inspection conducted on March 15, 1983, and in accordance with the NRC Enforcement Policy (10 CFR 2, Appendix C), the following viola-tions were identified:

Condition 16 of License No. SNM-1412 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in certain referenced applications and letters. One of these letters is dated June 6, 1973.

Item 4 of Page 2 of this letter requires that you follow the Medtronic's Protocol which (Paragraph 1, Page 3) requires that patients implanted with nuclear pacemakers have a followup examination every six months.

Contrary to this requirement, on the day of the inspection, March 15, 1983, your records indicated that one patient implanted with a nuclear pacemaker had not had a followup examination for a period in excess of six months.

This is a Severity Level IV violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Abington Memorial Hospital is hereby required to submit to this office within thirty days of the date of the letter which transmitted this Notice, a written statement or explanation in reply, including; (1) the corrective steps which have been taken and the results achieved; (2) corrective steps which will be taken to avoid further violations; and (3) the date when full compliance will be achieved. Where good cause is shown, consideration will be given to extending this response time.

OFFICIAL RECORD COPY 8305050140 830421 PDR ADOCK 07001402 C

PDR

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