ML20234B685
| ML20234B685 | |
| Person / Time | |
|---|---|
| Site: | 07001397 |
| Issue date: | 06/25/1987 |
| From: | Stohr J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML20234B666 | List: |
| References | |
| 70-1397-87-01, 70-1397-87-1, NUDOCS 8707060162 | |
| Download: ML20234B685 (1) | |
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ENCLOSURE NOTICE OF VIOLATION St. Mary's Hospital Docket No. 070-01397 Richmond, VA License No. SNM-1375 i During the Nuclear Regulatory Commission (NRC) inspection conducted on May 5, 1987, a violation of NRC requirements was identified. During the Nuclear Regulatory Commission (NRC) inspection conducted on May 5,1987, a violation of an NRC requirement was identified. The violation involved a failure to confirm follow-up examinations on patients implanted with pacemakers. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1986), the violation is listed below:
License Condition 16 requires the licensee to possess and use licensed material as specified in Items 6, 7, and 8 of this license in accord- ,
ance with statements, representations, and procedures contained in the j licensee's application, which was transmitted by letter dated June 19, 1 1973. The letter requires the licensee to see that the patient receives a follow-up examination every three months during the first year following implantation and every six months thereafter.
Contrary to the above, the licensee did not confirm that a follow-up examination had been conducted on a patient (iadividual BP) between June 23, 1984 and November 19, 1985, and August 28, 1986 and March 30, 1987, both intervals in excess of six months; and no records of follow-up examinations were available on another patient (individual IG).
This is a Severity Level IV violation (Supplement IV).
Pursuant to the provisions of 10 CFR 2.201, St. Mary's Hospital is hereby required to submit to this Office within 30 days of the date of the letter transmitting this Notice a written statement or explanation in reply including:
(1) admission or denial of the violation, (2) the reason for the violation if admitted, (3) the corrective steps which have been taken and the results )
achieved, (4) the 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, consideration will be given to extending the response time.
FOR ,THE NUCLEAR REGULATORY COMMISSION
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e J. Philip Stohr, Director Division of Radiation Safety and Safeguards Dated at,jtlanta, Georgia thisMQay of June 1987 8707060162 870625 REG 2 LIC70 SNM-1375 PDR