ML20206E446
| ML20206E446 | |
| Person / Time | |
|---|---|
| Site: | 07001718 |
| Issue date: | 10/28/1988 |
| From: | Russell W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20206E442 | List: |
| References | |
| EA-88-188, NUDOCS 8811180079 | |
| Download: ML20206E446 (2) | |
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NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY Shadyside Hospital Docket No. 70-01718 Pittsburgh, Pennsylvania License No. SNM-1531 EA 88-188 During an NRC inspection conductcd on April 15, 1987 at the licensee's factitty in Pittsburgh, Pennsylvania, and a subsequent investigation by the NRC Office of Investigations, a violation of NRC requiremnts was identif.ed.
In accordance with the "General Statement of Policy and Procedure fnr NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1987), the Nuclear Regulatory Commission proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1984, as amended ("Act"), 42 U.S.C. 2282 and 10 CFR 2.205.
The particular violation and the associated civil penalty are set forth below:
Condition 15 of License No. $NM-1531 requires that upon the death of a patient the nuclear pacemcker be recovered and returned to the manufacturer.
Contrary to the abova, upon the death, in December 1985, of an individual who had previously been implanted with a nuclear pacemaker at Shadyside Hospital, the pacemaker was not recovered by the Itcensee and returned to the manufacturer.
This is a Sevcrity Level III violation. (Supplement IV)
Civil Penalty - $2,500 Pursuant to the provisions of it, CFR 2.201, Shadysida Hospital (Licensee) is hereby required to submit a writte3 statement or exnlanation to the Director, Office of Enforcement U.S. Nuclear Regulatory Com:ninion, within 30 days of the date of this Notice.
This reply should be cletrly marked as a "Reply to a Notice of Violation" and should include for each alleged violation:
(1) admission or denial of the allegt d violation, (2) the reasons for tha violation if admitted, (3) the correc tive steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be a:hieved.
If an adequate reply is not received within the timt specified in this Notice, an order may be issued to show cause why the lice se should not be modified, suspended, or revoked or why such other action as may be proper thould not be taken. Consideration may be given to extending the response tim for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C.
2232, this response shall be submitted under oath or affirmation.
i Within the same time as provided for the response required above under 10 CFP. 2.201, the Licensee may pay the civil penalty by letter to the Director, t
Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, or money order pah ble to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulathe amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty in whole or in part by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission.
Should 0FFICIAL RELORD COPY CP PKG SHADYSIDE REV3 - C004.0.0 g Q g G81023 10/28/88
$NM-1531 ppc
the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued.
Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violation (s) listed in this Notice in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the pe"Ity should not be imposed.
In addition to protesting the civil penalty, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the five factors addressed in Section V.B of 10 CFR Part 2, Appendix C (1988), should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g.,
citing page and paragraph numbers) to avoid repetition.
The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
Upon failure to pay any civil penalty dus ihi.:
ubsequently has been deter-mined in accordance with the applicable provi-x s of 10 CFR 2.205, this matter raay be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be colierted oy civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
The responses to the Director, Of fice of Enforc tment, naed above (Reply to a Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to. Director, Office of Enforcement, U.S. Nuclear Regulatory Comm'.sion, ATIN:
Document Control Oesk, Washington, DC 20555 with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I.
FOR THE NUCLEAR REGULATORY COMMISSION ORIGINAL SIGNED BY:
JAMES M. ALLAN 1
d.
ator Dated at King of Prussia, Pennsylvania this # 4 ay of October 1988 0FFICIAL RECORD COPY CP PKG SHADYSIDE REV3 - 0005.0.0 10/28/88
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