ML20154F798
| ML20154F798 | |
| Person / Time | |
|---|---|
| Issue date: | 05/13/1988 |
| From: | Russell W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20154F782 | List: |
| References | |
| EA-88-097, EA-88-97, NUDOCS 8805240082 | |
| Download: ML20154F798 (4) | |
Text
_ _ _ _ _ _ _ _
1 I
l NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY Bridgeton Hospital License No. 29-15035-01 Bridgeton, New Jersey Docket No. 030-08463 l EA 88-97 During an NRC inspection conducted on March 25 and 28, 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 (1987), the Nuclear Regulatory Commission proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42
'J.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:
A. 10 CFR Part 71.5(a) equires that each licensee who delivers any licensed material to a crerier for transport to comply with the applicable require-ments of the regulations appropriate to the mode of transport of the Depart-ment of Transportation in 49 CFR Parts 170-189.
49 CFR Part 172.403 and 49 CFR Part 172.200, respectively require, that (1) unless excepted from labelling by Sections 173.421 through 173.425, each package of radioactive material shall be labelled with a Radioactive White-I, Radioactive Yellow-II, or Radioactive Yellow-III label as appro-priate; and (2) the material offered for transport shall be described on the shipping paper.
Contrary to the above, from January 1986 to March 25, 1988, packages con-taining approximately 225 millicuries of molybdenum-99 in used molybdenum-99/
technetium-99m generators were shipped on a weekly basis to the manufact-urer (E. I. Dupont - NEN Products), and these packages, which were not excepted from labelling in accordance with Sections 173.421-173.425 of 49 CFR:
- 1. did not have affixed an appropriate label indicating the radiation level at the surface of the package and transport index in accordance with 49 CFR 172.403; and
- 2. were incorrectly described on the shipping paper as "Empty".
B. 10 CFR 20.201(b) requires that each licensee make such surveys as may be necessary to comply with the regulations of Part 20, and are reasonable under the circumstances to evaluate the extent of radiation hazards that may be present. As defined in 10 CFR 20.201(a), "survey" means an evaluation of the radiation hazards incident to the production, use, release, disposal, or presence of radioactive materials or other sources of radiation under a specific set of conditions.
OFFICIAL RECORD COPY CP PKG BRIDGETON REV 1 A -
0004.0.0 05/11/88 8805240082 880513 RE01 LIC30 29-15035-01 DCD
1
, 2 Contrary to the above, on March 25, 1988, and for an indeterminate period prior to that date, a survey was not made to assure compliance with 10 CFR 20.301, which describes authorized means of disposing of licensed material contained in waste. Specifically, during that time, such material located in the Nuclear Medicine Department was surveyed at the end of each day, but the waste material was routinely not picked up until the following day.
As a result, the waste materials added subsequent to the survey but prior to the pickup were not surveyed to assure that licensed material was disposed of in a manner authorized by 10 CFR 20.301.
. C. 10 CFR 35.51(c) requires that each survey instrument be checked for proper operations with a dedicated check source each day of use.
! Contrary to the above, on March 25, 1988, technologists in the Nuclear i Medicine Department did not properly check their Ludlum Model 14C and Victoreen survey instruments for proper operation prior to use in that the checks were made to ensure that the instrument needle moved, but did 3
not ensure that the needle indicated the appropriate check reading.
Further, the checks of the Ludlum instrument were performed with the wrong source.
D. 10 CFR 35.204(b) requires that the molybdenum-99 concentration in each
! eluate or extract be measured by a licensee who uses molybdenum-99/
j technetium-99m generator for preparing a technetium-99m radiopharmaceutical.
Contrary to the above, from February 1985 to March 25, 1988, the molybdenum-99 concentration in each eluate from the molybdenum-99/
i technetium-99m generator was not properly measured in that the dose calibrator was set incoerectly during the assay. Specifically, the i dose calibrator should have been set for "030" and the results multiplied by 3.5, as specified by the manufacturer; however, the instrument was being operated at a setting of "180" with no correction factor applied.
E. 10 CFR 19.12 requires, in part, that all individuals working in any part of a restricted area be instructed in the purposes and functions of protective devices employed, and be instructed in the applicable provisions of the Commissions regulations and license conditions.
Contrary to the above, as of March 25, 1988, two individuals working in the Nuclear Medicine Department (a restricted arer) were not instructed in the proper use of the dose calibrator, a protective device, for making molybdenum breakthrough tests, were not instructed in the proper technique for performing operational checks on survey instruments, a protective device, and were not instructed in the Commission's regulations pertaining to the preparation of packages for shipment.
These violations are categorized in the agg egate as a Severity Level III problem. (Supplement IV, V and VI)
Civil Penalty - $1250 - assessed equally among the violations.
OFFICIAL RECORD COPY CP PKG BRIDGETON REV 1 A -
0004.1.0 05/11/88
3 Pursuant to the provisions of 10 CFR 2.201, Bridgeton Hospital (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice, This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation:
(1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, (3) the corrective steps that have been taken and the results achieved, (4) the corrective *teps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. 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. Consideration may be given to extending the response time 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.
Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter to the Director, Office of !.aforcement, U.S. Nuclear Regulatory Commission, with a check, draf t, or money order payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative 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 the Licenset 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 penalty 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 panalty, 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 due which subsequently has been deter-mined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
OFFICIAL RECORD COPY Cp PKG BRIDGETON REV 1 A -
0005.0.0 05/11/88
- 4 t
l The responses to th* Director, Office of Enforcement, noted 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 Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, U.S. Nuclear Regulatory i l Commission, Region I, 475 Allendale Road, King of Prussia, Pennsylvania, 19406. ,
1 J
FOR THE NUCLEAR REGULATORY COMMISSION Origir.cl Signed B7 UILL!A.. T. i.J032LL 4 William T. Russell Regional Administrator ,
l
- Dated at King of Prussia, Pennsylvania
- this /,3 day of May 1983 1
I t
a e
! i l
4 I
l I
1 i
1 r
i
- . - . , - - , . - - - - , . , . . - _ - . e s.- .- , , , , , , . - , . , , , , - < , - . . , , , . _ . _ . , - ,
. . , . , ,