EA-01-186 - University of Medicine & Dentistry of New Jersey

September 25, 2001

EA 01-186

Celia Dorantes Abalos, Esq.
Vice President for Regulatory Affairs
University of Medicine & Dentistry of New Jersey
335 George Street, Room 3100
P.O. Box 2688
New Brunswick, NJ 08903-2688

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $3,000 (NRC Inspection Report No. 030-09926/2001-001)

Dear Ms. Abalos:

This refers to the NRC inspection conducted on May 26 and 30, 2001, at your facility in Newark, New Jersey to review the circumstances associated with the loss of an iridium-192 (Ir-192) ribbon containing nine seeds of Ir-192 with a total activity of 7.7 millicuries (mCi). You reported this loss to the NRC on May 25, 2001. The inspection was continued in the Region I office until June 29, 2001, to review additional information (namely, the 30-day event report) provided to the NRC subsequent to the onsite inspection. As described in the NRC inspection report sent to you on August 9, 2001, two apparent violations of NRC requirements were identified during the inspection.

In the letter transmitting the inspection report, we provided you the opportunity to address the apparent violations identified in the report by either attending a predecisional enforcement conference or by providing a written response before we made our final enforcement decision. You declined to have a conference with the NRC and instead you provided a response to the apparent violations in a letter dated September 5, 2001. In your response, you stated that your staff believes that the lost source may have inadvertently fell into a toilet in the patient's room and been flushed into the sewer system. You also stated that you have implemented corrective actions to prevent recurrence.

Based on the information developed during the inspection, and the information provided in your response, the NRC has determined that two violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The more significant violation involved the failure to control radioactive material which resulted in the loss of the ribbon which was used for patient brachytherapy treatment. The violation occurred when one of the six ribbons implanted into the patient's neck was lost during the scheduled brachytherapy treatment. That ribbon was found to be missing at the end of the treatment period (approximately 42 hours). Although you were unable to specifically determine exactly how the ribbon was lost, the patient may have dislodged the source from his neck with a towel that he had used to absorb secretions from the treatment site. Afterwards, the source may have been put in the trash (and not surveyed before it left the patient's room), or it may have been inadvertently flushed down the toilet. Based on an investigation conducted by your staff, you have concluded that the waste was flushed down the toilet because surveys of the hospital, the solid waste disposal system, and the landfill did not identify any radioactive material. Although the source may not have been placed in the trash, your staff failed to perform a survey for radioactive material of trash and other items removed from the patient's room. This failure constituted the second violation which may have contributed to the failure to control the radioactive material.

The safety significance of these violations was minimized by the fact that the source, whether discarded in the toilet or the trash, is unlikely to come in close contact with any individual. Nonetheless, these violations are of concern to the NRC because (1) the failure to control radioactive material resulted in the subsequent loss of the source; and (2) such sources can result in substantial unintended radiation dose to an individual if placed in close contact with the individual's skin. Therefore, these violations are categorized collectively as a Severity Level III problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the current version of the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III violation or problem regarding the loss or improper disposal of radioactive material. Because your facility has not been the subject of an escalated enforcement action within the last two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These corrective actions included, but were not limited to: (1) ensuring that sources have colored ribbon to make them easier to see if they are dropped on the floor; (2) providing refresher training to all personnel involved in brachytherapy procedures; (3) issuance of an internal letter to the authorized user/physician and head of housekeeping because of their staffs' involvement in the incident (both individuals were required to provide a written response regarding what was done wrong, as well as actions taken to prevent recurrence); and (4) regarding surveys, revising your procedure to require survey instruments outside the patients' rooms during all treatments to detect unexpected events.

Therefore, application of the normal civil penalty assessment process would not result in a civil penalty in this case. However, the revised Enforcement Policy published December 18, 2000 (effective February 16, 2001), provides that, notwithstanding the normal civil penalty assessment process, a civil penalty of at least the base amount should normally be proposed in this type of case to reflect the significance of the violation and to emphasize the importance of maintaining control of licensed material (see section VII.A.1(g) of the Enforcement Policy). Therefore, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $3,000 for the Severity Level III problem. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you may reference any previous correspondence that is applicable to this case to avoid repetitive submissions. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

		Sincerely,
		/RA/ James T. Wiggins Acting For
		Hubert J. Miller Regional Administrator

Docket No. 030-09926
License No. 29-02957-13

Enclosure:  Notice of Violation and Proposed Imposition of Civil Penalty

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ENCLOSURE

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

University of Medicine & Dentistry of New Jersey Newark, NJ

License No. 29-02957-13 Docket No. 030-09926 EA 01-186

During an NRC inspection conducted on May 26 and 30, 2001 and continued in the Region I office until June 29, 2001, two violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the NRC proposes a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282 and 10 CFR 2.205. The violations and associated civil penalty are set forth below:

A.

10 CFR 20.1802 requires that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee. Contrary to the above, between May 23 and May 25, 2001, the licensee used licensed material, namely a ribbon containing 7.7 millicuries of iridium-192 (Ir-192), during the treatment of a patient in a restricted area. However, the licensee could not account for the material at the end of the treatment period and reported that the material could not be found in the patient's room or in any other area of the hospital. Therefore, the licensee failed to control and maintain constant surveillance of the material in controlled or unrestricted areas after it left the patient's room.

B.

10 CFR 20.1501 requires, in part, that the licensee make, or cause to be made, surveys that may be necessary for the licensee to comply with 10 CFR Part 20 and are reasonable under the circumstances to evaluate: the magnitude and extent of radiation levels; concentrations or quantities of radioactive material; and the potential radiological hazard that could be present. Pursuant to 10 CFR 10.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. Contrary to the above, between May 23 and May 25, 2001, the licensee did not make, or cause to be made, surveys that were necessary for the licensee to comply with 10 CFR 20.1802 and were reasonable under the circumstances to evaluate the magnitude and extent of radiation levels, concentrations or quantities of radioactive material, and the potential radiological hazard that could be present. Specifically, the licensee did not make, or cause to be made, surveys necessary to prevent the loss of control of 7.7 millicuries of iridium-192 which was removed from a patient's room prior to the end of treatment. The surveys performed did not include surveys of the trash removed from the patient's room. This is a Severity Level III problem (Supplement IV). Civil Penalty – $3,000.

Pursuant to the provisions of 10 CFR 2.201, University of Medicine & Dentistry of New Jersey is 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 of Violation and Proposed Imposition of Civil Penalty (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, and if denied, the reasons why, (3) the corrective 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 achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an Order or a Demand for Information may be issued as 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.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, a statement indicating when and by what method payment was made, 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 Licensee fail to answer within 30 days of the date of this Notice, 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 violations 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 in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.C.2 of the Enforcement Policy 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 determined 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.

The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: F. Congel, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I.

Because your response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy or proprietary information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 25th day of September 2001