EA-03-112 - Columbia Hospital

July 30, 2003

EA-03-112

Janet Boemer, Vice President
Clinical Support Services
Columbia Hospital
2025 East Newport Avenue
Milwaukee, WI 53211

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $3000 (NRC INSPECTION REPORT NO. 03003429/2002-001(DNMS) AND INVESTIGATION REPORT NO. 3-2002-036)

Dear Ms. Boemer:

This refers to the inspection conducted on November 7, 2002, at Columbia Hospital, Milwaukee, Wisconsin, and to the investigation completed by the NRC Office of Investigations on May 15, 2003. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. The inspection report was transmitted to you on December 18, 2002, and documented one unresolved item involving the failure to secure from unauthorized access or maintain constant surveillance of licensed material. The purpose of the investigation was to review potentially deliberate actions by members of your staff involving the failure to secure licensed materials. Based on the results of the inspection and investigation, one apparent willful violation was identified.

On July 2, 2003, a predecisional enforcement conference was conducted in the Region III office with you and members of your staff to discuss the apparent violation, its significance, its root causes, and your corrective actions.

Based on the information developed during the inspection and investigation, and the information that was provided during the conference, the NRC has determined that a willful violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described below and in detail in the subject inspection report. The violation involved the willful failure to secure from unauthorized access or maintain constant surveillance of licensed material. Specifically, on November 7, 2002, a nuclear medicine technologist exhibited careless disregard in reference to the radiation safety officer's (RSO) September 10, 2002, electronic correspondence regarding the security of licensed materials in the hot laboratory (hot lab).

Although there were no actual consequences, the willful failure to secure from unauthorized access or maintain constant surveillance over licensed materials is a significant safety issue. Implementation of adequate security measures is intended to prevent the loss or theft of licensed materials and to prevent members of the public from being unknowingly and unnecessarily exposed to radiation. It is also essential that the NRC be able to maintain the highest trust and confidence that licensees and their employees will act with integrity and abide by requirements to protect the health and safety of members of the public. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3000 is considered for a Severity Level III violation. Because the violation is considered willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit is not warranted for Identification, since the violation was NRC identified. Credit is warranted for Corrective Action that included: (1) immediately securing the hot lab; (2) informing the technologists that the hot lab door will remain locked at all times unless there is a technologist inside the lab; (3) formalizing and educating technologists on the hot lab surveillance policy; (4) establishing an education plan for all technologists regarding NRC regulations; (5) periodically verifying that the hot lab door is secured by the RSO and the medical imaging director; (6) clarifying roles in relation to the radiation safety program between the RSO, medical imaging director, and the lead technologist; and (7) developing a communication folder where information and new/revised policies will be placed for technologist review and signature. Based on the predecisional enforcement conference, it is our understanding that these corrective actions were completed by January 6, 2003.

Therefore, to emphasize the significance of willful violations and the importance of compliance with regulatory requirements, 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 $3000. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection efforts.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed on the docket in this letter. Therefore, you are not required to respond to the provisions of 10 CFR 2.201 unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice. However, you are required to either pay the civil penalty or respond in accordance with the instructions in the Notice.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response, if any, will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. The NRC also includes Issued Significant Enforcement Actions on its Web site.

		Sincerely,
		/RA/ James L. Caldwell for
		J. E. Dyer Regional Administrator

Docket No. 030-03429
License No. 48-02417-01

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

cc: State of Wisconsin

---

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Columbia Hospital Milwaukee, Wisconsin

Docket No. 030-03429 License No. 48-02417-01 EA-03-112

During an NRC inspection conducted on November 7, 2002, and the investigation completed on May 15, 2003, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose 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 particular violation and associated civil penalty are set forth below:

10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 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, on November 7, 2002, the licensee did not secure from unauthorized removal or access licensed materials that were stored in a controlled area, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, the Nuclear Medicine hot laboratory door was left unsecured and the laboratory contained 4 millicuries of iodine-131, 219 millicuries of technetium-99m, 20 millicuries of xenon-133, and 189 microcuries of cesium-137.

This is a Severity Level III violation (Supplement IV).
Civil Penalty – $3,000

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed on the docket in the letter transmitting this Notice of Violation (Notice). However, Columbia Hospital (licensee) is required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect the licensee's corrective actions or position. In that case, or if the licensee chooses to respond, clearly mark the response as a "Reply to a Notice of Violation; EA-03-112" and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region III, within 30 days of the date of the letter transmitting this Notice.

The licensee may pay the civil penalty proposed above 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 of Violation and Proposed Imposition of Civil Penalty, 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 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: Frank J. 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 III, 801 Warrenville Road, Suite 255, Lisle, IL 60532.

If the licensee chooses to respond, its response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

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

Dated this 30^th day of July 2003.