EA-98-149 - Minnesota, University of

April 10, 1998

EA 98-149

Fay Thompson, Ph.D.
Director, Environmental Health and Safety
University of Minnesota
W168 Boynton Health Service
410 Church Street, S.E.
Minneapolis, MN 55455

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 030-00842/98001(DNMS))

Dear Dr. Thompson:

This refers to the inspection conducted March 2 through 4, 1998, at Fairview-University Medical Center located at the University of Minnesota. The inspection included a review of an incident involving the loss of control of an iridium-192 brachytherapy source ribbon between February 6 and 26, 1998, at the Minneapolis, Minnesota, facility. During the inspection, apparent violations of NRC requirements were identified. A copy of the NRC inspection report was sent to you by a letter dated March 13, 1998. You were given the option of participating in a predecisional enforcement conference or addressing the apparent violations in writing. You chose to submit a written response dated April 2, 1998.

Based on the information developed during the inspection and the information provided in your April 2 response to the inspection report, the NRC has determined that violations of NRC requirements occurred. The violations involve failure to ensure that all sources taken from the storage area were returned; failure to secure and control licensed material; and failure to ensure that dose in unrestricted areas from external sources did not exceed two millirem in any one hour. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report.

The loss of control of byproduct material, even for short durations, is of significant concern to the NRC. Medical Center staff lost control of one ribbon containing six iridium-192 seeds (a total of 2.6 millicuries) for twenty days. During that time, the ribbon was handled by occupational and non-occupational workers who, as a result, received very small but undue radiation exposure. This event occurred primarily because responsible parties failed to follow established procedures developed for the express purpose of minimizing the potential for the loss of radioactive material. Specifically, the curator failed to observe the removal of sources by a trainee and failed to perform an independent source count following explant and prior to returning the sources to storage. The NRC expects its licensees to exercise control over licensed material in their possession and to avoid exposing members of the public and workers to unnecessary radiation.

Although the iridium-192 seeds were found and the doses to individuals as a result of the loss were a small fraction of 10 CFR Part 20 limits, the purpose of proper accountability measures is to minimize health and safety hazards. Because loss of control of licensed material is a significant safety concern, these violations are classified in the aggregate in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Based upon the corrective actions taken following the inspection and those actions identified in your letter dated April 2 ,1998, credit for Corrective Action was warranted. Beside addressing each individual violation, the corrective actions planned or taken to address the root cause include: (1) re-instruction for all radiation oncology department physicians and medical physicists on expectations for brachytherapy source accountability and possible consequences of further similar failures; (2) modification of forms used for source accountability to include documentation of applicator surveys following source removal; and (3) placement of a portable radiation survey meter in the brachytherapy source storage room to serve as an area monitor to alert personnel of the presence of an unshielded source(s). A permanent radiation area monitor will be installed in the brachytherapy source storage room by May 1998.

Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of previous escalated enforcement action, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of the Severity Level III problem constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence are already adequately addressed in your letter dated April 2, 1998. Therefore, you are not required to respond to this letter 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.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, the enclosed Notice, and your response, if you choose to respond, will be placed in the NRC Public Document Room.

Sincerely, Original Signed by James L. Caldwell for A. Bill Beach Regional Administrator

Docket No. 030-00842
License No. 22-00187-46

Enclosure: Notice of Violation

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NOTICE OF VIOLATION

University of Minnesota Minneapolis, Minnesota

Docket No. 030-00842 License No. 22-00187-46 EA 98-149

During an NRC inspection conducted on March 2 through 4, 1998, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

A. 10 CFR 35.406(a) requires that promptly after removing them from a patient, a licensee return brachytherapy sources to the storage area and count the number returned to ensure that all sources taken from the storage area have been returned.

Contrary to the above, on February 6, 1998, after removing 15 ribbons containing iridium-192 brachytherapy sources from a patient and returning them to the storage area, the licensee did not count the number returned to assure that all sources taken from the storage area had been returned. Consequently, one ribbon, containing six iridium-192 seeds, went unaccounted for 20 days. (01013)

B. 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, between February 6 and 26, 1998, the licensee did not secure from unauthorized removal or limit access to 2.6 millicuries of iridium-192 located in the licensee's Central Sterilization Unit and Operating Room Number 2, which are unrestricted areas, nor did the licensee control and maintain constant surveillance of this licensed material. (01023)

C. 10 CFR 20.1301(a)(2) requires that the licensee conduct operations so that the dose in any unrestricted area from external sources does not exceed two millirem in any one hour.

Contrary to the above, on February 9, 10, and 20 through 23, 1998, the conduct of licensee operations resulted in a dose of 10 millirem in an hour in the Central Sterilization Unit, an unrestricted area. In addition, on February 17, 1998, the licensee's operations resulted in a dose of five millirem in one hour between 11:20 a.m. and 12:20 p.m. in Operating Room Number 2, an unrestricted area. (01033)

These violations represent a Severity Level III Problem (Supplements IV and VI).

The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed in a letter from University of Minnesota dated April 2, 1998. However, you are required to respond to the provisions of 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U. S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region III, 801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation.

If you contest this enforcement action, you should also provide a copy of your response to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, D.C. 20555-0001.

If you choose to respond your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, it should not include any personal, privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. Under the authority of Section 182 of Act 42 U.S.C. 2232, any response shall be submitted under oath or affirmation.

Dated at Lisle, Illinois
this 10th day of April 1998