EA-02-050 - University of Pennsylvania

April 5, 2002

EA No. 02-050

Docket No. 03002939
Docket No. 03007056
License No. 37-00118-07
License No. 37-00118-11

Neal Nathanson, M.D.
Vice Provost
University of Pennsylvania
Radiation Safety Office
3160 Chestnut Street, Suite 400
Philadelphia, PA 19104-6021


Dear Dr. Nathanson:

On November 15, 2001, December 4 through 10, 2001, and February 22, 2002, James P. Dwyer of this office conducted a safety inspection at the above address and at the PENN Medicine facility located in Radnor, Pennsylvania of activities authorized by the above listed NRC licenses. The inspection was an examination of your licensed activities as they relate to radiation safety and compliance with the Commission's regulations and license conditions. The inspection consisted of observations by the inspector, interviews with personnel, and a selected examination of representative records. Additional information provided in your correspondence dated December 12, 2001; January 2, 2002; January 10, 2002; and February 28, 2002, was also examined as part of the inspection. The findings of the inspection were discussed with you and members of your organization at the conclusion of the inspection on February 22, 2002. The enclosed report presents the results of this inspection.

Based on the results of this inspection, it appears that certain activities were not conducted in full compliance with NRC requirements. The first violation involved 10 CFR 20.1302(a)(1), which requires that each licensee conduct operations so that the total effective dose equivalent to individual members of the public from licensed operation does not exceed 0.1 rem (1 millisievert) in a year. This requirement was violated on 16 occasions in 2001 when parents and guardians of minor patients treated with iodine-131 meta-iodobenzylguanidine at Childrens Hospital of Philadelphia received total effective dose equivalents exceeding 0.1 rem while providing care for those patients (typically their children) during these treatments. The violation is more fully described in Section V of the enclosed inspection report.

After considering the circumstances associated with this case, I have decided, after consultation with the Office of Enforcement, and in accordance with Section VII.B.6 of the enforcement policy, to exercise enforcement discretion and not cite this violation, for the following reasons: (1) you believed that parents who provided care for their children were occupationally exposed and, as a result, provided thorough training and dosimetry to those parents; (2) current regulations permit a licensee to request prior approval to increase the dose limit for individual members of the public to 500 millirem; (3) once you were made aware of the misinterpretation, on February 28, 2002, you requested authorization to increase the dose limit for individual members of the public providing such inpatient care during treatments to 500 millirem and the request was granted in an amendment issued on March 4, 2002; and (4) no exposures exceeded 500 millirem. Please note that in accordance with 10 CFR 20.2203(a)(2), exposures of members of the public exceeding regulatory and/or license limits will require written notification.

The second violation involved the failure to perform a required calibration at the specified frequency. A Notice of Violation is enclosed that describes the violation in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions, "(Enforcement Policy), NUREG 1600. The violation is classified as Severity Level IV. You are required to respond to this Notice of Violation and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790, a copy of this letter will be placed in the NRC Public Document Room and will be accessible from the NRC Web site at the Public NRC Library.

Your cooperation with us is appreciated.


Original signed by George Pangburn

Hubert J. Miller
Regional Administrator

Enclosure: Notice of Violation

Robert Forrest, C.H.P., Radiation Safety Officer
Commonwealth of Pennsylvania

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