EA-99-231 - Georgetown University Medical Center
September 10, 1999
Sam Wiesel, MD
Executive Vice President for Health Sciences
Georgetown University Medical Center
LM12, Preclinical Science Building
3900 Reservoir Road, NW
Washington, DC 20007
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-01315/99-001)
Dear Dr. Wiesel:
This refers to the NRC inspection conducted on August 16 through 19, 1999, at your facility in Washington, DC. The inspection was performed to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements. During the inspection, two apparent violations were identified, one of which involved the loss of control of a package containing a high dose rate (HDR) afterloader source (11.1 curies of iridium-192) that was delivered to your Washington, DC, facility in August 1999. In a telephone conversation on August 31, 1999, Ms. Sharon Flynn-Hollander, Hospital Chief Executive, informed Dr. M. Shanbaky of my staff that Georgetown University Medical Center did not believe that a predecisional enforcement conference, nor a written response, was needed, prior to the NRC deciding on appropriate enforcement action. The NRC agrees that it has sufficient information to take the action described below.
Based on the information developed during the inspection, the NRC has determined that two violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice). The most significant violation involved the failure to provide appropriate security of the HDR source. After the package was erroneously delivered to your Radiation Oncology Department without the normal source receipt process being used, the package was placed in an unrestricted area (reception area) that is frequented by patients and other personnel from your staff. Although the package was unsecured for only a relatively short duration of time, its removal could have occurred as previously happened at your facility under similar circumstances in 1990.
The violation is a significant concern because of the potential for high radiation exposure to unauthorized personnel or the public if the source had been opened by unauthorized personnel or transferred to an unauthorized facility. Therefore, the violation is categorized as a Severity Level III violation in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 and is described in Item A in the enclosed Notice of Violation (Notice).
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation or problem. 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.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions, at the time of the inspection, were considered prompt and comprehensive. These actions include, but are not limited to, (1) immediate control of the package after discovery, (2) training of all staff for identification of packages that contain radioactive material, and (3) contacting the shipper of the package to explain the correct delivery procedure.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.
A second violation was also identified by our inspectors during our recent inspection of your facility. The second violation involved the failure to determine prior occupational radiation dose and obtain records of cumulative radiation dose for individuals working at your facility. This violation was a concern due to the possibility of workers accumulating occupational radiation exposure above the NRC limits. This violation is also described in the enclosed Notice.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements. The NRC has concluded that the actions taken and planned to correct Violation A and prevent recurrence, were already addressed described adequately during the inspection as already described herein. Therefore, you are not required to respond Violation A unless this description does not accurately reflect your corrective actions. 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, its enclosure, and your response will be placed in the NRC Public Document Room (PDR).
JAMES T. WIGGINS
Docket No. 030-01315
License No. 08-01709-04
Enclosure: Notice of Violation
Catalina Kovats, Radiation Safety Officer
District of Columbia
NOTICE OF VIOLATION
|Georgetown University Medical Center
|Docket No. 030-01315
License No. 08-01709-04
During an NRC inspection conducted on August 16-19, 1999, 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 violations are listed below:
|A.||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 approximately 10:40 a.m. and 11:30 a.m. on August 2, 1999, the licensee did not secure from unauthorized removal or limit access to an 11 curie iridium-192 sealed source (for a high dose rate afterloader) located in the radiation oncology reception area, which is an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. (01013)
This is a Severity Level III violation (Supplement VI).
|B.||10 CFR 20.2104(a) requires that for
each individual who is likely to receive in a year an occupational
dose requiring monitoring pursuant to 10 CFR 20.1502, the licensee
shall: (1) determine the occupational radiation dose received
during the current year; and (2) attempt to obtain the records
of cumulative occupational radiation dose.
Contrary to the above, as of August 19, 1999, the licensee did not determine the occupational radiation dose received during the current year and did not attempt to obtain the records of cumulative occupational radiation dose for individuals requiring monitoring pursuant to 10 CFR 20.1502. Specifically, from January to August, 1999, the licensee did not determine prior or cumulative occupational dose for individuals requiring monitoring. (01024)
This is a Severity Level IV violation (Supplement IV).
The NRC has concluded that information regarding the reason for Violation A and the corrective actions taken and planned to correct the violation and prevent recurrence were adequately described during the inspection, and are already adequately addressed on the docket in the cover letter for this Notice.
With regard to the Violation B, pursuant to the provisions of 10 CFR 2.201,Georgetown University Medical Center is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include: (1) the reason for the Violation B, or, if contested, the basis for disputing the violation or severity level, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) 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 to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time. Also, you are required to submit a written statement or explanation if the description for the Violation A therein does not accurately reflect your corrective actions or your position.
Because your response will be placed in the NRC Public Document Room (PDR), 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. 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 basis 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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
If you contest any part of this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 10th day of September 1999