EA-04-075 - Navy, Department of the

April 23, 2004

EA-04-075

Department of the Navy
ATTN: CAPT D. Farrand, Executive Secretary
Naval Radiation Safety Committee
Office of the Chief of Naval Operations
Radiological Controls Branch (N455)
2000 Navy Pentagon (NC-1 Suite 2000)
Washington, DC 20350-2000

SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 03029462/2004001)

Dear CAPT Farrand:

This letter refers to an NRC inspection conducted on February 23, 2004, at the National Naval Medical Center (NNMC) facility located in Bethesda,Maryland. The NRC inspection included our review of an incident that occurred at your facility on July 1, 2003, involving a package containing Ir-192 seeds that was left unsecured and unattended in a hallway at the facility for approximately 90 minutes. The Radiation Safety Officer was notified after an employee identified this occurrence, and an inspection was conducted by the Naval Environmental Health Center (NEHC) since you possess a master materials license. The NEHC inspectors reviewed the incident, classified it as a Severity Level III deficiency of the U.S. Department of the Navy Master Materials License, and then notified the NRC. During the subsequent NRC inspection, one apparent violation was identified involving the failure to properly secure the NRC-licensed radioactive materials.

In a telephone conversation between LCDR Sanders, of your staff, and Mr. Thomas Decker, of the NRC Region I office, on March 31, 2004, Mr. Decker stated that the NRC had identified one apparent violation of NRC requirements, but the NRC had sufficient information regarding the violation and your corrective actions to make an enforcement decision. However, Mr. Decker offered the opportunity for the Department of the Navy to attend a predecisional enforcement conference or to provide a written response. LCDR Sanders indicated that the Department of the Navy declined the opportunity to discuss this issue in a predecisional enforcement conference or to provide a written response regarding the violation.

The violation is cited in the enclosed Notice of Violation (Notice), and the circumstances surrounding it are described in detail in the enclosed inspection report. The violation involved the failure to properly secure NRC-licensed radioactive materials after a package containing the Ir-192 seeds (approximately 27 millicuries total activity) was delivered to the wrong location at your facility (the loading dock). Although one of your employees attempted to deliver the material to the intended recipient (the main radiology supply office), the employee subsequently left the package in a hallway because the door to the area was locked.

The NRC staff determined that the NNMC response to the incident was timely and appropriate, and that the subsequent reviews by NEHC and NNMC were adequate. The NRC has also concluded that this failure to control NRC-licensed radioactive material did not directly result in any known dose to members of the public. However, this violation was of concern to the NRC because the failure to control radioactive material could have resulted in potential dose to members of the public. Therefore, the violation has been categorized at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last two years, 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 action is warranted because your corrective actions were considered prompt and comprehensive. These corrective actions included, but were not limited to: (1) providing training to the loading dock personnel regarding the proper receipt of radioactive material; (2) installing signs in the loading dock area stating that radioactive material should not be delivered to the loading dock and reminding loading dock personnel to contact the Radiation Safety staff upon the attempted delivery of radioactive material to the loading dock; (3) contacting the vendors to notify them of the appropriate address to send all radioactive material shipments; (4) developing and distributing an informational bulletin to all radioactive material users at your facility regarding the appropriate procedures for receipt, storage, security, and control of radioactive material; and (5) calculating potential dose estimates that determined if any exposures to members of the public had occurred, the dose would have been less than 1 millirem per person.

Therefore, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation with no civil penalty for this Severity Level III violation. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

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 this letter and enclosed Inspection Report No. 03029462/2004001. Therefore, you are not required to respond to this letter unless that description 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 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response (if you choose to provide one) 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. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

The NRC also includes Issued Significant Enforcement Actions on its Web site.

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

Docket No. 03029462
License No. 45-23645-01NA

Enclosures:
1. Notice of Violation
2. NRC Inspection Report No. 03029462/2004001

cc: State of Maryland


ENCLOSURE

NOTICE OF VIOLATION

National Naval Medical Center
Bethesda, Maryland
  Docket No. 03029462
License No. 45-23645-01NA
EA-04-075

During an NRC inspection conducted at the licensee's facility on February 23, 2004, one violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violation is 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 July 1, 2003, the licensee did not limit access to a package containing iridium-192 (Ir-192) seeds (total activity of approximately 27 millicuries) at the facility located in Bethesda, Maryland, which is a controlled area, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, after the package was delivered by a supplier to the loading dock (a location other than the intended recipient) on that date, a loading dock employee attempted to deliver the package to the intended recipient (the main radiology supply office), but since the office was locked, left the package unsecured in a hallway and no licensee personnel were in the area to maintain constant surveillance of the package.

This is a Severity Level III violation (Supplement VI).

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 this letter and Inspection Report No. 03029462/2004001. However, you are required to submit a written statement or explanation pursuant to 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, you should clearly mark your response as a "Reply to a Notice of Violation, EA-04-075" 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 I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

If you contest 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.

If you choose to respond, 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. 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 are required to post this Notice within two working days.

Dated this 23rd day of April 2004.

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