EA-97-146 - V.A. Department of, DE
Mr. Dexter D. Dix, Center Director
Veterans Administration Medical Center
1601 Kirkwood Highway
Wilmington, Delaware 19805
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-01301/97-001)
Dear Mr. Dix:
This refers to the NRC inspection conducted on March 26, 1997, at your facilities at Wilmington, Delaware, to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. During the inspection, five apparent violations of NRC requirements were identified, as described in the NRC inspection report transmitted with our letter, dated April 11, 1997. On May 1, 1997, a predecisional enforcement conference was conducted with you and members of your staff to discuss the violation, their causes, and your corrective action. A copy of the enforcement conference report will be sent to you by separate correspondence.
Based on the information developed during the inspection, and during the enforcement conference, the NRC has determined that four violations of NRC requirements occurred, and are cited in the enclosed Notice of Violation (Notice). The circumstances surrounding them are described in detail in the Notice and the subject inspection report. The violations involve (1) failure to prepare written directives prior to the administration of iodine-131 doses greater than 30 microcuries; (2) failure to measure, each six months, the ventilation rates available in areas of use of radioactive gas; (3) failure to conduct reviews to verify compliance with all aspects of the quality management program (QMP) at intervals no greater than 12 months (a review was not done between 1992 and 1997); and (4) failure to establish a quorum at Radiation Safety Committee (RSC) meetings. One of the apparent violations, involving failure of the RSC to meet at least quarterly, is being withdrawn, based on your presentation of records at the conference indicating that the meetings were held at the required frequency.
These violations disclose a significant lack of attention to licensed activities by the Radiation Safety Officer (RSO) and the RSC. Specifically, the RSO or RSC failed to fulfill their direct responsibilities to assure conduct of an annual review, and assure a quorum when the RSC meetings were held. Management attention to the radiation safety program is warranted to ensure that licensed activities are conducted safely and in accordance with requirements. While the violations in question did not have an impact on the health and safety of the public, or your staff, such violations are potential precursors to more serious problems. For example, the failure to prepare written directives reduces one of the barriers which are necessary to prevent the misadministration of material. Accordingly, it is important that the RSO and RSC actively look for, identify, and correct such problems. At your facility, this did not occur. Therefore, these violations have been classified in the aggregate as a Severity Level III problem 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 $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action 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.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were both prompt and comprehensive. These actions, which were described during the enforcement conference, and/or during the inspection, included, but were not limited to: (1) replacement of the RSO and RSC Chairman; (2) increased involvement of the facility management in overseeing the radiation safety program, including monitoring by the clinical executive board, the Chief of Staff, and your consultants; and (3) planned training of your technologists regarding QMP requirements.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.
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.
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).
Sincerely, Hubert J. Miller Regional Administrator
Docket No. 030-01301
License No. 07-09495-01
Enclosure: Notice of Violation
State of Delaware
Veterans Administration Medical Center Docket No. 030-01301 Wilmington, Delaware License No. 07-09495-01 EA 97-146
During an NRC inspection conducted on March 26, 1997, 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 35.32(a)(1)(iv), in part, requires that prior to administration, a written directive be prepared for any administration of quantities greater than 30 microcuries of iodine-131. 10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation and containing certain specified information.
Contrary to the above, on April 28, 1992, August 24, 1994, January 30, 1995, March 10, 1995, April 5, 1995, September 6, 1995, and April 4, 1996, an authorized user administered 28.8, 6, 10, 7, 10, 7.8, and 28.3 millicuries, respectively, of NaI I-131 to patients, but on no occasions was a written directive prepared. (01013)
B. 10 CFR 35.32(b) requires, in part, that the licensee develop procedures for and conduct a review to verify compliance with all aspects of the quality management program at intervals no greater than 12 months.
Contrary to the above, the licensee did not conduct a review to verify compliance with the quality management program between March 23, 1992 and March 26, 1997, an interval greater than 12 months. (01023)
C. 10 CFR 35.205(e) requires, in part, that a licensee that administers radioactive aerosols or gases measure each six months the ventilation rates available in areas of use of radioactive gas.
Contrary to the above, between October 3, 1995 and March 26, 1997, the licensee used radioactive xenon-133 gas in the planar camera room and did not, on any occasion, measure the ventilation rates therein. (01033)
E. 10 CFR 35.22(a)(3) requires, in part, that to establish a quorum and conduct business, at least one half of the Radiation Safety Committee's membership must be present, including the management representative.
Contrary to the above, on December 19, 1996, the licensee's Radiation Safety Committee met and conducted business without the management representative being present to establish a quorum. (01043)
These violations are categorized in the aggregate as a Severity Level III problem (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Veterans Administration Medical Center is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 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 for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (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.
Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
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 bases 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.
Dated at King of Prussia, Pennsylvania
this 2nd day of May 1997