EA-97-116 - V.A., Department, MD
Mr. Dennis H. Smith, Director
Department of Veterans Affairs
10 North Green Street
Baltimore, Maryland 21202
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-01789/97-001)
Dear Mr. Smith:
This refers to the NRC inspection conducted on February 26, 27 and March 13, 1997, at the above location, to determine whether activities authorized by your NRC license were conducted safely and in accordance with NRC requirements. At the conclusion of the inspection, the findings were discussed with those members of your staff identified in the inspection report. During the inspection, four apparent violations of NRC requirements were identified, as described in the NRC inspection report transmitted with our letter, dated April 1, 1997. In addition, a predecisional enforcement conference was held with you and members of your staff on April 30, 1997, to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report will be sent by separate correspondence.
Based on the information developed during the inspection and the information you provided during the conference, the NRC has determined that three violations of NRC requirements occurred. The 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 violations involve failure to secure licensed materials in an unrestricted area; failure to sign a written directive prior to administration; and failure to perform the dose calibrator linearity tests over the range of administered doses. One of the apparent violations is being retracted, for the reasons described in the enforcement conference report.
With respect to the first violation, the inspector discovered that the door to your hot laboratory, which contained more than 80 millicuries of NRC licensed material, was not locked. This violation, set forth in Section I, represents a significant regulatory concern because the failure to maintain appropriate security of material could result in the material being lost or stolen, and also has the potential to cause unnecessary exposures to members of your staff as well as members of the public. Therefore, the violation is classified 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 $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, at the time of the enforcement conference, were considered prompt and comprehensive. These actions, which were described at the enforcement conference, included, but not limited to, (1) installation of two locks that afford easier accessibility on the affected doors to the dosing area/hot laboratory; (2) communication of the finding to other staff as part of training; and (3) counselling the responsible individual.
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.
In addition to the security violation, two other violations are described in Section II of the enclosed Notice. Those additional violations are classified at Severity Level IV.
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. 030-01789
License No. 19-01058-01
Enclosure: Notice of Violation
State of Maryland
Department of Veterans Affairs Docket No. 030-01789 Medical Center License No. 19-01058-01 Baltimore, Maryland EA No. 97-116
During an NRC inspection conducted on February 26, 27 and March 13, 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:
I. VIOLATION OF SECURITY REQUIREMENTS
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 February 27, 1997, the licensee did not secure from unauthorized removal or limit access to licensed material (80 millicuries including technetium-99 and xenon, as well as a sealed source) located in the Nuclear Medicine prep room/hot lab, 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 IV).
II. OTHER VIOLATIONS OF NRC REQUIREMENTS
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 at least 1 occasions prior to March 13, 1996, such as on March 29, 1996, the authorized user did not sign the written directive prior to administering iodine-131 doses to patients. (02014)
This is a Severity Level IV violation (Supplement IV).
B. 10 CFR 35.50(b)(3) requires, in part, that a licensee test each dose calibrator for linearity upon installation and at least quarterly thereafter over a range from the highest dosage that will be administered to a patient or human research subject to 30 microcuries.
Contrary to the above, on several occassions, the licensee did not test linearity of the dose calibrator over a range from the highest dose administered to a patient to 30 microcuries. Specifically, the linearity test conducted during December of 1994 measured a high activity of 148 mCi and the highest dose administered during January 1995 was 155 mCi; the linearity test conducted for the second quarter 1996 measured a high activity of 113.9 mCi and the highest dose administered was 159 mCi; and the linearity test conducted for the third quarter of 1996 measured a high activity of 82 mCi and the highest dose administered was 152 mCi. (03014)
This is a Severity Level IV violation (Supplement IV).
Pursuant to the provisions of 10 CFR 2.201, Department of Veterans Affairs 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, or proprietary, 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).
Dated at King of Prussia, Pennsylvania
this 2nd day of May 1997