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EA-97-595 - Tri-State Area Nuclear Pharmacy

 January 8, 1998 
 
 EA 97-595 
 Tri-State Area Nuclear Pharmacy 
 ATTN: Craig Lewandowski, PharmD., RPh. 
 Manager and Radiation Safety Officer 
 611 7th Avenue 
 Huntington, WV 25701 
SUBJECT:  NOTICE OF VIOLATION
  (NRC INSPECTION REPORT NO. 47-25233-01MD/97-02)
 
 Dear Mr. Lewandowski: 
This refers to the inspection conducted on November 19-20, 1997, at your facility in Huntington, West Virginia. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with regulatory requirements. The results of the inspection were formally transmitted to you by letter dated December 19, 1997. An open predecisional enforcement conference was conducted in the Region II office on January 6, 1998, to discuss the apparent violations, the root causes, and your corrective actions to preclude recurrence. A list of conference attendees and copies of the Nuclear Regulatory Commission's (NRC) presentation material, and the letter you submitted at the conference are enclosed.
 
Based on the information developed during the inspection and the information you provided during the conference, the NRC has determined that 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.
 
Violation A includes two examples of the failure to secure licensed materials against unauthorized removal or access as required by 10 CFR 20.1801. The root cause of the violation was the failure to ensure that members of your staff were adequately trained in combination with a lack of understanding of the requirements associated with the security of licensed materials. Violation B involves the transfer of licensed material to a person who was not authorized to receive such material. The root cause of this violation was your lack of understanding of the specific requirements relating to transfer of licensed materials. Specifically, when a new entity began to conduct operations at the offices of a licensee you had been providing materials to previously, you failed to recognize the need to verify that the new entity had an NRC license because the delivery location and personnel remained unchanged.
 
Although the actual safety consequences of Violation A were low, the failure to secure licensed materials is a significant issue because of the potential radiological consequences of access to these materials by unauthorized and/or untrained individuals. The NRC expects licensees to maintain a high degree of compliance with security requirements to properly control licensed materials. In this case, the area unsecured, the hot lab, contained significant quantities of licensed material, and was accessible to anyone in the area. Theft, loss, or the unintentional removal of this material could have resulted in substantial unplanned exposures or release to the public. With regard to Violation B, the actual safety consequence was also low because the individuals receiving the materials were knowledgeable of and trained in radioactive material handling and use. However, this is another instance of lack of control of licensed material. These issues and their root causes indicate inadequate oversight and involvement in licensed activities by you, the Radiation Safety Officer (RSO). Therefore, Violations A and B have been classified in the aggregate in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III problem.
 
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2750 is considered for a Severity Level III problem. Because your facility has not been the subject of 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 described in Section VI.B.2 of the Enforcement Policy. Your corrective actions are described in detail in your enclosed letter dated January 6, 1998, and included the placement of locks on access doors, retraining and counseling of appropriate staff members with specific emphasis on the overall importance of security of radioactive materials, and posting of signs to remind employees and other individuals of the necessary security requirements. Corrective actions regarding Violation B included the cessation of shipments of licensed material to the unauthorized entity and plans to verify that future shipments of licensed material are to an entity in possession of an NRC license. The NRC concluded that the above corrective actions should be effective in controlling access to licensed materials, and would preclude shipments of licensed material to individuals not authorized by the NRC to receive such shipments. Based on these facts, the NRC determined that credit was warranted for the factor of Corrective Action.
 
Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of previous escalated enforcement, I have been authorized, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.
 
At the predecisional enforcement conference, discussions were held with you regarding your responsibilities as RSO, as well as your other responsibilities as facility manager and pharmacist. As stated above, the NRC concluded that the corrective actions taken should be effective in precluding recurrence of the issues. However, in addition to your response to the violations as discussed below, the NRC requests that you respond to how the violations may affect your approach to your overall duties as the RSO. Specifically, we would request that you address any initiatives and/or changes you plan to ensure that your RSO responsibilities are conducted adequately to ensure proper oversight, while remaining independent of your other responsibilities.
 
You are required to respond to this letter 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. 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 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and any response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.
 
If you have any questions regarding this letter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety at (404) 562-4700. 
    Sincerely,

    original signed by Bruce Mallett

    Luis A. Reyes
    Regional Administrator
 
 Docket No. 030-33027 
 License No. 45-25233-01MD 
 Enclosures: 
 1. Notice of Violation 
 2. List of Attendees 
 3. NRC Slides 
 4. Licensee Material 
 
 cc w/encls: 
 State of West Virginia 
 
 
 
 NOTICE OF VIOLATION 
 Tri-State Area Nuclear Pharmacy   Docket No. 030-33027
Huntington, WV    License No. 47-25233-01MD 
      EA 97-595
 
 During an NRC inspection conducted on November 19-20, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," 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 20.1003 defines an unrestricted area as an area, access to which is neither limited nor controlled by the licensee.
 
Contrary to the above, the licensee failed to secure from unauthorized removal or access licensed materials, as evidenced by the following:
 
 
1. On November 19, 1997, for a period of approximately one hour, licensed materials consisting of 10 curies of molybdenum 99 in three generators, 400 millicuries of technetium 99m in multidose vials, 50 millicuries of iodine 131 in liquid form, and other licensed materials, stored in the licensee's hot lab, an area the access to which was neither limited nor controlled by the licensee (unrestricted area), were not secured against unauthorized removal or access. 
 
 2. On November 16, 1997, a member of the building management janitorial staff gained unauthorized access to the licensee's facility and was found emptying the trash in the hot lab where licensed material was stored by a licensee employee returning from a delivery. (01013) 
 
 
B. 10 CFR 30.41(a) and (b)(5) require, in part, that no licensee transfer byproduct material except to a person authorized to receive such byproduct material under the terms of a specific or general license issued by the Commission or an Agreement State.
 
Contrary to the above, from January 15, 1996, to August 22, 1997, the licensee routinely transferred unit doses of technitium 99m to the Tri-State Medical Center, a person who was not authorized to receive such byproduct material under the terms of a specific or general license issued by the Commission or Agreement State. (01023)
 
 
 These violations represent a Severity Level III problem (Supplement VI).
 
Pursuant to the provisions of 10 CFR 2.201, Tri-State Area Nuclear Pharmacy 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 II, 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 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 previously 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.
 
If you contest this enforcement action, you should also provide a copy of your response to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
 
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 Atlanta, Georgia
this 8th day of January 1998
 
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