EA-96-454 - University of Connecticut Health Center
Mr. Paul F. Davern
Associate Vice President
University of Connecticut Health Center
Farmington, Connecticut 06030
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-01295/96-001)
Dear Mr. Davern:
This refers to the inspection conducted on October 21-25, 1996, at your Farmington and Norwich, Connecticut facilities. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. At the conclusion of the inspection, the findings were discussed with you and several members of your staff as identified in the subject Inspection Report. The inspector identified apparent violations of NRC requirements, which were described in the NRC inspection report transmitted with our letter, dated November 15, 1996. On November 25, 1996, a Predecisional Enforcement Conference was conducted with you, Mr. Leonard Paplauskas, Vice President for Research, and other members of your staff to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report will be forwarded to you by separate correspondence.
Based on the information developed during the inspection and the information provided during the conference, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violation involves two examples of failure to secure licensed radioactive material at the facility. The first example occurred on October 21, 1996, and involves the failure to secure from unauthorized removal or limit access to two 2.5 curie molybdenum-technetium generators located in the Nuclear Medicine Department Hot Lab, an unrestricted area. At the time the area was not controlled, and constant surveillance was not maintained of this licensed material. The second example occurred between February 10 and February 16, 1996. It involves the failure to secure from unauthorized removal or limiting access to greater than 100 microcuries of phosphorus-32 (P-32) in the form of alpha adenosine triphosphate (ATP) which was stored in an unlocked freezer in microbiology laboratory (L-2012). The material was removed by an unknown person, from the stock material vial located in an unlocked freezer. The amount withdrawn from the vial could not be determined since the individual did not record the amount withdrawn on the material utilization log. As a result of this, when a researcher attempted to withdraw some of this reagent on February 26, 1996, she found the vial empty.
On February 29, 1996, during a routine monthly laboratory survey, a researcher found significant contamination in the hood located in laboratory L-2012. The Radiation Safety Officer (RSO) was notified and found the contamination to be caused by P-32. The Licensee believes that the contamination was caused by the unknown person using the missing P-32 alpha ATP in the hood within the laboratory. This violation represents a significant safety and regulatory concern because it had the potential to cause exposures to members of your staff as well as members of the public. In addition, a potential existed for the spread of contamination since the P-32 spill was not reported in a timely manner to the RSO or the principal investigator. Therefore, the violation is classified in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600; at a Severity Level III.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 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.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 noted in the inspection report included, but were not limited to the following: (1) instituting a policy requiring that the Nuclear Medicine Department Hot Lab door remain locked and closed at all times; (2) installing an automatic door closure device on the Hot Lab door; (3) posting a sign on the Hot Lab door indicating that it is to remain locked and closed; (4) conducting several meeting with staff members discussing the requirement to lock the Hot Lab door; (5) including a check of the Hot Lab door during weekly surveys and documenting those checks; (6) requiring that all laboratories be locked when unattended; (7) conducting training sessions with laboratory staff concerning the requirement to lock laboratory doors; and (8) distributing a notice to all principal investigators concerning the security of laboratories.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, 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.
The NRC remains concerned with respect to your investigation into the missing P-32. In particular, the unknown person believed to have used the missing P-32 did not come forward with information concerning their use of the P-32. Therefore, when responding to this Notice please describe in detail what additional actions you will take to oversee the accountability of all licensed radioactive material, improve control of radioactive material by authorized users, and minimize the potential for lost or misplaced licensed radioactive material in your laboratories.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, and its enclosure will be placed in the NRC Public Document Room (PDR).
Sincerely, ORIGINAL SIGNED BY WILLIAM F.KANE FOR Hubert J. Miller Regional Administrator
Docket No. 030-01295
License No. 06-03022-01
Enclosure: Notice of Violation
State of Connecticut
University of Connecticut Health Center Docket No. 030-01295 Farmington, Connecticut License No. 20-01537-02 EA 96-454
During an NRC inspection conducted on October 21-25, 1996, 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:
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.
Contrary to the above the licensee failed to secure from unauthorized removal or limit access to licensed material stored in controlled or unrestricted areas, as evidenced by the following two examples.
- On October 21, 1996, the licensee did not secure from unauthorized removal or limit access to two 2.5 curie molybdenum-technetium generators located in the Nuclear Medicine Department Hot Lab nor did the licensee control and maintain constant surveillance of this licensed material. This was evidenced by the fact that an NRC inspector gained access to the Hot Lab where the radioactive materials were stored and used which were not under surveillance.
- Between February 10, and February 16, 1996, the licensee did not secure from unauthorized removal, or limit access to, greater than 100 microcuries of phosphorus-32 located in laboratory (L-2012), nor did the licensee control and maintain constant surveillance of this licensed material. (01013)
This is a Severity Level III violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, the University of Connecticut Health 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 address the required response. If an adequate reply is not received within the time specified in the Notice, an order or 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 29th day of November 1996