EA-96-104 - Syncor International Corporation

July 25, 1996

EA 96-104

Mr. Robert Funari, President and CEO
Syncor International Corporation
20001 Prairie Street
Chatsworth, California 91311

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $2,500 (NRC Inspection 030-33224 (Formerly 030-15134)/96-001)

Dear Mr. Funari:

This letter refers to the NRC inspection conducted on February 26-27, 1996, at your facility in Pittsburgh, Pennsylvania, of activities authorized by NRC License No. 37-18467-01MD (which has now been replaced by License No. 04-26507-01MD). The inspection report was sent to you on April 10, 1996. During the inspection, the inspectors reviewed the circumstances associated with an event that occurred at your facility in August 1995 involving the contamination of one of your workers. Based on the NRC review of this event, a deliberate violation of NRC requirements has been identified. On April 22, 1996, a predecisional enforcement conference was conducted by the NRC Region I office with Mr. Jack Coffey and other members of the Syncor staff, to discuss the apparent violation, its causes, and your corrective actions. A copy of the enforcement conference report was forwarded to you on May 3, 1996.

The violation, which is described in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty, involved the use of radioactive material in a manner not authorized by the license. Specifically, an individual worker's lock and locker at the facility were deliberately contaminated with technetium-99m, which led to contamination of the worker after he returned to the facility following delivery of radiopharmaceuticals to various destinations. The individual had gone to his locker upon returning from the deliveries, and then proceeded to the restricted area. Upon exiting the restricted area, the individual performed a survey and identified that he was contaminated. Surveys also determined that his lock and locker were contaminated and that the delivery vehicle was not contaminated. After the individual reported this finding to his management, you subsequently performed an investigation, but were unable to determine who was responsible for the contamination.

After reviewing all available information about this event, we have concluded that the violation most likely was deliberate because of the amount of contamination that was concentrated on the lock, and the fact that the only other contamination at the facility correlated with the activities of the contaminated individual after his visit to the locker. Moreover, there was a lack of a more credible explanation for the contamination of the lock. Given the deliberate nature of the violation, and the resultant contamination of an individual worker, the violation is of significant concern to the NRC.

It is noteworthy that your company was cited in November 1994 for a deliberate violation in which a worker at your Kansas City facility deliberately used licensed material in a manner not authorized by the license. In that case, the individual sprayed byproduct material on two butterflies in the unrestricted area outside of the Kansas City facility. Although you viewed that event as significant and terminated the responsible individual's employment, you did not take any corporate-wide action at the time to inform managers and employees at your other facilities about the event and the significance of deliberate misuse of material, so as to prevent a recurrence at your other facilities. You were in the process of seeking consolidation of your NRC licenses at the time. Especially under those circumstances, NRC would have expected specific corporate-wide action to highlight the unacceptability of deliberate misuse of licensed material.

The staff at all of your facilities must recognize that the licenses issued to Syncor International Corporation entrust responsibility for radiation safety not only to the Radiation Safety Officer (RSO) and licensee management, but also to each individual employee. The NRC expects, in addition to effective oversight of licensed programs by Syncor management and radiation safety staff, that each employee fully understands and implements the conditions of the license. Incumbent upon each NRC licensee and each licensee employee is the responsibility to protect the public health and safety by ensuring that all requirements of the NRC license are met and any potential violations of NRC requirements are identified and corrected expeditiously. Deliberately circumventing such requirements is a serious offense that will not be tolerated by the NRC. Such acts can result in civil action against the individual by the NRC, including prohibition from any involvement in NRC-licensed activities, and may result in criminal prosecution by the Department of Justice. Given the deliberate nature of the violation in this case, 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 $2,500 is considered for a Severity Level III violation. Although your facility has not been the subject of escalated enforcement actions in the past two years or two inspections, given the deliberate nature of the violation, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Since the event was identified by your staff and subsequently investigated, the NRC has determined that credit is warranted for your identification. Your corrective actions, which were described at the enforcement conference, included: (1) issuance of a memorandum, dated April 18, 1996, to all your employees regarding deliberate violations; (2) the prompt decontamination of the individual and control of the spread of contamination within the facility; (3) conduct of the investigation described in your records dated August 24 and 29, 1995, and November 29, 1995; (4) admonitions to the staff at the Pittsburgh pharmacy regarding adherence to requirements; and (5) distribution of a memorandum to all Syncor employees stating that deliberate misuse of any hazardous material is grounds for termination. Based on these actions, the NRC has determined that credit for your corrective action is also appropriate. Therefore, based on the credit provided for identification and corrective action, a civil penalty normally would not be issued for this violation.

However, the Enforcement Policy provides that discretion may be exercised to assess a civil penalty notwithstanding the normal civil penalty assessment factors for cases involving willfulness. The willful action of a Syncor employee in causing radioactive contamination that could expose another individual cannot be tolerated by the NRC. Moreover, as noted above, this violation represents the second occurrence of deliberate misuse of licensed material within Syncor International Corporation. Therefore, a significant sanction is warranted to emphasize to the licensee and its employees that such actions are not acceptable. Based on these concerns, the NRC has determined that it is appropriate to exercise enforcement discretion, as permitted in Section VII.A.1 of the Enforcement Policy, to propose a base civil penalty of $2,500.

Therefore, to emphasize: (1) the significance of deliberate violations, and (2) the importance of aggressive action to prevent deliberate misuse of licensed material, I have been authorized, after consultation with the Director, Office of Enforcement, and the Commission, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the amount of $2,500 for this Severity Level III violation.

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 you have taken and any additional actions you plan to take to prevent recurrence. You also should describe your plans for ensuring that notice of significant occurrences at any of your facilities is disseminated promptly to employees at all of your facilities. Such dissemination is particularly important given the consolidation of all of your licensed activities under a single NRC license issued by the NRC Region IV office. 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 enclosure, and your 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 10 CFR 2.790 material is included in your response, the response must place brackets around the proprietary material. In addition, a nonproprietary version, leaving the brackets intact but deleting the material within the brackets, must be submitted to be placed in the PDR.

The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Pub. L. No. 96.511.

Sincerely,

Thomas T. Martin Regional Administrator

Docket No. 030-33224 (Formerly 030-15134)
License No. 04-26507-01MD (Formerly 37-18467-01MD)

Enclosure: Notice of Violation and
Proposed Imposition of Civil Penalty

cc w/encl:
Commonwealth of Pennsylvania
State of California

---

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Syncor International Corporation Pittsburgh, Pennsylvania

Docket No. 030-33224 (Formerly 030-15134) License No. 04-26507-01MD (Formerly 37-18467-01MD) EA 96-104

During an NRC inspection conducted on February 26 – 27, 1996, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the Nuclear Regulatory Commission proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violation and associated civil penalty are set forth below:

10 CFR 30.34(c) requires, in part, that each licensee shall confine his possession and use of byproduct material to the locations and purposes authorized in the license. Condition 9.F. of License No. 37-18467-01MD authorized the use of technetium-99m, a byproduct material, for dispensing and/or distribution of prepared radiopharmaceuticals to authorized recipients and for processing with reagent kits in preparing radiopharmaceuticals.

Contrary to the above, on August 10, 1995, the licensee did not confine its possession and use of byproduct material to the locations and purposes authorized by the license. Specifically, an unidentified licensee employee (or employees) deliberately used technetium-99m to contaminate a lock and locker located in the garage, an unrestricted area, and consequently to contaminate an individual worker at the facility, which are uses not authorized by the license.

This is a Severity Level III violation (Supplement VI)
Civil Penalty – $2,500

Pursuant to the provisions of 10 CFR 2.201, Syncor International Corporation (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved.

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. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234(c) of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: Mr. James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I, 475 Allendale Road, King of Prussia, PA 19406.

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. However, if you find it necessary to include such information, you should clearly indicate the specific information by bracketing such information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public. In addition, a nonproprietary version much be submitted with the information in brackets redacted to be placed in the PDR.

Dated at King of Prussia, Pennsylvania
this 25th day of July 1996