EA-03-033 - York Hospital
April 18, 2003
Vice President, Operations
1001 South George Street
York, PA 17405-7198
|SUBJECT:||NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $3,000 (NRC Office of Investigations Report No. 1-2002-036)|
Dear Mr. Rosen:
This refers to the investigation conducted by the NRC Office of Investigations (OI) to review the circumstances associated with the transfer of NRC licensed material, namely depleted uranium (DU), from York Hospital to LINAC Systems, Inc. in March 2001. The OI investigation was completed on January 31, 2003. Based on the investigation, the NRC identified two apparent violations of NRC requirements, specifically, (1) the improper transfer of the DU material; and (2) the submission of inaccurate information to the NRC regarding transfer of the DU material. However, OI did not substantiate that the violations were willful. These findings were described in the synopsis of the OI report which was attached to the NRC letter sent to you on February 27, 2003. That letter also offered you the opportunity to attend a predecisional enforcement conference or to provide a written response to the apparent violations within 30 days.
In a telephone conversation on March 6, 2003, you informed Dr. Sandra Gabriel, of my staff, that you did not believe that a predecisional enforcement conference was needed, but that you would provide a written response, prior to the NRC decision on appropriate enforcement action. In your response, dated March 27, 2003, you stated that the transfer of the DU to an unauthorized entity was an oversight by your staff and that you had taken appropriate steps to prevent a similar occurrence. Further, you stated that the submission of inaccurate information was based on a misunderstanding during communications with the vendor who removed the linear accelerator.
As a result of the investigation and after a review of the information you provided in your March 27, 2003 response, the NRC has determined that the two non-willful violations of NRC requirements occurred as stated in our February 27, 2003 letter. The first violation involved the transfer of licensed byproduct radioactive material to an entity (LINAC Systems, Inc.) who was not authorized to receive it. The violation occurred in March 2001, when York Hospital transferred a Varian 6/100 linear accelerator (LINAC), containing the DU, to LINAC Systems (located in Lakewood, New Jersey) which did not have an NRC license authorizing possession of the DU material. Although this violation did not result in any actual safety consequences, the transfer of the DU material to an unauthorized recipient created the potential for loss, misuse, or inappropriate disposal of the radioactive material. However, this potential was minimized because LINAC Systems, after possessing the DU material for about four months, transferred the material to RT Technical Services, Inc., located in Alvarado, Texas, who subsequently sold and transferred the LINAC (with the DU material) to a medical clinic located in Reynosa, Mexico. Both RT Technical Services and the clinic in Mexico had the appropriate license or authorization for the possession of the DU material.
The second violation involved the submission of inaccurate information to the NRC regarding the transfer of the DU material. In a license renewal application, dated March 1, 2002, and in a follow-up letter to the NRC, dated August 8, 2002, you stated that the DU material had been transferred to an authorized recipient. This information was inaccurate in that, at the time the statements were submitted, the DU material had, in fact, already been transferred from York Hospital to LINAC Systems, Inc. in March 2001, and LINAC Systems did not have the proper authorization/license from the NRC to possess the DU material.
Since the violations involve the improper transfer of licensed material, as well as the submission of inaccurate information to the NRC regarding that transfer, the violations are categorized as a Severity Level III problem in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the current version of the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III violation or problem involving the loss or improper transfer/disposal of radioactive material. Because your facility has not been the subject of an 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 in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These actions included, but are not limited to: (1) your efforts, subsequent to the improper transfer, in determining the location of the LINAC and assuring that the possessors had appropriate license/authorization to possess the DU; (2) modifying your policy for disposal of medical equipment and developing a checklist to ensure that all applicable license requirements are met prior to disposal; and (3) reminding all staff of your administrative policy regarding the appropriate process for disposal of medical equipment.
Application of the civil penalty assessment process would not normally result in a civil penalty in this case. However, the revised Enforcement Policy, published December 18, 2000 (effective February 16, 2001), provides that, notwithstanding the normal civil penalty assessment process, a civil penalty of at least the base amount should normally be proposed for violations involving the loss or the inappropriate transfer/disposal of licensed material. The purpose of a penalty in such cases is to reflect the significance of the violation and to emphasize the importance of maintaining control of licensed material (see section VII.A.1.(g) of the Enforcement Policy). Therefore, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $3,000 for the Severity Level III problem. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required 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 and its enclosures, and your response will be available electronically for public inspection in the NRC Public Document Room or from the Publically Available Records (PARS) component of the NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.
|/RA/ James T. Wiggins Acting For|
|Hubert J. Miller
Docket No. 03003085
License No. 37-07161-01
Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty
Commonwealth of Pennsylvania
State of New Jersey
State of Texas
Radiation Authority of Mexico
NOTICE OF VIOLATION
PROPOSED IMPOSITION OF CIVIL PENALTY
|Docket No. 03003085
License No. 37-07161-01
During an NRC investigation conducted by the NRC Office of Investigations, the report of which was issued on January 31, 2003, two 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 NRC proposes 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 violations and associated civil penalty are set forth below:
10 CFR 40.51(a) and (b)(5) require, in part, that no licensee transfer source material except to a person authorized to receive such source material under the terms of a specific or general license issued by the Commission.
Contrary to the above, the licensee transferred source material to a person not authorized to receive such material. In March 2001, the licensee transferred a linear accelerator containing depleted uranium to LINAC Systems, Inc., located in Lakewood, New Jersey. LINAC Systems, Inc. was not authorized to receive such source material under the terms of a specific or general license issued by the Commission.
10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee shall be complete and accurate in all material respects.
Contrary to the above, on two occasions in 2002, the licensee submitted information to the Commission that was not accurate in all material respects. Specifically,
|1.||The licensee submitted a license renewal application, dated March 1, 2002, to the NRC stating that the depleted uranium had been transferred by the licensee to an authorized recipient, RT Technical (Services). In fact, the licensee had transferred the depleted uranium in March 2001 to LINAC Systems, Inc., an entity that was not authorized or licensed by the NRC to possess the depleted uranium. This information was material to the NRC because it was used to evaluate the license renewal application; and|
|2.||The licensee submitted a letter, dated August 8, 2002, to the NRC stating that the depleted uranium had been transferred by the licensee to an authorized recipient, RT Technical (Services). In fact, the licensee had transferred the depleted uranium in March 2001 to LINAC Systems, Inc., an entity that was not authorized or licensed by the NRC to possess the depleted uranium. This information was material to the NRC because it was used to evaluate the license renewal application.|
These violations represent a Severity Level III problem (Supplement VI).
Civil Penalty - $3,000
Pursuant to the provisions of 10 CFR 2.201, York Hospital 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, EA 03-033" 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. 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 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.
Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, a statement indicating when and by what method payment was made, 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 30 days of the date of this Notice, 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, EA 03-033" 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.C.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 234c of the Act, 42 U.S.C. 2282c.
The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: F. Congel, 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.
Because your response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy or proprietary information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. 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).
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 18th day of April 2003