Advanced Medical Imaging and Nuclear Services (Licensee) is the holder of Byproduct Nuclear Material License No. 37-30603-01 issued by the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR parts 30 and 35. License No. 37-30603-01 authorizes possession and use of certain byproduct material identified in 10 CFR 35.100 and 35.200 for any uptake, dilution, excretion, imaging and localization procedures approved in those parts. The license was issued on February 16, 2001, and is due to expire on February 28, 2011.
On November 30, 2001, the NRC commenced an inspection at the Licensee's facility in Easton, Pennsylvania. Based on the findings of the inspection to date, the NRC identified violations of requirements. The violations identified during the inspection involved the possession and use of radioactive materials (including the diagnostic administration to patients) from June 2001 to November 2001, even though the licensee did not have an authorized user (AU) and/or a Radiation Safety Officer (RSO) as required by the regulations and the license. The individual named on the license as the RSO and AU between February 16, 2001, and December 10, 2001, had neither been hired by the licensee's organization nor had ever acted as the RSO or AU for the licensee.
After these violations were identified, the NRC issued a Confirmatory Action Letter to the licensee on December 3, 2001, which in part, confirmed the Licensee's commitment to immediately place all byproduct material in its possession in secured storage, and cease all licensed activities until the Licensee retained an AU and RSO, and received approval from the NRC for the changes requiring a license amendment to bring the licensee's program into full compliance with 10 CFR Part 35. The licensee submitted an amendment request, and on December 11, 2001, NRC issued an amendment to the license, to reflect the new AU and RSO. The Licensee subsequently conducted activities without the supervision of the AU as required by 10 CFR 35.25. Specifically, shortly after the license amendment was issued, byproduct materials were ordered during the evening hours of December 11, 2001, and subsequently were received, possessed, and used for administration to patients on December 12, 2001, by an individual who had not received the required instructions from, and who was not under the supervision of, an AU. The individual was not provided instructions from the AU in the principles of radiation appropriate to the individual's use of byproduct materials, including, but not limited to, appropriate use of dosimetry, doses to be administered to patients, and procedures for radiation safety as required by 10 CFR 35.25. This constitutes an additional violation.
These violations are particularly significant because (1) The individual Start Printed Page 67554originally listed on the license as the AU/RSO was never employed by Advanced Medical Imaging and Nuclear Services, (2) a Licensee consultant informed the Licensee, as a result of an audit he conducted in October 2001, that certain documents (such as linearity tests, leak tests, quarterly inventory, survey results, and the prescribed dose schedule), had not been signed by the RSO listed on the license, as required, and (3) even after the Licensee had committed to the NRC to make the changes necessary to bring its program into full compliance, as documented in the referenced Confirmatory Action Letter, the Licensee continued to conduct activities without the required supervision by an AU.
The NRC must be able to rely on the Licensee and its employees to comply with NRC requirements. It is important that licensed material be used by, or under the supervision of, an AU, and that radiation safety aspects of the Licensee's program are being performed in accordance with approved procedures and regulatory requirements, as verified by a RSO. In this regard, it appears that the Licensee has repeatedly failed to comply with NRC requirements, as indicated herein. These actions by the Licensee have raised serious doubt as to whether the Licensee can be relied upon in the future to comply with NRC requirements.
Consequently, given these findings, as well as the fact that NRC was notified on or about December 13, 2001, by the Licensee's Vice-President that the AU currently listed on the license is no longer the AU, I lack the requisite reasonable assurance that the Licensee's current operations can be conducted under License No. 37-30603-01 in compliance with the Commission's requirements, and that the health and safety of the public, including the Licensee's employees, will be protected. Therefore, the health, safety and interest of the public require that License No. 37-30603-01 be suspended. Furthermore, pursuant to 10 CFR 2.202, I find that, given the safety significance of conducting licensed activities without an AU/RSO, and the conduct of such activities without the supervision of the AU designated in the amended license, the public health, safety, and interest require that this Order be immediately effective.
Accordingly, pursuant to sections 81, 161b, 161i, 161o, 182, and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202 and 10 CFR Parts 30 and 35, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY, THAT LICENSE No. 37-30603-01 IS SUSPENDED AS FOLLOWS, pending further Order.
A. All NRC-licensed material in the Licensee's possession shall be placed in secured storage.
B. All activities under License No. 37-30603-01 to use licensed material shall be suspended. All other requirements of the license remain in effect.
C. No material authorized by the license shall be ordered, purchased, received, or transferred by the Licensee while this Order is in effect.
D. All records related to licensed activities shall be maintained in their original form and must not be removed or altered in any way.
The Director of the Office of Enforcement, the Director of the Office of Nuclear Materials Safety and Safeguards, or the Regional Administrator, Region I, may, in writing, relax or rescind this order upon demonstration by the Licensee of good cause.
In accordance with 10 CFR 2.202, the Licensee must, and any other person adversely affected by this Order may, submit an answer to this Order, and may request a hearing on this Order, within 20 days of the date of this Order. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for an extension of time must be made in writing to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC, 20555, and include a statement of good cause for the extension. The answer may consent to this Order. Unless the answer consents to this Order, the answer shall, in writing and under oath or affirmation, specifically admit or deny each allegation or charge made in this order and set forth the matters of fact and law on which the Licensee or other person adversely affected relies and the reasons as to why the Order should not have been issued.
Any answer or request for a hearing shall be submitted to the Secretary, U.S. Nuclear Regulatory Commission, ATTN: Chief, Docketing and Services Section, Washington, DC 20555. Copies of the hearing request also should be sent to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, to the Assistant General Counsel for Materials Litigation and Enforcement at the same address, to the Regional Administrator, NRC Region I, 475 Allendale Road, King of Prussia, Pennsylvania, 19406, and to the Licensee if the hearing request is by a person other than the Licensee. If a person other than the Licensee requests a hearing, that person shall set forth with particularity the manner in which the individual's interest is adversely affected by this Order and shall address the criteria set forth in 10 CFR 2.714(d).
If a hearing is requested by the Licensee or a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Order should be sustained.
Pursuant to 10 CFR 2.202(c)(2)(i), the Licensee, may, in addition to demanding a hearing, at the time the answer is filed or sooner, move the presiding officer to set aside the immediate effectiveness of the Order on the ground that the Order, including the need for immediate effectiveness, is not based on adequate evidence but on mere suspicion, unfounded allegations, or error.
In the absence of any request for hearing, or a written approval of an extension of time in which to request a hearing, the provisions specified in Section IV above shall be final 20 days from the date of this Order without further order or proceedings. If an extension of time for requesting a hearing has been approved, the provisions specified in Section IV shall be final when the extension expires if a hearing request has not been received. An answer or a request for hearing shall not stay the immediate effectiveness of this order.
After reviewing your response, the NRC will determine whether further action is necessary to ensure compliance with regulatory requirements.Start Signature
Dated this 14th day of December, 2001.
For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Deputy Executive Director for Materials, Research and State Programs.
[FR Doc. 01-32063 Filed 12-28-01; 8:45 am]
BILLING CODE 7590-01-P