[Federal Register Volume 66, Number 250 (Monday, December 31, 2001)]
[Notices]
[Pages 67553-67554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-32063]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-35994, License No. 37-30603-01,EA-01-313]
In the Matter of Advanced Medical Imaging and Nuclear Services
Easton, PA 18045; Order Suspending License (Effective Immediately)
I
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.
II
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
[[Page 67554]]
originally 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.
III
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.
IV
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.
V
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.
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