[Federal Register Volume 59, Number 94 (Tuesday, May 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11929]
[[Page Unknown]]
[Federal Register: May 17, 1994]
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NUCLEAR REGULATORY COMMISSION
[IA 94-011]
Order Prohibiting Involvement in NRC-Licensed Activities
(Effective Immediately)
I
Dr. James Bauer, M.D. (Dr. Bauer) is listed as the Radiation Safety
Officer (RSO) and sole authorized user on NRC License No. 37-28179-01
(license) issued to the Indiana Regional Cancer Center (Licensee)
located in Indiana, Pennsylvania. Byproduct License No. 37-28179-01 was
issued by the Nuclear Regulatory Commission (NRC or Commission)
pursuant to 10 CFR parts 30 and 35, and authorizes the Licensee to use
a strontium-90 source for the treatment of superficial eye conditions
in accordance with the conditions specified therein. The license,
originally issued on April 25, 1988, was due to expire on April 30,
1993, but remained in effect, pursuant to 10 CFR 30.37(b), based on a
timely request for renewal that was received by the NRC on April 5,
1993. By an Order Modifying and Suspending License (Effective
Immediately), issued November 16, 1993, the license was modified to
prohibit Dr. Bauer from engaging in activities under the license and to
suspend the Licensee's authority to receive and use licensed material.
II
On November 11, 1993, the NRC performed an inspection at the
Licensee's facility in Indiana, Pennsylvania. During the inspection,
the NRC found that Dr. Bauer had used the Licensee's strontium-90
source to perform treatments of two patients for skin lesions on
several occasions between September and November 1993, even though the
license does not authorize the use of the strontium-90 for any purpose
other than the treatment of superficial eye conditions. Since the use
of the strontium-90 source for treatment of skin lesions not involving
the eye is not authorized by the license, a violation of the license
occurred.
Prior to identifying that violation during the inspection, the
inspectors asked Dr. Bauer, as the Radiation Safety Officer and only
authorized user listed on the license, about the treatment modalities
for which the strontium-90 source was used. Dr. Bauer stated that the
source had been used for the treatment of pterygium, an eye condition.
When the inspectors asked Dr. Bauer whether the source had ever been
used for any other modality, he again replied that the source had been
used to treat pterygium.
The inspectors then requested records of the last six patients who
received treatment with the strontium-90 source. The records provided
to the inspectors reflected only eye treatments. Subsequently, the
inspectors performed a review of the patient treatment log maintained
by Dr. Bauer's secretary, as well as a review of records of additional
patient treatments. The inspectors learned that the records initially
provided were not for the last six patients treated, and that the
records of the last six patient treatments included treatments for
superficial lesions of the skin using the strontium-90 source,
including a treatment that occurred on the day of the inspection before
the inspection took place.
Dr. Bauer's failure to inform the inspectors that he had used the
strontium-90 source to treat lesions of the skin, when specifically
asked if the source was used for any purpose other than superficial eye
treatments, caused the Indiana Regional Cancer Center to violate the
requirements of 10 CFR 30.9, in that Dr. Bauer failed to provide
information that was complete and accurate in all material respects to
the NRC. In addition, in view of Bauer's use of the strontium-90 source
for treatment of skin lesions prior to and on the day of the
inspection, Dr. Bauer's communications to the inspector also constitute
a violation of 10 CFR 30.10, in that Dr. Bauer deliberately provided to
the NRC information that he knew to be incomplete or inaccurate in some
material respect.
Previously, Dr. Bauer was involved in an incident in November 1992
at the Indiana Regional Cancer Center, as an authorized user and the
supervisor of a treatment with a High Dose Rate Remote Afterloader
(under Byproduct Materials License No. 37-28540-01 issued to Oncology
Services Corporation), that resulted in a patient being exposed to
significant levels of radiation, and numerous other members of the
public being exposed to unnecessary radiation. Dr. Bauer had failed to
cause a survey to be performed which was required by 10 CFR 20.201 and
which could have prevented the exposures.
Based on the above, the NRC issued a Demand for Information
(Demand) to Dr. Bauer on November 16, 1993. The Demand required Dr.
Bauer to state: (1) Why the NRC should not issue an Order prohibiting
Dr. Bauer's involvement in all NRC licensed activities; and (2) if such
an Order should not be issued, why the NRC should have confidence that
Dr. Bauer would comply with all Commission requirements. The Demand
also required Dr. Bauer to state each institution and location at which
Dr. Bauer engages in licensed activities.
In a letter dated January 5, 1994, Dr. Bauer, through his counsel,
responded to the Demand for Information. The response stated that Dr.
Bauer was a highly competent board certified radiation oncologist and
radiologist with in excess of thirty years of experience in the safe
use of radioactive materials; listed a number of areas where the
licensee was found to be in compliance with NRC requirements and noted
that there were no radiation safety violations, no harm to any
individuals, and no risk to the public health and safety; stated that
Dr. Bauer believed he was permitted to use the strontium-90 source for
superficial skin lesion treatments; stated that Dr. Bauer fully and
truthfully responded to all questions, and provided all requested
information to the inspectors during the November 11, 1993 inspection;
noted that the NRC had not attempted to levy any civil penalty for Dr.
Bauer's alleged ``failure to do an adequate survey in November 1992'',
and stated that the NRC has admitted that Dr. Bauer did not violate any
license condition in November 1992 by allegedly failing to do an
adequate survey; noted that the licensee's past performance has been
exemplary; stated that there is no basis for the NRC to believe that
Dr. Bauer will not comply with all Commission requirements, noting that
he has in the past and will at all times in the future continue to use
his best efforts to fully comply with all Commission requirements;
stated that there has never been any finding that Dr. Bauer willfully
or negligently violated any federal regulations or that he improperly
uses radioactive material; and argued that to bar Dr. Bauer from any
future licensed activities would constitute a travesty of justice to
Dr. Bauer, the patients who rely on him, and society in general.
III
Based on the above, and after giving due consideration to his
response to the Demand for Information, it appears that Dr. Bauer has
engaged in deliberate misconduct that has caused the Licensee to be in
violation of 10 CFR 30.9; deliberately provided to NRC inspectors
information that he knew to be incomplete or inaccurate in some respect
material to the NRC, in violation of 10 CFR 30.10; and failed to
conduct a required survey on November 16, 1992, which resulted in
unnecessary radiation exposure to members of the public and a
significant misadministration. The NRC must be able to rely on the
Licensee and its employees, especially its authorized users and
Radiation Safety Officer, to comply with all NRC requirements,
including the requirement to provide information to the NRC that is
complete and accurate in all material respects. Dr. Bauer's action in
causing the Indiana Regional Cancer Center to violate 10 CFR 30.9 and
his violation of 10 CFR 30.10 through deliberate misrepresentations to
the NRC, as well as his failure to perform the required survey noted
above, have raised serious doubt as to whether he can be relied upon to
comply with NRC requirements and to provide complete and accurate
information to the NRC.
Dr. Bauer is the sole authorized user and the Radiation Safety
Officer on NRC License No. 37-28179. As such, Dr. Bauer is required to
know the requirements of the License and adhere to them. Dr. Bauer is
not permitted to select those requirements that he will follow.
Consequently, I lack the requisite reasonable assurance that
licensed activities can be conducted in compliance with the
Commission's requirements and that the health and safety of the public
will be protected, if Dr. Bauer were permitted at this time to be named
in any capacity on an NRC license or were permitted to otherwise
perform licensed activities. Therefore, the public health, safety and
interest require that Dr. Bauer be prohibited from being named on an
NRC license in any capacity and from otherwise performing licensed
activities for a period of five years from the date of this order. For
an additional two years, the public health, safety, and interest
require that Dr. Bauer be required to notify the NRC of any involvement
in licensed activities to assure that the NRC can monitor the status of
Dr. Bauer's compliance with the Commission's regulatory requirements.
Furthermore, pursuant to 10 CFR 2.202, I find that the significance of
the violations and Dr. Bauer's conduct described above is such that the
public health, safety and interest require that this Order be
immediately effective.
IV
Accordingly, pursuant to sections 81, 161b, 161i, 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 30.10, It is Hereby Ordered,
Effective Immediately, That:
A. Dr. James Bauer, M.D., is prohibited for five (5) years from
the date of this Order from being named on an NRC license in any
capacity or from otherwise performing NRC-licensed activities.
B. For an additional two year period following the five year
prohibition in Paragraph IV.A. above, Dr. Bauer shall, within 20
days of his acceptance of an employment offer involving NRC-licensed
activities or becoming involved in NRC-licensed activities, provide
notice to the Director, Office of Enforcement, U.S. Nuclear
Regulatory Commission, Washington, D.C. 20555, of the name, address,
and telephone number of the employer or the licensed entity where
the licensed activities are or will be conducted.
The Director, Office of enforcement, may, in writing, relax or
rescind any of the above conditions upon demonstration by Dr. Bauer of
good cause.
V
In accordance with 10 CFR 2.202, Dr. Bauer 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. 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 shall set forth the matters of fact and
law on which Dr. Bauer 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 Service
Section, Washington, DC 20555. Copies also shall be sent to the
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, to the Assistant General Counsel for Hearings and
Enforcement at the same address, to the Regional Administrator, NRC
Region I, 475 Allendale Road, King of Prussia, PA 19406 and to Dr.
Bauer if the answer or hearing request is by a person other than Dr.
Bauer. If a person other than Dr. Bauer requests a hearing, that person
shall set forth with particularity the manner in which his or her
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 Dr. Bauer 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), Dr. Bauer, or any other person
adversely affected by this Order, 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 and 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, the provisions specified
in Section IV above shall be final 20 days from the date of this Order
without further order or proceedings. An answer or a request for
hearing shall not stay the immediate effectiveness of this order.
Dated at Rockville, Maryland this 10th day of May 1994.
For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards and
Operations Support.
[FR Doc.94-11929 Filed 5-16-94; 8:45 am]
BILLING CODE 7510-01-M
