[Federal Register Volume 60, Number 186 (Tuesday, September 26, 1995)]
[Notices]
[Pages 49638-49640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23805]
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[[Page 49639]]
NUCLEAR REGULATORY COMMISSION
[IA 95-037]
Dr. Hung Yu; Order Prohibiting Involvement in NRC-Licensed
Activities (Effective Immediately)
I
Dr. Hung Yu was employed by the Department of the Army at its
Madigan Army Medical Center, Fort Lewis (Tacoma, Washington). Madigan
Army Medical Center (Licensee) holds License No. 46-02645-03 issued by
the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10
CFR Parts 30 and 35 on May 12, 1960. The license authorizes possession
and use of byproduct material in accordance with the conditions
specified therein.
Dr. Yu was employed by the Licensee from approximately October 1993
to August 2, 1995, as a medical physicist. During his employment with
the Licensee, Dr. Yu reported to the Chief, Radiation Therapy Service,
and was responsible for supervising a radiation dosimetrist. Among
other tasks, Dr. Yu was responsible for all dosimetry, including
developing treatment plans, evaluating the adequacy and accuracy of the
treatment plan for each brachytherapy treatment, and modifying
treatment plans as required by authorized users. Dr. Yu was also
responsible for performing the duties of a radiation therapy
dosimetrist, as needed, and directing all physics aspects of
intracavitary and interstitial implants. The latter responsibilities
included ordering and accepting or receiving brachytherapy sources,
source preparation and related quality assurance tasks, and computer
calculations, including providing calibration and decay factors for
brachytherapy sources. In his role as a medical physicist who
supervised a dosimetrist, Dr. Yu was additionally responsible for
ensuring that the dosimetrist's activities were also in compliance with
NRC regulations and the Licensee's procedures and Quality Management
Program.
II
On June 2, 1995, the Licensee notified the NRC of a
misadministration which occurred on May 10, 1995, but had gone
unrecognized by the Licensee until June 2, 1995. This finding prompted
a review by the Licensee which identified additional
misadministrations. On June 8, 1995, the Licensee reported three
misadministrations which occurred on February 9 and August 23, 1994,
and January 11, 1995. On June 12, 1995, an additional misadministration
was reported to have occurred on February 3, 1995. The
misadministrations all involved brachytherapy implants using iridium-
192 sealed sources, and each treatment was performed in accordance with
a treatment plan developed by Dr. Yu or under his direction.
The NRC began an inspection of the events on June 6, 1995. An
investigation by the NRC's Office of Investigations (OI) was initiated
on June 13, 1995. Both the NRC inspection and NRC investigation are
ongoing. The Licensee initiated an internal investigation of the
misadministrations and related issues on June 2, 1995, and provided the
NRC with a written report of its investigation on August 22, 1995. The
NRC inspection and investigation demonstrate that the cause of the
misadministrations was an input error of one parameter used by the
computerized treatment planning system to calculate dose rates for
treatment plans. Specifically, Dr. Yu had instructed the dosimetrist to
use a value, for a ``calibration factor'' used by the system to
calculate dose rates, which was not calculated according to the
computer system manufacturer's instructions.
NRC's interviews of Dr. Yu and other Licensee personnel establish
that on June 2, 1995, Dr. Yu engaged in deliberate misconduct in
violation of 10 CFR Sec. 30.10(a)(2) by deliberately providing
inaccurate information to the Licensee on a matter material to the NRC,
specifically the dose calculation error that caused the May 10, 1995
misadministration. In response to repeated questions on June 2, 1995,
by the Radiation Safety Officer (RSO), and in the presence of the
authorized user (also the Chief, Radiation Therapy Service), regarding
the cause of the May 10, 1995 misadministration, Dr. Yu stated that it
was a ``computer error,'' that ``it was hardware error,'' and that it
was a ``software error.'' Dr. Yu's statements to the Licensee were
deliberately inaccurate because on May 16, 1995, Dr. Yu was made aware
by the computer system manufacturer that his data entry error (i.e.,
input error) to the treatment planning system was the cause for the
dose calculation errors and, immediately after being informed of his
error, Dr. Yu began to correctly enter the calibration factor. Only
after the RSO stated that he had discussed the treatment plan
calculations with the dosimetrist did Dr. Yu explain that the cause of
the misadministration was his use of an erroneous input parameter. Dr.
Yu's provision of inaccurate information to the RSO and Chief,
Radiation Therapy Service, regarding the cause of the dose calculation
error associated with the May 10, 1995 misadministration interfered
with the Licensee's investigation required by 10 CFR 35.21(b)(1) of
potential misadministrations.
Furthermore, in violation of 10 CFR 30.10(a)(1), Dr. Yu engaged in
deliberate misconduct which caused the Licensee to be in violation of
NRC requirements including: (1) 10 CFR 20.1906(b), which requires, in
part, that upon receipt of labelled packages containing brachytherapy
sources, the packages be tested for contamination; (2) 10 CFR
20.2103(a), which requires, in part, that each licensee maintain
records showing the results of surveys required by 10 CFR 20.1906(b);
and (3) 10 CFR 30.9 which requires, in part, that information required
to be maintained by the Commission's regulations shall be complete and
accurate in all material respects. For example, Dr. Yu, when questioned
about the package survey results of August 19, 1994, admitted to an NRC
inspector and OI investigator that he had failed to perform NRC-
required package receipt surveys for radioactive contamination and that
he had deliberately completed Licensee records to falsely reflect that
the contamination surveys had been performed. Dr. Yu stated that,
although he was aware of the NRC requirement to perform the survey, he
did not believe that the survey was important, that it was just a
requirement and a formality and, therefore, he just recorded that the
survey had been conducted.
III
Although the NRC investigation is continuing, based on the
information developed to date, the NRC concludes that Dr. Yu engaged in
deliberate misconduct: (1) In violation of 10 CFR 30.10(a)(2), by
knowingly providing to the Licensee on June 2, 1995, inaccurate
information relating to a matter material to the NRC, specifically the
cause of the error that resulted in the misadministration; and (2) in
violation of 10 CFR 30.10(a)(1), which caused the Licensee to be in
violation of NRC requirements, including 10 CFR 20.1906(b), 10 CFR
20.2103(a), and 10 CFR 30.9(a), by deliberately failing to conduct
surveys of labelled packages containing brachytherapy sources and
deliberately making entries to Licensee records to show that he had
conducted such surveys.
The NRC must be able to rely on the Licensee and its employees to
comply with NRC requirements, including the requirement to provide
information and maintain records that are complete and accurate in all
material respects. Dr. Yu's actions in causing the Licensee to violate
NRC requirements and his misrepresentations to the Licensee have
[[Page 49640]]
raised serious doubt as to whether he can be relied upon to comply with
NRC requirements and to provide complete and accurate information to
NRC licensees. Further, Dr. Yu has demonstrated an unwillingness to
comply with NRC requirements necessary for the protection of the health
and safety of personnel and patients affected by the areas of his
responsibility. Dr. Yu's deliberate false statements to Licensee
officials concerning radiological exposure to patients and his
deliberate violation of NRC requirements is not acceptable conduct for
a person engaged in NRC-licensed activities.
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
would be protected if Dr. Yu were permitted at this time to be involved
in any NRC-licensed activities.
Therefore, the public health, safety and interest require, pending
completion of the investigation and further action by the NRC, that Dr.
Yu be prohibited from involvement in licensed activities. Furthermore,
pursuant to 10 CFR 2.202, I find that the significance of the 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, 10 CFR 30.10, and 10 CFR 150.20, it is
hereby ordered, effective immediately, that:
Pending further investigation and order by the NRC, Hung Yu,
Ph.D. is prohibited from participation in any respect in NRC-
licensed activities. For the purposes of this paragraph, NRC-
licensed activities include licensed activities of: (1) An NRC
licensee, (2) an Agreement State licensee conducting licensed
activities in NRC jurisdiction pursuant to 10 CFR 150.20, and (3) an
Agreement State licensee involved in distribution of products that
are subject to NRC jurisdiction.
The Director, Office of Enforcement, may, in writing, relax or
rescind any of the above conditions upon demonstration by Dr. Yu of
good cause.
V
In accordance with 10 CFR 2.202, Hung Yu, Ph.D. 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
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 shall
set forth the matters of fact and law on which Hung Yu, Ph.D. 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 IV, Suite 400, 611 Ryan Plaza,
Arlington, Texas 76011, and to Hung Yu, Ph.D., if the answer or hearing
request is by a person other than Hung Yu, Ph.D. If a person other than
Hung Yu, Ph.D. 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 Hung Yu, Ph.D. 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), Hung Yu, Ph.D., 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 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 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.
Dated at Rockville, Maryland this 18th day of September 1995.
For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards, and
Operations Support.
[FR Doc. 95-23805 Filed 9-25-95; 8:45 am]
BILLING CODE 7590-01-P
