[Federal Register Volume 64, Number 234 (Tuesday, December 7, 1999)]
[Notices]
[Pages 68393-68394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31610]
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NUCLEAR REGULATORY COMMISSION
[IA 99-053]
John Urban; Confirmatory Order Requiring Notice to Certain
Employers and Prospective Employers and Notification of NRC of Certain
Employment in NRC-Licensed Activities (Effective Immediately)
I.
Mr. John Urban is currently involved in NRC-licensed activities as
an employee at MidMichigan Medical Center, Midland, Michigan.
MidMichigan Medical Center (MMC or Licensee) is the holder of Byproduct
Material License No. 21-01549-02 issued by the Nuclear Regulatory
Commission (NRC or Commission) pursuant to 10 CFR parts 30 and 35 and
last renewed on February 3, 1999. The license authorizes possession and
use of radioactive material for medical purposes in accordance with the
conditions specified therein.
II.
On June 1, 1999, the Licensee reported a misadministration
involving a patient undergoing treatment for thyroid carcinoma who
received approximately 100 millicuries of iodine-131 instead of 150
millicuries as prescribed. The misadministration occurred on May 24,
1999, when the chief technologist, Mr. John Urban, administered a 103
millicurie dose of iodine-131 without first verifying that the dosage
was in accordance with the written directive. The Licensee's quality
management program dated January 20, 1992, requires any individual
administering therapy dosages to review the written directive before
administering the dosage. After the patient left MMC, Mr. Urban looked
at the written directive and realized that there was an inconsistency
between what the patient received and what had been prescribed. Mr.
Urban did not attempt to contact the physician or anyone else regarding
this inconsistency. He then altered the written directive dosage from
150 millicuries to 100 millicuries. Two days later, on May 26, 1999,
the prescribing physician discovered the misadministration when he
realized that the written directive had been altered to reflect the
dose administered. Initially, Mr. Urban denied altering the written
directive to MMC and the NRC inspector. The Licensee reported the
misadministration to the NRC on June 1, 1999. An NRC inspection was
conducted on June 7-8, 1999, and the Office of Investigations (OI)
initiated an investigation on June 14, 1999. The OI report concluded
that Mr. John Urban engaged in deliberate misconduct by altering a
written directive, by providing incomplete and inaccurate information
to an NRC inspector, and thereby, in part, causing MMC to file an
untimely misadministration report. In addition, Mr. Urban demonstrated
careless disregard for license requirements when he did not review the
written directive prior to administering a therapeutic dosage. During
the predecisional enforcement conference held on September 17, 1999,
Mr. Urban indicated that on May 24, 1999, he believed, based on the
patient's statement and the dose ordered, that he had administered the
correct dosage.
III.
The Commission's regulation in 10 CFR 30.10 requires, in part, that
any employee of a licensee may not engage in deliberate misconduct that
causes a licensee to be in violation of any regulation issued by the
Commission. Based on the facts as set forth above, the staff concluded
that Mr. Urban engaged in deliberate misconduct that caused the
Licensee to be in violation of 10 CFR 30.9 and 35.33. Mr. Urban
provided incomplete and inaccurate information to an NRC inspector and
failed to alert MMC management to the misadministration which denied
them the opportunity to submit a timely misadministration report to
NRC. The NRC must be able to rely on the Licensee and its employees to
comply with NRC requirements. Mr. Urban's actions have raised serious
doubt as to whether he can be relied upon to comply with NRC
requirements and provide complete and accurate information to the NRC.
The NRC staff sent a letter dated November 10, 1999, to Mr. Urban
containing the proposed terms of this Confirmatory Order which are set
out in Section IV of this Confirmatory Order. The proposed terms are
that Mr. Urban is required to provide a copy of this Confirmatory Order
to any current employer (other than MMC) and future employer and is
required to notify the NRC of any new employment involving licensed
activities for a period of two years. The NRC staff requested Mr. Urban
to review the proposed items and indicate his agreement with those
terms by signing an enclosed waiver. By facsimile dated November 19,
1999, Mr. Urban transmitted the signed waiver indicating agreement with
the provisions, the issuance of the Confirmatory Order confirming the
provisions and waiving his right to have a hearing on such a
Confirmatory Order.
I find that Mr. Urban's commitments as agreed to in the facsimile
of November 19, 1999, are acceptable and necessary and conclude that
with these commitments public health and safety are reasonably assured.
In view of the foregoing, I have determined that public health and
safety require that Mr. Urban's commitments in the November 19, 1999
facsimile be confirmed by this Confirmatory Order. As stated above, Mr.
Urban has agreed to this action. Pursuant to 10 CFR 2.202, I have also
determined, based on Mr. Urban's consent and on the significance of the
conduct described above, that public health and safety require that
this Confirmatory 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, 10 CFR 30.10, and 10 CFR 150.20, it is
hereby ordered, effective immediately, that:
1. Should John Urban seek employment involving NRC-licensed
activities during the two year period from the date of this
Confirmatory Order, Mr. Urban shall provide a copy
[[Page 68394]]
of this Confirmatory Order to the prospective employer at the time that
Mr. Urban is soliciting or negotiating employment so that the person is
aware of the Confirmatory Order prior to making an employment decision.
NRC-licensed activities are those activities which are conducted
pursuant to a specific or general license issued by the NRC, including,
but not limited to, those activities of Agreement State licensees
conducted pursuant to the authority granted by 10 CFR 150.20.
2. For a two year period from the date of this Confirmatory Order,
John Urban shall, within 10 business days of his acceptance of an
employment offer involving NRC-licensed activities, provide notice to
the Director, Office of Enforcement, U. S. Nuclear Regulatory
Commission, Washington, DC 20555, of the name, address, and telephone
number of the employer.
3. If John Urban is currently involved in NRC-licensed activities
at any employer other than MidMichigan Medical Center, Mr. Urban shall,
within 30 days of the date of this Confirmatory Order, provide a copy
of this Confirmatory Order to any such employer and provide notice to
the Director, Office of Enforcement, at the address provided above, of
the name, address, and telephone number of any such employer.
The Director, Office of Enforcement, may, in writing, relax or
rescind any of the above conditions upon demonstration by Mr. Urban of
good cause.
V.
Any person adversely affected by this Confirmatory Order, other
than Mr. Urban, may request a hearing within 20 days of its issuance.
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. Any request for a hearing shall be
submitted to the Secretary, U.S. Nuclear Regulatory Commission, ATTN:
Rulemakings and Adjudications Staff, 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 III, 801 Warrenville Road, Lisle, IL
60532, and Mr. Urban. If a person other than Mr. Urban requests a
hearing, that person shall set forth with particularity the manner in
which his interest is adversely affected by this Confirmatory Order and
shall address the criteria set forth in 10 CFR 2.714(d).
If a hearing is requested by 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 Confirmatory Order should be
sustained. 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 Confirmatory 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 confirmatory order.
Dated this 26th day of November 1999.
For the Nuclear Regulatory Commission.
R.W. Borchardt,
Director, Office of Enforcement.
[FR Doc. 99-31610 Filed 12-6-99; 8:45 am]
BILLING CODE 7590-01-P
