[Federal Register Volume 59, Number 58 (Friday, March 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7062]
[[Page Unknown]]
[Federal Register: March 25, 1994]
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NUCLEAR REGULATORY COMMISSION
Confirmatory Order Modifying License (Effective Immediately)
In the Matter of Allegheny General Hospital Pittsburgh,
Pennsylvania [Docket Nos. 030-02981, 030-00462, 030-30452; License Nos.
37-01317-01, 37-01317-02, 37-01317-03 EA 94-051]
I
Allegheny General Hospital (Licensee), Pittsburgh, Pennsylvania, is
the holder of Byproduct/Source Material Licenses Nos 37-01317-01; 37-
01317-02; 37-01317-03 (Licenses), issued by the U.S. Nuclear Regulatory
Commission (NRC or Commission) pursuant to 10 CFR parts 30 and 33. The
Licenses authorize the Licensee to use radioactive material under a
broad scope license, possess an irradiator for calibrations of
instruments, and possess an irradiator for irradiation of blood
products and biological samples.
License No. 37-01317-01 was issued on October 25, 1956, and was due
to expire on January 31, 1989, but is currently under timely renewal
pending staff action based on a licensee request to renew the license,
dated December 15, 1988. License No. 37-01317-02 was issued on July 19,
1957, was renewed on March 23, 1992, and is due to expire on March 31,
1997. License No. 37-0117-03 was issued on May 31, 1988, was recently
renewed on October 4, 1993, and is due to expire on October 31, 1988.
II
On December 13-20, 1993, the NRC performed an inspection of
licensed activities at the Licensee's facility. During the inspection,
numerous violations of NRC requirements were identified. The violations
are described in detail in a Notice of Violation and Proposed
Imposition of Civil Penalties issued concurrently on this date. The
violations, which demonstrate a significant lack of management
attention to, and control of, licensed activities at the facility,
included: (1) 48 examples of failure to prepare written directives
prior to the administration of radioactive materials to patients at the
facility and a failure to instruct a nuclear medicine technologist in
the Licensee's Quality Management Program, as required by NRC
requirements; and (2) many other violations (related to such areas as
failure to maintain security over licensed material, and violations of
radiation safety requirements for irradiators, performing required
surveys, providing training to nursing staff, maintaining appropriate
procedures, ensuring control of material, and maintaining appropriate
records) which collectively are indicative of a significant lack of
management attention to, and control of, licensed activities.
The violations are of significant regulatory concern since the
Licensee possesses a large broad scope license which places a
significant responsibility on the Radiation Safety Committee (RSC), as
well as the Radiation Safety Officer (RSO), to ensure that licensed
activities are conducted safely and in accordance with NRC
requirements.
The Licensee's failure to maintain sufficient control of
radioactive materials raises significant questions regarding the
adequacy of the Licensee's oversight of activities at its facility, as
well as its ability to assure that activities at those facilities are
conducted safely and in accordance with NRC requirements. Accordingly,
without independent assessments of the Licensee's radiation safety
program and a performance improvement plan, there is a substantial
question as to whether licensed activities will be adequately
controlled at the Licensee's facilities.
III
During an enforcement conference on February 2, 1994, as well as in
telephone conversations on February 4 and 9, 1994, and March 16, 1994,
between Mr. Lou Shapiro of the Licensee's staff and Dr. Ronald Bellamy
of the NRC Region I staff, the Licensee committed to retain the
services of an independent consultant to perform an assessment of its
radiation safety program and to develop a performance improvement plan
based upon the assessment findings. The Licensee has consented to the
terms of this Order.
I find that Licensee's commitments are acceptable and necessary and
conclude that, with these commitments and the implementation of an
appropriate performance improvement plan, the public health and safety
are reasonably assured. In view of the foregoing, I have determined
that the public health and safety require that the Licensee's
commitments be confirmed by this Order. Pursuant to 10 CFR 2.202, I
have also determined, based on the Licensee's consent and on the
significant of the violations described above, that the public health
and safety 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 33, it is hereby
ordered, effective immediately, that licenses nos. 37-01317-01, 37-
01317-02, and 37-01317-03 are modified as follows:
A. The Licensee shall retain the services of a consultant, with
extensive experience in the management and implementation of a broad
scope radiation safety program, including activities similar to those
authorized under the Licensee's program, to perform an assessment of
the Licensee's radiation safety program. Within 30 days from the
effective date of this Order, the Licensee shall submit the name and
qualifications of the consultant to the Regional Administrator, NRC
Region I, for approval.
B. Within 90 days of NRC approval of the consultant selection as
described under Section IV.A of this Order, the assessment shall be
completed, and a copy of the assessment report shall be submitted to
the NRC within the following 15 days. The assessment of the Licensee's
radiation safety program shall include, but not be limited to, a review
of:
1. The Licensee's organization, and assigned responsibilities and
authorities within that organization;
2. The Licensee's program for training and retraining individuals
working with NRC-licensed materials, in NRC regulations, in the
conditions of the Licenses, and in radiologically safe practices for
using licensed material;
3. The Licensee's methods of approving individuals for the use of
licensed materials and developing procedures for the safe use of
licensed materials;
4. The Licensee's program for training and qualifying all
individuals involved in managing, supervising, inspecting and auditing
licensed activities;
5. The Licensee's program of surveillance and audits to determine
compliance by individual users of licensed materials with NRC
regulations, the conditions of the NRC Licenses, and the Licensee's own
procedures for the safe use of radioactive materials;
6. The adequacy of the existing staffing within the Radiation
Safety Department, to ensure that the items set forth in Sections
IV.B.2 through V.B.5 of this Order are adequately performed; and,
7. The Licensee's management of the radiation safety program,
including the function of the Radiation Safety Committee and its
methods of monitoring the program to ensure that problems, when they
exist, are promptly identified and effectively corrected.
C. Within 120 days of NRC approval of the consultant selection
described under Section IV.A of this Order, the Licensee shall submit a
performance improvement plan to the Regional Administrator, NRC Region
I, describing its methods of implementing the recommendations of the
assessment report, or providing justification for alternate or no
corrective action, if any specific recommendations are not adopted.
This plan shall include:
1. Action items completed or to be performed;
2. Schedules for, or dates of, completion of each specific action
item; and
3. A system for monitoring and tracking the status and completion
of the action items.
D. Upon completion of all action items, a final report shall be
submitted by the Licensee to the Regional Administrator, NRC Region I.
During implementation of the performance improvement plan, the Licensee
shall provide written quarterly status reports to the Regional
Administrator, NRC Region I, concerning the implementation of the plan,
until such time as all items in the performance improvement plan have
been implemented and the final report issued.
The Regional Administrator, NRC Region I, may relax or rescind, in
writing, any of the above conditions upon demonstration by the Licensee
of good cause.
V
Any person adversely affected by this Confirmatory Order, other
than the Licensee, may request a hearing within 20 days of its
issuance. Any request for a hearing shall be submitted to the
Secretary, U.S. Nuclear Regulatory Commission, ATTN: Chief, Docketing
and Service Section, Washington, D.C. 20555. Copies also shall be sent
to the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, Washington, D.C. 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,
Pennsylvania 19406, and to the Licensee. If such a person requests a
hearing, that person shall set forth with particularity the manner in
which his 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 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.
Pursuant to 10 CFR 2.202(c)(2)(i), (57 FR 20194) May 12, 1992, any
person adversely affected by this Order, other than the Licensee may,
in addition to demanding a hearing, 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, 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 17th day of March 1994.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
[FR Doc. 94-7062 Filed 3-24-94; 8:45 am]
BILLING CODE 7590-01-M
