[Federal Register Volume 63, Number 83 (Thursday, April 30, 1998)]
[Notices]
[Pages 23814-23816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11503]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-34060; [License No. 52-25113-02; EA-98-183]
In the Matter of Jose M. Colon Vaquer, M.D., Manati Puerto Rico;
Confirmatory Order Modifying License Effective Immediately
I
At present, Jose M. Colon Vaquer, M.D. (Licensee) is the holder of
NRC License No. 52-25113-02 issued by the Nuclear Regulatory Commission
(NRC or Commission) pursuant to 10 CFR Part 35. The license authorizes
the Licensee to possess and use a 125 millicurie (decay corrected to 91
millicurie) Strontium-90 (Sr-90) eye applicator for medical treatment
of superficial eye conditions. The license was issued on March 28,
1997, and is due to expire on March 31, 2002. The Licensee first
obtained license No. 52-25113-01 to possess and use a 125 millicurie
Sr-90 eye applicator for medical treatment of superficial eye
conditions on December
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17, 1990. That license expired on November 30, 1995. Subsequently, the
Licensee applied for a new license on January 31, 1996, which was
issued as License No. 52-25113-02 on March 28, 1997.
II
During a routine inspection on August 10, 1995 (inspection report
No. 52-25113-01/95-01), the NRC identified violations regarding the
failure to perform leak test of the sealed source as required by 10 CFR
35.59(b)(2) and the failure to perform a review of the Quality
Management Program (QMP) as required by 10 CFR 35.32(b)(1). Moreover,
the Licensee did not take actions to correct the violation within 30
days as required by the Notice of Violation dated August 10, 1995.
Thus, the Licensee continued to be in violation of the cited
requirements from the time they were identified on August 10, 1995,
until the expiration of the license No. 52-25113-01, on November 30,
1995.
The NRC conducted a special inspection of the Licensee on March 2
and 5, 1998. The inspection examined activities conducted under the
license with respect to the use of the Sr-90 eye applicator, proper
calibration and decay correction of the surface dose rate for the Sr-90
eye applicator, and the implementation of the Quality Management
Program (QMP). After identifying significant failures to comply with
NRC requirements in these areas, the scope of the inspection was
expanded to address radiation safety and compliance with other NRC
regulations and the conditions of the license.
During the inspection, the inspectors identified two
misadministrations resulting from treatments using the Sr-90 eye
applicator. These were brought to the Licensee's attention during the
inspection. One misadministration occurred when 1500 centigrays (cGy)
(1500 rads) was administered when 1000 cGy (1000 rads) was intended,
and the other involved the administration of 1000 cGy (1000 rads) when
1500 cGy (1500 rads) was intended.
Based on the results of this inspection, 10 violations were
identified. The violations involved: (1) The failure to use written
directives on multiple occasions as required by 10 CFR 35.32(a)(1); (2)
the failure to have a written procedure to ensure that final treatment
plans and related calculations (exposure time) were in accordance with
written directives as required by 10 CFR 35.32(a)(3); (3) the failure
to limit activities involving byproduct material to those related to
decommissioning following the expiration of license No. 52-25113-01 as
required by 10 CFR 30.36(c); (4) the failure to control and maintain
under constant surveillance licensed material as required by 10 CFR
20.1801; (5) the failure to perform annual reviews of the radiation
protection program as required by 10 CFR 20.1101(c); (6) the failure to
test a brachytherapy source for leakage as required by 10 CFR
35.59(b)(2) (this is a repeat violation); (7) the failure to perform
brachytherapy surveys quarterly as required by 10 CFR 35.59(h); (8) the
failure to issue personnel dosimetry monitoring as required by
condition 17 of license No. 52-25113-02; (9) the failure to record
brachytherapy source inventories as required by 10 CFR 35.59(g); and
(10) the failure to post copies of the current license and NRC
regulations as required by 10 CFR 19.11(a) and (b).
The NRC is concerned that following telephonic notification by the
NRC on December 1, 1995, that the license No. 52-25113-01 had expired
and that licensed material needed to placed in safe storage until a new
license was granted, the Licensee continued to use the licensed
material until a new license No. 52-25113-02 was received on March 28,
1997. In addition, the violations identified in 1995 and the number and
scope of the violations identified during the March 2 and 5, 1998,
inspection reflect current inadequate control over the safe use of
licensed material and a significant breakdown in the radiation safety
program and QMP. Collectively, these findings indicate a lack of regard
or carelessness toward licensed activities.
The Licensee met with NRC inspectors during the inspection exit
meeting at the Licensee's facility on March 5, 1998, to review the
findings of the inspection. During the inspection exit meeting, the
Licensee discussed his intentions to cease use of the Sr-90 eye
applicator and to place it in safe storage. The Licensee agreed to
submit these proposals to the NRC in writing.
III
By letter dated March 6, 1998, the Licensee indicated that,
effective immediately and until it is determined otherwise:
1. All use of the Sr-90 eye applicator will cease; and
2. The Sr-90 eye applicator will be placed in locked safe storage.
On April 16, 1998, the Licensee consented in writing to the
issuance of this Order and its provisions, as described in Section IV
below. The Licensee further agreed in its letter of April 16, 1998,
that this Order is to be effective upon issuance and that he has waived
his right to a hearing. Implementation of these commitments will
provide enhanced assurance that licensed material will remain secure
and in safe storage pending completion of satisfactory corrective
actions and resolution of the identified enforcement issues.
I find that the Licensee's commitments as set forth in Section IV
are acceptable and necessary and conclude that with these commitments
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. Based on
the above and the Licensee's consent, this Order is immediately
effective upon issuance.
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 Part 30 and 35, it is hereby
ordered, effective immediately, that, pending further action by the
NRC, License No. 52-25113-02 is modified as follows:
1. The Licensee shall discontinue all uses of the Sr-90 eye
applicator.
2. The licensee shall place the Sr-90 eye applicator in locked safe
storage until further Order of the Commission.
The Regional Administrator, Region II, may relax or rescind, in
writing, any of the above conditions upon a showing 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. 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, D.C. 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: Chief, Rulemaking and Adjudications Staff,
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 Deputy Assistant General Counsel for Enforcement at
the same address, to the Regional Administrator, NRC Region II, Atlanta
Federal Center, 23T85, 61 Forsyth Street, S.W., Atlanta, GA 30303-3415,
and to the Licensee. If such
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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.
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 21st day of April 1998.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
[FR Doc. 98-11503 Filed 4-29-98; 8:45 am]
BILLING CODE 7590-01-P
