[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]


-----------------------------------------------------------------------

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

[[Page 23815]]

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

[[Page 23816]]

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