EA-98-183 - José M. Colón Vaquer, M.D.

April 21, 1998

EA 98-183

José M. Colón Vaquer, M.D.
P.O. Box 76
Manatí, Puerto Rico 00674

SUBJECT: CONFIRMATORY ORDER MODIFYING LICENSE - EFFECTIVE IMMEDIATELY

Dear Dr. Colón:

The NRC has received your executed acknowledgment dated April 16, 1998, indicating your consent to the issuance of a Confirmatory Order Modifying License with the commitments described in the NRC's letter dated April 15, 1998. Accordingly, the enclosed Confirmatory Order Modifying License is being issued due to the Nuclear Regulatory Commission's (NRC) concerns regarding the number and scope of violations identified during an NRC inspection of your program on March 2 and 5, 1998. The inspection findings revealed a significant breakdown and lack of attention to your Radiation Protection and Quality Management Programs. As a result of the latter, two misadministrations occurred. It was also identified that you used licensed material during a period when your license was expired, contrary to regulatory requirements and verbal instructions by the NRC. Pursuant to the Order, your license is hereby modified to require that you immediately cease use of your Strontium-90 eye applicator and place it in safe storage.

Pursuant to Section 223 of the Atomic Energy Act of 1954, as amended, any person who willfully violates, attempts to violate, or conspires to violate, any provision of this Order shall be subject to criminal prosecution as set forth in that section. Violation of this Order may also subject the person to civil monetary penalty.

Questions concerning this Confirmatory Order Modifying License should be addressed to Douglas M. Collins, Director, Division of Nuclear Material Safety, who may be reached at (404) 562-4700.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosure will be placed in the NRC Public Document Room.

Sincerely, James Lieberman, Director Office of Enforcement

Docket No. 030-34060
License No. 52-25113-02

Enclosure: Confirmatory Order Modifying License

cc: Commonwealth of Puerto Rico
Commonwealth of Puerto Rico
Tribunal Examinador de Medicos de Puerto Rico
Dr. Humberto Vazquez, President
P. O. Box 13969
San Juan, Puerto Rico 00908

Commonwealth of Puerto Rico
Department of Health
Office of the Secretary
Dr. Carmen Feliciano de Melecio,
Secretary of Health
P. O. Box 70184
San Juan, Puerto Rico 00936

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UNITED STATES

NUCLEAR REGULATORY COMMISSION

In the Matter of JOSÉ M. COLÓN VAQUER, M.D. Manatí, Puerto Rico

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Docket No. 030-34060 License No. 52-25113-02 EA 98-183

CONFIRMATORY ORDER MODIFYING LICENSE

(EFFECTIVE IMMEDIATELY)

I

At present, José M. Colón 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 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 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.

FOR THE NUCLEAR REGULATORY COMMISSION James Lieberman, Director Office of Enforcement

Dated at Rockville, Maryland
this 21st day of April 1998