EA-00-141 - Buxeda-Dacri, M. D.

July 14, 2000

EA-00-141

Roberto Buxeda-Dacri, M. D.
Ashford Medical Center
Suite 110
Santurce, Puerto Rico 00907

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $2,750 (NRC INSPECTION REPORT NO. 52-11897-01/00-01)

Dear Dr. Buxeda-Dacri:

This is in reference to an NRC inspection conducted at the Santurce, Puerto Rico facility on May 2, 2000. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with Nuclear Regulatory Commission (NRC) requirements. The results of the inspection, including three apparent violations, were discussed with you at the conclusion of the inspection and formally transmitted to you by letter dated June 14, 2000. A closed, transcribed predecisional enforcement conference was conducted at the NRC's Region II office in Atlanta, Georgia, on June 28, 2000, to discuss the apparent violations, the root causes, and your corrective actions. A listing of conference attendees, the materials you presented at the conference, and the NRC's presentation materials are enclosed.

Based on the information developed during the inspection and the information that you provided during the conference, the NRC has determined that three violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation and Imposition of Civil Penalty (Notice), and the circumstances surrounding them are described in detail in the subject inspection report.

The violation in Part I of the Notice involves your failure to test for leakage at proper intervals an eye applicator source containing approximately 31 millicuries of Strontium-90, used in the medical treatment of eye conditions. Testing a source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State is required by 10 CFR 35.59(b)(2). As noted in our June 14, 2000 inspection report and as discussed at the predecisional enforcement conference, the failure to perform tests for leakage was identified as a violation in each of the three previous NRC inspections since 1993, and Notices of Violation were issued for these violations on October 7, 1993, March 21, 1995, and July 9, 1999.

The failure to test the source for leakage did not result in any actual safety consequences, as a test performed after the NRC's May 2, 2000, identification of this violation, confirmed the absence of any leakage. Nevertheless, testing a source for leakage at the required intervals is important, as the potential does exist for leakage of these types of devices. Testing provides you and the NRC with a level of assurance that users and the public are not unnecessarily exposed to radioactive material. Regardless of the actual safety significance of this issue, the NRC considers this violation to be particularly serious, because your actions, as the Radiation Safety Officer (RSO), represented careless disregard for the regulation requiring leak testing. Careless disregard is considered a type of willful violation under our Enforcement Policy. Willful violations are of significant concern to the NRC, because our ability to ensure public health and safety is based, in part, on the commitment of licensees to implement regulatory requirements in a trustworthy, consistent, and reliable manner.

At the conference, you stated that the cause of the violation in Part I of the Notice was your difficulty in retaining the services of a consultant to assist you in adhering to regulatory requirements, including the performance of leak testing the Strontium-90 source. As the NRC emphasized at the conference, your safe and continued use of NRC licensed material is contingent upon your active role, as the RSO, in ensuring proper oversight of the use of this licensed material. As the holder of License No. 52-11897-01, you are responsible for ensuring compliance with regulatory requirements. The use of consultants to assist you does not relieve you of your responsibilities under your license to comply with regulatory requirements. In this case, you failed to exercise the necessary management oversight to ensure compliance, as evidenced by the repeated occurrence of this violation. Therefore, based on the willful nature of your actions (i.e., careless disregard for the requirement), this violation is classified in accordance with NUREG 1600, "General Statement of Policy and Procedures for NRC Enforcement Actions, Enforcement Policy – May 1, 2000," as a Severity Level III violation.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because the violation was determined to be willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit was determined not to be warranted for Identification because the non-compliance was identified by the NRC during our May 2, 2000, inspection. At the conference, you stated that your corrective actions included: (1) leak testing the source; (2) obtaining the services of a consultant, who will provide you and your staff with training on the applicable regulatory requirements involving the use of your source; (3) with the assistance of a consultant, developing an administrative tracking process to review and monitor the status of leak testing your source; and (4) conducting a review of the radiation safety program. Based on these actions, the NRC determined that your corrective actions were prompt and comprehensive, and credit was warranted for the factor of Corrective Action. This assessment results in a base civil penalty.

Therefore, to emphasize the need for maintaining proper management oversight of licensed material and in recognition of the significance of a willful violation of regulatory requirements, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice in the amount of $2,750 for the Severity Level III violation. Please be advised that future violations of a similar nature or other indications of your inability to effectively oversee your licensed material could result in suspension or termination of your license. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

Two additional violations, described in Part II of the Notice, were discussed at the predecisional enforcement conference. Violation II.A involved the failure to measure the ambient dose rates in areas where a source was stored as required by 10 CFR 35.59(h), and Violation II.B involved the failure to review at least annually the radiation protection program content and implementation as required by 10 CFR 20.1101. The details regarding the violations were documented in the subject inspection report. Based on their relative safety significance, the NRC has determined that these two violations should be characterized separately at Severity Level IV with no civil penalty. As discussed during the conference, you must comply with these requirements, and the assistance you are receiving from your consultant in conducting the annual review of the radiation safety program is an initial indication of your commitment to improving your regulatory performance.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. Although you described immediate corrective actions at the conference, including obtaining the services of a consultant, you attributed the violations to the loss of your previous consultant. As described above, NRC does not agree that this is the root cause of the violations. As the NRC license holder, your are responsible for activities conducted under the licensee; thus, your written response should address your understanding of your responsibilities under the licensee as well as planned actions in the event of the loss of your consultant. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further enforcement action is necessary to ensure compliance with NRC regulatory requirements.

Based upon the findings by the NRC and discussions during the predecisional enforcement conference, we understand that you have determined that some changes need to be made in the conduct of your NRC regulated activities. During a July 5, 2000, telephone conversation between you and Mr. Douglas Collins of my staff, you indicated that you planned to request that your license be amended to name a new RSO and to include a commitment that you will submit the results of your audits completed in accordance with 10 CFR 20.1101 to the NRC on an annual basis for the next three years. We agree with these actions and look forward to your amendment request.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

If you have any questions regarding this letter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety at (404) 562-4700.

		Sincerely,
		/RA/ BSM for
		Luis A. Reyes Regional Administrator

Docket No. 030-03529
License No. 52-11897-01

Enclosure:Notice of Violation and Proposed Imposition of Civil Penalty

cc w/ enclos: Commonwealth of Puerto Rico

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Roberto Buxeda-Dacri, M. D. Santurce, Puerto Rico

Docket No.: 030-03529 License No.: 52-11897-01 EA-00-141

During an NRC inspection conducted on May 2, 2000, violations of NRC requirements were identified. In accordance with NUREG 1600, "General Statement of Policy and Procedures for NRC Enforcement Actions, Enforcement Policy - May 1, 2000," the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:

I.	Violation Assessed a Civil Penalty 10 CFR 35.59(b)(2) requires, in part, that a licensee in possession of a sealed source test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State. Contrary to the above, the licensee failed to test for leakage a sealed source containing approximately 31 millicuries of Strontium-90 between January 1998 and May 2, 2000, an interval in excess of six months, and no other interval was approved by the Commission or an Agreement State. (01013)
This is a Severity Level III violation (Supplement VI). Civil Penalty – $2,750.
II.	Violations Not Assessed a Civil Penalty
A.	10 CFR 35.59(h) requires a licensee in possession of a sealed source or brachytherapy source to measure the ambient dose rates quarterly in all areas where such sources are stored. Contrary to the above, from March 1997 until May 2, 2000, a period in excess of a calendar quarter, the licensee had not measured the ambient dose rates in areas where a sealed source was stored. (02014)
This is a Severity Level IV violation (Supplement VI).
B.	10 CFR 20.1101 requires, in part, that each licensee shall develop, document, and implement a radiation protection program and shall periodically (at least annually) review the radiation protection program content and implementation. Contrary to the above, as of May 2, 2000, reviews of the content and implementation of the radiation protection program were not performed annually for calendar years 1996 to 1999. (03014)
This is a Severity Level IV violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Dr. Roberto Buxeda-Dacri (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an Order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violation listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalties should not be imposed. In addition to protesting the civil penalties in whole or in part, such answer may request remission or mitigation of the penalties.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: Mr. R. William Borchardt, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region II.

Your response will be made publicly available. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days after receipt.

Dated at Atlanta, Georgia
this 14^th day of July 2000