EA-97-627 - De León, José N., M. D.

April 28, 1998

EA 97-627

Dr. José N. De León, M. D.
Condominio Castillo Del Mar
Suite #1427
Isla Verde, PR 00979

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $5,000 AND EXERCISE OF DISCRETION (NRC SPECIAL INSPECTION REPORT NO. 52-19206-01/97-01)

Dear Dr. De León:

This refers to the inspection conducted on December 11, 1997, at your facility in Isla Verde, Puerto Rico, and a medical consultant's review completed on February 20, 1998. The purpose of the inspection was to determine whether activities authorized by the license, specifically the use of a Strontium-90 (Sr-90) eye applicator, were conducted safely and in accordance with regulatory requirements. The results of the inspection were discussed with you at exit meetings on December 11 and 15, 1997, and formally transmitted to you by letter dated January 30, 1998. The results of the review by our medical consultant were transmitted to you on February 24, 1998. You responded to the conclusions of the medical report on April 9, 1998.

An open and transcribed predecisional enforcement conference was conducted in Isla Verde, Puerto Rico on March 2, 1998, with you to discuss the apparent violation, root causes, and corrective actions to preclude recurrence. A list of conference attendees and copies of the Nuclear Regulatory Commission's (NRC's) slides are enclosed. The apparent violation involved the failure to establish and maintain Quality Management Program (QMP) procedures for the use of strontium-90 in ophthalmic brachytherapy.

Based on the information developed during the inspection, the information you provided during the conference, and your letter of April 9, 1998, the NRC has determined that two examples of a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice), and the circumstances surrounding it are described in detail in the subject inspection report. The first example of the violation is associated with the failure to include in your QMP a written procedure to meet the objective of 10 CFR 35.32(a)(3) that final plans of treatment and related calculations for brachytherapy were in accordance with written directives. Specifically, between June 1, 1994 and July 3, 1996, your written QMP failed to include a procedure to verify the Sr-90 eye applicator surface dose rate, a key factor in calculations for brachytherapy, to account for radioactive material decay. On April 27, 1995, you submitted to the NRC an amended QMP which contained a revised treatment time necessary to achieve a 2,000 centigray dose, based on calculations performed by a Health Physics Consultant. These calculations contained a significant decay factor error that was used to determine the proper treatment time; however, you failed to identify this error. As a result, misadministrations of radiation dose to nine patients occurred, where each received approximately 4,000 centigrays instead of the intended dose of approximately 2,000 centigrays. The second example of the violation also involves the failure to include in your QMP a written procedure to meet the objective that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

Based on the NRC's medical consultant's evaluation of the significance of the nine misadministrations that occurred at your office, the violation is of significant regulatory concern because of the potential safety consequences to the patients, in that the probability of adverse consequences (i.e., cataract formation) to these patients has somewhat increased. The violation also is of particular regulatory concern due to the programmatic nature of the issues and the lack of oversight of Sr-90 treatments. Therefore, this violation has been categorized at Severity Level III in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, for a Severity Level III violation occurring before November 12, 1996, a base civil penalty of $2,500 is considered. However, in this case, the NRC determined the violation to be particularly egregious because you were directly responsible for nine misadministrations at your facility. You should have realized the significant change in treatment time calculated for you by a Health Physics Consultant when you amended your QMP by letter to the NRC dated April 27, 1995, and taken further action to verify the accuracy of the calculations prior to treatment of patients. Had you done this, all the misadministrations could have been prevented. Thus, the NRC is exercising discretion in accordance with Section VII.A.1 of the Enforcement Policy and proposing a civil penalty that is twice the base civil penalty.

Therefore, to emphasize the importance of conducting safe and compliant brachytherapy programs, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice for twice the base amount (i.e., $5,000) for the Severity Level III violation. Issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort. In addition, you should be aware that future similar violations may result in a prohibition against conducting licensed activities in NRC jurisdiction.

Since you have indicated your intent to discontinue use of your Sr-90 eye applicator in the future, the NRC will consider withdrawing the proposed civil penalty if you properly dispose of or transfer the Sr-90 eye applicator in accordance with existing regulations. If you decide to do so, you should specify in your response to the enclosed Notice the date on which this action will be completed, and provide written confirmation to the NRC when you have properly disposed of or transferred the Sr-90 eye applicator.

In addition to the misadministration of radiation doses to nine patients at your facility, you were directly responsible for 14 additional misadministrations at Ryder Memorial Hospital. Enclosure 2 documents the circumstances surrounding these misadministrations. The NRC also considers these misadministrations to be significant because: (1) they highlight your carelessness or lack of regard for your responsibilities as a user of byproduct material at Ryder Memorial Hospital, after being informed by the hospital that you could not use the Sr-90 source under their license; and (2) the hospital was not specifically listed as a location of use on your license.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and any response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

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

Sincerely, Luis A. Reyes Regional Administrator

Docket No. 030-17134
License No. 52-19206-01

Enclosures:
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. Misadministrations at Ryder Memorial Hospital
3. NRC Presentation Material
4. List of Attendees

cc w/ encls:
Commonwealth of Puerto Rico

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

José N. De León, M. D. Isla Verde, Puerto Rico

Docket No. 030-17134 License No. 52-19206-01 EA 97-627

During an NRC inspection conducted on December 11, 1997, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, 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 violation and associated civil penalty are set forth below:

10 CFR 35.32(a) requires, in part, that the licensee establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.

Pursuant to 10 CFR 35.32(a)(3), the quality management program (QMP) must include written policies and procedures to meet the specific objective that final plans of treatment and related calculations for brachytherapy are in accordance with a written directive, which is defined in 10 CFR 35.2.

10 CFR 35.2 defines a written directive for brachytherapy as an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of radiation, containing (1) prior to implantation: the radioisotope, number of sources, and source strengths; and (2) after implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).

Pursuant to 10 CFR 35.32(a)(5), the quality management program must include written policies and procedures to meet the specific objective that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

Contrary to the above,

A. Between June 1, 1994 and July 3, 1996, the licensee's quality management program did not include a written procedure to meet the objective that final plans of treatment and related calculations for brachytherapy were in accordance with written directives. Specifically, the licensee's written QMP failed to include a procedure to correct the eye applicator surface dose rate, a key factor for related calculations for brachytherapy, to account for radioactive material decay. As a result, nine misadministrations occurred.

B. Between June 1, 1994 and July 3, 1996, the licensee's QMP did not include a written procedure to meet the objective that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken. (01013)

This is a Severity Level III violation (Supplement VI).
Civil Penalty – $5,000.

Pursuant to the provisions of 10 CFR 2.201, Dr. José N. De León (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 to 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 by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, 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 penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

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, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, 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.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated at Atlanta, Georgia
this 28th day of April 1998