EA-97-137 - Fernández, José L., M.D.

June 11, 1997

EA 97-137

José L. Fernández, M.D.
160 Ponce de León Avenue
Puerta de Tierra
San Juan, Puerto Rico 00901

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $8,000 (NRC INSPECTION REPORT NOS. 52-25114-01/95-01 AND 96-01 AND NRC ORDER MODIFYING LICENSE NO. 52-25114-01)

Dear Dr. Fernández:

This letter transmits a Notice of Violation and Proposed Imposition of Civil Penalty (Notice) associated with the conduct of activities authorized under your Nuclear Regulatory Commission (NRC) License No. 52-25114-01. This action is based on inspections conducted on October 18, 1995, April 8-10, 1996, and August 7 and 9, 1996, and your actions in response to the "Order Modifying NRC Materials License No. 52-25114-01," (Order) issued by the NRC on October 21, 1996. Also, on March 31, 1997, as required by the Order, you submitted a report to the NRC discussing the results of your consultant's review of patient records, your enumeration of the number of misadministrations, and the status of patient and NRC notifications. The results of NRC's review of the issues associated with the subject documents were formally transmitted to you by letter dated April 11, 1997. That letter also provided you an opportunity to either respond to the apparent violations in writing or request a predecisional enforcement conference. Subsequently, you declined a conference and indicated your intention to respond to the apparent violations in writing. On May 9, 1997, you submitted additional information to us regarding the apparent violations, the reasons for the violations, and the corrective steps that had been taken, as requested in our letter dated April 11, 1997. We have reviewed the inspection results and the additional information you provided and have concluded that sufficient information is available to determine the appropriate enforcement action in this matter.

Based on the information developed during the inspections, your actions associated with the October 21, 1997, Order, and the information that was provided in your March 31 and May 9, 1997, submittals, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice), and the circumstances surrounding them are described in detail in the previously referenced documents.

The violations involved numerous failures to comply with regulatory requirements and the conditions of your NRC license and included the following: (1) the failure to establish a Quality Management Program (QMP) for the administration of strontium-90 (Sr-90) brachytherapy doses; (2) the failure to appropriately secure and/or control licensed material located in an unrestricted area; (3) the failure to limit use of licensed material to only those individuals authorized to use licensed material by your NRC license; (4) the failure to notify three patients of misadministrations to them within 24 hours of discovery; (5) the failure to provide a written report to three individuals regarding misadministrations to them and the potential consequences of the misadministration within 15 days of discovery; (6) the failure to leak test sealed sources at six-month intervals; (7) the failure to conduct a physical inventory of brachytherapy sources every calendar quarter; (8) the failure to transfer licensed material to an authorized recipient; and (9) the failure to transfer licensed material within the 90 days specified in NRC's Order of October 21, 1996.

In your response dated May 9, 1997, you admitted the violations with the exception of Violation B related to the security of licensed material. In your response, you stated that the source was always kept in a locked room and that a key was maintained in a secure place in the administration office of the Mayagüez clinic. In evaluating your position, the NRC considered the circumstances of the violation and noted the following: (1) at the time of the October 18, 1995, inspection, the Sr-90 source was located in a small, unlabeled box; (2) the box containing the source was locked; however, it was located in an unlocked storage room which was accessible to clinic staff; and (3) although entry to the storage room was somewhat controlled by the presence of a receptionist, surveillance of the storage room was not constant such that access to the source was possible by unauthorized clinic staff, patients, and members of the public. Based on discussions with the clinic staff, these were also the same circumstances of source storage during the period January 1994 through October 1995, with the key to the storage box being placed in the possession of an individual who was not knowledgeable of source control requirements (and who apparently permitted access to the source by an unauthorized user). For these reasons, the NRC concluded that Violation B should be cited as originally described in our letter of April 11, 1997.

Several of the violations in the enclosed Notice stemmed from the failure to assure that one of your eye applicators containing Sr-90 and used for patient eye treatment was properly calibrated. As a consequence, more than 200 misadministrations occurred during the period January 1994 through October 1995. Eye doses to these patients were determined to be more than two times greater than the intended dose, with the maximum being approximately 13,600 centigrays. Although the ultimate health impact of the overexposures to the patients is not fully known at this time, the violations are of very significant regulatory concern. The NRC would have expected you would have acquired the calibration certificate for the Sr-90 eye applicator or had the device output determined by an accredited testing facility, rather than relying on the information labelled on the box. The violations represent a significant lack of program oversight and are clearly indicative of your careless disregard for regulatory requirements.

As delineated in the Notice, the violations are not isolated to one program area (i.e., the failure to have a QMP); they encompass numerous facets of your NRC regulated brachytherapy program. Notwithstanding the programmatic scope of the identified noncompliances, your overall record of poor performance prior to and after identification of these issues further reflects the lack of importance you placed on regulatory compliance. Examples of this lack of regard include: (1) your failure to verify the output of the Sr-90 source prior to using it for brachytherapy treatments, even though no certification or traceable calibration was available to support the annotated source output; (2) your failure to establish and implement a QMP by July 1994 when the requirement became effective; (3) your failure to establish and implement a QMP as advised in Information Notice (IN) 94-17, "Strontium-90 Eye Applicators: Submission of Quality Management Plan (QMP), Calibration, and Use," dated March 11, 1995, a notice you acknowledged receiving; (4) your lack of rigor in the initial reviews of patient records to identify the total number of misadministrations which necessitated an NRC Order for you to obtain an independent consultant to accurately complete the review; (5) the protracted period of time you needed to contract the services of a qualified consultant to perform the records review; (6) your delay in transferring both of your Sr-90 sources when required to do so by an NRC Order; and (7) your failure to transfer the two Sr-90 sources to an authorized recipient.

The NRC distinguishes between the unavoidable risks attendant in properly following prescribed procedures and the unacceptable risk of improper or careless use of licensed material. The NRC is responsible, as part of its public health and safety mission, for establishing and enforcing regulations that protect the public from the risk of improper and careless use of licensed material. Therefore, based on the circumstances described above, the violations are classified in the aggregate in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level II problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $4,400 is considered for a Severity Level II problem occurring on or continuing after November 12, 1996 (61 Federal Register 53554). However, since most of the violations occurred prior to November 12, 1996, the base civil penalty considered for this case is $4,000 (NUREG-1600, July 1995). In accordance with the civil penalty assessment process described in Section VI.B.2 of the Enforcement Policy, the NRC considered whether credit was warranted for the factors of Identification and Corrective Action. The NRC determined that credit for Identification was not warranted in that the violations cited in the Notice were identified by NRC. Regarding Corrective Action, since October 1995, you obtained a source calibration for the eye applicator located at the Mayagüez clinic; discontinued use of both Sr-90 sources possessed under your NRC license; submitted a QMP to the NRC; completed a review of the total number of misadministrations; reported the records review results to patients and the NRC; and implemented the actions described in your March 31 and May 9, 1997, responses. Based on the above and the fact that significant NRC involvement and intervention¹ were required to ensure that actions were appropriately completed, the NRC concluded that credit was not warranted for Corrective Action which results in a civil penalty assessment of two times the base amount.

Therefore, to emphasize the importance of conducting safe and compliant brachytherapy programs and the need for prompt and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $8,000 for the Severity Level II problem.

Also, please be aware that, contrary to the statements in your March 31 and May 9, 1997, letters to the NRC, your NRC byproduct material License No. 52-25114-01 has not been terminated, although it expired on February 28, 1996. We recognize that you transferred your licensed material pursuant to the October 21, 1996, Order and that your August 20, 1996, letter to Mr. José Díaz Vélez of the NRC Region II office indicated your intent to terminate the license. However, in accordance with 10 CFR 30.36(c), your license is not terminated until NRC formally notifies you in writing of such termination. We will address this matter in future correspondence.

The NRC has concluded that information regarding the reason for the violations and the corrective actions taken are already adequately addressed on the docket in your letters to the NRC dated March 31 and May 9, 1997. Therefore, you are not required to comply with the provisions of 10 CFR 2.201 unless the description therein does not accurately reflect your actions or position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice. You are, however, required to respond to the proposed imposition of civil penalty and should do so in accordance with the instructions in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and any response you may provide will be placed in the NRC Public Document Room (PDR).

Sincerely,

Original signed by Luis A. Reyes Regional Administrator

Docket No. 030-31873
License No. 52-25114-01

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encl:
Commonwealth of Puerto Rico
Secretary of Health
Board of Medical Examiners

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

José L. Fernández, M.D. San Juan, Puerto Rico

Docket No. 030-31873 License No. 52-25114-01 EA 97-137

During an NRC inspection conducted on October 18, 1995, April 8-10, 1996, and August 7 and 9, 1996, violations of NRC requirements were 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 violations and associated civil penalty are set forth below:

A. 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.

Contrary to the above, between July 1, 1994, and October 18, 1995, the licensee failed to establish a written quality management program to govern its use of eye applicators containing strontium-90 (Sr-90) for the administration of brachytherapy radiation doses at its Mayagüez and San Juan, Puerto Rico offices. Consequently, numerous patients were administered radiation doses which were not as directed by the authorized user. (01012)

B. 10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas.

10 CFR 20.1802 requires that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.

As defined in 10 CFR 20.1003, "unrestricted area" means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, the licensee failed to comply with the requirements of 10 CFR 20.1801 and 20.1802 as evidenced by the following:

1. Between January 1994 and October 1994, the licensee failed to secure from unauthorized removal or access an eye applicator containing approximately 83 millicuries (mCi) of Sr-90, located in a materials storage room, an unrestricted area, nor did the licensee control or maintain constant surveillance of this licensed material. Specifically, the licensee amended its license to include a new place of use at an office in Mayagüez, Puerto Rico, took possession of the source, and left it unattended at the new place of use until the purchase of the practice and source from the previous licensee was finalized in October 1994.

2. Between October 1994 and October 18, 1995, following initiation of licensed activities at the Mayagüez office, the licensee failed to secure from unauthorized removal or access an eye applicator containing approximately 83 mCi of Sr-90, located in a materials storage room, an unrestricted area , nor did the licensee control or maintain constant surveillance of this licensed material. (01022)

C. License Condition No. 12 of NRC License No. 52-25114-01 requires that licensed material be used only by José L. Fernández, M.D., the licensee.

Contrary to the above, as of August 4, 1995, the licensee permitted an individual, other than José L. Fernández, M.D., to use licensed material on at least two occasions on human beings. (01032)

D. 10 CFR 35.33(a)(3) requires, in part, for a misadministration, that the licensee notify the patient, within 24 hours after discovery of the misadministration.

10 CFR 35.2 defines, in part, "misadministration," to mean an administered brachytherapy radiation dose that differs from the prescribed dose by more than 20 percent of the prescribed dose.

Contrary to the above, on March 1, 1996, the licensee became aware that 71 misadministrations occurred, but did not notify three of the 71 patients about the misadministrations until April 8, 1996, a period greater than 24-hours after discovery of the misadministrations. (01042)

E. 10 CFR 35.33(a)(4) requires, in part, for a misadministration, that the licensee furnish, within 15 days after discovery of the misadministration, a written report to the patient by sending either:

(1) a copy of the report that was submitted to the NRC; or (2) a brief description of both the event and the consequences as they may affect the patient, provided a statement is included that the report submitted to the NRC can be obtained from the Licensee.

Contrary to the above, on March 1, 1996, the licensee became aware that 71 misadministrations occurred, and the licensee notified the NRC on March 1, 1996, but did not notify three of the 71 patients about the misadministration until April 8, 1996, a period greater than 15 days after the discovery of the misadministrations. (01052)

F. 10 CFR 35.59(b)(2) requires, in part, that the 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, as of October 18, 1995, the licensee had not tested a sealed source containing approximately 83 mCi of Sr-90 for leakage since January 1994, an interval in excess of six months, and no other interval had been approved by the Commission. (01062)

G. 10 CFR 35.59(g) requires, in part, that a licensee in possession of a sealed source or brachytherapy source conduct a quarterly physical inventory of all such sources in its possession.

Contrary to the above, the licensee did not conduct a physical inventory of its brachytherapy sources during the period January through October 1994, a period in excess of a calendar quarter. (01072)

H. 10 CFR 30.41(a) and (b)(5) require, in part, that no licensee transfer byproduct material except to a person authorized to receive such byproduct material under the terms of a specific or general license or their equivalents issued by the Commission or an Agreement State.

10 CFR 30.41(c) requires that, prior to transferring byproduct material, the licensee verify that the transferee's license authorizes the receipt of the type, form, and quantity of byproduct material to be transferred. 10 CFR 30.41(d) specifies acceptable methods for this verification.

Contrary to the above, on February 20 and 26, 1997 the licensee transferred two sources containing approximately 83 mCi and 20 mCi of Sr-90, respectively, to Rafael Cavero, M.D., a person who was not authorized to receive such byproduct material under the terms of a specific license issued by the City of New York, Bureau of Radiological Health. None of the acceptable methods of verification specified in 10 CFR 30.41(d) were utilized by the licensee. (01082)

I. 10 CFR 30.34 states, in part, that each license issued or granted under Parts 31 through 36 and 39 of 10 CFR is subject to all valid rules, regulations, and Orders of the Commission.

Item IV.E of the "Order Modifying NRC Materials License No. 52-25114-01," issued on October 21, 1996, required that the licensee, within 90 days of the date of the Order (October 21, 1996), transfer all Sr-90 sources in its possession to an authorized recipient and provide to the Regional Administrator, Region II, Atlanta, Georiga, a completed NRC Form-314.

Contrary to the above, the licensee shipped the Sr-90 source located at the Mayagüez office on February 20, 1997, and the source located at the office in San Juan, Puerto Rico on February 26, 1997, to a physician in the city of New York; however, the transfers were not executed within 90 days of October 21, 1996, as specified in the Order. (01092)

This is a Severity Level II problem (Supplements IV and VI).
Civil Penalty – $8,000

The NRC has concluded that information regarding the reason for the violations, the circumstances surrounding the violations and the actions taken in response to them have already been adequately addressed on the docket in your letters to the Commission dated March 31 and May 9, 1997. However, Dr. José L. Fernández (Licensee) is required to submit a written statement or explanation pursuant to 10 CFR 2.201 within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty if the description therein does not accurately reflect the corrective actions taken or his position. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, any response shall be submitted under oath or affirmation.

Within the same time as provided for the response noted above, Dr. Fernández 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 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 2.206 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 violations 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.

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 U. S. 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 responses noted above (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. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

Dated at Atlanta, Georgia
this 11th day of June 1997

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¹ This involvement included October 19, 1995, and February 9, 1996, Confirmatory Action Letters, an October 21, 1996, Order Modifying License, and numerous pieces of correspondence, indicating the need for you to comply with regulatory requirements.