[Federal Register Volume 61, Number 211 (Wednesday, October 30, 1996)]
[Notices]
[Pages 56065-56068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27793]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-31873; License No. 52-25114-01; EA 96-154]


Jose L. Fernandez, M.D.,) San Juan, Puerto Rico; Order Modifying 
License (Effective Immediately)

I

    Jose L. Fernandez, M.D. (Licensee) is the holder of Byproduct 
Nuclear Material License No. 52-25114-01 (License) issued by the 
Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR 
Part 35. The License authorized the possession and use of a total of 
two strontium-90 sources not to exceed 150 millicuries for the 
treatment of superficial eye conditions on humans at medical facilities 
located at 160 Ponce de Leon Avenue, Puerta de Tierra, San Juan, Puerto 
Rico and at La Palma Building, Suite 1-A, Peral-De Diego Street, 
Mayaguez, Puerto Rico. The License, originally issued to the Licensee 
on March 22, 1991, was amended on January 14, 1994, and expired on 
February 28, 1996. Pursuant to 10 CFR 30.36(c), the Licensee is 
authorized to possess but not use licensed material.

II

    A routine, unannounced inspection of the Licensee's activities at 
the Mayaguez, Puerto Rico, facility was performed on October 18, 1995. 
During the inspection, an issue regarding the validity of the 
calibration of one of the Licensee's strontium-90 eye applicators and 
the possibility of multiple misadministrations was identified. The 
Licensee was unable to provide adequate documentation of source 
strength (i.e., a calibration from the National Institute of Standards 
and Technology or the source manufacturer).
    A Confirmatory Action Letter (CAL) was issued on October 19, 1995, 
which confirmed the Licensee's agreement to discontinue any use of the 
strontium-90 eye applicator and place it in storage until: (1) a 
Quality Management Program (QMP) was submitted to the NRC, and (2) NRC 
approved resumption of operations. Subsequently, a calibration of the 
source located at the Mayaguez office was performed by the source 
manufacturer, which indicated

[[Page 56066]]

that the source delivered approximately 53 centigrays per second, 
rather than the 24 centigrays per second that was assumed by the 
Licensee and used in treatments. The Licensee and the source 
manufacturer notified the NRC of the source dose rate on February 8, 
1996.
    Based on the fact that there was an error in the radiation dose 
rate and that this error caused patients to receive doses in amounts 
greater than that intended by the physician, the NRC issued a second 
CAL to the Licensee on February 9, 1996, to confirm that the Licensee 
would: (1) review, within 30 days, all patient radiation dose 
administrations performed at the Mayaguez office to identify any 
medical misadministrations; (2) comply with the notification and 
reporting requirements of 10 CFR 35.33 (within the time frame specified 
in the regulations) for each misadministration identified; and (3) 
maintain the strontium-90 sources in safe storage and refrain from 
using them until authorized by the NRC.
    The Licensee notified the NRC, via the NRC Operations Center, on 
March 1, 1996, that 71 patients had received misadministrations. In a 
letter received on March 15, 1996, the Licensee notified the NRC, in 
accordance with 10 CFR 35.33, that all patients determined to have 
received a misadministration had been notified in writing by March 8, 
1996. However, the written notification to the NRC failed to indicate 
whether the patients were notified within 24 hours of discovery, as 
required by 10 CFR 35.33(a)(3) and, if not, why not, and whether 
records of the misadministrations were retained by the Licensee as 
required by NRC requirements.
    To verify the status of the Licensee's actions to identify 
misadministrations and to complete patient notifications, the NRC 
conducted a second inspection at the Licensee's Mayaguez facility on 
April 8-10, 1996. During the inspection, the NRC determined, based on 
its review of Licensee records, that the Licensee had failed to: (1) 
identify 16 additional misadministrations that occurred since October 
1994, (2) notify, within 24-hours of discovery as required by 10 CFR 
35.33(a)(3), three individuals of their misadministrations, (3) provide 
written reports of misadministrations to three individuals within the 
15 days required by 10 CFR 35.33(a)(4), and (4) retain complete 
misadministration records as required by 10 CFR 35.33(b) in that only 
67 records were documented instead of the 71 originally identified by 
the Licensee (the four records were misplaced by the Licensee after the 
misadministrations were identified).
    In addition, during the October 1995 inspection, the Licensee 
informed the NRC that he had purchased the Mayaguez facility including 
one of the strontium-90 eye applicators in October 1994. Therefore, 
during the April 1996 inspection, the scope of the review was 
specifically confined to the period between October 1994 and October 
1995. However, the NRC determined that the initial date of operation 
(i.e., start of the possession and use of byproduct material at the 
Mayaguez facility) was not October 1994, as originally related by the 
Licensee. The Licensee actually took possession of the byproduct 
material in January 1994, prior to the change in ownership in October 
1994 and following receipt of the NRC's authorization to work under the 
Mayaguez license (amended on January 14, 1994). The NRC also determined 
that, during the period between January and October 1994, the 
Licensee's byproduct material had been used by an unauthorized user on 
at least two occasions, contrary to the requirements of 10 CFR 35.11. 
Moreover, the Licensee further identified 17 additional 
misadministrations that occurred during this period.
    Subsequently, in a June 13, 1996 letter to the Licensee, the NRC 
documented the results of a June 11, 1996 telephone call in which Dr. 
Fernandez agreed to hire an independent Health Physicist/Radiation 
Physicist consultant with expertise in therapy dosimetry calculations 
to perform a review of the Licensee's patient administration records to 
identify all misadministrations, to assess the completeness and 
accuracy of misadministration records, to determine if any unauthorized 
uses of byproduct materials had occurred, and to assist the Licensee in 
submitting a report to the NRC on the results of these reviews. On July 
10, 1996, the Licensee replied to the NRC's June 13, 1996 letter 
explaining Licensee difficulties in obtaining an independent consultant 
to complete the agreed-upon actions.
    During a third inspection on August 7 and 9, 1996, the NRC 
determined that certain of the patients, who received 
misadministrations and should have been notified of the 
misadministration verbally and in writing, stated that they had not 
received such notification. In addition, during this inspection the NRC 
identified seven additional misadministrations at the San Juan facility 
resulting from the failure to correct source strength to account for 
radioactive decay. These misadministrations appear to involve 
underdosing patients.
    By letter dated August 7, 1996, the NRC again requested the 
Licensee to provide to the NRC the name of a consultant and his 
credentials, and the Licensee's schedule for the completion of 
requested activities. The NRC also offered the Licensee the opportunity 
to participate in a predecisional enforcement conference. On August 20, 
1996, the Licensee replied to the NRC's August 7, 1996 letter 
reiterating the Licensee's inability to obtain a consultant, stating 
the intention to terminate the License, and declining the invitation to 
participate in a predecisional enforcement conference.
    As a result of the October 18, 1995, the April 8-10, 1996, and 
August 7 and 9, 1996 inspections, numerous violations were identified. 
The violations include the failure of the Licensee to: (1) establish 
and maintain a QMP, which included assurance that the radiation dose 
delivered was correct (i.e, the calibration of the applicator was 
correct), as required by 10 CFR 35.32 (the use of an inaccurate dose 
rate resulted in at least 104 misadministrations during the period 
January 1994 through October 1995); (2) maintain the security of 
byproduct material as required by 10 CFR 20.1801; (3) perform quarterly 
physical inventories of byproduct material as required by 10 CFR 
35.59(g); (4) test sealed sources for leakage at intervals not to 
exceed six months as required by 10 CFR 35.59(b); (5) notify 
individuals of a misadministration within 24 hours of discovery as 
required by 10 CFR 35.33(a)(3); (6) provide written reports to 
individuals within 15 days of discovery of a misadministration as 
required by 10 CFR 35.33(a)(4); (7) maintain misadministration records 
as required by 10 CFR 35.33(b); and (8) amend his license prior to 
permitting an individual to work as an authorized user as required by 
10 CFR 35.11.
    Representatives from NRC Region II met with the Licensee on 
September 27, 1996, and again the Licensee informed the staff that it 
intended to obtain a consultant to review its activities. At that 
meeting, NRC provided the Licensee with a list of consultants in Puerto 
Rico that might be considered. On October 3, 1996, the Licensee called 
the NRC to request that the NRC provide another copy of the 
consultant's list because it had lost the one provided on September 27, 
1996. At that time the Licensee stated that it planned to review the 
records, with the assistance of a consultant.

III

    Based on the above, the Licensee has demonstrated a significant 
lack of

[[Page 56067]]

control and attention to licensed activities. Specifically, the 
Licensee has failed to use accurate radiation dose rates for the 
strontium-90 eye applicators which resulted in numerous 
misadministrations and has repeatedly failed to fully evaluate and 
identify the number of misadministrations. This raises a significant 
concern as the patients, depending on the doses received, may develop 
complications, and without appropriate follow-up actions, these 
complications may go unrecognized and serious consequences may occur.
    Furthermore, the Licensee has failed to: (1) establish and maintain 
a QMP as required by 10 CFR 35.32; (2) maintain the security of 
byproduct material as required by 10 CFR 20.1801; (3) perform quarterly 
physical inventories of byproduct material as required by 10 CFR 
35.59(g); (4) test sealed sources for leakage at intervals not to 
exceed six months as required by 10 CFR 35.59(b); (5) notify 
individuals of a misadministration within 24 hours of discovery as 
required by 10 CFR 35.33(a)(3); (6) provide written reports to 
individuals within 15 days of discovery of a misadministration as 
required by 10 CFR 35.33(a)(4); (7) maintain misadministration records 
as required by 10 CFR 35.33(b); and (8) amend his license prior to 
permitting an individual to work as an authorized user as required by 
10 CFR 35.11.
    The Licensee has failed to honor its commitment to obtain a 
qualified consultant to review its patient records to assure as 
required by the Commission's regulations that all misadministrations 
are identified and proper patient notifications have been made. As a 
result, given the Licensee's past performance, the NRC does not have 
adequate assurance that all misadministrations have been identified, 
properly evaluated, and the involved patients properly notified.
    It is imperative that licensees conduct activities in accordance 
with NRC requirements and with the requisite sensitivity and attention 
to detail, especially with respect to the amount of radiation delivered 
to individuals. In addition, the Commission must be able to rely on its 
licensees to provide complete and accurate information.
    Consequently, I have concluded that the Licensee has failed to 
comply with a number of significant NRC requirements and that the 
actions Ordered in Section IV of this Order are required to protect the 
public health and safety. Given the number of misadministrations 
identified to date, the number of violations committed to date by the 
Licensee, the potential consequences to patients if not identified, 
notified, and monitored, the difficulty in locating patients over time, 
and the lack of meeting license requirements and commitments, I have 
concluded, pursuant to 10 CFR 2.202, that the public health and safety 
requires that this Order be immediately effective.

IV

    Accordingly, pursuant to Sections 81, 161b, 161i, 161o, 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 Parts 30 and 35, it is hereby 
ordered, effective immediately, that license No. 52-25144-01 is 
modified as follows:
    A. Within 30 days of the date of this Order, the Licensee shall 
submit to the Regional Administrator, NRC, Region II, for approval, the 
credentials of an independent Health Physicist/Radiation Physicist 
Consultant with expertise in therapy dosimetry calculations.
    B. The Licensee shall ensure that, within 45 days of acceptance of 
the consultant by the NRC, the Consultant:
    1. Performs, independent of the Licensee, a review of all patient 
radiation doses administered by the Licensee at the Mayaguez facility 
to identify all medical misadministrations that occurred between 
January 1994 and October 1995 and assure that the dose records are 
complete and accurate.
    2. Reviews the Licensee's misadministration records to verify 
completeness and accuracy in reference to the requirements of 10 CFR 
35.33. To the extent possible, incomplete records shall be 
appropriately corrected. Where records of individuals may not be 
accurately reconstructed, the consultant shall assume that the 
individual has received a misadministration based on 53 centigrays per 
second, rather than the 24 centigrays per second that was assumed by 
the Licensee and used in treatments.
    3. Reviews the Licensee's radiation dose administration records to 
determine if any additional unauthorized uses of byproduct material 
occurred between January 1994 and October 1995.
    4. Reviews the Licensee's misadministration notification records to 
identify any misadministrations where notification was not provided to: 
(a) the NRC as required by 10 CFR Part 35.33(a)(2); and (b) all 
affected patients and referring physicians as required by 10 CFR 
35.33(a)(3) and (4).
    5. Assists the Licensee in the review and submission to the NRC of 
an updated/revised report pursuant to 10 CFR 35.33(a)(2).
    C. Within 60 days of acceptance of the consultant by the NRC, the 
Licensee shall:
    1. Submit an updated, final report to the NRC, Regional 
Administrator, Region II, of all misadministrations, pursuant to 10 CFR 
35.33(a)(2), including a listing of any additional unauthorized uses of 
byproduct material that occurred between January 1994 and October 1995.
    2. Notify the referring physician and individuals who received 
misadministrations, including those individuals whose records may not 
be accurately reconstructed, of the misadministrations, pursuant to 10 
CFR 35.33(a)(3).
    D. The Licensee shall not receive or use any licensed material and 
shall maintain the strontium-90 sources in locked, safe storage until 
the material is transferred to an authorized recipient.
    E. The Licensee shall, within 90 days of this Order, transfer all 
strontium-90 sources in its possession to an authorized recipient and 
provide to the Regional Administrator, Region II, a completed Form-314.
    The Regional Administrator, Region II, may, in writing, relax or 
rescind any of the above conditions upon demonstration by the Licensee 
of good cause.

V

    In accordance with 10 CFR 2.202, the Licensee must, and any other 
person adversely affected by this Order may, submit an answer to this 
Order, and may request a hearing on this Order, within 20 days of the 
date of this Order. 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. The 
answer may consent to this Order. Unless the answer consents to this 
Order, the answer shall, in writing and under oath or affirmation, 
specifically admit or deny each allegation or charge made in this Order 
and set forth the matters of fact and law on which the Licensee or 
other person adversely affected relies and the reasons as to why the 
Order should not have been issued. Any answer or request for a hearing 
shall be submitted to the Director, Office of Enforcement, U.S. Nuclear 
Regulatory Commission, Washington, D.C. 20555, with a copy to the 
Commission's Document Control Desk, Washington, D.C. 20555. Copies also 
shall be sent to the Assistant General Counsel for Hearings and

[[Page 56068]]

Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 
20555, to the Regional Administrator, NRC Region II, 101 Marietta St., 
NW, Suite 2900, Atlanta, GA 30323-0199, and to the Licensee if the 
answer or hearing request is by a person other than the Licensee. If a 
person other than the Licensee 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 the Licensee or 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 Order 
should be sustained.
    Pursuant to 10 CFR 2.202(c)(2)(i), the Licensee, or any other 
person adversely affected by this Order, may, in addition to demanding 
a hearing, at the time the answer is filed or sooner, move the 
presiding officer to set aside the immediate effectiveness of the Order 
on the ground that the Order, including the need for immediate 
effectiveness, is not based on adequate evidence but on mere suspicion, 
unfounded allegations, or error.
    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 October 1996.

    For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards and 
Operations Support.
[FR Doc. 96-27793 Filed 10-29-96; 8:45 am]
BILLING CODE 7590-01-P