[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
