[Federal Register Volume 59, Number 104 (Wednesday, June 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13251]
[[Page Unknown]]
[Federal Register: June 1, 1994]
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NUCLEAR REGULATORY COMMISSION
[IA 94-12]
Kelli J. Hinds; Muncie, Indiana; Order Prohibiting Involvement In
Licensed Activities (Effective Immediately)
I
Ball Memorial Hospital, Muncie, Indiana (Ball or Licensee) is the
holder of Byproduct Material License No. 13-00951-03 issued by the
Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR
parts 30 and 35. The license authorizes the use of byproduct material
for medical purposes pursuant to 10 CFR part 35 (e.g., as
radiopharmaceuticals identified in 10 CFR 35.100, 35.200 and 35.300; as
brachytherapy sources identified in 10 CFR 35.400; as sealed sources
identified in 10 CFR 35.500; and as prepackaged in vitro kits
identified in 10 CFR 31.11). The facility where licensed materials are
authorized for use and storage is located at 2401 University Avenue,
Muncie, Indiana. The license, originally issued on August 19, 1958, was
last amended on February 24, 1994. The license was due to expire on
December 31, 1993, but continues in effect pursuant to 10 CFR 30.37(b).
Ms. Kelli J. Hinds was employed by Ball from October 17, 1988,
until her employment was terminated by Ball effective September 23,
1993. She most recently held the position of Acting Chief Nuclear
Medicine Technologist at Ball with responsibilities involving
compliance with NRC requirements for the use of byproduct materials.
II
On July 19, 1993, the NRC Region III Office received information
from an individual outside of the Licensee's organization that the
Licensee was investigating an allegation that it received from one of
its nuclear medicine technologists in early June 1993. NRC contacted
the Licensee to verify the information and determined that, allegedly,
the Acting Chief Nuclear Medicine Technologist at Ball Memorial
Hospital, Ms. Kelli J. Hinds, had increased the dosages of
radiopharmaceuticals used in nuclear medicine diagnostic studies in
order to reduce the imaging time and had falsified the records of the
dosage measurements. In mid-June 1993, during the Licensee's
investigation, Ms. Hinds admitted that she increased the dosages of
radiopharmaceuticals given to patients for nuclear medicine diagnostic
studies in order to minimize a patient's discomfort, to reduce the
duration of a study of a critically ill patient, or to enhance the
clarity of the image for a study performed on an obese patient. Based
on the Licensee's investigation, the Licensee terminated Ms. Hinds'
employment on September 23, 1993.
The NRC commenced an inspection on July 21, 1993, and determined
that, for approximately 10 percent of the lung, liver, bone and
gastrointestinal tract imaging studies using technetium-99m and xenon-
133 that she performed between October 1988 to June 1993, Ms. Hinds
increased the dosages of the radiopharmaceutical by as much as 40
percent above the approved dosage ranges without authorization from a
physician authorized user. Further, Ms. Hinds entered false information
in the dosage measurement records (i.e., dosages within the approved
range were indicated in the records even though the actual administered
dosages were higher). In addition, even after Ms. Hinds became Acting
Chief Nuclear Medicine Technologist in December 1992, she stated that
she requested and received approval from the Radiation Safety Committee
to increase dosage amounts for various studies but continued to
administer dosages greater than the authorized quantities without
physician approval and recorded false information. As a result of the
NRC inspection, a Confirmatory Action Letter (CAL) was issued to the
Licensee on July 26, 1993, and a Confirmatory Order was issued to the
Licensee on October 20, 1993 (EA 93-215). The CAL and Order documented
specific procedures and verifications to prevent any further
unauthorized increases in patient dosages.
The NRC Office of Investigations (OI) is conducting an
investigation of this matter. While the investigation has not been
completed, the available information establishes that, since 1988, Ms.
Hinds deliberately increased the dosges of NRC-licensed materials used
in certain nuclear medicine procedures and attempted to conceal the
increase in the dosage by falsifying the dosage measurement records. In
a transcribed sworn statement on September 1, 1993, Ms. Hinds stated
that she was aware of the authorized radiopharmaceutical dosage limits
at Ball and she admitted that, since 1988, she has increased the dosage
of radiopharmaceuticals given to some patients without express
authorization from a physician authorized user and that she falsified
the records of those radiopharmaceutical dosage measurements. Although
the NRC investigation is continuing, the following significant
violations have been identified to date:
A. Ms. Hinds' deliberate actions caused the Licensee to be in
violation of 10 CFR 35.25(a)(2) in that Ms. Hinds failed to follow the
instructions of the supervising physician authorized users as contained
in the Licensee's procedure, ``Approved Dose Ranges of
Radiopharmaceutical Use.'' That procedure specifies the radioisotope,
procedures and dosage ranges to be used. Ms. Hinds intentionally
increased the dosages beyond the range prescribed by the procedure.
B. Ms. Hinds' deliberate actions caused the Licensee to be in
violation of License Condition No. 16, which requires the Licensee to
implement the model safety rules published in NRC Regulatory Guide
10.8, appendix I, Item 14. Item 14 requires that each patient dosage be
assayed in the dose calibrator and prohibits the use of a dosage if it
is more than 10 percent off from the prescribed dosage. Ms. Hinds
indicated that she increased some patient dosages by 10-40%.
C. Ms. Hinds' deliberate actions caused the Licensee to be in
violation of 10 CFR 30.9(a), which requires that records required to be
maintained by a licensee be complete and accurate in all material
respects. More specifically, 10 CFR 35.53(c) requires that records of
the measurement of radiopharmaceutical dosages contain certain
information, including the prescribed dosage and activity of the dosage
at the time of measurement. Ms. Hinds admitted that from October 1988
to June 1993, she increased the activity of some radiopharmaceutical
dosages after the initial assay was performed and she did not enter
into the dosage measurement records the actual activity of the
radiopharmaceutical that was given to some patients. Rather, she
entered an activity level which was within the dosage range prescribed
by the physician authorized users at Ball.
The deliberate actions described in A-C above caused Ms. Hinds to
be in violation of 10 CFR 30.10(a)(1), which requires in part that any
employee of a licensee may not engage in deliberate misconduct that
causes or, but for detection, would have caused, a licensee to be in
violation of any rule, regulation, or order, or any term, condition, or
limitation of any license, issued by the Commission.
III
As the Licensee's Acting Chief Nuclear Medicine Technologist from
approximately December 1992 through June 1993, Ms. Hinds supervised the
other nuclear medicine technologists employed by Ball and Ms. Hinds was
responsible for ensuring that the Commission's rules, regulations, and
license conditions in her area of responsibility were met and the
records that were created to demonstrate compliance with the
Commission's rules, regulations, and license conditions were true and
accurate in all material respects.
As set forth above, Ms. Hinds engaged in deliberate misconduct from
October 1988 through June 1993, by increasing the dosages of
radiopharmaceuticals given to patients at Ball Memorial Hospital
without first receiving the approval of a physician authorized user as
required by the Commission's regulations. Ms. Hinds further engaged in
deliberate misconduct by entering false information into the dosage
measurement records for the dosages actually given to patients. These
actions constitute violations of 10 CFR 30.9, 35.25(a)(2), 35.53, and
Condition No. 16 of NRC Byproduct Materials License No. 13-00951-03 on
the part of the Licensee; and violations of 10 CFR 30.10 on the part of
Ms. Hinds.
Consequently, I lack the requisite reasonable assurance the NRC-
licensed activities can be conducted in compliance with the
Commission's requirements and that the health and safety of the public
will be protected, if Ms. Hinds is permitted at this time to supervise
or otherwise reengage in licensed activities. Therefore, the public
health, safety and interest require that Ms. Hinds be prohibited from
being involved in any NRC-licensed activities for a period of one year
from the date of this Order. In addition, for a three year period from
the date of the Order, the public health, safety and interest require
that Ms. Hinds be required to: (1) Provide a copy of this Order to any
prospective employer who engages in NRC-licensed activities at the time
that Ms. Hinds solicits or begins negotiating employment with such
prospective employer. The purpose of this notice is so that any
prospective employer is aware of Ms. Hinds' prohibition from NRC-
licensed activities for a period of 1 year from the date of this Order
and so that any prospective employer is aware of the Order prior to
making a decision regarding Ms. Hinds employment in NRC-licensed
activities for a period of 2 years following the 1 year prohibition
from NRC-licensed activities, and (2) notify the NRC of the acceptance
of employment involving NRC-licensed activities to assure that the NRC
can monitor the status of Ms. Hinds' compliance with the Commission's
regulatory requirements. Furthermore, pursuant to 10 CFR 2.202, I find
that the significance of the conduct described above is such that the
public health, safety and interest require that this Order be
immediately effective.
IV
Accordingly, pursuant to sections 81, 161b, 161c, 161i, 161o, 182
and 186 of the Atomic Energy Act of 1954, as amended, and the
Commission's regulations in 10 CFR 2.202, 10 CFR part 30, and 10 CFR
part 35, It Is Hereby Ordered, Effective Immediately, That:
A. Ms. Kelli J. Hinds is prohibited from engaging in NRC-licensed
activities for a period of one year from the date of this Order. NRC-
licensed activities are those activities which are conducted pursuant
to a specific or general license issued by the NRC, including, but not
limited to, those activities of Agreement State licensees conducted
pursuant to the authority granted by 10 CFR 150.20.
B. For a period of three years from the date of the Order, Ms.
Hinds shall:
1. Provide a copy of this Order to any prospective employer who
engages in NRC-licensed activities (as defined in A above) at the time
that Ms. Hinds solicits or begins negotiating employment with such
prospective employer. The purpose of this requirement is to ensure that
all prospective employers are aware of Ms. Hinds' prohibition from
engaging in NRC-licensed activities for a period of 1 year from the
date of this Order and are aware of the Order prior to making a
decision regarding Ms. Hinds' employment in NRC-licensed activities for
a period of 2 years following the 1 year prohibition from NRC-licensed
activities.
2. With 20 days of her acceptance of an employment offer involving
NRC-licensed activities, or her becoming involved in NRC-licensed
activities, provide notice to the Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, of the name,
address, and telephone number of the employer or the entity where she
is, or will be, involved in the NRC-licensed activities.
C. If Ms. Hinds is currently involved in NRC-licensed activities at
any employer or entity, Ms. Hinds shall, in accordance with Paragraph
IV.A above, immediately cease involvement in the NRC-licensed
activities and, within 20 days of the date of this Order, provide
notice to the Director, Office of Enforcement, at the address in
Paragraph IV.B.2 above, of the name, address, and telephone number of
the employer or entity where the licensed activities were being
conducted.
The Director, Office of Enforcement, NRC, may, in writing, relax or
rescind any of the above conditions upon demonstration by Ms. Hinds of
good cause.
V
In accordance with 10 CFR 2.202, Ms. Kelli J. Hinds must, and any
other person adversely affected by this Order may, submit an answer to
this Order, and may request a hearing within 20 days of the date of
this Order. 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 shall set forth the matters of fact and law on which
Ms. Hinds or other persons 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 Secretary, U.S. Nuclear Regulatory
Commission, ATTN: Chief, Docketing and Service Section, Washington, DC
20555. Copies also shall be sent to the Director, Office of
Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555;
to the Assistant General Counsel for Hearings and Enforcement at the
same address; to the Regional Administrator, Region III, U.S. Nuclear
Regulatory Commission, 801 Warrenville Road, Lisle, Illinois 60532-
4351; and to Ms. Hinds, if the answer or hearing request is by a person
other than Ms. Hinds. If a person other than Ms. Hinds request a
hearing, that person shall set forth with particularity the manner in
which his or her 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 Ms. Hinds 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), Ms. Hinds, or any person
adversely affected by this Order, may in addition to demanding a
hearing, at the time that 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 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. An Answer or a Request
for a Hearing Shall Not Stay the Immediate Effectiveness of This Order.
For The Nuclear Regulatory Commission
Dated at Rockville, Maryland, this 23rd day of May 1994.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards and
Operations Supports.
[FR Doc. 94-13251 Filed 5-31-94; 8:45 am]
BILLING CODE 7590-01-M