[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]
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