[Federal Register Volume 64, Number 46 (Wednesday, March 10, 1999)]
[Notices]
[Pages 11954-11956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5872]
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NUCLEAR REGULATORY COMMISSION
[IA 98-006]
Gary Isakoff; Order Prohibiting Involvement in NRC-Licensed
Activities
I
Mr. Gary Isakoff (Mr. Isakoff) was the Assistant Chief Nuclear
Medicine Technologist in the Nuclear Medicine Department (NMD) of
Temple University Hospital (TUH or licensee) between December 1990 and
February 13, 1997. TUH holds Facility License No. 37-00697-31, issued
by the Nuclear Regulatory Commission (NRC or Commission) pursuant to 10
CFR Parts 30 and 35, which authorizes TUH to use byproduct material for
medical use and research and development.
II
Between January 15 and September 30, 1997, an investigation was
conducted by the NRC Office of Investigations (OI) to determine if Mr.
Isakoff, while functioning as the Assistant Chief Nuclear Medicine
Technologist (a first line supervisor), deliberately falsified a record
of a weekly wipe test survey for removable contamination of the hot
lab. A second OI investigation was conducted between January 20 and
August 31, 1998, to determine whether Mr. Isakoff routinely failed to
record or to accurately record on Dose Dispensing Forms (DDFs)
information required by 10 CFR 35.53, pertaining to the administration
of radiopharmaceutical doses to patients, and whether Mr. Isakoff
boosted doses of radiopharmaceuticals to patients above the prescribed
dosages without authorization from an authorized user. A predecisional
enforcement conference was held with Mr. Isakoff on November 19, 1998.
TUH is required to conduct surveys for removable contamination once
each week of all areas where radiopharmaceuticals are routinely
prepared for use, administered or stored, and to retain a record of
each such survey for three years. 10 CFR 35.70 (e) and (h). Mr. Isakoff
maintained at the predecisional enforcement conference that he did in
fact perform a weekly wipe test survey of the hot lab for removable
contamination on Saturday, September 28, 1996, and that he accurately
recorded the results of that survey. Based upon all the evidence, the
NRC staff concludes, for reasons explained below, that Mr. Isakoff did
not perform a wipe test survey of the hot lab for the week ending
September 28, 1996, and that he deliberately created licensee records
to falsely indicate that he had performed a weekly wipe test survey of
the hot lab on September 28, 1996.
Due to a boil-over, a spill of a Technetium-99m sulfur colloid had
occurred in the hot lab on Thursday, September 26, 1996. A Nuclear
Medicine Technologist (NMT) stated to investigators that on Monday,
September 30, 1996, Mr. Isakoff instructed her to tell anyone who asked
that she had performed a wipe test survey of the hot lab on September
28. That NMT had not performed such a survey on September 28, 1996. A
second NMT overheard Mr. Isakoff's instruction. On Tuesday, October 1,
Mr. Isakoff asked the first NMT if the NRC, which was at the facility
conducting an inspection on that date, had inquired about the weekly
wipe test survey during its visit. The NMT told Mr. Isakoff that she
would not lie if asked about the weekly wipe test survey. On Wednesday,
October 2, Mr. Isakoff told the NMT that he ``forgot'' that he did come
in on Saturday, September 28, and that he had in fact performed a wipe
test survey of the hot lab on that date. Mr. Isakoff stated at the
enforcement conference that because of the spill, he and others
expected that the NRC would come to TUH the following week, and as a
result, he worked on Saturday, September 28, to ensure that everything
was perfect, and is certain he performed the weekly wipe test survey
that day.
There is no reliable documentary evidence to corroborate Mr.
Isakoff's statement that he was in the NMD on Saturday, September 28,
and no witness to his presence. Mr. Isakoff did not have on-call
responsibilities and thus was not scheduled to work on weekends. He
stated that, nonetheless, he frequently worked evenings during the
week, and on Saturdays or Sundays approximately once or twice per
month, in order to complete paperwork and make sure tests such as wipe
surveys and bar phantom tests had been performed, and that he made a
point of informing his supervisors when he did so. The Chief NMT,
however, stated that Mr. Isakoff did not mention working on Saturdays
[[Page 11955]]
or on September 28, 1996, until several weeks later, after the licensee
became aware that the September 28, 1996, wipe test record might have
been falsified.
Although the wipe test instrument register automatically prints the
date and time of a wipe test on the instrument register strip, that
portion of the strip showing the date and time of the wipe test, which
Mr. Isakoff claims to have performed on September 28, 1996, was missing
and appears to have been deliberately torn off. The register strip was
stapled to a department wipe test form dated September 28 and signed by
Mr. Isakoff.
The only other documentary evidence of Mr. Isakoff's presence in
the NMD on September 28, 1996, consists of a bar phantom test record
which, as explained below, was falsely dated September 28. Mr. Isakoff
stated during the enforcement conference that when he came in on
weekends, he generally completed paperwork and sometimes performed bar
phantom tests for the NMD cameras. Bar phantom tests are quality
assurance tests performed to ensure that resolution of the cameras is
adequate, and although not an NRC requirement, are required by licensee
procedures to be performed on a weekly basis. On November 19, 1996, Mr.
Isakoff stated during an interview with an investigator for TUH
concerning possible falsification of the weekly wipe test survey for
September 28, 1996, that he had performed one or two bar phantom tests
on September 28, 1996. Such test records would presumably provide an
indication of Mr. Isakoff's presence in the NMD on September 28, 1996.
However, the licensee examined its bar phantom test and computer
records because on November 21, 1996, the Director of the NMD found a
record of a bar phantom test, dated September 28, 1996, which had not
been present during the Director's review of bar phantom test records
on November 20, 1996. The licensee subsequently determined, during an
internal investigation, that the bar phantom test record dated
September 28, 1996, was in fact a copy of a record of a bar phantom
test performed on August 23, 1996, and that the September 28 date had
been inserted sometime between November 20 and 21, 1996, through
computer manipulation. As such, this bar phantom test record, although
not an NRC requirement, was also falsified and cannot be used as
evidence of Mr. Isakoff's presence in the NMD on September 28, 1996.
Based on the above, the NRC concludes that Mr. Isakoff did not
perform a weekly wipe test of the hot lab for removable contamination
for the week ending Saturday, September 28, 1996; that he deliberately
falsified licensee weekly wipe test survey records after an NMT refused
his September 30 request to falsely claim that she had performed a wipe
test of the hot lab on September 28; and that he deliberately created a
bar phantom test record falsely dated September 28, to conceal the fact
that he had falsified a record required by the NRC. The Chief NMT
stated that it was the responsibility of Mr. Isakoff and the Clinical
Chief NMT to ensure that the weekly wipe test survey was performed. Mr.
Isakoff acknowledged that he was aware of the requirement to perform a
weekly wipe test survey of the hot lab, and admitted that he, among
others, had responsibility, as Assistant Chief NMT for ensuring that
such surveys were performed. Accordingly, the NRC concludes that, in
violation of 10 C.F.R. 30.10(a)(2), Mr. Isakoff deliberately submitted
materially inaccurate information to the licensee.\1\
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\1\ On February 20, 1998, the NRC issued a Notice of Violation
to TUH for its violation of 10 C.F.R. Secs. 35.70 and 30.9, caused
by Mr. Isakoff's failure to conduct the weekly wipe test survey and
his falsification of wipe test records.
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Additionally, based on all the evidence, the NRC staff concludes
that Mr. Isakoff willfully recorded inaccurate information pertaining
to dose administration on numerous DDF records and failed to record
such information at all on multiple DDFs, thus putting the licensee in
violation of 10 C.F.R. 30.9 and 35.53, respectively. Licensees are
required to measure the activity of each dosage of photon-emitting
radionuclides prior to medical use, and to retain a record of the
measurement for three years, in accordance with 10 C.F.R. 35.53. TUH
used the DDF to satisfy Section 35.53.
A comparison of DDFs to patient records for July and October 1995
reveals that numerous DDFs completed by Mr. Isakoff for specific
patients reported syringe assay amounts different from doses reported
for the same patients on the NMC-1 Form.\2\ A review of DDFs for the
period January 1995 through December 1997 revealed multiple incomplete
DDFs due to Mr. Isakoff's failure to record the assayed dose. During
the course of one day in October 1995, Mr. Isakoff failed to record the
assayed dose on DDFs for four patients, which was documented in two
memoranda dated October 3, 1995, created by the Chief NMT and the
Administrative Chief NMT. Two former supervisors of Mr. Isakoff stated
that he consistently failed to record information pertaining to dose
administration on DDFs. Three NMTs stated that Mr. Isakoff, when
confronted with DDFs which had not been completed for patients, would
complete the forms without verifying the numbers or by pulling numbers
out of the air. During the enforcement conference, Mr. Isakoff admitted
that sometimes he did not record the syringe assay of the dose as soon
as it was assayed, or did not record the dose assay at all until it was
brought to his attention during monthly reviews of the DDFs by others.
Mr. Isakoff also stated that he was aware of the NRC requirement to
record administration of radioisotopes to patients, that he had been
admonished by the Chief NMT for failure to complete DDFs, and that he
himself had admonished NMTs for failure to complete DDFs.
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\2\ The NMC-1 Form (Nuclear Medicine Consultation Form) is an
internal document of TUH's NMD which is used to record the
technologist name, administered dose, and route of administration
for a radiopharmaceutical. The form also contains pertinent clinical
history and details of the examination being performed.
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Based on the above, the NRC concludes that Mr. Isakoff willfully
failed to record the activity of each dosage prior to administration on
multiple occasions in violation of 10 C.F.R. 35.53, and willfully
failed to accurately record the activity of each dosage on numerous
DDFs in violation of 10 C.F.R. 30.9.
III
Based on the above, it appears that Gary Isakoff, when involved in
licensed activities in a supervisory capacity, deliberately submitted
information to TUH which was inaccurate in respects material to the
NRC, in violation of 10 C.F.R. 30.10(a)(2), specifically: (1) a wipe
test survey instrument register strip and a department wipe test form,
both documenting a survey Mr. Isakoff claimed to have performed for
removable contamination in the hot lab on September 28, 1996, was
submitted notwithstanding that Mr. Isakoff in fact did not perform the
survey; and (2) a bar phantom test record dated September 28, 1996,
which was in fact conducted on August 23, 1996, and not on September
28, 1996, was provided by Mr. Isakoff as evidence that he was in the
hot lab on September 28, 1996. In addition, Mr. Isakoff caused the
Licensee to be in violation of 10 C.F.R. 30.9 by willfully failing to
accurately record information pertaining to dose administration on
numerous DDFs, and caused the licensee to be in violation of 10 C.F.R.
35.53 by willfully failing to record the assayed dose at all on
multiple DDFs.
The NRC must be able to rely on the Licensee and its employees to
comply with NRC requirements, including the
[[Page 11956]]
requirement to maintain records that are complete and accurate in all
material respects. Mr. Isakoff's actions in deliberately submitting
materially inaccurate information to the licensee, in willfully causing
the licensee to violate Commission requirements, and in his request to
a subordinate to falsely claim that she had conducted surveys pursuant
to NRC requirements, have raised serious doubt as to whether he can be
relied upon to comply with NRC requirements and to submit and maintain
complete and accurate information and records.
Consequently, I lack the requisite reasonable assurance that
licensed activities can be conducted in compliance with the
Commission's requirements and that the health and safety of the public
would be protected if Mr. Isakoff were permitted at this time to be
involved in NRC-licensed activities. Therefore, the NRC has determined
that the public health, safety and interest require that Mr. Isakoff be
prohibited from any involvement in NRC-licensed activities for a period
of one year. If, on the effective date of this Order, Mr. Isakoff is
involved in NRC-licensed activities, he must immediately cease such
activities, and inform the NRC of the name, address and telephone
number of the employer, and provide a copy of this Order to the
employer. Additionally, Mr. Isakoff is required to notify the NRC of
his first employment in NRC-licensed activities following the
prohibition period.
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, 10 CFR 30.10, and 10 CFR 150.20, it is
hereby ordered that:
1. Gary Isakoff is prohibited from engaging in NRC-licensed
activities for one year from the effective date of this Order. NRC-
licensed activities are those activities that 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.
2. If, on the effective date of this Order, Mr. Isakoff is involved
in NRC-licensed activities, he must, on the effective date of this
Order, immediately cease those activities, provide a copy of this Order
to the employer, and inform the NRC of the name, address and telephone
number of the employer.
3. For a period of one year after the one year period of
prohibition has expired, Mr. Isakoff shall, within 20 days of his
acceptance of each employment offer involving NRC-licensed activities,
as defined in Paragraph IV.1 above, 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 he
is, or will be, involved in the NRC-licensed activities. In the first
such notification, Mr. Isakoff shall include a statement of his
commitment to compliance with regulatory requirements and the basis why
the Commission should have confidence that he will now comply with
applicable NRC requirements.
The Director, Office of Enforcement, may, in writing, relax or
rescind any of the above conditions upon demonstration by Mr. Isakoff
of good cause.
V
In accordance with 10 CFR 2.202, Mr. Isakoff 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, DC 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 shall
set forth the matters of fact and law on which Mr. Isakoff 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 Secretary, U.S. Nuclear Regulatory Commission,
Attn: Chief, Rulemakings and Adjudications Staff, Washington, DC 20555.
Copies also shall be sent to the Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, to the Deputy
Assistant General Counsel for Enforcement at the same address, to the
Regional Administrator, NRC Region I, U.S. Nuclear Regulatory, 475
Allendale Road, King of Prussia, Pennsylvania 19406, and to Mr. Isakoff
if the answer or hearing request is by a person other than Mr. Isakoff.
If a person other than Mr. Isakoff requests a hearing, that person
shall set forth with particularity the manner in which that person's
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 Mr. Isakoff 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.
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.
Dated at Rockville, Maryland this 24th day of February, 1999.
For the Nuclear Regulatory Commission.
Malcolm R. Knapp,
Deputy Executive Director for Regulatory Effectiveness.
[FR Doc. 99-5872 Filed 3-9-99; 8:45 am]
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