[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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