99-5872. Gary Isakoff; Order Prohibiting Involvement in NRC-Licensed Activities  

  • [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]
    BILLING CODE 7590-01-U
    
    
    

Document Information

Published:
03/10/1999
Department:
Nuclear Regulatory Commission
Entry Type:
Notice
Document Number:
99-5872
Pages:
11954-11956 (3 pages)
Docket Numbers:
IA 98-006
PDF File:
99-5872.pdf