[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] ======================================================================= ----------------------------------------------------------------------- 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\ --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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