EA-01-257 - Geodax Technology, Inc.
January 4, 2002
Geodax Technology, Inc.
ATTN: Robert W. Beightol
1807 Murry Road, S.W., Suite H
Roanoke, Virginia 24018-1527
|SUBJECT:||NOTICE OF VIOLATION AND EXERCISE OF ENFORCEMENT DISCRETION (NRC INSPECTION REPORT NO. 45-25339-01MD/01-01 AND INVESTIGATION REPORT NO. 2-2001-014)|
Dear Mr. Beightol:
This refers to the inspection conducted on May 24, 2001, and an investigation conducted by the Nuclear Regulatory Commission's (NRC) Office of Investigations (OI) on June 19, 2001, at Geodax Technology, Inc., (GTI), Roanoke, Virginia. The purpose of the inspection was to examine activities conducted under your license as they related to safety and compliance with the Commission's rules and regulations and with the conditions of your license. The results of the inspection were transmitted to you by letter dated June 29, 2001. Additional details of our review of the inspection, including the identification of one apparent violation and the synopsis to the OI investigation, were discussed and formally transmitted to you by letter dated November 8, 2001. This letter also provided you the opportunity to either respond to the apparent violation in writing or request a predecisional enforcement conference. The NRC confirmed your desire not to attend a predecisional enforcement conference, and by letter dated December 3, 2001, you provided GTI's response to the apparent violation and addressed the causes and corrective actions to prevent recurrence. We have reviewed your response and have concluded that sufficient information is available to determine the appropriate enforcement action in this matter.
Based on the information developed during the inspection and the information that you provided in your response, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involved your allowing a pharmacist to work unsupervised as an authorized nuclear pharmacist (ANP) from June 2000 to May 24, 2001, without first providing any of the required notifications to the NRC and obtaining an approved license amendment identifying this pharmacist as an ANP, in violation of 10 CFR 32.72(b)(5).
In your response, you acknowledged that the pharmacist was working unsupervised as an ANP without having been approved on a license amendment. You stated that the cause for the violation was the Radiation Safety Officer's (RSO) inadvertent oversight in requesting and obtaining a license amendment. In your letter, you expressed strong disagreement that the pharmacist was told directly by the NRC inspector that he was prohibited from working without supervision by an authorized user. Your contention was that while this individual had been notified during the inspection that the pharmacist was not on the license as an authorized user, it was their impression that this matter involved only a paper work omission error that would be corrected once the RSO submitted the necessary documentation.
We agree with your assertion that the NRC inspector did not prohibit or otherwise order the pharmacist to refrain from dispensing licensed material until proper authorization was obtained. As a matter of NRC policy and practice, NRC inspectors do not prohibit or order licensees from conducting licensed activities unless the health and safety of the public is immediately affected. The inspector informed the pharmacist that the continued dispensing of licensed material without supervision of an authorized user was and would be a continuing violation of NRC requirements. During the OI investigation, the pharmacist indicated that he was aware he was not on the license after being informed by the inspector, and he admitted that he continued to dispense licensed material for two days to support pharmaceutical orders. As such, the NRC has concluded that the violation was willful.
In this case, there were no actual consequences because the pharmacist was technically qualified and took appropriate safety precautions. However, an unsupervised pharmacist who dispenses licensed material as an ANP without receiving an approved license amendment is of concern to the NRC. The NRC has oversight responsibility for ensuring that licensed radioactive material is used safely. In this case, the NRC was unaware that the pharmacist was unsupervised and was dispensing licensed material, and as such did not have prior opportunity to ensure, either through inspection or review of qualification and training records, that the individual was properly qualified to conduct licensed activities in a safe manner. Furthermore, willful violations are of particular concern because the NRC's regulatory program is based on licensees and their employees acting with integrity and candor in adhering to regulatory requirements. In this case, the NRC concluded that GTI willfully allowed a nuclear pharmacist to dispense licensed material for approximately one year without being an authorized user or under the supervision of an authorized user. As such, this violation is being categorized at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III violation. Because the violation was willful, the NRC considered whether credit was warranted for the factors of Identification and Corrective Action in accordance with the civil penalty assessment process described in Section VI.C.2 of the Enforcement Policy. The NRC identified the violation during our inspection, and thus credit is not warranted for this factor. Your corrective action included the implementation of an administrative check list for all new employees who will be actively engaged in preparation and dispensing of radioactive material and functioning as an ANP. This process will administratively ensure that pharmacists are added to the license prior to performing work as an ANP. In addition, when the RSO was informed of the inspection results, the pharmacist's activities were supervised until a license amendment was submitted and approved by the NRC. Based on the above, NRC concluded that your actions were prompt and comprehensive, and credit was warranted for the factor of Corrective Action.
This assessment normally would result in a proposed civil penalty of $3,000. However, the NRC may refrain from proposing a civil penalty for a Severity Level III violation in accordance with Section VII.B.6 of the Enforcement Policy. In this case, the NRC has concluded that the potential safety consequences were low because the individual was technically qualified and took appropriate safety precautions. In addition, the pharmacist was forthcoming during the inspection regarding his activities, the RSO promptly initiated supervision of the pharmacist upon being informed of the inspection finding, and all individuals involved accepted responsibility for the violation and cooperated during the investigation.
Therefore, to encourage prompt corrective actions and cooperation with the NRC, I have been authorized, with approval of the Director, Office of Enforcement, to propose that no civil penalty be assessed in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In particular, we request that you address the expectations of GTI management with respect to the willful aspects of the violation, and any corrective actions taken or planned to underscore your expectations of the RSO and authorized nuclear pharmacists in preventing such situations. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library .
If you have any questions regarding this matter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety at 404-562-4700.
| LOREN R. PLISCO FOR
| Bruce S. Mallett
Acting Regional Administrator
Docket No. 030-29105
License No. 52-24834-01
Enclosure: Notice of Violation
cc w/encl: Commonwealth of Virginia
NOTICE OF VIOLATION
| Geodax Technology, Inc.
| Docket No. 030-33893
License No. 45-25339-01MD
During an NRC inspection conducted on May 24, 2001, and an investigation conducted by the Nuclear Regulatory Commission's (NRC) Office of Investigations (OI) on June 19, 2001, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:
10 CFR 32.72(b)(5) requires, in part, that a licensee shall provide to the Commission a copy of each individual's certification by the Board of Pharmaceutical Specialties, the Commission or Agreement State license, or the permit issued by a licensee of broad scope for each individual, and a copy of the state pharmacy license or registration, no later than 30 days after the date that the licensee allows an individual to work as an authorized nuclear pharmacist pursuant to paragraphs (b)(2)(i) and (b)(2)(iii) of this section.
Condition 11 of License 45-25339-01 requires, in part, that licensed material be used by, or under the supervision of a pharmacist working or designated as an authorized nuclear pharmacist in accordance with 32.72(b)(2) and 32.72(b)(3) of 10 CFR Part 32.
Contrary to the above, as of May 24, 2001, the licensee allowed an individual to work as an authorized nuclear pharmacist (ANP) and did not provide to the NRC required notification within 30 days after the date that the licensee allowed the individual to work. Specifically, a pharmacist worked as an ANP from June 2000 to May 24, 2001 without any notification being made to the NRC.
This is a Severity Level III violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Geodax Technology, Inc., is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region II, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Because any response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 4th day of January 2002