EA-97-500 - Mobile Dynamic Imaging, Inc.
EA No. 97-500
Terrance C. Lee, M.D., President and
Radiation Safety Officer
Mobile Dynamic Imaging, Inc.
16 South Van Brunt Street
Englewood, New Jersey 07631
Dear Dr. Lee:
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report 030-34190/97-002)
This refers to the NRC inspection conducted at your facility on October 16, 1997 to determine if licensed activities were conducted safely and in accordance with requirements. This was the first NRC inspection conducted under this license after it was issued by the NRC on October 23, 1997. As described in the NRC inspection report which was sent to you on November 14, 1997, five apparent violations of NRC requirements were identified during the inspection. On November 26, 1997, a predecisional enforcement conference was conducted with you to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report was sent to you by separate correspondence on December 4, 1997.
Based on the information developed during the inspection, and the information provided during the conference, the NRC has determined that five violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation and the circumstances surrounding them are described in detail in the subject inspection report. The violations involve (1) your failure, as the Radiation Safety Officer, to establish and implement written policies and procedures to ensure that radiation safety activities were performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program, including the performance of checks of the dose calibrator; (2) failure to notify the NRC prior to commencement of licensed activities after the NRC issued your license on October 23, 1996; and (3) three violations involving the failures to perform dose calibrator accuracy tests, geometry dependance tests, and linearity tests, at installation and prior to dose administration.
In the letter transmitting the inspection report, the NRC also described an apparent violation involving licensed material being used for purposes not authorized by the license in that at least one individual was injected with technetium-99m for the purpose of performing QC tests on the dose calibrator rather than for clinical reasons. Based on your assertion at the conference that the individual, who was associated with your company, was injected with the material for clinical reasons, no violation will be issued on this matter. However, the NRC has concluded that your failure, as the Radiation Safety Officer, to establish and implement written policies and procedures for performing checks of the dose calibrator prior to those injections, constitutes a significant regulatory concern.
Since your license had only been recently issued at the time these violations occurred, and since your are the Radiation Safety Officer, you should have been particularly knowledgeable of, and sensitive to, these regulatory requirements, and you should have assured adherence to them. Your failure to do so represents a significant regulatory concern. This failure also indicates a breakdown in control of licensed activities that represents a significant lack of attention toward licensed responsibilities. Therefore, these violations have been classified in the aggregate as a Severity Level III problem 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 $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These actions, which were described at the conference, included plans to not resume activities under the license until a consultant was retained, as confirmed in a Confirmatory Action letter sent to you on December 4, 1997. Previously, you had ceased all activities at the facility in January 1997, and you have not resumed activities.
Therefore, a civil penalty is not being assessed in this case. However, you should be aware that the NRC staff gave serious consideration to the use of enforcement discretion to impose a civil penalty, notwithstanding the credit given for your corrective actions. The violations in the attached Notice and the near-total lack of involvement in the program on the part of the Radiation Safety Officer, as evidenced at the enforcement conference, reflect particularly poor licensee performance. Therefore, the inspection frequency of your licensed program is being increased. The NRC expects and requires that your licensed program be conducted in accordance with NRC requirements; therefore, failure to do so in the future may result in more significant enforcement action, including the assessment of civil penalties and modification, suspension, or revocation of your NRC license.
You are required to respond to this letter and the enclosed Notice, and you should follow the instructions specified in the enclosed Notice when preparing your response. 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 and its enclosure, will be placed in the NRC Public Document Room (PDR).
Sincerely, Hubert J. Miller Regional Administrator
Docket No. 030-34190
License No. 29-30322-01
Enclosure: Notice of Violation
State of New Jersey
Mobile Dynamic Imaging Docket No. 030-34190 Englewood, New Jersey License No. 29-30322-01 EA 97-500
During an NRC inspection conducted on October 16, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violations are listed below:
A. 10 CFR 35.21(a) states, in part, that the licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.
Contrary to the above, between October 23, 1996 (when the NRC license was issued), and January 1997, the licensee did not, through the Radiation Safety Officer, ensure that radiation safety activities were performed in accordance with approved procedures and regulatory requirements in the daily operation of the byproduct material program. Specifically, the Radiation Safety Officer delegated his responsibilities to a former partner, without knowing what his responsibilities entailed. The Radiation Safety Officer also did not provide adequate oversight of the byproduct material program to ensure that his delegated responsibilities were completed in accordance with the Commission's regulations and license conditions, as evidenced by the Violations B-E set forth herein. (01013)
B. Condition 11.A of License No. 29-30322-01 states, in part, that the licensee may not possess and use materials authorized by 10 CFR 35.200 until the U.S. Nuclear Regulatory Commission, Region I, has been notified in writing that activities authorized by the license will be initiated.
Contrary to the above, the licensee did not notify NRC Region I in writing that activities authorized by the license commenced. Specifically, on November 6, 1996, the licensee administered technetium-99m labeled Tetrofosmin to three individuals for a Cardiac Perfusion study, and did not notify the NRC that licensed activities were being initiated, prior to obtaining and using material. (01023)
C. 10 CFR 35.50(b)(2) requires, in part, that a licensee test each dose calibrator for accuracy at installation.
Contrary to the above, the licensee did not test their dose calibrator for accuracy at installation. Specifically, on November 6, 1996 the licensee administered technetium-99m labeled Tetrofosmin to three individuals, and prior to that date, the licensee did not test their dose calibrator for accuracy. (01033)
D. 10 CFR 35.50(b)(3) requires, in part, that a licensee test each dose calibrator for linearity at installation.
Contrary to the above, the licensee did not test its dose calibrator for linearity at installation. Specifically, on November 6, 1996, the licensee administered technetium-99m labeled Tetrofosmin to three individuals, and prior to that date, the licensee did not test their dose calibrator for linearity. (01043)
E. 10 CFR 35.50(b)(4) requires, in part, that a licensee test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used.
Contrary to the above, the licensee did not test its dose calibrator for geometry dependence over the range of volumes and volume configurations for which it will be used at installation. Specifically, on November 6, 1996, the licensee administered technetium-99m labeled Tetrofosmin to three individuals, and prior to that date, the licensee did not test their dose calibrator for geometry dependence. (01053)
These violations are classified in the aggregate as a Severity Level III problem (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Mobile Dynamic Imaging is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region I, 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, (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.
Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. 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.
Dated at King of Prussia, Pennsylvania
this 31st day of December 1997