EA-97-540 - Servicing Imaging Systems International

December 31, 1997

EA No. 97-540

Terrance C. Lee, M.D.
Radiation Safety Officer
Servicing Imaging Systems International
The Cardiology Group
111 Northfield Avenue, Suite 301
West Orange, New Jersey 07052

Dear Dr. Lee:

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 030-33828/97-001)

This refers to the NRC inspection conducted at your facility on November 5, 1997 to determine if licensed activities were conducted safely and in accordance with requirements. As described in the NRC inspection report which was sent to you on November 14, 1997, 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 eight 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) failure to perform daily surveys in areas where radiopharmaceuticals are routinely prepared for use or administered; (2) failure to perform a linearity check of the dose calibrator for the 3rd quarter of 1997; (3) failure to conspicuously note on the survey instrument the apparent exposure rate from a dedicated check source at the time of calibration; (4) failure to check the survey instrument for proper operation with the dedicated check source each day of use; (5) failure to provide a personnel finger monitor to an individual who handles radioactive material on a regular basis; (6) failure to perform leak tests of sealed sources; (7) failure to perform inventories of sealed sources; and (8) failure to perform an annual review of the radiation protection program.

The violations indicate that neither you, as the Radiation Safety Officer, nor others associated with the facility, provided appropriate attention to the radiation safety program to ensure that activities were conducted safely and in accordance with requirements, since fundamental aspects of the program were not implemented, as evidenced by the violations. The violations indicate 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 retain a consultant to assist with assessment and implementation of the radiation safety program, as confirmed in a Confirmatory Action letter sent to you on December 4, 1997. Further, you developed a list to assist with the timely completion of required tests and checks.

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 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. 030-33828
License No. 29-30214-01

Enclosure: Notice of Violation

cc w/encl:
Dr. Aharon Ben-Haim, Servicing Imaging Systems International
State of New Jersey

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NOTICE OF VIOLATION

Servicing Imaging Systems International West Orange, New Jersey

Docket No. 030-33828 License No. 29-30214-01 EA 97-540

During an NRC inspection conducted on November 5, 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, ensure that radiation safety activities are being performed in accordance with approved procedures. The licensee's procedures for external personnel monitoring are described in the application dated March 20, 1995, and were originally approved by License Condition No. 16 (Condition No. 15 of Amendment No. 02).

The application dated March 20, 1995, states in Item No. 9.4 that the licensee would establish and implement the model personnel external monitoring program published in Appendix D to Regulatory Guide 10.8, Revision 2. Appendix D states, in part, that all individuals who, on a regular basis, handle radioactive material that emits ionizing photons will be issued a film or TLD finger monitor.

Contrary to the above, as of November 5, 1997, film or TLD finger rings were not provided to all individuals who, on a regular basis, handle radioactive material. Specifically, a film or TLD finger ring was not issued to a Nuclear Medicine Technologist who handled radioactive material on a regular basis. (01013)

B. 10 CFR 35.51(a)(3) states, in part, that the licensee shall conspicuously note on survey instruments the apparent exposure rate from a dedicated check source as determined at the time of calibration, and the date of calibration.

Contrary to the above, as of November 5, 1997, the licensee had not conspicuously noted the apparent exposure rate from a dedicated check source on their Ludlum Model 3 survey instrument. (01023)

C. 10 CFR 35.51(c) states, in part, that a licensee shall check each survey instrument for proper operation with a dedicated check source each day of use.

Contrary to the above, as of November 5, 1997, the licensee did not check their survey instrument for proper operation with the dedicated check source each day of use. (01033)

D. 10 CFR 35.50(b)(3) states, in part, that a licensee shall test each dose calibrator for linearity upon installation and at least quarterly thereafter.

Contrary to the above, the licensee did not test their dose calibrator for linearity at least quarterly. Specifically, the licensee did not perform a linearity test on their dose calibrator during the third calendar quarter of 1997. (01043)

E. 10 CFR 35.70(a) states, that a licensee survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.

Contrary to the above, between February 1, 1997, and July 12, 1997, the licensee did not survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceutical are routinely prepared for use or administered. Specifically, daily surveys were not performed on February 1, 8 and 22, March 15 and 22, April 12 and 26, May 14 and 21, June 7, and July 12, 1997; days when radiopharmaceuticals were utilized at the facility. (01053)

F. 10 CFR 35.59(b)(2) states, in part, that a licensee in possession of a sealed source shall test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State.

Contrary to the above, the licensee did not test a sealed source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State. Specifically, as of November 5, 1997, the licensee had not leak tested a sealed source containing 238 microcuries of cesium-137 since May 5, 1996, an interval exceeding six months. (01063)

G. 10 CFR 35.59(g) states, in part, that a licensee in possession of a sealed source shall conduct a quarterly physical inventory of all such sources in its possession.

Contrary to the above, the licensee did not conduct quarterly physical inventories of sealed sources. Specifically, as of November 5, 1997, the licensee had not performed an inventory of a sealed source containing 238 microcuries of cesium-137 since May 5, 1996, an interval exceeding several calendar quarters. (01073)

H. 10 CFR 20.1101(c) states, in part, that the licensee periodically (at least annually) review the radiation program content and implementation.

Contrary to the above, as of November 5, 1997, the licensee had not previously reviewed the radiation program content and implementation. (01083)

These violations are classified in the aggregate as a Severity level III problem (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Servicing Imaging Systems International 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