EA-01-018 - Medical X-Ray Center, P.C.

February 15, 2001

EA-01-018

John Griffin, M.D.
Chair, Radiation Therapy Committee
Medical X-Ray Center, P.C.
1417 S. Minnesota
Sioux Falls, South Dakota 57105

SUBJECT:

NRC INSPECTION REPORT 030-33335/00-02 AND NOTICE OF VIOLATION

Dear Dr. Griffin:

This refers to the inspection conducted on December 20, 2000, at your facility in Sioux Falls, South Dakota. The inspection was an examination of activities conducted under NRC Byproduct Materials License 40-27480-01 as they relate to radiation safety and to compliance with the Commission's rules and regulations and the conditions of the license. The preliminary inspection findings were discussed briefly with you, and more extensively with Dr. Kirsten Erickson and other members of your staff on December 20, 2000. A final telephonic exit meeting was conducted with you and members of your staff on January 30, 2001.

During the telephonic exit briefing on January 30, 2001, you were informed that the NRC was considering escalated enforcement action for an apparent violation involving a failure to control and maintain constant surveillance of licensed material that was in a controlled or unrestricted area and that was not in storage. Additionally, you were informed that NRC believed it had sufficient information regarding the apparent violation and your corrective actions to make an enforcement decision without the need for a predecisional enforcement conference or a written response from you. You indicated that Medical X-Ray Center, P.C. (MXC) did not believe that a predecisional enforcement conference or written response was needed.

Therefore, based on the information developed during the inspection, the NRC has determined that a violation of NRC requirements occurred. The violation is described in the enclosed Notice of Violation (Notice), and involves your failure to control and maintain constant surveillance of licensed material that was in a controlled or unrestricted area and that was not in storage. The violation is of concern because the lack of security of licensed material could have resulted in the loss of control of curie quantities of iridium-192, potentially resulting in significant health and safety consequences to individuals involved. Therefore, this violation has been categorized in accordance with the General Statement of Policy and Procedure for NRC Enforcement Actions (Enforcement Policy), NUREG-1600, dated May 1, 2000, at Severity Level III.

In accordance with the Enforcement Policy, a civil penalty with a base value of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement action, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Based on MXC's prompt actions to address the violation, the NRC has determined that your corrective actions warrant credit. MXC's immediate corrective actions included revising the method of handling both incoming and outgoing source shipments to allow for positive control over all future shipments.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, you are on notice that significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in this report and in your letter dated January 8, 2001. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosure and your response will be 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.

		Sincerely,
		/RA/
		Ellis W. Merschoff Regional Administrator

Docket No.: 030-33335
License No.: 40-27480-01

Enclosure: Notice of Violation

cc w/enclosure:
South Dakota Radiation Control Program Director

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ENCLOSURE 1

NOTICE OF VIOLATION

Medical X-Ray Center, P.C. Sioux Falls, South Dakota

Docket No.: 030-33335 License No.: 40-27480-01 EA-01-018

During an NRC inspection completed on January 30, 2001, one 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 20.1802 requires that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on several occasions between November 1999 and December 2000, the licensee failed to control and maintain constant surveillance over licensed material in a controlled or unrestricted area and not in storage. Specifically, on November 19, 1999, February 24, 2000, June 30, 2000, October 13, 2000, and December 19, 2000, the licensee received packages containing iridium-192, in quantities ranging from 11-12 curies, in an alcove area located near the rear entrance to the licensee's facility (an unrestricted area) and left the sources unattended, intermittently, for 5-20 minutes at a time. On March 9, 2000, July 21, 2000, and October 23, 2000, the licensee also prepared packages of iridium-192, in quantities ranging from 2-4 curies, for return shipment to the manufacturer and placed them in the alcove area near the rear entrance to the facility, leaving the sources unattended, intermittently, for periods of time ranging from 4-6 hours.

This is a Severity Level III violation (Supplement IV).

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved is already adequately addressed on the docket in this report and in a facsimile letter received from Medical X-Ray Center, P.C. on January 8, 2001. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator Region IV, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

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, any response you choose to submit shall be submitted under oath or affirmation.

If you choose to respond, 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. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

In accordance with 10 CFR 19.11, you are required to post this Notice within two working days.

Dated this 15^th day of February 2001