EA-97-263 - Nuclear Imaging, Ltd.
Corrine Connelly, Operations Manager
Nuclear Imaging, Ltd.
109 South Petro Avenue
Sioux Falls, South Dakota 57107
SUBJECT: NOTICE OF VIOLATION (NRC INSPECTION REPORT 030-30273/97-01)
Dear Ms. Connelly:
This refers to the inspection conducted on April 15-16, 1997, at your Chamberlain, Oacaoma, and Sioux Falls, South Dakota facilities, and the subsequent in-office inspection activities. The inspection findings were discussed with you and members of your staff during a telephonic exit briefing conducted on May 30, 1997. The subject report, which was dated June 27, 1997, documented the inspection findings and identified one apparent violation which was being considered for escalated enforcement. The cover letter to the inspection report stated that before the NRC made an enforcement decision, we were providing you with an opportunity to either respond to the apparent violation in writing or request a predecisional enforcement conference. You did not request a predecisional enforcement conference and instead provided a response by letter dated July 11, 1997.
Based on the information developed during the inspection and the information that you provided in your July 11 response to the inspection report, 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 is described in detail in the subject inspection report. The violation involves the failure to secure or keep under constant surveillance and immediate control all byproduct material when in transit. Specifically, a technologist did not adequately secure a shipping package containing approximately 300 millicuries of technetium-99m in a vehicle compartment. As a result, the package fell from the vehicle during transit, was found by a member of the general public, and was retrieved within about 30 minutes.
Although the package survived the fall and there were no actual safety consequences, the potential safety consequence in this case is that, under slightly different circumstances, a member of the public could have become contaminated and/or received an unintended and unnecessary radiation exposure. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 at Severity Level III.
In accordance with the Enforcement Policy, a civil penalty in the base amount of $2750 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last 2 years or last two inspections, 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. As noted in the subject report, we noted that your actions to promptly and properly respond to the event were noteworthy. Your actions included immediately retrieving the material, conducting an investigation into the causes of the event, training all technologists on the event and on the requirements of 10 CFR 35.80, repairing the latch for the storage compartment on the vehicle, and requiring technologists to check all locks to ensure proper function.
Therefore, to encourage prompt comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized not to propose a civil penalty in this case. However, 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 the subject NRC Inspection Report and your July 11 letter. 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, its enclosure, and your response will be placed in the NRC Public Document Room.
Sincerely, Ellis W. Merschoff Regional Administrator
Docket No. 030-30273
License No. 40-26908-01
Enclosure: Notice of Violation
Minnesota Radiation Control Program Director
South Dakota Radiation Control Program Director
Nuclear Imaging, Ltd. Docket No. 030-30273 Sioux Falls, South Dakota License No. 40-26908-01 EA 97-263
During an NRC inspection conducted on April 15 through May 30, 1997, 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 35.80(c) requires, in part, that a licensee secure or keep under constant surveillance and immediate control all byproduct material when in transit.
Contrary to the above, on October 4, 1995, the licensee failed to secure or keep under constant surveillance and immediate control all byproduct material when in transit. Specifically, a shipping package containing approximately 300 millicuries of technetium-99m was placed in a vehicle compartment for transport. The package was not locked or otherwise secured and this resulted in the package falling from the vehicle during transit.
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 NRC Inspection Report No. 030-30273/97-01 and the Licensee's letter to the NRC dated July 11, 1997. 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, D.C. 20555 with a copy to the Regional Administrator, Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).
Because your response, if you submit one, 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).
Dated at Arlington, Texas,
this 31st day of July 1997