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NRC CAL – NOV (SL III)

EA-12-242 · CAL · Severity SLIII · Issued 2013-01-29 · Materials Licensees

Action

EA Number
EA-12-242
Licensee
NOV (SL III)
Category
Materials Licensees
Action type
CAL
Severity level
SLIII
Date issued
2013-01-29

Description

On January 29, 2013, the NRC issued a Notice of Violation to Missouri Baptist Medical Center Hospital for a Severity Level III violation involving the failure to develop, implement, and maintain written procedures to provide high confidence that each administration was in accordance with the written directive as required by 10 CFR 35.41(a). In accordance with 10 CFR 35.41(b)(2), the procedures required by 10 CFR 35.41(a) must address verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive. However, as of October 19, 2012, the licensee’s procedures failed to address verification that the administered dosage was in accordance with the prescribed dosage on the written directive prior to administration. Specifically, on or about May 1, 2012, a yttrium-90 (Y-90) procedure was performed, and the written directive indicated a prescribed dosage other than the authorized user intended to deliver to the patient. The authorized user electronically signed and dated the written directive immediately before the administration of the dose without verifying that the written directive indicated the intended activity. The administration represented a dosage 39 percent greater than the prescribed dosage documented on the written directive. Additionally, on or about May 31, 2012, a medical procedure involving samarium-153 was performed and the “prescribed activity” section was blank in the written directive as no data had been entered into the applicable area. The calculations attached to the written directive indicate that the authorized user intended to give a dosage that was within 20 percent of the administered dosage.

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