On January 6, 2012, the NRC issued a Notice of Violation to the Regents of the University of Michigan 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. Specifically, on March 9, 2011, the licensee administered a yttrium-90 TheraSphere™ liver treatment, but the licensee's procedures did not require verifying that the administration of byproduct material was in accordance with the applicable treatment plan and written directive.