The Nuclear Regulatory Commission on June 29 issued a notice of violation to Mallinckrodt Nuclear Medicine for an incident in which a worker spread contamination at the company’s nuclear medicine production facility in Maryland Heights, Mo.
The October 2016 incident, identified in a routine NRC inspection from Jan. 23-27 of this year, represents a Severity Level IV violation of agency regulations, according to the letter posted Monday on the NRC documents website. In the regulator’s parlance, that is a “more than minor” safety breach but still at the low end of the Severity Level ranking system.
“The inspectors determined that the October 10, 2016, contamination incident resulted from ineffective contamination control techniques by the individual who worked in the cyclotron chemistry laboratory,” according to the inspection report.
Specifically, while the worker had noticed that his hands had been contaminated, he still left the restricted area with a laboratory notebook that was also contaminated, the NRC said. That led to contamination of material in his office, which is designated as an unrestricted area. That is particularly worrisome as the contamination produced “a significant personnel exposure,” inspectors found.
The worker did not carry out sufficient personal surveys, encompassing material he took with him from the laboratory in which radioactive material was in use, the report says.
Mallinckrodt Nuclear Medicine has 30 days from the date of the notice to provide a written statement or explanation of the event to the NRC, covering four matters: the reason for the breach, or cause for disputing the breach or severity level; corrective actions that have been made; corrective actions that will be made; and the date of full compliance.
Mallinckrodt Nuclear Medicine was sold to IBA Molecular last year, then officially combined with the company in April to become nuclear imaging provider Curium.
