The US Nuclear Regulatory Commission (NRC) on March 11 issued a Notice of Violation to Avera St. Luke’s Hospital stemming from findings during an inspection of its Aberdeen, South Dakota facility in July 2019. During the inspection, NRC identified three apparent violations in the following areas:
- Monitoring occupational exposure of workers from various sources of radiation
- Developing and implementing a robust radiation protection program
- Reporting an occupational exposure in excess of the annual limits in 10 CFR 20.1201
On February 13, 2020, Avera representatives attended a predecisional enforcement conference at NRC headquarters to discuss the apparent violations, their significance, their root causes, and the corrective actions taken and to be taken by Avera.
The Notice of Violation
After considering all available information, NRC issued the Notice of Violation after concluding:
- Avera did not adequately monitor an individual’s occupational exposure to radiation sources or require the use of individual monitoring devices. NRC observed that the hospital’s failure to do so resulted in an exposure to an employee that could cause that employee to exceed NRC’s annual limit of five rems total effective dose equivalent.
- Avera did not develop and implement its radiation protection program to ensure compliance with NRC regulations. Among other things, Avera did not (1) review the occupational radiation dose records of all personnel working with byproduct material, (2) maintain and update its Radiation Safety Manual, and (3) perform a quarterly review of radiation exposures to assess trends.
- Avera did not submit a required written report within 30 days after learning of an overexposure.
No Civil Penalty for Avera, But Increased Inspections Possible
The NRC opted not to issue a civil penalty with the Notice of Violation in light of the various corrective actions Avera has taken or plans to take in the future. Such actions include updating policies and procedures to ensure that exposure is monitored accurately, users wear appropriate dosimetry, and personnel understand when and how to report overexposures. Avera also plans to evaluate potential dosimetry issues throughout the Avera healthcare system to identify whether similar issues exist at other Avera facilities.
Although the NRC ultimately did not propose a civil penalty in light of Avera’s corrective actions, NRC observed that the issued violations may subject the hospital to increased inspections, and that significant violations in the future could result in a civil penalty.
The Advisory Committee on the Medical Uses of Isotopes
The NRC’s Advisory Committee on the Medical Uses of Isotopes will hold a public meeting on March 30 and 31. Among other topics, the committee intends to discuss medical-related events, medical event reporting, and the US Federal Drug Administration's regulatory process for drugs and devices.
How We Can Help
Nuclear medicine licensees are subject to various requirements administered by the NRC, among other agencies. Lawyers in our nuclear practice have experience assisting licensees in the wake of such events and related regulatory compliance matters. Please contact any of the authors of this post or your regular Morgan Lewis contact if you have questions or need assistance with such matters.