EA-23-063 Sofie Co

NOTICE OF VIOLATION – SOFIE CO - NRC INSPECTION REPORT NO. 030- 32974/2023-001

Dear Patrick Phelps:

This letter refers to the U.S. Nuclear Regulatory Commission (NRC) announced, reactive inspection 
conducted on January 18-19, 2023, at your facilities in Kansas City, Missouri, in response to your 
report of an occupational overexposure event (NMED No. 230208) that occurred on October 31, 2022, 
and a routine inspection on April 19-20, 2023, at your facility in Morgantown, West Virginia, with 
continued in-office review through May 30, 2023. The inspections were an examination of activities 
conducted under your license as they relate to public health and safety to confirm compliance with 
the NRC rules, regulations, and with the conditions of your license. Within these areas, the 
inspection consisted of a selected examination of procedures and representative records, 
observations of activities, independent radiation measurements, and interviews with personnel. 
Based on the results of the inspections, the NRC identified three apparent violations (AV) of NRC 
requirements. The NRC discussed the AVs with SOFIE representatives during a telephonic exit meeting 
on June 5, 2023. The AVs were described in the NRC inspection report sent to you with a letter 
dated July 5, 2023 (ML23158A132).1

In our July 5, 2023, letter transmitting the inspection report, we informed you that the AVs were 
being considered for escalated enforcement action. On September 14, 2023, a public pre- decisional 
enforcement conference (PEC) was conducted at the NRC’s Region I Office in King of Prussia, PA with 
members of your staff to discuss the AVs, their significance, their root causes, and your 
corrective actions. Details of the PEC are found in Enclosure 1

Based on the information developed during the inspection and the information provided during the 
PEC, the NRC determined that three violations of NRC requirements occurred. These violations 
involved SOFIE’s failure to: (1) ensure that the occupational extremity exposure for one of your 
employees in calendar year 2022 remained within the NRC’s annual limits; (2) ensure that extremity 
dosimetry was worn while handling radiopharmaceuticals; and (3) restrict

Designation in parentheses refers to an Agency-wide Documents Access and Management System umber. 
Documents referenced in this letter are publicly-available using the
number in ADAMS.

Access to an area which exceeded 0.002 rem in any one hour. These violations are cited in the 
enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in 
detail in the subject inspection report.

The NRC considers Violation #1 to be significant because it resulted in an actual consequence when 
a former employee received dose to an extremity above regulatory limits. Exceeding regulatory 
limits placed the employee at risk of acute radiation injury. Therefore, this violation is 
categorized in accordance with the NRC Enforcement Policy as a Severity Level III (SL III) 
violation. The NRC Enforcement Policy can be found on the NRC’s website at 
http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. In accordance with the NRC 
Enforcement Policy, a base civil penalty in the amount of $8,750 is considered for a SL III 
violation. Because SOFIE has not been the subject of escalated enforcement actions within the last 
two years, the NRC considered whether credit was warranted for Corrective Action in accordance with 
the civil penalty assessment process in Section 2.3.4 of the Enforcement Policy. According to 
information developed during the inspection, immediate corrective actions taken to address 
Violation #1 included removing the individual from radiation-related duties, committing to revise 
the ALARA policy to account for dosimetry reporting delays, and lowering the stop-work trigger 
levels.

In addition to the immediate corrective action described above, during the PEC, SOFIE described the 
long-term corrective actions taken and planned to address the issues that resulted in the 
violations and to prevent reoccurrence. To address Violation #1, SOFIE described changes to its 
oversight and management of new and existing employees with regards to radiation safety and 
occupational exposure monitoring. These changes include: increasing resources for corporate 
oversight; increasing communication and collaboration among site Radiation Safety Officers; 
engineering changes and a roll-out of a system for requesting engineering changes that assist in 
reducing employee radiation exposure; enhancements to new employee training and qualifications; and 
revising the approach and process for dosimetry evaluation and assessment. To address Violation #2, 
SOFIE described corrective actions related to dosimetry compliance. These actions included: 
repositioning the mobile shielding; completing an estimate of extremity exposure for the Radiation 
Safety Officer; developing signage for staff reminders and awareness; incorporating specific 
elements into staff training; implementing dosimetry verification checks for staff; and building an 
enhanced safety culture. To address Violation #3, SOFIE, as described in the inspection report, 
installed a locking metal door.

Finally, after the PEC, in a letter dated September 26, 2023 (non-public document), SOFIE confirmed 
additional corrective actions related to Violations #1 and #2. Specifically, in response to 
Violation #1, SOFIE confirmed that on-the-job training and Task Performance Evaluation would be 
implemented at Kansas City, MO and Morgantown, WV by December 1, 2023, and a computerized 
maintenance management system would be implemented for Kansas City, MO and Morgantown, WV by 
December 1, 2023. In response to Violation #2, SOFIE completed a review of the extremity exposure 
to the individual.

The NRC determined that corrective action credit is warranted. Therefore, to encourage prompt and 
comprehensive correction of violations, and in recognition of the absence of previous escalated 
enforcement action, I have been authorized, after consultation with the Director, Office of 
Enforcement, 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 SL III violation constitutes 
escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that information regarding: (1) the reason for the violations; (2) the 
corrective actions that have been taken and the results achieved; and (3) the date when full 
compliance was achieved is already adequately addressed on the docket in Inspection Report No. 
030-32974/2023-001, and in a letter from SOFIE dated September 26, 2023. 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 2.390 of the NRC’s “Rules of Practice and Procedure,” a copy of this 
letter, its enclosure, and your response, if one is provided, will be made available electronically 
for public inspection in the NRC Public Document Room and from the NRC’s Agency-wide Documents 
Access and Management System (ADAMS), accessible from the NRC Web site at 
http://www.nrc.gov/reading-rm/adams.html. The NRC also includes significant
ns on its Web site at https://www.nrc.gov/reading-rm/doc-
collections/enforcement/actions/.