IR 015000037/2023001

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Jefferson University Radiology Associates, LLC, NRC Inspection Report No. 15000037/2023-001 and Notice of Violation
ML23219A149
Person / Time
Site: 15000037, 015000037
Issue date: 08/01/2023
From: Anne Defrancisco
NRC Region 1
To: Yoder J
Jefferson Univ Radiology Associates
References
IR 2023001
Download: ML23219A149 (1)


Text

August 1, 2023

SUBJECT:

JEFFERSON UNIVERSITY RADIOLOGY ASSOCIATES, LLC - NRC INSPECTION REPORT NO. 150-00037/2023-001 AND NOTICE OF VIOLATION

Dear Jay Yoder:

This letter refers to the reciprocity inspection conducted on June 1, 2023, at your mobile PET imaging trailer at St. Francis Healthcare in Wilmington, Delaware. This inspection examined activities conducted under your Commonwealth of Pennsylvania license as they relate to public health and safety, and to confirm compliance with the Commission's rules and regulations and with the conditions of your Commonwealth of Pennsylvania license. Within these areas, the inspection consisted of selected examination of procedures and representative records, independent radiation surveys, and interviews with personnel. The preliminary inspection findings were discussed with you telephonically, along with representatives of your staff following the onsite portion of the inspection on June 1, 2023. A final telephonic exit briefing was conducted with you on July 27, 2023.

Based on the results of this inspection, the NRC has determined that a Severity Level IV violation of NRC requirements occurred. This violation was evaluated in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRC's Web site at https://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The violation involved the failure to obtain a letter that permits the use of byproduct material and clearly delineates the authority and responsibility of the licensee and the client. To correct this violation, Jefferson University Radiology Associates, LLC, amended its contract with the host client, St. Francis Healthcare, to clearly delineate the authority and responsibility of each party as it pertains to the preparation, use, storage, and disposal of licensed byproduct materials. Jefferson University Radiology Associates, LLC, also committed to reviewing its other client-contracts or letters to evaluate the extent of condition of this violation and to ensure compliance with respect to other client facilities, NRC-licensed or otherwise.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. If you have additional information that you believe the NRC should consider, you may provide it in your response to the Notice. The NRC review of your response to the Notice will also determine whether further enforcement action is necessary to ensure compliance with regulatory requirements. In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice and Procedure," a copy of this letter and your response will be made available electronically for public inspection in the NRC Public Document Room located at NRC Headquarters in Rockville, MD, and from the NRCs document system, the ADAMS, accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy or proprietary information so that it can be made available to the Public without redaction.

If you have any questions regarding this matter, please contact Jason vonEhr of my staff at (610) 337-5256 or via electronic mail at Jason.vonEhr@nrc.gov.

Thank you for your cooperation.

Sincerely, Digitally signed by Christopher G.

Christopher G. Cahill Cahill Date: 2023.08.01 07:45:15 -04'00'

for Anne DeFrancisco, Chief Medical and Licensing Assistance Branch Division of Radiological Safety and Security Region I Docket No. 150-00037 License No. PA-1416 Enclosure:

Notice of Violation cc w/ enclosure Dwight Shearer, P.E., Bureau Director Bureau of Radiation Protection Pennsylvania Department of Environmental Protection