IR 015000037/2023001: Difference between revisions

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{{Adams
{{Adams
| number = ML23219A149
| number = ML23263B088
| issue date = 08/01/2023
| issue date = 09/05/2023
| title = Jefferson University Radiology Associates, LLC, NRC Inspection Report No. 15000037/2023-001 and Notice of Violation
| title = Jefferson University Radiology Associates, LLC - NRC Inspection No. 150-00037/2023 001 and Notice of Violation - Acknowledgement Letter
| author name = Defrancisco A
| author name = Cahill C
| author affiliation = NRC/RGN-I
| author affiliation = NRC/RGN-I
| addressee name = Yoder J
| addressee name = Yoder J
| addressee affiliation = Jefferson Univ Radiology Associates, LLC
| addressee affiliation = Jefferson Outpatient Imaging, Jefferson Univ Radiology Associates, LLC
| docket = 15000037
| docket = 15000037
| license number = PA-1416
| license number = PA-1416
Line 18: Line 18:


=Text=
=Text=
{{#Wiki_filter:August 1, 2023
{{#Wiki_filter:September 5, 2023


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


==Dear Jay Yoder:==
==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.
This letter refers to your August 31, 2023, correspondence, in response to our August 1, 2023, letter. Thank you for informing us of the corrective actions documented in your letter. After reviewing the information provided in your response to the Notice, we have concluded that your proposed actions appear to adequately address the regulatory noncompliances described in the Notice. We will review your implementation of these corrective actions during a future inspection to determine whether full compliance has been restored and whether compliance will be maintained.


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.
Please note that the NRC Region I address described in your letter (2100 Renaissance Blvd.,
Suite 100, King of Prussia, PA 19406) is no longer accurate. As of September 2022, the NRCs Region I office completed its move to the address noted at the top of this letter. Please update your records accordingly.


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.
Your cooperation with us is appreciated.
 
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.
Sincerely, Digitally signed by Christopher G.


Christopher G. Cahill Cahill Date: 2023.08.01 07:45:15 -04'00'
Christopher G. Cahill Cahill Date: 2023.09.05 11:50:20 -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:
Christopher Cahill, Chief Commercial, Industrial, R&D and Academic Branch Division of Radiological Safety and Security Region I Docket No. 150-00037 License No. PA-1416 cc:
Notice of Violation cc w/ enclosure Dwight Shearer, P.E., Bureau Director Bureau of Radiation Protection Pennsylvania Department of Environmental Protection
Dwight Shearer, P.E., Bureau Director Bureau of Radiation Protection Pennsylvania Department of Environmental Protection JEFFERSON UNIVERSITY RADIOLOGY ASSOCIATES, LLC - NRC INSPECTION NO. 150-00037/2023 001 AND NOTICE OF VIOLATION DATED SEPTEMBER 5, 2025 X Non-Sensitive X Publicly Available X SUNSI Review JEV Sensitive  Non-Publicly Available OFFICE RI:DRSS RI:DRSS NAME Jason vonEhr Chris Cahill DATE 09/01/2023 09/05/2023 OFFICIAL RECORD COPY
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Latest revision as of 23:50, 12 October 2023

Jefferson University Radiology Associates, LLC - NRC Inspection No. 150-00037/2023 001 and Notice of Violation - Acknowledgement Letter
ML23263B088
Person / Time
Site: 15000037, 015000037
Issue date: 09/05/2023
From: Christopher Cahill
NRC Region 1
To: Yoder J
Jefferson Outpatient Imaging, Jefferson Univ Radiology Associates
References
IR 2023001
Download: ML23263B088 (1)


Text

September 5, 2023

SUBJECT:

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

Dear Jay Yoder:

This letter refers to your August 31, 2023, correspondence, in response to our August 1, 2023, letter. Thank you for informing us of the corrective actions documented in your letter. After reviewing the information provided in your response to the Notice, we have concluded that your proposed actions appear to adequately address the regulatory noncompliances described in the Notice. We will review your implementation of these corrective actions during a future inspection to determine whether full compliance has been restored and whether compliance will be maintained.

Please note that the NRC Region I address described in your letter (2100 Renaissance Blvd.,

Suite 100, King of Prussia, PA 19406) is no longer accurate. As of September 2022, the NRCs Region I office completed its move to the address noted at the top of this letter. Please update your records accordingly.

Your cooperation with us is appreciated.

Sincerely, Digitally signed by Christopher G.

Christopher G. Cahill Cahill Date: 2023.09.05 11:50:20 -04'00'

Christopher Cahill, Chief Commercial, Industrial, R&D and Academic Branch Division of Radiological Safety and Security Region I Docket No. 150-00037 License No. PA-1416 cc:

Dwight Shearer, P.E., Bureau Director Bureau of Radiation Protection Pennsylvania Department of Environmental Protection JEFFERSON UNIVERSITY RADIOLOGY ASSOCIATES, LLC - NRC INSPECTION NO. 150-00037/2023 001 AND NOTICE OF VIOLATION DATED SEPTEMBER 5, 2025 X Non-Sensitive X Publicly Available X SUNSI Review JEV Sensitive Non-Publicly Available OFFICE RI:DRSS RI:DRSS NAME Jason vonEhr Chris Cahill DATE 09/01/2023 09/05/2023 OFFICIAL RECORD COPY