ML23219A149
| ML23219A149 | |
| Person / Time | |
|---|---|
| Site: | 15000037 |
| Issue date: | 08/01/2023 |
| From: | Anne Defrancisco NRC Region 1 |
| To: | Yoder J Jefferson Univ Radiology Associates |
| References | |
| IR 2023001 | |
| Download: ML23219A149 (1) | |
See also: IR 015000037/2023001
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
REGION I
475 ALLENDALE ROAD - SUITE 102
KING OF PRUSSIA, PA 19406-1415
August 1, 2023
Jay M. Yoder, M.S., DABR,
Radiation Safety Officer
Jefferson University Radiology Associates, LLC
d/b/a Jefferson Outpatient Imaging
840 Crescent Centre Drive, Suite 200
Franklin, TN 37067
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.
J. Yoder 2
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
J. Yoder 3
JEFFERSON UNIVERSITY RADIOLOGY ASSOCIATES, LLC - NRC INSPECTION REPORT
NO. 150-00037/2023-001 AND NOTICE OF VIOLATION DATED AUGUST 1, 2023
DISTRIBUTION:
None
X SUNSI Review JEV1
X Non-Sensitive X Publicly Available
Sensitive Non-Publicly Available
OFFICE RI:DRSS RI:DRSS
NAME Jason vonEhr ADeFrancisco/cgc for
DATE 07/13/2023 8/1/2023
OFFICIAL RECORD COPY
NOTICE OF VIOLATION
Jefferson University Radiology Associates, LLC Docket No. 150-00037
Franklin, TN License No. PA-1416
During an NRC inspection conducted on June 1, 2023, with in-office review through
July 27, 2023, a violation of NRC requirements was identified. In accordance with the NRC
Enforcement Policy, the violation is listed below:
10 CFR 35.80(a)(1) requires that the licensee providing mobile medical services shall obtain
a letter signed by the management of each client for which services are rendered that
permits the use of byproduct material at the client's address and clearly delineates the
authority and responsibility of the licensee and the client.
Contrary to the above, on June 1, 2023, the licensee provided mobile medical services and
failed to obtain a letter signed by the management of each client for which services were
rendered that permitted the use of byproduct material at the client's address and clearly
delineated the authority and responsibility of the licensee and the client. Specifically, the
licensee relied on its contract to address the 10 CFR 35.80(a)(1) regulation, but the contract
did not clearly address almost any aspect of the preparation, use, storage, or disposal of
NRC-licensed byproduct material and the respective responsibilities of the licensee and the
client.
This is a Severity Level IV violation (NRC Enforcement Policy Section 6.3.d).
Pursuant to the provisions of 10 CFR 2.201, Jefferson University Radiology Associates, LLC is
hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory
Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the
Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice
of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation"
and should include for each violation: (1) the reason for the violation, or, if contested, the basis
for disputing the violation, (2) the corrective steps that have been taken and the results
achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date
when full compliance will be achieved. Your response may reference or include previous
docketed correspondence, if the correspondence adequately addresses the required response.
If an adequate reply is not received within the time specified in this Notice, an order or a
Demand for Information may be issued as to why the license should not be modified,
suspended, or revoked, or why such other action as may be proper should not be taken. Where
good cause is shown, consideration will be given to extending the response time.
If you contest this enforcement action, you should also provide a copy of your response to the
Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington,
DC 20555-0001. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, any response
which contests an enforcement action shall be submitted under oath or affirmation.
Your response will be placed in the NRC Public Document Room (PDR) and on the NRC Web
site. To the extent possible, it should, therefore, not include any personal privacy, proprietary, or
safeguards information so that it can be made publicly available without redaction. However, if
you find it necessary to include such information, you should clearly indicate the specific
information that you desire not to be placed in the PDR and provide the legal basis to support
your request for withholding the information from the public.
Enclosure
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working
days of receipt.
Dated This 1st day of August, 2023
2