ML23219A149

Jefferson University Radiology Associates, LLC, NRC Inspection Report No. 15000037/2023-001 and Notice of Violation

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

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