ML21214A324

Jefferson University Radiology Associates, LLC, DBA, Jefferson Outpatient Imaging (Jura) - Notice of Violation - NRC Inspection Report 15000037/2021001

ML21214A324
Person / Time
Site:	15000037
Issue date:	08/30/2021
From:	Ray Lorson Region 1 Administrator
To:	Colarossi M Jefferson Outpatient Imaging, Jefferson Univ Radiology Associates
Marjorie McLaughlin
References
EA-21-023 IR 2021001
Download: ML21214A324 (6)

See also: IR 015000037/2021001

Text

UNITED STATES

NUCLEAR REGULATORY COMMISSION

REGION I

2100 RENAISSANCE BOULEVARD, SUITE 100

KING OF PRUSSIA, PA 19406-2713

August 30, 2021

EA-21-023

Margaret Colarossi, Administrator

Jefferson University Radiology Associates, LLC

dba Jefferson Outpatient Imaging

850 Walnut Street, Walnut Towers

Philadelphia, PA 19107

SUBJECT: JEFFERSON UNIVERSITY RADIOLOGY ASSOCIATES, LLC, DBA,

JEFFERSON OUTPATIENT IMAGING - NOTICE OF VIOLATION - NRC

INSPECTION REPORT NO. 15000037/2021001

Dear Ms. Colarossi:

This letter refers to the routine inspection conducted on January 15, 2021, with continued in-

office review through May 21, 2021, of activities performed in NRC jurisdiction by Jefferson

University Radiology Associates, LLC (JURA) under its Commonwealth of Pennsylvania license

No. PA-1416. Based on the results of the inspection, the NRC identified an apparent violation

(AV) of NRC requirements. The AV involved JURA staff providing inaccurate information that

was material to the NRC when filing for reciprocity. NRC staff discussed the AV with you during

a telephonic exit meeting on May 21, 2021, and described the AV in the NRC inspection report

sent to you with a letter dated May 25, 2021 (ML21147A018) 1.

In the letter transmitting the inspection report, we informed you that the AV identified in the

report was being considered for escalated enforcement and requested that you provide

information about corrective actions by either providing a written response or attending a

predecisional enforcement conference before we made our final enforcement decision. In

letters dated June 17, 2021 (ML21236A277), and July 7, 2021 (ML21236A276), you provided a

written response to the AV and described the actions taken and planned by JURA to address

the issue, as further described below.

Based on the information identified during the inspection and the information that your staff

provided in JURAs letters dated June 17, 2021, and July 7, 2021, the NRC has determined that

a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of

Violation (Notice) and the circumstances surrounding it are described in detail in the subject

inspection report. As described above, the violation involved the provision of inaccurate

information on submittals of NRC Form 241, Report of Proposed Activities in Non-Agreement

States. Specifically, on ten occasions between April 24, 2020, and December 30, 2020, JURA

staff submitted NRC Form 241 to the NRC with photocopied signatures of a former Radiation

Safety Officer (RSO) who was no longer afilliated with the licensee.

1 Designation in parentheses refers to an Agency-wide Documents Access and Management System

(ADAMS) accession number. Documents referenced in this letter are publicly-available using the

accession number in ADAMS.

M. Colarossi 2

The NRC considered the violation to be significant because the NRC relies on Agreement State

licensees to provide complete and accurate information in reciprocity filings so that the NRC can

evaluate whether the proposed activities will be performed safely and in accordance with NRC

requirements. The NRC relies on the RSO or management representative to maintain

awareness of the licensees activities in NRC jurisdiction and ensure that they are performed in

accordance with the specifications and limitations described on NRC Form 241. Providing

inaccurate information about the RSO impedes the NRCs ability to communicate with the

Agreement State licensee about the proposed activities. Therefore, this violation has been

categorized in accordance with the NRC Enforcement Policy at Severity Level III (SL III).

In accordance with the NRC Enforcement Policy, a base civil penalty in the amount of $7500 is

considered for a SL III violation. Because your facility has not been the subject of escalated

enforcement actions within the last two inspections, 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. The NRC staff determined that credit for corrective

action is warranted. Namely, the current JURA RSO ceased the past practice of providing

photocopies of pre-signed NRC Form 241 documents to the JURA staff who submit the forms to

the NRC. Rather, any required submittals are sent to the RSO for review and signature before

they are sent to the NRC. Additionally, JURA revised its filing process to reduce the number of

submittals required to be made for schedule changes in order to reduce the opportunities for

errors.

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 violation; (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. 15000037/2021001, and the letters from JURA dated June 17, 2021, and July 7, 2021.

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, a copy of this letter, its

enclosure, and your response, if you choose to provide one, will be made available

electronically for public inspection in the NRC Public Document Room and in the NRCs

Agencywide Documents Access and Management System (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, proprietary, or safeguards information so that it can be

made available to the Public without redaction. If personal privacy or proprietary information is

necessary to provide an acceptable response, please provide a bracketed copy of your

response that identifies the information that should be protected and a redacted copy of your

response that deletes such information. If you request withholding of such information, you

must specifically identify the portions of your response that you seek to have withheld and

provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of

M. Colarossi 3

information will create an unwarranted invasion of personal privacy or provide the information

required by 10 CFR 2.390(b) to support a request for withholding confidential commercial or

financial information). The NRC also includes significant enforcement actions on its Web site at

(http://www.nrc.gov/reading-rm/doc-collections/enforcement/actions/).

If you have any questions concerning this matter, please contact Shawn Seeley of my staff at

610-337-5102 or Shawn.Seeley@nrc.gov.

Sincerely,

Raymond Digitally signed by

Raymond K. Lorson

K. Lorson Date: 2021.08.30

16:18:13 -04'00'

Raymond K. Lorson

Deputy Regional Administrator

Docket No. 15000037

License No. PA-1416

Enclosure: Notice of Violation

SUBJECT: JEFFERSON UNIVERSITY RADIOLOGY ASSOCIATES, LLC, DBA,

JEFFERSON OUTPATIENT IMAGING (JURA) - NOTICE OF VIOLATION - NRC INSPECTION

REPORT NO. 15000037/2021001 DATED

DISTRIBUTION w/encl:

SECY RIDSSECYMAILCENTER

OEMAIL

OEWEB

M Doane, EDO RIDSEDOMAILCENTER

D Roberts, DEDM

Y Diaz-Sanabria, OEDO

M Lombard, OE RIDSOEMAILCENTER

T Martinez-Navedo, OE

J Peralta, OE

N Hasan, OE

L Sreenivas, OE

J Lubinski, NMSS RIDSNMSSOD RESOURCE

R Lewis, NMSS

K Williams, NMSS

M Burgess, NMSS

Enforcement Coordinators

RII, RIII, RIV (M Kowal; J Cameron; D Dodson)

M Lemoncelli, OGC RIDSOGCMAILCENTER

P Moulding, OGC

H Harrington, OPA RIDSOPAMAILCENTER

R Feitel, OIG RIDSOIGMAILCENTER

T Higgs, OI RIDSOIMAILCENTER

D DAbate, OCFO RIDSOCFOMAILCENTER

B Welling, DRSS, RI R1DRSSMAILRESOURCE

T Bloomer, DRSS, RI

T Weidner, DRSS, RI

S Seeley, DRSS, RI

D Screnci, PAO-RI / N Sheehan, PAO-RI

M Ford, SAO-RI / F Gaskins, SAO-RI

B Klukan, ORA, RI

R McKinley, ORA, RI

D Bearde, ORA, RI

S Villar, RI

ML21214A324

DOCUMENT NAME: https://usnrc-my.sharepoint.com/personal/mmm3_nrc_gov/Documents/MMM3/Shared Enforcement/Final

Actions/Jefferson Radiology NOV-III EA-21-023.docx

X Non-Sensitive X Publicly Available

X SUNSI Review/ MMM

Sensitive Non-Publicly Available

OFFICE RI/ORA RI/DRSS RI/ORA RI/ORA OE RI/DRSS

M McLaughlin/ J Nguyen for D B Klukan/ BMK via R McKinley/ L Sreenivas via B Welling via

MMM Janda via email email RRM via email email email

DATE 8/03/2021 8/03/21 8/04/21 8/04/21 8/16/21 8/25/21

OFFICE RA

Raymond Digitally signed by

R Lorson/Raymond K. Lorson

K. Lorson 16:24:06 -04'00'

Date: 2021.08.30

DATE 8/30/21

OFFICIAL RECORD COPY

NOTICE OF VIOLATION

Jefferson University Radiology Associates, LLC Docket No. 15000037

Philadelphia, Pennsylvania PA License No. PA-1416

EA-21-023

During an NRC inspection conducted on January 15, 2021, with continued in-office review

through May 21, 2021, a violation of NRC requirements was identified. In accordance with the

NRC Enforcement Policy, the violation is listed below:

10 CFR 30.9(a) states, in part, that information provided to the Commission by a licensee or

information required by statute or by the Commission's regulations, orders, or license

conditions to be maintained by the licensee shall be complete and accurate in all material

respects.

10 CFR 150.20(a)(1) states, in part, that any person who holds a specific license from an

Agreement State, where the licensee maintains an office for directing the licensed activity

and retaining radiation safety records, is granted a general license to conduct the same

activity in non-agreement states,

10 CFR 150.20(b)(1) states, in part, that an Agreement State licensee shall, at least 3 days

before engaging in each activity for the first time in a calendar year, file a submittal

containing an NRC Form 241, Report of Proposed Activities in Non-Agreement States.

The NRC Form 241 requires the signature approval of an RSO or management

representative who certifies, in part, that the information on the form is true and complete.

Contrary to the above, on ten occasions between April 24, 2020, and December 30, 2020,

Jefferson University Radiology, which holds a specific license from an Agreement State and,

therefore, holds a general license from the NRC to conduct the same activity in non-

agreement states, provided information to the NRC that was not complete and accurate in

all material respects. Specifically, the general licensee submitted ten NRC Form 241s with

photocopied signatures of a former RSO This information is material to the NRC because

the NRC relies on the RSO or management representative to maintain awareness of the

licensees activities in NRC jurisdiction and ensure that they are performed in accordance

with the specifications and limitations described on the NRC Form 241.

This is a Severity Level III violation (Enforcement Policy 6.9.c.1)

The NRC has concluded that information regarding the reason for the violation, the corrective

actions taken and planned to correct the violation and prevent recurrence, and the date when

full compliance was achieved, is already adequately addressed on the docket in Inspection

Report No. 15000037/2021001 (ML21147A018) 1, and the letters from JURA dated June 17,

2021 (ML21236A277), and July 7, 2021 (ML21236A276). However, you are required to submit

a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not

accurately reflect your corrective actions or your position. In that case, or if you choose to

respond, clearly mark your response as a "Reply to a Notice of Violation, (EA-21-023)," and

1 Designation in parentheses refers to an Agency-wide Documents Access and Management System

(ADAMS) accession number. Documents referenced in this letter are publicly-available using the

accession number in ADAMS.

Notice of Violation 2

send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk,

Washington, DC 20555-0001 with a copy to the Regional Administrator, Region I, within 30 days

of the date of the letter transmitting this Notice of Violation (Notice).

If you contest this enforcement action, you should also provide a copy of your response, with

the basis for your denial, to the Director, Office of Enforcement, United States Nuclear

Regulatory Commission, Washington, DC 20555-0001.

If you choose to respond, your response will be made available electronically for public

inspection in the NRC Public Document Room or in the NRCs ADAMS, accessible from the

NRC Web site at http://www.nrc.gov/reading-rm/adams.html. Therefore, to the extent possible,

the response should not include any personal privacy, proprietary, or safeguards information so

that it can be made available to the Public without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working

days of receipt.

Dated this 30th day of August, 2021.