ML21214A324
| 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
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
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
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.