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{{#Wiki_filter:UNITED STATES
{{#Wiki_filter:
                                NUCLEAR REGULATORY COMMISSION
                                                  REGION I
                                        2100 RENAISSANCE BLVD.
                                      KING OF PRUSSIA, PA 19406-2713
                                              May 25, 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 (JURA) - NRC INSPECTION
                REPORT 15000037/2021001 AND APPARENT VIOLATION
Dear Ms. Colarossi:
On January 15, 2021, with continued in-office review through May 21, 2021, Shawn Seeley of
this office conducted a routine remote inspection of your activities performed under your
Commonwealth of Pennsylvania license No. PA-1416. The inspector discussed the inspection
findings with Jay Yoder, Radiation Safety Officer, and you, telephonically, on May 21, 2021.
Based on the results of this inspection, the NRC determined that one apparent violation of NRC
requirements occurred related to the failure to provide accurate information to the NRC when
filing for reciprocity. This apparent violation is being considered for escalated enforcement in
accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on
the NRCs Web site at https://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html.
Since the NRC has not made a final determination in this matter, a Notice of Violation is not
being issued at this time. Please be advised that the number and characterization of the
apparent violations described in the enclosed inspection report may change as a result of
further review. You will be advised by separate correspondence of the results of our
deliberations on this matter. The circumstances surrounding the apparent violation, the
significance of the issue, and the need for lasting and effective corrective actions were
discussed with you during the May 21, 2021, telephone call.
Before the NRC makes its enforcement decision regarding the apparent violation, we request
that you provide additional information regarding JURAs corrective actions for this event.
Although we noted that your immediate corrective actions to change the reciprocity request
form appeared to be effective, it is not clear if adequate actions to prevent recurrence have
been developed and/or implemented. You should be aware that the promptness and
comprehensiveness of your actions will be considered in assessing any civil penalty for the
apparent violation. The guidance in the enclosed excerpt from NRC Information Notice 96-28,
"Suggested Guidance Relating to Development and Implementation of Corrective Action,"
may be helpful.
The written response should be sent to the NRC within 30 days of the date of this letter. The
NRC recognizes that many licensees have been impacted by the public health emergency
caused by the Coronavirus Disease 2019 (COVID-19). Consequently, you may request an
 
                                                2
extension of time to submit the response by contacting Donna Janda, Chief, Medical and
Licensing Assistance Branch, via electronic mail at donna.janda@nrc.gov. Such an extension
request should explain the basis for the request and should specify the amount of additional
time being requested. This extension request must be submitted to the NRC no later than 20
days from the date of this letter (i.e., at least 10 days before the initial 30-day deadline to submit
the written response).
Your response should include for each apparent violation: (1) the reason for the apparent
violation or, if contested, the basis for disputing the apparent violation; (2) the corrective steps
that have been taken and the results achieved; (3) the corrective steps that will be taken; and
(4) the date when full compliance will be achieved. Your response may reference or include
previously docketed correspondence, if the correspondence adequately addresses the
required response. You should clearly mark the response as a Response to Apparent
Violation in NRC Inspection Report No. 15000037/2021001; EA-21-023, and send it to the
U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC
20555-0001 with a copy to the Regional Administrator, NRC Region I, 2100 Renaissance
Boulevard, Suite 100, King of Prussia, PA 19406. If an adequate response is not received
within the time specified or an extension of time has not been granted by the NRC, the NRC
will proceed with its enforcement decision or schedule a pre-decisional enforcement
conference (PEC).
In lieu of providing this written response, you may choose to provide your perspective on this
matter, including the significance, cause, and corrective actions, as well as any other
information that you believe the NRC should take into consideration by: (1) requesting a PEC
to meet with the NRC and provide your views in person; or (2) requesting Alternative Dispute
Resolution (ADR).
If you choose to request a PEC, the meeting should be held within 30 days of the date of this
letter, although this timeframe may be extended due to impacts from COVID-19. The
conference will include an opportunity for you to provide your perspective on these matters and
any other information that you believe the NRC should take into consideration before making an
enforcement decision. The topics discussed during the PEC may include information to
determine whether a violation occurred, information to determine the significance of a violation,
information related to the identification of a violation, and information related to any corrective
actions taken or planned. Please note that if a PEC is held, the NRC would issue a press
release to announce the conference time and date.
In lieu of a PEC or written response, you may request ADR with the NRC in an attempt to
resolve this issue. ADR is a general term encompassing various techniques for resolving
conflicts using a neutral third party. The technique that the NRC has decided to employ is
mediation; a voluntary, informal process in which a trained neutral mediator works with parties
to help them reach resolution. If the parties agree to use ADR, they select a mutually
agreeable neutral mediator who has no stake in the outcome and no power to make decisions.
Mediation gives parties an opportunity to discuss issues, clear up misunderstandings, be
creative, find areas of agreement, and reach a final resolution of the issues. Additional
information concerning the NRC ADR program can be obtained at http://www.nrc.gov/about-
nrc/regulatory/enforcement/adr.html. The Institute on Conflict Resolution (ICR) at Cornell
University has agreed to facilitate the NRC program as a neutral third party. Please contact
 
                                                3
ICR at 877-733-9415 within 10 days of the date of this letter if you are interested in pursuing
resolution of this issue through ADR. The ADR mediation session should be held within 45
days of the date of this letter, although this timeframe may be extended due to impacts from
COVID-19. The mediation session would be closed to public observation, but the time and date
would be publicly announced.
Please contact Ms. Janda at donna.janda@nrc.gov within 10 days of the date of this letter to
notify the NRC which of the above options you choose. If you do not contact the NRC within the
time specified, and an extension of time has not been granted by the NRC, the NRC will
proceed with its enforcement decision.
In accordance with 10 CFR 2.390 of the NRCs 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 or from 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 you have any questions concerning this matter, please contact Shawn Seeley of my staff at
shawn.seeley@nrc.gov.
                                                    Sincerely,
                                                                          Digitally signed by Blake D.
                                                    Blake D. Welling    Welling
                                                                          Date: 2021.05.25 12:30:55 -04'00'
                                                    Blake Welling, Director
                                                    Division of Radiological Safety and Security
                                                    Region I
Docket No. 15000037
License No. PA-1416
Enclosures:
1. Inspection Report 15000037/2021001
2. NRC Information Notice 96-28
cc w/Encls:    Jay Yoder, RSO
                Commonwealth of Pennsylvania
 
                                                            4
JEFFERSON UNIVERSITY RADIOLOGY ASSOCIATES, LLC DBA JEFFERSON OUTPATIENT
IMAGING (JURA) - NRC INSPECTION REPORT 15000037/2021001, PHILADELPHIA,
PENNSYLVANIA DATED May 25, 2021
Distribution:
ADAMS (PARS)
J Peralta, OE
L Sreenivas, OE
N Hasan, OE
S Rodriguez, OE
M Burgess, NMSS
R Sun, NMSS
B Welling, DRSS
D Janda, DRSS
B Klukan, RI
R1Enforcement
D Garvin, ORA
S Villar, RI
Region I OE Files (with concurrences)
DOCUMENT NAME: https://usnrc.sharepoint.com/teams/Region-I-
MLA/Inspection%20Reports/jefferson%20radiology.2021001%20DMJ%20SWS%204-30-2021.docx
SUNSI Review Complete: SSeeley
After declaring this document An Official Agency Record it will be released to the Public.
To receive a copy of this document, indicate in the box: C = Copy w/o attach/encl E = Copy w/ attach/encl N = No copy
                                                                                                                            N
OFFICE          RI:DRSS                    N  RI:DRSS                  N  RI:ORA            N    RI:DRSS
                  SSeeley/SWS                    DJanda                      MMcLaughlin              BWelling
NAME
                5/212021                      05/21/2021                    05/04/2021              05/25/21
DATE
                                                    OFFICIAL RECORD COPY
 
                  U.S. NUCLEAR REGULATORY COMMISSION
                                      REGION I
                                INSPECTION REPORT
Inspection No.            15000037/2021001
Docket No.                15000037
License No.              PA-1416
EA No.                    EA-21-023
Licensee:                Jefferson University Radiology Associates, LLC
                          dba Jefferson Outpatient Imaging
Address:                  850 Walnut Street, Walnut Towers
                          Philadelphia, PA 19107
Inspection Dates:        January 15, 2021, through May 21, 2021
Exit Meeting:            May 21, 2021
Inspector:                Shawn W. Seeley                                          5-21-2021
                          Shawn Seeley                                            date
                          Health Physicist
                          Medical and Licensing Assistance Branch
                          Division of Radiological Safety and Security
                                                Digitally signed by Donna M.
                          Donna M. Janda Janda  Date: 2021.05.25 11:29:42 -04'00'
Approved By:
                          Donna M. Janda, Chief                                  date
                          Medical and Licensing Assistance Branch
                          Division of Radiological Safety and Security
                                                                                            Enclosure
                                                              Inspection Report 15000037/2021001
                                                              1515000037/202100115000037/2021
                                                              00115000037/2021001
 
                                      EXECUTIVE SUMMARY
        Jefferson University Radiology Associates, LLC dba Jefferson Outpatient Imaging
                          NRC Inspection Report No. 15000037/2021001
On January 15, 2021, the NRC initiated a routine announced inspection to review the
organization and scope of activities performed under Jefferson University Radiology
Associates, LLC dba Jefferson Outpatient Imaging (JURA) Commonwealth of Pennsylvania
License No. PA-1416. JURA is a small University Healthcare provider located in Philadelphia,
Pennsylvania and licensed by the Commonwealth to provide mobile Positron Emission
Tomography (PET) imaging to clients. The licensee has been conducting patient studies
under reciprocity for numerous years at St. Francis Healthcare, located in Wilmington,
Delaware.
One apparent violation of NRC requirements was identified and is being considered for
escalated enforcement. 10 CFR 30.9(a) states that information provided to the Commission by
an applicant for a license or by a licensee or information required by statute or by the
Commission's regulations, orders, or license conditions to be maintained by the applicant or the
licensee shall be complete and accurate in all material respects. 10 CFR 150.20(b) requires that
an Agreement State licensee shall, at least 3 days before engaging in licensed activity in non-
agreement states 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 regulation further requires
that the Agreement State licensee shall file an amended NRC Form 241 or letter with the
Regional Administrator to request approval for changes in work locations, radioactive material, or
work activities different from the information contained on the initial NRC Form 241. The NRC
Form 241 requires the signature approval of a Radiation Safety Officer (RSO) or management
representative who certifies, in part, that the information on the form is true and complete.
Contrary to the above, on 10 occasions between April 24, 2020 and December 30, 2020, the
Agreement State licensee provided information to the NRC that was not complete and accurate
in all material respects. Specifically, the general licensee submitted ten 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 Form 241.
Immediate corrective action included submitting a corrected form signed by an authorized
individual on January 21, 2021, for work to be conducted on January 22, 2021.
                                                  2          Inspection Report 15000037/2021001
                                                            15000037/2021001
 
                                    REPORT DETAILS
1.  Organization and Scope of the Program
a. Inspection Scope
    The inspector reviewed the organization and scope of activities performed under Jefferson
    University Radiology Associates, LLC dba Jefferson Outpatient Imagings (JURA)
    Commonwealth of Pennsylvania License No. PA-1416. Information was gathered through
    interviews with licensee staff, including the new Radiation Safety Officer, and through
    reviews of selected records.
b. Observations and Findings
    JURA is a small University Healthcare provider located in Philadelphia, PA. They are
    licensed by the Commonwealth of Pennsylvania (under timely renewal) to provide
    mobile Positron Emission Tomography (PET) imaging to clients. The licensee has been
    conducting patient studies under reciprocity for numerous years at St. Francis
    Healthcare, located in Wilmington, Delaware.
    The Radiation Safety Officer (RSO) for JURAs license is a health physics consultant who
    is available by telephone daily and onsite as necessary. The license was amended via
    letter dated April 17, 2020, to change the RSO from Mr. Adam Henry to Mr. Jay Yoder.
    The amended license was signed on April 24, 2020.
c.  Conclusions:
    No violations of NRC requirements were identified.
2.  Review of Licensed Activities
a. Inspection Scope
    The inspector performed a remote announced routine inspection utilizing NRC
    Inspection Procedure 87130, Nuclear Medicine Programs, Written Directive Not
    Required, to conduct the inspection. Information was gathered through interviews with
    cognizant personnel and a review of records.
                                              3        Inspection Report 15000037/2021001
                                                        15000037/2021001
 
b. Observations and Apparent violations
  The inspector determined the licensee submitted their initial NRC Form 241 for
  calendar year 2021, via facsimile to the Region I office on December 30, 2020, to
  conduct licensed activities at St. Francis Healthcare in Wilmington, DE on January 7th
  and 21st of 2021. The form was co-signed by Adam Henry, Radiation Safety Officer
  (RSO) and Lauren Odell, Certified Nuclear Medicine Technologist (CNMT). Whereas
  the fee was not included, NRC staff attempted to contact the licensee to inquire about
  the fee payment.
  Multiple attempts by telephone and email were made to Mr. Adam Henry, RSO, and
  Ms. Margaret Colarossi, Office Manager for Jefferson to obtain the payment information.
  Neither party responded until after January 7, 2021. On January 12, 2021, NRC staff
  contacted the client to alert them that Jefferson had not been approved for work on
  January 21, 2021. During this call, staff learned that Jefferson had conducted licensed
  activity on one patient on January 7, 2021. The client then contacted Jefferson about the
  upcoming patient schedule for January 21.
  On January 15, 2021, Ms. Margaret Colarossi was contacted and a payment was
  submitted over the phone. Subsequently, an inspection was opened by the Medical
  Branch.
  The inspection was conducted remotely due to the ongoing COVID PHE. During the
  inspection, the inspector determined that Jefferson had submitted forms on a monthly
  basis for prior years as patient cases dictated. The inspector attempted to contact the
  RSO, Mr. Adam Henry, to discuss the Form 241 filings. The inspector reached Mr. Jay
  Yoder, president of Keystone Health Physics, the consulting company supplying the RSO
  services to Jefferson, who informed the inspector that Mr. Henry had not worked there
  since the end of March 2020. The inspector determined that the licensee had used a pre-
  signed form by the RSO for the CNMT to submit whenever the patient schedule had been
  established each month. This pre-signed form was submitted on April 24, 2020, June 1,
  2020, June 29, 2020, July 17, 2020, August 28, 2020, September 28, 2020, November 2,
  2020, December 1, 2020, and December 16, 2020. The forms signed from June 29,
  2020, until the end of the year had been co-signed by the CNMT.
  The inspector determined that on 10 occasions, JURAs submittal of an NRC Form 241
  that had been pre-signed by an RSO who was no longer affiliated with the company,
  constituted an apparent violation of 10 CFR Part 30.9, Completeness and Accuracy of
  Information.
  Apparent Violation
  10 CFR 30.9(a) states that information provided to the Commission by a licensee or 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 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) 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
                                            4            Inspection Report 15000037/2021001
                                                          15000037/2021001
 
    containing an NRC Form 241, Report of Proposed Activities in Non-Agreement States.
    The Agreement State licensee shall file an amended NRC Form 241 or letter with the
    Regional Administrator to request approval for changes in work locations, radioactive
    material, or work activities different from the information contained on the initial NRC
    Form 241. 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 10 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 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
    Form 241.
    Summary of Corrective Actions
    Immediate corrective action included submitting a corrected form signed by an
    authorized individual on January 21, 2021, for work to be conducted on January 22,
    2021.
c. Conclusions
    One apparent violation of NRC requirements was identified and is being considered for
    escalated enforcement as noted above.
3.  Exit Meeting
    On May 21, 2021, the inspector presented the results of the inspection by telephone.
    The licensee acknowledged the apparent violation.
                                              5          Inspection Report 15000037/2021001
                                                          15000037/2021001
 
                      ATTACHMENT: SUPPLEMENTAL INFORMATION
                          PARTIAL LIST OF PERSONS CONTACTED
Licensee
*Jay Yoder, Radiation Safety Officer
*Margaret Colarossi, Administrator
*Present at telephone exit meeting on May 21, 2021
                              INSPECTION PROCEDURES USED
1) Manual Chapter 2800, Materials Inspection Program
2) Inspection Procedure 87130, Inspection of Nuclear Medicine Programs, Written Directive
Not Required
                        LIST OF NRC SURVEY INSTRUMENTS USED
            None used - remote inspection only
                                  LIST OF ACRONYMS USED
CFR            Code of Federal Regulations
CNMT          Certified Nuclear Medicine Technologist
NRC            Nuclear Regulatory Commission
RSO            Radiation Safety Officer
                                              6        Inspection Report 15000037/2021001
                                                        15000037/2021001
}}
}}

Revision as of 09:48, 8 September 2021

Jefferson University Radiology Associates, LLC, Dba Jefferson Outpatient Imaging (Jura) - NRC Inspection Report 15000037/2021001 and Apparent Violation
ML21147A018
Person / Time
Site: 15000037
Issue date: 05/25/2021
From: Blake Welling
Division of Nuclear Materials Safety I
To: Colarossi M
Jefferson Outpatient Imaging, Jefferson Univ Radiology Associates
References
EA-21-023, IN-96-028 IR 2021001
Download: ML21147A018 (10)
v • d • e


See also: IR 015000037/2021001

Text

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