ML21147A018

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)

See also: IR 015000037/2021001

Text

UNITED STATES

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

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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

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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.

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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.

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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

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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.

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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

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