official transcript of proceedings nuclear regulatory ... · 15 over to my colleague, michelle...

Official Transcript of Proceedings

NUCLEAR REGULATORY COMMISSION

Title: Predecisional Enforcement ConferenceRE Avera McKennan

Docket Number: EA-20-003

Location: teleconference

Date: Wednesday, July 15, 2020

Work Order No.: NRC-0974 Pages 1-43

NEAL R. GROSS AND CO., INC.Court Reporters and Transcribers1323 Rhode Island Avenue, N.W.

Washington, D.C. 20005(202) 234-4433

1

UNITED STATES OF AMERICA1

NUCLEAR REGULATORY COMMISSION2

PRE-DECISIONAL ENFORCEMENT CONFERENCE3

_____________________________4

IN THE MATTER OF No.5

Avera McKennan EA-20-0036

_____________________________7

Wednesday, July 15, 20208

Via Teleconference9

10

The above-entitled matter came on for pre-11

decisional enforcement conference at 9:00 a.m.12

13

14

From the Nuclear Regulatory Commission:15

SCOTT MORRIS, Regional Administrator, R-IV16

MARY MUESSLE, Director, Division of Nuclear Material17

Safety, R-IV18

PATRICIA SILVA, Chief, Materials Inspection Branch, R-19

IV20

JASON vonEHR, Health Physicist, Materials Inspection21

Branch, R-IV22

JEREMY GROOM, Team Leader, Allegation Coordination and23

Enforcement Staff, R-IV24

DAVID CYLKOWSKI, Regional Counsel, R-IV25

NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

2

JOHN KRAMER, Senior Enforcement Specialist, R-IV1

ROBERT SUN, Enforcement Coordinator, NMSS2

PETE SNYDER, Enforcement Specialist, Office of3

Enforcement4

LEELAVATHI SREENIVAS, Enforcement Specialist, Office5

of Enforcement6

LORRAINE BAER, Attorney, Office of General Counsel7

8

From Avera McKennan Hospital:9

DAVID FLICEK, President & Chief Executive Officer10

MICHAEL ELLIOTT, Chief Medical Officer11

JOHN MATHISON, Vice President of Specialty Care12

TRACI HOLLINGSHEAD, RSO, Radiation Oncology13

MICHELLE WHITE, RSO, Nuclear Medicine and PET/CT14

LEE KIESSEL, Radiation Safety Officer, Avera McKennan15

Radiology16

KRISTIN OLSON, Interventional Radiology Manager17

RHONDA ROESLER, Chief Compliance Officer18

ASHLEY HANSON, Nuclear Medicine Mobile Coordinator19

20

21

22

23

24

25



3

CONTENTS1

Page2

Opening Remarks 3

- Regional Administrator, RIV . . . . . . . 44

Enforcement Policy Overview 5

- Region IV Staff . . . . . . . . . . . . . 136

Apparent Violation 7

- Region IV Staff . . . . . . . . . . . . . 168

External Presentation . . . . . . . . . . . . . . 239

Questions . . . . . . . . . . . . . . . . . . . . 3610

Closing Remarks11

- Regional Administrator, RIV . . . . . . . 4212

13

14

15

16

17

18

19

20

21

22

23

24

25



4

P R O C E E D I N G S1

9:01 a.m.2

OPERATOR: Welcome and thank you for3

standing by. At this time, all participants are in a4

listen-only mode until the question-and-answer session5

of today's call. At that time, if you would like to6

ask a question, please press *1.7

I would now like to turn our meeting over8

to Mr. Scott Morris, Regional Administrator. Thank9

you, you may begin.10

MR. MORRIS: All right, thank you. Good11

morning, my name is Scott Morris, I am the Regional12

Administrator for the Nuclear Regulatory Commission's13

Region IV Office. This morning we're going to conduct14

a pre-decisional enforcement conference between the15

NRC and Avera McKennan to discuss six apparent16

violations of NRC requirements. 17

The apparent violations were described in18

an inspection report issued on Avera McKennan back on19

March 30 of this year. And if you haven't seen the20

report and you're listening in on the conference, the21

report is available in our document management system22

online at Accession No. ML20090D288.23

Ordinarily the NRC would have hosted this24

conference within about 45 days of issuing the report,25



5

which would have been, you know, approximately middle1

of May. But obviously these are not ordinary times. 2

You know, we would note that Avera McKennan is an3

important healthcare provider in South Dakota, and we4

respect the priority of healthcare-related activities5

relative to the enforcement matters that we're going6

to discuss today.7

So we didn't get this conference done in8

the timeframe that we would ordinarily do it, but we9

ultimately were able to work with Avera and identify10

a mutually agreeable date, which is today. So welcome11

to Avera McKennan.12

Please note that this meeting is being13

recorded for later transcription by a third party. 14

When you're speaking, please speak clearly and state15

your name before continuing.16

Before I go any further, I would like to17

introduce the NRC staff present on the telephone18

conference bridge today, and then I'll give Avera19

McKennan an opportunity to introduce its20

representatives.21

So on the call with me today from the22

Nuclear Regulatory Commission is Mary Muessle, she is23

the Director of the Region IV Division of Nuclear24

Materials Safety. In addition we have Patricia Silva,25



6

she's the Chief of the Materials Inspection Branch1

here in Region IV. 2

We also have Jeremy Groom. Jeremy is the3

Allegation Coordination and Enforcement Specialist4

Team Leader. We have Jason vonEhr, our lead Inspector5

for this case. We have David Cylkowski. David is our6

Regional Counsel. We have Robert Sun, he is an7

Enforcement Coordinator in the NRC's Headquarters8

Office of Nuclear Materials and Safety and Safeguards.9

We have Leelavathi Sreenivas, she's an10

Enforcement Specialist in our Office of Enforcement,11

also in Headquarters. And finally, Pete Snyder, also12

an Enforcement Specialist in our Headquarters Office13

of Enforcement.14

If I have missed anybody from the NRC15

who's on the bridge today, please make yourself known.16

MR. KRAMER: Hi, you have John Kramer, the17

Region IV Senior Enforcement Specialist.18

MR. MORRIS: Thanks, John, sorry I missed19

you. Okay, well, let me ask the representatives from20

Avera McKennan to introduce yourselves. And again,21

please state your name before speaking. Thank you.22

MR. FLICEK: Good morning, Dave Flicek,23

President and CEO of Avera McKennan.24

MS. OLSON: Kristin Olson, Interventional25



7

Radiology Manager.1

MS. ROESLER: Rhonda Roesler, Chief2

Compliance Officer for Avera Health.3

MS. HANSON: Ashley Hanson, Associate4

Radiation Safety Officer for Nuclear Medicine and5

PET/CT.6

MS. HOLLINGSHEAD: Traci Hollingshead,7

Radiation Safety Officer, Radiation Oncology.8

MS. WHITE: Michelle White, RSO, Nuclear9

Medicine and PET/CT.10

MR. MATHIESON: John Mathison, Vice11

President of Specialty Clinic.12

DR. ELLIOTT: Good morning, this is Mike13

Elliott, I'm the Chief Medical Officer at Avera14

McKennan Hospital.15

MR. KIESSEL: Lee Kiessel, Diagnostic16

Physicist and Radiology RSO.17

MS. HOLLINGSHEAD: That's everybody in the18

room representing Avera.19

MR. MORRIS: Okay, well, thank you, and20

welcome this morning. Again, this is Scott Morris.21

I want to emphasize the fact that we're22

conducting -- the fact that we're conducting this23

conference today does not mean that the NRC has made24

a final determination that violations have occurred or25



8

that any enforcement action will be taken. This is in1

part why the issues were described in the inspection2

report as, quote, apparent, unquote, violations.3

This conference is an important step in4

our deliberative decision making process. The main5

purpose of today's conference is to provide the -- is6

for Avera McKennan to provide the NRC with information7

it needs to make an informed enforcement decision. 8

However, no decisions will be reached or discussed9

during this conference today.10

So with that, I would encourage Avera to11

be candid in providing your perspectives on the12

apparent violations, their safety significance, the13

circumstances surrounding the apparent violations, any14

corrective actions taken, and/or plan, and any other15

information you believe bears on our decision.16

Copies of the agenda for today have been17

made available. Following my remarks, Patty Silva,18

who I introduced as the Chief of our Materials19

Inspection Branch, will provide some brief20

instructions and remarks. And then we'll give Avera21

McKennan an opportunity to present any of their22

opening remarks. 23

After that, Jeremy Groom, who is our team24

leader in our Region IV Allegation and Coordination25



9

and Enforcement Team, will discuss the NRC's1

enforcement policy and our process at a very high. 2

And then Patty Silva will, we'll go back to Patty and3

she'll talk about the six apparent violations that are4

at issue today. And she'll also talk about why the5

apparent violations are significant.6

And then Avera will be given an7

opportunity to discuss your perspectives. And I think8

that'll constitute the bulk of today's meeting.9

I would note that the agenda provides for10

a short break, you know, ten to fifteen minutes or so11

prior to the conclusion of the conference. The break12

will occur typically after -- we would typically have13

this break after our licensee, in this case Avera, has14

completed its presentation, at least the formal part15

of its presentation.16

And this break allows the NRC staff to17

review what we've heard and determine if we have any18

follow up questions. So we'll caucus offline for like19

I said, ten to fifteen minutes, determine if we have20

any subsequent questions, and then we'll come back on21

and we'll use the remaining time to ask those22

clarifying questions.23

And then of course when we're done with24

that, we'll proceed to concluding remarks and end the25



10

meeting. So with that, let me hand it off to Patti1

Silva.2

MS. SILVA: Good morning, I'm Patti Silva,3

the Chief of the Materials Inspection Branch in Region4

IV. This is a category one meeting between the Nuclear5

Regulatory Commission and Avera McKennan. It is open6

to public observation but not to public participation. 7

If there are observers present, NRC staff8

will be available after the business portion of this9

conference is concluded to answer questions from10

members of the public regarding the NRC enforcement11

process and to receive comments concerning our12

enforcement process.13

I'll now turn the floor over to Avera14

McKennan for any opening remarks they may have.15

DR. ELLIOTT: Yes, good morning, thank16

you, Patti. Thanks, Mr. Morris, and to all of your17

colleagues this morning. 18

I'm sure the NRC, just like Avera19

McKennan, is trying to be extra cautious during this20

pandemic. We certainly have curtailed and I'm sure21

you have travel and are very cautious around large22

group gatherings. So we much appreciate your ability23

and your willingness to hold this across the distance24

out of an interest of safety.25



11

We, we're happy to meet with you this1

morning, look forward to any feedback and comments2

that you might have. Want to just confirm to you that3

top down in this organization with Mr. Flicek, our4

President and CEO being in the room here this morning,5

we take safety very seriously. It is one of our key6

pillars to overall quality. So you will hear more as7

we dive into the actions, steps that we've taken in8

response to the apparent violations.9

MR. FLICEK: Yeah, so that was Mike10

Elliott, our Chief Medical Officer, and this is Dave11

Flicek, President and CEO. So yeah, our mission is12

rooted in the Gospel, so we plan to be very forthright13

and honest about the findings and how we're going to14

correct them. 15

So we want to thank you for time today and16

appreciate the fact that we didn't have to travel. 17

That was very helpful for us. And we're still trying18

to manage through our pandemic here in the Dakotas. 19

So hope all is well with you down there, and I'll turn20

it back over to you, thank you.21

But Mike Elliott, the Chief Medical22

Officer, will be our main speaker today.23

MS. SILVA: Thank you. The Division of24

Nuclear Materials Safety is responsible for performing25



12

nuclear materials safety and security inspections for1

licensees in Region IV's jurisdiction. I'll discuss2

the purpose of this conference and how the NRC will3

make its final decision regarding the apparent4

violations in just a minute.5

If there are no questions at this time6

about the agenda or the conduct of this conference, I7

will ask Jeremy Groom to discuss the Agency's8

enforcement policy and process.9

MR. GROOM: Thanks, Patti. Good morning. 10

Again, my name is Jeremy Groom, I'm the Allegations11

and Enforcement Team Leader for NRC Region IV.12

Similar to Scott's opening remarks, I13

would like to emphasize that the NRC has not reached14

any final enforcement decision on the matter15

communicated in our March 30, 2020 inspection report. 16

This conference is part of our information-gathering17

process used to help the NRC make an informed18

regulatory decision.19

The inspection report you received in late20

March provided our perspectives on the apparent21

violations of NRC requirements that we believe22

occurred. This conference is your opportunity to23

provide Avera McKennan's perspectives on the apparent24

violations and any additional information that you25



13

feel is pertinent to the NRC's enforcement decisions.1

I'm now going to take a few minutes to2

provide a very brief overview of the NRC's enforcement3

process.4

The NRC has three common types of actions5

used to meet our enforcement policy objectives. Those6

actions include a notice of violation, which is simply7

a written notice that a violation has occurred and how8

the requirement was violated. A written response from9

you may be required for a notice of violation.10

We also use notice of violations with a11

civil penalty. The purpose of a civil penalty is to12

emphasize compliance in a way that prevents future13

violations and focuses your attention on significance14

and significant violations.15

And finally, in rare cases the NRC can16

issue orders which can be used to modify, suspend, or17

revoke a license.18

When determining what sanctions should be19

employed, the NRC first works to determine whether a20

violation or violations occurred. If we determine21

that a violation occurred, we use severity levels to22

classify violations according to their significance. 23

The NRC uses four significance levels, one through24

four, with violations at severity level one being the25



14

most significant, and those at severity level four1

being the least significant.2

Severity level one, two, and three3

violations are considered escalating enforcement4

actions and are candidates for monetary civil5

penalties. We take four factors into consideration in6

determining the severity level of a violation.7

First, we consider if there were any8

actual consequences, which would include things like9

overexposures or unintended releases of radioactive10

material. Next we consider if there were any11

potential consequences. Third, we consider if the12

violation impacted the NRC's ability to perform its13

regulatory oversight function. And finally, we14

consider if there were any willful aspects of the15

violation.16

After we have determined significance, the17

NRC has a systematic process used to determine if a18

civil penalty is warranted, and if so, what should be19

the amount. Again, each violation classified at20

severity level three or above is a candidate for a21

monetary civil penalty.22

The civil penalty assessment process23

considers three elements. First, we consider your24

enforcement history and the severity level of the25



15

underlying violation. Next, we consider how the1

violation was identified, whether it be licensee-2

identified or revealed by some other means, like3

through an NRC inspection or self-revealed through an4

event.5

And finally, we look at corrective6

actions. For the NRC to assign corrective action7

credit, typically we look for actions that are prompt8

and comprehensive, such that they would prevent future9

violations from occurring. The NRC can exercise10

discretion depending on the circumstances to either11

increase or decrease the amount of a civil penalty.12

Although each case is different, as to the13

use of discretion, there are three possible outcomes14

for most cases. That would be no civil penalty,15

either a base civil penalty, and finally, we could16

issue a civil penalty at twice the base amount.17

Following this conference, we will make a18

decision based on the information we obtain during our19

inspection activities and considering any new20

information you provide during this meeting. When21

we're ready to issue our decision, we will notify you22

by phone and by letter. This process can take up to23

several weeks.24

NRC licensees have appeal rights and may25



16

challenge any NRC action. The instructions for1

challenging an enforcement action will be either in2

the action itself or in the transmittal letter. When3

civil penalties are issued, that particular action4

provides hearing rights, as well as another5

opportunity to request alternative dispute resolution.6

If a civil penalty is imposed or an order7

is issued, normally our Office of Public Affairs will8

issue a press release within a day or so of a final9

action being issued and received. 10

I would like to close by reminding you11

that everything I just discussed regarding sanctions,12

civil penalties, and the overall enforcement process13

used by the NRC is publically available and discussed14

in detail in our enforcement policy, which can be15

found at www.NRC.gov. 16

I would like to now turn it back over to17

Patricia Silva to discuss the apparent violations.18

MS. SILVA: Thank you, Jeremy, for the19

enforcement summary. This is Patricia Silva.20

The apparent violations that are the21

subject of this conference were described in the NRC's22

inspection report issued on March 30. In accordance23

with our normal practices, the documents associated24

with the conference, including any materials provided25



17

by Avera McKennan, will be placed in the Agency's1

public document room and in ADAMS, our electronic2

document retrieval system.3

If you believe that any information you4

provide is sensitive and should be withheld from the5

public, you need to provide us the basis for your6

request to withhold the information in writing. The7

NRC is also interested in feedback from participants8

and observers about how it conducts meetings, and in9

particular would be interested in comments about this10

meeting.11

We have provided written comment forms,12

which are available online. We invite any person who13

has comments to complete a form, a comment form. 14

Please leave the -- sorry. We can also accept15

comments from persons attending through the bridge16

following the conference.17

In brief, on November 18-22, 2019, the NRC18

conducted an unannounced, routine inspection of Avera19

McKennan. As a result of this inspection and20

resulting -- and resulting in-office review, six21

apparent violations of NRC requirements were22

identified. The purpose of this conference is to23

obtain your perspective regarding the apparent24

violations in order to allow us to reach an informed25



18

enforcement decisions.1

I'll go over -- I will go over the2

apparent violations as they were described in the3

inspection report.4

Apparent violation one. 10 CFR5

20.1502(a)(1) requires in part that each licensee6

shall monitor exposure to radiation and radioactive7

material at levels sufficient to demonstrate8

compliance with the occupational dose limits of 10 CFR9

Part 20. 10

At a minimum, each licensee shall monitor11

occupational exposure to radiation from licensed and12

unlicensed radiation sources under the control of the13

licensee and shall supply and require the use of14

individual monitoring devices by adults likely to15

receive in one year from sources external to the body16

a dose in excess of ten percent of the limits in 1017

CFR 20.1201(a).18

Contrary to this, from at least 2016 to19

November 22, 2019, the licensee failed to adequately20

monitor individuals' occupational exposure to21

radiation sources under control of the licensee and22

require the use of individual monitoring devices. 23

Specifically, at least two individuals whose24

occupational exposure exceeded ten percent of the25



19

limits of 10 CFR 20.1201(a) were not monitored over1

the course of at least three years.2

Apparent violation two. 10 CFR3

20.2203(a)(2)(i) requires in part that each licensee4

shall submit a written report within 30 days after5

learning of a dose in excess of the occupational dose6

limits for adults in 10 CFR 20.1201. Contrary to7

this, from September 27, 2019 to December 9 -- or 6,8

2019, the Licensee failed to submit a written report9

within 30 days after learning of a dose in excess of 10

the occupational limits for adults in 20.1201.11

Specifically, the Licensee was notified by12

its dosimetry vendor on August 27, 2019 of two13

exposures exceeding the NRC's annual dose limits for14

an individual and failed to provide any notification15

to the NRC within 30 days. A reconstruction of the16

subject authorized users was completed, demonstrating17

the authorized user's dose under the 10 CFR 20.120118

occupational dose limits for adults and submitted to19

the NRC on December 6, 2019.20

Apparent violation three. 10 CFR21

20.1101(a) requires in part that each licensee22

implement a radiation protection program commensurate23

with the scope and extent of licensed activities and24

sufficient to ensure compliance with the provisions of25



20

10 CFR Part 20. 1

Contrary to this, from April 11, 2018 to2

November 22, 2019, the Licensee failed to implement a3

radiation protection program commensurate with the4

scope and extent of licensed activities and sufficient5

to ensure compliance with the provisions of 10 CFR6

Part 20. 7

Specifically, the Licensee failed to, one,8

perform quarterly reviews of the external radiation9

exposures of authorized users and workers. Two,10

investigate all known instances of deviations from11

good ALARA practice. Three, investigate in a timely12

manner the cause of all (audio interference) exposures13

equally and exceeding investigational level two, which14

is 400 millirem per quarter or 200 millirem per month. 15

And four, develop, implement, and document corrective16

actions for violations of regulations, license17

additions, or program weaknesses that are identified.18

Apparent violation four. 10 CFR19

19.12(a)(3) requires in part that all individuals who20

in the course of employment are likely to receive in21

a year an occupational dose in excess of 100 millirems22

shall be instructed in and required to observe, to the23

extent within the worker's control, the applicable24

provisions of the Commission's regulation and licenses25



21

for the protection of personnel from exposure to1

radiation and/or radioactive material.2


November 18, 2019, the Licensee failed to perform --4

to provide instruction to individuals who in the5

course of employment were likely to receive in a year6

an occupational in excess of 100 millirems on the7

applicable provisions of the Commission regulations8

and licenses for the protection of personnel from9

exposure to radiation and/or radioactive material.10

Specifically, the Licensee failed to11

provide instructions regarding radiation safety12

involving the proper use of dosimeters to three13

occupational workers who were likely to receive an14

occupational dose in excess of 100 millirem in a year,15

which resulted in their failure to properly wear16

dosimetry to monitor their exposure to occupational17

radiation.18

Apparent violation five. 10 CFR19

19.13(d)(1) requires in part that the licensee shall20

provide an annual report to each individual monitored21

under 10 CFR 20.1502 of the dose received in that22

monitoring year if the individual's occupational dose23

exceeds 100 millirem total effective dose equivalent.24




22

November 18, 2019, the Licensee failed to provide an1

annual report to each individual monitored under 102

CFR 20.1502 of the dose received in that monitoring3

year when the individual's occupational dose exceeded4

100 millirems total effective dose equivalent.5

Specifically, the Licensee failed to6

provide radiation exposure data to three occupational7

workers in the course of their employment who had8

exceeded 100 millirem total effective dose equivalent.9

Apparent violation six. 10 CFR 35.24(f)10

requires in part that licensee shall establish a RSC11

to oversee all uses of byproduct material permitted by12

the license. The committee must include an authorized13

user of each type of use permitted by the license, the14

RSO, a representative of the nursing service, and a15

representative of management who is neither an16

authorized user nor an RSO.17

Contrary to this, from January 25, 201818

through October 19, 2019 -- October 9, 2019, the19

Licensee's RSC failed to include an authorized user of20

each type of use permitted by the license, the RSO, a21

representative of the nursing staff -- nursing22

service, and a representative of management who is23

neither an authorized user nor an RSO.24

Specifically, during the eight quarterly25



23

committee meetings between the above dates, there was1

not an authorized user on the Licensee committee to2

represent the 10 CFR 35.1000 Yttrium-90 microsphere3

use.4

Those were the six apparent violations. 5

I will turn it back over to Scott Morris.6

MR. MORRIS: All right, thanks, Patti,7

appreciate that summary. So unless there are any8

questions at this point about those apparent9

violations that Patti described or any questions about10

how this conference will be conducted, I'm going to go11

ahead and turn the conference over to Avera McKennan12

and allow you all to provide your perspectives on13

circumstances and context associated with the apparent14

violations that Patti described, and importantly, your15

corrective actions that are planned, completed --16

planned or completed. 17

So with that, let me turn it back over to18

Avera McKennan. Thank you.19

DR. ELLIOTT: Thanks, Scott, this is Mike20

Elliott again. I'm hoping that you have the slides in21

front of you that we will be talking from this22

morning.23

MR. MORRIS: We do, thank you.24

DR. ELLIOTT: The first -- good, good. 25



24

The first page is simply our introduction of our1

radiation safety officers. The next couple of slides2

go through at a high level the apparent violations3

that have already been summarized very well, so I4

don't think I need to go through those again.5

I'd like to draw your attention to slide6

4 of the presentation. And we, Avera McKennan, do not7

dispute these findings. The following slides I hope8

will demonstrate to you that we have taken these9

apparent violations seriously and we have in place and10

are continuing to add more actions to ensure that11

those violations are corrected and do not reoccur in12

the future.13

So with that brief intro, I will turn it14

over to my colleague, Michelle White, for the next15

slide.16

MS. WHITE: Thank you, Dr. Elliott. This17

is Michelle White responding to violation one, 10 CFR18

20.1502(a)(1), failure to monitor the occupational19

exposure of a worker from licensed and unlicensed20

sources of radiation.21

The Licensee made the RSO for the Nuclear22

Medicine Department responsible for the oversight of23

occupational exposures for the Interventional24

Radiology physician. See Exhibit 1. I will describe25



25

what is in front of you. 1

Starting in January and till May, we've2

been watching the dosimetry readings throughout the3

implementation of different courses of action. And4

you will see on slide -- the whole body dosimeter5

readings, the beginning dosimeter readings of the6

three physicians in question, starting in January,7

ending in May. And hopefully after extrapolation of8

these results, you'll see a decline in exposure9

dosimetry readings. Each line representing a10

different physician.11

The next part of that exhibit is the lens12

dosimeter readings. Same concept, after extrapolation13

there has been significant progress in the decline of14

exposures.15

Next slide. Nuclear Medicine RSO or16

designee will physically place and exchange the IR17

physician dosimeter on their lead aprons each month. 18

Confirm that spare badges are available if needed. 19

Created the use of a personal dosimetry policy20

describing how and when to wear personal dosimeters. 21

See Exhibit 2.22

This policy outlines when, where, how to23

wear their badges, including a diagram to assist the24

wearer in location of their monitors. 25



26

Created the manager responsibility in1

regards to radiation policy addressing dosimeter badge2

exchange frequency, declaration of pregnancy, fetal3

badge, and a list of exposed staff and area monitors. 4

See Exhibit 3.5

Next slide, I'll turn it over to my6

colleague, Lee Kiessel.7

MR. KIESSEL: Yeah, this is Lee Kiessel. 8

Just going over slide 6 in regards to violation two,9

our failure to submit a written report to the NRC10

within 30 days of a discovery of an overexposure11

involving an adult worker.12

We immediately took action to recalculate13

the authorized user radiation exposures. In certain14

cases, this is required upon certain calculations to15

that user's dosimeter readings. In other instances,16

estimations were performed or reconstructions were17

calculated to estimate the user's doses for instances18

in which we were lacking dosimetry information.19

Once these corrections -- these20

calculations and estimations were made, we contacted21

Landauer, our vendor, to make these dose corrections22

in their database. Unfortunately, we could only23

correct the year 2009, as Landauer informed us that24

they could only go back that far for changes. 25



27

And these dose reconstructions were1

provided to Jason vonEhr, the Inspector, in Region IV. 2

There were also provided to the physicians as well so3

they would have -- so they would know that the4

exposure that they have had while they were not being5

properly monitored.6

We also made revisions to our ALARA7

policy, if you can refer to Exhibit 4. Specifically,8

near the end you'll see that we've added specifically9

a section that outlines our responsibilities to notify10

the NRC in such cases where we do have instances where11

we do have exposure that exceeds those NRC limits.12

Moving on to slide 7, I will turn it back13

over to Michelle.14

MS. WHITE: This is Michelle speaking15

again on violation 3, 10 CFR 20.1101(a), failure to16

develop and implement certain elements of the17

radiation protection program.18

The licensee revised its ALARA policy, as19

Lee has indicated in his previous slide. The Licensee20

established new quarterly investigational levels that21

include the following two categories: Nuclear22

Medicine, PETCT Radiology, and Radiation Oncology,23

that's one; and Radiology Interventional Physicians as24

the second.25



28

The RSO for Nuclear Medicine and Dr.1

Douglas Yim, a physician lead for IR, Interventional2

Radiology, toured the department on March 25, 2020 to3

assess potential improvements that could be made in4

time, distance, and shielding during procedures.5

Continued with violation three, course of6

action. The Licensee's RSOs regularly meet to discuss7

operations within each area. See Exhibit 5. These8

are the minutes to the meetings.9

The following procedure was initiated. 10

Dr. Yim volunteered to be the Physician Champion for11

the Licensee to assist IR in improving time, distance,12

and shielding practices. Status updates will be13

reviewed by the RSC, Radiation Safety Committee. See14

Exhibit 6, minute meeting indicating such.15

Next slide, slide 8. Same violation,16

course of action. A safety checklist was placed on17

the wall in every IR suite. See Exhibit 7. The18

Circulating Technologist will use this checklist to19

assure the following are in place prior to each20

procedure. Ceiling mount is in place, nurse lead21

shields are in place, mobile shields are in place,22

fixed table aprons are in place, leaded glasses are23

being utilized when applicable, rad pads are available24

when needed. Perform timeout for dosimetry check and25



29

lead aprons are utilized.1

Slide 9, continued violation three. IR2

physicians' lead aprons were moved to the Reading Room3

away from other lead aprons to eliminate anyone from4

grabbing the wrong apron. The IR Manager worked with5

the IR physicians to determine what additional lead6

shielding could be utilized in the IR suite.7

The Licensee purchased and received two8

lead apron replacements; one lead eyeglass, now two;9

three mobile shields; and one pull-down ceiling shield10

in the CT suite.11

MR. KIESSEL: This is Lee, referring --12

moving on to slide 11. This is in reference to13

violation four, our failure to provide instructions14

regarding radiation safety involving the proper use of15

dosimeters and certain radiation workers.16

Immediately after inspection, the17

violations were discussed with administration, and the18

followup meeting was scheduled with the IR physicians.19

At that meeting, the physicians were made aware of the20

violations, and specifically their lack of use of21

personal dosimeters. The meeting -- we also at that22

meeting determined if the IR physicians needed to stop23

work based on their reported occupational exposure24

results.25



30

And at that time, based on initial dose1

reconstruction calculations by myself, the Licensee2

believed that the apparent overexposures were just due3

to not properly utilizing the dosimetry and was only 4

on paper. And we decided not to issue a stop-work5

order based on those reconstructions.6

Moving on to slide 12, I'll turn it back7

to Michelle.8

MS. WHITE: This is Michelle speaking on9

violation four. Staff meetings were held with IR that10

included education on the ALARA policy and personal11

dosimetry in several sessions to catch them all. See12

Exhibit 8.13

Provided education to manager of the IR14

Department on January 30, 2020 regarding the following15

topics: pregnancy declaration, reviewing and printing16

dosimetry reports, and how to get spare dosimeters.17

Next slide, 13, Michelle speaking. 18

Continued course of action for violation four. The19

Licensee held an intradepartmental meeting on March20

30, 2020 with IR staff and physicians to discuss the21

implementation of the radiation safety checklist. The22

IR circulating technologist will be responsible for23

the radiation safety timeout to maximize the shielding24

components of the ALARA principle. See Exhibit 9.25



31

This includes the documentation of the1

meeting as well as the process to document it2

electronically in the MEDITECH file. 3

The Licensee held an educational session4

on May 13, 2020 to demonstrate the best placement of5

staff to reduce exposure in the IR suite and the CT6

suite. See Exhibit 10.7

This includes the documentation of that8

walkthrough and teaching session, as well as the9

isotope map from the CT scanner in the suite with the10

star on the diagram indicating the sweet spot for11

people to stand to avoid the scatter.12

We'll move on to the next slide. 13

Violation five, 10 CFR 19.13(b)(1), failure to provide14

occupational exposure reports to certain radiation15

workers.16

The Licensee created the following17

policies: use of personal dosimetry, manager18

responsibilities in regards to radiation, and ALARA19

exposures notification letters, ALARA level one and20

ALARA level two. See Exhibits 2, 3, and 11 previously21

provided in the slide.22

And the next slide, slide 15, I will turn23

it over to Traci Hollingshead to speak on violation24

six.25



32

MS. HOLLINGSHEAD: This is Traci1

Hollingshead addressing violation number six, 10 CFR2

35.24(f), fail to ensure that an authorized user of3

each type of use permitted by the license was4

represented on the Radiation Safety Committee.5

The Licensee has (audio interference) the6

Radiation Safety Committee May of 2016 into the7

following two committees. One committee covered8

Nuclear Medicine and PETCT and Radiation Oncology, and9

the second committee was Radiology.10

Following the inspection and the11

violations that were identified in the IR Department,12

we moved the Radiation Safety Committee back, and it13

combined the three areas to cover Radiation Oncology,14

Nuclear Medicine and PETCT and Radiology all in one15

meeting that meets quarterly. 16

The Licensee restructured the Committee17

members and attendant expectations to ensure that an18

authorized user of each type of use permitted by the19

Licensee is represented on the Radiation Safety20

Committee.21

The Licensee created the Radiation Safety22

Committee charter, please see Exhibit 12.23

MS. WHITE: This is Michelle White24

speaking on other actions, which is slide 16. An25



33

Avera system approach is being initiated by the Avera1

Health Radiology Service Line Committee. This2

Radiation Safety Subcommittee has three areas of3

focus: to review policies and procedures, to reduce4

variations when practical. 5

And the ones listed are the ones that I've6

reviewed with the Committee, Subcommittee in the last7

meeting, which are duties and responsbilities of the8

Radiation Safety Officer, policy for declared pregnant9

workers, program for maintaining occupational10

radiation exposures, ALARA, and ALARA exposure11

notification letters.12

The other two areas of focus for the13

subcommittee radiology service line is to provide a14

resource for providers regarding regulatory changes15

and to serve as a collection point for strategic16

objectives. Moving on, the Licensee's RSOs will share17

the results of the foregoing action plans and report18

the results to the Radiation Safety Subcommittee.19

COVID-19 did slow the development of the20

Avera system approach, but it is moving forward. See21

Exhibit 13, the minutes to the meeting.22

I will turn the next slide over to Traci23

Hollingshead. That is slide 17.24

MS. HOLLINGSHEAD: This is Traci25



34

Hollingshead to expand on other actions that have been1

taken by the Licensee. Prior to the recent2

inspection, the Licensee was in the process of3

splitting the radioactive material license. The NRC4

split occurred on March 10, 2020. 5

As a result of the license split, the6

Licensee believes it has the right balance of7

Radiation Safety Officers to foster a culture of8

safety towards departments that use radiation.9

I'll turn it over to Dr. Elliott for the10

summary.11

DR. ELLIOTT: Yeah, thanks, Traci. So12

this is Dr. Elliott again. You know, I want to I13

guess start by just thanking the NRC for your time,14

both this morning and with your surveys of us and your15

assistance in helping us to improve. Again, I want to16

reiterate that Avera McKennan as a licensee agrees17

with the NRC's findings.18

I think it's important for you to note19

that it's Catholic-based organization, mission-rooted20

in the Gospel. We have core values of compassion,21

hospitality, and stewardship. And as we outline those22

values under compassion, quality is a key part of who23

we are and what we do. 24

And I'm sure you're all aware of25



35

Donabedian's model of quality that has structure,1

processes, and outcomes. We take that very seriously.2

AHRQ defined the six pillars of quality:3

effective; efficient; equitable; timely; patient-4

centered; and most importantly for this, safe. Safe5

care is a key part of what we do and who we want to6

be, safety for both our patients and for our staff.7

I hope that the overview of the slides8

we've presented this morning show you our dedication9

to the ongoing efforts for safety related to Nuclear10

Medicine and certainly today the focus in our11

Interventional Radiology Department.12

With that, I want to thank my colleagues13

here today for your presentations. I suspect the NRC14

can tell from the discussion that a lot of time,15

effort, and energy has been put into this. That's not16

to say that that only happens after one of your17

inspections, this is an ongoing effort. But the18

slides today are there to show you the dedicated19

efforts that have been put in place after your20

inspection.21

At this point in time, I'm happy to turn22

it over to you, Scott, your colleagues for any23

questions or suggestions or remarks.24

MR. MORRIS: Okay, well, thank you very25



36

much for that presentation. Again, my name is Scott1

Morris. So let me, normally we would take a quick2

recess at this point, but before we do that, let me3

just ask the staff, the NRC staff on the phone, if you4

have any specific questions about anything you heard5

in the presentation or anything specifically in the6

slides that were presented.7

Okay, well, I'm not hearing anything. So8

I think we're going to do at this point is take a9

short recess, maybe ten minutes or so. I'd just ask10

you to remain on the telephone bridge. You know, if11

the -- I would encourage you as well to, you know, if12

you think there's something else that maybe you wanted13

to mention and didn't, you know, to think through that14

kind of stuff. And we'll come back here in about ten,15

fifteen minutes, then we'll resume.16

Does that sound okay?17

DR. ELLIOTT: That sounds good, thank you.18

MR. MORRIS: Very good. All right, we're19

going to go on mute and have our caucus on a separate20

bridge line. Thank you.21

(Whereupon, the above-entitled matter went22

off the record at 10:52 a.m. and resumed at 11:1123

a.m.)24

MR. MORRIS: Okay, this is Scott Morris,25



37

Regional Administrator, Nuclear Regulatory Commission,1

Region IV Office in Arlington, TX. We're going to go2

ahead and resume the predecisional enforcement3

conference with Avera McKennan.4

We've had an opportunity to have a5

conversation internally about what we've heard so far6

and determine whether or not we needed to ask any7

followup or clarifying questions, and we do have one8

or two. So this is a question obviously for the9

Licensee here, and I'll pose it, with a bit of a10

preamble.11

So you know, first of all, let me just12

thank you for your presentation today. I appreciate13

-- we appreciate your perspectives and the scope and14

breadth of the corrective actions to which you've15

ascribed and have either implemented or have planned. 16

So definitely appreciate that, it's very helpful to17

us. 18

As Jeremy Groom mentioned, you know,19

that's a key element of our deliberative process as we20

contemplate what, if any, enforcement actions we're21

going to take, specifically a review or our assessment22

of your -- the nature and scope, breadth, and23

effectiveness of your corrective actions. So thank24

you for that.25



38

But so my question, or our question I1

should say, is really taking sort of maybe one giant2

step back or, you know, looking at it from a broader3

perspective. I mean, these six apparent violations4

associated with the hospital in question here -- I5

guess it causes me and us to wonder, and I would6

offer, I would invite you all to comment on this, you7

know, it seems to be, and I don't want to push this8

too far, but I mean, and you mentioned it briefly on9

your closing slide, but this notion of safety culture.10

And I wonder if you could comment on given11

the breadth and extent of the issues that we talked12

about here today and that are enumerated in our13

inspection report, is there something, you know, is14

there -- were you able to discern or identify maybe a15

specific, more fundamental underlying cause that sort16

of led to this what I'll call breakdown that17

ultimately led to the six apparent violations? 18

And you know, and to the extent there is19

a broader, more underlying foundational cause for20

this, to what extent have you internalized that and,21

you know, taken actions to try to focus on that22

underlying cause, such that, you know, you prevent23

further actions -- prevent further issues down the24

road. 25



39

I mean, I understand, we understand that1

many of the corrective actions you've taken now, if2

implemented effectively, will do that. But we can't3

help but wonder, particularly since you brought it up,4

this notion of the safety culture. To what extent5

have you internalized, you know, a more fundamental6

underlying root cause.7

And secondarily, to what extent have these8

lessons been shared with the broader Avera, you know,9

system. Obviously, there are other hospitals in the 10

system, and so, you know, in the interest of public11

health and safety, patient health and safety, your12

staff's health and safety which you've described, you13

know, to what extent have these, this information been14

shared more broadly within the system?15

So I would invite you to comment on that. 16

Thank you.17

DR. ELLIOTT: Sure, Scott, this is Mike18

Elliott. I'll respond to some of that, and then I'll19

turn it over to Mr. Flicek for more of the system20

viewpoint. I will refer you and your colleagues to21

slide 4 of our presentation as starting for a22

response.23

Really, after the inspection occurred,24

what became apparent to us was we needed more25



40

specificity, direct oversight, direct monitoring. And1

we feel through a series of steps that we outlined2

here that we have that. And that is, that was our3

fundamental error, we did not have the specificity in4

the policies, the role clarity, the responsibility5

clarified. And that is going to occur due to our6

changes going forward. 7

That's how I think at least from a8

hospital perspective we are going to tackle this. You9

know, the simple fact that, you know, we're doing a10

timeout now. That's nothing new to us. We've been11

doing a timeout for procedures for I want to say close12

to a decade. 13

But just simply, again, after the survey,14

after the apparent violations, recognizing that we can15

take the same safety precautions that we're using in16

other areas and apply them directly to Interventional17

Radiology is going to ensure that these violations do18

not reoccur. 19

And for the broader system perspective,20

I'll turn it over to Mr. Flicek.21

MR. FLICEK: Yeah, David Flicek. And I22

would agree, Mike, I think we have to own some of we23

have some blindspots, and that's what an inspection is24

for, is that you shed some light on it. I would say25



41

we do have a safety, a culture, our physicians were1

engaged right afterwards. We got them right involved. 2

And so they're sitting on the committees as we speak3

to help us improve our safety and quality. 4

So honestly we did have, we have to own5

the blindspots and we have to fix them. But I think6

we have a culture where we can do that, so there's no7

pushback on it. It's we want to do what's best for8

patients and employees. And so this is just helpful,9

so we look at it as being helpful to us.10

As far as the broader Avera Health system11

I'm involved in, we have 13 service lines. One of12

them is Radiology. And from the Radiology service13

line, that's six facilities spread out through South14

Dakota, Northwest Iowa, and Minnesota. It's a15

collection of individuals from the Radiology16

Departments that come together quarterly to discuss17

radiology issues. 18

So we're big, but we're not that big where19

we can't get together and talk about just something20

like this. There is actually a Radiation Safety Now21

Subcommittee that is part of the Radiology service22

line. And so that's where we plan to take this up. 23

Todd Forkel, a colleague of mine who's the24

CEO, and Dr. Brad Paulson is there. And so all these25



42

issues, now we have a forum to discuss and implement1

system-wide, as opposed to every facility doing their2

program. So I think we're positioned very well to3

take this forward and improve as we go forward. I4

hope that answers some of your questions.5

MR. MORRIS: Yeah, it's very helpful. Let6

me just invite anyone, this is Scott Morris again,7

anyone from the NRC staff to perhaps ask a followup8

question. Okay, well, hearing none, let me just ask9

you, Dave, do you have any final thoughts before we10

move to close today's conference?11

MR. FLICEK: Yeah, this is Dave Flicek. 12

Thanks for your time. Thanks for allowing us to give13

our side of the story here, and we look forward to14

moving forward with these corrective actions. Thank15

you.16

MR. MORRIS: All right, so again, Scott17

Morris here. So in closing this predecisional18

enforcement conference, I just want to remind19

everybody present and listening in that the six20

apparent violations discussed this morning are subject21

to further review based on, in no small part, the22

information provided today by the Licensee. 23

The violations may be revised prior to24

taking any enforcement actions, and statements or25



43

expressions of opinions made by anyone on the NRC side1

or the lack thereof, frankly, do not represent final2

Agency positions or determinations. 3

The NRC staff will consider the4

information provided today to make the appropriate5

enforcement action consistent with our enforcement6

policy that Jeremy Groom described. And it's7

available on our public website.8

And of course we'll notify Avera McKennan9

by phone and in writing when we're ready to announce10

our decision. Our goal is to complete our enforcement11

review and decisionmaking and communicate those12

decisions by the middle of August. So you know,13

around a month or so from now.14

So with that, the business portion of this15

conference is now closed, and I'm going to turn it16

back over to Patti Silva for any questions or comments17

that may come to us from the public. Patti.18

(Whereupon, the above-entitled matter went19

off the record at 10:21 p.m.)20

21

22

23

24

25



ADAMS ACCESSION NO. ML20205L580

official transcript of proceedings nuclear regulatory ... · 15 over to my colleague, michelle...

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