official transcript of proceedings nuclear regulatory ... · 15 over to my colleague, michelle...
TRANSCRIPT
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
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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
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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
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14
15
16
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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for the protection of personnel from exposure to1
radiation and/or radioactive material.2
Contrary to this, from at least 2016 to3
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
Contrary to this, from at least 2016 to25
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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NEAL R. GROSSCOURT REPORTERS AND TRANSCRIBERS
1323 RHODE ISLAND AVE., N.W.(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433
ADAMS ACCESSION NO. ML20205L580