[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Notices]
[Pages 32470-32475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11528]


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NUCLEAR REGULATORY COMMISSION

[Docket Nos. 030-11252 and 030-39216; License Nos. 40-16571-01 and -02; 
EA-21-027; NRC-2022-0122]


In the Matter of Avera McKennan Hospital

AGENCY: Nuclear Regulatory Commission.

ACTION: Confirmatory order; issuance.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a 
Confirmatory Order to Avera McKennan and Avera McKennan/Nuclear 
Medicine (collectively known as Avera McKennan) to document commitments 
made as part of a settlement agreement made between the NRC and Avera 
McKennan following an alternative dispute resolution mediation session 
held on April 20, 2022. The mediation addressed two apparent violations 
involving Avera McKennan's willful failure to accurately determine and 
record the activity of each dosage before medical use and the failure 
to maintain required information that was complete and accurate. Avera 
McKennan has committed to various measures intended to restore its 
ability to accurately measure dose activity, monitor the performance of 
its nuclear medicine technologists, and to train its employees and 
contractors on the NRC enforcement actions that may result from 
deliberate misconduct. The Confirmatory Order is effective upon 
issuance.

DATES: The Confirmatory Order was issued on May 19, 2022.

ADDRESSES: Please refer to Docket ID NRC-2022-0122 when contacting the 
NRC about the availability of information regarding this document. You 
may obtain publicly available information related to this document 
using any of the following methods:
    <bullet> Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2022-0122. Address 
questions about Docket IDs in Regulations.gov to Stacy Schumann; 
telephone: 301-415-0624; email: <a href="/cdn-cgi/l/email-protection#491a3d282a30671a2a213c2428272709273b2a672e263f"><span class="__cf_email__" data-cfemail="88dbfce9ebf1a6dbebe0fde5e9e6e6c8e6faeba6efe7fe">[email protected]</span></a>. For technical 
questions, contact the individual listed in the For FURTHER INFORMATION 
CONTACT section of this document.
    <bullet> NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly available documents online in the 
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS 
Search.'' For problems with ADAMS, please contact the NRC's Public 
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or 
by email to <a href="/cdn-cgi/l/email-protection#0b5b4f5925596e78647e79686e4b657968256c647d"><span class="__cf_email__" data-cfemail="207064720e7245534f55524345604e52430e474f56">[email protected]</span></a>. The Confirmatory Order to Avera 
McKennan is available in ADAMS under Accession No. ML22130A588.
    <bullet> NRC's PDR: You may examine and purchase copies of public 
documents, by appointment, at the NRC's PDR, Room P1 B35, One White 
Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make 
an appointment to visit the PDR, please send an email to 
<a href="/cdn-cgi/l/email-protection#7b2b3f2955291e08140e09181e3b150918551c140d"><span class="__cf_email__" data-cfemail="cf9f8b9de19daabca0babdacaa8fa1bdace1a8a0b9">[email protected]</span></a> or call 1-800-397-4209 or 301-415-4737, between 
8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except Federal 
holidays

FOR FURTHER INFORMATION CONTACT: Jeremy Groom, Region IV, U.S. Nuclear 
Regulatory Commission, telephone: 817-200-1182, email: 
<a href="/cdn-cgi/l/email-protection#410b2433242c386f06332e2e2c012f33226f262e37"><span class="__cf_email__" data-cfemail="53193621363e2a7d14213c3c3e133d21307d343c25">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The text of the Order is attached.

    Dated: May 24, 2022.

    For the Nuclear Regulatory Commission.
Scott A. Morris,
Regional Administrator, NRC Region IV.

Attached--Confirmatory Order

United States of America

Nuclear Regulatory Commission

    In the Matter of: AVERA MCKENNAN, AVERA MCKENNAN/NUCLEAR 
MEDICINE

Docket No. 030-11252, License No. 40-16571-01

Docket No. 030-39216, License No. 40-16571-02

EA-21-027

Confirmatory Order Modifying License

(Effective Upon Issuance)

I

    Avera McKennan and Avera McKennan/Nuclear Medicine (collectively 
known as Avera McKennan or the licensee) are the holders of Materials 
License Nos. 40-16571-01 and 40-16571-02 respectively, issued by the 
U.S. Nuclear Regulatory Commission (NRC or Commission) pursuant to Part 
30 of Title 10 of the Code of Federal Regulations (10 CFR). The 
licenses authorize the operation of facilities in accordance with 
conditions specified therein. The facilities are located on the 
licensee's sites in South Dakota.
    This Confirmatory Order (CO) is the result of an agreement reached 
during an Alternative Dispute Resolution (ADR) mediation session 
conducted on April 20, 2022.

II

    On February 13, 2019, the NRC's Office of Investigations (OI) 
opened an investigation (OI case No. 4-2019-007) at Avera McKennan. 
Based on the evidence developed during its investigation, the NRC 
identified two apparent violations involving the failure to determine, 
by direct measurement, the activity of dosages before medical use as 
required by 10 CFR 35.63(a); and the failure to maintain information 
that was complete and accurate in all material respects as required by 
10 CFR 30.9. It is Avera McKennan's view that no violation of 
requirements occurred.\1\ The parties agree to disagree on whether 
violations occurred. By letter dated December 21, 2021 (Agencywide 
Documents Access and Management System (ADAMS) Accession No. 
ML21355A366), the NRC notified Avera McKennan of the results of the 
investigation and provided Avera McKennan with an opportunity to: (1)

[[Page 32471]]

Attend a predecisional enforcement conference or (2) participate in an 
ADR mediation session in an effort to resolve these concerns.
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    \1\ Avera McKennan's view on the apparent violations is 
available at ML22117A183.
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    In response to the NRC's offer, Avera McKennan requested the use of 
the NRC ADR process. On April 20, 2022, the NRC and Avera McKennan met 
in an ADR session mediated by a professional mediator, arranged through 
Cornell University's Institute on Conflict Resolution. The ADR process 
is one in which a neutral mediator, with no decision-making authority, 
assists the parties in reaching an agreement to resolve any differences 
regarding the dispute. This Confirmatory Order is issued pursuant to 
the agreement reached during the April 20, 2022 ADR session.

III

    During the ADR session, Avera McKennan and the NRC reached a 
preliminary settlement agreement.
    ``Avera McKennan'' refers to the licensees of Avera McKennan 
(License 40-16571-01) and Avera McKennan/Nuclear Medicine (License 40-
16571-02). ``Contractors'' refers to individuals performing NRC 
licensed activities under either the Avera McKennan license (License 
40-16571-01) or the Avera McKennan/Nuclear Medicine license (License 
40-16571-02).
    The NRC recognizes the corrective actions that Avera McKennan has 
already implemented associated with the apparent violations:
    A. Avera McKennan ordered new dippers for use in all dose 
calibrators and replaced the modified dippers for all dose calibrators.
    B. Avera McKennan communicated that the new dippers were ordered 
and that modified dippers should not be used after new dippers arrived.
    C. Avera McKennan transitioned from the use of molybdenum 
generators to create individual dosages to the use of unit doses 
supplied by a third-party radiopharmacy.
    D. Avera McKennan implemented a field observation program that 
includes an annual one-on-one observation of each nuclear medicine 
technologist focused on ensuring radiation safety. Each annual 
observation includes formal documentation of any improvement, if 
needed.
    E. Avera McKennan has retained the use of an outside entity to 
provide an independent assessment of Avera McKennan performance.
    Additional commitments made in the preliminary settlement 
agreement, as signed by both parties, consist of the following:

Communications

    A. Avera McKennan will develop a communication that will: Include a 
summary of the events that resulted in the Confirmatory Order, stress 
the importance of complying with NRC regulations and the conditions of 
the license, and emphasize the importance of ensuring documents are 
complete and accurate, and the consequences for engaging in willful 
violations. Avera McKennan will submit the communication to the NRC for 
review and approval within 2 months of the issuance date of the 
Confirmatory Order.
    B. Within 2 months of NRC approval of the communication, Avera 
McKennan will issue the Condition A communication as a stand-alone 
communication from a senior hospital official to all authorized users, 
nuclear medicine technologists, all other employees performing in NRC 
licensed activities and Contractors. Avera McKennan will retain a copy 
of the communication presented and a record of the personnel receiving 
the communication.
    C. Beginning on the date Avera McKennan has issued the Condition A 
communication and until December 31, 2026, Avera McKennan will provide 
the Condition A communication to all new employees performing NRC 
licensed activities or Contractors prior to those individuals 
performing NRC licensed activities. Avera McKennan will also provide 
the Condition A communication to current employees or Contractors with 
new duties performing NRC licensed activities prior to those 
individuals performing the new duties. Avera McKennan will retain a 
record of the personnel receiving the communication.
    D. Within 6 months of the date Avera McKennan has issued the 
Condition A communication, Avera McKennan will issue an additional 
communication to all authorized users, nuclear medicine technologists, 
all other employees involved in NRC licensed activities, and 
Contractors reemphasizing its intolerance of willful misconduct and 
update such workforce on the status of compliance with this 
Confirmatory Order. Avera McKennan will continue to issue this 
communication at intervals not to exceed 12 months until December 31, 
2026. Avera McKennan will retain a copy of the communication presented 
and a record of the personnel receiving the communication. Avera 
McKennan will document the reason for any person not obtaining the 
communication and the additional efforts used to provide the 
communication.

Training

    E. Avera McKennan will develop a training program to provide to all 
authorized users, nuclear medicine technologists, all other employees 
involved in NRC licensed activities, and Contractors. The training will 
address what is meant by willfulness and the potential enforcement 
actions that the NRC may take against employees who engage in 
deliberate misconduct and the associated NRC enforcement actions that 
may be taken against a licensee. The training will request that the 
recipients provide feedback on the training. Avera McKennan will submit 
this training program to the NRC for review and approval within 6 
months of the issuance date of the Confirmatory Order.
    F. Within 6 months of NRC approval of the training program, Avera 
McKennan will provide this training to all authorized users, nuclear 
medicine technologists, all other employees involved in NRC licensed 
activities, and Contractors. Avera McKennan will continue to provide 
this training at least once every calendar year until December 31, 
2026. Avera McKennan will maintain a record of the individuals 
receiving the training, a summary of the feedback on the training, the 
instructor providing the training (if applicable), and the date of the 
training.
    G. Beginning on the date Avera McKennan has first provided the 
Condition E training and until December 31, 2026, Avera McKennan will 
provide the Condition E training to all new employees or Contractors 
within 3 months of starting work in NRC licensed activities. Avera 
McKennan will also provide the Condition E training to current 
employees or Contractors with new duties performing NRC licensed 
activities. Avera McKennan will retain a record of the individuals 
receiving the training, a summary of the feedback on the training, the 
instructor providing the training (if applicable), and the date of the 
training.
    H. Until December 31, 2024, while Ms. Shannon Gray remains employed 
by Avera McKennan, Avera McKennan will support and allow Ms. Gray to 
provide a total of eight live training sessions to personnel involved 
in NRC licensed activities at Avera McKennan, Avera St. Mary's Hospital 
(40-07328-03), Avera St. Luke's (40-18000-01), and Avera Sacred Heart 
Hospital (40-01683-01). Until December 31, 2024, while Ms. Traci 
Hollingshead remains employed by Avera McKennan, Avera McKennan will 
support and allow Ms. Hollingshead to provide a total of eight

[[Page 32472]]

live training sessions to personnel involved in NRC licensed activities 
at Avera McKennan, Avera St. Mary's Hospital (40-07328-03), Avera St. 
Luke's (40-18000-01), and Avera Sacred Heart Hospital (40-01683-01). 
These eight live training sessions may be co-presented by Ms. Gray and 
Ms. Hollingshead.

Field Observation Program, Applicable to License 40-16571-02 Only

    I. Avera McKennan will develop or maintain a field observation 
program for Avera McKennan/Nuclear Medicine license (License 40-16571-
02). Avera McKennan will observe NRC licensed activities performed by 
each nuclear medicine technologist. The observations shall include, at 
a minimum, mobile medical operations, dosage measurements, and 
dosimetry practices. Avera McKennan will submit the field observation 
program to the NRC for review and approval within 2 months of the 
issuance date of the Confirmatory Order.
    J. Within 2 months of NRC approval of the field observation 
program, Avera McKennan will conduct a field observation developed in 
Condition I and will document the results of the field observation. 
Avera McKennan will then perform an annual field observation for each 
nuclear medicine technologist until December 31, 2026, and will 
document the results of each field observation.

Assessment, Applicable to License 40-16571-02 Only

    K. Avera McKennan will engage an outside entity to perform a 
comprehensive assessment of Avera McKennan/Nuclear Medicine's radiation 
safety program. The outside entity should have familiarity and 
experience with 10 CFR 35.80 mobile nuclear medicine authorizations. 
The assessment will include an evaluation of the corrective actions 
associated with NRC Inspection Report 030-39216/2021-002 and 
Investigation Report 4-2019-007 dated December 21, 2021, and the 
corrective actions associated with the Notice of Violation, NRC 
Inspection Report 030-11252/2017-001 and Investigation Report 4-2016-
021 dated December 21, 2017. This will include the following actions:
    1. Within 3 months of the issuance date of the Confirmatory Order, 
Avera McKennan will submit the qualifications of the outside entity to 
the NRC for review and approval.
    2. Within 6 months of the NRC approval of the outside entity, Avera 
McKennan will submit a copy of the assessment report and Avera 
McKennan's written response to the assessment report to the NRC. Avera 
McKennan's written response will either address how it will implement 
the recommendations and corrective actions of the assessment report, 
including a proposed timeline; or provide an explanation and 
justification for why the recommendation(s) and corrective action(s) 
will not be implemented.

Organizational Health Survey

    L. Avera McKennan will engage an outside entity to develop and 
conduct an organizational health survey to identify safety culture 
concerns that could contribute to willful misconduct. The outside 
entity will also develop recommendations and corrective actions based 
on the results of the survey.
    1. Within 6 months of the issuance date of the Confirmatory Order, 
Avera McKennan will submit the qualifications of the outside entity to 
the NRC for review and approval.
    2. Within 6 months of the NRC approval of the outside entity, the 
outside entity will conduct the organizational health survey and will 
develop recommendations and corrective actions based on the results 
organizational health survey.
    3. Within 6 months of the conducting the Condition L.2 organization 
health survey, Avera McKennan will submit the survey results and a 
written response to the NRC. Avera McKennan's written response will 
either address how it will implement the recommendations and corrective 
actions of the survey, including a proposed timeline, or provide an 
explanation and justification for why the recommendation(s) and 
corrective action(s) will not be implemented.
    M. Between 24 to 36 months after the completion of the survey in 
Condition L, the outside entity will conduct a second organizational 
health survey and will develop recommendations and corrective actions 
based on the results of the survey.

Effectiveness Reviews

    N. By December 31 of calendar years 2022, 2024, and 2026 or 6 
months after the last organizational health survey is conducted, 
whichever is later, Avera McKennan will perform an effectiveness review 
of the corrective actions implemented as a result of this Confirmatory 
Order. The effectiveness review will include: The lessons learned from 
feedback from the communications and training, if any is received; and 
the results of the radiation safety program assessment, field 
observations, and the organizational health surveys. Avera McKennan 
will modify its corrective actions, as needed and consistent with this 
Confirmatory Order, based on the results of the effectiveness review. 
Avera McKennan will send a copy of the effectiveness review and 
provide, as applicable, a copy of any additional corrective actions and 
modifications made to previously developed corrective actions as a 
result of the effectiveness review to the NRC.

Administrative Items

    O. By March 31 of each calendar year 2023 through 2028, Avera 
McKennan will provide in writing to the NRC a summary of the actions 
implemented the previous calendar year as a result of the Confirmatory 
Order.
    P. Until December 31, 2028, Avera McKennan will retain a copy of 
all documentation created to demonstrate compliance with the conditions 
of the Confirmatory Order.
    Q. Documents that are required to be sent to the NRC as a result of 
the Confirmatory Order conditions will be sent the Director, Division 
of Radiological Safety and Security, U.S. Nuclear Regulatory 
Commission, Region IV, by email to <a href="/cdn-cgi/l/email-protection#520066173c343d2031373f373c26123c20317c353d24"><span class="__cf_email__" data-cfemail="1c4e2859727a736e7f79717972685c726e7f327b736a">[email protected]</span></a>.
    Based on the completed actions described above, and the commitments 
described in Section V below, the NRC agrees not to issue a Notice of 
Violation and not impose a civil penalty for the apparent violations 
discussed in NRC Inspection Report 030-39216/2021-002 and Investigation 
Report 4-2019-007 (EA-21-027) to Avera McKennan dated December 21, 
2021.
    On May 17, 2022, Avera McKennan consented to issuing this 
Confirmatory Order with the commitments, as described in Section V 
below. Avera McKennan further agreed that this Confirmatory Order is to 
be effective upon issuance, the agreement memorialized in this 
Confirmatory Order settles the matter between the parties, and that it 
has waived its right to a hearing.

IV

    I find that the corrective actions that Avera McKennan has already 
implemented, as described in Section III above, combined with the 
commitments as set forth in Section V below are acceptable and 
necessary, and I conclude that with these commitments the public health 
and safety are reasonably assured. In view of the foregoing, I have 
determined that public health and safety require that Avera McKennan's 
commitments be confirmed by this Confirmatory Order. Based on the above 
and Avera McKennan's

[[Page 32473]]

consent, this Confirmatory Order is effective upon issuance.

V

    Accordingly, pursuant to Sections 81, 161b, 161i, 161o, 182, and 
186 of the Atomic Energy Act of 1954, as amended, and the Commission's 
regulations in 10 CFR 2.202 and 10 CFR part 30, IT IS HEREBY ORDERED, 
EFFECTIVE UPON ISSUANCE, THAT LICENSE NOS. 40-16571-01 AND 40-16571-02 
ARE MODIFIED AS FOLLOWS:
    For the purposes of this Confirmatory Order, ``Avera McKennan'' 
refers to the licensees of Avera McKennan (License 40-16571-01) and 
Avera McKennan/Nuclear Medicine (License 40-16571-02). ``Contractors'' 
refers to individuals performing NRC licensed activities under either 
the Avera McKennan license (License 4016571-01) or the Avera McKennan/
Nuclear Medicine license (License 401657102).

Communications

    A. Avera McKennan will develop a communication that will: Include a 
summary of the events that resulted in the Confirmatory Order, stress 
the importance of complying with NRC regulations and the conditions of 
the license, emphasize the importance of ensuring documents are 
complete and accurate, and discuss the consequences for engaging in 
willful violations. Avera McKennan will submit the communication to the 
NRC for review and approval within 2 months of the issuance date of the 
Confirmatory Order.
    B. Within 2 months of NRC approval of the communication, Avera 
McKennan will issue the Condition A communication as a stand-alone 
communication from a senior hospital official to all authorized users, 
nuclear medicine technologists, all other employees and Contractors 
performing in NRC licensed activities. Avera McKennan will retain a 
copy of the communication presented and a record of the personnel 
receiving the communication.
    C. Beginning on the date Avera McKennan has issued the Condition A 
communication and until December 31, 2026, Avera McKennan will provide 
the Condition A communication to all new employees and Contractors 
performing NRC licensed activities prior to those individuals 
performing NRC licensed activities. Avera McKennan will also provide 
the Condition A communication to current employees and Contractors with 
new duties performing NRC licensed activities prior to those 
individuals performing the new duties. Avera McKennan will retain a 
record of the personnel receiving the communication.
    D. Within 6 months of the date Avera McKennan has issued the 
Condition A communication, Avera McKennan will issue an additional 
communication to all authorized users, nuclear medicine technologists, 
all other employees and Contractors involved in NRC licensed activities 
reemphasizing its intolerance of willful misconduct and update such 
workforce on the status of compliance with this Confirmatory Order. 
Avera McKennan will continue to issue this communication at intervals 
not to exceed 12 months until December 31, 2026. Avera McKennan will 
retain a copy of the communication presented and a record of the 
personnel receiving the communication. Avera McKennan will document the 
reason for any person not obtaining the communication and the 
additional efforts used to provide the communication.

Training

    E. Avera McKennan will develop a training program to provide to all 
authorized users, nuclear medicine technologists, all other employees 
and Contractors involved in NRC licensed activities. The training will 
address what is meant by willfulness and the potential enforcement 
actions that the NRC may take against employees who engage in 
deliberate misconduct and the associated NRC enforcement actions that 
may be taken against a licensee. The training will request that the 
recipients provide feedback on the training. Avera McKennan will submit 
this training program to the NRC for review and approval within 6 
months of the issuance date of the Confirmatory Order.
    F. Within 6 months of NRC approval of the training program, Avera 
McKennan will provide this training to all authorized users, nuclear 
medicine technologists, all other employees and Contractors involved in 
NRC licensed activities. Avera McKennan will continue to provide this 
training at least once every calendar year until December 31, 2026. 
Avera McKennan will maintain a record of the individuals receiving the 
training, a summary of the feedback on the training, the instructor 
providing the training (if applicable), and the date of the training.
    G. Beginning on the date Avera McKennan has first provided the 
Condition E training and until December 31, 2026, Avera McKennan will 
provide the Condition E training to all new employees and Contractors 
within 3 months of starting work in NRC licensed activities. Avera 
McKennan will also provide the Condition E training to current 
employees and Contractors with new duties performing NRC licensed 
activities. Avera McKennan will retain a record of the individuals 
receiving the training, a summary of the feedback on the training, the 
instructor providing the training (if applicable), and the date of the 
training.
    H. Until December 31, 2024, while Ms. Shannon Gray remains employed 
by Avera McKennan, Avera McKennan will support and allow Ms. Gray to 
provide a total of eight live (e.g., in person or virtual) training 
sessions to personnel involved in NRC licensed activities at Avera 
McKennan, Avera St. Mary's Hospital (License 40-07328-03), Avera St. 
Luke's (License 40-18000-01), and Avera Sacred Heart Hospital (License 
40-01683-01). Until December 31, 2024, while Ms. Traci Hollingshead 
remains employed by Avera McKennan, Avera McKennan will support and 
allow Ms. Hollingshead to provide a total of eight live training 
sessions to personnel involved in NRC licensed activities at Avera 
McKennan, Avera St. Mary's Hospital (License 40-07328-03), Avera St. 
Luke's (License 40-18000-01), and Avera Sacred Heart Hospital (License 
40-01683-01). These eight live training sessions may be co-presented by 
Ms. Gray and Ms. Hollingshead.

Field Observation Program, Applicable to License 40-16571-02 Only

    I. Avera McKennan will develop or maintain a field observation 
program for Avera McKennan/Nuclear Medicine license (License 40-16571-
02). Avera McKennan will observe NRC licensed activities performed by 
each nuclear medicine technologist. The observations shall include, at 
a minimum, mobile medical operations, dosage measurements, and 
dosimetry practices. Avera McKennan will submit the field observation 
program to the NRC for review and approval within 2 months of the 
issuance date of the Confirmatory Order.
    J. Beginning December 31, 2022, or within 2 months of NRC approval, 
whichever date is later, Avera McKennan will implement the field 
observation program developed under Condition I. Upon the program's 
implementation, and until December 31, 2026, Avera McKennan will 
perform annual field observations of each nuclear medicine technologist 
and will maintain documentation of the observations.

Assessment, Applicable to License 40-16571-02 Only

    K. Avera McKennan will engage an outside entity to perform a

[[Page 32474]]

comprehensive assessment of Avera McKennan/Nuclear Medicine's radiation 
safety program. The outside entity should have familiarity and 
experience with 10 CFR 35.80 mobile nuclear medicine authorizations. 
The assessment will include an evaluation of the corrective actions 
associated with NRC Inspection Report 030-39216/2021-002 and 
Investigation Report 4-2019-007 dated December 21, 2021, and the 
corrective actions associated with the Notice of Violation, NRC 
Inspection Report 030-11252/2017-001 and Investigation Report 4-2016-
021 dated December 21, 2017. This will include the following actions:
    1. Within 3 months of the issuance date of the Confirmatory Order, 
Avera McKennan will submit the qualifications of the outside entity to 
the NRC for review and approval.
    2. Within 6 months of the NRC approval of the outside entity, Avera 
McKennan will submit a copy of the assessment report and Avera 
McKennan's written response to the assessment report to the NRC. Avera 
McKennan's written response will either address how it will implement 
the recommendations and corrective actions of the assessment report, 
including a proposed timeline; or provide an explanation and 
justification for why the recommendation(s) and corrective action(s) 
will not be implemented.

Organizational Health Survey

    L. Avera McKennan will engage an outside entity to develop and 
conduct an organizational health survey to identify safety culture 
concerns that could contribute to willful misconduct. The outside 
entity will also develop recommendations and corrective actions based 
on the results of the survey.
    1. Within 6 months of the issuance date of the Confirmatory Order, 
Avera McKennan will submit the qualifications of the outside entity to 
the NRC for review and approval.
    2. Within 6 months of the NRC approval of the outside entity, the 
outside entity will conduct the organizational health survey and will 
develop recommendations and corrective actions based on the results 
organizational health survey.
    3. Within 6 months of the conducting the Condition L.2 organization 
health survey, Avera McKennan will submit the survey results and a 
written response to the NRC. Avera McKennan's written response will 
either address how it will implement the recommendations and corrective 
actions of the survey, including a proposed timeline, or provide an 
explanation and justification for why the recommendation(s) and 
corrective action(s) will not be implemented.
    M. Between 24 to 36 months after the completion of the survey in 
Condition L, the outside entity will conduct a second organizational 
health survey and will develop recommendations and corrective actions 
based on the results of the survey.

Effectiveness Reviews

    N. By December 31, 2022; December 31, 2024; and December 31, 2026 
or 6 months after the second organizational health survey described in 
Condition M is conducted, whichever is later, Avera McKennan will 
perform an effectiveness review of the corrective actions implemented 
as a result of this Confirmatory Order. The effectiveness review will 
include: The lessons learned from feedback from the communications and 
training, if any is received; and the results of the radiation safety 
program assessment, field observations, and the organizational health 
surveys. Avera McKennan will modify its corrective actions, as needed 
and consistent with this Confirmatory Order, based on the results of 
the effectiveness review. Avera McKennan will send a copy of the 
effectiveness review and provide, as applicable, a copy of any 
additional corrective actions and modifications made to previously 
developed corrective actions as a result of the effectiveness review to 
the NRC.

Administrative Items

    O. By March 31 of each calendar year 2023 through 2028, Avera 
McKennan will provide in writing to the NRC a summary of the actions 
implemented the previous calendar year as a result of the Confirmatory 
Order.
    P. Until December 31, 2028, Avera McKennan will retain a copy of 
all documentation created to demonstrate compliance with the conditions 
of the Confirmatory Order.
    Q. Documents that are required to be sent to the NRC as a result of 
the Confirmatory Order conditions will be sent the Director, Division 
of Radiological Safety and Security, U.S. Nuclear Regulatory 
Commission, Region IV, by email to <a href="/cdn-cgi/l/email-protection#84d6b0c1eae2ebf6e7e1e9e1eaf0c4eaf6e7aae3ebf2"><span class="__cf_email__" data-cfemail="1d4f2958737b726f7e78707873695d736f7e337a726b">[email protected]</span></a>.
    In the event of the transfer of the license(s) of Avera McKennan to 
another entity, the terms and conditions set forth hereunder shall 
continue to apply to the new entity and accordingly survive any 
transfer of ownership or license. The Regional Administrator, Region 
IV, may, in writing, relax, rescind, or withdraw any of the above 
conditions upon demonstration by Avera McKennan or its successors of 
good cause.

VI

    In accordance with 10 CFR 2.202 and 10 CFR 2.309, any person 
adversely affected by this Confirmatory Order, other than Avera 
McKennan, may request a hearing within thirty (30) calendar days of the 
date of issuance of this Confirmatory Order. Where good cause is shown, 
consideration will be given to extending the time to request a hearing. 
A request for extension of time must be made in writing to the 
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555, and include a statement of good cause for the 
extension.
    All documents filed in NRC adjudicatory proceedings, including a 
request for hearing and petition for leave to intervene (petition), any 
motion or other document filed in the proceeding prior to the 
submission of a request for hearing or petition to intervene, and 
documents filed by interested governmental entities that request to 
participate under 10 CFR 2.315(c), must be filed in accordance with the 
NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 
46562; August 3, 2012). The E-Filing process requires participants to 
submit and serve all adjudicatory documents over the internet, or in 
some cases to mail copies on electronic storage media. Detailed 
guidance on making electronic submissions may be found in the Guidance 
for Electronic Submissions to the NRC and on the NRC website at https://www.nrc.gov/site-help/e-submittals.html. Participants may not submit 
paper copies of their filings unless they seek an exemption in 
accordance with the procedures described below.
    To comply with the procedural requirements of E-Filing, at least 10 
days prior to the filing deadline, the participant should contact the 
Office of the Secretary by email at <a href="/cdn-cgi/l/email-protection#c7afa2a6b5aea9a0e9a3a8a4aca2b387a9b5a4e9a0a8b1"><span class="__cf_email__" data-cfemail="ed85888c9f84838ac389828e868899ad839f8ec38a829b">[email protected]</span></a>, or by 
telephone at 301-415-1677, to (1) request a digital identification (ID) 
certificate, which allows the participant (or its counsel or 
representative) to digitally sign submissions and access the E-Filing 
system for any proceeding in which it is participating; and (2) advise 
the Secretary that the participant will be submitting a petition or 
other adjudicatory document (even in instances in which the 
participant, or its counsel or representative, already holds an NRC-
issued digital ID certificate). Based upon this information, the 
Secretary will establish an electronic docket for the hearing in this 
proceeding

[[Page 32475]]

if the Secretary has not already established an electronic docket.
    Information about applying for a digital ID certificate is 
available on the NRC's public website at https://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a 
digital ID certificate and a docket has been created, the participant 
can then submit adjudicatory documents. Submissions must be in Portable 
Document Format (PDF). Additional guidance on PDF submissions is 
available on the NRC's public website at https://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the 
time the document is submitted through the NRC's E-Filing system. To be 
timely, an electronic filing must be submitted to the E-Filing system 
no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of 
a transmission, the E-Filing system time-stamps the document and sends 
the submitter an email notice confirming receipt of the document. The 
E-Filing system also distributes an email notice that provides access 
to the document to the NRC's Office of the General Counsel and any 
others who have advised the Office of the Secretary that they wish to 
participate in the proceeding, so that the filer need not serve the 
document on those participants separately. Therefore, applicants and 
other participants (or their counsel or representative) must apply for 
and receive a digital ID certificate before adjudicatory documents are 
filed so that they can obtain access to the documents via the E-Filing 
system.
    A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC's Electronic 
Filing Help Desk through the ``Contact Us'' link located on the NRC's 
public website at https://www.nrc.gov/site-help/e-submittals.html, by 
email to <a href="/cdn-cgi/l/email-protection#9fd2ccd7dbb1cdfaecf0eaedfcfadff1edfcb1f8f0e9"><span class="__cf_email__" data-cfemail="cb8698838fe599aeb8a4beb9a8ae8ba5b9a8e5aca4bd">[email protected]</span></a>, or by a toll-free call at 1-866-672-
7640. The NRC Electronic Filing Help Desk is available between 9 a.m. 
and 6 p.m., Eastern Time, Monday through Friday, excluding government 
holidays.
    Participants who believe that they have a good cause for not 
submitting documents electronically must file an exemption request, in 
accordance with 10 CFR 2.302(g), with their initial paper filing 
stating why there is good cause for not filing electronically and 
requesting authorization to continue to submit documents in paper 
format. Such filings must be submitted by: (1) First class mail 
addressed to the Office of the Secretary of the Commission, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: 
Rulemaking and Adjudications Staff; or (2) courier, express mail, or 
expedited delivery service to the Office of the Secretary, 11555 
Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and 
Adjudications Staff. Participants filing adjudicatory documents in this 
manner are responsible for serving the document on all other 
participants. Filing is considered complete by first class mail as of 
the time of deposit in the mail, or by courier, express mail, or 
expedited delivery service upon depositing the document with the 
provider of the service. A presiding officer, having granted an 
exemption request from using E-Filing, may require a participant or 
party to use E-Filing if the presiding officer subsequently determines 
that the reason for granting the exemption from use of E-Filing no 
longer exists.
    Documents submitted in adjudicatory proceedings will appear in the 
NRC's electronic hearing docket which is available to the public at 
https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the 
Commission or the presiding officer. If you do not have an NRC-issued 
digital ID certificate as described above, click ``cancel'' when the 
link requests certificates and you will be automatically directed to 
the NRC's electronic hearing dockets where you will be able to access 
any publicly available documents in a particular hearing docket. 
Participants are requested not to include personal privacy information, 
such as social security numbers, home addresses, or personal phone 
numbers in their filings, unless an NRC regulation or other law 
requires submission of such information. For example, in some 
instances, individuals provide home addresses in order to demonstrate 
proximity to a facility or site. With respect to copyrighted works, 
except for limited excerpts that serve the purpose of the adjudicatory 
filings and would constitute a Fair Use application, participants are 
requested not to include copyrighted materials in their submission.
    The Commission will issue a notice or order granting or denying a 
hearing request or intervention petition, designating the issues for 
any hearing that will be held and designating the presiding officer. A 
notice granting a hearing will be published in the Federal Register and 
served on the parties to the hearing.
    If a person (other than Avera McKennan) requests a hearing, that 
person shall set forth with particularity the manner in which his 
interest is adversely affected by this Confirmatory Order and shall 
address the criteria set forth in 10 CFR 2.309(d) and (f).
    If a hearing is requested by a person whose interest is adversely 
affected, the Commission will issue an order designating the time and 
place of any hearings. If a hearing is held, the issue to be considered 
at such hearing shall be whether this Confirmatory Order should be 
sustained.
    In the absence of any request for hearing, or written approval of 
an extension of time in which to request a hearing, the provisions 
specified in Section V above shall be final 30 days from the date of 
this Confirmatory Order without further order or proceedings. If an 
extension of time for requesting a hearing has been approved, the 
provisions specified in Section V shall be final when the extension 
expires if a hearing request has not been received.

    For the Nuclear Regulatory Commission,

Scott A. Morris,

Regional Administrator, NRC Region IV.

    Dated this 23rd day of May 2022.

[FR Doc. 2022-11528 Filed 5-27-22; 8:45 am]
BILLING CODE 7590-01-P


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