32470 Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 

1Avera McKennan’s view on the apparent 

violations is available at ML22117A183. 

hearing will be published in the Federal 

Register and served on the parties to the 

hearing. 

If a person (other than Traci 

Hollingshead) 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. 

Dated this 19th day of May 2022. 

For the Nuclear Regulatory Commission. 

Scott A. Morris, 

Regional Administrator, NRC Region IV. 

[FR Doc. 2022–11530 Filed 5–27–22; 8:45 am] 

BILLING CODE 7590–01–P 

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. 

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: 

• 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: 

Stacy.Schumann@nrc.gov. For technical 

questions, contact the individual listed 

in the For FURTHER INFORMATION

CONTACT section of this document. 

• 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 

PDR.Resource@nrc.gov. The 

Confirmatory Order to Avera McKennan 

is available in ADAMS under Accession 

No. ML22130A588. 

• 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 PDR.Resource@nrc.gov 

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: Jeremy.Groom@

nrc.gov. 

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) 


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Attend a predecisional enforcement 

conference or (2) participate in an ADR 

mediation session in an effort to resolve 

these concerns. 

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 


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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 R4Enforcement@nrc.gov. 

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 


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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 


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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 R4Enforcement@nrc.gov. 

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 EFiling 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/sitehelp/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 

hearing.docket@nrc.gov, 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 


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Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 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 EFiling 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/esubmittals.html, by email to 

MSHD.Resource@nrc.gov, or by a tollfree 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 

NUCLEAR REGULATORY 

COMMISSION 

[NRC–2022–0001] 

Sunshine Act Meetings 

TIME AND DATE: Weeks of May 30, June 

6, 13, 20, 27, July 4, 2022. The schedule 

for Commission meetings is subject to 

change on short notice. The NRC 

Commission Meeting Schedule can be 

found on the internet at: https://

www.nrc.gov/public-involve/publicmeetings/schedule.html. 

PLACE: The NRC provides reasonable 

accommodation to individuals with 

disabilities where appropriate. If you 

need a reasonable accommodation to 

participate in these public meetings or 

need this meeting notice or the 

transcript or other information from the 

public meetings in another format (e.g., 

Braille, large print), please notify Anne 

Silk, NRC Disability Program Specialist, 

at 301–287–0745, by videophone at 

240–428–3217, or by email at 

Anne.Silk@nrc.gov. Determinations on 

requests for reasonable accommodation 

will be made on a case-by-case basis. 

STATUS: Public. 

Members of the public may request to 

receive the information in these notices 

electronically. If you would like to be 

added to the distribution, please contact 

the Nuclear Regulatory Commission, 

Office of the Secretary, Washington, DC 

20555, at 301–415–1969, or by email at 


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