[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Notices]
[Pages 32466-32470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11530]


=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[IA-21-061; NRC-2022-0121]


In the Matter of Ms. Traci Hollingshead

AGENCY: Nuclear Regulatory Commission.

ACTION: Confirmatory order; issuance.

-----------------------------------------------------------------------

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a 
Confirmatory Order to Ms. Traci Hollingshead, an employee of Avera 
McKennan Hospital, to document commitments made as part of a settlement 
agreement made between the NRC and Ms. Holllingshead following an 
alternative dispute resolution mediation session held on April 19, 
2022. The mediation addressed an apparent violation involving 
deliberate misconduct which caused Avera McKennan to be in violation of 
NRC requirements. Ms. Hollingshead has implemented various corrective 
actions to identify the problem and restore compliance at Avera 
McKennan. Further, Ms. Hollingshead has committed to developing 
training on the events which led to the violation and lessons learned 
from the issue. Ms. Hollingshead will present the training to Avera 
McKennan staff and to additional outside hospital staff involved in 
nuclear medicine. The Confirmatory Order is effective upon issuance.

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

ADDRESSES: Please refer to Docket ID NRC-2022-0121 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-2022-0121. Address 
questions about Docket IDs in Regulations.gov to Stacy Schumann; 
telephone: 301-415-0624; email: <a href="/cdn-cgi/l/email-protection#72210613110b5c21111a071f131c1c321c00115c151d04"><span class="__cf_email__" data-cfemail="93c0e7f2f0eabdc0f0fbe6fef2fdfdd3fde1f0bdf4fce5">[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

[[Page 32467]]

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#df8f9b8df18dbaacb0aaadbcba9fb1adbcf1b8b0a9"><span class="__cf_email__" data-cfemail="9bcbdfc9b5c9fee8f4eee9f8fedbf5e9f8b5fcf4ed">[email protected]</span></a>. The 
Confirmatory Order to Ms. Traci Hollingshead is available in ADAMS 
under Accession No. ML22130A043.
    <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#1d4d594f334f786e72686f7e785d736f7e337a726b"><span class="__cf_email__" data-cfemail="fdadb9afd3af988e92888f9e98bd938f9ed39a928b">[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#d19bb4a3b4bca8ff96a3bebebc91bfa3b2ffb6bea7"><span class="__cf_email__" data-cfemail="3d77584f585044137a4f5252507d534f5e135a524b">[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 TRACI HOLLINGSHEAD)
IA-21-061

Confirmatory Order

(Effective Upon Issuance)

I

    Traci Hollingshead is employed by Avera McKennan in Sioux Falls, 
South Dakota. 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).
    This Confirmatory Order (CO) is the result of an agreement reached 
during an Alternative Dispute Resolution (ADR) mediation session 
conducted on April 19, 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 an apparent violation of 10 CFR 30.10(a)(1), which requires, 
in part, that an employee of a licensee may not engage in deliberate 
misconduct that causes a licensee to be in violation of any rule or 
regulation issued by the Commission, i.e., 10 CFR 35.63(a). Traci 
Hollingshead disagrees that a violation of 10 CFR 35.63(a) occurred and 
disagrees that deliberate misconduct was associated with the apparent 
violation.\1\ The parties agree to disagree on whether the violation 
occurred. By letter dated December 21, 2021 (Agencywide Documents 
Access and Management System (ADAMS) Accession No. ML21354A850), the 
NRC notified Traci Hollingshead of the results of the investigation and 
provided Traci Hollingshead with the opportunity to: (1) Provide a 
response in writing, (2) attend a predecisional enforcement conference, 
or (3) participate in an ADR mediation session in an effort to resolve 
this concern.
---------------------------------------------------------------------------

    \1\ Traci Hollingshead's view on the apparent violation is 
available at ML22117A183.
---------------------------------------------------------------------------

    In response to the NRC's offer, Traci Hollingshead requested the 
use of the NRC ADR process. On April 19, 2022, the NRC and Traci 
Hollingshead 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 19, 2022 
ADR session.

III

    During the ADR session, Traci Hollingshead and the NRC reached a 
preliminary settlement agreement.
    The NRC recognizes the corrective actions that Traci Hollingshead 
has already implemented associated with the apparent violations:
    A. Facilitated the reporting of the modified dippers to Avera 
McKennan management.
    B. Performed an informal evaluation of the consequences of the 
modified dippers and whether a medical event occurred.
    C. Agreed with another manager that ordering new dippers and 
replacement of the modified dippers when received would be appropriate.
    D. With another manager, communicated to technicians that the new 
dippers were ordered and that modified dippers should not be used after 
new dippers arrived.
    Additional commitments made in the preliminary settlement 
agreement, as signed by both parties, consist of the following:
    A. Traci Hollingshead will develop live training for Avera McKennan 
staff involved in NRC-regulated material. The training will include at 
least the following: (1) A summary of the events that led to the 
discovery of physically modified dose calibrators at Avera McKennan, 
(2) the importance of compliance with NRC regulations, (3) the 
consequences of engaging in willful violations, (4) what to do if there 
is a perceived or actual medical issue that conflicts with NRC 
regulations, and (5) any personal lessons-learned associated with this 
issue. The other manager involved with Avera McKennan case EA-21-027 
may co-present the training with Traci Hollingshead. This will include 
the following actions:
    1. Within 3 months of the issuance date of the Confirmatory Order, 
Traci Hollingshead will submit the training to the NRC for approval.
    2. Within 18 months of the NRC approval of the training and if 
supported by Avera McKennan, Traci Hollingshead will provide a total of 
five live training sessions split between the personnel of Avera 
McKennan (License 40-16571-01) and Avera McKennan/Nuclear Medicine 
(License 40-16571-02) involved with NRC regulated activities.
    3. Within 1 month of the completion of each training session, Traci 
Hollingshead will submit to the NRC the date of the training, a list of 
the personnel receiving the training, a summary of the feedback 
received on the training, and any lessons learned from providing the 
training.
    4. In the event that Avera McKennan does not agree to support Traci 
Hollingshead providing any of the five training sessions to personnel 
involved with NRC regulated activities, Traci Hollingshead will provide 
a written notice to the NRC within 1 month of the unwillingness of 
Avera McKennan to support any particular training session. The written 
notice will include the date of the notification and any details that 
Avera McKennan provided for not supporting the training sessions.
    B. Traci Hollingshead will develop three live training sessions, 
one for each of the following: Avera St. Mary's Hospital (40-07328-03), 
Avera St. Luke's (40-18000-01), and Avera Sacred Heart Hospital (40-
01683-01) that includes at least the following: (1) A summary of the 
events that led to the

[[Page 32468]]

discovery of physically modified dose calibrators at Avera McKennan, 
(2) the importance of compliance with NRC regulations, (3) the 
consequences of engaging in willful violations, (4) what to do if there 
is a perceived or actual medical issue that conflicts with NRC 
regulations, and (5) any personal lessons-learned associated with this 
issue. The other manager involved with Avera McKennan case EA-21-027 
may co-present the training with Traci Hollingshead.
    1. Within 3 months of the issuance date of the Confirmatory Order, 
Traci Hollingshead will submit the training to the NRC for approval.
    2. Within 18 months of NRC approval of the training, Traci 
Hollingshead will provide the three training sessions to the licensees 
identified in Condition B.
    3. Within 1 month of the completion of each training session, Traci 
Hollingshead will submit to the NRC the date of the training, a list of 
the personnel receiving the training, a summary of the feedback 
received on the training, and any lessons learned from providing the 
training.
    4. In the event that Avera McKennan or the recipient licensee does 
not agree to support Traci Hollingshead providing any of the three 
training sessions to personnel involved with NRC regulated activities, 
Traci Hollingshead will provide a written notice to the NRC within 1 
month of the unwillingness of Avera McKennan or the recipient licensee 
to support any particular training session. The written notice will 
include the date of the notification and any details that Avera 
McKennan or the recipient licensee provided for not supporting the 
training sessions.
    C. Documents that are required to be sent to the NRC as a result of 
the Confirmatory Order Conditions will be sent to 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#693b5d2c070f061b0a0c040c071d29071b0a470e061f"><span class="__cf_email__" data-cfemail="b2e086f7dcd4ddc0d1d7dfd7dcc6f2dcc0d19cd5ddc4">[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 for the apparent violation discussed in the NRC Investigation 
Report 4-2019-007 issued to Traci Hollingshead dated December 21, 2021.
    On May 16, 2022, Traci Hollingshead consented to issuing this 
Confirmatory Order with the commitments, as described in Section V 
below. Traci Hollingshead 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 
Traci Hollingshead has waived her right to a hearing.

IV

    I find that the corrective actions Traci Hollingshead has already 
implemented, as described in Section III above, combined with the 
commitments as set forth in Section V 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 Traci Hollingshead's commitments 
be confirmed by this Confirmatory Order. Based on the above and Traci 
Hollingshead's 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:
    A. Traci Hollingshead will develop live (e.g., in person or 
virtual) training for Avera McKennan staff involved in NRC-regulated 
material. The training will include at least the following: (1) A 
summary of the events that led to the discovery of physically modified 
dose calibrators at Avera McKennan, (2) the importance of compliance 
with NRC regulations, (3) the consequences of engaging in willful 
violations, (4) what to do if there is a perceived or actual medical 
issue that conflicts with NRC regulations, and (5) any personal 
lessons-learned associated with this issue. Shannon Gray may co-present 
the training with Traci Hollingshead. This will include the following 
actions:
    1. Within 3 months of the issuance date of the Confirmatory Order, 
Traci Hollingshead will submit the training to the NRC for approval.
    2. Within 18 months of the NRC approval of the training and if 
supported by Avera McKennan, Traci Hollingshead will provide a total of 
five live training sessions split between the personnel of Avera 
McKennan (License 40-16571-01) and Avera McKennan/Nuclear Medicine 
(License 40-16571-02) involved with NRC regulated activities.
    3. Within 1 month of the completion of each training session, Traci 
Hollingshead will submit to the NRC the date of the training, a list of 
the personnel receiving the training, a summary of the feedback 
received on the training, and any lessons learned from providing the 
training.
    4. In the event that Avera McKennan does not agree to support Traci 
Hollingshead providing any of the five training sessions to personnel 
involved with NRC regulated activities, Traci Hollingshead will provide 
a written notice to the NRC within 1 month of being informed of Avera 
McKennan's unwillingness to support any particular training session. 
The written notice will include the date of the notification and any 
details that Avera McKennan provided for not supporting the training 
sessions.
    B. Traci Hollingshead will develop three live (e.g., in person or 
virtual) training sessions, one for each of the following hospitals: 
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) that includes at least the following: (1) A summary of the 
events that led to the discovery of physically modified dose 
calibrators at Avera McKennan, (2) the importance of compliance with 
NRC regulations, (3) the consequences of engaging in willful 
violations, (4) what to do if there is a perceived or actual medical 
issue that conflicts with NRC regulations, and (5) any personal 
lessons-learned associated with this issue. Shannon Gray may co-present 
the training with Traci Hollingshead.
    1. Within 3 months of the issuance date of the Confirmatory Order, 
Traci Hollingshead will submit the training to the NRC for approval.
    2. Within 18 months of NRC approval of the training, Traci 
Hollingshead will provide the three training sessions to the licensees 
identified in Condition B.
    3. Within 1 month of the completion of each training session, Traci 
Hollingshead will submit to the NRC the date of the training, a list of 
the personnel receiving the training, a summary of the feedback 
received on the training, and any lessons learned from providing the 
training.
    4. In the event that Avera McKennan or any of the three involved 
hospitals do not agree to support Traci Hollingshead providing any of 
the three training sessions to personnel involved with NRC regulated 
activities, Traci Hollingshead will provide a written notice to the NRC 
within 1 month of being informed of Avera McKennan's or any of the 
involved hospitals' unwillingness to support any particular training 
session. The written notice will include the date of the notification 
and any details that Avera McKennan or the recipient licensee provided 
for not supporting the training sessions.
    C. Documents that are required to be sent to the NRC as a result of 
the

[[Page 32469]]

Confirmatory Order Conditions will be sent to 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#6e3c5a2b0008011c0d0b030b001a2e001c0d40090118"><span class="__cf_email__" data-cfemail="095b3d4c676f667b6a6c646c677d49677b6a276e667f">[email protected]</span></a>.
    The Regional Administrator, Region IV, may, in writing, relax, 
rescind, or withdraw any of the above conditions upon demonstration by 
Traci Hollingshead 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 Traci 
Hollingshead, 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#1c74797d6e75727b3278737f7779685c726e7f327b736a"><span class="__cf_email__" data-cfemail="f098959182999e97de949f939b9584b09e8293de979f86">[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 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#1c514f5458324e796f73696e7f795c726e7f327b736a"><span class="__cf_email__" data-cfemail="6429372c204a3601170b11160701240a16074a030b12">[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

[[Page 32470]]

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


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>