[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:
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: [email protected]. 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
[[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 [email protected]. The
Confirmatory Order to Ms. Traci Hollingshead is available in ADAMS
under Accession No. ML22130A043.
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
[email protected] 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:
[email protected].
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 [email protected].
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 [email protected].
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 [email protected], 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 [email protected], 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