[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44619-44623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18853]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[ Docket No. 030-33305; License No. 25-10994-04; EA-10-258; NRC-2011-
0163]
In the Matter of Bozeman Deaconess Foundation, dba Bozeman
Deaconess Hospital, Bozeman, MT; Confirmatory Order Modifying License;
(Effective Immediately)
I
Bozeman Deaconess Hospital (Licensee) is the holder of Materials
License No. 25-10994-04 issued by the Nuclear Regulatory Commission
(NRC or the Commission) pursuant to Title 10 of the Code of Federal
Regulations (10 CFR) parts 30 and 35. The license authorizes the
operation of the Licensee's facility in accordance with the conditions
specified therein, at 915 Highland Boulevard, Bozeman, Montana.
This Confirmatory Order is the result of an agreement reached
during an alternative dispute resolution (ADR) mediation session
conducted on May 25, 2011, at the NRC Region IV offices in Arlington,
Texas.
II
On January 27, 2010, the NRC conducted a routine unannounced
inspection of the Bozeman Deaconess Hospital facility to evaluate
radiation safety and security, as well as compliance with Commission
rules and regulations and the conditions of the license. During the
inspection, it was determined that an employee of Bozeman Deaconess
Hospital failed to secure radioactive materials from unauthorized
access or removal from the facility's nuclear medicine laboratory (hot
lab). On March 8, 2010, the NRC Office of Investigations (OI), Region
IV, began an investigation (OI Case No. 4-2010-033) to determine
whether employees from Bozeman Deaconess Hospital willfully failed to
secure radioactive material during periods when authorized personnel
were absent from the hot lab. Based on the results of the inspection
and the evidence developed during the investigation, the NRC identified
two apparent violations. The first apparent violation involved a
willful failure to secure licensed materials from unauthorized removal
or access as required by 10 CFR 20.1801. The second violation involved
a failure to control and maintain constant surveillance of licensed
material as required by 10 CFR 20.1802.
By letter dated April 12, 2011, the NRC transmitted the results of
the inspection and a factual summary of OI's Investigation Report 4-
2010-033 to Bozeman Deaconess Hospital. In the April 12 letter, the NRC
informed the Licensee that the NRC was considering escalated
enforcement action for the apparent violations. The NRC offered the
Licensee the opportunity to request a predecisional enforcement
conference or request ADR with the NRC in an attempt to resolve issues
associated with this matter. In response, on April 21, 2011, Bozeman
Deaconess Hospital requested ADR to resolve this matter with the NRC.
On May 25, 2011, the NRC and Licensee representatives met in an ADR
session with a professional mediator, arranged through the Cornell
University Institute on Conflict Resolution. ADR is a process in which
a neutral mediator with no decision-making authority assists the
parties in reaching an agreement on resolving any differences regarding
the dispute. This
[[Page 44620]]
Confirmatory Order is issued pursuant to the agreement reached during
the ADR process.
III
In response to the NRC's offer, the Licensee requested use of the
NRC's ADR process to resolve differences it had with the NRC. During
that ADR session, a preliminary settlement agreement was reached. The
elements of the agreement consisted of the following:
Pursuant to the NRC's ADR program, the following are the terms and
conditions agreed upon in principle by Bozeman Deaconess Hospital (the
hospital) and the NRC relating to the NRC Inspection Report 030-33305/
2010-001 (and Investigation Report No.4-2010-033) dated April 12, 2011.
Whereas, the NRC identified an apparent violation of 10 CFR 20.1801
and 20.1802 in that a nuclear medicine technician deliberately failed
to secure the nuclear medicine door during periods when hospital staff
were not available to secure radioactive materials from unauthorized
access and/or removal;
Whereas, the NRC identified instances of willfulness where hospital
employees raised a concern about the nuclear medicine technician's
failures to secure the nuclear medicine door, yet hospital managers did
not adequately address the concern and as a result, the violation had
been occurring for approximately 10 years;
Whereas, the NRC identified instances in which the hospital's
radiation safety officer also raised the concern to a hospital manager,
yet hospital management failed to adequately address the concern and
failed to prevent the violation from recurring;
Whereas, the NRC identified that the hospital's former radiation
safety officer stated he had no knowledge of NRC regulations that
required the nuclear medicine door to be secure in order to prevent the
removal and/or access to radioactive material, and the former radiation
safety officer did not attempt to become familiar with NRC requirements
in order to meet his responsibilities as defined in 10 CFR 35.24;
Whereas, the NRC is interested in obtaining comprehensive
corrective actions by the hospital that would prevent future failures
to secure licensed material; and any future willful violations;
Whereas, the NRC is interested in obtaining comprehensive
corrective actions that ensure hospital staff and managers understand
NRC regulations and the conditions of the license;
Whereas, the NRC is interested in obtaining comprehensive
corrective actions to ensure that hospital workers understand their
obligations to follow NRC requirements and to raise safety concerns to
hospital management;
Whereas the NRC is interested in ensuring that hospital managers
understand their obligations to follow NRC requirements and their
obligations to review and act on any concerns raised to them by
hospital staff;
Whereas, the NRC is interested in obtaining comprehensive
corrective actions by hospital management to ensure that the hospital
selects radiation safety officers who understand NRC regulations and
the license conditions, and who understand their responsibilities under
10 CFR 35.24;
Whereas, these terms and conditions shall not be binding on either
party until memorialized in a confirmatory order issued by the NRC to
the hospital relating to this matter.
Therefore, the parties agree to the following terms and conditions:
1. Within 45 days of the date of this Confirmatory Order, the
Licensee shall submit a license amendment request and provide its
procedure to comply with 10 CFR 20.1801 and 20.1802.
2. Within 30 days from the date of this confirmatory order, the
Licensee must contract with an independent third-party organization to
provide training to hospital staff and managers who are required to
receive training under 10 CFR 19.12 on: (1) What constitutes deliberate
misconduct under NRC regulations at 10 CFR 30.10, (2) the range of
enforcement actions that the NRC has taken against individuals and
licensees who engaged in deliberate misconduct, and (3) the definitions
of willfulness and careless disregard contained in the NRC Enforcement
Policy. The NRC Enforcement Policy (ADAMS Accession No. ML093480037)
and examples of significant NRC enforcement actions are found at http://www.nrc.gov/about-nrc/regulatory/enforcement/current.html. At least 14
days prior to commencing the training, the Licensee must submit the
name and resume of the independent third-party individual who will be
providing this training to the Director, Division of Nuclear Material
Safety; 612 E. Lamar Blvd., Arlington, TX 76011. The training must be
completed within 90 days of the date of this Confirmatory Order.
3. The Licensee must contract with an independent third-party
organization to provide training to hospital staff and managers who are
required to receive training under 10 CFR 19.12 on the following
topics:
A. The model training program in Appendix J to NUREG 1556, Volume
9, Revision 2; and
B. An overview of 10 CFR 19.16 and 10 CFR 30.7.
The extent of this training must be commensurate with potential
radiological health protection problems present in the work place. In
addition, the Licensee must develop a mechanism to assess the
effectiveness of the training that was conducted. At least 14 days
prior to commencing the training, the Licensee must submit the name and
resume of the independent third-party individual who will be providing
this training to the Director, Division of Nuclear Materials Safety;
612 E. Lamar Blvd., Arlington, TX 76011. The training must be completed
within 90 days of the date of this Confirmatory Order.
4. The hospital shall modify its internal requirements for new
worker training and for its annual refresher training to require that
the topics presented in Conditions 2 and 3 be made part of the
training. Training in these areas may be provided by qualified hospital
staff, and is required for managers and staff who are required to
receive training under 10 CFR 19.12. The training requirements must
include a mechanism to assess the effectiveness of the training. This
training must be commensurate with the potential radiological health
protection issues present in the work place. Within 45 days of the date
of this Confirmatory Order, the Licensee must submit to the NRC a
license amendment request to incorporate these requirements for new
worker training and annual refresher training.
5. Within 30 days of the date of this Confirmatory Order, the
Licensee must develop a procedure which assesses, during the selection
process for radiation safety officers, the person's understanding of 10
CFR parts 19, 20, and 35. Within 45 days of the date of this
Confirmatory Order, the Licensee shall submit a license amendment
request to have the procedure incorporated into its NRC license.
6. Within 30 days of the date of this Confirmatory Order, the
Licensee must develop and implement a procedure that allows hospital
employees and contractors to raise radiation safety concerns to
hospital management. The procedure must: (a) Accommodate anonymous
concerns and must maintain the anonymity of the individual; (b)
describe the reviews to be conducted by hospital management; and (c)
describe when the radiation safety committee will review and resolve
employee safety concerns. The procedure must describe the Licensee's
process for reviewing and
[[Page 44621]]
approving changes to this procedure. The Licensee is authorized to make
changes to this procedure without prior Commission approval as long as:
(a) The proposed revision is documented, reviewed, and approved by the
Licensee's radiation safety committee; (b) the revised procedure is in
accordance with regulatory requirements; (c) the Licensee's staff is
trained in the revised procedure prior to its implementation; and (d)
the Licensee's audit program evaluates the effectiveness of the change
and its implementation. Within 45 days of the date of this Confirmatory
Order, the Licensee must submit a license amendment request, which
requires that the Licensee maintain such a procedure.
7. Between 12-15 months from the date of this Confirmatory Order,
the Licensee shall perform an assessment of the effectiveness of the
training provided in Conditions 2 and 3. The results of its assessment
shall be maintained by the Licensee for 3 years and shall be available
for the NRC to review.
8. The Licensee agrees to pay a civil penalty of $3,500 within 30
days of the date of this Confirmatory Order.
On July 1, 2011, the Licensee consented to issuing this Order with
the commitments, as described in Section V below. The Licensee further
agreed that this Order is to be effective upon issuance and that it has
waived its right to a hearing.
IV
Since the Licensee has agreed to take additional actions to address
NRC concerns, as set forth in Item III above, the NRC has concluded
that its concerns can be resolved through issuance of this Confirmatory
Order.
I find that the Licensee's commitments as set forth in Section V
are acceptable and necessary and 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
the Licensee's commitments be confirmed by this Order. Based on the
above and the Licensee's consent, this Confirmatory Order is
immediately 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 Parts 20, 30, and 35, It is
hereby ordered, effective immediately, that License No. 25-10994-04 is
modified as follows:
1. Within 45 days of the date of this Confirmatory Order, the
Licensee shall submit a license amendment request and provide its
procedure to comply with 10 CFR 20.1801 and 20.1802.
2. Within 30 days from the date of this Confirmatory Order, the
Licensee must contract with an independent third-party organization to
provide training to hospital staff and managers who are required to
receive training under 10 CFR 19.12 on the following topics:
A. What constitutes deliberate misconduct under NRC regulations at
10 CFR 30.10;
B. The range of enforcement actions that the NRC has taken against
individuals and licensees who engaged in deliberate misconduct.
C. The definitions of willfulness and careless disregard contained
in the NRC Enforcement Policy (ADAMS Accession No. ML093480037).
The NRC Enforcement Policy (ADAMS Accession No.ML093480037) and
examples of significant NRC enforcement actions are found at http://www.nrc.gov/about-nrc/regulatory/enforcement/current.html. At least 14
days prior to commencing the training, the Licensee must submit the
name and resume of the independent third-party individual who will be
providing this training to the Director, Division of Nuclear Materials
Safety; 612 E. Lamar Blvd., Arlington, TX 76011. The training must be
completed within 90 days of the date of this Confirmatory Order.
3. The Licensee must contract with an independent third-party
organization to provide training to hospital staff and managers who are
required to receive training under 10 CFR 19.12 on the following
topics:
A. The Model Training Program in Appendix J to NUREG 1556, Volume
9, Revision 2; and
B. An overview of 10 CFR 19.16 and 10 CFR 30.7.
The extent of this training must be commensurate with potential
radiological health protection problems present in the workplace. In
addition, the Licensee must develop a mechanism to assess the
effectiveness of the training that was conducted. At least 14 days
prior to commencing the training, the Licensee must submit the name and
resume of the independent third-party individual who will be providing
this training to the Director, Division of Nuclear Materials Safety;
612 E. Lamar Blvd., Arlington, TX 76011. The training must be completed
within 90 days of the date of this Confirmatory Order.
4. The Licensee shall modify its internal requirements for new
worker training and for its annual refresher training to require that
the topics presented in Conditions 2 and 3 be made part of the
training. Training in these areas may be provided by qualified hospital
staff, and is required for managers and staff who are required to
receive training under 10 CFR 19.12. The training requirements must
include a mechanism to assess the effectiveness of the training. This
training must be commensurate with the potential radiological health
protection issues present in the workplace. Within 45 days of the date
of this Confirmatory Order, the Licensee must submit to the NRC a
license amendment request to incorporate these requirements for new
worker training and annual refresher training.
5. Within 30 days of the date of this Confirmatory Order, the
Licensee must develop a procedure which assesses, during the selection
process for radiation safety officers, the person's understanding of 10
CFR parts 19, 20, and 35. Within 45 days of the date of this
Confirmatory Order, the Licensee shall submit a license amendment
request to have the procedure incorporated into its NRC license.
6. Within 30 days of the date of this Confirmatory Order, the
Licensee must develop and implement a procedure that allows hospital
employees and contractors to raise radiation safety concerns to
hospital management. The procedure must: (a) Accommodate anonymous
concerns and must maintain the anonymity of the individual; (b)
describe the reviews to be conducted by hospital management; and (c)
describe when the radiation safety committee will review and resolve
employee safety concerns. The procedure must describe the Licensee's
process for reviewing and approving changes to this procedure. The
Licensee is authorized to make changes to this procedure without prior
Commission approval as long as: (a) The proposed revision is
documented, reviewed, and approved by the Licensee's radiation safety
committee; (b) the revised procedure is in accordance with regulatory
requirements; (c) the Licensee's staff is trained in the revised
procedure prior to its implementation; and (d) the Licensee's audit
program evaluates the effectiveness of the change and its
implementation. Within 45 days of the date of this Confirmatory Order,
the Licensee must submit a license amendment request, which requires
that the Licensee maintain such a procedure.
7. Between 12 and 15 months from the date of this Confirmatory
Order, the Licensee shall perform an assessment of the effectiveness of
the training provided in Conditions 2 and 3. The results of its
assessment shall be
[[Page 44622]]
maintained by the Licensee for 3 years and shall be available for the
NRC to review.
8. The Licensee agrees to pay a civil penalty of $3,500 within 30
days of the date of this Confirmatory Order. The Licensee must pay the
civil penalty, in accordance with NUREG/BR-0254 and by submitting to
the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD
20852-2738, a statement indicating when and by what method payment was
made.
The Regional Administrator, NRC Region IV, may, in writing, relax
or rescind any of the above conditions upon demonstration by the
Licensee of good cause.
VI
Any person adversely affected by this Confirmatory Order, other
than the Licensee, may request a hearing within 20 days of its
publication in the Federal Register. 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, a petition for leave to intervene, 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 participating under
10 CFR 2.315(c), must be filed in accordance with the NRC E-Filing rule
(72 FR 49139, August 28, 2007). 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.
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
ten (10) days prior to the filing deadline, the participant should
contact the Office of the Secretary by e-mail at
[email protected], or by telephone at 301-415-1677, to request (1)
A digital ID certificate, which allows the participant (or its counsel
or representative) to digitally sign documents and access the E-
Submittal server for any proceeding in which it is participating; and
(2) advise the Secretary that the participant will be submitting a
request or petition for hearing (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 NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/apply-certificates.html. System requirements for accessing
the E-Submittal server are detailed in NRC's ``Guidance for Electronic
Submission,'' which is available on the agency's public Web site at
http://www.nrc.gov/site-help/e-submittals.html. Participants may
attempt to use other software not listed on the Web site, but should
note that the NRC's E-Filing system does not support unlisted software,
and the NRC Meta System Help Desk will not be able to offer assistance
in using unlisted software.
If a participant is electronically submitting a document to the NRC
in accordance with the E-Filing rule, the participant must file the
document using the NRC's online, Web-based submission form. In order to
serve documents through the Electronic Information Exchange (EIE),
users will be required to install a Web browser plug-in from the NRC
Web site. Further information on the Web-based submission form,
including the installation of the Web browser plug-in, is available on
the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html.
Once a participant has obtained a digital ID certificate and a
docket has been created, the participant can then submit a request for
hearing or petition for leave to intervene. Submissions should be in
Portable Document Format (PDF) in accordance with NRC guidance
available on the NRC public Web site at http://www.nrc.gov/site-help/e-submittals.html. A filing is considered complete at the time the
documents are 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 e-mail notice confirming receipt of the document. The
E-Filing system also distributes an e-mail notice that provides access
to the document to the NRC 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
documents on those participants separately. Therefore, applicants and
other participants (or their counsel or representative) must apply for
and receive a digital ID certificate before a hearing request/petition
to intervene is filed so that they can obtain access to the document
via the E-Filing system.
A person filing electronically using the agency's adjudicatory E-
Filing system may seek assistance by contacting the NRC Meta System
Help Desk through the ``Contact Us'' link located on the NRC Web site
at http://www.nrc.gov/site-help/e-submittals.html, by e-mail at
[email protected], or by a toll-free call at 866-672-7640. The NRC
Meta System Help Desk is available between 8 a.m. and 8 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
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, Sixteenth
Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland
20852, Attention: Rulemaking and Adjudications Staff. Participants
filing a document 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
NRC's electronic hearing docket which is available to the public at
http://ehd1.nrc.gov/EHD/, unless excluded pursuant to an order of the
Commission, or the presiding officer. Participants are requested not to
include personal privacy information, such as Social
[[Page 44623]]
Security numbers, home addresses, or home phone numbers in their
filings, unless an NRC regulation or other law requires submission of
such information. 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.
If a person (other than the Licensee) 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 hearing. 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 20 days from the
date this Confirmatory Order is published in the Federal Register
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. A request for hearing shall not stay the
immediate effectiveness of this order.
Dated this 8th day of July 2011.
For the Nuclear Regulatory Commission.
Elmo E. Collins,
Administrator, NRC Region IV.
[FR Doc. 2011-18853 Filed 7-25-11; 8:45 am]
BILLING CODE 7590-01-P