[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]


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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]
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