[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11529-11532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4682]
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NUCLEAR REGULATORY COMMISSION
[NRC-2011-0047; IA-10-010]
Gregory Desobry, Ph.D.; Order Requiring Notification of
Involvement in NRC-Licensed Activities
I
Mr. Gregory Desobry previously performed duties as a medical
physicist at the Philadelphia Veterans Affairs Medical Center in
Philadelphia, Pennsylvania (PVAMC). The Department of Veterans Affairs
(VA) holds a Master Materials License (MML) Number 03-23853-01VA issued
by the U.S. Nuclear Regulatory Commission (NRC or Commission) pursuant
to Title 10 of the Code of Federal Regulations (10 CFR) part 30. The
PVAMC is a medical broad scope permittee which was authorized by the
MML to use a variety of byproduct materials for diagnostic and
therapeutic purposes. The therapeutic treatments included brachytherapy
iodine-125 used for permanent prostate implants. Mr. Desobry's role
included assuring the safe use of radioactive materials for patients,
including performance of a post-treatment determination of the actual
radiation treatment administered to the patient in order that the
actual treatment parameters could be verified with the intended
treatment identified in the written directive. Mr. Desobry was involved
with the vast majority of the permanent prostate implants under the
permit.
II
On May 16, 2008, the NRC received information that on May 5, 2008,
a potential medical event (as defined in 10 CFR 35.3045) occurred at
the PVAMC; this event report was followed by numerous others. By
October 2009, the VA had reported to the NRC that 97 medical events
involving prostate brachytherapy occurred at the PVAMC from February
2002 through June 2008. In addition, during the period from December
2006 through November 2007, post-treatment dose verification was not
performed for at least 16 patients due to computer system interface
problems. Even after the computer interface problems were resolved,
post-treatment plans were not completed for seven patients until
December 2007.
In response to the reported medical events, the VA National Health
Physics Program (NHPP) conducted onsite inspections at the PVAMC on May
28 through 29, 2008, and from June 24 through 25, 2008, and issued an
inspection report with violations of NRC requirements, dated October
16, 2008. The NHPP concluded that, for medical events occurring between
February 25, 2002, and May 5, 2008, Mr. Desobry was aware of the D90
doses (the minimum dose received by 90 percent of the prostate volume)
and, in some cases, of the seeds being implanted outside the prostate.
However, Mr. Desobry did not report these circumstances to the RSO to
evaluate as possible medical events. The NRC considered this a missed
opportunity to correct the issue, allowing further medical events to
occur. The NHPP also concluded that Mr. Desobry had adequate clinical
and technical knowledge of the patient circumstances surrounding the
medical events. Finally, the NHPP concluded that the lack of
evaluations by Mr. Desobry and his failure to raise this issue to
higher-level management was contrary to patient safety and demonstrated
a lack of a safety conscious work environment.
The NRC also responded to the medical events being reported by
conducting onsite inspections at the PVAMC on various dates from July
23, 2008, to October 16, 2009. The results of the NRC inspections were
documented in NRC Special Inspection Report No. 030-34325/2008-
029(DNMS), dated March 30, 2009, and NRC Reactive Inspection Report No.
030-34325/2009-001(DNMS), dated November 17, 2009. The NRC determined
that Mr. Desobry was the primary medical physicist at the PVAMC for
brachytherapy implants and participated in the majority of treatments
that subsequently resulted in reported medical events. Also, Mr.
Desobry was the primary medical physicist during the period when post
[[Page 11530]]
treatment dose verifications were not performed due to computer
interface problems. The NRC inspection reports documented eight
apparent violations of NRC requirements and noted that the VA's
internal Administrative Board of Investigation concluded that there was
a lack of a safety culture at the PVAMC where Mr. Desobry, among
others, accepted a substandard approach to brachytherapy treatments,
which resulted in poor implant techniques, a patient dose assessment
process that lacked rigor and formality, a failure to communicate
concerns with the implants, a misperception that safety checks were
performed by other team members, and an overall system that did not
demonstrate a commitment to safety.
The NRC discussed these violations with the VA in a Predecisional
Enforcement Conference conducted on December 17, 2009. In a letter
dated January 14, 2010, the VA accepted the violations, including the
root or basic causes identified by the VA and the NRC.
On March 17, 2010, the NRC issued a Notice of Violation with a
$227,500 proposed civil penalty to the VA. The Notice of Violation
included two Severity Level II violations and three Severity Level III
violations assessed a civil penalty; and one Severity Level II
violation and two Severity Level IV violations not assessed a civil
penalty. The VA provided the NRC with its response to the Notice of
Violation and proposed civil penalty, dated April 8, 2010, and
forwarded payment of the civil penalty provided in a follow-up letter,
dated April 13, 2010.
During interviews conducted by the NRC's Office of Investigations
(OI), Mr. Desobry acknowledged being involved in over 90 percent of the
brachytherapy procedures conducted at the PVAMC. Mr. Desobry also
informed the NRC OI that he had never received training as to what
constituted a medical event and was unaware of the reporting
requirements of a medical event.
Notwithstanding Mr. Desobry's training as a Medical Physicist, with
board certification by the American Board of Radiology in 1989 and
subsequent practice in the field of Medical Physics, Mr. Desobry's
actions at the PVAMC, as they contributed to these medical events,
called into question whether Mr. Desobry would work to assure that
radioactive materials are used safely for patients, adequately
understands the applicable NRC regulations, and would perform future
activities in accordance with applicable NRC requirements and the
Atomic Energy Act.
Therefore, on May 24, 2010, the NRC issued a Demand for Information
(DFI) to Mr. Desobry. This DFI required Mr. Desobry to provide
information about actions he had taken, or planned to take, to ensure
that Mr. Desobry fully understood: (1) The 10 CFR part 35 definition of
a medical event; and (2) his role and responsibilities pertaining to
his duties as a medical physicist and the steps necessary to identify
and report medical events to the NRC. The NRC further required
information about the names and locations of the facilities where Mr.
Desobry worked as a medical physicist. Finally, the NRC required
information about any other additional actions not already mentioned
that would provide the NRC with reasonable assurance about Mr.
Desobry's involvement in NRC-licensed activities.
Mr. Desobry responded to the DFI on June 28, 2010. His reply
indicated that he was not currently employed as a medical physicist,
but had been employed at the Capital Health System--Mercer Campus, in
Trenton, New Jersey, from January 2008 until December 2009; Capital
Health System was affiliated with the University of Pennsylvania Health
System during that time frame. Mr. Desobry indicated that while at
Capital Health System under the supervision of the Head of the
Department of Radiation Oncology, he worked with the Radiation Safety
Officer and with radiation oncology physicians to examine that
institution's definition of a medical event, which Mr. Desobry
indicated reinforced his understanding (and corrected any prior
misunderstanding) of the 10 CFR part 35 definition of a medical event;
his role and responsibility regarding medical events; and the steps
needed to be taken to identify and report medical events to the NRC.
Mr. Desobry indicated that he was dedicated to regulatory compliance
and patient safety and stated that, in the event that he should ever be
hired to work again as a medical physicist, he would request training
in this area at an appropriate and accredited institution.
III
Based on Mr. Desobry's response to the May 24, 2010, DFI, the NRC
recognizes that Mr. Desobry has taken steps to improve his
understanding of how to safely use radioactive material in treatment of
patients. Mr. Desobry worked with the Radiation Safety Officer and with
radiation oncology physicians at the Capital Health System facility to
correct and reinforce Mr. Desobry's understanding of the 10 CFR part 35
definition of a medical event, his role and responsibility regarding
medical events, and the steps needed to be taken to identify and report
medical events to the NRC. However, since Mr. Desobry was involved in a
large number of reported medical events at PVAMC, the NRC has concluded
that it needs the opportunity to inspect Mr. Desobry's involvement in
future similar NRC-licensed activities to assess the efficacy of Mr.
Desobry's actions to improve his understanding of the 10 CFR part 35
definition of a medical event, his role and responsibility regarding
medical events, and the steps needed to be taken to identify and report
medical events to the NRC, in the event that he accepts a position as a
medical physicist in the future. This action will provide NRC the
opportunity to confirm that reasonable assurance exists that licensed
activities can be conducted in compliance with the Commission's
requirements and that the health and safety of the public will be
protected.
Therefore, the public health, safety and interest require that Mr.
Desobry notify the NRC within 20 days of accepting a position as a
medical physicist.
IV
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 150.20, it is hereby ordered
that:
1. If Mr. Desobry accepts, or has accepted since the time of his
response to the DFI, dated May 24, 2010, a medical physicist position
involving the use of byproduct materials in either NRC jurisdiction or
in an Agreement State, he shall inform the NRC within 20 days of
acceptance of an employment offer or within 20 days of this Order,
whichever comes later. This notification is a one-time requirement and
no further notification is required for any subsequent acceptance of an
employment offer. This notification shall be provided to the Director,
Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001, with a copy to the Regional Administrator, Region III,
2443 Warrenville Road, Lisle, IL 60532. The notification shall include
the name, address, and telephone number of the employer or the entity
where he is or will be employed as a medical physicist.
2. This Order shall be effective 20 days following its publication
in the Federal Register and shall remain in effect until the conditions
of Item 1 have been met.
The Director, OE, may, in writing, relax or rescind any of the
above conditions upon demonstration by Mr. Desobry of good cause.
[[Page 11531]]
V
In accordance with 10 CFR 2.202, Mr. Gregory Desobry must, and any
other person adversely affected by this Order may, submit an answer to
this Order within 20 days of its publication in the Federal Register.
Mr. Desobry's answer must be submitted under oath and affirmation. In
addition, Mr. Desobry and any other person adversely affected by this
Order may request a hearing on this Order within 20 days of its
publication in the Federal Register. Where good cause is shown,
consideration will be given to extending the time to answer or request
a hearing. A request for extension of time must be directed to the
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission,
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 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 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.
[[Page 11532]]
If a person other than Mr. Desobry, Ph.D., requests a hearing, that
person shall set forth with particularity the manner in which his/her
interest is adversely affected by this Order and shall address the
criteria set forth in 10 CFR 2.309(d).
If a hearing is requested by a licensee or 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 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 IV above shall be final 20 days from
the date this 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 IV shall
be final when the extension expires if a hearing request has not been
received.
Dated this 23rd day of February 2011.
For the U.S. Nuclear Regulatory Commission.
Roy P. Zimmerman,
Director, Office of Enforcement.
[FR Doc. 2011-4682 Filed 3-1-11; 8:45 am]
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