[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]
BILLING CODE 7590-01-P