[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11526-11529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4680]


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NUCLEAR REGULATORY COMMISSION

[IA-09-035; NRC-2011-0048]


In the Matter of Dr. Gary Kao; Order Prohibiting Involvement In 
NRC-Licensed Activities

I

    Dr. Gary Kao has performed duties as an authorized user 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 authorized by the MML to use a variety of 
byproduct materials for diagnostic and therapeutic purposes. The 
therapeutic treatments include brachytherapy iodine-125 used for 
permanent prostate implants. Dr. Kao was an approved authorized user 
for brachytherapy iodine-125 used for 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. The NRC determined that Dr. Kao was the 
authorized physician during 91 of the 97 reported medical events.
    In addition, during the period from December 2006 through November 
2007, post-treatment dose verification, required pursuant to 10 CFR 
35.41(b)(2), was not performed for at least 16 patients under Dr. Kao's 
purview 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 and 29, 2008, and June 24 and 25, 2008. The VA NHPP issued an 
inspection report on October 16, 2008, documenting violations of NRC 
requirements. The NHPP concluded that, for medical events occurring 
between February 25, 2002, and May 5, 2008, Dr. Kao was aware of the 
D90 (dose to 90 percent of the prostate volume) doses and, in some 
cases, of the seeds being implanted outside the prostate. The NHPP 
determined that Dr. Kao had adequate clinical and technical knowledge 
of the patient circumstances surrounding the medical events. However, 
the NHPP concluded that Dr. Kao did not report these circumstances to 
the Radiation Safety Officer to evaluate as possible medical events. 
The NRC considered this a missed opportunity to correct the issue, 
allowing further medical events to occur.
    On July 17, 2008, the PVAMC Director convened an Administrative 
Board of Investigation (ABI) to review the brachytherapy program. The 
ABI submitted the results of its investigation in a memorandum to the 
PVAMC Director on September 4, 2008. The ABI report concluded that Dr. 
Kao was aware of the poor and inconsistent results from the 
brachytherapy treatments, but chose not to alert senior management or 
the Radiation Safety Committee. Additionally, the ABI report stated 
that Dr. Kao chose not to stop the program when problems were 
identified relating to post-treatment monitoring and evaluation because 
of data transmission issues from the radiology department. The ABI 
report also noted that Dr. Kao failed to take corrective action for 
those cases found to have low D90s or when the computerized tomography 
to treatment planning system network problem made post implant 
evaluations impossible.
    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 030-34325/2008-029(DNMS), 
dated March 30, 2009, and NRC Reactive Inspection Report 030-34325/
2009-001(DNMS), dated November 17, 2009. While the NRC inspection 
reports did not focus on the roles of individuals and their 
contributions to the issues at the PVAMC, the NRC recognized that Dr. 
Kao was the authorized user for almost all the reported medical events. 
The NRC identified that contributing factors to the medical events 
included a lack of a safety culture where safety concerns went 
unreported, and a non-rigorous and informal assessment of patient doses 
existed which did not demonstrate a commitment to improve performance. 
The NRC identified eight apparent violations of NRC requirements.
    The NRC discussed these violations with the VA at 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.

[[Page 11527]]

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.
    The information gathered through the multiple review processes 
outlined above called into question whether the NRC had reasonable 
assurance that Dr. Kao would perform his duties as an authorized user 
in accordance with NRC regulations and the Atomic Energy Act. As a 
result, on May 26, 2009, the NRC issued a Demand for Information (DFI) 
to Dr. Kao. This DFI was limited in scope to information about whether 
Dr. Kao was currently performing any activities using byproduct 
materials, if so, where, and, if not, requiring Dr. Kao to notify the 
NRC 72 hours before performing any such activities. In his May 28, 
2009, response, Dr. Kao indicated that he was not then participating in 
any activities using byproduct materials, including but not limited to 
brachytherapy activities, at any NRC or Agreement State licensed 
facilities and that he would inform the NRC 72 hours prior to 
participating in any such activities.
    On May 24, 2010, the NRC issued a second DFI to Dr. Kao, to provide 
an update to Dr. Kao's previous responses, and provide additional 
information about actions Dr. Kao had taken, or planned to take, to: 
(1) Ensure that, should he engage in activities involving the use of 
byproduct material, including but not limited to brachytherapy implant 
treatments, such activities would be performed safely and, 
specifically, that such activities would be in accordance with the 
written directive; (2) ensure that he fully understood NRC's definition 
of a medical event and the steps that he needed to take to identify and 
report medical events; and (3) to describe any additional information 
that would provide the NRC with reasonable assurance about his 
involvement in NRC-regulated activities.
    Dr. Kao responded to the NRC's second DFI on June 1, 2010. His 
reply indicated that he was not designated as an authorized user on any 
NRC or Agreement State license or any permit and was not currently 
involved in any activities involving byproduct material. The reply also 
indicated that Dr. Kao had not taken and did not plan to take any 
actions at this time to ensure that any future activities would be 
performed safely and in accordance with a written directive. The reply 
did not provide any information that indicated that Dr. Kao had taken 
any actions to gain understanding of the NRC's definition of a medical 
event or to ensure that Dr. Kao would identify and report medical 
events. Finally, Dr. Kao indicated that he was not currently engaged in 
the administration of brachytherapy treatment and had no plans to 
become so engaged in the future. Dr. Kao attested that, prior to 
performing any brachytherapy treatment, he would take all necessary and 
appropriate steps to ensure that he was current on all applicable NRC 
requirements.

III

    Based on Dr. Kao's performance at the PVAMC and his responses to 
the aforementioned DFI's, as set forth in Section II of this Order, the 
NRC lacks reasonable assurance until Dr. Kao takes the appropriate 
corrective actions and can demonstrate his knowledge of the safe use of 
radioactive material to protect health or to minimize the danger to 
life or property in compliance with the Commission's requirements. 
Therefore, the public health, safety and interest require that Dr. Kao 
be prohibited from any involvement in NRC-licensed activities until he 
can provide the NRC with reasonable assurance that he can safely use 
radioactive material in accordance with NRC requirements, and that he 
can correctly identify and report medical events.

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. Beginning on the effective date of this Order, Dr. Kao is 
prohibited from engaging in NRC-licensed activities. NRC-licensed 
activities are those activities that are conducted pursuant to a 
specific or general license issued by the NRC, including, but not 
limited to, those activities of Agreement State licensees conducted 
pursuant to the authority granted by 10 CFR 150.20.
    2. If, after issuance but prior to the effective date of this 
Order, Dr. Kao has performed NRC-licensed activities for another person 
or organization as an employee or contractor, he shall provide written 
notification to the Director of the NRC Office of Enforcement, with a 
copy to the Region III Regional Administrator, of the name, address and 
telephone number of that person or organization, and provide a copy of 
this Order to that person or organization. The notifications required 
by this paragraph, if applicable, shall be accomplished within 5 days 
of the effective date of this Order.
    3. If, after issuance but prior to the effective date of this 
Order, Dr. Kao has performed activities licensed by an Agreement State, 
then Dr. Kao shall (1) provide a copy of the Order to the person or 
organization by whom he was employed or contracted within 5 days of the 
effective date of this Order, and (2) provide written notification to 
the Director of the NRC Office of Enforcement, with a copy to the 
Region III Regional Administrator, within 5 days of the effective date 
of this Order. If, after the effective date of this Order, Dr. Kao 
accepts an offer of employment, enters a contract to perform work, or 
otherwise plans to perform activities licensed by an Agreement State, 
Dr. Kao shall (1) provide a copy of this Order to the person or 
organization by whom he will be employed or contracted, within 5 days 
of any such offer, contract, or plan, and (2) provide written 
notification to the Director of the NRC Office of Enforcement, with a 
copy to the Region III Regional Administrator, within 5 days of any 
such offer, contract, or plan.
    4. At any time after the effective date of this Order, Dr. Kao may 
file a written request with the Director of the NRC Office of 
Enforcement that the Order be rescinded, such that he could resume, for 
example, the activities of an authorized user for medical 
administrations, based upon the satisfactory completion of all of the 
following conditions:
    a. In addition to the training and qualification requirements set 
forth in NRC regulations applicable to the use of byproduct material, 
Dr. Kao shall provide documentation showing that he has successfully 
completed specialized training regarding (1) the definition of a 
medical event contained in NRC regulations, how to identify a medical 
event, and the requirements for proper reporting of a medical event, 
with particular emphasis on medical events arising out of prostate 
brachytherapy treatments, but not limited to such treatments; and (2) 
the importance of reporting non-compliances and identifying appropriate 
corrective actions under the NRC Enforcement Policy. Such documentation 
shall include training dates, course syllabi, and instructor 
qualifications;
    b. Dr. Kao shall provide documentation showing that he has 
successfully demonstrated, under the supervision of a trained and 
qualified authorized user competent in the identification and reporting 
of medical events, the ability to correctly identify and report medical 
events in accordance

[[Page 11528]]

with NRC regulations, including (but not limited to) medical events 
resulting from prostate brachytherapy. This paragraph does not permit 
Dr. Kao to use byproduct material, act as an authorized user, or 
otherwise engage in NRC-licensed activities. Such documentation shall 
include an attestation by the authorized user under whom Dr. Kao 
performed regarding the methodology (e.g., observation, examination, 
use of biologically equivalent human phantoms) used to demonstrate Dr. 
Kao's competence; and
    c. Dr. Kao shall provide to the Director of the NRC Office of 
Enforcement, with a copy to the Region III Regional Administrator, a 
written document describing in detail his understanding of: (1) The 10 
CFR part 35 definition of a medical event; (2) his role and 
responsibility regarding performing activities in accordance with a 
written directive; (3) the steps necessary to identify and report 
medical events to the NRC and (4) the process he would follow to 
identify the corrective actions that would be necessary if he were to 
be involved with a noncompliance of NRC regulations in the future, 
including (but not limited to) a medical event resulting from prostate 
brachytherapy.
    5. If Dr. Kao seeks rescission of this Order under Paragraph IV.4, 
the information required by Paragraph IV.4 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, Suite 210, Lisle Illinois 60532.
    6. This Order shall be effective 20 days following its publication 
in the Federal Register and shall remain in effect until the conditions 
specified above have been met and the Director of Office of Enforcement 
determines in writing that the Order is rescinded.
    The Director, OE, may, in writing, relax or rescind any of the 
above conditions upon demonstration by Dr. Kao of good cause.

V

    In accordance with 10 CFR 2.202, Dr. Gary Kao 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. Dr. 
Kao's answer must be submitted under oath and affirmation. In addition, 
Dr. Kao 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 <a href="/cdn-cgi/l/email-protection#8be3eeeaf9e2e5eca5efe4e8e0eeffcbe5f9e8a5ece4fd"><span class="__cf_email__" data-cfemail="9df5f8fceff4f3fab3f9f2fef6f8e9ddf3effeb3faf2eb">[email protected]</span></a>, 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 
<a href="/cdn-cgi/l/email-protection#c08d938884ee92a5b3afb5b2a3a580aeb2a3eea7afb6"><span class="__cf_email__" data-cfemail="a4e9f7ece08af6c1d7cbd1d6c7c1e4cad6c78ac3cbd2">[email protected]</span></a>, 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.

[[Page 11529]]

    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.
    If a person other than Dr. Kao 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. 2011-4680 Filed 3-1-11; 8:45 am]
BILLING CODE 7590-01-P


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