11526 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 

Contact person for more information: 

Rochelle Bavol, (301) 415–1651. 

* * * * * 

Additional Information 

By a vote of 5–0 on February 23 and 

24, 2011, the Commission determined 

pursuant to U.S.C. 552b(e) and 

§ 9.107(a) of the Commission’s rules that 

the above referenced Discussion of 

Management Issues be held on February 

28, 2011, with less than one week notice 

to the public. 

* * * * * 

The NRC Commission Meeting 

Schedule can be found on the Internet 

at: http://www.nrc.gov/public-involve/ 

public-meetings/schedule.html. 

* * * * * 

The NRC provides reasonable 

accommodation to individuals with 

disabilities, where appropriate. If you 

need a reasonable accommodation to 

participate in these public meetings, or 

need this meeting notice or the 

transcript or other information from the 

public meetings in another format (e.g., 

braille, large print), please notify Bill 

Dosch, Chief, Work Life and Benefits 

Branch, at 301–415–6200, TDD: 301– 

415–2100, or by e-mail at 

william.dosch@nrc.gov. Determinations 

on requests for reasonable 

accommodation will be made on a caseby-case basis. 

* * * * * 

This notice is distributed 

electronically to subscribers. If you no 

longer wish to receive it, or would like 

to be added to the distribution, please 

contact the Office of the Secretary, 

Washington, DC 20555 (301–415–1969), 

or send an e-mail to 

darlene.wright@nrc.gov. 

Dated: February 25, 2011. 

Richard J. Laufer, 

Technical Coordinator, Office of the 

Secretary. 

[FR Doc. 2011–4758 Filed 2–28–11; 4:15 pm] 

BILLING CODE 7590–01–P 

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 nonrigorous 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. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 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 


emcdonald on DSK2BSOYB1PROD with NOTICES
11528 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 

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 

hearing.docket@nrc.gov, 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 NRCissued 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/esubmittals.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/esubmittals.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 email 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/esubmittals.html, by e-mail at 

MSHD.Resource@nrc.gov, or by a tollfree 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. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 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 firstclass 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 

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 


emcdonald on DSK2BSOYB1PROD with NOTICES