[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]




                           ENFORCEMENT OF THE
                  U.S. DEPARTMENT OF VETERANS AFFAIRS'
                 BRACHYTHERAPY PROGRAM SAFETY STANDARDS

=======================================================================

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                     COMMITTEE ON VETERANS' AFFAIRS
                     U.S. HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 22, 2009

                               __________

                           Serial No. 111-36

                               __________

       Printed for the use of the Committee on Veterans' Affairs




                  U.S. GOVERNMENT PRINTING OFFICE
51-875                    WASHINGTON : 2009
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing 
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC 
area (202) 512-1800 Fax: (202) 512-2104  Mail: Stop IDCC, Washington, DC 
20402-0001





                     COMMITTEE ON VETERANS' AFFAIRS

                    BOB FILNER, California, Chairman

CORRINE BROWN, Florida               STEVE BUYER, Indiana, Ranking
VIC SNYDER, Arkansas                 CLIFF STEARNS, Florida
MICHAEL H. MICHAUD, Maine            JERRY MORAN, Kansas
STEPHANIE HERSETH SANDLIN, South     HENRY E. BROWN, Jr., South 
Dakota                               Carolina
HARRY E. MITCHELL, Arizona           JEFF MILLER, Florida
JOHN J. HALL, New York               JOHN BOOZMAN, Arkansas
DEBORAH L. HALVORSON, Illinois       BRIAN P. BILBRAY, California
THOMAS S.P. PERRIELLO, Virginia      DOUG LAMBORN, Colorado
HARRY TEAGUE, New Mexico             GUS M. BILIRAKIS, Florida
CIRO D. RODRIGUEZ, Texas             VERN BUCHANAN, Florida
JOE DONNELLY, Indiana                DAVID P. ROE, Tennessee
JERRY McNERNEY, California
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota
JOHN H. ADLER, New Jersey
ANN KIRKPATRICK, Arizona
GLENN C. NYE, Virginia

                   Malcom A. Shorter, Staff Director

                                 ______

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                  HARRY E. MITCHELL, Arizona, Chairman

ZACHARY T. SPACE, Ohio               DAVID P. ROE, Tennessee, Ranking
TIMOTHY J. WALZ, Minnesota           CLIFF STEARNS, Florida
JOHN H. ADLER, New Jersey            BRIAN P. BILBRAY, California
JOHN J. HALL, New York

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Veterans' Affairs are also 
published in electronic form. The printed hearing record remains the 
official version. Because electronic submissions are used to prepare 
both printed and electronic versions of the hearing record, the process 
of converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.










                            C O N T E N T S

                               __________

                             July 22, 2009

                                                                   Page
Enforcement of the U.S. Department of Veterans Affairs' 
  Brachytherapy Program Safety Standards.........................     1

                           OPENING STATEMENTS

Chairman Harry E. Mitchell.......................................     1
    Prepared statement of Chairman Mitchell......................    47
Hon. David P. Roe, Ranking Republican Member.....................     3
    Prepared statement of Congressman Roe........................    48
Hon. John H. Adler...............................................     4
Hon. John J. Hall................................................     5
Hon. Chaka Fattah................................................     5

                               WITNESSES

United States Nuclear Regulatory Commission, Steven A. Reynolds, 
  Director, Division of Nuclear Materials Safety Region III......    25
    Prepared statement of Mr. Reynolds...........................    55
U.S. Department of Veterans Affairs, Joseph A. Williams, Jr., RN, 
  BSN, MPM, Assistant Deputy Under Secretary for Health for 
  Operations and Management, Veterans Health Administration......    37
    Prepared statement of Mr. Williams...........................    65

                                 ______

Bieda, Michael R., M.S., Clinical Chief, Division of Medical 
  Physics, Department of Radiation Oncology, University of 
  Pennsylvania, School of Medicine, Philadelphia, PA.............    10
    Prepared statement of Mr. Bieda..............................    53
Hahn, Stephen M., M.D., Henry K. Pancoast Professor and Chair, 
  Department of Radiation Oncology, University of Pennsylvania, 
  School of Medicine, Philadelphia, PA...........................     9
    Prepared statement of Dr. Hahn...............................    51
Kao, Gary D., M.D., Ph.D., Associate Professor of Radiation 
  Oncology, Department of Radiation Oncology, University of 
  Pennsylvania, School of Medicine, Philadelphia, PA.............     6
    Prepared statement of Dr. Kao................................    48
American Society for Radiation Oncology, W. Robert Lee, M.D., 
  M.S., M.Ed., Professor, Department of Radiation Oncology, Duke 
  University, School of Medicine, Durham, NC.....................    26
    Prepared statement of Dr. Lee................................    58
The Joint Commission, Paul M. Schyve, M.D., Senior Vice President    23
    Prepared statement of Dr. Schyve.............................    53

                       SUBMISSIONS FOR THE RECORD

Desobry, Gregory E., Ph.D., Medical Physicist, Division of 
  Medical Physics, Department of Radiation Oncology, University 
  of Pennsylvania, School of Medicine, Philadelphia, PA, 
  statement......................................................    67
Lazarescu, George, Ph.D., Medical Physicist, Division of Medical 
  Physics, Department of Radiation Oncology, University of 
  Pennsylvania, School of Medicine, Philadelphia, PA, statement..    68
Stearns, Hon. Cliff, a Representative in Congress from the State 
  of Florida, statement..........................................    68

 
                 ENFORCEMENT OF THE U.S. DEPARTMENT OF
        VETERANS AFFAIRS' BRACHYTHERAPY PROGRAM SAFETY STANDARDS

                              ----------                              


                        WEDNESDAY, JULY 22, 2009

             U.S. House of Representatives,
                    Committee on Veterans' Affairs,
                                  Subcommittee on Oversight
                                        and Investigations,
                                                    Washington, DC.

    The Subcommittee met, pursuant to notice, at 10:00 a.m., in 
Room 334, Cannon House Office Building, Hon. Harry E. Mitchell 
[Chairman of the Subcommittee] presiding.

    Present: Representatives Mitchell, Walz, Adler, Hall, and 
Roe.

    Also Present: Representative Fattah.

             OPENING STATEMENT OF CHAIRMAN MITCHELL

    Mr. Mitchell. Good morning, and welcome to the Subcommittee 
on Oversight Investigations Hearing on Enforcement of U.S. 
Department of Veterans Affairs' (VA's) Brachytherapy Program 
Safety Standards. This is July 22, 2009, and this hearing will 
come to order.
    I ask unanimous consent that Mr. Fattah of Pennsylvania be 
invited to sit at the dais for the Subcommittee hearing today. 
Hearing no objection so ordered. Mr. Fattah, you are invited 
when you do come in, to come up to the dais.
    I would like to thank everyone for attending today's 
Oversight and Investigations Subcommittee Hearing entitled, 
Enforcement of U.S. Department of Veterans Affairs' 
Brachytherapy Safety Standards. Thank you especially to our 
witnesses for testifying today.
    All Members of this Subcommittee take particular interest 
in this issue, as well as the care of our Nation's veterans; 
however, I would like to especially thank Congressman John 
Adler of New Jersey for being such a passionate advocate for 
this issue.
    Reports of botched prostate cancer procedures, a lack of 
quality and standard controls in the VA health care system, and 
egregious errors in the brachytherapy treatment at the 
Philadelphia VA Medical Center are unacceptable and wrong.
    Brachytherapy is a form of radiotherapy often used to treat 
prostate cancer in which radioactive seeds are placed inside or 
next to a patient's malignancy. Failure to accurately place the 
radioactive seeds can cause serious damage. To say that it is 
disturbing to learn that veterans received bungled procedures 
and that safety protocols failed to safeguard against such 
mistreatment would be an understatement. As a result, we are 
here today to examine the system-wide safety standards for 
these procedures to ensure that our veterans are receiving the 
best and safest care possible.
    In 2003 and 2005, the Nuclear Regulatory Commission (NRC) 
received reports of botched placement of radioactive seeds and 
inconsistent dosages at the Philadelphia VA Medical Center. 
After careful review, it was determined that no NRC protocols 
were violated.
    In May of last year, the NRC received a notification of 
potential under dosing at the Philadelphia VA Center. This led 
to a VA Hospital Health Physics Program inspection evaluating 
all the 116 brachytherapy treatments that took place since the 
creation of the program in 2002.
    The New York Times reported last month that investigators 
for the Nuclear Regulatory Commission and VA officials found 
that 92 of the 116 men treated at the VA Medical Center in 
Philadelphia's brachytherapy program received incorrect doses 
of radiation seeds, often because they landed in nearby organs 
or surrounding tissue rather than the prostate.
    Dr. Gary Kao, who is here today at this hearing, performed 
the majority of the procedures under a VA contract with the 
University of Pennsylvania where he was on staff. Out of the 
four suspended brachytherapy programs, we know that 
Philadelphia was by the far the worst.
    On top of this, in March of this year the NRC issued a 
detailed inspection report citing the Philadelphia VA Medical 
Center with six violations of NRC regulations. This is 
downright unacceptable.
    While we are disturbed that perhaps there was a lack of 
proper local quality controls and management of these 
brachytherapy programs, our main concern is that the problem 
marring the program in Philadelphia could be happening at the 
other nine facilities still doing these procedures. As such, we 
have asked the VA Office of Inspector General (OIG) to review 
and assess the VA's brachytherapy programs, and although the 
complete NRC inspection report on the Philadelphia program, 
along with the other VA facilities using brachytherapy 
treatments, as well as the National Health Physics Program 
(NHPP) performance is not complete, we look forward to reading 
that report when it becomes available.
    Though it is commendable that VA's leadership took swift 
action once these issues were reported, it is still troubling 
that it took almost 6 years for these events to actually be 
reported. Even more troubling is just last month we were here 
discussing quality control and lack of proper procedures and 
oversight of endoscopy procedures being conducted by the VA, 
yet we are here again questioning the quality of care our 
veterans receive.
    The VA health system relies upon a complementary system of 
accountability to identify quality control problems throughout 
the entire system and at individual levels. Failure to ensure 
consistent oversight and safe treatment is unacceptable and 
wrong.
    I am anxious to hear VA assurances not only to this 
Subcommittee, but to all the veterans they serve, that the 
issues identified once a thorough review has been conducted is 
not occurring at any of the remaining brachytherapy programs 
across the country, and that the four suspended programs may 
continue to deliver this important treatment to our veterans.
    Last, I am equally interested in hearing from one of one 
our witnesses, Dr. Kao, regarding all allegations of erratic 
seed placements, as well as experts we have invited to provide 
their thoughts on the safety and effectiveness of the 
treatment.
    Thank you again to all of our witnesses who are testifying 
today and we look forward to your testimony.
    And before I recognize the Ranking Republican Member for 
his remarks I would like to swear in our witnesses. I ask that 
all witnesses from all three panels to please stand. Please 
raise your right hand.
    [Witnesses sworn.]
    Thank you. I now recognize Dr. Roe for opening remarks.
    [The prepared statement of Chairman Mitchell appears on p. 
47.]

             OPENING STATEMENT OF HON. DAVID P. ROE

    Mr. Roe. Thank you, Mr. Chairman, other Committee Members 
for being here today, I appreciate you holding this hearing.
    The issue we should really be addressing today is not only 
the instance of alleged medical malfeasance by one particular 
medical practitioner, but whether or not this is a symptom of 
an overreaching patient safety issue across the entire VA.
    Just last month, as the Chairman mentioned we held a 
hearing on the problems relating to cleaning and reprocessing 
of endoscopic equipment at the VA. Now we are hearing testimony 
today to discuss problems with brachytherapy treatments at the 
VA Medical Center in Philadelphia.
    Prostate cancer is a major problem for adults over 50 in 
the United States, and brachytherapy is an important tool used 
by oncologists to treat prostate and other cancers. The VA 
treats about 575 veterans annually with low dose brachytherapy 
at 13 centers nationwide.
    We need to tread cautiously today. We are here to hear 
testimony from the VA and other officials. We need to keep in 
mind the good quality care most veterans seem to be receiving 
in VA medical facilities and not seek to undermine the 
confidence veterans have in going to the VA for their health 
care needs.
    That being said, I am gravely concerned that these issues 
continue to crop up in the news media. VA needs to do a better 
job at policing itself before they let the New York Times 
sensationalize an issue in order to break the public's trust.
    Mr. Chairman, protection of our Nation's veterans who look 
at the VA for their care of a primary importance. To hear 
continual reports of various health issues such as an 
endoscopic cleaning issue last month and now the problem with 
brachytherapy at select facilities is worrisome to me and 
others on this Committee. We must continue to ensure that our 
veterans receive the best possible care available.
    I look forward to hearing the testimony from today's 
witnesses. And once again, Mr. Chairman, thank you for holding 
this hearing. I yield back my time.
    [The prepared statement of Congressman Roe appears on p. 
48.]
    Mr. Mitchell. Thank you, Dr. Roe. At this time I would like 
to recognize Mr. Adler.

            OPENING STATEMENT OF HON. JOHN H. ADLER

    Mr. Adler. I would like to thank Chairman Filner, Chairman 
Mitchell, the House Veterans Affairs' Committee, and the 
Subcommittee on Oversight and Investigation for holding today's 
hearing on the VA's brachytherapy program safety standards. I 
would also like to thank our witnesses for agreeing to testify.
    The veterans who sought treatment for prostate cancer at 
the Philadelphia VA Hospital did not receive the quality health 
care their selfless service to our country earned them. The 
people responsible for administering the substandard medical 
care in the brachytherapy program let our veterans down and 
sent the wrong message to young men and women thinking about 
joining our all-volunteer armed forces.
    We are here today to evaluate the suspended brachytherapy 
program at the Philadelphia VA Hospital who have treated 
prostate cancer patients from 2002 until the program was forced 
to close in June 2008, and also to evaluate the VA's broader 
brachytherapy program safety standards.
    News reports have depicted a rogue cancer unit and a rogue 
physician who botched nearly 80 percent of the procedures he 
was contracted to perform on our veterans. These multiple 
failures which went undetected year after year highlight 
significant problems in the VA's oversight system.
    Recent newspaper articles highlighted a prostate cancer 
treatment program that operated for 6 years with a glaring lack 
of oversight that should have been in place to protect our 
veterans.
    I am outraged. The brave men who so selflessly served our 
country have been subjected to such poor treatment and neglect 
by a hospital and a system that was created to protect them.
    I am further appalled that the routine safeguards that 
could have been in place to protect our veterans were either 
woefully inadequate or blatantly absent. Exposing our veterans 
to this type of mistreatment is not only unacceptable, it 
violates the bond our country made with them when they agreed 
to fight for the safety and security of this Nation.
    We must find and analyze the specific gaps in our system so 
these failures never happen again in this program, in this 
hospital, in any program in any VA hospital.
    What occurred at the Philadelphia's VA brachytherapy 
program is more than just one doctor's incompetence, the 
Federal Government failed on many levels to protect our 
veterans.
    The multiple-pronged system currently in place to oversee 
radiation procedures across the country is not working. It 
certainly was not working in Philadelphia. That is why the VA 
temporarily or permanently suspended other brachytherapy 
programs in Cincinnati, Washington, and Jackson, Mississippi.
    This hearing is an opportunity to continue our 
investigation into the failures that resulted in the forced 
closings of 4 out of 13 brachytherapy programs throughout our 
country. We must avoid a recurrence of this problem at all VA 
medical facilities.
    This hearing is also an opportunity to begin examining the 
entire VA health care system. This is a start of an ongoing 
process to ensure that our veterans are receiving the highest 
standard of medical care they deserve everywhere in the 
country.
    I am looking forward to getting some answers from the VA 
today about what steps they are taking to ensure that the 
problems of the brachytherapy program in Philadelphia are not 
repeated elsewhere in the VA health care system. My hope is 
that the VA can give our veterans some confidence that the VA 
system is working to provide the highest level of care.
    I yield back the balance of my time.
    Mr. Mitchell. Thank you. Mr. Hall.

             OPENING STATEMENT OF HON. JOHN J. HALL

    Mr. Hall. Thank you, Mr. Chairman, and thank you for 
holding this hearing. Also, thank you Ranking Member Roe.
    I agree with the comments of Mr. Adler and yourself and the 
Ranking Member, all of which are complimentary. Our veterans 
need to have obviously the best care available to them--and the 
VA I believe is in the process of trying to correct these 
problems where they are been identified.
    I am interested in not only answers to what went on and how 
it can be avoided, these cases of mistreatment or inadequate 
treatment, possibly harmful treatment to the patients can be 
avoided, but also your reaction to a New York Times article 
that came out recently that said that a prostate cancer 
diagnosis usually offers the patient the choice of five 
different routes, seed implantation being one of them, and that 
the most radical and expensive is proton acceleration, the 
least expensive is watchful waiting, and in between you have 
the removal of the prostate, radiation therapy, seed 
implantation, et cetera, and that no statistical difference has 
been shown yet in any of the studies in terms of lengthening 
the patient's life, especially if they are diagnosed at 65 
years or older.
    So are we in the VA medical system looking at the cost 
benefit analysis of these various choices of treatment and 
telling the veteran, the patient, what the choices are and the 
true statistical fact--it appears to be a fact--that one is not 
guaranteed a longer life by having one treatment over another?
    So if I may, Mr. Chairman, I will submit a longer statement 
for the record, but thank you again for holding the hearing and 
thank our witnesses for their testimony and I yield back.
    [No statement was submitted.]
    Mr. Mitchell. Thank you. Mr. Walz.
    Mr. Walz. Well thank you Chairman and Ranking Member for 
once again holding an important hearing. I am going to yield 
back my time so we can get right to our witnesses.
    Mr. Mitchell. Thank you. Mr. Fattah.

             OPENING STATEMENT OF HON. CHAKA FATTAH

    Mr. Fattah. Thank you, Mr. Chairman, and let me be brief. 
Let me thank the Committee and the Subcommittee for holding 
this hearing, and I think that it is important that we hear 
from the witnesses. When I first heard about this, I was 
obviously like others, outraged. Nevertheless, the more you dig 
into it there is more nuance to it and subtleties to this 
procedure, and I want us to make sure that we don't do anything 
to discourage people from seeking treatment.
    I think it would be very helpful to hear from the experts 
so that we can better understand what happened and where we can 
go from here. Specifically, to what degree were there 
difficulties in what is one of the best VA hospitals in this 
system, which is in Philadelphia, what was done about it, and 
where we can go from here. So thank you, Mr. Chairman.
    Mr. Mitchell. Thank you. I ask unanimous consent that all 
Members have 5 legislative days to submit a statement for the 
record. Hearing no objection so ordered.
    At this time I would like to welcome Panel One to the 
witness table. Joining us on our first panel is Dr. Gary Kao, 
Associate Professor in the Department of Radiation Oncology at 
the University of Pennsylvania. Also joining us is Dr. Steven 
Hahn, Professor and Chair of the Department of Radiation 
Oncology, University of Pennsylvania; Michael Bieda, Clinical 
Chief in the Division of Medical Physics, Department of 
Radiation Oncology, University of Pennsylvania. Mr. Bieda is 
accompanied by Dr. Greg Desobry, Medical Physicist, Division of 
Medical Physics, Department of Radiation Oncology, University 
of Pennsylvania; and Dr. George Lazarescu, Medical Physicist, 
Division of Medical Physics, Department of Radiation Oncology, 
University of Pennsylvania.
    I ask that all witnesses please stay within 5 minutes for 
their opening remarks. Your complete statements will be made 
part of the hearing record.
    At this time I would like to recognize Dr. Kao, then Dr. 
Hahn, and Mr. Bieda for up to 5 minutes each.
    Dr. Kao.

  STATEMENTS GARY D. KAO, M.D., PH.D., ASSOCIATE PROFESSOR OF 
     RADIATION ONCOLOGY, DEPARTMENT OF RADIATION ONCOLOGY, 
 UNIVERSITY OF PENNSYLVANIA, SCHOOL OF MEDICINE, PHILADELPHIA, 
  PA; STEPHEN M. HAHN, M.D., HENRY K. PANCOAST PROFESSOR AND 
    CHAIR, DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF 
PENNSYLVANIA, SCHOOL OF MEDICINE, PHILADELPHIA, PA; MICHAEL R. 
   BIEDA, M.S., CLINICAL CHIEF, DIVISION OF MEDICAL PHYSICS, 
 DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA, 
SCHOOL OF MEDICINE, PHILADELPHIA, PA; ACCOMPANIED BY GREGORY E. 
DESOBRY, PH.D., MEDICAL PHYSICIST, DIVISION OF MEDICAL PHYSICS, 
 DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA, 
  SCHOOL OF MEDICINE, PHILADELPHIA, PA; AND GEORGE LAZARESCU, 
    PH.D., MEDICAL PHYSICIST, DIVISION OF MEDICAL PHYSICS, 
 DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA, 
              SCHOOL OF MEDICINE, PHILADELPHIA, PA

             STATEMENT OF GARY D. KAO, M.D., PH.D.

    Dr. Kao. Thank you, Congressman Mitchell and other Members 
of the Subcommittee for the opportunity to appear before you so 
that we may be heard on this important subject matter and 
correct some very serious false allegations that have appeared 
in the media recently about me and the Philadelphia VA 
brachytherapy program.
    I have always worked very hard to best serve the field of 
radiation oncology and my patients in over 15 years of clinical 
practice. My dedication to my work is reflected in my 
educational achievements earning a bachelors degree in 
philosophy and a medical doctor degree from the John Hopkins 
University and its School of Medicine, followed by medical 
internship and residency, and completion of residency in 
radiation oncology at the University of Pennsylvania School of 
Medicine. This culminated in board certification in Radiation 
Oncology. I further earned a second doctorate, a Ph.D., in 
researching better ways of treating cancer.
    I am especially proud that during continuous clinical 
practice of medicine for over 15 years I have not had a single 
malpractice claim filed against me. My record and my commitment 
to the care of my patients make the false allegations against 
me and the brachytherapy program particularly devastating and 
misguided.
    I, along with others at the VA, implemented the program for 
brachytherapy in 2002 to best serve the interests of veterans. 
Contrary to the allegations that I was unsupervised and we were 
a rogue unit, we developed precise standard operating 
procedures and a system of oversight and monitoring of what was 
then a state of the art treatment for prostate cancer. We 
formulated the first algorithm of any radiation oncology 
procedure at the VA to define the standard operating procedure.
    As would be expected in any new program the brachytherapy 
program was not without its challenges. However, what has 
become clear over the last month is that a fundamental 
misunderstanding of elementary principles and concepts has led 
some to arrive at an inappropriate and incorrect conclusion 
that deficient care was routinely rendered to veterans who 
received brachytherapy in Philadelphia. This was not the case.
    To understand why it is important to understand certain 
critical issues related to the NRC's definition of a reportable 
medical event and its applicability to our work. Here are the 
facts.
    Fact 1: A standard definition of a reportable medical event 
as it applies to brachytherapy was not in existence when the 
program started at the VA. This definition was not referenced 
in my training in brachytherapy at the Northwest Hospital in 
Seattle, nor was it clarified by NRC personnel in their 
investigations in 2003 and 2005 when they were onsite in 
Philadelphia.
    The definition that the NRC has now chosen to retroactively 
apply to all cases of the Philadelphia program is predicated on 
a deviation from D90, the dose received by 90 percent of the 
prostate, but this is a definition that does not appear 
anywhere in the regulations published by the NRC.
    It should also be noted that there is disagreement within 
the medical community regarding the appropriateness of D90 as a 
defining metric for overall efficacy of the treatment.
    Fact 2: The definition of a reportable medical event as it 
applies to brachytherapy is not only unclear, but it is 
evolving. The Medical Advisory Committee of the NRC has 
repeatedly recommended that the definition be changed from one 
that is dose-based to one that is activity-based, in other 
words, in the number of seeds. Last summer, the NRC proposed a 
rule to change the definition, but the NRC is still using the 
old unpublished definition to judge the Philadelphia VA's 
brachytherapy cases.
    Fact 3: Even if a reportable medical event using the D90 
based metric occurred, this does not mean the treatment failed 
the standard of care.
    For example, the treatment of an unusually large prostate 
may result in a D90 that is under-dosed or a treatment of a 
small prostate may result in a D90 overdose, but in both cases 
the treatment could still be appropriate and effective in 
eradicating the cancer.
    Fact 4: Whether treatment delivered has been consistent 
with the standard of care should not be determined by whether 
the treatment resulted in a reportable medical event to the 
NRC.
    There are many more significant factors that determine 
appropriate treatment such as number of seeds; location of the 
seeds in a prostate; location of seeds outside the prostate; 
concentration of seeds to the affected area of the prostate; 
stage, grade, extent and location of the cancer; and the 
clinical follow up of prostrate-specific antigen (PSA) test 
results. None of these factors are addressed by the NRC.
    I also wish to address the now oft-repeated reference to 92 
botched cases. This characterization is simply wrong. It is 
unfair and extremely misleading. A case that meets the NRC 
definition of a reportable medical event does not mean the 
patient received ineffective or botched care. The efficacy of 
the treatments is evidenced by the fact that there had been no 
confirmed cases of tumor recurrence by the time the program was 
terminated, with many patients doing well up to 5 years after 
their treatment.
    Furthermore, the NRC review, which allegedly resulted in 92 
reportable cases, was determined through a re-analysis of our 
data without our participation. This participation would have 
been essential, since it is well recognized among radiation 
oncologists that prostate contouring is very subjective and 
volumes can vary substantially depending on who does the 
contouring. Because of this variability, the D90 dose 
calculated by different reviewers can vary by as much as 60 
percent. The calculations that we performed indicated that the 
number of patients with D90 lower or higher than 20 percent 
were far fewer than 92 cases. I do not believe that even with 
the use of a D90 base metric there are close to 92 reported 
cases.
    Brachytherapy is a relatively new and evolving field. While 
I recognize that certain conditions and circumstances at the 
Philadelphia VA could have been improved, but I remain 
confident based on my knowledge of the field and the nature of 
the patients that we treated that the patients received 
appropriate medical care and which was effective.
    I hope that through my statements and testimony I am able 
to contribute to a fuller understanding of brachytherapy 
treatment, but also bring a degree of reassurance to our 
veterans regarding the treatment that was provided, and 
ultimately improve the care for our veterans. Thank you.
    [The prepared statement of Dr. Kao appears on p. 48.]
    Mr. Mitchell. Thank you. Dr. Hahn.

               STATEMENT OF STEPHEN M. HAHN, M.D.

    Dr. Hahn. Yes, sir.
    Mr. Chairman and Members of the Subcommittee, I am grateful 
for the opportunity to appear before you here today.
    I am a professor of radiation oncology at the University of 
Pennsylvania, and since 2005 have been chair of the 
University's Department of Radiation Oncology.
    Before going any further I want to express my deepest 
regret that prostate cancer patients receiving brachytherapy at 
the Philadelphia VA Medical Center did not in every instance 
receive the best possible care. My highest priority as a 
physician and as chair of the Department of Radiation Oncology 
is to make sure that patients do indeed receive the best 
possible care.
    I want to personally apologize to the patients and their 
families for the distress that this has caused. I also know 
that the entire experience has been very difficult for the VA 
health care system, particularly in Philadelphia, as it has 
been for my department.
    Penn Medicine's relationship with the VA is long standing 
and we value it greatly. It is very important to our mission as 
an academic medical center dedicated to patient care, teaching, 
and research. We value this work and we believe that both of 
our organizations have learned a great deal from this painful 
experience.
    I will focus most of my testimony today on the steps we 
have taken in the last year in response to this situation and 
the process improvements we have implemented at Penn that we 
believe will improve the quality of care.
    The University's Department of Radiation Oncology, through 
a contract with the VA, provides radiation services, including 
brachytherapy. Radiation oncologists working at the VA are 
either directly employed by the VA or Department faculty 
provided under the contract.
    When the Department first learned in May of 2008 of 
potential concerns about the prostate brachytherapy program at 
the VA we took immediate action. The Department provided 
several faculty Members and staff to the VA to assist in its 
quality review of all prostate brachytherapy cases.
    In June 2008, when concerns arose regarding Dr. Kao's cases 
in particular, Dr. Kao agreed, at my request, to suspend his 
clinical practice, and he has not treated any patients since 
that time at the VA or at our hospitals.
    Since last summer, Departmental faculty, as part of their 
responsibilities at the VA, have been coordinating patients' 
follow-up.
    In addition, since the VA and the NRC began investigations 
into this matter in June 2008, we have cooperated fully, and we 
will certainly continue to do so.
    In June 2008, we also reviewed quality control and 
improvement measures to enhance them and to prevent a situation 
like this from ever happening again.
    We have adopted an additional review process that provides 
for patients who did not take part in the original 
brachytherapy procedure to assess its quality by reviewing the 
Computerized Axial Tomography (CT) scan and recalculating the 
delivered dose.
    We also have established a multi-level internal reporting 
system so that even a slight anomaly will be reported to our 
quality assurance (QA) Committee.
    Another notable development for us is that at Penn we 
recently completed the transition to a new treatment approach 
called ``real-time dosimetry,'' a technology that provides for 
instantaneous feedback about dose to the attending physician. 
We believe this approach should enhance our program.
    I do not know if the VA intends to restart its permanent 
prostate brachytherapy program, but if and when it does, we 
would of course be very happy to assist the VA in any way 
possible.
    Our Department's response has also been reviewed by Penn 
medicine quality reviewers and senior physicians. Further, to 
assure ourselves that we have considered every safety and 
quality option, we will be requesting an additional review by 
outside experts.
    Before closing, I want to briefly address NRC regulations, 
because the NRC, the VA, and the University all share a goal of 
seeing patients receive the best possible care. My hope is that 
we can work with the NRC to clarify the relevant regulations 
which should make early detection even more likely.
    Mr. Chairman and Members of the Subcommittee, I want to 
reiterate that I am sorry for the distress this has caused 
patients and their families. Let me again stress that Penn is 
committed to providing the highest standard of care to our 
Nation's veterans and to work closely with the VA moving 
forward. Thank you.
    [The prepared statement of Dr. Hahn appears on p. 51.]
    Mr. Mitchell. Thank you. Dr. Bieda.

              STATEMENT OF MICHAEL R. BIEDA, M.S.

    Mr. Bieda. Mr. Chairman and Members of the Subcommittee, 
thank you for the invitation to appear here today.
    I would like to use my time to provide you with some 
information about my background, as well as a description of 
the medical physicist's role in prostate brachytherapy. I am 
giving this statement on my behalf, as well as that of my two 
colleagues, Mr. Desobry and Lazarescu.
    In 1996, I was awarded a master's degree in physics from 
the University of Tennessee, and in 1999 was graduated from the 
master's program in medical physics at the MD Anderson Cancer 
Center at the University of Texas at Houston. Since that time, 
I have worked as a medical physicist at the Johns Hopkins 
University Oncology Center; at Christiana Care Health Systems 
in Newark, Delaware; and at Bryn Mawr Hospital in Bryn Mawr, 
Pennsylvania, in addition to the University of Pennsylvania's 
Department of Radiation Oncology. I worked at Penn from 2002 to 
2005, and then returned in August 2006 to take the position of 
Clinical Chief of Medical Physics for the Department. I am 
certified by the American Board of Radiology in therapeutic 
radiological physics and I have had several publications in the 
Journal of Medical Physics.
    I will describe three things that a medical physicist does 
to assist in prostate brachytherapy.
    First, based on the physician's prescription, which 
specifies the amount of radioactivity implanted into the 
patient, a physicist prepares what is called a ``preplan.'' To 
do this the physicist will review a series of ultrasound images 
of the prostate that is taken by the doctor in which the 
physician has identified the prostate. With this information 
from the doctor, the physicist will plan the places where the 
radioactive seeds will be implanted into and around the 
prostate and estimates the radioactive dose to be delivered to 
the prostate. This plan is always confirmed or potentially 
revised by the doctor.
    Second, not long after the doctor is to perform the 
implant, the physicist will check the activity level of a 
sample of seeds to be implanted and deliver those seeds to the 
doctor in the operating room (OR).
    The third thing a physicist does takes place after the 
implant. At the Pennsylvania VA Medical Center the doctor would 
order a CT scan of the patient's prostate the day after the 
implant. On this CT scan the physicist would identify the 
location of the implanted seeds, using a dedicated computer 
program for this purpose. Once this was done, the doctor would 
locate the prostate on the CT scan and draw it in. This would 
allow the computer program to generate what we call a ``dose 
volume histogram,'' which is essentially a graph showing how 
much of the prostate received how much of the prescription 
dose, as well as different dose parameters. This information is 
often referred to as ``post-implant dosimetry.''
    Post-implant dosimetry is performed so that the doctor 
might evaluate the implant as part of his overall assessment of 
his ongoing treatment plan for the patient.
    I recognize that the Subcommittee may have questions and I 
will do my best to answer them. Again, thank you for your 
consideration of my testimony.
    [The prepared statement of Mr. Bieda appears on p. 53.]
    Mr. Mitchell. Thank you very much. I have a couple 
questions. First of all I want to start with Dr. Kao.
    First, can you please explain the quality of care provided 
at the VA compared to the quality of care at other facilities 
you have worked at.
    Dr. Kao. The brachytherapy procedure that we adopted at the 
VA was identical to the system that was used at the University 
of Pennsylvania and also one of its satellites. And in my 
training, in fact, I went to observe brachytherapy procedures 
performed in art satellite in Trenton, New Jersey, and as a 
resident I was trained in brachytherapy by senior physicians at 
the University of Pennsylvania.
    Mr. Mitchell. What quality of care metrics do other 
facilities follow?
    Dr. Kao. My understanding is that the quality control--the 
quality assurance procedures are similar in that a CT is 
performed after the procedure and the dosimetry calculated from 
that CT.
    Mr. Mitchell. And the last one I have. What markers or red 
flags when conducting the brachytherapy procedures indicated a 
problem?
    Dr. Kao. I now understand that--one of my regrets is that I 
could have been much more assertive in engaging the NRC in what 
it defines as a reportable medical event.
    As a result of their investigation in 2003 and 2005, we 
were under the understanding that the definition of a 
reportable medical event was based on the number of seeds 
laying outside the prostate. Subsequently, I found out that 
that was not the case, that the NRC apparently is now relying 
on a D90 metric, and that is something that to my regret I 
could have been much more focused on using that metric.
    Mr. Mitchell. Mr. Bieda.
    Mr. Bieda. Yes.
    Mr. Mitchell. What do you think could have been done 
differently by the VA that would have prevented us having this 
hearing today?
    Mr. Bieda. Differently compared to Penn, differently 
compared to other hospitals?
    Mr. Mitchell. Differently so we wouldn't have had to have 
this hearing.
    Mr. Bieda. Right. My only, you know, potential thought on 
what could be done differently is to have a stricter peer 
review process by, you know, external physicians not involved 
directly in the cases, that probably could have, you know, 
helped the situation.
    Mr. Mitchell. And this is to either three of you. My 
understanding was that what caused this to become a red flag 
was the under dosage that the patients received. As a result of 
the under dosage what has happened with these patients in terms 
of prostate cancer? Has it come back? Has it been taken care 
of?
    Dr. Hahn. Mr. Chairman, the VA's own internal QA system 
picked up the sort of index situation that led to this 
discovery. And we personally, although we supplied physicians 
for the review of the patients' cases at the VA, this has been 
an internal VA investigation. We would not personally have a 
lot of information with respect to that clinical outcome, sir.
    Mr. Mitchell. One last question. You were called in I guess 
as a radiation oncology to perform this procedure. Who does 
that? Is it a urologist? There are other ways to handle 
prostate cancer. How is it determined that brachytherapy was 
the process to use here? Or do you know that?
    Dr. Hahn. Are you asking me, sir?
    Mr. Mitchell. Anybody there on the panel.
    Dr. Kao. You are correct, Mr. Chairman, patients with 
prostate cancer have different treatments available to them. 
The patient population that we served at the Philadelphia VA 
however was very special in that many of the patients came from 
very far away, from West Virginia, Ohio, upstate Pennsylvania 
for brachytherapy because they could not undergo surgery or 
external beam radiation, you know, due to the lack of these 
treatments back home or because of their individual personal 
situations.
    Mr. Mitchell. Okay.
    Dr. Kao. External beam radiation for instance would require 
8 weeks of daily Monday through Friday treatments, and I had a 
number of patients who for instance were farmers who could not 
afford the 2 months being away from their farm. It would have 
been economically devastating for them.
    Mr. Mitchell. Thank you. Dr. Roe.
    Mr. Roe. I am going to try to put a little English 
translation on all this for the non-medical people in here.
    What happens when you have--let us say you have a PSA that 
is elevated, you do a biopsy and you find a cancer, that cancer 
has a score called a ``Gleason score,'' which goes from zero to 
ten, and they also evaluate the size of your prostate gland, it 
is how big it is, how many cc's of volume does it have. So a 
very large volume prostate gland would not be one you would 
choose to treat with brachytherapy.
    And brachytherapy has really been developed since probably 
the 1970s, and one of my closest friends has been doing this 
actively since 1997, so it is not really new.
    When that diagnosis is made and you have a patient that 
meets the criteria they go to the operating room, they have an 
anesthetic, they have a rectal ultrasound placed in, and they 
have a device placed on the perineum.
    The calculations, and I would like to commend you on your 
choice of undergraduate schools too by the way, UT, the 
physicist has made a pretreatment plan. These seeds then under 
direct ultrasound guidance are placed. And the way--and I will 
let the physicist explain this a little closer in a minute--the 
way these calculations are made there is a thing called the 
``inverse square law'' and I won't go through all of that, but 
basically on where the seeds are, you can calculate how many 
grays or how many reds of therapy are given to a specific spot, 
and then the patient has a CT scan at some point after the 
procedure is over and they are able to look and he would make 
this calculation that yes, the dosimetry is right and he would 
know how many grays are required to kill a cancer cell that is 
fairly slow growing, let us say of a Gleason score of five.
    The problem that came up with the placement of these seeds, 
and I was looking here, and this may come up later in the 
testimony, but in one particular instance here there were 45 
seeds out of the 70 something that were placed that were not in 
the prostate gland but were in the bladder. So what had 
happened was, and I reviewed some of these diagrams here, that 
the seed placement was not appropriate and it didn't seem to be 
in the prostate. It was not in the prostate gland. And, 
therefore, when that happened, when the calculation was made 
afterward the dosimetry was not correct for the treatment of 
the disease. Am I right on that, Dr. Hahn?
    Dr. Hahn. Yes, correct.
    Mr. Roe. And would you either Dr. Kao or Dr. Hahn, one of 
you, discuss on placement of the seeds, because that is 
absolutely critical. And what the Chairman brought up is 
sometimes a radiation oncologist does that, sometimes a 
urologist does that in consultation with the oncologist, and 
sometimes they do it together. So it is not standard. Could you 
comment on placement of the seeds, and is that where the 
problem was?
    Dr. Hahn. So at our institution, Congressman Roe, the 
procedure is typically mostly done by the radiation oncologist 
with some participation by the urologist both in terms of 
identifying the base of the prostate using an ultrasound in the 
OR as you described, as well as perhaps the placement of some 
seeds. The predominant amount of seeds--number of seeds--is 
performed by the radiation oncologist in the operating room.
    Mr. Roe. And to just again further clarify for those, when 
you place this needle in as you bring it out you drop these 
seeds along, but if that needle is not in the prostate gland it 
obviously isn't getting it treated if it is near the rectum or 
if it is in the bladder. And I asked my colleague, my good 
friend that I have operated with hundreds, if not a thousands 
times, how many seeds that he dropped in the bladder over the 
years in the hundreds of cases that he had done, and he said 
now it almost never happens because of the ability--and it has 
happened in obstetrics ultrasound how refined the ultrasound 
is.
    So I guess I am asking the question, why did that happen? 
Why there were so many seeds placed outside the prostate or the 
dosimetry seemed to be? I think that is why when the 
calculations were made that the dose didn't seem to be proper.
    Dr. Kao. If I could address your question. As Dr. Hahn 
mentioned, the way we do brachytherapy in Philadelphia is in 
conjunction with the urologist. The urologist places the very 
first needle, and needle determines the depth by which all 
subsequent needles fall. So if that very first needle is off, 
as you pointed out, then the subsequent needles may also be 
off.
    The placement of the seeds also depends on the image 
quality. And early in the learning curve in our first few cases 
we did not prep the patients as thoroughly as needed, so if 
there is some stool in the rectum that would degrade the image 
quality of the ultrasound.
    The case that you are referring to, sir, I believe is one 
of the cases that resulted in an NRC investigation. We 
implemented several measures after that first case to help 
ensure that this situation did not arise again.
    Mr. Roe. Thank you, Mr. Chairman, I will have further 
questions later.
    Mr. Mitchell. Thank you. Mr. Adler.
    Mr. Adler. Thank you, Mr. Chairman. I guess my first 
question is for Dr. Kao. We have heard about the closure of 
this program in June of 2008. We have heard about possibly 92 
cases out of 116 with some concern. Some of us use the word 
``botched,'' you don't like that word. We have heard that the 
National Health Physics Program reported to NRC at least 35 
medical events later in 2008. We heard Dr. Hahn just now 
acknowledge on behalf of UPenn that not in every instance did 
every patient get the best possible care. This program is still 
closed. You were running this program. You were the principal 
operator of this program at the VA in Philadelphia.
    How do you reconcile your view in your own testimony here 
today that patients received appropriate medical care with the 
VA's view that it made mistakes during this period of years 
with UPenn's recognition that not every patient got the best 
possible care, with NHPP and NRC saying there are medical 
events even in a context where we probably don't define medical 
event sufficiently to trigger reporting to the extent probably 
we would want reporting? So let us assume there is some under-
reporting going on. Even with under-reporting we have at least 
35 instances from 2008 reported about over a period of time a 
program you ran.
    I am thinking you are in a dream world right now. I am 
thinking everybody else, all the other experts are looking at 
this and saying it didn't go well enough, that whether the 
number is 92 or some less than 92 we want the number to be zero 
botched cases.
    How do you reconcile your view that every patient received 
appropriate medical care with a view of every other expert, 
every potential supervisor, every contracting body, every 
regulatory body? I kind of want to hear you acknowledge you did 
things less well than you would have wanted to have done.
    Dr. Kao. Sir, I don't disagree with many of the other 
comments that were made. Medicine is both an art and a science, 
and the art of is it that even though the treatment may be 
effective it may be made to be even more optimal.
    A central theme here is what is defined as a reportable 
medical event. And a case that is a reportable medical event 
does not mean that the patient was harmed or did not receive 
effective treatment.
    When the program was closed in 2008, we did not have any 
confirmed cases of tumor recurrence. The NRC itself recognizes 
that a reportable medical event does not mean that it does not 
address the efficacy of the treatment.
    So in summary, I recognize there are many things--several 
things that I could have done better, but I still believe that 
the patients received the standard of care that was in place at 
the time.
    Mr. Adler. I am just seeing it differently than you are I 
guess.
    I understand from some news reports that it was at least a 
period of a year where you were not getting post-implant 
dosimetry information to gauge whether the patients had had the 
seeds placed properly and the seeds had stayed where you wanted 
them to be. Is it true that there was a year when you did not 
have that sort of post-implant dosimetry information?
    Dr. Kao. It is true that for a period of about 14 months 
there was a computer interface problem at the VA, that although 
the CTs that could be performed after the brachytherapy, but 
that data could not be transmitted to the workstation used to 
calculate the doses.
    During that time I followed the chain of command. I 
complained to radiation safety, to the Chief of the VA 
Radiology Oncology Department, and other Members of the program 
did the same, but this problem was never fixed.
    I was then faced with the very difficult choice of either 
stopping the program, but if I had done so then the patients 
would not have received any care. As I mentioned earlier, many 
of the patients who came to us did not have surgery or other 
forms of radiation as a choice. So given the choice between 
delivering no care and having their cancers progress or to go 
ahead and perform the procedure I made that decision.
    I could still see from the CT that the seeds were in the 
prostate and I could judge that the seeds were concentrated 
around the part of the prostate where the cancer was located. 
So these gave me a measure of confidence that the patients were 
being appropriately treated. But it is, you are correct, sir, 
that is one of my regrets that I should have broken the chain 
of command, I should have been more assertive, I should have 
stopped the program at that point.
    Mr. Adler. Well what number would you say is the number of 
patients who didn't get adequate care? The total you did was 
116, of that number what would you say? I have heard numbers, 
57, 35, and 92. What number would you say was the number?
    Dr. Kao. Sir, since 2008, I have not had access to the 
patient records, but I believe based on the calculations that 
our team performed before it was shut down that the cases were 
far fewer and probably closer to 20 cases that were reported--
that were defined as medical events. But again, a case that is 
defined as a medical event does not mean that the treatment was 
not effective, sir.
    Mr. Adler. Dr. Hahn, let me ask you. What lessons can UPenn 
take away from the situation and what sort of failures of 
oversight would you say were present from a UPenn perspective?
    Dr. Hahn. I think that we and our partners at the VA both 
would agree that there are many lessons that we have learned 
and will continue to learn from this very painful episode. And 
let me just say even if it were just one human being who did 
not receive the best possible care, Congressman Adler, that 
would be unacceptable.
    When we became aware of the allegations in June of 2008, we 
did a review of quality assurance and peer review, and we 
determined that they certainly could be improved. And as I 
mentioned in my statement, but not in great detail, we did 
institute a number of measures to allow for that improvement, 
including the oversight of each brachytherapy case that is 
performed by outside health care team Members within the 
Department but who didn't perform the procedure who will review 
the CT as well as the dosimetry to give another level of 
review.
    We have also instituted a system whereby the reportable 
events to the Department's leadership are such a low threshold 
such that even a slight anomaly would be reported giving us the 
opportunity to capture everything.
    We have also, in partnership with the VA, instituted a 
Department-wide system for reporting levels of toxicity. This 
uses clinical outcomes. If we detect severe or unexpected 
toxicities, it triggers presentation of what we call our 
morbidity and mortality conference where people inside and 
outside of the Department review those toxicities.
    And then this other issue of real-time dosimetry, which 
allows us to see the needle go in and see the dose in real-time 
with instantaneous feedback.
    We feel that these measures are prudent certainly, and that 
they will and should prevent similar occurrences from occurring 
in the future.
    Mr. Adler. Thank you, my time has expired. Mr. Chairman.
    Mr. Mitchell. Thank you, Mr. Walz.
    Mr. Walz. Well thank you again, Mr. Chairman, and I want to 
thank all of our witnesses for being here, and as I always say 
there is no doubt that everyone in this room wants the best 
care for our veterans, that is an absolute given. And I also 
say that it is a zero sum game, so I agree with you, Dr. Hahn. 
And I think talking about this there is a human face on this. 
There is Pastor Flippin and his story that was told. We keep 
that in mind.
    I also want to though note, and my colleague from 
Pennsylvania I think started hitting on this, that your 
willingness to come here today and answer questions openly is 
truly appreciated, and it is very obvious that your sense of 
concern on this is very real, and I am very appreciative of 
that. Because all too often we get caught up in the legal 
barriers that people are unwilling to try and fix this, and it 
is imperative that we get this right.
    So with that being said, I also want to thank Dr. Roe, he 
is always very helpful for me to understand the medical side of 
this. My postgraduate work was in systems analysis, so that is 
the part that I am most concerned about, and it seems that many 
times we keep coming back to that of looking at these things to 
see if they are not just isolated incidents, but if there are 
things--and building on what Mr. Adler was talking about--a 
couple of questions I have had.
    We have recently had the questions that come up here, 
improperly sterilized equipment, and we are asking where best 
practices fall. And something as simple as a checklist for who 
last cleaned the equipment, none of that was available.
    So one of the red flags I think in this whole thing that 
came up for me was listening to people talk about the lack of 
peer review involved in this. And many, and I think it was Dr. 
Welch who commented, in all of his medical practice he has 
never seen such a lack of peer review in the process that was 
happening.
    Can one of you comment on that of do you think that is true 
in the radial--the oncology here at VA as it stood in 
Philadelphia? Was there a severe break down in peer review, 
which is meant to be there as a safeguard? Can anyone comment 
on that?
    Dr. Hahn. Congressman Walz, there was peer review in place. 
Brachytherapy represents about 5 percent of the treatments that 
we give, and there is peer review for both external beam as 
well as all the treatments that are given. I think Congressman 
Walz, there is no question in our mind that when we looked back 
at the peer review processes, and I think it was the first 
process that we implemented--process change--that being 
dependent upon the local treatment team in and of itself to 
report quality issues without having a secondary look by 
external physicians and physicists was something that needed to 
be improved, sir.
    Mr. Walz. Would it be your experience, Dr. Hahn, that this 
same lack of peer review in the beginning or not strong enough 
is happening at other VA Medical Centers? The reason I ask this 
is, is the one nearest to me in Minneapolis that also practices 
this technique has not had--they are reporting zero medical 
events in this.
    And I want to be very clear on this, one of the things that 
gets highlighted on this is we don't know at private practices 
if this is happening because there is no reporting, so I think 
that needs to be kept in mind. Because I am wondering across 
our entire health care system outside the VA it is hard to make 
those comparisons. But inside the VA are there different peer 
review standards at different institutions as far as you know?
    Dr. Hahn. Congressman Walz, I wouldn't know the answer to 
that question at other VA institutions. I can tell you that at 
Penn across our own institution our processes were the same for 
all the patients that we delivered care to both at the 
satellites outside facilities and at Penn, and again, this 
provided us with an opportunity to look at our processes 
because we do uniformly apply them and to make sure that they 
get better constantly.
    Mr. Walz. Should this be something in your opinion, Dr. 
Hahn, on these things, and it comes up again, it is very 
similar to the question on the unsterilized equipment in the 
last hearing, should there be stronger standards set across the 
VA system, or do you still need to allow the Veterans 
Integrated Services Networks (VISNs), do you need flexibility 
on this for best practices, or is there a uniform best practice 
in this process that could have been set, followed, and that is 
it?
    Dr. Hahn. Well I think my esteemed colleague Dr. Lee will 
speak to some of these issues in the next panel, but I think 
that if you look at practice guidelines for brachytherapy, the 
consistency and application of those sort of guidelines would 
be very helpful, and I think we have learned a lot of this 
across medicine. You probably know better than I in terms of 
processes that standardization is often a very helpful thing 
with respect to ensuring quality.
    Mr. Walz. Very good. My last question, and this is to all 
of you as again a charge that was made, and I again want to 
make sure and I think it has been pointed out, that this is 
about improving the process not about finding fault.
    But the one thing was there was a comment made by Darrell 
Wideman I believe it is, senior health physicist for the 
Nuclear Commission that said, ``There was far too much trust 
put in contractors, that the VA said we hired the best, we went 
to a well-regarded team and we just turned over and capitulated 
our responsibility.''
    Can you comment on that? I know it is a little bit--I am 
going to ask each panel this or try and get that out. Being the 
contractors involved in this do you think there was a sense of 
that, that it is you guys do it and that is where it sets?
    Dr. Hahn. Congressman, I think one of the things, and I 
agree with you sort of what we learned about this and we sensed 
this--and I don't want to speak for the VA--but we sensed this 
as a joint responsibility of oversight, and sometimes when 
there is joint responsibility there is lack clarity and 
definition, and so I think there is plenty food for thought for 
us for all on this. And I really welcome the opportunity to 
work with the Philadelphia VA to provide clarity surrounding 
that.
    Mr. Walz. Well I appreciate your candidness and I yield 
back. Thank you, Mr. Chairman.
    Mr. Mitchell. Thank you. Mr. Fattah.
    Mr. Fattah. Thank you, Mr. Chairman. Let me just try to 
clarify one thing before I ask the question. I know that 
Senator Specter tried to do this at the last hearing, so I want 
to make sure we clarify this on the record. Reverend Flippin 
was not your patient; is that correct, Mr. Kao?
    Dr. Kao. He was initially seen by another radiation 
oncologist.
    Mr. Fattah. Right.
    Dr. Kao. But then I did the brachytherapy.
    Mr. Fattah. Okay. So he was in this program, brachytherapy. 
I looked at Google, and it says that one of the normal problems 
that comes up for brachytherapy is seeds outside the prostate 
in the rectum or in other areas.
    My point is that if this is a normal occurrence and this 
happens generally, why are there so few reports by the NRC that 
this is a medical reportable event? And I am speaking in 
generality, across both private and VA, you know, if it is 
happening regularly and nobody is reporting it then there seems 
to be a more system-wide problem that we may want to attend to 
that is well beyond the VA.
    Dr. Kao. Yes. As I testified last month at the panel, sir, 
that you were on, the definition of a reportable medical event 
is evolving, and it is likely that many practitioners are not 
aware of it or apply it. The Medical Advisory Committee to the 
NRC one Member, Dr. Nag, estimated that applying the current 
definition of a reportable medical event there should be 20,000 
reported cases, and this definition is, therefore, changing. So 
it is still not quite settled what constitutes a reportable 
medical event I think for most practitioners.
    Mr. Fattah. And how many were reported? If the NRC's 
medical advisor felt there should be 20,000, how many were 
reported across the country?
    Dr. Kao. Sir, I do not know.
    Mr. Fattah. Okay, all right. Now the program at a number of 
the VA centers, four of them have been closed down, including 
Philadelphia. So patients who were being treated, and I think 
you said that none of these tumors have re-emerged, where are 
they now being treated if they need this service?
    Dr. Kao. Our program made the decision early on that after 
the brachytherapy the patients could return back to their 
doctor that took care of them from where they were located. And 
that is one of my regrets is that we should have--we could have 
mandated that they come back to Philadelphia for follow up.
    In the case of Reverend Flippin, as I testified last month, 
I wasn't notified that he had developed problems. I wish I was, 
I could have done something about it.
    And so that is one of the recommendations that I had 
proposed in my written detailed testimony to the Committee that 
the VA could institute a system by which any patient that 
develops a problem that the original treating physician could 
be notified, and perhaps that would have prevented something 
like what happened to Reverend Flippin.
    Mr. Fattah. Well is it, and let me ask the Chair of the 
Department since, Penn has been treating people both in the VA 
and outside of the VA, you know, privately, right? Now again, 
when you research this on the Web it says that seeds going into 
the rectum or you know going outside the prostate is one of the 
problems that arises with this type of procedure, right? When 
patients have these challenges, is someone notified at the NRC? 
Are we reporting this as a medical noteworthy event or where 
are we at in this process now? I assume even though the VA 
program is shut down, Penn is continuing to provide this 
service to the patient.
    Dr. Hahn. Once we put our process improvements in place in 
the real-time dosimetry program yes, we recently did restart 
our prostate brachytherapy program, Congressman.
    Mr. Fattah. All right.
    Dr. Hahn. And I think Dr. Lee in his written testimony has 
written about many of the standards that the NRC, particularly 
with respect to dose, that the NRC has in its regulation.
    I can't speak per se to the VA and its reporting mechanism 
since it is a separate hospital and has a separate regulatory 
reporting. I will say in light of that, that the standard that 
has been applied to these cases is one that is in our belief 
complex and controversial, and is not----
    Mr. Fattah. Is that because the 90D fluctuates up to 60 
percent either way? So you are saying 90 percent of the dose 
should have been inside the prostate and it could fluctuate by 
a wide variance?
    Dr. Hahn. There can be some variation, yes, Congressman. 
And that standard or that criteria that has been recently 
applied isn't universally accepted by all the experts in the 
field.
    I think this goes back to the original comment that I had 
made, Congressman, about the fact that we would all very much 
welcome further clarification with respect to that. And the 
other part is that sort of distinction between a medical 
reportable event and clinical significance and outcome.
    Mr. Fattah. Right. Well, the main thing about prostate 
cancer is you don't want to get it, but if you want to get it 
you want to get treated, and we have a great difficulty getting 
men to get treated, to get checked out. So I want to make sure 
that we are careful here as we proceed when we have a treatment 
that--in this instance tumors didn't reemerge, and yes there 
was some discomfort. I read on Google that discomfort in the 
rectum or seeds in the rectum it is a very common occurrence in 
this procedure, right? So I want to make sure that we are not 
sending the wrong message to men in that we create a situation 
where they don't proceed with getting effective treatment that 
could save their lives.
    Dr. Hahn. Congressman, I think that is a really important 
point, and sir, I would like to sort of emphasize the fact that 
radiation therapy, despite the issues here, is a highly 
effective therapy for prostate cancer, and in the appropriate 
patients that is indeed the case.
    Mr. Mitchell. Thank you. I would hope that since University 
of Pennsylvania is a teaching hospital and research that what 
you have learned from this gets put into the appropriate 
journals, gets distributed to every urologist and everyone. I 
would think this would be a great source of information for 
other people doing the same thing.
    If the panel would indulge me I would like to call on Dr. 
Roe, he had a couple more questions.
    Mr. Roe. Just a couple things quickly. When you do this 
procedure you know, and I may be talking to the physicist, but 
we know what adequate dosimetry is, I mean that is a 
calculation, if you go below that level you know that you 
haven't received what we would consider adequate. That is 
fairly well determined, correct?
    Mr. Bieda. It is determined to the extent that the prostate 
can be defined on the imaging modality, in the case, CT. So it 
is well defined mathematically and algorithmatically, but there 
is some subjectivity because of the ability to clearly image 
the prostate, particularly in post-implant dosimetry.
    Mr. Roe. I know there is an art to it too, I certainly 
understand that.
    Mr. Bieda. Yeah.
    Mr. Roe. When you would see a pattern like this though, I 
was looking at these images last night, this being the prostate 
gland, these little green things here are the seeds, when you 
look at that the next day when you do the CT, some do it a 
month later, I think Duke does it a month later and looks at 
the dosimetry, I mean that would be a cause of concern when you 
would have a pattern that looked like that wouldn't it?
    Mr. Bieda. Yes, that would be a cause of concern, but what 
you have to understand is what you are visualizing there is a 
3-D rendering, that red object is the physician's, I would 
almost say best guess, at the contour of the prostate. You 
know, it is a dramatic diagram for sure, but it doesn't 
necessarily tell the whole story just because of the 
subjectivity of imaging the prostate.
    Mr. Roe. I mean, you would be like me----
    Mr. Bieda. Yeah.
    Mr. Roe [continuing]. You would be a whole lot happier if 
it looked like that.
    Mr. Bieda. Yes.
    Mr. Roe. I mean, I know I would be if that were my prostate 
and you had put seeds in it or radioactive iodine or palladium 
or whatever you used, I would be happier with that one.
    Mr. Bieda. I would.
    Mr. Roe. I guess the other question I had was why was it--
Dr. Kao's issue is that what was the problem with getting the 
dosimetry results back? And I guess I have confusion with that. 
Why was that so hard?
    Mr. Bieda. That was so hard simply because there was a 
roadblock in terms of an information technology (IT) issue at 
the--you know--at the VA. And to get these images into our 
system to do that full analysis was deemed to be nearly, you 
know, pretty much impossible, and we knew that the physician 
was reviewing the CTs, they just weren't able to get it into 
the system where the full analysis could be done.
    Mr. Roe. I would think that would be a system breakdown, I 
believe, and I think Dr. Kao is right about that, to be able to 
get that information.
    I know Congressman Walz is gone, but where we are at our 
university and in our tumor registry, we register every tumor 
patient and they are followed so you will know. I don't know 
what kind of follow up we had on these veterans or not, but in 
most places there is a tumor registry, there is a follow up, 
there is a follow up form. Has that been done for the veterans 
that have received this treatment? Dr. Hahn or Kao or whoever 
can answer that.
    Dr. Kao. I don't know the answer, sir.
    Mr. Roe. Not to interrupt, my time is about out, but that 
is critical, because you don't know what you are doing if you 
don't know what your patients are doing, so we register all 
ours on a tumor registry and follow those folks, have a method 
to do that. Congressman Fattah was right on the money, are 
these folks--how are they doing, what is the outcomes? And you 
can't say they are doing all right if you don't follow them, so 
that is a system break down.
    And I think that just to follow up, brachytherapy is an 
effective treatment for prostate cancer. My friend that I work 
with a lot said he had patients that could go out and golf in 2 
or 3 days after this so men won't be afraid to get that 
therapy. It is a good effective therapy when done 
appropriately.
    Thank you, Mr. Chairman, I yield back.
    Mr. Mitchell. Thank you. Does anyone else want to follow up 
before we go to the next panel?
    Mr. Adler. Maybe just one. I heard the colloquy between Dr. 
Kao and Congressman Fattah about sort of the art of 
brachytherapy that maybe not all the radiation seeds get to the 
prostate, that some of them may drift out to other parts around 
the prostate. What percentage of the seeds should end up in the 
prostate? If you have 100 percent of the seeds going in what is 
the percentage that should be ending up in the prostate for the 
art to be effective science? Because I guess what I am hearing 
is maybe a third sometimes drift around, half of them may get 
here or there. I would think that most of them should be ending 
up in the prostate if in fact the tumor you are addressing is 
in the prostate.
    Dr. Kao. That is correct. Most of the seeds should be in 
the prostate. However there are situations where it may be 
advantageous to have seeds actually outside the prostate. The 
prostate is a pear-shaped gland with a pointy end pointing 
down. If you have a cancer that is located in this apex of the 
prostate the seeds in the prostate alone may not be sufficient, 
so in that case you may intentionally want to place some seeds 
outside the prostate, which can then contribute radiation to 
treat that special location. So it depends on the location of 
the cancer and the extent.
    We are very careful to restrict brachytherapy to patients 
that only had a very early stage non-aggressive form of 
prostate cancer, sir.
    Mr. Adler. Thank you, I yield back.
    Mr. Mitchell. Mr. Fattah, do you have any other questions 
of this panel?
    Mr. Fattah. No, let me just thank the panel for their 
lifetime of study of this issue of cancer, it is a major 
challenge to our health in our country today, and prostate 
cancer is something that for veterans is a major issue, and in 
the African American community, particularly among African 
American males prostate cancer is a tremendously devastating 
disease. So I want to thank them for their studies and their 
work, and I think that as we go forward we want to see that we 
can make this an even more perfect process at the VA and 
outside the VA. Thank you.
    Mr. Mitchell. Thank you. And I would like to excuse the 
panel and thank you for your service and thank you as Mr. 
Fattah said for the research that you are doing.
    At this time I would like to welcome Panel Two to the 
witness table. From our second panel we will hear from Dr. 
Robert Lee, Professor in the Department of Radiation Oncology 
at Duke University testifying on behalf of the American Society 
for Radiation Oncology (ASTRO); Dr. Paul Schyve, Senior Vice 
President for Health Care Improvement at The Joint Commission; 
and Steven Reynolds, Director of Division of Nuclear Materials 
Safety Region III, U.S. Nuclear Regulatory Commission. Mr. 
Reynolds is accompanied by Dr. Charles Miller, Director of the 
Office of Federal and State Materials and Environmental 
Management Programs, U.S. Nuclear Regulatory Commission.
    Dr. Lee, before you begin your testimony I believe there 
are some slides that we are going to view and I would like for 
you to comment on the slides you find acceptable and the slides 
that are unacceptable in your professional medication.
    Before I begin I just want to say to Dr. Lee, Dr. Schyve 
and Mr. Reynolds, you have up to 5 minutes for your testimony 
and all of what you would like to say will be entered in the 
record. Dr. Lee.
    Dr. Lee. So a quick question, my comments on the slides and 
images----
    Mr. Mitchell. Will not be part of your other testimony.
    Dr. Lee. Thank you.
    Mr. Mitchell. Yeah.
    Dr. Lee. You want me to comment on the image in front of 
me?
    Mr. Mitchell. We don't have any.
    Dr. Lee. I think I see it but no one else does.
    Mr. Mitchell. Okay, we have just an IT problem, maybe we 
will move onto the next witnesses and come back to it. Okay. 
Dr. Schyve.

STATEMENTS OF PAUL M. SCHYVE, M.D., SENIOR VICE PRESIDENT, THE 
  JOINT COMMISSION; STEVEN A. REYNOLDS, DIRECTOR, DIVISION OF 
  NUCLEAR MATERIALS SAFETY REGION III, UNITED STATES NUCLEAR 
REGULATORY COMMISSION; ACCOMPANIED BY CHARLES L. MILLER, PH.D., 
      DIRECTOR, OFFICE OF FEDERAL AND STATE MATERIALS AND 
   ENVIRONMENTAL MANAGEMENT PROGRAMS, UNITED STATES NUCLEAR 
 REGULATORY COMMISSION; AND W. ROBERT LEE, M.D., M.S., M.ED., 
 PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY, DUKE UNIVERSITY, 
   SCHOOL OF MEDICINE, DURHAM, NC, ON BEHALF OF THE AMERICAN 
                 SOCIETY FOR RADIATION ONCOLOGY

               STATEMENT OF PAUL M. SCHYVE, M.D.

    Dr. Schyve. On behalf of The Joint Commission, thank you 
for the opportunity to testify at this important hearing. The 
Joint Commission's accreditation of Department of Veterans 
Affairs' hospitals strives to assure that our Nation's veterans 
are receiving high quality and safe care. The accreditation 
process reduces risks to patients through periodic unannounced 
on-site surveys of each hospital and feedback to the hospital 
of required improvements. However, no oversight process can 
entirely eliminate risk in health care, which has all the 
characteristics identified in other high risk endeavors, 
including complexity and heavy dependence on human 
intervention. By studying high risk endeavors that have 
developed enviable safety records, health care is learning how 
to become a high reliability endeavor.
    The first step is the development of evidence-based 
standardized policies and procedures, educating personnel in 
their implementation, making them available as memory aids to 
facilitate their use, and monitoring whether they are followed. 
However, in health care unexpected adverse events will still 
occur despite the best policies and procedures.
    To create high reliability requires three additional 
components. First, constant attention to things that go wrong 
in order to learn how to prevent them. But people will only 
report adverse events in an atmosphere of trust in which they 
are encouraged to report and their reports are acted upon.
    Second, prospective risk identification and prevention 
whenever new processes are planned or existing processes 
changed. Patients can be protected from harm by redesigning the 
proposed processes to eliminate the risk or building in 
protections for patients when the risk cannot be eliminated.
    And third, a culture of safety. In a ``culture of safety,'' 
safety is always on everyone's mind. There is preoccupation 
with the possibility of failure, a sensitivity to the detail of 
operations, and constant vigilance for unexpected events. 
Because, in complex processes such as those in health care, 
even small events can led to big, sometimes disastrous 
outcomes.
    Unfortunately, no oversight body can identify all the risks 
or breakdowns in a hospital, nor create the cultures of trust 
and safety needed for high reliability. Only the hospital 
itself can. The oversight bodies can set expectations, provide 
guidance, educate, and evaluate in order to enable and 
incentivize the hospital to make this change.
    To that end, The Joint Commission has established standards 
that require the hospital to create a culture in which adverse 
events are reported and evaluated for underlying causes and 
preventative actions are taken; to identify high-risk processes 
and prospectively determine their possible modes of failure, 
the effects of those failures, and the actions that will 
prevent the failures or mitigate their effects; and to 
establish a culture of safety throughout the hospital. This 
last accreditation requirement became effective January 1st, 
2009.
    With respect to brachytherapy, when the Joint Commission 
surveys a hospital the surveyors examine the radiology imaging 
services and, if the hospital provides it, its oncology 
service. However, a hospital may provide a brachytherapy 
service that, because it is usually a low volume, specialized 
service within the radiation oncology or other department, may 
not be reported to the surveyor and therefore may be unknown to 
the surveyor.
    In addition, brachytherapy is highly specialized and 
technical, utilizing the expertise of urologists, radiation 
oncologists, and radiation physicists. Even when its presence 
is known, it is not possible for the surveyor to have the 
specialized technical knowledge to review the effectiveness of 
the dosing schedule for a patient.
    Based on this case, the Joint Commission will instruct its 
surveyors to specifically ask if brachytherapy is provided, 
and, if so, to examine whether the hospital is providing the 
monitoring and peer review oversight that brachytherapy 
requires. And beginning this year, the surveyors are evaluating 
what the hospital's leaders are doing to create a culture of 
safety in their hospital.
    The Veterans Health Administration (VHA) central office has 
been a leader in learning from adverse events in its hospitals, 
in disseminating that knowledge to other hospitals in its 
system, and in openly discussing with the Joint Commission the 
events and what they have learned. They have also focused on 
creating a culture of safety in their hospitals.
    The Joint Commission's goal is to assist both the Veterans 
Health Administration and its individual hospitals to make this 
transition. Only by transforming our Nation's hospitals into 
high reliability organizations will health care fulfill its 
obligation to all our Nation's citizens, including its 
veterans, to ``first do no harm.''
    On behalf of The Joint Commission, I would like to thank 
you again for this opportunity to testify.
    [The prepared statement of Dr. Schyve appears on p. 53.]
    Mr. Mitchell. Thank you. Mr. Reynolds.

                STATEMENT OF STEVEN A. REYNOLDS

    Mr. Reynolds. Chairman Mitchell, Ranking Member Roe, 
Members of the Subcommittee and Congressman Fattah, I am 
honored to represent the U.S. Nuclear Regulatory Commission 
staff at today's hearing.
    The NRC is very concerned about what happened at the VA 
hospital in Philadelphia.
    Our mission as the regulator for the civilian use of 
nuclear material is to protect public health and safety, 
including medical uses of radioactive material. We take our 
mission very seriously and strive to make sure all patients, 
including our veterans, receive safe and effective medical 
care. We recognize that is not what happened at VA 
Philadelphia.
    The NRC does not regulate the practice of medicine. We do, 
however, set the rules under which licensees such as the VA use 
radioactive material. As the holder of an NRC license, it is 
the responsibility of the VA to identify problems in medical 
treatments using radioactive material and report those problems 
to the NRC.
    The NRC, once notified of the apparent problems at VA 
Philadelphia, began increasingly intensive inspections of the 
brachytherapy program at VA Philadelphia and the 12 other VA 
facilities that conduct this medical procedure. We are 
concerned about what we have found to date.
    The VA has suspended this procedure at five sites, includes 
VA Philadelphia, and they will not restart until we, the NRC, 
are satisfied they have addressed the problems. Our inspections 
are continuing, and once we complete our inspections later this 
summer, the agency will determine what, if any, enforcement 
actions are appropriate.
    As a regulatory agency we are accountable for ensuring the 
safe use of radioactive material in medical treatments; we have 
an obligation to aggressively oversee radioactive material use 
and make sure patients are properly treated. The VA's license 
issued by the NRC requires the VA to establish an internal, 
independent framework of oversight consistent with NRC 
regulations, and with inspection and enforcement policies, 
procedures, and guidance. The NRC relies on the integrity of 
this framework. Based on what we have identified to date, we, 
the NRC, are making changes. Had these changes been in effect 
in the past, we are confident that these issues would have been 
identified and resolved earlier.
    We have already initiated steps to enhance our oversight. 
These include an increased focus on safety culture at medical 
facilities, an increased focus on medical facilities oversight 
of contracted medical professionals, increased focus on 
ensuring that involved medical professionals and radiation 
safety staff understand the definition of a medical event and 
reportable requirements, an increased focus on extent of 
condition reviews, and increased focus on post-treatment dose 
verification. The NRC is also increasing our oversight of, and 
reducing our reliance on, the VA's National Health Physics 
Program.
    Going forward, we will continue to look critically at 
improving our inspection and licensing programs, as well as to 
consider proposed regulatory changes. The NRC is also assessing 
whether any additional changes are needed to strengthen our 
regulatory oversight of the VA with respect to the VA's 
internal regulatory framework.
    In closing, the NRC takes these medical events very 
seriously. We will do what it takes to ensure the use of 
radioactive material in medical treatments is as safe as 
possible. Thank you and I would be pleased to answer any 
questions.
    [The prepared statement of Mr. Reynolds appears on p. 55.]
    Mr. Mitchell. Thank you. Dr. Lee, I think we are ready.

         STATEMENT OF W. ROBERT LEE, M.D., M.S., M.ED.

    Dr. Lee. I would first like to thank the Committee for the 
opportunity to testify.
    I want to begin by pointing out that images are frequently 
deceptive, and I am going to hypothesize that--I am using the 
cursor here--that the green is the bladder, the red is the 
prostate, and the blue is the rectum. Recognize that there is a 
certain amount of disagreement among experts about what the red 
may look like, therefore any dosimetric quantifiers that are 
related to this volume may be different according to different 
reviewers.
    Now to Dr. Roe's point, would I rather have my seeds in my 
prostate here than down here? Absolutely. And I think one can 
look at that image, and if one assumes that the contours are 
done correctly, one can conclude that the seeds are in the 
prostate, but it does not follow necessarily that this is a 
good implant. It could be that there are too many seeds of too 
high activity, in which case there is an overdose, it could be 
that there are too few seeds of lower activity, hence too low 
of a dose.
    So I want to emphasize to the panel that images can be 
deceptive, and frequently you need more information.
    Additional information I would like to know is when was 
this image obtained? If it is obtained 2 hours after the 
implant then my standards for what is an acceptable implant are 
different than if it is done 30 days after an implant, and we 
really have no idea what the implications are of CT scans done 
a year or two after implants.
    I assume you have another image of--anything further there? 
I can't advance the images. Okay. I am going to take this 
opportunity to use this image as an example as was pointed out 
by Congressman Fattah.
    Frequently the radiation oncologist calls for and intends 
to place seeds outside of the prostate. There are many 
different techniques that are used. Some people like to keep 
the seeds inside, some people like to put a lot of extra 
prostatic seeds to lower the dose centrally. That is sort of 
the stylistic technique. And these seeds, which may be 
technically outside of the prostate, are in fact having a 
purpose in that it is physically not possible to bring your 
dose out far enough, especially at the edge of the prostate, 
unless you put seeds at the edge of or in fact outside of the 
prostate.
    Posteriorly, which is where most of the toxicity is, you 
need to be much more careful. And so a seed outside of the 
prostate here I am less concerned about than a seed outside of 
the prostate or multiple seeds out of the prostate posteriorly.
    Want me to scroll through? Okay. Given the uncertainty 
about when this was obtained relative to the prostate implant 
and the uncertainty with which the volumes are created this 
doesn't look good. There are no two ways about it. And if I saw 
this in one of my cases then this is a medical event. The 
question then becomes what do you do? Can you fix it? Do you 
put in more seeds up here? Do you add external beam? And that 
is where I don't think we have any confidence.
    Shall I proceed with testimony? Thank you.
    Chairman Mitchell, Ranking Member Roe, and Members of this 
distinguished Subcommittee, good morning and thank you for the 
opportunity to testify today on the use of brachytherapy to 
treat prostate cancer. I have personally witnessed the benefits 
of brachytherapy, and look forward to telling you about this 
treatment, focusing on its safety and its effectiveness.
    I am currently Professor of Radiation Oncology at Duke 
University School of Medicine and have performed prostate 
brachytherapy since 1997. I evaluate over 300 new prostate 
cancer patients each year. I have authored 100 or more original 
articles and reviews on reproductive and urinary system cancer, 
and I am considered an expert in the field of prostate cancer. 
I believe my testimony is critical to help Congress and the 
public understand that brachytherapy is a safe and effective 
procedure.
    On a more personal level, I am the son of a retired air 
force navigator who presently depends on the VA system for his 
health care.
    While I am not personally involved in the investigation 
into the Philadelphia VA, based on the information that is 
publicly available, I agree that there is cause for concern.
    ASTRO, whom I represent, is deeply troubled by the problems 
identified, but we are heartened that the NRC has found no 
evidence of widespread medical events involving brachytherapy. 
In fact, there are approximately 50,000 brachytherapy 
treatments performed in the U.S., and according to the most 
recent advisory Committee, only about 0.22 percentage of the 
procedures nationwide resulted in a medical event. Clearly 
brachytherapy is a very safe procedure.
    My hope is that patients, including our Nation's veterans, 
will recognize that the situation at the Philadelphia VA is an 
isolated incident, it should not dissuade patients from 
choosing brachytherapy if appropriate as a treatment for their 
cancer. At the same time, ASTRO is committed to working with 
Federal regulators to learn all of the facts from these serious 
events and use this information to ensure that this episode is 
not repeated.
    Radiation therapy is the use of radiation to safely and 
effectively treat cancer and other diseases. Patients receive 
radiation therapy externally or internally. During external 
beam radiation, a beam of radiation is directed at the tumor 
from the outside of the patient. Internal radiation or 
brachytherapy, is the placement of radioactive sources into or 
next a tumor. For more than 100 years brachytherapy has been an 
effective method of delivering radiation to the tumor while 
sparing surrounding tissues.
    I would be remiss if I didn't take this opportunity to 
briefly call your attention to the centers for Medicare and 
Medicaid Services' recent proposals to cut Medicare payments 
for community radiation oncology by 19 percent. ASTRO urges 
Congress to help prevent these draconian cuts that are certain 
to limit patient access to these life saving cancer services.
    ASTRO is also very concerned that had perverse financial 
incentives and rampant self-referral of radiation therapy 
services in the Medicare Program is resulting in prostate 
cancer patients not being fully informed of the full range of 
options, particularly brachytherapy, and we hope that the 
appropriate concerns over the brachytherapy program at the 
Philadelphia VA will not exacerbate the under use of this very 
effective treatment option.
    Prostate brachytherapy is a safe, effective, minimally 
invasive outpatient procedure that is associated with a quick 
recovery and return to normal activity and work. The benefits 
of prostate brachytherapy include equivalent cure rates with a 
lower incidence of impotence and incontinence than other 
treatments.
    Prostate brachytherapy is performed by inserting small 
metal seeds of radioactive iodine and palladium directly into 
the prostate gland and the periprostatic tissue.
    My written testimony includes clinical practice guidelines 
that have been published in the peer reviewed literature for at 
least a decade, and in particular, I want to highlight the 
importance of performing post-implant dosimetric assessment of 
some type of. Post-implant dosimetric assessment documents the 
actual dose that the prostate has received and the nearby 
normal tissues to identify any over dosage or under dosage.
    As you know, the NRC has jurisdiction over the use of 
radioactive materials, including medical isotopes and safety 
measures to protect the public and patients. Almost all 
radiation oncologists meet NRC's requirement by completing 4 
years of training within a residency program accredited by the 
Accreditation Council for Graduate Medical Education. Such 
training requires 700 years of work and study, including 
radiation physics, radiation biology, as well as safe handling, 
and use of radioactive materials. This is in addition to the 
extensive clinical training in oncology. Duke Medical Center 
has considerable safety protocols and procedures for prostate 
brachytherapy, the details of which can be found in my written 
testimony.
    Finally, I would like to illustrate the benefits of 
brachytherapy by telling you about the story of one of my 
patients. He is a university professor and an ardent long-
distance runner. I met him 8 years ago. He had early stage 
prostate cancer, and after discussion of all treatments, he 
chose brachytherapy. He told me he chose brachytherapy so he 
could continue to teach his students, coach his daughter's 
soccer team, and train for an upcoming marathon. He was treated 
with brachytherapy in the spring and later that year he ran in 
the Marine Corps marathon. Seven years after his treatment, his 
PSA is undetectable and he is very likely cured. He has run in 
a marathon every year since his treatment.
    ASTRO shares the Committee's concerns about the health and 
safety of veterans and recognizes the importance of maintaining 
veterans access to high quality cancer treatment. We look 
forward to having all of the facts from the VA investigation 
made public by making these issues transparent. Necessary steps 
can be taken to implement any corrective actions and enhance 
quality.
    ASTRO is committed to ensures that radiation oncologists 
and Members of the treatment team adhere to strict safety 
standards and clinical guidelines for all radiation therapy, 
including brachytherapy.
    Thank you for the opportunity to testify.
    [The prepared statement of Dr. Lee appears on p. 58.]
    Mr. Mitchell. Thank you very much. I just got a couple 
questions here, and this is for Dr. Lee.
    In your opinion, the situation in Philadelphia at the 
Medical Center there, is it an isolated event, or does the VA 
have a much larger problem? And I want to extend that, I don't 
want to just pick on the VA, because I have a feeling since 
what happened in Philadelphia was done with a contract with the 
University of Pennsylvania, that if this same procedure would 
have happened at the University of Pennsylvania hospital the 
same results would have occurred, it wouldn't have occurred 
just because it is in the VA hospital. I don't know if that is 
right or not. But is there a problem period, maybe in the VA 
system or in the system throughout this country with this--with 
the follow up and the therapy that was given which brought this 
to light to begin with?
    Dr. Lee. So I am speaking as an informed sort of 
professional here. Based on what I know publicly the NRC has 
been very proactive and is presenting a very high bar for the 
VAs to meet. In fact, perhaps some of the best and most 
important work in this field of prostate brachytherapy comes 
from the VA in Seattle. So that there is precedent and 
documented evidence that this can be done well within the VA 
system. I don't think it has anything to do with the VA.
    Mr. Mitchell. Well what about what happened in Philadelphia 
happening in private hospitals or happening other places?
    Dr. Lee. So the concern that this is a more widespread 
phenomenon?
    Mr. Mitchell. Right.
    Dr. Lee. I would say the NRC data suggests that that is not 
true, and there are two additional pieces of information that 
make me feel confident that good high quality brachytherapy is 
being done across the country.
    One piece of information relates to something called the 
``Radiation Therapy Oncology Group,'' which is an National 
Cancer Institute (NCI) supported oncology cooperative group in 
which institutions across North America treat patients 
according to protocols, and they had two, and have a third 
ongoing study at a deals specifically with prostate 
brachytherapy in which all of the information, including the 
post-implant CT scans, are sent centrally and reviewed by a 
reviewer. And I was the principal investigator of one of those 
reports, and based on my assessment of those institutions, good 
quality brachytherapy is available across the country.
    The second piece of information that I use to feel good 
that good brachytherapy is accomplished across the country is 
we do have some large Medicare claims-based data looking at 
prostate brachytherapy and looking for significant severe 
complications. And we have several publications in the 
literature that demonstrate that from 1991 all the way up to 
about 2000 that the complication rate associated with this 
procedure across the country in Medicare beneficiaries is very 
low, which is another piece of information that makes me feel 
confident that it is being done well.
    Mr. Mitchell. You mentioned one of your patients as a 
marathon runner and so on. When a person comes to you, you said 
you do about 300 or over 300--you see 300 prostate patients a 
year?
    Dr. Lee. I don't do 300 prostate brachytherapy, I see 300 
new prostate cancer patients.
    Mr. Mitchell. Right.
    Dr. Lee. Yeah.
    Mr. Mitchell. Does a person come to you after they have 
seen a urologist, or do they just come to you straight saying I 
want to look at brachytherapy? When does a patient get the pros 
and cons of all the treatments?
    Dr. Lee. So typically most of the patients I see have been 
biopsied by a urologist, and then frequently will ask for a 
quote, ``second opinion.''
    So at Duke where I work and like many other places we have 
something called a ``multi-disciplinary clinic'' in which 
patients with newly diagnosed prostate cancer come in, they see 
me as a radiation oncologist, they see a urologist, and they 
see a medical oncologist simultaneously in which the pros and 
cons of each treatment are discussed. And the vast majority of 
the time the treatment decision comes down to patients, and 
that it is very clear to pick a winner amongst the many 
treatments out there, and frequently the patient will decide 
based on his or his family's own concern.
    So in the best of all worlds all prostate cancer patients 
would be seen by a urologist and a radiation oncologist. I 
don't know how frequently that happens. At Duke it happens a 
lot, which is good.
    Mr. Mitchell. Are you aware when the brachytherapy is done, 
are there urologists in the room at the time?
    Dr. Lee. So this is a procedure that I continue to be 
amazed can be done in a number of different ways, and you still 
seem to come up with reasonably good results.
    So in my practice from the very beginning I have involved a 
urologist and we do it together. We train each other such that 
I can do it by myself and he can do it by himself, but we are 
there together, and I think it is sometimes better to have two 
heads. He brings his urologic or she brings her urologic 
expertise, I bring my understanding of three dimensional 
anatomy in physics, and together I think you get a better 
product.
    That said, there are multiple examples of radiation 
oncologists doing it themselves. Okay? And I have seen cases 
where urologists essentially do everything, and the radiation 
oncologist stands in the corner. Urologists can't do this 
because by themselves they need an authorized user, but it can 
be done any number of different ways.
    At Duke I do it with a urologist that has been doing it for 
10 years or 15 years, as much as I have, and he does a needle, 
I do a needle, he does a needle, I do a needle.
    Mr. Mitchell. Thank you.
    Dr. Lee. You are welcome.
    Mr. Mitchell. Dr. Roe.
    Mr. Roe. Dr. Lee, thank you, I am going to say hello to a 
mutual friend of ours, Dr. David Alballa. I spoke to him 
yesterday and I knew you were coming up here.
    So I guess a couple of things, and I won't take too long 
because we have to go with some votes here in a minute, but at 
the VA when they were doing this and they couldn't get the 
dosimetry, would that have waved a red flag for you to say wait 
a minute, if you can't get the dosimetry why are you continuing 
to do these cases?
    Dr. Lee. Yes, I think to be fair. And this is where I don't 
know the specifics so I don't want to be too critical. But from 
the very beginning of my practice, and I have been preaching 
this from the very beginning, is that post-implant dosimetric 
assessment is part of the treatment. It is a perfect example of 
how you can use safety measures. It is a feedback loop. You put 
the seeds in and then a period of time later you see well how 
well did we do? And if you are consistently low or consistently 
high or something like that then you can tweak your practice.
    So if I were in that situation then I would either stop the 
program or I would come up with a work around, where if they 
could get the images it is possible to do it by hand--do it the 
old fashion way and circle the prostate. It is a little bit 
more tedious and it takes more time and it is not as easy to 
bring the data into the treatment planning system digitally, 
but it is so vital that if it were me and someone told me 
tomorrow we can't do post-implant dosimetry for whatever 
reason, then I would say the program is shut down.
    Mr. Roe. And we should be able to, I know that I have 
worked with Duke and had patients treated there over the years, 
there is a tumor registry that we follow these patients and you 
know--and I will bet the VA does this. I know there is not 
anyone up there and you can't answer this, but I would almost 
bet that they do have a tumor registry and follow them and be 
able to tell what the outcomes are.
    The other thing I guess, and I would like to know, is what 
is a definition of a medical event? And it seems to be a moving 
target.
    Dr. Lee. Right.
    Mr. Roe. And could you elaborate a little bit on that?
    Dr. Lee. So I can tell you what a medical event is at Duke. 
Medical event is wrong patient, wrong organ, wrong isotope, 
wrong dose in this context. So if you are supposed to put in 
iodine and you put in palladium, medical event. If you put Mr. 
Jones' seeds in Mr. Miller's prostate, medical event.
    Mr. Roe. Pretty common sense stuff. But is that 
standardized across the country? Because what happened with 
this I think when we saw this 112 or 114 patients and there 
were 92 medical events, I started asking myself what is a 
medical event?
    Dr. Lee. Uh-huh.
    Mr. Roe. And is the definition the same at Duke as it is at 
the VA in Philadelphia, and maybe the NRC, Mr. Reynolds can 
answer that.
    Dr. Lee. This is where the NRC I think should comment. In 
2002, this misadministration changed to a medical event. So a 
little bit of it is semantics. Okay? But the wrong patient, 
wrong isotope, wrong organ, wrong dose have been there for at 
least ever since I have been in the business.
    I think it is fair to say though that there has been some 
inhomogeneity in how in particular the dose question has been 
asked. From what I have seen of the VA rules, they for the 
first time have incorporated this specific dosimetric 
quantifier D90, which does not appear in any of the NRC's 
statutes. Okay? And I think that is one possible explanation. 
That said, I think anyone if they see this that is a medical 
event.
    Mr. Roe. What would be the wrong dose at Duke University? 
How would you define wrong dose?
    Dr. Lee. So for a medical event if I were using--this is 
the problem, is there is some inconsistency. Do you use D90 or 
do you do D100? Okay. I fortunately haven't had any medical 
events. And if I were pressed to say what is your medical event 
for dose it would be--I would actually go lower, I would say 
D80 of 80 percent, so I wouldn't put it as high. And the reason 
I do that is because I am concerned if you put the bar too high 
then community practitioners that attempt to get over that bar 
will end up putting in too much activity and increase toxicity.
    Mr. Roe. But if you weren't doing the dosimetry you 
wouldn't know you had a medical event.
    Dr. Lee. Correct, absolutely.
    Mr. Roe. Which is what was happening.
    Dr. Lee. Right.
    Mr. Roe. So you wouldn't even know. And I think that is 
critical to know that so you can change. I mean, not anybody in 
this room has not wanted to do the job right. There is no 
question in my mind about that. The problem is you don't know 
you are doing it right if you don't get the right data.
    So Mr. Reynolds, do you have any comment on that?
    Mr. Reynolds. I was just going to read to you what our 
regulations say a medical event is.
    Mr. Roe. Okay, thank you.
    Mr. Reynolds. I will read two versions. One is the one that 
was published January 1st, 2009. ``The total dose delivered 
differs from the prescribed dose by 20 percent or more.''
    Mr. Roe. Okay.
    Mr. Reynolds. It also talks about the other things that Dr. 
Lee talked about.
    Now I will read from the January 1st, 2001, version of 
Title 10 Code of Federal Regulation, Part 35. ``When the 
calculated administered dose differs from the prescribed dose 
by more than 20 percent of the prescribed dose.'' Twenty 
percent.
    Mr. Roe. Twenty percent, so it is pretty well defined. And 
to let folks know that these seeds when they go in, I want to 
make it clear, they have a half-life between 17 and 60 days, so 
that radiation is not there forever.
    Dr. Lee. If I can just comment. Twenty percent sounds like 
a well it is 20 percent or not? The problem that I see is that 
frequently that dose in the brachytherapy world has been 
translated to mean activity, and so that if you order 100 seeds 
of.4 millicuries and you have 40 millicuries, if you put in 20 
percent more than that or 20 percent less than that then that 
is a medical event. I am not saying that is right, I am not 
saying that is wise, what I am saying is that in my 
conversations with many people across the country that that is 
their interpretation of the NRC statute.
    Mr. Roe. Thank you, Mr. Chairman.
    Mr. Mitchell. Thank you. Mr. Adler.
    Mr. Adler. Thank you, Mr. Chairman.
    Dr. Schyve, as I heard your testimony and read your written 
testimony my sense was you were explaining how the Joint 
Commission accredited the Philadelphia VA just 2 days after the 
prostate cancer program--the brachytherapy program was shut 
down in Philadelphia. My sense was you were saying it is such a 
small program, such a low volume program, 20, 30, 40 patients a 
year, that it sort of flew under the radar of the surveyor, 
wasn't reported by Philadelphia to the surveyor, so Joint 
Commission sort of couldn't find it unless it knew to ask for 
that particular program. Is that really the essence of your 
testimony?
    Dr. Schyve. That is basically correct. The surveyor is 
looking throughout the organization at all kinds of things, 
always visits the imaging service and always asks if there is 
radiation oncology, and if so looks at that. But if, as it may 
be common, the radiation oncology department doesn't say, ``Oh, 
and we are also doing brachytherapy over here,'' the surveyor 
may be unaware that brachytherapy is there. And so consequently 
doesn't look at whether or not there is adequate peer review 
and so on for brachytherapy, as the surveyor does for radiation 
oncology in general.
    Mr. Adler. I would respectfully suggest to you that maybe 
the Joint Commission should pay particular attention to those 
programs that are more likely to fly under the radar because of 
the low volume, because those are the programs that probably 
don't have quality assurance, don't have peer review, don't 
because of the low volume have the proficiency that comes with 
doing a program over and over and over again. You get better as 
you do it more.
    Dr. Schyve. Yes.
    Mr. Adler. I am hoping one of your take aways for the Joint 
Commission is to ask those questions. Not about brachytherapy, 
I think we are now a little bit more cognizant of that program 
which is going well in most parts of the country, wasn't going 
so well in Philadelphia, but there might be 3 or 33 other 
programs like that in the world that we have to ask about so we 
don't accredit too quickly. Is that a fair take away for you?
    Dr. Schyve. Yes. As I indicated in my testimony we will 
clearly be asking about brachytherapy, but we have had exactly 
the same thought that that you just described. In fact, we may 
make that part of the application form that organizations 
complete before the survey--to tell us and check off that they 
do we have this service, do have this service and so on. So we 
would know before the surveyor goes in.
    Mr. Adler. I would really respectfully urge you to do that 
so that Congress doesn't mandate you to do that, because I 
think our big concern here is that we don't have failures in 
other programs somewhere else in the country. We have 
identified an isolated situation, one small program in 
Philadelphia which is unique, in Philadelphia it is otherwise a 
very good history of providing very high medical care as 
Congressman Fattah said. We want to make sure it doesn't happen 
in some other similar small volume program elsewhere, whether 
it is Philadelphia or elsewhere in the country geographically.
    Dr. Lee, let me come back to you. You mentioned the 
situation in Philadelphia that it was an isolated incident. 
Would you overall agree that it didn't go that well?
    Dr. Lee. Absolutely.
    Mr. Adler. Okay. Because I guess I kept hearing from Dr. 
Kao in Philadelphia when we spoke with him in a hearing there 
and then again today that it was adequate medical care. My 
sense was the program wasn't good enough, and I think everyone 
else acknowledges it, UPenn, VA Philadelphia, VA nationally, 
NHPP, NRC. You would concur that it wasn't really the best 
level program.
    Dr. Lee. Yes.
    Mr. Adler. Okay. I just wanted to sort of establish that so 
there is no confusion factually other than from Dr. Kao's own 
testimony.
    Mr. Reynolds, are you satisfied now that you and the VA are 
sort of on a common track toward having a definition of medical 
event that is in the patient's best interest?
    Mr. Reynolds. Yes, sir.
    Mr. Adler. Do we already have it, or we are on the way 
toward getting it? I guess that is part of my confusion. 
Because I heard from our previous conversations in 
Philadelphia, my sense was NRC sort of thought it was the VA's 
fault that they didn't report well enough and so the program 
didn't come to light as a problem until the fall of 2008, and 
that seems to me at least is too late, and maybe your standards 
have to be different to make them report more clearly so that 
we catch it sooner.
    Mr. Reynolds. Well we always look at how we can enhance our 
regulations and make them clearer. What I read to you seems 
fairly clear to me. But as I said in my opening statement, we 
are making changes, trying to get better, and we are looking 
for the VA to make changes to get better.
    Mr. Adler. I thank you, sir. Dr. Miller.
    Dr. Miller. Congressman Adler if I can amplify that.
    Mr. Adler. You have to amplify with the button on.
    Dr. Miller. There we go. My office is responsible for 
setting the programmatic standards for the NRC, and we consider 
ourselves a learning organization. We would like to take what 
we have learned from VA, what we have heard here today, and 
information we get from the medical community to always try to 
make sure that our standards and the guidance that goes along 
with those standards are clear. Where we find that it hasn't 
been clear or if we find that people are having trouble 
interpreting it, we strive to make it clear so that it does set 
a standard across the industry, and we will continue to strive 
to do so.
    Mr. Adler. Thank you, doctor.
    Mr. Mitchell. Mr. Adler, votes have just been called so 
very quickly if you don't mind I would like to see if Mr. 
Fattah has any quick questions of this panel.
    Mr. Fattah. Yes, I do, and thank you, Mr. Chairman.
    So Dr. Lee, first of all, thank you for your work that you 
are doing at Duke and with ASTRO.
    There were 50,000 of procedures last year, and based on 
your testimony there were 111 medical events in which 102 of 
them were related to the VA. So that in all of the other 
private hospitals, private facilities where this is done there 
were literally almost none. When you play golf, you self-report 
when you do something wrong, right? And what is amazing to me 
is that basically if you close down the program at 
Philadelphia, right, nobody else has made a mistake anywhere in 
the country in 50,000 different surgeries. Does that seem 
plausible?
    Dr. Lee. Well I think there is an event rate, it is very 
small. Let me state emphatically that I completely disagree 
with Dr. Nag's statement about 20,000 medical events out of 
50,000 implants.
    Mr. Fattah. He is the medical advisor to the NRC.
    Dr. Lee. I know Dr. Nag very well. I have no idea where he 
comes up with that number.
    Mr. Fattah. Okay.
    Dr. Lee. I base my statements on the NRC data, my own 
individual experience with looking at many post-implant CTs 
from institutions all across the country within the context of 
an NCI supported cancer oncology group, and it strikes me 
that----
    Mr. Fattah. Let us assume that the VA got out of this 
business, there would be no medical events in this surgery 
anywhere in the country this year given if you pushed these 
statistics forward, right? This notion of self-reporting 
challenges people at times in all different professions, with 
the exception of surgeons who perform this surgery.
    Dr. Lee. I am not sure I understand your question.
    Mr. Fattah. What I am saying is how reliable should the NRC 
or anyone else be that since there were almost no reportable 
medical events outside the VA at these four institutions that 
were cited, should we just assume that there aren't any other 
instances or that people are not reporting them? Which side of 
this should we come down on given your expertise?
    Dr. Lee. You know, I guess I find no objective data to 
suggest that it is as widespread as you seem to intimate.
    Mr. Fattah. No, I am not trying to intimate, I am going off 
your testimony. You said 50,000 surgeries----
    Dr. Lee. Fifty thousand, and I am using the NRC data.
    Mr. Fattah. There are 111 medical events.
    Dr. Lee. And for the last decade----
    Mr. Fattah. And 102 of them were from the VA.
    Dr. Lee [continuing]. And for the last decade roughly a 
handful of prostate brachytherapy have been medical events each 
year.
    Mr. Fattah. No problem.
    Dr. Lee. So I think wrong dose, wrong isotope, wrong 
patient, those should be rare events.
    Mr. Fattah. Okay. And I just have one last question, Dr. 
Lee.
    Dr. Lee. And when you look at it in context to wrong site 
surgery our number is probably much less. And forgive me for 
tooting the radiation oncology's own horn, but from day one in 
training programs there is a safety culture. Residents learn 
that this is radiation. It is the gift that keeps on giving. 
You cannot take it back.
    Mr. Fattah. I think it is a very safe procedure from what I 
have read.
    One last question. Is a medical event, which in this 
instance we are talking about low dosage, right?
    Dr. Lee. Low dose rate, yes.
    Mr. Fattah. Okay. What does that really mean? Is it as 
ominous as it sounds or in your view is it something that when 
reported--in this instance in Philadelphia this was reported by 
the institution, this wasn't discovered by someone else--and 
when it is reported what should we take from that in terms of 
what it means to the--in terms of this program in Philadelphia?
    Dr. Lee. So that is an excellent question. I think the 
panel should be careful not to equate medical event with 
malpractice, negligence, patient harm, et cetera. A medical 
event is a specific definition that the NRC has come up with, 
and it does not necessarily mean that the patient is harmed. I 
suspect that----
    Mr. Fattah. So when Dr. Kao said the same thing, my 
colleague who from New Jersey, Congressman Adler was puzzled by 
it, and that is why I think it is important to hear you comment 
on it.
    And I thank the Chairman for his time.
    Mr. Mitchell. Thank you very much. And I want to thank you 
for appearing here today. We are going to excuse this panel. We 
are going take a recess because we have only about 7 minutes 
left to vote. We have five votes. And we will come back and 
continue this. Thank you very much. Let us plan on a 30 minute 
recess.
    [Recess.]
    Mr. Mitchell. And I would like to welcome Panel Three to 
the witness table. Joining us on the third panel is Joseph 
Williams, Assistant Deputy Under Secretary for Health for 
Operations and Management, the Veterans Health Administration, 
U.S. Department of Veterans Affairs. Can you put that all on a 
name tag? Assistant Deputy Under Secretary for Health for 
Operations and Management, Veterans Health Administration, U.S. 
Department of Veterans Affairs. That's a pretty good title. Mr. 
Williams is accompanied by Dr. Madhulika Agarwal, Chief Officer 
for Patient Care Services; Dr. Michael Hagan, National Director 
of Radiation Oncology Services, E. Lynn McGuire, National 
Health Physics Program Director; Michael Moreland, Network 
Director for VISN 4; Dr. Richard Whittington, a Staff Physician 
at the Philadelphia VA Medical Center; Dr. Kent Wallner, Chief 
of Radiation Oncology, Puget Sound Health Care System and 
Associate Professor of Medicine at the University of 
Washington.
    We will recognize Mr. Williams for 7 minutes, and then 
anything that goes over, of course, your testimony will be in 
the record and then we will have questions. Thank you for 
appearing.

 STATEMENT OF JOSEPH A. WILLIAMS, JR., RN, BSN, MPM, ASSISTANT 
     DEPUTY UNDER SECRETARY FOR HEALTH FOR OPERATIONS AND 
MANAGEMENT, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF 
VETERANS AFFAIRS; ACCOMPANIED BY MADHULIKA AGARWAL, M.D., MPH, 
     CHIEF OFFICER, PATIENT CARE SERVICES, VETERANS HEALTH 
 ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS; MICHAEL 
  HAGAN, M.D., PH.D., NATIONAL DIRECTOR OF RADIATION ONCOLOGY 
 SERVICES, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF 
 VETERANS AFFAIRS; E. LYNN McGUIRE, MS, DABMP, NATIONAL HEALTH 
  PHYSICS PROGRAM DIRECTOR, OFFICE OF PATIENT CARE SERVICES, 
  VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS 
   AFFAIRS; MICHAEL E. MORELAND, FACHE, NETWORK DIRECTOR, VA 
   HEALTH CARE-VISN 4, VETERANS HEALTH ADMINISTRATION, U.S. 
  DEPARTMENT OF VETERANS AFFAIRS; RICHARD WHITTINGTON, M.D., 
STAFF PHYSICIAN, PHILADELPHIA VETERANS AFFAIRS MEDICAL CENTER, 
  VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS 
 AFFAIRS; AND KENT E. WALLNER, M.D., CHIEF RADIATION ONCOLOGY, 
PUGET SOUND HEALTH CARE SYSTEM, VETERANS HEALTH ADMINISTRATION, 
U.S. DEPARTMENT OF VETERANS AFFAIRS, AND ASSOCIATE PROFESSOR OF 
    MEDICINE, UNIVERSITY OF WASHINGTON, SCHOOL OF MEDICINE, 
                          SEATTLE, WA

    Mr. Williams. Thank you, Mr. Chairman and Members of the 
Subcommittee. Thanks for the opportunity to discuss VA's 
enforcement of brachytherapy program safety standards.
    First before I proceed I would like to take the opportunity 
to reach out and give my apologies to the veterans and the 
families that have been affected by this event.
    In addition, I would like to acknowledge the Subcommittee 
and the Members that you represent, as well as the Nation that 
we have committed to taking care of those who have served in 
this country.
    VA has a well-documented record of quality care, but when 
there are exceptions, whatever the cause may be, we accept the 
responsibility and we work with individuals at every level to 
ensure that we address the needs. We further analyze what went 
wrong. We take corrective actions. And we look for lessons 
learned that can be applied throughout our National health care 
system. VA is not afraid to admit when we make a mistake, and 
we strive for as few mistakes as possible. We also understand 
that with transparency comes great responsibility.
    My testimony today will briefly describe brachytherapy, 
review what happened at the Philadelphia VA Medical Center, 
will explain the VA's enforcement of safety standards for 
brachytherapy, and discuss the current status of those programs 
throughout VA.
    Brachytherapy, as you know, is a therapy for prostate 
cancer. This is a form of nuclear radiotherapy where small 
radioactive seeds are implanted in the prostate to destroy 
cancerous cells. Although risk to healthy tissues in the body 
is minimal, side effects are known to occur.
    Brachytherapy is an appropriate treatment and it is an 
appropriate approach for low-risk patients with prostate 
cancer, but implant quality must be monitored closely, and in 
each case performed, and with each procedure it must be 
reviewed regularly.
    And I am thankful that a VA employee identified this and 
brought it forward, but I regret that it took so long for this 
to be recognized.
    We accept responsibility for the care of your veterans, and 
we acknowledge that some of the brachytherapy treatments 
provided at the Philadelphia VA Medical Center did not deliver 
the intended dose, and we regret that, but we have reached out 
to the patients. We have notified them by mail and by 
telephone. We are covering all costs associated with the 
additional tests while continuing to monitor the care of our 
patients.
    A review was conducted by independent, external physicians 
and physicists with no involvement with the Philadelphia 
program. Ninety-two events involving possible under-dosing or 
doses to organs other than to treatment site were found that 
met the definition of medical event according to the NRC. It is 
important to highlight that the definition of medical event 
does not necessarily mean that a veteran was harmed, and 
experts still debate the long-term impact of this treatment.
    We are working with NRC on regulatory issues related to 
prostate brachytherapy, and NRC is refining the definition of a 
medical event as this pertains to these procedures.
    The Philadelphia Medical Center brachytherapy program has 
been suspended since June 2008 and will not be reopened until 
NRC's concerns have been satisfied and until requirements for 
the VA's Radiation Oncology Program are met.
    Enforcing program safety standards is essential to ensuring 
patients receive the care that they require. VA, as do other 
health systems, relies on complementary systems of 
accountability to identify issues. These are both important to 
us as it relates to system issues and opportunities, as well as 
individual issues.
    We use multiple internal and external surveys and 
inspection processes; we use patient satisfaction reports; 
complaints; individual peer review in our oversight process. 
The deficits in this program at the Philadelphia Medical Center 
went undetected by many of these systems for almost 6 years, 
and it was the recognition of the potential problems by an 
employee, as I noted earlier, that brought this forward and 
eventually lead to an in-depth investigation, review, and 
subsequent disclosure to patients.
    We have made much progress since May 2008 and we continue 
to strengthen our partnership with the people who were on the 
panels earlier; the University, NRC, Joint Commission, et 
cetera, and we do this in an effort to strengthen our standards 
and improve our outcomes.
    In November 2008, VA amended the criteria for suspending 
prostate brachytherapy programs, and we required immediate 
suspension for any such program where medical events were 
discovered for 20 percent or more of the patient treatment that 
were reviewed or evaluated by regulatory compliance.
    Moreover, VA also requires the National Health Physics 
Program to inspect any report of medical events to confirm 
regulatory compliance and implementation of VHA standards. VA 
will suspend any prostate brachytherapy program if the results 
of this inspection indicates significant program deficiencies 
and program suspension is deemed warranted by the National 
Radiation Safety Committee in consultation with the Director of 
the National Radiation Oncology Program and the Principal 
Deputy Under Secretary for Health.
    In response to the concerns raised by the NRC and to ensure 
other VAMCs were performing prostate brachytherapy procedures 
correctly, VA completed inspections by January of 2009 of all 
VA facilities that had active programs. VA also developed and 
implemented standard procedures to prostate brachytherapy 
programs addressing quality issues and assurance measures for 
the safety program.
    Regarding future actions to prevent similar situations, VA 
has asked the American College of Radiology (ACR) to conduct 
site surveys for each facility, that is each facility 
performing brachytherapy for prostate cancer. Our goal is 100 
percent accreditation. And it is important to note that 
nationally in the private sector in the VA, only 15 percent of 
their practices are accredited now.
    Furthermore, each facility performing permanent implant 
prostate brachytherapy must develop, maintain, and implement 
written procedures based on the American College of Radiology's 
Practice Guidelines for Transperineal Permanent Brachytherapy 
of Prostate Cancer and publications by the American Association 
of Physicists in Medicine.
    We embrace change and we are ready to learn from it. VA has 
used the situation in Philadelphia to conduct a comprehensive 
review of brachytherapy programs and has developed criteria for 
suspending and restarting these programs. The VHA clinical 
standards and procedures are now among the most rigorous 
standards in the health care industry. There are currently nine 
programs that meet the standard for brachytherapy, and at this 
time seven of those nine are active programs. Durham has 
voluntarily elected to contract their patients in the greater 
Los Angeles facility as positive program.
    Senior leadership in VA is committed to a top down, bottom 
up review, and we are going to hold the facilities, the 
networks to the highest quality of standards for our 
organization.
    We regret that these incidents occurred and we are prepared 
this afternoon to answer any questions that you may have 
regarding the situation.
    Thank you very much for the opportunity.
    [The prepared statement of Mr. Williams appears on p. 65.]
    Mr. Mitchell. Thank you very much. I have just got a couple 
questions, Mr. Williams.
    In the brachytherapy procedures conducted at the VA, what 
is the measure of success?
    Mr. Williams. Well could I defer that to Dr. Hagan?
    Dr. Hagan. Well ultimately the measure of success is a low 
and stable PSA for the remainder of the patient's lifetime. So 
the goal of treatment is to remove all vestige of disease. And 
so patients are diagnosed on the basis of generally having a 
PSA, prostrate-specific antigen, that is either rising too fast 
or is above abnormal limits, and so that is the metric that we 
use to follow patients for the success of their treatment.
    Mr. Mitchell. As a follow up to that, how do you know it 
has been successful? Do you bring the patient back in?
    Dr. Hagan. Oh, yes.
    Mr. Mitchell. How often is that done? I mean, I would have 
thought that that would have been caught in Philadelphia. So 
how often do you bring them in?
    I happen to have had prostate cancer, and every year I get 
a letter from my hospital with a questionnaire, and I also see 
my urologist every year. It didn't seem like that is what 
happened in Philadelphia. Or did it?
    Dr. Hagan. Well, I believe it did actually, Mr. Chairman. 
And the last report I have from the chief at Philadelphia is 
that out of the 116 cases that we have heard discussed that Dr. 
Kao treated, there are 6 patients who have met criteria for 
biochemical failure, that is a rising PSA, that has met our 
current guidelines of PSA of two above the nadir value, which I 
can explain if you are interested in the specifics. And there 
are a further eight who have rising PSAs. The rest are low and 
stable. But I hasten to add that this is a procedure that the 
success of which, as you well know, we find out in the long 
term. And so the fact that there are many of these that are low 
and stable at present doesn't mean that they will continue to 
be low and stable through the next decade.
    Mr. Mitchell. This is a question for Dr. Wallner.
    Dr. Wallner, what lessons can other VA facilities learn 
from the implants that happened in Philadelphia? What are we 
going to do different?
    Dr. Wallner. Well, I think we do need oversight for these 
sort of low volume procedures that are done in a limited number 
of places. And I think what the NRC is doing and the VA is 
doing is a step in the right direction. I mean, there are going 
to be other procedures where this is going to come up and 
hopefully we can keep on top of it better than this. I mean, it 
is a moving target.
    Mr. Mitchell. One of the things I gathered from the earlier 
testimony is that there was a failure in some of the IT 
equipment and that they would have noticed this earlier and 
quicker if the equipment would have been up and operating.
    Dr. Wallner. Yeah, I mean, it is difficult. I have worked 
in VA for 11 years, I love it, but it is difficult sometimes to 
get things done in a timely fashion.
    I mean, there is no question that the head of the program 
should have stopped it right then. I mean, you cannot do an 
implant if you do not have the feedback to know if you did a 
good job. I mean, to me that was probably the biggest fault in 
the whole thing.
    Mr. Mitchell. And that was a fault of the equipment or the 
facility in Philadelphia?
    Dr. Wallner. Well, I mean, the people running the program 
should have stopped it.
    Mr. Mitchell. You know, the contract between Philadelphia 
and the VA Medical Center and the University of Pennsylvania 
was on an interim contract with extensions for 4 years. What 
was the contracting authority that led the VA to extend this? 
Did you have authority to extend this?
    Mr. Moreland. Yes, sir, we did have authority to extend it. 
We issue contracts, and then we at different times we extend 
the contract or we don't extend the contract or we go out and 
find a new vendor. But in this case we had a contract and we 
extended it.
    Mr. Mitchell. I understand that the VA and the OIG Office 
of Contract Review did a pre-award audit for a new award 
contract in 2005. And can you tell us why that contract was 
awarded?
    Mr. Moreland. I don't have that information at my hand.
    Mr. Mitchell. All right, thank you. Dr. Roe.
    Mr. Roe. Thank you, Mr. Chairman.
    I think one of the things that we have learned and the 
Chairman and I have been on a number of these in the last 7 
months is that we need to have systems. We saw it in our 
endoscopy oversight and investigation meeting where systems 
broke down within the hospitals. And it is very complex. This 
is not a simple procedure that you are doing, where the 
endoscopy systems broke down. And when we did our last medical 
malpractice review--the last two we have done in Tennessee--we 
do it with airline pilots to go through checklists, and they 
have--something medicine really ought to look at. The more I 
hear of this the more I am convinced we ought to be doing that. 
And Dr. Wallner, I know at the VA where you are, at least what 
I have heard, is you have some of the best results that there 
are in the country in the VA system. Anything you can share 
that you are doing with other VAs, I think you have to look at 
sites of excellence and see what are you doing. Have you done 
that?
    Dr. Wallner. Yeah, I mean, that is a really tough one to 
answer. I mean, we happen to do a huge number of these 
procedures, and we have it done to a science, we specialize in 
it, we get scans on patients before we let them out the door. I 
mean, my feeling is I can't sleep well at night unless we check 
these before the patient walks out the door. Not every place 
can do that. They are doing a lot of other things. They don't 
do a lot of this particular procedure. I don't have an easy 
answer. I still would go back to the NRC and an oversight of 
the programs would probably be the most practical.
    Mr. Roe. Well it would seem like--I guess what I would say, 
there is no reason to reinvent the wheel. You have already got 
systems in place, and to share those experiences that you have 
with the other ten or so VAs that are doing that across the 
country, since there are not that many sites. This is a lot 
easier to get a handle on I think.
    Dr. Wallner. Yeah, I mean, it is tough. You know it was in 
the newspaper today about some of the lawsuits I have been 
through over the years. I mean, I think if anything 
unfortunately this is scaring some of the practitioners away 
from this, because it is difficult to do it right, and I don't 
know what the answer is to that.
    Mr. Roe. You are talking to an obstetrician here.
    Dr. Wallner. Yeah, that is even worse.
    Mr. Roe. I understand.
    Mr. Williams. Sir, if I may comment.
    Mr. Roe. Mr. Williams.
    Mr. Williams. We are an organization that is committed to 
continuous learning. We have learned from this situation and we 
have made a number of--taken a number of actions to address 
that. Things that range from training. NRC has spoke about the 
standards that they were putting in place. I would offer to 
you, sir, that we have worked very closely with the NRC in 
establishing those standards and implements those standards in 
our facilities. Two include pre-implant assessments, 
assessments during and after treatment for implants. So we have 
learned from this.
    When we talk about how we convey information and training 
and education and lessons learned to other parts of an 
organization, you know, we have a vast network of systems and 
we are using the lessons learned from this, the hard lessons 
learned from this.
    Mr. Roe. I guess one of the things that concern me was that 
you have your patient there, you have a vital piece of 
information which is dosimetry, very critical piece of 
information, and nobody had that information, and yet we kept 
on doing the procedure, and that was a time I think to take a 
deep breath, a step back and call a time out and stop.
    Mr. Williams. Yes, sir.
    Mr. Roe. The other thing, and I know I feel like I know Dr. 
Agarwal now by her first name, I have seen her so many times up 
here. But I know the VA has a tumor registry, at least ours at 
Mountain Home does, and our hospital does. Very, very vital to 
have that information. You may think you are doing a pretty 
good job until you look back over a few years and find out 
maybe I need to change here. That piece of information is 
something that you get long term. Five, 10, 15, 20 year data is 
critical to therapy that you are doing now and you may want to 
change it. Would you comment on that?
    Dr. Agarwal. Sir, you're absolutely correct. We do have a 
very robust tumor registry, and we have a tracking system right 
now that also helps us in going back and looking longitudinally 
on the interventions that have been administered to our 
patients and some of the outcomes. So we certainly have been 
part of the larger system in having that in place. And in fact 
at Philadelphia itself all the patients who had this procedure 
have been tracked and have been followed up.
    Mr. Roe. So everyone has been.
    I guess the last question before we finish, and this will 
be again to Dr. Wallner. In absence of a national standard, 
would the VA in Seattle be the gold standard, should that be?
    Dr. Wallner. I think we are looked at as doing an extremely 
good job at this, and you know, we want to be involved with 
helping set a standard.
    Mr. Roe. Okay. Thank you, Mr. Chairman.
    Mr. Mitchell. Thank you. Mr. Adler.
    Mr. Adler. Mr. Chairman, thank you.
    First I would like to thank the panelists. I have met with 
most of you, not all of you, but most of you some days ago, and 
it helped my thinking, made me appreciate the professionalism 
that you have undertaken over a number of years and also your 
seriousness of purpose to make sure that what happened in 
Philadelphia isn't a recurring problem, not just in this 
particular program, but in any program for any veteran anywhere 
in the country, and so I really appreciate your commitment and 
your recommitment to provide the level of care that our 
veterans have earned by their service to our country.
    I would like to speak for a couple minutes about the notion 
of using independent contractors, because my sense is that in 
Philadelphia at least there was inadequate oversight by VA 
professionals of the UPenn professional who was running the 
program and whatever sort of folks that UPenn had working with 
that professional. So could you comment on your sense of 
whether or not there was adequate, or as I believe, inadequate 
VA supervision of the brachytherapy program in Philadelphia?
    Mr. Moreland. Yes, Congressman, I have mentioned to you 
before, I believe that there was an absence of good oversight 
at the front end level of this from both our staff and by the 
provider as well. And had we had that kind of quality data to 
be looking at this more closely we would have identified this 
much earlier.
    Again, I am proud of the staff at the VA in Philadelphia 
because they did find out, all be it late, but they did find 
it. There was courage to bring it forward and point it out, and 
we have taken significant action since then.
    But I do believe that the issue was the frontline oversight 
to make sure that we were getting the quality data that we 
needed to get, and that was missed, and we have learned a lot 
from that. It has allowed us to go back and look at other areas 
where we have a very low volume technical procedure where we 
have limited people who know what the procedure is and how it 
works, that we can bring in other experts to help us. Mr. 
Williams mentioned some of the external experts we have hired 
to come in and do that system wide. I think that will benefit 
all of us.
    So sir, I think you are right, I think that is in fact the 
root cause of the issue at our facility any way, and we have 
identified that and we are moving forward.
    Mr. Adler. Maybe Mr. Moreland, you can help some of the 
other panelists as well address this concern about the low-
volume procedures. Because my conversation with Dr. Schyve 
about the problem in Philadelphia from an accreditation point 
of view is a problem I feel may arise somewhere else in the 
system for veterans somewhere in the country. So maybe all of 
you could discuss for a moment what you have undertaken to 
review low-volume programs to make sure those programs that 
might not get as much attention are the ones that right now are 
getting the attention they need so that we have the supervision 
that guarantees the quality of care the veterans deserve.
    And just to be clear, I am not just asking in a 
brachytherapy context, in a prostate cancer context, in a 
cancer context, I am asking in a veterans medical care context 
across the spectrum.
    Dr. Hagan. Well Congressman, I can answer in terms of what 
we have done VHA wide for brachytherapy, but in the wider 
context I won't have the information that you are looking for. 
But for brachytherapy we have implemented standard procedures 
at each one of the sites that are currently performing. So 
conducting implants under ACR guidelines is a requirement. A 
checklist was developed and used based on those centers that 
were performing excellently, and that checklist is a 
requirement for each program. It is part of a seven point 
response to Philadelphia that was crafted by the NRC and our 
NHPP that identified criteria for evaluating programs, that 
conducted a nationwide evaluation of those programs, recognized 
those that didn't meet the standard and suspended them, 
developed criteria for restarting programs, criteria for 
initiating programs in centers that are not currently providing 
radiation oncology brachytherapy for prostate. And each one of 
the programs as of the 1st of May had implemented the standard 
procedures across the country.
    Mr. Adler. Doctor, I thank you. I am sorry to interrupt 
you. I wonder if Dr. Agarwal can describe more generally for 
other programs across the country where the VA is now trying to 
identify those low-volume programs and procedures and target 
them for medical effectiveness.
    Dr. Agarwal. Congressman, thank you for that question. You 
are absolutely correct. You know, we are committed to providing 
quality health care all across the board. We have a rigorous 
performance measurement system with about 250 or so indicators 
that are currently in place that are used to track at the 
individual level, the facility level, the network level, and at 
the national level. But I think it has been eluded to, at least 
I think by the individual from Joint Commission, that no matter 
how many measurements or measures you have in place it is 
somewhat of a challenge to do it very comprehensively for every 
nuance where we deliver health care.
    So we have learned a lot from some of the instances that 
have happened in our recent past, or even more distant past, 
and every time when an issue arises, be it a surgical issue in 
a certain place or the use of endoscopy or reprocessing issues, 
or right now with brachytherapy, we take that as something to 
improve our entire system.
    There is a very rigorous effort to look at it internally 
with internal oversights with our System-wide Ongoing 
Assessment and Review Strategy (SOARS) program and our 
Clinician Administered PTSD Scale (CAPS), and of course we have 
external accrediting bodies that come into play.
    There are a couple recent directives that have been in 
place and--a relatively new office--Office of Associate Deputy 
Under Secretary for Quality and Safety has been stood up with 
the explicit purpose of ensuring that we continue to maintain 
and sustain high quality care and have a higher degree of 
accountability in quality and safety for all health care 
delivery across the Nation.
    Mr. Adler. Doctor, I thank you, I am sure you don't want to 
have to come testify before us again and again. I can assure 
you on behalf of the Members of the Subcommittee we don't want 
to have to bring panels before us to explain why veterans 
didn't get the quality of care they deserve, and most 
importantly I am sure veterans don't want to be missing the 
care they have earned.
    Dr. Agarwal. Congressman, you are right.
    Mr. Adler. I thank you. I yield back, thank you.
    Mr. Mitchell. Thank you. Just two quick questions.
    First, I understand that the VA OIG report found that none 
of the clinical staff in Philadelphia had received the Nuclear 
Regulatory Commission recommended training. Is that correct?
    Mr. Moreland. I don't have that information with me. I can 
certainly get that information and provide it to you, sir.
    [The report was received on August 5, 2009, and will be 
retained in the Committee files.]
    Mr. Mitchell. Yeah, this was just a report that, it was the 
Administrative Board of Investigation. Any way, if that is true 
I am sure that we need to make sure that all of those 
procedures are followed and that everybody involved with this 
has the recommended training.
    Dr. Hagan. Mr. Chairman, I can add that they have certainly 
received that training now. That was part of the response to 
NRC. As one of the seven points ways that training would be 
conducted. This was fully implemented as of the 1st of May. So 
all centers have had that training now.
    Mr. Mitchell. One other quick question.
    Dr. Agarwal, you mentioned that everyone has been 
contacted, everyone who received the brachytherapy. And you 
also said, Dr. Hagan, that success is based on if the PSA goes 
up or whatever. Those that had low dosages because the seeds 
were not properly implanted, do you know if any of those were 
the ones that the PSA has gone up?
    Because what is horrible about this is that there is not 
too many options once you have the radiation therapy, and the 
options aren't really the nicest. And so I just wonder if 
anybody who had undergone the treatment at Philadelphia who had 
low doses, if any of those people are one that is are having an 
elevated PSA.
    Dr. Hagan. Mr. Chairman, I can't specifically----
    Mr. Mitchell. Yeah, and it could happen in spite of that 
any way. They could have had the right ones and it still could 
have gone up.
    Dr. Hagan. And I would not be surprised to find that that 
is the case.
    However, one piece of information I can add is that it is 
very unusual to see recurrent disease within the prostate in an 
area that has been adequately treated with brachytherapy. The 
corollary to that statement is that it is possible then with a 
supplemental implant or a salvage implant as we term it in the 
literature, to recapture PSA control in disease that has not 
escaped the prostate. And so that is a procedure that though 
not done commonly has been done. We have done it in Richmond. 
And Dr. Wallner has addressed some of the patients from 
Philadelphia in that regard.
    Mr. Mitchell. Thank you. Dr. Roe.
    Mr. Roe. Just very quickly. I guess one of the things that 
I would bring up and you all probably looked at it, there is a 
certain volume of patients you need to do to get good at 
something, and if you are doing 14, 15, 1 a month, it is a lot 
harder to get really good at it unless you are doing 1 a day or 
1 every 3 days or something like that like probably you are in 
Washington. So I would look at my volumes. If you look at 
volumes in cardiac surgery and any other surgery, cancer, 
chemotherapy, whatever, you are doing a lot of you are just 
good at it. And I would certainly look at it. And maybe it is 
more inconvenient for the veteran, but it is better to get it 
done right than to get it done not right, so I would do that. 
And I think very simply it would be easy to get a set of 
standards for nine hospitals. I say easy, relatively easy, and 
follow those procedures. That is exactly what we found in our 
endoscopy, and then expect people to do it. Train them.
    One of the things, Mr. Chairman, we insisted on during 
that, if you remember, is the training that all are to have, 
and it sounds like we need to document everybody that has been 
trained, are we doing the same procedure, and if you vary in 
that procedure you better halt what you are doing until you're 
back doing the correct thing. And I think that could easily be 
done in this therapy.
    And I also want to thank whoever stepped up. This happened 
in Murfreesboro, the endoscopy issue, and whoever the person 
that stepped up and said we want to do what is right for 
patients, even though they knew it was going to bring them a 
lot of grief, which it did I am sure, was the right thing to 
do, and I applaud someone who will step up and look after the 
benefit of patients.
    So I appreciate you all being here today and I yield back, 
Mr. Chairman.
    Mr. Mitchell. Thank you. Any other questions?
    Well again, I would just as Dr. Roe said, thank you so much 
for doing this, and we understand this was self-reported, and 
you taking corrective actions, and that is the important thing, 
that these things don't happen again and we can learn from all 
these mistakes and hopefully get better at it.
    So again thank you very, very much. And with that this 
hearing is adjourned.
    [Whereupon, at 1:21 p.m., the Subcommittee was adjourned.]



                            A P P E N D I X

                              ----------                              

        Prepared Statement of Hon. Harry E. Mitchell, Chairman,
              Subcommittee on Oversight and Investigations
    I would like to thank everyone for attending today's Oversight and 
Investigations Subcommittee hearing entitled, Enforcement of U.S. 
Department of Veterans Affairs Brachytherapy Safety Standards. Thank 
you especially to our witnesses for testifying today.
    All the Members of this Subcommittee take particular interest in 
this issue as well as the care of our Nation's veterans; however, I 
would like to especially thank Congressman John Adler of New Jersey for 
being such a passionate advocate of this issue. Reports of botched 
prostate cancer procedures, a lack of quality and standard controls in 
the VA health care system and egregious errors in the brachytherapy 
treatment at the Philadelphia VA Medical Center are unacceptable and 
wrong.
    Brachytherapy is a form of radiotherapy, often used to treat 
prostate cancer, in which radioactive seeds are placed inside or next 
to a patient's malignancy. Failure to accurately place the radioactive 
seeds can cause serious harm. To say that it is disturbing to learn 
that veterans received bungled procedures and that safety protocols 
failed to safeguard against such mistreatment would be an 
understatement. As a result, we are here today to examine the system-
wide safety standards for these procedures to ensure that our veterans 
are receiving the best and safest care available.
    In 2003 and 2005, the Nuclear Regulatory Commission (NRC) received 
reports of botched placement of radioactive seeds and inconsistent 
dosage at the Philadelphia VA Medical Center. After careful review, it 
was determined that no NRC protocols were violated. In May of last 
year, the NRC received a notification of potential under dosing at the 
Philadelphia VA Medical Center. This led to a VA National Health 
Physics Program Inspection (NHPP), evaluating all 116 brachytherapy 
treatments that took place since the creation of the program in 2002.
    The New York Times reported last month that investigators for the 
Nuclear Regulatory Commission and VA officials found that 92 of the 116 
men treated at the VA Medical Center in Philadelphia's brachytherapy 
program received incorrect doses of the radiation seeds, often because 
they landed in nearby organs or surrounding tissue, rather than the 
prostate. Dr. Gary Kao, who is here today at this hearing, performed 
the majority of the procedures under a VA contract with the University 
of Pennsylvania, where he was on staff. Out of the four suspended 
brachytherapy programs, we know that Philadelphia was by far the worst.
    On top of this, in March of this year, the NRC issued a detailed 
inspection report citing the Philadelphia VA Medical Center with six 
violations of NRC regulations. This is downright unacceptable. While we 
are disturbed that, perhaps, there was a lack of proper local quality 
controls and management of these brachytherapy programs, our main 
concern is that the problems marring the program in Philadelphia could 
be happening at the other nine facilities still doing these procedures.
    As such, we have asked the VA Office of Inspector General to review 
and assess the VA's brachytherapy programs and, although the complete 
NRC inspection report on the Philadelphia program, along with the other 
VA facilities using brachytherapy treatments, as well as the NHPP 
performance is not complete, we look forward to reading that report 
when it becomes available.
    Though it is commendable that VA's leadership took swift action 
once these issues were reported, it is still troubling that it took 
almost 6 years for these events to actually be reported. Even more 
troubling is just last month we were here discussing quality control 
and lack of proper procedures and oversight of endoscopy procedures 
being conducted by the VA, yet we are here again, questioning the 
quality of care our veterans receive.
    The VA health care system relies upon a complementary system of 
accountability to identify quality control problems throughout the 
entire system and at individual levels. Failure to ensure consistent 
oversight and safe treatment is unacceptable and wrong. I am anxious to 
hear VA assurances not only to this Subcommittee, but to all the 
veterans they serve, that the issues identified, once a thorough review 
has been conducted, is not occurring at any of the remaining 
brachytherapy programs across the country, and that the four suspended 
programs may continue to deliver this important treatment to our 
veterans. Last, I am equally interested in hearing from one of one our 
witnesses, Dr. Kao, regarding allegations of erratic seed placements, 
as well as experts we have invited to provide their thoughts on the 
safety and effectiveness of the treatment.
    Thank you again to all of our witnesses for testifying today and we 
look forward to your testimony.

                                 
  Prepared Statement of Hon. David P. Roe, Ranking Republican Member, 
              Subcommittee on Oversight and Investigations
    Mr. Chairman, I appreciate you holding this hearing today.
    The issue we should really be addressing today is not only the 
instance of alleged medical malfeasance by one particular medical 
practitioner, but whether or not this is a symptom of an overreaching 
patient safety issue across the VA. Just last month, we held a hearing 
on the problems relating to the cleaning and reprocessing of endoscopy 
equipment at the VA. Now we are hearing testimony today to discuss 
problems with brachytherapy treatments at the VA Medical Center in 
Philadelphia.
    Prostate cancer is a major problem for adults over age 50 in the 
United States, and brachytherapy is a treatment tool used by 
oncologists to treat prostate and other cancers. The VA treats around 
575 veterans annually with low dose-rate brachytherapy at 13 centers 
nationwide.
    We need to tread cautiously here today. As we hear testimony from 
the VA and other officials, we need to keep in mind the good quality 
care most veterans seem to be receiving at VA medical facilities, and 
not seek to undermine the confidence veterans have in going to the VA 
for their health care needs. That being said, I am gravely concerned 
that these issues continue to crop up in the news media. VA needs to do 
a better job at policing itself, before they let the New York Times 
sensationalize an issue in order to break the public's trust.
    Mr. Chairman, the protection of our Nation's veterans who look to 
the VA for their care is of primary importance. To hear continual 
reports of various health issues, such as the endoscopy cleaning issue 
last month, and now the problem with brachytherapy at select facilities 
is worrisome to me. We must continue to ensure that our veterans 
receive the best possible care available. I look forward to hearing the 
testimony from today's witnesses and yield back my time.

                                 
       Prepared Statement of Gary D. Kao, M.D., Ph.D., Associate
   Professor of Radiation Oncology, Department of Radiation Oncology,
    University of Pennsylvania, School of Medicine, Philadelphia, PA
    Thank you, Congressman Mitchell and other Members of the Committee, 
for the opportunity to voluntarily appear before you so that I may be 
heard on this important subject matter and correct some very serious 
false allegations about me contained in recent publications, most 
notably the New York Times.
    I have worked very hard in my life to best serve the field of 
radiation oncology and my patients in over 15 years of clinical 
practice. My dedication to my work is reflected in my educational 
achievements--earning a Bachelors degree in Philosophy and a Medical 
Doctor degree from John Hopkins University and its School of Medicine, 
followed by medical internship and residency, and completion of 
residency in Radiation Oncology at the University of Pennsylvania 
School of Medicine. This culminated in Board Certification in Radiation 
Oncology. I am especially proud that during continuous clinical 
practice of medicine for over 15 years, I have not had a single 
malpractice claim filed against me. My record and my commitment to the 
care of my patients make the false accusations against me particularly 
devastating and misguided.
    I, along with others at the VA, implemented the Program for 
Brachytherapy in 2002 within the Philadelphia VA to serve the best 
interests of veterans. Contrary to the allegations that I was a 
``rogue'' physician, we developed precise standard operating procedures 
and a system of oversight and monitoring of what was then a state-of-
art treatment. We formulated the first algorithm of any radiation 
oncology procedure at the VA, to define the standard operating 
procedure. As would be expected in any new program, the brachytherapy 
program was not without its challenges.
    However, what has become clear over the last month is that a 
fundamental misunderstanding of elementary principles and concepts has 
led some to arrive at an inappropriate and incorrect conclusion--that 
deficient care was routinely rendered to veterans who received 
brachytherapy at the Philadelphia VA. This was not the case and to 
understand why it is important to understand certain critical issues 
related to the NRC's definition of a reportable medical event and its 
applicability to our work at the VA.
    Here are the facts:

       Fact 1: A standard definition of a reportable medical event as 
it applies to Brachytherapy was not in existence when the Program 
started at the VA. The definition was not referenced in my training in 
Brachytherapy at the Northwest Hospital in Seattle, nor was it 
clarified by NRC personnel in their investigations in 2003 or 2005 when 
they were onsite at the Philadelphia VA. The definition that the NRC 
has now chosen to retroactively apply to all cases of the Philadelphia 
VA Program is predicated on a deviation from D90, the dose received by 
90 percent of the prostate, but it is a definition that does not appear 
anywhere in the regulations published by the NRC. It should also be 
noted that there is significant disagreement within the medical 
community regarding the appropriateness of D90 as a defining metric for 
a reportable Medical Event. Studies analyzing large numbers of patients 
appropriately selected for brachytherapy suggest that there are very 
few relapses even in patients who had a D90 < 80 percent.
       Fact 2: The definition of a reportable medical event as it 
applies to brachytherapy is not only unclear, but it is evolving. The 
Medical Advisory Committee of the NRC has repeatedly recommended that 
the definition be changed from one that is dose-based to a definition 
that is activity-based, i.e. the number of seeds. Last summer, the NRC 
proposed a rule to change the definition, but the NRC is still using 
the old definition--unpublished--to evaluate the Philadelphia VA's 
brachytherapy cases.
       Fact 3: The fact that a reportable medical event to the NRC 
occurred does not mean that the treatment did not meet the standard of 
care. A patient whose treatment results in a reportable medical event 
may still have received effective treatment that is within the 
appropriate standard of medical care. A patient's prostate may 
temporarily swell after the procedure, or the size and shape of the 
prostate or the patient's medical condition may dictate that a higher 
or lower dose of radiation is prudent.
       Fact 4: Whether brachytherapy treatment has been delivered 
consistent with the standard of care should not be determined by 
whether the treatment resulted in a reportable medical event to the 
NRC. There are many more significant factors that determine appropriate 
treatment such as: the number of seeds; the location of the seeds in 
the prostate; the location of seeds outside the prostate; the 
concentration of seeds to the affected area of the prostate; the size 
and shape of the prostate; the stage, grade, extent and location of the 
cancer; and the clinical follow up of PSA test results. None of these 
factors are addressed by the NRC.

    I also wish to address the now oft-repeated reference to ``92 
botched cases.'' This characterization is simply wrong--it is unfair 
and extremely misleading. A case that meets the NRC definition of a 
reportable Medical Event does not mean that a patient received 
ineffective or ``botched'' care or that the treatment did not meet the 
standard of care that existed at the time the treatment was given. The 
Preplanned Method that we used was ``state of the art'' in 2002, and 
was used effectively to treat the patients that we carefully screened 
for the procedure. The efficacy of the treatments is evidenced by the 
fact that there were no confirmed cases of tumor recurrence at the time 
the Program was terminated in 2008, with many patients doing well up to 
5 years after their brachytherapy treatment.
    Furthermore, the NRC review which allegedly resulted in ``92 
reportable cases,'' was determined by the NRC through a reanalysis of 
our data without the participation of the personnel who administered 
the Brachytherapy Program. Such participation would have been essential 
to an understanding by the NRC investigators of how each of the 
prostates was contoured prior to the treatment. It is well recognized 
in the radiation oncology community that the prostate contouring 
process is very subjective and that prostate volumes can vary 
substantially depending on who performs the contouring. The D90 dose 
calculated by different reviewers may vary by as much as 60 percent. 
The calculations performed by our Team indicated that the number of 
patients with D90 below or higher by 20 percent than prescribed was far 
fewer than 92 cases. Although I do not have access to the patients' 
data and files, I do not believe that there are close to the 92 
reportable cases identified by the NRC, even by applying the NRC's 
unpublished D90 standard. While I acknowledge that there would likely 
have been a higher number of reportable Medical Events at the PVAMC if 
we had been informed of the current NRC definition, the number would be 
substantially below 92 cases.
    The field of Brachytherapy is a relatively new and rapidly evolving 
field. While certain conditions and circumstances at the Philadelphia 
VA could have been improved, I am confident, based on my knowledge of 
the field and the nature of the patients treated at the VA during my 
tenure, that the patients received appropriate medical care that was 
effective in addressing their prostate cancer.
    It is my hope that, through my statements and my testimony, I am 
able to contribute to a fuller understanding of brachytherapy 
treatment, bring a degree of reassurance to our veterans regarding the 
treatment that was provided, and ultimately help to improve care for 
our veterans.
ADDENDUM
    As the physician that led the PVAMC Prostate Brachytherapy Program 
(``Program''), I must accept a portion of the responsibility for some 
of the breakdowns in performance of the Program. However, as explained 
in the statements provided to the U.S. Senate Committee on Veterans' 
Affairs Field Hearing on June 29, 2009, many of the allegations and 
conclusions concerning the Program are simply not accurate and convey 
inappropriate conclusions about the care provided to the veterans and 
the import of the NRC regulations concerning ``reportable Medical 
Events''. My efforts in supplying the statements, in voluntarily 
appearing at the Senate Field Hearing and in providing this Addendum 
are not designed to affix blame to others, but rather to provide better 
insight to the appropriate context of the fundamental precepts of 
brachytherapy at the VA. In so doing, I expect that the false 
statements made about the Program will be re-addressed and that some 
measure of comfort will be rendered to the veterans who received care 
at the VA. Additionally, I recognize that improvements to the Program 
and the VA can be made and therefore, have made certain recommendations 
based on my experience with the Brachytherapy Program at the VA in 
Philadelphia. For purposes of convenience, I reiterate those 
recommendations here as follows:

    1.  A system should be established so that a treating VA physician 
is notified whenever his or her patient presents for treatment at any 
other VA medical center. This should be accomplished with appropriate 
confidentiality and privacy safeguards, but which would enable a VA 
physician to have access to the patient's electronic medical records at 
any other VA medical center.
    2.  For complex medical procedures such as brachytherapy, there 
should be a uniform set of standard operating procedures established 
through a collaboration of the involved health care professionals and 
administrative personnel. Once defined, these standard operating 
procedures should be applied throughout the entire VA system, with 
appropriate training.
    3.  There should be a method of categorizing systematic problems by 
level of urgency so that serious problems, such as those involving 
failures of medical equipment or transfer of patient-related data, will 
receive immediate attention from the proper personnel and be quickly 
resolved.
    4.  There should be a formal system which would require the NRC and 
other national regulatory bodies to continually train doctors and other 
personnel in the latest defined standards.
    5.  The respective medical disciplines of separate VA hospitals 
should have a formal system of continuous dialog together about 
difficulties encountered during practice, and possible suggested 
solutions. This could be accomplished with the aid of a 
videoconferencing system to which all VA physicians have access.
    6.  For every complex medical procedure, there should be sufficient 
funds for the VA to provide timely and complete care to veterans. 
Relating to my own experience, having a full-time medical physicist 
dedicated to brachytherapy would have enabled us to transition earlier 
to a real-time system of brachytherapy.

    As a final note, I wish to draw attention to two issues discussed 
at the June 29 Hearing which should be clarified.
    First, regarding the number of reportable Medical Events, it should 
be noted that the Philadelphia VA hospital was not the only VA facility 
which was found to have unreported Medical Events. In at least three 
other VA hospitals the NRC found unreported events. It is significant 
to note that the reviews of these other hospitals consisted only of a 
small sampling of their cases, a fact that has not been revealed to 
date. In contrast, the Philadelphia VA was subjected to a full audit. A 
full audit at those other institutions would have disclosed more than a 
few instances of reportable Medical Events. Supporting the probability 
of a higher number of Medical Events that currently remain unreported, 
a Member of the advisory Committee to the NRC (Advisory Committee on 
Medical Uses of Isotopes), Subir Nag, M.D., said that of the 100,000 
cases of the Prostate Brachytherapy Program across the country 
(including those outside the VA) applying the current NRC definition of 
reportable Medical Event, ``you are going to have 20,000 cases which 
will meet the current definition of [reportable Medical Event].'' It is 
highly unlikely that the Philadelphia VA would be an isolated 
aberration, if a similar degree of audit was to be performed.
    Second, at the hearing, there were several references to ``92 
botched cases''. This was very misleading as I explained in my original 
submitted statements. For the many reasons articulated, a case that 
fits the NRC definition of a reportable Medical Event does not imply 
that ineffective or ``botched'' care was given, and which did not meet 
the medical standard of care. Furthermore, the NRC review which 
allegedly resulted in 92 reportable cases, was a reanalysis of our data 
performed without the participation of the personnel who administered 
the Brachytherapy Program. We dispute that there were 92 reportable 
Medical Events, but we do not have access to the patients' data and 
files. It is well recognized in the radiation oncology community that 
the prostate contouring process is very subjective, and prostate 
volumes can vary substantially depending on who performs the 
contouring. The D90 dose calculated by different reviewers can 
therefore vary by as much as 60 percent. While we acknowledge that 
there would have been a substantial number of reportable Medical Events 
at Philadelphia VA had we been informed of the current NRC definition; 
the number would be substantially below the now oft-quoted allegation 
of 92 cases.

                                 
     Prepared Statement of Stephen M. Hahn, M.D., Henry K. Pancoast
         Professor and Chair, Department of Radiation Oncology,
    University of Pennsylvania, School of Medicine, Philadelphia, PA
    Mr. Chairman and Members of the Committee, I am grateful for the 
opportunity to appear here today. I am a professor of radiation 
oncology at the University of Pennsylvania and since 2005 have been the 
chair of the University's Department of Radiation Oncology.
    Before going any further, I want to express my deepest regret that 
prostate cancer patients receiving brachytherapy at the Philadelphia 
Veterans Affairs Medical Center (PVAMC) did not in every instance 
receive the best possible care. My highest priority as a physician and 
as chair of our Department is to make sure patients receive the best 
possible care. I want to personally apologize to the patients and their 
families for the distress this has caused. I also know that this entire 
experience has been very difficult for the VA health care system, 
particularly in Philadelphia, as it has been for my Department. Penn 
Medicine's relationship with the PVAMC is long standing and very 
important to our mission as an academic medical center dedicated to 
patient care, teaching and research. We value our work with the PVAMC 
highly and believe that both our organizations have learned a great 
deal from this painful experience that will serve to improve patient 
care in the future.
    I will focus most of my testimony today on the steps we have taken 
in the last year in response to this situation and the process 
improvements we have implemented at Penn that we believe will enhance 
the quality of care for patients undergoing brachytherapy. First, 
however, I want to provide some background information which I think 
should be useful regarding prostate brachytherapy as well as a 
description of our Department's role at the PVAMC.
    Prostate brachytherapy refers to the permanent implantation of 
small radioactive seeds into or around the prostate gland to treat 
prostate cancer. Along with prostate removal surgery and external beam 
radiotherapy, prostate brachytherapy represents a well-established 
option for the treatment of prostate cancer. During the procedure, the 
physician implants the seeds using loaded needles. The placement of the 
needles and seeds is determined by a ``pre-plan,'' in which the dose to 
the prostate and desired location are estimated by a medical physicist 
and confirmed by the physician (based on an ultrasound image of the 
patient's prostate), as well as ultrasonic image guidance at the time 
of the implant.
    The implanted seeds' location determines the radioactive dose 
delivered to the prostate and surrounding tissue. It is important to 
note, however, that even among experienced and skilled physicians there 
is variation in the results afforded by prostate implant brachytherapy, 
not only with respect to patient outcome and possible complications, 
but also with respect to dose delivered to the prostate volume and 
surrounding tissue. This can be due to patient anatomy (the texture of 
the prostate, and normal anatomical variation); prostate swelling after 
implantation; and the way that the dose to the prostate is measured 
after the implant--often by identifying the prostate and seeds on a CT 
scan--which itself can allow for considerable variation in the measured 
dose. I offer these facts not as an excuse, but only to make the point 
that this is a complicated therapy.
    The University's Department of Radiation Oncology, through a 
contract with the PVAMC, provides radiation oncology services, 
including brachytherapy. Radiation oncologists working at the PVAMC are 
either employed directly by the PVAMC or Department faculty provided 
under the contract.
    When the Department first learned in May 2008 of potential concerns 
about the prostate brachytherapy program at the PVAMC, we took 
immediate action. The Department provided several faculty members and 
staff to the PVAMC to assist with a quality review of all prostate 
brachytherapy cases. In June 2008, when concerns arose regarding Dr. 
Gary Kao's cases in particular, Dr. Kao agreed, at my request, to 
suspend his clinical practice, and he has not treated any patients 
since that time at the PVAMC or at our hospitals. Since last summer, 
Department faculty, as part of their responsibilities at the PVAMC, 
have been coordinating patients' follow-up care and closely following 
PVAMC patients with symptoms of concern. In addition, since the VA and 
the Nuclear Regulatory Commission (NRC) began investigations into this 
matter in June 2008, we have cooperated fully, and we will continue to 
do so.
    At the same time as the VA and NRC undertook their investigations, 
in June 2008 we also reviewed quality control and improvement measures 
to determine whether we could enhance them to prevent a situation like 
this from ever happening again. Although our Department's brachytherapy 
programs have been in compliance with the American College of Radiology 
and the American Society of Therapeutic Radiology and Oncology's 
Practice Guideline, we have adopted an additional review process that 
provides for persons who did not take part in the procedure to assess 
the quality of each prostate brachytherapy implant. This quality review 
process includes a re-review of the CT scan and a recalculation of the 
delivered dose. We also have established a multi-level internal 
reporting system so that even slight anomalies will be reported to our 
quality assurance Committee and reviewed, regardless of whether they 
rise to the level of an NRC-reportable event.
    Another very significant development is that we recently completed 
the transition to a new brachytherapy implant protocol. At the Hospital 
of the University of Pennsylvania, in early 2008, as part of ongoing 
quality improvement, we began transitioning to what is called ``real-
time dosimetry,'' which incorporates new equipment and programming and 
allows for calculation and recalculation of the dose delivered to the 
prostate after each radioactive seed is implanted during the procedure. 
This provides the attending physician with instantaneous feedback and 
an opportunity to modify his or her plan if necessary to achieve the 
desired radioactive dose to the prostate. We believe this approach 
should lead to greater consistency with respect to seed location and 
the delivered dose.
    I do not know if the PVAMC intends to restart its permanent 
prostate brachytherapy program, but if and when it does, we would of 
course assist the PVAMC in modernizing its program along these lines.
    The steps my Department has taken in response to this issue also 
have been reviewed by Penn Medicine quality reviewers and senior 
physicians. Further, to assure ourselves that we have considered every 
safety and quality option, we will be requesting an additional review 
by outside experts.
    Before closing, I want to address briefly the NRC regulations 
applicable to prostate brachytherapy. I am confident that the NRC, the 
PVAMC, and the University all share the desire to see clear and 
consistent prostate brachytherapy regulations instituted so that we can 
all be confident that uniformly high quality care is delivered to all 
patients who undergo this procedure. In August 2008, the NRC, based on 
recommendations from its Advisory Committee for the Medical Uses of 
Isotopes, published proposed amendments to its regulation that 
establishes what constitutes a reportable ``medical event.'' That 
proposed rule would have gone some way toward removing the ambiguity 
that exists in the current rule as applied to prostate brachytherapy, 
inasmuch as the current rule does not specify how a deviation from 
desired dose is to be measured, or at what point in the treatment 
process. It is my understanding, however, that the NRC is reconsidering 
the proposed rule in light of this case. In my view, the criteria the 
NRC applied to these cases are overbroad, and they are not generally 
accepted by experts in the field or, I believe, experts on the NRC's 
own Advisory Committee. The criteria could result in reporting to the 
NRC when there was neither a poor implant nor suboptimal patient care. 
My point here is not to contest the importance of the issue we are 
dealing with today--were it simply one instance in which a veteran 
received less than the best possible health care, I would find that 
just as unacceptable. I share a desire with my colleagues at the VA and 
the NRC to create clear rules and regulations leading to the delivery 
of quality care, and I believe it would be of great use to the medical 
community at large for the NRC to clarify its regulations as they apply 
to prostate brachytherapy, which will make it more likely that any 
developing problem elsewhere will be discovered at the earliest 
possible time.
    Mr. Chairman, and Members of the Committee, let me again stress 
that Penn is committed to providing the highest standard of care to our 
Nation's veterans and to working closely with the VA moving forward.

                                 
     Prepared Statement of Michael R. Bieda, M.S., Clinical Chief,
     Division of Medical Physics, Department of Radiation Oncology,
    University of Pennsylvania, School of Medicine, Philadelphia, PA
    Mr. Chairman and Members of the Committee, thank you for the 
invitation to appear here today. I would like to use my time to provide 
you with some information about my background, as well as a description 
of the medical physicist's role in prostate brachytherapy.
    In 1996, I was awarded a master's degree in physics from University 
of Tennessee, and in 1999, was graduated from the master's program in 
medical physics at the MD Anderson Cancer Center at the University of 
Texas Health Science Center at Houston. Since that time, I have worked 
as a medical physicist at the Johns Hopkins University Oncology Center 
in Baltimore; at Christiana Care Health Systems in Newark, Delaware; 
and at Bryn Mawr Hospital In Bryn Mawr, Pennsylvania, in addition to 
the University of Pennsylvania's Department of Radiation Oncology. I 
first worked at Penn from 2002 to 2005, and then returned in August 
2006 to take the position of clinical chief of medical physics for the 
Department.
    I am certified by the American Board of Radiology, in therapeutic 
radiological physics, and I have had several publications in the 
journal Medical Physics.
    A medical physicist does three things to assist in prostate 
brachytherapy.
    First, based on the doctor's prescription, which specifies the 
amount of radioactivity to be implanted into the patient, the physicist 
prepares what is called a preplan. To do this, the physicist will 
review a series of ultrasound images of the prostate that is taken by a 
doctor and in which the doctor has identified the prostate. With this 
information from the doctor, the physicist will plan the places where 
the radioactive seeds should be implanted into and around the prostate 
and estimates the radioactive dose to be delivered to the prostate. 
This plan always is confirmed (or revised) by the doctor.
    Second, not long before the doctor is to perform the implant, the 
physicist will check the activity level of a sample of the seeds to be 
implanted and deliver those seeds to the doctor in the operating room.
    The third thing a physicist does takes place after the implant. At 
the PVAMC, the doctor would order a CT scan of the patient's prostate 
the day after the implant. On this CT scan, the physicist would 
identify the location of the implanted seeds, using a dedicated 
computer program for this purpose. Once this was done, the doctor would 
locate the prostate on the CT scan and draw it in. This would allow the 
computer program to generate a ``dose volume histogram,'' essentially a 
graph showing how much of the prostate received how much of a dose, as 
well as different dose parameters. This information is often referred 
to as ``post-implant dosimetry.''
    Post-implant dosimetry is performed so that the doctor might 
evaluate the implant as part of his overall assessment of his ongoing 
treatment plan for the patient.
    I recognize that the Committee may have questions, and I will do my 
best to answer them.
    Again, thank you for your consideration of my testimony.

                                 
              Prepared Statement of Paul M. Schyve, M.D.,
              Senior Vice President, The Joint Commission
    Mr. Chairman, Ranking Member, and Members of the Committee, on 
behalf of The Joint Commission, thank you for the opportunity to 
testify at this important hearing.
    The Joint Commission accredits approximately 146 Department of 
Veterans Affairs organizations, including all of its hospitals. We 
strive to assure that our Nation's veterans are receiving high quality 
and safe care.

    Joint Commission accreditation is a risk-reduction process, based 
on:

      First, establishing evidence-based Standards, National 
Patient Safety Goals, and Performance Measures
      Second, collection of data about a hospital in the form 
of performance measures (including patient outcomes), complaints, and 
past survey results
      Third, periodic unannounced onsite surveys of the 
hospital, focused on the care provided to a selected cohort of patients 
whose care is ``traced'' throughout their hospitalization
      Fourth, feedback to the hospital of the results of its 
survey and required improvements, including a timeline for their 
implementation
      Fifth, public reporting of the results of the survey on 
the Internet and to the Veterans' Health Administration
      Sixth, an annual self-assessment by the hospital of its 
ongoing compliance with Joint Commission standards

    I described accreditation as a risk-reduction process. No process 
can entirely eliminate risk in health care. Hospital-level health care 
is inherently risky. It has all the characteristics identified in other 
high-risk endeavors:

      Complexity
      Variable input--that is, patients
      Time constraint
      Tight coupling
      Heavy dependence on human intervention--since ``to err is 
human.''

    So in health care, adverse events will happen. The Joint 
Commission, the Veterans' Administration, and this Committee all share 
the goal of reducing adverse events and protecting patients from their 
harmful effects.
    By studying other high risk endeavors that have developed enviable 
safety records--such as the commercial air passenger system, nuclear 
power, and aircraft carrier flight decks--health care is learning how 
to become a ``high reliability'' endeavor also.
    The first step is the development of evidence-based, standardized 
policies and procedures, educating personnel in their implementation, 
making them available as memory-aids (such as in check lists) to 
facilitate their use, and monitoring whether they are followed. This 
may be all that is necessary to assure high reliability in a production 
line to manufacture widgets. But it is only the beginning in a high 
risk endeavor like health care.
    In health care, unexpected adverse events and unpredicted 
outcomes--often called ``unintended consequences''--occur regularly, 
despite the best designed and monitored policies and procedures. To 
create high reliability in health care, therefore, requires three 
additional components:

      The first component is constant attention to things that 
are unexpected or go wrong in order to learn from them so as to prevent 
their recurrence. However, personnel will only report errors and other 
adverse events in an atmosphere of trust in which they will be 
rewarded, not punished, for reporting, and their reports will be taken 
seriously and acted upon.
      The second component is prospective risk identification 
and prevention whenever new processes are to be implemented or existing 
processes changed. By prospectively redesigning the proposed processes 
to eliminate the risk or building in protections for patients when the 
risk cannot be eliminated, patients can be protected from harm. While 
the first component is to learn from adverse events to prevent their 
recurrence, this second component is to learn before the adverse events 
to prevent their occurrence.
      The third component of high reliability--and perhaps the 
hardest to achieve and maintain--is a ``culture of safety.'' A culture 
of safety means that safety is consistently on everyone's mind, there 
is preoccupation with the possibility of failure, a sensitivity to the 
detail of operations, and constant vigilance for the small unexpected 
events--because small events can lead to big, sometimes disastrous 
outcomes in complex processes such as those in health care.

    Unfortunately, no oversight body, whether the Veterans' Health 
Administration, the Nuclear Regulatory Commission, or The Joint 
Commission, is able to identify all the risks and even all the actual 
breakdowns in a hospital. Nor can the oversight bodies create the 
cultures of trust and safety in the hospital needed for high 
reliability. Only the hospital itself can. The oversight bodies can set 
expectations, provide guidance, educate, and evaluate in order to 
enable and incentivize the hospital to make this change.
    To that end, The Joint Commission has established standards that 
require the hospital to:

      Create a culture in which adverse events are reported and 
evaluated for underlying (``root'') causes, and preventative actions 
are taken.
      Identify high-risk processes and prospectively determine 
their possible modes of failure, the effects of those failures, and the 
actions that will prevent the failures or mitigate their effects.
      Establish a culture of safety throughout the hospital. 
This accreditation standard became effective January 1, 2009, although 
its purpose and expectations were publicized for over a year in 
advance.

    When The Joint Commission surveys a hospital, the surveyors always 
physically examine the radiology imaging services and, if the hospital 
provides it, its external beam radiation oncology services. From this 
case, The Joint Commission has learned that a hospital may provide 
brachytherapy services that, because they are usually a low-volume, 
highly specialized service within the radiation oncology department, 
may not be reported by the department as part of the services it 
provides--and, therefore, may be unknown to the surveyor. Brachytherapy 
is especially highly specialized and technical--utilizing the expertise 
of a urologist, a radiation oncologist, and a radiation physicist. Even 
when its presence is known to the surveyor, it is not possible for the 
surveyor to have the specialized technical knowledge to review the 
effectiveness of the dosing schedule for the patient. However, based on 
this case, The Joint Commission will instruct its surveyors to ask if 
brachytherapy is provided, and, if so, to examine whether the hospital 
is providing the monitoring and peer review oversight that 
brachytherapy requires. And, beginning this year, the surveyors are 
evaluating what the hospital's leaders are doing to create a culture of 
safety in their hospital.
    The Veterans' Health Administration has been a leader in learning 
from adverse events in its hospitals, in disseminating that knowledge 
to other hospitals in its system, and in openly discussing with The 
Joint Commission the events and their investigations and responses. 
They have also started down the long road of creating a culture of 
safety in their hospitals. The Joint Commission's goal is to assist 
both the Veterans' Health Administration and its individual hospitals 
to make this transition. Only by transforming our Nation's hospitals 
into high reliability organizations will health care fulfill its 
obligation to all our Nation's citizens--including its veterans--to 
``first, do no harm.''
    On behalf of The Joint Commission, I would like to thank you again 
for this opportunity to testify.

                                 
Prepared Statement of Steven A. Reynolds, Director, Division of Nuclear 
     Materials Safety Region III, United States Nuclear Regulatory 
                               Commission
INTRODUCTION
    Chairman Mitchell, Ranking Member Roe, and Members of the 
Committee, I am honored to appear before you today to discuss the U.S. 
Nuclear Regulatory Commission's (NRC) regulatory role, actions, and 
findings to date regarding medical events at the U.S. Department of 
Veterans Affairs hospitals, particularly the Veterans Affairs Medical 
Center in Philadelphia, Pennsylvania (VA Philadelphia). I hope that my 
testimony will be helpful to the Committee's work.
NRC'S REGULATORY ROLE
    The NRC is an independent agency created by Congress to license and 
regulate the civilian use of radioactive materials. The NRC issues 
licenses to facilities that authorize the safe and secure possession 
and use of radioactive material. In the nuclear medicine area, the NRC 
does not regulate the practice of medicine. NRC's regulations seek to 
ensure the adequate protection of those working with radioactive 
material, as well as the public and the environment, and that the 
patient receives the radiation dose intended and prescribed by the 
medical practitioner.
    The NRC has a specific set of regulatory requirements for the 
medical use of radioactive materials. These regulations include the 
definition, criteria, and reporting requirements for medical events. 
Prior to 2002, the term ``misadministration'' was used in the 
regulations to describe these events. The NRC replaced the term 
``misadministration'' with ``medical event'' as this term more 
correctly and simply conveys that the radioactive material or the 
radiation from the material, was not delivered as directed by the 
physician.
    The NRC requires licensees to report a medical event because such 
an event indicates that the licensee had technical or quality assurance 
problems in administering the physician's prescription. A dose error of 
20 percent or more may indicate treatment delivery problems in the 
medical facility's operations that need correcting. Actual harm to a 
patient, whether it is an injury from overexposure or inadequate 
treatment due to underexposure, must be determined through a separate 
analysis by a physician. In severe events, when the dose error is well 
over 20 percent too high or too low, such as the events that occurred 
at the VA Philadelphia, NRC inspection teams are supplemented with a 
medical consultant, who is a licensed physician. The medical consultant 
assesses the patient's risk of harm.
    The agency's Region III office, based in Lisle, Illinois, provides 
regulatory oversight of the Department of Veterans Affairs' license. 
The VA was issued a master materials license (MML) in March 2003. An 
MML is issued only to Federal Government agencies or departments and 
authorizes the use of radioactive material at multiple sites. The 
holder of the MML is responsible for ensuring that NRC requirements are 
met. Prior to issuance of the MML, the NRC issued a separate license to 
each VA site throughout the United States. The VA's license requires 
the VA to establish an internal, independent framework of oversight 
consistent with NRC regulations, and with inspection and enforcement 
policies, procedures, and guidance. Within this framework, the 
responsibility for patient safety and day-to-day oversight of VA 
medical procedures using radioactive materials lies with the VA's 
National Radiation Safety Committee. The VA's National Health Physics 
Program (NHPP) acts as the VA's regulatory organization and is 
responsible for issuing permits, conducting inspections and event 
follow-up, investigating incidents, allegations, and enforcement.
BACKGROUND OF THE VA MEDICAL CENTER IN PHILADELPHIA
    VA Philadelphia began performing permanent implant prostate 
brachytherapy in 2002, using contracted doctors from the University of 
Pennsylvania Hospital. The NRC received a report of a potential medical 
event in 2003. The NRC conducted an inspection and examined the record 
of the event, as well as the procedures for prostate implants, and 
interviewed the physician involved but did not identify any violations 
of NRC regulations. In 2005, a similar potential medical event was 
reported to the VA's NHPP. The NRC was informed of the event and 
evaluated the performance of the NHPP inspectors by observing the NHPP 
inspection of the event. NHPP did not identify any violations at VA 
Philadelphia.
    On May 18, 2008, the NRC received notification of a potential 
medical event from the VA that a patient undergoing treatment for 
prostate cancer at the VA Philadelphia received a dose that was over 20 
percent lower than what was prescribed.
    In response to this prostate under dose at VA Philadelphia, the 
NHPP conducted an inspection at the facility in May 2008. Based on the 
preliminary inspection findings, the NHPP requested VA Philadelphia to 
review more prostate brachytherapy treatments. Ultimately, all 116 
prostate brachytherapy treatments performed since the inception of the 
program were reviewed by the VA.
NRC'S RESPONSE TO DATE
    NRC closely followed the initial actions of the VA Philadelphia and 
the NHPP and, based on additional potential events, determined that it 
was necessary to accelerate our direct involvement.
    First, the NRC conducted an independent inspection at VA 
Philadelphia in July 2008. Second, based on the NRC's preliminary 
inspection findings and the growing number of potential medical events, 
the NRC launched a Special Inspection in September 2008. The NRC's 
ongoing Special Inspection was tasked to:

      conduct further on-site inspections at the VA 
Philadelphia;
      conduct on-site inspections at all of the VA hospitals 
authorized to perform prostate brachytherapy treatments;
      review the circumstances surrounding the multiple medical 
events at the VA Philadelphia;
      assess prostate brachytherapy programs at the other VA 
facilities;
      assess the performance of the NHPP;
      determine whether the problems at the VA Philadelphia 
could be affecting other medical facilities; and
      conduct, with the assistance of a medical consultant, an 
independent assessment of possible health effects on patients who had 
received the wrong doses.

    Third, in October 2008, the NRC issued a Confirmatory Action Letter 
to the VA, which confirms commitments made to the NRC by the VA to 
identify, address, and prevent the problems that have led to these 
medical events, including the following actions:

      conduct NHPP inspections at all 13 VA hospitals 
authorized to perform prostate brachytherapy treatments;
      develop and implement standardized procedures for 
prostate brachytherapy treatments at all VA hospitals;
      identify causes of the medical events and implement 
corrective actions;
      suspend any prostate brachytherapy treatment program 
where 20 percent or more of the treatments have been identified as 
medical events;
      conduct an inspection to confirm that all necessary 
corrective actions have been taken prior to restarting any suspended 
brachytherapy treatment program; and
      conduct an inspection of new prostate brachytherapy 
treatment programs prior to start up to confirm they meet the enhanced 
standards.

    Because the physician conducting many of the prostrate 
brachytherapy treatments also worked at a local hospital, the 
Commonwealth of Pennsylvania and the local hospital were notified.
    The NRC will verify through inspections that the commitments in the 
Confirmatory Action Letter have been successfully completed. The VA has 
agreed not to restart prostate brachytherapy treatment programs at five 
sites, including the VA Philadelphia, until all commitments have been 
met.
    Fourth, on March 30, 2009, the NRC issued a Special Inspection 
Report on the medical events at the Philadelphia VA that identified six 
apparent violations of NRC regulations: (1) the failure to develop 
adequate written procedures to provide high confidence that each 
prostate seed implant administration is in accordance with the written 
directive; (2) the failure to develop procedures that address methods 
for verifying that administration is in accordance with the treatment 
plan and written directive; (3) the failure to train supervised 
individuals regarding identification and reporting requirements for 
medical events; (4) the failure to instruct a non-supervised individual 
regarding identification and reporting of medical events; (5) the 
failure to record total dose received by a patient on a written 
directive; and, (6) the failure to provide required information in 
several 15-day reports to the NRC. In addition to these apparent 
violations, the NRC identified concerns involving inadequate management 
oversight by the Radiation Safety Officer and the Radiation Safety 
Committee at VA Philadelphia, and a pattern of unreported safety 
concerns.
    Finally, in response to a Demand For Information issued to him by 
the NRC, the physician who performed the majority of the brachytherapy 
treatments at the VA Philadelphia, confirmed that he is currently not 
performing these treatments at any facility--VA or otherwise. He has 
also confirmed that he would give prior notification to the NRC if and 
when he resumes these treatments.
FUTURE NRC ACTIONS
    The NRC is continuing to review the events at VA Philadelphia. We 
plan to issue separate Special Inspection reports that will address the 
findings of the inspections conducted at VA Philadelphia and at the 
other VA facilities authorized to perform prostate brachytherapy 
treatments, and the NHPP's performance at the conclusion of these 
inspection activities. As part of our response, the agency will 
consider what enforcement actions are warranted in these cases. The NRC 
will also notify all facilities administering this type of treatment 
about findings from these inspections that may inform their practice 
and where there may be common implications for the medical community 
and other stakeholders. These actions will be publicly available.
    The NRC will apply the findings of our evaluations to our own 
regulatory practices. In this case, two areas that we have identified 
so far as needing increased NRC attention are licensee oversight of 
contract doctors and the safety culture at materials licensees. We will 
continue to look critically at our licensing and inspection program to 
determine what enhancements are needed. The NRC is also assessing 
whether any specific changes may be needed to strengthen our regulatory 
oversight of the VA's MML with respect to both the VA's internal 
regulatory framework and the NRC's regulatory practices.
    Prior to the current events at the VA, the NRC had been evaluating, 
with input from the nuclear medicine community and other stakeholders, 
a proposed change to our regulations that may prohibit physicians from 
changing written treatment orders after the procedure begins. The issue 
of changing these orders during procedures was identified as a concern 
in the practice at the VA Philadelphia.
CONCLUSION
    The NRC takes these medical events very seriously and continues our 
in-depth inspection. Once we have completed this work, we will evaluate 
the VA's response to our findings and determine what enforcement 
actions are warranted. Thank you for the opportunity to testify here 
today. I would be pleased to respond to your questions.

                                 
   Prepared Statement of W. Robert Lee, M.D., M.S., M.Ed., Professor,
 Department of Radiation Oncology, Duke University, School of Medicine,
  Durham, NC, on Behalf of the American Society for Radiation Oncology
    Chairman Mitchell, Ranking Member Roe, and Members of this 
distinguished Committee, good morning and thank you for the opportunity 
to testify today on the use of brachytherapy in the treatment of 
prostate cancer. I have personally witnessed the great benefits of 
brachytherapy for cancer patients and look forward to telling you the 
history of this treatment, how it works, as well as the required 
training and safety requirements and clinical practice guidelines.
    I received my undergraduate training at the College of William and 
Mary studying Chemistry and Classical Antiquities. I matriculated at 
the University of Virginia School of Medicine and received my medical 
degree in 1989. I completed a residency in radiation oncology at the 
University of Florida in 1993. I have held faculty positions at Fox 
Chase Cancer Center in Philadelphia, Wake Forest University School of 
Medicine in Winston-Salem, NC, and at present I am a Professor of 
Radiation Oncology at the Duke University School of Medicine. I have 
authored over 100 original articles and reviews on many aspects of 
genitourinary cancer. My clinical practice is limited to men with 
prostate cancer. Together with my colleagues at Duke, I see more than 
300 new patients per year. I have used prostate brachytherapy and 
external beam radiation therapy for more than a decade. My particular 
research interests are exploring innovation with external beam 
radiation treatment of prostate cancer and the measurement of quality 
following prostate brachytherapy. In addition, I am the incoming 
Chairman of the Residency Review Committee that oversees all radiation 
oncology training programs, and I have served as an oral examiner for 
individuals that take the radiation oncology board exam. I am also a 
Past-president of the American Brachytherapy Society (ABS) and the 
Director of the Duke Radiation Oncology Training Program.
    I am considered an expert in the field of prostate cancer and 
believe my testimony is critical to help Congress and the public 
understand that brachytherapy is a very safe procedure with a long 
track record of effectively curing cancer with minimal side effects 
compared to other treatments. I am not personally involved in the 
investigation into the Philadelphia VA and my knowledge of the specific 
circumstances in the case consists of a number of reports from the 
Nuclear Regulatory Commission (NRC), Department of Veterans Affairs 
(VA) and news publications. It is also important to note that neither 
I, nor ASTRO, were involved in the accreditation of any health care 
facilities, including the Veterans Affairs Medical Centers. Based on 
information that 92 medical events were identified out of 116 cases, 
including 35 involving unintended doses to an organ or tissue other 
than the prostate and 57 events where the dose delivered to the 
prostate was less than prescribed, I agree that there is clearly cause 
for concern that inadequate care was delivered to veterans treated at 
this facility.
    While ASTRO is deeply troubled by the problems identified at 
brachytherapy programs at the Philadelphia and other VA centers, we are 
heartened that NRC investigators have found no evidence of widespread 
medical events involving brachytherapy. Based on my clinical training 
and my experience with brachytherapy, I would have been very surprised 
if investigators found problems with this important radiation therapy 
procedure. In fact, there have been only an infinitesimally small 
number of reported medical events nationwide.
    Each year, there are approximately 50,000 brachytherapy treatments 
performed in the United States. According to the Advisory Commission on 
the Medical Uses of Isotopes' report to the NRC at a May 2009 meeting, 
there were a total of 9 reported medical events involving 111 patients 
nationwide in 2008. Of the 111 patients involved, 102 were from 2 
medical events that occurred within the VA system. Ninety-two of these 
patients were treated at the Philadelphia VA. The other 7 medical 
events involved 9 patients--with the most common error being 
misidentification of the prostate in transrectal ultrasound (3 medical 
events; 3 patients). While the VA investigation spans several years, 
these medical events were all reported in 2008. Even with the 
consolidation of these medical events into 1 year, only about 0.22 
percent of the procedures nationwide resulted in a reportable event. 
Brachytherapy is an extremely safe and effective procedure.
    My hope is that patients, particularly our Nation's veterans, will 
recognize that the situation at the Philadelphia VAMC is an isolated 
incident and should not dissuade patients from choosing brachytherapy, 
if appropriate, as a treatment for their cancer. At the same time, the 
radiation oncology community is committed to working with Federal 
regulators to learn from these serious events and apply the lessons to 
help ensure that such mistakes don't happen again.
ASTRO and Radiation Oncology
    Founded in 1958, ASTRO's mission is to advance the practice of 
radiation oncology by promoting excellence in patient care, providing 
opportunities for educational and professional development, promoting 
research and disseminating research results and representing radiation 
oncology in the rapidly evolving health care environment. Radiation 
oncologists, radiation oncology nurses, medical physicists, radiation 
technologists, dosimetrists and biologists comprise ASTRO's more than 
10,000 members, making it the largest radiation oncology organization 
in the world. These medical professionals, found at hospitals and 
cancer treatment centers around the globe, make up the radiation 
therapy treatment teams that are critical in the fight against cancer.
    Radiation therapy is the use of various forms of radiation to 
safely and effectively treat cancer and other diseases. Doctors use 
radiation therapy to eradicate cancer, to control the growth of the 
cancer or to relieve symptoms, such as pain. It can be used to treat 
cancer in almost any part of the body, although breast cancer, lung 
cancer and prostate cancer typically make up more than half of all 
patients receiving radiation therapy. Radiation may also be used to 
treat several benign diseases, such as non-cancerous tumors, heart 
disorders and thyroid problems.
    Patients receive radiation therapy in one of two ways: externally 
or internally. During external beam radiation, a beam of radiation is 
directed to the tumor and immediate surrounding area in order to 
destroy the tumor and any nearby cancer cells. Internal radiation, or 
brachytherapy, from the Greek word brachy meaning close by, is the 
placement of radioactive sources in or next to a tumor. To position the 
sources accurately, special catheters or applicators are used. Because 
the radiation sources are placed so close to the tumor, doctors can 
deliver a large dose of radiation directly to the cancer cells with 
minimal exposure to normal tissue.
    Radiation therapy works by damaging the DNA in cancer cells so that 
they cannot repair or reproduce. New technology and improved techniques 
allow radiation oncologists to better target radiation to eliminate 
cancer cells while protecting healthy cells. Radiation therapy is less 
invasive than other cancer treatments, making it an attractive option 
for men and women who want to maintain their lifestyles and jobs while 
receiving treatments. When a physician determines that radiation 
therapy may be a treatment option for his or her patient, a referral is 
made to a radiation oncologist. As highly trained specialists, 
radiation oncologists know the various forms of radiation therapy--
brachytherapy or external beam radiation--their efficacy in specific 
cases, and the potential side effects and risks.
    Radiation oncology practices, including caring treatment teams of 
clinical nurses, physicists and technologists, use sophisticated 
equipment to provide patients with safe, effective care. Radiation 
oncologists discuss and agree upon treatment options with their 
patients and their families and plan and deliver that care in 
conjunction with the patient's other physicians, as well as non-
physician members of the patient's care team. This team approach 
assures that the radiation therapy component of a patient's clinical 
care fits appropriately in the overall patient treatment plan.
    ASTRO supports Congressional efforts to promote quality measurement 
and improvement, particularly through the adoption and effective use of 
health information technology (HIT). ASTRO has devoted significant time 
and resources to developing clinical guidelines and quality measures 
for radiation oncology, including the treatment of prostate cancer. 
ASTRO also is proud of the high rates of HIT adoption among radiation 
oncology practices. ASTRO is leading efforts to develop 
interoperability standards to allow vital clinical information to be 
passed seamlessly from one radiation oncology system to another system, 
within and across practices, and made readily available at the point of 
care. In sum, ASTRO wants patients to have peace of mind when it comes 
to safety, quality and efficacy of radiation therapy.
History of Brachytherapy
    In the early 1900s, Marie and Pierre Curie laboriously extracted 
the element Polonium from tons of Uranium ore and, shortly after, 
extracted Radium. In 1901, Pierre Curie, after observing a burn on his 
skin from a sample of radium left in his coat pocket, suggested to 
doctors at St. Louis Hospital in Paris that a small radium tube be 
inserted into a tumor to produce the same effect. This was the birth of 
brachytherapy. Independently that same year, Alexander Graham Bell made 
a similar suggestion. It was found in these early experiences that 
inserting radioactive materials into tumors caused cancers to shrink.
    Brachytherapy is a highly effective way of delivering radiation 
tailored to the shape of the tumor while sparing surrounding normal 
tissues. Estimates are that approximately 40,000 Medicare beneficiaries 
chose brachytherapy as part of their cancer treatment plan each year. 
Over the last 15 years, sophisticated computerized treatment planning 
and advances in medical imaging have helped to achieve increased 
accuracy and superior, optimized dose distribution for cancer patients.
Prostate Cancer and Brachytherapy
    Much has been made about the difficulty prostate cancer patients 
face in determining a treatment option for their disease. Indeed, the 
Agency for Health Care Research and Quality issued a February 2008 
comparative effectiveness report on therapies for clinically localized 
prostate cancer that found that no one therapy--watchful waiting 
(active surveillance), surgery to remove the prostate gland (radical 
prostatectomy), external beam radiotherapy (EBRT) and interstitial 
radiotherapy (brachytherapy), freezing the prostate (cryotherapy) or 
androgen deprivation therapy (ADT)--could be considered the preferred 
treatment for localized prostate cancer due to limitations in the body 
of evidence as well as the likely tradeoffs an individual patient must 
make between estimated treatment effectiveness, necessity, and adverse 
effects. In 2008, the Institute for Clinical Effectiveness Research in 
the United Kingdom suggested that when brachytherapy is clinically 
indicated, its high efficacy and low cost make it a particularly cost-
effective option in prostate cancer.
    As a prostate cancer expert, I work to analyze the path of my 
patient's prostate cancer and discuss with him the benefits and risks 
of each treatment option. Some men can safely postpone treatment for 
prostate cancer and watch it closely to see if treatment is needed. 
This is called watchful waiting or active surveillance. For others, 
surgery or external beam radiation therapy may, for a number of 
particular clinical reasons, be preferred. If the cancer is relatively 
small and not too aggressive and the man has a small prostate and good 
urinary function then brachytherapy becomes a reasonable option. 
Brachytherapy may be used alone or in conjunction with external 
radiation treatments to treat prostate cancer. A combination of 
treatments, such as external beam radiation followed by brachytherapy, 
is often preferred for men with more advanced cancer. I will advise 
patients of the management option that is most appropriate to their 
specific case. (For additional information, see Attachment A, 
``Radiation Therapy for Prostate Cancer.'')
    The benefits of brachytherapy vary depending on the patient, their 
priorities, their age and diagnosis stage and preferences. 
Brachytherapy is a relatively simple, minimally invasive outpatient 
procedure that avoids hospitalization and allows the patient an early 
recovery and rapid return to normal activity. It produces good 10-year 
outcomes with relatively low morbidity. The benefits of using 
brachytherapy in the treatment of early stage prostate cancer are quite 
pronounced and include a lower incidence of impotence and incontinence 
than is commonly reported with a radical prostatectomy. The high degree 
of accuracy achievable in prostate implants nowadays is partly due to 
technological improvements, but quality implants still require skill, 
adequate training, and attention to detail.
    ASTRO has expressed concerns to Congress and the Administration 
that financial incentives and rampant self-referral of radiation 
therapy services in the Medicare program are leading to patients not 
being fully informed on the full range of treatment options, 
particularly brachytherapy. Instead, business arrangements have 
flourished that involve frequently steering patients to more expensive 
and profitable prostate cancer treatments. We hope that the appropriate 
concerns over the prostate cancer brachytherapy program at the 
Philadelphia VAMC will not exacerbate underuse of this important 
treatment option.
Brachytherapy Clinical Practice Guidelines
    Prostate brachytherapy, or seed implants, are given by inserting 
small metal seeds of radioactive iodine or palladium directly into the 
prostate gland. These radioactive sources have relatively low energy 
levels and half-lives of between 17 and 60 days. Patients are under 
anesthesia during this brief outpatient surgery procedure. The seeds 
are temporarily radioactive and deliver the radiation to the prostate 
over several weeks. After losing their radioactivity, the seeds remain 
in the prostate. The seeds are then harmless and should not bother the 
patient. For the short time that the seeds are giving off radiation, 
men are asked not to be in close proximity to children or pregnant 
women because of the very small chance that the radiation may harm 
their rapidly growing bodies.
    It is essential that postimplant dosimetry be performed on all 
patients undergoing permanent prostate brachytherapy. Dosimetry is the 
calculation of the absorbed dose in tissue resulting from the exposure 
to ionizing radiation. The dose distributions following implantation 
are never exactly the same for each man as those planned prior to the 
implant. Because the dose distributions may differ ever so slightly, it 
is important to document the actual dose that the prostate and normal 
adjacent tissues will receive over the life of the implant. This can 
only be determined if a postimplant dosimetric assessment is performed. 
It is my understanding that this key step may have been missed in the 
cases that were reviewed for the NRC report.
    The information obtained from postimplant dosimetry is essential 
for optimal patient care. Significant over-dosing of the prostate may 
increase the risk of side-effects. Significant under-dosing of the 
prostate can lead to treatment failure. The latter can potentially be 
rectified using supplemental external beam radiation therapy or 
additional seed implants. While the timing may vary in part due to the 
half-life of the isotope, the most reproducible dosimetric results will 
be obtained if the scan is performed 1 month post-implant.
    According to clinical practice guidelines, brachytherapy is 
indicated for treatment where the target volume or tumor can be well 
defined and is accessible to source placement. The goal of treatment 
(curative, palliative, or to establish local tumor control) should be 
documented as clearly as possible. Treatment options and their relative 
merits and risks should be discussed with the patient. A summary of the 
consultation should be communicated to the referring physician.
    Guidelines also recommend that brachytherapy involve the 
interaction of multiple specialists. The choice and placement of 
radioactive sources are the responsibility of the radiation oncologist. 
Each type of brachytherapy procedure has its own set of unique 
characteristics. The brachytherapy team should operate according to an 
established system of procedural steps that have been developed by the 
radiation oncologist and brachytherapy team members. This systematic 
approach to applicator or source insertion should include a description 
of pre-implantation steps, sedation or anesthesia procedures, the 
specific applicators used, and the insertion techniques. Standard 
orders or care guidelines may enhance the systematic approach to the 
insertion process.
    At the conclusion of the course of treatment, a written summary of 
the treatment delivery parameters is generated, including the total 
dose of brachytherapy and the total dose of external beam therapy if 
given, treatment technique, treatment volume, acute side effects, 
clinical course, and patient disposition. Patients treated with 
brachytherapy should be evaluated after treatment at regular intervals 
by the radiation oncologist for response and early and late effects on 
normal tissues.
NRC Training Requirements
    As you know, the NRC has jurisdiction over the use of radioactive 
materials--including medical isotopes--and safety measures to protect 
the public and patients. Unlike other medical procedures where 
physicians must simply have a State license to practice medicine, the 
NRC requires certain training requirements for physicians who use 
radioactive materials. While the NRC recognized an alternative pathway 
to achieve permission to perform permanent seed implants with similar 
requirements, most radiation oncologists meet or exceed NRC's 
requirement that physicians complete a 3-year radiation oncology 
residency training (The Accreditation Council for Graduate Medical 
Education (ACGME) requires 4 years of training).
    This training must include a structured educational program in 
basic radionuclide handling techniques applicable to the use of 
brachytherapy sources that includes 500 hours of work experience in 
preparing, implanting, and removing brachytherapy sources; using 
administrative controls to prevent a medical event involving the use of 
radioactive material; ordering, receiving and unpacking radioactive 
materials safely and performing the related radiation surveys; checking 
survey meters for proper operation; maintaining running inventories of 
material on hand; and using emergency procedures to control radioactive 
material. Further, the NRC requires these radiation oncology residency 
programs to include 200 hours of classroom and laboratory training in 
radiation physics and instrumentation, radiation protection, 
mathematics pertaining to the use and measurement of radioactivity, and 
radiation biology.
    These combined 700 hours are in addition to the extensive clinical 
training in oncology, such as taking histories and conducting physical 
exams, understanding behavior and spread of cancers, interpreting 
pathology reports and laboratory tests, and evaluating scans and X-
rays. Finally, those physicians who have successfully completed a 
radiation oncology residency program must then pass an oral exam 
related to these topics. As an examiner for the Board, I find students 
who have completed the training to be quite thorough in their knowledge 
of radiation biology and safety and the appropriate clinical 
applications for radiation to treat cancer. Those who are not thorough 
in their knowledge do not pass this rigorous exam.
    The brachytherapy team also includes a medical physicist. Per NRC 
requirements, medical physicists who are authorized to participate in 
brachytherapy must have a master's or doctoral degree in physics, 
medical physics or other physical science (such as engineering or 
applied mathematics from an accredited college or university) and have 
2 years of full-time practical training and/or supervised experience in 
medical physics under the supervision of a medical physicist who is 
board certified or working with a physician who performs brachytherapy.
    A variety of applicators are used in brachytherapy. These 
applicators, as well as treatment-planning computers and software, and 
treatment aids should be appropriately selected for the clinical 
application. Regular inspection, maintenance, and repair of this 
equipment are mandatory. In general, the physicist supervising the 
quality improvement program is responsible for documenting the 
maintenance and repair of manual equipment and applicators. The Medical 
Director of Radiation Oncology is responsible for the institution and 
ongoing supervision of continuing quality improvement (CQI). It is the 
responsibility of the director to identify problems, see that actions 
are taken, and evaluate the effectiveness of the actions.
    The NRC also requires that brachytherapy is administered according 
to a written directive that must be signed and dated by the radiation 
oncologist. Before loading, the written directive must designate the 
treatment site, the type of radiation (isotope) to be used, the number 
of sources, the planned dose, and the dose rate to designated points. 
Applicator geometry and isotope positions are defined with simulation 
radiographs. The specific isotope positions are designated by the 
radiation oncologist. Computerized dosimetry is performed by the 
medical physicist or designee and approved by the radiation oncologist. 
Independent verification of brachytherapy dose calculations (by another 
person or another method) is done pre-treatment.
Prostate Brachytherapy at Duke
    As an example, I would like to share with the Committee the safety 
protocols and procedures for brachytherapy at my institution. I believe 
these protocols are representative of those across radiation oncology 
departments nationwide as they rely on published guidelines and best 
practices. Our own procedure at Duke is as follows:
Initial consultation with patient
    a.   History, physical exam, and review of all pertinent lab and 
scan data.
    b.   Determine whether or not treatment for the prostate cancer is 
necessary and, if so, whether or not brachytherapy is an appropriate 
option.
    c.   Determine whether the patient fully understands all their 
options together with the advantages and disadvantages of each 
approach.
Volume study
    The patient returns to have a complete assessment of their prostate 
made by the radiation oncologist and a urologist. This involves a 
transrectal ultrasound (TRUS) study in which a series of images are 
taken through the entire length of the prostate. On each of these, the 
radiation oncologist outlines the ``target volume''. This is usually 
the prostate plus, in some cases, a small margin if there is concern 
that the cancer may have leaked through the prostate capsule. In some 
cases, where there are case-specific concerns about the risk of side 
effects the target volume may be less than the entire prostate. The 
images are then downloaded to a computer containing the radiation 
planning software. A record is made of the exact position of the 
patient during the volume study so that the position may be reproduced 
at the implantation procedure in the operating room on a subsequent 
date. If, for anatomic reasons the prostate is poorly visualized or if, 
on scan, it is determined that the prostate has a large median lobe or 
the bladder empties incompletely, then the patient will not proceed to 
brachytherapy. We will choose a different option as the risk of a 
complication is increased by any of these factors.
    At the end of the procedure, the radiation oncologist writes 
clearly the preferred choice of radioactive isotope (iodine or 
palladium) and the prescription radiation dose in grays (Gy). The 
radiation oncologist will also state constraints for specific normal 
tissues (e.g., the urethra is not to receive more than 130 percent of 
the prescribed dose or, say, reduce dose to the anterior base of the 
prostate to 90 percent). These constraints are tailored to patients 
individually and help to minimize morbidity. The radiation oncologist 
will specify whether seeds are to be ``free'' or ``stranded''.
Plan development
    The physicist will then reconstruct a 3-dimensional image of the 
prostate on a computer and then determine the best number and 
``activity'' of the seeds and their best placement within or around the 
prostate in order to match the radiation oncologists prescription. The 
radiation oncologist will then choose between several of these plans 
picking the best for the individual patient. Each needle is planned to 
deliver one or more seeds at the pre-determined insertion point in the 
prostate and a check list of these needle locations is then drawn up. 
The plan is then verified by a second physicist. This plan which 
includes the dose prescription and number and activity of seeds is the 
written directive. A date is made for the brachytherapy procedure and 
the seeds ordered.
Pre-operative testing
    A physical exam and relevant blood work, EKG and chest X-ray are 
taken 1 week before the procedure to determine the patients suitability 
for general anesthesia. The patient is given a prescription for 
antibiotics to reduce the risk of infection, an alpha-blocker to 
improve the urine flow in the first post-implant month, and 
occasionally a steroid medication. The latter is given to those with 
larger prostate glands to reduce the risk that, as a result of acute 
swelling, they will be unable to urinate after the procedure.
Radioactive source intake
    Upon arrival at Duke, the physicist will determine the position of 
the seeds within the pre-loaded brachytherapy needles and verify by X-
ray film. The film exposes the exact location of each seed and this 
allows a check on the number and position of each seed within each 
needle.
Brachytherapy procedure
 a..................................  ``Time out'' in which all Members
                                      of the team (radiation oncologist,
                                      urologist, anesthesiologist,
                                      operating room nurse and
                                      physicists) agree on the patient
                                      using two different identifiers
                                      and the procedure.
b..................................  The plan is once again checked by
                                      radiation oncologist and
                                      physicist.
c..................................  General anesthesia is used to
                                      ensure an immobile patient.
d..................................  The patient is placed in a position
                                      that mirrors the one used in the
                                      volume study.
e..................................  Aerated gel is placed into the
                                      urethra to visualize, and thus
                                      avoid, the urethra.
f..................................  Transrectal ultrasound is placed
                                      into rectum and manipulated until
                                      the image exactly mirrors the
                                      image obtained at volume study.
                                      The probe is then locked into
                                      place. If visualization is poor
                                      the procedure is canceled.
g..................................  Needles containing seeds are
                                      numbered according to the plan and
                                      called sequentially by the
                                      physicist. A double check on the
                                      correct number of seeds is made by
                                      observing the length of protrusion
                                      of the trocar from each needle.
                                      The protrusion length correlates
                                      exactly with seed number. Each
                                      needle is then placed into the
                                      correct position within the
                                      prostate as called by the
                                      radiation physicist working from
                                      the plan and the checklist. The
                                      correct placement is ensured by
                                      visualizing each numbered needle
                                      as it passes through a perineal
                                      template and into the prostate
                                      gland. The needle location is
                                      verified using transverse images
                                      which show its side-to-side and up-
                                      and-down location and a sagittal
                                      image which shows whether or not
                                      the needle has reached the correct
                                      depth within the prostate. Image
                                      verification is made for each
                                      needle and a double check comes
                                      from measuring the degree of
                                      protrusion of the needle from the
                                      template. When needles are
                                      correctly placed, and agreement
                                      reached between physicist and
                                      radiation oncologist, the seeds
                                      may be unloaded into the prostate.
h..................................  At repeated intervals during the
                                      procedure, an assessment is made
                                      of the position of the prostate
                                      base as this can become deeper if
                                      the prostate swells.
i..................................  A final check is made with
                                      ultrasound and/or fluoroscopy to
                                      determine whether any regions of
                                      the prostate appear under-
                                      implanted and whether or not there
                                      are any seeds in the bladder.
j..................................  If any visible area of under-
                                      implantation is identified,
                                      additional seeds, which are always
                                      pre-ordered, may be inserted at
                                      this point and a notation is made
                                      of their number.
k..................................  The bladder may be irrigated or a
                                      cystoscopy performed in the
                                      unlikely event that a seed has
                                      passed into that organ. If so, the
                                      seed is retrieved safely and
                                      either a substitute seed is
                                      inserted or its absence noted.
l..................................  The patient is awakened and brought
                                      to the recovery room.
m..................................  The patient goes home one to 4
                                      hours later once he has urinated
                                      spontaneously.
n..................................  Prior to departure from the
                                      hospital, measurements are taken
                                      of radiation activity at the
                                      patient's skin surface and at one
                                      meter. These are to ensure safe
                                      levels for family members.
                                      Measurements are taken within the
                                      operating room, recovery room, and
                                      from the patients urine and linen
                                      to ensure no seeds have been
                                      unknowingly lost.
o..................................  The patient goes home with
                                      procedure safety instructions, a
                                      lead container and a urinary
                                      sieve. They are instructed to pass
                                      their urine through this sieve
                                      and, if any seeds are retrieved,
                                      to place them into a lead
                                      container with tweezers and bring
                                      them back to the Duke Radiation
                                      Oncology Department during their
                                      next visit.
Post-implant dosimetry
    Approximately 1 month after the procedure, patients return for a 
history and physical evaluation to determine whether or not the side 
effects are in line with expectations and to determine that they are 
successfully emptying their bladders. Any passed seeds may be returned 
to the radiation oncologist at this time and these must be accounted 
for in the post-implant dosimetry.
    A CT scan is performed of the prostate area and the images analyzed 
using seed identification software. The prostate is then outlined and a 
computer calculation then made by the physicist of the radiation 
distribution. The volume drawing and measurements are performed by the 
trained physicist independent of the radiation oncologist to ensure 
veracity and consistency. Certain measurable parameters are collected 
including the urethral dose and the dose to the rectum to confirm that 
it is not greater than the dose prescribed. These may be used for 
internal quality control and for comparison with national measures. 
These parameters are peer-reviewed by the multidisciplinary 
genitourinary radiation oncology group within our department.
Medical events
    At Duke, we adhere to the following protocols that conform to NRC 
regulations. Per those protocols, we determine that a medical event has 
occurred if any of the following situations apply:

    1.  Wrong patient treated.
    2.  Wrong area/side implanted (for a partial prostate implant).
    3.  Wrong isotope used.
    4.  Wrong dose used in patient ( 20 percent).

    If it is determined that a medical event has occurred, a report is 
immediately made to the Duke Radiation Safety Officer, who evaluates 
and reports to the NRC. The patient and referring physician would also 
be alerted immediately. ASTRO and ABS are participating in the NRC's 
rulemaking process to ensure that the revised definition of a medical 
event for permanent implant brachytherapy protects the safety of 
patients.
Subsequent follow-up
    Visits to the radiation oncologist in the clinic occur every 3 to 6 
months. History, physical exam, and PSA measurement are performed at 
each visit. Parameters are recorded in the institutional prospective 
quality assurance database.
    Finally, I would like to illustrate the benefits of brachytherapy 
by telling you the story of one of my patients. He is a 50-year-old 
university professor and ardent long-distance runner whom I first met 
about 8 years ago. He had early stage prostate cancer and after 
discussion of all treatment options, he elected prostate brachytherapy. 
He told me that he chose brachytherapy so that he could continue to 
teach his students, coach his daughter's soccer team and train for an 
upcoming marathon. I, along with my colleagues at Wake Forest, 
performed prostate brachytherapy in the spring and he ran in the Marine 
Corps marathon later that year. His postimplant dosimetry was good and 
7 years after his treatment, his PSA is undetectable and he has 
excellent urinary function. He has run in a marathon every year since 
his treatment.
    ASTRO shares the Committee's concerns about the health and safety 
of veterans and recognizes the importance of maintaining veterans' 
access to high quality cancer treatment. We support the NRC's 
investigation into the causes of the medical events at the Philadelphia 
VAMC. By bringing these issues to the forefront, necessary steps can be 
taken to implement corrective actions and enhance quality of care 
standards for prostate cancer treatments at all VA hospitals. ASTRO 
appreciates the opportunity to work closely with the Committee and NRC 
to ensure the safety of radioactive materials for medical use.
    ASTRO is committed to ensuring that radiation oncologists and 
members of the treatment team adhere to strict safety standards and 
clinical guidelines for all radiation therapy, including brachytherapy. 
Thank you again for the opportunity to testify.
Online References:
      Agency for Health Care Research and Quality (http://
www.effectivehealthca
re.ahrq.gov/repFiles/2008_0204ProstateCancerExecSum.pdf)
      American Brachytherapy Society 
(www.americanbrachytherapy.org)
      American College of Radiology
        (http://www.acr.org/SecondaryMainMenuCategories/quality_safety/
        guidelines/ro/low_dose_rate_brachytherapy.aspx;
        http://www.acr.org/SecondaryMainMenuCategories/quality_safety/
        app_criteria/pdf/
        ExpertPanelonRadiationOncologyProstateWorkGroup/
        PermanentSourceBra
        chytherapyforProstateCancerDoc5.aspx)
      American Urologic Association (http://www.auanet.org/
content/guidelines-and-qualitycare/clinical-guidelines/main-reports/
proscan07/content.pdf)
      Nuclear Regulatory Commission (http://www.nrc.gov/
reading-rm/doccollections/cfr/part035/)
      RT Answers (www.rtanswers.org)
Bibliography:
      Nag, S et al. American Brachytherapy Society (ABS) 
Recommendations for Transperineal Permanent Brachytherapy of Prostate 
Cancer, Int. J. Radiation Oncology Biol. Phys., Vol. 44, No. 4, pp. 
789-799, 1999.
      Nag, S et al. American Brachytherapy Society (ABS) 
Recommendations for Permanent Prostate Brachytherapy Postimplant 
Dosimetric Analysis, Int. J. Radiation Oncology Biol. Phys., Vol. 46, 
No. 1, pp. 221-230, 2000.

                                 
 Prepared Statement of Joseph A. Williams, Jr., RN, BSN, MPM, Assistant
   Deputy Under Secretary for Health for Operations and Management, 
  Veterans Health Administration, U.S. Department of Veterans Affairs
    Good morning, Mr. Chairman and Members of the Subcommittee. Thank 
you for the opportunity to discuss the Department of Veterans Affairs' 
(VA) enforcement of VA's brachytherapy program safety standards. I am 
accompanied today by Dr. Madhulika Agarwal, Chief Officer, Patient Care 
Services, Veterans Health Administration (VHA); Dr. Michael Hagan, 
National Director for Radiation Oncology in VHA; E. Lynn McGuire, MS, 
DABMP, National Health Physics Program Director in the Office of 
Patient Care Services, VHA, Michael E. Moreland, FACHE, Network 
Director, VA Health care--VISN 4, and Dr. Richard Whittington, a 
physician at the Philadelphia VA Medical Center (VAMC).
    My testimony today will briefly describe brachytherapy, review what 
happened at the Philadelphia VAMC, explain VA's enforcement of safety 
standards for brachytherapy, and discuss the current status of these 
programs throughout VA. Brachytherapy for prostate cancer is a form of 
nuclear radiotherapy where small radioactive seeds are implanted in the 
prostate to destroy cancerous cells. Although risk to healthy tissues 
in the body is minimal, side effects may occur. Brachytherapy is an 
appropriate treatment approach for low-risk patients with prostate 
cancer, but implant quality must be monitored closely in each case and 
programs performing this procedure must be regularly reviewed.
    VA acknowledges that some of the brachytherapy treatments provided 
at the Philadelphia VAMC did not deliver the intended dose; we regret 
this occurred. We have notified patients by mail and by telephone and 
are covering all costs associated with additional tests while 
continuing to monitor the care of our patients, whether they are seen 
at VA or private facilities. A review by independent, external 
physicians and physicists with no involvement in the Philadelphia 
VAMC's brachytherapy program examined patient scans, dosages and 
medical records and discovered that 92 events involving under-dosing or 
doses to organs other than the treatment site were found that met the 
definition of a medical event according to the Nuclear Regulatory 
Commission (NRC). It is important to highlight that the definition of 
``medical event'' does not necessarily mean Veterans were harmed, and 
experts still debate the long-term impact of this treatment. We are 
working with NRC on regulatory issues related to prostate 
brachytherapy, and NRC is refining the definition of ``medical event'' 
as it pertains to these procedures. The Philadelphia VAMC's 
brachytherapy program has been suspended since June 2008 and will not 
be reopened until NRC's concerns have been satisfied and until 
requirements of the VA's Radiation Oncology program are met. VA's 
National Health Physics Program (NHPP) is responsible for radiation 
safety oversight through a license issued by NRC and reports to VA's 
National Radiation Safety Committee. NHPP has conducted site 
inspections at all facilities where prostate brachytherapy is performed 
and when a possible medical event is reported.
    Enforcing program safety standards is essential to ensuring 
patients receive the care they require. VA, as do other health systems, 
relies on complementary systems of accountability to identify quality 
problems like these on the system and individual levels. We use 
multiple internal and external survey and inspection processes (e.g., 
Joint Commission, American College of Radiology Oncology, American 
College of Radiology, Nuclear Regulatory Commission, and others); 
patient satisfaction and complaints; and individual peer review. The 
deficits in this program at the Philadelphia VAMC went undetected by 
many of these systems for almost 6 years, and it was only the 
recognition of potential problems by the staff at the Philadelphia VAMC 
that eventually led to more in-depth investigation, review and 
subsequent disclosure to patients and the public.
    In November 2008, VA amended the criteria for suspending a prostate 
brachytherapy program to require immediate suspension of any such 
program where medical events are discovered for 20 percent or more of 
patient treatments reviewed or evaluated for regulatory compliance. VA 
is requiring these reviews use a minimum sample size of 10 recent 
patient treatments or the total number of patient treatments in the 
last 3 years, whichever is less, for initial evaluation. If 20 percent 
or more patient treatments are discovered as medical events, VA 
requires increasing the sample size to at least 30 or all patient 
treatments within the last 3 years, whichever is less. If 20 percent or 
more of the final sample size is confirmed to be medical events, the 
program must be immediately suspended. Moreover, VA also requires its 
NHPP to inspect any report of medical events to confirm regulatory 
compliance and implementation of VHA standard procedures. VA will 
suspend any prostate brachytherapy program if the results of this 
inspection indicate significant program deficiencies and program 
suspension is deemed warranted by the National Radiation Safety 
Committee in consultation with the Director of the National Radiation 
Oncology Program and the Principal Deputy Under Secretary for Health.
    In response to concerns raised by NRC and to ensure other VAMCs 
were performing prostate brachytherapy procedures correctly, VA 
completed inspections by January 2009 of all VA facilities with active 
programs. VA also developed and implemented standard procedures for 
prostate brachytherapy programs, addressing quality assurance measures 
and patient safety. These include the following:

      Initial and periodic training for physicians, medical 
physicists, dosimetrists, and Radiation Safety Officers and staff;
      Training in the definition and criteria of medical 
events, how to identity a medical event, and reporting requirements for 
medical events;
      Methods and procedures for verifying correct seed 
placement and determining proper needle placement during prostate 
brachytherapy procedures;
      Preparation and completion of written directives; and
      Methods and procedures for pre-implant treatment 
planning, post-implant treatment planning, and post-treatment dose 
analysis.

    VA clinical standards and procedures are now among the most 
rigorous in the health care industry.
    Regarding future actions to prevent similar situations, VA has 
asked the American College of Radiology (ACR) to conduct site surveys 
at each facility performing brachytherapy for prostate cancer. Our goal 
is 100 percent accreditation of our facilities; nationally in the 
private sector and VA, only 15 percent of practices are accredited now. 
Furthermore, each facility performing permanent implant prostate 
brachytherapy must develop, maintain and implement written procedures 
based on the American College of Radiology's ``Practice Guidelines for 
Transperineal Permanent Brachytherapy of Prostate Cancer'' and 
publications by the American Association of Physicists in Medicine. We 
are also drafting a VHA handbook for radiation oncology.
    VA has used the situation in Philadelphia to conduct a 
comprehensive review of its prostate brachytherapy programs. Fifteen VA 
facilities have provided prostate implants since 2005, although two, 
Reno, NV and Birmingham, AL, are currently inactive without plans for 
resumption. Seven facilities, including Albany, NY, Boston, MA, 
Brooklyn, NY, Minneapolis, MN, Richmond, VA, San Francisco, CA, and 
Seattle, WA, are currently active and offering brachytherapy 
treatments. In our comprehensive review, we found these facilities have 
provided appropriate treatments. VA's NHPP has temporarily suspended 
four programs, including Cincinnati, OH; Washington, DC; Jackson, MS; 
and Philadelphia because problems were found involving under-dosing. 
Based upon these reviews, the Cincinnati program was found to be in 
compliance with VA standards and is in the process of fulfilling 
national VA requirements for resuming prostate brachytherapy. Complete 
reviews of the Jackson and Washington programs continue. Problems with 
the treatments offered at the Philadelphia VAMC were discussed 
previously. The Durham, NC, VAMC has voluntarily chosen to no longer 
provide this procedure in-house and is providing this service through a 
fee-basis agreement with Durham Regional Hospital. The VA Greater Los 
Angeles Health Care System in California has elected to pause its 
program to conduct a review of procedures, with new patients scheduled 
for July 2009.
    Secretary Shinseki and VA's senior leadership are conducting a top-
to-bottom review of the Department and are implementing aggressive 
actions to ensure the right policies and procedures are in place to 
protect our Veterans while providing them the highest quality health 
care possible. It is important that our Veterans and their loved ones 
have faith and confidence in our medical system and in our system of 
care. Thank you once again for the opportunity to testify. My 
colleagues and I are prepared to answer your questions at this time.

                                 
       Statement of Gregory E. Desobry, Ph.D., Medical Physicist,
     Division of Medical Physics, Department of Radiation Oncology,
    University of Pennsylvania, School of Medicine, Philadelphia, PA
    Mr. Chairman and Members of the Committee, thank you for the 
invitation to appear here today. I would like to use my time to provide 
you with some information about my background, as well as a description 
of the medical physicist's role in prostate brachytherapy.
    Before undertaking my graduate studies in physics, I studied for 
about 10 years in the Jesuit order of the Catholic church. During that 
time, among other things I did missionary work in Zambia, teaching 
junior high school students science, math, and English. Afterward, I 
returned to school, and in 1976 I was awarded a Ph.D. in physics from 
the University of Virginia. My early career as a physicist included 
work for the McDonnell Douglas Corp. in Houston, Texas, designing and 
testing NASA's space shuttle software.
    I began studying to become a medical physicist in 1986, and in 
1989, I was certified by the American Board of Radiology in therapeutic 
radiological physics. Thereafter, I was an assistant physicist at the 
MD Anderson Cancer Center in Houston and a clinical physicist for Fox 
Chase Cancer Center in Philadelphia. In 1999, I joined the Department 
of Radiation Oncology at the University of Pennsylvania.
    I first assisted with prostate brachytherapy implants a few years 
thereafter, received some training from Dr. Richard Whittington, and 
worked part-time at the Philadelphia Veterans Affairs Medical Center 
from the start of the prostate brachytherapy program there in 2002 
until 2007.
    A medical physicist does three things to assist In prostate 
brachytherapy.
    First, based on the doctor's prescription, which specifies the 
amount of radioactivity to be implanted into the patient, the physicist 
prepares what is called a preplan. To do this, the physicist will 
review a series of ultrasound images of the prostate that is taken by a 
doctor and in which the doctor has identified the prostate. With this 
information from the doctor, the physicist will plan the places where 
the radioactive seeds should be implanted into and around the prostate 
and estimates the radioactive dose to be delivered to the prostate. 
This plan always is confirmed (or revised) by the doctor.
    Second, not long before the doctor is to perform the implant, the 
physicist will verify that the activity level and the loading of the 
seeds is correct. The physicist also delivers the seeds to the doctor 
in the operating room.
    The third thing a physicist does takes place after the implant. At 
the PVAMC, the doctor would order a CT scan of the patient's prostate 
the day after the implant. On this CT scan, the physicist would 
identify the location of the implanted seeds, using a dedicated 
computer program for this purpose.
    Once this was done, the doctor would locate the prostate on the CT 
scan and draw it in. This would allow the computer program to generate 
a ``dose volume histogram,'' essentially a graph showing how much of 
the prostate received how much of a dose, as well as different dose 
parameters. This information is often referred to as ``post-implant 
dosimetry.''
    Post-implant dosimetry is performed so that the doctor might 
evaluate the implant as part of his overall assessment of his ongoing 
treatment plan for the patient.
    I recognize that the Committee may have questions, and I will do my 
best to answer them.
    Again, thank you for your consideration of my testimony.

                                 
        Statement of George Lazarescu, Ph.D., Medical Physicist,
     Division of Medical Physics, Department of Radiation Oncology,
    University of Pennsylvania, School of Medicine, Philadelphia, PA
    Mr. Chairman and Members of the Committee, thank you for the 
invitation to appear here today. I will offer in these prepared remarks 
a brief description of my background.
    I received a Ph.D. in physics in 1974 from the Institute for Atomic 
Physics in Bucharest, Romania, and in 1991 was graduated with a master 
of science in medical physics from the Medical Physics Graduate Program 
of the Wayne State University School of Medicine in Detroit, Michigan. 
In 1996, I was certified in radiation oncology physics by the American 
Board of Medical Physics, which is a certification recognized by the 
American Board of Radiology.
    From 1996 to 2003, I was an associate professor at the State 
University of New York Health Science Center in Brooklyn, New York, and 
in 2003 I joined the Hospital of the University of Pennsylvania's 
Department of Radiation Oncology as a medical physicist. My clinical 
work since that time has primarily been at the Philadelphia Veterans 
Affairs Medical Center, working with external beam radiotherapy.
    I recognize that the Committee may have questions, and I will do my 
best to answer them. Again, thank you for your consideration of my 
testimony.

                                 
                    Statement of Hon. Cliff Stearns,
         a Representative in Congress from the State of Florida
    Thank you, Mr. Chairman.
    I am pleased to be here for this important hearing, although I do 
wish we were here under better circumstances.
    For almost 6 years, serious problems with the brachytherapy program 
at the Philadelphia VA Medical Center (VAMC) went undetected. That's 6 
years in which potential harm could have been caused to some of our 
Nation's veterans seeking treatment for prostate cancer. Presently, 4 
of the VA's brachytherapy programs have been suspended--this is a 
worrisome number given there are only a total of 7 active programs at 
the moment--so more than half of the VA's active brachytherapy programs 
are suspended. That's a dismal statistic.
    From May through October 2008, a series of ``medical events'' were 
finally detected and reported, with the stand-out case being the Philly 
VAMC in which 92 events involving either under dosing, or dosing to 
organs other than the intended treatment site, were reported. Seventeen 
other medical events were also reported at VA Medical Centers in 
Jackson, MS, Cincinnati, OH, and Washington, DC.
    I am dismayed that prior to this issue coming to light, the VA did 
not have standard procedures for prostate brachytherapy programs, 
including methods and procedures to verify seed placement and for 
determining proper dosage of post treatment dose analysis. It seems 
like the VA is often more reactive than proactive, and this shouldn't 
be the case given the fact that the VA is a national leader in quality 
health care.
    To the VA's credit, they have taken proper action since the 
discovery of these problems, and they appear to be working toward a 
comprehensive makeover of its brachytherapy programs. However, VA 
ultimately holds responsibility for the safety and health of our 
veterans treated at VA facilities.
    It is my hope that today's hearing will afford us the opportunity 
to address the issues surrounding the evolving definition of a 
reportable ``medical event,'' and to clear up the discrepancy over why 
there was no peer review or Quality Assurance of the brachytherapy 
program at the Philly VA.
    Thank you, and I look forward to the hearing.

                                 
