[Senate Hearing 111-204]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 111-204
 
   FIELD HEARING: PHILADELPHIA VA TERMINATED CANCER TREATMENT PROGRAM 

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

                                HEARING

                               BEFORE THE

                     COMMITTEE ON VETERANS' AFFAIRS
                          UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 29, 2009

                               __________

       Printed for the use of the Committee on Veterans' Affairs


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                     COMMITTEE ON VETERANS' AFFAIRS

                   Daniel K. Akaka, Hawaii, Chairman
John D. Rockefeller IV, West         Richard Burr, North Carolina, 
    Virginia                             Ranking Member
Patty Murray, Washington             Lindsey O. Graham, South Carolina
Bernard Sanders, (I) Vermont         Johnny Isakson, Georgia
Sherrod Brown, Ohio                  Roger F. Wicker, Mississippi
Jim Webb, Virginia                   Mike Johanns, Nebraska
Jon Tester, Montana
Mark Begich, Alaska
Roland W. Burris, Illinois
Arlen Specter, Pennsylvania
                    William E. Brew, Staff Director
                 Lupe Wissel, Republican Staff Director
























                            C O N T E N T S

                              ----------                              

                             June 29, 2009
                                SENATORS

                                                                   Page
Specter, Hon. Arlen, U.S. Senator from Pennsylvania..............     1

                            REPRESENTATIVES

Adler, Hon. John, U.S. Representative from New Jersey............     6
Fattah, Hon. Chaka, U.S. Representative from Pennsylvania........     7

                               WITNESSES

Flippin, Reverend Ricardo, U.S. Air Force Veteran................     2
    Prepared statement...........................................     4
Kao, Gary, M.D., Ph.D., Associate Professor, Radiation Oncology, 
  University of Pennsylvania.....................................     8
    Prepared statement...........................................    10
    Response to written questions submitted by Hon. Richard Burr.    16
        Exhibits.................................................    19
Cross, Gerald M., M.D., FAAFP, Acting Under Secretary for Health, 
  Veterans Health Administration, U.S. Department of Veterans 
  Affairs; accompanied by Michael E. Moreland, FACHE, Director, 
  VISN 4; Richard Citron, FACHE, Director, Philadelphia VA 
  Medical Center; Michael Hagan, M.D., Ph.D., National Director, 
  Radiation Oncology Program, Richmond VA Medical Center; Mary 
  Moore, Radiation Safety Officer, Philadelphia VA Medical 
  Center; and Joel Maslow, M.D., Chairman, Philadelphia VA 
  Medical Center Radiation Safety Committee......................    43
    Prepared statement...........................................    45
    Response to written questions submitted by Hon. Richard Burr.    46
Richard Whittington, M.D., Chief of Radiation Oncology, 
  Philadelphia VA Medical Center,................................    49
Reynolds, Steve A., Director, Division of Nuclear Materials 
  Safety, Region III, U.S. Regulatory Commission.................    50
    Prepared statement...........................................    50
    Response to written questions submitted by Hon. Richard Burr.    53

                                APPENDIX

Schwartz, Hon. Allyson Y., U.S. Representative from Pennsylvania; 
  prepared statement.............................................    75


                     FIELD HEARING: PHILADELPHIA VA
                  TERMINATED CANCER TREATMENT PROGRAM

                              ----------                              


                         MONDAY, JUNE 29, 2008

                                       U.S. Senate,
                            Committee on Veterans' Affairs,
                                                  Philadelphia, PA.
    The Committee met, pursuant to notice, at 10 a.m., in 
multipurpose room 1, Philadelphia VA Medical Center, Hon. Arlen 
Specter, presiding.
    Present: Senator Specter, House Representatives Adler and 
Fattah.

           OPENING STATEMENT OF HON. ARLEN SPECTER, 
                 U.S. SENATOR FROM PENNSYLVANIA

    Senator Specter. Good morning, ladies and gentlemen. The 
hour of 10 having arrived, we will proceed with this hearing of 
the Veterans' Affairs Committee of the U.S. Senate.
    One of the constitutional responsibilities of the Senate is 
to conduct oversight on activities of the Federal Government. 
We all know the tremendous debt which is owed by our society to 
the veterans of America who have fought in wars to establish 
and maintain our liberty, and one of the responses by a 
grateful government has been to provide medical care for the 
veterans. This is a subject which is very near and dear to my 
heart, because the first veteran I knew was my own father, 
Harry Specter.
    My story is a typical American story, both parents were 
immigrants. My father came to this country from Russia in 1911 
at the age of 18 and spoke about the privilege of being an 
American and serving with the American expeditionary force in 
France in 1918 to make the world safe for democracy. He was 
wounded in action. The government promised World War I veterans 
a $500 bonus--you could say they made him a $500 promise, too--
and that promise was broken, as so many promises are broken by 
the Federal Government.
    After being elected in 1980, I immediately joined the 
Veterans' Affairs Committee in the U.S. Senate because of my 
concern for fair and equitable treatment for veterans, and had 
the honor to serve for 6 years as Chairman of the Veterans' 
Affairs Committee.
    This hearing has been convened as a result of widespread 
publicity about problems in the Veterans Administration here in 
the city of Philadelphia. A week ago yesterday, there were 
extensive Sunday stories by both the Philadelphia Inquirer and 
The New York Times. Those stories reported that there was a 
systematic problem on the treatment of prostate cancer at the 
Philadelphia VA Medical Center, causing 82 veterans to receive 
incorrect doses of radiation. There was a procedure undertaken 
where there were seeds implanted to kill the cancer cells, but 
the seeds were planted, in some cases, in the bladder or 
elsewhere. The New York Times characterized the procedures here 
as a ``rogue cancer unit.''
    One factor which we will inquire about today is why these 
errors were not detected for a period of some 6 years; and why 
the oversight was done by the operative physicians themselves, 
as opposed to some independent agency; and a major question 
exists as to what can be done to correct whatever problem 
existed; and what assurances can be given to the veterans and 
the public that the procedures will be maintained and corrected 
so that appropriate service will be given to the veterans who 
are served here.
    We now turn to our first witness, who is Reverend Ricardo 
Flippin, a patient who was mentioned in the articles that I 
referred to. Reverend Flippin is a 21-year veteran of the U.S. 
Air Force who received his treatment here. He is a native of 
Philadelphia, but currently resides in Charleston, West 
Virginia.
    In accordance with the standard procedures, we will have 
testimony limited to 5 minutes, and then there will be 
questioning.
    I expect to be joined by Congressman John Adler from New 
Jersey of the House of Representatives Veterans' Committee, and 
we will ask all witnesses to observe the time limit. There is a 
clock in front of each witness.
    Reverend Flippin, we thank you for coming from West 
Virginia. We understand that you are a native of Philadelphia, 
Pennsylvania and we look forward to your testimony. You may 
proceed.

            STATEMENT OF REVEREND RICARDO FLIPPIN, 
                UNITED STATES AIR FORCE VETERAN

    Rev. Flippin. Thank you. Senator Specter, I would like to 
thank you for your interest in this situation at the 
Philadelphia VA, and for inviting me here today.
    Although I was born and raised in Philadelphia, I had been 
absent from the Philadelphia area from the time that I left to 
join the Air Force. I returned to Philadelphia in 2004 to take 
care of my mother, whose health was failing. As I did not have 
a private physician in this area, I decided that I would try to 
take advantage of my benefits as a veteran and I sought medical 
care from the Philadelphia VA. This was my first contact with 
the VA health care 
system.
    On April 15, 2004, I made my first trip to the Philadelphia 
VAMC, because my family doctor in Charleston told me that my 
PSA was increasing and that I should make a point of following 
up with the doctor when I got to Philadelphia. A PSA test was 
performed on my first visit, which showed a level of 7.04. It 
took the VA until May 9, 2005, to actually treat my prostate.
    On June 3, 2004, I returned to the Philadelphia VA and was 
given a referral for a urology consult. This consult took place 
on June 29, 2004. I was scheduled for a biopsy which took place 
on August 26, 2004.
    On September 23, 2004, I was advised that I had cancer. In 
December 2004, I met with a physician to discuss my opinions.
    In January 2005, I believe that I met with the radiation 
oncologist. He was quite convincing that brachytherapy was the 
best option for my situation and that he had received good 
results from this procedure in the past; and he had performed 
hundreds of them. Let me say at this point that that is what 
impressed me, that this physician had told me--looking me 
eyeball to eyeball--that he had actually performed over 600 
brachytherapy procedures. My procedure was not scheduled until 
May 9, 2005. By then, my mother had passed away and I had 
returned to Charleston, West Virginia to be with my wife, my 
granddaughter, and my niece.
    During the time after my procedure, I had medical problems 
that required me to return to the VA on several occasions for 
additional medical care. Eventually, the VA sent me to the Ohio 
State University for an additional procedure with a specialist. 
Until I received notification from the VA in Philadelphia that 
they were investigating my medical care as well as the medical 
care of other veterans, no one had ever told me that there had 
been any problem with the procedure that was performed at the 
Philadelphia VA. To date, no one from the Philadelphia VA has 
specifically told me what went wrong with my procedure, nor 
have I been advised to what the effects of this procedure has 
been and will be on me.
    On July 2, 2008, they sent me a letter saying, ``Our review 
of your treatment program has indicated that there is a 
possibility that you received the radiation to your prostate 
gland that was less than your physician intended,'' which led 
me to believe that there was something wrong with the seeds or 
perhaps the equipment. The letter never mentioned that other 
parts of my body apparently got a radiation dose greater than 
my physician intended.
    On August 15, 2008, they sent me a letter saying that the 
treatment did not meet the VA standard of care. The results of 
a CT scan indicate that the treatment that you received did not 
meet the VA's high standard of care. ``You recently were 
notified by telephone of this result, and this letter is being 
sent to confirm that conversation. We have also advised your VA 
primary care physician of this fact, and we will send him/her a 
copy of this letter.''
    They sent me some forms for filing a claim, which was nice 
of them, but not one person in the VA told me what the effects 
of the surgery that I received were. No one from the 
Philadelphia VA and no one from the West Virginia VA has 
written me or called me and said that I am more likely to get a 
reoccurrence. No one has said----
    Senator Specter. Reverend Flippin, before your time 
expires, would you tell us what injuries, if any, you 
sustained.
    Rev. Flippin. I sustained a radiation burn to my rectum 
which caused me to be laid up for 5 months; 24 hours a day, 
bedridden.
    Senator Specter. You may proceed.
    Rev. Flippin. For the last several years, I have worked 
with a program designed to help veterans deal with the issues 
that they face. My biggest concern is that there may be 
veterans out there who have had this happen to them and they 
have not gotten the message from the VA. As someone who has 
spent 20 years active duty in the Air Force and as someone who 
regularly works with veterans to see that they get the services 
they need, I know that there are probably some veterans out 
there who received letters but did not open them because they 
were from the VA. They also may have received phone calls they 
did not return because they were from the VA. And my hope is 
that the attention that this is creating will make those guys 
or, more likely, their spouses or family members, go back and 
open those letters and get the follow-up treatment that they 
need.
    Finally, I really cannot add anything to the discussion 
about Dr. Kao. I have never met the gentleman. He was not the 
doctor who I met with to decide the type of therapy to select. 
I was surprised to learn this week that he was a contractor. No 
one told me that my surgery was going to be done by someone who 
did not work for the VA.
    Thank you for your concern about the medical care that 
veterans are receiving from the Department of Veterans' 
Affairs.
    [The prepared statement of Rev. Flippin follows:]
Prepared Statement of Rev. Ricardo C. Flippin, U.S. Air Force Veteran, 
                       Charleston, West Virginia
    I would like to thank you for your interest in the situation at the 
Philadelphia VA, and for inviting the here today.
    Although I was born and raised in Philadelphia, I had been absent 
from the Philadelphia area from the time that I left to join the Air 
Force. I returned to Philadelphia and 2004 to take care of my mother, 
whose health was failing. As I did not have a private physician in this 
area, I decided that I would try to take advantage of my benefits as a 
veteran and I sought medical care from the Philadelphia VA. This was my 
first contact the VA health care system.
    On April 15, 2004, I made my first trip to the Philadelphia VA, 
because my family doctor in Charleston had told me that my PSA was 
increasing and that I should make a point of following up with the 
doctor, when I got Philadelphia. A PSA test was performed on my first 
visit, which showed a level of 7.04. It took the VA until May 9, 2005, 
to actually treat my prostate.
    On June 3, 2004, I returned to the Philadelphia VA and was given a 
referral for an urology consult. This consult took place on June 29, 
2004. I was scheduled for a biopsy, which took place on August 26, 
2004. On September 23, 2004, I was advised that I had cancer. In 
December 2004, I met with the physician to discuss my options. In 
January 2005, I believe that I met with a radiation oncologist. He was 
quite convincing that brachytherapy was the best option for my 
situation and that he had received good results from this procedure in 
the past and had performed hundreds of them. My procedure was not 
scheduled until May 9, 2005. By then, my mother had passed away and I 
had returned to Charleston, West Virginia, to be with my wife, my 
granddaughter and niece.
    During the time after my procedure, I had medical problems that 
required me to return to the VA on several occasions for additional 
medical care. Eventually, the VA sent me to Ohio State University for 
an additional procedure with a specialist. Until I received 
notification from the VA, in Philadelphia, that they were investigating 
my medical care, as well as the medical care of other veterans, no one 
ever told me that there had been any problem with the procedure that 
was performed at the Philadelphia VA. To date, no one from the 
Philadelphia VA has specifically told me what went wrong with my 
procedure, nor have I been advised as to what the effects of this 
procedure have and will be on me.
    On July 2, 2008, they sent me a letter saying ``. . . Our review of 
your treatment program has indicated that there is a possibility that 
you received a radiation dose to your prostate gland that was less than 
your physician intended. . . .''
    Which led me to believe, that there was something wrong with the 
seeds, or perhaps the equipment? The letter never mentions that other 
parts of my body, apparently, got a radiation dose greater than my 
doctor intended.
    [The July 2, 2008, letter follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
                                 ______
                                 
    On August 15, 2008, they sent me a letter saying that the treatment 
did not meet the VA's standard of care.

        ``. . . The results of the CT scan indicate that the treatment 
        you received did not meet VA's high standard of care. You 
        recently were notified by telephone of this result and this 
        letter is being sent to confirm that conversation. We have also 
        advised your VA primary care physician of this fact, and we 
        will send him/her a copy of this letter.''

    [The August 15, 2008, letter follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    They sent me some forms for filing a claim, which was nice of them, 
but not one person in the VA told me what the effects of the surgery 
that I received were. No one from the Philadelphia VA, no one from the 
Charleston VA, has written me, or called me, and said that I'm more 
likely to get a reoccurrence, no one has said that I should come in 
more regularly for monitoring, no one from the VA has said that you're 
going to be fine. I learned from the newspaper that they had 6 veterans 
go out to the Seattle VA to have their procedures redone, so I hope 
that I'm not that bad. It is particularly upsetting that they have not 
told me anything about my future because some of the NRC materials make 
it seem as if a very thorough investigation has been commissioned by 
the VA and that an expert has reviewed each of the cases. As a matter 
of fairness, one would think that they would have told each veteran 
what the results of the outside study were, or that they would have 
provided this information to my primary care doctor, to help them with 
my future medical care.
    For the last several years I have worked with a program designed to 
help veterans deal with the issues that they face. My biggest concern 
is that there may be veterans out there who have had this happen to 
them, and they have not gotten the message from the VA. As someone who 
spent twenty years on active duty in the Air Force, and as someone who 
regularly works with veterans, to see that they get the services that 
they need, I know that are probably some veterans out there who didn't 
open the letters that they got from the VA, because they were from the 
VA, they didn't return the phone calls they got from the VA, because 
they were from the VA, and my hope is that the attention that this 
hearing is creating will make those guys, or more likely their spouses 
or family members, go back and open those letters and get the follow up 
treatment that they may need.
    Finally, I really can't add anything to the discussion about Dr. 
Kao. I have never met the gentleman. He was not the doctor who I met 
with to decide which type of therapy to select. I was surprised to 
learn this week that he was a contractor; no one told me that my 
surgery was going to be done by someone who did not work for the VA.

    Thank you for your concern about the medical care that veterans are 
receiving from the Department of Veterans Affairs.

    Senator Specter. Thank you, Reverend Flippin.
    Without objection, I will put into the record a statement 
from U.S. Representative Allyson Y. Schwartz of Pennsylvania's 
District 13.
    [The prepared statement of Ms. Schwartz is found in the 
Appendix.]
    Senator Specter. I would like to turn now to Congressman 
John Adler, House of Representatives, who is a member of the 
Veterans' Affairs Committee and who, early on, spoke out about 
this issue.
    Welcome, Congressman Adler. Would you care to make an 
opening statement?

                 STATEMENT OF HON. JOHN ADLER, 
                 REPRESENTATIVE FROM NEW JERSEY

    Mr. Adler. Senator, thank you very much, and thank you as 
well on behalf of the veterans of America and the people of 
America for your calling this field hearing here today. You 
acted promptly when you learned about the troubles we have had 
with the brachytherapy program here at this VA hospital. Your 
concern for veterans has been noted for a number of years, but 
the fact that you would have such a prompt hearing, I think the 
country thanks you for that.
    Our first President, George Washington, once said, ``The 
willingness with which our young people are likely to serve in 
any war, no matter how justified, shall be directly 
proportional as to how they perceive the veterans of earlier 
wars were treated and appreciated by their country.''
    The veterans like Reverend Flippin who sought treatment for 
their 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 
care in brachytherapy let our veterans down and sent the wrong 
message to young men and women thinking about joining our all-
volunteer Armed Forces. We must do better for them.
    So, it is my sense that this hearing today and the hearing 
we will have in Washington next week are about evaluating what 
happened, not to cast blame, although there is certainly some 
blame to go around, but to reassure our veterans and those 
considering volunteering for our Armed Forces in the future, 
that we will keep faith with the commitment we have made to 
them as they have kept faith with us by keeping us safe, 
keeping us free, and keeping us the strongest country in the 
world.
    Reverend Flippin, I thank you for your 20 years of active 
duty service; that would have been enough. But I thank you as 
well for coming forward to share with us in this room, the 
newspapers, and America, the substandard care you received. It 
would have been enough if you had just soldiered on as you had 
while on active duty and suffered quietly, but the fact that 
you would share your experience, share your physical pain and 
your emotional trauma so that we can learn from it, so that we 
can set in place a new standard of care to meet the needs of 
our veterans, like yourself, going forward, is greatly to your 
credit. It is part of your ongoing service to your country, and 
I appreciate it. I am sure Senator Specter appreciates it, 
Representative Schwartz appreciates it, all the people from our 
region and from the whole country should join us in thanking 
you for testifying.
    I wonder at what point you first decided we were letting 
you down as a country. At what point did you think--during your 
process, during your treatment--that the VA Hospital was not 
giving you the standard of care you deserved.
    Senator Specter. Congressman Adler, we are going to hold 
the questions for the first round of questioning.
    Mr. Adler. I am sorry. Fine. I apologize.
    Senator Specter. It is OK.
    We will turn now to Congressman Chaka Fattah for an opening 
statement.
    Thank you for joining us, Congressman Fattah.

   OPENING STATEMENT HON. CHAKA FATTAH, REPRESENTATIVE FROM 
                          PENNSYLVANIA

    Mr. Fattah. Well, Senator, I rearranged my schedule so that 
I could be here. I want to thank you for holding this hearing. 
It is very timely. This is a great facility that has provided a 
lot of care for our veterans over many years, but this incident 
raises an extraordinary level of concern, and I want to thank 
you for convening us today. I am here to get some answers.
    So, rather than giving a major opening statement, I want to 
thank the Reverend for his service to the country. My brother 
also served in the Air Force, and I think it also says a great 
deal about you that you returned to Philadelphia to care for 
your ailing mother, and that you are leading a faith community. 
You are of service to our country in every respect, and we want 
to get to the bottom of what happened. In incidents where 
mistakes happened, we are all human beings--but the question 
becomes, what was done once the mistake was realized, and 
whether or not, in this instance, all of our veterans were best 
served.
    I thank the Senator for using the weight of his office to 
convene us so that we could begin to get to the answers to this 
question. Senator Specter, for your leadership on this subject, 
I thank you.
    Senator Specter. Thank you, Congressman Fattah.
    Before turning to questions, we are going to hear from 
other witnesses.
    I would like to call now Dr. Gary Kao to the witness stand, 
if Dr. Kao would step forward.
    Dr. Kao has a bachelor's degree from John Hopkins 
University, an M.D. from John Hopkins School of Medicine, and a 
Ph.D. from the University of Pennsylvania. He was board 
certified in 1994 by the American Board of Radiology, and was 
contracted by the VA in 2002.
    We are calling on Dr. Kao early because he has been 
identified in the news accounts as having performed a number of 
the operative procedures in question.
    I note that you are accompanied Dr. Kao, and if those who 
have accompanied you would identify themselves, I would 
appreciate it.
    Mr. Vaira. Good morning, Senator Specter, Congressmen. I am 
Peter Vaira of the Law Firm of Vaira & Riley, and my associate 
is William Murray, from my law firm.
    Senator Specter. Thank you very much, Mr. Vaira.
    Dr. Kao, the floor is yours and you may proceed.

   STATEMENT OF GARY KAO, M.D., PH.D., ASSOCIATE PROFESSOR, 
RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA; ACCOMPANIED BY 
PETER F. VAIRA, ATTORNEY, SHAREHOLDER, VAIRA & RILEY, P.C.; AND 
     WILLIAM J. MURRAY JR., ASSOCIATE, VAIRA & RILEY, P.C.

    Dr. Kao. Thank you, Senator Specter and Congressmen, for 
the opportunity to voluntarily appear before you so that I may 
be heard on this very important subject matter and correct some 
very serious false allegations contained in recent publications 
about me, 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 bachelor's degree and a 
medical doctorate degree from Johns Hopkins University and its 
School of Medicine, followed by medical internship and 
residency and radiation oncology residency. This culminated in 
board certification in radiation oncology.
    I am especially proud that, in 15 years of continuous 
medical practice, there has not been a single malpractice claim 
against me. My impeccable background and commitment to the care 
of my patients make the false accusations against me 
particularly devastating and misguided.
    Let me first express my sincere sadness to the plight of 
Reverend Flippin. I would have welcomed the opportunity to do 
anything I could to help him, but I have never been contacted 
by Reverend Flippin or anyone on his behalf after the 
procedure; and therefore, do not know about his complaints and 
symptoms which arose about a year after his procedure.
    I was first notified about Reverend Flippin from The New 
York Times article published the previous Sunday, and because I 
have not had access to any of his records since leaving the VA, 
I am unable to further comment on his medical treatment or 
condition.
    What I can truthfully report is that I, along with others 
at the Philadelphia VA, implemented the program for 
brachytherapy to serve the best interest of veterans. Contrary 
to allegations that I was a ``rogue physician,'' there were 
precise standard operating procedures formulated and followed 
and a system of monitoring and oversight. We formulated the 
first algorithm of any radiation oncology procedure at the VA 
to define those standard operating procedures. As with any 
program, it is not without incidents or challenges; however, I 
have always acted in the best interests of the patients in 
delivering this important treatment. I have never, nor would I 
ever, falsify documents, cover up results, or act in a manner 
detrimental to the interest of any patient.
    What has become clear is that a misunderstanding of 
elementary principles or concepts have led some to 
inappropriately and incorrectly conclude that deficient care 
was routinely rendered; it was not the case. It is important 
that these issues be clearly understood. A fundamental issue 
which I want to directly address and which has been 
misunderstood is the subject of what the NRC defines as a 
reportable medical event and its applicability to our work at 
the VA.
    Here are the facts:
    Fact one, the standard definition of a reportable medical 
event to the NRC was not in existence when the brachytherapy 
program started at the VA. The definition was specifically 
never mentioned 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 on site at the Philadelphia VA. This definition was not 
the subject of any training provided to us by the NRC or the 
VA.
    Fact two, the definition of a reportable medical event to 
the NRC does not define a standard of effectiveness of medical 
treatment either scientifically or medically.
    A patient whose treatment results in a reportable medical 
event may still have received effective treatment and be within 
the appropriate standard of medical care.
    Fact three, the appropriate standard of medical care for 
brachytherapy should not be determined by the NRC definition of 
a reportable medical event. There are many more significant 
factors that determine appropriate treatment, such as the 
number of seeds, the location of seeds in the prostate, 
location of seeds outside the prostate, the concentration of 
seeds in the affected area of the prostate, the size, shape of 
the prostate, the stage, grade, extent, and location of the 
cancer, and the clinical follow-up of the PSA test results, all 
of which are not addressed in the NRC defined standards.
    The field of brachytherapy during the period of 2002 to 
2008 was, and still is, an 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--that 
during my tenure the patients received appropriate medical 
care, which was effective in addressing their cancer.
    In considering my experience at the VA and experience in 
the brachytherapy program, however, there are certainly issues 
which need to be addressed and implemented regarding the care 
provided to our veterans. These include the following:
    One, a system should be established so that a treating VA 
physician is notified when 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.
    For complex medical procedures such as brachytherapy, two, 
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 treatment.
    Three, there should be a method of categorizing systemic 
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 to be quickly resolved.
    Four, there should be a formal system by which the NRC and 
other national regulatory bodies would be required to 
continually train doctors and other personnel in the latest 
defined standards.
    Five, 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.
    Six, 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.
    Thank you, Senator and Congressmen.
    [The prepared statement of Dr. Kao follows:]
   Prepared Statement of Gary Kao, M.D., Ph.D., Associate Professor, 
             Radiation Oncology, University of Pennsylvania
                              introduction
    I became a doctor because of my desire to help people. I am and 
always have considered myself to be a compassionate dedicated physician 
who prides himself in taking care of his patients. I have never 
knowingly hurt any of my patients and my record shows that to be true--
I am proud that I have not had a single malpractice claim filed against 
me in fifteen years of continuous clinical practice. In 1984 I 
graduated from Johns Hopkins University with a Bachelor of Arts in 
Philosophy and graduated in 1988 as a Medical Doctor from the Johns 
Hopkins School of Medicine. I completed two years of Internal Medicine 
Residency followed by completion of a Residency in Radiation Oncology, 
all at the University of Pennsylvania School of Medicine (``Penn''). I 
have been Board Certified in Radiation Oncology since 1994, and an 
Attending Physician at Penn since that time. I am also a member of 
American Society for Therapeutic Radiation Oncology.
    In order to gain additional expertise in anticancer treatment, I 
completed a doctoral dissertation at Penn in Molecular Biology, which I 
successfully defended in 1998 and was awarded a Ph.D. from Penn in 
Molecular Biology. While still on staff at Penn, I completed a 
Postdoctoral Fellowship at the Fox Chase Cancer Center in 2002. Shortly 
after completing my Fellowship, I was assigned to the Philadelphia 
Veterans Affairs Medical Center (``PVAMC'') and then became a full-time 
staff member of the PVAMC. I was asked by the PVAMC to start a 
brachytherapy program at the PVAMC and was proud to have earned this 
honor. I accepted the responsibility and worked hard with others at the 
PVAMC to develop a top notch program in this evolving area of medicine. 
I remained a PVAMC staff physician in Radiation Oncology continuously 
until the beginning of 2008.
    Given all that I have worked so hard to achieve and my commitment 
to patient care, I was devastated, personally and professionally, by 
the false allegations published in The New York Times on Father's Day, 
branding me as a ``rogue doctor'' who had covered up mistakes and 
operated in isolation and without supervision. Never in my career have 
I ever falsified any medical records and never have I participated in a 
cover-up.
    On the contrary, what happened at the PVAMC in connection with the 
brachytherapy program is in no way what has been depicted by the New 
York Times article. The truth is that the Prostate Brachytherapy team 
at the PVAMC was a collaborative interdisciplinary effort that I led, 
but which was minutely supervised every step of the way by the 
Radiation Oncology Department, the Radiation Safety Office and 
ultimately by the Administration of the PVAMC. Under sometimes 
challenging circumstances, the Team tried to deliver quality care to 
veterans, who would otherwise not have access to treatment.
    That is why the malicious allegations against me and the Program 
are so deeply hurtful. So too is the claim that I operated on my own, 
without supervision and without guidance. The falsity of that 
allegation is easily demonstrated because there was a standard 
operating procedure for the administration of brachytherapy. The 
procedure was codified in a Prostate Brachytherapy Algorithm that was 
jointly created by Radiation Oncology, Medical Physics, Urology, 
Radiation Safety and Nursing and disseminated to and approved by all 
levels of the PVAMC Administration. This Algorithm was constantly 
reviewed and revised as our Team gained more expertise in delivering 
care to our patients. The Algorithm established a consensus, providing 
structure for a procedure that had no precedence or guiding standards 
at the PVAMC when I was asked to help start this Program. Each 
brachytherapy patient treated by me or any other physician at the PVAMC 
was cared for according to the SOP established by Algorithm.
    The following points address specific aspects in greater detail:

    1. The PVAMC Prostate Brachytherapy Program was a multidisciplinary 
collaboration.

          The members of the Brachytherapy Team consisted of:

                   i. Radiation Oncology
                   ii. Urology
                  iii. Radiation Safety
                  iv. Medical Physics
                   v. Nursing/Program Coordinator
                  vi. Administration

          The program was supervised by Radiation Safety. I was not a 
        member of the Radiation Safety Committee and was not invited to 
        attend meetings of the Committee.

    2. The PVAMC Brachytherapy Program team members received the 
necessary training for Prostate Brachytherapy.

          a. As a resident physician, I was taught prostate 
        brachytherapy at Penn by senior attending physicians.
          b. I completed the same Prostate Brachytherapy course in 
        Seattle, WA at the Northwest Hospital that others from the 
        PVAMC also attended.
          c. We observed the Prostate Brachytherapy Program at the 
        Mercer Hospital affiliate of the Department of Radiation 
        Oncology in Trenton, NJ, a program that also utilized the 
        preloaded method of brachytherapy.
          d. I was proctored in the performing of my first ten 
        Brachytherapy cases at the PVAMC by experienced physicians.
          e. Other physicians were available for immediate consultation 
        and additional mentoring.
          f. The allegations in the NY Times of a lack of brachytherapy 
        training or supervision are therefore untrue.

    3. I created the protocol for providing brachytherapy treatment 
(``Algorithm'') with collective multidisciplinary input, vetted through 
the PVAMC Administration.

          a. The absence of standard policy regarding Brachytherapy in 
        the PVAMC prompted the need for written consensus when the 
        Program was first created in February 2002:

          b. The first version was completed before the first patient 
        was treated in February 2002, and continuously updated through 
        the years of the Program.
          c. The Algorithm was collaboratively written by all members 
        of the Brachytherapy Team, and represented our collaborative 
        expertise regarding the Standard Operating Procedure for 
        providing brachytherapy.
          d. The Algorithm describes those patients for whom 
        brachytherapy was most suited as well as those for whom the 
        procedure would not be effective. It also details the steps 
        each patient undergoes through the Brachytherapy process 
        beginning with the pre- procedure planning and following 
        through with the actual procedure and the post-procedure follow 
        up.
          e. The Algorithm does not include any reference to reportable 
        Medical Events as defined by the Nuclear Regulatory Commission 
        (``NRC'') because no such definitions existed at the start of 
        the program.
          f. Because the PVAMC served a wide geographical patient 
        population, the Algorithm recognized that those patients living 
        far from Philadelphia may have to receive post procedure care 
        at their local hospitals.
          g. The NRC, in its investigation, and the NY Times failed to 
        mention the existence and purpose of the VA Prostate 
        Brachytherapy Algorithm.

    4. The Initial and Revised Written Directives serve different 
purposes.

          a. The New York Times article falsely accuses me of altering 
        the Written Directive.
          b. The Written Directive is mandated by the NRC and VA's 
        Office of Radiation Safety. The forms were designed by 
        Radiation Safety, completed by both Medical Physics and 
        Radiation Oncology, signed by the physicians, and processed by 
        Radiation Safety.
          c. The Initial Written Directive (WD) specifies the number of 
        seeds to be ordered by Radiation Safety, i.e. the prescription 
        for number of seeds. It is completed by the Medical Physicist 
        together with the Radiation Oncologist physician, who then 
        signs the WD.
          d. A copy of the Initial WD is submitted to Radiation Safety, 
        which places the order of the number of seeds, and then 
        receives and secures the seeds. The original WD remains in the 
        patient's medical chart.
          e. On the day of the Brachytherapy procedure, Radiation 
        Safety brings the seeds to the procedure room (adjacent to the 
        OR suite), remains in the room to supervise the procedure, and 
        to store and safeguard any seeds that are retrieved by Urology 
        from the bladder or found outside the patient.
          f. Integral to the procedure is the Urologist. Immediately 
        after the implanting of the seeds, the Urologist, using a 
        cystoscope, will retrieve any seeds that have either migrated 
        to or been implanted in the bladder. This action by the 
        Urologist is done in connection with every procedure since a 
        recognized risk of the procedure is that seeds will come to 
        rest in the bladder.
          g. After the seeds are retrieved by the Urologist, that 
        physician and Radiation Safety inform the Radiation Oncologist 
        of the number of seeds that do not remain in the patient. 
        Through this collaborative process, the Team determines the 
        actual number of seeds that remain in the patient.
          h. Under supervision by Radiation Safety, the Radiation 
        Oncologist completes the Revised WD that states the actual 
        number of seeds retained within the patient. The Revised WD is 
        submitted to Radiation Safety, and a copy is again placed in 
        the patient's medical chart. Radiation Safety staff and Urology 
        are present throughout the brachytherapy procedure.
          i. The WD can be revised yet again prior to the discharge of 
        the patient on the day following the procedure. This revision 
        would reflect any seeds passed by the patient in his urine 
        while recovering from the procedure. If there is a second 
        revision, it too is submitted to Radiation Safety and a copy is 
        retained in the patient's chart.
          j. The procedure described above assures that there is an 
        accurate count of the disposition of all of the seeds 
        originally ordered by Radiation Safety for a particular 
        procedure.
          k. Given the appropriateness and the different purposes of 
        the Initial and Revised Written Directives, my handling of the 
        Written Directives was entirely appropriate and legal. I did 
        not falsify or erase any Written Directive at any time, 
        contrary to the allegations of the New York Times, nor was it 
        likely that any other member of the Team did so. It is for this 
        reason that these allegations are not only false but 
        scurrilously so.

    5. How the Brachytherapy Procedure is performed.

          a. The prostate is an organ the size of a walnut and is 
        immediately adjacent to the bladder and rectum.
          b. The procedure performed at the PVAMC was via the 
        Preplanned, Preloaded Method. This entailed a transrectal 
        ultrasound sizing of the prostate completed at least two weeks 
        prior to the actual implant of the seeds. This ultrasound 
        serves as the basis for the treatment planning which includes 
        determining the number of seeds and needles required to be 
        ordered by Radiation Safety via the Initial Written Directive.
          c. Informed consent is obtained from the patient, who is 
        counseled that seeds can migrate away from the prostate, and 
        that up to 5% of patients may develop complications that 
        include an inflammatory condition of the rectum known as 
        radiation proctitis.
          d. The patient is taken into the procedure room and 
        anesthesia is induced.
          e. Stabilizing needles are inserted.
          f. The Urologist places the ultrasound probe, and inserts the 
        first needle containing seeds into the prostate, and deposits 
        the seeds contained within the first needle. This establishes 
        the base of the prostate, and the deepest extent that all 
        subsequent needles will reach.
          g. The Radiation Oncologist then inserts the remaining 
        needles following the lead of the Urologist and deposits the 
        remainder of the seeds.
          h. The Urologist then performs the previously mentioned 
        cystoscopy to scan for and remove any blood clots or seeds from 
        the bladder.
          i. Radiation Safety uses a Geiger counter to scan the entire 
        room and every person leaving the room, to retrieve and store 
        any seeds not in the patient.
          j. Anesthesia is reversed, and patient is moved to recovery.

    6. The brachytherapy incident of 2003 was reported to the NRC and 
resulted in a thorough investigation.

          a. A patient who was implanted on February 3, 2003, had a 
        significant number of seeds in his bladder. All such seeds were 
        retrieved by the Urologist
          b. As per standard operating procedure and under the 
        direction of Radiation Safety, the patient had an Initial WD 
        that specified the numbers of seeds ordered, and then a revised 
        WD to reflect the actual number of seeds that were retained 
        within the patient A copy of both the Initial and Revised 
        directive was retained by Radiation Safety, and the original 
        put in the patient's medical chart.
          c. This event was promptly reported to the NRC, who then came 
        to PVAMC to conduct a full multiday investigation. The NRC 
        ultimately cleared the Program to resume treating patients.
          d. Because the dose of radiation delivered to the prostate 
        was considered inadequate, a repeat brachytherapy was performed 
        on March 31, 2003. This was successful in increasing the 
        radiation dose received by the prostate. There were 
        subsequently no unusual or unexpected complications or toxicity 
        reported.
          e. Contrary to what was alleged by the New York Times, at no 
        time did I or anyone cover-up the patient's treatment by 
        altering the Written Directive.

    7. The brachytherapy incident of 2005 was reported to the NRC and 
resulted in a thorough investigation.

          a. A patient was initially seen and accepted for 
        Brachytherapy by another Radiation Oncologist I performed the 
        Brachytherapy on 5/19/05. Because of poor imaging quality (due 
        to the patient's inability to complete the necessary bowel 
        preparation), many seeds were inserted into the bladder.
          b. As per the standard operating procedure and under the 
        direction of Radiation Safety, the patient had an Initial WD 
        that specified the numbers of seeds ordered, and then a revised 
        WD to reflect the actual number of seeds that were retained 
        within the patient. A copy of both the Initial and Revised 
        directive was retained by Radiation Safety, and the original 
        put in the patient's medical chart.
          c. During the course of the cystoscopy that is performed 
        after every brachytherapy, a large number of seeds were 
        retrieved from the bladder. This fulfilled the definition of a 
        reportable Medical Event as I understood that definition at 
        that time, and the case was promptly reported to the NRC. The 
        NRC then came to PVAMC to conduct a full multiday 
        investigation, and ultimately cleared the Program to resume 
        treating patients.
          d. On re-evaluation of the patient, the consensus among the 
        Prostate Brachytherapy Team was not to reimplant this patient, 
        as the patient's limited expected life span rendered the risks 
        greater than the expected benefit
          e. Contrary to what was alleged by the New York Times, the 
        NRC performed a thorough investigation of this case.

    8. The NRC definition of a reportable Medical Event has evolved 
over time and continues to be a subject of debate.

          a. There was no NRC definition of a reportable Medical Event 
        when the Brachytherapy Program was first started at the PVAMC 
        in 2002.
          b. The physicians and physicists never received NRC training 
        on this issue throughout the years the Program was operational.
          c. The instruction following the investigation by NRC of the 
        2003 prostate brachytherapy incident was that ``if greater than 
        20% of the seeds prescribed were retrieved from the bladder;'' 
        this would constitute a reportable Medical Event and would 
        trigger a repeat NRC investigation.
          d. The brachytherapy incident of 2005 was clearly therefore a 
        reportable Medical Event and appropriately reported.
          e. The Prostate Brachytherapy Team was never instructed 
        regarding 090 (the % of the prescribed dose that 90% of the 
        prostate receives) as a metric that constitutes a reportable 
        Medical Event. This means that no one on the Team was advised 
        that if the dose received by the prostate was 20% greater or 
        20% less than the optimal dose it would constitute a Medical 
        Event and would have to be reported to the NRC.
          f. The definition of a medically reportable Medical Event 
        that consists of a 090 that is either 20% above or below the 
        prescribed dose was not in existence when the Prostate 
        Brachytherapy Program was first started, nor was that ever an 
        instruction provided to the Team.
          g. While achieving a 090 that is not over and below 20% of 
        the prescribed radiation dose rule is an optimal standard to 
        strive for under NRC guidelines, it does not constitute a 
        clinical standard of care for brachytherapy treatment. Indeed, 
        recent articles published in the medical literature suggest 
        treatment may be appropriate even when the 090 is less than 
        80%. I am happy to provide copies of those articles to the 
        Committee should it wish to review them.

    9. I have never ordered the wrong seed strength.

          a. My cases have been standardized on the 0.509 mCi seed 
        strength.
          b. The discrepancy between 0.380 mCi and 0.509 mCi seed 
        strengths that are mentioned in the NRC Inspection Report of 
        March 30, 2009, involved prostate brachytherapy cases at the 
        PVAMC that did not involve my patients.
          c. The discrepancy between the seed strengths calculated and 
        actually ordered was discovered by Radiation Safety and 
        reported to the NRC.

    10. The dose to the rectum has not been defined as a reportable 
Medical Event by the NRC.

          a. As already stated, and as counseled in every consent form, 
        radiation proctitis is a known and recognized risk of 
        brachytherapy.
          b. Given the close proximity of the rectum to the prostate, 
        brachytherapy cannot be performed in a way that avoids dose to 
        the rectum. In fact, every seed implanted in the prostate 
        delivers radiation dose to the rectum, since the prostate is 
        immediately adjacent to the rectum.
          c. The dose to the rectum was not a metric that either PVAMC 
        Radiation Safety or the NRC requested that we measure.

    11. Despite the lack of computer interface between the CT scanner 
and the Variseed treatment planning workstation during 2006-2007. I 
provided effective treatment to my patients.

          a. At the conclusion of a procedure, a CT scan is done to 
        determine the location of the seeds.
          b. The images of the CT scan are then transferred to a 
        workstation that contains the software program called Variseed 
        and which calculates the dose actually received.
          c. In or around November 2006 a computer interface problem 
        between the CT scanner and the workstation containing the 
        Variseed software occurred that prevented the precise 
        calculation of doses of radiation.
          d. I reported this issue on several occasions to the 
        appropriate persons overseeing the Program, but the problem 
        persisted.
          e. I offered to take the CT scans on disk or flash drive to 
        Penn to perform the Variseed calculations. However this was 
        refused by the PVAMC due to confidentiality/privacy/security 
        concerns.
          f. CT images however were still viewable and showed the 
        location of the seeds, all of which were concentrated in areas 
        of the prostate that contained cancer.
          g. I had only two choices: to stop the Brachytherapy Program, 
        or to continue to deliver medical care which the patients 
        needed. Most of the patients treated for Brachytherapy did not 
        have the option of alternative treatments such as surgery or 
        external beam radiation. External beam radiation would have 
        required the patients to be treated on a daily basis, five days 
        a week, for eight weeks. Surgery also had serious drawbacks 
        including incontinence and impotence. Without brachytherapy, 
        the patients' cancers would have gone untreated.
          h. I elected to continue treatment based on Concern for the 
        patients' welfare.
          i. The treatment was effective and well within the standard 
        of care and was effective. The proof of the effectiveness was 
        demonstrated in follow up visits with the patients and 
        evaluation of their PSA levels.

    12. There were a number of systematic failures at the PVAMC that 
affected the Brachytherapy Program.

          a. Prior to the development of the PVAMC Prostate 
        Brachytherapy Program, there were no guidelines or policies for 
        the design and operation of a VA brachytherapy program. 
        Consequently, the Brachytherapy Team had to design its own set 
        of procedures and policies, which led to the creation of the 
        Prostate Brachytherapy Algorithm.
          b. When the Brachytherapy Program was first started, there 
        was no standard definition of what is a reportable Medical 
        Event.
          c. There was no system to train key members of the 
        Brachytherapy Program on what later became a definition of a 
        reportable Medical Event.
          d. There was no full time medical physicist dedicated to the 
        brachytherapy program. This impacted on the ability to timely 
        calculate the dose received by the patients.
          e. The lack of a computer interface between the CT scanner 
        and the Variseed dose calculation workstation prevented the 
        precise calculation of the doses of radiation received by the 
        patient.
          f. There was no mechanism by which concerns regarding key 
        steps of the procedure could bypass the chain of command to 
        solve problems, such as the computer interface problem.
          g. Understandable concerns about patient confidentiality 
        prevented the alternative transport of data from the CT scanner 
        via memory storage media and devices.

    13. To address some of these concerns, the Brachytherapy Program 
was in the process of moving from Preloaded to Real-time Treatment 
Systems.

          a. The members of the Brachytherapy Program recognized the 
        drawbacks of the Preloaded Brachytherapy System, such as the 
        inability to customize the placement of the seeds to match the 
        patient's actual anatomy.
          b. Consequently, members of the Team were in the process of 
        receiving training in the Real-time Treatment System, which 
        does account for changes in the patient's anatomy and which 
        includes continuous fluoroscopic verification of the location 
        of the deposited seeds.
          c. Real-time treatment would allow for the seeds to be 
        customized to the prostate on the day of the procedure.
          d. The Brachytherapy Program was halted before the change in 
        Treatment approach could be implemented.

    14. During a meeting of the Advisory Committee on the Medical Uses 
of Isotopes of the NRC, held in Rockville, MD, on May 7, 2009, it was 
falsely alleged that a key physician of the Brachytherapy Program had 
made certain statements and actions (``Committee Meeting Transcript''). 
Inflammatory statements and actions were falsely attributed to this 
member of the Prostate Brachytherapy Program, including:

                   i. ``The physician that did this particular implant, 
                once again, he felt that the 24 Gray was clinically 
                acceptable.'' Committee Meeting Transcript at page 192.
                   ii. ``And if he felt that 24 Gray was satisfactory, 
                that is the way it was.'' Committee Meeting Transcript 
                at page 192.
                  iii. ``Well, one of the things that we noticed was 
                that the physician that was primarily involved in the 
                brachytherapy program, he consistently did this. They 
                didn't use fluoroscopy during seed placement. He 
                refused to use fluoroscopy, said he didn't need it.'' 
                Committee Meeting Transcript at page 204.
                  iv. ``--yes, 2002, and--but from the time the 
                physician had received training to the time they 
                started the implant program, there was some delay. And 
                there was no--there was no effort on the part of the 
                physician to maybe proctor or observe or be involved 
                with some implants before they decided to go and 
                proceed and treat their first patient . . . that was a 
                decision that was made by the Authorized User.'' 
                Committee Meeting Transcript at page 221.
                   v. ``No. According to him, it was clinically 
                acceptable. As a matter of fact, his exact words are, 
                `43 Gray is better than zero Gray.' '' Committee 
                Meeting Transcript at page 241.
                  vi. ``But it is mindboggling to me that a physician 
                could say that a dose of 40 Gray, 24 Gray, is 
                acceptable, and then look at these implants and not 
                realize that this is gross incompetence.'' Committee 
                Meeting Transcript at page 243.

          a. These inflammatory actions and statements that are being 
        attributed to a key physician are being attributed to me, but 
        are not accurate. I neither said these statements nor took the 
        actions described.
          b. These false attributions are appropriately alarming and 
        inflamed the subsequent discussions of the Committee.
                               conclusion
    I have come to the hearing today to answer questions and to submit 
this written statement in order to correct the record and salvage my 
reputation. I hope that, through the hearing process, the 
investigations and through media reports, the truth will emerge. I am 
not the physician who has been portrayed in the media. I am not willing 
to be the scapegoat for the complex, systematic problems that affected 
the Brachytherapy Program at the PVAMC. I hope that the information I 
have provided today will help the Committee understand my role and 
responsibilities in developing and directing the Brachytherapy' 
Program. More importantly, it is also my hope that this information 
will help improve future medical care for 
veterans.
                                 ______
                                 
 Response to Post-Hearing Questions Submitted by Hon. Richard Burr to 
                      Dr. Gary D. Kao, M.D., Ph.D.
    Question 1. In your written testimony, you stated that, ``Shortly 
after completing my Fellowship, I was assigned to the Philadelphia 
Veterans Affairs Medical Center (``PVAMC'') and then became a full-time 
staff member of the PVAMC.'' The VA maintains that you were not a VA 
physician but that you were on contract from the University of 
Pennsylvania. Can you please clarify your current and past employers 
and employment status?
    Response. In 2003, I was awarded an Advanced Research Career 
Development Award (ARCD) by the Office of Research and Development 
Medical Research Service, Department of Veterans Affairs. This provided 
support not only for laboratory research but also for my clinical 
activities at the PVAMC. My understanding of the ARCD Award is that it 
mandated that I became a full-time employee of the Research Service of 
the PVAMC. In fact, from that point forward I was compensated by the 
PVAMC and received W-2 tax forms each year. When the ARCD ended in or 
around March 2007, I was switched to the Medical Service of the PVAMC 
as a ``5/8's'' staff physician and I continued to be compensated by the 
PVAMC and continued to receive W-2's for my work at the PVAMC. Near the 
end of 2007 or beginning of 2008, I became a ``contract physician'' of 
the University of Pennsylvania, assigned to the VA. At that point, I no 
longer received compensation from the PVAMC, but instead was paid 
directly by Penn.

    Question 2. At the hearing, you testified that, ``. . . at the time 
that the program was implemented, the definition of what is reportable 
to the NRC was not in existence and only came later on.''
    When asked about this statement, the NRC's Mr. Reynolds testified 
that, ``. . . Dr Kao is mistaken. The requirements to report to NRC 
when there is adverse care to patients went into effect in 1979.''
    Can you please clarify, if necessary, your statement, or explain 
why Mr. Reynolds is mistaken?
    Response. Mr. Reynolds is mistaken on two accounts. First, the NRC 
has never clarified the definition of a reportable medical event as it 
pertains to brachytherapy. The NRC's current regulation to report 
variations in delivered dose does not directly address brachytherapy or 
the determination of a medical event related to that therapy. [See 
relevant portions of the current regulation, attached as Exhibit 4].\1\ 
In the current regulation, ``total dose delivered'' is not defined. In 
contrast to external beam radiation, for example, where the target does 
not change in size or shape and would be expected to receive all the 
dose of radiation delivered, for brachytherapy the dose delivered to 
the target depends on numerous factors and hence is subjective. The 
subjectivity is inherent in the procedure due to multiple factors 
including how one contours the prostate, when the prostate is contoured 
after brachytherapy (when the prostate can be swollen), the recognized 
risk of seed migration away from the prostate and the implantation of 
seeds in tissues or other organs adjacent to the prostate, and the 
contribution of radiation dose from all the seeds, whether or not 
actually implanted into the prostate. Without clarification of these 
parameters, the definition of what constitutes a reportable medical 
event remains quite subjective. Even after the NRC investigations of 
2003 and 2005 were conducted on-site at the PVAMC, the NRC provided no 
clear definition of a reportable event other than the number of seeds 
located outside the prostate, as was communicated to the Brachytherapy 
Team by officials of the PVAMC Radiation Safety Office. [See note from 
PVAMC Radiation Safety, Exhibit 5].
---------------------------------------------------------------------------
    \1\ These Exhibits were attached to the Written Testimony recently 
submitted to the House Veterans' Affairs Committee (HVAC). We have 
elected to retain the same numbering system for each Exhibit as 
employed in the submission to the HVAC in order to avoid confusion for 
readers who may read this document as well as the documents submitted 
to the HVAC.
---------------------------------------------------------------------------
    The NRC's definition of a reportable Medical Event for 
brachytherapy continues to be unsettled. On August 6, 2008, the NRC 
published a proposed rule aimed, in part, at how properly to determine 
a medical event in the context of brachytherapy. As was stated by the 
NRC in the proposed rule, it was reconsidering ``the appropriateness 
and adequacy of the regulations for ME's (Medical Events) and WD's 
(Written Directives) with regard to the use of byproduct material that 
required completion of a WD'' (like brachytherapy). The proposed rule, 
if adopted, will change the definition of what constitutes a ME from 
one based on dose received by the prostate to one based on ``activity'' 
(i.e. radioactivity, or the number of seeds implanted in the prostate).
    In proposing the adoption of this rule (which, in my view, is akin 
to an effort to account for the location and disposition of nuclear 
byproducts, a function uniquely suited to the NRC, different from 
evaluating the clinical efficacy of a procedure, clearly not within the 
expertise of the NRC), the agency stated that under current guidelines 
based on dose (related to brachytherapy), ``there is no basis for 
determining whether an ME has occurred.'' [See Proposed Rule, I. 
Background, page 4, recognizing the necessary distinctions between 
brachytherapy treatment and other treatments utilizing byproduct 
material, and Sections 35.40(b) and 35.3045(a)(2), attached as Exhibit 
7].
    In addition to the proposed rule, the NRC's own Advisory Committee 
on the Medical Uses of Isotopes (ACMUI) has repeatedly urged that the 
definition of a Medical Event be changed from a definition that is 
strictly dose-based to a definition that is radiation activity-based, 
i.e. that relies on the counting of the number of seeds inside versus 
outside the prostate [See memo from ACMUI to the NRC Director, Exhibit 
8, and transcript of May 7, 2009 ACMUI meeting, Exhibit 9, pages 193-
197]. The NRC has acknowledged that this proposed definition, if 
adopted, would likely decrease the number of cases that the NRC regards 
as reportable Medical Events, including the cases performed at the 
PVAMC [See Proposed Rule, I. Background, Exhibit 7]. Members of the 
ACMUI have asked the NRC to analyze the PVAMC's brachytherapy cases 
using this new definition but, to our knowledge, the NRC has not yet 
done so.
    In evaluating the brachytherapy cases at the PVAMC, the NRC has 
utilized an unpublished (and inappropriate) interpretation of the 
current regulation to determine the existence of reportable medical 
events at the PVAMC in the 2002-2008 period. Under this unpublished 
interpretation of a reportable Medical Event, the NRC based it 
calculations on the use of the D90 metric. This calculation, which 
measures the dose that 90% of the prostate receives, while not part of 
the current reportable Medical Event regulation, was applied 
retroactively to determine that the bulk of the brachytherapy 
procedures done at the PVAMC were performed in a manner contrary to the 
regulation. D90 is a metric that has never appeared in any regulations 
or notices issued by the NRC. Nevertheless, the NRC in its recent 
investigation determined that a reportable Medical Event existed where 
the dose received by the prostate was less than 80% of the D90 dose. It 
is for all these reasons that I can state that the NRC's current 
definition of a reportable medical event that is now based on D90 was 
not in existence in 2002, remains unpublished and may soon change due 
to a proposed rule change.
    Second, Mr Reynolds is mistaken in his claim that ``requirements to 
report to NRC when there is adverse care to patients went into effect 
in 1979.'' He appears to be referring to the Medical Policy Statement 
published by the NRC in 1979. This document (attached) in fact is a 
broad statement of the intent of the NRC to regulate the medical use of 
radioisotopes. It did not contain details regarding the reporting of 
Medical Events to the NRC and states that the NRC ``will (not intrude) 
into medical judgments affecting patients and other areas . . . of the 
practice of medicine.'' More recently, the NRC again acknowledged that 
it ``does not prescribe dose (as it is) a medical decision'' [See page 
192 line 16-19 of the NRC transcript of May 2009, Exhibit 9].
    I continue to believe that appropriate care was provided to 
veterans by the PVAMC Prostate Brachytherapy Program. The treatment has 
been effective, and any adverse effects have been within the known 
risks of the procedure. The effectiveness of the treatment can be seen, 
in part, based upon the recent admission of Mr. Reynolds during his 
testimony of July 22, 2009 before the House Veterans' Affairs 
Committee, Subcommittee on Oversight and Investigations. When directly 
asked about the results of the treatment rendered at the PVAMC, Mr. 
Reynolds conceded that of the 114 total cases, the NRC was aware of 
only six cases where the PSA has risen on consecutive testing and 
another eight cases where a rise in PSA has been noted. However, none 
of these patients have undergone rebiopsy to confirm whether or not the 
cancer has returned. A rebiopsy is crucial because temporary PSA 
increases are common after prostate brachytherapy even in the absence 
of tumor recurrence, a phenomenon that is well-recognized among 
prostate cancer experts and often referred as ``PSA bounce.'' \2\
---------------------------------------------------------------------------
    \2\ Crook J, Gillan C, Yeung I, Austen L, McLean M, Lockwood G. PSA 
kinetics and PSA bounce following permanent seed prostate 
brachytherapy. Int J Radiat Oncol Biol Phys. 2007 Oct 1;69(2):426-33.
---------------------------------------------------------------------------
    The importance of Mr. Reynolds' concession is his recognition that 
at least 100 out of the 114 cases did not result in ineffective 
treatments. This represents an effective treatment rate that is at 
least 88%. Nonetheless, the NRC, in applying an unpublished standard 
during its reanalysis of the procedures performed at the PVAMC, 
inappropriately judged that the Program had caused harm to the 
patients. The cumulative effect of the NRC's action in casting the 
reporting of a Medical Event as a medical judgment on the efficacy of 
the treatment provided has unduly alarmed veterans and the public, and 
adversely affected the perception of brachytherapy by them and by 
physicians. In all these ways, the NRC has interfered with the delivery 
of medical care.
                                 ______
                                 
   Exhibits to Dr. Gary D. Kao's Response to Post-Hearing Questions 
                     Submitted by Hon. Richard Burr

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                        attachments to exhibit 8

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Senator Specter. Thank you, Dr. Kao.
    We are now going to turn to Panel 3 before any of the 
questioning so we can have a factual basis for the questioning 
beyond what has appeared in the press.
    So, I would like to call at this time Dr. Gerald Cross, Dr. 
Richard Whittington, Director Michael Moreland, Director 
Richard Citron, Dr. Michael Hagan, and Director Steve Reynolds.
    Our first witness on this panel will be Dr. Gerald Cross, 
who has an M.D. from Loma Linda University. He is the Veteran 
Administration's top doctor, and is the Principal Deputy Under 
Secretary for Health. Dr. Cross appeared at a hearing of the 
Senate Veterans' Affairs Committee last week and graciously 
consented to come to this hearing, although it caused a change 
to his plans. So, we appreciate your becoming available, as we 
did want to proceed at the earliest practical date.
    Dr. Cross, the floor is yours for 5 minutes.

STATEMENT OF GERALD M. CROSS, MD, FAAFP, ACTING UNDER SECRETARY 
 FOR HEALTH, U.S. DEPARTMENT OF VETERANS' AFFAIRS; ACCOMPANIED 
   BY MICHAEL E. MORELAND, FACHE, DIRECTOR, VISN 4; RICHARD 
   CITRON, FACHE, DIRECTOR, PHILADELPHIA VA MEDICAL CENTER; 
 MICHAEL HAGAN, MD, PHD, NATIONAL DIRECTOR, RADIATION ONCOLOGY 
  PROGRAM, RICHMOND VA MEDICAL CENTER; MARY MOORE, RADIATION 
   SAFETY OFFICER, PHILADELPHIA VA MEDICAL CENTER; AND JOEL 
MASLOW, MD, CHAIRMAN, PHILADELPHIA VA MEDICAL CENTER RADIATION 
                        SAFETY COMMITTEE

    Dr. Cross. Good morning, Senator and Congressmen. Thank you 
for the opportunity to discuss the treatment of veterans with 
prostate cancer through brachytherapy.
    VA has a well-documented record of quality care, but when 
there are exceptions, whatever the cause may be, we apologize 
and express our deep regret to the patient, as I do now.
    Indeed, we go beyond that. We work with the individual 
patient to provide them the care that they need. We further 
analyze what went wrong, we take corrective actions, and we 
look at the 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 to make as few mistakes as 
possible.
    The staff at the Philadelphia VAMC discovered the problem, 
a possible underdosing and incorrect dosage of patients in May 
2008, and the VA Medical Center Director immediately suspended 
the program and convened the Administrative Board of 
Investigation to uncover the facts.
    We informed and treated all affected veterans. The VA 
National Director of Radiation Oncology continues to 
investigate the reasons why these problems were not detected 
earlier.
    My testimony today will briefly describe brachytherapy, 
explain what happened as we currently understand the facts, and 
describe VA's response.
    In brachytherapy for prostate cancer, small radioactive 
seeds are implanted in the prostate to destroy cancerous cells. 
Although the risk to healthy tissues to the body is minimal, 
side effects may occur.
    So, what has been learned? A lot. We value our 
relationships with universities, but the responsibilities for 
care and oversight must be well defined at the outset, even 
when, as in this case, there is a contract with a university. 
Despite those facts, at the end of the day, VA must oversee the 
quality of care for veterans.
    External oversight is also important, but not sufficient. 
Noteworthy is the fact that the VA program is accredited while 
about 85 percent of the programs outside the VA are not.
    We will continue to ensure that all stakeholders are made 
aware of all-important developments, positive and negative, 
concerning veterans' health care.
    Now, I will describe the details. On May 5, 2008, a 
radiation oncologist performed a brachytherapy procedure using 
seeds of a lower apparent activity than intended. A physicist 
discovered this underdosing 10 days after the initial 
procedure. The physicist notified the facility's radiation 
safety officer, who immediately reported the problem to VA's 
National Health Physics Program.
    On May 16, 2008, VA's National Health Physics Program also 
notified the Nuclear Regulatory Commission. VA convened a 
clinical risk assessment advisory board, which recommended that 
all prior treatments be reviewed and notification of all 
patients who received inadequate radiation dosages.
    External physicians and physicists with no involvement with 
the Philadelphia VAMC brachytherapy program conducted these 
examinations of patient scans, dosages, and medical records. 
During this review, we found up to 92 potential events 
involving underdosing or imprecise placement.
    It is important to highlight for these additional cases 
that the definition of ``medical event'' does not necessarily 
mean veterans were harmed, and experts still debate the long-
term impact of the treatment. Nonetheless, VA took the 
conservative approach of notifying these veterans.
    On July 2, 2008, the Philadelphia VAMC issued a press 
release and notified local Members of Congress and veteran 
service organizations; that was in 2008. The facility also took 
the proactive steps to contact each of the 114 veterans who 
underwent brachytherapy at VAMC from 2002, when the program 
started, to 2008, whether they experienced a medical event or 
not.
    VA sent each veteran a certified letter and called each 
veteran or the veteran's family directly. We also established a 
toll-free telephone number to answer questions. VA is covering 
all costs associated with additional tests and continuing to 
monitor their care at other VA and private facilities.
    We regret this problem went undetected. VA, as with other 
health systems, relies on complimentary systems of 
accountability to identify quality problems. Many of these 
systems failed to detect the less-than-optimal care in this 
case, and in fact, it was only the recognition of potential 
problems by VA staff that eventually led to more in-depth 
investigation, review, and subsequent disclosure to patients 
and to the public.
    The Philadelphia VAMC brachytherapy program has been 
suspended since June 2008, and will not reopen until the NRC's 
concerns have been satisfied and until requirements of the VA 
radiation oncology program are met.
    Senator Specter. Did you say suspended in June 2008?
    Dr. Cross. Yes, sir. This notice was sent out in June 2008.
    VA currently offers brachytherapy at nine other facilities, 
and we are working to ensure the highest quality of care for 
prostate brachytherapy. Currently, the NRC is refining the 
definition of medical event as it pertains to these procedures.
    VA has developed criteria for suspending and restarting 
prostate brachytherapy program. VA's National Health Physics 
Program will continue to conduct the site inspections at all 
facilities where prostate brachytherapy is conducted.
    VA clinical standards and procedures are now among the most 
rigorous in the health care industry.
    Secretary Shinseki in VA----
    Senator Specter. Dr. Cross, how much more time will you 
need?
    Dr. Cross. Thirty seconds.
    Senator Specter. Thank you.
    Dr. Cross. Thank you, sir.
    VA Secretary Shinseki and VA senior leadership are 
conducting a top-to-bottom review of the Department and are 
implementing aggressive actions to ensure the right procedures 
are in place to protect our veterans in providing them the 
highest quality of care possible.
    Let me again emphasize our regret that this incident 
occurred and how proud I am of the work our staff at the 
Philadelphia VAMC does on behalf of America's veterans. While 
we recognize the seriousness of this situation, it is important 
that our veterans and their loved ones have faith and 
confidence in our medical system.
    Thank you once again for the opportunity to testify, 
Senator.
    [The prepared statement of Dr. Cross follows:]
 Prepared Statement of Gerald M. Cross, MD, Acting Under Secretary for 
              Health, U.S. Department of Veterans Affairs
    Good morning, Senator Specter and Congressman Adler. Thank you for 
the opportunity to discuss the Philadelphia Veterans Affairs Medical 
Center's (VAMC) treatment of Veterans with prostate cancer through 
brachytherapy. I am accompanied today by Mr. Michael E. Moreland, 
Director, VISN 4; Mr. Richard Citron, Director, Philadelphia VA Medical 
Center; Dr. Michael Hagan, National Director for Radiation Oncology in 
the Veterans Health Administration; and Dr. Richard Whittington, 
Physician in Radiation Therapy at the Philadelphia VAMC. The staff at 
the Philadelphia VAMC discovered the problem of possible under-dosing 
and incorrect dosage of patients in May 2008, and the VA medical center 
director did not hesitate to immediately suspend the program and 
convene an Administrative Board of Investigation to uncover the facts. 
We informed and treated all affected Veterans and promptly suspended 
the program. The VA National Director of Radiation Oncology is 
continuing to investigate the reasons why these problems were not 
detected earlier. My testimony today will briefly describe 
brachytherapy, explain what happened as we currently understand the 
facts, and describe VA's response. Please let me begin by saying I am 
disappointed my fellow Veterans did not always receive the quality 
health care they deserve.
    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.
    On May 5, 2008, a radiation oncologist performed a permanent 
implant prostate brachytherapy procedure using seeds of a lower 
apparent activity than intended. A physicist discovered this under-
dosage ten days after the initial procedure. The physicist notified the 
facility's Radiation Safety Officer, who immediately reported the 
problem to VA's National Health Physics Program. On May 16, 2008, VA's 
National Health Physics Program also notified the Nuclear Regulatory 
Commission (NRC). VA convened a Clinical Risk Assessment Advisory 
Board, which recommended that all prior treatments be reviewed and that 
all patients who received inadequate radiation dosages be notified. 
Independent, external physicians and physicists with no involvement 
with the Philadelphia VAMC's brachytherapy program conducted these 
examinations of patient scans, dosages, and medical records. During 
this review, it was discovered that 92 events involving under-dosing or 
doses to organs or tissues other than the treatment site were found 
that met the definition of a medical event according to the NRC. VA has 
regularly informed the NRC of any updates. It is important to highlight 
for these additional cases that the definition of ``medical event'' 
does not necessarily mean Veterans were harmed, and experts still 
debate the long-term impact of this treatment. Nonetheless, VA took the 
conservative approach of notifying these Veterans because we did not 
deliver a treatment as promised.
    On July 2, 2008, the Philadelphia VAMC issued a press release and 
notified local Members of Congress and Veterans Service Organizations. 
The facility also took proactive steps to contact each of the 114 
Veterans who underwent brachytherapy at the VAMC from 2002 (when the 
program started) to 2008, whether they experienced a medical event or 
not. VA sent each Veteran a certified letter and called each Veteran or 
the Veteran's family directly. We also established a toll-free 
telephone number to answer questions. VA is covering all costs 
associated with additional tests and continuing to monitor their care 
at other VA and private facilities.
    We regret this problem went undetected for nearly six years. VA, as 
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); review of public databases such as the National 
Practitioner Data bank; patient satisfaction and complaints; and 
individual peer review. Many of these systems failed to detect the 
aberrant care at Philadelphia, and, in fact, it was only the 
recognition of potential problems by VA staff that eventually led to 
more in-depth investigation, review, and subsequent disclosure to 
patients and the public.
    The Philadelphia VAMC's brachytherapy program has been suspended 
since June 2008 and will not be reopened until the NRC's concerns have 
been satisfied and until requirements of the VA Radiation Oncology 
Program are met. VA also temporarily suspended programs at facilities 
in Washington, DC, Cincinnati, Ohio, and Jackson, Mississippi. Based 
upon these reviews, the Cincinnati program was found satisfactory and 
is in the process of fulfilling national VA requirements for resuming 
prostate brachytherapy. Complete reviews of the Jackson and Washington 
programs continue. VA will also notify any additional Veterans if we 
determine they experienced a medical event.
    VA currently offers brachytherapy at nine other facilities, and we 
are working with the NRC on regulatory issues related to prostate 
brachytherapy. Currently, the NRC is refining the definition of 
``medical event'' as it pertains to these procedures. VA has developed 
criteria for suspending and restarting prostate brachytherapy programs. 
VA's National Health Physics Program will be conducting periodic site 
inspections at all facilities where prostate brachytherapy is performed 
and whenever a possible medical event is reported. VA clinical 
standards and procedures are now among the most rigorous in the health 
care industry.
    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.
    Let me again emphasize our regret that this incident occurred, and 
add how proud I am of the work our staff at the Philadelphia VAMC does 
on behalf of America's Veterans. Nearly 60,000 Veterans receive world-
class health care at this facility every year and these events are 
uncharacteristic of the level of care we provide. While we recognize 
the seriousness of the situation, 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.
                                 ______
                                 
 Response to Post-Hearing Questions Submitted by Hon. Richard Burr to 
                  U.S. Department of Veterans Affairs
    Question 1a: I am trying to better understand the number of VA 
facilities affected by the issues surrounding the brachytherapy 
program.
    On Monday, June 22, SVAC staff met with Dr. Cross and other staff 
at VACO. VA informed the staff that there were 13 facilities nationwide 
where this procedure was performed, and 3 facilities had reported 
problems (Philadelphia, PA, Jackson, MS, and Washington, DC). When 
asked to clarify whether the other ten facilities were foud to not have 
issues and continued to operate, VA answered in the affirmative.
    In a follow up briefing on Friday, June 26 given to SVAC and HVAC 
staff, VA detailed that there actually were four hospitals where 
problems were discovered, informing the staff about issues at the 
Cincinnati hospital.
    At the Monday, June 29 hearing on this issue in Philadelphia, VA 
reaffirmed this number four and testified that, ``The Philadelphia 
VAMC's brachytherapy program has been suspended since June 2008 . . . 
VA also temporarily suspended programs at facilities in Washington, DC, 
Cincinnati, OH, and Jackson, MS.''
    Yet, in written testimony, Mr. Reynolds of the NRC stated that, 
``The VA has agreed to not restart the prostate brachytherapy treatment 
programs at five sites, including the VA Philadelphia, until all 
commitments have been met.''
    According to the NRC, procedures at the Los Angeles VAMC were also 
``suspended.'' When SVAC staff went back to VA to confirm the number of 
facilities still open, they learned that the Durham VAMC had 
voluntarily halted these procedures. In addition, two other hospitals, 
in Reno and Birmingham, maintain inactive programs. Therefore, I am now 
under the impression that only seven of the 15 hospitals that offered 
this procedure since 2005 are still performing brachytherapy.
    To clarify for the record, how many of these 15 hospitals are 
considered to have ``active'' brachytherapy programs? How many have 
been ``suspended'' by the NRC? How many have voluntarily ceased 
operations?
    Response. Beginning in June 2008, the Department of Veterans 
Affairs (VA) used the situation in Philadelphia to proactively conduct 
a comprehensive review of its prostate brachytherapy programs. Fifteen 
VA facilities have provided prostate implants since 2005. Of those 15 
sites, 2 had already voluntarily deactivated its programs prior to the 
comprehensive 2008 review for reasons other than regulatory violations. 
Of those two inactive programs (Birmingham, AL and Reno, NV), 
Birmingham does not plan to restart and Reno plans to consider 
resumption of its program upon hiring of appropriate urology staff.
    Of the 13 remaining programs, 4 (Cincinnati, OH; Philadelphia, PA; 
Washington, DC; and Jackson, MS) have been suspended by VA's National 
Health Physics Program (NHPP).
    There are currently nine programs that meet the standard to provide 
brachytherapy. Seven facilities, including Albany, NY; Boston, MA; 
Brooklyn, NY; Minneapolis, MN; Richmond, VA; San Francisco, CA; and 
Seattle, WA are active and offering brachytherapy treatments. In our 
comprehensive review, we found these facilities have provided 
treatments within approved standards.
    Two programs meet the standard to provide brachytherapy but are 
currently not active. These include the Durham, NC, VA Medical Center 
(VAMC), which 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, and the Greater Los Angeles 
Healthcare System (GLA). After internally deciding to pause to review 
its procedures, GLA had planned to resume its program in July 2009, but 
the Nuclear Regulatory Commission (NRC) reported during the field 
hearing June 29, 2009 that the prostate brachytherapy program at the 
facility was suspended. The Veterans Health Administration (VHA) has 
requested clarification from NRC and we are awaiting a response.
    The following provides a summary for the 15 facilities mentioned 
above:
Albany.........................  Active
Birmingham.....................  Inactive, with no current plans to
                                  restart this service
Boston.........................  Active
Brooklyn.......................  Active
Cincinnati.....................  Suspended by VA's NHPP, completing the
                                  process to restart the program
Durham.........................  Non-active; service chief elected to no
                                  longer provide this procedure in-house
Greater LA.....................  Non-active; chief of staff and service
                                  chief elected to pause the program to
                                  review procedures. NRC concluded the
                                  pause represented suspension requiring
                                  the facility to have a restart
                                  inspection. Upon completion of this
                                  review the facility will begin the
                                  restart process.
Jackson........................  Suspended by NHPP (100 percent look-
                                  back to 2005 ordered)
Minneapolis....................  Active
Philadelphia...................  Suspended by NHPP (100 percent look-
                                  back); will not be reopened until all
                                  NRC concerns have been satisfied and
                                  until the requirements of VA's
                                  radiation oncology program are met
Reno...........................  Inactive, but will consider restarting
                                  the program upon hiring of appropriate
                                  urology staff
Richmond.......................  Active
San Francisco..................  Active
Seattle........................  Active
Washington, DC.................  Suspended by NHPP (100 percent look-
                                  back to 2005 ordered)

    Question 1b: How many of the facilities that offer brachytherapy 
treatment do so on an in-house basis, contract basis with an outside 
provider or contract basis but within the VA facility?
    Response. Of the 13 programs cited in our response to Question 1a, 
Albany, NY; Boston, MA; Brooklyn, NY; Cincinnati, OH; Richmond, VA; 
Seattle, WA; and Washington, DC, exclusively conducted operations in 
house during 2008. Greater Los Angeles, Philadelphia, and San Francisco 
exclusively used fee-basis or contract authority to provide these 
services in 2008. Durham, Jackson and Minneapolis conducted these 
operations in-house and through fee-basis or contract authority in 
2008.
    Question 1c: For those eight hospitals that are no longer 
performing these procedures, please state the individual reasons for 
each becoming inactive. Have they been mandated for shutdown by an 
outside entity or has VA central office or local VA officials elected 
to stop the procedures independently?
    Response. VA's NHPP has temporarily suspended four programs, 
including Cincinnati, Washington, DC, Jackson and Philadelphia because 
problems were found involving under-dosing. Based upon a comprehensive 
review, the Cincinnati program was found to be in compliance with VA 
clinical standards and is completing the process to fulfill national VA 
requirements for resuming prostate brachytherapy. Cincinnati underwent 
a restart inspection during June 30 to July 1, 2009, with one pending 
action to obtain a new treatment planning system. A restart might be 
possible in August 2009 from the VHA perspective; however, NRC informed 
VHA that restart must be approved by NRC. Philadelphia was suspended by 
the Veterans Integrated Service Network (VISN) and VAMC after a 
comprehensive review found that 91 possible events involving under-
dosing or doses to organs or tissues other than the treatment site were 
found that met the definition of a medical event according to NRC. 
Philadelphia's program will not be reopened until all NRC concerns have 
been satisfied and until the requirements of VA's radiation oncology 
program are met. Complete reviews of the Jackson and Washington, DC, 
programs continue.
    Two facilities (Birmingham and Reno) voluntarily deactivated its 
programs prior to a comprehensive internal review for reasons other 
than regulatory violations. Reno intends to re-open its program when 
they have re-established a urology support program, but Birmingham does 
not intend to resume operations. No medical events were found with past 
patients at these two sites. Durham voluntarily chose to no longer 
provide these services and GLA has temporarily paused its program.
    Question 1d: Is there a reason for VA's oversight to mention the 
Los Angeles and Durham facilities at the various briefings and hearing 
on this topic?
    Response. The Durham VAMC is still authorized to perform this 
procedure; however, the service chief 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. In mid 
2008, VHA, through NHPP, made a commitment to the NRC to use D90, which 
is the dose to 90 percent of the volume of the prostate, to determine 
if a medical event had occurred. The physician who was on contract to 
provide these services in-house at Durham believed that using this 
parameter for regulatory purposes is unacceptable. He decided to stop 
offering the procedure because he was concerned regarding the risk of 
liability for medical events as defined by the D90 parameter. His 
concern was triggered by the intense regulatory scrutiny of the 
brachytherapy program, with numerous inspections over the last year 
involving multiple definitions of the term, medical event. Patients 
requiring this procedure are currently being provided it on a fee-basis 
at the Durham Regional Hospital.
    There is a proposed revision to the NRC regulations pertaining to 
the definition of medical event as regards these procedures, which, if 
adopted, would allow reconsideration of the decision.
    The prostate implant program at Durham has been inspected numerous 
times within the last year, and no regulatory violations have been 
cited.
    The VA GLA has elected on its own to pause its program to conduct a 
review of procedures; upon completion of this review the facility will 
begin the restart process. NRC has made an interpretation that the 
local decision requires the facility to have a restart inspection. This 
is the basis for NRC to have listed a fifth seed implant program as 
being suspended. Confusion might have resulted from use of the 
``suspended'' terminology by facility staff during the on-site NRC 
inspection. VHA does not agree with this interpretation and has 
requested clarification on this issue from NRC.
    Question 1e: In VA's written statement, after describing problems 
found in Philadelphia, Jackson, Washington, DC, and Cincinnati, you 
testified that, ``VA currently offers brachytherapy at nine other 
facilities . . .'' In light of the information about Los Angeles and 
Durham, does VA stand by this testimony?
    Response. The information provided to the Committee in our 
testimony should have been more precise: VA offers brachytherapy at 
seven other facilities. There are nine programs that meet the standard 
to provide brachytherapy, but as indicated earlier, Los Angeles and 
Durham are not currently offering such procedures. Los Angeles is 
working to restart brachytherapy, while Durham has chosen not to offer 
the procedure in-house.
    Question 2a: With respect to Dr. Kao, Reverend Flippin testified 
that, ``I have never met the gentleman. He was not the doctor who I met 
with to decide the type of therapy to select.'' VA has informed SVAC 
staff that, ``the veteran who testified at the Philadelphia field 
hearing concerning prostate brachytherapy received treatment from Dr. 
Kao, not another provider.'' Please clarify for the record if Dr. Kao 
was in fact the doctor who performed the brachytherapy procedure on 
Reverend Flippin.
    Response. Dr. Kao performed the brachytherapy implant; a note 
written by Dr. Kao in the patient's medical record states that he 
performed the implant.
    Question 2b: More broadly, what is VA's policy with respect to 
informing veterans of the doctor performing a medical procedure on 
them? Is it protocol that a VA doctor meet with a patient before 
performing a procedure on them? Does VA allow a doctor to perform a 
procedure on a patient without the specific consent of that patient 
regarding the identity of the doctor performing the procedure?
    Response. VHA Handbook 1004.1, VHA Informed Consent for Clinical 
Treatments and Procedures, requires that informed consent be obtained 
and documented by a practitioner who is clinically privileged to 
perform the treatment or procedure in question. Clinicians in training 
(e.g., medical or dental residents) are also authorized by the policy 
to obtain informed consent. Clinicians in training must identify their 
supervising attending on the consent form and the patient must be 
informed of that supervising attending's name and the names of any 
other individuals responsible for authorizing or performing the 
treatment or procedure. The policy does not require that the individual 
obtaining consent be the practitioner who ends up performing the 
procedure although practitioners are obligated to identify, on the 
consent form, the clinicians on the treatment team who will perform the 
procedure.
    Due to the requirements of medical training programs, VA attendings 
and residents rotate services regularly. It is common for practitioners 
to cover a medical service at the time of obtaining the informed 
consent and then to rotate off service before the procedure is 
scheduled or performed. For this reason, the performing and supervising 
practitioners identified on the consent form may not always be the 
practitioners ultimately assigned to the case. In such instances, 
policy requires that the patient be notified of the change, and that 
the discussion and the patient's assent be documented in the record. 
This documentation clarifies that the patient was made aware of the 
change and agreed to the change of providers. The policy does not 
require that a new signature consent form be completed in such 
instances. Please note that Handbook 1004.1 is currently in revision 
and is expected to be published by the fall of 2009. However, 
requirements for informing patients of who will be performing the 
treatment or procedure will remain unchanged in the revised version.

    Senator Specter. Thank you very much, Dr. Cross.
    Our next witness is Dr. Richard Whittington. Dr. 
Whittington is the physician on radiation therapy at the 
Philadelphia VA Medical Center, former head of radiation 
oncology here; his doctorate degree and M.D. are from Rice 
University.
    Thank you for joining us, Dr. Whittington, and we look 
forward to your testimony.

  STATEMENT OF RICHARD WHITTINGTON, M.D., CHIEF OF RADIATION 
            ONCOLOGY, PHILADELPHIA VA MEDICAL CENTER

    Dr. Whittington. I do not have a formal opening statement, 
Senator. I am sorry.
    All I would like to say is that I have been around the 
Veterans' Administration for most of my life. My father 
recently retired from the Veteran's Administration after 
working with the VA for 52 years. My sister has worked for the 
VA for 33 years. My brother worked for the Veterans' 
Administration until the day he died. I am a veteran myself, 
and I have to say that these incidents that are described are 
the low point in my professional career, because it happened on 
my watch.
    Senator Specter. Thank you. We will turn next to Steve 
Reynolds, a Director of the Division of Nuclear Materials 
Safety from the Nuclear Regulatory Commission, bachelor of 
science in engineering from Florida Institute of Technology, 
and the Director of the Nuclear Materials Safety Center since 
2005.
    Thank you for joining us, Director Reynolds, and the floor 
is yours for 5 minutes.

 STATEMENT OF STEVE A. REYNOLDS, DIRECTOR, DIVISION OF NUCLEAR 
     MATERIALS SAFETY, REGION III, U.S. NUCLEAR REGULATORY 
                           COMMISSION

    Mr. Reynolds. Thank you. Senator Specter, Congressman 
Adler, and Congressman Fattah, I am honored to represent the 
U.S. Nuclear Regulatory Commission at today's hearing.
    The NRC is very concerned about this issue. An important 
part of our mission as the regulator for the civilian use of 
nuclear material is to protect public health and safety, 
including medical uses. Therefore, we are concerned about all 
patients receiving medical care, including our veterans.
    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 a holder of the NRC license, it is the 
responsibility of the VA to identify problems in medical 
treatments and report those problems to the NRC.
    The NRC, once notified of the apparent problems, began 
increasingly intensive inspections of the brachytherapy program 
at VA Philadelphia and at 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, 
including Philadelphia, and they will not restart until we, the 
NRC, are satisfied they have addressed all the problems. Our 
inspections are continuing, and once we complete these later 
this summer, the Agency will determine if enforcement action is 
necessary.
    We are also looking at NRC procedures to see if there are 
improvements we can make in our oversight system. We will 
continue to look critically at our inspection and licensing 
programs, as well as to consider proposed regulatory changes.
    In closing, the NRC takes these medical events very 
seriously, and continues to be actively engaged on these 
issues. Thank you.
    [The prepared statement of Mr. Reynolds follows:]
  Prepared Statement of Steven Reynolds Director, Division of Nuclear 
    Materials Safety Region III, U.S. Nuclear Regulatory Commission
                              introduction
    Senator Specter, Members of the Committee, and Representative 
Adler, 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 ensure 
the adequate protection of those working with radioactive material, the 
public, the environment and that the patient receives the doctor's 
intended radiation dose.
    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 organizations 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 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 inspection and enforcement policies, 
procedures, and guidance. In 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 underdose 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 implementing 
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 startup 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 to not 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 also apply the findings of our evaluations to our own 
regulatory practices. In this case, two areas that we have identified 
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.
    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.
                                 ______
                                 
 Response to Post-Hearing Questions Submitted by Hon. Richard Burr to 
Steven Reynolds, Director, Division of Nuclear Materials Safety, United 
                  States Nuclear Regulatory Commission

    Question 1. How many non-VA facilities has the NRC issued licenses 
to for the possession and use of radioactive material? How many 
facilities use that material for prostate brachytherapy treatment? Is 
the University of Pennsylvania Hospital one of the facilities which 
possesses a license?
    Response. There are currently approximately 3400 active NRC 
licenses in the 13 States regulated by NRC which authorize the 
possession and use of radioactive material. Over 500 NRC licensees are 
approved to use radioactive materials for brachytherapy. The NRC's 
database does not differentiate between prostate brachytherapy and 
other brachytherapy uses, so this number is all-inclusive. The 
University of Pennsylvania possessed an NRC license until March 31, 
2008, when the NRC relinquished the authority for licensing to the 
Commonwealth of Pennsylvania. On that date, Pennsylvania became an 
Agreement State. Under certain conditions (as allowed by Section 274 of 
the Atomic Energy Act), the NRC enters into agreements with State 
Governors. Those agreements authorize individual States to regulate the 
safe use of specific radioactive materials within their borders. This 
includes radioisotopes used in medicine and industry.

    Question 2. Are the NRC guidelines that VA follows for reporting a 
potential medical event the same guidelines that non-VA facilities are 
required to follow? Are they the same guidelines that the University of 
Pennsylvania Hospital is required to 
follow?
    Response. Yes, the NRC reporting requirements for both VA and non-
VA facilities are the same. The NRC reporting requirements are found in 
Title 10 of the Code of Federal Regulations (CFR), Part 35, Section 
35.3045. Prior to the Commonwealth of Pennsylvania becoming an 
Agreement State on March 31, 2008, the University of Pennsylvania 
Hospital was required to follow the NRC reporting requirements. Since 
March 31, 2008, the University of Pennsylvania Hospital is required to 
follow Pennsylvania's reporting requirements, which are identical to 
the NRC's. Pennsylvania's Code Title 25, Chapter 224.10 (a) 
incorporates 10 CFR Part 35 by reference, meaning that Pennsylvania's 
regulations for the medical use of byproduct material are identical to 
NRC's.

    Question 3. How many brachytherapy treatment procedures were 
conducted nationwide since 2002? How many reports of potential medical 
events with respect to brachytherapy treatment have you received from 
non-VA facility licensees since that time? How many on-site inspections 
has the NRC performed since that time on non-VA facilities authorized 
to perform brachytherapy treatments? How many actual violations have 
you found? How many facilities have had to suspend their brachytherapy 
treatment programs until compliance with NRC guidelines was achieved? 
Did the NRC ever receive reports of potential medical events from the 
University of Pennsylvania Hospital? Did the NRC ever investigate the 
University of Pennsylvania Hospital's brachytherapy treatment program? 
If so, what was the conclusion?
    Response. The NRC understands that the question pertains to manual 
prostate seed implant brachytherapy procedures. The NRC does not 
maintain statistics regarding the number of brachytherapy treatment 
procedures conducted annually. However, based on information gathered 
from professional organizations involved in brachytherapy, an estimated 
annual average of 40,000 brachytherapy procedures (all-inclusive, not 
limited to prostate brachytherapy) have been conducted nationwide since 
2002. Between 2002 and July 17, 2009, the NRC received 53 reports of 
medical events involving manual prostate seed implant brachytherapy 
procedures that were administered to 208 patients. Forty-three of these 
reports were received from non-VA facilities and involved 95 patients. 
Ten reports were received from VA facilities and involved 113 patients.
    Between 2002 and July 17, 2009, the NRC conducted 806 inspections 
at non-VA facilities that perform all types of brachytherapy, including 
prostate brachytherapy. The NRC does not maintain separate inspection 
statistics limited to only prostate brachytherapy. The NRC issued a 
total of seven violations specific to prostate brachytherapy. In 
addition to the five suspended VA brachytherapy programs, two non-VA 
facilities suspended their brachytherapy programs as a result of 
medical events. These two programs resumed after implementing 
corrective actions to achieve compliance with NRC requirements.
    The NRC received one report of a medical event from the University 
of Pennsylvania Hospital involving a prostate implant. On May 5, 2001, 
that hospital reported a misadministration (now referred to as a 
``medical event'') involving a leaking seed which was implanted into 
the prostate of a patient. The NRC conducted a special inspection on 
May 7, 2001. No violations of regulatory requirements were identified 
during the special inspection. It should be noted that having a medical 
event in itself is not a violation.
    The NRC conducted other inspections at the University of 
Pennsylvania, including its hospital. The most recent NRC inspection 
conducted March 19 through 22, 2007, did not identify any violations 
associated with the prostate brachytherapy activities. Previous NRC 
inspections were conducted November 29 through December 3, 2004 and 
December 9 through 12, 2002; no violations were identified regarding 
the prostate brachytherapy program during these previous inspections.

    Question 4. Your testimony states that ``VA has agreed to not 
restart prostate brachytherapy treatment programs at five sites . . . 
.'' However, VA testimony states that only four sites, including 
Philadelphia, were temporarily suspended. What is the 5th site you are 
referring to that VA is not? Why would that site not be included in 
VA's testimony?
    Response. The fifth site NRC referred to was the VA Greater Los 
Angeles (GLA) Medical Center. The NRC included this as a suspended site 
based on information provided in a report dated February 24, 2009 from 
the VA National Health Physics Program (NHPP), which states ``the 
prostate implant program at GLA was suspended by the GLA Chief of Staff 
on February 13, 2009.'' The other four VA sites were suspended by the 
NHPP (in consultation with each VA Medical Center's senior management) 
and include: VA Philadelphia, Pennsylvania (June 11, 2008); VA Jackson, 
Mississippi (September 2008); VA Washington, D.C (September 26, 2008); 
VA Cincinnati, Ohio (October 2008). Each of these VA prostate 
brachytherapy programs remain suspended. The NRC does not have an 
explanation or any additional information regarding why the VA's 
testimony did not include the fifth site (GLA).

    Question 5. I have learned that the Durham VA medical center 
voluntarily ceased its brachytherapy program, in large part due to a 
provider's discomfort with adhering to NRC's guidelines. I understand 
that this same provider will perform brachytherapy treatments at Duke 
University Hospital which is subject to North Carolina guidelines on 
what is a reportable medical event. Does the NRC delegate licensing 
authority to States? What is the difference between the state 
guidelines and NRC's guidelines? Are States free to use their own 
guidelines on reportable medical events or must they follow the NRC's? 
If they may use their own guidelines, does it make sense to have two 
different standards?
    Response. Under certain conditions (as allowed by Section 274 of 
the Atomic Energy Act), the NRC enters into agreements with State 
Governors. Those agreements authorize individual States to regulate the 
safe use of specific radioactive materials within their borders. This 
includes radioisotopes used in medicine and industry.
    States that meet these conditions and agree to regulate materials 
must meet specific criteria for compatability with NRC requirements. 
Typically, Agreement States regulate additional sources of radiation 
that the NRC does not. This generally includes naturally occurring 
radioactive materials within their borders. In addition, the States 
regulate radiation-producing machines, such as X-ray machines (both 
medical and industrial) and particle accelerators.
    When an agreement is signed, the NRC discontinues its authority and 
the State asserts State authority under its laws and regulations for 
the material under the Agreement. However, under the Agreement, certain 
regulations and program elements are adopted by an Agreement State to 
maintain a compatible program with NRC requirements in accordance with 
criteria for compatibility. These criteria sometimes must require 
identical regulations and sometimes allow limited flexibility to the 
state in implementing its program. With respect to guidelines for 
reporting medical events, the Agreement State requirements must be 
identical to the NRC requirements. Normally, the Agreement States will 
adopt those identified regulations within a three year timeframe. The 
regulations in 10 CFR Part 35, including regulations for reporting a 
medical event, have been identified as regulations that must be adopted 
by Agreement States to maintain a compatible program. North Carolina's 
regulations for the Records and Reports of Misadministration, found in 
North Carolina Administrative Code Title 15A, Chapter 11, Section .0350 
are identical to NRC 10 CFR 35.3045, Report and Notification of a 
Medical Event.

    Question 6. You stated at the hearing that the requirements to 
report to NRC when there is adverse care to patients went into effect 
in 1979. Dr. Kao's testimony states that the standard definition of a 
reportable medical event to the NRC ``was not in existence when the 
Brachytherapy Program started at the VA.'' Were you and he talking 
about two different things? Please resolve the apparent contradiction.
    Response. The VA started its brachytherapy program in February 
2002. The requirement to report ``misadministrations'' to the NRC was 
incorporated into the regulations in 1980 (45 FR 31701; May 14, 1980). 
Events were then classified as misadministrations when the calculated 
administered dose differed from the prescribed dose by more than 20%. 
In 2002 (April, 24), the NRC replaced the term ``misadministration'' 
with ``medical event'' and revised the reporting requirements. The term 
``medical event'' more correctly and simply conveys that the 
radioactive material, or the radiation from there, was not delivered as 
directed by the physician. NRC has therefore had reporting requirements 
in place since 1980 that require reporting of events such as those that 
took place at the VA hospitals.

    Question 7. Dr. Kao's testimony also states that ``The definition 
of a reportable medical event to the NRC does not define a standard of 
effectiveness of medical treatment either scientifically or medically. 
A patient whose treatment results in a reportable medical event may 
still have received effective treatment and be within the appropriate 
standard of medical care.'' Is he correct? How did NRC arrive at its 
definition of what is a reportable medical event? Does the NRC 
collaborate with the medical and scientific community when arriving at 
a definition?
    Response. The reason for medical event reporting requirements is to 
identify incidents where the end result of a medical use of radioactive 
material is significantly different from what was planned. The medical 
event could be a result of an error in calculating or delivering a 
radiation dose, administering the wrong radionuclide or the wrong 
amount of the correct radionuclide or other factors that are described 
in 10 CFR 35.3045.
    The occurrence of medical events may reflect quality assurance 
problems with the licensees' programs and the reporting of medical 
events in accordance with the criteria established in section 35.3045 
is intended to capture those events that result in actual harm to the 
patient. However, the threshold for reporting medical events is set at 
a level so as to also capture precursor events that may lead to harm to 
a patient, if not reported and investigated. Therefore, it is possible 
that patients, whose treatment results in a reportable medical event, 
may still have received effective treatment and be within the 
appropriate standard of medical care. However, the NRC has determined 
that the reporting requirements are necessary to protect public health 
and safety.
    NRC's Medical Use Policy for radioactive materials is not to 
intrude into medical judgments affecting patients, except as necessary 
to provide for the radiation safety of workers and the general public. 
Under this policy, NRC will, when justified by the risk to patients, 
regulate the radiation safety of patients primarily to assure that the 
use of radionuclides is in accordance with the physician's directions.
    The NRC developed the first definition of reportable 
misadministrations through a rulemaking process that culminated in the 
final rule published in 1980. Discussions of the need for this 
definition began in 1972, based on an incident that occurred where the 
use of radiopharmaceuticals on a patient resulted in death. Discussions 
on the definition and incident data collection continued through the 
1970s, focusing on patient death, harm, or large radiation doses to 
unanticipated tissues. The definition of a misadministration has been 
substantially changed since its inception in 1980. One revision 
occurred on July 25, 1991, when the rule was revised to require that 
events be classified as misadministrations when the calculated 
administered dose differed from the prescribed dose by more than 20% 
(instead of 10%). Another revision occurred in April 2002, when the 
term ``misadministration'' was changed to ``medical event.''
    All of the revisions described above were implemented through the 
NRC's rulemaking process, which requires that proposed rules are 
published in the Federal Register and that the public is given time to 
provide written comments for consideration by the NRC staff. Once the 
public comment period has closed, the public comments are addressed and 
the final rule is published in the Federal Register. The NRC's Advisory 
Committee on the Medical Uses of Isotopes (ACMUI), which provided input 
in all of the above rule changes, advises NRC on policy and technical 
issues that arise in the regulation of the medical uses of radioactive 
materials in diagnosis and therapy. Members of this Committee include 
health care professionals from various disciplines who provide comments 
and recommendations on changes to NRC regulations and guidance and 
bring key issues to the attention of the 
Commission.

    Question 8. Dr. Kao's testimony suggests other significant factors 
that the NRC should include in its defined standards (see ``Fact 3'' in 
his testimony). Please comment on his suggestions.
    Response. The significant factors identified by Dr. Kao as 
standards that should be addressed in the NRC definition of a 
reportable medical event include: number of seeds; location of the 
seeds in the prostate; location of seeds outside the prostate; 
concentration of seeds to the affected areas of the prostate; stage, 
grade and extent of the cancer; and the clinical follow up of the PSA 
test results. These significant factors pertain to the practice of 
medicine and the medical judgment of the physician. In accordance with 
NRC's Medical Use Policy Statement (65 FR 47654 dated August 3, 2000), 
NRC will not intrude into medical judgments affecting patients, except 
as necessary to provide for the radiation safety of workers and the 
general public. It is not the policy of NRC to regulate the practice of 
medicine. The practice of medicine is regulated by the States' boards 
of medicine. The NRC Medical Use Policy Statement also states that the 
NRC will regulate the radiation safety of patients where justified by 
the risk to patients and where voluntary standards or compliance with 
these standards are inadequate. This is why the NRC requires 
identification of the treatment site, radionuclide, and dose in the 
written directive. The purpose of NRC regulations of the medical use of 
byproduct material is to reduce unnecessary radiation exposure to 
patients, workers, and the public. The focus of NRC regulation to 
protect the patient's health and safety is primarily to ensure that the 
authorized user physician's directions are followed as they pertain to 
the administration of the radiation or radionuclide, rather than to 
other, non-radiation (e.g., stage, grade, and extent of the cancer) 
related aspects of the administration.

    Question 9. In response to questions for Representative Fattah, Dr. 
Kao stated that ``it is almost unavoidable'' that some implanted seeds 
end up outside the prostate because it is an ``inherently subjective 
procedure.'' You stated, however, that based on what is reported to you 
and based on NRC's own independent inspections that ``medical events 
dealing with seeds outside the prostate happen very, very 
infrequently.'' Is it possible that Dr. Kao is right and that these 
events simply aren't being reported to NRC, or that you are not 
catching them during your inspections?
    Response. Based on a search of NRC's events database, between 2002 
and July 17, 2009, the NRC received 53 reports of medical events 
involving manual prostate seed implant brachytherapy procedures that 
were administered to 208 patients. Forty-three of these reports were 
received from non-VA facilities and involved 95 patients. Ten reports 
were received from VA facilities and involved 113 patients. These 
statistics demonstrate that events are being identified and reported to 
the NRC and that a percentage of the events include seeds that were 
implanted outside of the prostate. Additionally, the NRC periodically 
performs inspections of licensees with brachytherapy programs. One part 
of the inspections is to review a sample of records and determine if 
the licensees are correctly evaluating their procedures for medical 
events, and reporting the medical events when, and if, they occur.

    Question 10. During the hearing Dr. Kao referenced transcripts in 
which a physician advisor to the NRC commented that if NRC ``were to 
audit all the programs that do brachytherapy in this country, there 
would be 20,000 reportable medical events.'' You, in response to a 
question from Representative Fattah, stated that NRC receives ``very 
few'' medically reportable events. Is the physician advisor in error 
with his statement? Or, could it be that he's correct, and that lax 
oversight has resulted in very few events being reported?
    Response. NRC understands the question to pertain to manual 
prostate seed implant brachytherapy procedures. Dr. Kao referenced a 
section of transcript made by a physician advisor from NRC's Advisory 
Committee on the Medical Uses of Isotopes meeting in May 2009. The 
physician advisor was speaking to a hypothetical situation and was not 
implying that 20,000 medical events go undetected by NRC.
    NRC regulations in 10 CFR 35.3045(c) require medical licensees to 
report medical events the next calendar day after they are discovered. 
NRC requires licensees to be familiar with the regulations, identify 
a medical event, and report it to the agency.
    Licensees performing permanent implant brachytherapy are inspected 
every 2-3 years, depending on the size of the medical use program. NRC 
has performed over 800 inspections of licensees with brachytherapy 
programs since 2002 and has not seen anything to suggest such a high 
rate of occurrence. One part of the inspections is to review a sample 
of records and determine if the licensees are correctly evaluating 
their procedures for medical events, and reporting the medical events 
when, and if, they occur. In this timeframe, the NRC received 53 
reports of medical events nationwide from NRC licensees and Agreement 
State regulators, involving prostate brachytherapy procedures that were 
administered to 208 patients. Of these reports, 43 were received from 
non-VA facilities and involved 95 patients. The remaining 10 reports 
were received from VA facilities and involved 113 patients.

    Question 11. Please confirm when the NRC began to regulate 
brachytherapy 
procedures.
    Response. The Atomic Energy Act of 1954 and Energy Reorganization 
Act of 1974 give the NRC the responsibility to regulate the safe use of 
byproduct, source and special nuclear material. In 1954, NRC's 
precursor, the Atomic Energy Commission, implemented its authority to 
regulate the use of sealed sources for ``human use'' by physicians in 
10 CFR 30.24(c). In 1975, NRC specifically amended its regulations to 
include the regulation of brachytherapy sources in 10 CFR 35.14 and 10 
CFR 35.100, Schedule A, group VI. Additional regulations covering 
brachytherapy requirements were incorporated into 10 CFR Part 35 in 
1980.

    Question 12. What guidance has changed from the NRC over the past 
twelve months?
    Response. The NRC is currently assessing whether any additional 
changes are needed to its regulations or guidance, and is taking a 
critical look at potential enhancements to continually improve its 
processes. These enhancements include an increased focus on the safety 
culture at medical facilities, increased focus on medical facilities' 
oversight of contracted medical professionals, increased focus on 
whether the involved medical professionals and radiation safety staff 
understand the definition of a medical event and reporting 
requirements, increased focus on extent of condition reviews, and 
increased focus on post treatment results, to verify that the results 
are in accordance with the physicians' written directives.

    Question 13. Please outline any changes throughout the years that 
have been made to the guidelines issued by the NRC as to what is 
considered a medical event.
    Response. The following is an outline of changes that have been 
made to guidelines issued by the NRC as to what is considered a medical 
event:

    May 1980: 45 FR 31704, Final Rule On Misadministrations was issued, 
which established misadministration criteria in 10 CFR 35.41, reporting 
of therapy misadministrations in 10 CFR 35.42, reporting of diagnostic 
misadministrations to NRC in 10 CFR 35.43, and requiring a record of 
all misadministrations in 10 CFR 35.44.
    October 1986: 51 FR 36932, Final Rule On Medical Use of Byproduct 
Material. The diagnostic administration reporting requirement in 10 CFR 
35.33 was changed to require reports of misadministrations that 
resulted in a whole body dose greater than 500 millirem, or an organ 
dose greater than 2 rem.
    Misadministration was defined in part in 10 CFR 35.2 as an 
administration of a therapy radiation dose from a sealed source such 
that errors in the treatment geometry in a calculated total treatment 
dose differing from the final prescribed total treatment dose by more 
than 10 percent.
    July 1991: The definition of ``misadministration'' was revised in 
10 CFR 35.2 to add as reportable events any dosage of I-125 or I-131 
greater than 30 microcuries, where the administered dosage differs from 
the prescribed dosage by more than 20 percent. Also, a dose threshold 
of 5 rem dose equivalent or 50 rem dose equivalent to any individual 
organ was added to the definition of a diagnostic radiopharmaceutical 
misadministration.
    September 1995: The definition of misadministration in 10 CFR 35.2 
was amended by removing the term ``patient or human research subject'' 
and inserting the word ``individual.''
    April 2002: Final rule was promulgated, which provides the current 
definition for medical events, 67 FR 20370. The term 
``misadministrations'' was changed to ``medical events.'' Section 35.33 
``Notifications, reports, and records of misadministrations'' was 
deleted and reporting requirements were moved to section 35.3045.
    The dose threshold of 5 rem dose equivalent or 50 rem dose 
equivalent to any individual organ is added to the criteria for 
reporting an incident as a medical event.
    Changes to the requirements made the reporting threshold dose-based 
where possible and addressed two problem areas, patient intervention 
and wrong treatment site.
    March 2006: A minor edit to the definition of medical event, 71 FR 
15008. Medical event is defined as an event that meets the criteria in 
10 CFR 35.3045(a) or (b).

    Senator Specter. Thank you very much, Director Reynolds.
    The other individuals who are here are for the purpose of 
answering questions. So, at this time, I would like Reverend 
Flippin and Dr. Kao to return to the witness table, and Dr. 
Cross and Director Reynolds to stay, and the other prospective 
witnesses to step back and we may call on you as the occasion 
presents itself.
    We will now turn to the opening rounds of questions of the 
witnesses, and they will also be 5 minutes in duration.
    Dr. Cross, according to the media accounts, there were 92 
veterans at the Philadelphia VA Medical Center who received 
incorrect doses of radiation. They received substantially less 
than the radioactive seeds and other patients received 
excessive radiation to nearby tissue, including bladder and 
other organs. The incorrect doses were performed, according to 
media reports, at the University of Pennsylvania by a doctor 
under contract to the VA, and that doctor has been identified 
as Dr. Gary Kao.
    According to the press reports: it took more than 6 years 
to catch the mistakes; and the checks were made by those who 
were in the program; that the quality assurance aspects of the 
program were conducted by the contracted doctors themselves and 
were not independent enough to assure getting an unbiased 
report.
    What has your investigation disclosed with respect to those 
allegations?
    Dr. Cross. We have indeed found on our own investigation 
after we discovered this problem ourselves that up to 92 
individuals could have been underdosed--and that is potentially 
underdosed. Some investigation still continues into that area.
    It is important to understand--and I am a family physician, 
so this is not my area of specialty, but as I have learned more 
about this in the recent days, I have been impressed--this is 
both an art and a science. The art is in how the patient is 
addressed; how the seeds are actually lined up and planted.
    We did not rely just on internal review, Senator, and that 
is important for you to know. And I want to read one 10-second 
statement.
    We also had external review. We were accredited whereas 
most programs are non-accredited, and we received a statement 
in 2007 from the American College of Radiation Oncology that 
specifically mentions brachytherapy. In summary it states the 
following of the review: ``In summary, your PVMC practice, as 
noted above, is a well organized and operated radiation 
oncology practice that not only meets but in many aspects 
exceeds the ACRO standards for practice accreditation, and we 
are pleased to inform you that the PVAMC has been awarded a 3-
year accreditation.''
    They go on to complement the quality assurance program and 
so forth. Now, this is an external review organization that 
came in to review our program.
    Senator Specter. Dr. Cross, you have stated in your opening 
statement that it is up to the Veterans Administration to do 
the oversight.
    Dr. Cross. Yes, sir.
    Senator Specter. What is your response to the allegation 
that the quality assurance aspects of the program were 
conducted by the contracted doctors themselves and were not 
independent enough to assure that there was an unbiased report?
    Dr. Cross. I think that is a valid statement.
    Senator Specter. Why, Dr. Cross, did it take 6 years to 
find out what was going on?
    Dr. Cross. For two reasons.
    The first is that any complication or underdosing is not 
immediately apparent unless specifically measured.
    Number 2, the measures that were put in place to check on 
the quality, like the one that I just read to you, suggested 
that things were not only good, but better than the national 
average.
    Senator Specter. Dr. Cross, with respect to the VA 
procedure generally, is this aberrational what went on here at 
the veterans' hospital? Or is this, with respect to two items, 
something that could be occurring other places, and that is, 
number 1, the failure of having objective observers to make a 
determination; and, second, a failure to find a problem for 
such a long period of time?
    We are obviously concerned about what happened here, but we 
are also very concerned about what the practices are by the VA 
nationally.
    My time is up and the red light is on. I am going to shift 
and have 10-minute questioning rounds by each of the panelists 
to give you a chance to respond, Dr. Cross.
    Dr. Cross. There is, in fact, something unique in this 
situation at Philadelphia that I think is more so than we would 
find at other locations, and that is the nature of the contract 
and the nature of the relationship with the University.
    In my review of this program, it is almost 
indistinguishable as to where the University ends and the VA 
begins. In fact, the radiation oncology reviewer----
    Senator Specter. Well, that may be indistinguishable, but 
you are saying that the Veterans' Administration has the 
responsibility for oversight.
    Dr. Cross. That is exactly my point. That arrangement, I 
think, was part of the problem. We value tremendously our 
relationship with our university affiliates, but in this case 
there was a contract, and the contract had some rather, in my 
experience, unusual language to the point that when the 
reviewers reviewed the program from the American College of 
Radiation Oncology, they made the following statement: ``This 
VA radiation oncology department is under the control of the 
University of Pennsylvania.''
    I think that we, regardless of any such relationships, 
regardless of any such contracts, we, the VA, must prevail in 
having our oversight of this program and other programs.
    Senator Specter. Well, what are you doing to correct this 
kind of problem here and nationally?
    Dr. Cross. It is quite a long list of things, Senator, but 
let me highlight just a couple of them.
    Number 1, we hired a highly regarded radiation oncologist 
to review our programs.
    Number 2, we invested in training--mandatory training. In 
fact, in January of this year, we brought all of the key 
individuals involved in these programs to Washington, DC, for 
additional review and training of current procedures and 
policies.
    Number 3, when we found the problem here at Philadelphia, 
we did not stop there. We mandated that we review all of our 
other programs, as well, and we did that ourselves.
    Senator Specter. When you suspended the program in June 
2008, as you testified, did you know about these failures at 
that time?
    Dr. Cross. When we curtailed the program here at 
Philadelphia in 2008, we notified the VSOs, we notified the 
Congressional Offices, we notified the media, then we took 
further action----
    Senator Specter. The answer to my question is, yes, you did 
know about the problem?
    Dr. Cross. No, sir. We decided to start an investigation at 
that time of all of our other sites, as well.
    Senator Specter. And did you later find out about the 
problems?
    Dr. Cross. We did find some other problems, as well.
    Senator Specter. And what action did you take at that time 
to notify congressional oversight?
    Dr. Cross. We notified the Committee Members.
    Senator Specter. Notified?
    Dr. Cross. Committee staffers.
    Senator Specter. I did not hear you.
    Dr. Cross. We notified Committee staffers.
    Senator Specter. Let me turn to you, Dr. Kao. You have 
counsel with you; but let me say that, as you have noted, you 
are appearing here voluntarily and you are under no obligation 
to respond to questions. But we do appreciate your being here.
    The allegations, as you have already heard, are very 
serious. You have been identified as the individual who 
performed these procedures on most of the 92 veterans. The 
allegation has been made that the seeds were not planted in the 
prostate where they should have been, but they were instead 
lodged in the bladder and other organs that there were 
insufficient seeds planted. Did you plant seeds that went into 
the bladder and other organs?
    Dr. Kao. Senator, let me first correct something that has 
been incorrectly stated----
    Senator Specter. Why don't you do that, but answer my 
question first.
    Dr. Kao. Sir, yes, there have been occasions where seeds 
have been implanted in the bladder or outside the prostate.
    Senator Specter. What action did you take on that to notify 
the patients?
    Dr. Kao. The chance of seeds in the bladder or outside of 
the prostate is a recognized risk of the procedure and----
    Senator Specter. Well, it is a recognized risk, but did you 
notify the patients?
    Dr. Kao. No, sir.
    Senator Specter. Why not?
    Dr. Kao. Even when seeds are outside the prostate, they 
still contribute a radiation dose to the cancer, so----
    Senator Specter. The allegations are that you also had 
excessive radiation. Is that true?
    Dr. Kao. I believe some of our cases had seeds and 
radiation outside the prostate which would constitute a 
medically reportable event.
    Senator Specter. But did you have excessive radiation?
    Dr. Kao. By that definition, sir, it would be yes.
    Senator Specter. And did you notify those patients about 
the excessive radiation?
    Dr. Kao. I did not.
    Senator Specter. I am 35 seconds over.
    Congressman Adler----
    Mr. Vaira. Can he explain that?
    Senator Specter. Oh, yes. Pardon me. You may proceed with 
explanation.
    Mr. Vaira. He would just like to explain that. Yes or no 
sometimes gives a bad definition.
    Dr. Kao, would you please, in about a minute, explain that.
    Senator Specter. Take whatever time you need, Dr. Kao. I 
wanted you to answer my questions, but you are privileged to 
say whatever you care to on that.
    Dr. Kao. So, every step of the brachytherapy procedure was 
defined in the algorithm that we collaboratively wrote; and at 
the time that the program was implemented, the definition of 
what is reportable to the NRC was not in existence and only 
came later on. If we had been aware of this definition, we 
would have acted to notify the NRC and the patient.
    We were working very closely and continually supervised by 
the radiation safety of the VA and we trusted their advice as 
to what should be reported. In retrospect, I should have known 
that the definition of what is reportable has changed through 
the years.
    Senator Specter. Thank you, Dr. Kao.
    I will turn now to Congressman Adler.
    Mr. Adler. Thank you, Senator.
    Doctor, you seem to be the only person in this room except 
perhaps counsel that fails to recognize the statistics we have 
been dealing with. Colleagues at your table here have been 
acknowledging that we have, out of 116 procedures, 92 botched 
procedures.
    You quarrel with the New York Times, you quarrel with the 
Philadelphia Inquirer, it seems you are quarreling with the 
panelists here who are acknowledging the VA has responsibility 
to 92 for inadequate medical care.
    Do you care in any way to refine your testimony to talk 
about whether there was any substandard care on your part.
    Dr. Kao. No, Congressman, I do not believe that our 
procedures were botched.
    I do recognize there were occasions where we could have 
done better. I still maintain that we rendered effective 
treatment, 
Senator.
    Through the years of the program, we were continually 
improving our results, and yet, we recognize that we can still 
do better and we were in the process of transitioning to the 
real-time brachytherapy system, which would have also helped in 
improving the quality of our treatment, Congressman.
    Mr. Adler. Doctor, I heard you earlier, I think, sort of 
blame a lack of training for the problems that this program 
encountered. I heard you sort of blame the Radiation Oncology 
Department and its lack of supervision of you and your 
coworkers. I heard you blame the Radiation Safety Office and 
the VA hospital administration, it is in your written 
testimony.
    I am sort of baffled. We have these 92 people who got, by 
any fair measure, substandard care. I understand there are 
legal concerns you face right now. I am concerned about the 
medical concerns and the America-obligation concerns these 92 
people--this is a good chance for you to say I am sorry--not to 
take all the blame. There may be other people that deserve 
blame. This would be your chance to say to Reverend Flippin, I 
am sorry for what you went through.
    This would be a good chance. Why don't you do that right 
now, say, I am sorry for the pain you suffered, sir.
    Dr. Kao. Congressman, I agree with you. I do accept a share 
of the blame. I do believe that we could have and should be 
doing better. I am saddened by the plight of the Reverend and 
wish that I had the chance to do anything, anything at all to 
help him.
    Mr. Adler. Gosh, it seems to me you had a chance when you 
were performing the radiation procedure on him; that was the 
chance.
    Dr. Cross, you told us a moment ago that after the 
revelation of this problem in June 2008, you reviewed all 
programs. Can you go into a little bit more detail, because I 
guess what we need to hear, not just for patients coming to 
this VA hospital which, by and large, as Congressman Fattah 
suggests, has provided very good care in so many different 
fields for so many different veterans over the years,--but why 
don't you reassure us that you, in fact, reviewed all of the 
programs so that this problem--which was not isolated to one 
doctor, but this program occurred massively here at 
Philadelphia and, to a lesser extent, I guess, in Jackson, in 
Cincinnati, and in Washington, DC--that this problem is unique 
and that, by and large, the VA program is delivering the 
quality of care that America owes its veterans.
    Dr. Cross. Thank you, Congressman. Of course, VA does 
deliver good quality of care, but we are also a trusted 
organization. And the point here is, when we find something 
wrong, our policy, our ethics is to acknowledge it, accept it, 
and do something about it. And that is what we did.
    We found the problem. It was not the external reviewers, it 
was not all those accrediting groups that found it, it was our 
own staff who found it. And when they found it, they brought it 
forward, bravely, appropriately; and our leadership then said, 
let's disclose it, let's notify Congress, let's notify the 
media, let's notify the VSOs, and let's take action.
    One of the things that we discuss when we find a problem 
is, well, that is one place. Could this problem be occurring 
elsewhere? And so, we mandated that all of our other facilities 
undergo a special review which our staff put together and 
conducted to see how they were doing.
    We did find some problems, not to the level of concern that 
I had in Philadelphia, but when we find those problems, we work 
with the NRC--who have been very collaborative and helpful with 
us as a partner in this--to make sure that the corrective 
actions are taken. We are still working on that.
    Mr. Adler. Doctor, I thank you for that answer.
    I guess I am still stumped as to how this could have gone 
on for 6 years before it reached your level to be addressed for 
this facility and nationally.
    How could it have gone on for that long? It seems like a 
long time for the folks at the top not to know what the folks 
in the field are doing to rather than for our veterans.
    Dr. Cross. I think the lesson learned here is we have to 
find a better way to monitor this kind of very highly, highly 
specialized, relatively unusual procedure that we deal with in 
hospitals nationwide. I do not think this is just an issue for 
the VA, I think this is an issue for the entire national health 
system, that we have to address this and do a better job of it.
    As a result of that, that is why we are working with the 
NRC and the Joint Commission and others to make sure that we 
have the lessons learned from this and are better able to 
detect it more quickly.
    Mr. Adler. I guess I am still not getting the answer I need 
to hear for my satisfaction and for the satisfaction of the 
people of America about why it took so long to catch it in the 
sense that this was 6 years from the first botched procedure to 
the closure of the program. Why 6 years? Why not, we caught it 
after 20 patients got substandard treatment? Why do we wait for 
92 patients to get less than what they deserved, having served 
in uniform our country? Why did it take that long for us to 
catch a problem and really stop it?
    Dr. Cross. My impression, based on the reviews I have done, 
is there was not adequate follow-up on the measurement done 
afterwards, number 1.
    Number 2, all of the people that we brought in to do the 
external review said we were doing a great job.
    Mr. Adler. Maybe I could turn to Mr. Reynolds.
    We treat nuclear products, whether very small, like a 
radiation seed, or very large, like a nuclear power plant, very 
seriously. That is why we have a Federal agency to keep America 
safe, the Nuclear Regulatory Commission. So, whether it is 
power plants around the country or whether it is a nuclear 
materials program, I have to think that it cannot be a good 
thing to put nuclear material in the wrong parts of somebody's 
body. Am I wrong on that?
    Mr. Reynolds. We expect that when the medical professionals 
use radioactive material they put it in the right spot in the 
body; absolutely, sir.
    Mr. Adler. Is it in any way problematic to you--to me, it 
is outrageous--but maybe just problematic, a lower threshold, 
that we are taking these seeds of nuclear radioactive material 
and putting them not where they are designed to fight a cancer, 
but in other body parts in that general region, but not 
actually the spot that has the cancer. Is that not at least 
problematic to you?
    Mr. Reynolds. Right. We expect--in fact, the VA's license 
requires them to identify problems like this and report them to 
us.
    Mr. Adler. Well, given the seriousness of putting nuclear 
material in somebody's body, how did it break down so badly 
here where--apparently just one doctor doing the procedures, 
but lots of people floating around in the hospital in the VA 
system, with the NRC--how do so many people not catch this and 
say, this is a pattern of substandard care? How did it take so 
long before the NRC or the VA system shut this outrage down?
    Mr. Reynolds. Let me try to answer that for you.
    Again, I will go back. The VA is responsible for 
identifying their medical problems and reporting them to us. 
This means that the doctors involved--Dr. Kao and the other 
doctor, the medical physicist--when they perform the 
procedures, when they identify a problem, they are supposed to 
report that. They are required to identify the problem and 
report it. This also includes the VA Philadelphia's Radiation 
Safety Officer. She is responsible for the day-to-day oversight 
of the doctors and the medical physicists and the rest of the 
medical staff in their use of radioactive material. This also 
includes the VA Philadelphia's Radiation Safety Committee, who 
is responsible here in Philadelphia for reviewing medical 
treatments and reviewing them critically, then assessing if 
anything needs to happen and reporting them. Also responsible 
is the VA National Health Physics Program. The National Health 
Physics Program is responsible for performing inspections at 
the VA hospitals where they use radioactive material. All those 
people did not identify the problems and did not report them.
    What we have seen and what we have documented in our 
inspection report is a lack of a strong safety culture here at 
the VA Philadelphia; and safety culture is one where people are 
expected and are free to raise safety issues. Based on 
interviews we have had with some of the medical physicists and 
others, they were aware of substandard treatments, and for 
whatever reason that I do not understand, they did not raise 
that to their management or to the NRC.
    Mr. Adler. Do other VA hospitals around the country that 
have brachytherapy programs have a different reporting 
standard, or did this VA hospital just fail to meet the 
standard that is nationwide?
    Mr. Reynolds. The reporting standard is the same for all 
hospitals, VA or otherwise, that do this treatment.
    Mr. Adler. My time is expired.
    Senator Specter. Thank you Congressman Adler, Congressman 
Fattah.
    Mr. Fattah. Thank you.
    Mr. Reynolds, is it not true that these reporting standards 
for a medically reportable event were not in place at the time 
that these procedures were taking place?
    Mr. Reynolds. No, sir. I believe Dr. Kao is mistaken. The 
requirements to report to NRC when there is adverse care to 
patients went into effect in 1979.
    Mr. Fattah. Was this part of that doctrine in 1979, because 
we were not doing seeds in 1979, were we? We were implanting 
seeds in 1979?
    Mr. Reynolds. I am not sure exactly when prostate 
brachytherapy started.
    Mr. Fattah. OK. I will come back to that.
    Doctor--how do you pronounce your name?
    Dr. Kao. Kao.
    Mr. Fattah. Kao. Let me thank you. You are one of the most 
educated people in the country when it comes to cancer and 
radiation therapy, is that correct?
    Dr. Kao. Thank you, Congressman, yes.
    Mr. Fattah. A journalist wrote a story claiming that you 
did certain things, so I would like to give you a chance to get 
some things cleared up here.
    When the allegation in the New York Times story said that 
seeds or overdoses of radiation in these seeds that were 
implanted in patients, did that relate to any of the patients 
that you treated?
    Dr. Kao. I believe, yes, Congressman.
    Mr. Fattah. So, didn't you use a standardized seed 
strength?
    Dr. Kao. Yes, Congressman.
    Mr. Fattah. So, when there are references made to more 
strength than might have been desired, or weakened, what does 
that refer to?
    Dr. Kao. I believe the allegation was that there was an 
incorrect number of seeds outside or inside the prostate, 
Congressman.
    Mr. Fattah. Now, the prostate is a walnut-sized organ, 
right?
    Dr. Kao. Yes, Congressman. I am sorry, it is difficult to 
see from your angle, but it is this little thing that sits 
below the prostate--I am sorry, below the bladder, in front of 
the rectum, and above the testicles.
    Mr. Fattah. Is it a normal occurrence when you are 
implanting seeds that some seeds end up outside the prostate, 
across the breadth and width of this type of medical treatment?
    Dr. Kao. It is almost unavoidable, Congressman. 
Brachytherapy is an inherently subjective procedure where seeds 
are put in by hand, and so that is a recognized risk and in 
every consent form, Congressman.
    Mr. Fattah. So, if we looked at all these cases across the 
country, it would be an abnormality for seeds not to end up 
outside the prostate.
    Dr. Kao. It would be very frequent.
    Mr. Fattah. OK. It would be very frequent for them to end 
up in the rectum or in the bladder.
    Dr. Kao. Bladder or outside--and sometimes it migrates into 
other organs, such as the lung.
    Mr. Fattah. Now, Dr. Reynolds, is it a reportable medical 
event if a seed ends up in the rectum, under the rules of the 
NRC?
    Mr. Reynolds. Well, the requirements have not changed since 
Dr. Kao has been practicing and----
    Mr. Fattah. No, no. I am asking--is it a reportable event 
if a seed ends up in the rectum?
    Mr. Reynolds. It depends on the placement of the seed and 
the strength of that seed, but most likely, yes.
    Mr. Fattah. It is not always reportable, but in some cases, 
it is.
    Mr. Reynolds. Right. It depends on what the doctor has 
prescribed for the patient.
    Mr. Fattah. Now, there is a Safety Committee at the NRC. 
And there was a meeting on May 7, 2009, where there were 
various quotes that were ascribed to the doctor from that 
meeting. He says in his testimony, his voluntary testimony 
before the Committee today, in his written testimony, that none 
of these quotes were made by him.
    Dr. Cross, is there any way for us to figure out how that 
can be the case, that there are quotes in a report ascribed to 
the doctor, that he asserts before this Committee that he did 
not make?
    Dr. Cross. Sir, did you say that is the NRC Committee or--
--
    Mr. Fattah. Yes, it is an NRC Committee, not a VA 
committee, but I am asking you----
    Dr. Cross. I would not be able to comment.
    Mr. Fattah. OK. So, well, it was a VA procedure, so I just 
figured you may have had some input in this process.
    Can you help us, Director Reynolds.
    Mr. Reynolds. I am sorry. I am confused about what, 
specifically, you are talking about.
    Mr. Fattah. Well on number 14 of page 8, the doctor says 
that there are a number of quotes--and he goes through them, in 
detail--from this safety report, which he says he did not make 
and the report says that he did.
    Mr. Reynolds. Could you mention the doctor's name for me?
    Mr. Fattah. Dr. Kao.
    Mr. Reynolds. Oh, OK. I am sorry. I was thinking you were 
saying somebody else.
    Mr. Fattah. Is there anyone accompanying you who can help 
us with this mystery?
    Mr. Reynolds. I thought you were talking about somebody 
else. Please ask your question, again. I think I can answer it.
    Mr. Fattah. There are some quotes in the report from May 7, 
2009, from the Safety Committee, and it ascribes specific 
quotes, extensive quotes to the doctor that he asserts in his 
written testimony to the Committee today that he did not make.
    I am trying to figure out how we can determine how that 
could have happened.
    Mr. Vaira. There are two statements that we handed out. One 
is a lengthy one, and I think that is the one you are quoting 
from. It is about 14 or 15 pages.
    Mr. Fattah. Yes.
    Mr. Vaira. I do not know if the Director--your examiner 
there--has that in front of him.
    Mr. Fattah. OK. Well, it is probably too much of a time 
constraint for us to try to get to it at this point, but it is 
of interest that you can have these extensive quotes--yes?
    Mr. Reynolds. I am sorry. They handed me his statements 
right now. This is information that, when our inspectors talked 
to Dr. Kao, this is what he told our inspectors.
    It may not be verbatim what Dr. Kao told our inspectors, 
but this is our inspectors' words of what Dr. Kao said to our 
inspectors during our inspection.
    Mr. Fattah. So, these are quotes that are not quotes.
    Mr. Reynolds. No, these are quotes of what was said at the 
Advisory Committee for the Medical Use of Isotopes (ACMUI) 
meeting.
    Mr. Fattah. OK. Well, thank you.
    Dr. Cross, you said in your response to Senator Specter, 
there are a number of VA programs in terms of prostate cancer 
that have been put on hold. How many are there that have been 
put on hold?
    Dr. Cross. At the moment, I believe we have two that are 
still under investigation and several more that----
    Mr. Fattah. Well, originally that were put on hold, based 
on this review.
    Dr. Cross. I would have to--I do not have my experts at the 
table with me, so----
    Mr. Fattah. The gentleman that is behind you is trying to 
tell you.
    Dr. Cross. Four.
    Mr. Fattah. Four, OK. So, this is not a Philadelphia VA 
issue, this is something that you were looking at across the 
board.
    Dr. Cross. Exactly, and that is the routine procedure for 
us. When we find a problem in one place we look----
    Mr. Fattah. Did you say that this problem exists in non-VA 
medical facilities, and perhaps even more so?
    Dr. Cross. I think the issue of compliance with the 
standards, the oversight, and the accreditation are all issues 
that apply not only to the VA but to the broader system, as 
well.
    Mr. Fattah. OK. Senator Specter, I also want to acknowledge 
the presence of Congressman Brady, who has a staffer here and 
Councilwoman Jannie Blackwell, who represents this area. I want 
to thank you again for holding this hearing.
    Senator Specter. Thank you very much, Congressman Fattah.
    We will proceed now with a second round of questioning--5 
minutes.
    Reverend Flippin, what injuries did you sustain as a result 
of this procedure?
    Rev. Flippin. I was informed by a doctor at Ohio State 
University that I had a radiation burn to my rectum.
    Senator Specter. And what is the consequence of that?
    Rev. Flippin. The consequence of that was loss of a job, 
approximately 4\1/2\ months of 24/7 bedrest----
    Senator Specter. You earlier told me that there was 
bleeding involved.
    Rev. Flippin. Oh, yes, when I went to the bathroom.
    Senator Specter. Indelicate as it is, it is important for 
the record. What specifically happened to you in that respect.
    Rev. Flippin. OK. What sent me back to the West Virginia VA 
hospital was that I started experiencing bleeding in my stool 
and----
    Senator Specter. Reverend Flippin, you had testified 
earlier that no one from the VA ever informed you about what 
had happened. Is that so?
    Rev. Flippin. Right. I did not know anything about this 
until I receive the first letter.
    Senator Specter. First letter from whom?
    Rev. Flippin. From the VA.
    Senator Specter. When did you get that?
    Rev. Flippin. Last year. It was July 2, 2008, when I 
received the letter about the brachytherapy and the care that I 
had received.
    Senator Specter. Dr. Cross, the information is that there 
were similar problems in Jackson, Cincinnati, the District of 
Columbia, where Philadelphia had 97, Jackson 8, Cincinnati 6, 
and DC 3. What action has the Veterans' Administration taken 
with respect to those other sites.
    Dr. Cross. The one definitive action, I believe, in 
Cincinnati, is that they have been cleared. It turned out that 
they got a good review, and when we get a go from the NRC, they 
can proceed to continue on.
    The only two that are still being reviewed further are 
Washington, DC, and Jackson, as I recall.
    Senator Specter. Dr. Cross, you testified that there needs 
to be some attention to this kind of issue, as you put it, by a 
national health system. Would you amplify what you think could 
be done? We are now considering comprehensive health reform. 
This could well be an issue to be included. What specifically 
would you like to see be done by the national health system?
    Dr. Cross. Sir, I was not referring to health reform, I was 
referring to the oversight organizations that we work with 
every day. We work with a number of them.
    Senator Specter. Well, what could be done better on the 
oversight, then?
    Dr. Cross. I think that we have to put in place some 
better, clearer, more easily understood standards, perhaps. 
There is still debate on some of the issues as to whether or 
not these specific standards that are in place right now, which 
we are trying vigorously to enforce, are really relevant 
clinically in the long term, over time. That has to be 
clarified, and I think we would like to work with the 
organizations that do that, to be useful in that regard.
    Senator Specter. Director Reynolds, Dr. Kao has stated that 
there was not a sufficient definition of a reportable medical 
standard.
    Do you think there is any substance to that position?
    Mr. Reynolds. The entire medical community across the 
Nation has been subject to that standard for many years and has 
used it successfully.
    Senator Specter. You think there is a sufficient definition 
of a reportable incident?
    Mr. Reynolds. Yes, sir.
    Senator Specter. So, you think that if there was excessive 
radiation or seeds went into the bladder that would clearly be 
something that ought to be reported, at least to the patient.
    Mr. Reynolds. Yes, sir. In fact----
    Senator Specter. What corrective action do you anticipate 
from your Nuclear Regulatory Commission?
    Mr. Reynolds. Well, first, we expect the VA to address all 
their problems to ensure these problems will not happen again; 
and that includes developing nationwide standards and 
procedures, and it includes training of all the staff that Dr. 
Cross already talked about. And then, we are also looking at 
our inspection procedures to see if we can enhance them, and 
would we want the VA's National Health Physics Program to do 
inspections more often. Then, do we need to do more inspections 
on the VA and the VA's National Health Physics Program?
    Senator Specter. Congressman Adler, would you like a second 
round of 5 minutes?
    Mr. Adler. Reverend Flippin, Let us just imagine that over 
the course of 6 years you performed 116 sermons, and out of 
those 116 sermons, 92 of them were lousy, don't you think you 
would get booed out of your church?
    Rev. Flippin. Yes, sir.
    Mr. Adler. Aren't you, as I am, surprised that Dr. Kao 
still has a medical license after botching 92 of 116 
procedures?
    Rev. Flippin. I do not know anything about Dr. Kao. The 
only thing I would say is that when you mentioned, wouldn't it 
be nice to say something to Reverend Flippin, I was moved, and 
I thought he might look at me and say something. Now, I have an 
impression of Dr. Kao that I had not before coming in here.
    Mr. Adler. I thought we both got the same impression, sir.
    Dr. Cross, you heard Dr. Kao say that there might be 
grossly inadequate training for the physicians who perform 
brachytherapy procedures. Do you have any comment about the 
adequacy of training the doctors receive or standards that the 
VA uses to evaluate doctors before allowing them to perform 
this procedure in Philadelphia or anywhere around the country 
over the last number of years.
    Dr. Cross. I am not sure I heard the statement as you 
quoted it; however, training is always important, and when we 
find an issue like this, my natural inclination is to look at 
training and see if it was adequate. That is always the first 
place to look.
    We have good people, and if they are well trained and ready 
to go, we can usually avoid problems. So, I think, naturally, 
that is the first place to look; and then the accreditation and 
the oversight and all those kind of things that go along with 
it.
    Mr. Adler. I kind of heard Dr. Kao pointing at you and the 
VA system and that is why he did not do such a good job.
    I also heard Mr. Reynolds say the reason the NRC did not 
hear about problems is because people in the VA system failed 
to report to the NRC some of these problems.
    Is that generally accurate, Mr. Reynolds?
    Mr. Reynolds. Correct.
    Mr. Adler. So, I guess I am asking you what you--not you, 
personally, but the system--would have done differently over 
the years to report to the NRC this inadequate use of 
radioactive materials in the bodies of veterans who are coming 
for good care, and lots of cases--80 percent of the time--did 
not get that good care.
    Dr. Cross. First, I think it is important to note that we 
did report to the NRC at the time that this was uncovered in 
June 2008, and in fact, I have the exact date right here and 
who was contacted.
    We consider them to be important allies in this effort. The 
point that you are making is we should have done that sooner 
and that should have been discovered sooner. And that is where 
we have to put the mechanisms in place within the VA and 
outside the VA which will ensure that this is more easily 
detected, and more quickly detected.
    Mr. Adler. Do you have a sense why peer review did not 
catch this problem here, right in the hospital, before it ever 
got to 20 patients and 40 patients and 60 patients--before it 
got to 92 patients.
    Dr. Cross. I think I do, actually. There was a quality 
assurance program, but perhaps not as effective as it should 
have been.
    Peer review really focuses more on finding things where 
there are complications that have occurred, grading them, and 
taking action as a result. In none of these situations would 
such an event have occurred--where there was a clear 
complication happening.
    Mr. Adler. I guess you are sitting next to a clear 
complication. Poor Reverend Flippin had a----
    Dr. Cross. I am pointing out that that was over a year 
later, and I think that is the point right there--that time lag 
and the lack of identifiable complications right then.
    Mr. Adler. I guess I am hoping that you and Mr. Reynolds--
the NRC and the VA system--can coordinate better. I am hearing 
some sort of blame, at least from the NRC toward the VA system. 
I think you have been much more respectful about owning up to 
responsibility in a shared way. But I guess I am hoping to 
leave this hearing, and maybe a subsequent hearing in 
Washington, with greater confidence than I had coming in here 
since you have owned the problems, shared the responsibility 
with the NRC, and are defining a reporting schedule, a peer 
review system, a level of checks and balances throughout the 
system so we do not have to hear from the next Reverend 
Flippin, the next Air Force or Army, Marine, or Navy person who 
came to get good care--maybe not on prostate but on something 
else--and it somehow slipped through in a different way, 
different than this one, but just as troubling as this one.
    Can you give you me and this Committee the reassurance we 
need for America?
    Dr. Cross. Absolutely. I can do that because I view our 
colleagues who do oversight--whether it be the Joint 
Commission, the ACRO, or the Nuclear Regulatory Commission--as 
colleagues. I believe they are allies. I see them as very 
important to this effort, and I engage them, pull them into our 
discussions, invite them to our meetings, and invite them to 
our offices to work closely with us. That is the kind of 
relationship we are going to have, and that relationship is 
going to make this a success.
    Mr. Adler. Well, Doctor, we certainly need that process and 
we certainly need better results.
    Thank you.
    Senator Specter. Congressman Fattah.
    Mr. Fattah. Thank you, Senator.
    Dr. Reynolds, I want to try to delve into this on a more 
general basis here.
    Do you have a sense of how many of these procedures have 
been done, say, over the last 5 years, in our country.
    Mr. Reynolds. At VA hospitals or across the board?
    Mr. Fattah. No, across the board.
    Mr. Reynolds. Thousands.
    Mr. Fattah. Thousands. Can you tell us or give us a general 
understanding of how many medically reported events have 
occurred that have been reported to you?
    Mr. Reynolds. Very few.
    Mr. Fattah. Very few. That is what I want to delve into. I 
want to try to reconcile a couple of things.
    The doctor who is one of the experts in this whole field 
says that it is a very frequent occurrence that, in planting 
these seeds, that this happens. And my colleague says that 
anyone who does this, has botched a procedure; and he is 
surprised that the doctor still has a medical license. But if 
this is going on in thousands of cases and nobody is reporting 
it to you, then I am trying to figure out--and this gets to 
Senator Specter's earlier point--is if we are trying to fix 
health care nationwide we need to figure out how we deal with 
this on a systematic basis. If this is happening, it is not an 
event that can be avoided because of the proximity of the 
prostate to the rectum and the bladder; and, therefore, it is 
going to be visited upon almost anyone who gets this treatment, 
or it is a botched procedure in which nobody who is performing 
them are reporting them to you anywhere across the country. 
Now, which one is it?
    Mr. Reynolds. In addition to licensees, including the VA 
being required to report problems to us, we go out and do 
independent inspections. Based on our independent inspections 
of the other hospitals that do brachytherapy treatment, we have 
not seen this problem. The prostate is properly treated with 
seeds. We do not see medical events nowhere near the extent you 
see at VA Philadelphia.
    Mr. Fattah. So, you are saying this is an aberration, and 
that it is not the case that seeds end up outside the prostate 
on a normal occurrence.
    Mr. Reynolds. You may have an occasional----
    Mr. Fattah. I am going to give you a chance to review that 
before you comment.
    Mr. Reynolds. Could you ask your question again, I lost my 
train of thought.
    Mr. Fattah. Is this occurring in a great many of these 
procedures?
    Mr. Reynolds. No. Medical events----
    Mr. Fattah. No, not just the generality of medical events, 
but a reportable medical event having to do with seeds ending 
up outside the prostate.
    Mr. Reynolds. Right. Medical events dealing with seeds 
outside the prostate happen very, very infrequently based on 
reports to us and based on our direct inspections.
    Mr. Fattah. So, you get almost no reports.
    Mr. Reynolds. That is correct.
    Mr. Fattah. And therefore, you believe it almost never 
happens.
    Mr. Reynolds. Based on the reporting to us and our 
inspections, that is correct--outside of VA Philadelphia.
    Mr. Fattah. So, then the doctor is completely wrong that 
this is a frequent occurrence.
    Doctor, go right ahead.
    Dr. Kao. In the same transcript that, Congressman, you had 
referenced earlier, a physician advisor to the NRC has 
commented that if they were to audit all the programs that do 
brachytherapy in this country, there would be 20,000 reportable 
medical events. No program has undergone the level of scrutiny 
that this program has undergone, Congressman.
    Mr. Fattah. So, there could be cases where the Reverend who 
got this treatment ended up with a situation and nobody told 
him about it. There could be a lot of people who are facing 
symptoms from seeds outside the prostate which may not be 
avoidable, but nonetheless, could--because, at the end of the 
procedure, the urologist is supposed to go in and get the 
seeds, right?
    Dr. Kao. That is correct.
    Mr. Fattah. And there are seeds that are unaccounted for. 
That is how this works, right?
    Dr. Kao. That is correct.
    Mr. Fattah. And those seeds are somewhere.
    Dr. Kao. That is correct, Congressman.
    Mr. Fattah. And they are probably somewhere close to the 
prostate, either in the rectum or the bladder.
    Dr. Kao. Or in the tissue surrounding the prostate, 
Congressman.
    Mr. Fattah. So, there is a great deal of interest in this 
matter based on the way the New York Times wrote this story. I 
think that the bigger story here is that this is not about this 
hospital or this doctor. This is about a procedure designed to 
help men with a very serious health problem in which, part and 
parcel to that procedure, is the real danger that these seeds 
can end up outside the prostate, and which almost no doctors 
are reporting--to doctors to anybody, including you.
    You are the person that it should be reported to, both 
inside the VA and outside the VA. I think that Senator Specter 
has brought this to our attention in a way that will impact 
national policy and that will be meaningful; and it is not part 
of any kind of witch hunt about a particular program or doctor 
here in Philadelphia.
    Senator Specter. Thank you, Congressman Fattah.
    Congressman Adler, do you care to make a final statement.
    Mr. Adler. Let me first, again, thank Senator Specter for 
organizing this field hearing, and thank all the panelists for 
coming before us. I particularly thank Dr. Cross and folks from 
the VA hospital who have owned up to the seriousness of the 
problem that occurred here. For some of these procedures to 
have half the seeds planted wrongly outside the prostate, that 
is not a near miss; that is clearly a mistake. I thank Dr. 
Cross and Dr. Whittington and other folks from the hospital and 
from the VA system who want to solve a problem, who acknowledge 
the seriousness of the problem, who know that we let down 
patients who came here to get high-quality care and did not get 
it. I thank the VA system for shutting down this program until 
they get it right, and shutting down programs around the 
country until they get it right.
    I understand a couple programs have been reopened. I hope 
this program is restored properly here. But until it is gotten 
right, we should not do it. This is not just an art; there is a 
science to it, and the science is to put these seeds in the 
right body part, not kind of close, but right where they are 
needed to destroy the cancer rather than cause harm to patients 
who came here for good medical care.
    Mr. Reynolds, I thank you for sharing your concerns about 
the reporting up to the NRC. I am hoping you will be more 
active in redefining what is a medical event so that you get 
more of the reporting that Congressman Fattah was talking 
about, because I think we need to have better communication and 
a better understanding of what is going right and what is going 
wrong. My sense is that this hospital does a lot of things 
right, but in this one program was doing a lot of things wrong, 
and it is the aberration for this very good facility. But it is 
an aberration that lasted for too long.
    I hope we get to the bottom of this situation here. I hope 
it does not recur in this program, in this facility, or 
anywhere in the country. I think our veterans deserve better 
care than they got in this particular situation here.
    Thank you, Senator.
    Senator Specter. Thank you, Congressman Adler.
    Congressman Fattah, closing statement?
    Mr. Fattah. No, I think I agree with my colleague when he 
says that our veterans deserve the very best care and that this 
is a great hospital. I definitely agree with that, since it is 
headquartered in my District.
    I just think that, again, the real issue here and the 
benefit of this hearing is in our opportunity to impact 
national policy; and I want to thank Senator Specter for 
convening us.
    Senator Specter. Thank you, Congressman Fattah.
    One final point, Dr. Kao. Reverend Flippin raised the issue 
about your looking at him directly and saying something to him 
personally. You were not the doctor who attended Reverend 
Flippin, but you represent the whole process.
    Would you care to look at him and say something to him?
    Dr. Kao. Reverend Flippin, we should have, we can do 
better. I hope we will have the chance to do better by you and 
your colleagues in the future.
    Senator Specter. Well, that is great symbolism to conclude 
our hearing.
    Mr. Vaira. Senator Specter.
    Senator Specter. Sure.
    Mr. Vaira. Congressman Fattah quoted from a not lengthy but 
about a 15-page statement that my client made. It is damn good. 
It has got a lot of medical definitions and explanations in it.
    If you want a copy, I know the staff has a copy. If anybody 
here wants a copy--we do not have enough with us--call my law 
firm and we will make it available to everybody. It is a good 
learning experience.
    Thank you very much, Senator.
    Senator Specter. Thank you, Mr. Vaira. Now that you have 
testified, I think you have to understand that you are subject 
to cross-examination.
    Mr. Vaira. You and I go a long way back, Senator, a long, 
long, way.
    Senator Specter. Peter Vaira is used to cross-examination, 
and customarily, he is doing it, but thank you.
    Thank you, Dr. Kao, for being as candid as you have been, 
and thank you, Dr. Cross, for similarly giving up your vacation 
plans and coming here today. Director Reynolds and Reverend 
Flippin, the most important thing that needs to come out of 
this hearing is that this is not the final chapter. The House 
Veterans' Affairs Committee will be having a hearing in 
Washington. I will be talking to the Chairman of the Senate 
Veterans' Affairs Committee, Senator Akaka, and we will be 
looking further. But we have identified some very, very serious 
problems, and we need to learn from our mistakes. When Dr. Kao 
candidly said he planted seeds in the wrong organs and should 
have told people; he candidly said there was excessive 
radiation and he should have told people. That should be a 
lesson for other doctors similarly situated.
    The business of not having review and oversight by somebody 
who is outside the system is obvious, but that has to be done. 
And we have identified it as a national problem in Cincinnati, 
DC, and across the country. So, this is something which has to 
be attended to.
    I want to thank my staff, Will Wagner and Trevor Benitone 
and others who have worked here on short order. I thought it 
was very important to have this initial oversight done very 
promptly because I hear a lot of street talk about what is 
going on and what the care is for veterans. When great 
institutions like the Hospital of the University of 
Pennsylvania and the Philadelphia VA Center has a problem like 
this it causes a lot of skepticism and doubt. But I think we 
have taken a significant step forward and very symbolic to have 
Dr. Kao and Reverend Flippin embrace, which is a great sign for 
America.
    That concludes our hearing.
    [Whereupon, at 11:35 a.m., the hearing was concluded.]
                            A P P E N D I X

                              ----------                              


   Prepared Statement of Hon. Allyson Y. Schwartz, Representative in 
                Congress from the State of Pennsylvania
    Mr. Chairman, today's hearing is an important step toward restoring 
confidence in the Philadelphia VA Medical Center. I commend Senator 
Arlen Specter for working quickly to convene this field hearing to 
shine light on the reports of an ongoing and serious pattern of error 
in prostate cancer care at the Philadelphia VA.
    According to the Nuclear Regulatory Commission (NRC), serious, 
health-jeopardizing errors were committed in 92 out of 116 prostate 
brachytherapy treatments performed at the Philadelphia VA between 
February 2002 and May 2008. In 57 of those cases, patients received 
less than 80 percent of the prescribed radiation dose, and in 35 cases, 
patients received excessive doses to other organs.
    When this disturbing pattern came to light in June 2008, the 
leadership of the Philadelphia VA acted appropriately to terminate the 
prostate brachytherapy program and to contact the affected veterans. 
However, two questions remain: Why did it take so long for this 
disturbing pattern of substandard care to come to light? And are there 
other areas of the veterans' healthcare system that also lack necessary 
quality safeguards?
    Our Nation's veterans deserve to know that they are receiving the 
highest quality of care from the VA health system. It is my hope that 
the scrutiny of Congress will help to ensure that the Department of 
Veterans Affairs offers an honest accounting of what happened in 
prostate cancer care in Philadelphia, and even more importantly, to 
take steps to make sure that no similar pattern of error is allowed to 
take place again.

    Thank you.
      

                                  
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