[Senate Hearing 111-204]
[From the U.S. Government Publishing Office]
S. Hrg. 111-204
FIELD HEARING: PHILADELPHIA VA TERMINATED CANCER TREATMENT PROGRAM
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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
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
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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
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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
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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
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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.