[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
ENFORCEMENT OF THE
U.S. DEPARTMENT OF VETERANS AFFAIRS'
BRACHYTHERAPY PROGRAM SAFETY STANDARDS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
JULY 22, 2009
__________
Serial No. 111-36
__________
Printed for the use of the Committee on Veterans' Affairs
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COMMITTEE ON VETERANS' AFFAIRS
BOB FILNER, California, Chairman
CORRINE BROWN, Florida STEVE BUYER, Indiana, Ranking
VIC SNYDER, Arkansas CLIFF STEARNS, Florida
MICHAEL H. MICHAUD, Maine JERRY MORAN, Kansas
STEPHANIE HERSETH SANDLIN, South HENRY E. BROWN, Jr., South
Dakota Carolina
HARRY E. MITCHELL, Arizona JEFF MILLER, Florida
JOHN J. HALL, New York JOHN BOOZMAN, Arkansas
DEBORAH L. HALVORSON, Illinois BRIAN P. BILBRAY, California
THOMAS S.P. PERRIELLO, Virginia DOUG LAMBORN, Colorado
HARRY TEAGUE, New Mexico GUS M. BILIRAKIS, Florida
CIRO D. RODRIGUEZ, Texas VERN BUCHANAN, Florida
JOE DONNELLY, Indiana DAVID P. ROE, Tennessee
JERRY McNERNEY, California
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota
JOHN H. ADLER, New Jersey
ANN KIRKPATRICK, Arizona
GLENN C. NYE, Virginia
Malcom A. Shorter, Staff Director
______
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
HARRY E. MITCHELL, Arizona, Chairman
ZACHARY T. SPACE, Ohio DAVID P. ROE, Tennessee, Ranking
TIMOTHY J. WALZ, Minnesota CLIFF STEARNS, Florida
JOHN H. ADLER, New Jersey BRIAN P. BILBRAY, California
JOHN J. HALL, New York
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Veterans' Affairs are also
published in electronic form. The printed hearing record remains the
official version. Because electronic submissions are used to prepare
both printed and electronic versions of the hearing record, the process
of converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
current publication process and should diminish as the process is
further refined.
C O N T E N T S
__________
July 22, 2009
Page
Enforcement of the U.S. Department of Veterans Affairs'
Brachytherapy Program Safety Standards......................... 1
OPENING STATEMENTS
Chairman Harry E. Mitchell....................................... 1
Prepared statement of Chairman Mitchell...................... 47
Hon. David P. Roe, Ranking Republican Member..................... 3
Prepared statement of Congressman Roe........................ 48
Hon. John H. Adler............................................... 4
Hon. John J. Hall................................................ 5
Hon. Chaka Fattah................................................ 5
WITNESSES
United States Nuclear Regulatory Commission, Steven A. Reynolds,
Director, Division of Nuclear Materials Safety Region III...... 25
Prepared statement of Mr. Reynolds........................... 55
U.S. Department of Veterans Affairs, Joseph A. Williams, Jr., RN,
BSN, MPM, Assistant Deputy Under Secretary for Health for
Operations and Management, Veterans Health Administration...... 37
Prepared statement of Mr. Williams........................... 65
______
Bieda, Michael R., M.S., Clinical Chief, Division of Medical
Physics, Department of Radiation Oncology, University of
Pennsylvania, School of Medicine, Philadelphia, PA............. 10
Prepared statement of Mr. Bieda.............................. 53
Hahn, Stephen M., M.D., Henry K. Pancoast Professor and Chair,
Department of Radiation Oncology, University of Pennsylvania,
School of Medicine, Philadelphia, PA........................... 9
Prepared statement of Dr. Hahn............................... 51
Kao, Gary D., M.D., Ph.D., Associate Professor of Radiation
Oncology, Department of Radiation Oncology, University of
Pennsylvania, School of Medicine, Philadelphia, PA............. 6
Prepared statement of Dr. Kao................................ 48
American Society for Radiation Oncology, W. Robert Lee, M.D.,
M.S., M.Ed., Professor, Department of Radiation Oncology, Duke
University, School of Medicine, Durham, NC..................... 26
Prepared statement of Dr. Lee................................ 58
The Joint Commission, Paul M. Schyve, M.D., Senior Vice President 23
Prepared statement of Dr. Schyve............................. 53
SUBMISSIONS FOR THE RECORD
Desobry, Gregory E., Ph.D., Medical Physicist, Division of
Medical Physics, Department of Radiation Oncology, University
of Pennsylvania, School of Medicine, Philadelphia, PA,
statement...................................................... 67
Lazarescu, George, Ph.D., Medical Physicist, Division of Medical
Physics, Department of Radiation Oncology, University of
Pennsylvania, School of Medicine, Philadelphia, PA, statement.. 68
Stearns, Hon. Cliff, a Representative in Congress from the State
of Florida, statement.......................................... 68
ENFORCEMENT OF THE U.S. DEPARTMENT OF
VETERANS AFFAIRS' BRACHYTHERAPY PROGRAM SAFETY STANDARDS
----------
WEDNESDAY, JULY 22, 2009
U.S. House of Representatives,
Committee on Veterans' Affairs,
Subcommittee on Oversight
and Investigations,
Washington, DC.
The Subcommittee met, pursuant to notice, at 10:00 a.m., in
Room 334, Cannon House Office Building, Hon. Harry E. Mitchell
[Chairman of the Subcommittee] presiding.
Present: Representatives Mitchell, Walz, Adler, Hall, and
Roe.
Also Present: Representative Fattah.
OPENING STATEMENT OF CHAIRMAN MITCHELL
Mr. Mitchell. Good morning, and welcome to the Subcommittee
on Oversight Investigations Hearing on Enforcement of U.S.
Department of Veterans Affairs' (VA's) Brachytherapy Program
Safety Standards. This is July 22, 2009, and this hearing will
come to order.
I ask unanimous consent that Mr. Fattah of Pennsylvania be
invited to sit at the dais for the Subcommittee hearing today.
Hearing no objection so ordered. Mr. Fattah, you are invited
when you do come in, to come up to the dais.
I would like to thank everyone for attending today's
Oversight and Investigations Subcommittee Hearing entitled,
Enforcement of U.S. Department of Veterans Affairs'
Brachytherapy Safety Standards. Thank you especially to our
witnesses for testifying today.
All Members of this Subcommittee take particular interest
in this issue, as well as the care of our Nation's veterans;
however, I would like to especially thank Congressman John
Adler of New Jersey for being such a passionate advocate for
this issue.
Reports of botched prostate cancer procedures, a lack of
quality and standard controls in the VA health care system, and
egregious errors in the brachytherapy treatment at the
Philadelphia VA Medical Center are unacceptable and wrong.
Brachytherapy is a form of radiotherapy often used to treat
prostate cancer in which radioactive seeds are placed inside or
next to a patient's malignancy. Failure to accurately place the
radioactive seeds can cause serious damage. To say that it is
disturbing to learn that veterans received bungled procedures
and that safety protocols failed to safeguard against such
mistreatment would be an understatement. As a result, we are
here today to examine the system-wide safety standards for
these procedures to ensure that our veterans are receiving the
best and safest care possible.
In 2003 and 2005, the Nuclear Regulatory Commission (NRC)
received reports of botched placement of radioactive seeds and
inconsistent dosages at the Philadelphia VA Medical Center.
After careful review, it was determined that no NRC protocols
were violated.
In May of last year, the NRC received a notification of
potential under dosing at the Philadelphia VA Center. This led
to a VA Hospital Health Physics Program inspection evaluating
all the 116 brachytherapy treatments that took place since the
creation of the program in 2002.
The New York Times reported last month that investigators
for the Nuclear Regulatory Commission and VA officials found
that 92 of the 116 men treated at the VA Medical Center in
Philadelphia's brachytherapy program received incorrect doses
of radiation seeds, often because they landed in nearby organs
or surrounding tissue rather than the prostate.
Dr. Gary Kao, who is here today at this hearing, performed
the majority of the procedures under a VA contract with the
University of Pennsylvania where he was on staff. Out of the
four suspended brachytherapy programs, we know that
Philadelphia was by the far the worst.
On top of this, in March of this year the NRC issued a
detailed inspection report citing the Philadelphia VA Medical
Center with six violations of NRC regulations. This is
downright unacceptable.
While we are disturbed that perhaps there was a lack of
proper local quality controls and management of these
brachytherapy programs, our main concern is that the problem
marring the program in Philadelphia could be happening at the
other nine facilities still doing these procedures. As such, we
have asked the VA Office of Inspector General (OIG) to review
and assess the VA's brachytherapy programs, and although the
complete NRC inspection report on the Philadelphia program,
along with the other VA facilities using brachytherapy
treatments, as well as the National Health Physics Program
(NHPP) performance is not complete, we look forward to reading
that report when it becomes available.
Though it is commendable that VA's leadership took swift
action once these issues were reported, it is still troubling
that it took almost 6 years for these events to actually be
reported. Even more troubling is just last month we were here
discussing quality control and lack of proper procedures and
oversight of endoscopy procedures being conducted by the VA,
yet we are here again questioning the quality of care our
veterans receive.
The VA health system relies upon a complementary system of
accountability to identify quality control problems throughout
the entire system and at individual levels. Failure to ensure
consistent oversight and safe treatment is unacceptable and
wrong.
I am anxious to hear VA assurances not only to this
Subcommittee, but to all the veterans they serve, that the
issues identified once a thorough review has been conducted is
not occurring at any of the remaining brachytherapy programs
across the country, and that the four suspended programs may
continue to deliver this important treatment to our veterans.
Last, I am equally interested in hearing from one of one
our witnesses, Dr. Kao, regarding all allegations of erratic
seed placements, as well as experts we have invited to provide
their thoughts on the safety and effectiveness of the
treatment.
Thank you again to all of our witnesses who are testifying
today and we look forward to your testimony.
And before I recognize the Ranking Republican Member for
his remarks I would like to swear in our witnesses. I ask that
all witnesses from all three panels to please stand. Please
raise your right hand.
[Witnesses sworn.]
Thank you. I now recognize Dr. Roe for opening remarks.
[The prepared statement of Chairman Mitchell appears on p.
47.]
OPENING STATEMENT OF HON. DAVID P. ROE
Mr. Roe. Thank you, Mr. Chairman, other Committee Members
for being here today, I appreciate you holding this hearing.
The issue we should really be addressing today is not only
the instance of alleged medical malfeasance by one particular
medical practitioner, but whether or not this is a symptom of
an overreaching patient safety issue across the entire VA.
Just last month, as the Chairman mentioned we held a
hearing on the problems relating to cleaning and reprocessing
of endoscopic equipment at the VA. Now we are hearing testimony
today to discuss problems with brachytherapy treatments at the
VA Medical Center in Philadelphia.
Prostate cancer is a major problem for adults over 50 in
the United States, and brachytherapy is an important tool used
by oncologists to treat prostate and other cancers. The VA
treats about 575 veterans annually with low dose brachytherapy
at 13 centers nationwide.
We need to tread cautiously today. We are here to hear
testimony from the VA and other officials. We need to keep in
mind the good quality care most veterans seem to be receiving
in VA medical facilities and not seek to undermine the
confidence veterans have in going to the VA for their health
care needs.
That being said, I am gravely concerned that these issues
continue to crop up in the news media. VA needs to do a better
job at policing itself before they let the New York Times
sensationalize an issue in order to break the public's trust.
Mr. Chairman, protection of our Nation's veterans who look
at the VA for their care of a primary importance. To hear
continual reports of various health issues such as an
endoscopic cleaning issue last month and now the problem with
brachytherapy at select facilities is worrisome to me and
others on this Committee. We must continue to ensure that our
veterans receive the best possible care available.
I look forward to hearing the testimony from today's
witnesses. And once again, Mr. Chairman, thank you for holding
this hearing. I yield back my time.
[The prepared statement of Congressman Roe appears on p.
48.]
Mr. Mitchell. Thank you, Dr. Roe. At this time I would like
to recognize Mr. Adler.
OPENING STATEMENT OF HON. JOHN H. ADLER
Mr. Adler. I would like to thank Chairman Filner, Chairman
Mitchell, the House Veterans Affairs' Committee, and the
Subcommittee on Oversight and Investigation for holding today's
hearing on the VA's brachytherapy program safety standards. I
would also like to thank our witnesses for agreeing to testify.
The veterans who sought treatment for prostate cancer at
the Philadelphia VA Hospital did not receive the quality health
care their selfless service to our country earned them. The
people responsible for administering the substandard medical
care in the brachytherapy program let our veterans down and
sent the wrong message to young men and women thinking about
joining our all-volunteer armed forces.
We are here today to evaluate the suspended brachytherapy
program at the Philadelphia VA Hospital who have treated
prostate cancer patients from 2002 until the program was forced
to close in June 2008, and also to evaluate the VA's broader
brachytherapy program safety standards.
News reports have depicted a rogue cancer unit and a rogue
physician who botched nearly 80 percent of the procedures he
was contracted to perform on our veterans. These multiple
failures which went undetected year after year highlight
significant problems in the VA's oversight system.
Recent newspaper articles highlighted a prostate cancer
treatment program that operated for 6 years with a glaring lack
of oversight that should have been in place to protect our
veterans.
I am outraged. The brave men who so selflessly served our
country have been subjected to such poor treatment and neglect
by a hospital and a system that was created to protect them.
I am further appalled that the routine safeguards that
could have been in place to protect our veterans were either
woefully inadequate or blatantly absent. Exposing our veterans
to this type of mistreatment is not only unacceptable, it
violates the bond our country made with them when they agreed
to fight for the safety and security of this Nation.
We must find and analyze the specific gaps in our system so
these failures never happen again in this program, in this
hospital, in any program in any VA hospital.
What occurred at the Philadelphia's VA brachytherapy
program is more than just one doctor's incompetence, the
Federal Government failed on many levels to protect our
veterans.
The multiple-pronged system currently in place to oversee
radiation procedures across the country is not working. It
certainly was not working in Philadelphia. That is why the VA
temporarily or permanently suspended other brachytherapy
programs in Cincinnati, Washington, and Jackson, Mississippi.
This hearing is an opportunity to continue our
investigation into the failures that resulted in the forced
closings of 4 out of 13 brachytherapy programs throughout our
country. We must avoid a recurrence of this problem at all VA
medical facilities.
This hearing is also an opportunity to begin examining the
entire VA health care system. This is a start of an ongoing
process to ensure that our veterans are receiving the highest
standard of medical care they deserve everywhere in the
country.
I am looking forward to getting some answers from the VA
today about what steps they are taking to ensure that the
problems of the brachytherapy program in Philadelphia are not
repeated elsewhere in the VA health care system. My hope is
that the VA can give our veterans some confidence that the VA
system is working to provide the highest level of care.
I yield back the balance of my time.
Mr. Mitchell. Thank you. Mr. Hall.
OPENING STATEMENT OF HON. JOHN J. HALL
Mr. Hall. Thank you, Mr. Chairman, and thank you for
holding this hearing. Also, thank you Ranking Member Roe.
I agree with the comments of Mr. Adler and yourself and the
Ranking Member, all of which are complimentary. Our veterans
need to have obviously the best care available to them--and the
VA I believe is in the process of trying to correct these
problems where they are been identified.
I am interested in not only answers to what went on and how
it can be avoided, these cases of mistreatment or inadequate
treatment, possibly harmful treatment to the patients can be
avoided, but also your reaction to a New York Times article
that came out recently that said that a prostate cancer
diagnosis usually offers the patient the choice of five
different routes, seed implantation being one of them, and that
the most radical and expensive is proton acceleration, the
least expensive is watchful waiting, and in between you have
the removal of the prostate, radiation therapy, seed
implantation, et cetera, and that no statistical difference has
been shown yet in any of the studies in terms of lengthening
the patient's life, especially if they are diagnosed at 65
years or older.
So are we in the VA medical system looking at the cost
benefit analysis of these various choices of treatment and
telling the veteran, the patient, what the choices are and the
true statistical fact--it appears to be a fact--that one is not
guaranteed a longer life by having one treatment over another?
So if I may, Mr. Chairman, I will submit a longer statement
for the record, but thank you again for holding the hearing and
thank our witnesses for their testimony and I yield back.
[No statement was submitted.]
Mr. Mitchell. Thank you. Mr. Walz.
Mr. Walz. Well thank you Chairman and Ranking Member for
once again holding an important hearing. I am going to yield
back my time so we can get right to our witnesses.
Mr. Mitchell. Thank you. Mr. Fattah.
OPENING STATEMENT OF HON. CHAKA FATTAH
Mr. Fattah. Thank you, Mr. Chairman, and let me be brief.
Let me thank the Committee and the Subcommittee for holding
this hearing, and I think that it is important that we hear
from the witnesses. When I first heard about this, I was
obviously like others, outraged. Nevertheless, the more you dig
into it there is more nuance to it and subtleties to this
procedure, and I want us to make sure that we don't do anything
to discourage people from seeking treatment.
I think it would be very helpful to hear from the experts
so that we can better understand what happened and where we can
go from here. Specifically, to what degree were there
difficulties in what is one of the best VA hospitals in this
system, which is in Philadelphia, what was done about it, and
where we can go from here. So thank you, Mr. Chairman.
Mr. Mitchell. Thank you. I ask unanimous consent that all
Members have 5 legislative days to submit a statement for the
record. Hearing no objection so ordered.
At this time I would like to welcome Panel One to the
witness table. Joining us on our first panel is Dr. Gary Kao,
Associate Professor in the Department of Radiation Oncology at
the University of Pennsylvania. Also joining us is Dr. Steven
Hahn, Professor and Chair of the Department of Radiation
Oncology, University of Pennsylvania; Michael Bieda, Clinical
Chief in the Division of Medical Physics, Department of
Radiation Oncology, University of Pennsylvania. Mr. Bieda is
accompanied by Dr. Greg Desobry, Medical Physicist, Division of
Medical Physics, Department of Radiation Oncology, University
of Pennsylvania; and Dr. George Lazarescu, Medical Physicist,
Division of Medical Physics, Department of Radiation Oncology,
University of Pennsylvania.
I ask that all witnesses please stay within 5 minutes for
their opening remarks. Your complete statements will be made
part of the hearing record.
At this time I would like to recognize Dr. Kao, then Dr.
Hahn, and Mr. Bieda for up to 5 minutes each.
Dr. Kao.
STATEMENTS GARY D. KAO, M.D., PH.D., ASSOCIATE PROFESSOR OF
RADIATION ONCOLOGY, DEPARTMENT OF RADIATION ONCOLOGY,
UNIVERSITY OF PENNSYLVANIA, SCHOOL OF MEDICINE, PHILADELPHIA,
PA; STEPHEN M. HAHN, M.D., HENRY K. PANCOAST PROFESSOR AND
CHAIR, DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF
PENNSYLVANIA, SCHOOL OF MEDICINE, PHILADELPHIA, PA; MICHAEL R.
BIEDA, M.S., CLINICAL CHIEF, DIVISION OF MEDICAL PHYSICS,
DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA,
SCHOOL OF MEDICINE, PHILADELPHIA, PA; ACCOMPANIED BY GREGORY E.
DESOBRY, PH.D., MEDICAL PHYSICIST, DIVISION OF MEDICAL PHYSICS,
DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA,
SCHOOL OF MEDICINE, PHILADELPHIA, PA; AND GEORGE LAZARESCU,
PH.D., MEDICAL PHYSICIST, DIVISION OF MEDICAL PHYSICS,
DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA,
SCHOOL OF MEDICINE, PHILADELPHIA, PA
STATEMENT OF GARY D. KAO, M.D., PH.D.
Dr. Kao. Thank you, Congressman Mitchell and other Members
of the Subcommittee for the opportunity to appear before you so
that we may be heard on this important subject matter and
correct some very serious false allegations that have appeared
in the media recently about me and the Philadelphia VA
brachytherapy program.
I have always worked very hard to best serve the field of
radiation oncology and my patients in over 15 years of clinical
practice. My dedication to my work is reflected in my
educational achievements earning a bachelors degree in
philosophy and a medical doctor degree from the John Hopkins
University and its School of Medicine, followed by medical
internship and residency, and completion of residency in
radiation oncology at the University of Pennsylvania School of
Medicine. This culminated in board certification in Radiation
Oncology. I further earned a second doctorate, a Ph.D., in
researching better ways of treating cancer.
I am especially proud that during continuous clinical
practice of medicine for over 15 years I have not had a single
malpractice claim filed against me. My record and my commitment
to the care of my patients make the false allegations against
me and the brachytherapy program particularly devastating and
misguided.
I, along with others at the VA, implemented the program for
brachytherapy in 2002 to best serve the interests of veterans.
Contrary to the allegations that I was unsupervised and we were
a rogue unit, we developed precise standard operating
procedures and a system of oversight and monitoring of what was
then a state of the art treatment for prostate cancer. We
formulated the first algorithm of any radiation oncology
procedure at the VA to define the standard operating procedure.
As would be expected in any new program the brachytherapy
program was not without its challenges. However, what has
become clear over the last month is that a fundamental
misunderstanding of elementary principles and concepts has led
some to arrive at an inappropriate and incorrect conclusion
that deficient care was routinely rendered to veterans who
received brachytherapy in Philadelphia. This was not the case.
To understand why it is important to understand certain
critical issues related to the NRC's definition of a reportable
medical event and its applicability to our work. Here are the
facts.
Fact 1: A standard definition of a reportable medical event
as it applies to brachytherapy was not in existence when the
program started at the VA. This definition was not referenced
in my training in brachytherapy at the Northwest Hospital in
Seattle, nor was it clarified by NRC personnel in their
investigations in 2003 and 2005 when they were onsite in
Philadelphia.
The definition that the NRC has now chosen to retroactively
apply to all cases of the Philadelphia program is predicated on
a deviation from D90, the dose received by 90 percent of the
prostate, but this is a definition that does not appear
anywhere in the regulations published by the NRC.
It should also be noted that there is disagreement within
the medical community regarding the appropriateness of D90 as a
defining metric for overall efficacy of the treatment.
Fact 2: The definition of a reportable medical event as it
applies to brachytherapy is not only unclear, but it is
evolving. The Medical Advisory Committee of the NRC has
repeatedly recommended that the definition be changed from one
that is dose-based to one that is activity-based, in other
words, in the number of seeds. Last summer, the NRC proposed a
rule to change the definition, but the NRC is still using the
old unpublished definition to judge the Philadelphia VA's
brachytherapy cases.
Fact 3: Even if a reportable medical event using the D90
based metric occurred, this does not mean the treatment failed
the standard of care.
For example, the treatment of an unusually large prostate
may result in a D90 that is under-dosed or a treatment of a
small prostate may result in a D90 overdose, but in both cases
the treatment could still be appropriate and effective in
eradicating the cancer.
Fact 4: Whether treatment delivered has been consistent
with the standard of care should not be determined by whether
the treatment resulted in a reportable medical event to the
NRC.
There are many more significant factors that determine
appropriate treatment such as number of seeds; location of the
seeds in a prostate; location of seeds outside the prostate;
concentration of seeds to the affected area of the prostate;
stage, grade, extent and location of the cancer; and the
clinical follow up of prostrate-specific antigen (PSA) test
results. None of these factors are addressed by the NRC.
I also wish to address the now oft-repeated reference to 92
botched cases. This characterization is simply wrong. It is
unfair and extremely misleading. A case that meets the NRC
definition of a reportable medical event does not mean the
patient received ineffective or botched care. The efficacy of
the treatments is evidenced by the fact that there had been no
confirmed cases of tumor recurrence by the time the program was
terminated, with many patients doing well up to 5 years after
their treatment.
Furthermore, the NRC review, which allegedly resulted in 92
reportable cases, was determined through a re-analysis of our
data without our participation. This participation would have
been essential, since it is well recognized among radiation
oncologists that prostate contouring is very subjective and
volumes can vary substantially depending on who does the
contouring. Because of this variability, the D90 dose
calculated by different reviewers can vary by as much as 60
percent. The calculations that we performed indicated that the
number of patients with D90 lower or higher than 20 percent
were far fewer than 92 cases. I do not believe that even with
the use of a D90 base metric there are close to 92 reported
cases.
Brachytherapy is a relatively new and evolving field. While
I recognize that certain conditions and circumstances at the
Philadelphia VA could have been improved, but I remain
confident based on my knowledge of the field and the nature of
the patients that we treated that the patients received
appropriate medical care and which was effective.
I hope that through my statements and testimony I am able
to contribute to a fuller understanding of brachytherapy
treatment, but also bring a degree of reassurance to our
veterans regarding the treatment that was provided, and
ultimately improve the care for our veterans. Thank you.
[The prepared statement of Dr. Kao appears on p. 48.]
Mr. Mitchell. Thank you. Dr. Hahn.
STATEMENT OF STEPHEN M. HAHN, M.D.
Dr. Hahn. Yes, sir.
Mr. Chairman and Members of the Subcommittee, I am grateful
for the opportunity to appear before you here today.
I am a professor of radiation oncology at the University of
Pennsylvania, and since 2005 have been chair of the
University's Department of Radiation Oncology.
Before going any further I want to express my deepest
regret that prostate cancer patients receiving brachytherapy at
the Philadelphia VA Medical Center did not in every instance
receive the best possible care. My highest priority as a
physician and as chair of the Department of Radiation Oncology
is to make sure that patients do indeed receive the best
possible care.
I want to personally apologize to the patients and their
families for the distress that this has caused. I also know
that the entire experience has been very difficult for the VA
health care system, particularly in Philadelphia, as it has
been for my department.
Penn Medicine's relationship with the VA is long standing
and we value it greatly. It is very important to our mission as
an academic medical center dedicated to patient care, teaching,
and research. We value this work and we believe that both of
our organizations have learned a great deal from this painful
experience.
I will focus most of my testimony today on the steps we
have taken in the last year in response to this situation and
the process improvements we have implemented at Penn that we
believe will improve the quality of care.
The University's Department of Radiation Oncology, through
a contract with the VA, provides radiation services, including
brachytherapy. Radiation oncologists working at the VA are
either directly employed by the VA or Department faculty
provided under the contract.
When the Department first learned in May of 2008 of
potential concerns about the prostate brachytherapy program at
the VA we took immediate action. The Department provided
several faculty Members and staff to the VA to assist in its
quality review of all prostate brachytherapy cases.
In June 2008, when concerns arose regarding Dr. Kao's cases
in particular, Dr. Kao agreed, at my request, to suspend his
clinical practice, and he has not treated any patients since
that time at the VA or at our hospitals.
Since last summer, Departmental faculty, as part of their
responsibilities at the VA, have been coordinating patients'
follow-up.
In addition, since the VA and the NRC began investigations
into this matter in June 2008, we have cooperated fully, and we
will certainly continue to do so.
In June 2008, we also reviewed quality control and
improvement measures to enhance them and to prevent a situation
like this from ever happening again.
We have adopted an additional review process that provides
for patients who did not take part in the original
brachytherapy procedure to assess its quality by reviewing the
Computerized Axial Tomography (CT) scan and recalculating the
delivered dose.
We also have established a multi-level internal reporting
system so that even a slight anomaly will be reported to our
quality assurance (QA) Committee.
Another notable development for us is that at Penn we
recently completed the transition to a new treatment approach
called ``real-time dosimetry,'' a technology that provides for
instantaneous feedback about dose to the attending physician.
We believe this approach should enhance our program.
I do not know if the VA intends to restart its permanent
prostate brachytherapy program, but if and when it does, we
would of course be very happy to assist the VA in any way
possible.
Our Department's response has also been reviewed by Penn
medicine quality reviewers and senior physicians. Further, to
assure ourselves that we have considered every safety and
quality option, we will be requesting an additional review by
outside experts.
Before closing, I want to briefly address NRC regulations,
because the NRC, the VA, and the University all share a goal of
seeing patients receive the best possible care. My hope is that
we can work with the NRC to clarify the relevant regulations
which should make early detection even more likely.
Mr. Chairman and Members of the Subcommittee, I want to
reiterate that I am sorry for the distress this has caused
patients and their families. Let me again stress that Penn is
committed to providing the highest standard of care to our
Nation's veterans and to work closely with the VA moving
forward. Thank you.
[The prepared statement of Dr. Hahn appears on p. 51.]
Mr. Mitchell. Thank you. Dr. Bieda.
STATEMENT OF MICHAEL R. BIEDA, M.S.
Mr. Bieda. Mr. Chairman and Members of the Subcommittee,
thank you for the invitation to appear here today.
I would like to use my time to provide you with some
information about my background, as well as a description of
the medical physicist's role in prostate brachytherapy. I am
giving this statement on my behalf, as well as that of my two
colleagues, Mr. Desobry and Lazarescu.
In 1996, I was awarded a master's degree in physics from
the University of Tennessee, and in 1999 was graduated from the
master's program in medical physics at the MD Anderson Cancer
Center at the University of Texas at Houston. Since that time,
I have worked as a medical physicist at the Johns Hopkins
University Oncology Center; at Christiana Care Health Systems
in Newark, Delaware; and at Bryn Mawr Hospital in Bryn Mawr,
Pennsylvania, in addition to the University of Pennsylvania's
Department of Radiation Oncology. I worked at Penn from 2002 to
2005, and then returned in August 2006 to take the position of
Clinical Chief of Medical Physics for the Department. I am
certified by the American Board of Radiology in therapeutic
radiological physics and I have had several publications in the
Journal of Medical Physics.
I will describe three things that a medical physicist does
to assist in prostate brachytherapy.
First, based on the physician's prescription, which
specifies the amount of radioactivity implanted into the
patient, a physicist prepares what is called a ``preplan.'' To
do this the physicist will review a series of ultrasound images
of the prostate that is taken by the doctor in which the
physician has identified the prostate. With this information
from the doctor, the physicist will plan the places where the
radioactive seeds will be implanted into and around the
prostate and estimates the radioactive dose to be delivered to
the prostate. This plan is always confirmed or potentially
revised by the doctor.
Second, not long after the doctor is to perform the
implant, the physicist will check the activity level of a
sample of seeds to be implanted and deliver those seeds to the
doctor in the operating room (OR).
The third thing a physicist does takes place after the
implant. At the Pennsylvania VA Medical Center the doctor would
order a CT scan of the patient's prostate the day after the
implant. On this CT scan the physicist would identify the
location of the implanted seeds, using a dedicated computer
program for this purpose. Once this was done, the doctor would
locate the prostate on the CT scan and draw it in. This would
allow the computer program to generate what we call a ``dose
volume histogram,'' which is essentially a graph showing how
much of the prostate received how much of the prescription
dose, as well as different dose parameters. This information is
often referred to as ``post-implant dosimetry.''
Post-implant dosimetry is performed so that the doctor
might evaluate the implant as part of his overall assessment of
his ongoing treatment plan for the patient.
I recognize that the Subcommittee may have questions and I
will do my best to answer them. Again, thank you for your
consideration of my testimony.
[The prepared statement of Mr. Bieda appears on p. 53.]
Mr. Mitchell. Thank you very much. I have a couple
questions. First of all I want to start with Dr. Kao.
First, can you please explain the quality of care provided
at the VA compared to the quality of care at other facilities
you have worked at.
Dr. Kao. The brachytherapy procedure that we adopted at the
VA was identical to the system that was used at the University
of Pennsylvania and also one of its satellites. And in my
training, in fact, I went to observe brachytherapy procedures
performed in art satellite in Trenton, New Jersey, and as a
resident I was trained in brachytherapy by senior physicians at
the University of Pennsylvania.
Mr. Mitchell. What quality of care metrics do other
facilities follow?
Dr. Kao. My understanding is that the quality control--the
quality assurance procedures are similar in that a CT is
performed after the procedure and the dosimetry calculated from
that CT.
Mr. Mitchell. And the last one I have. What markers or red
flags when conducting the brachytherapy procedures indicated a
problem?
Dr. Kao. I now understand that--one of my regrets is that I
could have been much more assertive in engaging the NRC in what
it defines as a reportable medical event.
As a result of their investigation in 2003 and 2005, we
were under the understanding that the definition of a
reportable medical event was based on the number of seeds
laying outside the prostate. Subsequently, I found out that
that was not the case, that the NRC apparently is now relying
on a D90 metric, and that is something that to my regret I
could have been much more focused on using that metric.
Mr. Mitchell. Mr. Bieda.
Mr. Bieda. Yes.
Mr. Mitchell. What do you think could have been done
differently by the VA that would have prevented us having this
hearing today?
Mr. Bieda. Differently compared to Penn, differently
compared to other hospitals?
Mr. Mitchell. Differently so we wouldn't have had to have
this hearing.
Mr. Bieda. Right. My only, you know, potential thought on
what could be done differently is to have a stricter peer
review process by, you know, external physicians not involved
directly in the cases, that probably could have, you know,
helped the situation.
Mr. Mitchell. And this is to either three of you. My
understanding was that what caused this to become a red flag
was the under dosage that the patients received. As a result of
the under dosage what has happened with these patients in terms
of prostate cancer? Has it come back? Has it been taken care
of?
Dr. Hahn. Mr. Chairman, the VA's own internal QA system
picked up the sort of index situation that led to this
discovery. And we personally, although we supplied physicians
for the review of the patients' cases at the VA, this has been
an internal VA investigation. We would not personally have a
lot of information with respect to that clinical outcome, sir.
Mr. Mitchell. One last question. You were called in I guess
as a radiation oncology to perform this procedure. Who does
that? Is it a urologist? There are other ways to handle
prostate cancer. How is it determined that brachytherapy was
the process to use here? Or do you know that?
Dr. Hahn. Are you asking me, sir?
Mr. Mitchell. Anybody there on the panel.
Dr. Kao. You are correct, Mr. Chairman, patients with
prostate cancer have different treatments available to them.
The patient population that we served at the Philadelphia VA
however was very special in that many of the patients came from
very far away, from West Virginia, Ohio, upstate Pennsylvania
for brachytherapy because they could not undergo surgery or
external beam radiation, you know, due to the lack of these
treatments back home or because of their individual personal
situations.
Mr. Mitchell. Okay.
Dr. Kao. External beam radiation for instance would require
8 weeks of daily Monday through Friday treatments, and I had a
number of patients who for instance were farmers who could not
afford the 2 months being away from their farm. It would have
been economically devastating for them.
Mr. Mitchell. Thank you. Dr. Roe.
Mr. Roe. I am going to try to put a little English
translation on all this for the non-medical people in here.
What happens when you have--let us say you have a PSA that
is elevated, you do a biopsy and you find a cancer, that cancer
has a score called a ``Gleason score,'' which goes from zero to
ten, and they also evaluate the size of your prostate gland, it
is how big it is, how many cc's of volume does it have. So a
very large volume prostate gland would not be one you would
choose to treat with brachytherapy.
And brachytherapy has really been developed since probably
the 1970s, and one of my closest friends has been doing this
actively since 1997, so it is not really new.
When that diagnosis is made and you have a patient that
meets the criteria they go to the operating room, they have an
anesthetic, they have a rectal ultrasound placed in, and they
have a device placed on the perineum.
The calculations, and I would like to commend you on your
choice of undergraduate schools too by the way, UT, the
physicist has made a pretreatment plan. These seeds then under
direct ultrasound guidance are placed. And the way--and I will
let the physicist explain this a little closer in a minute--the
way these calculations are made there is a thing called the
``inverse square law'' and I won't go through all of that, but
basically on where the seeds are, you can calculate how many
grays or how many reds of therapy are given to a specific spot,
and then the patient has a CT scan at some point after the
procedure is over and they are able to look and he would make
this calculation that yes, the dosimetry is right and he would
know how many grays are required to kill a cancer cell that is
fairly slow growing, let us say of a Gleason score of five.
The problem that came up with the placement of these seeds,
and I was looking here, and this may come up later in the
testimony, but in one particular instance here there were 45
seeds out of the 70 something that were placed that were not in
the prostate gland but were in the bladder. So what had
happened was, and I reviewed some of these diagrams here, that
the seed placement was not appropriate and it didn't seem to be
in the prostate. It was not in the prostate gland. And,
therefore, when that happened, when the calculation was made
afterward the dosimetry was not correct for the treatment of
the disease. Am I right on that, Dr. Hahn?
Dr. Hahn. Yes, correct.
Mr. Roe. And would you either Dr. Kao or Dr. Hahn, one of
you, discuss on placement of the seeds, because that is
absolutely critical. And what the Chairman brought up is
sometimes a radiation oncologist does that, sometimes a
urologist does that in consultation with the oncologist, and
sometimes they do it together. So it is not standard. Could you
comment on placement of the seeds, and is that where the
problem was?
Dr. Hahn. So at our institution, Congressman Roe, the
procedure is typically mostly done by the radiation oncologist
with some participation by the urologist both in terms of
identifying the base of the prostate using an ultrasound in the
OR as you described, as well as perhaps the placement of some
seeds. The predominant amount of seeds--number of seeds--is
performed by the radiation oncologist in the operating room.
Mr. Roe. And to just again further clarify for those, when
you place this needle in as you bring it out you drop these
seeds along, but if that needle is not in the prostate gland it
obviously isn't getting it treated if it is near the rectum or
if it is in the bladder. And I asked my colleague, my good
friend that I have operated with hundreds, if not a thousands
times, how many seeds that he dropped in the bladder over the
years in the hundreds of cases that he had done, and he said
now it almost never happens because of the ability--and it has
happened in obstetrics ultrasound how refined the ultrasound
is.
So I guess I am asking the question, why did that happen?
Why there were so many seeds placed outside the prostate or the
dosimetry seemed to be? I think that is why when the
calculations were made that the dose didn't seem to be proper.
Dr. Kao. If I could address your question. As Dr. Hahn
mentioned, the way we do brachytherapy in Philadelphia is in
conjunction with the urologist. The urologist places the very
first needle, and needle determines the depth by which all
subsequent needles fall. So if that very first needle is off,
as you pointed out, then the subsequent needles may also be
off.
The placement of the seeds also depends on the image
quality. And early in the learning curve in our first few cases
we did not prep the patients as thoroughly as needed, so if
there is some stool in the rectum that would degrade the image
quality of the ultrasound.
The case that you are referring to, sir, I believe is one
of the cases that resulted in an NRC investigation. We
implemented several measures after that first case to help
ensure that this situation did not arise again.
Mr. Roe. Thank you, Mr. Chairman, I will have further
questions later.
Mr. Mitchell. Thank you. Mr. Adler.
Mr. Adler. Thank you, Mr. Chairman. I guess my first
question is for Dr. Kao. We have heard about the closure of
this program in June of 2008. We have heard about possibly 92
cases out of 116 with some concern. Some of us use the word
``botched,'' you don't like that word. We have heard that the
National Health Physics Program reported to NRC at least 35
medical events later in 2008. We heard Dr. Hahn just now
acknowledge on behalf of UPenn that not in every instance did
every patient get the best possible care. This program is still
closed. You were running this program. You were the principal
operator of this program at the VA in Philadelphia.
How do you reconcile your view in your own testimony here
today that patients received appropriate medical care with the
VA's view that it made mistakes during this period of years
with UPenn's recognition that not every patient got the best
possible care, with NHPP and NRC saying there are medical
events even in a context where we probably don't define medical
event sufficiently to trigger reporting to the extent probably
we would want reporting? So let us assume there is some under-
reporting going on. Even with under-reporting we have at least
35 instances from 2008 reported about over a period of time a
program you ran.
I am thinking you are in a dream world right now. I am
thinking everybody else, all the other experts are looking at
this and saying it didn't go well enough, that whether the
number is 92 or some less than 92 we want the number to be zero
botched cases.
How do you reconcile your view that every patient received
appropriate medical care with a view of every other expert,
every potential supervisor, every contracting body, every
regulatory body? I kind of want to hear you acknowledge you did
things less well than you would have wanted to have done.
Dr. Kao. Sir, I don't disagree with many of the other
comments that were made. Medicine is both an art and a science,
and the art of is it that even though the treatment may be
effective it may be made to be even more optimal.
A central theme here is what is defined as a reportable
medical event. And a case that is a reportable medical event
does not mean that the patient was harmed or did not receive
effective treatment.
When the program was closed in 2008, we did not have any
confirmed cases of tumor recurrence. The NRC itself recognizes
that a reportable medical event does not mean that it does not
address the efficacy of the treatment.
So in summary, I recognize there are many things--several
things that I could have done better, but I still believe that
the patients received the standard of care that was in place at
the time.
Mr. Adler. I am just seeing it differently than you are I
guess.
I understand from some news reports that it was at least a
period of a year where you were not getting post-implant
dosimetry information to gauge whether the patients had had the
seeds placed properly and the seeds had stayed where you wanted
them to be. Is it true that there was a year when you did not
have that sort of post-implant dosimetry information?
Dr. Kao. It is true that for a period of about 14 months
there was a computer interface problem at the VA, that although
the CTs that could be performed after the brachytherapy, but
that data could not be transmitted to the workstation used to
calculate the doses.
During that time I followed the chain of command. I
complained to radiation safety, to the Chief of the VA
Radiology Oncology Department, and other Members of the program
did the same, but this problem was never fixed.
I was then faced with the very difficult choice of either
stopping the program, but if I had done so then the patients
would not have received any care. As I mentioned earlier, many
of the patients who came to us did not have surgery or other
forms of radiation as a choice. So given the choice between
delivering no care and having their cancers progress or to go
ahead and perform the procedure I made that decision.
I could still see from the CT that the seeds were in the
prostate and I could judge that the seeds were concentrated
around the part of the prostate where the cancer was located.
So these gave me a measure of confidence that the patients were
being appropriately treated. But it is, you are correct, sir,
that is one of my regrets that I should have broken the chain
of command, I should have been more assertive, I should have
stopped the program at that point.
Mr. Adler. Well what number would you say is the number of
patients who didn't get adequate care? The total you did was
116, of that number what would you say? I have heard numbers,
57, 35, and 92. What number would you say was the number?
Dr. Kao. Sir, since 2008, I have not had access to the
patient records, but I believe based on the calculations that
our team performed before it was shut down that the cases were
far fewer and probably closer to 20 cases that were reported--
that were defined as medical events. But again, a case that is
defined as a medical event does not mean that the treatment was
not effective, sir.
Mr. Adler. Dr. Hahn, let me ask you. What lessons can UPenn
take away from the situation and what sort of failures of
oversight would you say were present from a UPenn perspective?
Dr. Hahn. I think that we and our partners at the VA both
would agree that there are many lessons that we have learned
and will continue to learn from this very painful episode. And
let me just say even if it were just one human being who did
not receive the best possible care, Congressman Adler, that
would be unacceptable.
When we became aware of the allegations in June of 2008, we
did a review of quality assurance and peer review, and we
determined that they certainly could be improved. And as I
mentioned in my statement, but not in great detail, we did
institute a number of measures to allow for that improvement,
including the oversight of each brachytherapy case that is
performed by outside health care team Members within the
Department but who didn't perform the procedure who will review
the CT as well as the dosimetry to give another level of
review.
We have also instituted a system whereby the reportable
events to the Department's leadership are such a low threshold
such that even a slight anomaly would be reported giving us the
opportunity to capture everything.
We have also, in partnership with the VA, instituted a
Department-wide system for reporting levels of toxicity. This
uses clinical outcomes. If we detect severe or unexpected
toxicities, it triggers presentation of what we call our
morbidity and mortality conference where people inside and
outside of the Department review those toxicities.
And then this other issue of real-time dosimetry, which
allows us to see the needle go in and see the dose in real-time
with instantaneous feedback.
We feel that these measures are prudent certainly, and that
they will and should prevent similar occurrences from occurring
in the future.
Mr. Adler. Thank you, my time has expired. Mr. Chairman.
Mr. Mitchell. Thank you, Mr. Walz.
Mr. Walz. Well thank you again, Mr. Chairman, and I want to
thank all of our witnesses for being here, and as I always say
there is no doubt that everyone in this room wants the best
care for our veterans, that is an absolute given. And I also
say that it is a zero sum game, so I agree with you, Dr. Hahn.
And I think talking about this there is a human face on this.
There is Pastor Flippin and his story that was told. We keep
that in mind.
I also want to though note, and my colleague from
Pennsylvania I think started hitting on this, that your
willingness to come here today and answer questions openly is
truly appreciated, and it is very obvious that your sense of
concern on this is very real, and I am very appreciative of
that. Because all too often we get caught up in the legal
barriers that people are unwilling to try and fix this, and it
is imperative that we get this right.
So with that being said, I also want to thank Dr. Roe, he
is always very helpful for me to understand the medical side of
this. My postgraduate work was in systems analysis, so that is
the part that I am most concerned about, and it seems that many
times we keep coming back to that of looking at these things to
see if they are not just isolated incidents, but if there are
things--and building on what Mr. Adler was talking about--a
couple of questions I have had.
We have recently had the questions that come up here,
improperly sterilized equipment, and we are asking where best
practices fall. And something as simple as a checklist for who
last cleaned the equipment, none of that was available.
So one of the red flags I think in this whole thing that
came up for me was listening to people talk about the lack of
peer review involved in this. And many, and I think it was Dr.
Welch who commented, in all of his medical practice he has
never seen such a lack of peer review in the process that was
happening.
Can one of you comment on that of do you think that is true
in the radial--the oncology here at VA as it stood in
Philadelphia? Was there a severe break down in peer review,
which is meant to be there as a safeguard? Can anyone comment
on that?
Dr. Hahn. Congressman Walz, there was peer review in place.
Brachytherapy represents about 5 percent of the treatments that
we give, and there is peer review for both external beam as
well as all the treatments that are given. I think Congressman
Walz, there is no question in our mind that when we looked back
at the peer review processes, and I think it was the first
process that we implemented--process change--that being
dependent upon the local treatment team in and of itself to
report quality issues without having a secondary look by
external physicians and physicists was something that needed to
be improved, sir.
Mr. Walz. Would it be your experience, Dr. Hahn, that this
same lack of peer review in the beginning or not strong enough
is happening at other VA Medical Centers? The reason I ask this
is, is the one nearest to me in Minneapolis that also practices
this technique has not had--they are reporting zero medical
events in this.
And I want to be very clear on this, one of the things that
gets highlighted on this is we don't know at private practices
if this is happening because there is no reporting, so I think
that needs to be kept in mind. Because I am wondering across
our entire health care system outside the VA it is hard to make
those comparisons. But inside the VA are there different peer
review standards at different institutions as far as you know?
Dr. Hahn. Congressman Walz, I wouldn't know the answer to
that question at other VA institutions. I can tell you that at
Penn across our own institution our processes were the same for
all the patients that we delivered care to both at the
satellites outside facilities and at Penn, and again, this
provided us with an opportunity to look at our processes
because we do uniformly apply them and to make sure that they
get better constantly.
Mr. Walz. Should this be something in your opinion, Dr.
Hahn, on these things, and it comes up again, it is very
similar to the question on the unsterilized equipment in the
last hearing, should there be stronger standards set across the
VA system, or do you still need to allow the Veterans
Integrated Services Networks (VISNs), do you need flexibility
on this for best practices, or is there a uniform best practice
in this process that could have been set, followed, and that is
it?
Dr. Hahn. Well I think my esteemed colleague Dr. Lee will
speak to some of these issues in the next panel, but I think
that if you look at practice guidelines for brachytherapy, the
consistency and application of those sort of guidelines would
be very helpful, and I think we have learned a lot of this
across medicine. You probably know better than I in terms of
processes that standardization is often a very helpful thing
with respect to ensuring quality.
Mr. Walz. Very good. My last question, and this is to all
of you as again a charge that was made, and I again want to
make sure and I think it has been pointed out, that this is
about improving the process not about finding fault.
But the one thing was there was a comment made by Darrell
Wideman I believe it is, senior health physicist for the
Nuclear Commission that said, ``There was far too much trust
put in contractors, that the VA said we hired the best, we went
to a well-regarded team and we just turned over and capitulated
our responsibility.''
Can you comment on that? I know it is a little bit--I am
going to ask each panel this or try and get that out. Being the
contractors involved in this do you think there was a sense of
that, that it is you guys do it and that is where it sets?
Dr. Hahn. Congressman, I think one of the things, and I
agree with you sort of what we learned about this and we sensed
this--and I don't want to speak for the VA--but we sensed this
as a joint responsibility of oversight, and sometimes when
there is joint responsibility there is lack clarity and
definition, and so I think there is plenty food for thought for
us for all on this. And I really welcome the opportunity to
work with the Philadelphia VA to provide clarity surrounding
that.
Mr. Walz. Well I appreciate your candidness and I yield
back. Thank you, Mr. Chairman.
Mr. Mitchell. Thank you. Mr. Fattah.
Mr. Fattah. Thank you, Mr. Chairman. Let me just try to
clarify one thing before I ask the question. I know that
Senator Specter tried to do this at the last hearing, so I want
to make sure we clarify this on the record. Reverend Flippin
was not your patient; is that correct, Mr. Kao?
Dr. Kao. He was initially seen by another radiation
oncologist.
Mr. Fattah. Right.
Dr. Kao. But then I did the brachytherapy.
Mr. Fattah. Okay. So he was in this program, brachytherapy.
I looked at Google, and it says that one of the normal problems
that comes up for brachytherapy is seeds outside the prostate
in the rectum or in other areas.
My point is that if this is a normal occurrence and this
happens generally, why are there so few reports by the NRC that
this is a medical reportable event? And I am speaking in
generality, across both private and VA, you know, if it is
happening regularly and nobody is reporting it then there seems
to be a more system-wide problem that we may want to attend to
that is well beyond the VA.
Dr. Kao. Yes. As I testified last month at the panel, sir,
that you were on, the definition of a reportable medical event
is evolving, and it is likely that many practitioners are not
aware of it or apply it. The Medical Advisory Committee to the
NRC one Member, Dr. Nag, estimated that applying the current
definition of a reportable medical event there should be 20,000
reported cases, and this definition is, therefore, changing. So
it is still not quite settled what constitutes a reportable
medical event I think for most practitioners.
Mr. Fattah. And how many were reported? If the NRC's
medical advisor felt there should be 20,000, how many were
reported across the country?
Dr. Kao. Sir, I do not know.
Mr. Fattah. Okay, all right. Now the program at a number of
the VA centers, four of them have been closed down, including
Philadelphia. So patients who were being treated, and I think
you said that none of these tumors have re-emerged, where are
they now being treated if they need this service?
Dr. Kao. Our program made the decision early on that after
the brachytherapy the patients could return back to their
doctor that took care of them from where they were located. And
that is one of my regrets is that we should have--we could have
mandated that they come back to Philadelphia for follow up.
In the case of Reverend Flippin, as I testified last month,
I wasn't notified that he had developed problems. I wish I was,
I could have done something about it.
And so that is one of the recommendations that I had
proposed in my written detailed testimony to the Committee that
the VA could institute a system by which any patient that
develops a problem that the original treating physician could
be notified, and perhaps that would have prevented something
like what happened to Reverend Flippin.
Mr. Fattah. Well is it, and let me ask the Chair of the
Department since, Penn has been treating people both in the VA
and outside of the VA, you know, privately, right? Now again,
when you research this on the Web it says that seeds going into
the rectum or you know going outside the prostate is one of the
problems that arises with this type of procedure, right? When
patients have these challenges, is someone notified at the NRC?
Are we reporting this as a medical noteworthy event or where
are we at in this process now? I assume even though the VA
program is shut down, Penn is continuing to provide this
service to the patient.
Dr. Hahn. Once we put our process improvements in place in
the real-time dosimetry program yes, we recently did restart
our prostate brachytherapy program, Congressman.
Mr. Fattah. All right.
Dr. Hahn. And I think Dr. Lee in his written testimony has
written about many of the standards that the NRC, particularly
with respect to dose, that the NRC has in its regulation.
I can't speak per se to the VA and its reporting mechanism
since it is a separate hospital and has a separate regulatory
reporting. I will say in light of that, that the standard that
has been applied to these cases is one that is in our belief
complex and controversial, and is not----
Mr. Fattah. Is that because the 90D fluctuates up to 60
percent either way? So you are saying 90 percent of the dose
should have been inside the prostate and it could fluctuate by
a wide variance?
Dr. Hahn. There can be some variation, yes, Congressman.
And that standard or that criteria that has been recently
applied isn't universally accepted by all the experts in the
field.
I think this goes back to the original comment that I had
made, Congressman, about the fact that we would all very much
welcome further clarification with respect to that. And the
other part is that sort of distinction between a medical
reportable event and clinical significance and outcome.
Mr. Fattah. Right. Well, the main thing about prostate
cancer is you don't want to get it, but if you want to get it
you want to get treated, and we have a great difficulty getting
men to get treated, to get checked out. So I want to make sure
that we are careful here as we proceed when we have a treatment
that--in this instance tumors didn't reemerge, and yes there
was some discomfort. I read on Google that discomfort in the
rectum or seeds in the rectum it is a very common occurrence in
this procedure, right? So I want to make sure that we are not
sending the wrong message to men in that we create a situation
where they don't proceed with getting effective treatment that
could save their lives.
Dr. Hahn. Congressman, I think that is a really important
point, and sir, I would like to sort of emphasize the fact that
radiation therapy, despite the issues here, is a highly
effective therapy for prostate cancer, and in the appropriate
patients that is indeed the case.
Mr. Mitchell. Thank you. I would hope that since University
of Pennsylvania is a teaching hospital and research that what
you have learned from this gets put into the appropriate
journals, gets distributed to every urologist and everyone. I
would think this would be a great source of information for
other people doing the same thing.
If the panel would indulge me I would like to call on Dr.
Roe, he had a couple more questions.
Mr. Roe. Just a couple things quickly. When you do this
procedure you know, and I may be talking to the physicist, but
we know what adequate dosimetry is, I mean that is a
calculation, if you go below that level you know that you
haven't received what we would consider adequate. That is
fairly well determined, correct?
Mr. Bieda. It is determined to the extent that the prostate
can be defined on the imaging modality, in the case, CT. So it
is well defined mathematically and algorithmatically, but there
is some subjectivity because of the ability to clearly image
the prostate, particularly in post-implant dosimetry.
Mr. Roe. I know there is an art to it too, I certainly
understand that.
Mr. Bieda. Yeah.
Mr. Roe. When you would see a pattern like this though, I
was looking at these images last night, this being the prostate
gland, these little green things here are the seeds, when you
look at that the next day when you do the CT, some do it a
month later, I think Duke does it a month later and looks at
the dosimetry, I mean that would be a cause of concern when you
would have a pattern that looked like that wouldn't it?
Mr. Bieda. Yes, that would be a cause of concern, but what
you have to understand is what you are visualizing there is a
3-D rendering, that red object is the physician's, I would
almost say best guess, at the contour of the prostate. You
know, it is a dramatic diagram for sure, but it doesn't
necessarily tell the whole story just because of the
subjectivity of imaging the prostate.
Mr. Roe. I mean, you would be like me----
Mr. Bieda. Yeah.
Mr. Roe [continuing]. You would be a whole lot happier if
it looked like that.
Mr. Bieda. Yes.
Mr. Roe. I mean, I know I would be if that were my prostate
and you had put seeds in it or radioactive iodine or palladium
or whatever you used, I would be happier with that one.
Mr. Bieda. I would.
Mr. Roe. I guess the other question I had was why was it--
Dr. Kao's issue is that what was the problem with getting the
dosimetry results back? And I guess I have confusion with that.
Why was that so hard?
Mr. Bieda. That was so hard simply because there was a
roadblock in terms of an information technology (IT) issue at
the--you know--at the VA. And to get these images into our
system to do that full analysis was deemed to be nearly, you
know, pretty much impossible, and we knew that the physician
was reviewing the CTs, they just weren't able to get it into
the system where the full analysis could be done.
Mr. Roe. I would think that would be a system breakdown, I
believe, and I think Dr. Kao is right about that, to be able to
get that information.
I know Congressman Walz is gone, but where we are at our
university and in our tumor registry, we register every tumor
patient and they are followed so you will know. I don't know
what kind of follow up we had on these veterans or not, but in
most places there is a tumor registry, there is a follow up,
there is a follow up form. Has that been done for the veterans
that have received this treatment? Dr. Hahn or Kao or whoever
can answer that.
Dr. Kao. I don't know the answer, sir.
Mr. Roe. Not to interrupt, my time is about out, but that
is critical, because you don't know what you are doing if you
don't know what your patients are doing, so we register all
ours on a tumor registry and follow those folks, have a method
to do that. Congressman Fattah was right on the money, are
these folks--how are they doing, what is the outcomes? And you
can't say they are doing all right if you don't follow them, so
that is a system break down.
And I think that just to follow up, brachytherapy is an
effective treatment for prostate cancer. My friend that I work
with a lot said he had patients that could go out and golf in 2
or 3 days after this so men won't be afraid to get that
therapy. It is a good effective therapy when done
appropriately.
Thank you, Mr. Chairman, I yield back.
Mr. Mitchell. Thank you. Does anyone else want to follow up
before we go to the next panel?
Mr. Adler. Maybe just one. I heard the colloquy between Dr.
Kao and Congressman Fattah about sort of the art of
brachytherapy that maybe not all the radiation seeds get to the
prostate, that some of them may drift out to other parts around
the prostate. What percentage of the seeds should end up in the
prostate? If you have 100 percent of the seeds going in what is
the percentage that should be ending up in the prostate for the
art to be effective science? Because I guess what I am hearing
is maybe a third sometimes drift around, half of them may get
here or there. I would think that most of them should be ending
up in the prostate if in fact the tumor you are addressing is
in the prostate.
Dr. Kao. That is correct. Most of the seeds should be in
the prostate. However there are situations where it may be
advantageous to have seeds actually outside the prostate. The
prostate is a pear-shaped gland with a pointy end pointing
down. If you have a cancer that is located in this apex of the
prostate the seeds in the prostate alone may not be sufficient,
so in that case you may intentionally want to place some seeds
outside the prostate, which can then contribute radiation to
treat that special location. So it depends on the location of
the cancer and the extent.
We are very careful to restrict brachytherapy to patients
that only had a very early stage non-aggressive form of
prostate cancer, sir.
Mr. Adler. Thank you, I yield back.
Mr. Mitchell. Mr. Fattah, do you have any other questions
of this panel?
Mr. Fattah. No, let me just thank the panel for their
lifetime of study of this issue of cancer, it is a major
challenge to our health in our country today, and prostate
cancer is something that for veterans is a major issue, and in
the African American community, particularly among African
American males prostate cancer is a tremendously devastating
disease. So I want to thank them for their studies and their
work, and I think that as we go forward we want to see that we
can make this an even more perfect process at the VA and
outside the VA. Thank you.
Mr. Mitchell. Thank you. And I would like to excuse the
panel and thank you for your service and thank you as Mr.
Fattah said for the research that you are doing.
At this time I would like to welcome Panel Two to the
witness table. From our second panel we will hear from Dr.
Robert Lee, Professor in the Department of Radiation Oncology
at Duke University testifying on behalf of the American Society
for Radiation Oncology (ASTRO); Dr. Paul Schyve, Senior Vice
President for Health Care Improvement at The Joint Commission;
and Steven Reynolds, Director of Division of Nuclear Materials
Safety Region III, U.S. Nuclear Regulatory Commission. Mr.
Reynolds is accompanied by Dr. Charles Miller, Director of the
Office of Federal and State Materials and Environmental
Management Programs, U.S. Nuclear Regulatory Commission.
Dr. Lee, before you begin your testimony I believe there
are some slides that we are going to view and I would like for
you to comment on the slides you find acceptable and the slides
that are unacceptable in your professional medication.
Before I begin I just want to say to Dr. Lee, Dr. Schyve
and Mr. Reynolds, you have up to 5 minutes for your testimony
and all of what you would like to say will be entered in the
record. Dr. Lee.
Dr. Lee. So a quick question, my comments on the slides and
images----
Mr. Mitchell. Will not be part of your other testimony.
Dr. Lee. Thank you.
Mr. Mitchell. Yeah.
Dr. Lee. You want me to comment on the image in front of
me?
Mr. Mitchell. We don't have any.
Dr. Lee. I think I see it but no one else does.
Mr. Mitchell. Okay, we have just an IT problem, maybe we
will move onto the next witnesses and come back to it. Okay.
Dr. Schyve.
STATEMENTS OF PAUL M. SCHYVE, M.D., SENIOR VICE PRESIDENT, THE
JOINT COMMISSION; STEVEN A. REYNOLDS, DIRECTOR, DIVISION OF
NUCLEAR MATERIALS SAFETY REGION III, UNITED STATES NUCLEAR
REGULATORY COMMISSION; ACCOMPANIED BY CHARLES L. MILLER, PH.D.,
DIRECTOR, OFFICE OF FEDERAL AND STATE MATERIALS AND
ENVIRONMENTAL MANAGEMENT PROGRAMS, UNITED STATES NUCLEAR
REGULATORY COMMISSION; AND W. ROBERT LEE, M.D., M.S., M.ED.,
PROFESSOR, DEPARTMENT OF RADIATION ONCOLOGY, DUKE UNIVERSITY,
SCHOOL OF MEDICINE, DURHAM, NC, ON BEHALF OF THE AMERICAN
SOCIETY FOR RADIATION ONCOLOGY
STATEMENT OF PAUL M. SCHYVE, M.D.
Dr. Schyve. On behalf of The Joint Commission, thank you
for the opportunity to testify at this important hearing. The
Joint Commission's accreditation of Department of Veterans
Affairs' hospitals strives to assure that our Nation's veterans
are receiving high quality and safe care. The accreditation
process reduces risks to patients through periodic unannounced
on-site surveys of each hospital and feedback to the hospital
of required improvements. However, no oversight process can
entirely eliminate risk in health care, which has all the
characteristics identified in other high risk endeavors,
including complexity and heavy dependence on human
intervention. By studying high risk endeavors that have
developed enviable safety records, health care is learning how
to become a high reliability endeavor.
The first step is the development of evidence-based
standardized policies and procedures, educating personnel in
their implementation, making them available as memory aids to
facilitate their use, and monitoring whether they are followed.
However, in health care unexpected adverse events will still
occur despite the best policies and procedures.
To create high reliability requires three additional
components. First, constant attention to things that go wrong
in order to learn how to prevent them. But people will only
report adverse events in an atmosphere of trust in which they
are encouraged to report and their reports are acted upon.
Second, prospective risk identification and prevention
whenever new processes are planned or existing processes
changed. Patients can be protected from harm by redesigning the
proposed processes to eliminate the risk or building in
protections for patients when the risk cannot be eliminated.
And third, a culture of safety. In a ``culture of safety,''
safety is always on everyone's mind. There is preoccupation
with the possibility of failure, a sensitivity to the detail of
operations, and constant vigilance for unexpected events.
Because, in complex processes such as those in health care,
even small events can led to big, sometimes disastrous
outcomes.
Unfortunately, no oversight body can identify all the risks
or breakdowns in a hospital, nor create the cultures of trust
and safety needed for high reliability. Only the hospital
itself can. The oversight bodies can set expectations, provide
guidance, educate, and evaluate in order to enable and
incentivize the hospital to make this change.
To that end, The Joint Commission has established standards
that require the hospital to create a culture in which adverse
events are reported and evaluated for underlying causes and
preventative actions are taken; to identify high-risk processes
and prospectively determine their possible modes of failure,
the effects of those failures, and the actions that will
prevent the failures or mitigate their effects; and to
establish a culture of safety throughout the hospital. This
last accreditation requirement became effective January 1st,
2009.
With respect to brachytherapy, when the Joint Commission
surveys a hospital the surveyors examine the radiology imaging
services and, if the hospital provides it, its oncology
service. However, a hospital may provide a brachytherapy
service that, because it is usually a low volume, specialized
service within the radiation oncology or other department, may
not be reported to the surveyor and therefore may be unknown to
the surveyor.
In addition, brachytherapy is highly specialized and
technical, utilizing the expertise of urologists, radiation
oncologists, and radiation physicists. Even when its presence
is known, it is not possible for the surveyor to have the
specialized technical knowledge to review the effectiveness of
the dosing schedule for a patient.
Based on this case, the Joint Commission will instruct its
surveyors to specifically ask if brachytherapy is provided,
and, if so, to examine whether the hospital is providing the
monitoring and peer review oversight that brachytherapy
requires. And beginning this year, the surveyors are evaluating
what the hospital's leaders are doing to create a culture of
safety in their hospital.
The Veterans Health Administration (VHA) central office has
been a leader in learning from adverse events in its hospitals,
in disseminating that knowledge to other hospitals in its
system, and in openly discussing with the Joint Commission the
events and what they have learned. They have also focused on
creating a culture of safety in their hospitals.
The Joint Commission's goal is to assist both the Veterans
Health Administration and its individual hospitals to make this
transition. Only by transforming our Nation's hospitals into
high reliability organizations will health care fulfill its
obligation to all our Nation's citizens, including its
veterans, to ``first do no harm.''
On behalf of The Joint Commission, I would like to thank
you again for this opportunity to testify.
[The prepared statement of Dr. Schyve appears on p. 53.]
Mr. Mitchell. Thank you. Mr. Reynolds.
STATEMENT OF STEVEN A. REYNOLDS
Mr. Reynolds. Chairman Mitchell, Ranking Member Roe,
Members of the Subcommittee and Congressman Fattah, I am
honored to represent the U.S. Nuclear Regulatory Commission
staff at today's hearing.
The NRC is very concerned about what happened at the VA
hospital in Philadelphia.
Our mission as the regulator for the civilian use of
nuclear material is to protect public health and safety,
including medical uses of radioactive material. We take our
mission very seriously and strive to make sure all patients,
including our veterans, receive safe and effective medical
care. We recognize that is not what happened at VA
Philadelphia.
The NRC does not regulate the practice of medicine. We do,
however, set the rules under which licensees such as the VA use
radioactive material. As the holder of an NRC license, it is
the responsibility of the VA to identify problems in medical
treatments using radioactive material and report those problems
to the NRC.
The NRC, once notified of the apparent problems at VA
Philadelphia, began increasingly intensive inspections of the
brachytherapy program at VA Philadelphia and the 12 other VA
facilities that conduct this medical procedure. We are
concerned about what we have found to date.
The VA has suspended this procedure at five sites, includes
VA Philadelphia, and they will not restart until we, the NRC,
are satisfied they have addressed the problems. Our inspections
are continuing, and once we complete our inspections later this
summer, the agency will determine what, if any, enforcement
actions are appropriate.
As a regulatory agency we are accountable for ensuring the
safe use of radioactive material in medical treatments; we have
an obligation to aggressively oversee radioactive material use
and make sure patients are properly treated. The VA's license
issued by the NRC requires the VA to establish an internal,
independent framework of oversight consistent with NRC
regulations, and with inspection and enforcement policies,
procedures, and guidance. The NRC relies on the integrity of
this framework. Based on what we have identified to date, we,
the NRC, are making changes. Had these changes been in effect
in the past, we are confident that these issues would have been
identified and resolved earlier.
We have already initiated steps to enhance our oversight.
These include an increased focus on safety culture at medical
facilities, an increased focus on medical facilities oversight
of contracted medical professionals, increased focus on
ensuring that involved medical professionals and radiation
safety staff understand the definition of a medical event and
reportable requirements, an increased focus on extent of
condition reviews, and increased focus on post-treatment dose
verification. The NRC is also increasing our oversight of, and
reducing our reliance on, the VA's National Health Physics
Program.
Going forward, we will continue to look critically at
improving our inspection and licensing programs, as well as to
consider proposed regulatory changes. The NRC is also assessing
whether any additional changes are needed to strengthen our
regulatory oversight of the VA with respect to the VA's
internal regulatory framework.
In closing, the NRC takes these medical events very
seriously. We will do what it takes to ensure the use of
radioactive material in medical treatments is as safe as
possible. Thank you and I would be pleased to answer any
questions.
[The prepared statement of Mr. Reynolds appears on p. 55.]
Mr. Mitchell. Thank you. Dr. Lee, I think we are ready.
STATEMENT OF W. ROBERT LEE, M.D., M.S., M.ED.
Dr. Lee. I would first like to thank the Committee for the
opportunity to testify.
I want to begin by pointing out that images are frequently
deceptive, and I am going to hypothesize that--I am using the
cursor here--that the green is the bladder, the red is the
prostate, and the blue is the rectum. Recognize that there is a
certain amount of disagreement among experts about what the red
may look like, therefore any dosimetric quantifiers that are
related to this volume may be different according to different
reviewers.
Now to Dr. Roe's point, would I rather have my seeds in my
prostate here than down here? Absolutely. And I think one can
look at that image, and if one assumes that the contours are
done correctly, one can conclude that the seeds are in the
prostate, but it does not follow necessarily that this is a
good implant. It could be that there are too many seeds of too
high activity, in which case there is an overdose, it could be
that there are too few seeds of lower activity, hence too low
of a dose.
So I want to emphasize to the panel that images can be
deceptive, and frequently you need more information.
Additional information I would like to know is when was
this image obtained? If it is obtained 2 hours after the
implant then my standards for what is an acceptable implant are
different than if it is done 30 days after an implant, and we
really have no idea what the implications are of CT scans done
a year or two after implants.
I assume you have another image of--anything further there?
I can't advance the images. Okay. I am going to take this
opportunity to use this image as an example as was pointed out
by Congressman Fattah.
Frequently the radiation oncologist calls for and intends
to place seeds outside of the prostate. There are many
different techniques that are used. Some people like to keep
the seeds inside, some people like to put a lot of extra
prostatic seeds to lower the dose centrally. That is sort of
the stylistic technique. And these seeds, which may be
technically outside of the prostate, are in fact having a
purpose in that it is physically not possible to bring your
dose out far enough, especially at the edge of the prostate,
unless you put seeds at the edge of or in fact outside of the
prostate.
Posteriorly, which is where most of the toxicity is, you
need to be much more careful. And so a seed outside of the
prostate here I am less concerned about than a seed outside of
the prostate or multiple seeds out of the prostate posteriorly.
Want me to scroll through? Okay. Given the uncertainty
about when this was obtained relative to the prostate implant
and the uncertainty with which the volumes are created this
doesn't look good. There are no two ways about it. And if I saw
this in one of my cases then this is a medical event. The
question then becomes what do you do? Can you fix it? Do you
put in more seeds up here? Do you add external beam? And that
is where I don't think we have any confidence.
Shall I proceed with testimony? Thank you.
Chairman Mitchell, Ranking Member Roe, and Members of this
distinguished Subcommittee, good morning and thank you for the
opportunity to testify today on the use of brachytherapy to
treat prostate cancer. I have personally witnessed the benefits
of brachytherapy, and look forward to telling you about this
treatment, focusing on its safety and its effectiveness.
I am currently Professor of Radiation Oncology at Duke
University School of Medicine and have performed prostate
brachytherapy since 1997. I evaluate over 300 new prostate
cancer patients each year. I have authored 100 or more original
articles and reviews on reproductive and urinary system cancer,
and I am considered an expert in the field of prostate cancer.
I believe my testimony is critical to help Congress and the
public understand that brachytherapy is a safe and effective
procedure.
On a more personal level, I am the son of a retired air
force navigator who presently depends on the VA system for his
health care.
While I am not personally involved in the investigation
into the Philadelphia VA, based on the information that is
publicly available, I agree that there is cause for concern.
ASTRO, whom I represent, is deeply troubled by the problems
identified, but we are heartened that the NRC has found no
evidence of widespread medical events involving brachytherapy.
In fact, there are approximately 50,000 brachytherapy
treatments performed in the U.S., and according to the most
recent advisory Committee, only about 0.22 percentage of the
procedures nationwide resulted in a medical event. Clearly
brachytherapy is a very safe procedure.
My hope is that patients, including our Nation's veterans,
will recognize that the situation at the Philadelphia VA is an
isolated incident, it should not dissuade patients from
choosing brachytherapy if appropriate as a treatment for their
cancer. At the same time, ASTRO is committed to working with
Federal regulators to learn all of the facts from these serious
events and use this information to ensure that this episode is
not repeated.
Radiation therapy is the use of radiation to safely and
effectively treat cancer and other diseases. Patients receive
radiation therapy externally or internally. During external
beam radiation, a beam of radiation is directed at the tumor
from the outside of the patient. Internal radiation or
brachytherapy, is the placement of radioactive sources into or
next a tumor. For more than 100 years brachytherapy has been an
effective method of delivering radiation to the tumor while
sparing surrounding tissues.
I would be remiss if I didn't take this opportunity to
briefly call your attention to the centers for Medicare and
Medicaid Services' recent proposals to cut Medicare payments
for community radiation oncology by 19 percent. ASTRO urges
Congress to help prevent these draconian cuts that are certain
to limit patient access to these life saving cancer services.
ASTRO is also very concerned that had perverse financial
incentives and rampant self-referral of radiation therapy
services in the Medicare Program is resulting in prostate
cancer patients not being fully informed of the full range of
options, particularly brachytherapy, and we hope that the
appropriate concerns over the brachytherapy program at the
Philadelphia VA will not exacerbate the under use of this very
effective treatment option.
Prostate brachytherapy is a safe, effective, minimally
invasive outpatient procedure that is associated with a quick
recovery and return to normal activity and work. The benefits
of prostate brachytherapy include equivalent cure rates with a
lower incidence of impotence and incontinence than other
treatments.
Prostate brachytherapy is performed by inserting small
metal seeds of radioactive iodine and palladium directly into
the prostate gland and the periprostatic tissue.
My written testimony includes clinical practice guidelines
that have been published in the peer reviewed literature for at
least a decade, and in particular, I want to highlight the
importance of performing post-implant dosimetric assessment of
some type of. Post-implant dosimetric assessment documents the
actual dose that the prostate has received and the nearby
normal tissues to identify any over dosage or under dosage.
As you know, the NRC has jurisdiction over the use of
radioactive materials, including medical isotopes and safety
measures to protect the public and patients. Almost all
radiation oncologists meet NRC's requirement by completing 4
years of training within a residency program accredited by the
Accreditation Council for Graduate Medical Education. Such
training requires 700 years of work and study, including
radiation physics, radiation biology, as well as safe handling,
and use of radioactive materials. This is in addition to the
extensive clinical training in oncology. Duke Medical Center
has considerable safety protocols and procedures for prostate
brachytherapy, the details of which can be found in my written
testimony.
Finally, I would like to illustrate the benefits of
brachytherapy by telling you about the story of one of my
patients. He is a university professor and an ardent long-
distance runner. I met him 8 years ago. He had early stage
prostate cancer, and after discussion of all treatments, he
chose brachytherapy. He told me he chose brachytherapy so he
could continue to teach his students, coach his daughter's
soccer team, and train for an upcoming marathon. He was treated
with brachytherapy in the spring and later that year he ran in
the Marine Corps marathon. Seven years after his treatment, his
PSA is undetectable and he is very likely cured. He has run in
a marathon every year since his treatment.
ASTRO shares the Committee's concerns about the health and
safety of veterans and recognizes the importance of maintaining
veterans access to high quality cancer treatment. We look
forward to having all of the facts from the VA investigation
made public by making these issues transparent. Necessary steps
can be taken to implement any corrective actions and enhance
quality.
ASTRO is committed to ensures that radiation oncologists
and Members of the treatment team adhere to strict safety
standards and clinical guidelines for all radiation therapy,
including brachytherapy.
Thank you for the opportunity to testify.
[The prepared statement of Dr. Lee appears on p. 58.]
Mr. Mitchell. Thank you very much. I just got a couple
questions here, and this is for Dr. Lee.
In your opinion, the situation in Philadelphia at the
Medical Center there, is it an isolated event, or does the VA
have a much larger problem? And I want to extend that, I don't
want to just pick on the VA, because I have a feeling since
what happened in Philadelphia was done with a contract with the
University of Pennsylvania, that if this same procedure would
have happened at the University of Pennsylvania hospital the
same results would have occurred, it wouldn't have occurred
just because it is in the VA hospital. I don't know if that is
right or not. But is there a problem period, maybe in the VA
system or in the system throughout this country with this--with
the follow up and the therapy that was given which brought this
to light to begin with?
Dr. Lee. So I am speaking as an informed sort of
professional here. Based on what I know publicly the NRC has
been very proactive and is presenting a very high bar for the
VAs to meet. In fact, perhaps some of the best and most
important work in this field of prostate brachytherapy comes
from the VA in Seattle. So that there is precedent and
documented evidence that this can be done well within the VA
system. I don't think it has anything to do with the VA.
Mr. Mitchell. Well what about what happened in Philadelphia
happening in private hospitals or happening other places?
Dr. Lee. So the concern that this is a more widespread
phenomenon?
Mr. Mitchell. Right.
Dr. Lee. I would say the NRC data suggests that that is not
true, and there are two additional pieces of information that
make me feel confident that good high quality brachytherapy is
being done across the country.
One piece of information relates to something called the
``Radiation Therapy Oncology Group,'' which is an National
Cancer Institute (NCI) supported oncology cooperative group in
which institutions across North America treat patients
according to protocols, and they had two, and have a third
ongoing study at a deals specifically with prostate
brachytherapy in which all of the information, including the
post-implant CT scans, are sent centrally and reviewed by a
reviewer. And I was the principal investigator of one of those
reports, and based on my assessment of those institutions, good
quality brachytherapy is available across the country.
The second piece of information that I use to feel good
that good brachytherapy is accomplished across the country is
we do have some large Medicare claims-based data looking at
prostate brachytherapy and looking for significant severe
complications. And we have several publications in the
literature that demonstrate that from 1991 all the way up to
about 2000 that the complication rate associated with this
procedure across the country in Medicare beneficiaries is very
low, which is another piece of information that makes me feel
confident that it is being done well.
Mr. Mitchell. You mentioned one of your patients as a
marathon runner and so on. When a person comes to you, you said
you do about 300 or over 300--you see 300 prostate patients a
year?
Dr. Lee. I don't do 300 prostate brachytherapy, I see 300
new prostate cancer patients.
Mr. Mitchell. Right.
Dr. Lee. Yeah.
Mr. Mitchell. Does a person come to you after they have
seen a urologist, or do they just come to you straight saying I
want to look at brachytherapy? When does a patient get the pros
and cons of all the treatments?
Dr. Lee. So typically most of the patients I see have been
biopsied by a urologist, and then frequently will ask for a
quote, ``second opinion.''
So at Duke where I work and like many other places we have
something called a ``multi-disciplinary clinic'' in which
patients with newly diagnosed prostate cancer come in, they see
me as a radiation oncologist, they see a urologist, and they
see a medical oncologist simultaneously in which the pros and
cons of each treatment are discussed. And the vast majority of
the time the treatment decision comes down to patients, and
that it is very clear to pick a winner amongst the many
treatments out there, and frequently the patient will decide
based on his or his family's own concern.
So in the best of all worlds all prostate cancer patients
would be seen by a urologist and a radiation oncologist. I
don't know how frequently that happens. At Duke it happens a
lot, which is good.
Mr. Mitchell. Are you aware when the brachytherapy is done,
are there urologists in the room at the time?
Dr. Lee. So this is a procedure that I continue to be
amazed can be done in a number of different ways, and you still
seem to come up with reasonably good results.
So in my practice from the very beginning I have involved a
urologist and we do it together. We train each other such that
I can do it by myself and he can do it by himself, but we are
there together, and I think it is sometimes better to have two
heads. He brings his urologic or she brings her urologic
expertise, I bring my understanding of three dimensional
anatomy in physics, and together I think you get a better
product.
That said, there are multiple examples of radiation
oncologists doing it themselves. Okay? And I have seen cases
where urologists essentially do everything, and the radiation
oncologist stands in the corner. Urologists can't do this
because by themselves they need an authorized user, but it can
be done any number of different ways.
At Duke I do it with a urologist that has been doing it for
10 years or 15 years, as much as I have, and he does a needle,
I do a needle, he does a needle, I do a needle.
Mr. Mitchell. Thank you.
Dr. Lee. You are welcome.
Mr. Mitchell. Dr. Roe.
Mr. Roe. Dr. Lee, thank you, I am going to say hello to a
mutual friend of ours, Dr. David Alballa. I spoke to him
yesterday and I knew you were coming up here.
So I guess a couple of things, and I won't take too long
because we have to go with some votes here in a minute, but at
the VA when they were doing this and they couldn't get the
dosimetry, would that have waved a red flag for you to say wait
a minute, if you can't get the dosimetry why are you continuing
to do these cases?
Dr. Lee. Yes, I think to be fair. And this is where I don't
know the specifics so I don't want to be too critical. But from
the very beginning of my practice, and I have been preaching
this from the very beginning, is that post-implant dosimetric
assessment is part of the treatment. It is a perfect example of
how you can use safety measures. It is a feedback loop. You put
the seeds in and then a period of time later you see well how
well did we do? And if you are consistently low or consistently
high or something like that then you can tweak your practice.
So if I were in that situation then I would either stop the
program or I would come up with a work around, where if they
could get the images it is possible to do it by hand--do it the
old fashion way and circle the prostate. It is a little bit
more tedious and it takes more time and it is not as easy to
bring the data into the treatment planning system digitally,
but it is so vital that if it were me and someone told me
tomorrow we can't do post-implant dosimetry for whatever
reason, then I would say the program is shut down.
Mr. Roe. And we should be able to, I know that I have
worked with Duke and had patients treated there over the years,
there is a tumor registry that we follow these patients and you
know--and I will bet the VA does this. I know there is not
anyone up there and you can't answer this, but I would almost
bet that they do have a tumor registry and follow them and be
able to tell what the outcomes are.
The other thing I guess, and I would like to know, is what
is a definition of a medical event? And it seems to be a moving
target.
Dr. Lee. Right.
Mr. Roe. And could you elaborate a little bit on that?
Dr. Lee. So I can tell you what a medical event is at Duke.
Medical event is wrong patient, wrong organ, wrong isotope,
wrong dose in this context. So if you are supposed to put in
iodine and you put in palladium, medical event. If you put Mr.
Jones' seeds in Mr. Miller's prostate, medical event.
Mr. Roe. Pretty common sense stuff. But is that
standardized across the country? Because what happened with
this I think when we saw this 112 or 114 patients and there
were 92 medical events, I started asking myself what is a
medical event?
Dr. Lee. Uh-huh.
Mr. Roe. And is the definition the same at Duke as it is at
the VA in Philadelphia, and maybe the NRC, Mr. Reynolds can
answer that.
Dr. Lee. This is where the NRC I think should comment. In
2002, this misadministration changed to a medical event. So a
little bit of it is semantics. Okay? But the wrong patient,
wrong isotope, wrong organ, wrong dose have been there for at
least ever since I have been in the business.
I think it is fair to say though that there has been some
inhomogeneity in how in particular the dose question has been
asked. From what I have seen of the VA rules, they for the
first time have incorporated this specific dosimetric
quantifier D90, which does not appear in any of the NRC's
statutes. Okay? And I think that is one possible explanation.
That said, I think anyone if they see this that is a medical
event.
Mr. Roe. What would be the wrong dose at Duke University?
How would you define wrong dose?
Dr. Lee. So for a medical event if I were using--this is
the problem, is there is some inconsistency. Do you use D90 or
do you do D100? Okay. I fortunately haven't had any medical
events. And if I were pressed to say what is your medical event
for dose it would be--I would actually go lower, I would say
D80 of 80 percent, so I wouldn't put it as high. And the reason
I do that is because I am concerned if you put the bar too high
then community practitioners that attempt to get over that bar
will end up putting in too much activity and increase toxicity.
Mr. Roe. But if you weren't doing the dosimetry you
wouldn't know you had a medical event.
Dr. Lee. Correct, absolutely.
Mr. Roe. Which is what was happening.
Dr. Lee. Right.
Mr. Roe. So you wouldn't even know. And I think that is
critical to know that so you can change. I mean, not anybody in
this room has not wanted to do the job right. There is no
question in my mind about that. The problem is you don't know
you are doing it right if you don't get the right data.
So Mr. Reynolds, do you have any comment on that?
Mr. Reynolds. I was just going to read to you what our
regulations say a medical event is.
Mr. Roe. Okay, thank you.
Mr. Reynolds. I will read two versions. One is the one that
was published January 1st, 2009. ``The total dose delivered
differs from the prescribed dose by 20 percent or more.''
Mr. Roe. Okay.
Mr. Reynolds. It also talks about the other things that Dr.
Lee talked about.
Now I will read from the January 1st, 2001, version of
Title 10 Code of Federal Regulation, Part 35. ``When the
calculated administered dose differs from the prescribed dose
by more than 20 percent of the prescribed dose.'' Twenty
percent.
Mr. Roe. Twenty percent, so it is pretty well defined. And
to let folks know that these seeds when they go in, I want to
make it clear, they have a half-life between 17 and 60 days, so
that radiation is not there forever.
Dr. Lee. If I can just comment. Twenty percent sounds like
a well it is 20 percent or not? The problem that I see is that
frequently that dose in the brachytherapy world has been
translated to mean activity, and so that if you order 100 seeds
of.4 millicuries and you have 40 millicuries, if you put in 20
percent more than that or 20 percent less than that then that
is a medical event. I am not saying that is right, I am not
saying that is wise, what I am saying is that in my
conversations with many people across the country that that is
their interpretation of the NRC statute.
Mr. Roe. Thank you, Mr. Chairman.
Mr. Mitchell. Thank you. Mr. Adler.
Mr. Adler. Thank you, Mr. Chairman.
Dr. Schyve, as I heard your testimony and read your written
testimony my sense was you were explaining how the Joint
Commission accredited the Philadelphia VA just 2 days after the
prostate cancer program--the brachytherapy program was shut
down in Philadelphia. My sense was you were saying it is such a
small program, such a low volume program, 20, 30, 40 patients a
year, that it sort of flew under the radar of the surveyor,
wasn't reported by Philadelphia to the surveyor, so Joint
Commission sort of couldn't find it unless it knew to ask for
that particular program. Is that really the essence of your
testimony?
Dr. Schyve. That is basically correct. The surveyor is
looking throughout the organization at all kinds of things,
always visits the imaging service and always asks if there is
radiation oncology, and if so looks at that. But if, as it may
be common, the radiation oncology department doesn't say, ``Oh,
and we are also doing brachytherapy over here,'' the surveyor
may be unaware that brachytherapy is there. And so consequently
doesn't look at whether or not there is adequate peer review
and so on for brachytherapy, as the surveyor does for radiation
oncology in general.
Mr. Adler. I would respectfully suggest to you that maybe
the Joint Commission should pay particular attention to those
programs that are more likely to fly under the radar because of
the low volume, because those are the programs that probably
don't have quality assurance, don't have peer review, don't
because of the low volume have the proficiency that comes with
doing a program over and over and over again. You get better as
you do it more.
Dr. Schyve. Yes.
Mr. Adler. I am hoping one of your take aways for the Joint
Commission is to ask those questions. Not about brachytherapy,
I think we are now a little bit more cognizant of that program
which is going well in most parts of the country, wasn't going
so well in Philadelphia, but there might be 3 or 33 other
programs like that in the world that we have to ask about so we
don't accredit too quickly. Is that a fair take away for you?
Dr. Schyve. Yes. As I indicated in my testimony we will
clearly be asking about brachytherapy, but we have had exactly
the same thought that that you just described. In fact, we may
make that part of the application form that organizations
complete before the survey--to tell us and check off that they
do we have this service, do have this service and so on. So we
would know before the surveyor goes in.
Mr. Adler. I would really respectfully urge you to do that
so that Congress doesn't mandate you to do that, because I
think our big concern here is that we don't have failures in
other programs somewhere else in the country. We have
identified an isolated situation, one small program in
Philadelphia which is unique, in Philadelphia it is otherwise a
very good history of providing very high medical care as
Congressman Fattah said. We want to make sure it doesn't happen
in some other similar small volume program elsewhere, whether
it is Philadelphia or elsewhere in the country geographically.
Dr. Lee, let me come back to you. You mentioned the
situation in Philadelphia that it was an isolated incident.
Would you overall agree that it didn't go that well?
Dr. Lee. Absolutely.
Mr. Adler. Okay. Because I guess I kept hearing from Dr.
Kao in Philadelphia when we spoke with him in a hearing there
and then again today that it was adequate medical care. My
sense was the program wasn't good enough, and I think everyone
else acknowledges it, UPenn, VA Philadelphia, VA nationally,
NHPP, NRC. You would concur that it wasn't really the best
level program.
Dr. Lee. Yes.
Mr. Adler. Okay. I just wanted to sort of establish that so
there is no confusion factually other than from Dr. Kao's own
testimony.
Mr. Reynolds, are you satisfied now that you and the VA are
sort of on a common track toward having a definition of medical
event that is in the patient's best interest?
Mr. Reynolds. Yes, sir.
Mr. Adler. Do we already have it, or we are on the way
toward getting it? I guess that is part of my confusion.
Because I heard from our previous conversations in
Philadelphia, my sense was NRC sort of thought it was the VA's
fault that they didn't report well enough and so the program
didn't come to light as a problem until the fall of 2008, and
that seems to me at least is too late, and maybe your standards
have to be different to make them report more clearly so that
we catch it sooner.
Mr. Reynolds. Well we always look at how we can enhance our
regulations and make them clearer. What I read to you seems
fairly clear to me. But as I said in my opening statement, we
are making changes, trying to get better, and we are looking
for the VA to make changes to get better.
Mr. Adler. I thank you, sir. Dr. Miller.
Dr. Miller. Congressman Adler if I can amplify that.
Mr. Adler. You have to amplify with the button on.
Dr. Miller. There we go. My office is responsible for
setting the programmatic standards for the NRC, and we consider
ourselves a learning organization. We would like to take what
we have learned from VA, what we have heard here today, and
information we get from the medical community to always try to
make sure that our standards and the guidance that goes along
with those standards are clear. Where we find that it hasn't
been clear or if we find that people are having trouble
interpreting it, we strive to make it clear so that it does set
a standard across the industry, and we will continue to strive
to do so.
Mr. Adler. Thank you, doctor.
Mr. Mitchell. Mr. Adler, votes have just been called so
very quickly if you don't mind I would like to see if Mr.
Fattah has any quick questions of this panel.
Mr. Fattah. Yes, I do, and thank you, Mr. Chairman.
So Dr. Lee, first of all, thank you for your work that you
are doing at Duke and with ASTRO.
There were 50,000 of procedures last year, and based on
your testimony there were 111 medical events in which 102 of
them were related to the VA. So that in all of the other
private hospitals, private facilities where this is done there
were literally almost none. When you play golf, you self-report
when you do something wrong, right? And what is amazing to me
is that basically if you close down the program at
Philadelphia, right, nobody else has made a mistake anywhere in
the country in 50,000 different surgeries. Does that seem
plausible?
Dr. Lee. Well I think there is an event rate, it is very
small. Let me state emphatically that I completely disagree
with Dr. Nag's statement about 20,000 medical events out of
50,000 implants.
Mr. Fattah. He is the medical advisor to the NRC.
Dr. Lee. I know Dr. Nag very well. I have no idea where he
comes up with that number.
Mr. Fattah. Okay.
Dr. Lee. I base my statements on the NRC data, my own
individual experience with looking at many post-implant CTs
from institutions all across the country within the context of
an NCI supported cancer oncology group, and it strikes me
that----
Mr. Fattah. Let us assume that the VA got out of this
business, there would be no medical events in this surgery
anywhere in the country this year given if you pushed these
statistics forward, right? This notion of self-reporting
challenges people at times in all different professions, with
the exception of surgeons who perform this surgery.
Dr. Lee. I am not sure I understand your question.
Mr. Fattah. What I am saying is how reliable should the NRC
or anyone else be that since there were almost no reportable
medical events outside the VA at these four institutions that
were cited, should we just assume that there aren't any other
instances or that people are not reporting them? Which side of
this should we come down on given your expertise?
Dr. Lee. You know, I guess I find no objective data to
suggest that it is as widespread as you seem to intimate.
Mr. Fattah. No, I am not trying to intimate, I am going off
your testimony. You said 50,000 surgeries----
Dr. Lee. Fifty thousand, and I am using the NRC data.
Mr. Fattah. There are 111 medical events.
Dr. Lee. And for the last decade----
Mr. Fattah. And 102 of them were from the VA.
Dr. Lee [continuing]. And for the last decade roughly a
handful of prostate brachytherapy have been medical events each
year.
Mr. Fattah. No problem.
Dr. Lee. So I think wrong dose, wrong isotope, wrong
patient, those should be rare events.
Mr. Fattah. Okay. And I just have one last question, Dr.
Lee.
Dr. Lee. And when you look at it in context to wrong site
surgery our number is probably much less. And forgive me for
tooting the radiation oncology's own horn, but from day one in
training programs there is a safety culture. Residents learn
that this is radiation. It is the gift that keeps on giving.
You cannot take it back.
Mr. Fattah. I think it is a very safe procedure from what I
have read.
One last question. Is a medical event, which in this
instance we are talking about low dosage, right?
Dr. Lee. Low dose rate, yes.
Mr. Fattah. Okay. What does that really mean? Is it as
ominous as it sounds or in your view is it something that when
reported--in this instance in Philadelphia this was reported by
the institution, this wasn't discovered by someone else--and
when it is reported what should we take from that in terms of
what it means to the--in terms of this program in Philadelphia?
Dr. Lee. So that is an excellent question. I think the
panel should be careful not to equate medical event with
malpractice, negligence, patient harm, et cetera. A medical
event is a specific definition that the NRC has come up with,
and it does not necessarily mean that the patient is harmed. I
suspect that----
Mr. Fattah. So when Dr. Kao said the same thing, my
colleague who from New Jersey, Congressman Adler was puzzled by
it, and that is why I think it is important to hear you comment
on it.
And I thank the Chairman for his time.
Mr. Mitchell. Thank you very much. And I want to thank you
for appearing here today. We are going to excuse this panel. We
are going take a recess because we have only about 7 minutes
left to vote. We have five votes. And we will come back and
continue this. Thank you very much. Let us plan on a 30 minute
recess.
[Recess.]
Mr. Mitchell. And I would like to welcome Panel Three to
the witness table. Joining us on the third panel is Joseph
Williams, Assistant Deputy Under Secretary for Health for
Operations and Management, the Veterans Health Administration,
U.S. Department of Veterans Affairs. Can you put that all on a
name tag? Assistant Deputy Under Secretary for Health for
Operations and Management, Veterans Health Administration, U.S.
Department of Veterans Affairs. That's a pretty good title. Mr.
Williams is accompanied by Dr. Madhulika Agarwal, Chief Officer
for Patient Care Services; Dr. Michael Hagan, National Director
of Radiation Oncology Services, E. Lynn McGuire, National
Health Physics Program Director; Michael Moreland, Network
Director for VISN 4; Dr. Richard Whittington, a Staff Physician
at the Philadelphia VA Medical Center; Dr. Kent Wallner, Chief
of Radiation Oncology, Puget Sound Health Care System and
Associate Professor of Medicine at the University of
Washington.
We will recognize Mr. Williams for 7 minutes, and then
anything that goes over, of course, your testimony will be in
the record and then we will have questions. Thank you for
appearing.
STATEMENT OF JOSEPH A. WILLIAMS, JR., RN, BSN, MPM, ASSISTANT
DEPUTY UNDER SECRETARY FOR HEALTH FOR OPERATIONS AND
MANAGEMENT, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF
VETERANS AFFAIRS; ACCOMPANIED BY MADHULIKA AGARWAL, M.D., MPH,
CHIEF OFFICER, PATIENT CARE SERVICES, VETERANS HEALTH
ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS; MICHAEL
HAGAN, M.D., PH.D., NATIONAL DIRECTOR OF RADIATION ONCOLOGY
SERVICES, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF
VETERANS AFFAIRS; E. LYNN McGUIRE, MS, DABMP, NATIONAL HEALTH
PHYSICS PROGRAM DIRECTOR, OFFICE OF PATIENT CARE SERVICES,
VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS
AFFAIRS; MICHAEL E. MORELAND, FACHE, NETWORK DIRECTOR, VA
HEALTH CARE-VISN 4, VETERANS HEALTH ADMINISTRATION, U.S.
DEPARTMENT OF VETERANS AFFAIRS; RICHARD WHITTINGTON, M.D.,
STAFF PHYSICIAN, PHILADELPHIA VETERANS AFFAIRS MEDICAL CENTER,
VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS
AFFAIRS; AND KENT E. WALLNER, M.D., CHIEF RADIATION ONCOLOGY,
PUGET SOUND HEALTH CARE SYSTEM, VETERANS HEALTH ADMINISTRATION,
U.S. DEPARTMENT OF VETERANS AFFAIRS, AND ASSOCIATE PROFESSOR OF
MEDICINE, UNIVERSITY OF WASHINGTON, SCHOOL OF MEDICINE,
SEATTLE, WA
Mr. Williams. Thank you, Mr. Chairman and Members of the
Subcommittee. Thanks for the opportunity to discuss VA's
enforcement of brachytherapy program safety standards.
First before I proceed I would like to take the opportunity
to reach out and give my apologies to the veterans and the
families that have been affected by this event.
In addition, I would like to acknowledge the Subcommittee
and the Members that you represent, as well as the Nation that
we have committed to taking care of those who have served in
this country.
VA has a well-documented record of quality care, but when
there are exceptions, whatever the cause may be, we accept the
responsibility and we work with individuals at every level to
ensure that we address the needs. We further analyze what went
wrong. We take corrective actions. And we look for lessons
learned that can be applied throughout our National health care
system. VA is not afraid to admit when we make a mistake, and
we strive for as few mistakes as possible. We also understand
that with transparency comes great responsibility.
My testimony today will briefly describe brachytherapy,
review what happened at the Philadelphia VA Medical Center,
will explain the VA's enforcement of safety standards for
brachytherapy, and discuss the current status of those programs
throughout VA.
Brachytherapy, as you know, is a therapy for prostate
cancer. This is a form of nuclear radiotherapy where small
radioactive seeds are implanted in the prostate to destroy
cancerous cells. Although risk to healthy tissues in the body
is minimal, side effects are known to occur.
Brachytherapy is an appropriate treatment and it is an
appropriate approach for low-risk patients with prostate
cancer, but implant quality must be monitored closely, and in
each case performed, and with each procedure it must be
reviewed regularly.
And I am thankful that a VA employee identified this and
brought it forward, but I regret that it took so long for this
to be recognized.
We accept responsibility for the care of your veterans, and
we acknowledge that some of the brachytherapy treatments
provided at the Philadelphia VA Medical Center did not deliver
the intended dose, and we regret that, but we have reached out
to the patients. We have notified them by mail and by
telephone. We are covering all costs associated with the
additional tests while continuing to monitor the care of our
patients.
A review was conducted by independent, external physicians
and physicists with no involvement with the Philadelphia
program. Ninety-two events involving possible under-dosing or
doses to organs other than to treatment site were found that
met the definition of medical event according to the NRC. It is
important to highlight that the definition of medical event
does not necessarily mean that a veteran was harmed, and
experts still debate the long-term impact of this treatment.
We are working with NRC on regulatory issues related to
prostate brachytherapy, and NRC is refining the definition of a
medical event as this pertains to these procedures.
The Philadelphia Medical Center brachytherapy program has
been suspended since June 2008 and will not be reopened until
NRC's concerns have been satisfied and until requirements for
the VA's Radiation Oncology Program are met.
Enforcing program safety standards is essential to ensuring
patients receive the care that they require. VA, as do other
health systems, relies on complementary systems of
accountability to identify issues. These are both important to
us as it relates to system issues and opportunities, as well as
individual issues.
We use multiple internal and external surveys and
inspection processes; we use patient satisfaction reports;
complaints; individual peer review in our oversight process.
The deficits in this program at the Philadelphia Medical Center
went undetected by many of these systems for almost 6 years,
and it was the recognition of the potential problems by an
employee, as I noted earlier, that brought this forward and
eventually lead to an in-depth investigation, review, and
subsequent disclosure to patients.
We have made much progress since May 2008 and we continue
to strengthen our partnership with the people who were on the
panels earlier; the University, NRC, Joint Commission, et
cetera, and we do this in an effort to strengthen our standards
and improve our outcomes.
In November 2008, VA amended the criteria for suspending
prostate brachytherapy programs, and we required immediate
suspension for any such program where medical events were
discovered for 20 percent or more of the patient treatment that
were reviewed or evaluated by regulatory compliance.
Moreover, VA also requires the National Health Physics
Program to inspect any report of medical events to confirm
regulatory compliance and implementation of VHA standards. VA
will suspend any prostate brachytherapy program if the results
of this inspection indicates significant program deficiencies
and program suspension is deemed warranted by the National
Radiation Safety Committee in consultation with the Director of
the National Radiation Oncology Program and the Principal
Deputy Under Secretary for Health.
In response to the concerns raised by the NRC and to ensure
other VAMCs were performing prostate brachytherapy procedures
correctly, VA completed inspections by January of 2009 of all
VA facilities that had active programs. VA also developed and
implemented standard procedures to prostate brachytherapy
programs addressing quality issues and assurance measures for
the safety program.
Regarding future actions to prevent similar situations, VA
has asked the American College of Radiology (ACR) to conduct
site surveys for each facility, that is each facility
performing brachytherapy for prostate cancer. Our goal is 100
percent accreditation. And it is important to note that
nationally in the private sector in the VA, only 15 percent of
their practices are accredited now.
Furthermore, each facility performing permanent implant
prostate brachytherapy must develop, maintain, and implement
written procedures based on the American College of Radiology's
Practice Guidelines for Transperineal Permanent Brachytherapy
of Prostate Cancer and publications by the American Association
of Physicists in Medicine.
We embrace change and we are ready to learn from it. VA has
used the situation in Philadelphia to conduct a comprehensive
review of brachytherapy programs and has developed criteria for
suspending and restarting these programs. The VHA clinical
standards and procedures are now among the most rigorous
standards in the health care industry. There are currently nine
programs that meet the standard for brachytherapy, and at this
time seven of those nine are active programs. Durham has
voluntarily elected to contract their patients in the greater
Los Angeles facility as positive program.
Senior leadership in VA is committed to a top down, bottom
up review, and we are going to hold the facilities, the
networks to the highest quality of standards for our
organization.
We regret that these incidents occurred and we are prepared
this afternoon to answer any questions that you may have
regarding the situation.
Thank you very much for the opportunity.
[The prepared statement of Mr. Williams appears on p. 65.]
Mr. Mitchell. Thank you very much. I have just got a couple
questions, Mr. Williams.
In the brachytherapy procedures conducted at the VA, what
is the measure of success?
Mr. Williams. Well could I defer that to Dr. Hagan?
Dr. Hagan. Well ultimately the measure of success is a low
and stable PSA for the remainder of the patient's lifetime. So
the goal of treatment is to remove all vestige of disease. And
so patients are diagnosed on the basis of generally having a
PSA, prostrate-specific antigen, that is either rising too fast
or is above abnormal limits, and so that is the metric that we
use to follow patients for the success of their treatment.
Mr. Mitchell. As a follow up to that, how do you know it
has been successful? Do you bring the patient back in?
Dr. Hagan. Oh, yes.
Mr. Mitchell. How often is that done? I mean, I would have
thought that that would have been caught in Philadelphia. So
how often do you bring them in?
I happen to have had prostate cancer, and every year I get
a letter from my hospital with a questionnaire, and I also see
my urologist every year. It didn't seem like that is what
happened in Philadelphia. Or did it?
Dr. Hagan. Well, I believe it did actually, Mr. Chairman.
And the last report I have from the chief at Philadelphia is
that out of the 116 cases that we have heard discussed that Dr.
Kao treated, there are 6 patients who have met criteria for
biochemical failure, that is a rising PSA, that has met our
current guidelines of PSA of two above the nadir value, which I
can explain if you are interested in the specifics. And there
are a further eight who have rising PSAs. The rest are low and
stable. But I hasten to add that this is a procedure that the
success of which, as you well know, we find out in the long
term. And so the fact that there are many of these that are low
and stable at present doesn't mean that they will continue to
be low and stable through the next decade.
Mr. Mitchell. This is a question for Dr. Wallner.
Dr. Wallner, what lessons can other VA facilities learn
from the implants that happened in Philadelphia? What are we
going to do different?
Dr. Wallner. Well, I think we do need oversight for these
sort of low volume procedures that are done in a limited number
of places. And I think what the NRC is doing and the VA is
doing is a step in the right direction. I mean, there are going
to be other procedures where this is going to come up and
hopefully we can keep on top of it better than this. I mean, it
is a moving target.
Mr. Mitchell. One of the things I gathered from the earlier
testimony is that there was a failure in some of the IT
equipment and that they would have noticed this earlier and
quicker if the equipment would have been up and operating.
Dr. Wallner. Yeah, I mean, it is difficult. I have worked
in VA for 11 years, I love it, but it is difficult sometimes to
get things done in a timely fashion.
I mean, there is no question that the head of the program
should have stopped it right then. I mean, you cannot do an
implant if you do not have the feedback to know if you did a
good job. I mean, to me that was probably the biggest fault in
the whole thing.
Mr. Mitchell. And that was a fault of the equipment or the
facility in Philadelphia?
Dr. Wallner. Well, I mean, the people running the program
should have stopped it.
Mr. Mitchell. You know, the contract between Philadelphia
and the VA Medical Center and the University of Pennsylvania
was on an interim contract with extensions for 4 years. What
was the contracting authority that led the VA to extend this?
Did you have authority to extend this?
Mr. Moreland. Yes, sir, we did have authority to extend it.
We issue contracts, and then we at different times we extend
the contract or we don't extend the contract or we go out and
find a new vendor. But in this case we had a contract and we
extended it.
Mr. Mitchell. I understand that the VA and the OIG Office
of Contract Review did a pre-award audit for a new award
contract in 2005. And can you tell us why that contract was
awarded?
Mr. Moreland. I don't have that information at my hand.
Mr. Mitchell. All right, thank you. Dr. Roe.
Mr. Roe. Thank you, Mr. Chairman.
I think one of the things that we have learned and the
Chairman and I have been on a number of these in the last 7
months is that we need to have systems. We saw it in our
endoscopy oversight and investigation meeting where systems
broke down within the hospitals. And it is very complex. This
is not a simple procedure that you are doing, where the
endoscopy systems broke down. And when we did our last medical
malpractice review--the last two we have done in Tennessee--we
do it with airline pilots to go through checklists, and they
have--something medicine really ought to look at. The more I
hear of this the more I am convinced we ought to be doing that.
And Dr. Wallner, I know at the VA where you are, at least what
I have heard, is you have some of the best results that there
are in the country in the VA system. Anything you can share
that you are doing with other VAs, I think you have to look at
sites of excellence and see what are you doing. Have you done
that?
Dr. Wallner. Yeah, I mean, that is a really tough one to
answer. I mean, we happen to do a huge number of these
procedures, and we have it done to a science, we specialize in
it, we get scans on patients before we let them out the door. I
mean, my feeling is I can't sleep well at night unless we check
these before the patient walks out the door. Not every place
can do that. They are doing a lot of other things. They don't
do a lot of this particular procedure. I don't have an easy
answer. I still would go back to the NRC and an oversight of
the programs would probably be the most practical.
Mr. Roe. Well it would seem like--I guess what I would say,
there is no reason to reinvent the wheel. You have already got
systems in place, and to share those experiences that you have
with the other ten or so VAs that are doing that across the
country, since there are not that many sites. This is a lot
easier to get a handle on I think.
Dr. Wallner. Yeah, I mean, it is tough. You know it was in
the newspaper today about some of the lawsuits I have been
through over the years. I mean, I think if anything
unfortunately this is scaring some of the practitioners away
from this, because it is difficult to do it right, and I don't
know what the answer is to that.
Mr. Roe. You are talking to an obstetrician here.
Dr. Wallner. Yeah, that is even worse.
Mr. Roe. I understand.
Mr. Williams. Sir, if I may comment.
Mr. Roe. Mr. Williams.
Mr. Williams. We are an organization that is committed to
continuous learning. We have learned from this situation and we
have made a number of--taken a number of actions to address
that. Things that range from training. NRC has spoke about the
standards that they were putting in place. I would offer to
you, sir, that we have worked very closely with the NRC in
establishing those standards and implements those standards in
our facilities. Two include pre-implant assessments,
assessments during and after treatment for implants. So we have
learned from this.
When we talk about how we convey information and training
and education and lessons learned to other parts of an
organization, you know, we have a vast network of systems and
we are using the lessons learned from this, the hard lessons
learned from this.
Mr. Roe. I guess one of the things that concern me was that
you have your patient there, you have a vital piece of
information which is dosimetry, very critical piece of
information, and nobody had that information, and yet we kept
on doing the procedure, and that was a time I think to take a
deep breath, a step back and call a time out and stop.
Mr. Williams. Yes, sir.
Mr. Roe. The other thing, and I know I feel like I know Dr.
Agarwal now by her first name, I have seen her so many times up
here. But I know the VA has a tumor registry, at least ours at
Mountain Home does, and our hospital does. Very, very vital to
have that information. You may think you are doing a pretty
good job until you look back over a few years and find out
maybe I need to change here. That piece of information is
something that you get long term. Five, 10, 15, 20 year data is
critical to therapy that you are doing now and you may want to
change it. Would you comment on that?
Dr. Agarwal. Sir, you're absolutely correct. We do have a
very robust tumor registry, and we have a tracking system right
now that also helps us in going back and looking longitudinally
on the interventions that have been administered to our
patients and some of the outcomes. So we certainly have been
part of the larger system in having that in place. And in fact
at Philadelphia itself all the patients who had this procedure
have been tracked and have been followed up.
Mr. Roe. So everyone has been.
I guess the last question before we finish, and this will
be again to Dr. Wallner. In absence of a national standard,
would the VA in Seattle be the gold standard, should that be?
Dr. Wallner. I think we are looked at as doing an extremely
good job at this, and you know, we want to be involved with
helping set a standard.
Mr. Roe. Okay. Thank you, Mr. Chairman.
Mr. Mitchell. Thank you. Mr. Adler.
Mr. Adler. Mr. Chairman, thank you.
First I would like to thank the panelists. I have met with
most of you, not all of you, but most of you some days ago, and
it helped my thinking, made me appreciate the professionalism
that you have undertaken over a number of years and also your
seriousness of purpose to make sure that what happened in
Philadelphia isn't a recurring problem, not just in this
particular program, but in any program for any veteran anywhere
in the country, and so I really appreciate your commitment and
your recommitment to provide the level of care that our
veterans have earned by their service to our country.
I would like to speak for a couple minutes about the notion
of using independent contractors, because my sense is that in
Philadelphia at least there was inadequate oversight by VA
professionals of the UPenn professional who was running the
program and whatever sort of folks that UPenn had working with
that professional. So could you comment on your sense of
whether or not there was adequate, or as I believe, inadequate
VA supervision of the brachytherapy program in Philadelphia?
Mr. Moreland. Yes, Congressman, I have mentioned to you
before, I believe that there was an absence of good oversight
at the front end level of this from both our staff and by the
provider as well. And had we had that kind of quality data to
be looking at this more closely we would have identified this
much earlier.
Again, I am proud of the staff at the VA in Philadelphia
because they did find out, all be it late, but they did find
it. There was courage to bring it forward and point it out, and
we have taken significant action since then.
But I do believe that the issue was the frontline oversight
to make sure that we were getting the quality data that we
needed to get, and that was missed, and we have learned a lot
from that. It has allowed us to go back and look at other areas
where we have a very low volume technical procedure where we
have limited people who know what the procedure is and how it
works, that we can bring in other experts to help us. Mr.
Williams mentioned some of the external experts we have hired
to come in and do that system wide. I think that will benefit
all of us.
So sir, I think you are right, I think that is in fact the
root cause of the issue at our facility any way, and we have
identified that and we are moving forward.
Mr. Adler. Maybe Mr. Moreland, you can help some of the
other panelists as well address this concern about the low-
volume procedures. Because my conversation with Dr. Schyve
about the problem in Philadelphia from an accreditation point
of view is a problem I feel may arise somewhere else in the
system for veterans somewhere in the country. So maybe all of
you could discuss for a moment what you have undertaken to
review low-volume programs to make sure those programs that
might not get as much attention are the ones that right now are
getting the attention they need so that we have the supervision
that guarantees the quality of care the veterans deserve.
And just to be clear, I am not just asking in a
brachytherapy context, in a prostate cancer context, in a
cancer context, I am asking in a veterans medical care context
across the spectrum.
Dr. Hagan. Well Congressman, I can answer in terms of what
we have done VHA wide for brachytherapy, but in the wider
context I won't have the information that you are looking for.
But for brachytherapy we have implemented standard procedures
at each one of the sites that are currently performing. So
conducting implants under ACR guidelines is a requirement. A
checklist was developed and used based on those centers that
were performing excellently, and that checklist is a
requirement for each program. It is part of a seven point
response to Philadelphia that was crafted by the NRC and our
NHPP that identified criteria for evaluating programs, that
conducted a nationwide evaluation of those programs, recognized
those that didn't meet the standard and suspended them,
developed criteria for restarting programs, criteria for
initiating programs in centers that are not currently providing
radiation oncology brachytherapy for prostate. And each one of
the programs as of the 1st of May had implemented the standard
procedures across the country.
Mr. Adler. Doctor, I thank you. I am sorry to interrupt
you. I wonder if Dr. Agarwal can describe more generally for
other programs across the country where the VA is now trying to
identify those low-volume programs and procedures and target
them for medical effectiveness.
Dr. Agarwal. Congressman, thank you for that question. You
are absolutely correct. You know, we are committed to providing
quality health care all across the board. We have a rigorous
performance measurement system with about 250 or so indicators
that are currently in place that are used to track at the
individual level, the facility level, the network level, and at
the national level. But I think it has been eluded to, at least
I think by the individual from Joint Commission, that no matter
how many measurements or measures you have in place it is
somewhat of a challenge to do it very comprehensively for every
nuance where we deliver health care.
So we have learned a lot from some of the instances that
have happened in our recent past, or even more distant past,
and every time when an issue arises, be it a surgical issue in
a certain place or the use of endoscopy or reprocessing issues,
or right now with brachytherapy, we take that as something to
improve our entire system.
There is a very rigorous effort to look at it internally
with internal oversights with our System-wide Ongoing
Assessment and Review Strategy (SOARS) program and our
Clinician Administered PTSD Scale (CAPS), and of course we have
external accrediting bodies that come into play.
There are a couple recent directives that have been in
place and--a relatively new office--Office of Associate Deputy
Under Secretary for Quality and Safety has been stood up with
the explicit purpose of ensuring that we continue to maintain
and sustain high quality care and have a higher degree of
accountability in quality and safety for all health care
delivery across the Nation.
Mr. Adler. Doctor, I thank you, I am sure you don't want to
have to come testify before us again and again. I can assure
you on behalf of the Members of the Subcommittee we don't want
to have to bring panels before us to explain why veterans
didn't get the quality of care they deserve, and most
importantly I am sure veterans don't want to be missing the
care they have earned.
Dr. Agarwal. Congressman, you are right.
Mr. Adler. I thank you. I yield back, thank you.
Mr. Mitchell. Thank you. Just two quick questions.
First, I understand that the VA OIG report found that none
of the clinical staff in Philadelphia had received the Nuclear
Regulatory Commission recommended training. Is that correct?
Mr. Moreland. I don't have that information with me. I can
certainly get that information and provide it to you, sir.
[The report was received on August 5, 2009, and will be
retained in the Committee files.]
Mr. Mitchell. Yeah, this was just a report that, it was the
Administrative Board of Investigation. Any way, if that is true
I am sure that we need to make sure that all of those
procedures are followed and that everybody involved with this
has the recommended training.
Dr. Hagan. Mr. Chairman, I can add that they have certainly
received that training now. That was part of the response to
NRC. As one of the seven points ways that training would be
conducted. This was fully implemented as of the 1st of May. So
all centers have had that training now.
Mr. Mitchell. One other quick question.
Dr. Agarwal, you mentioned that everyone has been
contacted, everyone who received the brachytherapy. And you
also said, Dr. Hagan, that success is based on if the PSA goes
up or whatever. Those that had low dosages because the seeds
were not properly implanted, do you know if any of those were
the ones that the PSA has gone up?
Because what is horrible about this is that there is not
too many options once you have the radiation therapy, and the
options aren't really the nicest. And so I just wonder if
anybody who had undergone the treatment at Philadelphia who had
low doses, if any of those people are one that is are having an
elevated PSA.
Dr. Hagan. Mr. Chairman, I can't specifically----
Mr. Mitchell. Yeah, and it could happen in spite of that
any way. They could have had the right ones and it still could
have gone up.
Dr. Hagan. And I would not be surprised to find that that
is the case.
However, one piece of information I can add is that it is
very unusual to see recurrent disease within the prostate in an
area that has been adequately treated with brachytherapy. The
corollary to that statement is that it is possible then with a
supplemental implant or a salvage implant as we term it in the
literature, to recapture PSA control in disease that has not
escaped the prostate. And so that is a procedure that though
not done commonly has been done. We have done it in Richmond.
And Dr. Wallner has addressed some of the patients from
Philadelphia in that regard.
Mr. Mitchell. Thank you. Dr. Roe.
Mr. Roe. Just very quickly. I guess one of the things that
I would bring up and you all probably looked at it, there is a
certain volume of patients you need to do to get good at
something, and if you are doing 14, 15, 1 a month, it is a lot
harder to get really good at it unless you are doing 1 a day or
1 every 3 days or something like that like probably you are in
Washington. So I would look at my volumes. If you look at
volumes in cardiac surgery and any other surgery, cancer,
chemotherapy, whatever, you are doing a lot of you are just
good at it. And I would certainly look at it. And maybe it is
more inconvenient for the veteran, but it is better to get it
done right than to get it done not right, so I would do that.
And I think very simply it would be easy to get a set of
standards for nine hospitals. I say easy, relatively easy, and
follow those procedures. That is exactly what we found in our
endoscopy, and then expect people to do it. Train them.
One of the things, Mr. Chairman, we insisted on during
that, if you remember, is the training that all are to have,
and it sounds like we need to document everybody that has been
trained, are we doing the same procedure, and if you vary in
that procedure you better halt what you are doing until you're
back doing the correct thing. And I think that could easily be
done in this therapy.
And I also want to thank whoever stepped up. This happened
in Murfreesboro, the endoscopy issue, and whoever the person
that stepped up and said we want to do what is right for
patients, even though they knew it was going to bring them a
lot of grief, which it did I am sure, was the right thing to
do, and I applaud someone who will step up and look after the
benefit of patients.
So I appreciate you all being here today and I yield back,
Mr. Chairman.
Mr. Mitchell. Thank you. Any other questions?
Well again, I would just as Dr. Roe said, thank you so much
for doing this, and we understand this was self-reported, and
you taking corrective actions, and that is the important thing,
that these things don't happen again and we can learn from all
these mistakes and hopefully get better at it.
So again thank you very, very much. And with that this
hearing is adjourned.
[Whereupon, at 1:21 p.m., the Subcommittee was adjourned.]
A P P E N D I X
----------
Prepared Statement of Hon. Harry E. Mitchell, Chairman,
Subcommittee on Oversight and Investigations
I would like to thank everyone for attending today's Oversight and
Investigations Subcommittee hearing entitled, Enforcement of U.S.
Department of Veterans Affairs Brachytherapy Safety Standards. Thank
you especially to our witnesses for testifying today.
All the Members of this Subcommittee take particular interest in
this issue as well as the care of our Nation's veterans; however, I
would like to especially thank Congressman John Adler of New Jersey for
being such a passionate advocate of this issue. Reports of botched
prostate cancer procedures, a lack of quality and standard controls in
the VA health care system and egregious errors in the brachytherapy
treatment at the Philadelphia VA Medical Center are unacceptable and
wrong.
Brachytherapy is a form of radiotherapy, often used to treat
prostate cancer, in which radioactive seeds are placed inside or next
to a patient's malignancy. Failure to accurately place the radioactive
seeds can cause serious harm. To say that it is disturbing to learn
that veterans received bungled procedures and that safety protocols
failed to safeguard against such mistreatment would be an
understatement. As a result, we are here today to examine the system-
wide safety standards for these procedures to ensure that our veterans
are receiving the best and safest care available.
In 2003 and 2005, the Nuclear Regulatory Commission (NRC) received
reports of botched placement of radioactive seeds and inconsistent
dosage at the Philadelphia VA Medical Center. After careful review, it
was determined that no NRC protocols were violated. In May of last
year, the NRC received a notification of potential under dosing at the
Philadelphia VA Medical Center. This led to a VA National Health
Physics Program Inspection (NHPP), evaluating all 116 brachytherapy
treatments that took place since the creation of the program in 2002.
The New York Times reported last month that investigators for the
Nuclear Regulatory Commission and VA officials found that 92 of the 116
men treated at the VA Medical Center in Philadelphia's brachytherapy
program received incorrect doses of the radiation seeds, often because
they landed in nearby organs or surrounding tissue, rather than the
prostate. Dr. Gary Kao, who is here today at this hearing, performed
the majority of the procedures under a VA contract with the University
of Pennsylvania, where he was on staff. Out of the four suspended
brachytherapy programs, we know that Philadelphia was by far the worst.
On top of this, in March of this year, the NRC issued a detailed
inspection report citing the Philadelphia VA Medical Center with six
violations of NRC regulations. This is downright unacceptable. While we
are disturbed that, perhaps, there was a lack of proper local quality
controls and management of these brachytherapy programs, our main
concern is that the problems marring the program in Philadelphia could
be happening at the other nine facilities still doing these procedures.
As such, we have asked the VA Office of Inspector General to review
and assess the VA's brachytherapy programs and, although the complete
NRC inspection report on the Philadelphia program, along with the other
VA facilities using brachytherapy treatments, as well as the NHPP
performance is not complete, we look forward to reading that report
when it becomes available.
Though it is commendable that VA's leadership took swift action
once these issues were reported, it is still troubling that it took
almost 6 years for these events to actually be reported. Even more
troubling is just last month we were here discussing quality control
and lack of proper procedures and oversight of endoscopy procedures
being conducted by the VA, yet we are here again, questioning the
quality of care our veterans receive.
The VA health care system relies upon a complementary system of
accountability to identify quality control problems throughout the
entire system and at individual levels. Failure to ensure consistent
oversight and safe treatment is unacceptable and wrong. I am anxious to
hear VA assurances not only to this Subcommittee, but to all the
veterans they serve, that the issues identified, once a thorough review
has been conducted, is not occurring at any of the remaining
brachytherapy programs across the country, and that the four suspended
programs may continue to deliver this important treatment to our
veterans. Last, I am equally interested in hearing from one of one our
witnesses, Dr. Kao, regarding allegations of erratic seed placements,
as well as experts we have invited to provide their thoughts on the
safety and effectiveness of the treatment.
Thank you again to all of our witnesses for testifying today and we
look forward to your testimony.
Prepared Statement of Hon. David P. Roe, Ranking Republican Member,
Subcommittee on Oversight and Investigations
Mr. Chairman, I appreciate you holding this hearing today.
The issue we should really be addressing today is not only the
instance of alleged medical malfeasance by one particular medical
practitioner, but whether or not this is a symptom of an overreaching
patient safety issue across the VA. Just last month, we held a hearing
on the problems relating to the cleaning and reprocessing of endoscopy
equipment at the VA. Now we are hearing testimony today to discuss
problems with brachytherapy treatments at the VA Medical Center in
Philadelphia.
Prostate cancer is a major problem for adults over age 50 in the
United States, and brachytherapy is a treatment tool used by
oncologists to treat prostate and other cancers. The VA treats around
575 veterans annually with low dose-rate brachytherapy at 13 centers
nationwide.
We need to tread cautiously here today. As we hear testimony from
the VA and other officials, we need to keep in mind the good quality
care most veterans seem to be receiving at VA medical facilities, and
not seek to undermine the confidence veterans have in going to the VA
for their health care needs. That being said, I am gravely concerned
that these issues continue to crop up in the news media. VA needs to do
a better job at policing itself, before they let the New York Times
sensationalize an issue in order to break the public's trust.
Mr. Chairman, the protection of our Nation's veterans who look to
the VA for their care is of primary importance. To hear continual
reports of various health issues, such as the endoscopy cleaning issue
last month, and now the problem with brachytherapy at select facilities
is worrisome to me. We must continue to ensure that our veterans
receive the best possible care available. I look forward to hearing the
testimony from today's witnesses and yield back my time.
Prepared Statement of Gary D. Kao, M.D., Ph.D., Associate
Professor of Radiation Oncology, Department of Radiation Oncology,
University of Pennsylvania, School of Medicine, Philadelphia, PA
Thank you, Congressman Mitchell and other Members of the Committee,
for the opportunity to voluntarily appear before you so that I may be
heard on this important subject matter and correct some very serious
false allegations about me contained in recent publications, most
notably the New York Times.
I have worked very hard in my life to best serve the field of
radiation oncology and my patients in over 15 years of clinical
practice. My dedication to my work is reflected in my educational
achievements--earning a Bachelors degree in Philosophy and a Medical
Doctor degree from John Hopkins University and its School of Medicine,
followed by medical internship and residency, and completion of
residency in Radiation Oncology at the University of Pennsylvania
School of Medicine. This culminated in Board Certification in Radiation
Oncology. I am especially proud that during continuous clinical
practice of medicine for over 15 years, I have not had a single
malpractice claim filed against me. My record and my commitment to the
care of my patients make the false accusations against me particularly
devastating and misguided.
I, along with others at the VA, implemented the Program for
Brachytherapy in 2002 within the Philadelphia VA to serve the best
interests of veterans. Contrary to the allegations that I was a
``rogue'' physician, we developed precise standard operating procedures
and a system of oversight and monitoring of what was then a state-of-
art treatment. We formulated the first algorithm of any radiation
oncology procedure at the VA, to define the standard operating
procedure. As would be expected in any new program, the brachytherapy
program was not without its challenges.
However, what has become clear over the last month is that a
fundamental misunderstanding of elementary principles and concepts has
led some to arrive at an inappropriate and incorrect conclusion--that
deficient care was routinely rendered to veterans who received
brachytherapy at the Philadelphia VA. This was not the case and to
understand why it is important to understand certain critical issues
related to the NRC's definition of a reportable medical event and its
applicability to our work at the VA.
Here are the facts:
Fact 1: A standard definition of a reportable medical event as
it applies to Brachytherapy was not in existence when the Program
started at the VA. The definition was not referenced in my training in
Brachytherapy at the Northwest Hospital in Seattle, nor was it
clarified by NRC personnel in their investigations in 2003 or 2005 when
they were onsite at the Philadelphia VA. The definition that the NRC
has now chosen to retroactively apply to all cases of the Philadelphia
VA Program is predicated on a deviation from D90, the dose received by
90 percent of the prostate, but it is a definition that does not appear
anywhere in the regulations published by the NRC. It should also be
noted that there is significant disagreement within the medical
community regarding the appropriateness of D90 as a defining metric for
a reportable Medical Event. Studies analyzing large numbers of patients
appropriately selected for brachytherapy suggest that there are very
few relapses even in patients who had a D90 < 80 percent.
Fact 2: The definition of a reportable medical event as it
applies to brachytherapy is not only unclear, but it is evolving. The
Medical Advisory Committee of the NRC has repeatedly recommended that
the definition be changed from one that is dose-based to a definition
that is activity-based, i.e. the number of seeds. Last summer, the NRC
proposed a rule to change the definition, but the NRC is still using
the old definition--unpublished--to evaluate the Philadelphia VA's
brachytherapy cases.
Fact 3: The fact that a reportable medical event to the NRC
occurred does not mean that the treatment did not meet the standard of
care. A patient whose treatment results in a reportable medical event
may still have received effective treatment that is within the
appropriate standard of medical care. A patient's prostate may
temporarily swell after the procedure, or the size and shape of the
prostate or the patient's medical condition may dictate that a higher
or lower dose of radiation is prudent.
Fact 4: Whether brachytherapy treatment has been delivered
consistent with the standard of care should not be determined by
whether the treatment resulted in a reportable medical event to the
NRC. There are many more significant factors that determine appropriate
treatment such as: the number of seeds; the location of the seeds in
the prostate; the location of seeds outside the prostate; the
concentration of seeds to the affected area of the prostate; the size
and shape of the prostate; the stage, grade, extent and location of the
cancer; and the clinical follow up of PSA test results. None of these
factors are addressed by the NRC.
I also wish to address the now oft-repeated reference to ``92
botched cases.'' This characterization is simply wrong--it is unfair
and extremely misleading. A case that meets the NRC definition of a
reportable Medical Event does not mean that a patient received
ineffective or ``botched'' care or that the treatment did not meet the
standard of care that existed at the time the treatment was given. The
Preplanned Method that we used was ``state of the art'' in 2002, and
was used effectively to treat the patients that we carefully screened
for the procedure. The efficacy of the treatments is evidenced by the
fact that there were no confirmed cases of tumor recurrence at the time
the Program was terminated in 2008, with many patients doing well up to
5 years after their brachytherapy treatment.
Furthermore, the NRC review which allegedly resulted in ``92
reportable cases,'' was determined by the NRC through a reanalysis of
our data without the participation of the personnel who administered
the Brachytherapy Program. Such participation would have been essential
to an understanding by the NRC investigators of how each of the
prostates was contoured prior to the treatment. It is well recognized
in the radiation oncology community that the prostate contouring
process is very subjective and that prostate volumes can vary
substantially depending on who performs the contouring. The D90 dose
calculated by different reviewers may vary by as much as 60 percent.
The calculations performed by our Team indicated that the number of
patients with D90 below or higher by 20 percent than prescribed was far
fewer than 92 cases. Although I do not have access to the patients'
data and files, I do not believe that there are close to the 92
reportable cases identified by the NRC, even by applying the NRC's
unpublished D90 standard. While I acknowledge that there would likely
have been a higher number of reportable Medical Events at the PVAMC if
we had been informed of the current NRC definition, the number would be
substantially below 92 cases.
The field of Brachytherapy is a relatively new and rapidly evolving
field. While certain conditions and circumstances at the Philadelphia
VA could have been improved, I am confident, based on my knowledge of
the field and the nature of the patients treated at the VA during my
tenure, that the patients received appropriate medical care that was
effective in addressing their prostate cancer.
It is my hope that, through my statements and my testimony, I am
able to contribute to a fuller understanding of brachytherapy
treatment, bring a degree of reassurance to our veterans regarding the
treatment that was provided, and ultimately help to improve care for
our veterans.
ADDENDUM
As the physician that led the PVAMC Prostate Brachytherapy Program
(``Program''), I must accept a portion of the responsibility for some
of the breakdowns in performance of the Program. However, as explained
in the statements provided to the U.S. Senate Committee on Veterans'
Affairs Field Hearing on June 29, 2009, many of the allegations and
conclusions concerning the Program are simply not accurate and convey
inappropriate conclusions about the care provided to the veterans and
the import of the NRC regulations concerning ``reportable Medical
Events''. My efforts in supplying the statements, in voluntarily
appearing at the Senate Field Hearing and in providing this Addendum
are not designed to affix blame to others, but rather to provide better
insight to the appropriate context of the fundamental precepts of
brachytherapy at the VA. In so doing, I expect that the false
statements made about the Program will be re-addressed and that some
measure of comfort will be rendered to the veterans who received care
at the VA. Additionally, I recognize that improvements to the Program
and the VA can be made and therefore, have made certain recommendations
based on my experience with the Brachytherapy Program at the VA in
Philadelphia. For purposes of convenience, I reiterate those
recommendations here as follows:
1. A system should be established so that a treating VA physician
is notified whenever his or her patient presents for treatment at any
other VA medical center. This should be accomplished with appropriate
confidentiality and privacy safeguards, but which would enable a VA
physician to have access to the patient's electronic medical records at
any other VA medical center.
2. For complex medical procedures such as brachytherapy, there
should be a uniform set of standard operating procedures established
through a collaboration of the involved health care professionals and
administrative personnel. Once defined, these standard operating
procedures should be applied throughout the entire VA system, with
appropriate training.
3. There should be a method of categorizing systematic problems by
level of urgency so that serious problems, such as those involving
failures of medical equipment or transfer of patient-related data, will
receive immediate attention from the proper personnel and be quickly
resolved.
4. There should be a formal system which would require the NRC and
other national regulatory bodies to continually train doctors and other
personnel in the latest defined standards.
5. The respective medical disciplines of separate VA hospitals
should have a formal system of continuous dialog together about
difficulties encountered during practice, and possible suggested
solutions. This could be accomplished with the aid of a
videoconferencing system to which all VA physicians have access.
6. For every complex medical procedure, there should be sufficient
funds for the VA to provide timely and complete care to veterans.
Relating to my own experience, having a full-time medical physicist
dedicated to brachytherapy would have enabled us to transition earlier
to a real-time system of brachytherapy.
As a final note, I wish to draw attention to two issues discussed
at the June 29 Hearing which should be clarified.
First, regarding the number of reportable Medical Events, it should
be noted that the Philadelphia VA hospital was not the only VA facility
which was found to have unreported Medical Events. In at least three
other VA hospitals the NRC found unreported events. It is significant
to note that the reviews of these other hospitals consisted only of a
small sampling of their cases, a fact that has not been revealed to
date. In contrast, the Philadelphia VA was subjected to a full audit. A
full audit at those other institutions would have disclosed more than a
few instances of reportable Medical Events. Supporting the probability
of a higher number of Medical Events that currently remain unreported,
a Member of the advisory Committee to the NRC (Advisory Committee on
Medical Uses of Isotopes), Subir Nag, M.D., said that of the 100,000
cases of the Prostate Brachytherapy Program across the country
(including those outside the VA) applying the current NRC definition of
reportable Medical Event, ``you are going to have 20,000 cases which
will meet the current definition of [reportable Medical Event].'' It is
highly unlikely that the Philadelphia VA would be an isolated
aberration, if a similar degree of audit was to be performed.
Second, at the hearing, there were several references to ``92
botched cases''. This was very misleading as I explained in my original
submitted statements. For the many reasons articulated, a case that
fits the NRC definition of a reportable Medical Event does not imply
that ineffective or ``botched'' care was given, and which did not meet
the medical standard of care. Furthermore, the NRC review which
allegedly resulted in 92 reportable cases, was a reanalysis of our data
performed without the participation of the personnel who administered
the Brachytherapy Program. We dispute that there were 92 reportable
Medical Events, but we do not have access to the patients' data and
files. It is well recognized in the radiation oncology community that
the prostate contouring process is very subjective, and prostate
volumes can vary substantially depending on who performs the
contouring. The D90 dose calculated by different reviewers can
therefore vary by as much as 60 percent. While we acknowledge that
there would have been a substantial number of reportable Medical Events
at Philadelphia VA had we been informed of the current NRC definition;
the number would be substantially below the now oft-quoted allegation
of 92 cases.
Prepared Statement of Stephen M. Hahn, M.D., Henry K. Pancoast
Professor and Chair, Department of Radiation Oncology,
University of Pennsylvania, School of Medicine, Philadelphia, PA
Mr. Chairman and Members of the Committee, I am grateful for the
opportunity to appear here today. I am a professor of radiation
oncology at the University of Pennsylvania and since 2005 have been the
chair of the University's Department of Radiation Oncology.
Before going any further, I want to express my deepest regret that
prostate cancer patients receiving brachytherapy at the Philadelphia
Veterans Affairs Medical Center (PVAMC) did not in every instance
receive the best possible care. My highest priority as a physician and
as chair of our Department is to make sure patients receive the best
possible care. I want to personally apologize to the patients and their
families for the distress this has caused. I also know that this entire
experience has been very difficult for the VA health care system,
particularly in Philadelphia, as it has been for my Department. Penn
Medicine's relationship with the PVAMC is long standing and very
important to our mission as an academic medical center dedicated to
patient care, teaching and research. We value our work with the PVAMC
highly and believe that both our organizations have learned a great
deal from this painful experience that will serve to improve patient
care in the future.
I will focus most of my testimony today on the steps we have taken
in the last year in response to this situation and the process
improvements we have implemented at Penn that we believe will enhance
the quality of care for patients undergoing brachytherapy. First,
however, I want to provide some background information which I think
should be useful regarding prostate brachytherapy as well as a
description of our Department's role at the PVAMC.
Prostate brachytherapy refers to the permanent implantation of
small radioactive seeds into or around the prostate gland to treat
prostate cancer. Along with prostate removal surgery and external beam
radiotherapy, prostate brachytherapy represents a well-established
option for the treatment of prostate cancer. During the procedure, the
physician implants the seeds using loaded needles. The placement of the
needles and seeds is determined by a ``pre-plan,'' in which the dose to
the prostate and desired location are estimated by a medical physicist
and confirmed by the physician (based on an ultrasound image of the
patient's prostate), as well as ultrasonic image guidance at the time
of the implant.
The implanted seeds' location determines the radioactive dose
delivered to the prostate and surrounding tissue. It is important to
note, however, that even among experienced and skilled physicians there
is variation in the results afforded by prostate implant brachytherapy,
not only with respect to patient outcome and possible complications,
but also with respect to dose delivered to the prostate volume and
surrounding tissue. This can be due to patient anatomy (the texture of
the prostate, and normal anatomical variation); prostate swelling after
implantation; and the way that the dose to the prostate is measured
after the implant--often by identifying the prostate and seeds on a CT
scan--which itself can allow for considerable variation in the measured
dose. I offer these facts not as an excuse, but only to make the point
that this is a complicated therapy.
The University's Department of Radiation Oncology, through a
contract with the PVAMC, provides radiation oncology services,
including brachytherapy. Radiation oncologists working at the PVAMC are
either employed directly by the PVAMC or Department faculty provided
under the contract.
When the Department first learned in May 2008 of potential concerns
about the prostate brachytherapy program at the PVAMC, we took
immediate action. The Department provided several faculty members and
staff to the PVAMC to assist with a quality review of all prostate
brachytherapy cases. In June 2008, when concerns arose regarding Dr.
Gary Kao's cases in particular, Dr. Kao agreed, at my request, to
suspend his clinical practice, and he has not treated any patients
since that time at the PVAMC or at our hospitals. Since last summer,
Department faculty, as part of their responsibilities at the PVAMC,
have been coordinating patients' follow-up care and closely following
PVAMC patients with symptoms of concern. In addition, since the VA and
the Nuclear Regulatory Commission (NRC) began investigations into this
matter in June 2008, we have cooperated fully, and we will continue to
do so.
At the same time as the VA and NRC undertook their investigations,
in June 2008 we also reviewed quality control and improvement measures
to determine whether we could enhance them to prevent a situation like
this from ever happening again. Although our Department's brachytherapy
programs have been in compliance with the American College of Radiology
and the American Society of Therapeutic Radiology and Oncology's
Practice Guideline, we have adopted an additional review process that
provides for persons who did not take part in the procedure to assess
the quality of each prostate brachytherapy implant. This quality review
process includes a re-review of the CT scan and a recalculation of the
delivered dose. We also have established a multi-level internal
reporting system so that even slight anomalies will be reported to our
quality assurance Committee and reviewed, regardless of whether they
rise to the level of an NRC-reportable event.
Another very significant development is that we recently completed
the transition to a new brachytherapy implant protocol. At the Hospital
of the University of Pennsylvania, in early 2008, as part of ongoing
quality improvement, we began transitioning to what is called ``real-
time dosimetry,'' which incorporates new equipment and programming and
allows for calculation and recalculation of the dose delivered to the
prostate after each radioactive seed is implanted during the procedure.
This provides the attending physician with instantaneous feedback and
an opportunity to modify his or her plan if necessary to achieve the
desired radioactive dose to the prostate. We believe this approach
should lead to greater consistency with respect to seed location and
the delivered dose.
I do not know if the PVAMC intends to restart its permanent
prostate brachytherapy program, but if and when it does, we would of
course assist the PVAMC in modernizing its program along these lines.
The steps my Department has taken in response to this issue also
have been reviewed by Penn Medicine quality reviewers and senior
physicians. Further, to assure ourselves that we have considered every
safety and quality option, we will be requesting an additional review
by outside experts.
Before closing, I want to address briefly the NRC regulations
applicable to prostate brachytherapy. I am confident that the NRC, the
PVAMC, and the University all share the desire to see clear and
consistent prostate brachytherapy regulations instituted so that we can
all be confident that uniformly high quality care is delivered to all
patients who undergo this procedure. In August 2008, the NRC, based on
recommendations from its Advisory Committee for the Medical Uses of
Isotopes, published proposed amendments to its regulation that
establishes what constitutes a reportable ``medical event.'' That
proposed rule would have gone some way toward removing the ambiguity
that exists in the current rule as applied to prostate brachytherapy,
inasmuch as the current rule does not specify how a deviation from
desired dose is to be measured, or at what point in the treatment
process. It is my understanding, however, that the NRC is reconsidering
the proposed rule in light of this case. In my view, the criteria the
NRC applied to these cases are overbroad, and they are not generally
accepted by experts in the field or, I believe, experts on the NRC's
own Advisory Committee. The criteria could result in reporting to the
NRC when there was neither a poor implant nor suboptimal patient care.
My point here is not to contest the importance of the issue we are
dealing with today--were it simply one instance in which a veteran
received less than the best possible health care, I would find that
just as unacceptable. I share a desire with my colleagues at the VA and
the NRC to create clear rules and regulations leading to the delivery
of quality care, and I believe it would be of great use to the medical
community at large for the NRC to clarify its regulations as they apply
to prostate brachytherapy, which will make it more likely that any
developing problem elsewhere will be discovered at the earliest
possible time.
Mr. Chairman, and Members of the Committee, let me again stress
that Penn is committed to providing the highest standard of care to our
Nation's veterans and to working closely with the VA moving forward.
Prepared Statement of Michael R. Bieda, M.S., Clinical Chief,
Division of Medical Physics, Department of Radiation Oncology,
University of Pennsylvania, School of Medicine, Philadelphia, PA
Mr. Chairman and Members of the Committee, thank you for the
invitation to appear here today. I would like to use my time to provide
you with some information about my background, as well as a description
of the medical physicist's role in prostate brachytherapy.
In 1996, I was awarded a master's degree in physics from University
of Tennessee, and in 1999, was graduated from the master's program in
medical physics at the MD Anderson Cancer Center at the University of
Texas Health Science Center at Houston. Since that time, I have worked
as a medical physicist at the Johns Hopkins University Oncology Center
in Baltimore; at Christiana Care Health Systems in Newark, Delaware;
and at Bryn Mawr Hospital In Bryn Mawr, Pennsylvania, in addition to
the University of Pennsylvania's Department of Radiation Oncology. I
first worked at Penn from 2002 to 2005, and then returned in August
2006 to take the position of clinical chief of medical physics for the
Department.
I am certified by the American Board of Radiology, in therapeutic
radiological physics, and I have had several publications in the
journal Medical Physics.
A medical physicist does three things to assist in prostate
brachytherapy.
First, based on the doctor's prescription, which specifies the
amount of radioactivity to be implanted into the patient, the physicist
prepares what is called a preplan. To do this, the physicist will
review a series of ultrasound images of the prostate that is taken by a
doctor and in which the doctor has identified the prostate. With this
information from the doctor, the physicist will plan the places where
the radioactive seeds should be implanted into and around the prostate
and estimates the radioactive dose to be delivered to the prostate.
This plan always is confirmed (or revised) by the doctor.
Second, not long before the doctor is to perform the implant, the
physicist will check the activity level of a sample of the seeds to be
implanted and deliver those seeds to the doctor in the operating room.
The third thing a physicist does takes place after the implant. At
the PVAMC, the doctor would order a CT scan of the patient's prostate
the day after the implant. On this CT scan, the physicist would
identify the location of the implanted seeds, using a dedicated
computer program for this purpose. Once this was done, the doctor would
locate the prostate on the CT scan and draw it in. This would allow the
computer program to generate a ``dose volume histogram,'' essentially a
graph showing how much of the prostate received how much of a dose, as
well as different dose parameters. This information is often referred
to as ``post-implant dosimetry.''
Post-implant dosimetry is performed so that the doctor might
evaluate the implant as part of his overall assessment of his ongoing
treatment plan for the patient.
I recognize that the Committee may have questions, and I will do my
best to answer them.
Again, thank you for your consideration of my testimony.
Prepared Statement of Paul M. Schyve, M.D.,
Senior Vice President, The Joint Commission
Mr. Chairman, Ranking Member, and Members of the Committee, on
behalf of The Joint Commission, thank you for the opportunity to
testify at this important hearing.
The Joint Commission accredits approximately 146 Department of
Veterans Affairs organizations, including all of its hospitals. We
strive to assure that our Nation's veterans are receiving high quality
and safe care.
Joint Commission accreditation is a risk-reduction process, based
on:
First, establishing evidence-based Standards, National
Patient Safety Goals, and Performance Measures
Second, collection of data about a hospital in the form
of performance measures (including patient outcomes), complaints, and
past survey results
Third, periodic unannounced onsite surveys of the
hospital, focused on the care provided to a selected cohort of patients
whose care is ``traced'' throughout their hospitalization
Fourth, feedback to the hospital of the results of its
survey and required improvements, including a timeline for their
implementation
Fifth, public reporting of the results of the survey on
the Internet and to the Veterans' Health Administration
Sixth, an annual self-assessment by the hospital of its
ongoing compliance with Joint Commission standards
I described accreditation as a risk-reduction process. No process
can entirely eliminate risk in health care. Hospital-level health care
is inherently risky. It has all the characteristics identified in other
high-risk endeavors:
Complexity
Variable input--that is, patients
Time constraint
Tight coupling
Heavy dependence on human intervention--since ``to err is
human.''
So in health care, adverse events will happen. The Joint
Commission, the Veterans' Administration, and this Committee all share
the goal of reducing adverse events and protecting patients from their
harmful effects.
By studying other high risk endeavors that have developed enviable
safety records--such as the commercial air passenger system, nuclear
power, and aircraft carrier flight decks--health care is learning how
to become a ``high reliability'' endeavor also.
The first step is the development of evidence-based, standardized
policies and procedures, educating personnel in their implementation,
making them available as memory-aids (such as in check lists) to
facilitate their use, and monitoring whether they are followed. This
may be all that is necessary to assure high reliability in a production
line to manufacture widgets. But it is only the beginning in a high
risk endeavor like health care.
In health care, unexpected adverse events and unpredicted
outcomes--often called ``unintended consequences''--occur regularly,
despite the best designed and monitored policies and procedures. To
create high reliability in health care, therefore, requires three
additional components:
The first component is constant attention to things that
are unexpected or go wrong in order to learn from them so as to prevent
their recurrence. However, personnel will only report errors and other
adverse events in an atmosphere of trust in which they will be
rewarded, not punished, for reporting, and their reports will be taken
seriously and acted upon.
The second component is prospective risk identification
and prevention whenever new processes are to be implemented or existing
processes changed. By prospectively redesigning the proposed processes
to eliminate the risk or building in protections for patients when the
risk cannot be eliminated, patients can be protected from harm. While
the first component is to learn from adverse events to prevent their
recurrence, this second component is to learn before the adverse events
to prevent their occurrence.
The third component of high reliability--and perhaps the
hardest to achieve and maintain--is a ``culture of safety.'' A culture
of safety means that safety is consistently on everyone's mind, there
is preoccupation with the possibility of failure, a sensitivity to the
detail of operations, and constant vigilance for the small unexpected
events--because small events can lead to big, sometimes disastrous
outcomes in complex processes such as those in health care.
Unfortunately, no oversight body, whether the Veterans' Health
Administration, the Nuclear Regulatory Commission, or The Joint
Commission, is able to identify all the risks and even all the actual
breakdowns in a hospital. Nor can the oversight bodies create the
cultures of trust and safety in the hospital needed for high
reliability. Only the hospital itself can. The oversight bodies can set
expectations, provide guidance, educate, and evaluate in order to
enable and incentivize the hospital to make this change.
To that end, The Joint Commission has established standards that
require the hospital to:
Create a culture in which adverse events are reported and
evaluated for underlying (``root'') causes, and preventative actions
are taken.
Identify high-risk processes and prospectively determine
their possible modes of failure, the effects of those failures, and the
actions that will prevent the failures or mitigate their effects.
Establish a culture of safety throughout the hospital.
This accreditation standard became effective January 1, 2009, although
its purpose and expectations were publicized for over a year in
advance.
When The Joint Commission surveys a hospital, the surveyors always
physically examine the radiology imaging services and, if the hospital
provides it, its external beam radiation oncology services. From this
case, The Joint Commission has learned that a hospital may provide
brachytherapy services that, because they are usually a low-volume,
highly specialized service within the radiation oncology department,
may not be reported by the department as part of the services it
provides--and, therefore, may be unknown to the surveyor. Brachytherapy
is especially highly specialized and technical--utilizing the expertise
of a urologist, a radiation oncologist, and a radiation physicist. Even
when its presence is known to the surveyor, it is not possible for the
surveyor to have the specialized technical knowledge to review the
effectiveness of the dosing schedule for the patient. However, based on
this case, The Joint Commission will instruct its surveyors to ask if
brachytherapy is provided, and, if so, to examine whether the hospital
is providing the monitoring and peer review oversight that
brachytherapy requires. And, beginning this year, the surveyors are
evaluating what the hospital's leaders are doing to create a culture of
safety in their hospital.
The Veterans' Health Administration has been a leader in learning
from adverse events in its hospitals, in disseminating that knowledge
to other hospitals in its system, and in openly discussing with The
Joint Commission the events and their investigations and responses.
They have also started down the long road of creating a culture of
safety in their hospitals. The Joint Commission's goal is to assist
both the Veterans' Health Administration and its individual hospitals
to make this transition. Only by transforming our Nation's hospitals
into high reliability organizations will health care fulfill its
obligation to all our Nation's citizens--including its veterans--to
``first, do no harm.''
On behalf of The Joint Commission, I would like to thank you again
for this opportunity to testify.
Prepared Statement of Steven A. Reynolds, Director, Division of Nuclear
Materials Safety Region III, United States Nuclear Regulatory
Commission
INTRODUCTION
Chairman Mitchell, Ranking Member Roe, and Members of the
Committee, I am honored to appear before you today to discuss the U.S.
Nuclear Regulatory Commission's (NRC) regulatory role, actions, and
findings to date regarding medical events at the U.S. Department of
Veterans Affairs hospitals, particularly the Veterans Affairs Medical
Center in Philadelphia, Pennsylvania (VA Philadelphia). I hope that my
testimony will be helpful to the Committee's work.
NRC'S REGULATORY ROLE
The NRC is an independent agency created by Congress to license and
regulate the civilian use of radioactive materials. The NRC issues
licenses to facilities that authorize the safe and secure possession
and use of radioactive material. In the nuclear medicine area, the NRC
does not regulate the practice of medicine. NRC's regulations seek to
ensure the adequate protection of those working with radioactive
material, as well as the public and the environment, and that the
patient receives the radiation dose intended and prescribed by the
medical practitioner.
The NRC has a specific set of regulatory requirements for the
medical use of radioactive materials. These regulations include the
definition, criteria, and reporting requirements for medical events.
Prior to 2002, the term ``misadministration'' was used in the
regulations to describe these events. The NRC replaced the term
``misadministration'' with ``medical event'' as this term more
correctly and simply conveys that the radioactive material or the
radiation from the material, was not delivered as directed by the
physician.
The NRC requires licensees to report a medical event because such
an event indicates that the licensee had technical or quality assurance
problems in administering the physician's prescription. A dose error of
20 percent or more may indicate treatment delivery problems in the
medical facility's operations that need correcting. Actual harm to a
patient, whether it is an injury from overexposure or inadequate
treatment due to underexposure, must be determined through a separate
analysis by a physician. In severe events, when the dose error is well
over 20 percent too high or too low, such as the events that occurred
at the VA Philadelphia, NRC inspection teams are supplemented with a
medical consultant, who is a licensed physician. The medical consultant
assesses the patient's risk of harm.
The agency's Region III office, based in Lisle, Illinois, provides
regulatory oversight of the Department of Veterans Affairs' license.
The VA was issued a master materials license (MML) in March 2003. An
MML is issued only to Federal Government agencies or departments and
authorizes the use of radioactive material at multiple sites. The
holder of the MML is responsible for ensuring that NRC requirements are
met. Prior to issuance of the MML, the NRC issued a separate license to
each VA site throughout the United States. The VA's license requires
the VA to establish an internal, independent framework of oversight
consistent with NRC regulations, and with inspection and enforcement
policies, procedures, and guidance. Within this framework, the
responsibility for patient safety and day-to-day oversight of VA
medical procedures using radioactive materials lies with the VA's
National Radiation Safety Committee. The VA's National Health Physics
Program (NHPP) acts as the VA's regulatory organization and is
responsible for issuing permits, conducting inspections and event
follow-up, investigating incidents, allegations, and enforcement.
BACKGROUND OF THE VA MEDICAL CENTER IN PHILADELPHIA
VA Philadelphia began performing permanent implant prostate
brachytherapy in 2002, using contracted doctors from the University of
Pennsylvania Hospital. The NRC received a report of a potential medical
event in 2003. The NRC conducted an inspection and examined the record
of the event, as well as the procedures for prostate implants, and
interviewed the physician involved but did not identify any violations
of NRC regulations. In 2005, a similar potential medical event was
reported to the VA's NHPP. The NRC was informed of the event and
evaluated the performance of the NHPP inspectors by observing the NHPP
inspection of the event. NHPP did not identify any violations at VA
Philadelphia.
On May 18, 2008, the NRC received notification of a potential
medical event from the VA that a patient undergoing treatment for
prostate cancer at the VA Philadelphia received a dose that was over 20
percent lower than what was prescribed.
In response to this prostate under dose at VA Philadelphia, the
NHPP conducted an inspection at the facility in May 2008. Based on the
preliminary inspection findings, the NHPP requested VA Philadelphia to
review more prostate brachytherapy treatments. Ultimately, all 116
prostate brachytherapy treatments performed since the inception of the
program were reviewed by the VA.
NRC'S RESPONSE TO DATE
NRC closely followed the initial actions of the VA Philadelphia and
the NHPP and, based on additional potential events, determined that it
was necessary to accelerate our direct involvement.
First, the NRC conducted an independent inspection at VA
Philadelphia in July 2008. Second, based on the NRC's preliminary
inspection findings and the growing number of potential medical events,
the NRC launched a Special Inspection in September 2008. The NRC's
ongoing Special Inspection was tasked to:
conduct further on-site inspections at the VA
Philadelphia;
conduct on-site inspections at all of the VA hospitals
authorized to perform prostate brachytherapy treatments;
review the circumstances surrounding the multiple medical
events at the VA Philadelphia;
assess prostate brachytherapy programs at the other VA
facilities;
assess the performance of the NHPP;
determine whether the problems at the VA Philadelphia
could be affecting other medical facilities; and
conduct, with the assistance of a medical consultant, an
independent assessment of possible health effects on patients who had
received the wrong doses.
Third, in October 2008, the NRC issued a Confirmatory Action Letter
to the VA, which confirms commitments made to the NRC by the VA to
identify, address, and prevent the problems that have led to these
medical events, including the following actions:
conduct NHPP inspections at all 13 VA hospitals
authorized to perform prostate brachytherapy treatments;
develop and implement standardized procedures for
prostate brachytherapy treatments at all VA hospitals;
identify causes of the medical events and implement
corrective actions;
suspend any prostate brachytherapy treatment program
where 20 percent or more of the treatments have been identified as
medical events;
conduct an inspection to confirm that all necessary
corrective actions have been taken prior to restarting any suspended
brachytherapy treatment program; and
conduct an inspection of new prostate brachytherapy
treatment programs prior to start up to confirm they meet the enhanced
standards.
Because the physician conducting many of the prostrate
brachytherapy treatments also worked at a local hospital, the
Commonwealth of Pennsylvania and the local hospital were notified.
The NRC will verify through inspections that the commitments in the
Confirmatory Action Letter have been successfully completed. The VA has
agreed not to restart prostate brachytherapy treatment programs at five
sites, including the VA Philadelphia, until all commitments have been
met.
Fourth, on March 30, 2009, the NRC issued a Special Inspection
Report on the medical events at the Philadelphia VA that identified six
apparent violations of NRC regulations: (1) the failure to develop
adequate written procedures to provide high confidence that each
prostate seed implant administration is in accordance with the written
directive; (2) the failure to develop procedures that address methods
for verifying that administration is in accordance with the treatment
plan and written directive; (3) the failure to train supervised
individuals regarding identification and reporting requirements for
medical events; (4) the failure to instruct a non-supervised individual
regarding identification and reporting of medical events; (5) the
failure to record total dose received by a patient on a written
directive; and, (6) the failure to provide required information in
several 15-day reports to the NRC. In addition to these apparent
violations, the NRC identified concerns involving inadequate management
oversight by the Radiation Safety Officer and the Radiation Safety
Committee at VA Philadelphia, and a pattern of unreported safety
concerns.
Finally, in response to a Demand For Information issued to him by
the NRC, the physician who performed the majority of the brachytherapy
treatments at the VA Philadelphia, confirmed that he is currently not
performing these treatments at any facility--VA or otherwise. He has
also confirmed that he would give prior notification to the NRC if and
when he resumes these treatments.
FUTURE NRC ACTIONS
The NRC is continuing to review the events at VA Philadelphia. We
plan to issue separate Special Inspection reports that will address the
findings of the inspections conducted at VA Philadelphia and at the
other VA facilities authorized to perform prostate brachytherapy
treatments, and the NHPP's performance at the conclusion of these
inspection activities. As part of our response, the agency will
consider what enforcement actions are warranted in these cases. The NRC
will also notify all facilities administering this type of treatment
about findings from these inspections that may inform their practice
and where there may be common implications for the medical community
and other stakeholders. These actions will be publicly available.
The NRC will apply the findings of our evaluations to our own
regulatory practices. In this case, two areas that we have identified
so far as needing increased NRC attention are licensee oversight of
contract doctors and the safety culture at materials licensees. We will
continue to look critically at our licensing and inspection program to
determine what enhancements are needed. The NRC is also assessing
whether any specific changes may be needed to strengthen our regulatory
oversight of the VA's MML with respect to both the VA's internal
regulatory framework and the NRC's regulatory practices.
Prior to the current events at the VA, the NRC had been evaluating,
with input from the nuclear medicine community and other stakeholders,
a proposed change to our regulations that may prohibit physicians from
changing written treatment orders after the procedure begins. The issue
of changing these orders during procedures was identified as a concern
in the practice at the VA Philadelphia.
CONCLUSION
The NRC takes these medical events very seriously and continues our
in-depth inspection. Once we have completed this work, we will evaluate
the VA's response to our findings and determine what enforcement
actions are warranted. Thank you for the opportunity to testify here
today. I would be pleased to respond to your questions.
Prepared Statement of W. Robert Lee, M.D., M.S., M.Ed., Professor,
Department of Radiation Oncology, Duke University, School of Medicine,
Durham, NC, on Behalf of the American Society for Radiation Oncology
Chairman Mitchell, Ranking Member Roe, and Members of this
distinguished Committee, good morning and thank you for the opportunity
to testify today on the use of brachytherapy in the treatment of
prostate cancer. I have personally witnessed the great benefits of
brachytherapy for cancer patients and look forward to telling you the
history of this treatment, how it works, as well as the required
training and safety requirements and clinical practice guidelines.
I received my undergraduate training at the College of William and
Mary studying Chemistry and Classical Antiquities. I matriculated at
the University of Virginia School of Medicine and received my medical
degree in 1989. I completed a residency in radiation oncology at the
University of Florida in 1993. I have held faculty positions at Fox
Chase Cancer Center in Philadelphia, Wake Forest University School of
Medicine in Winston-Salem, NC, and at present I am a Professor of
Radiation Oncology at the Duke University School of Medicine. I have
authored over 100 original articles and reviews on many aspects of
genitourinary cancer. My clinical practice is limited to men with
prostate cancer. Together with my colleagues at Duke, I see more than
300 new patients per year. I have used prostate brachytherapy and
external beam radiation therapy for more than a decade. My particular
research interests are exploring innovation with external beam
radiation treatment of prostate cancer and the measurement of quality
following prostate brachytherapy. In addition, I am the incoming
Chairman of the Residency Review Committee that oversees all radiation
oncology training programs, and I have served as an oral examiner for
individuals that take the radiation oncology board exam. I am also a
Past-president of the American Brachytherapy Society (ABS) and the
Director of the Duke Radiation Oncology Training Program.
I am considered an expert in the field of prostate cancer and
believe my testimony is critical to help Congress and the public
understand that brachytherapy is a very safe procedure with a long
track record of effectively curing cancer with minimal side effects
compared to other treatments. I am not personally involved in the
investigation into the Philadelphia VA and my knowledge of the specific
circumstances in the case consists of a number of reports from the
Nuclear Regulatory Commission (NRC), Department of Veterans Affairs
(VA) and news publications. It is also important to note that neither
I, nor ASTRO, were involved in the accreditation of any health care
facilities, including the Veterans Affairs Medical Centers. Based on
information that 92 medical events were identified out of 116 cases,
including 35 involving unintended doses to an organ or tissue other
than the prostate and 57 events where the dose delivered to the
prostate was less than prescribed, I agree that there is clearly cause
for concern that inadequate care was delivered to veterans treated at
this facility.
While ASTRO is deeply troubled by the problems identified at
brachytherapy programs at the Philadelphia and other VA centers, we are
heartened that NRC investigators have found no evidence of widespread
medical events involving brachytherapy. Based on my clinical training
and my experience with brachytherapy, I would have been very surprised
if investigators found problems with this important radiation therapy
procedure. In fact, there have been only an infinitesimally small
number of reported medical events nationwide.
Each year, there are approximately 50,000 brachytherapy treatments
performed in the United States. According to the Advisory Commission on
the Medical Uses of Isotopes' report to the NRC at a May 2009 meeting,
there were a total of 9 reported medical events involving 111 patients
nationwide in 2008. Of the 111 patients involved, 102 were from 2
medical events that occurred within the VA system. Ninety-two of these
patients were treated at the Philadelphia VA. The other 7 medical
events involved 9 patients--with the most common error being
misidentification of the prostate in transrectal ultrasound (3 medical
events; 3 patients). While the VA investigation spans several years,
these medical events were all reported in 2008. Even with the
consolidation of these medical events into 1 year, only about 0.22
percent of the procedures nationwide resulted in a reportable event.
Brachytherapy is an extremely safe and effective procedure.
My hope is that patients, particularly our Nation's veterans, will
recognize that the situation at the Philadelphia VAMC is an isolated
incident and should not dissuade patients from choosing brachytherapy,
if appropriate, as a treatment for their cancer. At the same time, the
radiation oncology community is committed to working with Federal
regulators to learn from these serious events and apply the lessons to
help ensure that such mistakes don't happen again.
ASTRO and Radiation Oncology
Founded in 1958, ASTRO's mission is to advance the practice of
radiation oncology by promoting excellence in patient care, providing
opportunities for educational and professional development, promoting
research and disseminating research results and representing radiation
oncology in the rapidly evolving health care environment. Radiation
oncologists, radiation oncology nurses, medical physicists, radiation
technologists, dosimetrists and biologists comprise ASTRO's more than
10,000 members, making it the largest radiation oncology organization
in the world. These medical professionals, found at hospitals and
cancer treatment centers around the globe, make up the radiation
therapy treatment teams that are critical in the fight against cancer.
Radiation therapy is the use of various forms of radiation to
safely and effectively treat cancer and other diseases. Doctors use
radiation therapy to eradicate cancer, to control the growth of the
cancer or to relieve symptoms, such as pain. It can be used to treat
cancer in almost any part of the body, although breast cancer, lung
cancer and prostate cancer typically make up more than half of all
patients receiving radiation therapy. Radiation may also be used to
treat several benign diseases, such as non-cancerous tumors, heart
disorders and thyroid problems.
Patients receive radiation therapy in one of two ways: externally
or internally. During external beam radiation, a beam of radiation is
directed to the tumor and immediate surrounding area in order to
destroy the tumor and any nearby cancer cells. Internal radiation, or
brachytherapy, from the Greek word brachy meaning close by, is the
placement of radioactive sources in or next to a tumor. To position the
sources accurately, special catheters or applicators are used. Because
the radiation sources are placed so close to the tumor, doctors can
deliver a large dose of radiation directly to the cancer cells with
minimal exposure to normal tissue.
Radiation therapy works by damaging the DNA in cancer cells so that
they cannot repair or reproduce. New technology and improved techniques
allow radiation oncologists to better target radiation to eliminate
cancer cells while protecting healthy cells. Radiation therapy is less
invasive than other cancer treatments, making it an attractive option
for men and women who want to maintain their lifestyles and jobs while
receiving treatments. When a physician determines that radiation
therapy may be a treatment option for his or her patient, a referral is
made to a radiation oncologist. As highly trained specialists,
radiation oncologists know the various forms of radiation therapy--
brachytherapy or external beam radiation--their efficacy in specific
cases, and the potential side effects and risks.
Radiation oncology practices, including caring treatment teams of
clinical nurses, physicists and technologists, use sophisticated
equipment to provide patients with safe, effective care. Radiation
oncologists discuss and agree upon treatment options with their
patients and their families and plan and deliver that care in
conjunction with the patient's other physicians, as well as non-
physician members of the patient's care team. This team approach
assures that the radiation therapy component of a patient's clinical
care fits appropriately in the overall patient treatment plan.
ASTRO supports Congressional efforts to promote quality measurement
and improvement, particularly through the adoption and effective use of
health information technology (HIT). ASTRO has devoted significant time
and resources to developing clinical guidelines and quality measures
for radiation oncology, including the treatment of prostate cancer.
ASTRO also is proud of the high rates of HIT adoption among radiation
oncology practices. ASTRO is leading efforts to develop
interoperability standards to allow vital clinical information to be
passed seamlessly from one radiation oncology system to another system,
within and across practices, and made readily available at the point of
care. In sum, ASTRO wants patients to have peace of mind when it comes
to safety, quality and efficacy of radiation therapy.
History of Brachytherapy
In the early 1900s, Marie and Pierre Curie laboriously extracted
the element Polonium from tons of Uranium ore and, shortly after,
extracted Radium. In 1901, Pierre Curie, after observing a burn on his
skin from a sample of radium left in his coat pocket, suggested to
doctors at St. Louis Hospital in Paris that a small radium tube be
inserted into a tumor to produce the same effect. This was the birth of
brachytherapy. Independently that same year, Alexander Graham Bell made
a similar suggestion. It was found in these early experiences that
inserting radioactive materials into tumors caused cancers to shrink.
Brachytherapy is a highly effective way of delivering radiation
tailored to the shape of the tumor while sparing surrounding normal
tissues. Estimates are that approximately 40,000 Medicare beneficiaries
chose brachytherapy as part of their cancer treatment plan each year.
Over the last 15 years, sophisticated computerized treatment planning
and advances in medical imaging have helped to achieve increased
accuracy and superior, optimized dose distribution for cancer patients.
Prostate Cancer and Brachytherapy
Much has been made about the difficulty prostate cancer patients
face in determining a treatment option for their disease. Indeed, the
Agency for Health Care Research and Quality issued a February 2008
comparative effectiveness report on therapies for clinically localized
prostate cancer that found that no one therapy--watchful waiting
(active surveillance), surgery to remove the prostate gland (radical
prostatectomy), external beam radiotherapy (EBRT) and interstitial
radiotherapy (brachytherapy), freezing the prostate (cryotherapy) or
androgen deprivation therapy (ADT)--could be considered the preferred
treatment for localized prostate cancer due to limitations in the body
of evidence as well as the likely tradeoffs an individual patient must
make between estimated treatment effectiveness, necessity, and adverse
effects. In 2008, the Institute for Clinical Effectiveness Research in
the United Kingdom suggested that when brachytherapy is clinically
indicated, its high efficacy and low cost make it a particularly cost-
effective option in prostate cancer.
As a prostate cancer expert, I work to analyze the path of my
patient's prostate cancer and discuss with him the benefits and risks
of each treatment option. Some men can safely postpone treatment for
prostate cancer and watch it closely to see if treatment is needed.
This is called watchful waiting or active surveillance. For others,
surgery or external beam radiation therapy may, for a number of
particular clinical reasons, be preferred. If the cancer is relatively
small and not too aggressive and the man has a small prostate and good
urinary function then brachytherapy becomes a reasonable option.
Brachytherapy may be used alone or in conjunction with external
radiation treatments to treat prostate cancer. A combination of
treatments, such as external beam radiation followed by brachytherapy,
is often preferred for men with more advanced cancer. I will advise
patients of the management option that is most appropriate to their
specific case. (For additional information, see Attachment A,
``Radiation Therapy for Prostate Cancer.'')
The benefits of brachytherapy vary depending on the patient, their
priorities, their age and diagnosis stage and preferences.
Brachytherapy is a relatively simple, minimally invasive outpatient
procedure that avoids hospitalization and allows the patient an early
recovery and rapid return to normal activity. It produces good 10-year
outcomes with relatively low morbidity. The benefits of using
brachytherapy in the treatment of early stage prostate cancer are quite
pronounced and include a lower incidence of impotence and incontinence
than is commonly reported with a radical prostatectomy. The high degree
of accuracy achievable in prostate implants nowadays is partly due to
technological improvements, but quality implants still require skill,
adequate training, and attention to detail.
ASTRO has expressed concerns to Congress and the Administration
that financial incentives and rampant self-referral of radiation
therapy services in the Medicare program are leading to patients not
being fully informed on the full range of treatment options,
particularly brachytherapy. Instead, business arrangements have
flourished that involve frequently steering patients to more expensive
and profitable prostate cancer treatments. We hope that the appropriate
concerns over the prostate cancer brachytherapy program at the
Philadelphia VAMC will not exacerbate underuse of this important
treatment option.
Brachytherapy Clinical Practice Guidelines
Prostate brachytherapy, or seed implants, are given by inserting
small metal seeds of radioactive iodine or palladium directly into the
prostate gland. These radioactive sources have relatively low energy
levels and half-lives of between 17 and 60 days. Patients are under
anesthesia during this brief outpatient surgery procedure. The seeds
are temporarily radioactive and deliver the radiation to the prostate
over several weeks. After losing their radioactivity, the seeds remain
in the prostate. The seeds are then harmless and should not bother the
patient. For the short time that the seeds are giving off radiation,
men are asked not to be in close proximity to children or pregnant
women because of the very small chance that the radiation may harm
their rapidly growing bodies.
It is essential that postimplant dosimetry be performed on all
patients undergoing permanent prostate brachytherapy. Dosimetry is the
calculation of the absorbed dose in tissue resulting from the exposure
to ionizing radiation. The dose distributions following implantation
are never exactly the same for each man as those planned prior to the
implant. Because the dose distributions may differ ever so slightly, it
is important to document the actual dose that the prostate and normal
adjacent tissues will receive over the life of the implant. This can
only be determined if a postimplant dosimetric assessment is performed.
It is my understanding that this key step may have been missed in the
cases that were reviewed for the NRC report.
The information obtained from postimplant dosimetry is essential
for optimal patient care. Significant over-dosing of the prostate may
increase the risk of side-effects. Significant under-dosing of the
prostate can lead to treatment failure. The latter can potentially be
rectified using supplemental external beam radiation therapy or
additional seed implants. While the timing may vary in part due to the
half-life of the isotope, the most reproducible dosimetric results will
be obtained if the scan is performed 1 month post-implant.
According to clinical practice guidelines, brachytherapy is
indicated for treatment where the target volume or tumor can be well
defined and is accessible to source placement. The goal of treatment
(curative, palliative, or to establish local tumor control) should be
documented as clearly as possible. Treatment options and their relative
merits and risks should be discussed with the patient. A summary of the
consultation should be communicated to the referring physician.
Guidelines also recommend that brachytherapy involve the
interaction of multiple specialists. The choice and placement of
radioactive sources are the responsibility of the radiation oncologist.
Each type of brachytherapy procedure has its own set of unique
characteristics. The brachytherapy team should operate according to an
established system of procedural steps that have been developed by the
radiation oncologist and brachytherapy team members. This systematic
approach to applicator or source insertion should include a description
of pre-implantation steps, sedation or anesthesia procedures, the
specific applicators used, and the insertion techniques. Standard
orders or care guidelines may enhance the systematic approach to the
insertion process.
At the conclusion of the course of treatment, a written summary of
the treatment delivery parameters is generated, including the total
dose of brachytherapy and the total dose of external beam therapy if
given, treatment technique, treatment volume, acute side effects,
clinical course, and patient disposition. Patients treated with
brachytherapy should be evaluated after treatment at regular intervals
by the radiation oncologist for response and early and late effects on
normal tissues.
NRC Training Requirements
As you know, the NRC has jurisdiction over the use of radioactive
materials--including medical isotopes--and safety measures to protect
the public and patients. Unlike other medical procedures where
physicians must simply have a State license to practice medicine, the
NRC requires certain training requirements for physicians who use
radioactive materials. While the NRC recognized an alternative pathway
to achieve permission to perform permanent seed implants with similar
requirements, most radiation oncologists meet or exceed NRC's
requirement that physicians complete a 3-year radiation oncology
residency training (The Accreditation Council for Graduate Medical
Education (ACGME) requires 4 years of training).
This training must include a structured educational program in
basic radionuclide handling techniques applicable to the use of
brachytherapy sources that includes 500 hours of work experience in
preparing, implanting, and removing brachytherapy sources; using
administrative controls to prevent a medical event involving the use of
radioactive material; ordering, receiving and unpacking radioactive
materials safely and performing the related radiation surveys; checking
survey meters for proper operation; maintaining running inventories of
material on hand; and using emergency procedures to control radioactive
material. Further, the NRC requires these radiation oncology residency
programs to include 200 hours of classroom and laboratory training in
radiation physics and instrumentation, radiation protection,
mathematics pertaining to the use and measurement of radioactivity, and
radiation biology.
These combined 700 hours are in addition to the extensive clinical
training in oncology, such as taking histories and conducting physical
exams, understanding behavior and spread of cancers, interpreting
pathology reports and laboratory tests, and evaluating scans and X-
rays. Finally, those physicians who have successfully completed a
radiation oncology residency program must then pass an oral exam
related to these topics. As an examiner for the Board, I find students
who have completed the training to be quite thorough in their knowledge
of radiation biology and safety and the appropriate clinical
applications for radiation to treat cancer. Those who are not thorough
in their knowledge do not pass this rigorous exam.
The brachytherapy team also includes a medical physicist. Per NRC
requirements, medical physicists who are authorized to participate in
brachytherapy must have a master's or doctoral degree in physics,
medical physics or other physical science (such as engineering or
applied mathematics from an accredited college or university) and have
2 years of full-time practical training and/or supervised experience in
medical physics under the supervision of a medical physicist who is
board certified or working with a physician who performs brachytherapy.
A variety of applicators are used in brachytherapy. These
applicators, as well as treatment-planning computers and software, and
treatment aids should be appropriately selected for the clinical
application. Regular inspection, maintenance, and repair of this
equipment are mandatory. In general, the physicist supervising the
quality improvement program is responsible for documenting the
maintenance and repair of manual equipment and applicators. The Medical
Director of Radiation Oncology is responsible for the institution and
ongoing supervision of continuing quality improvement (CQI). It is the
responsibility of the director to identify problems, see that actions
are taken, and evaluate the effectiveness of the actions.
The NRC also requires that brachytherapy is administered according
to a written directive that must be signed and dated by the radiation
oncologist. Before loading, the written directive must designate the
treatment site, the type of radiation (isotope) to be used, the number
of sources, the planned dose, and the dose rate to designated points.
Applicator geometry and isotope positions are defined with simulation
radiographs. The specific isotope positions are designated by the
radiation oncologist. Computerized dosimetry is performed by the
medical physicist or designee and approved by the radiation oncologist.
Independent verification of brachytherapy dose calculations (by another
person or another method) is done pre-treatment.
Prostate Brachytherapy at Duke
As an example, I would like to share with the Committee the safety
protocols and procedures for brachytherapy at my institution. I believe
these protocols are representative of those across radiation oncology
departments nationwide as they rely on published guidelines and best
practices. Our own procedure at Duke is as follows:
Initial consultation with patient
a. History, physical exam, and review of all pertinent lab and
scan data.
b. Determine whether or not treatment for the prostate cancer is
necessary and, if so, whether or not brachytherapy is an appropriate
option.
c. Determine whether the patient fully understands all their
options together with the advantages and disadvantages of each
approach.
Volume study
The patient returns to have a complete assessment of their prostate
made by the radiation oncologist and a urologist. This involves a
transrectal ultrasound (TRUS) study in which a series of images are
taken through the entire length of the prostate. On each of these, the
radiation oncologist outlines the ``target volume''. This is usually
the prostate plus, in some cases, a small margin if there is concern
that the cancer may have leaked through the prostate capsule. In some
cases, where there are case-specific concerns about the risk of side
effects the target volume may be less than the entire prostate. The
images are then downloaded to a computer containing the radiation
planning software. A record is made of the exact position of the
patient during the volume study so that the position may be reproduced
at the implantation procedure in the operating room on a subsequent
date. If, for anatomic reasons the prostate is poorly visualized or if,
on scan, it is determined that the prostate has a large median lobe or
the bladder empties incompletely, then the patient will not proceed to
brachytherapy. We will choose a different option as the risk of a
complication is increased by any of these factors.
At the end of the procedure, the radiation oncologist writes
clearly the preferred choice of radioactive isotope (iodine or
palladium) and the prescription radiation dose in grays (Gy). The
radiation oncologist will also state constraints for specific normal
tissues (e.g., the urethra is not to receive more than 130 percent of
the prescribed dose or, say, reduce dose to the anterior base of the
prostate to 90 percent). These constraints are tailored to patients
individually and help to minimize morbidity. The radiation oncologist
will specify whether seeds are to be ``free'' or ``stranded''.
Plan development
The physicist will then reconstruct a 3-dimensional image of the
prostate on a computer and then determine the best number and
``activity'' of the seeds and their best placement within or around the
prostate in order to match the radiation oncologists prescription. The
radiation oncologist will then choose between several of these plans
picking the best for the individual patient. Each needle is planned to
deliver one or more seeds at the pre-determined insertion point in the
prostate and a check list of these needle locations is then drawn up.
The plan is then verified by a second physicist. This plan which
includes the dose prescription and number and activity of seeds is the
written directive. A date is made for the brachytherapy procedure and
the seeds ordered.
Pre-operative testing
A physical exam and relevant blood work, EKG and chest X-ray are
taken 1 week before the procedure to determine the patients suitability
for general anesthesia. The patient is given a prescription for
antibiotics to reduce the risk of infection, an alpha-blocker to
improve the urine flow in the first post-implant month, and
occasionally a steroid medication. The latter is given to those with
larger prostate glands to reduce the risk that, as a result of acute
swelling, they will be unable to urinate after the procedure.
Radioactive source intake
Upon arrival at Duke, the physicist will determine the position of
the seeds within the pre-loaded brachytherapy needles and verify by X-
ray film. The film exposes the exact location of each seed and this
allows a check on the number and position of each seed within each
needle.
Brachytherapy procedure
a.................................. ``Time out'' in which all Members
of the team (radiation oncologist,
urologist, anesthesiologist,
operating room nurse and
physicists) agree on the patient
using two different identifiers
and the procedure.
b.................................. The plan is once again checked by
radiation oncologist and
physicist.
c.................................. General anesthesia is used to
ensure an immobile patient.
d.................................. The patient is placed in a position
that mirrors the one used in the
volume study.
e.................................. Aerated gel is placed into the
urethra to visualize, and thus
avoid, the urethra.
f.................................. Transrectal ultrasound is placed
into rectum and manipulated until
the image exactly mirrors the
image obtained at volume study.
The probe is then locked into
place. If visualization is poor
the procedure is canceled.
g.................................. Needles containing seeds are
numbered according to the plan and
called sequentially by the
physicist. A double check on the
correct number of seeds is made by
observing the length of protrusion
of the trocar from each needle.
The protrusion length correlates
exactly with seed number. Each
needle is then placed into the
correct position within the
prostate as called by the
radiation physicist working from
the plan and the checklist. The
correct placement is ensured by
visualizing each numbered needle
as it passes through a perineal
template and into the prostate
gland. The needle location is
verified using transverse images
which show its side-to-side and up-
and-down location and a sagittal
image which shows whether or not
the needle has reached the correct
depth within the prostate. Image
verification is made for each
needle and a double check comes
from measuring the degree of
protrusion of the needle from the
template. When needles are
correctly placed, and agreement
reached between physicist and
radiation oncologist, the seeds
may be unloaded into the prostate.
h.................................. At repeated intervals during the
procedure, an assessment is made
of the position of the prostate
base as this can become deeper if
the prostate swells.
i.................................. A final check is made with
ultrasound and/or fluoroscopy to
determine whether any regions of
the prostate appear under-
implanted and whether or not there
are any seeds in the bladder.
j.................................. If any visible area of under-
implantation is identified,
additional seeds, which are always
pre-ordered, may be inserted at
this point and a notation is made
of their number.
k.................................. The bladder may be irrigated or a
cystoscopy performed in the
unlikely event that a seed has
passed into that organ. If so, the
seed is retrieved safely and
either a substitute seed is
inserted or its absence noted.
l.................................. The patient is awakened and brought
to the recovery room.
m.................................. The patient goes home one to 4
hours later once he has urinated
spontaneously.
n.................................. Prior to departure from the
hospital, measurements are taken
of radiation activity at the
patient's skin surface and at one
meter. These are to ensure safe
levels for family members.
Measurements are taken within the
operating room, recovery room, and
from the patients urine and linen
to ensure no seeds have been
unknowingly lost.
o.................................. The patient goes home with
procedure safety instructions, a
lead container and a urinary
sieve. They are instructed to pass
their urine through this sieve
and, if any seeds are retrieved,
to place them into a lead
container with tweezers and bring
them back to the Duke Radiation
Oncology Department during their
next visit.
Post-implant dosimetry
Approximately 1 month after the procedure, patients return for a
history and physical evaluation to determine whether or not the side
effects are in line with expectations and to determine that they are
successfully emptying their bladders. Any passed seeds may be returned
to the radiation oncologist at this time and these must be accounted
for in the post-implant dosimetry.
A CT scan is performed of the prostate area and the images analyzed
using seed identification software. The prostate is then outlined and a
computer calculation then made by the physicist of the radiation
distribution. The volume drawing and measurements are performed by the
trained physicist independent of the radiation oncologist to ensure
veracity and consistency. Certain measurable parameters are collected
including the urethral dose and the dose to the rectum to confirm that
it is not greater than the dose prescribed. These may be used for
internal quality control and for comparison with national measures.
These parameters are peer-reviewed by the multidisciplinary
genitourinary radiation oncology group within our department.
Medical events
At Duke, we adhere to the following protocols that conform to NRC
regulations. Per those protocols, we determine that a medical event has
occurred if any of the following situations apply:
1. Wrong patient treated.
2. Wrong area/side implanted (for a partial prostate implant).
3. Wrong isotope used.
4. Wrong dose used in patient ( 20 percent).
If it is determined that a medical event has occurred, a report is
immediately made to the Duke Radiation Safety Officer, who evaluates
and reports to the NRC. The patient and referring physician would also
be alerted immediately. ASTRO and ABS are participating in the NRC's
rulemaking process to ensure that the revised definition of a medical
event for permanent implant brachytherapy protects the safety of
patients.
Subsequent follow-up
Visits to the radiation oncologist in the clinic occur every 3 to 6
months. History, physical exam, and PSA measurement are performed at
each visit. Parameters are recorded in the institutional prospective
quality assurance database.
Finally, I would like to illustrate the benefits of brachytherapy
by telling you the story of one of my patients. He is a 50-year-old
university professor and ardent long-distance runner whom I first met
about 8 years ago. He had early stage prostate cancer and after
discussion of all treatment options, he elected prostate brachytherapy.
He told me that he chose brachytherapy so that he could continue to
teach his students, coach his daughter's soccer team and train for an
upcoming marathon. I, along with my colleagues at Wake Forest,
performed prostate brachytherapy in the spring and he ran in the Marine
Corps marathon later that year. His postimplant dosimetry was good and
7 years after his treatment, his PSA is undetectable and he has
excellent urinary function. He has run in a marathon every year since
his treatment.
ASTRO shares the Committee's concerns about the health and safety
of veterans and recognizes the importance of maintaining veterans'
access to high quality cancer treatment. We support the NRC's
investigation into the causes of the medical events at the Philadelphia
VAMC. By bringing these issues to the forefront, necessary steps can be
taken to implement corrective actions and enhance quality of care
standards for prostate cancer treatments at all VA hospitals. ASTRO
appreciates the opportunity to work closely with the Committee and NRC
to ensure the safety of radioactive materials for medical use.
ASTRO is committed to ensuring that radiation oncologists and
members of the treatment team adhere to strict safety standards and
clinical guidelines for all radiation therapy, including brachytherapy.
Thank you again for the opportunity to testify.
Online References:
Agency for Health Care Research and Quality (http://
www.effectivehealthca
re.ahrq.gov/repFiles/2008_0204ProstateCancerExecSum.pdf)
American Brachytherapy Society
(www.americanbrachytherapy.org)
American College of Radiology
(http://www.acr.org/SecondaryMainMenuCategories/quality_safety/
guidelines/ro/low_dose_rate_brachytherapy.aspx;
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/
app_criteria/pdf/
ExpertPanelonRadiationOncologyProstateWorkGroup/
PermanentSourceBra
chytherapyforProstateCancerDoc5.aspx)
American Urologic Association (http://www.auanet.org/
content/guidelines-and-qualitycare/clinical-guidelines/main-reports/
proscan07/content.pdf)
Nuclear Regulatory Commission (http://www.nrc.gov/
reading-rm/doccollections/cfr/part035/)
RT Answers (www.rtanswers.org)
Bibliography:
Nag, S et al. American Brachytherapy Society (ABS)
Recommendations for Transperineal Permanent Brachytherapy of Prostate
Cancer, Int. J. Radiation Oncology Biol. Phys., Vol. 44, No. 4, pp.
789-799, 1999.
Nag, S et al. American Brachytherapy Society (ABS)
Recommendations for Permanent Prostate Brachytherapy Postimplant
Dosimetric Analysis, Int. J. Radiation Oncology Biol. Phys., Vol. 46,
No. 1, pp. 221-230, 2000.
Prepared Statement of Joseph A. Williams, Jr., RN, BSN, MPM, Assistant
Deputy Under Secretary for Health for Operations and Management,
Veterans Health Administration, U.S. Department of Veterans Affairs
Good morning, Mr. Chairman and Members of the Subcommittee. Thank
you for the opportunity to discuss the Department of Veterans Affairs'
(VA) enforcement of VA's brachytherapy program safety standards. I am
accompanied today by Dr. Madhulika Agarwal, Chief Officer, Patient Care
Services, Veterans Health Administration (VHA); Dr. Michael Hagan,
National Director for Radiation Oncology in VHA; E. Lynn McGuire, MS,
DABMP, National Health Physics Program Director in the Office of
Patient Care Services, VHA, Michael E. Moreland, FACHE, Network
Director, VA Health care--VISN 4, and Dr. Richard Whittington, a
physician at the Philadelphia VA Medical Center (VAMC).
My testimony today will briefly describe brachytherapy, review what
happened at the Philadelphia VAMC, explain VA's enforcement of safety
standards for brachytherapy, and discuss the current status of these
programs throughout VA. Brachytherapy for prostate cancer is a form of
nuclear radiotherapy where small radioactive seeds are implanted in the
prostate to destroy cancerous cells. Although risk to healthy tissues
in the body is minimal, side effects may occur. Brachytherapy is an
appropriate treatment approach for low-risk patients with prostate
cancer, but implant quality must be monitored closely in each case and
programs performing this procedure must be regularly reviewed.
VA acknowledges that some of the brachytherapy treatments provided
at the Philadelphia VAMC did not deliver the intended dose; we regret
this occurred. We have notified patients by mail and by telephone and
are covering all costs associated with additional tests while
continuing to monitor the care of our patients, whether they are seen
at VA or private facilities. A review by independent, external
physicians and physicists with no involvement in the Philadelphia
VAMC's brachytherapy program examined patient scans, dosages and
medical records and discovered that 92 events involving under-dosing or
doses to organs other than the treatment site were found that met the
definition of a medical event according to the Nuclear Regulatory
Commission (NRC). It is important to highlight that the definition of
``medical event'' does not necessarily mean Veterans were harmed, and
experts still debate the long-term impact of this treatment. We are
working with NRC on regulatory issues related to prostate
brachytherapy, and NRC is refining the definition of ``medical event''
as it pertains to these procedures. The Philadelphia VAMC's
brachytherapy program has been suspended since June 2008 and will not
be reopened until NRC's concerns have been satisfied and until
requirements of the VA's Radiation Oncology program are met. VA's
National Health Physics Program (NHPP) is responsible for radiation
safety oversight through a license issued by NRC and reports to VA's
National Radiation Safety Committee. NHPP has conducted site
inspections at all facilities where prostate brachytherapy is performed
and when a possible medical event is reported.
Enforcing program safety standards is essential to ensuring
patients receive the care they require. VA, as do other health systems,
relies on complementary systems of accountability to identify quality
problems like these on the system and individual levels. We use
multiple internal and external survey and inspection processes (e.g.,
Joint Commission, American College of Radiology Oncology, American
College of Radiology, Nuclear Regulatory Commission, and others);
patient satisfaction and complaints; and individual peer review. The
deficits in this program at the Philadelphia VAMC went undetected by
many of these systems for almost 6 years, and it was only the
recognition of potential problems by the staff at the Philadelphia VAMC
that eventually led to more in-depth investigation, review and
subsequent disclosure to patients and the public.
In November 2008, VA amended the criteria for suspending a prostate
brachytherapy program to require immediate suspension of any such
program where medical events are discovered for 20 percent or more of
patient treatments reviewed or evaluated for regulatory compliance. VA
is requiring these reviews use a minimum sample size of 10 recent
patient treatments or the total number of patient treatments in the
last 3 years, whichever is less, for initial evaluation. If 20 percent
or more patient treatments are discovered as medical events, VA
requires increasing the sample size to at least 30 or all patient
treatments within the last 3 years, whichever is less. If 20 percent or
more of the final sample size is confirmed to be medical events, the
program must be immediately suspended. Moreover, VA also requires its
NHPP to inspect any report of medical events to confirm regulatory
compliance and implementation of VHA standard procedures. VA will
suspend any prostate brachytherapy program if the results of this
inspection indicate significant program deficiencies and program
suspension is deemed warranted by the National Radiation Safety
Committee in consultation with the Director of the National Radiation
Oncology Program and the Principal Deputy Under Secretary for Health.
In response to concerns raised by NRC and to ensure other VAMCs
were performing prostate brachytherapy procedures correctly, VA
completed inspections by January 2009 of all VA facilities with active
programs. VA also developed and implemented standard procedures for
prostate brachytherapy programs, addressing quality assurance measures
and patient safety. These include the following:
Initial and periodic training for physicians, medical
physicists, dosimetrists, and Radiation Safety Officers and staff;
Training in the definition and criteria of medical
events, how to identity a medical event, and reporting requirements for
medical events;
Methods and procedures for verifying correct seed
placement and determining proper needle placement during prostate
brachytherapy procedures;
Preparation and completion of written directives; and
Methods and procedures for pre-implant treatment
planning, post-implant treatment planning, and post-treatment dose
analysis.
VA clinical standards and procedures are now among the most
rigorous in the health care industry.
Regarding future actions to prevent similar situations, VA has
asked the American College of Radiology (ACR) to conduct site surveys
at each facility performing brachytherapy for prostate cancer. Our goal
is 100 percent accreditation of our facilities; nationally in the
private sector and VA, only 15 percent of practices are accredited now.
Furthermore, each facility performing permanent implant prostate
brachytherapy must develop, maintain and implement written procedures
based on the American College of Radiology's ``Practice Guidelines for
Transperineal Permanent Brachytherapy of Prostate Cancer'' and
publications by the American Association of Physicists in Medicine. We
are also drafting a VHA handbook for radiation oncology.
VA has used the situation in Philadelphia to conduct a
comprehensive review of its prostate brachytherapy programs. Fifteen VA
facilities have provided prostate implants since 2005, although two,
Reno, NV and Birmingham, AL, are currently inactive without plans for
resumption. Seven facilities, including Albany, NY, Boston, MA,
Brooklyn, NY, Minneapolis, MN, Richmond, VA, San Francisco, CA, and
Seattle, WA, are currently active and offering brachytherapy
treatments. In our comprehensive review, we found these facilities have
provided appropriate treatments. VA's NHPP has temporarily suspended
four programs, including Cincinnati, OH; Washington, DC; Jackson, MS;
and Philadelphia because problems were found involving under-dosing.
Based upon these reviews, the Cincinnati program was found to be in
compliance with VA standards and is in the process of fulfilling
national VA requirements for resuming prostate brachytherapy. Complete
reviews of the Jackson and Washington programs continue. Problems with
the treatments offered at the Philadelphia VAMC were discussed
previously. The Durham, NC, VAMC has voluntarily chosen to no longer
provide this procedure in-house and is providing this service through a
fee-basis agreement with Durham Regional Hospital. The VA Greater Los
Angeles Health Care System in California has elected to pause its
program to conduct a review of procedures, with new patients scheduled
for July 2009.
Secretary Shinseki and VA's senior leadership are conducting a top-
to-bottom review of the Department and are implementing aggressive
actions to ensure the right policies and procedures are in place to
protect our Veterans while providing them the highest quality health
care possible. It is important that our Veterans and their loved ones
have faith and confidence in our medical system and in our system of
care. Thank you once again for the opportunity to testify. My
colleagues and I are prepared to answer your questions at this time.
Statement of Gregory E. Desobry, Ph.D., Medical Physicist,
Division of Medical Physics, Department of Radiation Oncology,
University of Pennsylvania, School of Medicine, Philadelphia, PA
Mr. Chairman and Members of the Committee, thank you for the
invitation to appear here today. I would like to use my time to provide
you with some information about my background, as well as a description
of the medical physicist's role in prostate brachytherapy.
Before undertaking my graduate studies in physics, I studied for
about 10 years in the Jesuit order of the Catholic church. During that
time, among other things I did missionary work in Zambia, teaching
junior high school students science, math, and English. Afterward, I
returned to school, and in 1976 I was awarded a Ph.D. in physics from
the University of Virginia. My early career as a physicist included
work for the McDonnell Douglas Corp. in Houston, Texas, designing and
testing NASA's space shuttle software.
I began studying to become a medical physicist in 1986, and in
1989, I was certified by the American Board of Radiology in therapeutic
radiological physics. Thereafter, I was an assistant physicist at the
MD Anderson Cancer Center in Houston and a clinical physicist for Fox
Chase Cancer Center in Philadelphia. In 1999, I joined the Department
of Radiation Oncology at the University of Pennsylvania.
I first assisted with prostate brachytherapy implants a few years
thereafter, received some training from Dr. Richard Whittington, and
worked part-time at the Philadelphia Veterans Affairs Medical Center
from the start of the prostate brachytherapy program there in 2002
until 2007.
A medical physicist does three things to assist In prostate
brachytherapy.
First, based on the doctor's prescription, which specifies the
amount of radioactivity to be implanted into the patient, the physicist
prepares what is called a preplan. To do this, the physicist will
review a series of ultrasound images of the prostate that is taken by a
doctor and in which the doctor has identified the prostate. With this
information from the doctor, the physicist will plan the places where
the radioactive seeds should be implanted into and around the prostate
and estimates the radioactive dose to be delivered to the prostate.
This plan always is confirmed (or revised) by the doctor.
Second, not long before the doctor is to perform the implant, the
physicist will verify that the activity level and the loading of the
seeds is correct. The physicist also delivers the seeds to the doctor
in the operating room.
The third thing a physicist does takes place after the implant. At
the PVAMC, the doctor would order a CT scan of the patient's prostate
the day after the implant. On this CT scan, the physicist would
identify the location of the implanted seeds, using a dedicated
computer program for this purpose.
Once this was done, the doctor would locate the prostate on the CT
scan and draw it in. This would allow the computer program to generate
a ``dose volume histogram,'' essentially a graph showing how much of
the prostate received how much of a dose, as well as different dose
parameters. This information is often referred to as ``post-implant
dosimetry.''
Post-implant dosimetry is performed so that the doctor might
evaluate the implant as part of his overall assessment of his ongoing
treatment plan for the patient.
I recognize that the Committee may have questions, and I will do my
best to answer them.
Again, thank you for your consideration of my testimony.
Statement of George Lazarescu, Ph.D., Medical Physicist,
Division of Medical Physics, Department of Radiation Oncology,
University of Pennsylvania, School of Medicine, Philadelphia, PA
Mr. Chairman and Members of the Committee, thank you for the
invitation to appear here today. I will offer in these prepared remarks
a brief description of my background.
I received a Ph.D. in physics in 1974 from the Institute for Atomic
Physics in Bucharest, Romania, and in 1991 was graduated with a master
of science in medical physics from the Medical Physics Graduate Program
of the Wayne State University School of Medicine in Detroit, Michigan.
In 1996, I was certified in radiation oncology physics by the American
Board of Medical Physics, which is a certification recognized by the
American Board of Radiology.
From 1996 to 2003, I was an associate professor at the State
University of New York Health Science Center in Brooklyn, New York, and
in 2003 I joined the Hospital of the University of Pennsylvania's
Department of Radiation Oncology as a medical physicist. My clinical
work since that time has primarily been at the Philadelphia Veterans
Affairs Medical Center, working with external beam radiotherapy.
I recognize that the Committee may have questions, and I will do my
best to answer them. Again, thank you for your consideration of my
testimony.
Statement of Hon. Cliff Stearns,
a Representative in Congress from the State of Florida
Thank you, Mr. Chairman.
I am pleased to be here for this important hearing, although I do
wish we were here under better circumstances.
For almost 6 years, serious problems with the brachytherapy program
at the Philadelphia VA Medical Center (VAMC) went undetected. That's 6
years in which potential harm could have been caused to some of our
Nation's veterans seeking treatment for prostate cancer. Presently, 4
of the VA's brachytherapy programs have been suspended--this is a
worrisome number given there are only a total of 7 active programs at
the moment--so more than half of the VA's active brachytherapy programs
are suspended. That's a dismal statistic.
From May through October 2008, a series of ``medical events'' were
finally detected and reported, with the stand-out case being the Philly
VAMC in which 92 events involving either under dosing, or dosing to
organs other than the intended treatment site, were reported. Seventeen
other medical events were also reported at VA Medical Centers in
Jackson, MS, Cincinnati, OH, and Washington, DC.
I am dismayed that prior to this issue coming to light, the VA did
not have standard procedures for prostate brachytherapy programs,
including methods and procedures to verify seed placement and for
determining proper dosage of post treatment dose analysis. It seems
like the VA is often more reactive than proactive, and this shouldn't
be the case given the fact that the VA is a national leader in quality
health care.
To the VA's credit, they have taken proper action since the
discovery of these problems, and they appear to be working toward a
comprehensive makeover of its brachytherapy programs. However, VA
ultimately holds responsibility for the safety and health of our
veterans treated at VA facilities.
It is my hope that today's hearing will afford us the opportunity
to address the issues surrounding the evolving definition of a
reportable ``medical event,'' and to clear up the discrepancy over why
there was no peer review or Quality Assurance of the brachytherapy
program at the Philly VA.
Thank you, and I look forward to the hearing.