[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
MEDICAL RADIATION: AN OVERVIEW OF THE ISSUES
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 26, 2010
__________
Serial No. 111-100
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
_____
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah JOHN SULLIVAN, Oklahoma
JANE HARMAN, California TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
C O N T E N T S
__________
Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Hon. Ed Whitfield, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 3
Prepared statement........................................... 5
Hon. Betty Sutton, a Representative in Congress from the State of
Ohio, opening statement........................................ 8
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 9
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 16
Prepared statement........................................... 18
Hon. Sue Wilkins Myrick, a Representative in Congress from the
State of North Carolina, prepared statement.................... 25
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 132
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, prepared statement.................................... 141
Hon. Tammy Baldwin, a Representative in Congress from the State
of Wisconsin, prepared statement............................... 143
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 146
Witnesses
James and Donna Parks, Gulfport, Mississippi..................... 27
Prepared statement........................................... 30
Suzanne Lindley, Canton, Texas................................... 32
Prepared statement........................................... 35
Rebecca Smith-Bindman, M.D., Professor in Residence, Radiology
and Epidemiology and Biostatistics, Obstetrics, Gynecology, and
Reproductive Medicine, University of California, San Francisco. 37
Prepared statement........................................... 40
Eric E. Klein, Ph.D., Professor of Radiation Oncology, Washington
University in St. Louis........................................ 46
Prepared statement........................................... 48
Cynthia H. McCollough, Ph.D., Director, CT Clinical Innovation
Center, Department of Radiology, Mayo Clinic, Professor of
Radiological Physics, College of Medicine, Mayo Clinic......... 50
Prepared statement........................................... 53
Tim R. Williams, M.D., Chair, Board of Directors, American
Society for Radiation Oncology (ASTRO)......................... 74
Prepared statement........................................... 77
Michael G. Herman, Ph.D., President, American Association of
Physicists in Medicine......................................... 87
Prepared statement........................................... 89
Answers to submitted questions............................... 157
Sandra Hayden, B.S., R.T(T), Vice Speaker of the House, American
Society of Radiologic Technologists............................ 93
Prepared statement........................................... 95
Answers to submitted questions............................... 162
E. Steven Amis, Jr., M.D., FACR, Former Chair, Board of
Chancellors, American College of Radiology..................... 101
Prepared statement........................................... 103
Answers to submitted questions............................... 167
Kenneth Mizrach, MHA, Director, VA New Jersey Health Care System,
Department of Veterans Affairs................................. 107
Prepared statement........................................... 109
Answers to submitted questions............................... 173
David N. Fisher, Executive Director, Medical Imaging Technology
Alliance....................................................... 111
Prepared statement........................................... 113
Answers to submitted questions............................... 204
John J. Donahue, Vice-Chairman, Medicalis, Inc................... 123
Prepared statement........................................... 125
Answers to submitted questions............................... 207
Submitted Material
Statement of H. Michael Heuser, submitted by Mr. Waxman.......... 12
Statement of the Society of Interventional Radiology............. 149
Statement of the Society for Radiation Oncology Administration... 153
MEDICAL RADIATION: AN OVERVIEW OF THE ISSUES
----------
FRIDAY, FEBRUARY 26, 2010
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:03 a.m., in
Room 2123 of the Rayburn House Office Building, Hon. Frank
Pallone, Jr. [Chairman of the Subcommittee] presiding.
Members present: Representatives Pallone, Eshoo, Green,
Schakowsky, Barrow, Christensen, Castor, Sutton, Waxman (ex
officio), Whitfield, Shimkus, Myrick and Gingrey.
Staff present: Steve Cha, Professional Staffer; Ruth Katz,
Chief Public Health Counsel; Elana Leventhal, Professional
Staff; Eric Flamm, FDA Detailee; Alvin Banks, Special
Assistant; and Chad Grant, Legislative Analyst.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. The Subcommittee is called to order and today
we are meeting to discuss the topic medical radiation and the
overview of the issues.
By now, I am sure many of you have read or at least heard
of the New York Times article series on medical radiation
errors. The patient's stories highlighted in those articles are
heartrending and they have raised huge concerns and questions
for me as well as for many of my fellow members in the House of
Representatives. I actually was just reading now today's New
York Times where there is a front page story about a group, a
radiation oncology group in Melbourne, Florida that raised a
lot of the issues. I mean the article today raised many of the
issues that we are going to bring out today but particularly
disturbing was the fact that this group practice apparently had
the physicians who were not present, who were actually overseas
and were billing on the assumption that those physicians were
present and I guess had to be present under the rules and yet
they were not. So those are some of the problems that are
highlighted in today's New York Times and have been in a whole
series.
I want to start, however, by saying that medical radiation
undoubtedly saves lives. It has reshaped the world of
diagnostics and has offered patients less invasive alternatives
for treating complex and life-threatening conditions.
Personally, I don't want to express any concern that in having
this hearing that we are sending the message that medical
radiation is bad. I want to assure you that that is not the
case. It is important that patients do not stop going to their
scheduled treatments or getting their CAT scans when they need
them, and we are not here today to make the statement that
medical radiation should not be used.
But we are here today to learn more about the field and to
examine what the driving factors are when things go wrong. Due
to the dangerous nature of these technologies, when things do
go wrong the effects on patients are horrendous. As mentioned,
the benefits that we as a society have gained from these
advances are enormous but we often forget the fact that we are
still dealing with something that is toxic to the human body.
When it is delivered correctly, a single CAT scan can deliver
as much radiation as 300 chest x-rays. With the operating
technology as powerful and dangerous as this it is even more
crucial that quality and safety are always front and center,
but tragically, as highlighted in these New York Times
articles, this is not always the case. A procedure with such a
small margin of error should be stringently overseen and
monitored but these critical steps appear to be lacking in many
cases.
With all the advances the industry has made, these
technologies have become more complex and complicated to
operate. It is shocking to me that in many States individuals
who operate these devices do not need to be licensed and are
therefore not regulated at all in terms of education and
expertise. Even in States where there are licensing
requirements, the requirements to report errors and the
penalties for making errors are basically nonexistent or not
enforced. Now as a result, we have no idea how often these
errors occur and have no good data on where the weaknesses in
the system truly are.
I understand Mr. Barrow has legislation that deals with
training and possibly accreditation as well so, you know,
obviously when we have these hearings we are looking at the
possibility of legislation and Mr. Barrow's is certainly one of
those that we would be looking at. I think part of the problem
could be the fact that no single agency has authority over the
entire spectrum of issues related to medical radiation and
because of this things are more likely to fall through the
cracks and I am eager to hear from our witnesses today about
this and what problems it presents.
In addition to the lack of oversight from a regulatory
perspective, there also appears to be very little guidance to
physicians on the appropriateness of use of these technologies
especially with respect to radiation dosage and lifetime
exposure of radiation. One of our witnesses today will go into
more detail on this issue but for example, dosing for the same
CAT scan can vary by huge amounts between and within
facilities. In addition, there are questions as to the
appropriateness of use of these scans.
I know from personal experience that health care providers
are very quick to order yet another CAT scan without talking to
patients about the health risks let alone the cumulative
effects of multiple scans. When I say my own experience is from
my mom. My mom passed away last December and the reality--not
this December but the previous one, and I remember she had
pancreatic cancer that when we were going around to different
hospitals and we ended up I think at four different hospitals,
every time I would go to a new hospital I would bring the scan
with me, you know, the disc I guess. And I would give it to
them and they would say well we can't use that and I would say
well why, and they would say well, you know, our machines don't
operate that way of maybe it is a good idea to have another one
and I wasn't concerned. I mean frankly I wasn't addressing it
from a cost perspective although that is a big factor but I was
worried about the health implications and, you know, frankly
most no one said to me that there was a problem. It was always
like oh that is not a problem, you know, she can have it done
again and nobody actually would use the previous one. I was
never able to get them to use the disc that I had brought with
me. They always had a reason why they couldn't use it and maybe
there was a good reason but it just seems that maybe the lack
of interoperability or, you know, one of those things that
needs to be addressed.
Many in Congress have questioned the overuse of medical
imaging but for the most part those conversations has centered
on cost implications. I have to wonder though if there are not
also health implications as well and I am eager to hear from
our witnesses today about the issue and what is being done to
study the long term cumulative effects of medical radiation.
Our witnesses today are all intimately familiar with these
types of technologies, the possibilities they hold and the
dangers they can present and I would like to welcome especially
Ken Mizrach who is--where is Ken? Oh he is on the next panel I
guess, who has traveled here from my home State of New Jersey
and also Mr. Parks, whose son's story was featured in one of
the New York Times articles, and we appreciate your taking the
time to speak to the committee on this very important issue,
and I think we are going to have some interesting conversation.
Before I recognize Mr. Whitfield though I did want to say
that, you know, just reading today's New York Times article
there are so many different factors here. You know, how much
radiation, what type of technologies are used, whether we
should have doctors present, how long they should be present,
whether they should be nearby or there the whole time, and it
is a very complex issue and I don't need to be simplistic about
it but we should also get to the bottom of it. So with that, I
will recognize my colleague from Kentucky, Mr. Whitfield.
OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Whitfield. Well, thank you, Chairman Pallone, and I
also want to thank the witnesses for being here today to help
educate us on this particularly important subject matter.
Medical radiation involves both radiation therapy and
medical imaging. The medical community uses radiation therapy
to treat cancerous tumors including brain cancer, breast
cancer, lung cancer and prostate cancer just to name a few.
They use medical imaging like CT scans and mammograms to find
those tumors and identify other problems. It is clear that the
overwhelming majority of Americans who receive radiation
therapy and medical imaging benefit greatly and thousands of
lives are saved each year because of these treatments and
procedures.
This hearing will also however focus in part on tragic
events associated with radiation therapy. These events raise
legitimate questions that we need to explore and my hope is
that the members of the committee and the public will listen to
the witnesses who are experts in this field and not proceed
with preconceived notions. We must examine the issues
associated with radiation therapy and medical imaging and if
there are problems to be addressed we need to work with the
manufacturers and the health care providers to do so. However,
as we examine these issues it is important that no one comes
away from this hearing thinking radiation therapy and medical
imaging are too dangerous to use because too many lives are at
stake.
I am particularly interested to hear from the manufacturers
how these lifesaving technique devices work. I am also
interested in hearing from the various provider groups on the
training associated with operating these complex devices and
how the different professional societies develop criteria so
these devices can be operated safely. Radiation treatment is a
complex issue and so we welcome the witnesses here today and
are excited that you can help educate us on what if anything
and what steps we need to take.
And I would yield back the balance of my time.
[The prepared statement of Mr. Whitfield follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you.
The gentlewoman from Ohio, Ms. Sutton, is next for an
opening.
OPENING STATEMENT OF HON. BETTY SUTTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO
Ms. Sutton. Thank you, Mr. Chairman, and I appreciate you
holding this hearing today. It is an important and complex
issue that deserves our attention.
All of us know someone whose life has been saved by medical
radiation whether a tumor was discovered with a CT scan and
treated before it grew into something unmanageable or whether
someone we love beat prostate cancer through the help of
radiological seeds. There is no doubt that medical radiation
has allowed people to stay on this earth with their loved ones
much longer. However, as we have learned terrible, tragic,
heartbreaking events can occur and have occurred when something
goes awry with medical radiation therapy primarily in cancer
patients.
I was greatly saddened to read the stories in the New York
Times which included a tragic story about a breast cancer
patient from my district who suffered a radiation overdose in
2006 when a physicist entered incorrect information into the
treatment planning computer. Her name who Myra Jean Garman and
she was in so much pain from the radiation overdose and
resulting side-effects that she eventually committed suicide.
According to the Ohio Department of Health there have been 18
incidence reports with respect to medical radiation over the
past 2 years. Obviously, we want to reach a place where there
is no need to file any incidence reports because there are no
incidents.
Patient safety must always be our primary concern and
patient safety in radiation therapy as well as patient safety
in diagnostic radiation, are critical. We are here today to
learn about the best way to ensure patients are protected to
ensure that patients are given the right tests at the right
time and that no patient ever suffers through a radiation
overdose, to ensure that our medical equipment is safe and that
our workers are well-trained, and I look forward to learning
about the issues surrounding medical radiation from our
witnesses today and I thank the witnesses for being here to
deal with this very complex issue.
And I yield back my time.
Mr. Pallone. Thank you.
We are going to have votes and I know there are quite a few
and I think they are the last ones of the day. I will find out
soon but just so that we probably are not going to get the
panel before the votes. We will try to do as many openings as
we can and then you will have to wait around probably an hour
or so for us to come back, unfortunately.
Next is the gentleman from Illinois, Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman. I want to thank the
Parks family for their attendance and being here. We know it is
not easy.
I want to concur with the comments of the Chairman.
Radiation therapy has been very successful in saving lives.
Early diagnosis and early treatment has prolonged the lives of
thousands of Americans and this should be in no way an attempt,
not an attempt but we don't want to scare people away from
doing this and some of these stories are starting to do that
and we just have to be careful. You know, cancer survival rates
have gone from 50 percent to upwards of 95 percent in many
cancer cases and that is because of this technology in this. We
have to address, identify the problem, encourage people to move
forward so these mistakes don't occur and in this case it would
be software applications and training. In talking with health
care professionals and the like, a scalpel in the hands of a
trained professional does great good. A scalpel in the hands of
someone who is untrained does great harm and that is, I hope,
the focus of this hearing and we look forward to the testimony.
We do thank the Parks family and those who have suffered loss
and your testimony is very, very important because it helps us
focus on the truth.
And I yield back, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Shimkus.
The gentleman from Georgia, Mr. Barrow, and sponsor of the
bill that we mentioned before.
Mr. Barrow. Thank you, Mr. Chairman and thank you for
holding this hearing to call attention to the serious problem
of accidents and errors in the delivery of radiological
services.
While we can't expect either the people or the technology
to be perfect, when you go into a doctor's office or you enter
the hospital you have the right to expect a certain level of
competence and training from the people taking care of you. I
am the lead sponsor of the Care Bill which will set minimum
educational and certification requirements for the technical
personnel who perform medical imaging and radiologic therapy.
Most people are surprised to find that many States don't
license or regulate radiologic technologists at all. Common
sense tells us that properly educated and certified personnel
will produce better medical outcomes, not only that but more
efficient delivery and reduction in duplicative testing and
waste will also cut costs. I recognize that the problems
highlighted by recent media reports are likely to require
multifaceted solutions but I am convinced that we must start by
ensuring that the workforce is properly trained and certified.
With that, I yield back. Thank you, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Barrow.
The other gentleman from Georgia, Mr. Gingrey.
OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Gingrey. Mr. Chairman, thank you.
Whether used in the detection or treatment of patients,
medical radiation has become an important part of medical care
in this country. From the latter half of the 20th century
through today we have seen this technology evolve and add to
the quality of health care in our country. As an OB/GYN
physician for nearly 30 years, I have seen firsthand the
benefits of this technology for the health and welfare of my
patients. The chances of survival for a cancer patient, as
already mentioned, are increased exponentially the earlier
cancer is detected.
During this Congress we have heard from patients and indeed
members of Congress alike who credit their health and their
welfare to the early detection of cancer. For others radiation
treatments like chemotherapy prove the decisive factor in life
or death. Ms. Lindley is one such patient who credits Selective
Internal Radiation Therapy with saving her life and thank you
for coming before this committee and sharing your story with us
today, Ms. Lindley.
Unfortunately for all of the benefit that patients see from
such technology, there are also troubling stories of trauma and
sorrow. The story of James Parks is one such case and the
trauma his son, indeed his whole family endured because of a
radiation accident is a sobering tale. His story reminds us how
important adherence to proper safety protocols is as well as
the review of adverse medical events can be to the overall
health of all of our patients.
Earlier this month the Food and Drug Administration
announced a new initiative to reduce unnecessary radiation
exposure from medical imaging. Therefore, this is a very timely
hearing and I would like to thank Chairman Pallone for calling
it today, however, I would like to sound one note of caution.
Remember the furor that surrounded the United States
Preventative Services Task Force recommendations on mammography
screenings that had this information, of course, has not faded
from the psyche of this country. That incident and the
Congressional hearings that followed outline for this committee
the importance of protecting the rights of patients and their
physicians to decide what medical treatments are appropriate.
Medicine is an art form. It can be taught from a book but it
must be practiced with medical experience and yes, balanced
judgment.
With that thought in mind I want to thank all of you
witnesses for coming before the committee today. I look forward
to hearing from you and the question period.
I yield back, Mr. Chairman, my time.
Mr. Pallone. Thank you.
I am going to try to get two more members in so I guess
that would be Ms. Eshoo and Mr. Green, and then we are going to
have to break but we will continue after if anyone, you know,
for those who come back.
The gentlewoman from California.
Ms. Eshoo. Thank you, Mr. Chairman, for holding this
important hearing.
I think all of us in reading the recent articles on
vulnerable patients and what happened to them, we are really
stunned by it. That is number one. Number two, I can really
track over just the period of time that I have been a member of
Congress. This is my 18th year and the co-chair of the medical
device caucus, tremendous improvements in this area which holds
out so much hope for especially cancer patients in our country.
But clearly, something needs to be done in the area of
supervision, the area of licensing and that we in my view need
national standards in this area because it is right now it is
catch-as-catch can so my, I will submit my full statement for
the record.
I look forward to hearing from the witnesses. This is an
important hearing. If we need more information, I will
certainly participate in all of the hearings so that we come up
with a framework that really fits what the problems are so that
no one is subjected to the over-radiation that we have read
about.
I also would like to ask for a unanimous consent request
that Mr. Waxman's statement for the record be accepted and that
he has a--let's see, a statement for the record that is
relative to a 52-year-old who is a constituent of his, you
know, and the father of three children in Los Angeles and what
happened to him relative to excessive radiation at Cedars Sinai
Medical Center in Los Angeles.
[The statement of H. Michael Heuser follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Without objection, so ordered.
Ms. Eshoo. Thank you, Mr. Chairman.
Mr. Pallone. Thank you.
I think we can get two more in on this so and Ms.
Christensen wants to stay. We will start with Mr. Green and
then go to Ms. Christensen.
Mr. Green. Thank you, Mr. Chairman.
I ask unanimous consent my full statement be placed in the
record.
[The information was unavailable at the time of printing.]
Mr. Pallone. Without objection, so ordered.
Mr. Green. First, I am glad you are having this hearing. A
lot of us read the information and our health subcommittee has
worked for many years on expanding opportunity for CT scans and
treatment because of the new technologies are changing everyday
and I will give my own example. I went about 7 years ago in
Houston Heart Institute and they had a concern about a problem
and I did a scan of my heart, an image of my cardiovascular
system and that was great. I went back a few years later but
staff and the equipment had already changed because we are
seeing better equipment every day and we don't want to lose
that ability to diagnose and to treat in the case of cancers.
The problem is that if we don't deal with this, we will scare
both practitioners and also patients away from it.
So that is why the hearing is so important today, Mr.
Chairman. Thank you for doing it. We need to get it right
because the next generation of treatment can be less invasive
then what it is now but we surely don't want to stop it because
people are scared they are going to be over-radiated, a person
is not trained to use the equipment they are using or that it
is not the proper dosage.
So, Mr. Chairman, thank you and I look forward to working
with you and see what we need to do to deal with it.
Mr. Pallone. Thank you.
The gentlewoman from the Virgin Islands.
Mrs. Christensen. Thank you, Mr. Chairman, and thank you
for holding this hearing.
I would also like to ask that my full statement be included
in the record.
You know, as a physician the practice for if I include my
residency maybe 25 years, I have had the opportunity to see the
benefits that the diagnostic and therapeutic radiology have and
I am sure everyone of us on this committee either ourselves or
in our family have seen those benefits firsthand. But we always
have to balance the benefits and the risks and in favor of the
benefit to the patient and minimizing the risk. So we have seen
some instances recently where--and this has happened over the
years--where people have been over-radiated and have had severe
repercussions because of it and we have at least one vehicle
before us that can rectify this and it is something that we
must do.
And I look forward to working with my colleagues to ensure
that when individuals go for either diagnostic reasons or
therapeutic reasons that they are not harmed by the machinery
and the radiation. And so I look forward to hearing the
testimony of our witnesses this morning and your comments on
how we can improve the safety of radiation for our patients.
Thank you.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you.
I think we have at least an hour of votes so we will come
back after that. If anyone else comes back, we will let them do
an opening statement, otherwise we will go right to you but we
were talking I am sure no earlier than 11:30. Thank you.
The committee is in recess.
[Recess.]
Mr. Pallone. The subcommittee hearing is reconvened and we
still have some opening statements starting on our side with
our Chairman, Mr. Waxman, from California.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you, Chairman Pallone, for holding this
important hearing and I know we are anxious to hear from our
witnesses and I regret that we had the votes that interrupted
our hearing.
But we are looking today at the extraordinary benefits and
examining the possible risks associated with the use of
radiation in medicine. And let me be clear at the outset,
diagnostic technologies like CAT scans that identify tumors and
therapeutic procedures such as radioactive seeds that treat
prostate cancer are potentially lifesaving. They are important
interventions in our medical toolbox and our health care system
is unquestionably much better because of them.
But recent reports and studies have raised questions about
the relative safety of these technologies. No medical
intervention is 100 percent safe and patients' individual
tolerance for risks and being exposed to such procedures varies
as well. These are dangers that generally cannot be avoided
altogether but the purpose of this hearing is to learn more
about those risks and hazards from radiation that would appear
to be preventable and there have been recent examples as
reported in the press. Investigators at the NRC found that a
cancer unit at the VA hospital in Philadelphia botched 92 out
of 116 procedures using radioactive seeds to treat patients
with prostate cancers. Over 200 patients were mistakenly
exposed to up to eight times the normal dose of radiation
during brain scans at Cedar Sinai Hospital in Los Angeles.
Because of a computer error that went undetected, Scott Jerome-
Parks, the son of one of today's witnesses was blasted with
excess radiation on three consecutive days during his treatment
for tongue cancer. Scott died from his radiation exposure at
the age of 43. Despite these patients' need and consent for the
lifesaving technology used, the end result clearly is not what
they signed up for.
Alarmingly, as we will hear from a number of today's
witnesses, these are not isolated cases. The mistakes made in
these instances while perhaps not widespread, we hope not
widespread, appear to be more than just random and rare. They
are occurring all across the country and in hospitals and
physician offices alike.
The reasons for this poor quality of care would seem to be
multifaceted. Whether it is a lack of standardization of
equipment or laxity or even nonexistent State licensing
requirements for machine operators or outdated Federal
oversight authority, experts tell us that more can and should
be done to reduce unnecessary radiation exposure and medical
errors. Indeed, action has already been called for by the
medical imaging manufacturers and some radiation provider
groups whom we will hear from today.
As we move forward I would hope that we can all agree on
two basic premises. First is the enormous medical value of our
various radiologic techniques. As I mentioned earlier we want
to underscore the point again both diagnostic and therapeutic
radiology interventions save lives and we want them. We need
them. Second is the obligation to ensure that these
interventions are as safe as they can be and that everything is
being done to make that a reality. Patients are entitled to
nothing less. With these principles in mind, I believe our job
today is simple and straightforward--to understand how to lower
the risk associated with radiation in medicine to make it as
safe as possible without reducing its many benefits to patients
and researchers.
We have an outstanding group of witnesses. It is no longer
this morning. It is afternoon. They are here to help us learn
more about these issues. I thank each of them in advance for
their testimony and I look forward to hearing from them but in
my case from reading their testimony because I am compelled to
go to a meeting with the Speaker on health care which will
require me to miss the testimony but I will have a chance to
review and I thank the witnesses for being here.
[The prepared statement of Mr. Waxman follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Chairman Waxman.
The gentlewoman from North Carolina, Mrs. Myrick.
Mrs. Myrick. Thank you, Mr. Chairman, and for the sake of
time I am going to submit my statement for the record along
with a letter from the Society for Radiation Oncology
Administrators.
[The prepared statement of Mrs. Myrick follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Without objection, so ordered.
Mrs. Myrick. Thank you.
Mr. Pallone. Thank you.
And so I think we have had opening statements from everyone
else so we will move to our panel and let me introduce each of
the panelists if I could. Beginning on my left is Mr. James and
Mrs. Donna Parks from Gulfport, Mississippi. Thank you for
being with us today and Suzanne Lindley from Canton, Texas. And
then we have Dr. Rebecca Smith-Bindman, who is Professor in
Residence, Radiology and Epidemiology and Biostatistics,
Obstetrics, Gynecology, and Reproductive Medicine. I didn't
realize you have all those at the University of California in
San Francisco. And then we have Dr. Eric Klein who is Professor
of Radiation Oncology at Washington University in St. Louis.
And then we have Dr. Cynthia H. McCollough who is Director of
the CT Clinical Innovation Center, Department of Radiology at
the Mayo Clinic and Professor of Radiological Physics at the
College of Medicine at the Mayo Clinic. That is our panel. We
ask you to give us 5-minute opening statements if you can limit
it to that please and your statements, your full statements
become part of the record. Then we will have questions from the
panel. I should mention that beyond this you may get additional
written questions from the panel within the next 10 days or so,
as well.
We will start with you, Mr. Parks. Thank you for being
here. Let's make sure that your microphone is on. It should be
the green light and maybe bring that a little closer to you,
Mr. Parks, so that we can.
STATEMENTS OF JAMES AND DONNA PARKS, GULFPORT, MISSISSIPPI;
SUZANNE LINDLEY, CANTON, TEXAS; REBECCA SMITH-BINDMAN, M.D.,
PROFESSOR IN RESIDENCE, RADIOLOGY AND EPIDEMIOLOGY AND
BIOSTATISTICS, OBSTETRICS, GYNECOLOGY, AND REPRODUCTIVE
MEDICINE, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO; ERIC E.
KLEIN, PH.D., PROFESSOR OF RADIATION ONCOLOGY, WASHINGTON
UNIVERSITY IN ST. LOUIS; AND CYNTHIA H. MCCOLLOUGH, PH.D.,
DIRECTOR, CT CLINICAL INNOVATION CENTER, DEPARTMENT OF
RADIOLOGY, MAYO CLINIC, PROFESSOR OF RADIOLOGICAL PHYSICS,
COLLEGE OF MEDICINE, MAYO CLINIC
STATEMENT OF JAMES PARKS
Mr. Parks. Mr. Chairman and committee members, we want to
thank you for the opportunity of coming here to talk.
We are here to testify on behalf of our son, Scott, who
died from an extreme overdose of radiation by a very inept team
of therapists using a linear accelerator. It is a horrible way
to die. What was to be a minimally invasive procedure turned
out to be a 2-year nightmare for the whole family, especially
he and his wife. They were in New York City and that is where
most of this occurred. We were with Scott and Carmen when
Scott's feeding tube was implanted. At that time we had been
convinced that we were doing the right thing. He had not wanted
a surgical procedure which would have been very bad. My hearing
aid just went out.
So he chose what he called the laser treatment and we
thought it would be very quick. After the implant we thought
that was just sort of an inconvenience that would be temporary
but it didn't work out that way.
We in Mississippi and our son was in New York so what you
get here are snapshots in time as to when we saw him. His wife,
Carmen, of course, was with him every moment of every day for 2
years and suffered all of the things he suffered but she can't
speak because of a gag order and it is tied to her financial
settlement. She is the one who should be here and isn't. She
knows everything that has happened.
Each time we would go visit, about every 3 or 4 months we
would see him and of course he would change dramatically every
time we would go. I am not sure all patients do this but he
rapidly became blind and deaf and he had constant pain and
vomiting. He became extremely weak and sleepy. We couldn't
hardly--he could last for about 15 minutes but he always kept
his interests in Carmen. He said he would keep himself alive to
make sure that she was all right and he did that. We admired
him for suffering so much until the process ran its course and
that she was finally taken care of.
We met him for the last time at Christmas when he called us
all together, his brothers and aunts and Donna and I, and we
had Christmas with him, and it was very, very touching. One of
his friends had sent a big box and in the box was sand and two
pails, and on the video that he made he said just lay back and
put your feet in the sand and pretend that you are back in
Mississippi where you should be, and Scott did that and he
wasn't hardly with it at that time. This was at Christmas.
One of his problems was hiccupping. I don't know if that is
he would hiccup all the time as you were talking to him,
violent hiccups and of course his jaw was calcifying and his
teeth were falling out. He couldn't eat. He didn't eat anything
from the time he got the stomach implant until he died and he
used to like to eat but all he would go to Central Park and
this is he would sit on a bench and feed himself with the
liquid meals that he would have and that was remarkable for him
to do that.
The way it unfolded, he had four successful treatments. On
the fifth one it was a terrible onslaught to him. His head
swelled up and he suddenly became retching. His wife was there
and she got alarmed and asked them to stop the treatment but
they ignored her and this went on for a second time and then a
third time when the machine was wide open and he got blasted
with unguarded amounts of radiation. The hospital I think made
an error in that they told Scott that this has never, ever
happened before and that there was be something wrong with him
because the machine always works perfectly. Of course, they
found out that wasn't true and as for when Scott went into this
he knew he was going die. He and his doctor were very close.
They were and he went on kind of a mission to make his dying a
cause for him to live for as long as he could and he stayed all
through all the suffering and until finally there was a
financial settlement. And he told me that Carmen was the reason
he was staying alive and at the Christmas party I remember
hugging him and he whispered to me very weakly that Carmen is
going to be all right and he can die now. He says I am ready to
go and he, after we left at Christmas, he was very rapidly got
much worse and soon died.
It was traumatic for all of us, particularly his wife,
Carmen, and she was wanting to testify and, of course, she
can't do that and it is a shame that this is a secret that we
aren't supposed to talk about and that is why we are here. I
told him I would do what I could and what I did is wrote a
staving obituary for him which didn't do any good and I wrote a
letter to the editor which didn't do any good. And by some
miracle, I don't know how it happened but the New York Times
picked up on this whole issue and has gone and it has
snowballed. I think it is making an impact and that is exactly
what Scott wanted. I am sure he is up looking down and he is
very pleased.
I would like to say that we are not impressed with the
machines. They are not as good as they could be and they must
be improved to where they are--we have made a couple of
recommendations and I would like to quickly read them. We must
develop a strong mandatory database that we don't have and all
medical institutions should report to the database and it could
become a repository for evaluating trends and identifying
medical problems, all medical problems not just radiation. The
Veterans Administration has developed a reporting system that
reports and responds to medical accidents called NCPS. That is
all I know about it but it works in the VA system very well and
I think it would be nice if the whole country would adopt such
a thing. We are very encouraged that the SBA has taken a
regulatory role in radiology and I understand the IMRT systems
will be involved in that, too.
We ask the medical equipment manufacturers to develop a
failsafe interactive expert system that can interact with human
technicians to reduce and eliminate human errors. I think that
is what really killed Scott was human errors and the machines
must talk to the technicians and, of course, the technicians
should be very trained. Oncologists and supervising physicists
must learn to micromanage their radiology departments. That is
the only way they will work. If you don't do that you are going
to have people dying. It is outrageous to us that untrained and
unskilled workers can get anywhere near this dangerous
equipment but they do and it happened in Scott's case.
Thank you.
[The prepared statement of Mr. Parks follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you very much, Mr. Parks and also Mrs.
Parks, for being here. I mean I know how tough--I shouldn't say
I know. It had to be tough for you to be here and give us your
testimony but it is really important because this is the very
thing that we are trying to prevent in the future so I don't
know what to say but to say that it at least your being here in
some way, you know, can maybe make up in some way for your loss
and at least you are trying to prevent it from happening to
others. Thank you.
Mr. Parks. Thank you.
Mr. Pallone. Ms. Lindley. Ms. Lindley, I think you got to
turn that on and move it closer to you. Otherwise we can't hear
you. I think it is still not on. Is the green light on? I don't
think it is on. I hate to bother you but is the green light on?
Do you want to try Mrs. Parks' there maybe.
STATEMENT OF SUZANNE LINDLEY
Ms. Lindley. As a patient, I too want to make sure that I
am in safe, qualified hands when I have treatment and it is
hard to follow a story like yours, especially when mine has
been the complete opposite. Thank you for having me today and
as a resident of Canton, Texas I would also like to say a
special hello to my fellow Texans on the committee, Congressman
Green, Gonzalez, Hall, Barton and Burgess. I am honored to be
here to share my experience as not only a cancer survivor but
as a patient advocate.
I am here because of cancer research, because of medical
imaging technology and because of radiation therapy. I was 31
years old when I was diagnosed with cancer. That was 11 years
ago. It was then that I was diagnosed with stage four colon
cancer and there are only four stages. Mine was the very most
advanced. We found out that I had tumors that had already
spread to my liver and I was told that I had about 6 months to
live. We were scared. We were sad and we planned our first
Thanksgiving as though it would be my last vacation or holiday
with family. My daughters were 8 and 11 years old. We focused
on the fact that I was going to die and we very much lost sight
of the fact that I would live.
I posted a note on an online server asking for guidance
from other cancer patients on how to prepare my two young
daughters for life without me and instead of answering my
question, a gentleman wrote back, Shelly Whiler, and said that
he too was going through stage four colon cancer and I should
look for some hope and that is what we did. I started with the
only chemotherapy that was available, 5-FU. It had been around
for 30 years. I was fortunate that colon cancer research was
rampant and as my cancer progressed I was able to benefit from
each new treatment as it was developed. That worked about 6
years and then the cancer began to spread. There were no more
approved options so we went into clinical trials and those
bought me a little bit of time, too. Then my liver became just
laced with tumors. They were multiplying to the point where it
looked like the stars lit up the sky at night. My stomach was
swollen. My skin was yellow and I was tired. Every breath,
every move was hard and the doctors said that there was nothing
else that they could do and that basically I should call in
hospice and that my condition was terminal.
We prepared my family again and I sent out an e-mail to
friends letting them know that I was at the end of the line.
Then after calling hospice, planning a funeral and picking out
a casket, I got a phone call from one of the friends that I had
written a letter to and he told me about his doctor in
Wisconsin that was using Selective Internal Radiation Therapy.
And they are little radioactive beads that are implanted
internally and they attack the liver tumors and they leave the
healthy tissue healthy. It sounded too good to be true and so
at first I was hesitant to call the doctor. And then he kept
calling me a dozen times that day and finally I picked up the
phone and I called the doctor and we talked for awhile and it
turned out that I was a good candidate for the treatment. I
went back to my oncologist and I told him about the procedure
and thought he would be really, really excited for me and
instead he said, you know, I don't think it is going to help
you, and then he turned around and said what do you have to
lose. No one knew how much I had to gain.
I received the outpatient treatment called radio
embolization in January of 2005, and I call them little, magic
beads. After a 6-month period we saw a 65 percent of shrinkage
and then after awhile we started seeing necrosis of those
tumors so they were literally dying from the inside out. My
belly started to get back to where there wasn't fluid in it. My
color came back and I began to live again. I learned how to
scuba dive. I went skydiving. I started telling my private
story in very public places. I connected with other people and
I met and shared experiences that I had never seen if it hadn't
been for this disease or these treatments. I have continued
with systemic therapy and I have also received additional
targeted radiation treatments to stay ahead of the curve. I
have had external beam radiation for tumors that spread to my
spine and that has helped me with the pain control and has
given me a better quality of life. I have had Gamma Knife used
to treat a brain lesion. I have had radio frequency ablation to
treat a returning liver tumor and I have had Cyberknife for
lung tumors and they have all given me a little bit more time
with my kids.
When you start anything new and especially a new treatment,
you hope for the extreme. You pray for the best. You prepare
for the worst and you don't really know what is going to happen
but all you have is hope. These advance radiation therapy
technologies have given me that hope. They have allowed me to
watch my daughters grow up, to see them walk across a stage for
graduation, to start college and to become adults. They are 19
and 22 now and are both in college. These treatments have
allowed me to walk hand-in-hand with my husband and hopefully
we will have more of these treatments and we will be able to
spend our rocking chair days together.
I still have tumors here, there and everywhere. Systemic
therapy after 11 years is just now part of my normal routine.
Along with that, I will continue to use the targeted
radiological therapies when needed. They allow me to live with
colon cancer as a chronic condition and not a terminal one.
These existing treatments and medical innovations will be a
part of my life until there is a cure for this disease. What
they have been able to give me is nothing short of miraculous.
The grandest miracle is the realization that I am not dying
from cancer. I am living fully in spite of it. I have reaped
the benefits of research, of dedicated tumor doctors and
increasing options. In my arsenal there has been 5-FU
Fluorouracil, with Leuvocorin, Irinotecan, Oxaliplatin, free
clinical trials, numerous surgeries, radio frequency ablation,
Gamma Knife and vertebroplasty. None of these, other than the
5-FU existed when I was diagnosed. It is important that the
momentum continue and that it is not thwarted, not only for me
and for my family but for the 1,500 Americans that will lose
their lives today and each and every day after today.
Before I close I want to leave you with this one thought.
As my personal story makes painfully clear there are barriers
out there already and I realize that you are not trying to
build those barriers and that you are trying to make them safe
but we also don't want to scare patients or take away their
hope at the same time. Thank you.
[The prepared statement of Ms. Lindley follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you very much really for being with us
today and sharing that. We appreciate it. Dr. Smith-Bindman. I
guess the name is spelled wrong there. I am sorry. It says
Binder.
Dr. Smith-Bindman. That is how we spell it though.
Mr. Pallone. All right, Bindman, thank you.
STATEMENT OF REBECCA SMITH-BINDMAN
Dr. Smith-Bindman. Chairman Pallone, Ranking Member
Whitfield and members of the Health Subcommittee, thank you for
the opportunity to testify today.
My name is Dr. Rebecca Smith-Bindman, Professor of
Radiology, Epidemiology and Biostatistics at the University of
California, San Francisco School of Medicine. I am a clinical
radiologist and my research focuses on assessing the risks and
benefits of medical imaging.
My testimony today focuses on CT because it is one of the
most common imaging tests we use and it is the test with the
greatest potential for causing harm. CT uses x-rays to obtain
extremely detailed images of internal organs and the
development of CT is widely considered one of the most
important advances in medicine allowing a more timely and
accurate diagnosis of disease across every area of medicine. It
is simply an extraordinary test and currently one in five
individuals in the United States undergoes a CT scan every
year.
Although CT scanning is useful, it delivers much higher
doses of radiation then do conventional x-rays and exposure to
radiation can lead to the development of cancer. To help put
this into context, when you go to the dentist and you are
offered dental x-rays some of you may pause to consider any
potential harm from those x-rays. The most common type of CT
scan that patients undergo in the U.S., an abdominal CT
delivers approximately the same amount of radiation as getting
1,500 dental x-rays all at the same time. Additionally, newer
applications of CTs such as those used to assess blood vessels
in the brain require even higher doses of radiation, as much as
5,000 or more dental x-rays. The increase in the number of CTs
and the higher dose for some CTs has resulted in a large
increase in the population's exposure to radiation from medical
imaging.
The National Council on Radiation Protection, a group
dedicated to ensuring that the U.S. population is as safe as
possible as it relates to radiation has estimated that the U.S.
population's exposure to radiation from imaging has increased
dramatically the risks. Exposure to radiation increases a
person's risk of getting cancer. The National Academy of
Sciences National Research Council reviewed all of the
published literature on the health risks of radiation. They
found people who received doses in the same range as a single
CT would increase risk of developing cancer. Further, many
patients in the U.S. receive multiple CT scans over time and
their risks are even higher. Thus the doses that we experience
everyday as part of routine CT scanning are potentially
dangerous. The cancers may not develop for 5, 10 or 20 years.
Even though we can't see the harms immediately, we must take
them seriously.
Oversight for CT radiation dosing is very fragmented. The
FDA oversees the approval of the CT scanners and medical
devices but does not regulate how the test is used in clinical
practice. Radiologists determine how the CT tests are
performed, however there are few national guidelines on how
these studies should be conducted and therefore is great
potential for practice variation that could introduce
unnecessary harm for excessive radiation dosing. The American
College of Radiology has established a voluntary accreditation
process to try to standardize practice and collects dose
information but only on a very small sample of tests. This
approach is promising but at this point in time the data
collection is extremely limited making it difficult if not
impossible for the college to monitor facilities comply with
their guidelines.
The manufacturers of CT equipment have begun work to
establish standards of how radiation dose information should be
measured and reported. However, the manufacturers have not
adopted or implemented these standards.
My research team at UCSF conducted a study to assess the
doses associated with typical CT scans. We collected radiation
doses on over a thousand patients and found that for nearly
every type of CT scan the radiation doses were much higher than
commonly reported, that the doses varied substantially between
different facilities and even within the same facility the
doses varied dramatically between patients. As part of this
study, we also quantified the risk of CT. We found that for
some patients the risk of a single test could be as high as 1
in 100. That means of 100 patients who undergo a CT, one of
them could get cancer from the test. This is an extremely high
risk for a test that is supposed to find cancer, not cause it.
What needs to happen to improve the safety of CT imaging?
Given the importance of CT and yes, its potential for causing
cancer, it is imperative that we make CT scanning as safe as
possible. To do this we need to do two things. First, we need
to lower the dose from routine CT scans and second, we need to
ensure that we use this technology only when necessary. To
lower the dose several steps are important. We need very clear
standards for what are acceptable levels of radiation exposure
and there should be regulatory oversight for setting of these
standards. Doses used in actual patients need to be monitored.
Despite the potentially high radiation dose CT can deliver
there is no regulation of CT practice in the United States. The
dose information should be prominently displayed when CTs are
done so that technologists can easily make adjustments if
needed if the doses are too high. And lastly, the dose
associated with each CT examination should be documented and
recorded in each patient's medical record and this information
should be tracked over time. Recording and tracking dose
information would help educate patients and providers about
radiation exposure and would lead to activities to minimize
dose.
There are currently private businesses that offer full-body
CT screening to healthy individuals. The FDA and most
professional organizations have voiced concerns that using CT
as a screening test could cause more cancers than they find.
For diagnostic CT, these are tests that are done in patients
who have a clinical problem who have a symptom. It is generally
been thought that if the patient is sick enough to get a CT
scan that the benefit of that test will outweigh any risk,
however we have started to use CT scanning so often and in
patients who are really not very sick at all that we need to
really think about whether the test is necessary and whether it
could cause more harm than benefit. Neither physicians nor
patients are aware of the risks associated with CT nor the
importance of limiting exposures.
In summary, consensus is growing that efforts are needed to
minimize radiation dose from CT and to ensure that patients
receive the minimum dose necessary to produce a medical
benefit. These efforts must include reducing unnecessary
studies, reducing the dose per study and reducing the variation
in dose across patients in facilities. Despite the frequency
importance of CT imaging, there are no resources available to
the research community to study or improve the quality of CT
scanning. Creation of an academic consortium to study CT and
make it as safe as possible would go a long way towards
improving its utilization and safety.
Thank you for allowing me to contribute to this important
discussion and I would be happy to answer any questions.
[The prepared statement of Dr. Smith-Bindman follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Doctor.
Dr. Klein.
STATEMENT OF ERIC E. KLEIN
Mr. Klein. Mr. Chairman and members of the committee, thank
you very much for the invitation to come and speak here today.
My name is Eric Klein. I am a professor of radiation
oncology at Washington University and have been a clinical
medical physicist for 28 years. Over this time period, I have
seen dramatic changes in terms of our profession's capability
to diagnose and treat cancer. Our ability to image patients
with modalities such as CT, MRI and PET allow us to visualize
tumors and involved lymph nodes with millimeter accuracy. We
can now customize how doses are delivered to tumors by
performing sophisticated calculations allowing physicians to
escalate dose to increase cure rates. Simultaneously we can
reduce doses to critical organs, even those close to a tumor.
The delivery technique of intensely modulated radiotherapy,
IMRT, which provides superior treatment delivery customization,
comes with an increase in complexity in irradiation time
compared with conventional radiation therapy thereby increasing
risk. Thousands of hospitals and private treatment facilities
all over the country have purchased IMRT machinery, often for
competitive purposes and far too often without properly trained
staff in place.
Hospitals need to ensure staffing levels are adequate not
only in number but in expertise. There should be hands-on
testing methods before therapists begin to treat patients with
testing on a frequent basis. The training for all staff
involved should include the consequence if something is
incorrect. There can be as many as 100 steps in each process
and each step must be understood by everyone involved
especially those steps with greatest volatility. We do a good
job teaching people what to do and what to watch out for but
not the consequence or the impact if something is wrong. Though
the anecdotal reported rate of errors in radiation oncology is
quoted as less than one in ten thousand, there are two problems
with this quoted rate. First, it may be inaccurate as there is
no repository or statewide mandate for reporting such errors.
In many States hospitals are not obligated to report errors
occurring with a linear accelerator. A national repository for
error reporting, anonymous or otherwise should be instituted in
order for the community to learn from such errors or even near-
misses.
The second problem with this low anecdotal reported rate is
that is still too high. Hospitals need to encourage scheduling
patterns to allow for timeouts before each treatment begins to
allow for cross-checking of all parameters by therapists.
Related to this, the time leading up to a patient's first
treatments should allow for careful review by the physicist of
all parameters to be used. In addition, the manufacturers
testing of radiotherapy delivery and treatment planning
equipment should include fault testing and compatibility
between systems.
In regards to medical physicists, we are the vital
interface between physicians' orders and the eventual
treatment. We are responsible for many things including the
accuracy of the images used for the treatment plan, the
validity of the calculations, the quality of the result and
patient treatment plan, the accuracy of the liner accelerators
delivery systems and the overall end-to-end validation that
each patient will be treated accurately. But having the
intuition and wisdom to detect the potential or underlying
problem only occurs with rigorous training. Medical physicists
are educated in many important areas and after proper training
ideally in an accredited residency program may become certified
by the American Board of Radiology, ABR.
Starting in 2014, the ABR will only allow physicists who
have completed a residency program to sit for the Boards. This
will raise the bar for the exam, thereby raising the competency
of all medical physicists in the very near future. But the ABR
has to wait until 2014 to allow the growth for the number of
accredited programs for this to take place. The growth has been
hampered by lack of funding. There are some funding mechanisms
but the most assured and balanced method would be for the
Center for Medicare Services to provide reimbursement for
training physics residents similar to the method that is in
place for training physician residents.
And finally, there is an ironic situation regarding
oversight of radiation treatment equipment. To operate a
mammography unit and to be reimbursed for the procedure, a
robust quality assurance program must be in place with
oversight by a qualified medical physicist and most importantly
programmatic overview by the FDA and the American College of
Radiology. This model of requiring a quality program and
qualified personnel to be in place with a review by an agency
in order to be reimbursed for providing radiotherapy treatments
should strongly be considered for radiotherapy as a profession.
In closing, approximately a million patients per year are
safely and accurately treated with radiation therapy, receiving
outstanding and vital treatments but further steps to ensure
patients' safety can and must be made.
Thank you.
[The prepared statement of Mr. Klein follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Dr. Klein.
Dr. McCollough.
STATEMENT OF CYNTHIA H. McCOLLOUGH
Ms. McCollough. Thank you. I do have some visual aids for
some of the points.
I want to thank you very sincerely for having this meeting
today. It is an honor to be here and I want to speak to you
about the safety of x-ray computed tomography most commonly
referred to as CT scanning. Next slide, please.
[Slide]
I would like to begin by reviewing the difference between
the dose levels from radiation therapy and from diagnostic
imaging. On the right there at the extreme high doses such as
what is required to effectively treat cancer, radiation can
cause severe biological effects. In this high dose region the
effects are predictable based on the dose that is delivered and
can result in cell death, skin injury, skin reddening, hair
loss. Next, please.
[Slide]
In contrast, let's look at medical imaging which uses a
factor of 1000 times lower radiation doses. At the doses used
in medical imaging, there is a chance an effect might occur but
there is considerable controversy about the level of risk in
developing a cancer from these low doses. Next.
[Slide]
In fact if we look at the risk levels, the blue line here
is a relative risk of one meaning no increase in risk, and the
vertical lines on the data points are error bars or
uncertainties. The National Academy of Sciences report on the
Biological Effects of Ionizing Radiation and the Health Physics
Society state that these uncertainties, these error bars do not
support making any risk estimates below approximately 100
millisievert. A CT dose is about 10 milliSieverts. In this
range below 100 milliSieverts, the risk is either so small or
zero but it is impossible to definitively measure. Next,
please.
[Slide]
So with regards specifically to CT technology, modern
systems are equipped with feedback systems that will monitor
the amount of radiation passing through a patient and reaching
the detectors and then to adjust that radiation output
throughout the patient and throughout the scan to adapt the
amount of radiation so you get the image quality that is needed
at the lowest dose. These systems automatically adapt the dose
across within the patient but across the spectrum of patient
sizes from children all the way up to morbidly obese patient.
So here is an example of an automated setting taking the dose
from the adult level which would be about 165 and it tailored
it automatically down to a child level. Next, please.
[Slide]
I would also like to point out that the patient dose for a
single CT exam of the abdomen, chest or pelvis is a factor of
two or three times lower now then it was two decades ago. The
current technical innovations continue to drive doses lower.
Next, click.
[Slide]
Even though throughout the years the image quality keeps
getting better, these numbers here the section width is the
thickness represented by one image and we continue to get
thinner which gives higher detail, better image quality.
However, CT is a sophisticated medical device and as with any
device or procedure human errors or electrical mechanical
errors can happen and that is why I am very grateful for the
interest of the committee, the FDA and the whole imaging
community in ensuring that medical imaging is performed as
safely as possible whether or not the exams involve ionizing
radiation. Next, please.
[Slide]
I believe that the technology is not our fundamental
problem. I believe that the concern is of education for the
technologists that operate the equipment, the medical
physicists who test the equipment optimizing it, and the
radiologists who prescribe the exam protocols. The education
has not been able to keep up with the rapidly growing changes
in technology and the single most important factor to make this
more safe for our patients is to ensure that all personnel
involved in operating medical imaging systems meet nationally
prescribed minimum levels of training and competency. The
needed accreditation and certification programs already exist
but without mandatory requirements for a consistent level of
education we are allowing in some cases inappropriately trained
personnel to operate some extremely advanced medical equipment.
Next slide.
[Slide]
One of the examples of the educational efforts being made
by the imaging community is a Dose Summit by the American
Association of Physicists in Medicine and we are having this in
April of this year. We organized this to teach users how to
adapt the scan protocols to make sure that they are appropriate
for the diagnostic task and for the specific patient. The
faculty and attendees includes physicists, radiologists,
technologists and regulators, and the meeting is being
contributed to by a large number of professional organizations
in the imaging community. Of note, the registration is capped
at 200 participants and the meeting was sold out within 1 week
of registration going live. Next slide, please.
[Slide]
So in summary, today's medical imaging as you have heard
and you are well aware has some absolutely amazing technology.
It can non-invasively diagnose and guide treatment for injuries
and diseases that couldn't be accomplished in any other way.
Without CT there would be more unnecessary surgeries such as
for suspected appendicitis that didn't turn out to be
appendicitis, more invasive diagnostic tests and less effective
treatments.
Before the advent of CT, exploratory surgery was not
uncommon. But clearly, medical tests whether it has ionizing
radiation or not should only be performed when they are
medically appropriate. When they are, the benefit far outweighs
any potential risk. In fact, there is a very real risk to the
patient's health if the necessary medical information is not
obtained.
Unfortunately, right now the patients are being frightened
by the media reports about the dangers of radiation. We are
seeing patients come into the clinic with symptoms of
potentially severe illness or needing lifesaving surgeries or
treatments who have refused their CT exam because they have
heard on TV or in the papers about this cancer causing stuff.
They are being harmed because of not getting the needed medical
information.
Mr. Pallone. I am going to ask you to wrap it up only
because I know some of the members aren't going to be able to
stay.
Ms. McCollough. OK, I am on my closing right here.
So patients and loved ones, I think, shouldn't be concerned
about whether or not the imaging exam is being done properly.
We should take care of that with training. They should be
concerned about whether they need it.
When my 11-year-old daughter ended up in the emergency room
an ultrasound showed a potentially lacerated spleen. They went
to CT for the definitive diagnosis. It was normal thankfully
and I don't think that was an unnecessary exam. It saved us
from having unnecessary surgery.
Thank you.
[The prepared statement of Ms. McCollough follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Doctor, and I agree with you.
I am going to pass and have Ms. Eshoo go first because I
know she has another commitment.
Ms. Eshoo. Thank you, Mr. Chairman. It is called the
commute to California, hopefully getting the plane but I didn't
want to leave you.
First, I want to thank each of you, the witnesses starting
with Mr. and Mrs. Parks. I am a parent and it just should not
be the case where parents bury their own child so what you have
done in coming forward today is enormously helpful to us, and
it is painful for you but I think that what you are doing in
the name of your son is an enormous contribution for us to
really address and get to the heart of what has happened, and
that would be the greatest tribute to him so I want to thank
you. And to Ms., is it Lindley? I think that you articulated so
well what these technologies bring forward and the hope that
they represent, and your own example, and by no means does
anyone on this committee want to put a dent in what we have
produced in our country and that is in so many cases second to
none in terms of the application of the technologies that are
lifesaving and life-extending, and I think that what you said
really points to that. To the professionals, to the doctors
that are here, it is wonderful to have someone from our region
from UCSF, absolutely terrific.
Let me just make a couple of observations. We have, it
seems to me in looking at all of this that we have safety
procedures and oversight that need to be addressed, that we
have obviously 50 States and we have a patchwork quilt of
regulations. There isn't any consistency that I can find in
terms of what I have read. There is the whole issue of proper
supervision. Radiation is lifesaving and it can kill someone so
I mean this is something that needs to be supervised and there
has to be proper supervision but there also has to be education
and training in this, and we don't really have any national
standards on that. One of the doctors mentioned the practice
variations that exist and there are really no standards across
the manufacturing field. Accreditation, I mean I don't think
there is any national standard relative to accreditation. What
I am stunned by is that there aren't more cases that other than
Mr. and Mrs. Parks coming in. Thank God but this has really
sent up the red flag.
So what I would like to ask is of the professionals, of the
doctors, A, would you recommend national standards in these
areas? I can't help but think of the Mammography Quality
Standards Act that one of the staffers and it is in our staff
report here that many years ago we were facing with mammography
and the Congress stepped up and put that law on the books and
it addressed many of the issues that we are talking about here
today.
Do any of you disagree about national standards needing to
be addressed? So you all agree.
Do you believe that there should be accreditation in this
area and licensure of those that administer the radiation?
Ms. McCollough. In CT, the American College of Radiology
has an accreditation program that is not mandatory by
regulators but has become mandatory in a de facto sense because
the insurance companies started requiring it in order to get
reimbursed, and so the program actually has thousands of units
that are accredited. The program does address those. We measure
those. We have a database of those and as part of that
accreditation program, I have seen it continue to raise the bar
of quality in CT since its inception in 2001.
Ms. Eshoo. Now, what again from the doctors, what
responsibility do you believe the manufacturers have in this?
What positive role can they play? Where do you--I mean maybe
this is a sticky wicket for you to be telling us but I am not
on a hunt against anyone but it seems to me that we have got to
examine each facet of this and if you think that there is an
important role for them to play in this and what that would be.
Dr. Smith-Bindman. I think in the area of diagnostic
medical imaging we have very little data about what is
currently going on.
Ms. Eshoo. What does that mean, going on?
Dr. Smith-Bindman. It means that Dr. McCollough told us
that a CT scan has a dose of 10 milliSieverts. When we went and
collected dose information, in fact the doses were two to
threefold higher then that on average and for one patient the
doses ranged for one type of problem ranged from five to 100
milliSieverts for the kind of test that is supposed to have a
dose of 10. So in fact we don't know what is currently going
on. The doses in general could be much higher then we think and
more variable. Part of the problem is there is no organization
collecting those, documenting those and part of the difficulty
in that is the standards for reporting those vary across the
board. So there is no consistent way that dose is reported that
a radiologist could easily look at the information on an
individual scan and understand. So you asked about the role of
the manufacturers. There are several very important committees
that over the last several years have agreed upon standards for
reporting dose information, for putting that information in the
medical records. These standards have not been adopted by the
manufacturers. If these standards were adopted by the
manufacturers, we could quickly know what is going on and then
determine how closely different facilities abide by those
guidelines that we would put out there. So we need guidelines
about what is allowable and we need data to decide if places
are within those guidelines so I think the manufacturers could
enormously move this field forward by adopting these standards
immediately and having this data available.
Ms. Eshoo. That is very helpful. I know they are going to
testify at the on the next panel but I won't be here and we
definitely need to work with them.
Dr. Klein, did you want to add to that?
Mr. Klein. I would rather have Dr. McCollough respond.
Ms. Eshoo. OK, great and then I will yield back.
Ms. McCollough. I do have a slightly different perspective
on this. There is an organization called the International
Electrotechnical Commission and it is a trade organization that
is worldwide that the U.S. participates in through the National
Standards Institute and that organization, the IEC, actually
sets very well-prescribed standards about how the radiation
output of a scanner is to be measured and the scanners effect
in Europe can't even be published with some of these. So in the
U.S. we have the same IEC labeling if you will, on all our
standards and the value of the dose output of the scanner is
actually shown on the console. It is mandatory that it be
shown.
Ms. Eshoo. Well, who reads that?
Ms. McCollough. It is right in front of the technologist.
Ms. Eshoo. They do read that before they use it, really?
Ms. McCollough. It is in front of them and one of the
things is the protocols tend to be prescribed for a given
patient and diagnostic task, and the variation that you are
hearing about radiation gets stops kind of quickly in tissue so
every four centimeters of extra-thick that a patient is, you
need to actually double the machine output to get the same
image quality. So from a thin, perhaps Asian woman to an obese
patient that is a factor of 64.
Ms. Eshoo. Yes, I have to tell you, I mean you are
absolutely brilliant. You know this better than anyone. That is
why you are one of the expert in terms of testifying but to
suggest that the knowledge is somehow transferred through the
system because there is a sticker or something on the equipment
doesn't do it for me. I have to say that but thank you very
much, Mr. Chairman, and this is going to require some work of
our committee but it is what we are here for. And I think that
with the people that you have assembled, and we need all of you
to be part of the, I am sure legislation that we will draft and
pass, and it should be bipartisan. This is something that knows
no partisanship because it could be me. It could be you. It
could be anyone of us so thank you very, very much.
Mr. Pallone. Thank you, Ms. Eshoo.
You can continue, Dr. Klein.
Mr. Klein. Well, in regards to radiation oncology equipment
and manufacturing responsibility it certainly the machinery
goes through quite a bit of testing as when it is in the
factory and as it gets delivered. What could be done better is
the training for the users, fault training to demonstrate if
this message shows up this is exactly what it means and some of
the manufacturers are inconsistent on some of the testing that
they perform with the users, with the physicists. One company
does a very good job, for example, of forcing errors to happen
and then watching that the machine will stop and show you what
that error is but it is not consistent. And the other problem
that is a wide variation is problem reporting. How errors or
how machines that aren't functioning properly, how that
information gets to all the users. It varies again how we get
that information. Unfortunately, sometimes it is anecdotal or
list servers, rather than direct communication to any potential
user of this equipment. It might be better to do overkill
communication right now which is scant and irregular. Thank
you.
Mr. Pallone. Thank you.
Mr. Whitfield.
Mr. Whitfield. Mr. and Mrs. Parks, I also want to thank you
for being here today and sharing your son's ordeals with us. We
appreciate that and, Ms. Lindley, thank you for being here, as
well.
When we talk about medical imaging, it is rather limited. I
mean we talk about CAT scans, MRIs, x-rays and that is
primarily it but then when we talk about radiation therapy I am
assuming that there, would there be hundreds of radiation
therapies or I know that we have linear accelerators. We have
Gamma Knives. We have--Dr. Klein, would you help me with that
about the different kinds of radiation therapy?
Mr. Klein. Sure, the main core of patients are treated with
linear accelerators which come in some differences. There are
the far majority come in machineries that can deliver what are
called photon, means deep-penetrating and maybe with or without
being called electrons which are not so penetrating. And then
there are very customized treatment delivery equipment with
external beams such as was mentioned by Ms. Lindley as
Cyberknife and Gamma Knife which are very specific for specific
sites. There is also the use of actual radioactive sources
directly placed in the tumor for a technique called
Brachytherapy which again was what happened with the VA
hospital was a form of Brachytherapy. So there are variations
but the core of patients are treated with linear accelerators.
Mr. Whitfield. Yes, oK, and when we talk about beads being
placed, what is that?
Mr. Klein. Those would, I am sure certain that those must
have meant radioactive seeds which are placed in the tumor.
Mr. Whitfield. OK.
Mr. Klein. Sometimes they are given over a few days or 5
days or sometimes left in permanently.
Mr. Whitfield. OK, well, let's take a linear accelerator
for just a moment. Of course, we have the manufacturer involved
because they made it. Typically, how many people would be
required to be on the site when the linear accelerator is being
used as it was on the Parks' son?
Mr. Klein. I would say for the most part two ration
therapists are at the console. There can be three, hopefully,
not one although I have witnessed that on some occasions.
Mr. Whitfield. So two radiation therapists?
Mr. Klein. Yes.
Mr. Whitfield. Now, are radiation therapists medical
doctors?
Mr. Klein. No, the word therapist does throw people off.
These are radiation technologists who have had the education to
become radiation therapists in treating patients but they go by
the name therapist.
Mr. Whitfield. Well, I know that from reading about Mr. and
Mrs. Parks' son, it appears that his injury was sustained
because of the filters. The filters were not calibrated or
adjusted in the proper way.
Mr. Klein. What happens with regulator radiation therapy
conventional is that there is an opening beam that treats a
patient. With Intensely Modulated Radiation Therapy, there are
devices, a little culmination devices that move in and out of
the beam which gives it this very customized way of delivering
therapy and so if those aren't in place, then the results can
be problematic and I am sorry, and that is because of the
irradiation time. The time it takes to deliver IMRT, as I
mentioned in my testimony, is longer then conventional therapy
because the beam for the most part is being blocked so it
creates extra time.
Mr. Whitfield. Right, right, well, from the testimony, you
all can correct me if I am wrong but it appears that the
recording of errors, the doses being used, the sharing of
information to the people that should know it, it appears to be
really a fragmented system that I am assuming would vary
greatly with every institution. Would I be correct in that
assumption?
Mr. Klein. It certainly would. An institution does from
institution to institution is how they handle errors, what type
of database they have and how they examine and report back to
the entire staff I know will vary considerably.
Mr. Whitfield. Yes.
Mr. Klein. And then obviously from State to State and so
forth.
Mr. Whitfield. Well, you know, I am really glad we are
having this hearing because all three of you have indicated
that you do feel like there does need to be some national
standards to assist in this area, and when we are dealing with
equipment like this that can certainly provide healing powers
and do miraculous work, it can certainly destroy a person as
well, so your testimony has really been helpful and I do thank
you all three of you for being here.
Let me ask Dr. McCollough one question just out of
curiosity and now this isn't anything technical but I noticed
that either in your testimony or in your resume that it talks
about College of Medicine, and I wasn't, I guess I should have
been aware but I wasn't even aware there was a College of
Medicine and Mayo Clinic. I mean I know you have residency
programs.
Ms. McCollough. We have a medical school, also.
Mr. Whitfield. There is a medical school.
Ms. McCollough. Yes and that is where our academic
appointments.
Mr. Whitfield. And how many students do you have there?
Ms. McCollough. I don't know offhand. It is a relatively
small class size, probably 50 to 100.
Mr. Whitfield. So this would be interns or residents or
undergraduates or all three?
Ms. McCollough. Well, the medical school is to train
physicians.
Mr. Whitfield. Right.
Ms. McCollough. The residencies would be physicians in
their specialty training, and we have Ph.D. programs, and we
train technologists and allied health.
Mr. Whitfield. OK, so you have the whole gamut then.
Ms. McCollough. We try.
Mr. Whitfield. OK, thank you.
Mr. Pallone. Thank you, Mr. Whitfield.
I am going to ask some questions now. I wanted to first
again I don't know how I could thank the Parks' enough for
being here and, you know, for relating the story of your son.
It is just really a sobering reminder of, you know, why we are
here today, frankly, that you are relating to us.
I just wanted to ask Mr. Parks, you mentioned the error
reporting, why is that so important, if you would. You
mentioned the error reporting, you know, that when they report
the errors you mentioned that. Why do you think that is so
important, the reporting? Again, I got to ask you to turn that,
yes.
Mr. Parks. My understanding is these machines have like a
focus and ordinarily it seemed to me they should be shut so
that they can over, they can't kill anybody but in this case it
was wide open and it was wide open at 3 days in a row where the
physicist didn't check the machine. Nobody did and in the
little we know about it, there were four unauthorized,
untrained people who fiddled with that machine during those 3
days, and that I can't explain that. I don't know why that
happened.
Mr. Pallone. OK, so your view you are basically saying is
that if there was more supervision and these things were
reported then we might prevent it.
Mr. Parks. Yes, the physicist, it is our understanding, was
gone. She went somewhere to a meeting or to a seminar or
something, and left. There was no one else qualified there.
They should not have run the machine if there is nobody can run
it but they did, and there needs to be enough staff to where
there is somebody all the time watching that machine. Also, we
found that the ones that were there were watching the monitor,
and apparently it give them some sort of a medication that
makes patients vomit sometimes, and his face was covered with a
mask and they were watching to make sure he didn't vomit into
the mask and aspirate. They weren't watching the monitor that
was telling them that something is wrong but they didn't look
at it. They didn't look at the monitor and he didn't vomit, of
course, but there was just inattentiveness there.
Mr. Pallone. OK, thank you, thank you so much.
Ms. Lindley, you know, I think it is I mean obviously you
said and I have said that it is critical that these
technologies be available but you also, do you also think that
more needs to be done to make them safer? Maybe let me get the
mike again there.
Ms. Lindley. I have been in pretty safe hands and I think
that especially with Selective Internal Radiation Therapy that
I had which was they implanted radiation they did after I had
the procedure they actually took me back and did a spec scan to
ensure that the radiation was in my liver and that everything
was good, and so with it I was very confident. After I read
their article, I know that the next time I have a treatment
that I will definitely ask more questions and I think that it
is good to be proactive.
Mr. Pallone. All right, thank you so much.
Let me ask the three doctors, I know time is running out
here but I wanted to ask the three doctors a question and this
gets a little complicated but if we look at ways to improve the
system there are two major models that I know of. One is the
Mammography Quality Standards Act which I guess I will call
MQSA and then there are changes in the Medicare Improvement for
Patients and Provider Act which is MIPPA, I guess. I hate to
use these acronyms but I have no choice, and my understanding
is that the MQSA is much more detailed and sort of aggressive.
That is sort of a general statement on my part. There is no
accreditation required for radiation treatment facilities. No
licensing requirement for personnel. So let me start with Dr.
Klein, you mentioned the mammography standards in your
testimony. I guess that is the MQSA. You know, I believe in the
importance of these standards but the question is, you know,
radiation therapy too complicated or too diverse for Congress
to regulate it the way we are doing with the MQSA? I mean would
you think that we could go that route or do you think that we
should just leave it up to the practice of medicine?
Mr. Klein. I think because of its complication, complexity
it is even more necessary to have oversight and to have
accreditation for facilities.
Mr. Pallone. So you would--would you use the MQSA model?
Mr. Klein. Not exactly that model but what it is trying to
accomplish, yes, which is uniformity that all mammography
centers are giving the lowest doses possible to get the best
images, and I think that philosophy should be carried forth
that every facility before it turns on a beam has been checked,
and the personnel know exactly what they are doing.
Mr. Pallone. OK, now, can I make a distinction between, you
know, the mammography standards, the MQSA, and the MIPPA in
your mind and, you know, whether you think one is a better
model then the other?
Ms. McCollough. The MQSA model is very prescriptive in
terms of the credentials that each member of the health care
team needs in terms of the quality assurance program, how
frequently it needs to be performed, and in that sense the sort
of consensus of the professionals in the community were able to
give a set of best practices. I am not familiar as much with
the MIPPA but my understanding is that it has not got as in
depth and prescriptive credentialing requirements for the
staff, for example certainly not going into the detail with the
quality assurance.
Mr. Pallone. So you would be more inclined to use the more
detailed or aggressive model of the MQSA. I hate to, you know,
I am using my own terms here to describe it but you would be
inclined that way?
Ms. McCollough. I think it has been a very good program.
Certainly, there is, you know, a lot of overhead that comes
with it so we would just want to be very, you know, cautious as
we move forward that we, you know, do the best without adding
too many levels of extra steps.
Mr. Pallone. Do you want to comment, Dr. Smith-Bindman?
Dr. Smith-Bindman. I do. A lot of my research focuses on
breast cancer so I know the MQSA rules and regulations in
detail, and I know the impact they have had on the quality of
mammography cannot be overstated. Mammography has improved
profoundly since the enactment of MQSA regulation and one of
the things that is so wonderful about this is they actually
follow what happens at the patient level in terms of what they
are likely to get when they go for a mammogram to ensure that
it is of a high quality. So I think there is probably a role
for both of those in oversight but MQSA has improved both the
technical quality of mammography, and it has also improved the
interpretation of mammography by having agreed upon standards
by which these exams are done and interpreted across the
country, and so the impact has been really phenomenal on the
quality and improving women's access to high-quality
mammography.
Mr. Pallone. I know I am out of time but let me just ask
one more thing since I am on this. Now, CMS is currently
implementing the MIPPA standards so I guess one could say, you
know, should we see if they are fully implemented before we,
you know, use them as an example?
Dr. Smith-Bindman. I think it is very important to think
about what accreditation is going to do, and I think if
accreditation is going to put some general standards out there,
that is absolutely a move in the right direction but what you
really want to make sure is that every patient at every
facility is safe and getting the best quality exam they can,
and I am not sure that an overview of accreditation will give
you that. So I think it is certainly a place to start. It makes
no sense to have facilities that are not accredited as long as
we make sure that accreditation actually gets a quality. But I
think in addition to that we also need some safety measure to
make sure that we are actually getting the highest possible
quality out of these tests as possible.
Mr. Pallone. All right, thank you very much.
Mr. Green.
Mr. Green. Thank you, Mr. Chairman, and like everyone, I
would like to thank all our witnesses and, Ms. Lindley,
particularly as I say to my colleagues on the committee, you
and I don't have to have an interpreter to talk since we are
both from Texas, and but thank you for bringing this up. And I
have watched them because some of us have served on the
committee for many years and health care is as much a part of
my life as it is a physicians, I think, because we, our goal is
to expand access and over the last 2 years when we have seen
what has happened and, you know, take away that trust that both
patients and families have in some of the technology we have,
that is what worries me because I look at it, and you all heard
in my opening statement that in medical technology we are
growing every day in our ability. I know on our next panel is a
staff member for M.D. Anderson and I have been there and
watched what both as it was being built but also their laser
treatment facility there. It is amazing what can be done today
that use to couldn't be done simply because surgery couldn't do
it, and that is why I am so concerned about making sure we get
it right so we don't take away that growth into technology that
makes us healthier people.
Dr. Klein, can you describe the latest advances in
radiation therapy? And like I said having been to M.D. Anderson
a number of times, I know my local one but I know there are
also great facilities all over the country.
Mr. Klein. As I mentioned before, there are numerous
variations on linear accelerators and what has been the most
exciting addition to these linear accelerators as the ability,
as the addition of imaging devices actually in the treatment
room, and this has had a huge impact because now we can capture
exactly how the patient is setting up, and for that matter
being maintained in the right position during treatment, and
this is very important. So this is what is known as Image
Guidance Radiation Therapy. So this has helped us improve our
accuracy of setup and also how the patients are being treated
throughout the course of a given treatment.
The other new technology that is starting to boom, of
course, is Proton Radiation Therapy. These are large facilities
that deliver a very different type of radiation therapy, very
customized and idealized for pediatric radiation therapy, for
example.
So these are some of the new things that are coming and
nothing should ever stop these from happening, again, but the
people trained to use them and how they are used, again, needs
to be looked at with scrutiny.
Mr. Green. Well, I know there is a difference between
radiation that maybe we have all been accustomed to for decades
but compared to what is happening today whether it be proton or
even hyphened usage of radiation, could you just talk about
that, the difference between what has happened in the last few
years on treating particularly cancer?
Mr. Klein. Well, being not a physician, I think almost
every tumor sites now, and when I mean site I mean by site of
the body, has found a way to be treated with radiation therapy
more uniquely and customized. For example, not every patient is
a great candidate for Intensely Modulated Radiation Therapy.
There are some that still benefit from conventional therapy but
certainly for the most cases IMRT has improved our ability
because a lot of these tumor sites are in locations that happen
to be right next to a critical organ that we don't want to give
any dose to and lately we have been able to give, again, the
curative doses we need to those tumors while not giving the
dosage that would cause problems to the organs nearby, and that
has only been improving over the last 5 or 10 years.
Mr. Green. OK, well, and I know having heard Mr. Parks and,
again, what happened to Mr. Parks' son is it just seems like we
ought to be able to prevent it but on can we do better on
reporting the error although we know there is reporting because
otherwise we wouldn't be here today because we see it in lots
of different, varying facilities around the country even a VA
facility so is it do we need to do better on reporting errors
so we can make changes or corrections sooner?
Mr. Klein. I always think of error reporting in two
flavors. One is anonymous reporting. Reporting that someone
sends in an error that it happens with this particular
machinery and does an analysis of why it happened but they do
it anonymously so that they are more likely to do that because
of there wouldn't be any direct liability. Now, the industry
learned that that was a great way to go for learning about
incidents and near misses too, and not just incidents that
happened but ones that almost happened and everyone learns from
that. And then, of course, there is the other error reporting
for an actual damage to a patient and they sort of both have to
happen but again you can learn something from both. But
anonymous reporting is something that we use and need to
consider, and a lot of facilities are reticent to do so because
they are afraid is they can clearly submit an anonymous report
without getting into trouble.
Mr. Green. Well, and I know from other members' questions
on both sides of the aisle that it is not something we may be
able to do voluntarily, you know, the industry to regulate
itself. It sounds like we actually need legislation to deal
with it, is that correct?
Mr. Klein. I think that if we go to the step of having
error report, every error reported as mandatory then it
obviously has to come from an agency. Now, the Nuclear
Regulatory Commission does that right now. If you are in a
State that is where the isotope used, use of radioactive
materials it is still governed by the Nuclear Regulatory
Commission. Not every State has that, two-thirds do not but in
Missouri if an error were to happen with use of an isotope for
radiotherapy such as Gamma Knife, we absolutely have to report
that but if an error happened with a linear accelerator in
Missouri, we wouldn't have to report it to anyone.
Mr. Green. Well, Mr. Chairman, it sounds like we have some
ideas on what we need to deal with on the legislative. Thank
you. I know my time has run out.
Mr. Pallone. Thank you, Mr. Green.
Ms. Castor.
Ms. Castor. Well, thank you very much, Chairman Pallone,
for calling this important hearing and thank you each and every
one of you for being here today.
There have been such tremendous technological advances in
medical treatment but along with these advances come increased
hazards when the equipment malfunctions or is improperly setup
or used incorrectly, and as the equipment becomes more
powerful, I think we would all agree that it is imperative that
everything possible be done to minimize the risk of something
going wrong. And there was a terrible case in my hometown at
the premiere cancer center that has a sterling reputation. It
is just outstanding but, unfortunately, and this was a few
years ago 77 brain cancer patients were over-radiated because a
newer, more advanced machine had not been setup correctly. The
problem wasn't discovered until inspectors from the
Radiological Physics Center, a Federally financed testing
service, came in for an inspection, and the director of the
Radiological Physics Center said that if the inspection
occurred earlier or if the Center had a regular practice which
included inspections earlier they--we really could have avoided
these terrible errors. So I know you all have called for
greater training, broader accreditation but on this narrow
topic what about the folks that come in and install? The
manufacturers' representatives are they--do they bear some
responsibility of catching these errors and doing that testing?
Should accreditation programs include the manufacturers'
technical representatives? Dr. McCollough, do you want to
start?
Ms. McCollough. It is incumbent on the facility to actually
have one of their own physicists or a hired physicist or
something to test as an independent measure because the
equipment manufacturers come and make sure it is operating
according to specifications but then there is what I assume
happened in this case the secondary test that then that the in-
house people measure and calibrate it and set it up for their
usage. So I think duplicative systems are always good, checks
and balances, and so the manufacturers make sure it is
operating. The users then have to make sure they set it up
correctly and use it correctly.
Ms. Castor. Yes, because according to their in-house tests,
it was operating adequately or acceptably, and it wasn't until
the Radiological Physics Center came to again that they noted
the errors.
Dr. Smith-Bindman. I think that it is very important to
know how the machines are used in actual practice, not how they
are used before they leave the factory, and the manufacturers
when they come in to setup every CT scan for diagnostic
imaging, at least, they work with the local physicians to
figure out how to setup those scans. And it turns out it is a
complicated topic but you get prettier pictures if you turn the
dose up higher, and those default settings are crucial in terms
of what most patients receive, and if those default settings
are set in such a way that you get the most beautiful pictures
then it turns out the patients are getting higher radiation
doses then they need to support those pictures. So one of the
things that the manufacturers are on the ground doing is
setting up those protocols with the physicians and there should
be guidelines for how those default settings, the settings that
most patients experience are setup. So I would say that is one
way the manufacturers could help ensure most patients receive
the lowest dose possible.
Second, this awareness of the potential harm for radiation
is currently getting a lot of attention and the manufacturers
actually have a lot of ways to lower dose so the doses for the
most typical scans that patients undergo could be reduced by 50
percent without reducing quality at all, and there are lots of
ways to make that happen. Dr. McCollough is an expert on how
you make those parameters as low-dose as possible but the
manufacturers have a lot of expertise around that area as well.
They have algorithms that you can apply to existing machinery
to lower dose, and I would really push for the manufacturers to
make those software products available to everyone who
currently owns a CT scan and at a reasonable price so that we
can get those dose reduction algorithms out there in active
practice. I think on the newer machines that will be sold over
the next 5 years, this problem may be addressed to a greater
degree but I think we really need to ensure the current scans
that are out there are done, and there are ways to lower dose
dramatically.
Mr. Klein. In regards to radiation therapy and in
particular maybe to what happened in Florida, that manufacturer
did not have any control over the training of the individual
who would have been--who was responsible for determining how
the machine was designating the dose rate and that is where the
problem was lying. The manufacturer did not have control so
that the physicist who was responsible would have demanded, and
we drive our manufacturers crazy, to do extra tests to validate
that everything was going correctly. However, if the
manufacturer had said OK, you are buying this very expensive
piece of equipment. It is complex and it is potentially
dangerous. We are going to supply an expert physicist to come
in from the outside to validate what you are doing. A very
simple solution that it would have caught what had happened.
Ms. Castor. Thank you very much.
Now, I will yield back so we can get to the next panel.
Mr. Pallone. Thank you. We are not going to have a second
round because we have to go to the next panel but Mr. Whitfield
who has been here by himself on the Republican side would like
to ask some questions so I am going to let him do so.
Mr. Whitfield. I want to thank you for your sympathy and
understanding.
When we talk about Federal guidelines for accreditation and
reporting of errors and so forth, I want to ask you three
physicians, do we have to be concerned about HIPAA regulations
when we get into that area?
Dr. Smith-Bindman. I think one of the problems in easily
collecting data is that you don't want to release information
about the patient and privacy information that would be
concerned. As it turns out for the area that we are talking
about, you don't need to release any private patient
information. To understand those, you need to know a little bit
about that patient such as their age and their sex. None of
those are covered by HIPAA, and the dose that they receive, and
that is all you need, and none of that data are protected under
HIPAA. So I think we use that sometimes as an excuse for not
collecting the data but in this particular area for diagnostic
imaging, we don't need any of that personal data to understand
quality.
Mr. Whitfield. And, oh, OK, Dr. Klein.
Mr. Klein. There are some databases right now that have a
databank of errors that have been reported, the IAEA, and there
is also an interesting group, European group called ROSIS, and
I can supply that information later. It is all voluntary and
everything is anonymous in terms of the patient information and
it works very well to learn from that system so I don't think
it is an issue really.
Mr. Whitfield. OK, I mentioned to Chairman Pallone that if
he is going in for radiation he better have his own checklist
to look at and then, you know, when we started thinking about
that a little bit more and I think that is one of the problems
with our medical system today is frequently patients go in and
they just make themselves totally compliant to whatever is
going on in there. And should we pursue that in areas like this
that have such dire consequences that the providers provide the
patient or the patient's family with a checklist that they
should be focused on as they go through their treatment?
Mr. Pallone. What we are basically asking is, is there
anything you can do proactively as a patient to check what is
going on? Now, if you go in, can I ask some questions about
what is going on here to make sure that I don't get
overexposed?
Ms. McCollough. One of the things we encourage we have a
patient information brochure at the check-in desk after you
have agreed with your physician that this is an important exam,
is just to make sure your physician aware if you have had any
exams recently because perhaps the one you are having today
isn't necessary. But also we encourage in general the topic of
just making sure that the institution knows that they need to
right-size the dose, so to speak. Is this exam being tailored
for my particular illness or diagnostic question and for my
particular body size, as we all come in different shapes and
sizes.
Mr. Pallone. Sure, go ahead. That whistling, I think, is
the wind. It is not somebody holding a whistle.
Dr. Smith-Bindman. It is a win situation although for
diagnostic imaging if you went in as an informed patient and
said to the technologist or the physician, can you tell me what
my dose is on this exam, the answer currently would be I don't
know. I have received dozens of e-mails and letters and phone
calls from patients who are really very concerned about this,
and one described his experience of asking his physician about
the radiation dose and he was told by the hospital that he
could hire a private physicist if he wanted that information,
and that information is in the CT scan albeit it is a little
tricky to get out but I think that information belongs in that
patient's medical records. So if you as a patient go to the
emergency department and they need to give you a medication
there is a big sticker that goes on your chart if you have an
allergy to a medicine, and we have tried to put checks and
balances in place to make sure that if you have an allergy you
don't get that medication. I think around the issue of
radiation safety, we need to start thinking about that way so
when a doctor sees you and orders your test, they know if you
have had 15 others of those tests in the last 2 weeks. They
might still get that test but that information would be very
important so if information is in the medical record, I think
doctors could make more informed choices. Certainly, a patient
should keep track of everything they have had done and ask the
right questions but we need to have a system in place at the
other end that there are answers and information that they can
get back.
Ms. McCollough. One of--if I could?
Mr. Pallone. Yes, go ahead, sure.
Ms. McCollough. One of the difficult things about seeing
the dose is that the equipment and what the manufacturers can
do is say what is this machine putting out. The actual dose to
the patient then gets much more complex because it is this
interaction of the patient, their body size, with what the
machine is putting out. And so the data is very clear as to how
the machine is set up and then a physicist can go back and make
estimates and models of what that patient got, but unless you
went to the extent of almost radiation treatment planning on
each and every patient, you really can't tell them what your
liver dose or your lung dose without actually having a full CT
of their body and then modeling what the scanner gives with
them.
I don't think I did a great job answering Ms. Eshoo's
question about is this information available, and the number
that is available is what the scanner is set up to give for a
standard patient. Our technologists look at that rigorously, I
mean religiously and that tells them have I set up my exam
correctly. Are all my parameters typed in and then at that
point the scanner adapts to the patient size. Mammography
systems do this, fluoroscopy, radiography because the math that
is involved to figuring how much is getting through this size
patient or that is something you can't kind of do on the side
on a calculator. So most radiographic systems actually have
that feedback loop and that is where you can't explicitly say
what Mrs. Smith is going to get in her liver because it will
take the scan of Mrs. Smith and give the feedback of just how
big she is to set the dose.
Mr. Pallone. All right, thank you very much. So this is
very instructive and I know that, you know, several members
have said, you know, are we going to do legislation? Do we need
a follow-up? I mean we could easily after we have this hearing
today decide that we need additional hearings or get back to
you and you may get some additional written questions within
the next 10 days or so. So thank you all. We appreciate it and
thank you in particular, the Parks and Ms. Lindley, as well.
Thank you.
We are going to move to the second panel. All right. It
looks like we are very crowded here. I didn't realize that you
were going to be rubbing shoulders. So let me start with our
second panel and introduce the panelists from my left to right.
First is Dr. Tim Williams who is chair of the board of
directors of the American Society for Radiation Oncology. And
then we have Dr. Michael Herman who is president of the
American Association of Physicists in Medicine. And then we
have Sandra Hayden who is vice speaker of the house for the
American Society of Radiologic Technologists. And then Dr.
Steven Amis who is former chair of the board of chancellors for
the American College of Radiology. And then from New Jersey is
Kenneth Mizrach who is director of the VA New Jersey Health
Care System within the Department of Veterans Affairs. And then
we have David Fisher who is executive director of the Medical
Imaging Technology Alliance, and finally, John Donahue who is
vice chairman of Medicalis, Inc.
Thank you all for being here and I think you were all here
before when I said 5 minutes and your full statements become
part of the record and then we will have questions. Now, I have
to apologize I mean I know when it is a Friday, of course, if
the votes are over we don't have as many people participate
but, you know, we had originally scheduled this for a day when
it snowed, when we had all the snow so when we tried to
reschedule it we didn't have a lot of options so that is why we
are here on Friday.
And we will start with Dr. Williams.
STATEMENTS OF TIM R. WILLIAMS, M.D., CHAIR, BOARD OF DIRECTORS,
AMERICAN SOCIETY FOR RADIATION ONCOLOGY (ASTRO); MICHAEL G.
HERMAN, PH.D., PRESIDENT, AMERICAN ASSOCIATION OF PHYSICISTS IN
MEDICINE; SANDRA HAYDEN, B.S., R.T(T), VICE SPEAKER OF THE
HOUSE, AMERICAN SOCIETY OF RADIOLOGIC TECHNOLOGISTS; E. STEVEN
AMIS, JR., M.D., FACR, FORMER CHAIR, BOARD OF CHANCELLORS,
AMERICAN COLLEGE OF RADIOLOGY; KENNETH MIZRACH, MHA, DIRECTOR,
VA NEW JERSEY HEALTH CARE SYSTEM, DEPARTMENT OF VETERANS
AFFAIRS; DAVID N. FISHER, EXECUTIVE DIRECTOR, MEDICAL IMAGING
TECHNOLOGY ALLIANCE; AND JOHN J. DONAHUE, VICE-CHAIRMAN,
MEDICALIS, INC.
STATEMENT OF TIM R. WILLIAMS
Dr. Williams. Thank you. Chairman Pallone and
Representative Whitfield and members of this distinguished
committee, good afternoon and thank you for the opportunity to
testify at today's hearing.
I am a practicing, board-certified radiation oncologist and
I have been in my location for over 20 years, and I have
personally taken care of almost 7,000 cancer patients. I care
deeply about the health and safety of my patients.
ASTRO wants patients to have peace of mind when it comes to
safety, quality and efficacy of radiation therapy. We are
committed to stronger error reporting, enhanced accreditation,
better use of health information technology, patient-centered
educational tools and Federal advocacy to help protect
patients. I was not involved in any of the tragic situations
described by the New York Times but I want to offer my own
personal sympathies to those families and particularly the
family of Scott Jerome Parks, whose father shared his story
with us earlier. His wish was that no one else would go through
what he did. We agree. No medical error is acceptable. Cancer
patients have enough to worry about.
I have personally witnessed the great benefits of radiation
therapy for cancer patients as the medical director of the
department of radiation oncology at the Lynn Cancer Institute
of Boca Raton Community Hospital. I currently serve as chair of
the board of directors of the American Society for Radiation
Oncology for whom I am representing here today.
Radiation oncology is an important tool in the fight
against cancer, contributing over the past 25 years to steady
increases in survival rates for cancer patients. In the mid-
1970s, for example, the 5 year survival rate for breast cancer
was 75 percent, for prostate cancer it was 69 percent. Today
that survival rate has increased to 98 percent for breast
cancer and 99 percent for prostate cancer. These are important
gains. More are needed.
ASTRO's highest priority is ensuring that patients receive
the safest, most effective treatments. A culture of safety and
quality control is woven into the fabric of our field with many
checks and balances to assure that safe and effective care is
delivered to our patients. While ASTRO is alarmed and concerned
by the errors described in recent press reports, we do not
believe that there are widespread radiation mistakes leading to
patient harm across the country. However, the reports do
highlight that there is more work to do. Any error, no matter
how small, must be reported, understood and utilized as a tool
to reduce the potential for future errors. Failing to report
known errors is unacceptable.
This moment is an opportunity to further improve our
efforts to strengthen the practice of radiation oncology. We
have developed a six-point action plan we call target safely.
Number one. Work to strengthen error reporting and to create a
national database for the reporting of medical errors.
Number two. Advocate for new and expanded Federal
initiatives to help protect patients from radiation errors.
This includes supporting passage of the CARE Act that requires
national standards for radiation treatment team members,
supporting increased funding for the Radiological Physics
Center at the M.D. Anderson Cancer Center and the quality
assurance activities of the Advanced Technology Consortium
support a Congressional inquiry into self-referral. ASTRO is
concerned that self-referral of radiation therapy services may
result in short-changing essential quality control assurance
and patient safety protections.
Number three. Work with cancer support organizations to
help patients know what to ask their doctors about radiation
therapy. Empowered patients who actively engage in their care
are important members of our team fighting to beat cancer.
Number four. Enhance the joint ASTRO ACR Radiation Oncology
Practice Accreditation program. ASTRO recommends that all
radiation oncology practices undergo accreditation.
Number Five. Expand educational training programs to
include an intensive focus on quality assurance and safety.
ASTRO strongly encourages that all radiation oncologists
participate in maintenance of certification.
Number Six. Accelerate our ongoing health information
technology interoperability effort. We want device
manufacturers to implement standards that allow the transfer of
treatment information from one machine to another seamlessly to
reduce the chance of a medical error.
ASTRO has been developing and refining many of these
programs for years. In today's environment, medical technology
and decision-making are increasingly complex. The above plan
holds the promise of ensuring patient safety in this
challenging atmosphere.
Finally, I would like to demonstrate the benefits of
radiation by telling you the story of one of my patients from
South Florida. I treated a 50-year-old woman 15 years ago who
presented with bilateral breast cancer. At that time, the
standard therapy was bilateral mastectomies and the idea of a
lumpectomy and radiation for both sides at the same time was
considered a very advanced form of therapy. She didn't want
both of her breasts removed and we went ahead and proceeded
with the lumpectomy on both sides and simultaneous radiation to
both breasts. She is now alive 15 years late. I have been
following her for the entire time period and she spends time
with her family, enjoys a good quality of life and is a true
success story for today.
This is what keeps me hopeful and looking for advances in
the field. My hope is that patients across the country will
recognize these incidents for what they are, isolated acts and
that these reports will not dissuade patients who need
radiation therapy from receiving needed treatments. We support
the committee's review of these issues and we look forward to
working with you to further enhance the quality of care
patients receive.
Thank you for the opportunity to testify.
[The prepared statement of Dr. Williams follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Dr. Williams.
Dr. Herman.
STATEMENT OF MICHAEL G. HERMAN
Mr. Herman. Chairman Pallone and distinguished members,
good afternoon. Thank you for the opportunity to testify.
My name is Michael Herman and I am president of the
American Association of Physicists and Medicine. Medical
physicists are responsible for accuracy, quality and safety of
the radiation-producing technology and diagnostic imaging and
radiation therapy. Although rare, medical errors can be
devastating. We all wish that no one ever made a mistake but
errors still can and do occur due to a combination of unlikely
events occurring sequentially or simultaneously, many times
under unusual circumstances that involve complex systems.
The use of medical radiation occurs in radiation oncology
and in radiology practices with millions of people receiving
that radiation annually to their benefit. Each patient
procedure is a complex, multi-system process which combines
technology and human actions. To make the process work requires
coordination and participation of a team of humans, physicians,
medical physicists, dosimetrists, radiation therapists,
radiation technologists. All focus on the treatment of each
patient.
One of AAPM's primary goals is to identify and implement
improvements and patient safety for the medical use of
radiation. We do this through our association's activities and
in cooperation with other societies and regulatory and
government bodies. Some of these include the development of
procedures and guidelines, producing detailed scientific
educational and practical reports, guidance to regulatory and
accrediting bodies, oversight of quality assurance and
calibration processes, facilitating medical information system
communication and providing education on medical errors.
AAPM believes that the position of qualified medical
physicists should be recognized nationally for anyone
practicing clinical medical physics. A qualified medical
physicist is an individual who has completed a unique
combination of graduate education, rigorous clinical training
and board certification in medical physics. All of these
efforts mentioned move us toward more effective patient care
and in achieving the absolute minimum error rate, however, some
challenges remain.
There is no consistent national recognition of qualified
medical physicists. Medical physicists are licensed in only
four States in this country and regulated at widely varying
levels in the other States. The reports and guidelines that
AAPM and others publish have only the force and effect of
professional and scientific guidelines. There are no consensus
national staffing guidelines for qualified medical physic
services nor are there consistent standards established for
accrediting practices that utilize medical physic services.
So what can we do? Well, much effort and progress is being
made to improve quality of care and increase patient safety but
we can and must do more. Together medical radiation team
members, professional associations, manufacturers and
government must strive for nationally consistent recognition of
the qualified medical physicist and equivalent competency for
all medical radiation team members by passing H.R. 3652, the
Consistency, Accuracy, Responsibility and Excellence in Medical
Imaging and Radiation Therapy Act of 2009, and specifically
requiring that all medical physicists involved in medical
imaging and radiation therapy be included in this bill. Provide
consistent procedure-specific consensus minimum standards for
national practice guidance in radiation oncology and medical
imaging that recognize qualified individuals for specific
responsibilities. Define communication of the team. Establish
minimum staffing levels and receive timely review and
amendment. Establish a rigorous minimum standard for all bodies
at accredit clinical medical radiation practices based on the
previously mentioned staff list national guidance that includes
additional accredit requirements for highly-specialized
procedures. Link CMS reimbursement to rigorous practice
accreditation for all medical imaging and radiation therapy
practices. Create a national data collection system to learn
from actual and potential adverse events in the medical use of
radiation that allows complete and consistent reporting by
medical staff, manufacturers and others. Improve the review
effectiveness of product quality in the equipment clearance
process.
In summary, we believe that patient safety and the use of
medical radiation will be increased through consistent
education and certification of medical team members, whose
qualifications are recognized nationally, and who follow
consensus practice guidelines that meet established national
accrediting standards. We have been working together for years
on many of these issues. We must do more and we need some help.
Together we will continue to make the use of medical radiation
safer and more effective for the people that need it.
Thank you for the opportunity to speak to you today.
[The prepared statement of Mr. Herman follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Dr. Herman.
Ms. Hayden.
STATEMENT OF SANDRA HAYDEN
Ms. Hayden. Mr. Chairman.
Mr. Pallone. It sounds like it is working. Go ahead.
Ms. Hayden. Mr. Chairman and members of the committee, my
name is Sandra Hayden and I am a radiation therapist at M.D.
Anderson Cancer Center in Houston. I also serve on the board of
the American Society of Radiologic Technologists and it is in
that role that I address you today.
On behalf of the ASRT's 134,000 members, thank you for the
opportunity to contribute to this dialogue on the quality of
radiation therapy and other medical procedures that use
radiation. Radiation therapy is the cornerstone of cancer
management programs worldwide. It can contain, control and cure
cancer however radiation therapy must be precise to be
effective. Accuracy is equally important during medical
imagining exams that diagnose cancer. X-ray exams, CT scans and
other imaging tests use radiation and radiation comes with some
risk. Errors, although rare, can cause devastating side
effects.
The ASRT believes the best way to ensure quality and safety
of medical radiation procedures is to establish national
educational and certification standards for technical personnel
who perform them. CT scanners, gamma cameras and linear
accelerators are some of the most complex medical equipment in
the world however this technology is ineffective in the wrong
hands. That is because the quality of any medical radiation
procedure is directly linked to the scale and competence of the
person performing it. Individuals must have extensive education
and training to perform the exam correctly. Patient safety is
in the hands of these individuals yet they remain largely
unregulated.
Radiographers are not licensed in eight States. Radiation
therapists such as myself are not regulated in 17 States,
including the District of Columbia. Medical physicists have no
oversight in 31 States and no State regulates medical
dosimetrists. Even in States with some type of regulation, the
rules are sometimes so weak they offer patients little
protection. In some States hairdressers are better regulated
than people who perform medical radiation procedures.
Unqualified personnel are a danger to patients. An
underexposed x-ray can't reveal a malignant tumor. An
inaccurate radiation therapy treatment can't stop its spread.
Even worse, when medical radiation is used improperly it can
harm the very patients it was meant to help as you have heard
from earlier.
The solution is the Consistency, Accuracy, Responsibility
and Excellence in Medical Imaging and Radiation Therapy bill.
The CARE bill introduced by Representative Barrow as H.R. 3652
and pending before Congress since 2000 uses a three-tiered
approach to improving quality and safety.
First, individuals who perform medical imaging and
radiation therapy would be required to graduate from a
specialized educational program. Second, they would be required
to pass a national certification exam and third, they would be
required to maintain competency by obtaining continuing
education.
Only qualified personnel should be allowed to perform
medical imaging or radiation therapy. The CARE bill will ensure
a minimum level of education, knowledge and skill for those who
are responsible for medical radiation procedures. For patient
safety, the ASRT encourages Congress to pass the CARE bill.
The ASRT also calls for consistent and mandatory methods of
reporting medical radiation errors. Mistakes must be reported
and investigated so others may learn from them. By learning how
errors occur, we can implement safeguards to prevent them.
Currently, States and Federal oversight of radiation errors
is inconsistent. Regulatory bodies do not share information.
Even worse, some States do not require that errors be
documented at all. The ASRT calls for mandatory reporting of
medical radiation errors and also for a consistent system of
data collection and tracking.
A model to consider is the FDA's MedWatch program which
takes a systemic approach. A reporting system such as MedWatch
would build a knowledge based on patient safety and help reduce
errors.
Thanks to medical imaging and radiation therapy millions of
Americans are cancer survivors. The vast majority of medical
radiation procedures are administered safely and successfully
however any mistake is unacceptable. ASRT's recommendation will
lead to safer care and will help more patients win the battle
against cancer.
Thank you again for inviting me to speak on this important
issue.
[The prepared statement of Ms. Hayden follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Ms. Hayden.
Dr. Amis.
STATEMENT OF E. STEVEN AMIS, JR.
Dr. Amis. Chairman Pallone, Congressman Whitfield and
distinguished members of the subcommittee, thank you for the
opportunity to speak today.
I am Dr. Steven Amis, Professor and Chair of Radiology, The
Albert Einstein College of Medicine in Montefiore Medical
Center in New York. I am a past president of the American
College of Radiology and I am testifying today in my capacity
as chair of ACR's blue ribbon panel on radiation dose in
medicine.
The ACR which represents more than 36,000 radiologists,
radiation oncologists, nuclear medicine physicians and medical
physicists is committed to ensuring appropriate use of
radiation in medicine. One message I must highlight today is
that the proper use of radiation in medicine whether diagnostic
or therapeutic saves lives and improves the quality of care for
millions of patients each year.
Please consider the following. Advances in medical imaging
have rendered exploratory surgery virtually obsolete.
Interventional radiologic procedures often replace more
invasive surgical options resulting in approved outcomes and
reduced hospital stays, and over one million patients each year
are cured or experience relief of pain due to treatment of
their tumors with radiation therapy.
Still as has been known for the past 100 years, recent
media reports remind us that the medical use of radiation is
not without risk. We can and must do a better job of preventing
errors.
The ACR has long been involved with numerous radiation-
related quality improvement initiatives. These include
development of guidelines to ensure that patients get the right
exam or treatment performed in the right way. Creation of
registries and other tools to help physicians compare their
outcomes with those of their peers, and education of
radiologists, fellow physicians and the public about the risks
and benefits of both diagnostic and therapeutic radiation. Of
particular note, ACR strongly supports Image Gently, an
educational initiative conceived by pediatric radiologists to
promote safe imaging of children.
To help prevent further adverse radiation-related events,
ACR asks that Congress seriously consider the following
recommendation and we are not pulling any punches. A formal
accreditation process must be mandatory for all diagnostic
imaging service and radiation therapy practices. In this
process hospitals and freestanding facilities should be held to
the same standards as patients have a right to safe and high-
quality care regardless of the setting in which they receive
it. Such a process should be robust and focus on considerations
unique to imaging and radiation therapy such as image quality,
dose monitoring, phantom testing, equipment calibration and
maintenance, and the qualifications of all involved personnel.
As a corollary, since CT scans are a growing cause of
radiation exposure in the United States, a CT dose registry
should be required as a component of accreditation for CT
practices. This would help ensure ongoing compliance with
accreditation baseline.
ACR has been working with industry to develop such a
registry but a Congressional mandate would facilitate this
process. Congress has already recognized the importance of
accreditation. MQSA requires accreditation of mammography
practices and has helped save tens of thousands of lives. A
similar approach is seen in MIPPA. It has already been
described, which requires accreditation of non-hospital-based
imaging practices. Both MQSA and MIPPA offer important lessons
on how to design an optimal accreditation process.
Further, it is essential that the accrediting bodies have a
proven track record in imaging and radiation therapy
accreditation. The ACR is the nation's oldest and most
recognized medical imaging and radiation therapy accrediting
body and is the only nationwide FDA approved accrediting body
for MQSA. ACR accreditation designed to be educational in
nature is an efficient process of both self-assessment by the
practice being reviewed and independent, external audit by
physicians and medical physicists who are recognized experts in
the specific type of practice being evaluated.
We recognize there is a desirable middle ground between an
accreditation process that is overly burdensome and one that
lacks the substance to ensure quality and safety. We stand
ready to work with members of this committee to find the right
balance.
Thank you again for the opportunity to testify and for
holding this hearing on such an important topic.
[The prepared statement of Dr. Amis follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Doctor.
Mr. Mizrach.
STATEMENT OF KENNETH MIZRACH
Mr. Mizrach. Good afternoon, Mr. Chairman. Thank you for
the opportunity to share the radiation oncology experience at
the VA New Jersey Health Care System.
I will describe for you our 3-year journey that includes
how we identify the problem and the quality of care for
radiation oncology patients, how we responded and how we
rebuilt our program to make sure that these circumstances would
not happen again. Transparency was our constant focus
throughout this process and guided our decisions to ensure that
we acted in the best interest of our patients, and as soon as
we determine that specific patients did not receive the quality
of care they deserved, we disclosed this information to 53
patients and their families consistent with the Veterans Health
Care Administration policy.
Of the 53 patients, we determined that two patients were
harmed. We informed the other 51 patients that they experienced
errors that created a risk for them for the future. We are
following these patients for any subsequent signs of injury
resulting from the identity of any of these errors.
Prior to December of 2006, the East Orange campus of the VA
New Jersey Health Care System radiation oncology program was
accredited by a nationally recognized, external, reviewing
agency. Our patients were satisfied. Staff members had no
complaints and all indications suggested our program was
delivering quality care.
In December of 2006, we first heard that two radiation
therapy contract technicians unexpectedly were no longer
reporting to work at our facility. When we inquired as to why
this happened, we learned that they had raised concerns about
the quality of care being providing resulting in a conflict
with the supervisory staff.
We immediately initiated a review that included a series of
increasingly detailed investigations of the quality of care in
radiation oncology. The first review by a quality manager
validated that the concern raised by the technicians were
credible. In response, we made the decision to close the
program down until a thorough review was complete and we were
certain our program provided safe, quality care for our
veterans.
Patients in the need of radiation therapy have received
care through fee-basis arrangements with local accredited
facilities in their communities. Subsequent reviews by external
VHA teams of experts and final comprehensive review by the
American College of Radiology confirmed there were deficits in
our programs. These included issues of staff qualifications and
communication, implementation of new technology without
adequate education and training, gaps in procedures for
managing patients and the lack of a robust, quality assurance
program.
These findings became the framework for rebuilding our
radiation oncology program. We needed to be sure we would
deliver the highest standard of care possible and implement
corrective actions to rectify all deficits identified by the
ACR.
During the course of the investigation, the clinical staff
who had been working in our programs resigned. At the same
time, the contract for radiation therapy technicians and for
contract physicists expired. We then made the decision that it
would not be renewed.
We began by improving our program by hiring new staff
members including a nationally respected, experience and board-
certified chief of radiation oncology. We also hired properly
trained and credentialed physicists, a dosimetrist and
radiation therapy technicians.
As radiation therapy is complex and rapidly changing, we
established a program of continuous education for all staff and
a major component of this initial and ongoing training of new
technology and equipment. We next established policies and
procedures to guide patients' care and instituted a
comprehensive quality management program.
Such a program includes meeting the standards established
by the American College of Radiology. This entails identifying
quality control for every step of radiation therapy including
the dose and technique prescribed, the energy the machine
delivers, the dose of radiation the patient receives and how
the patient responds to the therapy. We are continuing the
routine tests of our machines simulating patient encounters,
checking dose calculations, tracking patient outcomes and
instituting routine quality reviews of care including peer
review.
A culture of openness is fundamental to patient safety.
This means an environment where all staff members are
considered an equal part of the health care team. To this end,
we established multi-disciplinary team meetings prior to,
during and after treatment to review all aspects of care. We
encourage our staff members at all times to raise questions of
concern about that care being provided. The most important
lesson we learned through this process was that staff members
must be able to communicate openly to feel comfortable about
raising issues and to feel confidant that leadership will
respond to their concerns.
Thank you again for the opportunity to share my experience.
I am now available for questions at a later time.
[The prepared statement of Mr. Mizrach follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Mr. Mizrach. Thank you for being
here too, today. I appreciate it.
Mr. Fisher.
STATEMENT OF DAVID N. FISHER
Mr. Fisher. Mr. Chairman, Congressman Whitfield,
Congresswoman Castor, thank you for the opportunity to be here
today.
I serve as the executive director of the Medical Imaging
and Technology Alliance, the leading association representing
the manufacturers, innovators and developers of medical imaging
and radiation therapy systems. We are here today because of a
tragic situation and as an industry we are committed to doing
our part to prevent such things from occurring in the future.
At the outset, it is important to note that computed
tomography, CT, and radiation therapy, RT, are very different
modalities used for different purposes. CT is a diagnostic tool
that utilizes ionizing radiation to create detailed images of
internal tissues. Radiation therapy or RT on the other hand, is
a therapeutic tool that utilizes a focused beam of radiation to
kill cancer cells. Due to their distinct purposes, the amount
of radiation associated with these modalities differs by orders
of magnitude.
These two modalities have revolutionized health care
delivery. The New England Journal of Medicine recently called
medical imaging one of the top health care innovations ever.
Likewise, radiation therapy offers highly personalized, non-
invasive and cost effective care for up to 60 percent of all
diagnosed cancer patients in the U.S.
MITA has a long history of working with its members,
physicians, physicists, technologists, regulatory bodies and
other stakeholders to track and reduce medical radiation. Our
members continue to introduce new products in system
innovations that reduce radiation dose for many procedures
while continually improving image quality. New technologies
like weight and age-based protocols, automatic exposure
control, software improvements and improved interfaces with
operators all enable dose reduction.
MITA is also working collaboratively with other
stakeholders on issues related to medical radiation and the use
of radiation in the equipment. For example, in November of last
year, MITA convened a meeting including physicians, physicists,
industry and Food and Drug Administration official to discuss
ways to prevent future medical errors that involve ionizing
radiation. MITA is also cosponsoring an upcoming CT dose summit
and is also considering a radiation therapy summit to work with
the AAPM on a radiation therapy summit to further the education
of providers, physicists and others on the new technologies,
dose reduction technologies in particular our companies
manufacture.
As part of the access to medical imaging coalition, MITA
helps to develop appropriateness criteria for advanced medical
imaging included in the Medicare Improvements for Patients and
Providers Act or MIPPA. More recently, MITA announced its
support for the President's proposal in the fiscal year 2011
budget to develop a National Dose Registry. We also welcome the
FDA's recent actions regarding radiation dose and support many
of the policies proposed in their initiative to reduce
unnecessary radiation exposure for medical imaging. MITA
intends to participate fully with FDA as they work to implement
dose reduction policies and MITA has also recently made two
announcements in the area of radiation dose that may be of
interest to this committee.
Yesterday, MITA announced a new dose check initiative in
which CT manufacturers committed to do three things. First, a
new radiation dose alert feature which is designed to provide a
clear indication that the settings for the CT exam will result
in a dose higher than a predetermined reference dose for
routine scans. Second, manufacturers are committed to including
a dose warning feature to prevent CT scanning at higher,
potentially dangerous radiation levels. This feature is
designed to prevent hazardous levels of radiation that could
lead to injuries. This feature can also be configured by
hospitals or imaging facilities to prevent scans at these
higher radiation levels. Third, manufacturers will also
standardize dose reporting to help better understand dose
levels and facilitate the development of the National Dose
Registry proposed by the President.
Several weeks ago MITA also announced a dose reduction plan
including the development of radiation dose reference levels to
assist clinicians to understand the relative amount of
radiation associated with the scan. Expansion of the
appropriateness criteria mentioned earlier to ensure that
patients receive the right test at the right time, the
development of training standards for hospitals and free-
standing imaging facilities that purchase imaging equipment
that involve the use of radiation and radiation therapy
equipment, efforts to develop safety checklists to reduce
medical errors and to incorporate those new standards into our
training offerings. Efforts to ensure standardize reporting
across stakeholders in a manner that is transparent for
patients, their families and physicians. An examination of
whether the MIPPA accreditation policy should be expanded to
include additional facilities where radiation therapy medical
devices are in use, and the establishment of minimum standards
for radiologic technologists who perform diagnostic medical
imaging exams and deliver radiation therapy treatments.
In each of these cases, MITA and our member companies stand
ready to work with professional organizations, regulatory
bodies, individual clinicians and other stakeholders on these
features. Lastly, MITA continues to work with all of our
members whose companies manufacture products that ionizing
radiation to develop new ways to reduce dose and reduce medical
errors, and I am hopeful we will continue to make strides in
this area. As we look to the future of health care in this
country, we cannot see our way to better outcomes and lower
costs without the lens that medical imaging provides. The
medical technologies MITA member companies research, develop
and manufacture are the future of delivering better health
outcomes at lower costs.
Thank you for this opportunity today. As the legislation
process proceeds, MITA looks forward to continuing to work with
Congress and the Administration to ensure appropriate use of
and access to medical imaging and radiation therapy.
[The prepared statement of Mr. Fisher follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Mr. Fisher.
Mr. Donahue.
STATEMENT OF JOHN J. DONAHUE
Mr. Donahue. Thank you, Chairman Pallone, Congressman
Whitfield.
My name is John Donahue and I am grateful to be here to
discuss the issues surrounding ionizing radiation in medicine.
I want to begin by expressing my profound admiration for the
courage of the Parks Family.
I am here as the vice-chairman of Medicalis. Medicalis is a
leading innovator of technology and clinical solutions focused
on improving access to high-quality, safe, clinically-
appropriate, advanced diagnostic imaging. We are a company
founded by the radiologists and information technologists of
the Brigham and Women's Hospital in Boston. We provide
physicians at the point of ordering with web-based radiation
safety and clinical appropriateness decision support.
By way of background, I have been in the health care, the
international health care industry for over 25 years in the
pharmaceutical vaccine and the radiology industry. In the late
1990s, I co-founded and acted as president and CEO of one of
the nation's first and the largest radiology benefit management
companies. I have had the opportunity to interact extensively
with CMS, MedPAC, the GAO, Congressional offices and many of
the stakeholders in this area on an array of imaging issues.
Diagnostic imaging is rife with many health policy and
Federal legislative opportunities. I am hopeful that after
today's hearing, we will all agree that radiation safety in
imaging is a measurable and very serious issue but there are
specific steps that we can take to mitigate the risk.
Radiation safety has been very much in discussion since
1895 when a new kind of light, the x-ray was discovered. In
July of 2005, the National Academy of Science has issued a
seminal study that examined health risks from exposure to low
level ionizing radiation. Today this study is commonly referred
to as the BEIR VII report or the Biological Effect of Ionizing
Radiation report. The watershed conclusion was that any level
of ionizing radiation can induce a carcinogenic effect. The
report showed that a single CT of the abdomen emitting 10
milliSieverts of ionizing radiation increases the risk of
induced cancer to 1 in 1000 times. Further and importantly,
cumulative dosage totaling 100 milliSieverts can ratchet up
this carcinogenic risk to 1 in 100 times.
It is also important to note that although radiosensitivity
values vary dramatically by body tissue as well as by gender
and by age, studies have shown that there are meaningful dose
estimates that can be measured. For example, the Cleveland
Clinic submits that an abdominal CT emits roughly 10
milliSieverts of radiation, a Cardiac PET 15, a CT urographic
study 44, while a plain chest x-ray emits less than .1
millisieverts.
In 2006, I helped lead a radiation safety dosage initiative
and awareness program. The results were startling and they were
highlighted extensively in the Wall Street Journal. Firstly,
some individuals received radiation exposure more than 1000
percent higher than recommended guidelines. And secondly, one
patient received 341 CT scans over an 18-month period bringing
the radiation exposure level to almost 1000 milliSieverts.
In 2007, I presented yet another radiation safety
initiative focused on the Medicare population. In this
particular study over a 12-month period, almost 20 percent of
the medical population, of the Medicare population receive
radiation exposure that exceeded the BIER VII radiation
recommended levels.
Diagnostic imaging is an extraordinary clinical tool. We
want to encourage and expand the appropriate and the safe use
of diagnostic imaging but the evidence appears to be
incontrovertible that patients are all too often exposed to
unnecessary level of ionizing radiation.
I believe the solution is to do four things. Firstly to
ensure that every advanced imaging study is clinically proven
by evidence and that it is not redundant. Secondly, to measure
and report on individual cumulative milliSievert dosage, and
present this ionizing history to physicians at the point of
ordering. Thirdly, I believe we should require recommendations
of viable clinical alternatives to enhanced radiation risk when
they exist. For example, could an ultrasound, a lab test or
some blood work be sufficient for an initial diagnosis?
Finally, the fourth is I believe that once these tests pass
these three criteria that they should be performed in
facilities by physicians and by RAD techs who are accredited
and trained, and that the equipment is assured to be set at the
correct specifications.
My company, Medicalis, is able to deliver clinical
appropriateness and radiation safety today. We continuously
survey and present available patient information to physicians
at the point of ordering, including an individual-specific
radiation history dosage. We also evaluate the clinical
appropriateness of the test and present alternative
recommendations if radiation safety sparks a concern.
In 2010, we have no excuse but to leverage available
clinical evidence, innovative technology and regulatory policy
to assure that all Americans receive clinically-appropriate and
safe advanced diagnostic imaging. I would respectfully suggest
that Congress encourage CMS to encourage a web-based or to
include a web-based, clinical decision support in radiology
safety program in the upcoming radiology pilots.
In addition and finally, I want to commend the Food and
Drug Administration's unveiling of its recent radiology
initiative, specifically, the two underlying principles of
appropriate justification of a radiation procedure and the
optimization of the radiation dosage. These two issues address
many of the concerns that I have raised in this testimony and
we look forward to working with the FDA and other imaging
stakeholders as this effort moves forward.
I want to thank the chairman and I want to thank the entire
committee for your focus on this issue, and I would be pleased
to answer any questions.
[The prepared statement of Mr. Donahue follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Mr. Donahue.
Thank all of you. We will take some questions now.
Let me start out by saying that Dr. Michael Hagan, I guess,
is here to accompany Mr. Mizrach. That is you? Raise your hand,
OK, and that would be if we have any questions about the VA in
general, I understand.
And then I also would ask unanimous consent to enter into
the record a statement by our Chairman Emeritus John Dingell.
Without objection, so ordered.
[The prepared statement of Mr. Dingell follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. I am going to start the questioning and I
wanted to start with Ken Mizrach if I could. Again, the reason
why your testimony is so valuable in my opinion is because you
at the VA hospital in New Jersey went through a situation where
there were problems. You closed the facility. You came back and
corrected them and so I think that example is sort of a good
one, and in part what I am asking is whether these changes that
you have made, you know, could be utilized at other facilities?
I mean that is really what I am trying to get down to but let
me just say, Mr. Mizrach, you mentioned in your testimony that
you will require continuous education for all staff
specifically with respect to the technology and equipment. Can
you elaborate on this in more detail and explain how you think
this is going to work in practice and, I guess, also whether it
will be useful for other hospitals.
Mr. Mizrach. Well, I think there needs to be a constant,
continuous education on any new piece of equipment in a medical
center, whether it is in radiation oncology or radiology
department or audiology and speech. There are programs
available nationwide constantly being offered. We need to make
sure that our specialists are certified and trained before they
have any opportunity to use the equipment. Recently, as we are
getting ready to open our program, we brought in the
manufacturers to work with our staff to observe simulations and
that was part of the process, and before we get the green light
to open, we need to make sure that everyone is equipped. I want
to know that my airline pilot is ready to fly that new piece of
equipment before I get on that plane and there should be no
difference in being treated in a medical center.
Mr. Pallone. Now, you mentioned conducting routine tests of
the machines to make sure that the therapy you are providing is
correct and safe. One of the recent articles in the New York
Times highlighted a hospital that has been over-radiating
patients for the past 5 years, and their regular system checks
did not catch the error. So can you just elaborate a little
more on this aspect of the quality assurance plan and how these
types of tests work and again, how they would be, you know,
help prevent situations in other hospitals?
Mr. Mizrach. I would really like to defer that to Dr. Hagan
who really has the expertise.
Mr. Pallone. Sure, all right, he will have to come up, I
guess, and take your place there. I don't know where or use one
of the mikes.
Dr. Hagan. Mr. Chairman, after East Orange, shortly after
East Orange the VA nationally required ACR accreditation for
all radiation oncology facilities within the VA. Nationally,
fewer than 20 percent of radiation oncology practices are ACR
accredited. This requirement for accreditation comes with some
teeth.
In the last year under signature by the principal deputy
under secretary, any finding by a surveyor at a VA site now
must be corrected. And the authority for that correction goes
up to the network director, and the network director is
required to report through my program office to the under
secretary that each item has been corrected so that puts the
quality control loop.
To answer your specific question though about the physics
oversight for radiation oncology, it is a little bit different
although when ACR evaluates, they evaluate both with medical
physics and the process with the radiation oncologists. Most of
our centers put patients on NCI-sponsored trials and so they
fall under quality assurance program for the Radiologic Physics
Center. You have heard that mentioned by a couple of panelists
today. It is a federally-funded, undergrad center out of M.D.
Anderson.
Prior to initiating treatment again in East Orange, our PC
paid a visit and went through their very extensive evaluation
of the linear accelerator at that facility and so they have
been surveyed with almost 36 hours of continuous operation with
a physicist going through each of the planned operations and
actually it is a result of that initial evaluation that we are
going to hold on treatment of the first patient until all of
the issues that were found by the RPC have been resolved.
Mr. Pallone. I guess going back to my initial statement, to
what extent is what you are doing now something that you would
see that we should apply nationwide or to other hospitals not
in the VA system?
Dr. Hagan. That is an excellent question and RPC is
mandated to support with onsite evaluations, all centers place
patients on NCI-sponsored trials. To be able to expand that
kind of service nationwide would require an order of magnitude
increase in the size and facility of like RPC. Actually, it
would jeopardize their ability to perform their mandate which
is to support clinical trials but to use RPC as a model and
then fund a similar organization that can do that level of
observation on a routine basis in each center should be
mandatory.
Mr. Pallone. OK, thank you very much.
I don't even know what my time is here so I have another 2
minutes. I am not sure that is accurate. I think I may have
given myself more time but in any case the, let's see, I am
going to ask this of Dr. Herman, I guess, if I could have
shortened this with the time.
In one of the New York Times articles in order to qualify
for a clinical trial in radiation therapy, the institution has
to submit to enhanced testing to make sure that they were
delivering therapy properly. And I guess a lot of the
institutions failed those tests according to the New York
Times, but in the report by your association, Dr. Herman, you
also said this was a sobering statistic, and I agree, and that
the tests are quite rigorous but still when our nation's top
institutions apply to a clinical trial and often fail we should
wonder what is happening. So I wanted to ask you do you think
that this is a sign of a larger problem and I don't know, I
just wanted someone to respond to that. I guess it could be
you, Dr. Herman, sure.
Mr. Herman. It is certainly an indication that it is
difficult to carry out IMRT treatments. One of the things the
sentence that follows the part about the sobering statistic in
that same report suggests that there is a larger consideration
with the commissioning portion of the systems that comes before
the clinical use. So the details of the algorithm and some of
the other things that can create additional variations and some
of the results, some of the cases that didn't pass in the
first, the RPM phantoms, were also due to not using the entire
team to do the treatments. So I think one of the things that
would be helpful is to have the phantom go through the entire
identical process to what a patient goes through as opposed to
sometimes having physicists try to do the whole thing because
you are not taking advantage of the entire team component.
Mr. Pallone. OK and, Ms. Hayden, you talked about all these
variations in terms of education, standards, accreditation from
one State to the next, and you obviously mentioned the CARE
bill that you would like to see that promulgated. It seems to
me frankly that, you know, what you suggested is probably, you
know, it may be one of the most important things to do because
the technicians are such an important part of this so I just I
don't know if you wanted to comment any more about, you know,
the importance of national standards but I have to say that it
was really disturbing to me to read that there was so much
variation from State to State. And I don't know if you wanted
to hit anything more about it but I just thought that that was
really sobering more than anything else.
Ms. Hayden. Of course, Chairman Pallone, I appreciate this
opportunity to speak again on behalf of the ASRT as well as on
behalf of the radiologic technologists that administer
radiation therapy and do the radiologic technology medical
imaging exams. There is--it is very sobering. The radiation
therapists in my case which is what I am, we are the last line
of defense for the patients. We are the safety net for the
patients. We are the ones that are turning on that machine. We
work in collaboration and we follow the prescription from the
physician. We work hand-in-hand with physics. I feel like I
want to hold hands at the table but certainly the CARE bill
itself is just commonsense to have educationally prepared,
clinically competent practitioners, radiologic technologists is
what we like to be referred as, to actually deliver this care
for patients. Patients should be the number one focus of this
and I am awfully happy to have the opportunity to comment.
Mr. Pallone. Well, let me just ask this and this will be my
last question. If we were to implement, let's say we were to
pass the CARE bill, I guess you would have to--you couldn't--
you would have to make it pro, you know, moving forward. You
couldn't make it retroactive presumably. How long would it take
before, you know, you would be able to have enough people to
perform these tasks that would meet the standards of the CARE
bill? I mean are we in position that we would have to say, you
know, 2, 3, 4 years from now before we could actually have
enough people that would meet the standards?
Ms. Hayden. Yes.
Mr. Pallone. Sure.
Ms. Hayden. We actually have timeframes. There will not be
a shortage in regards to the people that will actually be
performing examinations with the CARE bill or the passage of
the CARE bill. As a total opposite, it also will help save
money in regards to not having repeated images and things of
that nature. And in addition to that there is effective dates
to the CARE bill and so you would, you know, definitely follow
that and I have it in my hand here for you but we just want to
be sure, the ASRT, that the people providing care to patients
that deliver radiation therapy and medical imaging have minimal
education requirements and are competent.
Mr. Pallone. It makes perfect sense to me.
Mr. Whitfield.
Mr. Whitfield. Thank you.
Ms. Hayden, I would just like to expand a little bit on
Chairman Pallone's questioning. You indicated you felt like you
should be holding hands with Dr. Herman there.
Ms. Hayden. We do all the time. I work at night with
physics all the time.
Mr. Whitfield. But to help me have a little better
understanding of this, you are at M.D. Anderson, correct?
Ms. Hayden. Yes, sir.
Mr. Whitfield. OK so the team that is involved in the
treatment or the diagnostic work would be you, the medical
physicist and the radiation oncologist, would that basically be
the team for treatment?
Ms. Hayden. We also have medical dosimetrists as well and
radiation therapists.
Mr. Whitfield. OK and now what is your educational
background? What is required to be a radiation therapist? Do
you have to have an undergraduate degree and then?
Ms. Hayden. Well, you ask--my personal credentials is I
have a Baccalaureate in Science degree in radiation therapy
technology from Michigan, Wayne State University, and so but
there is different qualifications for radiation therapists now
as you heard within 17 States. I received registry in my
certification exam I passed through the American Registry of
Radiologic Technologists which then makes me able to then be a
qualified radiation therapy professional.
Mr. Whitfield. Now, in some States could you be a radiation
therapist with just an undergraduate degree?
Ms. Hayden. Yes, you can be radiation therapist with any
sort of qualification in the States that don't regulate it. I
worked in Michigan and practiced there for over 10 years, sir,
and I worked side-by-side by people because Michigan is an
unregulated State for radiation therapy that did not have
credentials. And I must say it was very painful and I made sure
that our patients were cared for but it is very--it is not a
good practice to be able to have practitioners that have all
sorts of varying credentials or non-credentials, delivering
radiation therapy care.
Mr. Whitfield. So, Dr. Williams, are you and Dr. Herman
very much concerned about that as well?
Dr. Williams. Yes, sir.
Mr. Whitfield. Are there 17 States that does not require
licensure, is that what you said?
Dr. Williams. I am not sure of the exact number, sir, but
there are number of States that don't require any licensure
whatsoever.
Mr. Whitfield. So then the hospital or facility that hires
them, they just have the free reign to hire whoever they want
to, is that correct?
Dr. Williams. Yes, Congressman.
Mr. Whitfield. And then, hopefully, they have the training
program of some kind and go from there.
OK we have some work to do.
Dr. Amis, in your testimony you indicated that MIPPA's
accreditation mandate should apply to all facilities including
hospitals and I was wondering what other settings besides
hospitals are not covered by the MIPPA requirement?
Dr. Amis. It is my understanding that basically there is
hospital-based and then there are independent centers and that
MIPPA only does apply to the free-standing, non-hospital-base
centers, and we feel that if there is going to be mandatory
accreditation, it should involve all centers so that we all
have the same standard of care for patients.
Mr. Whitfield. Yes, OK, so free-standing has to meet the
requirements and the hospitals are not required to do so.
Dr. Amis. That is correct and my understanding under the
MIPPA.
Mr. Whitfield. OK, now, Mr. Fisher, you and Mr. Donahue are
involved in a different way in this area we are talking about.
You represent some of the medical device manufacturers.
Mr. Fisher. Yes.
Mr. Whitfield. And you also Dr. Donahue, I mean Mr.
Donahue?
Mr. Donahue. No, I represent a medical management company
that focuses on providing radiation safety to physicians when
they order advanced imaging.
Mr. Whitfield. So you are a contract manager then for a
facility?
Mr. Donahue. Yes, we are a health care information
technology and a clinical company.
Mr. Whitfield. OK.
Mr. Donahue. And we work with large hospitals like the
Brigham and Women's system. We work with General Electric and
increasingly are working with health insurers throughout the
country who are again very focused on clinical appropriateness
and radiation safety.
Mr. Whitfield. Yes, I remember in your testimony you talked
a little bit, I believe, about individual radiation history.
Mr. Donahue. That is correct.
Mr. Whitfield. And does your company actually do that now?
Mr. Donahue. Yes, sir, we do. It is there are metrics
available, readily available that can create a very accurate
measure of radiation dosage when it is applied and it is
critically important to track this over a long period of time
to assure that cumulative dosage doesn't put a patient into
carcinogenic risk. So we as a company perform that service. We
track dosage. We measure it and embed that information into the
electronic medical record of the patient so it is there for the
life of the patient irregardless of the insurer or if they move
into a Medicare environment.
Mr. Whitfield. Isn't the dosage that a patient receives is
it required that that be in the medical record, Dr. Williams or
Dr. Herman?
Dr. Williams. No, sir, not at this time.
Mr. Whitfield. It is not. So if a patient comes to a
facility that you manage and you don't know anything about what
they have been exposed to so you are talking about only while
they are a patient at the area you are managing.
Mr. Donahue. Yes, sir, but what we do for our health
insurers for example, is this is such a concerning issue we do
a forensic analysis based on their claims data and based on any
available clinical data to try to create a history of ionizing
radiation. So for example, we can delve into a multimillion
data set of claims data and put together how many CTs, what
body part and what the cumulative exposure would be for a
patient. So we feel so strongly enough about the safety issue
that it is worth the effort to go back and to do this and then
on an ongoing basis every new imaging procedure gets measured
and tracked. And importantly, if there is a situation where a
patient becomes at enhanced risk that that next incremental
study could present a carcinogenic risk, the physician is
immediately alerted electronically and provided with
alternative action to consider.
Mr. Whitfield. And how many facilities do you all manage?
Mr. Donahue. We are a relatively young company. Our largest
facility is the Brigham and Women's Hospital System in Boston
which is we manage inpatient and outpatient very extensively
but this approach is gaining a lot of attention and traction
throughout the country.
Mr. Whitfield. Right.
Ms. Hayden, is it required at M.D. Anderson that on the
medical record the dosage of radiation given to a patient be on
the medical record?
Ms. Hayden. Sir, I respectfully in regard to diagnostic
imaging which is not a department that I work in I can get back
that answer to you in regards to my own facility. In regards to
radiation therapy, yes, the dosage is recorded for radiation
therapy.
Mr. Whitfield. Oh, OK for radiation.
Ms. Hayden. Not for, yes.
Mr. Whitfield. OK, OK, well, Mr. Chairman, I see I started
with 5 minutes and I now have 10 minutes and 50 seconds to go
so.
Mr. Pallone. Yes, I think our clocks are a little off.
Mr. Whitfield. But I would like to ask unanimous consent
however to enter into the record a letter from the Society of
Interventional Radiologists simply on their views on this issue
and also from the Radiopharmaceuticals views on this issue.
Mr. Pallone. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Whitfield. Thank you all very much for your time and
your testimony today. We really appreciate it.
Mr. Pallone. Thank you, Mr. Whitfield.
Did you want to add something, Mr. Donahue? No.
Let me say this, I mean this has been incredibly useful and
thought provoking. As I mentioned to the previous panel we will
undoubtedly get back to you with additional written questions,
usually about 10 days from now and then we will ask you about
it but I got to be honest and this is in no way meant to be
offensive. As much as valuable as your responses were in many
ways I felt that we ended up with more questions as a result of
your responses. In other words, I think it is very likely that
we are going to have to have an additional hearing on this
subject because so many questions came up today that, you know,
that I didn't even think about initially, and if we are going
to develop legislation, well, I shouldn't say develop. We
already have the CARE legislation. I think before we move on
that or, you know, have a legislative hearing or draft
something else that we probably will need to have an additional
hearing because I just had so many questions that came out of
this today, and but really you were extremely helpful in us
trying to get to the bottom of some of the problems out there.
And not to suggest that again, we are not suggesting that we
don't want people to proceed with CAT scans or other diagnostic
tools or other forms of radiation because we know how important
that is but there are just a lot of questions I think that need
to be answered.
So thank you very much and we will conclude the hearing
today but I can't emphasize enough how valuable this was, and
without objection, the hearing is concluded.
[Whereupon, at 2:40 p.m., the Subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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