[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





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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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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:]



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    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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