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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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

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 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 


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SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, 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 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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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 


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VI 

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 


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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 


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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 


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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 


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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:] 


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STATEMENT OF THE HONORABLE ED WHITFIELD 

COMMITTEE ON ENERGY AND COMMERCE 

HEALTH SUBCOMMITTEE HEARING: 

MEDICAL RADIATION: AN OVERVIEW OF THE ISSUES 

February 26,2010 

Thank you, Mr. Chairman for holding this hearing. I 

also want to thank our distinguished witnesses for coming 

here today to educate the Committee on this important 

topic. 

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 
6 


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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 focus in part on tragic events 

associated with radiation therapy. These events raise 

legitimate questions that we need to explore. My hope is 

that the Members of the Committee and the public will 

listen to the witnesses without preconceptions. We must 

examine the issues associated with radiation therapy and 

medical imaging, and ifthere are problems to be addressed, 

we need to work with the manufacturers and 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 not safe. Too 

many lives are at stake. 

2 
7 


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As an engineer, I am particularly interested to hear 

from the manufacturers how these life-saving devices work. 

I am also interested in hearing from the various provider 

groups on the training associated with operating these 

devices and how the different professional societies 

develop criteria so these devices are operated safely. 

These are complex issues because there are so many 

moving parts, both literally and figuratively. I look forward 

to listening to the testimony of our witnesses and learning 

more about this important topic. I yield back. 

3 
8 

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 


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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 welVerDate Mar 15 2010 04:22 Nov 09, 2012 Jkt 076012 PO 00000 Frm 00015 Fmt 6633 Sfmt 6633 E:\HR\OC\A012.XXX A012

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fare 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 


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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-yearold 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:] 


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Statement by H. Michael Heuser to the Committee on Energy & Commerce, 

United States House of Representatives 

February 26, 2010 

My name is H. Michael Heuser. I am a 52 year-old father of three and I live in Los 

Angeles, California. I am, according to the California Department of Public Health, 

"Patient 1", or the first patient discovered to have been subjected to excessive radiation 

overdosing while a patient at Cedars-Sinai Medical Center in Los Angeles. 

My discovery in August of 2009 brought to light the radiation overdosing of 259 other 

patients by CT brain perfusion scans at Cedars-Sinai. As the Food & Drug 

Administration has confirmed to me, the discovery of my radiation overdosing at CedarsSinai triggered their nationwide alert regarding CT brain perfusion scans to hospitals 

across the country and ultimately "resulted in local, state and federal investigations." 

I found out about my radiation overdosing after I went completely bald in a perfectly 

symmetrical 4-inch wide band that extended from ear to ear all the way around my head. 

I have provided a photograph to the Committee for reference. 

I had three CT brain perfusion scans during a two-week hospitalization at Cedars-Sinai 

following a stroke on July 4, 2009. At the time, CT brain perfusion scans at that hospital 

were exposing patients to eight times the allowable radiation level. This excessive 

radiation overdosing had been going on undetected for 18 months at the hospital. 

According to the Food & Drug Administration's Center for Devices and Radiological 

Health, one CT brain perfusion scan is the equivalent of several hundred chest x-rays. 

With 3 CT brain perfusion scans at eight times the usual radiation dose, plus several 

regular CT head and neck scans, it is safe to say that I was exposed to the equivalent of 

roughly 10,000 chest x-rays to my head. Using recent research reports from the 

University of California San Francisco, I calculate that I was exposed to roughly 12 times 

the level of radiation exposure that caused increased cancer risk to people near atomic 

bomb blasts. 

Aside from being shocking and outrageous, this radiation overdosing never had to happen 

and never should have been allowed to happen. The system is clearly broken when 

patients trust that certain medical devices will help or save them only to be harshly 

betrayed with consequences that could have been avoided altogether had someone been 

paying attention. 

As the patient responsible for helping expose this serious public health issue, I am 

pleased that the U.S. House of Representatives Committee on Energy & Commerce 

Subcommittee on Health is holding hearings on this critical matter. As a person who will 

have to live with a constant fear of developing cancers and other maladies from my 

excessive radiation exposure, I hope Congress will push for meaningful changes now so 

that others are not exposed to such extreme levels of radiation by medical devices in the 

future. 
13 


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We must change the current system that allows medical devices, which can produce 

dangerous and sometimes deadly levels of radiation, to reach the market with little 

oversight and regulation. 

I urge Members of the Committee to pay particular attention to the lack of built-in safety 

protocols for these medical devices manufactured by General Electric and others. 

I also urge Members to look closely at GE's involvement in the 18 months during which 

the radiation emitted by the GE scanners was devastatingly high at Cedars-Sinai. It is my 

understanding that GE technicians help service and provide oversight for the devices they 

manufacture, market and sell to hospitals. This clearly did not happen at Cedars-Sinai. 

I am prepared to testify before the Committee at any point in time. I also hope the 

Committee will bring GE Healthcare executives and other medical device manufacturers 

before Congress to testify on this critical public health issue to account for their role in 

the crisis and to acknowledge what they knew about excessive radiation caused by their 

machines and when they knew it. 

### 
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15 

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 witVerDate Mar 15 2010 04:22 Nov 09, 2012 Jkt 076012 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 E:\HR\OC\A012.XXX A012

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nesses 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. 


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17 

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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Opening Statement of Chairman Henry A. Waxman 

Committee on Energy and Commerce 

Subcommittee on Health 

Hearing on "Medical Radiation: An Overview of the 

Issues" 

February 26, 2009 

Thank you, Chairman Pallone for holding this 

important hearing. 

Today we will look at the extraordinary benefits and 

examine the possible risks associated with the use of 

radiation in medicine. Let me be clear at the outset: 

Diagnostic technologies like CT scans that identify tumors 

and therapeutic procedures such as radioactive seeds to 

treat prostate cancer are potentially lifesaving. They are 

important interventions in our medical toolbox and our 

health care system is unquestionably much better for them. 
19 


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But recent reports and studies have raised questions 

about the relative safety ofthese technologies. Of course, 

no medical intervention is 100 percent safe. And patients' 

tolerance for risk in being exposed to such procedures 

varies as well- a person is more likely to accept a 

potentially fatal side effect for a therapy to treat a lethal 

cancer than for a less serious disease. These are dangers 

that generally cannot be avoided altogether. 

The purpose oftoday's hearing is to learn more about 

those risks and hazards from radiation that would appear to 

be preventable. Some recent examples as reported in the 

New York Times: 

• Investigators at the Nuclear Regulatory 

Commission 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 cancer. 

2 
20 


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• Over 200 patients were mistakenly exposed 

to up to eight times the normal dose of radiation 

during brain scans at Cedars 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 

life saving technology used, the end result clearly is not 

what they signed up for. 

3 
21 


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Alarmingly, as we will hear from a number oftoday's 

witnesses, these are not isolated cases. The mistakes made 

in these instances, while perhaps not widespread, appearto 

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 lax and even non-existing 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. 

4 
22 


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As we move forward, I would hope that we can all 

agree on at least two basic premises. First is the enormous 

medical value of our various radiologic technologies. I 

mentioned this earlier, but want to underscore the point 

again: Both diagnostic and therapeutic radiology 

interventions save lives. 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 straight forward - to understand how to lower 

the risks associated with radiation in medicine to make it as 

safe as possible without reducing its many benefits to 

patients and researchers. 

5 
23 


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We have an outstanding group of witnesses this 

morning who are here to help us learn more about these 

issues. I thank each of them in advance for their testimony 

and look forward to hearing from them. 

6 
24 

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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Medical Radiation: An Overview of the Issues 

February 26, 2010 

Rep. Sue Myrick, Opening Statement 

• Thank you, Mr. Chairman. Welcome, to our many 

witnesses. 

• I realize that this hearing touches on both 

radiation therapy and medical imaging in general, 

but I'll focus my comments on radiation therapy. 

• I'm a beneficiary of radiation therapy. We know 

for a fact that this treatment, done properly, kills 

cancerous tumors and extends life. 

• [Insert a few details about your experience with 

radiation therapy] 

• It's also tragically apparent that this delicate and 

potent treatment can, in a tiny fraction of cases, 

cause damage and even death for some patients. 

• This should be addressed in a measured and 

responsible way. 
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• Radiation therapy involves complicated medical 

technology that requires training and expertise. 

• There is bound to be a Inargin of error. But there 

must be a way to at least ensure that mistakes 

don't result in irreparable harm, and certainly not 

death-- death by attelnpted treatment, in this case. 

• I hope that we can work together to address these 

risks in a sensible way. 

• If the Chairman permits, I would like to submit a 

letter for the Committee record, from the Society 

for Radiation Oncology Administrators. 

• This letter discusses current state regulation on 

Inandatory reporting of medical errors, radiation 

therapy department policies that work to prevent 

these mistakes, and efforts to set a national 

minimum education standard for those who 

administer radiation through imaging or therapy. 

• Thank you, Mr. Chairman, I yield back. 

2 
27 

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. 


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28 

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 weakVerDate Mar 15 2010 04:22 Nov 09, 2012 Jkt 076012 PO 00000 Frm 00034 Fmt 6633 Sfmt 6633 E:\HR\OC\A012.XXX A012

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29 

ly 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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Mister Chairman, and members of the subcommittee, thank you for the 

opportunity to present this statement on this important issue. 

We are to here testify at this hearing to make public our son's terrible ordeal and death due to a 

radiation accident. When our son learned that the over-exposure to radiation was to take his life, he 

felt he had a mission to prevent this atrocity from happening to others. He asked that all of us work to 

make his suffering and death have some meaning. He confided to us that he was worried about his 

wife, and must stay alive until he knows she will be OK. After more than two years of hideous agony 

he let himself die hoping that his ordeal might save many others from the same terrible suffering. 

Scott's primary care giver, his wife Carmen, suffered through every moment of every day for over two 

years as she helplessly saw her husband go blind, and deaf, and lose his teeth with his face contorted 

with gangrene tissue over his ear and scalp .. He suffered constant, acute pain and vomiting every day 

with constant hiccupping that he had to cope with as best he could. Perhaps unfortunately, his brain 

was least affected during all but the last stages, and he was aware of all that was happening to his 

body. The last time we saw Scott, at our Christmas family gathering for him, he was a caricature of 

what our son used to be. He became a helpless invalid at the end. He did whisper to me that "Carmen 

will be OK. I'm ready to go." What we can give you are only snap shots in time since we could visit 

Scott only every 3 or 4 months. The person who knows every detail of the tragedy is Carmen, but she 

,11ust remain silent because of a gag order tied to the financial settlement. It is the hospital's way of 

making serious accidents a guarded secret. Our son's widow should be here testifying to this panel, 

but she must remain silent. 

My wife and I have devoted our entire professional careers to working in hospitals,. Donna as a 

registered nurse and I a psychiatric social worker. After all of our years of service, we are particularly 

appalled that a hospital killed our son. We know how hospitals work. We know that medical 

accidents happen. We know that hospitals have a vested interest in making serious accident go away 

as quickly and quietly as possible. Hospitals in general cannot be relied upon to report or make 

public, serious medical accidents without strong external sanctions. 

From our point of view, we have two recommendations to be considered. 

1. The United States must develop a strong, mandatory, data base, and force all medical institutions 

to report all serious medical accidents. It would be a repository for evaluating trends and identifying 

medical problems throughout the nation. In order to work it must have the ability to force compliance 

on threat of fines and imprisonment. The Veterans Administration has developed a model system of 

reporting and responding to medical accidents called NCPS that is working well within the 158 V.A. 

hospitals. A system like that should be developed for all medical facilities. At present only few states 

have any semblance of reporting capability and there is almost no coordination among states. We are 

pleased to learn that the FDA is taking a regulatory role in Radiology that will include IMRT 

operations. 
31 


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Mister Chairman, and members of the subcommittee, thank you for the 

opportunity to present this statement on this important issue. 

2. We ask that medical equipment manufactures of deadly machines develop failsafe interactive 

expert systems that can interact with human technicians to reduce, or eliminate human errors. It is 

further recommended that such dangerous equipment never be operated by anyone not fully trained 

and qualified. Oncologists and supervising physicists must learn to micromanage every aspect of the 

Radiology Department. It is outrageous that any untrained and unskilled personnel can get anywhere 

near such dangerous equipment. 
32 

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. 


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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 


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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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House of Representatives Committee on Energy and Commerce: Subcommittee on Health 

Medical Radiation Hearing: February 26, 2010 

Suzanne Lindley Testimony 

Mr. Chairman and Ranking Member, thank you very much for your i""itation to testify at this 

hearing today on medical radiation. As a current resident of Canton, Texas, I'd also like to say a 

special hello to my fellow Texans on the Committee: Congressmen Green, Gonzalez, HaU and 

Burgess. I am honored to be here to share my experience as a cancer sun·ivor and patient advocate. 

To put it simply I would not be here today without medical imaging technology and advances in 

radiation therapy. 

My battle with cancer began in 1998, when I was only 31 years old. It was then that I was diagnosed 

with stage IV colon cancer - the most advanced stage of the disease. I found out that the cancer had 

alxeady spread to my liver and I was told that I had just six months to live. 

For a short time, I thought that was it. My husband and I were planning Thanksgiving as if it would 

be my last boliday with our family and I posted a note to the Association of Cancer Online 

Resources (ACOR) list-serv, asking for guidance from other cancer patients on how to tell my two 

young daughters that I would not be around for much longer. Sadly, in many ways, I was 

overlooking the fact that I was still very much alive. 

Rather than answering my question, I was fortunate that one of the patients who responded to my 

post - Shelly Weiler urged me to get a second opinion instead. 

With little time left, I did just that and started receiving what was the only therapy for colon cancer 

available at that time chemotherapy (Sfu). I cycled through many different types of chemo, often 

seeing short term results, only to then sec the cancer grow stronger. When I was out of approved 

chemotherapy options, I turned to clinical trials. 

My liver tumors began to grow and multiply. They were innumerable. .like the stars lighting the 

sky at night. My stomach was swollen, my skin was yellowing, and I was exhausted. Every breath, 

every move was difficult. After my all-too-brief reprieve of hope, I suddenly found myself back at 

square one. I was told that there were no more options and that I should come accept that my 

condition was terminal. 

This time the prognosis was even more clire the doctors predicted that I had about three months 

to live. 

We once again prepared family and I sent out an email to all of my friends letting them know that I 

had reached the end of the line. Then, after planning my funeral, picking out my casket and calling 

hospice, I received a call from one of those friends. "There is a new treatment that can save your 

life," he told me, urging me to call his oncologist in Wisconsin who had been using Selective 

Internal Radiation Therapy tiny little radioactive beads that are implanted in tumors to reduce and 

eliminate cancer. 

It sounded good. It sounded too good. With only three months, I was hesitant -- to say the least. I 

was afraid to get my hopes up again. My friend was persistent. He called dozens of times, and finally 

I relented. It turns out that I was a good candidate for the procedure. 
36 


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[ went back to my oncologist and told him about Selective Internal Radiation Therapy, expecting 

him to be excited. Instead he told me that be didn't think it would work - but then addeo "what 00 

you have to lose?" 

I receiveo the outpatient treatment, called radioembolization (I call them little magic beads) in 

January, 2005 and over a six-month period saw a 6S percent reduction in my liver tumors as well as 

necrosis (or dying) of those tumors. More than that, the fluid in my belly started to disappear, my 

color retnrned, ano my energy was back!! 

I really began to live! 

I learned to scuba dive. I have been sky diving. I have connected with other survivors, and have met 

people and shared experiences that I would have never seen had it not been for this very disease that 

will eventnally end my life. 

Since then, I have continued with systemic chemotherapy and I have also received additional 

targeted radiation treatments to stay ahead of the cutye with my disease. I have received external 

beam radiation for spinal metastases (cancer that spread to my spine) - which has given me good 

pain control and enhanced my quality of life. I have also benefiteo from Gamma Knife, which 

treated a metastatic brain lesion, radio frequency ablation for a single returning liver tnmor, and 

Cyberknife for my associated lung tumors (again keeping me one step aheao of the tnmor growth). 

Together, these advanced radiation therapy technologies have allowed me to watch my daughters 

grow up lo see llitem walk across the stage for their graduations, to start college, to become adults. 

Today they are 19 and 22. These technologies have also allowed me to walk hand in hand with my 

husband and will, hopefully, allow us to share our rocking chair days together. 

I count myself blessed to be a cancer survivor during such a revolutionary time in the world of 

cancer treatments ano to have been able to benefit from such amazing innovation. What these 

technologies are able to do, and what they have done for me, is nothing short of miraculous. They 

have tnrned miniscule moments into magical milestones. 

Today, I still have tnmors here, there, and everywhere. I continue to receive systemic chemotherapy 

and will continue to use targeted radiological therapies when needed. Cancer, for me, is chronic and 

not terminal thanks in a large part to procedures using medical radiation. These existing treatments, 

and ongoing cancer research and medical innovation, will be a part of my life untiL there is a cure for 

cancer. 

Before I close, I'd like to leave you with this thought: 

As my personal story makes painfully clear, there are enough barriers already out there, keeping 

patients from effective treatments: patients thinking, like I did, that they're at the end of the road, 

when in reality, there are not. The last thing we need is to add yet another barrier by invoking 

unwarranted fcar about the radiation used in these miraculous procedures. 

1bankyou! 

2 
37 

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 


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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 scanVerDate Mar 15 2010 04:22 Nov 09, 2012 Jkt 076012 PO 00000 Frm 00044 Fmt 6633 Sfmt 6633 E:\HR\OC\A012.XXX A012

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39 

ning 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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Testimony of Rebecca Smith-Bindman, MD 

Professor of Radiology, Epidemiology and Biostatistics, 

Obstetrics, Gynecology and Reproductive Sciences, 

University of California, San Francisco 

Before 

The Subcommittee on Health 

Committee on Energy and Commerce 

United States House of Representatives 

Medical Radiation: An Overview of the Issues 

February 26, 2010 
41 


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Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for this 

opportunity to testify today. I am 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 I 

conduct research focused on assessing the risks and benefits of medical imaging. I recently published a paper in 

the Archives of Internal Medicine focused on safety of diagnostic CT and I have included a copy of this paper 

with my testimony. 

My testimony today focuses on computed tomography - CT - because it is one of the most common imaging 

tests that we use in medical diagnosis, and the test with the greatest potential for causing harm. 

CT uses x-rays to obtain extremely detailed images of internal organs, and the development ofCT is widely 

considered among the most important advances in medicine. It is a simply an extraordinary test, allowing the 

more accurate diagnosis of disease across nearly every area of medicine. In part because it is so useful, the 

utilization of CT has risen dramatically and currently I in 5 individuals in the U.S. undergoes a CT every year. 

Although CT is useful, it delivers much higher doses of radiation than 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, you may pause, in order to consider the potential harm associated with getting x-rays. 

The most common type ofCT scan patients undergo in the U.S. - a CT of the abdomen - delivers approximately 

the same radiation as getting 1500 dental x-rays. Additionally, newer applications ofCT, such as those used to 

assess the heart, or to assess the 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 CT tests that are done each year, and the higher dose per CT test, has resulted in a 

very 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 US population is as safe as possible in relation to 
42 


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radiation exposures, has estimated that the US population's exposure to radiation from medical imaging has 

increased 6 times since the 1980s. 

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 related to health risks ofradiatjon. They 

found people who received doses in the same range as a single CT scan were at increased risk of developing 

cancer. Further, some patients receive multiple CT scans over time - and their risks are even higher. Thus the 

doses that we experience every day 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. 

versight 

Oversight for CT radiaiion dosing is currently very fragmented. The FDA oversees the approval of the CT 

scanners, as 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 there is great potential for practice variation that could introduce 

unnecessary harm from excessive radiation dosing. Furthermore, since information on radiation is reported 

differently across the different types of CT machines, it is difficult for radiologists to standardize their 

practice. 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 oftests. 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 if facilities comply with their recommendations. The manufacturers of 

CT equipment have begun work to establish standards of how radiation dose information should be measured 
43 


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and reported. These steps could lead to collection, standardization and reporting of dose information that 

would improve the safety of CT. But, the manufacturers have not adopted or implemented these standards. 

As a result of this fragmentation, information on CT dose is extremely limited. 

My research team at UCSF conducted a research study to assess the doses associated with typical CT scans. 

We collected radiation dose information on over 1000 patients and found that for nearly all types ofCTs, the 

radiation doses were much higher than commonly reported, that the radiation dose varied substantially 

between different facilities, and that even within the same facility, that the doses varied dramatically between 

patients evaluated for the same clinical problem. For example, we found that one patient had 20-times the 

radiation dose as another patient for a routine head CT when both studies were done at the same institution. 

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 1/100. That means of 100 patients who undergo a CT, one of them could 

get cancer from that test. This is an extremely high risk for a test that is supposed to find cancer, not 

cause it. 

There are private businesses that currently offer full body CT screening to healthy individuals. The FDA 

and professional organizations have voiced concerns that using CT as a screening test could cause 

more cancers than they find. For diagnostic CT- tests that are done in patients who have a clinical problem 

- it has generally been thought that if a patient is sick enough to get a CT scan, the benefit of the test 

outweighs any risk. However, we have started to use CT so often, and in patients who really are not very 

sick, that we need to think about whether the test is really 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. 
44 


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What Needs to Happen to Improve the Safety of CT Imaging 

Given the importance ofCT and yet its potential for causing cancer, it's imperative that we make CT 

scanning is as safe as possible, To do this, we need to do two things: first, we need to lower the radiation 

dose of routine CT scans; and second, we need to ensure we use CT only when necessary. 

To lower the doses, several steps are important. We need very clear standards for what are acceptable levels 

of radiation exposure associated with CT and there should be regulatory oversight for setting of these 

standards. There is evidence that for many types of CTs the radiation dose can be reduced 50% or more 

without reducing quality. 

Dose used in actual patients needs to be monitored. Despite the potentially high radiation doses CT can 

deliver, there is no regulation ofCT practice in the United States, as the FDA does not have a legislative 

mandate to do so. 

The default settings set by the manufacturers should be ones that yield the lowest possible doses and this 

dose information should be prominently displayed when CTs are done so that technologists can easily make 

adjustments as 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 this 
45 


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information would help educate patients and providers about radiation exposure and would lead to activities 

to minimize dose, 

Summary 

In summary, consensus is growing that efforts are needed to minimize radiation exposure from CT, and to 

ensure 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 

and facilities, Despite the frequency and importance of CT imaging, there are no resources available to the 

research community to study or improve the quality of CT imaging, Creation of an academic consortium to 

study CT and to make it as safe as possible would go along way toward improving its utilization and safety, 

Thank you for allowing me to contribute to this discussion and I would be happy to answer any questions, 
46 

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 


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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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Testimony to tbe Subcommittee on Healtb of tbe United States House Committee on Energy 

and Commerce 

Topic: Medical Radiation: An Overview of the Issues. 

Date: February 26, 2010 

Eric E. Klein, Ph.D. 

Mr. Chairman and members of the committee, 

My narne 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. I doubt if any other 

medical discipline has experienced technological advances to the degree Radiation Oncology has. 

Our ability to image patients with modalities, such as CT, MRl, and PET, allows 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. This has resulted in reduced toxicity. 

The delivery technique of intensity modulated radiotherapy (IMRT), which provides superior 

treatment delivery customization, comes with an increase in irradiation time by a factor of2 to 10 

compared with conventional radiation therapy. 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 are allowed to treat patients, with re-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 for each process, and each step must 

be understood by everyone, especially those with greatest volatility. We do a good job teaching 

people what to do and what to watch for, but not the consequence 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 rate. First, it may be inaccurate, as there is no 

depository, nor statewide mandate for reporting such errors. In most states, hospitals are not 

obligated to report errors occurring with their linear accelerator. A national depository for 

anonymous error reporting should be instituted in order for the community to learn from such 

errors (or 'near misses'). The second problem with the low anecdotal reported error rate, is that it 

is too high. 
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Hospitals also need to encourage scheduling patterns to allow for "time-outs" before each 

treatment begins to allow for cross-checking of all parameters by the therapists. Related to this, 

the time leading up to the patient's first treatment, should allow for careful review by the 

physicist of all parameters to be used. 

In addition, the manufacturers' testing of radiotherapy equipment should include fault and 

interface testing. 

In regards to Medical Physicists, we are the vital interface between the physician's orders and the 

eventual treatment. We are responsible for; the accuracy of the images used for planning, the 

validity of the calculations, the quality of a resultant patient treatment plan, the accuracy of the 

linear accelerator's delivery systems, and the overall end-to-end validation that each patient will 

be treated accurately. But, having the intuition and wisdom to detect a potential or underlying 

problem only occurs with rigorous residency training. Medical Physicists are educated in many 

important areas including quality assurance and radiation safety, 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 

medical physicists in the very near future. The ABR has to wait till 2014 is to allow growth in 

the number of accredited residency programs, which is 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 in place for Physician Residents. 

And finally there is an ironic situation regarding oversight of radiation treatment equipment. To 

operate a mammography unit, and 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 review by an agency, in 

order to be reimbursed for providing treatments, should be strongly considered for radiotherapy. 

In closing, approximately a million patients per year are safely and accurately treated with 

radiation therapy, receiving outstanding and vital treatment. But further steps to ensure patient 

safety, can and must be made. 
50 

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] 


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51 

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 illVerDate Mar 15 2010 04:22 Nov 09, 2012 Jkt 076012 PO 00000 Frm 00057 Fmt 6633 Sfmt 6633 E:\HR\OC\A012.XXX A012

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52 

ness 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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Medical Radiation: An Overview of the Issues 

House Energy and Commerce Committee, Subcommittee on Health 

February 26,2010 

Oral Statement from Cynthia H. McCollough, Ph.D. 

Professor of Radiological Physics 

Mayo Clinic, Rochester, MN 

Mr. Chairman and Members of the Committee, 

I want to thank you - honestly and very sincerely - for holding these hearings 

today. It is an honor to be here and to speak to you regarding the safety of x-ray 

computed tomography, which is more commonly referred to as CT scanning. 

I would like to begin by reviewing the differences between the radiation dose 

levels used in diagnostic imaging versus from radiation therapy. At extremely high 

doses, such as what is required for the effective treatment of cancer, radiation can 

cause severe biological effects. In this high dose region, the effects are predictable 

based on the dose delivered, and can include cell death, skin reddening and hair loss. 

In contrast, medical imaging uses 1000 times lower doses of radiation. At the low 

doses used in medical imaging, there is a chance an effect might occur, but there is 

considerable controversy about the level of risk of developing a cancer from these low 

doses. In fact, the National Academy of Sciences report on the Biological Effects of 

Ionizing Radiation and the Health Physics Society state that the uncertainties in the data 

do not support making 9ill'. estimates of risk in this region. The risk is either so small as 

to be nearly impossible to definitively measure, or the risk is zero. 

With regard specifically to CT, modern systems are equipped with feedback 

systems that monitor the amount of radiation passing through the patient and reaching 

the detectors, and then adjust the radiation output to deliver the required level of image 

quality using the lowest possible dose. These systems automatically adapt the dose to 

differences in patient size, both within an individual patient and across the full spectrum 

of humanity, from newborns to morbidly obese patients. 
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It is important for to realize that the patient dose for a single CT exam of the 

chest, abdomen, or pelvis is a factor of 2 - 3 times lower now than it was approximately 

20 years ago. And current technical innovations continue to drive the dose even lower. 

However, CT is a sophisticated medical device. And, as with any medical device 

or procedure, both human and electrical/mechanical systems can fail. That is why I am 

incredibly grateful for the interest of this committee, the Food and Drug Administration, 

and the imaging community in ensuring that medical imaging is performed in as safe a 

manner as possible, whether the exams involve ionizing radiation or not. 

The technology is not, however, our fundamental problem. Rather, education 

and training of the technologists who operate the equipment, the medical physicists who 

test and optimize the equipment, and the radiologists who prescribe the exam protocols 

has not kept up with the rapid developments in the technology. The single most 

important contribution we can make to patient safety is to ensure that all personnel 

involved in the operation of CT systems meet nationally-prescribed, minimum levels of 

training and competency. The needed accreditation and certification programs exist, 

but without mandatory requirements for a consistent level of advanced education, we 

are allowing, in some cases, minimally-trained personnel to operate extremely 

advanced medical equipment. 

As one example of the numerous multi-disciplinary efforts being made to ensure 

patient safety through education, the American Association of Physicists in Medicine is 

holding a CT Dose Summit in April of this year. We organized this meeting specifically 

to teach users how to be sure that the scan protocols used are appropriate to the 

specific diagnostic task and the specific patient. The faculty and attendees include 

medical physicists, radiologists, technologists, and regulators. The meeting is endorsed 

by a large number of professional societies, and received educational grants from the 

National Institute of Biomedical Imaging and Bioengineering, the American College of 

Radiology, and the Medical Imaging Technical Alliance. We will offer repeat 

presentations at any society meeting that will have us, and we will repeat the Summit as 

long as demand continues. This is but one example of the many educational and quality 

initiatives from the imaging community. 
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In summary, today's medical imaging uses some absolutely amazing technology 

and can non-invasively diagnose and guide treatment for injuries and diseases that 

could not be accomplished in any other way. Without CT, there would be more 

unnecessary surgeries, such as for suspected appendicitis that turned out to not be 

appendicitis, more invasive diagnostic tests, and less effective treatments. Before the 

advent of CT, exploratory surgery was not uncommon. 

But clearly, medical tests, with ionizing radiation or not, should only be performed 

when medically justified. When they are medically appropriate, the benefit far outweighs 

any potential risk. In fact, there is a very real risk that the patient's health will be harmed 

if the necessary medical information is not obtained through the appropriate imaging 

exam. But, unfortunately, patients are being unnecessarily frightened by media reports 

about the danger of radiation at the dose levels associated with CT. We are seeing 

patients come to us with symptoms of potentially severe illnesses or needing life-saving 

surgeries who are refusing CT exams, because they have heard on television or read in 

the paper about that "cancer-causing stuff," even though the standard of care would be 

to have a CT exam. The reality is that the risk of radiation injury from a CT scan is 

virtually non-existent. Patients and their loved ones should be concerned only about 

whether or not an imaging exam is needed to help the physician make the best possible 

diagnosis and treatment decision. If the information is of potential benefit to that 

patient's medical care, then the patient should absolutely proceed with having the CT 

exam. 

When my 11-year-old daughter fell from a bunk bed and landed on the edge of a 

piece of furniture, the portable ultrasound scanner in the emergency room showed a 

large, ominous shadow consistent with a lacerated spleen. Because ultrasound 

imaging can "be fooled" and her condition was stable, a CT was recommended - to give 

us a definitive diagnosis. I did not hesitate to agree to the CT examination. Thankfully, 

the CT was negative, showing no abdominal injuries. I do not consider that CT exam, 

even though it was "normal," to be unnecessary. Rather, I consider it to have been 

invaluable, as it avoided unnecessary emergency abdominal surgery. 

Thank you for allowing me to share this information with you, and for taking the 

time and interest to consider the best interest of our patients. 
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As a supplement tomy oral testimony, I include here additional information for your 

consideration. 

Radiation Dose and Safety During Computed Tomography 

In general, the radiation dose levels from most diagnostic medical imaging examinations, 

including er, nuclear medicine, and fluoroscopy, may increase a patient's risk of a fatal 

cancer by only fractions of a percent. This can be compared with the background rate of a 

fatal cancer in the U.s., which is about 22%. Because the potential risks are so small, there 

is considerable uncertainty as to the exact numerical value of risk at the low dose levels 

assOCiated with medical imaging and prudent assumptions are made to assign this value 

that are consistent with the existing data so that the medical community may have some 

guidance when making risk/benefit decisions. The risks may, however, be zero. 

Radiation induced cancers can not be distinguished from cancers caused by other sources, 

and the cancers can take from years to decades to occur. Because the risks at the low doses 

associated with medicatimaging are so small compared to at higher doses, definitive 

observational evidence of increased risk due to medical imaging that uses ioinizing radiation 

is not likely to ever be 'able to be demonstrated. For the dose associated with a typical 

cardiac CT or a CT of the abdomen and pelvis, between 1- to 10-million exposed individuals 

would need to be followed over their entire life to discern any statistically valid increase in 

risk compared to background cancer rates! Thus, ionizing radiation is at worst case a very 

weak carcinogen. Particularly in adults, where 85% of CT examinations are performed, the 

risk of a radiation induced cancer from the naturally occurlng amounts of background 

radiation received each year of one's childhood exceeds the incremental risk from any 

diagnostic imaging exam received in adulthood. 

In light of the very small level of potential risk and the absence of consensus as to whether 

there is any risk at the low levels associated with medical imaging, why is the concern about 

cancer from CT exams, for example, so great? The answer is primarily because of the large 

numbers of CT exams performed each year (an estimated 60-70 million exams per year in 

the U.S.). The concern is amplified by the generally held perception that radiation is 

extremely dangerous, the lack of familiarity with radiation units and effects, and the 

tendency to underestimate risk aSSOCiated with more familiar behaviors. The risk of death 

by drowning is greater than the risk of death from a cardiac or body CT exam, yet the CT 

exam is widely perceived as having a much higher risk. 

What then is a rationale response to concerns regarding the radiation associated with 

medical imaging exams such as coronary angiography, body CT, or radlonuclide imaging? 

First, steps must be taken to ensure that exams are medically justified. Even a small 

amount of risk, as may be the case f'Or medical imaging, is inappropriate if there is no 

anticipated benefit. Secondly, steps to keep d'Oses as low as pOSSible, such as dose 
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reduction technology, accreditation programs, and improved user training must contrnue to 

be a high priority thorughout the medical imaging community. Much progress has been 

made in radiation dose reduction and dose management techniques over the last decade, 

but best practices in the field of dose management must by dispersed across the spectrum 

of practice types and sizes. 

Modern Ci systems, and by this I mean systems manufactured within the last 5 or so years, 

are equipped with sophisticated software algorithms that automatically adjust the amount of 

radiation coming out of the scanner according to the size and shape of each particular 

patient and according to the diagnostic imaging task. The systems know how to dial down 

the radiation output and how to increase the radiation output for obese patients. Systems 

are also able to automatically adjust the acceptable level of image quality according to the 

type of examination the physician prescribed. Low-dose CT scans of the chest or colon for 

cancer screening produce extremely noisy images that are nonetheless highly accurate at 

seeing soft tissue lesions against a background of air. Other examinations, such as CT 

exams of the small bowel to detect very small amounts of bleeding in the small bowel, for 

exams to detect small and subtle cancerous liver lesions, require images of much higher 

quality. All current systems allow the userto select from a variety of protocols according to 

the individual needs of the specific patient. 

The imaging community, including the manufacturers and professional societies, has been 

actively engaged in a quest for lower and lower doses, and as a result, modern CT exams 

use 'doses that are factor of 2 or 3 lower than in the 1980s.and early 1990s. Not only are 

the doses lower, but the image quality Is much, much better. Instead of 10 mm thick slices 

of anatomy, images representing thicknesses of less than 1 mm are routinely available. 

Instead of performing several overlapping scans to allow the patient to take a breath every 

so often during the exam, current scanners can scan a 6-foot adult from head to toe in less 

than 20 seconds. The downSide of these tremendous advances in technology is the 

difficulty in maintaining adequate training in such a rapidly-changing field. Professional 

organizations offer continuing education courses and special sessions on advances in dose 

reduction methods at numerous times through any scientific meeting. 

In April of this year, I will be co-directing a CT dose summit that is sponsored by the 

American Association of Physicists in Medicine and is financially supported by the American 

College of Radiology, the National Institute of Biomedical Imaging and Bioengineering, and 

the Medical Imaging Technology Alliance. It is co-sponsored by the Radiological SOciety of 

North America, the Health Physics SOciety, the Conference of Radiation Control Program 

Directors, and the America! Board of Radiology Foundation. AAPM organized this meeting 

as a direct response to the reports of overexposures for neuro CT perfusion scanning in just 

over a month's timeframe. Registration is capped at 200 participants, and we sold out after 

only one week of open registration. I point to this as an example of the engagement of the 

medical imaging community in providing education related to CT dose management. 
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What is the typical radiation dose associated with CT? 

Today's CT scanners use a much lower dose of radiation than was used even 5 years ago. 

This is a result of recent concerted efforts by imaging scientist and manufacturers of 

imaging equipment to decrease the radiation doses associated with CT imaging. The dose 

used in a CT examination is now tailored specifically to each patient's body size and the 

diagnostic questions being asked. Particularly in pediatric patients, the imaging community 

clearly understands that a "one dose fits all" approach is not appropriate. 

The risk of radiation exposure from a medical imaging examination, often expressed in 

terms of effective dose, should be put into proper perspective. The increased risk of a fatal 

cancer from a 10-mSv cardiac CT or abdomen/pelvis CT examination is very small. Some 

data suggest that at such low doses, there is actually no Increase in cancer risk. However, 

to err on the side of safety, a non-zero risk is assumed for any radiation exposure, no 

matter how small, with the risk increasing linearly with the effective dose. 

Using the most current consensus risk estimates from the National Academy of Sciences, 

the risk of death from a 10-mSv cardiac or abdomen/pelvis CT is lower than a person's 

lifetime risk of drowning (O.9 in 1,000) or being killed after being hit by a vehicle while 

walking (1.6 in 1,000). 

The radiation doses associated with a CT examination (""1-14 mSv) depend on the specific 

equipment and examination type. This range of doses is comparable to the dose received 

annually from naturally occurring sources of radiation such as radon and cosmic radiation 

(""3 mSv per year). However, depending on the elevation and soil type where a person lives, 

the amount of naturally occurring (i.e., background) radiation can vary from 1 to 10 mSv. 

Some communities with very high background levels of radiation have been extensively 

studied for carcinogenic effects from ionizing radiation. Interestingly, these population 

groups have a decreased cancer rate relative to similar communities in which the 

background radiation level is much lower. In some parts of the world, background radiation 

levels are 10 to 400 times higher than the typical background in the United States, yet no 

increase in the frequency of cancer has been documented in populations living in these 

areas of high natural background radiation. 

When should CT be used? How does the radiation dose from CT 

compare with that from other imaging examinations? 

CT examinations should be performed only when the expected information from the 

examination has a potential clinical benefit to the patient. The American College of 

Radiology has professional guidelines detailing the appropriateness of a CT examination for 
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various symptoms or conditions. Compared with magnetic resonance imaging, CT is a much 

quicker examination and has far fewer patient contra indications (e.g., implanted electronic 

medical devices such as pacemakers). Relative to ultrasonography, CT has much better 

spatial resolution, is a quicker examination, and has minimal variability in image quality due 

to different skill levels of the imaging technologist or sonographer. Hence, CT is frequently 

considered the first-line recommendation when diagnostic imaging is required. 

The radiation dose from a CT examination is similar in magnitude to that from nuclear 

medicine examinations, such as cardiac stress testing, or from some fluoroscopic 

procedures, such as invasive angiography. It is important to remind patients that although 

CT does involve more radiation than conventional radiography, it also provides much more 

information. For example, a chest CT scal:1 can image a thorax in a few seconds with 

submillimeter resolution. From this one scan, hundreds of images can be produced for 

detailed views of a patient's anatomy. Such detailed information allows for making more 

rapid and accurate diagnoses and more efficient and effective treatment decisions than is 

possible with standard radiography. 

What is being done to decrease the radiation dose received 

during CT scans? 

First, CT scans are optimized to use doses as low as reasonably achievable without 

compromising the diagnostic task. The most basic step to minimize radiation dose for a 

medically justified examination is to adjust the technique factors to ensure that the right 

dose is delivered based on the patient's size (attenuation) and the specific diagnostic 

question. This is considered the current standard of care in CT imaging. In some cases, this 

may mean that increasing the dose is the most appropriate action (e.g., in obese patients or 

those with traumatic injuries). 

Since the mid 19905, automated exposure techniques have been used to further tailor the 

dose used in CT examinations to the specific patient and diagnostic task. These 

sophisticated systems automatically set the dose to the lowest appropriate level. These 

automatic exposure control systems can lower patient doses substantially, typically by 20% 

to 50%. In addition, as CT technology has progressed, the dose inefficiencies of earlier 

multislice systems have been resolved. 

In the 1980s, 10-mm wide images and multiple breath-holds were considered state-of-theart in body CT imaging. Now, a 5-mm image width and a single breath-hold is considered 

routine, with 2- to 3-mm image widths used for many applications (e.g., CT enterography or 

angiography); reconstructions of 1 mm or less are routinely used for multiplanar 

reformations (e.g., coronal or sagittal views) or 3D surface or volume renderings. Thus, 

today's CT systems provide thinner image widths with improved spatial and low-contrast 

resolution at a fraction of the scanning time and patient dose used just a decade ago. 
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• Every day, people are exposed to ionizing radiation from many naturally occurring sources such as 

radon gas in the home, radiation from outer space, radiation in rocks and soil, and naturally 

occurring radioactive elements in the body (e.g., small amounts of radioactive potassium are 

present in the human body). 

• After a computed tomography (CT) study, no radiation remains in the body.There is no limit 

placed on the number of CT images a person can have. Each scan should be justified by the 

current medical situation. 

• CT may be ordered in pregnant patients if the mother's medical condition requires imaging to 

make an accurate diagnosis or guide treatment. Even from a CT examination of the abdomen and 

pelvis, the radiation exposure to the fetus is considered negligible. In a woman who has not been 

exposed to ionizing radiation, the probability of the baby having no congenital malformations or 

defects is approximately 96%; a CT scan directly over the fetus, even with multiple contrast 

phases, changes the odds to approximately 95.99%. In fact, no diagnostic imaging examination 

delivers a high enough dose to the fetus to consider termination of the pregnancy. 

• A report on sources of ionizing radiation in the United States (NCRP report No. 160, titled "Ionizing 

Radiation Exposure of the Population of the United States"), caused many people concern about 

increased radiation doses from CT scans. Although the use of CT has increased considerably in the 

past decade, the dose per examination is decreasing. There is no increased risk to the population 

in general, since only those receiving a medical exposure incur any potential increase in risk. It is 

essential to remember that the increased use of CT is due to the increased number of clinical 

applications for which CT now is the most appropriate diagnostic tool. 

Prepared and presented by: 

Cynthia H. McCollough, Ph.D. 

Director, CT Clinical Innovation Center 

Professor' of Radiological Physics 

Department of Radiology 

Mayo Clinic 

200 First Street S.w. 

Rochester, MN 55905 

Phone: 507-284-6875 

FAX: 507-284-2405 

E-mail: mccollough.cynthia@mayo.edu 
61 

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 


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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 wellprescribed 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 


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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 


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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 peoVerDate Mar 15 2010 04:22 Nov 09, 2012 Jkt 076012 PO 00000 Frm 00070 Fmt 6633 Sfmt 6633 E:\HR\OC\A012.XXX A012

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ple 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 


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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 


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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 highquality 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, 


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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. 


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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 


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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 


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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, 


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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 


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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. 


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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 


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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 selfreferral. 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. 


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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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AS RO AR ETING C N C HE 

Statement of 

Tim R. Williams, M.D., 

Chairman of the Board of Directors 

On Behalf of the American Society for Radiation Oncology (ASTRO) 

Before the Health Subcommittee of the 

House Energy and Commerce Committee 

February 26, 2010 

Chainnan Pallone, Ranking Member Deal, and members of this distinguished eommittee, good 

morning and thank you for the opportunity to testify at today's hearing, "Medical Radiation: 

An Overview of the Issues." I have personally witnessed the great benefits of radiation therapy 

for cancer patients. I care deeply about my profession and care even more deeply about the 

health and safety of my patients. I look forward to telling you how radiation therapy works, 

ASTRO's longstanding efforts to improve quality and patient safety, as well as ASTRO's plans 

to further enhance patient protections. All patients deserve to feel reassured about their 

treatment's safety; cancer patients have enough to worry about. 

While, I am not personally involved in any of the tragic situations described by the New York 

Times I do want to offer my sympathies to those families and especially to the parents of the 

courageous Scott Jerome-Parks, who are here today and shared his story. According to the New 

York Times article of January 24th it was his wish that this tragedy be used to make sure no one 

else goes through what he did. We agree. No medical error is acceptable. I believe my 

testimony is critical to help Congress and the public understand that radiation therapy is a very 

safe treatment with a long track record of effectively curing cancer with minimal side effects. 

I am the Medical Director of the Department of Radiation Oncology at the Eugene M. and Christine 

E. Lynn Cancer Institute at Boca Raton Community Hospital, where I've practiced as a board 

certified radiation oncologist since 1989. We treat about 1,300 patients per year and I have treated 

more than 6,500 patients in the past 20 years. My medical education was at the Medical College 

of Georgia, and my residency was at Shands Hospital at the University of Florida. Before moving to 

the Lynn Cancer Institute, I was an Assistant Professor at the Bowman Gray School of Medicine of 

Wake Forest University. I serve as the Chairman of the Board of Directors of the American Society 

for Radiation Oncology (ASTRO), which I am representing today. I have also served as President of 

the American Registry of Radiologic Technology, President of the Florida Radiological Society, and 

Councilor to the American College of Radiology from Florida. Additionally, I am the Medical 

Director of the radiation therapy technology training program for Broward Community College, and 

a member of the Advisory Committee for Radiation Protection for the State of Florida Department 

of Health. 

As you know, radiation oncology is an important tool in the fight against cancer. Over the last 25 

years, the five-year survival rate for cancer patients has increased steadily. Advances in radiation 

oncology have contributed to saving lives. For example, in the mid-1970s, the five year survival 

rate for breast cancer was 75%, for prostate cancer it was 69%. Today, the five year survival rate 

SOCIETY FOR ONCOLOGY 

8280WILLOWOAKSCORPORATEDRIVE ' SUITE500 • FAIRFAX. VA 22011 • 800J162,7876 • 701.502,15S0 • FAX:701.s02.7852 
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Dr. Tim R. Williams Testimony 

February 26, 2010 

Page 2 

has increased to 98% for breast cancer and 99% for prostate cancer. While these are important 

gains for some of the most common cancers, progress lags for other cancers such as lung, ovarian, 

and pancreatic cancer where the five-year survival rate remains below 50%. 

ASTRO's highest priority has always been ensuring patients receive the safest, most effective 

treatments by providing education and professional guidance to our members. A culture of 

safety and quality control is woven into the very fabric of our field, and there are many checks 

and balances, at many levels, to assure that the safest and most effective care is delivered to our 

patients. We have been a leader in efforts to improve patient safety within our specialty, and 

protecting our patients from radiation mistakes requires constant vigilance. While ASTRO is 

alarmed and concerned by the errors described in recent press reports, we do not believe nor is 

there evidence to support that there are widespread radiation errors leading to patient harm 

across the country. However, recent reports do highlight to us that there is more work to do to 

protect our patients. Any error, no matter how small, must be reported, understood and utilized 

as a tool to further reduce the potential for future errors. Failing to report known errors is 

unacceptable. 

ASTRO's Board of Directors has committed to redouble our efforts with respect to quality and 

safety so that patients can be reassured about their care. A systemic, 360-degree review of our 

ongoing patient safety and quality assurance projects was conducted and an action plan 

emerged, consolidating all of our efforts into a unified six point plan to: 

1) Work closely with relevant regulatory authorities to create a national database for the 

reporting of linear accelerator medical errors. 

2) Significantly enhance the radiation oncology practice accreditation program, and 

develop additional accreditation modules specifically addressing new technologies, such 

as Intensity Modulated Radiation Therapy (IMRT), Stereotactic Body Radiation 

Therapy (SBRT), as well as other radiation treatments. 

3) Expand our educational training programs to include an intensive focus on quality 

assurance and safety. 

4) Work with cancer support organizations to develop tools for cancer patients and their 

families for use in their discussions with their physicians to help them understand the 

quality and safety programs at the sites where they are being treated. 

5) Accelerate an ASTRO-Ied effort, called Integrating the Healthcare EnterpriseRadiation Oncology (IHE-RO). IHE-RO works to ensure that radiation therapy 

technologies from different device manufacturers can transfer treatment information 

seamlessly to reduce the chance of a medical error. 

6) Advocate for new and expanded federal initiatives to help protect patients from radiation 

errors, including support for immediate passage of the Consistency, Accuracy, 

Responsibility and Excellence in Medical Imaging and Radiation Therapy ("CARE") 

Act to require national standards for radiation therapy treatment team members; 

additional resources for the National Institutes of Health's investments in this area; and 

federal examination of the impact of physician self-referral arrangements on the quality 

of radiation therapy treatments in those clinics. 

ASTRO has been developing and refining many of these programs for years, and they have 

been making a huge difference in the quality of cancer treatment. Now, we are redoubling our 
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Dr. Tim R. Williams Testimony 

February 26, 2010 

Page 3 

efforts to ensure that patients receive the safest possible care. We welcome the opportunity to 

work with this Committee and other stakeholders to gather data and learn about where 

additional improvements can be made. For instance, we are working with patient support 

organizations to develop a toolkit for cancer patients and caregivers for use in their discussions 

with their radiation oncologist to help them understand their quality and safety protocols. This 

toolkit will include a series of questions to ask their treatment team, such as, "Do you have daily 

safety checks?" and "What kinds of safeguards do you have to make sure I'm given the right 

treatment?" It is important to have empowered patients who actively engage in their care. 

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. It's hard enough to face a cancer diagnosis, and we are concerned 

that patients may be frightened into not receiving life saving treatments. 

ASTRO and Radiation Oncology 

Founded in 1958, ASTRO's mission is to advance the practice of radiation oncology by 

promoting excellence in patient care, providing opportunities for educational and professional 

development, promoting research and disseminating research results and representing radiation 

oncology in the rapidly evolving healthcare environment. Radiation oncologists, radiation 

oncology nurses, medical physicists, radiation technologists, dosimetrists and biologists 

comprise ASTRO's more than lO,OOO members, making it the largest radiation oncology 

organization in the world. These medical professionals, found at hospitals and cancer treatment 

centers around the globe, make up the radiation therapy treatment teams that are critical in the 

fight against cancer. 

Radiation therapy is a treatment to safely and effectively treat cancer and other diseases. 

Doctors use radiation therapy to eradicate cancer, to control the growth of the cancer or to 

relieve symptoms, such as pain. It can be used to treat cancer in almost any part of the body, 

although breast cancer, lung cancer and prostate cancer typically make up more than half of all 

patients receiving radiation therapy. 

Radiation therapy works by damaging the DNA in cancer cells so that they cannot repair or 

reproduce. New technology and improved techniques allow radiation oncologists to better target 

radiation to eliminate cancer cells while protecting healthy cells. As highly trained specialists, 

radiation oncologists know the various forms of radiation therapy - brachytherapy or external 

beam radiation - their efficacy in specific cases, and the potential side effects and risks. 

Radiation oncology practices, including caring treatment teams of clinical nurses, physicists and 

technologists, use sophisticated equipment to provide patients with safe, effective care. 

Radiation oncologists discuss and agree upon treatment options with their patients and their 

families and plan and deliver that care in conjunction with the patient's other physicians, as well 

as non-physician members of the patient's care team. This team approach assures that the 

radiation therapy component of a patient's clinical care fits appropriately in the overall patient 

treatment plan. 
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Dr. Tim R. Williams Testimony 

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Training Requirements 

Radiation oncologists complete four years of medical school followed by five years of postgraduate training in a radiation oncology residency program. To earn board certification after 

residency, they must pass three components of a written examination (clinical, radiobiology, 

and physics) as well as an oral examination. Ninety-eight percent of all practicing radiation 

oncologists in the United States are board certified. Radiation therapy should only be delivered 

by physicians who have been specifically trained to deliver this type of treatment. 

There are approximately 4,500 board-certified radiation oncologists in the United States, and 

about half of them must participate in maintenance of certification (MOC) programs to maintain 

their board-certified status. As you know, MOC programs are designed to evaluate six essential 

competencies on a continuous basis: medical knowledge; patient care; interpersonal and 

communication skills; professionalism; practice-based learning and improvement; and systembased practice. 

In addition to passing an oral exam every 10 years, the MOC process requires radiation 

oncologists to attain 200 hours of CME credits (80 percent of which must be related to radiation 

therapy or oncology), to take eight self assessment modules (SAMs), and to complete three 

Practice Quality Improvement (PQI) projects. ASTRO currently offers 23 SAMs on a wide 

range of topics including radiation cancer and biology, thoracic malignancies, gynecologic 

malignancies, central nervous system tumors, and genitourinary cancers. 

ASTRO recently launched a new quality and safety focused self-assessment module on best 

practices to improve clinical care in radiation oncology. This online education tool provides 

best practice guidelines for dosimetrists, physicists, therapists, physicians, and nurses. The new 

module emphasizes the use of peer review, including an analysis of treatment steps that may be 

prone to human error, documentation of "near misses," development of departmental checklists 

to catch errors, and engaging the entire radiation oncology treatment team to openly discuss 

patient safety. 

In today's environment, medical technology and decision-making are increasingly complex, and 

rapid changes in diagnosis and care delivery compound the situation. Initial certification and 

maintenance of certification offer a strong defense against loss of skills and provide continuous 

and rigorous quality assurance throughout one's medical career. ASTRO strongly encourages 

that all radiation oncologists participate in maintenance of certification and ongoing 

quality improvement activities. 

In March, ASTRO's journal, which is the leading radiation oncology professional journal, will 

have a supplement dedicated to practical guidance about recommended radiation dose for 16 

organs/disease sites. These articles represent a comprehensive review of the literature and are 

product of more than 60 physicians and physicists from ASTRO and the AAPM working 

together. This effort was prompted by a desire to consolidate information about how different 

radiation doses affect healthy tissue and to identify future research that would help radiation 

oncologists reduce side effects for patients. 
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Dr. Tim R. Williams Testimony 

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ASTRO also has led the field in educating radiation oncology team members in advanced 

technologies and techniques. Specifically, ASTRO began sponsoring a hands-on meeting for 

radiation oncologists, radiation therapists, physicists and dosimetrists focusing on the treatment 

team's approach to safe use ofIMRT in 2002. We launched another meeting in 2006 focused 

on the safe use of image-guided radiation therapy (IGRT). Through these programs, ASTRO 

has educated thousands of professionals about the clinical applications and safe use of these 

technologies. This year, we have combined the IMRT and IGRT meetings to also include SBRT 

into a single symposium. These courses provide entire treatment teams with hands on training 

on the latest technologies. In addition, ASTRO's Annual Scientific Meeting attracts 12,000 

medical professionals from around the world who discuss the latest breakthroughs in cancer 

treatments. 

Additionally, ASTRO provides "eContouring" courses, both online and in person. Contouring is 

the term used to describe how a radiation oncologist outlines the contours of a tumor to best 

target them for radiation therapy. These sessions are designed to provide crucial clinical 

education for physicians and provide an opportunity to practice and discuss core treatment 

issues. Participants have the opportunity to practice contouring and compare their contours to 

those of world renowned experts in a particular disease site. In addition, participants can take 

sample cases home with them to continue to practice and further improve their skill. 

High quality radiation therapy requires not only highly skilled and well trained physicians, but 

also medical physicists, dosimetrists, and technologists. We applaud the leadership of Rep. 

Barrow, along with seven Members of the Energy and Commerce Committee, for 

supporting the CARE Act (HR 3652) to require credentialing of these radiation oncology 

team members. ASTRO supports passage of this important legislation. ASTRO also 

supports requiring board certification for medical physicists. 

Quality Assurance 

Over the last two decades, the sophistication of and technologies available to improve clinical 

cancer patient care delivered with radiation therapy have advanced dramatically. Modern 

radiotherapy techniques including 3-D treatment planning, IMRT, stereotactic radiosurgery 

(SRS), SBRT, IGRT, high-dose-rate (HDR) brachytherapy, and other such sophisticated 

systems are in wide clinical use. These technologies provide significant new capabilities that 

can improve our ability to treat and control the patient's cancer while minimizing potential 

toxicity and side effects. Technology, however, cannot substitute for appropriate medical 

training and clinical judgment. 

The safe use of these new technologies requires the concerted efforts of the entire team involved 

in the delivery of patient care. This multi-faceted team must continually work together to assure 

quality throughout all aspects of the treatment planning and delivery processes. A primary 

focus of this team is to effectively identify risks, develop improved methods for avoidance of 

errors, and to identify and investigate possible sources of errors. 

Error reduction and quality assurance, in particular, has been the subject of major efforts by 

ASTRO and collaborating organizations including the American Association of Physicists of 

Medicine (AAPM), American College of Radiology (ACR), and other groups. Collaboration 
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between the National Cancer Institute (NCI), ASTRO, ACR, AAPM, and the Food and Drug 

Administration (FDA) and other organizations, led to a September 2005 roundtable meeting to 

identify proposals to address improvements in our ability to avoid errors. One of the important 

outgrowths of this meeting was the creation of the ASTRO quality assurance symposium, 

"Quality Assurance of Radiation Therapy and the Challenges of Advanced Technologies" held 

in February 2007. 

This symposium directly focused on error prevention, and the quality assurance needs of 

modern high technology radiotherapy treatment. The symposium participants proposed that our 

field adopt modern process-oriented and risk-aware failure analysis methods, and systems 

engineering approaches that have proven successful in other fields. ASTRO and AAPM have 

launched new initiatives based on this workshop, including presentations and panel discussions, 

as well as the publication of a special supplement to our professional journal dedicated to papers 

given at this symposium. Both organizations have groups working to provide quality assurance 

guidance to the radiation oncology community for IMRT and other high tech procedures. 

ASTRO currently is working to develop a "Best Practices" paper and on-line course from the 

results of this symposium to make sure this information is easily accessible and understood by 

the entire field. 

Improving our processes to reduce the risk of error is an ongoing effort. We must continually 

balance quality assurance checks of equipment and processes that are aimed at avoiding errors 

with the need for efficient delivery of high quality treatment. New technologies and evolving 

methods for using existing technologies should be analyzed in detail to develop processes that 

minimize potential failure, both technological and human. Such analyses require the 

cooperation of radiation oncologists, medical physicists, dosimetrists, therapists, and other 

radiation oncology professionals, and related organizations, including the vendor community. 

Through cooperation and collaboration, these groups must work together to identify possible 

limitations and failure modes in radiation oncology equipment (hardware and software), in the 

clinical process for treatment planning and delivery, and in the medical decisions that guide 

therapy. Systematic quality assurance checks, including peer-review methods, are an important 

component part of this process. We must continue and accelerate our efforts to improve both 

technical and medical quality improvement methods. 

Reporting Requirements 

There is a patchwork of federal and state regulations that applies to the provision of radiation 

therapy services. While the FDA has authority over the safety of medical devices, the Nuclear 

Regulatory Commission (NRC) has authority to protect against radiation exposure associated 

with radioactive materials. States have jurisdiction over patient protection of radiationproducing equipment. 

The FDA requires manufacturers of electronic products to report all accidental radiation 

occurrences arising from the manufacturing, testing, or use of any product introduced or 

intended to be introduced into commerce. "Accidental radiation occurrence" is defined as a 

single event or series of events that resulted in injurious or potentially injurious exposure of any 

person to electronic product radiation (21 CPR 1000.3). In addition, the FDA encourages health 

professionals and consumers to voluntarily report problems with medical products including 
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serious reactions, product quality problems and product use errors. The data collected through 

voluntary reporting is used to maintain the FDA's safety surveillance of all the products it 

regulates, and a voluntary report can result in a modification in use or design of the product. 

ASTRO sees opportunities for advancing necessary data collection by working with the FDA to 

reach the goals of the Center for Devices and Radiological Health's FY2010 Strategic Priorities. 

These goals include putting in place systems and procedures to more efficiently and effectively 

capture, analyze, and share high-quality information about adverse events (Goal 1.1.3.1), 

implementing strategies to increase real-time adverse event reporting and establishing pathways 

for interactive information exchange with healthcare providers (Goal 1.1.3.2), and developing 

collaborative relationships to promote the establishment of and gain access to registries that 

provide important information for medical device surveillance (Goal 1.1.3.3). ASTRO 

welcomes the opportunity to participate in initiatives underway at the FDA. 

The NRC, which regulates the medical use of radiological materials, requires licensees to report 

medical events, defined in detail at 10 CFR 35.3045. Medical events include an administration 

of a wrong radioactive drug, administration by the wrong route, to the wrong individual or 

delivered by the wrong mode of treatment, or a total dose delivered that differs from the 

prescribed dose by 20 percent or more or the fractionated dose delivered differs from the 

prescribed dose, for a single fraction, by 50 percent or more. 

Reporting of medical events or misadministrations involving radiation-producing machines is 

regulated by each individual state. There is some variability from state-to-state in how a 

misadministration or a medical event is defined and in the reporting requirements. New York is 

seen as a leader in its misadministration reporting requirements and data collection. New York 

regulations [10 NYCRR 16 (Part 16)] define "misadministrations" as a radiopharmaceutical or 

radiation from a source other than the one ordered, or by route of administration or to a part of 

the body other than that intended by the ordering physician. Not all events that are defined as 

misadministrations result in harm to a patient, but all occurrences involve an error or errors in a 

patient's treatment, and are required to be reported in New York. 

To help create a standardized national reporting framework, ASTRO will be working with state 

regulators through the Conference of Radiation Control Program Directors (CRCPD), a national 

professional organization of state regulators dedicated to radiation protection. Once standards 

are developed, we will collaborate on a pilot tracking system for machine-based radiation 

medical events. Although the overall clinical benefit and safety record for radiation therapy and 

other radiation procedures is high, ASTRO believes that errors in administration should be 

tracked for causes and trends to help facilitate the establishment of effecti ve prevention 

strategies. The pilot would include the development of a definition of reportable events to 

include radiation therapy using linear accelerators and electronic-brachytherapy technology. 

ASTRO supports this Committee's efforts to promote quality measurement and improvement, 

particularly through the adoption and effective use of health information technology (HIT). 

ASTRO has devoted significant time and resources to developing clinical guidelines and quality 

measures for radiation oncology. ASTRO is proud of the high rates of HIT adoption among 

radiation oncology practices. In addition, ASTRO is leading IHE-RO to develop interoperability 
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standards to allow vital clinical information to be passed seamlessly from one manufacturer's 

radiation oncology system to another system, within and across practices, and made readily 

available at the point of care. This effort reduces the chances that a medical error can occur. 

ASTRO encourages device manufacturers to rapidly implement these interoperability 

standards as we partner to protect patients. 

Practice Accreditation 

In late 2008, ASTRO and ACR entered into an agreement to offer radiation oncology practice 

accreditation. The accreditation process is designed to promote quality. It includes an on-site 

survey performed by board certified radiation oncologists and board certified medical 

physicists. Over the past year, we have been working with our colleagues at ACR to review and 

strengthen the accreditation program. 

In its current format, surveyors review 10 charts of recent! y treated patients, including deidentified patient records with simulation information and CT planning documentation. The 

surveyors also collect medical and dosimetry/physics data from the cases selected for review. 

Each chart is assessed by answering questions on the data collection forms developed by the 

joint ACRIASTRO Radiation Oncology Practice Accreditation Committee. The data are used to 

evaluate information contained in the patient chart, including such items as consent forms, 

pathology reports, history and physical, physician management during treatment and follow-up, 

completeness of prescription, simulation, treatment planning and simulation and dosimetry 

activities. The radiation oncology physicist surveyor is responsible for the design and 

implementation of the physics quality management program. 

Because of the thoroughness of the review, this practice accreditation process is resource 

intensive. We are exploring creative new ways to increase the pool of volunteer surveyors, such 

as requiring accredited facilities to provide a volunteer surveyor to review another facility. 

ASTRO is working with ACR to significantly enhance this practice accreditation program, and 

to begin the development of additional accreditation modules specifically addressing 

technologies such as IMRT, SBRT and brachytherapy. ASTRO is recommending that all 

radiation oncology practices undergo practice accreditation. 

NCI Investments 

ASTRO has long advocated for increased funding for the National Cancer Institute (NCI), 

and we appreciate the efforts of this Committee to strengthen the NCI in its battle to defeat this 

dreaded disease. It is hard to find a family in this nation that has not been touched by cancer and 

we need all the resources possible to alleviate the suffering it causes. Indeed, one of the many 

reasons that ASTRO supports increased funding for NCI is the important work done by the oneof-a-kind Radiological Physics Center at the M.D. Anderson Cancer Center in Houston. 

ASTRO strongly supports the important work of the RPC to ensure that institutions 

participating in clinical trials deliver prescribed radiation doses that are clinically comparable 

and consistent. We believe that RPC's auditing and monitoring tools have led to improved 

radiation dosimetry. RPC is an NCI grantee with a budget of approximately $3.5 million per 

year, $2.5 million of which comes from NCI and the rest from fees levied on participating 

institutions. Unfortunately, RPC's funding has decreased over the past decade. 
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ASTRO is aware of and troubled by 2008 RPC data showing that approximately 30 percent of 

participants failed to accurately irradiate head and neck phantoms, which simulate human 

patients. While RPC uses more stringent standards for determining accuracy than regulatory 

agencies, quibbling over the data misses the point: there is room for improvement. Prior to and 

since the release of RPC's data, numerous institutions have worked with the RPC to identify 

and resolve problems. RPC also has called problems to the attention of manufacturers, who 

have used the information to upgrade their equipment and software. We greatly appreciate the 

efforts of the RPC to shed light on shortcomings, develop quality assurance protocols, and help 

educate the radiation oncology community to resolve quality problems. We are confident that 

participating institutions will continue to improve their performance in future RPC analysis. 

ASTRO also has incorporated information and tools from the RPC to develop enhanced quality 

assurance programs to educate its membership. 

ASTRO also supports the mission of the Advanced Technology Consortium (ATC) at 

Washington University's School of Medicine in St. Louis. The ATC capitalizes on the existing 

infrastructure of national quality assurance programs. It facilitates and supports NCI sponsored 

advanced technology clinical trials, particularly those requiring digital data submission. This 

effort includes radiation therapy quality assurance, image and radiation therapy digital data 

management, and clinical research and developmental efforts. 

ASTRO asks Congress to support increased funding to expand the capabilities of the RPC 

and ATC to deal with increasingly complex treatment technologies and processes as well 

as to further analyze already existing data to ascertain their clinical significance. 

Physician Self-Referral 

ASTRO has expressed concern to Congress and the Administration that financial incentives and 

the self-referral of radiation therapy services in the Medicare program may be leading to 

patients not being fully informed on the full range of treatment options and potentially to the 

overutilization of health care services. ASTRO also is concerned about anecdotal information 

indicating that when self-referral is in place, those business arrangements often can cut comers 

on important quality assurance and patient safety essentials like having robust staffing and 

qualified medical physicists on-site. We believe Congress should request a study to examine the 

quality of radiation therapy delivered to patients when self-referral is involved. 

Conclusion 

Finally, I would like to illustrate the benefits of radiation therapy by telling you the story of one 

of my patients. I treated a 50 year old woman in 1995 for bilateral breast cancer. A breast cancer 

diagnosis is always scary, and in the mid-1990s, we were in the process of making the 

discoveries that have led to the current overall 98 percent five year survival rate for breast 

cancer patients. At that time, her surgeon recommended bilateral mastectomies, but she opted 

for bilateral wide excisions followed by radiation. Both breasts were treated at the same time, 

and we used what was then considered a new, advanced technology called 3D conformal 

radiation. She is now 15 years out from treatment, lives a full life, spends time with family and 

friends, and still has both her breasts. Together with the treatment team, we successfully treated 

her tumors while preserving her quality of life. This is what keeps me hopeful and looking 

forward to advances in the field. 
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In sum, 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, more training, 

enhanced accreditation, better use of health information technology, patient-centered 

educational tools and federal advocacy to help protect patients. ASTRO shares the Committee's 

concerns about the health and safety of all patients and recognizes the importance of 

maintaining access to high quality cancer treatment. We support the Committee's review of 

these issues. We look forward to working with you on policies that could be implemented 

to further enhance the quality of care patients receive. 

Thank you again for the opportunity to testify. 
87 

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 

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cist 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:] 


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American Association of Physicists in Medicine 

Statement of Michael G. Herman, Ph.D., FAAPM, FACMP 

On Behalf of the American Association of Physicists in Medicine (AAPM) 

Before the Subcommittee on Health of the House 

Committee on Energy and Commerce 

February 26, 20lO 

Chairman Pallone, Ranking member Deal and members of this distinguished committee, good 

morning and thank you for the opportunity to testify today on Medical Radiation: an Overview of the 

Issues. 

It is my pleasure to be here representing the American Association of Physicists in Medicine, known 

generally as the AAPM. AAPM is a scientific and professional organization, founded in 1958, 

composed of nearly 7000 scientists whose clinical practice is dedicated to ensuring accuracy, safety 

and quality in the use of radiation in medical procedures such as medical imaging and radiation 

therapy. We are generally known as medical physicists and are uniquely positioned across medical 

specialties due to our responsibility to connect the physician to the patient through the use of 

radiation producing technology in both diagnosing and treating people. The responsibility of the 

medical physicist is to assure that the radiation prescribed in imaging and radiation therapy is 

delivered accurately and safely. As such, our members are deeply saddened by the tragic events 

recently reported. 

The use of medical radiation occurs in radiology and radiation oncology practices with millions of 

people receiving that radiation to their benefit annually. Patients and the public may see the results of 

medical radiation, but few understand how it is done. Each patient procedure is a complex multisystem process, in which each system involves a combination oftechnology and human actions. To 

make the process work requires the coordination and participation of teams of human beings: 

physicians, medical physicists, dosimetrists, radiation therapists, radiologic technologists, information 

system engineers, linear accelerator and other vendor related engineers, nursing and support staff - all 

of these individuals and all of their effort must be focused on the treatment of each patient. 

Although rare, medical errors can be devastating. We all wish that no one ever made a mistake, even 

more so, no event that could injure another person. 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 the complex systems in the delivery of this type of medical care. 

One of~e primary goals of the AAPM is the identification and implementation of improvements in 

patient safety for the medical use of radiation in imaging and radiation therapy. We do this through 

our association's activities and in cooperation with other societies such as the American Society for 

Radiation Oncology (ASTRO) and the American College of Radiology (ACR). I would like to 

mention some of the steps we have taken, and continue to take to increase safety for our patients. 

• The AAPM participates in the development of procedures and guidelines for the safe, 

efficacious implementation and utilization of existing, new and advanced technologies. This 
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Michael G. Herman, Ph.D., FAAPM, FACMP - AAPM Medical Radiation Testimony 

February 26, 2010 

Page 2 of4 

includes developing cooperative technical standards with the ACR and performing new 

technology/procedure assessment with ASTRO. 

• The AAPM is a founding member of the Image Gently Alliance for radiation safety in 

pediatric imaging and of the new Image Wisely Campaign for safer imaging in adults. 

• The AAPM produces many detailed scientific, educational and practical reports for 

technology and procedures for medical imaging and radiation therapy. These reports include 

specific processes for radiation dose measurement and calibration, quality assurance and peer 

review. These reports are presented in educational forums at national and regional meetings 

and are also publicly available. 

• The AAPM has initiated a comprehensive review of existing reports and recommendations to 

identify areas for improvement. 

• The AAPM provides medical physics guidance to the Intersociety Accrediting Commission 

(lAC) and cooperates with the ACR accrediting program. We intend to reach out to the newly 

designated accrediting body for advanced imaging modalities, the Joint Commission. 

• The AAPM initiated (over 40 years ago) and provides oversight of the Radiological Physics 

Center in Houston, Texas, which is federally funded to provide medical physics and quality 

review support to the National Cancer Institute (NCI) and national clinical trials groups. 

• The AAPM accredits national dosimetry calibration laboratories, which provide accurate 

calibration of field instrmnents used by medical physicists to determine clinical dose levels. 

• The AAPM has been a leader and partner in guiding and facilitating improved system 

connectivity and communication in the medical information environment, specifically as it 

relates to accurate information transfer during procedures that use medical radiation. 

• The AAPM provides education on medical errors, error analysis and reduction and responds 

rapidly to needs in the area of technical quality and safety. For example: 

o The special Quality Assurance meeting held in 2007, together with ASTRO and NCI; 

o A Computed Tomography (CT) Dose Summit is occurring in April, 2010 to address CT 

dose protocol consistency; and 

o A Safety in Radiation Therapy meeting to include treatment team members, 

manufacturers, government agencies, and patient interest groups is planned for June 2010. 

In addition to these activities, AAPM has devoted a substantial part of its energy to the creation and 

recognition of a position known as Qualified Medical Physicist, or QMP. These physicists have a 

unique combination of education in the principles of physics, radiobiology, human anatomy, 

physiology and oncology through a graduate degree, as well as clinical training in the applications of 

radiation physics to medicine, such as the technologies of medical imaging and treatment delivery, 

radiation dose planning and measurement, as well as safety analysis and quality control methods. 

Following this, an individual demonstrates competence in hislher discipline by obtaining board 

certification (currently offered for ionizing radiation imaging and radiation therapy through the 
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Michael G. Hennan, Ph.D., F AAPM, FACMP - AAPM Medical Radiation Testimony 

February 26, 2010 

Page 3 of4 

American Board of Radiology). Certification is a rigorous, multi-year process that requires 

considerable supervised clinical experience as well as passage of written and oral examinations. The 

AAPM recognizes a Qualified Medical Physicist for the purpose of providing clinical medical 

physics services, as an individual who is board-certified in the appropriate medical subfield and has 

documented continuing education. 

All of the efforts mentioned are aimed at providing safer, more accurate and more effective patient 

procedures using medical radiation and we will continue to work toward achieving the absolute 

minimum error rate. However, there are some challenges we face in trying to meet these goals: 

• While the AAPM has a clear definition of a Qualified Medical Physicist, there is no consistent 

national recognition of this credential. Medical physicists are licensed in 4 states (TX, NY, 

FL, and HI) and regulated at widely varying levels in the other 46 states. 

• The reports that AAPM (and others) publish have only the force and effect of professional and 

scientific guidelines. 

• There are also no consistent national staffing guidelines for medical physics services nor are 

there consistent standards established for accrediting practices that utilize medical physics 

services. 

Specific Areas of Focus to Improve Patient Safety in the Medical Use of Radiation 

The following are specific areas where much effort has been placed and progress is being made, yet 

we can and must do more to improve the quality of care and increase patient safety. Together we all 

(medical radiation team members, professional associations, manufacturers and government) must: 

1. Provide robust, consistent, and financially-stable education, training and clinical experience for 

the Qualified Medical Physicist in clinical practice. To achieve this, we must: 

• continue strong support for the AAPM 2012/2014 initiative, which will meet the goal of 

requiring every candidate who applies to take the American Board of Radiology medical 

physics exams to receive structured didactic medical physics education and complete an 

accredited clinical residency prior to completing the certification exam beginning in 2014 and 

• obtain recognition for medical physics residency programs for Centers for Medicare & 

Medicaid (CMS) reimbursement equivalent to that of physician residencies. 

2. 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"(CARE Act) and specifically requiring that all 

medical physicists involved in medical imaging and radiation therapy be included in the bill 

and 

• facilitating consistent implementation of the CARE Act nationally. 

3. Provide national practice guidance in radiation oncology and medical imaging based on 

consensus and consistent minimum quality standards. Standards must: 
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February 26, 2010 

Page 4 of4 

• recognize qualified individuals; specifically the Qualified Medical Physicist, 

• establish miuimum staffing levels, 

• require that Qualified Medical Physicists be involved in the supervision of the processes that 

detennine image quality and patient dose/exposure, 

• define procedure-specific guidance, including explicit process communication within and 

beyond the medical team, and 

• undergo periodic review with timely amendment or replacement when necessary. 

4. Establish a rigorous minimum standard for accrediting clinical practices that specifically includes 

the oversight of dose and quality assurance for medical imaging and radiation therapy technology. 

This standard should require that 

• sites have work performed per national practice guidance by qualified individuals with 

appropriate staffing levels, 

• additional accreditation requirements are established for highly specialized procedures, 

and 

• practice reviews be performed by qualified individuals. 

5. Link Centers for Medicare & Medicaid (CMS) reimbursement to rigorous practice accreditation 

for all medical imaging and radiation therapy practices to insure steps one through four above are 

followed. 

6. Create a national data collection system to learn from actual and potential adverse events in the 

medical use of radiation. The system must: 

• allow reporting by medical staff and manufacturers and others in a complete and 

consistent manner, 

• be searchable to identify patterus, risks and corrective actions and to provide education, 

and 

• require a partnership between all involved (federal and state government, manufacturers, 

users, patient advocates). 

7. Improve the effectiveness of product clinical quality, application and integration review in the 

regulatory eqnipment clearance process by partnering with the U.S. Food and Drug 

Administration (FDA), the International Electrotechnical Commission, (lEC) and manufacturers. 

In summary, the AAPM believes that patient safety in 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 must also learn from our mistakes by collecting and evaluating them at the 

national level. AAPM has been working directly and in cooperation with other stakeholders for years 

on some of these issues and we are saddened that some people are injured during what should be 

beneficial procedures. We believe that more effort on all seven areas offocus, by all of us, working 

cooperatively, 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 talk to you about medical physics and our efforts toward patient 

safety in the medical use of radiation. 
93 

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 naVerDate Mar 15 2010 04:22 Nov 09, 2012 Jkt 076012 PO 00000 Frm 00099 Fmt 6633 Sfmt 6633 E:\HR\OC\A012.XXX A012

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tional 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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American Societv of 

Radiologic Techn(lfogist~ 

Ensuring Safe, Accurate Medical Radiation Procedures 

Statement by the American Society of Radiologic Technologists 

Submitted to the House Energy and Commerce Committee, Subcommittee on Health 

"Medical Radiation: An Overview of the Issues" 

February 26, 2010 

Testimony delivered by Sandra Hayden, B.S., R.T.(T) 

Board Member, American Society of Radiologic Technologists 

15000 Central Ave. SE 

Albuquerque, NM 87123-3909 

800-444-2778 www.asrtorg 

Mr. Chairman and members of the Committee, my name is Sandra Hayden, and I am a 

radiation therapist at MD 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 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. 

As recently as the 1950s, few cancer patients had any hope of long-term survivaL 

Diagnosis of the disease was difficult, and treatment options were limited both in type and 

effectiveness. Today, thanks to better diagnostic capabilities and aggressive treatment, many 

types of cancer are being cured and more people are surviving the disease than ever before. 

In particular, external beam radiation therapy, which delivers a high dose of cancerkilling radiation directly to a tumor site, has dramatically improved the chances of survival for 
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many cancer patients. Radiation therapy is now the cornerstone of cancer management programs 

worldwide. Nearly two-thirds of Americans diagnosed with cancer - more than I million patients 

a year - undergo radiation therapy as part of their treatment. Administered accurately, radiation 

therapy can ease pain, control the spread of cancer and, in many cases, cure patients of disease. 

However, radiation therapy must be precise in order to be effective. 

Accuracy is equally important during the medical imaging exams that physicians rely 

upon to diagnose cancer. Medical imaging is used during virtually every stage of a patient's 

cancer management program, from initial detection to staging the tumor's size and shape to 

following up to ensure that treatment has been effective. The x-ray exams, CT scans and other 

imaging tests performed on cancer patients use radiation, and radiation comes with some risk. 

Errors, although rare, can cause devastating side effects. 

The ASRT believes the best way to ensure the 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's because the quality of any medical radiation procedure is directly linked to the skill and 

competence of the person performing it. Individuals must have extensive education and training 

to perform the exam or treatment correctly. 

The effective detection and treatment of cancer demands precision, reliability, 

consistency and a level of teamwork that few other professions can match. The medical team 

responsible for detecting and treating cancer includes the patient's primary care physician, a 

radiologic technologist who performs the imaging exams, a radiologist who interprets those 

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images and makes a diagnosis, a radiation oncologist who determines the best course of 

treatment, a medical physicist who designs the treatment protocol, a medical dosimetrist who 

calculates the proper radiation dosage, and a radiation therapist who delivers the prescribed 

amount of radiation and provides direct patient care. 

Patient safety is in the hands of these individuals, yet many members of the cancer 

management team are largely unregulated in terms of education, experience and competence. 

Radiographers are not licensed or regulated in eight states; radiation therapists are not regulated 

in 17 states; medical physicists have no oversight in 31 states; and no state licenses medical 

dosimetrists. Even in states with some type of regulation, the rules are sometimes so weak that 

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, and 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. 

Cancer patients should not have to wonder whether the person performing their CT scan 

or planning their radiation therapy treatment is competent. 

The solution is the Consistency, Accuracy, Responsibility and Excellence in Medical 

Imaging and Radiation Therapy bill. 

The CARE bill, introduced in the House of Representatives by Rep. John Barrow in 

September 2009 as H.R. 3652, asks the federal government to establish minimum educational 

and credentialing standards for technical personnel who perform medical imaging examinations 

and who plan or deliver radiation therapy treatments. Each state then would be responsible for 

regUlating personnel according to those standards. 

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The CARE bill uses a three-tiered approach to improving quality and safety. First, 

individuals who perform medical imaging or 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. Together, these three criteria will help ensure that personnel have the skills 

to perform their duties competently and free of error. 

Only qualified personnel should be allowed to perform medical imaging and radiation 

therapy. When a CT scan has to be repeated because of improper positioning or poor technique, 

the patient receives double the radiation dose. Taking a CT scan or delivering radiation therapy 

involves much more than just pushing a button. Patients could be injured or even killed if this 

equipment is not used properly. The CARE bill will ensure a minimum level of education, 

knowledge and skill for those who are responsible for medical radiation procedures. 

In addition, the CARE bill will reduce health care costs. Repeated medical imaging 

examinations cost the U.S. health care system millions of dollars annually in needless medical 

bills, and the federal goverrunent pays for many of those mistakes. Ifwe can reduce the number 

of repeated x-ray, fluoroscopy and sonography examinations by just 1 percent, the ASRT 

conservatively estimates Medicare could save $50 million to $70 million over five years. 

More importantly, reducing errors in medical imaging will mean that cancer patients will 

receive an earlier diagnosis, when the disease is most treatable and before it has spread to other 

parts of the body. To improve the quality of patient care, the ASRT's 134,000 members 

encourage Congress to pass the CARE bill. 

The ASRT is not alone in its support for the CARE bill. The bill is backed by the 

Alliance for Quality Medical Imaging and Radiation Therapy, a coalition of25 organizations that 

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represent more than 500,000 health care professionals. In addition, the bill has received support 

from patient advocacy groups, including the American Cancer Society. 

The safety, quality and cost of medical imaging procedures affects us all. Only competent 

personnel should be allowed to perform these procedures. The CARE bill will ensure a minimum 

level of education and skill for those who are responsible for medical imaging and radiation 

therapy. By requiring personnel to meet national standards, the CARE bill would help ensure that 

patients receive the best care possible, provided by the most qualified caregivers possible. 

As an additional step to improve the quality and safety of medical radiation 

procedures, the ASRT calls for the establishment of consistent and mandatory methods of 

reporting medical radiation errors. 

Errors that occur during medical radiation procedures, while rare, must be reported and 

investigated so that others may learn from them. Quality-oriented medical facilities and health 

care professionals continually strive to learn from their mistakes to ensure that they are not 

repeated. By investigating how, why and where medical errors occur, providers can implement 

safeguards to prevent them. 

Currently, state and federal oversight of radiation therapy errors is uncoordinated and 

inconsistent. A variety of agencies and regulatory bodies are involved, and they often do not 

share information with one another. Reporting of medical radiation errors is voluntary in some 

states, and other states do not require that errors be documented at all. As a result, important 

information is lost that could be used to establish patterns of concern or identify critical issues. 

The ASRT calls for mandatory, public reporting of errors that occur during medical 

radiation procedures, and also for a consistent system of data collection and tracking. 

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A reporting model to consider is the FDA's MedWatch program, which takes a systemic 

approach to the reporting of adverse medical events. This is the approach recommended by the 

Agency for Healthcare Research and Quality. Establishment of a reporting system such as 

MedWatch would represent an unprecedented opportunity to build the knowledge base on patient 

safety and 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, radiation comes with risk, and more can and should be done to improve 

the safety of patients. The recommendations offered by ASRT will lead to safer patient care and 

will help more patients win the battle against cancer. 

Thank you again for inviting me to speak on this important issue. 

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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. 


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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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ACRrn 

AMERICAN Cot...LE:GE OF" www.acr.org 

RADIOLOGY Statement ofE. Stephen Amis, Jr., M.D., FACR 

Former Chair, Board of Chancellors, American College of Radiology 

To the 

House Energy and Commerce Health Subcommittee's 

Hearing on 

"Medical Radiation: An Overview of the Issues" 

February 26, 2010 

Chainnan Pallone and Distinguished Members ofthe Subcommittee: 

On behalf of the American College of Radiology (ACR)-a professional organization representing more 

than 36,000 radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians, 

and medical physicists-I appreciate the opportunity to discuss the importance of quality and safety in the 

medical use of radiation. The ACR is deeply committed to ensuring the appropriate use of medical 

radiation in all modalities and clinical settings, and we believe this can best be achieved through robust 

mandatory accreditation of medical imaging and radiation therapy. In addition to expressing our support 

for mandatory accreditation, ACR would also like to share with the Health Suhcommittee some of ACR's 

efforts to improve medical imaging and radiation therapy services through our quality and safety programs, 

education and public awareness campaigns, and related projects. 

First and foremost, it should be emphasized that medical imaging and radiation therapy procedures 

irrefutably save lives and improve patient care. Advances in medical imaging over the past few decades 

have rendered exploratory surgery virtually obsolete. Disease processes can be discovered and 

characterized earlier, and treatments can be monitored more readily to allow for optimal patient care. 

Image-guided medical procedures have replaced more invasive surgical options for many patients while 

improving outcomes and reducing hospitalization and recovery times. Furthennore, clinical trials and 

experience have demonstrated the benefits of radiation therapy in curing cancer, extending life, and 

alleviating pain and suffering for over one million patients each year. 

However, the series of New York Times articles that gave rise to this hearing was a heart-wrenching 

reminder that the benefits received from medical radiation are not without risk. As a profession, we can 

and must do a better job of preventing such errors - not only to ensure all patients get the best quality of 

care we can provide, but also to maintain the confidence ofthe public who rely on our care. The ACR 

believes that the best way to address this is through expansion of existing federally mandated medical 

imaging accreditation requirements to encompass all clinical settings and radiation therapy modalities, 

enacting new minimum standards for technologists such as H.R. 3652, the Consistency, Accuracy, 

Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009 or CARE Act, 

using experienced accrediting bodies to run the program and requiring a CT dose index registry. 

Accreditation 

The ACR is the nation's oldest and most recognized medical imaging and radiation oncology accrediting 

body with a long history of developing and administering accreditation programs that assess the quality of 

imaging facilities. Designed to be educational in nature, ACR accreditation is an efficient process of both 

self-assessment and independent external expert audit, based on the ACR practice guidelines and technical 

HEADQUARTERS 

1891 Preston White Drive 

Reston, VA 20191 

703~648~8900 

GOVERNMENT RelATIONS 

505 Ninth St. N.W., Suite 910 

WashIngton, DC 20004 

202·223·1670 

CLINICAL RESEARCH 

1 818 Market St., Suite 1600 

Philadelphia, PA 19103 

215-574-3150 
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standards, which assesses the qualifications of personnel, policies and procedures, equipment 

specifications, quality assurance (QA) activities, patient safety, and ultimately the quality of patient care. 

ACR accreditation began in 1987, with the then-voluntary mammography and radiation oncology 

accreditation programs. Due to ACR's success with the voluntary mammography program, Congress 

passed the Mammography Quality Standards Act (MQSA) in 1992 to mandate accreditation of all 

mammography facilities. In 1994, the ACR became the only national accrediting body for mammography 

to be approved by the Food and Drug Administration (FDA) under MQSA. 

Mandatory mammography accreditation has been credited with saving tens of thousands of women's lives 

and vastly improving the quality of patient care since the implementation ofMQSA. Much of the success 

of MQSA can be attributed to the fact that FDA did not attempt to recreate the wheel when establishing the 

standards it would adopt. Instead it built upon standards and processes that were already being successfully 

implemented on a voluntary basis within the profession. Further, rather than relegating the quality review 

to federal employees who may not have had practical experience in the field, MQSA relies upon 

accrediting bodies, named and reviewed by FDA, to serve these functions. I 

In addition to the mammography and the now joint ACR and American Society of Therapeutic Radiology 

and Oncology (ASTRO) radiation oncology programs, the College developed accreditation programs for 

ultrasound (1995), stereotactic breast biopsy (1996), magnetic resonance imaging (1996), breast ultrasound 

(1998), nuclear medicine (1999), computed tomography (2002) and radiographyffluoroscopy (2002). Like 

the radiation oncology program, these other accreditation programs were not mandatory. However, 

Congress adopted accreditation requirements as a requisite to Centers for Medicare and Medicare Services 

(CMS) payment for advanced diagnostic imaging services as part of the Medicare Improvements for 

Patients and Providers Act (MIPPA) in 2008. The MIPPA requirements represented a paradigm shift in 

which Congress made the decision to tie payment to quality and safety in medical imaging. 

During implementation of the MIPPA provisions, CMS recognized the ACR, the Intersocietal 

Accreditation Commission (lAC), and the Joint Commission in January 2010 as deemed accrediting 

organizations. However, not all accreditation programs are robust enough to sufficiently improve quality 

and safety. Accreditation can only be successful if the accrediting bodies can clearly demonstrate their 

experience, expertise, and a track record in evaluating quality and phantom review in the overseen 

modalities. These elements are the foundation of any valid accreditation program and were specifically 

included in the medical imaging provisions contained in MIPP A. 

While previously voluntary accreditation programs for certain medical imaging modalities will become 

mandatory in ambulatory settings in 2012 due to MIPPA, radiation oncology accreditation remains 

voluntary and participation is not as extensive as is clearly needed. This is made evident by the fact that the 

radiation oncology accreditation program is utilized by less than 10% of radiation therapy practices in the 

country. Congress must step in and mandate accreditation for radiation therapy per the lessons learned by 

MQSA and MIPPA. 

ACR Appropriateness Criteria 

In addition to its respected accreditation programs, the ACR offers other important quality and safety 

resources to the radiology and referring physician communities, not the least of which being the ACR 

Appropriateness Criteria (Ae). The ACR Task Force on Appropriateness Criteria was created in 1993 to 

1 Destouet 1M, Bassett L W, Yaffe MJ, Butler PF, Wilcox P A. The ACR's Mammography Accreditation Program: ten years 

of experience since MQSA. J Am ColI Radiol. 2005 Jul;2(7):585-94. 

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develop nationally accepted, scientifically-based guidelines to assist referring physicians in making 

appropriate imaging decisions for given patient clinical conditions. Currently, the ACR AC are the most 

comprehensive, evidence based guidelines for diagnostic imaging selection, radiation therapy protocols, 

and image-guided interventional procedures. There are 167 topics with over 800 variants as of the 

September 2009 iteration. ACR has also worked with software vendors to include ACR AC in 

computerized radiology order entry systems to address appropriateness of imaging orders by referring 

physicians.2 By using these guidelines in making decisions regarding radiologic imaging and treatment, 

physicians enhance quality of care and contribute to the most efficacious use of radiology services.3 

With regard to radiation dose, the ACR AC is guided by the principle that the overall risk of cancer 

induction from a diagnostic imaging procedure involving ionizing radiation is small, but it is not zero. 

Therefore, ACR AC recognizes the importance of minimizing patient radiation exposure and avoiding the 

ordering of unnecessary examinations. ACR AC advises referring physicians who are planning to order an 

imaging exam for their patient to consider the patient's previous imaging examinations. Above all, any 

exposure that accompanies an imaging examination should be justified based on the benefit to the patient. 

In 2008, Congress recognized the potential for better patient care and reducing imaging utilization by 

including a demonstration project for AC in MIPP A. Future data from this demonstration project may 

indicate the value of expanding the use of AC to all physicians throughout the country, which the ACR 

strongly supports. Currently, despite the benefits in terms of quality, safety, and cost-effectiveness, the 

voluntary utilization of AC by referring physicians who order medical imaging studies is relatively low.4 

"Image Gently" and "Image Wisely" Awareness Campaigns 

A.CR helped launch the Image Gently campaign in January 2008 as a founding member of The Alliance for 

Radiation Safety in Pediatric Imaging-a coalition of 41 organizations dedicated to raising awareness and 

promoting education about radiation protection for children undergoing medical imaging examinations. 

The Image Gently campaign is an effort to help ensure that medical protocols for the imaging of children 

keep pace with advancing technology. The goal of the campaign is to educate radiologic technologists, 

medical physicists, radiologists, pediatricians and parents about radiation dose used during the more than 4 

million pediatric computed tomography (CT) examinations performed on children in the U.S. each year. 

The program has been recently expanded to include pediatric interventional radiology procedures as well. 

The Image Gently website includes protocols that can be used to optimize pediatric technique used during 

CT imaging of children based on weight. The campaign emphasizes the need to differentiate these methods 

for children compared to adults. To date, 3,973 providers have taken the pledge on the Web site to "image 

gently" when performing pediatric imaging exams. 

Due to the success of the campaign for pediatric CT, ACR and the Radiological Society of North America 

(RSNA) began the Image Wisely campaign to expand the principles and educational resources of the Image 

Gently campaign to CT imaging of adult patients. Image Wisely's partners have grown to include the 

American Association of Physicists in Medicine (AAPM) and the American Society of Radiological 

2 Sistrom CS, Dang PA, Weilburg JB, Dreyer KJ, Rosenthal DI, and Thrall lli. Effect of Computerized Order Entry with 

Integrated Decision Support on the Growth of Outpatient Procedure Volumes: Seven-year Time Series Analysis. Radiol 

251: 147-155; 2009. 

'Hadley JL, Agola J, Wong P. Potential impact of the American College of Radiology appropriateness criteria on CT for 

trauma. AJR Am J Roentgenol. 2006 Apr;186(4):937-42. 

4 Bautista AB, Burgos A, Nickel BJ, Yoon n, Tilara AA, Amorosa JK; American College of Radiology Appropriateness. 

Do clinicians use the American College of Radiology Appropriateness criteria in the management of their patients? AJR 

Am J Roentgenol. 2009 Jun;I92(6):1581-5. 

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Technologists (ASRT). When roJled out in 2010, the Image Wisely Campaign will feature educational 

resources for radiologists, medical physicists, and technologists, and will eventually work on increasing 

awareness in the referring physician and patient communities. 

ACR National Radiology Data Registry: Dose Index Registry 

Another pertinent ACR program is the Dose Index Registry (DIR), which will collect and provide feedback 

on radiation dose estimate information from various modalities. A pilot program focusing on CT that 

allows participants to compare average volume CT dose index (CTDIvol) and the dose length product (DLP) 

values across facilities is currently in progress, and there are plans to expand the pilot in 2010. 

DIR is part of the ACR's larger National Radiology Data Registry (NRDR) program, which is a data 

warehouse for the DIR, General Radiology Improvement Database (GRID), National Mammography 

Database (NMD), CT Colonography (CTC), National Oncologic Positron Emission Tomography (NOPR), 

and IV Contrast Extravasation (ICE) data registries. The primary purpose ofNRDR is to aid facilities with 

their quality improvement programs and efforts to improve patient care by comparing facility data to that of 

their region and the nation. Participating facilities may choose to share data with any or all registries as 

appropriate for their practice, and ultimately use NRDR to compare their own performance to that of other 

participants. 

Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 

2009 

The ACR strongly supports H.R. 3652, the Consistency, Accuracy, Responsibility, and Excellence in 

Medical Imaging and Radiation Therapy Act of2009 or CARE Act, which would require personnel 

performing the technical components of medical imaging and radiation therapy to meet federal education 

and credentialing standards in order to participate in federal health programs. The ACR encourages 

passage of the CARE Act in concert with mandated accreditation, dose index registry requirement, and the 

other aforementioned programs. 

Conclusion 

Although the use of radiation in medicine saves lives and improves patient care, the recent New York 

Times articles remind us that the use of medical radiation has certain risks. The ACR recognizes that even 

the most strenuous accreditation programs will never eliminate all medical errors in the respective services 

being accredited; however, the success ofMQSA is proof that mandatory accreditation helps to 

significantly reduce these risks and ultimately improve quality. 

The ACR believes Congress should expand the current MIPP A accreditation requirements for advanced 

imaging to include radiation therapy. In addition, the accreditation mandate should apply to all facilities, 

including hospital settings. Furthermore, the accrediting of these imaging and radiation therapy procedures 

should only be conducted by those accrediting bodies with experience and expertise in the area for which 

they are accrediting. Lastly, a required dose index registry would be a critical new component that could 

measure ongoing performance of the accreditation baseline. Such a dose registry index may have helped 

identify many of the problems covered in media reports far sooner. ACR has been working with industry 

to develop such a registry but a congressional mandate would aid this process. 

As always, the College is ready to assist the Subcommittee and Congress in accomplishing these goals so 

that we can improve the treatment, safety and quality of care for our patients. 

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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 conVerDate Mar 15 2010 04:22 Nov 09, 2012 Jkt 076012 PO 00000 Frm 00113 Fmt 6633 Sfmt 6633 E:\HR\OC\A012.XXX A012

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tract 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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STATEMENT OF 

KENNETH H. MlZRACH, MPH 

DIRECTOR, VA NEW JERSEY HEALTH CARE SYSTEM 

VETERANS HEALTH ADMINIS TRA TION 

DEP ARTMENT OF VETERANS AFFAIRS 

BEFORE THE 

COMMITTEE ON ENERGY AND COMMERCE 

S UBCOMMlTTEE ON HEALTH 

UNITED STATES HOUSE OF REPRESENTATIVES 

FEBRUARY 26, 2010 

Good Morning, Mr. Chairman. Thank you for the opportunity to share the Radiation 

Oncology experience at VA New Jersey Health Care System. I will describe for you our 

3 year journey that includes how we identified a problem in 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 we acted in 

the best interest of our patients. As soon as we determined that specific patients did not 

receive the quality of care they deserved, we disclosed this information to 53 patients 

and their families consistent with Veterans Health Administration (VHA) 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 future harm. We are 

following these patients for any subsequent signs of injury resulting from the errors 

identified. 

Prior to December 2006, the East Orange Campus of the VA New Jersey Health Care 

System's 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 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 provided, resulting in conflict with 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 our quality manager validated that the 

concerns raised by the technicians were credible. In response, we made the decision to 

close the program until a thorough review was complete and we were certain our 

program provided safe, quality care for our Veterans. Patients in 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 a final comprehensive 

review by the American College of Radiology (ACR) confirmed there were deficits in our 

programs. These included issues with 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. 
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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 investigation, the clinical staff who had been working in our 

program resigned. At the same time the contract for radiation therapy technicians and 

for contract physicists expired; we then made a decision that it would not be renewed. 

We began improving our program by hiring all new staff members, including a nationally 

respected, experienced 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 is initial and 

ongoing training of new technology and equipment. 

We next established policies and procedures to guide patient 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 controls 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 conducting 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 or concerns about the 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 confident that leadership will 

respond to their concerns. 

Thank you again for the opportunity to share my experience with you. I am now 

available to answer your questions. 

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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 


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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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Testimony of David Fisher 

Executive Director, Medical Imaging and Technology Alliance 

Energy and Commerce Health Subcommittee 

February 26, 2010 

Mr. Chainnan and Ranking Member, I would like to thank you for your invitation to testify today. It 

is an honor to be here to speak about the important issue of medical radiation. 

I am here today as the Executive Director of the Medical Imaging & Technology Alliance (MITA), 

the leading association representing the manufacturers, innovators and developers of medical 

imaging and radiation therapy systems. Our more than 50 member companies comprise more than 

90 percent of the market for X-ray imaging, computed tomography (CT), radiation therapy, 

diagnostic ultrasound, nuclear medicine imaging, magnetic resonance (MR), and medical imaging 

informatics equipment. 

MlTA is a division of the National Electrical Manufacturers Association (NEMA), a longestablished standards-development organization. NEMA standards include widely accepted 

guidelines for medical imaging equipment that utilizes radiation, as well as other voluntary guidelines 

that establish commonly accepted methods of design, production, and testing. 

I'd like to begin by stating unequivocally that MlTA and its member companies believe that any 

medical error is one too many and that we want to work with the Committee, relevant agencies, 

providers and patients to reduce the number of medical errors to as Iowa number as possible. 

Value of Radiation Therapy and Medical Imaging 

Radiation therapy and medical imaging such as computer tomography (C1) are two complementary 

but distinct aspects of patient care involving medical radiation that have revolutionized health care 

delivery in America. 

Not only has the New England Jonrnal of Medicine proclaimed medical imaging one of the top 

"developments that changed the face of clinical medicine" during the last millennium, along with 

anesthesia and antibiotics, but physicians on the front lines of patient care reinforce that belief each 

and every day. As one example, in the Dartmouth-Stanford Survey of Medical Innovations, leading 

general internists ranked MRI and CT technology as the most valuable medical innovations in the 

last 30 years. 

As we continue to innovate, we were heartened to hear President Obama in his State of the Union 

address specifically reference "treatment that kills cancer cells but leaves healthy ones untouched," 

as an example of what is possible through innovation. Thanks to the leading-edge research and 

development of our member companies, the President's vision is not far from reality. To this end, it 

is critical that health care policies continue to facilitate, not restrict, industry innovation. 

With an estimated 1.4 million Americans diagnosed with cancer in 2008 alone, and malignancies 

claiming over half a million lives, access to radiation therapy is essential for ensuring high quality 

cancer care. Radiation therapy has become a standard of care for treating many types of cancer. 

Evolved far beyond the large field, one size fits all therapies of the past, modem radiation therapy 
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offers highly personalized, tailored, non-invasive and cost-effective care for up to 60 percent of all 

diagnosed cancer patients in the U.S. That translates to approximately 850,000 Americans each year 

who are able to attack their cancer. 

Both medical imaging and radiation therapy are integral to established medical guidelines. Th",se 

guidelines reflect Clinical recommendations developed by specialty physician groups on how best to 

diagnose and treat specific medical conditions. They are based upon proven best practices, widely 

accepted standards and scientific evidence. Some examples include the following: 

• 

• 

Guidelines by the American Heart Association and the American College of Cardiology 

recommend use of CT and other imaging technologies to diagnose peripheral arterial 

disease.' 

Guidelines developed by the American Cancer Society, the American Medical Association, 

the American College of Radiology, the National Cancer Institute and the American College 

of Obstetrics and Gynecology recommend regular mammograms for woman and regular 

MR imaging for women in specified high-risk categories. 

Guidelines by the National Comprehensive Cancer Network on the most appropriate 

treatments for various disease sites. 

Guidelines developed by the American Association of Physicists in Medicine that define 

necessary quality assurance measures for intensity modulated radiation therapy to ensure 

accurate and safe treatment for cancer patients." 

Guidelines by the National Cancer Institute defme standards of care for screening and 

testing of specific cancers."; 

Our technologies are not only fundamental to standards of care, but they also help patients avoid or 

limit more invasive procedures, and return to their families, lives, and work more quickly. Indeed, it 

is because of these advanced technologies that the term "exploratory surgery" is all but obsolete. 

For most of us, our own experiences bear this out. We have either benefited personally from or 

know someone whose life was saved or improved by these technologies. The mother whose MRI of 

the breast will detect cancer in time to avoid radical surgery. The father who's chest CT tells his 

doctor that the blockage is worse than anticipated and immediate action is needed. The aunt, uncle, 

grandparent, and cousin whose Intensity Modulated Radiation Therapy (IMR1) saved their life. 

Beyond the anecdotes and what common sense dictates, we also know that the value of medical 

imaging and radiation therapy is demonstrated empirically. 

From receiving a CT scan instead of a cardiac catheterization or detecting a polyp before it is 

cancerous, or receiving a course of radiotherapy that allows a patient to keep his daily schedule of 

work and home commitments rather than endure invasive surgery, peer-reviewed research confirms 

that these medical technologies not only improve health outcomes and save lives, but also reduce 

health care costs and drive down spending. 

Just to give you a brief snapshot into the power of medical imaging and the curative effects of 

radiation therapy, consider these research findings: 

Increased regular mammography screenings have resulted in a 24 percent decrease in the 

death rate from breast cancer from 1990 - 2004. If detected early, the five-year survival rate 

for breast cancer exceeds 95 percent. " 

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• 

.. 

• 

A recent study in the Lancet found that in women who recently underwent mastectomy, the 

five-year risk of local breast cancer recurr~nce was only 6 percent for women who also 

received radiation therapy, compared to 23 percent for those without. Radiation therapy 

provides a similar advantage in women who undergo breast conserving surgeries or 

lumpectomies. 

For all cancers, physicians have reported that PET scanning allowed them to avoid 

additional tests or procedures 77 percent of the time. Moreover, in over 36 percent of cases, 

PET scanning resulted in a physician'S decision to alter their patient's course of treatment. v 

Used together, external beam radiation therapy and Brachy therapy (where a radiation source 

or "seed" is placed inside the area requiring treatment) have demonstrated five-year PSAbased cure rates of 96-100 percent for low risk patients and 69-97 percent for those at high 

or very high risk. ~ 

A recent study showed that after treatment with a boosted dose of radiotherapy following a 

course of external beam radiotherapy, patients with locally advanced nasal carcinoma had 

excellent outcomes. Five years later, 98 percent of patients were free from local relapse, 83 

percent were free from nodal relapse, and overall survival was 69 percent.~' 

Coronary Computed Tomographic Angiography (CerA) rules out coronary artery disease 

with over 90 percent accuracy, saving patients from unnecessary surgery or un-needed trips 

to the cath lab. ~" 

Increased utilization of advanced medical imaging, such as CT and MRI, between 1991 and 

2004 improved life expectancy by 0.62 to 0.71 years. This effect was greater than the 

increases in mortality caused by obesity over the same time frame. " 

Simply put: innovative medical imaging and radiation therapy technologies tum patients into 

survivors. 

Beyond the life-saving impact of medical imaging, researchers have also found that it saves money in 

the long-run. 

For example, every $1 spent on inpatient imaging correlates to approximately $3 in total savings: 

and according to researchers at Harvard Medical School, every $385 spent on imaging decreases a 

patient's hospital stay by one day, saving approximately $3,000 per patient." '" 

Other, disease specific studies have found that increased imaging could save up to $1.2 billion 

annually in the treatment of stroke patients,'"' and since 1998, cr scans have been found to 

significantly reduce the negative appendectomy rate and the number of unnecessary hospital 

admissions, saving $447 per patient.''' 

In short, 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 and minimally invasive radiotherapy 

provides. The medical technologies MITA's member companies research, develop and manufacture 

are the future of delivering better health outcomes at lower costs. 

Proactively Ensuring the Safe and Effective Use of Medical Radiation 

Each year, millions of treatments and imaging sessions involving the use ·of medial radiation are 

completed without error because of the efforts of clinicians, manufacturers, and regulators to adhere 

to extensive current procedures and standards. Efforts to promote safety over the last several 

decades have reduced the incidence of errors and misadministration to their lowest levels. 

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For example, during the design process an extensive analysis is done to evaluate the potential for 

malfunctions and errors that might affect patient or operator safety and the quality of treatments. 

For each possible error, remedies are designed, which may include fail-safe interlocks, operator 

warnings, safe operating procedures, etc. All of these remedies are then tested and documented as 

part of the verification and validation of the product before it can be released for use. 

The utmost care is taken so that imaging devices that use radiation and radiation therapy devices are 

installed appropriately, calibrated, and ready for clinical use. Additional quality and safety checks are 

performed frequently, in accordance with guidelines established by the American Association of 

Physicists in Medicine (AAPM), the Radiological Society of North America (RSNA), and the 

equipment manufacturer. 

When errors or malfunctions that affect patient safety are reported to manufacturers, they inform 

the Food and Drug Administration (FDA), investigate the cause to determine what actions should 

be taken to reduce or eliminate the possibility of harm in the future. 

Industry Innovations Reduce Radiation Dose and Improve Safety 

The imaging industry supports and is committed to the ALARA principle, which stands for "as low 

as reasonably achievable." This is a universally adhered to principle of radiation dose management 

and optimization incorporated into all imaging procedures and technologies and is mandated by 

nearly all regulatory bodies and licensing agencies, including the Nuclear Regulatory Commission. ~ 

This foundational industry consensus principle to minitnize and optimize radiation exposure 

demonstrates the commitment of all involved parties to patient dose concerns, both in the short and 

long term. ~ 

CTImaging 

In addition to working with medical professionals and federal agencies on efforts to reduce dose 

during imaging procedures, our members have introduced new products and system innovations 

during the past 20 years that have reduced radiation dose for J;/lany procedures by up to 75 percent, 

wlUle maintaining, and even improving image quality, enhancing the ability of physicians to diagnose 

and treat disease. 

CT innovations have been especially prevalent with significant advancements that have effectively 

"built-in" dose reduction into the equipment. For example: 

Weight-based age-based and other CT scan protocols have been developed by luminary 

imaging institutions around the world and manufacturers incorporate these protocols into 

new equipment to help users achieve optimum diagnostic results. These protocols are 

designed as a starting point for doctors and imaging facilities to provide appropriate 

diagnostic information wlUle minitnizing radiation, and are particularly effective in 

optimizing dose for clUldren and infants. 

• Automatic exposure control (AEO' alters the amount of radiation dose used when scanning 

different parts of the body. For example, more tube current is needed to maintain image 

quality during a CT scan in a large or dense area of the body as compared to smaller areas. 

AEC protocols automatically adjust the current up or down within prescribed bounds as 

needed, . without relying on the imaging technologist. Studies of AEC procedures have 

shown radiation dose reductions between 20 and 60 percent. ><Vi, 

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Beam collimation limits dose delivery to coincide with the detector area of interest and 

scanning field of view, thereby minimizing the photons that do not contribute to the image. 

• Beam ftltration reduces low energy photons likely to be absorbed by the patient (and not 

contribute to image formation). They can also shape the beam to optimize it for patient size. 

Adaptive software ftltration is governed by noise management software to selectively reduce 

noise in uniform areas of an image while preserving edges. This enables a lower dose to be 

utilized while preserving image quality. 

• Dose display. CT imaging equipment provides access to dose data, generally by displaying 

the data on the console, in consistently defined parameters, prior to scanning. This allows 

the operator to better understand the dose implications of protocol choices and how any 

change to the protocol will affect dose. 

ECG tube current control for CT cardiac examinations. The advent of cardiac imaging 

resulted in an additional modulation method based on cardiac cycle as opposed to body 

location. The primary focus of cardiac dose modulation is to ensure that dose is only 

delivered during the resting phase of the ECG cycle to reduce the effects of image degrading 

motion and motion associated artifacts. 

It is important however to keep in mind that dose reduction depends not only on equipment, but 

also on the use of the equipment and the physician determination of the appropriate dose levels for 

each individual patient. MITA and our members work closely with the physicians and radiologic 

technologists who use this equipment. We value their feedback and cooperation in developing initial 

and ongoing training related to these products. 

Radiation Therapy: Safe Targeted, Effective 

In the case of diagnostic imaging technologies that use radiation to create images, we are seeking to 

reduce dose. On the other hand, radiotherapy requires a high amount of narrowly targeted radiation 

aimed at the cancerous cells to cure and to control the cancer. Radiation therapy provides safe and 

effective treatment for an increasingly wide range of cancers. By delivering a targeted high dose of 

radiation directly to cancerous tissue, radiation therapy causes the malignant cells to either stop 

growing or to die, while simultaneously minimizing radiation exposure to surrounding healthy tissue. 

During the past several years, researchers have developed highly targeted and customizable radiation 

planning and delivery tools. These advances in radiation oncology are translating directly into better 

clinical outcomes, as well as greater safety and convenience for patients such as fewer treatmentrelated side effects and complications, and shorter and more convenient courses of therapy. 

Generally a non-invasive, radiation therapy is often performed in the outpatient setting, which 

minimizes disruption of daily activities for many of the estimated 643,000 cancer patients who 

receive radiation treatments each year. 

Based on evidence from a large and ever-expanding body of scientific and medical literature, 

radiation therapy has become integral to medical guidelines and best practices as a standard of care 

for many types of cancer including breast, prostate, lung, head and neck, rectal, and central nervous 

system tumors. In some cases, radiation treatments are used instead of surgery. Alternatively, they 

may be used pre-operatively to shrink a tumor and provide for less invasive, safer and more effective 

surgery or used post-operatively to prevent disease progression or spread after surgery. 

In addition, guidelines for clinical use of radiation therapy have been developed by a number of 

different national organizations and medical specialty groups, such as the National Comprehensive 

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Cancer Network and the American Society of Clinical Oncology (a professional organization 

representing over 25,000 oncologists and others who provide care for cancer patients). 

Radiation therapy is prescribed by radiation oncologists to treat cancerous tumors or other diseases 

that respond to therapeutic radiation. The modern radiotherapy process is a series of steps designed 

to deliver the radiation oncologist's prescription of radiation dose. This process makes use of a 

variety of hardware and software equipment to diagnose, prescribe, plan, verify and deliver the 

patient's treatment. 

Systems typically used in the radiotherapy process include: 

• 

• 

Diagnostic systems, which allow the radiation oncologist to locate the disease within the 

patient and defIne the shape of the targeted tumor; 

Treatment planning systems, which allow the physician, medical dosimetrist, and medical 

physicist to calculate the amount of dose that different potential treatments will deliver to 

the patient's tumor and surrounding tissue and even vary the plan as the patient's treatment 

needs change; 

Treatment information management systems, which contain the patient's medical chart, 

including the prescription, schedule of treatments, specifIc instructions for the treatment 

machine, a record of treatments completed, patient images, billing data, and other 

information that is used by clinicians to assure quality and safety; 

Quality assurance systems, with which the medical physicist verifIes the calibration of the 

treatment machine and the accuracy of a patient's specific treatment plan prior to and during 

the course of the patient's treatment; and 

The treatment machine, which consists of a treatment couch used by the radiation therapist 

to precisely position the patient prior to treatment using a variety of imaging and positioning 

sub-systems, and the radiation delivery system itself, which is used by the Radiation 

Therapist to control, deliver, and monitor the radiation beam(s) in accordance with the 

approved prescription and the patient's chart. 

I-l:ardware and software systems used in the radiotherapy process have multiple safety features 

designed to assure safe and effective completion of the treatment prescribed by the radiation 

oncologist. Treatment management systems typically do continuous consistency and integrity 

checks of the data that controls the radiation dose that will be delivered to the patient. They verify 

that all pieces of critical data are present before the treatment will be allowed to proceed. The 

system also checks that the particular patient's treatment plan matches with #>e requirements and 

capabilities of the treatment machine and prevents the start of treatment if there is a discrepancy. 

These systems also include features that allow only authorized users to approve and make changes 

to treatment plans. The system provides critical data for quality assurance checks performed by the 

medical physics staff prior to treatment. These are only a few of the numerous safety features 

contained in the treatment management system. 

In addition, treatment delivery systems and the treatmentdelivety machines themselves 

have redundant safety features. For example, there are two independent monitoring systems that 

measure the radiation coming out of the machine during the treatment. The intensity and 

unifortnity of the treatment beam is monitored continuously, and an interlock will stop treatment if 

the values are abnormal. The system records and retains key data during the actual treatment so 

that, in the event of a premature shut-down, the radiation oncologist and medical physicist can 

precisely reconstruct the treatment and proceed to complete it accurately thereafter. Critical aspects 

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of the treatment are displayed on a treatment console for careful monitoring by radiation therapists 

during treatments. The systems require the radiation therapists or other trained clinical personnel to 

be physically present in the treatment room prior to treatment to correctly position the patient so 

that the dose is delivered accurately to the target. These are just a few of the numerous safety 

features in treatment delivery software and hardware systems. 

It is important to note that radiation therapy devices and systems are subject to requirements, 

oversight and regulation by numerous government and professional organizations 

worldwide, including the FDA, international regulatory bodies, and international standards 

organizations. Radiotherapy device manufacturers adhere to the requirements of these organizations 

in designing and building their systems and with potential safety implications that come to their 

attention. Radiotherapy device manufacturers are regularly audited for compliance with regulations 

and fully cooperate with FDA and other regulatory and standards based inspections. 

Efforts to Reduce Radiation Dose 

MITA has a long history of working with its members and other stakeholders to track and reduce 

medical radiation. One essential element in that effort is the Digital Imaging and Communication in 

Medicine (DICOM) Standards which MITA manages. This is the universal standard for the 

interoperability of medical images, even when generated by different scanners. Thanks to these 

standards, imaging is, without a doubt, the most "networked" aspect of health care in the clinical 

setting. Importantly, the DICOM system already records dose information. 

MITA collaborates to proactively tackle issues related to radiation safety. For example, in November 

2009 MIT A convened a stakeholders meeting in Chicago including physicians, physicists, industry 

and FDA officials to discuss ways to prevent future medical errors that involve radiation. MITA is 

also co-sponsoring upcoming CT and Radiation Therapy Radiation Dose Summits to further the 

education of providers and physicists on the new technologies our member companies have 

developed and are manufacturing. MITA members have also involved with Image Gently in 

development of targeted training on pediatric CT. 

MITA also believes in ensuring that patients receive the right test at the right rime. As part of the 

Access to Medical Imaging Coalition (AMIC), MITA helped to develop appropriateness criteria for 

advanced medical imaging included in the Medicare Improvements for Patients and Providers Act 

(MIPPA). We believe strongly that the integration of these criteria into clinical decision-making by 

physicians, will help to eliminate unnecessary images. This policy is not only helpful because it can 

save money, but it also ensures unnecessary scans are climinated and that patients receive the right 

test at the right rime for their specific symptoms. MIT A is committed to working with physicians, 

CMS and other stakeholders to continue to examine this promising demonstration program and 

expand it in the future. 

More recently, MITA announced its support for the President's proposal in thc fiscal year 2011 

budget to develop a national dose registry and its support for the FDA Initiative to Reduce Unnecessary 

Radiation Exposure from Medical Imaging. MITA intends to participate fully in FDA's efforts to reduce 

radiation dose. 

MITA has also proposed several additional policies designed to reduce medical errors, reduce 

radiation dose and raise awareness of radiation dose among providers. 

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New Dose Check Features 

Earlier this week, MITA's CT manufactures committed to including a new radiation dose check 

feature on their new CT products. This new feature will provide an alert when dose levels as 

determined by hospitals, imaging centers and clinicians are exceeded. This alert is designed to 

provide a clear indication that the settings for the exam resulted in a dose higher than the predetermined reference dose for routine use. 

In addition, manufacturers are committed to including an additional safeguard which allows 

hospitals and imaging facilities to set upper radiation dose limits to prevent CT scanning at higher, 

potentially dangerous radiation levels. This feature is designed to prevent hazardous levels of 

radiation that could lead to bums, hair loss or other injuries. 

Manufactures are also committed to standardizing dose recording by incorporating the DICOM 

structured dose report. 

Our manufactures are already working on or have implemented some of these new features and 

most will be able to include them on new releases of CT products and to begin deploying to their 

CT installed base before the end of this year. With this deployment strategy, most new CTs and 

similarly compatible installed base systems will include these new features during the 2012 calendar 

year. 

MITA and our member companies stand ready to work with professional organizations, regulatory 

bodies, individual clinicians and other stakeholders on these features. 

Reference Values 

Another important and specific way that additional understanding of radiation dose can be 

promoted is through the development of radiation dose reference levels or reference values. The 

recently announced manufacturer dose check feature could utilize these values and MIT A is eager to 

assist stakeholders in their development. Once determined, the radiation dose reference level serves 

as a data point at which physicians, physicists and technologists can compare the dose level of the 

specific procedure they are administering to a wide sample of similar tests. This information gives 

medical professionals an additional tool to develop and deliver optimized scans commensurate with 

current clinical practice. 

Enhanced Training and Protocols 

Training of operators of medical imaging and radiation therapy equipment on the specific machines 

in their facility is important to the proper use of this complex equipment. To that end, imaging and 

radiation therapy equipment manufacturers currently provide comprehensive training and education 

to the users of their equipment. 

Training delivery venues include: 1) Onsite training at the customer facility using their own installed 

equipment, 2) Instructor led classroom training, including lab work as appropriate, delivered at the 

manufacturer's training center, 3) Remote instructor led training done via the internet and! or 4) 

Customer self-directed eLearning modules produced by the manufacturer. 

Training is especially important when radiation is involved and users of imaging and radiotherapy 

equipment must have the appropriate clinical competence and professional training in order to 

leverage the additional education we provide on our specific equipment. 

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MITA encourages the development of training standards for hospitals and free-standing imaging 

facilities that purchase imaging equipment that involves the use of radiation and radiation therapy 

equipment. It's also important to remember that training doesn't end when our equipment is 

installed. Instead, it is an ongoing effort by the hospital and imaging facilities that includes 

continuing education, training of new employees and achieving and maintaining certifications and 

accreditations. We would like to work with all interested parties on these efforts. 

MITA members are also eager to work with stakeholders to develop additional operational safety 

procedures and checklists to reduce medical errors and incorporate those new standards into our 

training offerings. 

Error Reporting 

MIT A companies are currently mandated by the FDA to report serious injuries that involve their 

products. This is a mandate that MITA companies take very seriously and work to meticulously 

comply with. 

MIT A supports efforts to ensure standardized reporting across stakeholders in a manner that is 

transparent for patients, their families and physicians. As part of that effort MIT A supports 

mandatory reporting by providers of all medical. errors involving medical radiation. 

As this committee considers ways to increase the frequency and completeness of error reporting, it 

must also carefully consider potential disincentives to under-report errors. 

Accreditation and Certification 

MITA is also committed to policies developed with stakeholders regarding the accreditation of 

advanced imaging facilities included in MIPP A and the certification of radiologic technologists. The 

accreditation of imaging facilities has begun this year and will continue with all providers required to 

be accredited by 2012. MITA supports an examination of whether this policy should be expanded 

to include additional facilities where radiation therapy medical devices are in use and would like to 

work with the Committee in this effort. 

In addition, MITA supports the establishment of miuirnum standards for radiologic technologists 

who perform diagnostic medical imaging exams and deliver radiation therapy treatments. 

Conclusion 

Thank you for your consideration of this important issue. As the legislative process moves forward, 

MITA, along with physicians and patient groups, look forward to continuing to work with Congress 

and the administration to ensure appropriate use of medical radiation and access to life-saving 

technologies proven to decrease costs, prevent and treat illness, cure illness and improve quality of 

life for millions of Americans. 

, ACC/AHA Practice Guidelines for the Management of Patients with Peripheral Arterial Disease (Lower Extremity, Renal, 

Mesenteric, and Abdominal Aortic): Executive Summary." Hirsch AT, et. al.. Circulation, March 21, 2006, pp. 1474-1547. ii - Guidance Document on Delivery, Treatment Planning. and Clinical Implementation ofIMRT: Report of the lMRT Subcommittee of the 

~PM Radiation Therapy Committee, Ezzel et al., Med. Phys. 30 .8,. August 2003 

hi http://www.cancer.gov/cancertopics/screening 

IV American Cancer Society. Cancer Facts & Figures 2008. Atlanta, Ga: American Cancer Society; 2008. 

9 
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.. Hillner et al. Relationship Between Cancer Type and Impact of PET and PET/Cr on Intended Management: Findings of the National Oncologic 

PET Registry. Journal a/Nuclear Medicine, 2008; 49 (12) 1928-1935001: 10.2967/jnumed.108.D56713 

"I Pisansky TM, et al. High-dose-rate brachytherapy in the curative treatment of patients with localized prostate cancer. Mayo Clin Proc 

2008;83(12): 1364·1372. 

vii Ham W. et al. Excellent local control with stereotactic radiotherapy boost after external beam radiotherapy in patients with nasopharyngeal 

carcinoma. lnt J Radiat Oncol Bioi Phys 2008;71(2):393-400. 

"'U Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed) (2008, August 27). Newer Cardiac Imaging 

Machines Effective In Detecting Coronary Artery Stenosis. ScienceDai/y. Retrieved January 8, 2009, from hnp:llwww.sciencedaily.com 

Ireleasesl2008/08/080826 I I 5909.htm 

ix The Quality of Medical Care, Behavioral Risk Factors. and Longevity Growth. Dr. Grank Lichtenberg. Ph.D .• National Bureau of Economic 

Research. June 2009. 

"Diagnostic Imaging Costs: Are They Driving Up the Costs of Hospital Care?; Molly T. Beinfeld. MPH and G. Scott Gazelle. MD. MPH. PhD; 

Radiology. June 2005. 

~l Ibid. 

~" According to Medical Expenditure Panel Survey (2004). «the average expense per night for a hospitalization in 2004 was about $3.000 while 

the median per diem was about $I.BOO." Accessed from http://meps.ahrq.gov/mepsweb/data_files/publications/stl64/stat164.pdfon 1/07/09. 

xm Goldstein. James A. et a1. "A Randomized Controlled Trial ofMulti~Slice Coronal)' Computed Tomography for Evaluatjon of Acute Chest 

Pain." Journal of the American College o/Cardiology. 2007: 9(8) 

xiv Rao, Patrick M., Rhea. James T,. Novelline. Robert A.. Mostafavi. Amy A.. McCabe. Charles 1. Effect of Computed Tomography of the 

Appendix on Treatment of Patients and Use of Hospital Resources. N EnglJ Med 1998338: 141 w l46 

xv, http://www.hps.org/publicinformation/ate/q435.html 

XVI "The ALARA Concept in Radiographic Dose Reduction," Radiologic Technology, November 2004, 

~V1' "In Planning CT Dose Reduction. One Size Does Not Fit All," Diagnostic Imaging, November 1,2003. 

10 
123 

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 cofounded 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 xray 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 


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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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House Committee on Energy & Commerce 

Subcommittee on Health 

Hearing on Medical Radiation: An Overview of the Issues 

February 26, 2010 

Chairman Pallone, Ranking Member Deal and Members of the Subcommittee, my name 

is John Donahue and I am honored and grateful to be here to discuss the issues 

surrounding ionizing radiation in medicine. I am here as the Vice Chairman of Medicalis 

Inc. Medicalis is a leading innovator of technology and clinical solutions focused on 

improving access to high quality, safe, clinically appropriate and affordable diagnostic 

imaging care. We are a company founded by the radiologists and health technologists 

at the Brigham and Women's hospital system in Boston; we provide on-line, point of 

order, web-based radiation safety and clinical appropriateness decision support 

guidance to physicians. 

By way of background, I have worked in health care for over 25 years in the 

international pharmaceutical, vaccine, biotech and clinical laboratory industry. In the 

late 1990's, I co-founded and was the President and CEO, of one the nation's first and 

largest radiology benefit management companies. In that capacity, I had the privilege to 

testify in 2005 before this Committee on imaging policy. Since that time, I have had the 

opportunity to interact extensively with CMS, MedPAC, GAO, Congressional offices and 

many of the industry stakeholders on an array of imaging topics. I also lecture at the 

Harvard School of Public Health on imaging, medical management and health policy 

matters. 

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Diagnostic imaging is rife with many health policy and Federal legislative opportunities. 

I am hopeful that after today's hearing, we will agree that radiation safety in imaging is a 

measurable and very serious issue, and that there are specific steps that the Federal 

government and the industry can take now to mitigate risk of over-exposure. Requiring 

on-line radiation safety guidance and clinical decision support at the point of ordering for 

all Medicare and Medicaid patients would meaningfully lower the incidence of cancer 

and improve health outcomes for patients as well as reduce health care spending in the 

public health programs. 

Radiation safety has been in discussion since 1895 when "a new kind of light", the XRay, was discovered. In the 1990's, our Food and Drug Administration (FDA) 

suggested a methodology for recording X-ray absorption. In late 2001, FDA again 

issued a notice to all health-care professionals emphasizing the need to minimize 

radiation exposure in pediatric patients. In July 2005, the National Academy of 

Sciences issued a seminal study that examined health risks from exposure to low levels 

of ionizing radiation. Today, this is commonly referred to as the BIOLOGICAL EFFECT 

OF IONIZING RADIATION or the BEIR VII 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 (the most common unit of 

measure, "mSv") of radiation can result in radiation induced cancer 1 in 1000 times. 

Further, cumulative dosage totaling 100 mSv can ratchet this carcinogenic risk up to 1 

in 100 times. Statistically, as exposure to mSv increases so does the likelihood of 

cancer. 

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It is important to note that radiosensitivity varies by body tissue as well as by the gender 

and age of the patient. Studies have shown meaningful dose estimates can be 

measured. For example, the Cleveland Clinic submits that an abdominal CT emits 

roughly 10 mSv, a Cardiac PET - 15 mSv, aCT urographic study - 44 mSv, while a 

plain chest Xray emits less that .1 mSv. 

In 2006, I helped lead a radiation dosage safety and awareness program, in conjunction 

with a leading health insurer. The results were startling. They highlighted widespread 

radiation safety concerns and were reported extensively in the Wall Street Journal: 

1. some individuals received radiation exposure levels rnore than 1000 percent 

higher than that recommended by medical guidelines, and 

2. one patient, received 341 CT scans over an 18-rnonth period, bringing the 

radiation exposure level to 993.3 mSv. 

In 2007, I presented yet another study on imaging appropriateness and radiation safety 

to one Medicare Advantage plan. The conclusion was that in one 12-month period, 

almost 20 percent of this population received radiation exposure exceeding the first 

BEIR VII threshold of 10 mSv. Additional studies show that there are still widespread 

misconceptions amongst ordering phYSicians. One example is that shorter scanning 

times result in lower dosage. In fact, the opposite can be true because time and CT 

radiation dose are not proportional. 

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Diagnostic imaging is an extraordinary clinical tool and the benefit of diagnostic imaging 

in this context almost always exceeds the risk of induced carcinogenic effects. 

However, the studies cited above show incontrovertibly that patients are too often 

needlessly exposed to dangerously high levels of ionizing radiation that can induce the 

adverse outcomes of carcinogenesis. I would point out that, in addition, the GAO, 

MedPAC and CMS have concluded that imaging utilization is growing far ahead of 

overall health inflation and much of this growth is not clinically warranted and is 

unsupported by clinical evidence. 

I believe the solution is to leverage the clinical evidence, measurement techniques and 

web technology available to us today to: 

1. ensure every advanced imaging exam is clinically supported by evidence and is 

not redundant 

2. measure and report on individual cumulative mSv dosage and present this 

ionizing history to physicians at the point of ordering 

3. require recommendations of viable clinical alternatives to enhanced radiation 

risks when they exist. For example, is an ultrasound or is a blood or lab test 

sufficient for an initial diagnosis? 

4. ensure that these tests, once deemed clinically supported and safe, are 

performed by a physician and at a facility that adheres to the highest levels of 

clinical quality. 

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My company, Medicalis, is able today to deliver clinical appropriateness and radiation 

safety guidance to physicians, thereby improving health care outcomes, materially 

reducing radiation risk, and meaningfully lowering costs by eliminating unnecessary 

tests. Medicalis has a health data integration tool that links into lab, pharmacy, 

utilization management, archive systems, electronic medical records and claims data 

sets. We continuously survey all available patient data, including their personal ionizing 

radiation history. When physicians use our point of ordering, decision support, web 

based tool to request an imaging exam, we immediately present clinical evidence to 

guide that physician to the clinically appropriate test in the form of decision support. We 

also immediately present an intuitive patient-specific, risk assessment of radiation 

exposure: by the actual precise absorbed dose for a procedure when available, or by an 

algorithm considering patient age, gender, and body part based on the estimated mSv 

dosage for each procedure. If there is further ancillary risk, such as MR gadolinium 

contrast in certain renal conditions, we immediately present the information to the 

physician and offer alternative clinical action. Critically, all of this information becomes 

imbedded into the patient's electronic medical record. 

In 2010, we have no excuse but to leverage available clinical evidence, innovative 

technology and federal legislative and regulatory policy to provide all Americans with 

clinically appropriate, radiation safe and affordable imaging care. I would respectfully 

suggest that Congress encourage CMS to include web-based, clinically proven decision 

guidance with actual radiation safety capabilities into the upcoming radiology pilot 

initiatives and seriously consider any additional legislation to address these very serious 

policy concerns. 

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In addition, the Food and Drug Administration should be commended for the unveiling of 

its recent, "Initiative to Reduce Unnecessary Radiation Exposure from Medical 

Imaging." This effort will focus on the safe use of medical imaging devices, support 

informed clinical decision-making and increase patient awareness of their own 

exposure. Specifically, FDA has highlighted two underlying principles: appropriate 

justification of the radiation procedure and optimization of the radiation dose. This effort 

addresses many of the concerns raised in my testimony and Medicalis looks forward to 

working with the FDA and other industry stakeholders as this effort moves forward. 

I want to thank the Chairman and the Subcommittee again for your focus on the medical 

radiation issues. I would be pleased to answer all questions and to provide any further 

information. 

6 
131 

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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Statement ofthe Honorable John D. Dingell 

Subcommittee on Health 

Hearing on "Medical Radiation: An Overview of the Issues" 

February 26, 2010 

Thank you, Mr. Chainnan for holding this important hearing. 

Recent newspaper stories have highlighted the consequences of negligence 

associated with the use of medical radiation devices and therapies. Patients today receive 

far more radiation than ever before. With the ever increasing number of devices and 

therapies that have transfonned the diagnosis and treatment oflife threatening diseases, 

and their more frequent use, comes the realization that patients are sometimes subject to 

radiation overexposure. 

While rare, accidental exposure to excessive amounts of radiation can cause 

injuries, such as skin burns, hair loss, and cataracts, and can increase a person's lifetime 

cancer risk. 

I appreciate the fact that today' s hearing will allow us to focus on this important 

issue. It affords us the opportunity to ask some very critical questions relevant to the 

safety of medical radiation. 

• Are medical radiation technicians and professionals adequately trained to 

perfonn the critical tasks we expect them to perfonn? 

• Are hospitals providing the necessary financial support and personnel to operate 

the sophisticated devices safely? 

• Are manufacturers doing all they can to develop reliable equipment, and are they 

providing proper training support for facilities that purchase their products? 

• Are our federal regulators, more specifically the Food and Drug Administration 

and the Nuclear Regulatory Commission, doing what must be done to ensure the 

safety of American patients that benefit from these medical devices and 

therapies? 

• Are our laws and regulations keeping up with an increasingly complex medical 

radiation device market? 

• Do we have adequate error reporting systems so that we can more fully 

understand their underlying causes? 

The stories we have all read about clearly demonstrate that more can and should be 

done to ensure the safety of American patients. I was encouraged by FDA's recent 

announcement that it plans to take steps to reduce unnecessary radiation exposure from 
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certain medical imaging procedures. I hope this is the first in a serious of steps the 

Agency takes on this issue. The uncertainty surrounding medical radiation diagnostics 

and therapies is not good for the health of patients. Nor is it good for the advancement of 

science. 

Let me be very clear. I am convinced that the benefit these devices and therapies 

provide far outweigh the risks associated with them. They can be credited with saving 

countless lives and prolonging many others. They have also transformed the care 

provided to patients in a way that is more accurate, less invasive, and much more 

efficient. However, seeking ways to make their use safer for patients should be a neverending quest. 

Mr. Chairman, I look forward to hearing from today's witnesses. I also look 

forward to working on this issue in the future. 

Thank you. I yield back the balance of my time. 
134 

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 


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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 federallyfunded, 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 


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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. 


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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. 


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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 hospitalbased 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. 


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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 


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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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U.S. Representative Kathy Castor 

Committee on Energy and Commerce - Subcommittee on Health 

Hearing on Medical Radiation 

February 26, 2010 

• Mr. Chairman, thank you for holding today's hearing on such an 

important issue. 

• Advances in radiation therapies and screenings have undeniably saved 

lives and enabled us to detect potentially devastating conditions early 

enough to save lives - a benefit that we did not have in generations 

past. 

• Radiation technology and equipment continues to grow and advance 

quickly. And while this is exciting for the future of health care, it 

comes with added concerns and safety issues for patients that are the 

first to undergo some of the latest treatments. 

• Not long ago in my hometown of Tampa, the Moffitt Cancer Center, a 

premier Cancer Institute in Florida, and one of the best nationwide, 

had an extended series of errors resulting from a miscalibrated 

machine to treat cancer patients. 

• Between 2004 and 2005, 77 brain cancer patients were overradiated 

because a newer and more advanced machine had not been set up 

correctly. The problem wasn't discovered until inspectors from the 

Radiological Physics Center, a federally financed testing service came 

in for an inspection. 

• The director of the Radiological Physics Center said that if the 

inspection occurred earlier or if centers had a regular practice which 

included inspections such as those which they performed, these errors 

could have been avoided. 

• An article in today's New York Times highlighted another incident in 

Florida, which was very concerning. Unlike the accidental errors in 

Tampa, a radiation center in Melbourne Florida, associated with one 

of the State's largest physician practices was accused of fraudulent 

activities on two fronts. 
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• First, Medicare requires certain cancer treatments be administered 

only when the patient's radiation oncologist is present or nearby. 

However the physician group submitted claims for more than 200 

treatments when radiation oncologists were not only absent from 

treatment, but out of the country. 

• Another accusation came when a patient was overradiated and almost 

died. A 51 year old woman was told by her doctor, "I'm sorry, but 

yes, we overradiated you." It was alleged that doctors may have had a 

financial interest in providing certain more advanced treatments in 

their own centers, for which they stood to receive a financial benefit. 

These treatments were more lucrative for the doctors, but may have 

been medically unnecessary for the patients. 

• It is critical that we take a closer look at modem radiology screenings 

and treatments. We must work to ensure that unfortunate accidents no 

longer occur and that centers are testing more diligently for potential 

errors in dosages. 

• If there are cases where terrible and dangerous treatments are given to 

patients due to neglect or fraudulent activities, physicians must be 

held accountable. 

• I look forward to investigating this issue and welcome input from 

those who have personal experiences with treatment as well as experts 

in radiology, radiation oncology, radiological physics and others with 

expertise in the field. 
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Opening Statement 

Congresswoman Tammy Baldwin 

Hearing on Medical Radiation: An Overview of the Issues 

February 26, 2010 

Page 1 of3 

Thank you, Mr. Chairman, for convening this hearing on medical 

radiation. My primary concern, of course, is the health and safety of 

my constituents, and all Americans. As always, we want to strike the 

right balance. We want to ensure safety while prompting innovation, 

like the development of technologies that target radiation more 

accurately, assuring the right dose, to the right location, at the right 

time. I have the privilege of representing a number of companies, 

small and big, new and established, that are developing innovative 

new radiological therapies and manufacturing state of the art imaging 

devices. 

The issue of medical radiation and human health is complicated. 

There are so many actors involved. There are doctors and radiological 

technicians in the health care system, the federal and state government 
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Page 2 of3 

payers and regulators, and the private sector manufacturers of devices 

and programmers of software. 

To make a diagnosis, we rely on the doctors, technicians and 

manufacturers to work together to develop and abide by 

appropriateness criteria. To treat a disease, we again rely on health 

care providers and manufacturers to develop treatment plans that 

target the disease while minimizing negative effects to the patient's 

overall health. 

To prevent mistakes, and to confront mistakes after they happen, we 

rely on the FDA to oversee the manufacturers; eMS to oversee the 

providers; and our states to oversee the professional personnel. 

And in the private sector, we see consistent innovation to refine and 

perfect radiation in health care. The imaging industry has dedicated 

itself to reducing the level of radiation that is necessary while still 

providing doctors with the images they need to make a diagnosis. 
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Page 3 of3 

And radiation therapy technology is improving as we speak. Torno 

Therapy, a company in my district, increases the effectiveness of 

radiation therapy with integrated imaging technology. It gives 

clinicians increased flexibility, allowing them to change treatment on 

a daily basis as the anatomy of the patient's malignancy changes and 

heals. Doctors are then able to reduce unnecessary radiation to 

healthy cells. 

My heart goes out to those testifying today, and the many Americans 

they represent, who have suffered harm. I hope we can take a careful 

look at this issue to ensure that we use the medical tool of radiation to 

do the most good for human health. 

Again, thank you Mr. Chairman for convening this hearing and I yield 

back. 
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STATEMENT OF THE HONORABLE JOE BARTON 

RANKING MEMBER COMMITTEE ON ENERGY AND 

COMMERCE 

HEALTH SUBCOMMITTEE HEARING: 

MEDICAL RADIATION: AN OVERVIEW OF THE ISSUES 

February 26, 2010 

Thank you, Mr. Chairman for holding this hearing. I 

also want to thank our distinguished witnesses for coming 

here today to educate the Committee on this important 

topic. 

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 
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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 focus in part on tragic events 

associated with radiation therapy. These events raise 

legitimate questions that we need to explore. My hope is 

that the Members of the Committee and the public will 

listen to the witnesses without preconceptions. 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 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 not safe. Too 

many lives are at stake. 

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As an engineer, I am particularly interested to hear 

from the manufacturers how these life-saving devices work. 

I am also interested in hearing from the various provider 

groups on the training associated with operating these 

devices and how the different professional societies 

develop criteria so these devices are operated safely. 

These are complex issues because there are so many 

moving parts, both literally and figuratively. I look forward 

to listening to the testimony of our witnesses and learning 

more about this important topic. I yield back. 

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February 24, 2010 

The Honorable Nathan Deal 

Congress of the United States 

House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Health 

2125 Rayburn House Office Building 

Washington, DC 20515-6115 

Dear Congressman Deal: 

Society of Interventional Radiology 

3975 Fair Ridge Drive, Suite 400 North 

Fairfax, VA 22033 

(703) 691-1805 

RE: Hearing on "Medical Radiation: An Overview of the Issue" 

The Society ofInterventional Radiology (SIR) appreciates the opportunity to submit 

comments to the Subcommittee on Health, Committee on Energy and Commerce, U.S. 

House of Representatives, for the hearing on "Medical Radiation: An Overview of the 

Issues." We commend you for convening this important hearing. 

SIR is a professional medical society representing more than 4,500 practicing 

interventional radiology physicians, clinical associates, PhD scientists, and medical 

physicists whose mission is to improve the health ofthe public through pioneering 

advances in image-guided therapy. 

Interventional radiology is the medical specialty credited with pioneering modem minimally 

invasive medicine-medical treatment without scalpels-by reaching the source of a medical 

problem through blood vessels or directly through a small nick in the skin to deliver a 

precise, targeted treatment. Interventional radiologists are responsible for much of the 

medical innovation and development of minimally invasive treatments that are commonplace 

today. From the invention of angioplasty and the catheter-delivered stent, which were both 

first used to treat peripheral arterial disease in the legs, to drug-eluting stents, balloon 

angioplasty, catheter delivery systems and clot-removing devices of today-these specialists 

continue to shape and change the medical landscape and improve patient care. IR treatments 

delivered by board-certified experts can deliver solutions with less risk, less pain and less 

recovery time than traditional surgery. 

Interventional radiologists use ionizing radiation (fluoroscopy) as well as other imaging 

modalities in the performance of their procedures. They have demonstrated competency 

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through their American Board of Medical Specialties (ABMS)-sanctioned Board 

Certification. All interventional radiologists receive extensive training in radiation 

physics, radiation biology, and radiation safety in their residency. 

SIR is committed to radiation safety and has a long history of advocating for radiation 

dose reduction for patients. For the past thirty-five years, SIR has taken a leading role in 

measuring and assessing radiation dosage; developing educational programs on radiation 

safety, radiation protection, and reduction of skin dosage; developing radiation safety 

guidelines; and promoting the safety of patients and health care professionals for imageguided therapies. (1, 2). 

We agree with the fundamental principles of ALARA (as low as reasonably achievable) 

and support efforts to ensure the lowest possible dose. SIR's position is clearly stated in 

our Statement on Radiation Safety: 

Those who use radiation must be adequately trained in radiation safety, radiation 

physics, the biologic effects of radiation, and injury prevention to ensure patient 

safety. The use of radiation in diagnosing and treating patients has significantly 

advanced the field of medicine and saved or extended countless lives ... The use of 

radiation, however, is not without risk ... Those who use radiation must be adequately 

trained in radiation safety, radiation physics, the biologic effects of radiation, and 

injury prevention to ensure patient safety. This training is standard in radiology and 

interventional radiology training programs. (3) 

For an individual patient, radiation risks, while real, must be interpreted in the context of 

relative risk and benefit. Certainly, cumulative dose is important as well and all efforts must 

be made to minimize both. But, these efforts must be balanced against the expected benefit 

of any interventional or diagnostic procedure. (4) 

After fluoroscopy was developed at the turn of the last century, it was applied widely in and 

out of the medical space. After the discovery that X-rays could cause injury, its use was 

constrained in medicine and a specialty called Radiology was created to manage this 

beneficial but potentially harmful tool. The risks of radiation are not a new concept for our 

discipline. With more advanced technological platforms, increasingly complex procedures, 

and dissemination of use outside of our discipline, we have been aware of the increasing 

possibility of radiation-related injuries since the early 1990s, when the issue was first raised 

by the U.S. Food and Drug Administration (FDA). SIR conducted the first detailed study of 

radiation doses in IR procedures in the late 1990s at the request of FDA-the RAD-IR study. 

(5,6) We shared the results ofthe RAD-IR study with FDA prior to publication and have 

been involved in measures to educate the pUblic, our members, referring clinicians, and 

equipment manufacturers very actively both before and since then. 

Only an appropriately credentialed physician has the skills, training, and experience to 

oversee the safe performance of fluoroscopy. It must be remembered that fluoroscopic 

procedures carry a risk of exposure to radiation, with related injuries (5, 6, 7). Patient 

radiation dose during fluoroscopy is dependent on the operator's training, experience with the 

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fluoroscope. and efficiency in completing the study. The influence of training on radiation 

times and exposures has been demonstrated in studies of complex fluoroscopically-guided 

procedures (8,9). Patients can be harmed as a result of these fluoroscopically-guided 

procedures, as demonstrated in multiple publications, including the FDA document by Shope 

(10). These injuries can occur even when fluoroscopy is used by well-trained persons; 

imagine the risk from use by those not well trained or not trained at all in radiation protection 

and radiation management. There can be substantial increases in radiation dose to the patient 

when the fluoroscopist does not use proper technique (11). 

In addition to the patient, we must consider those receiving occupational exposure. Without 

proper training, and without the use of appropriate technique, the operator's occupational 

dose will be higher than necessary (12). For orthopedic and pain management procedures, 

this is particularly true for the operator's hands (13). SIR continues to advocate with 

industry, partner societies, and regulatory agencies for reduced operator dose, through 

training, standards, and board certification of our members. We have worked with our 

partner organizations representing technologists and nurses. We strongly believe that the use 

of any tool that carries risk should require demonstrated competency and adherence to 

standards by the user prior to its application. 

Thank you for your consideration of our comments. If we can provide any additional 

information or if you have questions and would like to discuss our comments in more 

detail, please do not hesitate to contact me at bstainken@rwmc.org or (40 I) 456-2204, 

Tricia McClenny, Associate Executive Director, in the SIR office at tricia@SIRweb.org 

or (703) 691-1805, or Doug Huynh, Manager of Govemment Affairs, at 

dhuvnMvSIRweb.org or (703) 691-1805. 

Sincerely, 

Brian Stainken, MD, FSIR 

President, Society ofInterventional Radiology 

References: 

1. Stecker M8, Balter S, Towbin R, Miller D, et. aI. Guidelines for patient radiation 

dose management. J Vasc Interv Radio12009; 20:8263-8273. 

2. Miller DL, Balter 8, Wagner LK, et al. Quality improvement guidelines for 

recording patient radiation dose in the medical record. J Vasc Interv Radiol 

2004;15:423-9. 

3. Cardella JF, Miller DL, Cole PE, Lewis, CA. 80ciety ofInterventional Radiology 

position statement on radiation safety. J Vasc Interv RadioI2003;14:S387. 

4. Miller DL. Overview of contemporary interventional fluoroscopy procedures. 

Health Phys 2008;95(5):638-644. 

5. Miller DL, Balter S, Cole PE, et al. Radiation doses in interventional radiology: 

the RAD-IR study. Part I: overall measures of dose. J Vasc Interv Radio12003; 

14:711-727. 

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6. Miller DL, BaIter S, Cole PE, et al. Radiation doses in interventional radiology: 

the RAD-IR study. Part II: skin dose. J Vase Interv Radio12003; 14:977-990. 

7. Balter S, Hopewell JW, Miller DL, Wagner LK, Zelefsky MJ. Fluoroscopically 

guided interventional procedures: A review of radiation effects on patients' hair and 

skin. Radiology 2010; 254:326-34l. 

8. Verdun FR, Aroua A, Trueb PR, Vock P, Valley JF. Diagnostic and interventional 

radiology: a strategy to introduce reference dose level taking into account the 

national practice. Radiat Prot Dosimetry 2005;114:188-91. 

9. Bor D, Sancak T, Toklu T, Olgar T, Ener S. Effects of radiologists' skill and 

experience on patient doses in interventional examinations. Radiat Prot Dosimetry 

2008; 129:32-5. 

10. Shope TB. Radiation-induced skin injuries from fluoroscopy. Radiographies 

2006;16:1195-1199. 

11. Mavrikou I, Kottou S, Tsapaki V, Neofotistou V. High patient doses in 

interventional cardiology due to physicians' negligence: how can they be prevented? 

Radiat Prot Dosimetry 2008; 129:67-70. 

12. Detorie N, Mahesh M, Schueler BA. Reducing occupational exposure from 

fluoroscopy. J Am Coil RadioI2007;4:335-7. 

13. Tsalafoutas lA, Tsapaki V, Kaliakmanis A, et al. Estimation of radiation doses to 

patients and surgeons from various fluoroscopically guided orthopaedic surgeries. 

Radiat Prot Dosimetry 2008;128:112-9. 

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SOCBIE'I'\" J<'OR RI\OJl,\.,!ION ON(;OLOG'l' lU)'lUNIIS1'R;\TORS 

5272 River Road, Suito 630· Bethesda, MO 20816 • 866-458-7762· Fax 301-656-0989· www.sroa.org 

February 19, 2010 

Society for Radiation Oncology Administrators Statement 

on 

Quality Radiation Therapy 

Submitted to Representative Sue Myrick, Member, Subcommittee on Health, 

Committee on Energy and Commerce, House of Representatives, Congress of 

the United States, for consideration at the Subcommittee Hearing on "Medical 

Radiation: An Overview of the Issues," 

On behalf of the Society for Radiation Oncology Administrators (SROA), we 

thank you for allowing us to contribute to a dialogue on the quality of radiation 

therapy and its effect on our patients across the country. 

You will hear from radiation therapists, radiation oncologists, medical physicists, 

administrators and others who are all essential members of a larger team treating 

millions of cancer patients. We understand the reason behind calling this hearing 

in light of the questions cancer patients and their families across the nation are 

asking these professionals following the New York Times articles on radiation 

overdoses. However, as the administrators who oversee the staff, quality 

assurance and patient safety of radiation oncology programs, we are here to 

reassure this body and the public that our efforts to ensure that patients receive 

the best and safest care possible are vigorous and ongoing, 

To provide background, the Society for Radiation Oncology is the authority on 

radiation oncology operations. As such, we are committed to providing education, 

advocacy and information to radiation oncology administrators, Our 600 plus 

members work in all settings where radiation therapy is provided, SROA is 

guided by four objectives: 

1. Improve the administration of the business and nonmedical management 

aspects of radiation oncology and the practice of radiation oncology as a 

cost-effective form of health care delivery, 

2, Provide a forum for dialogue among the members on matters of 

professional interest 

T:iJC sOllrce fiJI proactive so/uliolJS for Cdneer carl! delivery. 
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Page 2 

3. Disseminate information to and among the members of the Society. 

4. Generally promote the field of radiation oncology administration. 

Unfortunately, the recent New York Times articles did not highlight the day-to-day 

efforts to and successes in providing safe, effective cancer treatments. You will 

hear from one of the accrediting bodies for radiation oncology, the American 

College of Radiology that currently accredits 213 radiation oncology centers in 

the United States. These centers have undergone a rigorous review process 

based on nationally accepted standards and guidelines that compare the facility's 

personnel, equipment, treatment planning and treatment records, along with its 

quality control measures 

To provide an idea of the number of staff that work diligently to provide patient 

safety in radiation therapy centers across the United States, in 2004 there were 

an estimated 29,970 individuals working in these facilities, according to RT 

Answers at www.rtanswers.comistatistics/aboutradiationtherapy.aspx. Those 

personnel included 3,900 radiation oncologists; 8,900 radiation therapists; 3,400 

nurses; 2,600 radiation physicists; 2,500 dosimetrists; 5,300 clerical employees; 

2,400 administrative staff and 900 other full-time employees. 

As managers and administrators, we take responsibility for knowing national and 

state standards that apply to these practices. Because we have different 

backgrounds, we voluntarily seek additional education and use a team approach 

in applying quality assurance (QA). Our industry overall follows strict QA 

guidelines that establish a multilevel "check and balance" of preplanning, 

planning and treatment delivery processes for radiation therapy. We also have 

policies and procedures that define the steps to follow when a treatment deviates 

or an adverse event occurs. Our facilities must also meet and maintain national 

and state requirements for delivering radiation to patients. These statutes range 

from registering radiation-producing equipment to reporting a radiation medical 

event. 

All these factors help ensure that patients who come to us for radiation therapy 

services are safe. We must earn the patient's trust. We also understand that 

patients who enter our facilities already may carry a load of fear along with pain 

and other symptoms related to the cancer Therefore, our phYSicians and staff 

work hard to assure them and their families that the treatment they receive is 

applied at the highest possible standards and that we place patient safety above 

all else. 

However, when the rare medical event happens, it is incumbent on the 

healthcare system as a whole to acknowledge and to learn from those mistakes 

immediately. We could use stronger regulatory bodies, such as state radiation 

control bureaus, that would hold physicians and staff responsible for reporting 
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Page 3 

treatment deviation errors. Currently, many state regulations allow the radiation 

oncologist prescribing the treatment regimen to decide whether an error should 

be reported to the patient. 

The National Academy for State Health Policy stated that only 21 states require 

some form of mandatory reporting of medical errors, according to the Statebased Mandatory Reporting of Medical Errors An Analysis of the Legal and 

Policy Issues at www.hashp.org/node/832. In tum, we need standard criteria on 

how to define the errors that can occur in our departments. 

Most errors in radiation oncology are defined as treatment deviations. These are 

further defined as minor deviations because they can be corrected and 

insignificantly affect a patient's treatment outcome. However, the severity of a 

treatment deviation is user defined unless it falls under federal or state 

regulations that define a medica! event such as but not limited to: 

• The total dose delivered differs from the prescribed dose by 20 percent or 

more; 

• The total dose delivered differs from the prescribed dose by 20 percent or 

more or falls outside the prescribed dose range; or the fractionated dose 

delivered differs from the prescribed dose, for a single fraction, by 50 

percent or more. 

n Administration of a dose or dosage to the wrong individual or human 

research subject. 

.. Administration of a dose or dosage delivered by the wrong mode of 

treatment. 

(Federal regulations, Subparl M-Reporls § 35.3045 Reporl and notification of a 

medica! event.) 

Despite published reports, a large majority of radiation therapy departments have 

adopted a treatment deviation policy and a procedure to record, evaluate the 

cause of the deviation and establish corrective action to prevent future 

occurrences. However, we beHeve that it would be preferable to have a nearmiss policy and procedure that documents the events leading to the discovery. 

Routine reporting of events and attention to near misses can help identify weak 

spots in this system and are particularly critical for reducing the risk of random 

errors but do not reduce risk of systematic errors. 

As our processes become more and more complicated through technological 

advancements that seemingly automate much of the process, it is inherent that 

we maintain the human aspect of this care environment that monitors and guards 

against misadministrations. 
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Page 4 

As administrators, we also need adequate qualified staffing and reasonable 

workloads and funds to train staff on interpersonal skills, provide tools for patient 

education and communication, and monitor staff interactions, SROA has aligned 

with 22 other professional organizations to support the American Society of 

Radiologic Technologists (ASRT) in its efforts to achieve a national minimum 

education standard for those administering diagnostic or therapeutic radiation 

through the Consistency, Accuracy, Responsibility and Excellence in Medical 

Imaging and Radiation Therapy (CARE) bill, H, R 3652 bill, This effort began in 

1999. We are frustrated and disappointed with a process that is costly and has 

brought us no closer to reality for our patients through the very education and 

certification that the New York Times article said we needed. Our industry needs 

the legislative and the executive branches to listen to our profession's experts so 

that stronger requirements can be passed to make the use of medical radiation 

safer for the public today and tomorrow 

Finally, our membership would like to know why it takes reports of catastrophic 

events as the "lead story" on the 6 p.m. and 10 p.m. newscasts or the front page 

of one or more of our national newspapers to get the attention that this issue and 

our patients deserve. For decades, the radiation oncology professional 

organizations have worked together to make the use of medical radiation safe, 

where 99.996% of radiation treatments are correctly administered. However, that 

is not good enough, so we strive to reach 100%. Our patients and the public 

deserve that. 

This brings us full circle to the most important aspect of every practice: the 

patient. With so many of our patients now questioning the safety of their radiation 

treatments, SROA is creating tools and looking to our fellow professional 

organizations' tools to provide our members with guidelines that they can use to 

assess their radiation oncology practices and improve patient education on 

radiation safety. We want to empower our patients and our profession in aI/ the 

ways we have suggested in this statement. 

Thank your for considering our comments. Please contact SROA if you have 

questions. 

Gail L Satterfield 

President, SROA 

R Alan Burns, BS, RT.(R)(T) 

Chair. Advocacy Committee 
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American Association of Physicists in Medicine 

One Physics Ellipse 

College Park, MD 20740-3846 

(301) 209-3350 

Fax (30 I) 209-0862 

http://www.aapm.org 

March 31, 2010 

Rep. Edward Markey 

House of Representatives 

c/o Earley Green, Chief Clerk 

2108 Rayburn House Office Building 

Washington, DC 20515 

Office of the President 

Michael G. Herman, PhD 

Professor and Chair, Medical Physics 

Department of Radiation Oncology 

Mayo Clinic 

200 First St SW 

Rochester, MN 55905 

Phone: 507-284-7763 Fax: 507-284-0079 

E-mail: herman.michael@mayo.edu 

Re: March 15, 2010 Letter from Chainnan Waxman - "Medical Radiation - An Overview of the 

Issues" 

Dear Representati ve Markey: 

On behalf of the American Association of Physicists in Medicine (AAPM) attached are our responses 

to your follow-up questions from the Subcommittee on Health's February 26th hearing titled 

"Medication Radiation: an Overview of the Issues." AAPM represents more than 7,000 medical 

physicists and is committed to ensuring that all patients receive safe, high quality medical care. 

If you have additional questions or require further infonnation, please contact Lyrme Fairobent, 

AAPM's Manager of Legislative and Regulatory Affairs at Iynne@aapm.org or 301-209-3364 or me. 

Sincerely, 

Michael G. Hennan, Ph.D., FAAPM, FACMP 

Cc: Committee on Energy and Commerce 

I Attachment 

The Association's Scientific Journal is MEDICAL PHYSICS 

Member Soclety of the American Institute of Physics and the International Organization of Medical Physics 
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The American Association of Physicists in Medicine's Response to 

Questions from the Honorable Edward J. Markey 

(Text in italics quoted from Rep. Markey's letter) 

Last summer an article in the New York Timesl detailed a series of major medical mistakes that 

occurred at the Philadelphia Veterans Affairs Medical Center (VAMC) where a doctor 

retroactively altered treatment plans on procedures involving use of radioisotopes. In one 

particular case, the doctor incorrectly implanted radioactive iodine seeds into the patient's 

health healthy bladder, instead of into the patient's prostate gland where it was intended to treat 

his prostate cancer. These incidents raised many questions about the adequacy of the Nuclear 

Regulatory Commission, which has jurisdiction over these types of medical errors, to oversee 

and investigate these sorts of procedures. 

1. Do you think that if a physician accidently irradiates the wrong body part during 

therapeutic treatment that this should be reported as an error, to the patient, the 

hospital and to regulatory authorities? 

Yes. It is the responsibility of the physician to inform the patient, the hospital authority 

and the regulatory agency. 

2. There are currently different reporting rules for different types of radiation-related 

errors that depend largely on what the source of radiation is. For example, errors 

related to irradiation with medical devices are reported to FDA, while the Nuclear 

Regulatory Commission (NRC) has authority over radiation exposure associated with 

radioactive materials. Do you think that if the wrong part of the body is irradiated that 

the rules for how this error is recorded and reported should be uniform despite the 

source ofradiation? 

Yes. If the wrong part of the body is irradiated, the rules for how the error is recorded 

and reported should be uniform despite the source of radiation. From the impact of the 

radiation exposure, the risks and effects are the same for a similar dose of radiation, no 

matter what the source of the radiation was. 

3. Do you think that for oversight and research purposes it would be helpful to have data 

on medical errors, such as the one described above, collected by a centralized source? 

lfyes, who do you think that source should he? Ifnot, why not? 

Yes, data on medical errors is essential to conduct a trend analysis, make assessments, 

inform the community, and make improvements. We agree that there should be a 

centralized data repository of medical errors. Exactly how this is achieved should be 

discussed further. An independent source for the data collection such as the Conference 
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AAPM Response to Rep. Markey's Questions 

March 31, 2010 

Page 2 of 4 

of Radiation Control Program Directors (CRCPD), that represents all state regulators 

could provide such a solution. A partnership between agencies, the medical community 

and organizations such as CRCPD could also effectively cooperate to develop this 

repository. The important requirements are that the system allows all of us to learn from 

actual and potential adverse events in the medical use of radiation by: 

• allowing central reporting by medical staff (including radiation therapy physicians, 

medical physicists, radiation therapists, dosimetrists, others), manufacturers and 

others in a complete and consistent manner, 

• providing search capability to identity patterns, risks and corrective actions and to 

inform the community, and 

• require a partnership between all involved (federal and state government, 

manufacturers, users, patient advocates). 

The national system must be set up in such a way as to be independent of any reporting 

entity to prevent bias in the data reported. The database should be established such that 

no patient identification is included in the reports submitted to the reporting entity. The 

AAPM has been in conversation with FDA to organize a national roundtable for exactly 

this discussion. 

4. What kind of information about the circumstances of a medical error should be 

reported and collected? 

The essential components of any database should include description of the event, the 

specific equipment, protocol, and procedure type, all in a HIP AA compliant manner. 

This is similar to the essential components required in the Nuclear Regulatory 

Commission's Nuclear Materials Event Database (NMED). The reporter should also 

include at least a preliminary analysis of the root causes of the event. Provisions should 

be made for anonymous reporting of events, which has been demonstrated to increase the 

frequency of reports. 

5. Currently, requirements on patient notification after a medical error such as 

irradiating the wrong organ, varies widely and depends again on the source of 

radiation. Under what circumstances do you think that patients should be notified of 

errors in their radiation procedure? Do you believe that rules about patient notification 

should be uniform across all States? 

Yes, except in rare cases where notification would cause more patient harm than help. 

Patients should be notified and the rules should be uniform across all states. 

6. How should medical error and mis-administrations be defined? 

AAPM believes that the definition of medical error should be uniform across radiation 

treatments. We also believe that the stakeholder community should have an opportunity 

to work with the regulatory authorities to establish the definition of a medical event that 

would be uniformly applied. It is possible that the definition of medical error may be 
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AAPM Response to Rep. Markey's Questions 

March 31, 2010 

Page 3 of4 

procedure specific, but should remain consistent across the country. There are various 

models (NRC, some states, FDA- and internationally IAEA) that exist, are different, but 

could serve as a beginning for developing a uniform system. Such definitions should be 

expanded to include events that do not cause harm to the patient, but have the potential to 

do so. 

7. Do you think that there should be a standardized definition and mandatory reporting 

framework for machine-based radiation that is consistent in every State? 

Yes, and this should follow our answers to items 3, 4, 5 and 6 above. There are several 

states (e.g., PA, NY, FL) that currently have definitions and mandatory reporting systems 

in place, but many that do not. A central and national system as described above should 

include these events. 

8. Do you think that errors in administration should be consistently tracked by the States, 

independent of the source of radiation (i.e., for both machine-based and non-machinebased radiation)? 

Yes. The impact of the radiation exposure, the risks and effects are the same for a similar 

dose, no matter what the source of the radiation was - whether radioactive materials or 

resulting from the operation of radiation-producing equipment. 

In 1997. NRC changed its regulations (10 CFR 35. 75) to allow the immediate release of 

most cancer patients being treated with medical radioisotopes. In some cases this allows 

patients who could be emitting unsafe levels of radiation to be released, potentially 

harming people who might come into contact with them. According to a letter sent.from 

the Nuclear Regulatory Commission to Congressman Edward Markey, it changed these 

rules because it assumed that the treating physician would be able to perform an 

individualized analysis of a patient's living situation to ensure that they would not pose 

harm to their family or the public. 

9. Some patients choose to go to hotels to recover rather than return home to their 

families. Is a physician capable of performing an individualized analysis of a hotel 

room that he or she has never seen to ensure that neither hotel personnel nor future 

room inhabitants would be exposed to unsafe levels of radiation? 

The current regulation does not mandate but allows patient release after a determination 

is made that the patient can comply with appropriate restrictions. It is the responsibility 

of the licensee to determine if a patient can be released in accordance with 10 CFR § 

35.75. Licensees who are authorized to release patients containing more than 33 mCi of 

radioactive iodine-131 are required to perform an analysis of the potential radiation 

exposure to others to assure regulatory limits are not exceeded. NUREG-1556, Volume 9 

Section 8.36, Release of Patients or Human Research Subjects specifies the guidelines 
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AAPM Response to Rep. Markey's Questions 

March 31, 2010 

Page 4 of4 

that must be followed by a licensee prior to releasing a patient in accordance with 10 

CFR § 35.75. 

The assumptions that the licensee is required to make are conservative. We believe that 

the existing regulation provides adequate protection of the public. There are patients who 

may not be candidates for release but that determination should continue to be based on 

an assessment by the authorized medical professionals involved, and not solely dictated 

by a simplistic regulation based on a defined quantity of administered radioactivity. 

It is imperative, however, that the patient answers questions truthfully and follows the 

written instructions. Licensees should not be held accountable for patients who choose to 

ignore the instructions and directions given prior to their release. This is no different than 

a patient who disregards the instructions on a prescription drug label or over the counter 

drug. 

AAPM discourages the release of patients to hotels following treatment with radioactive 

iodine-131. While the actual risk to hotel staff might be very small, the public perception 

of such activity is quite negative and the practice may not reflect an adequate safety 

culture." 

10. In this type of a release situation, how does a physician take into account exposure of 

hotel workers or future hotel guests who might come into contact with the radioactive 

sheets and other contamination that the patient leaves behind? 

NUREG 1556, Volume 9, Appendix U: Model Procedure for Release of Patients or 

Human Research Subjects Administered Radioactive Materials lists activities for 

commonly used radionuclides and the corresponding dose rates with which a patient may 

be released in compliance with the dose limits in 10 CFR § 35.75. The activity at which 

patients could be released is calculated by using, as a starting point, the method discussed 

in the National Council on Radiation Protection and Measurements (NCRP) Report No. 

37, Precautions in the Management of Patients Who Have Received Therapeutic Amounts 

of Radionuclides. 

Appendix U also discusses the instructions that must be given to the patient prior to the 

release. Many facilities require the patient to sign these instructions sheets 

acknowledging the conditions under which they are being released. As stated in response 

to Question 9 above, licensees should not be held accountable for patients that do not 

follow the instructions provided to them. 

We note that the current dose limit of5 mSv per treatment to others post-release of the 

patient assumes that they will be family members, caregivers or others with an interest in 

the patient, and who will have rare exposure in such situations. Hotel workers do not fall 

in this category and thus should be limited to I mSv per year. Such a prediction is 

generally beyond the ability of the licensee to make, thus the general process of release to 

a hotel should be prohibited. 
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March 26, 2010 

Rep. Henry A. Waxman 

Chairman 

Committee on Energy and Commerce 

House of Representatives 

clo Earley Green, Chief Clerk 

2125 Rayburn House Office Building 

Washington, DC 20515-6115 

Dear Chairman Waxman: 

Thank you for the opportunity to respond to Rep. Edward Markey's follow-up questions from 

the Subcommittee on Health's Feb. 26 hearing titled "Medication Radiation: an Overview of the 

Issues." I was honored to be invited to testify on this important issue, and I appreciate being 

asked to provide additional information. 

I am submitting the attached responses on behalf of the American Society of Radiologic 

Technologists, which represents more than 134,000 medical imaging and radiation therapy 

professionals. The ASRT is committed to ensuring that all patients receive safe, high quality 

radiologic care. 

If you have additional questions or require further information, please contact me. 

Sincerely, 

Sandra Hayden, B.S., R.T.(T) 

Vice Speaker of the ASRT House of Delegates 

15000 Central Ave. SE 

Albuquerque, NM 87123-3909 

shayden@Yasrt.org 
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"Medical Radiation: An Overview of the Issues" ASRT Responses to Follow-up Questions 

Last summer an article in the New York Timesl detailed a series of major medical mistakes that 

occurred at the Philadelphia Veterans Affairs Medical Center (VAMC) where a doctor 

retroactively altered treatment plans on procedures involving use of radioisotopes. In one 

particular case, the doctor incorrectly implanted radioactive iodine seeds into the patient's health 

healthy bladder, instead of into the patient's prostate gland where it was intended to treat his 

prostate cancer. These incidents raised many questions about the adequacy of the Nuclear 

Regulatory Commission, which has jurisdiction over these types of medical errors, to oversee 

and investigate these sorts of procedures. 

1. Do you think that if a physician accidently irradiates the wrong body part during therapeutic 

treatment that this should be reported as an error, to the patient, the hospital and to regulatory 

authorities? 

ASRT Response: The error at the Philadelphia V AMC involved brachytherapy (the internal 

placement of radioactive seed implants to treat cancer). External beam radiation therapy 

treatment is delivered by a radiation therapist based on prescriptive orders from a physician, 

development of a treatment plan by either a medical physicist or medical dosimetrist and 

treatment simulation by a radiation therapist. Ultimately it is the radiation therapist who delivers 

the radiation dose to the patient. The CARE Bill (H.R. 3652) will require all technical personnel 

performing medical imaging, along with radiation therapists, medical dosimetrists and medical 

physicists treating Medicare patients, to meet education and certification standards to help ensure 

treatments are conducted safely and effectively. 

Misadministration of radiation dose should be reported if it results in an outcome that is different 

from what was originally intended. Reporting requirements should be based on severity: 

• A minor misadministration of dose that has no clinical significance need only be reported 

to internal quality management bodies. 

• A misadministration of dose that affects the patient should be reported to the patient, 

hislher referring physician, the radiation oncologist supervising the patient's treatment, 

and external quality management bodies. 

• The supervising physician is responsible for reporting any misadministrations to the 

patient, while the radiation therapist or medical physicist is responsible for reporting any 

deviations to the facility. 

• The facility in which the treatment took place is responsible to state or federal regulatory 

authorities for any required reports. 

• For treatment using radioisotopes or radioactive seeds, the Nuclear Regulatory 

Commission has clear guidance and criteria on what constitutes a reportable event at 10 

CFR 35.3045. FDA requires the manufacturer and the facility using radiation-emitting 

equipment to report any accidental radiation occurrences during the manufacture, testing 

or use of any product. Equipment operators and consumers may voluntarily report 

information to FDA. 

2. There are currently different reporting rules for different types of radiation-related errors that 

depend largely on what the source of radiation is. For example, errors related to irradiation 

with medical devices are reported to FDA, while the Nuclear Regulatory Commission (NRC) 

has authority over radiation exposure associated with radioactive materials. Do you think that 

2 
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"Medical Radiation: An Overview of the Issues" ASRT Responses to Follow-up Questions 

if the wrong part of the body is irradiated that the rules for how this error is recorded and 

reported should be uniform despite the source of radiation? 

ASRT Response: Each federal regulatory body's authority is determined by statute. Currently 

FDA is responsible for equipment that emits ionizing radiation (such as CT scanners or linear 

accelerators used in radiation therapy treatments) while NRC is responsible for radioactive 

materials (radioisotopes and radiation emitting seeds). Each agency should collect the same type 

of information using standardized definitions so that reporting is consistent and data can be 

compiled and analyzed to develop best practices for avoiding misadministrations or deviations 

from prescribed dose. Reporting requirements should be uniformly defined and applied. 

3. Do you think that for oversight and research purposes it would be helpful to have data on 

medical errors, such as the one described above, collected by a centralized source? If yes, 

who do you think that source should be? Ifnot, why not? 

ASRT Response: Blinded data on medical radiation misadministrations should be collected, 

analyzed and available for research. Comprehensive data collections are vital to developing 

methods to prevent errors from occurring during treatment. FDA and NRC currently make 

radiation misadministration and equipment malfunction data available to the public. If this data 

was collected in a centralized source, the Agency for Healthcare Quality and Research may be 

the best repository. 

4. What kind of information about the circumstances of a medical error should be reported and 

collected? 

ASRT Response: All relevant data surrounding a medical error event should be collected. In the 

case of a radiation error, data should include the patient's condition for which the 

exam/treatment was prescribed, the prescribing physician, the supervising physician during the 

exam/treatment, patient demographic information, and the location, time and date where the 

event took place; the name/certificationslbackground of the operator performing the treatment or 

exam; the make and manufacturer of the equipment used, including software versions; technique 

and dose data for the exam/treatment; and any other information that is required by the agency to 

which the event is reported. 

5. Currently, requirements on patient notification after a medical error such as irradiating the 

wrong organ, varies widely and depends again on the source of radiation. Under what 

circumstances do you think that patients should be notified of errors in their radiation 

procedure? Do you believe that rules about patient notification should be uniform across all 

States? 

ASRT Response: Because the ordering and supervising physician(s) are responsible for patient 

notification, ASRT defers to their opinion and the position of their professional organizations. 

In general, the decision to notify the patient should be made by the head of the department of the 

patient's attending physician, after consulting with the attending physician and with the 

department's quality management organization. 

3 
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"Medical Radiation: An Overview of the Issues" ASRT Responses to Follow-up Questions 

6. Currently, reporting of medical errors or misadministrations involving radiation producing 

machines is regulated differently by individual States, with variability in both the reporting 

requirements and how a misadministration or medical event is defined. How should medical 

error and misadministrations be defined? 

ASRT Response: ASRT recommends that nationally recognized medical research organizations 

(such as the Institutes of Medicine) be consulted to define the terms "medical error" or 

"misadministration." States also may have definitions of"misadministration" as parts of 

reporting policies. For example, Pennsylvania Code (25 Pa. Code § 219.3) defines a reportable 

event in radiation therapy as: 

"Medical reportable event for radiation-producing machine therapy. The administration 

to a human being, except for an administration resulting from a direct intervention ofa 

patient that could not have been reasonably prevented by the licensee or registrant, that 

results in one of the following: 

(i) An administration of a therapeutic radiation dose to the wrong individual; 

(ii) An administration of a dose for therapy when the result is an increase in the total 

expected doses inside or outside the intended treatment volume for organs, tissue, or skin 

that exceeds 20% of the total prescribed dose for the intended target volume; 

(iii) A total dose delivered to the treatment site identified in a written directive for 

therapy that is outside the prescribed dose range or differs from the total prescribed dose 

by more than 20%, or for a fractionated dose, when the weekly administered dose differs 

from the weekly prescribed dose by more than 30%." 

7. Do you think that there should be a standardized definition and mandatory reporting 

framework for machine-based radiation that is consistent in every State? 

ASRT Response: ASRT believes that definitions and reporting requirements should be 

standardized and consistent in each state. By developing data collection requirements, research 

organizations and associations representing the professions involved in medical imaging and 

radiation therapy can develop best practices and evidence-based methods to reduce the potential 

of misadministrations and errors. 

8. Do you think that errors in administration should be consistently tracked by the States, 

independent of the source of radiation (i.e. for both machine-based and nonmachine-based 

radiation)? 

ASRT Response: Radiation administered by an educated and certified individual can be used to 

detect, diagnose and treat disease and illness. However, in the hands of an untrained operator, 

radiation has the potential to harm, or even kill, those who may benefit from its medical use. 

Any error or unintended consequence resulting from the misuse of radiation, regardless ofthe 

source (equipment emitting ionizing radiation or physical sources of radiation like radioisotopes 

or radiation emitting seeds) should be tracked and recorded. 

4 
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"Medical Radiation: An Overview of the Issues" ASRT Responses to Follow-up Questions 

In 1997, NRC changed its regulations (10 CFR 35.75) to allow the immediate release of most 

cancer patients being treated with medical radioisotopes. In some cases this allows patients who 

could be emitting unsafe levels of radiation to be released, potentially harming people who might 

come into contact with them. According to a letter sent from the Nuclear Regulatory 

Commission to Congressman Edward Markey, it changed these rules because it assumed that the 

treating physician would be able to perform an individualized analysis of a patient's living 

situation to ensure that they would not pose harm to their family or the pUblic. 

9. Some patients choose to go to hotels to recover rather than return home to their families. Is a 

physician capable of performing an individualized analysis of a hotel room that he or she has 

never seen to ensure that neither hotel personnel nor future room inhabitants would be 

exposed to unsafe levels of radiation? 

ASRT Response: National, and general, guidelines should exist to protect members of the 

public. It should be the responsibility of the licensee to properly advise the patient of proper 

procedures to be followed in order to minimize unnecessary irradiation of family members or 

members of the public. 

10. In this type of a release situation, how does a physician take into account exposure of hotel 

workers or future hotel guests who might come into contact with the radioactive sheets and 

other contamination that the patient leaves behind? 

ASRT Response: Instructions provided to the patient should provide specific guidance such that 

the exposure of members of the public are maintained as low as reasonable achievable. It should 

be the responsibility ofthe licensee to show how this has been done. 

5 
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March 31, 2010 

Earley Green, Chief Clerk 

Committee on Energy and Commerce 

United States House of Representatives 

2125 Rayburn HOB 

Washington, DC 20515-6115 

Via e-mail: Earley.Green@mail.house.gov 

Dear Chief Clerk Green: 

The following response is given in reply to Chairman Waxman's request dated March 15, 2010 as 

follow-up to the February 26, 2010 hearing entitled Medical Radiation, An Overview of Issues." 

Sincerely, 

E. Stephen Amis, Jr, MD, FACR 

Albert Einstein College of Medicine/Montefiore Medical Center 

Chair, ACR Blue Ribbon Panel on Radiation Dose in Medicine 

Last summer an article in the New York Times detailed a series of major medical mistakes that 

occurred at the Philadelphia Veterans Affairs Medical Center (VAMC) where a doctor 

retroactively altered treatment plans on procedures involving use of radioisotopes. In one 

particular case, the doctor incorrectly implanted radioactive iodine seeds into the patient's 

health healthy bladder, instead of into the patient's prostate gland where it was intended to 

treat his prostate cancer. These incidents raised many questions about the adequacy of the 

Nuclear Regulatory Commission, which has jurisdiction over these types of medical errors, to 

oversee and investigate these sorts of procedures. 

Question 1: Do you think that if a physician accidently irradiates the wrong body part during 

therapeutic treatment that this should be reported as an error, to the patient, the hospital 

and to regulatory authorities? 

Irradiation of a wrong body part during a therapy under the specific circumstances that occurred 

at the Philadelphia Veterans Affairs Medical Center (VAMC) should be reported. In that case, 

"medical event" reporting was required to patients, providers, and the appropriate authorities. 

10 CFR Part 35.3045 regulates reporting and notification of medical events involving radioactive 

materials. These regulations address reporting to the patient/guardian, referring physicians, 
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and NRC within specific timeframes after discovery of the medical event. The VAMC was found 

to be in violation ofthe regulations and was penalized accordingly. 

Error reporting is an "after the fact" approach that, by itself, is of questionable value. Resources 

for radiation therapy quality improvement and assessment would be better spent on monitoring 

medical facilities as part of a mandatory accreditation program to catch potential problem areas 

before errors occur. The VAMC exemplifies the limits of even the most stringent and punitive 

federal/State reporting requirements. It also emphasizes the importance of relying only on 

recognized accrediting bodies that offer a robust program carried out by experts in the 

modalities being accredited. 

Question 2: There are currently different reporting rules for different types of radiationrelated errors that depend largely on what the source of radiation is. For example, errors 

related to irradiation with medical devices are reported to FDA, while the Nuclear Regulatory 

Commission (NRC) has authority over radiation exposure associated with radioactive 

materials. Do you think that if the wrong part of the body is irradiated that the rules for how 

this error is recorded and reported should be uniform despite the source of radiation? 

The goal for any medical error reporting system should be quality improvement. Generally, 

error reporting and quality improvement initiatives will be most effective at the facility level 

where the consequences of a medical error are most keenly felt and where the specific 

circumstances giving rise to an error can be most readily identified and remedied. 

Speaking specifically to the question of uniformity, there are meaningful differences in medical 

errors involving various uses of radiation; a regulatory scheme that treats all errors as though 

they were identical would be counterproductive. For example, radioisotopes, which are subject 

to NRC reporting requirements, are used and administered differently, have different handling 

requirements, use different equipment, and have different quality assurance/quality control 

requirements than devices that use external radiation. 

Before deciding whether to collect medical error data at the national level, a risk threshold 

should be developed in an open deliberative process, relying on the expertise of clinicians 

(physicians and medical physicists) who plan and perform the specific types of procedures being 

discussed. Errors that do not result in adverse outcomes should continue to be reported locally 

to the respective healthcare facility and, if feaSible, de-identified summary statistics might also 

be included in a medical specialty data registry, such as the American College of Radiology's 

General Radiology Improvement Database (GRID). 

Furthermore, to ensure that the reported data is viewed in the appropriate context, there 

should be mechanisms to verify consistency in reporting among all providers. Repeat exams 

resulting from poor techniques, antiquated imaging equipment, inadequate clinical skills, etc. 

should also be reportable if the additional dose required by the repeat exam triggers the 

reporting threshold. Repeat examinations are more prevalent in certain ambulatory settings in 

which physicians without extensive training in radiology-including the radiation safety 

fundamentals taught in residency training of radiologists, radiation oncologists, and nuclear 

medicine physicians-are providing diagnostic imaging or radiation therapy services. 
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Question 3: Do you think that for oversight and research purposes it would be helpful to have 

data on medical errors, such as the one described above, collected by a centralized source? If 

yes, who do you think that source should be? If not, why not? 

De-identified data on medical errors across medicine collected specifically for research purposes 

could potentially be useful depending on how the data is used. However, ACR believes the 

relative usefulness of data collection is low unless several additional steps are taken to translate 

the research into clinical practice at the facility level. If a decision to collect such data is made, it 

should be collected across all medical specialties without regard to the practice setting, device, 

procedure, specialty of the clinician, or whether the error involved radiation. We are hopeful 

that reporting of this data would be, in the near future, facilitated by health information 

technology and exchange capabilities. 

In terms of where the data is retained, there may not be a need for a centralized 

archive/storage location for this data, as long as this data is accessible to those who need it. The 

Agency for Healthcare Research and Quality (AHRQ) has made some headway on a variety of 

topics related to medical errors data reporting and analysis. 1 

Furthermore, defining what constitutes a medical error can be challenging as demonstrated by 

the deliberations of NRC's Advisory Committee on the Medical Uses of Isotopes on such topics. 

There are certainly occasions where most physicians would agree that an error was made, 

others where most would agree a mistake was not made, and still others where no consensus 

would be found. Schemes for mandatory reporting should be designed so as not to interfere 

with the appropriate practice of medicine with respect to the individualized needs and 

circumstances of the patients. The development of criteria for medical error reporting should 

be done in an open deliberative process, relying on the expertise of clinicians (physicians and 

medical physicists) who plan and perform the specific types of procedures being discussed. 

Question 4: What kind of information about the circumstances of a medical error should be 

reported and collected? 

The circumstances of a medical error that would be useful would undoubtedly vary by 

procedure. For this reason, ACR would strongly recommend that the development of criteria 

for medical error reporting should be done in an open deliberative process, relying on the 

expertise of clinicians who plan and perform the specific types of procedures being discussed. 

Question 5: Currently, requirements on patient notification after a medical error such as 

irradiating the wrong organ, varies widely and depends again on the source of radiation. 

Under what circumstances do you think that patients should be notified of errors in their 

radiation procedure? Do you believe that rules about patient notification should be uniform 

across all States? 

Ideally, patient notification requirements relating to medical errors should be consistent for all 

medical errors without regard to whether radiation was used and lor the source of the 

1 Agency for Healthcare Research and Quality (AHRQ), "Medical Errors & Patient Safety," 

http://www.ahrg.gov/gual/errorsix.htm. 
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radiation. Consideration should be given as to whether a patient was harmed or potentially 

harmed by the error, what information should be conveyed and how it can be conveyed so as to 

urge any appropriate follow-up but not cause undue worry, etc. 

The NRC currently has regulations in 10 CFR Part 35.3045 that address the reporting and 

notification of "medical events" including, but not limited to, errors and misadministrations 

involving radioactive materials. Medical events are not necessarily "preventable adverse 

events;" that is, they do not always result in harm to patients. As a result, NRC's reporting 

requirements can sometimes cause patients, and referring physicians who are not familiar with 

NRC medical event reporting requirements, undue confusion and anxiety. 

Many States have malpractice protections in place to facilitate reporting of medical errorsdisclosure protections are strongly encouraged for medical errors that do not result in adverse 

events. 

Currently, reporting of medical errors or mis-administrations involving radiation producing 

machines is regulated differently by individual States, with variability in both the reporting 

requirements and how a mis-administration or medical event is defined. 

Question 6: How should medical error and mis-administrations be defined? 

The Institute of Medicine (10M) defines a medical "error" as the failure to complete a planned 

action as intended or the use of a wrong plan to achieve an aim. A "misadministration" in 

nuclear medicine services is related to incorrect procedure, dose, route of administration, or 

target area-this term is also used across medical disciplines in general reference to medication 

administration errors. 

As noted above, ACR would strongly recommend that the development of criteria for medical 

error reporting should be done in an open deliberative process, relying on the expertise of 

clinicians who perform the specific types of procedures being discussed. 

Question 7: Do you think that there should be a standardized definition and mandatory 

reporting framework for machine-based radiation that is consistent in every State? 

Standardization would facilitate cross-state analysis of reporting data. Not knowing what the 

standardized definition or reporting framework might be, it is impossible to comment on 

whether a universal application of the framework or definition would be helpful or harmful. 

Question 8: Do you think that errors in administration should be consistently tracked by the 

States, independent of the source of radiation (ie. for both machine-based and nonmachinebased radiation)? 

Consistent tracking of medical errors by the appropriate federal/State authorities could facilitate 

analysis of errors that could potentially foster quality improvement efforts. The definition of 

medical error and the types of information that might be useful to collect could vary based on 

the type of procedure, the characteristics of the body part treated, the device or material used, 
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the degree to which a procedure requires an exercise of medical judgment in carrying out a 

procedure, etc. 

ACR would strongly recommend that the development of criteria for medical errors should be 

done in an open deliberative process, relying on the expertise of clinicians who plan and 

perform the specific types of procedures being discussed. 

In 1997, NRC changed its regulations (10 CFR 35.75) to allow the immediate release of most 

cancer patients being treated with medical radioisotopes. In some cases this allows patients 

who could be emitting unsafe levels of radiation to be released, potentially harming people 

who might come into contact with them. According to a letter sent from the Nuclear 

Regulatory Commission to Congressman Edward Markey, it changed these rules because it 

assumed that the treating physician would be able to perform an individualized analysis of a 

patient's living situation to ensure that they would not pose harm to their family or the public. 

Question 9: Some patients choose to go to hotels to recover rather than return home to their 

families. Is a physician capable of performing an individualized analysis of a hotel room that 

he or she has never seen to ensure that neither hotel personnel nor future room inhabitants 

would be exposed to unsafe levels of radiation? 

Physicians can make the determination to hospitalize or release patients administered 

radiOisotopes in accordance with 10 CFR Part 35.75. NRC also provides regulatory guidance in 

Appendix U of NUREG 1556, Volume 9, Revision 2 and in Regulatory Issue Summary (RIS) 2008-

11. Additionally, several medical and scientific organizations provide guidelines and standards 

that address aspects of 1-131 therapy in general, including patient release. 

A physician who decides to hospitalize or release a patient following 1-131 therapy makes 

reasonable assumptions and conservative calculations, in accordance with modern scientific 

methodologies, regarding radiation exposure risk to the public. Physicians and/or medical 

physicists and health physicists can make safe, conservative assessments of public exposure risk 

without reviewing floor plans, as the major method for estimating exposure risk conservatively 

assumes a hypothetical person would consistently be within 1 meter of the patient. Since 1997, 

when 10 CFR Part 35.75 was updated to be in accordance with modern scientific methodologies, 

there have been no known physical harms resulting from public exposure to appropriately 

released 1-131 patients. 

Question 10: In this type of a release situation, how does a physiCian take into account 

exposure of hotel workers or future hotel guests who might come into contact with the 

radioactive sheets and other contamination that the patient leaves behind? 

For all patient release scenarios, licensees must determine that the total effective dose 

equivalent to any other individual from exposure to the patient is not likely to exceed 5 mSv in 

accordance with 10 CFR Part 35.75. As mentioned in the previous answer, medical personnel 

have various scientific methodologies that facilitate this determination. Studies show that the 
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resultant radiation exposure to those around appropriately released 1-131 patients is well below 

safe ICRP/NCRP recommended and NRC-mandated levels. 2,3 

2 Grigsby PW, Siegel BA, Baker S, Eichling JO, Radiation exposure from outpatient radioactive 

iodine (

1311) therapy for thyroid carcinoma. JAMA, 2000 May 3;283(17):2272-4, 

3 Venencia, C. 0" Germanier, A. G., Bustos, S, R., Giovannini, A. A., and Wyse, E. P. Hospital 

discharge of patients with thyroid carcinoma treated with 131. J.Nucl.Med., 43: 61-65, 2002. 
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Questions for the Record 

The Honorable Henry Waxman 

Chairman 

House Committee on Energy and Commerce 

Subcommittee on Health 

"Medical Radiation: An Overview of the Issues" 

February 26, 2010 

Question 1: Do you think that if a physician accidently irradiates the wrong body part 

during therapeutic treatment that this should be reported as an error, to the patient, the 

hospital and to regulatory authorities? 

Response: Yes. These disclosures should not be limited to wrong body part. 

Depending on specific circumstances, the administration of any wrong treatment (such 

as overdosing, underdosing, or misaligned exposures from therapeutic radiation) or the 

occurrence of an adverse event should be disclosed to the patient and the hospital's 

quality management and patient safety offices. 

Veterans Health Administration (VHA) facilities and individual VHA providers have an 

ethical and legal obligation to disclose to patients adverse events that have been 

sustained in the course of their care, including cases where the adverse event may not 

be obvious or severe, or where the harm may only be evident in the future. An adverse 

event (AE) is any unanticipated occurrence that ultimately results in harm to the patient. 

Disclosure of AEs and the reporting of adverse events to regulatory agencies are 

separate requirements. Actions taken to disclose adverse events to patients according 

to VHA Directive 2008-002 "Disclosure of Adverse Events to Patients" in no way 

obviates the need to report adverse events (and close calls) as required under VHA 

Handbook 1050.01. Clinical disclosure of an adverse event must occur within 24 hours 

of a practitioner's discovery of the event. Other adverse events, such as unanticipated 

toxicity of treatment, must be disclosed within 24 hours upon information made available 

to the practitioner. 

Treatment of the wrong patient, wrong organ or with the wrong isotope must be reported 

as a medical event in certain conditions per 10 CFR part 35 (the Nuclear Regulatory 

Commission's regulations on Medical Use of Byproduct Material) when that treatment 

involves the use of byproduct material. A medical event is a specific term related to the 

inappropriate medical use of certain radioactive materials. Specific indications of 

inappropriate use are defined in 10 CFR part 35.3045. Generally, indications include 

the following: administration of the wrong radioisotope, wrong route of administration, 

administration to the wrong patient and administration of the wrong dose. 

These regulations also require reporting when the correct site is treated but the dose 

over that course of treatment deviates by 20 percent from the planned dose. These 
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reports require notification of the patient, the referring physician, the Nuclear Regulatory 

Commission (NRC) and within VHA, notification of the National Health Physics Program 

(NHPP). VHA, through its NHPP, has reported to the NRC each medical event 

discovered at VA medical centers, whether a medical event was discovered by the 

medical center staff or the NHPP inspectors. The Philadelphia VA Medical Center was 

cited by both the NHPP and by the NRC for not recognizing medical events at an earlier 

date. 

Question 2: There are currently different reporting rules for different types of radiationrelated errors that depend largely on what the source of radiation is. For example, 

errors related to irradiation with medical devices are reported to FDA, while the NRC 

has authority over radiation exposure associated with radioactive materials. Do you 

think that if the wrong part of the body is irradiated that the rules for how this error is 

recorded and reported should be uniform despite the source of radiation? 

Response: Yes. Both a uniform set of definitions of radiation delivery errors and 

uniform requirements for their reporting should be requirements for licensing and 

accreditation of each radiation treatment facility. Note that for medical devices that 

incorporate or use radioactive materials, both FDA and NRC adverse event reporting 

rules will apply, depending on whether the reporting criteria are met. 

Reporting of medical errors involving radioactive materials falls under both the FDA and 

the NRC for VHA. Reporting of certain patient injuries and medical errors related to the 

use of radiation-emitting medical devices are required by the Food and Drug 

Administration (FDA), as the FDA regulates the manufacturers of medical devices and 

electronic products that emit radiation. Likewise, reporting of medical misadministration 

is required by the NRC, as the NRC regulates facilities that produce and use radioactive 

materials for medical purposes. While both FDA and NRC have established process for 

communicating safety issues, there is value in improving uniformity of reporting criteria 

and rules. 

In addition, medical physics oversight for quality assurance should be a requirement for 

licensure and accreditation. While several persons testifying at the hearing introduced 

the current Medical Physics Quality Assurance (QA) Program run by the National 

Cancer Institute (NCI), which provides routine surveys of VHA radiation oncology 

services, this program supports a limited number of radiation oncology practices. A 

national medical physics QA program offering this level of assurance to every radiation 

oncology practice would require a much larger effort. 

Defining medical treatment errors related to radiation therapy is a complex task. Each 

of the professional agencies: the American Association of Physicists in Medicine 

(AAPM), the American College of Radiology (ACR), and the American Society for 

Radiation Oncology (ASRO) has committees or task groups that address radiation 

safety. As a result of the New York Times articles, these three organizations have 

formed a Joint Safety Task Force, which could address this very important need. The 

VA supports this important effort. 
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Question 3: Do you think that for oversight and research purposes it would be helpful 

to have data on medical errors, such as the one described above, collected by a 

centralized source? If yes, who do you think that source should be? If not, why not? 

Response: Yes, VA supports the concept of having a centralized source for data on 

medical errors. One way to achieve this could be to have the Federal Government 

recreate regional Centers for Radiologic Physics (CRP) that would operate radiation 

therapy quality assurance programs. Data related to medical errors could then be 

tracked nationally, providing a larger database. 

These centers fell into disuse more than 20 years ago, although the Radiologic Physics 

Center still exists and operates the National Cancer Institute's medical physics quality 

assurance program. The centers were funded by user fees, but their use was not 

mandatory. 

Other alternatives might also be viable. For example, HHS's Agency for Healthcare 

Research and Quality currently lists Patient Safety Organizations (PSOs) with whom 

health care providers can voluntarily contract to collect, aggregate, and analyze adverse 

event reports. Eventually, all adverse event data collected by PSOs nationwide is 

expected to be connected through a Network of Patient Safety Databases. VA has not 

engaged in discussions with the Nuclear Regulatory Commission or other organizations 

on this subject. 

Question 4: What kind of information about the circumstances of a medical error 

should be reported and collected? 

Response: The appropriate medical and medical physics data will include an 

anatomical description of the treated volume, a description of collaterally irradiated 

tissues, a description of the 3D volumetric dose distribution including the dose volume 

histograms, medical equipment and/or radioactive sources involved in the event, as well 

as those dosimetric parameters required to characterize the exposure. The specific 

data will depend on the nature of the irradiation source, delivery mode and exposed 

volume. This level of detail should be provided by the relevant professional 

organizations, such as the Joint Safety Task Force introduced in the response to 

question 2. In addition, FDA's Medical Device Reporting regulations at 21 CFR part 803 

require user facilities to report certain data relating to individual adverse event reports. It 

is important to note that reporting of data relating a medical error will require not only 

notification of the patient, but their referring physician and appropriate regulatory 

authorities. 

Question 5: Currently, requirements on patient notification after a medical error such 

as irradiating the wrong organ, varies widely and depends again on the source of 

radiation. Under what circumstances do you think that patients should be notified of 

errors in their radiation procedure? Do you believe that rules about patient notification 

should be uniform across all States? Currently, reporting of medical errors or misadministrations involving radiation producing machines is regulated differently by 
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individual States, with variability in both the reporting requirements and how a misadministration or medical event is defined. 

Response: While the specifics of this response should be provided by a consensus 

panel of experts from the appropriate professional societies, the general indications for 

patient notification are clear. These include any error in treatment which has the 

potential to cause injury, regardless of the inclusion of this level of injury in the informed 

consent process. 

Rules related to the notification of patients due to an error in the delivery of medical 

radiation should not differ among individual states and Federal agencies. This 

uniformity should also apply to the definition(s) of medical radiation errors. 

Question 6: How should medical error and mis-administrations be defined? 

Response: Medical errors and mis-administrations of ionizing radiation produced by 

machine sources should be defined based upon the anatomy of the intended target 

volume and absorbed dose. Medical events for administrations involving radioactive 

materials are already defined, at the Federal level, in 10 CFR part 35. The accurate 

definition of a medical error involving machine sources will be complex, relating both to 

the dose delivered and to anatomic and/or geometric deviations from the planned 

treatment. Due to differences in the inherent accuracies of various forms of radiation 

treatment, there must be corresponding differences in which deviations constitute 

unacceptable errors. 

Question 7: Do you think that there should be a standardized definition and mandatory 

reporting framework for machine-based radiation that is consistent in every State? 

Response: Yes. As stated in the response to Question 2, above, uniformity of 

definitions and standardization of terminology are critically important. The most 

effective way to ensure this consistency is for a Federal entity to have responsibility, as 

suggested in the response to Question 3. 

Question 8: Do you think errors in administration should be consistently tracked by the 

States, independent of the source of radiation (i.e. for both machine-based and nonmachine-based radiation)? 

Response: Data related to medical errors should be tracked nationally, providing a 

larger database. The larger database would have the potential to identify early 

emerging trends in radiation errors. See the responses to questions 2 and 3 for 

additional information. 

Question 9: Some patients choose to go to hotels to recover rather than return home 

to their families. Is a physician capable of performing an individualized analysis of a 

hotel room that he or she has never seen to ensure that neither hotel personnel nor 

future room inhabitants would be exposed to unsafe levels of radiation? 
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Response: Yes, the physician authorized user is fully capable of evaluating patient 

circumstances in conjunction with the facility Radiation Safety Officer to make a 

determination about patient release. The NRC does not restrict the release of a patient 

to a hotel and has issued regulatory guidelines specific to this issue. These guidelines 

are in NUREG - 1556, Volume 9, Revision 2. A copy of this guidance is included as an 

attachment. 

Question 10: In this type of a release situation, how does a physician take into account 

exposure of hotel workers or future hotel guests who might come into contact with the 

radioactive sheets and other contamination that the patient leaves behind? 

Response: The NRC, through title 10, Code of Federal Regulations, Section 35.75 (b) 

restricts the release from confinement of any patient having received by-product 

material or certain cyclotron produced materials. Restrictions are based upon exposure 

levels determined by the physician in conjunction with the radiation safety officer. 

NUREG1556v9_rev2 Appendix U provides guidelines associated with those materials 

used in medical procedures. 

Patients are classified into the following three groups: those whose release is 

unacceptable; those who once released have no limitation; and those who require 

special instructions regarding potential exposures to any other individual. 

Examples of these instructions, deemed appropriate by NRC, are provided in the 

NUREG1556 cited above. For example, Appendix U Section 2.3.2 provides instructions 

for patients receiving a radioactive implant. The physician must, however, assess 

individual patient's capacity to follow these instructions. Once the physician and 

radiation safety officer have determined that a patient to be released meets those 

criteria requiring special instructions, those instructions are a mandatory condition of the 

release. 

Attachment 
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APPENDIXU 

Model Procedure for Release of Patients or Human 

Research Subjects Administered Radioactive 

Materials 
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APPENDlXU 

Model Procedure for Release of Patients or Human Research Subjects 

Administered Radioactive Materials 

With the implementation of the EPAct, the NRC now has regulatory authority over acceleratorproduced radioactive materials and discrete sources ofradium-226. Therefore, the procedures 

for releasing patients administered radioactive materials also apply to the medical administration 

of accelerator-produced radioactive materials and discrete sources ofradium-226 after NRC's 

waiver of August 31, 2005, is tenninated for medical use facilities. The NRC waiver that 

applied to Government agencies, Federally recognized Indian tribes, Delaware, the District of 

Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana was tenninated 

on November 30,2007. The NRC Regional Offices should be contacted to confirm the waiver 

tennination date for other medical use facilities. 

Section 35.75, "Release ofIndividuals Containing Unsealed Byproduct Material or Implants 

Containing Byproduct Material," of J 0 CFR Part 35, '"Medical Use of Byproduct Material," 

pennits a licensee to "authorize the release from its control any individual who has been 

administered unsealed byproduct material or implants containing byproduct material if the total 

effective dose equivalent to any other individual from exposure to the released individual is not 

likely to exceed 5 millisieverts (0.5 rem)." Note: As a result of the EPAct, byproduct material 

now includes accelerator-produced radioactive materials and discrete sources of radium-226. 

In this Appendix, the individual or human research subject to whom the radioactive material has 

been administered is called the "patient." 

Release Equation 

The activity at which patients could be released was calculated by using, as a starting point, the 

method discussed in the National Council on Radiation Protection and Measurements (NCRP) 

Report No. 37, "Precautions in the Management of Patients Who Have Received Therapeutic 

Amounts of Radionuclides." This report uses the following equation to calculate the exposure 

until time t at a distance r from the patient: 

Equation U.1: 

where: 

D(t)= 34.6 r 

D(t)= Accumulated exposure at time t, in roentgens 

34.6= Conversion factor of 24 hrs/day times the total integration of decay 

(1.44) 

r = Specitlc gamma ray constant for a point source, R/mCi-hr at 1 em 

Qo = Initial activity of the point source in millicuries, at the time of the 

release 

Tp Physical halt~life in days 

Distance from the point source to the point of interest, in centimeters 

Exposure time in days. 

U-1 NUREG - 1556, Vol. 9, Rev. 2 
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APPENDIXU 

This Appendix uses the NCRP equation (Equation U.I) in the following manner to calculate the 

activities at which patients may be released. 

The dose to an individual likely to receive the highest dose from exposure to the patient is 

taken to be the dose to total decay. Therefore, (l-e .O.693UTp ) is set equal to 1. 

It is assumed that I roentgen is equal to 10 millisieverts (I rem). 

The exposure-rate constants and physical half-lives for radionuclides typically used in 

nuclear medicine and brachytherapy procedures are given in Supplement A of Table U.S in 

this Appendix. 

Default activities at which patients may be released are calculated using the physical 

half-lives of the radionuclides and do not account for the biological half-lives of the 

radionuclidcs. 

When release is based on biological elimination (i.e., the effective half-life) rather than just 

the physical half-life of the radionuclidc, Equation U.l is modified to account for the 

uptake and retention of the radionuclide by the patient, as discussed in Supplement B.2. 

For radionuclides with a physical half-life greater than I day and no consideration of 

biological elimination, it is assumed that the individual likely to receive the highest dose 

from exposure to the patient would receive a dose of 25% of the dose to total decay (0.25 

in Equation U.2), at a distance of I meter. Selection of25% of the dose to total decay at 

I meter for estimating the dose is based on measurements discussed in the supporting 

regulatory analysis that indicate the dose calculated using an occupancy factor, E, of25% 

at I meter is conservative in most normal situations. 

For radionuclides with a physical half-life less than or equal to I day, it is difficult to 

justify an occupancy factor of 0.25, because relatively long-tenn averaging of behavior 

cannot be assumed. Under this situation, occupancy factors from 0.75 to 1.0 may be more 

appropriate. 

Thus, for radionuclides with a physical half-life greater than 1 day: 

Equation U.2: 

34.6 r Qo T (0.25) D(oo) ~ p 

(100 em)' 

For radionuclides with a physical half-life less than or equal to I day, and if an occupancy factor 

of 1.0 is used: 

Equation U.3: 

D(oo) 

NUREG· 1556, Vol. 9, Rev 2 

34.6 r Qo Tp (1) 

(100 em)' 

U·2 
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APPENDIXU 

Equations U.2 and U.3 calculate the dose from external exposure to gamma radiation. These 

equations do not include the dose from internal intake by household members and members of 

the public, because the dose from intake by other individuals is expected to be small for most 

radiophannaceuticals (less than a few percent), relative to the external gamma dose (see 

"Internal Dose," of Supplement B). Further, the equations above do not apply to the dose to 

breast-feeding infants or children who continue to breast-feed. Patients who are breast-feeding 

an infant or child must be considered separately, as discussed in Item U.l.l, "Release of Patients 

Based on Administered Activity." 

U.1 Release Criteria 

Licensees should use one of the following options to release a patient to whom unsealed 

byproduct material or implants containing byproduct material have been administered in 

accordance with regulatory requirements. As a result of the EP Act, the unsealed byproduct 

material or implants now include accelerator-produced radioactive materials or discrete sources 

ofradium-226. 

U.1.1 Release of Patients Based on Administered Activity 

In compliance with the dose limit in 10 CFR 35.75(a), licensees may release patients from 

licensee control if the activity administered is no greater than the activity in Column I of 

Table U.l. The activities in Table U.l are based on a total effective dose equivalent of 

5 millisieverts (0.5 rem) to an individual using the following conservative assumptions: 

Administered activity; 

Physical half~life; 

Occupancy factor of 0.25 at I meter for physical half-lives greater than 1 day and, to be 

conservative, an occupancy factor of 1 at 1 meter for physical half-lives less than or equal 

to I day; and 

No shielding by tissue. 

The total effective dose equivalent is approximately equal to the external dose because the 

internal dose is a small fraction of the external dose (see Section B.3, "Internal Dose," of 

Supplement B). In this case, no record of the release of the patient is required unless the patient 

is breast-feeding an infant or child, as discussed in Item U.3.2, "Records of Instructions for 

Breast-Feeding Patients." The licensee may demonstrate compliance by using the records of 

activity that are already required by 10 CFR 35.40 and 35.63. 

If the activity administered exceeds the activity in Colunm I of Table U.l, the licensee may 

release the patient when the activity has decayed to the activity in Column 1 of Table U .1. In 

this case, 10 CFR 35.75(c) requires a record because the patient's release is based on the retained 

activity rather than the administered activity. The activities in Column 1 of Table U.l were 

calculated using either Equation U.2 or U.3, depending on the physical half-life of the 

radionuclide. 

U-3 NUREG - 1556, Vol. 9, Rev. 2 
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APPENDIXU 

If a radionuc1ide that is not listed in Table U.I is administered, the licensee can demonstrate 

compliance with the regulation by maintaining, for NRC inspection, a calculation of the release 

activity that corresponds to the dose limit of 5 miHisievert (0.5 rem). Equation U.2 or U.3 may 

be used, as appropriate, to calculate the activity Q corresponding to 5 millisieverts (0.5 rem). 

The release activities in Column I of Table U.I do not include consideration of the dose to a 

breast-feeding infant or child from ingestion of radio pharmaceuticals contained in the patient's 

breast milk. When the patient is breast-feeding an infant or child, the activities in Colunm 1 of 

Table U.1 are not applicable to the infant or child. In this case, it may be necessary to give 

instructions as described in Items U.2.2 and U.2.3 as a condition for release. If failure to 

interrupt or discontinue could result in a dose to the breast-feeding infant or ehild in excess of 

5 millisieverts (0.5 rem), a record that instructions were provided is required by 

10 CFR 35.75(d). 

U.1.2 Release of Patients Based on Measured Dose Rate 

Licensees may release patients to whom radionuclides have been administered in amounts 

greater than the activities listed in Column I of Table U.l, provided the measured dose rate at 

1 meter (from the surface of the patient) is no greater than the value in Colnmn 2 of Table U.l 

for that radionuclide. In this case, however, 10 CFR 35.75(c) requires a record because the 

release is based on considering shielding by tissue. 

If a radionuclide not listed in Table U.1 is administered and the licensee chooses to release a 

patient based on the measured dose rate, the licensee should first calculate a dose rate that 

corresponds to the 5 millisieverts (0.5 rem) dose limit. If the measured dose rate at 1 meter is no 

greater than the calculated dose rate, the patient may be released. A record of the release is 

required by 10 CFR 35.75(c). The dose rate at 1 meter may be calculated fr0111 Equation U.2 or 

U .3, as appropriate, because the dose rate at 1 meter is equal to r Q ! 10,000 em'. 

U.1.3 Release of Patients Based on Patient-Specific Dose 

Calculations 

Licensees may release patients based on dose calculations using patient-specific parameters. 

With this method, based on 10 CFR 35.75(a), the licensee must calculate the maximum likely 

dose to an individual exposed to the patient on a case-by-case basis. If the calculated maximum 

likely dose to an individual is no greater than 5 millisicvcrt (0.5 rem), the patient may be 

released. Using this method, licensees may be able to release patients with activities greater than 

those listed in Column 1 of Table U.l by taking into account the effective half-life of the 

radioactive material and other factors that may be relevant to the p31iicular case. In this case, a 

record of the release is required by 10 CFR 35.75(c). If the dose calculation considered retained 

activity, an occupancy factor less than 0.25 at 1 meter, effective half-life, or shielding by tissue, 

a record of the basis for the release is required by 10 CFR 3S.75(c). 

Supplement B contains procedures for perfonning patient-specific dose calculations, and it 

describes how various factors may be considered in the calculations. 

}'1]REG - 1556. Vol. 9, Rev 2 U-4 
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APPENDlXU 

Table U.1 Activities and Dose Rates for Authorizing Patient Releaset 

COLUMN 1 COLU:\1N 2 

Activity At or Below Which Dose Rate at 1 Meter, At or Below 

Radionuclide Patients May Be Released Which Patieuts May Be Released* 

(GBq) (mCi) (mSv/hr) (mrem/hr) 

Ag-ll1 19 520 0.08 8 

Au-198 3.5 93 0.21 21 

I 4.8 130 0.02 2 

8.4 230 0.27 27 

Cu-67 14 390 0.22 22 

Ga-67 8.7 240 0.18 18 

-123 6 160 0.26 26 

-125 0.25 7 0.01 I 

I-125 implant 0.33 9 0.01 I 

I-131 1.2 33 0.07 7 

In-lIl 2.4 64 0.2 20 

If-I 92 implant 0.074 2 0.008 0.8 

P-32 **   **  

Pd-I03 implant 1.5 40 0.03 3 

Re-186 28 770 0.15 15 

Re-188 29 790 0.2 20 

Sc-47 11 310 0.17 17 

Se-75 0.089 2 0.005 0.5 

Sm-lS3 26 700 0.3 30 

Sn-117m I.l 29 0.04 4 

Sr-89 **   **  

Tc-99m 28 760 0.58 58 

TI-201 16 430 0.19 19 

Y-90 **   **  

IYb-169 0.37 10 0.02 2 

Footnotes for Table U-I 

The activity values were computed based on 5 millisicverts (0.5 rem) total effective dose equivalent. 

* If the release is based on the dose rate at 1 meter in Column 2, the licensee must maintain a record as required by 

10 CFR 35.75(c), because the measurement includes shielding by tissue. See Item U.3.1, "Records of Release," 

for infonl1ation on records. 

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APPENDlXU 

** Activity and dose rate limits are not applicable in this case because of the minimal exposures to members of the 

public resulting from activities normally administercd for diagnostic or therapeutic purposes. 

NtJ/es: Thc millicurie values were calculated using Equations U.2 or U.3 and the physical half-life. The 

gigabecquerel values were calculated using the millicurie values and the conversion factor from millicurie 

to gigabecquerels. The dose rate values arc calculated using the millicurie values and the exposure rate 

constants, 

In general, the values arc rounded to two significant figures: however, values less than 0.37 gigabecquerel 

(10 millicuries) or 0.1 millisievert (10 millirems) per hour are rounded to one significant figure. Details of 

the calculations are provided in NUREG-1492. 

Although non-byproduct materials arc not regulated by NRC, information on non-byproduct material is 

included for the convenience of the licensee. 

Agreement State regulations may vary. Agreement State licensees should check with their State regulations 

before using these values. 

U.2 Instructions 

This Section provides acceptable instructions for release of patients administered radioactive 

materials. Licensees may either adopt these model instructions or develop their own instructions 

to meet the requirements of 10 CFR 35.75. 

U.2.1 Activities and Dose Rates Requiring Instructions 

Based on 10 CFR 35.75(b), for some administrations the released patients must be given 

instructions, including written instructions, on how to maintain doses to other individuals 

ALARA after the patients are released. I Column I of Table U.2 provides the activity above 

which instructions must be given to patients. Column 2 provides corresponding dose rates at 

1 meter, based on the activities in Column 1. The activities or dose rates in Table U.2 may be 

used for detennining when instructions must be given. If the patient is breast-feeding an infant 

or child, additional instructions may be necessary (see Item U.2.2, "Additional Instructions for 

Release of Patients Who Could Be Breast-Feeding After Release"). 

When patient-specific calculations (as described in Supplement B) are used, instructions must be 

provided if the calculation indicates a dose greater than I millisievert (0.1 rem). 

If a radionuclide not listed in Table U.2 is administered, the licensee may calculate the activity or 

dose rate that corresponds to I millisievert (0.1 rem). Equation U.2 or UJ, as appropriate, may 

be used. 

U.2.2 Additional Instructions for Release of Patients Who Could Be 

Breast-Feeding After Release 

The requirement in 10 CFR 35.75(b) that a licensee provide instructions on the discontinuation 

or the interruption period of breast-feeding, and the consequences of failing to follow the 

recommendation, presumes the licensee will inquire, as appropriate, regarding the breast-feeding 

statns ofthe patient.! The purpose o[the instructions (e.g .. on interruption or discontinuation) is 

!NRC does not intend to enforce patient compliance with the instructions nor is it the licensee's 

responsibility to do so. 

NUREG - 1556, Vol. 9, Rev 2 U-6 
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APPENDlXU 

to pennit licensees to release a paticnt who could be breast-feeding an infant or child when the 

dose to the infant or child could exceed 5 millisieverts (0.5 rem) if there is no interruption of 

breast-feeding. 

If the patient could be breast-feeding an infant or child after release, and if a radiophannaceutical 

with an activity above the value stated in Column 1 of Table U.3 was administered to the patient, 

the licensee must give the patient instructions on the discontinuation or intenuption period for 

breast-feeding and the consequences of failing to follow the recommendation. The patient 

should also be infonned if there would be no consequences to the breast-feeding infant or child. 

Table U.3 also provides reconnllcndations for interrupting or discontinuing breast-feeding to 

minimize the dosc to below 1 millisievert (0.1 rem) if the patient has received certain 

radiopharnlaceutical doses. The radiopharnlaceuticals listed in Table UJ are conunonly used in 

medical diagnosis and treatment. 

If a radiophannaceutical not listed in Table U.3 is administered to a patient who could be 

breast-feeding, the licensee should evaluate whether instructions or records (or both) are 

required. If information on the excretion of the radiophannaceutical is not available, an 

acceptable method is to assume that 50% ofthe administered activity is excreted in the breast 

milk. The dose to the infant or child can be calculated by using the dose conversion factors 

given for a newborn infant by Stabin (see Reference). 

U.2.3 Content of Instructions 

The instructions should be specific to the type of treatment given, such as permanent implants or 

radioiodine for hyperthyroidism or thyroid carcinoma, and they may include additional 

infonnation for individual situations; however, the instructions should not interfere with or 

contradict the best medical judgment of physicians. The instructions may include the name of a 

knowledgeable contact person and that person's telephone number, in case the patient has any 

questions. Additional instructions appropriate for each modality, as shown in examples below, 

may be provided (refer to U.2.3.1 and U.2.3.2). 

Table U.2 Activities and Dose Rates Above Which Instructions Should Be 

Given When Authorizing Patient Release' 

COLUMNl COLUMN 2 

Actiyity Above Which Instructions Dose Rate at 1 Meter Aboyc Which 

Radionuclide Are Required Instructions Are Required 

(CBq) (mCi) (mSv/hr) (mrem/hr) 

Ag-Ill 3.8 100 0.02 2 

Au-198 0.69 19 0.04 4 

Cr-51 0.96 26 0.004 0.4 

jCu-64 1.7 45 0.05 5 

!Cu-67 2.9 77 0.04 4 

IGa-67 1.7 47 0.04 4 

1-123 1.2 33 0.05 5 

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APPENDlXU 

IITabie U.2 Activities and Dose Rates Above Which Instructions Should Be 

Given When Authorizing Patient Release* (continued) 

COLUMN 1 COLUMN 2 

Activity Above Which Instructions Dose Rate at 1 Meter Above Which 

Radionuclide Are Required Instructions Are Required 

(GBq) (mCi) (mSv/hr) (mrem/hr) 

1-125 0.05 1 0.002 0.2 

1-125 implant 0.074 2 0.002 0.2 

1-131 0.24 7 0.02 2 

n-I11 0.47 13 0.04 4 

r-192 implant 0.01l 0.3 0.002 0.2 

P-32 **   **  

Pd-I03 implant 0.3 8 0.007 0.7 

~86 5.7 150 0.03 3 

88 5.8 160 0.04 4 

7 2.3 62 0.03 3 

Se-75 0.018 0.5 0.001 0.1 

Sm-153 5.2 140 0.06 6 

Sn-117m 0.21 6 0.009 0.9 

Sr-89 **   **  

Tc-99m 5.6 150 0.12 12 

III-201 3.1 85 0.04 4 

Y-90 **   **  

Yb-169 0.073 2 0.004 0.4 

Footnotes for Table U.2 

• The activity values were computed based on I millisievert (0.1 rem) total effective dose equivalent. 

** Activity and dose rate limlts are not applicable in this case because of the minimal exposures to members of the 

public resulting from activities normally administered for diagnostic or therapeutic purposes. 

NOles: The values for activity were calculated using Equations U.2 or U.3 and the physical half-life. The values 

given in Sl units (gigabecquercl values) were using conversion factors. 

In general. values are rounded to two significant figures: however. values less than 0.37 gigabecquerel 

(10 millicurics) or 0.1 millisievert (10 millirems) per hour are rounded to one significant figure. Details of 

the calculations are provided in NUREG-1492. 

Agreement State regulations may vaty. Agreement State licensees should check their State regulations 

before using these values. 

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APPENDIXU 

ITable U.3 Activities of Radiopharmaceuticals That Require Instructions and 

Records When Administered to Patients Who Are Breast-Feeding 

an Infant or Child 

COLUMN 1 COLUMN 2 COLUMN 3 Activity Above Which Activity Above Which Examples of Instructions Are 

Radionuclide Required a Record is Required Recommended 

Duration of 

(MBq) (mCi) (MBq) (mCi) Interruption of 

Breast-Feeding 

-131 Nal 0.01 0'()004 0.07 0.002 Complete cessation (for 

this infant or child) 

-123 NaI 20 0.5 100 3 

-1230IH 100 4 700 20 

1-123 MIBG 70 2 400 10 24 hours for 370 MBq 

(10 mCi) 

12 hours for 150 MBq 

(4 mCi) 

l-1250IH 3 0.08 10 0.4 

I-1310IH 10 0.3 60 1.5 

Tc-99m DTPA 1000 30 6000 150 

Tc-99mMAA 50 1.3 200 6.5 12.6 hours for 150 MBq 

(4 mCi) 

Tc-99m 100 3 600 15 24 hours for 1,100 MBq 

Pertechnetate (30 mCi) 

12 hours for 440 MBq 

(12 mCi) 

c-99m DlSlDA 1000 30 6000 150 

c-99m 1000 30 6000 170 

Glucoheptonate 

c-99mMIBI 1000 30 6000 150 

c-99m MDP 1000 30 6000 150 

c-99mPYP 900 25 4000 120 

Tc-99m Red 400 10 2000 50 6 hours for 740 MBq 

Blood Cell In (20mCi) 

Vivo Labeling 

Tc-99m Red 1000 30 6000 150 

Blood Cell In 

Vitro Labeling 

U-9 NUREG - 1556. Vol. 9, Rev. 2 
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APPENDIXU 

Table U.3 Activities of Radiopharmaceuticals That Require Instructions and 

Records When Administered to Patients Who Are Breast-Feeding 

an Infant or Child (continued) 

COLUMN 1 COLUMN 2 COLUMN 3 Activity Above Which Activity Abovc Which Examples of Instructions Are 

Radionuclide Required a Record is Required Recommended 

Duration of 

(MBq) (mCi) (MBq) (mCi) Interruption of 

Breast-Feeding 

~S"lfu' 300 7 1000 35 6 hours for 440 MBq 

(12mCi) 

DTPA 1000 30 6000 150 

erosol 

Tc-99mMAG3 1000 30 6000 150 

Tc-99m White 100 4 600 15 24 hours for 1,100 MBq 

Blood Cells (30 mCi) 

12 hours for 440 MBq 

(12 mCi) 

Ga-67 Citrate 1 0.04 7 0.2 I month for 150 MBq 

(4mCi) 

2 weeks for 50 MBq 

(1.3 mCi) 

I week for 7 MBq 

(0.2 mCi) 

Cr-51 EDTA 60 1.6 300 8 

In-Ill White 10 0.2 40 1 1 week for 20 MBq 

Blood Cells (0.5 mCi) 

TI-201 Chloride 40 I 200 5 2 weeks for 110 MBq 

1(3 mCi) 

Footnotes for Table U.3 

* The duration of interruption ofbrcast-feeding is selected to reduce the maximum dose to a newborn infant to less 

than I millisievert (0.1 rem), although the regulatory limit is 5 millisieverts (0.5 rem). The actual doses that 

would be received by most infants would be far below I millisievert (0.1 rem). Of course, the physician may use 

discretion in the recommendation, increasing or decreasing the duration of interruption. 

IVotes: Activities are rounded to one significant figure, except when it was considered appropriate to usc two 

significant figures. Details of the calculations are shown in NUREG-1492, "Regulatory Analysis on 

Criteria for the Release of Patients Administered Radioactive Material." 

lfthere is no recommendation in Column 3 of this table, the maximum activity normally administered is 

below the activities that require instructions on interruption or discontinuation of breast-feeding. 

Agreement State regulations may vary. Agreement State licensees should check their State regulations 

before using these values. 

NUREG - 1556, Vol. 9, Rev 2 U-IO 
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APPENDlXU 

U.2.3.1 Instructions Regarding Radiopharmaceutical Administrations 

For procedures involving radiophannaceuticals, additional instructions may include the 

following: 

Maintaining distance from other persons, including separate sleeping arrangements. 

Minimizing time in public places (e.g., public transportation, grocery stores, shopping 

centers, theaters, restaurants, sporting events). 

Precautions to reduce the spread of radioactive contamination. 

The length of time each of the precautions should be in effect. 

The Society of Nuclear Medicine published a pamphlet in 1987 that provides infonnation for 

patients receiving treatment with radioiodine. This pamphlet was prepared jointly by the Society 

of Nuclear Medicine and the NRC. The pamphlet contains blanks for the physician to fill in the 

length of time that each instruction should be followed. Although this pamphlet was written for 

the release of patients to whom less than I, II 0 mcgabecquerels (30 millicuries) of iodine-131 

had been administered, the NRC still considers the instructions in this pamphlet to be an 

acceptable method for meeting the requirements of 10 CFR 35.75(b), provided the times filled in 

the blanks are appropriate for the activity and the medical condition. 

If additional instructions are required because the patient is breast-feeding, the instructions 

should include appropriate recommendations on whether to interrupt breast-feeding, the length 

of time to intemtpt breast-feeding, or, if necessary, the discontinuation of breast-feeding. The 

instructions should include infonnation on the consequences of failure to follow the 

recommendation to interrupt or discontinue breast-feeding. The consequences should be 

explained so that the patient will understand that, in some cases, breast-feeding after an 

administration of certain radionuc1ides should be avoided. For example, a consequence of 

procedures involving iodine-131 is that continued breast-feeding could harm the infant's or 

child's thyroid. Most diagnostic procedures involve radionuclides other than radioiodine and 

there would be no consequences; guidance should simply address avoiding any unnecessary 

radiation exposure to the infant or child from breast-feeding. If the Society of Nuclear 

Medicine's pamphlet is given at release to a patient who is breast-feeding an infant or child, the 

pamphlet should be supplemented with information specified in 10 CFR 35.75(b)(I) and (2). 

The requirement of 10 CFR 35.75(b) regarding written instmctions to patients who could be 

breast-feeding an infant or child is not in any way intended to interfere with the discretion and 

judgment of the physician in providing detailed instructions and recommendations. 

U-ll NUREG - 1556, Vol. 9, Rev. 2 
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APPENDIX tJ 

U.2.3.2 Instructions Regarding Implants 

For patients who have received implants, additional instructions may include the following: 

A small radioactive source has been placed (implanted) inside your body. The source is 

actually many small metallic pellets or seeds, which are each about 113 to 114 of an inch long, 

similar in size and shape to a grain of rice. To minimize exposure to radiation to others from 

the source inside your body, you should do the following for ___ days. 

Stay at a distance of ___ feet from ___ . 

Maintain separate sleeping arrangements. 

Minimize time with children and pregnant women. 

Do not hold or cuddle children. 

Avoid public transportation. 

Examine any bandages or linens that come into contact with the implant site for any 

pellets or seeds that may have come out of the implant site. 

Jfyou find a seed or pellet that falls out: 

Do not handle it with your fingers. Use something like a spoon or tweezers to 

place it in a jar or other container that you can close with a lid. 

Place the container with the seed or pellet in a location away from people. 

Notify ____________ at telephone number ______ _ 

U.3 Records 

U.3.1 Records of Release 

There is no requirement for recordkeeping on the release of patients who were released in 

accordance with ColUlm11 of Table U.l; however, if the release of the patient is based on a dose 

calculation that considered retained activity, an occupancy factor less than 0.25 at 1 meter, 

effective half-life, or shielding by tissue, a record of the basis for the release is required by 

10 CFR 35.75(c). This record should include the patient identifier (in a way that ensures that 

confidential patient infonnation is not traceable or attributable to a specific patient), the 

radioactive material administered, the administered activity, and the date of the administration. 

In addition, depending on the basis for release, records should include the following infonnation: 

For Immediate Release of a Patient Based on a Patient-Specific Calculation: The 

equation used, including the patient-specific factors and their bases that were used in 

calculating the dose to the person exposed to the patient, and the calculated dose. The 

patient-specific factors (see Supplement B of this Appendix) include the effective half-life 

and uptake fraction for each component of the biokinetic model, the time that the physical 

half-life was assumed to apply to retention, and the occupancy factor. The basis for 

selecting each of these values should be included in the record. 

l\TtJREG - 1556, Vol. 9, Rev 2 tJ-12 
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APPENDIXU 

For Immediate Release of a Patient Based on Measured Dose Rate: The results of the 

measurement, the specific survey instnllnent used, and the name of the individual 

performing the survey. 

For Delayed Release of a Patient Based on Radioactive Decay Calculation: The time 

of the administration, the date and time of release, and the results of the decay calculation. 

For Delayed Release of a Patient Based on Measured Dose Rate: The results of thc 

survey meter measurement, the specific survey instrument used, and the name of the 

individual perfonning the survey. 

In some situations, a calculation may be case-specific for a class of patients who all have the 

same patient-specific factors. In this case, the record for a particular patient's release may 

reference the calculation for the class of patients. 

Records, as required by 10 CFR 35.75(c), should be kept in a manner that ensures the patient's 

confidentiality; that is, the records should not contain the patient's name or any other 

information that could lead to identification of the patient. These recordkeeping requirements 

may also be used to verify that licensees have proper procedures in place for assessing potential 

third-party exposure associated with and arising from exposure to patients who were 

administered radioactive material. 

U.3.2 Records of Instructions for Breast-Feeding Patients 

If failure to interrupt or discontinue breast-feeding could result in a dose to the infant or child in 

excess of 5 mi11isieverts (0.5 rem), a record that instructions were provided is required by 

10 CFR 35.75(d). Column 2 of Table U.3 states, for the radiopharmaceuticals commonly used in 

medical diagnosiS and treatment, the activities that would require such records when 

administered to patients who are breast-feeding. 

The record should include the patient's identifier (in a way that ensures that confidential patient 

infom1ation is not traceable or attributable to a specific patient), the radiophannaceutical 

administered, the administered activity, the date of the administration, and whether instructions 

were provided to the patient who could be breast-feeding an infant or child. 

U.4 Summary Table 

Table U.4 summarizes the criteria for releasing patients and the requirements for providing 

instructions and maintaining records. 

U-13 NUREG - 1556, Vol. 9, Rev. 2 
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APPENDIX U 

ITable U.4 Summary of Release Criteria, Required Instructions to Patients, and 

Records to Be Maintained 

Patient Group Basis for Criteria for Instructions Release Records 

Release Release Needed? Required? 

All patients, Administered Administered Yes- if No 

including patients activity activity ,;Column administered 

who are breast- 1 of Table U.l activity > 

feeding an infant Column 1 of 

or child Table U.2 

Retained activity Retained activity Yes _. if retained Yes 

I s COIUlllil I of activity> 

Table U.I COIUlllillof 

Table U.2 

Measured dose Measured dose Yes - if dose rate Yes 

rate rate,; Colunm 2 > Column 2 of 

of Table U.1 Table U.2 

Patient-specific Calculated dose Yes-if Yes 

calculations I:;; 5 mSv (0.5 calculated dose> 

rem) 1 mSv (0.1 rem) 

Patients who are All the above Additional Records that 

breast-feeding an bases for release instructions instructions were 

infant or child required if: provided are 

Administered required if: 

activity > Administered 

Colunm 1 of activity > 

Table U.3 Colunm20f 

Table U.3 or 

Licensee or 

calculated dose Licensee 

from breast- calculated dose 

feeding> 1 mSv from continued 

(0.1 rem) to the breast-feeding> 

infant or child 5 mSv (0.5 rem) 

to the infant or 

child 

Implementation 

The purpose of this section is to provide infonnation to licensees and applicants regarding NRC 

staff's plans for using this Appendix. Except in those cases in which a licensee proposes an 

acceptable alternative method for complying with 10 CFR 35.75, the methods described in this 

Appendix will be used in the evaluation ora licensee's compliance with 10 CFR 35.75. 

NUREG - 1556. Vol. 9. Rev 2 U-14 
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APPENDlXU 

Supplement A 

Table U.5 Half-Lives and Exposure Rate Constants of Radionuclides Used in 

Medicine 

Radionuclidc Physical Half-Life (days)' Exposure Rate Constant' 

(RlmCi-h at 1 cm) 

Ag-III 7.45 0.15 

Au-198 2.696 2.3 

rr-SI 27.704 0.16 

ru-64 0.529 1.2 

Cu-67 2.578 0.58 

Ga-67 3.261 0.753 

-123 0.55 1.61 

-125 60.14 1.42 

-125 implant' 60.14 1.114 

-131 8.04 2.2 

In-Ill 2.83 3.21 

r-l92 implant' 74.02 4.594 

P-32 14.29 N/A' 

Pd-I03 implant' 16.96 0.865 

~:: 3.777 0.2 

0.708 0.26 

47 3.351 0.56 

75 119.8 2 

Sn-117m 13.61 1.48 

Sr-89 50.5 N/A' 

Tc-99m 0.251 0.756 

1-201 3.044 0.447 

Yb-l69 32.01 1.83 

Y-90 2.67 N/A' 

Yb-169 32.01 1.83 

Footnotes for Table U.S 

, K. F. Eckennan, A. B. Wolbarst, and A. C. B. Richardson, "Federal Guidance Report No. 11, Limiting Values of 

Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submersion, and 

Ingestion," Report No. EPA-520il-88-020, Office of Radiation Programs, U.S. Environmental Protection 

Agency, Washington, DC, 1%8. 

U-15 l\UREG 1556, Vo1. 9, Rev. 2 
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APPENDIXU 

Values for the exposure rate constant for Au-198, Cr-51, Cu-64, 1-131, Sc-47, and Se-75 were taken from the 

Radiological Health Handbook, U.s. Department of Health, Education, and Welfare, p. 135, 1970. For Cu-67, 

1-123, In-I! L Re-186, and Re-!88, the values for the exposure rate constant were taken from D. E. Barber, J. 

W. Baum, and C. B. :-1einhold, "Radiation Safety Issues Related to Radiolabeled Antibodies," 

NUREG/CR-4444, U.S. NRC. Washington, DC. 1991. For Ag-lll, Ga-67, [-125, Sm-IS3, Sn-117m, Tc-99m, 

TI-20 1, and Yb-169, the exposure rate constants were calculated because the published values for these 

radionuclides were an approximation. presented as a rangc, or varied from one reference to another. Details of 

the calculation of the exposure rate constants arc shown in Table A.2 of Appendix A to NUREG-1492, 

"RegulatOlY Analysis on Critcria for the Release of Patients Administered Radioactive Material," U.S. NRC, 

February 1997. 

3 R. ;\lath, A. S. Meigooni, and J. A. Meli. "Dosimetry on Transverse Axes of "'I and '''Ir Interstitial 

Brachytherapy Sources," Medical Physics, Volume 17, Number 6, November/December 1990. The exposure 

rate constant given is a measured value averaged for several source models and takes into account the attenuation 

of gamma rays within the implant capsule itself. 

4 A. S. Meigooni, S. Sabnis, R. Nalh, "Dosimetry of Palladium-l 03 Brachytherapy Sources for Pennanent 

Implants." Endocurietherapy Hvperrhermia Oncology. Volume 6, April 1990. The exposure rate constant given 

is an "apparent" value (Le., with respect to an apparent source activity) and takes into account the attenuation of 

gamma rays within the implant capsule itself. 

Not applicable (N/A) because the release activity is not based on beta emissions. 

References 

National Council on Radiation Protection and Measurements (NCRP), "Precautions in the 

Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," 

NCRP Report No, 37, October 1,1970. (Available for sale from the NCRP, 7910 Woodmon! 

Avenue, Suite 400, Bethesda, MD 20814-3095.) 

S, Schneider and S. A. McGuire, "Regulatory Analysis on Criteria for the Release of Patients 

Administered Radioactive Material," NUREG-1492 (Final Report), NRC, February 1997. 

M, Stabin, "Internal Dosimetry in Pediatric Nuclear Medicine," in Pediatric Nuclear Medicine, 

edited by S. Treves, Springer Verlag, New York, 1995. 

"Guidelines for Patients Receiving Radioiodine Treatment," Society of Nuclear Medicine, 1987. 

This pamphlet may be obtained from the Society of Nuclear Medicine, 1850 Samuel Morse 

Drive, Reston, VA 20190-5316. 

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APPENDIX U 

Supplement B 

Procedures for Calculating Doses Based on Patient-Specific Factors 

A licensee may release a patient to whom an activity with a value higher than thc.values listed in 

Column I of Table U.l of this supplement has been administered if dose calculations using 

patient-specific parameters, which are less conservative than the conservative assumptions, show 

that the potential total effective dose equivalent to any individual would be no greater than 

5 millisieverts (0.5 rem). 

If the release of a patient is based on a patient-specific calculation that considered retained 

activity, an occupancy factor less than 0.25 at I meter, biological or effective half-life, or 

shielding by tissue, a record of the basis of the release is required by 10 CFR 35.75(c). The 

following equation can be used to calculate doses: 

Equation B-1: 

34.6 r TE (I - e -0.69311T,) 

D(t) ~ ---'='---;:------'-

where: D(t) = Accumulated dose to time t, in rem; 

34.6 = Conversion factor of 24 hrs/day times the total integration of decay 

(1.44); 

r Exposure rate constant for a point source. RJmCi x hI' at 1 cm; 

Qo Initial activity at the start of the time interval; 

Tp Physical half-life, in days; 

E Occupancy factor that accounts for different occupancy times and 

distances when an individual is around a patient; 

r Distance in centimeters. This value is typically 100 cm; and 

Exposure time in days. 

B.1 Occupancy Factor 

B.1.1 Rationale for Occupancy Factors Used to Derive Table U.1 

In Table U.I in this Appendix, the activities at which patients could be released were calculated 

using the physical half-life of the radionuclide and an occupancy factor at I meter of either 0.25 

(ifthe radionuc1ide has a half-life longer than I day) or 1.0 (if the radionuclide has a half-life 

less than or equal to I day). The basis for the occupancy factor of 0.25 at 1 meter is that 

measurements of doses to family members, as well as considerations of normal human behavior 

(as discussed in the supporting regulatory analysis (Ref. B-1)), suggest that an occupancy factor 

of 0.25 at I meter, when used in combination with the physical half-life, will produce a generally 

conservative estimate of the dose to family members when instructions on minimizing doses to 

others are given. 

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APPENDlXU 

An occupancy factor of 0.25 at I meter may not be appropriate when the physical half-life is less 

than or equal to I day, and hence, the dose is delivered over a short time. Specifically, the 

assumptions regarding patient behavior that led to an occupancy factor of 0.25 at I meter include 

the assumption that the patient will not be in close proximity to other individuals for several 

days; however, when the dose is from a short-lived radionuclide, the time that individuals spend 

in close proximity to the patient immediately following release will be most significant because 

the dose to other individuals could be a large fraction of the total dose from the short-lived 

radionuclide. Thus, to be conservative when providing generally applicable release quantities 

that may be used with little consideration of the specific details ofa particular patient's release, 

the values calculated in Table U.I were based on an occupancy factor of I at I meter when the 

half-life is less than or equal to I day. If infon11ation about a particular patient implies the 

assumptions were too conservative, licensees may consider case-specific conditions. 

Conversely, if young children are present in the household of the patient who is to be discharged, 

conservative assumptions about occupancy may be appropriate. 

8.1.2 Occupancy Factors to Consider for Patient-Specific 

Calculations 

The selection of an occupancy factor for patient-specific calculations will depend on whether the 

physical or effective half-life of the radionuclide is used and whether instructions are provided to 

the patient before release. The following occupancy factors, E, at I meter, may be useful for 

patient-specific calculations: 

E = 0.75 when a physical half-life, an effective half-life, or a specific time period under 

consideration (e.g., bladder holding time) is less than or equal to I day. 

E 0.25 when an effective half-life is greater than I day, if the patient has been given 

instructions, such as: 

Maintain a prudent distance from others for at least the first 2 days; 

Sleep alone in a room for at least the first night; 

Do not travel by airplane or mass transportation for at least the first day; 

Do not travel on a prolonged automobile trip with others for at least the first 

2 days; 

Have sole use of a bathroom for at least the first 2 days; and 

Drink plenty of fluids for at least the first 2 days. 

E = 0.125 when an effective half-life is greater than I day if the patient has been given 

instructions, such as: 

Follow the instructions for E = 0.25 above; 

Live alone for at least the first 2 days; and 

Have few visits by family or friends for at least the first 2 days. 

In a two-component model (c. g., uptake of iodine-131 using thyroidal and 

extrathyroidal components), if the effective half-life associated with one component is 

less than or equal to I day but is greater than I day for the other component, it is more 

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APPENDIXU 

justifiable to use the occupancy factor associated with the dominant component for both 

components. 

Example 1: Calculate the maximum likely dose to an individual exposed to a patient who has 

received 2,220 megabecquerels (60 millicurics) of iodine-I3I. The patient received instructions 

to maintain a prudcnt distance from others for at least 2 days, lives alone, drives home alone, aud 

stays at home for several days withont visitors. 

Solution: The dose to total decay (t = =) is calculated based on the physical half-life using 

Equation B-1. (This calculation illustrates the use of physical half-life. To account for 

biological elimination, calculations described in the next section should be used.) 

Because the patient has received instructions for reducing exposure as recommended for an 

occupancy factor of E = 0.125, the occupancy factor of 0.!25 at I metcr may be used. 

D(oo) = 34.6 (2.2 B~_c",_2!111_qthr)(60mCi)(8.04 d)(O.125) 

(100 em)' 

D (00) = 4.59 millisieverts (0.459 rem) 

Since the dose is less !han 5 millisievert (0.5 rem), the patient may be released, but 

]0 CFR 35.75(b) requires that instructions be given to the patient on maintaining doses to others 

as low as is reasonably achievable. A record of the calculation must be maintained, pursuant to 

10 CFR 35.75(c), because an occupancy factor ofless than 0.25 at I meter was used. 

B.2 Effective Half-Life 

A licensee may take into account the effective half-life of the radioactive material to demonstrate 

compliance with the dose limits for individuals exposed to the patient that are stated in 

!O CFR 35.75. The effective half-life is defined as: 

Equation B-2: 

where: Tb Biological half-life of the radionuc1ide and 

Tp = Physical half-life of the radionuclide. 

The behavior of iodine-13! can be modeled using two components: extrathyroidal iodide 

(i.e., existing outside of the thyroid) and thyroidal iodide following uptake by the thyroid. The 

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APPENDlXU 

effective half-lives for the extrathyroidal and thyroidal fractions (i.e., F, and F2, respectively) can 

be calculated with the following equations. 

Equation B-3: 

Equation B-4: 

where: Biological half-life for extrathyroidal iodide; 

Biological half-life of iodide following uptake by the thyroid; and 

Physical half-life of iodine-13 I. 

However, simple exponential excretion models do not account for: (a) the time for the 

iodine-131 to be absorbed from the stomach to the blood; and (b) the holdup of iodine in the 

urine while in the bladder. Failure to account for these factors could result in an underestimate 

of the dose to another individual. Therefore, this supplement makes a conservative 

approximation to account for these factors by assuming that, during the first 8 hours after the 

administration, about 80% of the iodine administered is removed from the body at a rate 

dctennined only by the physical half-life ofiodine-13!. 

Thus, an equation to calculate the dose from a patient administered iodine-131 may have three 

components. First is the dose for the first 8 hours (0.33 day) after administration. This 

component comes directly from Equation B-1, using the physical half-life and a factor of80%. 

Second is the dose from the extrathyroidal component from 8 hours to total decay. In this 

component, the first exponential factor represents the activity at t = 8 hours based on the physical 

half-life of iodine-I3!. The second exponential factor represents the activity from t 8 hours to 

total decay based on the effective half-life of the extrathyroidal component. The third 

component, the dose from the thyroidal component for 8 hours to total decay, is calculated in the 

same manner as the second component. The full equation is shown as Equation B-5. 

Equation B-5: 

where: 

D( 00 ) = 34.6 r Qo f E T (08)(1- -0 693(0 33)!1;. ) (I OOcm) , \ , 1" e 

+ e F, T,elT .). e -0.693(OmT, 

Extrathyroidal uptake fraction; 

Thyroidal uptake fraction; 

\ E, F, T,e{{ J 

Occupancy factor for the first 8 hours; and 

Occupancy factor fr0111 8 hours to total decay. 

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APPENDIXU 

All the other parameters are as defined in Equations B-1, B-3, and B-4. Acceptable values for 

FI , Tldf, F" and T',ff are shown in Table U.6 for thyroid ablation and treatment of thyroid 

remnants after surgical removal of the thyroid for thyroid cancer. If these values have been 

measured for a specific individual, the measured values may be used. 

The record of the patient's release required by 10 CFR 35.75(c) is described in Item U.3.! of this 

Appendix. 

Example 2, Thyroid Cancer: Calculate the maximum likely dose to an individual exposed to a 

patient to whom 5550 megabecquerels (150 millicuries) of iodine-13! have been administered 

for the treatment of thyroid remnants and metastasis. 

Solution: In this example, the dose will be calculated by using Equation B-5 to account for the 

elimination of iodine-131 from the body, based on the effective half-lives appropriate for thyroid 

cancer. The physical half-life and the exposure rate constant are from Table U.5. The uptake 

fractions and effective half-lives are from Table U.6. An occupancy factor, E, 0[0.75 at 1 meter, 

will be used for the first component because the time period under consideration is less than 

1 day; however, for the second and third components, an occupancy factor 0[0.25 will be used, 

because: (1) the effective half-life associated with the dominant component is greater than 

1 day; and (2) patient-specific questions were provided to the patient to justifY the occupancy 

factor (see Section B.1.2, "Occupancy Factors to Consider for Patient-Specific Calculations," of 

this Supplement). 

iTable U.6 Uptake Fractions and Effective Half-Lives for lodine-131 Treatments 

Extrathyroidal Component Thyroidal Component 

Medical Uptake Fraction Effective Uptake Fraction Effective 

Condition F. Half-Life TMf F, Half-Life T"" 

(day) (day) 

ypelthyroidism 0.20' 0.32' 0.80' 5.21 

osl- 0.953 0.32' 0.053 7.3' 

hyroideclomy [or 

hyroid Cancer 

Footnotes for Table U.6 

, M. G. Stabin et aI., "Radiation Dosimetry for the Adult Female and Fetus from lodine-13 I Administration in 

Hyperthyroidism," JOllrna1 o(Nuciear Medicine, Volume 32, Number 5, May 1991. The thyroid uptake fraction 

of O.gO was selected as one that is seldom exceeded by the data shown in Figure I in this referenced document. 

The effective half-life of 5.2 days for the thyroidal component was derived from a biological half-life of IS days, 

which was obtained from a straight-line fit that accounts for about 75% of the data points shown in Figure I of 

the Journal a/Nue/ear Medicine document. 

International Commission on Radiological Protection (ICRP), "Radiation Dose to Patients from 

Radiopharmaceuticals;' ICRP Publication No. 53. March 1987. (Available for sale from Pergamon Press, Inc., 

Elmsford, NY 10523.) The data in that document suggest that the extrathyroidal component ~ffective half-life in 

nonnal subjects is about 0.32 days. Lacking other data. this value is applied to hyperthyroid and thyroid cancer 

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APPENDlXU 

patients. For thyroid cancer, the thyroidal component effective half-life of 7.3 days is based on a biological 

half-life of80 days (adult thyroid), as suggested in the leRP document. 

, The thyroidal uptake fraction of 0.05 was recommended by Dr. M. Pollycove, M.D., NRC Medical Visiting 

Fellow, as an upper-limit post-thyroidectomy for thyroid cancer. 

Substituting the appropriate values into Equation B-5, the dose to total decay is: 

D(oo) ~ (34,6) (2.2) (150) {(0,7S) (8.04) (0.8) (I ,,-0693 (0.33)/ '04) 

(100 em}2 

+ e -0.693 (0.33) I 8.04 (0,25) (0,95) (0.32) 

+ e -0.693 (0.33)! 8-"4 (0.25) (0,05) (7.3)) 

0(00) = 3.40 mSv (0.340 rem) 

Therefore, thyroid cancer patients to whom 5550 megabecquerels (150 millicuries) of iodine-131 

or less have been administered would not have to remain under licensee control and could be 

released under 10 CfR 35,75, assuming that the foregoing assumptions can be justified for the 

individual patient's case and that the patient is given instructions, Patients administered 

somewhat larger activities could also be released immediately if the dose is not greater than 

5 millisieverts (0,5 rem), 

In the example above, the thyroidal fraction, F2 = 0,05, is a conservative assumption for persons 

who have had surgery to remove thyroidal tissue, If F 2 has been measured for a specific patient, 

the measured value may be used. 

Example 3, Hyperthyroidism: Calculate the maximum likely dose to an individual exposed to 

a patient to whom 2035 megabecquerels (55 millicuries) ofiodine-13I have been administered 

for the treatment of hyperthyroidism (i,e., thyroid ablation). 

Solution: In this example, the dose will again be calculated using Equation B-5, Table U.S, and 

Table U,6, to account for the elimination ofiodine-131 from the body by using the effective 

half-lives appropriate for hyperthyroidism, An occupancy factor, E, of 0,25 at 1 meter will be 

used for the second and third components of the equation because patient-specific instructions 

were provided to justify the occupancy factor (see Section B.1.2, "Occupancy Factors to 

Consider for Patient-Specific Calculations"), 

Substituting the appropriate values into Equation B-5, the dose to total decay is: 

D(oo) ~ (34,6) (2.2) (55) {(0,7S) (8.04) (0.8) (I en693 (0.33) I '04) 

(100 em)2 

+ e -0.693 (0.33)! 8.04 (0.25) (0.20) (0.32) 

+ e -0.693 (0.33) I 8.04 (0.25) (0.80) (5,2)) 

0(00) = 4.86 mSv (0.486 rem) 

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APPENDIXU 

Therefore, hypelihyroid patients to whom 2035mcgabecquerels (55 millicuries) ofiodine-131 

have been administered would not have to remain under licensee control and could be released 

under 10 CFR 35.75 when the occupancy factor of 0.25 in the second and third components of 

the equation is justified. 

In the example above, the thyroidal fraction F2 = 0.8 is a conservative assumption for persons 

who have this treatment for hyperthyroidism. IfF2 has been measured for a specific patient, the 

measured valuc may be used. 

B.3 Internal Dose 

For some radionuclides, such as iodine-131, there may be concerns that the internal dose of an 

individual from exposure to a released patient could be significant. A rough estimate of the 

maximum likely conmlitted effective dose equivalent from internal exposure can be calculated 

from Equation 8-6. 

Equation 8-6: 

where: 

Q 

10.5 

DCF 

D; = Q (1 0·5)(DCF) 

Maximum likely internal committed effective dose equivalcnt to 

the individual exposed to the patient in rem; 

Activity administered to the patient in millicuries; 

Assumed fractional intake; and 

Dose conversion factor to conveli an intake in millicuries to an 

internal committed effective dose equivalent (such as tabulated in 

Rcference B-2). 

Equation B-6 uses a value of 10.5 as the fraction of the activity administered to the patient that 

would be taken in by the individual exposed to the patient. A common rule of thumb is to 

assume that no more than 1 millionth of the activity being handled will become an intake to an 

individual working with the material. This rule of thumb was developed in Reference B-3 for 

cases of worker intakes during normal workplace operations, worker intakes from accidental 

exposures, and public intakes from accidental airborne releases from a facility, but it does not 

specifically apply to cases of intake by an individual exposed to a patient. However, two studies 

(Refs. B-4 and B-5) regarding the intakes of individuals exposed to patients administered 

iodine-131 indicated that intakes were generally of the order of I millionth of the activity 

administered to the patient and that internal doses were far below external doses. To account for 

the most highly exposed individual and to add a degree of conservatism to the calculations, a 

fractional transfer of 10.5 has been assumed. 

Example 4, Internal· Dose: Using the ingestion pathway, calculate the maximum internal dose 

to a person exposed to a patient to whom 1221megabecquerels (33 millicuries) ofiodine-131 

have been administered. The ingestion pathway was selected because it is likely that most of the 

intake would be through the mouth or through the skin, which is most closely approximated by 

the ingestion pathway. 

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APPENDlXU 

Solution: This is an example of the use of Equation B-6. The dose conversion factor DCF for 

the ingestion pathway is 53 rem/millicurie from Table 2.2 of Reference B-2. 

Substituting the appropriate values into Equation B-6, the maximum internal dose to the 

person is: 

D; = (33 mCi)(10·5)(53 rem/mCi) 

D, 0.17 mSv (0.017 rem) 

Using Equation B-1 and assuming the patient has received instructions for reducing exposure as 

recommended for an occupancy factor of 0.25, the external dose is approximately 5 mSv 

(0.5 rem). Thus, the internal dose is about 3% of the external dose due to gamma rays. Internal 

doses may be ignored in calculations of total dose if they are likely to be less than 10% of the 

external dose because the internal dose due to this source is small in comparison to the 

magnitude of uncertainty in the external dose. 

The conclusion that internal contamination is relatively unimportant in the case of patient release 

was also reached by the NCRP. The NCRP addressed the risk of intake of radio nuclides from 

patients' secretions and excreta in NCRP Commentary No. 11, "Dose Limits for Individuals 

Who Receive Exposure from Radionuc1ide Therapy Patients" (Ref. B-6). The NCRP concluded, 

"Thus, a contamination incident that could lead to a significant intake of radioactive material is 

very unlikely." For additional discussion on the subject, see Reference B-1. 

Example 5, Internal Dose: Calculate the maximum internal dose to a person exposed to a 

patient to whom 5550 megabecquerels (150 millicuries) ofiodine-131 have been administered 

for the treatment of thyroid remnants and metastasis. 

Solution: In this example, the dose is again calculated using Equation B-6 and selecting the 

ingestion pathway. Substituting the appropriate values into Equation B-6, the maximum internal 

dose to the person is: 

D; = (150 mCi)(W5)(53 rem/mCi) 

D; = 0.80 mSv (0.08 rem) 

In this case, the external dose to the other person from Example 2, Thyroid Cancer, was 

approximately 3.4 millisieverts (0.34 rem), while the internal dose would be about 

0.80 millisievert (0.08 rem). Thus, the internal dose is about 24% of the external gamma dose. 

Therefore, the internal and external doses must be summed to determine the total dose; 

4.2 millisieverts (0.42 rem). 

References for Supplement B 

B-1. S. Schneider and S. A. McGuire, "Regulatory Analysis on Criteria for the Release of 

Patients Administered Radioactive Material," U.S. NRC, NUREG-1492, February 1997. 

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APPENDlXU 

B-2. K. F. Eckerman, A. B. Wolbarst, and A. C. B. Richardson, "Limiting Values of 

Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, 

Submersion, and Ingestion," Federal Guidance Report No.ll, U. S. Environmental 

Protection Agency, Washington, DC, 1988. 

B-3. A. Brodsky, "Resuspension Factors and Probabilities ofIntake of Material in Process (or 

'Is 10-6 a Magic Number in Health Physics?')," Health Physics, Volume 39, 

Number 6, 1980. 

B-4. R. C. T. Buchanan and 1. M. Brindle, "Radioiodine Therapy to Out-patients - The 

Contamination Hazard," British Journal of Radiology, Volume 43, 1970. 

B-5. A. P. Jacobson, P. A. Plato, and D. Toeroek, "Contamination of the Home Environment 

by Patients Treated with Iodinc-131 ," American Journal of Public Health, Volume 68, 

Number 3,1978. 

B-6. National Council on Radiation Protection and Measurements, "Dose Limits for 

Individuals Who Receive Exposure from Radionuclide Therapy Patients," Commentary 

No. II, February 28,1995. 

Regulatory Analysis 

"Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" 

(NUREG-1492, February 1997) provides the regulatory basis and examines the costs and 

benefits. A copy ofNUREG-1492 is available for inspection and copying for a fee at NRC's 

Public Document Room, 2120 L Street NW, Washington, DC. Copies may be purchased at 

current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 

20402-9328 (telephone (202) 512-2249), or from the National Technical Information Service by 

writing NTIS at 5285 Port Royal Road, Springfield, VA 22161. 

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MITA 

MEDICAL IMAGING & TECHNOLOGY ALUANCE 

ADIVISIONOf ..... 

The Honorable Edward J. Markey 

U.S. House of Representatives 

c/o lennifer Berenholz 

Committee on Energy and Connnerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

Via e-mail to Jcnnifer.Bercnholz@mail.hollse.goY 

Re: Written questions for the record - Feb. 26, 2010 Hearing of the Health 

Subcommittee "Medical Radiation - An Overview of the Issues" 

Dear Representative Markey: 

Attached please find answers to written questions submitted to the Medical 

Imaging & Technology Alliance (MIT A), the leading association representing the 

manufacturers, innovators and developers of medical imaging and radiation 

therapy systems. 

If you have additional questions or require further information, please feel free to 

contact me. 

Sincerely, 

Executive 

~if Director 

Medical Imaging and Technology Alliance 

703-841-3279 

dfisher((vmedicalimaging.org 

Attachment: MIT A responses 
205 


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I. Do you think that if a physician accidently irradiates the wrong body part 

during therapeutic treatment that this should be reported as an error, to the patient, 

the hospital and to regulatory authorities? 

Yes. Manufacturers are required to provide Medical Device Reports to 

FDA when an incident occurs that causes or has the potential to cause 

death or serious injury when the manufacturer becomes aware of the 

incident. 

MIT A encourages and is participatory in strong medical error reporting 

requirements. It is the responsibility ofthe physician to inform the patient, 

the hospital, and regulatory authorities. 

Manufacturers should also have access to such reports to search for 

patterns or solutions to be used in the process of further technological 

innovations, 

2. There are currently different reporting rules for different types of radiationrelated errors that depend largely on what the source of radiation is. For example, 

errors related to irradiation with medical devices are reported to FDA, while the 

Nuclear Regulatory Comnrission (NRC) has authority over radiation exposure 

associated with radioactive materials, Do you think that if the wrong part ofthe 

body is irradiated that the rules for how this error is recorded and reported should 

be unifonn despite the source of radiation? 

Yes. MIT A supports coordinated and consistent reporting of errors. All 

radiation has a delivery device and an operator. Therefore, all the rules 

should be consistent no matter what the source of radiation. 

3. Do you think that for oversight and research purposes it would be helpful to 

have data on medical errors~ such as the one described above, collected by a 

centralized source? If yes, who do you think that source should be? If not, why 

not? 

Yes. MITA supports a unifonn and transparent medical error reporting 

system. 

4. What kind of infonnation about the circumstances of a medical error should be 

reported and collected? 

We recommend following the FDA Guidance for Medical Device Reports 

on what infonnation should be collected. We also recommend a 

comprehensive review of existing requirements for medical error reporting 

with the intent ofhannonizing reporting requirements across various 

jurisdictions. 

5. Currently, requirements on patient notification after a medical error such as 

irradiating the wrong organ, varies widely and depends again on the source of 

radiation. Under what circumstances do you think that patients should be notified 
206 


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of errors in their radiation procedure? Do you believe that rules about patient 

notification should be unifonn across all States? 

MIT A supports unifonn and transparent medical error reporting. We 

believe that providers have an ethical obligation to inform their patients 

when an error occurs, 

6. How should medical error and mis-administrations be defined? 

As manufacturers, we leave the definition of a medical error or misadministration to clinicians I healthcare providers. However we believe 

that to maximize the usability of reported data, both the reporting 

requirements and the definitions of reportable events must be hannonized 

among individual states and jurisdictions. 

7. Do you think that there should be a standardized definition and mandatory 

reporting framework for machine-based radiation that is consistent in every State? 

See #6 above. All efforts at standardized and centralized reporting will 

aid in the study and future avoidance of medical errors. 

8. Do you think that errors in administration should be consistently tracked by the 

States, independent ofthe source of radiation (ie. for both machine-based and 

nonmachine-based radiation)? 

MIT A supports the consistent tracking of medical errors, whether it is at 

the State or Federalleve!' We believe the rules of reporting should be 

consistent no matter what the source of radiation. 

9. Some patients choose to go to hotels to recover rather than return home to their 

families. Is a physician capable of performing an individualized analysis of a 

hotel room that he or she has never seen to ensure that neither hotel persormel nor 

future room inhabitants would be exposed to unsafe levels of radiation? 

As equipment manufacturers we do not have the clinical experience to 

determine the circumstances under which a patient may be released. 

Therefore, we defer to other clinical stakeholders with experience and 

responsibility in this area to respond. While we understand that there are 

applicable Federal Regulations our responsibilities or subject matter 

expertise as manufacturers do not include enforcement or evaluation of 

such regulations. 

10. In this type of a release situation, how does a physician take into account 

exposure of hotel workers or future hotel guests who might come into contact 

with the radioactive sheets and other contamination that the patient leaves behind? 

We refer to our response to Question 9 above. In closing we note that 

increasing safety can only be achieved by cooperation among clinicians, 

patients, device manufacturers and regulators/lawmakers. 
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Earley Green 

Chief Clerk 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515-6115 

Dear Chief Clerk Green, 

March 31, 2010 

It is my honor and pleasure to respond to the questions relating to my February 

26th, 2010 testimony on "Medical Radiation: An Overview of the Issues." I am 

responding directly to three questions I have input on that were posed by the 

Honorable Edward J. Markey: 

1. Yes, if a physician accidently irradiates the wrong body part during a 

therapeutic treatment it should be reported immediately as an error to the 

patient, facility and regulatory authorities. Immediate medical attention 

should be provided the patient to mitigate any further health damage. 

2. Yes, regardless of the current reporting process, future guidelines should be 

uniform to enhance clarity and increase the likelihood of corrective action. 

3. Regarding data on radiation specific medical errors, data should be collected 

systematically and maintained in a central database to facilitate research 

preventing further instances. Most importantly, Medicalis believes point of 

ordering preventative action should be electronically facilitated when 

advanced diagnostic imaging is considered. 

As my testimony indicated, we provide a web based radiology decision 

support and radiation safety guidance application that safeguards the patient 

before ionizing radiation procedures are applied. This solution measures 

anticipated milliSevert dosage rates and shows the physician the cumulative 

dosage that specific patient has encountered. We would advise strongly that 

clinical evidence supported and web enabled decision support should be 

mandated at the point of ordering to prevent over radiation before it occurs. 

I hope the response to these questions is helpful and I remain entirely available to 

assist the Committee in any manner. Thanks for the opportunity to respond and 

please let me know if I can provide any more information in the future. 

Respectfully, 

John J. Donahue 

Vice-Chairman 

Medicalis, Inc 

41 Club Road 

Riverside, CT 06878 

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