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FIELD HEARING: PHILADELPHIA VA TERMINATED 

CANCER TREATMENT PROGRAM 

HEARING 

BEFORE THE

COMMITTEE ON VETERANS’ AFFAIRS 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

JUNE 29, 2009 

Printed for the use of the Committee on Veterans’ Affairs 

( 

Available via the World Wide Web: http://www.access.gpo.gov/congress/senate 

(II) 

COMMITTEE ON VETERANS’ AFFAIRS 

DANIEL K. AKAKA, Hawaii, Chairman 

JOHN D. ROCKEFELLER IV, West Virginia 

PATTY MURRAY, Washington 

BERNARD SANDERS, (I) Vermont 

SHERROD BROWN, Ohio 

JIM WEBB, Virginia 

JON TESTER, Montana 

MARK BEGICH, Alaska 

ROLAND W. BURRIS, Illinois 

ARLEN SPECTER, Pennsylvania 

RICHARD BURR, North Carolina, Ranking 

Member 

LINDSEY O. GRAHAM, South Carolina 

JOHNNY ISAKSON, Georgia 

ROGER F. WICKER, Mississippi 

MIKE JOHANNS, Nebraska 

WILLIAM E. BREW, Staff Director 

LUPE WISSEL, Republican Staff Director 

(III) 

C O N T E N T S 

JUNE 29, 2009 

SENATORS 

Page 

Specter, Hon. Arlen, U.S. Senator from Pennsylvania ......................................... 1 

REPRESENTATIVES 

Adler, Hon. John, U.S. Representative from New Jersey .................................... 6 

Fattah, Hon. Chaka, U.S. Representative from Pennsylvania ............................ 7 

WITNESSES 

Flippin, Reverend Ricardo, U.S. Air Force Veteran .............................................. 2 

Prepared statement .......................................................................................... 4 

Kao, Gary, M.D., Ph.D., Associate Professor, Radiation Oncology, University 

of Pennsylvania .................................................................................................... 8 

Prepared statement .......................................................................................... 10 

Response to written questions submitted by Hon. Richard Burr ................. 16 

Exhibits ...................................................................................................... 19 

Cross, Gerald M., M.D., FAAFP, Acting Under Secretary for Health, Veterans 

Health Administration, U.S. Department of Veterans Affairs; accompanied 

by Michael E. Moreland, FACHE, Director, VISN 4; Richard Citron, 

FACHE, Director, Philadelphia VA Medical Center; Michael Hagan, M.D., 

Ph.D., National Director, Radiation Oncology Program, Richmond VA Medical Center; Mary Moore, Radiation Safety Officer, Philadelphia VA Medical 

Center; and Joel Maslow, M.D., Chairman, Philadelphia VA Medical Center 

Radiation Safety Committee ............................................................................... 43 

Prepared statement .......................................................................................... 45 

Response to written questions submitted by Hon. Richard Burr ................. 46 

Richard Whittington, M.D., Chief of Radiation Oncology, Philadelphia VA 

Medical Center, .................................................................................................... 49 

Reynolds, Steve A., Director, Division of Nuclear Materials Safety, Region 

III, U.S. Regulatory Commission ........................................................................ 50 

Prepared statement .......................................................................................... 50 

Response to written questions submitted by Hon. Richard Burr ................. 53 

APPENDIX 

Schwartz, Hon. Allyson Y., U.S. Representative from Pennsylvania; prepared 

statement .............................................................................................................. 75 

(1) 

FIELD HEARING: PHILADELPHIA VA 

TERMINATED CANCER TREATMENT PROGRAM 

MONDAY, JUNE 29, 2008 

U.S. SENATE, COMMITTEE ON VETERANS’ AFFAIRS, Philadelphia, PA. 

The Committee met, pursuant to notice, at 10 a.m., in multipurpose room 1, Philadelphia VA Medical Center, Hon. Arlen Specter, 

presiding. 

Present: Senator Specter, House Representatives Adler and 

Fattah. 

OPENING STATEMENT OF HON. ARLEN SPECTER, 

U.S. SENATOR FROM PENNSYLVANIA 

Senator SPECTER. Good morning, ladies and gentlemen. The hour 

of 10 having arrived, we will proceed with this hearing of the Veterans’ Affairs Committee of the U.S. Senate. 

One of the constitutional responsibilities of the Senate is to conduct oversight on activities of the Federal Government. We all 

know the tremendous debt which is owed by our society to the veterans of America who have fought in wars to establish and maintain our liberty, and one of the responses by a grateful government 

has been to provide medical care for the veterans. This is a subject 

which is very near and dear to my heart, because the first veteran 

I knew was my own father, Harry Specter. 

My story is a typical American story, both parents were immigrants. My father came to this country from Russia in 1911 at the 

age of 18 and spoke about the privilege of being an American and 

serving with the American expeditionary force in France in 1918 to 

make the world safe for democracy. He was wounded in action. The 

government promised World War I veterans a $500 bonus—you 

could say they made him a $500 promise, too—and that promise 

was broken, as so many promises are broken by the Federal Government. 

After being elected in 1980, I immediately joined the Veterans’ 

Affairs Committee in the U.S. Senate because of my concern for 

fair and equitable treatment for veterans, and had the honor to 

serve for 6 years as Chairman of the Veterans’ Affairs Committee. 

This hearing has been convened as a result of widespread publicity about problems in the Veterans Administration here in the 

city of Philadelphia. A week ago yesterday, there were extensive 

Sunday stories by both the Philadelphia Inquirer and The New 

York Times. Those stories reported that there was a systematic 

problem on the treatment of prostate cancer at the Philadelphia VA 

2 

Medical Center, causing 82 veterans to receive incorrect doses of 

radiation. There was a procedure undertaken where there were 

seeds implanted to kill the cancer cells, but the seeds were planted, 

in some cases, in the bladder or elsewhere. The New York Times 

characterized the procedures here as a ‘‘rogue cancer unit.’’ 

One factor which we will inquire about today is why these errors 

were not detected for a period of some 6 years; and why the oversight was done by the operative physicians themselves, as opposed 

to some independent agency; and a major question exists as to 

what can be done to correct whatever problem existed; and what 

assurances can be given to the veterans and the public that the 

procedures will be maintained and corrected so that appropriate 

service will be given to the veterans who are served here. 

We now turn to our first witness, who is Reverend Ricardo 

Flippin, a patient who was mentioned in the articles that I referred 

to. Reverend Flippin is a 21-year veteran of the U.S. Air Force who 

received his treatment here. He is a native of Philadelphia, but 

currently resides in Charleston, West Virginia. 

In accordance with the standard procedures, we will have testimony limited to 5 minutes, and then there will be questioning. 

I expect to be joined by Congressman John Adler from New Jersey of the House of Representatives Veterans’ Committee, and we 

will ask all witnesses to observe the time limit. There is a clock in 

front of each witness. 

Reverend Flippin, we thank you for coming from West Virginia. 

We understand that you are a native of Philadelphia, Pennsylvania 

and we look forward to your testimony. You may proceed. 

STATEMENT OF REVEREND RICARDO FLIPPIN, 

UNITED STATES AIR FORCE VETERAN 

Rev. FLIPPIN. Thank you. Senator Specter, I would like to thank 

you for your interest in this situation at the Philadelphia VA, and 

for inviting me here today. 

Although I was born and raised in Philadelphia, I had been absent from the Philadelphia area from the time that I left to join the 

Air Force. I returned to Philadelphia in 2004 to take care of my 

mother, whose health was failing. As I did not have a private physician in this area, I decided that I would try to take advantage of 

my benefits as a veteran and I sought medical care from the Philadelphia VA. This was my first contact with the VA health care 

system. 

On April 15, 2004, I made my first trip to the Philadelphia 

VAMC, because my family doctor in Charleston told me that my 

PSA was increasing and that I should make a point of following up 

with the doctor when I got to Philadelphia. A PSA test was performed on my first visit, which showed a level of 7.04. It took the 

VA until May 9, 2005, to actually treat my prostate. 

On June 3, 2004, I returned to the Philadelphia VA and was 

given a referral for a urology consult. This consult took place on 

June 29, 2004. I was scheduled for a biopsy which took place on 

August 26, 2004. 

On September 23, 2004, I was advised that I had cancer. In December 2004, I met with a physician to discuss my opinions. 

3 

In January 2005, I believe that I met with the radiation 

oncologist. He was quite convincing that brachytherapy was the 

best option for my situation and that he had received good results 

from this procedure in the past; and he had performed hundreds 

of them. Let me say at this point that that is what impressed me, 

that this physician had told me—looking me eyeball to eyeball— 

that he had actually performed over 600 brachytherapy procedures. 

My procedure was not scheduled until May 9, 2005. By then, my 

mother had passed away and I had returned to Charleston, West 

Virginia to be with my wife, my granddaughter, and my niece. 

During the time after my procedure, I had medical problems that 

required me to return to the VA on several occasions for additional 

medical care. Eventually, the VA sent me to the Ohio State University for an additional procedure with a specialist. Until I received 

notification from the VA in Philadelphia that they were investigating my medical care as well as the medical care of other veterans, no one had ever told me that there had been any problem 

with the procedure that was performed at the Philadelphia VA. To 

date, no one from the Philadelphia VA has specifically told me 

what went wrong with my procedure, nor have I been advised to 

what the effects of this procedure has been and will be on me. 

On July 2, 2008, they sent me a letter saying, ‘‘Our review of 

your treatment program has indicated that there is a possibility 

that you received the radiation to your prostate gland that was less 

than your physician intended,’’ which led me to believe that there 

was something wrong with the seeds or perhaps the equipment. 

The letter never mentioned that other parts of my body apparently 

got a radiation dose greater than my physician intended. 

On August 15, 2008, they sent me a letter saying that the treatment did not meet the VA standard of care. The results of a CT 

scan indicate that the treatment that you received did not meet the 

VA’s high standard of care. ‘‘You recently were notified by telephone of this result, and this letter is being sent to confirm that 

conversation. We have also advised your VA primary care physician of this fact, and we will send him/her a copy of this letter.’’ 

They sent me some forms for filing a claim, which was nice of 

them, but not one person in the VA told me what the effects of the 

surgery that I received were. No one from the Philadelphia VA and 

no one from the West Virginia VA has written me or called me and 

said that I am more likely to get a reoccurrence. No one has 

said—— 

Senator SPECTER. Reverend Flippin, before your time expires, 

would you tell us what injuries, if any, you sustained. 

Rev. FLIPPIN. I sustained a radiation burn to my rectum which 

caused me to be laid up for 5 months; 24 hours a day, bedridden. 

Senator SPECTER. You may proceed. 

Rev. FLIPPIN. For the last several years, I have worked with a 

program designed to help veterans deal with the issues that they 

face. My biggest concern is that there may be veterans out there 

who have had this happen to them and they have not gotten the 

message from the VA. As someone who has spent 20 years active 

duty in the Air Force and as someone who regularly works with 

veterans to see that they get the services they need, I know that 

there are probably some veterans out there who received letters 

4 

but did not open them because they were from the VA. They also 

may have received phone calls they did not return because they 

were from the VA. And my hope is that the attention that this is 

creating will make those guys or, more likely, their spouses or family members, go back and open those letters and get the follow-up 

treatment that they need. 

Finally, I really cannot add anything to the discussion about Dr. 

Kao. I have never met the gentleman. He was not the doctor who 

I met with to decide the type of therapy to select. I was surprised 

to learn this week that he was a contractor. No one told me that 

my surgery was going to be done by someone who did not work for 

the VA. 

Thank you for your concern about the medical care that veterans 

are receiving from the Department of Veterans’ Affairs. 

[The prepared statement of Rev. Flippin follows:] 

PREPARED STATEMENT OF REV. RICARDO C. FLIPPIN, U.S. AIR FORCE VETERAN, 

CHARLESTON, WEST VIRGINIA

I would like to thank you for your interest in the situation at the Philadelphia 

VA, and for inviting the here today. 

Although I was born and raised in Philadelphia, I had been absent from the 

Philadelphia area from the time that I left to join the Air Force. I returned to Philadelphia and 2004 to take care of my mother, whose health was failing. As I did not 

have a private physician in this area, I decided that I would try to take advantage 

of my benefits as a veteran and I sought medical care from the Philadelphia VA. 

This was my first contact the VA health care system. 

On April 15, 2004, I made my first trip to the Philadelphia VA, because my family 

doctor in Charleston had told me that my PSA was increasing and that I should 

make a point of following up with the doctor, when I got Philadelphia. A PSA test 

was performed on my first visit, which showed a level of 7.04. It took the VA until 

May 9, 2005, to actually treat my prostate. 

On June 3, 2004, I returned to the Philadelphia VA and was given a referral for 

an urology consult. This consult took place on June 29, 2004. I was scheduled for 

a biopsy, which took place on August 26, 2004. On September 23, 2004, I was advised that I had cancer. In December 2004, I met with the physician to discuss my 

options. In January 2005, I believe that I met with a radiation oncologist. He was 

quite convincing that brachytherapy was the best option for my situation and that 

he had received good results from this procedure in the past and had performed 

hundreds of them. My procedure was not scheduled until May 9, 2005. By then, my 

mother had passed away and I had returned to Charleston, West Virginia, to be 

with my wife, my granddaughter and niece. 

During the time after my procedure, I had medical problems that required me to 

return to the VA on several occasions for additional medical care. Eventually, the 

VA sent me to Ohio State University for an additional procedure with a specialist. 

Until I received notification from the VA, in Philadelphia, that they were investigating my medical care, as well as the medical care of other veterans, no one ever 

told me that there had been any problem with the procedure that was performed 

at the Philadelphia VA. To date, no one from the Philadelphia VA has specifically 

told me what went wrong with my procedure, nor have I been advised as to what 

the effects of this procedure have and will be on me. 

On July 2, 2008, they sent me a letter saying ‘‘. . . Our review of your treatment 

program has indicated that there is a possibility that you received a radiation dose 

to your prostate gland that was less than your physician intended. . . .’’ 

Which led me to believe, that there was something wrong with the seeds, or perhaps the equipment? The letter never mentions that other parts of my body, apparently, got a radiation dose greater than my doctor intended. 

[The July 2, 2008, letter follows:] 

5 

On August 15, 2008, they sent me a letter saying that the treatment did not meet 

the VA’s standard of care. 

‘‘. . . The results of the CT scan indicate that the treatment you received 

did not meet VA’s high standard of care. You recently were notified by telephone of this result and this letter is being sent to confirm that conversation. We have also advised your VA primary care physician of this fact, and 

we will send him/her a copy of this letter.’’ 

[The August 15, 2008, letter follows:] 


629FLIP1.eps 629FLIP2.eps
6 

They sent me some forms for filing a claim, which was nice of them, but not one 

person in the VA told me what the effects of the surgery that I received were. No 

one from the Philadelphia VA, no one from the Charleston VA, has written me, or 

called me, and said that I’m more likely to get a reoccurrence, no one has said that 

I should come in more regularly for monitoring, no one from the VA has said that 

you’re going to be fine. I learned from the newspaper that they had 6 veterans go 

out to the Seattle VA to have their procedures redone, so I hope that I’m not that 

bad. It is particularly upsetting that they have not told me anything about my future because some of the NRC materials make it seem as if a very thorough investigation has been commissioned by the VA and that an expert has reviewed each 

of the cases. As a matter of fairness, one would think that they would have told 

each veteran what the results of the outside study were, or that they would have 

provided this information to my primary care doctor, to help them with my future 

medical care. 

For the last several years I have worked with a program designed to help veterans deal with the issues that they face. My biggest concern is that there may be 

veterans out there who have had this happen to them, and they have not gotten 

the message from the VA. As someone who spent twenty years on active duty in 

the Air Force, and as someone who regularly works with veterans, to see that they 

get the services that they need, I know that are probably some veterans out there 

who didn’t open the letters that they got from the VA, because they were from the 

VA, they didn’t return the phone calls they got from the VA, because they were from 

the VA, and my hope is that the attention that this hearing is creating will make 

those guys, or more likely their spouses or family members, go back and open those 

letters and get the follow up treatment that they may need. 

Finally, I really can’t add anything to the discussion about Dr. Kao. I have never 

met the gentleman. He was not the doctor who I met with to decide which type of 

therapy to select. I was surprised to learn this week that he was a contractor; no 

one told me that my surgery was going to be done by someone who did not work 

for the VA. 

Thank you for your concern about the medical care that veterans are receiving 

from the Department of Veterans Affairs. 

Senator SPECTER. Thank you, Reverend Flippin. 

Without objection, I will put into the record a statement from 

U.S. Representative Allyson Y. Schwartz of Pennsylvania’s District 

13. 

[The prepared statement of Ms. Schwartz is found in the Appendix.] 

Senator SPECTER. I would like to turn now to Congressman John 

Adler, House of Representatives, who is a member of the Veterans’ 

Affairs Committee and who, early on, spoke out about this issue. 

Welcome, Congressman Adler. Would you care to make an opening statement? 

STATEMENT OF HON. JOHN ADLER, 

REPRESENTATIVE FROM NEW JERSEY 

Mr. ADLER. Senator, thank you very much, and thank you as 

well on behalf of the veterans of America and the people of America 

for your calling this field hearing here today. You acted promptly 

when you learned about the troubles we have had with the brachytherapy program here at this VA hospital. Your concern for veterans has been noted for a number of years, but the fact that you 

would have such a prompt hearing, I think the country thanks you 

for that. 

Our first President, George Washington, once said, ‘‘The willingness with which our young people are likely to serve in any war, 

no matter how justified, shall be directly proportional as to how 

they perceive the veterans of earlier wars were treated and appreciated by their country.’’ 

7 

The veterans like Reverend Flippin who sought treatment for 

their prostate cancer at the Philadelphia VA Hospital did not receive the quality health care their selfless service to our country 

earned them. 

The people responsible for administering the substandard care in 

brachytherapy let our veterans down and sent the wrong message 

to young men and women thinking about joining our all-volunteer 

Armed Forces. We must do better for them. 

So, it is my sense that this hearing today and the hearing we 

will have in Washington next week are about evaluating what happened, not to cast blame, although there is certainly some blame 

to go around, but to reassure our veterans and those considering 

volunteering for our Armed Forces in the future, that we will keep 

faith with the commitment we have made to them as they have 

kept faith with us by keeping us safe, keeping us free, and keeping 

us the strongest country in the world. 

Reverend Flippin, I thank you for your 20 years of active duty 

service; that would have been enough. But I thank you as well for 

coming forward to share with us in this room, the newspapers, and 

America, the substandard care you received. It would have been 

enough if you had just soldiered on as you had while on active duty 

and suffered quietly, but the fact that you would share your experience, share your physical pain and your emotional trauma so that 

we can learn from it, so that we can set in place a new standard 

of care to meet the needs of our veterans, like yourself, going forward, is greatly to your credit. It is part of your ongoing service 

to your country, and I appreciate it. I am sure Senator Specter appreciates it, Representative Schwartz appreciates it, all the people 

from our region and from the whole country should join us in 

thanking you for testifying. 

I wonder at what point you first decided we were letting you 

down as a country. At what point did you think—during your process, during your treatment—that the VA Hospital was not giving 

you the standard of care you deserved. 

Senator SPECTER. Congressman Adler, we are going to hold the 

questions for the first round of questioning. 

Mr. ADLER. I am sorry. Fine. I apologize. 

Senator SPECTER. It is OK. 

We will turn now to Congressman Chaka Fattah for an opening 

statement. 

Thank you for joining us, Congressman Fattah. 

OPENING STATEMENT HON. CHAKA FATTAH, 

REPRESENTATIVE FROM PENNSYLVANIA 

Mr. FATTAH. Well, Senator, I rearranged my schedule so that I 

could be here. I want to thank you for holding this hearing. It is 

very timely. This is a great facility that has provided a lot of care 

for our veterans over many years, but this incident raises an extraordinary level of concern, and I want to thank you for convening 

us today. I am here to get some answers. 

So, rather than giving a major opening statement, I want to 

thank the Reverend for his service to the country. My brother also 

served in the Air Force, and I think it also says a great deal about 

you that you returned to Philadelphia to care for your ailing mothVerDate Nov 24 2008 17:43 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00011 Fmt 6633 Sfmt 6601 H:\ACTIVE\062909.TXT SVETS PsN: PAULIN
8 

er, and that you are leading a faith community. You are of service 

to our country in every respect, and we want to get to the bottom 

of what happened. In incidents where mistakes happened, we are 

all human beings—but the question becomes, what was done once 

the mistake was realized, and whether or not, in this instance, all 

of our veterans were best served. 

I thank the Senator for using the weight of his office to convene 

us so that we could begin to get to the answers to this question. 

Senator Specter, for your leadership on this subject, I thank you. 

Senator SPECTER. Thank you, Congressman Fattah. 

Before turning to questions, we are going to hear from other witnesses. 

I would like to call now Dr. Gary Kao to the witness stand, if 

Dr. Kao would step forward. 

Dr. Kao has a bachelor’s degree from John Hopkins University, 

an M.D. from John Hopkins School of Medicine, and a Ph.D. from 

the University of Pennsylvania. He was board certified in 1994 by 

the American Board of Radiology, and was contracted by the VA 

in 2002. 

We are calling on Dr. Kao early because he has been identified 

in the news accounts as having performed a number of the operative procedures in question. 

I note that you are accompanied Dr. Kao, and if those who have 

accompanied you would identify themselves, I would appreciate it. 

Mr. VAIRA. Good morning, Senator Specter, Congressmen. I am 

Peter Vaira of the Law Firm of Vaira & Riley, and my associate 

is William Murray, from my law firm. 

Senator SPECTER. Thank you very much, Mr. Vaira. 

Dr. Kao, the floor is yours and you may proceed. 

STATEMENT OF GARY KAO, M.D., PH.D., ASSOCIATE PROFESSOR, RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA; ACCOMPANIED BY PETER F. VAIRA, ATTORNEY, 

SHAREHOLDER, VAIRA & RILEY, P.C.; AND WILLIAM J. MURRAY JR., ASSOCIATE, VAIRA & RILEY, P.C. 

Dr. KAO. Thank you, Senator Specter and Congressmen, for the 

opportunity to voluntarily appear before you so that I may be 

heard on this very important subject matter and correct some very 

serious false allegations contained in recent publications about me, 

most notably The New York Times. I have worked very hard in my life to best serve the field of radiation oncology and my patients in over 15 years of clinical practice. 

My dedication to my work is reflected in my educational achievements, earning a bachelor’s degree and a medical doctorate degree 

from Johns Hopkins University and its School of Medicine, followed 

by medical internship and residency and radiation oncology residency. This culminated in board certification in radiation oncology. 

I am especially proud that, in 15 years of continuous medical 

practice, there has not been a single malpractice claim against me. 

My impeccable background and commitment to the care of my patients make the false accusations against me particularly devastating and misguided. 

Let me first express my sincere sadness to the plight of Reverend 

Flippin. I would have welcomed the opportunity to do anything I 

9 

could to help him, but I have never been contacted by Reverend 

Flippin or anyone on his behalf after the procedure; and therefore, 

do not know about his complaints and symptoms which arose about 

a year after his procedure. 

I was first notified about Reverend Flippin from The New York 

Times article published the previous Sunday, and because I have 

not had access to any of his records since leaving the VA, I am unable to further comment on his medical treatment or condition. 

What I can truthfully report is that I, along with others at the 

Philadelphia VA, implemented the program for brachytherapy to 

serve the best interest of veterans. Contrary to allegations that I 

was a ‘‘rogue physician,’’ there were precise standard operating procedures formulated and followed and a system of monitoring and 

oversight. We formulated the first algorithm of any radiation oncology procedure at the VA to define those standard operating procedures. As with any program, it is not without incidents or challenges; however, I have always acted in the best interests of the 

patients in delivering this important treatment. I have never, nor 

would I ever, falsify documents, cover up results, or act in a manner detrimental to the interest of any patient. 

What has become clear is that a misunderstanding of elementary 

principles or concepts have led some to inappropriately and incorrectly conclude that deficient care was routinely rendered; it was 

not the case. It is important that these issues be clearly understood. A fundamental issue which I want to directly address and 

which has been misunderstood is the subject of what the NRC defines as a reportable medical event and its applicability to our work 

at the VA. 

Here are the facts: 

Fact one, the standard definition of a reportable medical event 

to the NRC was not in existence when the brachytherapy program 

started at the VA. The definition was specifically never mentioned 

in my training in brachytherapy at the Northwest Hospital in Seattle, nor was it clarified by NRC personnel in their investigations 

in 2003 or 2005 when they were on site at the Philadelphia VA. 

This definition was not the subject of any training provided to us 

by the NRC or the VA. 

Fact two, the definition of a reportable medical event to the NRC 

does not define a standard of effectiveness of medical treatment either scientifically or medically. 

A patient whose treatment results in a reportable medical event 

may still have received effective treatment and be within the appropriate standard of medical care. 

Fact three, the appropriate standard of medical care for brachytherapy should not be determined by the NRC definition of a reportable medical event. There are many more significant factors 

that determine appropriate treatment, such as the number of 

seeds, the location of seeds in the prostate, location of seeds outside 

the prostate, the concentration of seeds in the affected area of the 

prostate, the size, shape of the prostate, the stage, grade, extent, 

and location of the cancer, and the clinical follow-up of the PSA 

test results, all of which are not addressed in the NRC defined 

standards. 

10 

The field of brachytherapy during the period of 2002 to 2008 was, 

and still is, an evolving field. While certain conditions and circumstances at the Philadelphia VA could have been improved, I am 

confident—based on my knowledge of the field and the nature of 

the patients treated at the VA—that during my tenure the patients 

received appropriate medical care, which was effective in addressing their cancer. 

In considering my experience at the VA and experience in the 

brachytherapy program, however, there are certainly issues which 

need to be addressed and implemented regarding the care provided 

to our veterans. These include the following: 

One, a system should be established so that a treating VA physician is notified when his or her patient presents for treatment at 

any other VA medical center. This should be accomplished with appropriate confidentiality and privacy safeguards, but which would 

enable a VA physician to have access to the patient’s electronic 

medical records at any other VA medical center. 

For complex medical procedures such as brachytherapy, two, 

there should be a uniform set of standard operating procedures established through a collaboration of the involved health care professionals and administrative personnel. Once defined, these standard 

operating procedures should be applied throughout the entire VA 

system with appropriate treatment. 

Three, there should be a method of categorizing systemic problems by level of urgency, so that serious problems such as those involving failures of medical equipment or transfer of patient-related 

data will receive immediate attention from the proper personnel to 

be quickly resolved. 

Four, there should be a formal system by which the NRC and 

other national regulatory bodies would be required to continually 

train doctors and other personnel in the latest defined standards. 

Five, the respective medical disciplines of separate VA hospitals 

should have a formal system of continuous dialog, together about 

difficulties encountered during practice, and possible suggested solutions. This could be accomplished with the aid of a videoconferencing system to which all VA physicians have access. 

Six, for every complex medical procedure, there should be sufficient funds for the VA to provide timely and complete care to veterans. Relating to my own experience, having a full-time medical 

physicist dedicated to brachytherapy would have enabled us to 

transition earlier to a real-time system of brachytherapy. 

Thank you, Senator and Congressmen. 

[The prepared statement of Dr. Kao follows:] 

PREPARED STATEMENT OF GARY KAO, M.D., PH.D., ASSOCIATE PROFESSOR, RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA

INTRODUCTION

I became a doctor because of my desire to help people. I am and always have considered myself to be a compassionate dedicated physician who prides himself in taking care of his patients. I have never knowingly hurt any of my patients and my 

record shows that to be true—I am proud that I have not had a single malpractice 

claim filed against me in fifteen years of continuous clinical practice. In 1984 I graduated from Johns Hopkins University with a Bachelor of Arts in Philosophy and 

graduated in 1988 as a Medical Doctor from the Johns Hopkins School of Medicine. 

I completed two years of Internal Medicine Residency followed by completion of a 

Residency in Radiation Oncology, all at the University of Pennsylvania School of 

11 

Medicine (‘‘Penn’’). I have been Board Certified in Radiation Oncology since 1994, 

and an Attending Physician at Penn since that time. I am also a member of American Society for Therapeutic Radiation Oncology. 

In order to gain additional expertise in anticancer treatment, I completed a doctoral dissertation at Penn in Molecular Biology, which I successfully defended in 

1998 and was awarded a Ph.D. from Penn in Molecular Biology. While still on staff 

at Penn, I completed a Postdoctoral Fellowship at the Fox Chase Cancer Center in 

2002. Shortly after completing my Fellowship, I was assigned to the Philadelphia 

Veterans Affairs Medical Center (‘‘PVAMC’’) and then became a full-time staff member of the PVAMC. I was asked by the PVAMC to start a brachytherapy program 

at the PVAMC and was proud to have earned this honor. I accepted the responsibility and worked hard with others at the PVAMC to develop a top notch program 

in this evolving area of medicine. I remained a PVAMC staff physician in Radiation 

Oncology continuously until the beginning of 2008. 

Given all that I have worked so hard to achieve and my commitment to patient 

care, I was devastated, personally and professionally, by the false allegations published in The New York Times on Father’s Day, branding me as a ‘‘rogue doctor’’ 

who had covered up mistakes and operated in isolation and without supervision. 

Never in my career have I ever falsified any medical records and never have I participated in a cover-up. 

On the contrary, what happened at the PVAMC in connection with the 

brachytherapy program is in no way what has been depicted by the New York Times 

article. The truth is that the Prostate Brachytherapy team at the PVAMC was a 

collaborative interdisciplinary effort that I led, but which was minutely supervised 

every step of the way by the Radiation Oncology Department, the Radiation Safety 

Office and ultimately by the Administration of the PVAMC. Under sometimes challenging circumstances, the Team tried to deliver quality care to veterans, who would 

otherwise not have access to treatment. 

That is why the malicious allegations against me and the Program are so deeply 

hurtful. So too is the claim that I operated on my own, without supervision and 

without guidance. The falsity of that allegation is easily demonstrated because there 

was a standard operating procedure for the administration of brachytherapy. The 

procedure was codified in a Prostate Brachytherapy Algorithm that was jointly created by Radiation Oncology, Medical Physics, Urology, Radiation Safety and Nursing and disseminated to and approved by all levels of the PVAMC Administration. 

This Algorithm was constantly reviewed and revised as our Team gained more expertise in delivering care to our patients. The Algorithm established a consensus, 

providing structure for a procedure that had no precedence or guiding standards at 

the PVAMC when I was asked to help start this Program. Each brachytherapy patient treated by me or any other physician at the PVAMC was cared for according 

to the SOP established by Algorithm. 

The following points address specific aspects in greater detail: 

1. The PVAMC Prostate Brachytherapy Program was a multidisciplinary collaboration. 

The members of the Brachytherapy Team consisted of: 

i. Radiation Oncology 

ii. Urology 

iii. Radiation Safety 

iv. Medical Physics 

v. Nursing/Program Coordinator 

vi. Administration 

The program was supervised by Radiation Safety. I was not a member of the 

Radiation Safety Committee and was not invited to attend meetings of the Committee. 

2. The PVAMC Brachytherapy Program team members received the necessary 

training for Prostate Brachytherapy. 

a. As a resident physician, I was taught prostate brachytherapy at Penn by 

senior attending physicians. 

b. I completed the same Prostate Brachytherapy course in Seattle, WA at the 

Northwest Hospital that others from the PVAMC also attended. 

c. We observed the Prostate Brachytherapy Program at the Mercer Hospital 

affiliate of the Department of Radiation Oncology in Trenton, NJ, a program 

that also utilized the preloaded method of brachytherapy. 

d. I was proctored in the performing of my first ten Brachytherapy cases at 

the PVAMC by experienced physicians. 

12 

e. Other physicians were available for immediate consultation and additional 

mentoring. 

f. The allegations in the NY Times of a lack of brachytherapy training or supervision are therefore untrue. 

3. I created the protocol for providing brachytherapy treatment (‘‘Algorithm’’) with 

collective multidisciplinary input, vetted through the PVAMC Administration. 

a. The absence of standard policy regarding Brachytherapy in the PVAMC 

prompted the need for written consensus when the Program was first created 

in February 2002: 

b. The first version was completed before the first patient was treated in February 2002, and continuously updated through the years of the Program. 

c. The Algorithm was collaboratively written by all members of the 

Brachytherapy Team, and represented our collaborative expertise regarding the 

Standard Operating Procedure for providing brachytherapy. 

d. The Algorithm describes those patients for whom brachytherapy was most 

suited as well as those for whom the procedure would not be effective. It also 

details the steps each patient undergoes through the Brachytherapy process beginning with the pre- procedure planning and following through with the actual 

procedure and the post-procedure follow up. 

e. The Algorithm does not include any reference to reportable Medical Events 

as defined by the Nuclear Regulatory Commission (‘‘NRC’’) because no such 

definitions existed at the start of the program. 

f. Because the PVAMC served a wide geographical patient population, the Algorithm recognized that those patients living far from Philadelphia may have 

to receive post procedure care at their local hospitals. 

g. The NRC, in its investigation, and the NY Times failed to mention the existence and purpose of the VA Prostate Brachytherapy Algorithm. 

4. The Initial and Revised Written Directives serve different purposes. 

a. The New York Times article falsely accuses me of altering the Written Directive. 

b. The Written Directive is mandated by the NRC and VA’s Office of Radiation Safety. The forms were designed by Radiation Safety, completed by both 

Medical Physics and Radiation Oncology, signed by the physicians, and processed by Radiation Safety. 

c. The Initial Written Directive (WD) specifies the number of seeds to be ordered by Radiation Safety, i.e. the prescription for number of seeds. It is completed by the Medical Physicist together with the Radiation Oncologist physician, who then signs the WD. 

d. A copy of the Initial WD is submitted to Radiation Safety, which places 

the order of the number of seeds, and then receives and secures the seeds. The 

original WD remains in the patient’s medical chart. 

e. On the day of the Brachytherapy procedure, Radiation Safety brings the 

seeds to the procedure room (adjacent to the OR suite), remains in the room 

to supervise the procedure, and to store and safeguard any seeds that are retrieved by Urology from the bladder or found outside the patient. 

f. Integral to the procedure is the Urologist. Immediately after the implanting 

of the seeds, the Urologist, using a cystoscope, will retrieve any seeds that have 

either migrated to or been implanted in the bladder. This action by the Urologist is done in connection with every procedure since a recognized risk of the 

procedure is that seeds will come to rest in the bladder. 

g. After the seeds are retrieved by the Urologist, that physician and Radiation Safety inform the Radiation Oncologist of the number of seeds that do not 

remain in the patient. Through this collaborative process, the Team determines 

the actual number of seeds that remain in the patient. 

h. Under supervision by Radiation Safety, the Radiation Oncologist completes 

the Revised WD that states the actual number of seeds retained within the patient. The Revised WD is submitted to Radiation Safety, and a copy is again 

placed in the patient’s medical chart. Radiation Safety staff and Urology are 

present throughout the brachytherapy procedure. 

i. The WD can be revised yet again prior to the discharge of the patient on 

the day following the procedure. This revision would reflect any seeds passed 

by the patient in his urine while recovering from the procedure. If there is a 

second revision, it too is submitted to Radiation Safety and a copy is retained 

in the patient’s chart. 

j. The procedure described above assures that there is an accurate count of 

the disposition of all of the seeds originally ordered by Radiation Safety for a 

particular procedure. 

13 

k. Given the appropriateness and the different purposes of the Initial and Revised Written Directives, my handling of the Written Directives was entirely appropriate and legal. I did not falsify or erase any Written Directive at any time, 

contrary to the allegations of the New York Times, nor was it likely that any 

other member of the Team did so. It is for this reason that these allegations 

are not only false but scurrilously so. 

5. How the Brachytherapy Procedure is performed. 

a. The prostate is an organ the size of a walnut and is immediately adjacent 

to the bladder and rectum. 

b. The procedure performed at the PVAMC was via the Preplanned, Preloaded Method. This entailed a transrectal ultrasound sizing of the prostate 

completed at least two weeks prior to the actual implant of the seeds. This 

ultrasound serves as the basis for the treatment planning which includes determining the number of seeds and needles required to be ordered by Radiation 

Safety via the Initial Written Directive. 

c. Informed consent is obtained from the patient, who is counseled that seeds 

can migrate away from the prostate, and that up to 5% of patients may develop 

complications that include an inflammatory condition of the rectum known as 

radiation proctitis. 

d. The patient is taken into the procedure room and anesthesia is induced. 

e. Stabilizing needles are inserted. 

f. The Urologist places the ultrasound probe, and inserts the first needle containing seeds into the prostate, and deposits the seeds contained within the first 

needle. This establishes the base of the prostate, and the deepest extent that 

all subsequent needles will reach. 

g. The Radiation Oncologist then inserts the remaining needles following the 

lead of the Urologist and deposits the remainder of the seeds. 

h. The Urologist then performs the previously mentioned cystoscopy to scan 

for and remove any blood clots or seeds from the bladder. 

i. Radiation Safety uses a Geiger counter to scan the entire room and every 

person leaving the room, to retrieve and store any seeds not in the patient. 

j. Anesthesia is reversed, and patient is moved to recovery. 

6. The brachytherapy incident of 2003 was reported to the NRC and resulted in 

a thorough investigation. 

a. A patient who was implanted on February 3, 2003, had a significant number of seeds in his bladder. All such seeds were retrieved by the Urologist 

b. As per standard operating procedure and under the direction of Radiation 

Safety, the patient had an Initial WD that specified the numbers of seeds ordered, and then a revised WD to reflect the actual number of seeds that were 

retained within the patient A copy of both the Initial and Revised directive was 

retained by Radiation Safety, and the original put in the patient’s medical 

chart. 

c. This event was promptly reported to the NRC, who then came to PVAMC 

to conduct a full multiday investigation. The NRC ultimately cleared the Program to resume treating patients. 

d. Because the dose of radiation delivered to the prostate was considered inadequate, a repeat brachytherapy was performed on March 31, 2003. This was 

successful in increasing the radiation dose received by the prostate. There were 

subsequently no unusual or unexpected complications or toxicity reported. 

e. Contrary to what was alleged by the New York Times, at no time did I 

or anyone cover-up the patient’s treatment by altering the Written Directive. 

7. The brachytherapy incident of 2005 was reported to the NRC and resulted in 

a thorough investigation. 

a. A patient was initially seen and accepted for Brachytherapy by another 

Radiation Oncologist I performed the Brachytherapy on 5/19/05. Because of poor 

imaging quality (due to the patient’s inability to complete the necessary bowel 

preparation), many seeds were inserted into the bladder. 

b. As per the standard operating procedure and under the direction of Radiation Safety, the patient had an Initial WD that specified the numbers of seeds 

ordered, and then a revised WD to reflect the actual number of seeds that were 

retained within the patient. A copy of both the Initial and Revised directive was 

retained by Radiation Safety, and the original put in the patient’s medical 

chart. 

c. During the course of the cystoscopy that is performed after every 

brachytherapy, a large number of seeds were retrieved from the bladder. This 

fulfilled the definition of a reportable Medical Event as I understood that definiVerDate Nov 24 2008 17:43 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00017 Fmt 6633 Sfmt 6621 H:\ACTIVE\062909.TXT SVETS PsN: PAULIN
14 

tion at that time, and the case was promptly reported to the NRC. The NRC 

then came to PVAMC to conduct a full multiday investigation, and ultimately 

cleared the Program to resume treating patients. 

d. On re-evaluation of the patient, the consensus among the Prostate 

Brachytherapy Team was not to reimplant this patient, as the patient’s limited 

expected life span rendered the risks greater than the expected benefit 

e. Contrary to what was alleged by the New York Times, the NRC performed 

a thorough investigation of this case. 

8. The NRC definition of a reportable Medical Event has evolved over time and 

continues to be a subject of debate. 

a. There was no NRC definition of a reportable Medical Event when the 

Brachytherapy Program was first started at the PVAMC in 2002. 

b. The physicians and physicists never received NRC training on this issue 

throughout the years the Program was operational. 

c. The instruction following the investigation by NRC of the 2003 prostate 

brachytherapy incident was that ‘‘if greater than 20% of the seeds prescribed 

were retrieved from the bladder;’’ this would constitute a reportable Medical 

Event and would trigger a repeat NRC investigation. 

d. The brachytherapy incident of 2005 was clearly therefore a reportable 

Medical Event and appropriately reported. 

e. The Prostate Brachytherapy Team was never instructed regarding 090 (the 

% of the prescribed dose that 90% of the prostate receives) as a metric that constitutes a reportable Medical Event. This means that no one on the Team was 

advised that if the dose received by the prostate was 20% greater or 20% less 

than the optimal dose it would constitute a Medical Event and would have to 

be reported to the NRC. 

f. The definition of a medically reportable Medical Event that consists of a 

090 that is either 20% above or below the prescribed dose was not in existence 

when the Prostate Brachytherapy Program was first started, nor was that ever 

an instruction provided to the Team. 

g. While achieving a 090 that is not over and below 20% of the prescribed 

radiation dose rule is an optimal standard to strive for under NRC guidelines, 

it does not constitute a clinical standard of care for brachytherapy treatment. 

Indeed, recent articles published in the medical literature suggest treatment 

may be appropriate even when the 090 is less than 80%. I am happy to provide 

copies of those articles to the Committee should it wish to review them. 

9. I have never ordered the wrong seed strength. 

a. My cases have been standardized on the 0.509 mCi seed strength. 

b. The discrepancy between 0.380 mCi and 0.509 mCi seed strengths that are 

mentioned in the NRC Inspection Report of March 30, 2009, involved prostate 

brachytherapy cases at the PVAMC that did not involve my patients. 

c. The discrepancy between the seed strengths calculated and actually ordered was discovered by Radiation Safety and reported to the NRC. 

10. The dose to the rectum has not been defined as a reportable Medical Event 

by the NRC. 

a. As already stated, and as counseled in every consent form, radiation proctitis is a known and recognized risk of brachytherapy. 

b. Given the close proximity of the rectum to the prostate, brachytherapy 

cannot be performed in a way that avoids dose to the rectum. In fact, every seed 

implanted in the prostate delivers radiation dose to the rectum, since the prostate is immediately adjacent to the rectum. 

c. The dose to the rectum was not a metric that either PVAMC Radiation 

Safety or the NRC requested that we measure. 

11. Despite the lack of computer interface between the CT scanner and the 

Variseed treatment planning workstation during 2006–2007. I provided effective 

treatment to my patients. 

a. At the conclusion of a procedure, a CT scan is done to determine the location of the seeds. 

b. The images of the CT scan are then transferred to a workstation that contains the software program called Variseed and which calculates the dose actually received. 

c. In or around November 2006 a computer interface problem between the CT 

scanner and the workstation containing the Variseed software occurred that 

prevented the precise calculation of doses of radiation. 

d. I reported this issue on several occasions to the appropriate persons overseeing the Program, but the problem persisted. 

15 

e. I offered to take the CT scans on disk or flash drive to Penn to perform 

the Variseed calculations. However this was refused by the PVAMC due to confidentiality/privacy/security concerns. 

f. CT images however were still viewable and showed the location of the 

seeds, all of which were concentrated in areas of the prostate that contained 

cancer. 

g. I had only two choices: to stop the Brachytherapy Program, or to continue 

to deliver medical care which the patients needed. Most of the patients treated 

for Brachytherapy did not have the option of alternative treatments such as 

surgery or external beam radiation. External beam radiation would have required the patients to be treated on a daily basis, five days a week, for eight 

weeks. Surgery also had serious drawbacks including incontinence and impotence. Without brachytherapy, the patients’ cancers would have gone untreated. 

h. I elected to continue treatment based on Concern for the patients’ welfare. 

i. The treatment was effective and well within the standard of care and was 

effective. The proof of the effectiveness was demonstrated in follow up visits 

with the patients and evaluation of their PSA levels. 

12. There were a number of systematic failures at the PVAMC that affected the 

Brachytherapy Program. 

a. Prior to the development of the PVAMC Prostate Brachytherapy Program, 

there were no guidelines or policies for the design and operation of a VA 

brachytherapy program. Consequently, the Brachytherapy Team had to design 

its own set of procedures and policies, which led to the creation of the Prostate 

Brachytherapy Algorithm. 

b. When the Brachytherapy Program was first started, there was no standard 

definition of what is a reportable Medical Event. 

c. There was no system to train key members of the Brachytherapy Program 

on what later became a definition of a reportable Medical Event. 

d. There was no full time medical physicist dedicated to the brachytherapy 

program. This impacted on the ability to timely calculate the dose received by 

the patients. 

e. The lack of a computer interface between the CT scanner and the Variseed 

dose calculation workstation prevented the precise calculation of the doses of radiation received by the patient. 

f. There was no mechanism by which concerns regarding key steps of the procedure could bypass the chain of command to solve problems, such as the computer interface problem. 

g. Understandable concerns about patient confidentiality prevented the alternative transport of data from the CT scanner via memory storage media and 

devices. 

13. To address some of these concerns, the Brachytherapy Program was in the 

process of moving from Preloaded to Real-time Treatment Systems. 

a. The members of the Brachytherapy Program recognized the drawbacks of 

the Preloaded Brachytherapy System, such as the inability to customize the 

placement of the seeds to match the patient’s actual anatomy. 

b. Consequently, members of the Team were in the process of receiving training in the Real-time Treatment System, which does account for changes in the 

patient’s anatomy and which includes continuous fluoroscopic verification of the 

location of the deposited seeds. 

c. Real-time treatment would allow for the seeds to be customized to the prostate on the day of the procedure. 

d. The Brachytherapy Program was halted before the change in Treatment 

approach could be implemented. 

14. During a meeting of the Advisory Committee on the Medical Uses of Isotopes 

of the NRC, held in Rockville, MD, on May 7, 2009, it was falsely alleged that a 

key physician of the Brachytherapy Program had made certain statements and actions (‘‘Committee Meeting Transcript’’). Inflammatory statements and actions were 

falsely attributed to this member of the Prostate Brachytherapy Program, including: 

i. ‘‘The physician that did this particular implant, once again, he felt 

that the 24 Gray was clinically acceptable.’’ Committee Meeting Transcript 

at page 192. 

ii. ‘‘And if he felt that 24 Gray was satisfactory, that is the way it was.’’ 

Committee Meeting Transcript at page 192. 

iii. ‘‘Well, one of the things that we noticed was that the physician that 

was primarily involved in the brachytherapy program, he consistently did 

this. They didn’t use fluoroscopy during seed placement. He refused to use 

16 

fluoroscopy, said he didn’t need it.’’ Committee Meeting Transcript at page 

204. 

iv. ‘‘—yes, 2002, and—but from the time the physician had received 

training to the time they started the implant program, there was some 

delay. And there was no—there was no effort on the part of the physician 

to maybe proctor or observe or be involved with some implants before they 

decided to go and proceed and treat their first patient... that was a decision that was made by the Authorized User.’’ Committee Meeting Transcript at page 221. 

v. ‘‘No. According to him, it was clinically acceptable. As a matter of fact, 

his exact words are, ‘43 Gray is better than zero Gray.’ ’’ Committee Meeting Transcript at page 241. 

vi. ‘‘But it is mindboggling to me that a physician could say that a dose 

of 40 Gray, 24 Gray, is acceptable, and then look at these implants and not 

realize that this is gross incompetence.’’ Committee Meeting Transcript at 

page 243. 

a. These inflammatory actions and statements that are being attributed to a 

key physician are being attributed to me, but are not accurate. I neither said 

these statements nor took the actions described. 

b. These false attributions are appropriately alarming and inflamed the subsequent discussions of the Committee. 

CONCLUSION

I have come to the hearing today to answer questions and to submit this written 

statement in order to correct the record and salvage my reputation. I hope that, 

through the hearing process, the investigations and through media reports, the 

truth will emerge. I am not the physician who has been portrayed in the media. 

I am not willing to be the scapegoat for the complex, systematic problems that affected the Brachytherapy Program at the PVAMC. I hope that the information I 

have provided today will help the Committee understand my role and responsibilities in developing and directing the Brachytherapy’ Program. More importantly, it 

is also my hope that this information will help improve future medical care for 

veterans. 

RESPONSE TO POST-HEARING QUESTIONS SUBMITTED BY HON. RICHARD BURR TO

DR. GARY D. KAO, M.D., PH.D. 

Question 1. In your written testimony, you stated that, ‘‘Shortly after completing 

my Fellowship, I was assigned to the Philadelphia Veterans Affairs Medical Center 

(‘‘PVAMC’’) and then became a full-time staff member of the PVAMC.’’ The VA 

maintains that you were not a VA physician but that you were on contract from 

the University of Pennsylvania. Can you please clarify your current and past employers and employment status? 

Response. In 2003, I was awarded an Advanced Research Career Development 

Award (ARCD) by the Office of Research and Development Medical Research Service, Department of Veterans Affairs. This provided support not only for laboratory 

research but also for my clinical activities at the PVAMC. My understanding of the 

ARCD Award is that it mandated that I became a full-time employee of the Research Service of the PVAMC. In fact, from that point forward I was compensated 

by the PVAMC and received W–2 tax forms each year. When the ARCD ended in 

or around March 2007, I was switched to the Medical Service of the PVAMC as a 

‘‘5/8’s’’ staff physician and I continued to be compensated by the PVAMC and continued to receive W–2’s for my work at the PVAMC. Near the end of 2007 or beginning 

of 2008, I became a ‘‘contract physician’’ of the University of Pennsylvania, assigned 

to the VA. At that point, I no longer received compensation from the PVAMC, but 

instead was paid directly by Penn. 

Question 2. At the hearing, you testified that, ‘‘. . . at the time that the program 

was implemented, the definition of what is reportable to the NRC was not in existence and only came later on.’’ 

When asked about this statement, the NRC’s Mr. Reynolds testified that, 

‘‘. . . Dr Kao is mistaken. The requirements to report to NRC when there is adverse care to patients went into effect in 1979.’’ 

Can you please clarify, if necessary, your statement, or explain why Mr. Reynolds 

is mistaken? 

Response. Mr. Reynolds is mistaken on two accounts. First, the NRC has never 

clarified the definition of a reportable medical event as it pertains to brachytherapy. 

17 

1These Exhibits were attached to the Written Testimony recently submitted to the House Veterans’ Affairs Committee (HVAC). We have elected to retain the same numbering system for 

each Exhibit as employed in the submission to the HVAC in order to avoid confusion for readers 

who may read this document as well as the documents submitted to the HVAC. 

The NRC’s current regulation to report variations in delivered dose does not directly 

address brachytherapy or the determination of a medical event related to that therapy. [See relevant portions of the current regulation, attached as Exhibit 4].1 In the 

current regulation, ‘‘total dose delivered’’ is not defined. In contrast to external beam 

radiation, for example, where the target does not change in size or shape and would 

be expected to receive all the dose of radiation delivered, for brachytherapy the dose 

delivered to the target depends on numerous factors and hence is subjective. The 

subjectivity is inherent in the procedure due to multiple factors including how one 

contours the prostate, when the prostate is contoured after brachytherapy (when the 

prostate can be swollen), the recognized risk of seed migration away from the prostate and the implantation of seeds in tissues or other organs adjacent to the prostate, and the contribution of radiation dose from all the seeds, whether or not actually implanted into the prostate. Without clarification of these parameters, the definition of what constitutes a reportable medical event remains quite subjective. Even 

after the NRC investigations of 2003 and 2005 were conducted on-site at the 

PVAMC, the NRC provided no clear definition of a reportable event other than the 

number of seeds located outside the prostate, as was communicated to the 

Brachytherapy Team by officials of the PVAMC Radiation Safety Office. [See note 

from PVAMC Radiation Safety, Exhibit 5]. 

The NRC’s definition of a reportable Medical Event for brachytherapy continues 

to be unsettled. On August 6, 2008, the NRC published a proposed rule aimed, in 

part, at how properly to determine a medical event in the context of brachytherapy. 

As was stated by the NRC in the proposed rule, it was reconsidering ‘‘the appropriateness and adequacy of the regulations for ME’s (Medical Events) and WD’s 

(Written Directives) with regard to the use of byproduct material that required completion of a WD’’ (like brachytherapy). The proposed rule, if adopted, will change the 

definition of what constitutes a ME from one based on dose received by the prostate 

to one based on ‘‘activity’’ (i.e. radioactivity, or the number of seeds implanted in 

the prostate). 

In proposing the adoption of this rule (which, in my view, is akin to an effort to 

account for the location and disposition of nuclear byproducts, a function uniquely 

suited to the NRC, different from evaluating the clinical efficacy of a procedure, 

clearly not within the expertise of the NRC), the agency stated that under current 

guidelines based on dose (related to brachytherapy), ‘‘there is no basis for determining whether an ME has occurred.’’ [See Proposed Rule, I. Background, page 4, 

recognizing the necessary distinctions between brachytherapy treatment and other 

treatments utilizing byproduct material, and Sections 35.40(b) and 35.3045(a)(2), attached as Exhibit 7]. 

In addition to the proposed rule, the NRC’s own Advisory Committee on the Medical Uses of Isotopes (ACMUI) has repeatedly urged that the definition of a Medical 

Event be changed from a definition that is strictly dose-based to a definition that 

is radiation activity-based, i.e. that relies on the counting of the number of seeds 

inside versus outside the prostate [See memo from ACMUI to the NRC Director, Exhibit 8, and transcript of May 7, 2009 ACMUI meeting, Exhibit 9, pages 193–197]. 

The NRC has acknowledged that this proposed definition, if adopted, would likely 

decrease the number of cases that the NRC regards as reportable Medical Events, 

including the cases performed at the PVAMC [See Proposed Rule, I. Background, 

Exhibit 7]. Members of the ACMUI have asked the NRC to analyze the PVAMC’s 

brachytherapy cases using this new definition but, to our knowledge, the NRC has 

not yet done so. 

In evaluating the brachytherapy cases at the PVAMC, the NRC has utilized an 

unpublished (and inappropriate) interpretation of the current regulation to determine the existence of reportable medical events at the PVAMC in the 2002–2008 

period. Under this unpublished interpretation of a reportable Medical Event, the 

NRC based it calculations on the use of the D90 metric. This calculation, which 

measures the dose that 90% of the prostate receives, while not part of the current 

reportable Medical Event regulation, was applied retroactively to determine that the 

bulk of the brachytherapy procedures done at the PVAMC were performed in a 

manner contrary to the regulation. D90 is a metric that has never appeared in any 

regulations or notices issued by the NRC. Nevertheless, the NRC in its recent investigation determined that a reportable Medical Event existed where the dose received 

by the prostate was less than 80% of the D90 dose. It is for all these reasons that 

I can state that the NRC’s current definition of a reportable medical event that is 

18 

2 Crook J, Gillan C, Yeung I, Austen L, McLean M, Lockwood G. PSA kinetics and PSA bounce 

following permanent seed prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2007 Oct 

1;69(2):426–33. 

now based on D90 was not in existence in 2002, remains unpublished and may soon 

change due to a proposed rule change. 

Second, Mr Reynolds is mistaken in his claim that ‘‘requirements to report to 

NRC when there is adverse care to patients went into effect in 1979.’’ He appears 

to be referring to the Medical Policy Statement published by the NRC in 1979. This 

document (attached) in fact is a broad statement of the intent of the NRC to regulate the medical use of radioisotopes. It did not contain details regarding the reporting of Medical Events to the NRC and states that the NRC ‘‘will (not intrude) into 

medical judgments affecting patients and other areas . . . of the practice of medicine.’’ More recently, the NRC again acknowledged that it ‘‘does not prescribe dose 

(as it is) a medical decision’’ [See page 192 line 16–19 of the NRC transcript of May 

2009, Exhibit 9]. 

I continue to believe that appropriate care was provided to veterans by the 

PVAMC Prostate Brachytherapy Program. The treatment has been effective, and 

any adverse effects have been within the known risks of the procedure. The effectiveness of the treatment can be seen, in part, based upon the recent admission of 

Mr. Reynolds during his testimony of July 22, 2009 before the House Veterans’ Affairs Committee, Subcommittee on Oversight and Investigations. When directly 

asked about the results of the treatment rendered at the PVAMC, Mr. Reynolds conceded that of the 114 total cases, the NRC was aware of only six cases where the 

PSA has risen on consecutive testing and another eight cases where a rise in PSA 

has been noted. However, none of these patients have undergone rebiopsy to confirm 

whether or not the cancer has returned. A rebiopsy is crucial because temporary 

PSA increases are common after prostate brachytherapy even in the absence of 

tumor recurrence, a phenomenon that is well-recognized among prostate cancer experts and often referred as ‘‘PSA bounce.’’ 2

The importance of Mr. Reynolds’ concession is his recognition that at least 100 

out of the 114 cases did not result in ineffective treatments. This represents an effective treatment rate that is at least 88%. Nonetheless, the NRC, in applying an 

unpublished standard during its reanalysis of the procedures performed at the 

PVAMC, inappropriately judged that the Program had caused harm to the patients. 

The cumulative effect of the NRC’s action in casting the reporting of a Medical 

Event as a medical judgment on the efficacy of the treatment provided has unduly 

alarmed veterans and the public, and adversely affected the perception of 

brachytherapy by them and by physicians. In all these ways, the NRC has interfered with the delivery of medical care. 

19 

EXHIBITS TO DR. GARY D. KAO’S RESPONSE TO POST-HEARING QUESTIONS SUBMITTED

BY HON. RICHARD BURR


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Senator SPECTER. Thank you, Dr. Kao. 

We are now going to turn to Panel 3 before any of the questioning so we can have a factual basis for the questioning beyond 

what has appeared in the press. 

So, I would like to call at this time Dr. Gerald Cross, Dr. Richard 

Whittington, Director Michael Moreland, Director Richard Citron, 

Dr. Michael Hagan, and Director Steve Reynolds. 


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Our first witness on this panel will be Dr. Gerald Cross, who has 

an M.D. from Loma Linda University. He is the Veteran Administration’s top doctor, and is the Principal Deputy Under Secretary 

for Health. Dr. Cross appeared at a hearing of the Senate Veterans’ 

Affairs Committee last week and graciously consented to come to 

this hearing, although it caused a change to his plans. So, we appreciate your becoming available, as we did want to proceed at the 

earliest practical date. 

Dr. Cross, the floor is yours for 5 minutes. 

STATEMENT OF GERALD M. CROSS, MD, FAAFP, ACTING 

UNDER SECRETARY FOR HEALTH, U.S. DEPARTMENT OF 

VETERANS’ AFFAIRS; ACCOMPANIED BY MICHAEL E. 

MORELAND, FACHE, DIRECTOR, VISN 4; RICHARD CITRON, 

FACHE, DIRECTOR, PHILADELPHIA VA MEDICAL CENTER; 

MICHAEL HAGAN, MD, PHD, NATIONAL DIRECTOR, RADIATION ONCOLOGY PROGRAM, RICHMOND VA MEDICAL CENTER; MARY MOORE, RADIATION SAFETY OFFICER, PHILADELPHIA VA MEDICAL CENTER; AND JOEL MASLOW, MD, 

CHAIRMAN, PHILADELPHIA VA MEDICAL CENTER RADIATION SAFETY COMMITTEE 

Dr. CROSS. Good morning, Senator and Congressmen. Thank you 

for the opportunity to discuss the treatment of veterans with prostate cancer through brachytherapy. 

VA has a well-documented record of quality care, but when there 

are exceptions, whatever the cause may be, we apologize and express our deep regret to the patient, as I do now. 

Indeed, we go beyond that. We work with the individual patient 

to provide them the care that they need. We further analyze what 

went wrong, we take corrective actions, and we look at the lessons 

learned that can be applied throughout our national health care 

system. VA is not afraid to admit when we make a mistake, and 

we strive to make as few mistakes as possible. 

The staff at the Philadelphia VAMC discovered the problem, a 

possible underdosing and incorrect dosage of patients in May 2008, 

and the VA Medical Center Director immediately suspended the 

program and convened the Administrative Board of Investigation to 

uncover the facts. 

We informed and treated all affected veterans. The VA National 

Director of Radiation Oncology continues to investigate the reasons 

why these problems were not detected earlier. 

My testimony today will briefly describe brachytherapy, explain 

what happened as we currently understand the facts, and describe 

VA’s response. 

In brachytherapy for prostate cancer, small radioactive seeds are 

implanted in the prostate to destroy cancerous cells. Although the 

risk to healthy tissues to the body is minimal, side effects may 

occur. 

So, what has been learned? A lot. We value our relationships 

with universities, but the responsibilities for care and oversight 

must be well defined at the outset, even when, as in this case, 

there is a contract with a university. Despite those facts, at the end 

of the day, VA must oversee the quality of care for veterans. 

44 

External oversight is also important, but not sufficient. Noteworthy is the fact that the VA program is accredited while about 

85 percent of the programs outside the VA are not. 

We will continue to ensure that all stakeholders are made aware 

of all-important developments, positive and negative, concerning 

veterans’ health care. 

Now, I will describe the details. On May 5, 2008, a radiation 

oncologist performed a brachytherapy procedure using seeds of a 

lower apparent activity than intended. A physicist discovered this 

underdosing 10 days after the initial procedure. The physicist notified the facility’s radiation safety officer, who immediately reported 

the problem to VA’s National Health Physics Program. 

On May 16, 2008, VA’s National Health Physics Program also notified the Nuclear Regulatory Commission. VA convened a clinical 

risk assessment advisory board, which recommended that all prior 

treatments be reviewed and notification of all patients who received inadequate radiation dosages. 

External physicians and physicists with no involvement with the 

Philadelphia VAMC brachytherapy program conducted these examinations of patient scans, dosages, and medical records. During 

this review, we found up to 92 potential events involving underdosing or imprecise placement. 

It is important to highlight for these additional cases that the 

definition of ‘‘medical event’’ does not necessarily mean veterans 

were harmed, and experts still debate the long-term impact of the 

treatment. Nonetheless, VA took the conservative approach of notifying these veterans. 

On July 2, 2008, the Philadelphia VAMC issued a press release 

and notified local Members of Congress and veteran service organizations; that was in 2008. The facility also took the proactive steps 

to contact each of the 114 veterans who underwent brachytherapy 

at VAMC from 2002, when the program started, to 2008, whether 

they experienced a medical event or not. 

VA sent each veteran a certified letter and called each veteran 

or the veteran’s family directly. We also established a toll-free telephone number to answer questions. VA is covering all costs associated with additional tests and continuing to monitor their care at 

other VA and private facilities. 

We regret this problem went undetected. VA, as with other 

health systems, relies on complimentary systems of accountability 

to identify quality problems. Many of these systems failed to detect 

the less-than-optimal care in this case, and in fact, it was only the 

recognition of potential problems by VA staff that eventually led to 

more in-depth investigation, review, and subsequent disclosure to 

patients and to the public. 

The Philadelphia VAMC brachytherapy program has been suspended since June 2008, and will not reopen until the NRC’s concerns have been satisfied and until requirements of the VA radiation oncology program are met. 

Senator SPECTER. Did you say suspended in June 2008? 

Dr. CROSS. Yes, sir. This notice was sent out in June 2008. 

VA currently offers brachytherapy at nine other facilities, and we 

are working to ensure the highest quality of care for prostate 

45 

brachytherapy. Currently, the NRC is refining the definition of 

medical event as it pertains to these procedures. 

VA has developed criteria for suspending and restarting prostate 

brachytherapy program. VA’s National Health Physics Program 

will continue to conduct the site inspections at all facilities where 

prostate brachytherapy is conducted. 

VA clinical standards and procedures are now among the most 

rigorous in the health care industry. 

Secretary Shinseki in VA—— 

Senator SPECTER. Dr. Cross, how much more time will you need? 

Dr. CROSS. Thirty seconds. 

Senator SPECTER. Thank you. 

Dr. CROSS. Thank you, sir. 

VA Secretary Shinseki and VA senior leadership are conducting 

a top-to-bottom review of the Department and are implementing 

aggressive actions to ensure the right procedures are in place to 

protect our veterans in providing them the highest quality of care 

possible. 

Let me again emphasize our regret that this incident occurred 

and how proud I am of the work our staff at the Philadelphia 

VAMC does on behalf of America’s veterans. While we recognize 

the seriousness of this situation, it is important that our veterans 

and their loved ones have faith and confidence in our medical system. 

Thank you once again for the opportunity to testify, Senator. 

[The prepared statement of Dr. Cross follows:] 

PREPARED STATEMENT OF GERALD M. CROSS, MD, ACTING UNDER SECRETARY FOR

HEALTH, U.S. DEPARTMENT OF VETERANS AFFAIRS

Good morning, Senator Specter and Congressman Adler. Thank you for the opportunity to discuss the Philadelphia Veterans Affairs Medical Center’s (VAMC) treatment of Veterans with prostate cancer through brachytherapy. I am accompanied 

today by Mr. Michael E. Moreland, Director, VISN 4; Mr. Richard Citron, Director, 

Philadelphia VA Medical Center; Dr. Michael Hagan, National Director for Radiation Oncology in the Veterans Health Administration; and Dr. Richard 

Whittington, Physician in Radiation Therapy at the Philadelphia VAMC. The staff 

at the Philadelphia VAMC discovered the problem of possible under-dosing and incorrect dosage of patients in May 2008, and the VA medical center director did not 

hesitate to immediately suspend the program and convene an Administrative Board 

of Investigation to uncover the facts. We informed and treated all affected Veterans 

and promptly suspended the program. The VA National Director of Radiation Oncology is continuing to investigate the reasons why these problems were not detected 

earlier. My testimony today will briefly describe brachytherapy, explain what happened as we currently understand the facts, and describe VA’s response. Please let 

me begin by saying I am disappointed my fellow Veterans did not always receive 

the quality health care they deserve. 

Brachytherapy for prostate cancer is a form of nuclear radiotherapy where small 

radioactive seeds are implanted in the prostate to destroy cancerous cells. Although 

risk to healthy tissues in the body is minimal, side effects may occur. 

On May 5, 2008, a radiation oncologist performed a permanent implant prostate 

brachytherapy procedure using seeds of a lower apparent activity than intended. A 

physicist discovered this under-dosage ten days after the initial procedure. The 

physicist notified the facility’s Radiation Safety Officer, who immediately reported 

the problem to VA’s National Health Physics Program. On May 16, 2008, VA’s National Health Physics Program also notified the Nuclear Regulatory Commission 

(NRC). VA convened a Clinical Risk Assessment Advisory Board, which recommended that all prior treatments be reviewed and that all patients who received inadequate radiation dosages be notified. Independent, external physicians and physicists with no involvement with the Philadelphia VAMC’s brachytherapy program 

conducted these examinations of patient scans, dosages, and medical records. During this review, it was discovered that 92 events involving under-dosing or doses to 

46 

organs or tissues other than the treatment site were found that met the definition 

of a medical event according to the NRC. VA has regularly informed the NRC of 

any updates. It is important to highlight for these additional cases that the definition of ‘‘medical event’’ does not necessarily mean Veterans were harmed, and experts still debate the long-term impact of this treatment. Nonetheless, VA took the 

conservative approach of notifying these Veterans because we did not deliver a 

treatment as promised. 

On July 2, 2008, the Philadelphia VAMC issued a press release and notified local 

Members of Congress and Veterans Service Organizations. The facility also took 

proactive steps to contact each of the 114 Veterans who underwent brachytherapy 

at the VAMC from 2002 (when the program started) to 2008, whether they experienced a medical event or not. VA sent each Veteran a certified letter and called each 

Veteran or the Veteran’s family directly. We also established a toll-free telephone 

number to answer questions. VA is covering all costs associated with additional 

tests and continuing to monitor their care at other VA and private facilities. 

We regret this problem went undetected for nearly six years. VA, as other health 

systems, relies on complementary systems of accountability to identify quality problems like these on the system and individual levels. We use multiple internal and 

external survey and inspection processes (e.g., Joint Commission, American College 

of Radiology Oncology, American College of Radiology, Nuclear Regulatory Commission, and others); review of public databases such as the National Practitioner Data 

bank; patient satisfaction and complaints; and individual peer review. Many of these 

systems failed to detect the aberrant care at Philadelphia, and, in fact, it was only 

the recognition of potential problems by VA staff that eventually led to more indepth investigation, review, and subsequent disclosure to patients and the public. 

The Philadelphia VAMC’s brachytherapy program has been suspended since June 

2008 and will not be reopened until the NRC’s concerns have been satisfied and 

until requirements of the VA Radiation Oncology Program are met. VA also temporarily suspended programs at facilities in Washington, DC, Cincinnati, Ohio, and 

Jackson, Mississippi. Based upon these reviews, the Cincinnati program was found 

satisfactory and is in the process of fulfilling national VA requirements for resuming 

prostate brachytherapy. Complete reviews of the Jackson and Washington programs 

continue. VA will also notify any additional Veterans if we determine they experienced a medical event. 

VA currently offers brachytherapy at nine other facilities, and we are working 

with the NRC on regulatory issues related to prostate brachytherapy. Currently, the 

NRC is refining the definition of ‘‘medical event’’ as it pertains to these procedures. 

VA has developed criteria for suspending and restarting prostate brachytherapy programs. VA’s National Health Physics Program will be conducting periodic site inspections at all facilities where prostate brachytherapy is performed and whenever 

a possible medical event is reported. VA clinical standards and procedures are now 

among the most rigorous in the health care industry. 

Secretary Shinseki and VA’s senior leadership are conducting a top-to-bottom review of the Department and are implementing aggressive actions to ensure the right 

policies and procedures are in place to protect our Veterans while providing them 

the highest quality health care possible. 

Let me again emphasize our regret that this incident occurred, and add how 

proud I am of the work our staff at the Philadelphia VAMC does on behalf of America’s Veterans. Nearly 60,000 Veterans receive world-class health care at this facility 

every year and these events are uncharacteristic of the level of care we provide. 

While we recognize the seriousness of the situation, it is important that our Veterans and their loved ones have faith and confidence in our medical system and in 

our system of care. Thank you once again for the opportunity to testify. 

RESPONSE TO POST-HEARING QUESTIONS SUBMITTED BY HON. RICHARD BURR TO

U.S. DEPARTMENT OF VETERANS AFFAIRS

Question 1a: I am trying to better understand the number of VA facilities affected 

by the issues surrounding the brachytherapy program. 

On Monday, June 22, SVAC staff met with Dr. Cross and other staff at VACO. 

VA informed the staff that there were 13 facilities nationwide where this procedure 

was performed, and 3 facilities had reported problems (Philadelphia, PA, Jackson, 

MS, and Washington, DC). When asked to clarify whether the other ten facilities 

were foud to not have issues and continued to operate, VA answered in the affirmative. 

47 

In a follow up briefing on Friday, June 26 given to SVAC and HVAC staff, VA 

detailed that there actually were four hospitals where problems were discovered, informing the staff about issues at the Cincinnati hospital. 

At the Monday, June 29 hearing on this issue in Philadelphia, VA reaffirmed this 

number four and testified that, ‘‘The Philadelphia VAMC’s brachytherapy program 

has been suspended since June 2008 . . . VA also temporarily suspended programs 

at facilities in Washington, DC, Cincinnati, OH, and Jackson, MS.’’ 

Yet, in written testimony, Mr. Reynolds of the NRC stated that, ‘‘The VA has 

agreed to not restart the prostate brachytherapy treatment programs at five sites, 

including the VA Philadelphia, until all commitments have been met.’’ 

According to the NRC, procedures at the Los Angeles VAMC were also ‘‘suspended.’’ When SVAC staff went back to VA to confirm the number of facilities still 

open, they learned that the Durham VAMC had voluntarily halted these procedures. 

In addition, two other hospitals, in Reno and Birmingham, maintain inactive programs. Therefore, I am now under the impression that only seven of the 15 hospitals that offered this procedure since 2005 are still performing brachytherapy. 

To clarify for the record, how many of these 15 hospitals are considered to have 

‘‘active’’ brachytherapy programs? How many have been ‘‘suspended’’ by the NRC? 

How many have voluntarily ceased operations? 

Response. Beginning in June 2008, the Department of Veterans Affairs (VA) used 

the situation in Philadelphia to proactively conduct a comprehensive review of its 

prostate brachytherapy programs. Fifteen VA facilities have provided prostate implants since 2005. Of those 15 sites, 2 had already voluntarily deactivated its programs prior to the comprehensive 2008 review for reasons other than regulatory violations. Of those two inactive programs (Birmingham, AL and Reno, NV), Birmingham does not plan to restart and Reno plans to consider resumption of its program upon hiring of appropriate urology staff. 

Of the 13 remaining programs, 4 (Cincinnati, OH; Philadelphia, PA; Washington, 

DC; and Jackson, MS) have been suspended by VA’s National Health Physics Program (NHPP). 

There are currently nine programs that meet the standard to provide 

brachytherapy. Seven facilities, including Albany, NY; Boston, MA; Brooklyn, NY; 

Minneapolis, MN; Richmond, VA; San Francisco, CA; and Seattle, WA are active 

and offering brachytherapy treatments. In our comprehensive review, we found 

these facilities have provided treatments within approved standards. 

Two programs meet the standard to provide brachytherapy but are currently not 

active. These include the Durham, NC, VA Medical Center (VAMC), which has voluntarily chosen to no longer provide this procedure in-house and is providing this 

service through a fee-basis agreement with Durham Regional Hospital, and the 

Greater Los Angeles Healthcare System (GLA). After internally deciding to pause 

to review its procedures, GLA had planned to resume its program in July 2009, but 

the Nuclear Regulatory Commission (NRC) reported during the field hearing June 

29, 2009 that the prostate brachytherapy program at the facility was suspended. 

The Veterans Health Administration (VHA) has requested clarification from NRC 

and we are awaiting a response. 

The following provides a summary for the 15 facilities mentioned above: 

Albany ..................... Active 

Birmingham ............ Inactive, with no current plans to restart this service 

Boston ..................... Active 

Brooklyn .................. Active 

Cincinnati ............... Suspended by VA’s NHPP, completing the process to restart 

the program 

Durham ................... Non-active; service chief elected to no longer provide this procedure in-house 

Greater LA .............. Non-active; chief of staff and service chief elected to pause 

the program to review procedures. NRC concluded the pause 

represented suspension requiring the facility to have a restart inspection. Upon completion of this review the facility 

will begin the restart process. 

Jackson .................... Suspended by NHPP (100 percent look-back to 2005 ordered) 

Minneapolis ............ Active 

Philadelphia ............ Suspended by NHPP (100 percent look-back); will not be reopened until all NRC concerns have been satisfied and until 

the requirements of VA’s radiation oncology program are met 

Reno ......................... Inactive, but will consider restarting the program upon hiring of appropriate urology staff 

48 

Richmond ................ Active 

San Francisco ......... Active 

Seattle ..................... Active 

Washington, DC ..... Suspended by NHPP (100 percent look-back to 2005 ordered) 

Question 1b: How many of the facilities that offer brachytherapy treatment do so 

on an in-house basis, contract basis with an outside provider or contract basis but 

within the VA facility? 

Response. Of the 13 programs cited in our response to Question 1a, Albany, NY; 

Boston, MA; Brooklyn, NY; Cincinnati, OH; Richmond, VA; Seattle, WA; and Washington, DC, exclusively conducted operations in house during 2008. Greater Los Angeles, Philadelphia, and San Francisco exclusively used fee-basis or contract authority to provide these services in 2008. Durham, Jackson and Minneapolis conducted 

these operations in-house and through fee-basis or contract authority in 2008. 

Question 1c: For those eight hospitals that are no longer performing these procedures, please state the individual reasons for each becoming inactive. Have they 

been mandated for shutdown by an outside entity or has VA central office or local 

VA officials elected to stop the procedures independently? 

Response. VA’s NHPP has temporarily suspended four programs, including Cincinnati, Washington, DC, Jackson and Philadelphia because problems were found 

involving under-dosing. Based upon a comprehensive review, the Cincinnati program was found to be in compliance with VA clinical standards and is completing 

the process to fulfill national VA requirements for resuming prostate brachytherapy. 

Cincinnati underwent a restart inspection during June 30 to July 1, 2009, with one 

pending action to obtain a new treatment planning system. A restart might be possible in August 2009 from the VHA perspective; however, NRC informed VHA that 

restart must be approved by NRC. Philadelphia was suspended by the Veterans Integrated Service Network (VISN) and VAMC after a comprehensive review found 

that 91 possible events involving under-dosing or doses to organs or tissues other 

than the treatment site were found that met the definition of a medical event according to NRC. Philadelphia’s program will not be reopened until all NRC concerns 

have been satisfied and until the requirements of VA’s radiation oncology program 

are met. Complete reviews of the Jackson and Washington, DC, programs continue. 

Two facilities (Birmingham and Reno) voluntarily deactivated its programs prior 

to a comprehensive internal review for reasons other than regulatory violations. 

Reno intends to re-open its program when they have re-established a urology support program, but Birmingham does not intend to resume operations. No medical 

events were found with past patients at these two sites. Durham voluntarily chose 

to no longer provide these services and GLA has temporarily paused its program. 

Question 1d: Is there a reason for VA’s oversight to mention the Los Angeles and 

Durham facilities at the various briefings and hearing on this topic? 

Response. The Durham VAMC is still authorized to perform this procedure; however, the service chief has voluntarily chosen to no longer provide this procedure inhouse, and is providing this service through a fee-basis agreement with Durham Regional Hospital. In mid 2008, VHA, through NHPP, made a commitment to the NRC 

to use D90, which is the dose to 90 percent of the volume of the prostate, to determine if a medical event had occurred. The physician who was on contract to provide 

these services in-house at Durham believed that using this parameter for regulatory 

purposes is unacceptable. He decided to stop offering the procedure because he was 

concerned regarding the risk of liability for medical events as defined by the D90 

parameter. His concern was triggered by the intense regulatory scrutiny of the 

brachytherapy program, with numerous inspections over the last year involving 

multiple definitions of the term, medical event. Patients requiring this procedure 

are currently being provided it on a fee-basis at the Durham Regional Hospital. 

There is a proposed revision to the NRC regulations pertaining to the definition 

of medical event as regards these procedures, which, if adopted, would allow reconsideration of the decision. 

The prostate implant program at Durham has been inspected numerous times 

within the last year, and no regulatory violations have been cited. 

The VA GLA has elected on its own to pause its program to conduct a review of 

procedures; upon completion of this review the facility will begin the restart process. 

NRC has made an interpretation that the local decision requires the facility to have 

a restart inspection. This is the basis for NRC to have listed a fifth seed implant 

program as being suspended. Confusion might have resulted from use of the ‘‘suspended’’ terminology by facility staff during the on-site NRC inspection. VHA does 

not agree with this interpretation and has requested clarification on this issue from 

NRC. 

49 

Question 1e: In VA’s written statement, after describing problems found in Philadelphia, Jackson, Washington, DC, and Cincinnati, you testified that, ‘‘VA currently 

offers brachytherapy at nine other facilities . . .’’ In light of the information about 

Los Angeles and Durham, does VA stand by this testimony? 

Response. The information provided to the Committee in our testimony should 

have been more precise: VA offers brachytherapy at seven other facilities. There are 

nine programs that meet the standard to provide brachytherapy, but as indicated 

earlier, Los Angeles and Durham are not currently offering such procedures. Los 

Angeles is working to restart brachytherapy, while Durham has chosen not to offer 

the procedure in-house. 

Question 2a: With respect to Dr. Kao, Reverend Flippin testified that, ‘‘I have 

never met the gentleman. He was not the doctor who I met with to decide the type 

of therapy to select.’’ VA has informed SVAC staff that, ‘‘the veteran who testified 

at the Philadelphia field hearing concerning prostate brachytherapy received treatment from Dr. Kao, not another provider.’’ Please clarify for the record if Dr. Kao 

was in fact the doctor who performed the brachytherapy procedure on Reverend 

Flippin. 

Response. Dr. Kao performed the brachytherapy implant; a note written by Dr. 

Kao in the patient’s medical record states that he performed the implant. 

Question 2b: More broadly, what is VA’s policy with respect to informing veterans 

of the doctor performing a medical procedure on them? Is it protocol that a VA doctor meet with a patient before performing a procedure on them? Does VA allow a 

doctor to perform a procedure on a patient without the specific consent of that patient regarding the identity of the doctor performing the procedure? 

Response. VHA Handbook 1004.1, VHA Informed Consent for Clinical Treatments 

and Procedures, requires that informed consent be obtained and documented by a 

practitioner who is clinically privileged to perform the treatment or procedure in 

question. Clinicians in training (e.g., medical or dental residents) are also authorized by the policy to obtain informed consent. Clinicians in training must identify 

their supervising attending on the consent form and the patient must be informed 

of that supervising attending’s name and the names of any other individuals responsible for authorizing or performing the treatment or procedure. The policy does not 

require that the individual obtaining consent be the practitioner who ends up performing the procedure although practitioners are obligated to identify, on the consent form, the clinicians on the treatment team who will perform the procedure. 

Due to the requirements of medical training programs, VA attendings and residents rotate services regularly. It is common for practitioners to cover a medical 

service at the time of obtaining the informed consent and then to rotate off service 

before the procedure is scheduled or performed. For this reason, the performing and 

supervising practitioners identified on the consent form may not always be the practitioners ultimately assigned to the case. In such instances, policy requires that the 

patient be notified of the change, and that the discussion and the patient’s assent 

be documented in the record. This documentation clarifies that the patient was 

made aware of the change and agreed to the change of providers. The policy does 

not require that a new signature consent form be completed in such instances. 

Please note that Handbook 1004.1 is currently in revision and is expected to be published by the fall of 2009. However, requirements for informing patients of who will 

be performing the treatment or procedure will remain unchanged in the revised 

version. 

Senator SPECTER. Thank you very much, Dr. Cross. 

Our next witness is Dr. Richard Whittington. Dr. Whittington is 

the physician on radiation therapy at the Philadelphia VA Medical 

Center, former head of radiation oncology here; his doctorate degree and M.D. are from Rice University. 

Thank you for joining us, Dr. Whittington, and we look forward 

to your testimony. 

STATEMENT OF RICHARD WHITTINGTON, M.D., CHIEF OF 

RADIATION ONCOLOGY, PHILADELPHIA VA MEDICAL CENTER 

Dr. WHITTINGTON. I do not have a formal opening statement, 

Senator. I am sorry. 

All I would like to say is that I have been around the Veterans’ 

Administration for most of my life. My father recently retired from 

the Veteran’s Administration after working with the VA for 52 

50 

years. My sister has worked for the VA for 33 years. My brother 

worked for the Veterans’ Administration until the day he died. I 

am a veteran myself, and I have to say that these incidents that 

are described are the low point in my professional career, because 

it happened on my watch. 

Senator SPECTER. Thank you. We will turn next to Steve Reynolds, a Director of the Division of Nuclear Materials Safety from 

the Nuclear Regulatory Commission, bachelor of science in engineering from Florida Institute of Technology, and the Director of 

the Nuclear Materials Safety Center since 2005. 

Thank you for joining us, Director Reynolds, and the floor is 

yours for 5 minutes. 

STATEMENT OF STEVE A. REYNOLDS, DIRECTOR, DIVISION OF 

NUCLEAR MATERIALS SAFETY, REGION III, U.S. NUCLEAR 

REGULATORY COMMISSION 

Mr. REYNOLDS. Thank you. Senator Specter, Congressman Adler, 

and Congressman Fattah, I am honored to represent the U.S. Nuclear Regulatory Commission at today’s hearing. 

The NRC is very concerned about this issue. An important part 

of our mission as the regulator for the civilian use of nuclear material is to protect public health and safety, including medical uses. 

Therefore, we are concerned about all patients receiving medical 

care, including our veterans. 

The NRC does not regulate the practice of medicine. We do, however, set the rules under which licensees such as the VA use radioactive material. As a holder of the NRC license, it is the responsibility of the VA to identify problems in medical treatments and report those problems to the NRC. 

The NRC, once notified of the apparent problems, began increasingly intensive inspections of the brachytherapy program at VA 

Philadelphia and at the 12 other VA facilities that conduct this 

medical procedure. We are concerned about what we have found to 

date. 

The VA has suspended this procedure at five sites, including 

Philadelphia, and they will not restart until we, the NRC, are satisfied they have addressed all the problems. Our inspections are 

continuing, and once we complete these later this summer, the 

Agency will determine if enforcement action is necessary. 

We are also looking at NRC procedures to see if there are improvements we can make in our oversight system. We will continue 

to look critically at our inspection and licensing programs, as well 

as to consider proposed regulatory changes. 

In closing, the NRC takes these medical events very seriously, 

and continues to be actively engaged on these issues. Thank you. 

[The prepared statement of Mr. Reynolds follows:] 

PREPARED STATEMENT OF STEVEN REYNOLDS DIRECTOR, DIVISION OF NUCLEAR

MATERIALS SAFETY REGION III, U.S. NUCLEAR REGULATORY COMMISSION

INTRODUCTION

Senator Specter, Members of the Committee, and Representative Adler, I am honored to appear before you today to discuss the U.S. Nuclear Regulatory Commission’s (NRC) regulatory role, actions, and findings to date regarding medical events 

at the U. S. Department of Veterans Affairs hospitals, particularly the Veterans AfVerDate Nov 24 2008 17:43 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00054 Fmt 6633 Sfmt 6621 H:\ACTIVE\062909.TXT SVETS PsN: PAULIN
51 

fairs Medical Center in Philadelphia, Pennsylvania (VA Philadelphia). I hope that 

my testimony will be helpful to the Committee’s work. 

NRC’S REGULATORY ROLE

The NRC is an independent agency created by Congress to license and regulate 

the civilian use of radioactive materials. The NRC issues licenses to facilities that 

authorize the safe and secure possession and use of radioactive material. In the nuclear medicine area, the NRC does not regulate the practice of medicine. NRC’s regulations ensure the adequate protection of those working with radioactive material, 

the public, the environment and that the patient receives the doctor’s intended radiation dose. 

The agency’s Region III office, based in Lisle, Illinois, provides regulatory oversight of the Department of Veterans Affairs’ license. The VA was issued a master 

materials license (MML) in March, 2003. An MML is issued only to Federal organizations and authorizes the use of radioactive material at multiple sites. The holder 

of the MML is responsible for ensuring that NRC requirements are met. Prior to 

issuance of the MML, the NRC issued a license to each VA site throughout the 

United States. The VA’s license requires the VA to establish an internal, independent framework of oversight consistent with NRC regulations, and inspection 

and enforcement policies, procedures, and guidance. In this framework, the responsibility for patient safety and day-to-day oversight of VA medical procedures using 

radioactive materials lies with the VA’s National Radiation Safety Committee. The 

VA’s National Health Physics Program (NHPP) acts as the VA’s regulatory organization and is responsible for issuing permits, conducting inspections and event follow-up, investigating incidents, allegations and enforcement. 

BACKGROUND OF THE VA MEDICAL CENTER IN PHILADELPHIA

VA Philadelphia began performing permanent implant prostate brachytherapy in 

2002, using contracted doctors from the University of Pennsylvania Hospital. The 

NRC received a report of a potential medical event in 2003. The NRC conducted an 

inspection and examined the record of the event as well as the procedures for prostate implants and interviewed the physician involved but did not identify any violations of NRC regulations. In 2005, a similar potential medical event was reported 

to the VA’s NHPP. The NRC was informed of the event and evaluated the performance of the NHPP inspectors by observing the NHPP inspection of the event. NHPP 

did not identify any violations at VA Philadelphia. 

On May 18, 2008, the NRC received notification of a potential medical event from 

the VA that a patient undergoing treatment for prostate cancer at the VA Philadelphia received a dose that was over 20 percent lower than what was prescribed. 

In response to this prostate underdose at VA Philadelphia, the NHPP conducted 

an inspection at the facility in May 2008. Based on the preliminary inspection findings, the NHPP requested VA Philadelphia to review more prostate brachytherapy 

treatments. Ultimately, all 116 prostate brachytherapy treatments performed since 

the inception of the program were reviewed by the VA. 

NRC’S RESPONSE TO DATE

NRC closely followed the initial actions of the VA Philadelphia and the NHPP 

and, based on additional potential events, determined that it was necessary to accelerate our direct involvement. 

First, the NRC conducted an independent inspection at VA Philadelphia in July 

2008. Second, based on the NRC’s preliminary inspection findings and the growing 

number of potential medical events, the NRC launched a Special Inspection in September 2008. The NRC’s ongoing Special Inspection was tasked to: 

• conduct further on-site inspections at the VA Philadelphia; 

• conduct on-site inspections at all of the VA hospitals authorized to perform 

prostate brachytherapy treatments; 

• review the circumstances surrounding the multiple medical events at the VA 

Philadelphia; 

• assess prostate brachytherapy programs at the other VA facilities; 

• assess the performance of the NHPP; 

• determine whether the problems at the VA Philadelphia could be affecting other 

medical facilities; and 

• conduct, with the assistance of a medical consultant, an independent assessment of possible health effects on patients who had received the wrong doses. 

Third, in October 2008, the NRC issued a Confirmatory Action Letter to the VA, 

which confirms commitments made to the NRC by the VA to identify, address, and 

52 

prevent the problems that have led to these medical events, including the following 

actions: 

• conduct NHPP inspections at all 13 VA hospitals authorized to perform prostate 

brachytherapy treatments; • develop and implement standardized procedures for prostate brachytherapy 

treatments at all VA hospitals; • identify causes of the medical events and implementing corrective actions; • suspend any prostate brachytherapy treatment program where 20 percent or 

more of the treatments have been identified as medical events; • conduct an inspection to confirm that all necessary corrective actions have been 

taken prior to restarting any suspended brachytherapy treatment program; and • conduct an inspection of new prostate brachytherapy treatment programs prior 

to startup to confirm they meet the enhanced standards. 

Because the physician conducting many of the prostrate brachytherapy treatments also worked at a local hospital, the Commonwealth of Pennsylvania and the 

local hospital were notified. 

The NRC will verify through inspections that the commitments in the Confirmatory Action Letter have been successfully completed. The VA has agreed to not restart prostate brachytherapy treatment programs at five sites, including the VA 

Philadelphia, until all commitments have been met. 

Fourth, on March 30, 2009, the NRC issued a Special Inspection Report on the 

medical events at the Philadelphia VA that identified six apparent violations of 

NRC regulations: (1) the failure to develop adequate written procedures to provide 

high confidence that each prostate seed implant administration is in accordance 

with the written directive; (2) the failure to develop procedures that address methods for verifying that administration is in accordance with the treatment plan and 

written directive; (3) the failure to train supervised individuals regarding identification and reporting requirements for medical events; (4) the failure to instruct a nonsupervised individual regarding identification and reporting of medical events; (5) 

the failure to record total dose received by a patient on a written directive; and, (6) 

the failure to provide required information in several 15-day reports to the NRC. 

In addition to these apparent violations, the NRC identified concerns involving inadequate management oversight by the Radiation Safety Officer and the Radiation 

Safety Committee at VA Philadelphia, and a pattern of unreported safety concerns. 

Finally, in response to a Demand For Information issued to him by the NRC, the 

physician who performed the majority of the brachytherapy treatments at the VA 

Philadelphia, confirmed that he is currently not performing these treatments at any 

facility—VA or otherwise. He has also confirmed that he would give prior notification to the NRC if and when he resumes these treatments. 

FUTURE NRC ACTIONS

The NRC is continuing to review the events at VA Philadelphia. We plan to issue 

separate Special Inspection reports that will address the findings of the inspections 

conducted at VA Philadelphia and at the other VA facilities authorized to perform 

prostate brachytherapy treatments, and the NHPP’s performance at the conclusion 

of these inspection activities. As part of our response, the agency will consider what 

enforcement actions are warranted in these cases. The NRC will also notify all facilities administering this type of treatment about findings from these inspections 

that may inform their practice and where there may be common implications for the 

medical community and other stakeholders. These actions will be publicly available. 

The NRC will also apply the findings of our evaluations to our own regulatory 

practices. In this case, two areas that we have identified as needing increased NRC 

attention are licensee oversight of contract doctors and the safety culture at materials licensees. We will continue to look critically at our licensing and inspection program to determine what enhancements are needed. 

Prior to the current events at the VA, the NRC had been evaluating, with input 

from the nuclear medicine community and other stakeholders, a proposed change to 

our regulations that may prohibit physicians from changing written treatment orders after the procedure begins. The issue of changing these orders during procedures was identified as a concern in the practice at the VA Philadelphia. 

CONCLUSION

The NRC takes these medical events very seriously and continues our in-depth 

inspection. Once we have completed this work, we will evaluate the VA’s response 

to our findings and determine what enforcement actions are warranted. Thank you 

for the opportunity to testify here today. I would be pleased to respond to your 

questions. 

53 

RESPONSE TO POST-HEARING QUESTIONS SUBMITTED BY HON. RICHARD BURR TO

STEVEN REYNOLDS, DIRECTOR, DIVISION OF NUCLEAR MATERIALS SAFETY, UNITED

STATES NUCLEAR REGULATORY COMMISSION

Question 1. How many non-VA facilities has the NRC issued licenses to for the 

possession and use of radioactive material? How many facilities use that material 

for prostate brachytherapy treatment? Is the University of Pennsylvania Hospital 

one of the facilities which possesses a license? 

Response. There are currently approximately 3400 active NRC licenses in the 13 

States regulated by NRC which authorize the possession and use of radioactive material. Over 500 NRC licensees are approved to use radioactive materials for 

brachytherapy. The NRC’s database does not differentiate between prostate 

brachytherapy and other brachytherapy uses, so this number is all-inclusive. The 

University of Pennsylvania possessed an NRC license until March 31, 2008, when 

the NRC relinquished the authority for licensing to the Commonwealth of Pennsylvania. On that date, Pennsylvania became an Agreement State. Under certain conditions (as allowed by Section 274 of the Atomic Energy Act), the NRC enters into 

agreements with State Governors. Those agreements authorize individual States to 

regulate the safe use of specific radioactive materials within their borders. This includes radioisotopes used in medicine and industry. 

Question 2. Are the NRC guidelines that VA follows for reporting a potential medical event the same guidelines that non-VA facilities are required to follow? Are they 

the same guidelines that the University of Pennsylvania Hospital is required to 

follow? 

Response. Yes, the NRC reporting requirements for both VA and non-VA facilities 

are the same. The NRC reporting requirements are found in Title 10 of the Code 

of Federal Regulations (CFR), Part 35, Section 35.3045. Prior to the Commonwealth 

of Pennsylvania becoming an Agreement State on March 31, 2008, the University 

of Pennsylvania Hospital was required to follow the NRC reporting requirements. 

Since March 31, 2008, the University of Pennsylvania Hospital is required to follow 

Pennsylvania’s reporting requirements, which are identical to the NRC’s. Pennsylvania’s Code Title 25, Chapter 224.10 (a) incorporates 10 CFR Part 35 by reference, 

meaning that Pennsylvania’s regulations for the medical use of byproduct material 

are identical to NRC’s. 

Question 3. How many brachytherapy treatment procedures were conducted nationwide since 2002? How many reports of potential medical events with respect to 

brachytherapy treatment have you received from non-VA facility licensees since that 

time? How many on-site inspections has the NRC performed since that time on nonVA facilities authorized to perform brachytherapy treatments? How many actual 

violations have you found? How many facilities have had to suspend their 

brachytherapy treatment programs until compliance with NRC guidelines was 

achieved? Did the NRC ever receive reports of potential medical events from the 

University of Pennsylvania Hospital? Did the NRC ever investigate the University 

of Pennsylvania Hospital’s brachytherapy treatment program? If so, what was the 

conclusion? 

Response. The NRC understands that the question pertains to manual prostate 

seed implant brachytherapy procedures. The NRC does not maintain statistics regarding the number of brachytherapy treatment procedures conducted annually. 

However, based on information gathered from professional organizations involved in 

brachytherapy, an estimated annual average of 40,000 brachytherapy procedures 

(all-inclusive, not limited to prostate brachytherapy) have been conducted nationwide since 2002. Between 2002 and July 17, 2009, the NRC received 53 reports of 

medical events involving manual prostate seed implant brachytherapy procedures 

that were administered to 208 patients. Forty-three of these reports were received 

from non-VA facilities and involved 95 patients. Ten reports were received from VA 

facilities and involved 113 patients. 

Between 2002 and July 17, 2009, the NRC conducted 806 inspections at non-VA 

facilities that perform all types of brachytherapy, including prostate brachytherapy. 

The NRC does not maintain separate inspection statistics limited to only prostate 

brachytherapy. The NRC issued a total of seven violations specific to prostate 

brachytherapy. In addition to the five suspended VA brachytherapy programs, two 

non-VA facilities suspended their brachytherapy programs as a result of medical 

events. These two programs resumed after implementing corrective actions to 

achieve compliance with NRC requirements. 

The NRC received one report of a medical event from the University of Pennsylvania Hospital involving a prostate implant. On May 5, 2001, that hospital reported 

a misadministration (now referred to as a ‘‘medical event’’) involving a leaking seed 

54 

which was implanted into the prostate of a patient. The NRC conducted a special 

inspection on May 7, 2001. No violations of regulatory requirements were identified 

during the special inspection. It should be noted that having a medical event in 

itself is not a violation. 

The NRC conducted other inspections at the University of Pennsylvania, including 

its hospital. The most recent NRC inspection conducted March 19 through 22, 2007, 

did not identify any violations associated with the prostate brachytherapy activities. 

Previous NRC inspections were conducted November 29 through December 3, 2004 

and December 9 through 12, 2002; no violations were identified regarding the prostate brachytherapy program during these previous inspections. 

Question 4. Your testimony states that ‘‘VA has agreed to not restart prostate 

brachytherapy treatment programs at five sites... .’’ However, VA testimony 

states that only four sites, including Philadelphia, were temporarily suspended. 

What is the 5th site you are referring to that VA is not? Why would that site not 

be included in VA’s testimony? 

Response. The fifth site NRC referred to was the VA Greater Los Angeles (GLA) 

Medical Center. The NRC included this as a suspended site based on information 

provided in a report dated February 24, 2009 from the VA National Health Physics 

Program (NHPP), which states ‘‘the prostate implant program at GLA was suspended by the GLA Chief of Staff on February 13, 2009.’’ The other four VA sites 

were suspended by the NHPP (in consultation with each VA Medical Center’s senior 

management) and include: VA Philadelphia, Pennsylvania (June 11, 2008); VA Jackson, Mississippi (September 2008); VA Washington, D.C (September 26, 2008); VA 

Cincinnati, Ohio (October 2008). Each of these VA prostate brachytherapy programs 

remain suspended. The NRC does not have an explanation or any additional information regarding why the VA’s testimony did not include the fifth site (GLA). 

Question 5. I have learned that the Durham VA medical center voluntarily ceased 

its brachytherapy program, in large part due to a provider’s discomfort with adhering to NRC’s guidelines. I understand that this same provider will perform 

brachytherapy treatments at Duke University Hospital which is subject to North 

Carolina guidelines on what is a reportable medical event. Does the NRC delegate 

licensing authority to States? What is the difference between the state guidelines 

and NRC’s guidelines? Are States free to use their own guidelines on reportable 

medical events or must they follow the NRC’s? If they may use their own guidelines, 

does it make sense to have two different standards? 

Response. Under certain conditions (as allowed by Section 274 of the Atomic Energy Act), the NRC enters into agreements with State Governors. Those agreements 

authorize individual States to regulate the safe use of specific radioactive materials 

within their borders. This includes radioisotopes used in medicine and industry. 

States that meet these conditions and agree to regulate materials must meet specific criteria for compatability with NRC requirements. Typically, Agreement States 

regulate additional sources of radiation that the NRC does not. This generally includes naturally occurring radioactive materials within their borders. In addition, 

the States regulate radiation-producing machines, such as X-ray machines (both 

medical and industrial) and particle accelerators. 

When an agreement is signed, the NRC discontinues its authority and the State 

asserts State authority under its laws and regulations for the material under the 

Agreement. However, under the Agreement, certain regulations and program elements are adopted by an Agreement State to maintain a compatible program with 

NRC requirements in accordance with criteria for compatibility. These criteria sometimes must require identical regulations and sometimes allow limited flexibility to 

the state in implementing its program. With respect to guidelines for reporting medical events, the Agreement State requirements must be identical to the NRC requirements. Normally, the Agreement States will adopt those identified regulations 

within a three year timeframe. The regulations in 10 CFR Part 35, including regulations for reporting a medical event, have been identified as regulations that must 

be adopted by Agreement States to maintain a compatible program. North Carolina’s regulations for the Records and Reports of Misadministration, found in North 

Carolina Administrative Code Title 15A, Chapter 11, Section .0350 are identical to 

NRC 10 CFR 35.3045, Report and Notification of a Medical Event. 

Question 6. You stated at the hearing that the requirements to report to NRC 

when there is adverse care to patients went into effect in 1979. Dr. Kao’s testimony 

states that the standard definition of a reportable medical event to the NRC ‘‘was 

not in existence when the Brachytherapy Program started at the VA.’’ Were you and 

he talking about two different things? Please resolve the apparent contradiction. 

Response. The VA started its brachytherapy program in February 2002. The requirement to report ‘‘misadministrations’’ to the NRC was incorporated into the regVerDate Nov 24 2008 17:43 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00058 Fmt 6633 Sfmt 6621 H:\ACTIVE\062909.TXT SVETS PsN: PAULIN
55 

ulations in 1980 (45 FR 31701; May 14, 1980). Events were then classified as 

misadministrations when the calculated administered dose differed from the prescribed dose by more than 20%. In 2002 (April, 24), the NRC replaced the term 

‘‘misadministration’’ with ‘‘medical event’’ and revised the reporting requirements. 

The term ‘‘medical event’’ more correctly and simply conveys that the radioactive 

material, or the radiation from there, was not delivered as directed by the physician. 

NRC has therefore had reporting requirements in place since 1980 that require reporting of events such as those that took place at the VA hospitals. 

Question 7. Dr. Kao’s testimony also states that ‘‘The definition of a reportable 

medical event to the NRC does not define a standard of effectiveness of medical 

treatment either scientifically or medically. A patient whose treatment results in a 

reportable medical event may still have received effective treatment and be within 

the appropriate standard of medical care.’’ Is he correct? How did NRC arrive at its 

definition of what is a reportable medical event? Does the NRC collaborate with the 

medical and scientific community when arriving at a definition? 

Response. The reason for medical event reporting requirements is to identify incidents where the end result of a medical use of radioactive material is significantly 

different from what was planned. The medical event could be a result of an error 

in calculating or delivering a radiation dose, administering the wrong radionuclide 

or the wrong amount of the correct radionuclide or other factors that are described 

in 10 CFR 35.3045. 

The occurrence of medical events may reflect quality assurance problems with the 

licensees’ programs and the reporting of medical events in accordance with the criteria established in section 35.3045 is intended to capture those events that result 

in actual harm to the patient. However, the threshold for reporting medical events 

is set at a level so as to also capture precursor events that may lead to harm to 

a patient, if not reported and investigated. Therefore, it is possible that patients, 

whose treatment results in a reportable medical event, may still have received effective treatment and be within the appropriate standard of medical care. However, 

the NRC has determined that the reporting requirements are necessary to protect 

public health and safety. 

NRC’s Medical Use Policy for radioactive materials is not to intrude into medical 

judgments affecting patients, except as necessary to provide for the radiation safety 

of workers and the general public. Under this policy, NRC will, when justified by 

the risk to patients, regulate the radiation safety of patients primarily to assure 

that the use of radionuclides is in accordance with the physician’s directions. 

The NRC developed the first definition of reportable misadministrations through 

a rulemaking process that culminated in the final rule published in 1980. Discussions of the need for this definition began in 1972, based on an incident that occurred where the use of radiopharmaceuticals on a patient resulted in death. Discussions on the definition and incident data collection continued through the 1970s, 

focusing on patient death, harm, or large radiation doses to unanticipated tissues. 

The definition of a misadministration has been substantially changed since its inception in 1980. One revision occurred on July 25, 1991, when the rule was revised 

to require that events be classified as misadministrations when the calculated administered dose differed from the prescribed dose by more than 20% (instead of 

10%). Another revision occurred in April 2002, when the term ‘‘misadministration’’ 

was changed to ‘‘medical event.’’ 

All of the revisions described above were implemented through the NRC’s rulemaking process, which requires that proposed rules are published in the Federal 

Register and that the public is given time to provide written comments for consideration by the NRC staff. Once the public comment period has closed, the public comments are addressed and the final rule is published in the Federal Register. The 

NRC’s Advisory Committee on the Medical Uses of Isotopes (ACMUI), which provided input in all of the above rule changes, advises NRC on policy and technical 

issues that arise in the regulation of the medical uses of radioactive materials in 

diagnosis and therapy. Members of this Committee include health care professionals 

from various disciplines who provide comments and recommendations on changes to 

NRC regulations and guidance and bring key issues to the attention of the 

Commission. 

Question 8. Dr. Kao’s testimony suggests other significant factors that the NRC 

should include in its defined standards (see ‘‘Fact 3’’ in his testimony). Please comment on his suggestions. 

Response. The significant factors identified by Dr. Kao as standards that should 

be addressed in the NRC definition of a reportable medical event include: number 

of seeds; location of the seeds in the prostate; location of seeds outside the prostate; 

concentration of seeds to the affected areas of the prostate; stage, grade and extent 

56 

of the cancer; and the clinical follow up of the PSA test results. These significant 

factors pertain to the practice of medicine and the medical judgment of the physician. In accordance with NRC’s Medical Use Policy Statement (65 FR 47654 dated 

August 3, 2000), NRC will not intrude into medical judgments affecting patients, except as necessary to provide for the radiation safety of workers and the general public. It is not the policy of NRC to regulate the practice of medicine. The practice of 

medicine is regulated by the States’ boards of medicine. The NRC Medical Use Policy Statement also states that the NRC will regulate the radiation safety of patients 

where justified by the risk to patients and where voluntary standards or compliance 

with these standards are inadequate. This is why the NRC requires identification 

of the treatment site, radionuclide, and dose in the written directive. The purpose 

of NRC regulations of the medical use of byproduct material is to reduce unnecessary radiation exposure to patients, workers, and the public. The focus of NRC regulation to protect the patient’s health and safety is primarily to ensure that the authorized user physician’s directions are followed as they pertain to the administration of the radiation or radionuclide, rather than to other, non-radiation (e.g., stage, 

grade, and extent of the cancer) related aspects of the administration. 

Question 9. In response to questions for Representative Fattah, Dr. Kao stated 

that ‘‘it is almost unavoidable’’ that some implanted seeds end up outside the prostate because it is an ‘‘inherently subjective procedure.’’ You stated, however, that 

based on what is reported to you and based on NRC’s own independent inspections 

that ‘‘medical events dealing with seeds outside the prostate happen very, very infrequently.’’ Is it possible that Dr. Kao is right and that these events simply aren’t 

being reported to NRC, or that you are not catching them during your inspections? 

Response. Based on a search of NRC’s events database, between 2002 and July 

17, 2009, the NRC received 53 reports of medical events involving manual prostate 

seed implant brachytherapy procedures that were administered to 208 patients. 

Forty-three of these reports were received from non-VA facilities and involved 95 patients. Ten reports were received from VA facilities and involved 113 patients. These 

statistics demonstrate that events are being identified and reported to the NRC and 

that a percentage of the events include seeds that were implanted outside of the 

prostate. Additionally, the NRC periodically performs inspections of licensees with 

brachytherapy programs. One part of the inspections is to review a sample of 

records and determine if the licensees are correctly evaluating their procedures for 

medical events, and reporting the medical events when, and if, they occur. 

Question 10. During the hearing Dr. Kao referenced transcripts in which a physician advisor to the NRC commented that if NRC ‘‘were to audit all the programs 

that do brachytherapy in this country, there would be 20,000 reportable medical 

events.’’ You, in response to a question from Representative Fattah, stated that 

NRC receives ‘‘very few’’ medically reportable events. Is the physician advisor in 

error with his statement? Or, could it be that he’s correct, and that lax oversight 

has resulted in very few events being reported? 

Response. NRC understands the question to pertain to manual prostate seed implant brachytherapy procedures. Dr. Kao referenced a section of transcript made by 

a physician advisor from NRC’s Advisory Committee on the Medical Uses of Isotopes 

meeting in May 2009. The physician advisor was speaking to a hypothetical situation and was not implying that 20,000 medical events go undetected by NRC. 

NRC regulations in 10 CFR 35.3045(c) require medical licensees to report medical 

events the next calendar day after they are discovered. NRC requires licensees to 

be familiar with the regulations, identify a medical event, and report it to the agency. 

Licensees performing permanent implant brachytherapy are inspected every 2–3 

years, depending on the size of the medical use program. NRC has performed over 

800 inspections of licensees with brachytherapy programs since 2002 and has not 

seen anything to suggest such a high rate of occurrence. One part of the inspections 

is to review a sample of records and determine if the licensees are correctly evaluating their procedures for medical events, and reporting the medical events when, 

and if, they occur. In this timeframe, the NRC received 53 reports of medical events 

nationwide from NRC licensees and Agreement State regulators, involving prostate 

brachytherapy procedures that were administered to 208 patients. Of these reports, 

43 were received from non-VA facilities and involved 95 patients. The remaining 10 

reports were received from VA facilities and involved 113 patients. 

Question 11. Please confirm when the NRC began to regulate brachytherapy 

procedures. 

Response. The Atomic Energy Act of 1954 and Energy Reorganization Act of 1974 

give the NRC the responsibility to regulate the safe use of byproduct, source and 

special nuclear material. In 1954, NRC’s precursor, the Atomic Energy Commission, 

implemented its authority to regulate the use of sealed sources for ‘‘human use’’ by 

57 

physicians in 10 CFR 30.24(c). In 1975, NRC specifically amended its regulations 

to include the regulation of brachytherapy sources in 10 CFR 35.14 and 10 CFR 

35.100, Schedule A, group VI. Additional regulations covering brachytherapy requirements were incorporated into 10 CFR Part 35 in 1980. 

Question 12. What guidance has changed from the NRC over the past twelve 

months? 

Response. The NRC is currently assessing whether any additional changes are 

needed to its regulations or guidance, and is taking a critical look at potential enhancements to continually improve its processes. These enhancements include an increased focus on the safety culture at medical facilities, increased focus on medical 

facilities’ oversight of contracted medical professionals, increased focus on whether 

the involved medical professionals and radiation safety staff understand the definition of a medical event and reporting requirements, increased focus on extent of condition reviews, and increased focus on post treatment results, to verify that the results are in accordance with the physicians’ written directives. 

Question 13. Please outline any changes throughout the years that have been 

made to the guidelines issued by the NRC as to what is considered a medical event. 

Response. The following is an outline of changes that have been made to guidelines issued by the NRC as to what is considered a medical event: 

May 1980: 45 FR 31704, Final Rule On Misadministrations was issued, which established misadministration criteria in 10 CFR 35.41, reporting of therapy 

misadministrations in 10 CFR 35.42, reporting of diagnostic misadministrations to 

NRC in 10 CFR 35.43, and requiring a record of all misadministrations in 10 CFR 

35.44. 

October 1986: 51 FR 36932, Final Rule On Medical Use of Byproduct Material. 

The diagnostic administration reporting requirement in 10 CFR 35.33 was changed 

to require reports of misadministrations that resulted in a whole body dose greater 

than 500 millirem, or an organ dose greater than 2 rem. 

Misadministration was defined in part in 10 CFR 35.2 as an administration of a 

therapy radiation dose from a sealed source such that errors in the treatment geometry in a calculated total treatment dose differing from the final prescribed total 

treatment dose by more than 10 percent. 

July 1991: The definition of ‘‘misadministration’’ was revised in 10 CFR 35.2 to 

add as reportable events any dosage of I–125 or I–131 greater than 30 microcuries, 

where the administered dosage differs from the prescribed dosage by more than 20 

percent. Also, a dose threshold of 5 rem dose equivalent or 50 rem dose equivalent 

to any individual organ was added to the definition of a diagnostic radiopharmaceutical misadministration. 

September 1995: The definition of misadministration in 10 CFR 35.2 was amended by removing the term ‘‘patient or human research subject’’ and inserting the 

word ‘‘individual.’’ 

April 2002: Final rule was promulgated, which provides the current definition for 

medical events, 67 FR 20370. The term ‘‘misadministrations’’ was changed to ‘‘medical events.’’ Section 35.33 ‘‘Notifications, reports, and records of misadministrations’’ was deleted and reporting requirements were moved to section 35.3045. 

The dose threshold of 5 rem dose equivalent or 50 rem dose equivalent to any individual organ is added to the criteria for reporting an incident as a medical event. 

Changes to the requirements made the reporting threshold dose-based where possible and addressed two problem areas, patient intervention and wrong treatment 

site. 

March 2006: A minor edit to the definition of medical event, 71 FR 15008. Medical 

event is defined as an event that meets the criteria in 10 CFR 35.3045(a) or (b). 

Senator SPECTER. Thank you very much, Director Reynolds. 

The other individuals who are here are for the purpose of answering questions. So, at this time, I would like Reverend Flippin 

and Dr. Kao to return to the witness table, and Dr. Cross and Director Reynolds to stay, and the other prospective witnesses to step 

back and we may call on you as the occasion presents itself. 

We will now turn to the opening rounds of questions of the witnesses, and they will also be 5 minutes in duration. 

Dr. Cross, according to the media accounts, there were 92 veterans at the Philadelphia VA Medical Center who received incorrect doses of radiation. They received substantially less than the 

radioactive seeds and other patients received excessive radiation to 

58 

nearby tissue, including bladder and other organs. The incorrect 

doses were performed, according to media reports, at the University of Pennsylvania by a doctor under contract to the VA, and that 

doctor has been identified as Dr. Gary Kao. 

According to the press reports: it took more than 6 years to catch 

the mistakes; and the checks were made by those who were in the 

program; that the quality assurance aspects of the program were 

conducted by the contracted doctors themselves and were not independent enough to assure getting an unbiased report. 

What has your investigation disclosed with respect to those allegations? 

Dr. CROSS. We have indeed found on our own investigation after 

we discovered this problem ourselves that up to 92 individuals 

could have been underdosed—and that is potentially underdosed. 

Some investigation still continues into that area. 

It is important to understand—and I am a family physician, so 

this is not my area of specialty, but as I have learned more about 

this in the recent days, I have been impressed—this is both an art 

and a science. The art is in how the patient is addressed; how the 

seeds are actually lined up and planted. 

We did not rely just on internal review, Senator, and that is important for you to know. And I want to read one 10-second statement. 

We also had external review. We were accredited whereas most 

programs are non-accredited, and we received a statement in 2007 

from the American College of Radiation Oncology that specifically 

mentions brachytherapy. In summary it states the following of the 

review: ‘‘In summary, your PVMC practice, as noted above, is a 

well organized and operated radiation oncology practice that not 

only meets but in many aspects exceeds the ACRO standards for 

practice accreditation, and we are pleased to inform you that the 

PVAMC has been awarded a 3-year accreditation.’’ 

They go on to complement the quality assurance program and so 

forth. Now, this is an external review organization that came in to 

review our program. 

Senator SPECTER. Dr. Cross, you have stated in your opening 

statement that it is up to the Veterans Administration to do the 

oversight. 

Dr. CROSS. Yes, sir. 

Senator SPECTER. What is your response to the allegation that 

the quality assurance aspects of the program were conducted by 

the contracted doctors themselves and were not independent 

enough to assure that there was an unbiased report? 

Dr. CROSS. I think that is a valid statement. 

Senator SPECTER. Why, Dr. Cross, did it take 6 years to find out 

what was going on? 

Dr. CROSS. For two reasons. 

The first is that any complication or underdosing is not immediately apparent unless specifically measured. 

Number 2, the measures that were put in place to check on the 

quality, like the one that I just read to you, suggested that things 

were not only good, but better than the national average. 

Senator SPECTER. Dr. Cross, with respect to the VA procedure 

generally, is this aberrational what went on here at the veterans’ 

59 

hospital? Or is this, with respect to two items, something that 

could be occurring other places, and that is, number 1, the failure 

of having objective observers to make a determination; and, second, 

a failure to find a problem for such a long period of time? 

We are obviously concerned about what happened here, but we 

are also very concerned about what the practices are by the VA nationally. 

My time is up and the red light is on. I am going to shift and 

have 10-minute questioning rounds by each of the panelists to give 

you a chance to respond, Dr. Cross. 

Dr. CROSS. There is, in fact, something unique in this situation 

at Philadelphia that I think is more so than we would find at other 

locations, and that is the nature of the contract and the nature of 

the relationship with the University. 

In my review of this program, it is almost indistinguishable as 

to where the University ends and the VA begins. In fact, the radiation oncology reviewer—— 

Senator SPECTER. Well, that may be indistinguishable, but you 

are saying that the Veterans’ Administration has the responsibility 

for oversight. 

Dr. CROSS. That is exactly my point. That arrangement, I think, 

was part of the problem. We value tremendously our relationship 

with our university affiliates, but in this case there was a contract, 

and the contract had some rather, in my experience, unusual language to the point that when the reviewers reviewed the program 

from the American College of Radiation Oncology, they made the 

following statement: ‘‘This VA radiation oncology department is 

under the control of the University of Pennsylvania.’’ 

I think that we, regardless of any such relationships, regardless 

of any such contracts, we, the VA, must prevail in having our oversight of this program and other programs. 

Senator SPECTER. Well, what are you doing to correct this kind 

of problem here and nationally? 

Dr. CROSS. It is quite a long list of things, Senator, but let me 

highlight just a couple of them. 

Number 1, we hired a highly regarded radiation oncologist to review our programs. 

Number 2, we invested in training—mandatory training. In fact, 

in January of this year, we brought all of the key individuals involved in these programs to Washington, DC, for additional review 

and training of current procedures and policies. 

Number 3, when we found the problem here at Philadelphia, we 

did not stop there. We mandated that we review all of our other 

programs, as well, and we did that ourselves. 

Senator SPECTER. When you suspended the program in June 

2008, as you testified, did you know about these failures at that 

time? 

Dr. CROSS. When we curtailed the program here at Philadelphia 

in 2008, we notified the VSOs, we notified the Congressional Offices, we notified the media, then we took further action—— 

Senator SPECTER. The answer to my question is, yes, you did 

know about the problem? 

Dr. CROSS. No, sir. We decided to start an investigation at that 

time of all of our other sites, as well. 

60 

Senator SPECTER. And did you later find out about the problems? 

Dr. CROSS. We did find some other problems, as well. 

Senator SPECTER. And what action did you take at that time to 

notify congressional oversight? 

Dr. CROSS. We notified the Committee Members. 

Senator SPECTER. Notified? 

Dr. CROSS. Committee staffers. 

Senator SPECTER. I did not hear you. 

Dr. CROSS. We notified Committee staffers. 

Senator SPECTER. Let me turn to you, Dr. Kao. You have counsel 

with you; but let me say that, as you have noted, you are appearing 

here voluntarily and you are under no obligation to respond to 

questions. But we do appreciate your being here. 

The allegations, as you have already heard, are very serious. You 

have been identified as the individual who performed these procedures on most of the 92 veterans. The allegation has been made 

that the seeds were not planted in the prostate where they should 

have been, but they were instead lodged in the bladder and other 

organs that there were insufficient seeds planted. Did you plant 

seeds that went into the bladder and other organs? 

Dr. KAO. Senator, let me first correct something that has been 

incorrectly stated—— 

Senator SPECTER. Why don’t you do that, but answer my question first. 

Dr. KAO. Sir, yes, there have been occasions where seeds have 

been implanted in the bladder or outside the prostate. 

Senator SPECTER. What action did you take on that to notify the 

patients? 

Dr. KAO. The chance of seeds in the bladder or outside of the 

prostate is a recognized risk of the procedure and—— 

Senator SPECTER. Well, it is a recognized risk, but did you notify 

the patients? 

Dr. KAO. No, sir. 

Senator SPECTER. Why not? 

Dr. KAO. Even when seeds are outside the prostate, they still 

contribute a radiation dose to the cancer, so—— 

Senator SPECTER. The allegations are that you also had excessive 

radiation. Is that true? 

Dr. KAO. I believe some of our cases had seeds and radiation outside the prostate which would constitute a medically reportable 

event. 

Senator SPECTER. But did you have excessive radiation? 

Dr. KAO. By that definition, sir, it would be yes. 

Senator SPECTER. And did you notify those patients about the excessive radiation? 

Dr. KAO. I did not. 

Senator SPECTER. I am 35 seconds over. 

Congressman Adler—— 

Mr. VAIRA. Can he explain that? 

Senator SPECTER. Oh, yes. Pardon me. You may proceed with explanation. 

Mr. VAIRA. He would just like to explain that. Yes or no sometimes gives a bad definition. 

Dr. Kao, would you please, in about a minute, explain that. 

61 

Senator SPECTER. Take whatever time you need, Dr. Kao. I wanted you to answer my questions, but you are privileged to say whatever you care to on that. 

Dr. KAO. So, every step of the brachytherapy procedure was defined in the algorithm that we collaboratively wrote; and at the 

time that the program was implemented, the definition of what is 

reportable to the NRC was not in existence and only came later on. 

If we had been aware of this definition, we would have acted to notify the NRC and the patient. 

We were working very closely and continually supervised by the 

radiation safety of the VA and we trusted their advice as to what 

should be reported. In retrospect, I should have known that the 

definition of what is reportable has changed through the years. 

Senator SPECTER. Thank you, Dr. Kao. 

I will turn now to Congressman Adler. 

Mr. ADLER. Thank you, Senator. 

Doctor, you seem to be the only person in this room except perhaps counsel that fails to recognize the statistics we have been 

dealing with. Colleagues at your table here have been acknowledging that we have, out of 116 procedures, 92 botched procedures. 

You quarrel with the New York Times, you quarrel with the 

Philadelphia Inquirer, it seems you are quarreling with the panelists here who are acknowledging the VA has responsibility to 92 for 

inadequate medical care. 

Do you care in any way to refine your testimony to talk about 

whether there was any substandard care on your part. 

Dr. KAO. No, Congressman, I do not believe that our procedures 

were botched. 

I do recognize there were occasions where we could have done 

better. I still maintain that we rendered effective treatment, 

Senator. 

Through the years of the program, we were continually improving our results, and yet, we recognize that we can still do better 

and we were in the process of transitioning to the real-time brachytherapy system, which would have also helped in improving the 

quality of our treatment, Congressman. 

Mr. ADLER. Doctor, I heard you earlier, I think, sort of blame a 

lack of training for the problems that this program encountered. I 

heard you sort of blame the Radiation Oncology Department and 

its lack of supervision of you and your coworkers. I heard you 

blame the Radiation Safety Office and the VA hospital administration, it is in your written testimony. 

I am sort of baffled. We have these 92 people who got, by any 

fair measure, substandard care. I understand there are legal concerns you face right now. I am concerned about the medical concerns and the America-obligation concerns these 92 people—this is 

a good chance for you to say I am sorry—not to take all the blame. 

There may be other people that deserve blame. This would be your 

chance to say to Reverend Flippin, I am sorry for what you went 

through. 

This would be a good chance. Why don’t you do that right now, 

say, I am sorry for the pain you suffered, sir. 

Dr. KAO. Congressman, I agree with you. I do accept a share of 

the blame. I do believe that we could have and should be doing betVerDate Nov 24 2008 17:43 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00065 Fmt 6633 Sfmt 6601 H:\ACTIVE\062909.TXT SVETS PsN: PAULIN
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ter. I am saddened by the plight of the Reverend and wish that I 

had the chance to do anything, anything at all to help him. 

Mr. ADLER. Gosh, it seems to me you had a chance when you 

were performing the radiation procedure on him; that was the 

chance. 

Dr. Cross, you told us a moment ago that after the revelation of 

this problem in June 2008, you reviewed all programs. Can you go 

into a little bit more detail, because I guess what we need to hear, 

not just for patients coming to this VA hospital which, by and 

large, as Congressman Fattah suggests, has provided very good 

care in so many different fields for so many different veterans over 

the years,—but why don’t you reassure us that you, in fact, reviewed all of the programs so that this problem—which was not 

isolated to one doctor, but this program occurred massively here at 

Philadelphia and, to a lesser extent, I guess, in Jackson, in Cincinnati, and in Washington, DC—that this problem is unique and 

that, by and large, the VA program is delivering the quality of care 

that America owes its veterans. 

Dr. CROSS. Thank you, Congressman. Of course, VA does deliver 

good quality of care, but we are also a trusted organization. And 

the point here is, when we find something wrong, our policy, our 

ethics is to acknowledge it, accept it, and do something about it. 

And that is what we did. 

We found the problem. It was not the external reviewers, it was 

not all those accrediting groups that found it, it was our own staff 

who found it. And when they found it, they brought it forward, 

bravely, appropriately; and our leadership then said, let’s disclose 

it, let’s notify Congress, let’s notify the media, let’s notify the VSOs, 

and let’s take action. 

One of the things that we discuss when we find a problem is, 

well, that is one place. Could this problem be occurring elsewhere? 

And so, we mandated that all of our other facilities undergo a special review which our staff put together and conducted to see how 

they were doing. 

We did find some problems, not to the level of concern that I had 

in Philadelphia, but when we find those problems, we work with 

the NRC—who have been very collaborative and helpful with us as 

a partner in this—to make sure that the corrective actions are 

taken. We are still working on that. 

Mr. ADLER. Doctor, I thank you for that answer. 

I guess I am still stumped as to how this could have gone on for 

6 years before it reached your level to be addressed for this facility 

and nationally. 

How could it have gone on for that long? It seems like a long 

time for the folks at the top not to know what the folks in the field 

are doing to rather than for our veterans. 

Dr. CROSS. I think the lesson learned here is we have to find a 

better way to monitor this kind of very highly, highly specialized, 

relatively unusual procedure that we deal with in hospitals nationwide. I do not think this is just an issue for the VA, I think this 

is an issue for the entire national health system, that we have to 

address this and do a better job of it. 

As a result of that, that is why we are working with the NRC 

and the Joint Commission and others to make sure that we have 

63 

the lessons learned from this and are better able to detect it more 

quickly. 

Mr. ADLER. I guess I am still not getting the answer I need to 

hear for my satisfaction and for the satisfaction of the people of 

America about why it took so long to catch it in the sense that this 

was 6 years from the first botched procedure to the closure of the 

program. Why 6 years? Why not, we caught it after 20 patients got 

substandard treatment? Why do we wait for 92 patients to get less 

than what they deserved, having served in uniform our country? 

Why did it take that long for us to catch a problem and really stop 

it? 

Dr. CROSS. My impression, based on the reviews I have done, is 

there was not adequate follow-up on the measurement done afterwards, number 1. 

Number 2, all of the people that we brought in to do the external 

review said we were doing a great job. 

Mr. ADLER. Maybe I could turn to Mr. Reynolds. 

We treat nuclear products, whether very small, like a radiation 

seed, or very large, like a nuclear power plant, very seriously. That 

is why we have a Federal agency to keep America safe, the Nuclear 

Regulatory Commission. So, whether it is power plants around the 

country or whether it is a nuclear materials program, I have to 

think that it cannot be a good thing to put nuclear material in the 

wrong parts of somebody’s body. Am I wrong on that? 

Mr. REYNOLDS. We expect that when the medical professionals 

use radioactive material they put it in the right spot in the body; 

absolutely, sir. 

Mr. ADLER. Is it in any way problematic to you—to me, it is outrageous—but maybe just problematic, a lower threshold, that we 

are taking these seeds of nuclear radioactive material and putting 

them not where they are designed to fight a cancer, but in other 

body parts in that general region, but not actually the spot that 

has the cancer. Is that not at least problematic to you? 

Mr. REYNOLDS. Right. We expect—in fact, the VA’s license requires them to identify problems like this and report them to us. 

Mr. ADLER. Well, given the seriousness of putting nuclear material in somebody’s body, how did it break down so badly here 

where—apparently just one doctor doing the procedures, but lots of 

people floating around in the hospital in the VA system, with the 

NRC—how do so many people not catch this and say, this is a pattern of substandard care? How did it take so long before the NRC 

or the VA system shut this outrage down? 

Mr. REYNOLDS. Let me try to answer that for you. 

Again, I will go back. The VA is responsible for identifying their 

medical problems and reporting them to us. This means that the 

doctors involved—Dr. Kao and the other doctor, the medical physicist—when they perform the procedures, when they identify a problem, they are supposed to report that. They are required to identify 

the problem and report it. This also includes the VA Philadelphia’s 

Radiation Safety Officer. She is responsible for the day-to-day oversight of the doctors and the medical physicists and the rest of the 

medical staff in their use of radioactive material. This also includes 

the VA Philadelphia’s Radiation Safety Committee, who is responsible here in Philadelphia for reviewing medical treatments and reVerDate Nov 24 2008 17:43 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00067 Fmt 6633 Sfmt 6601 H:\ACTIVE\062909.TXT SVETS PsN: PAULIN
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viewing them critically, then assessing if anything needs to happen 

and reporting them. Also responsible is the VA National Health 

Physics Program. The National Health Physics Program is responsible for performing inspections at the VA hospitals where they use 

radioactive material. All those people did not identify the problems 

and did not report them. 

What we have seen and what we have documented in our inspection report is a lack of a strong safety culture here at the VA Philadelphia; and safety culture is one where people are expected and 

are free to raise safety issues. Based on interviews we have had 

with some of the medical physicists and others, they were aware 

of substandard treatments, and for whatever reason that I do not 

understand, they did not raise that to their management or to the 

NRC. 

Mr. ADLER. Do other VA hospitals around the country that have 

brachytherapy programs have a different reporting standard, or did 

this VA hospital just fail to meet the standard that is nationwide? 

Mr. REYNOLDS. The reporting standard is the same for all hospitals, VA or otherwise, that do this treatment. 

Mr. ADLER. My time is expired. 

Senator SPECTER. Thank you Congressman Adler, Congressman 

Fattah. 

Mr. FATTAH. Thank you. 

Mr. Reynolds, is it not true that these reporting standards for a 

medically reportable event were not in place at the time that these 

procedures were taking place? 

Mr. REYNOLDS. No, sir. I believe Dr. Kao is mistaken. The requirements to report to NRC when there is adverse care to patients 

went into effect in 1979. 

Mr. FATTAH. Was this part of that doctrine in 1979, because we 

were not doing seeds in 1979, were we? We were implanting seeds 

in 1979? 

Mr. REYNOLDS. I am not sure exactly when prostate brachytherapy started. 

Mr. FATTAH. OK. I will come back to that. 

Doctor—how do you pronounce your name? 

Dr. KAO. Kao. 

Mr. FATTAH. Kao. Let me thank you. You are one of the most 

educated people in the country when it comes to cancer and radiation therapy, is that correct? 

Dr. KAO. Thank you, Congressman, yes. 

Mr. FATTAH. A journalist wrote a story claiming that you did certain things, so I would like to give you a chance to get some things 

cleared up here. 

When the allegation in the New York Times story said that seeds 

or overdoses of radiation in these seeds that were implanted in patients, did that relate to any of the patients that you treated? 

Dr. KAO. I believe, yes, Congressman. 

Mr. FATTAH. So, didn’t you use a standardized seed strength? 

Dr. KAO. Yes, Congressman. 

Mr. FATTAH. So, when there are references made to more 

strength than might have been desired, or weakened, what does 

that refer to? 

65 

Dr. KAO. I believe the allegation was that there was an incorrect 

number of seeds outside or inside the prostate, Congressman. 

Mr. FATTAH. Now, the prostate is a walnut-sized organ, right? 

Dr. KAO. Yes, Congressman. I am sorry, it is difficult to see from 

your angle, but it is this little thing that sits below the prostate— 

I am sorry, below the bladder, in front of the rectum, and above 

the testicles. 

Mr. FATTAH. Is it a normal occurrence when you are implanting 

seeds that some seeds end up outside the prostate, across the 

breadth and width of this type of medical treatment? 

Dr. KAO. It is almost unavoidable, Congressman. Brachytherapy 

is an inherently subjective procedure where seeds are put in by 

hand, and so that is a recognized risk and in every consent form, 

Congressman. 

Mr. FATTAH. So, if we looked at all these cases across the country, it would be an abnormality for seeds not to end up outside the 

prostate. 

Dr. KAO. It would be very frequent. 

Mr. FATTAH. OK. It would be very frequent for them to end up 

in the rectum or in the bladder. 

Dr. KAO. Bladder or outside—and sometimes it migrates into 

other organs, such as the lung. 

Mr. FATTAH. Now, Dr. Reynolds, is it a reportable medical event 

if a seed ends up in the rectum, under the rules of the NRC? 

Mr. REYNOLDS. Well, the requirements have not changed since 

Dr. Kao has been practicing and—— 

Mr. FATTAH. No, no. I am asking—is it a reportable event if a 

seed ends up in the rectum? 

Mr. REYNOLDS. It depends on the placement of the seed and the 

strength of that seed, but most likely, yes. 

Mr. FATTAH. It is not always reportable, but in some cases, it is. 

Mr. REYNOLDS. Right. It depends on what the doctor has prescribed for the patient. 

Mr. FATTAH. Now, there is a Safety Committee at the NRC. And 

there was a meeting on May 7, 2009, where there were various 

quotes that were ascribed to the doctor from that meeting. He says 

in his testimony, his voluntary testimony before the Committee 

today, in his written testimony, that none of these quotes were 

made by him. 

Dr. Cross, is there any way for us to figure out how that can be 

the case, that there are quotes in a report ascribed to the doctor, 

that he asserts before this Committee that he did not make? 

Dr. CROSS. Sir, did you say that is the NRC Committee or—— 

Mr. FATTAH. Yes, it is an NRC Committee, not a VA committee, 

but I am asking you—— 

Dr. CROSS. I would not be able to comment. 

Mr. FATTAH. OK. So, well, it was a VA procedure, so I just figured you may have had some input in this process. 

Can you help us, Director Reynolds. 

Mr. REYNOLDS. I am sorry. I am confused about what, specifically, you are talking about. 

Mr. FATTAH. Well on number 14 of page 8, the doctor says that 

there are a number of quotes—and he goes through them, in deVerDate Nov 24 2008 17:43 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00069 Fmt 6633 Sfmt 6601 H:\ACTIVE\062909.TXT SVETS PsN: PAULIN
66 

tail—from this safety report, which he says he did not make and 

the report says that he did. 

Mr. REYNOLDS. Could you mention the doctor’s name for me? 

Mr. FATTAH. Dr. Kao. 

Mr. REYNOLDS. Oh, OK. I am sorry. I was thinking you were saying somebody else. 

Mr. FATTAH. Is there anyone accompanying you who can help us 

with this mystery? 

Mr. REYNOLDS. I thought you were talking about somebody else. 

Please ask your question, again. I think I can answer it. 

Mr. FATTAH. There are some quotes in the report from May 7, 

2009, from the Safety Committee, and it ascribes specific quotes, 

extensive quotes to the doctor that he asserts in his written testimony to the Committee today that he did not make. 

I am trying to figure out how we can determine how that could 

have happened. 

Mr. VAIRA. There are two statements that we handed out. One 

is a lengthy one, and I think that is the one you are quoting from. 

It is about 14 or 15 pages. 

Mr. FATTAH. Yes. 

Mr. VAIRA. I do not know if the Director—your examiner there— 

has that in front of him. 

Mr. FATTAH. OK. Well, it is probably too much of a time constraint for us to try to get to it at this point, but it is of interest 

that you can have these extensive quotes—yes? 

Mr. REYNOLDS. I am sorry. They handed me his statements right 

now. This is information that, when our inspectors talked to Dr. 

Kao, this is what he told our inspectors. 

It may not be verbatim what Dr. Kao told our inspectors, but this 

is our inspectors’ words of what Dr. Kao said to our inspectors during our inspection. 

Mr. FATTAH. So, these are quotes that are not quotes. 

Mr. REYNOLDS. No, these are quotes of what was said at the Advisory Committee for the Medical Use of Isotopes (ACMUI) meeting. 

Mr. FATTAH. OK. Well, thank you. 

Dr. Cross, you said in your response to Senator Specter, there 

are a number of VA programs in terms of prostate cancer that have 

been put on hold. How many are there that have been put on hold? 

Dr. CROSS. At the moment, I believe we have two that are still 

under investigation and several more that—— 

Mr. FATTAH. Well, originally that were put on hold, based on this 

review. 

Dr. CROSS. I would have to—I do not have my experts at the 

table with me, so—— 

Mr. FATTAH. The gentleman that is behind you is trying to tell 

you. 

Dr. CROSS. Four. 

Mr. FATTAH. Four, OK. So, this is not a Philadelphia VA issue, 

this is something that you were looking at across the board. 

Dr. CROSS. Exactly, and that is the routine procedure for us. 

When we find a problem in one place we look—— 

Mr. FATTAH. Did you say that this problem exists in non-VA 

medical facilities, and perhaps even more so? 

67 

Dr. CROSS. I think the issue of compliance with the standards, 

the oversight, and the accreditation are all issues that apply not 

only to the VA but to the broader system, as well. 

Mr. FATTAH. OK. Senator Specter, I also want to acknowledge 

the presence of Congressman Brady, who has a staffer here and 

Councilwoman Jannie Blackwell, who represents this area. I want 

to thank you again for holding this hearing. 

Senator SPECTER. Thank you very much, Congressman Fattah. 

We will proceed now with a second round of questioning—5 minutes. 

Reverend Flippin, what injuries did you sustain as a result of 

this procedure? 

Rev. FLIPPIN. I was informed by a doctor at Ohio State University that I had a radiation burn to my rectum. 

Senator SPECTER. And what is the consequence of that? 

Rev. FLIPPIN. The consequence of that was loss of a job, approximately 41⁄2 months of 24/7 bedrest—— 

Senator SPECTER. You earlier told me that there was bleeding involved. 

Rev. FLIPPIN. Oh, yes, when I went to the bathroom. 

Senator SPECTER. Indelicate as it is, it is important for the 

record. What specifically happened to you in that respect. 

Rev. FLIPPIN. OK. What sent me back to the West Virginia VA 

hospital was that I started experiencing bleeding in my stool 

and—— 

Senator SPECTER. Reverend Flippin, you had testified earlier that 

no one from the VA ever informed you about what had happened. 

Is that so? 

Rev. FLIPPIN. Right. I did not know anything about this until I 

receive the first letter. 

Senator SPECTER. First letter from whom? 

Rev. FLIPPIN. From the VA. 

Senator SPECTER. When did you get that? 

Rev. FLIPPIN. Last year. It was July 2, 2008, when I received the 

letter about the brachytherapy and the care that I had received. 

Senator SPECTER. Dr. Cross, the information is that there were 

similar problems in Jackson, Cincinnati, the District of Columbia, 

where Philadelphia had 97, Jackson 8, Cincinnati 6, and DC 3. 

What action has the Veterans’ Administration taken with respect 

to those other sites. 

Dr. CROSS. The one definitive action, I believe, in Cincinnati, is 

that they have been cleared. It turned out that they got a good review, and when we get a go from the NRC, they can proceed to continue on. 

The only two that are still being reviewed further are Washington, DC, and Jackson, as I recall. 

Senator SPECTER. Dr. Cross, you testified that there needs to be 

some attention to this kind of issue, as you put it, by a national 

health system. Would you amplify what you think could be done? 

We are now considering comprehensive health reform. This could 

well be an issue to be included. What specifically would you like 

to see be done by the national health system? 

68 

Dr. CROSS. Sir, I was not referring to health reform, I was referring to the oversight organizations that we work with every day. 

We work with a number of them. 

Senator SPECTER. Well, what could be done better on the oversight, then? 

Dr. CROSS. I think that we have to put in place some better, 

clearer, more easily understood standards, perhaps. There is still 

debate on some of the issues as to whether or not these specific 

standards that are in place right now, which we are trying vigorously to enforce, are really relevant clinically in the long term, over 

time. That has to be clarified, and I think we would like to work 

with the organizations that do that, to be useful in that regard. 

Senator SPECTER. Director Reynolds, Dr. Kao has stated that 

there was not a sufficient definition of a reportable medical standard. 

Do you think there is any substance to that position? 

Mr. REYNOLDS. The entire medical community across the Nation 

has been subject to that standard for many years and has used it 

successfully. 

Senator SPECTER. You think there is a sufficient definition of a 

reportable incident? 

Mr. REYNOLDS. Yes, sir. 

Senator SPECTER. So, you think that if there was excessive radiation or seeds went into the bladder that would clearly be something that ought to be reported, at least to the patient. 

Mr. REYNOLDS. Yes, sir. In fact—— 

Senator SPECTER. What corrective action do you anticipate from 

your Nuclear Regulatory Commission? 

Mr. REYNOLDS. Well, first, we expect the VA to address all their 

problems to ensure these problems will not happen again; and that 

includes developing nationwide standards and procedures, and it 

includes training of all the staff that Dr. Cross already talked 

about. And then, we are also looking at our inspection procedures 

to see if we can enhance them, and would we want the VA’s National Health Physics Program to do inspections more often. Then, 

do we need to do more inspections on the VA and the VA’s National 

Health Physics Program? 

Senator SPECTER. Congressman Adler, would you like a second 

round of 5 minutes? 

Mr. ADLER. Reverend Flippin, Let us just imagine that over the 

course of 6 years you performed 116 sermons, and out of those 116 

sermons, 92 of them were lousy, don’t you think you would get 

booed out of your church? 

Rev. FLIPPIN. Yes, sir. 

Mr. ADLER. Aren’t you, as I am, surprised that Dr. Kao still has 

a medical license after botching 92 of 116 procedures? 

Rev. FLIPPIN. I do not know anything about Dr. Kao. The only 

thing I would say is that when you mentioned, wouldn’t it be nice 

to say something to Reverend Flippin, I was moved, and I thought 

he might look at me and say something. Now, I have an impression 

of Dr. Kao that I had not before coming in here. 

Mr. ADLER. I thought we both got the same impression, sir. 

Dr. Cross, you heard Dr. Kao say that there might be grossly inadequate training for the physicians who perform brachytherapy 

69 

procedures. Do you have any comment about the adequacy of training the doctors receive or standards that the VA uses to evaluate 

doctors before allowing them to perform this procedure in Philadelphia or anywhere around the country over the last number of 

years. 

Dr. CROSS. I am not sure I heard the statement as you quoted 

it; however, training is always important, and when we find an 

issue like this, my natural inclination is to look at training and see 

if it was adequate. That is always the first place to look. 

We have good people, and if they are well trained and ready to 

go, we can usually avoid problems. So, I think, naturally, that is 

the first place to look; and then the accreditation and the oversight 

and all those kind of things that go along with it. 

Mr. ADLER. I kind of heard Dr. Kao pointing at you and the VA 

system and that is why he did not do such a good job. 

I also heard Mr. Reynolds say the reason the NRC did not hear 

about problems is because people in the VA system failed to report 

to the NRC some of these problems. 

Is that generally accurate, Mr. Reynolds? 

Mr. REYNOLDS. Correct. 

Mr. ADLER. So, I guess I am asking you what you—not you, personally, but the system—would have done differently over the 

years to report to the NRC this inadequate use of radioactive materials in the bodies of veterans who are coming for good care, and 

lots of cases—80 percent of the time—did not get that good care. 

Dr. CROSS. First, I think it is important to note that we did report to the NRC at the time that this was uncovered in June 2008, 

and in fact, I have the exact date right here and who was contacted. 

We consider them to be important allies in this effort. The point 

that you are making is we should have done that sooner and that 

should have been discovered sooner. And that is where we have to 

put the mechanisms in place within the VA and outside the VA 

which will ensure that this is more easily detected, and more 

quickly detected. 

Mr. ADLER. Do you have a sense why peer review did not catch 

this problem here, right in the hospital, before it ever got to 20 patients and 40 patients and 60 patients—before it got to 92 patients. 

Dr. CROSS. I think I do, actually. There was a quality assurance 

program, but perhaps not as effective as it should have been. 

Peer review really focuses more on finding things where there 

are complications that have occurred, grading them, and taking action as a result. In none of these situations would such an event 

have occurred—where there was a clear complication happening. 

Mr. ADLER. I guess you are sitting next to a clear complication. 

Poor Reverend Flippin had a—— 

Dr. CROSS. I am pointing out that that was over a year later, and 

I think that is the point right there—that time lag and the lack of 

identifiable complications right then. 

Mr. ADLER. I guess I am hoping that you and Mr. Reynolds—the 

NRC and the VA system—can coordinate better. I am hearing some 

sort of blame, at least from the NRC toward the VA system. I think 

you have been much more respectful about owning up to responsibility in a shared way. But I guess I am hoping to leave this hearVerDate Nov 24 2008 17:43 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00073 Fmt 6633 Sfmt 6601 H:\ACTIVE\062909.TXT SVETS PsN: PAULIN
70 

ing, and maybe a subsequent hearing in Washington, with greater 

confidence than I had coming in here since you have owned the 

problems, shared the responsibility with the NRC, and are defining 

a reporting schedule, a peer review system, a level of checks and 

balances throughout the system so we do not have to hear from the 

next Reverend Flippin, the next Air Force or Army, Marine, or 

Navy person who came to get good care—maybe not on prostate 

but on something else—and it somehow slipped through in a different way, different than this one, but just as troubling as this 

one. 

Can you give you me and this Committee the reassurance we 

need for America? 

Dr. CROSS. Absolutely. I can do that because I view our colleagues who do oversight—whether it be the Joint Commission, the 

ACRO, or the Nuclear Regulatory Commission—as colleagues. I believe they are allies. I see them as very important to this effort, 

and I engage them, pull them into our discussions, invite them to 

our meetings, and invite them to our offices to work closely with 

us. That is the kind of relationship we are going to have, and that 

relationship is going to make this a success. 

Mr. ADLER. Well, Doctor, we certainly need that process and we 

certainly need better results. 

Thank you. 

Senator SPECTER. Congressman Fattah. 

Mr. FATTAH. Thank you, Senator. 

Dr. Reynolds, I want to try to delve into this on a more general 

basis here. 

Do you have a sense of how many of these procedures have been 

done, say, over the last 5 years, in our country. 

Mr. REYNOLDS. At VA hospitals or across the board? 

Mr. FATTAH. No, across the board. 

Mr. REYNOLDS. Thousands. 

Mr. FATTAH. Thousands. Can you tell us or give us a general understanding of how many medically reported events have occurred 

that have been reported to you? 

Mr. REYNOLDS. Very few. 

Mr. FATTAH. Very few. That is what I want to delve into. I want 

to try to reconcile a couple of things. 

The doctor who is one of the experts in this whole field says that 

it is a very frequent occurrence that, in planting these seeds, that 

this happens. And my colleague says that anyone who does this, 

has botched a procedure; and he is surprised that the doctor still 

has a medical license. But if this is going on in thousands of cases 

and nobody is reporting it to you, then I am trying to figure out— 

and this gets to Senator Specter’s earlier point—is if we are trying 

to fix health care nationwide we need to figure out how we deal 

with this on a systematic basis. If this is happening, it is not an 

event that can be avoided because of the proximity of the prostate 

to the rectum and the bladder; and, therefore, it is going to be visited upon almost anyone who gets this treatment, or it is a botched 

procedure in which nobody who is performing them are reporting 

them to you anywhere across the country. Now, which one is it? 

Mr. REYNOLDS. In addition to licensees, including the VA being 

required to report problems to us, we go out and do independent 

71 

inspections. Based on our independent inspections of the other hospitals that do brachytherapy treatment, we have not seen this 

problem. The prostate is properly treated with seeds. We do not see 

medical events nowhere near the extent you see at VA Philadelphia. 

Mr. FATTAH. So, you are saying this is an aberration, and that 

it is not the case that seeds end up outside the prostate on a normal occurrence. 

Mr. REYNOLDS. You may have an occasional—— 

Mr. FATTAH. I am going to give you a chance to review that before you comment. 

Mr. REYNOLDS. Could you ask your question again, I lost my 

train of thought. 

Mr. FATTAH. Is this occurring in a great many of these procedures? 

Mr. REYNOLDS. No. Medical events—— 

Mr. FATTAH. No, not just the generality of medical events, but a 

reportable medical event having to do with seeds ending up outside 

the prostate. 

Mr. REYNOLDS. Right. Medical events dealing with seeds outside 

the prostate happen very, very infrequently based on reports to us 

and based on our direct inspections. 

Mr. FATTAH. So, you get almost no reports. 

Mr. REYNOLDS. That is correct. 

Mr. FATTAH. And therefore, you believe it almost never happens. 

Mr. REYNOLDS. Based on the reporting to us and our inspections, 

that is correct—outside of VA Philadelphia. 

Mr. FATTAH. So, then the doctor is completely wrong that this is 

a frequent occurrence. 

Doctor, go right ahead. 

Dr. KAO. In the same transcript that, Congressman, you had referenced earlier, a physician advisor to the NRC has commented 

that if they were to audit all the programs that do brachytherapy 

in this country, there would be 20,000 reportable medical events. 

No program has undergone the level of scrutiny that this program 

has undergone, Congressman. 

Mr. FATTAH. So, there could be cases where the Reverend who 

got this treatment ended up with a situation and nobody told him 

about it. There could be a lot of people who are facing symptoms 

from seeds outside the prostate which may not be avoidable, but 

nonetheless, could—because, at the end of the procedure, the urologist is supposed to go in and get the seeds, right? 

Dr. KAO. That is correct. 

Mr. FATTAH. And there are seeds that are unaccounted for. That 

is how this works, right? 

Dr. KAO. That is correct. 

Mr. FATTAH. And those seeds are somewhere. 

Dr. KAO. That is correct, Congressman. 

Mr. FATTAH. And they are probably somewhere close to the prostate, either in the rectum or the bladder. 

Dr. KAO. Or in the tissue surrounding the prostate, Congressman. 

Mr. FATTAH. So, there is a great deal of interest in this matter 

based on the way the New York Times wrote this story. I think that 

72 

the bigger story here is that this is not about this hospital or this 

doctor. This is about a procedure designed to help men with a very 

serious health problem in which, part and parcel to that procedure, 

is the real danger that these seeds can end up outside the prostate, 

and which almost no doctors are reporting—to doctors to anybody, 

including you. 

You are the person that it should be reported to, both inside the 

VA and outside the VA. I think that Senator Specter has brought 

this to our attention in a way that will impact national policy and 

that will be meaningful; and it is not part of any kind of witch hunt 

about a particular program or doctor here in Philadelphia. 

Senator SPECTER. Thank you, Congressman Fattah. 

Congressman Adler, do you care to make a final statement. 

Mr. ADLER. Let me first, again, thank Senator Specter for organizing this field hearing, and thank all the panelists for coming before us. I particularly thank Dr. Cross and folks from the VA hospital who have owned up to the seriousness of the problem that occurred here. For some of these procedures to have half the seeds 

planted wrongly outside the prostate, that is not a near miss; that 

is clearly a mistake. I thank Dr. Cross and Dr. Whittington and 

other folks from the hospital and from the VA system who want to 

solve a problem, who acknowledge the seriousness of the problem, 

who know that we let down patients who came here to get highquality care and did not get it. I thank the VA system for shutting 

down this program until they get it right, and shutting down programs around the country until they get it right. 

I understand a couple programs have been reopened. I hope this 

program is restored properly here. But until it is gotten right, we 

should not do it. This is not just an art; there is a science to it, 

and the science is to put these seeds in the right body part, not 

kind of close, but right where they are needed to destroy the cancer 

rather than cause harm to patients who came here for good medical care. 

Mr. Reynolds, I thank you for sharing your concerns about the 

reporting up to the NRC. I am hoping you will be more active in 

redefining what is a medical event so that you get more of the reporting that Congressman Fattah was talking about, because I 

think we need to have better communication and a better understanding of what is going right and what is going wrong. My sense 

is that this hospital does a lot of things right, but in this one program was doing a lot of things wrong, and it is the aberration for 

this very good facility. But it is an aberration that lasted for too 

long. 

I hope we get to the bottom of this situation here. I hope it does 

not recur in this program, in this facility, or anywhere in the country. I think our veterans deserve better care than they got in this 

particular situation here. 

Thank you, Senator. 

Senator SPECTER. Thank you, Congressman Adler. 

Congressman Fattah, closing statement? 

Mr. FATTAH. No, I think I agree with my colleague when he says 

that our veterans deserve the very best care and that this is a 

great hospital. I definitely agree with that, since it is headquartered in my District. 

73 

I just think that, again, the real issue here and the benefit of 

this hearing is in our opportunity to impact national policy; and I 

want to thank Senator Specter for convening us. 

Senator SPECTER. Thank you, Congressman Fattah. 

One final point, Dr. Kao. Reverend Flippin raised the issue about 

your looking at him directly and saying something to him personally. You were not the doctor who attended Reverend Flippin, but 

you represent the whole process. 

Would you care to look at him and say something to him? 

Dr. KAO. Reverend Flippin, we should have, we can do better. I 

hope we will have the chance to do better by you and your colleagues in the future. 

Senator SPECTER. Well, that is great symbolism to conclude our 

hearing. 

Mr. VAIRA. Senator Specter. 

Senator SPECTER. Sure. 

Mr. VAIRA. Congressman Fattah quoted from a not lengthy but 

about a 15-page statement that my client made. It is damn good. 

It has got a lot of medical definitions and explanations in it. 

If you want a copy, I know the staff has a copy. If anybody here 

wants a copy—we do not have enough with us—call my law firm 

and we will make it available to everybody. It is a good learning 

experience. 

Thank you very much, Senator. 

Senator SPECTER. Thank you, Mr. Vaira. Now that you have testified, I think you have to understand that you are subject to crossexamination. 

Mr. VAIRA. You and I go a long way back, Senator, a long, long, 

way. 

Senator SPECTER. Peter Vaira is used to cross-examination, and 

customarily, he is doing it, but thank you. 

Thank you, Dr. Kao, for being as candid as you have been, and 

thank you, Dr. Cross, for similarly giving up your vacation plans 

and coming here today. Director Reynolds and Reverend Flippin, 

the most important thing that needs to come out of this hearing is 

that this is not the final chapter. The House Veterans’ Affairs Committee will be having a hearing in Washington. I will be talking to 

the Chairman of the Senate Veterans’ Affairs Committee, Senator 

Akaka, and we will be looking further. But we have identified some 

very, very serious problems, and we need to learn from our mistakes. When Dr. Kao candidly said he planted seeds in the wrong 

organs and should have told people; he candidly said there was excessive radiation and he should have told people. That should be 

a lesson for other doctors similarly situated. 

The business of not having review and oversight by somebody 

who is outside the system is obvious, but that has to be done. And 

we have identified it as a national problem in Cincinnati, DC, and 

across the country. So, this is something which has to be attended 

to. 

I want to thank my staff, Will Wagner and Trevor Benitone and 

others who have worked here on short order. I thought it was very 

important to have this initial oversight done very promptly because 

I hear a lot of street talk about what is going on and what the care 

is for veterans. When great institutions like the Hospital of the 

74 

University of Pennsylvania and the Philadelphia VA Center has a 

problem like this it causes a lot of skepticism and doubt. But I 

think we have taken a significant step forward and very symbolic 

to have Dr. Kao and Reverend Flippin embrace, which is a great 

sign for America. 

That concludes our hearing. 

[Whereupon, at 11:35 a.m., the hearing was concluded.] 

(75) 

A P P E N D I X 

PREPARED STATEMENT OF HON. ALLYSON Y. SCHWARTZ, REPRESENTATIVE IN

CONGRESS FROM THE STATE OF PENNSYLVANIA

Mr. Chairman, today’s hearing is an important step toward restoring confidence 

in the Philadelphia VA Medical Center. I commend Senator Arlen Specter for working quickly to convene this field hearing to shine light on the reports of an ongoing 

and serious pattern of error in prostate cancer care at the Philadelphia VA. 

According to the Nuclear Regulatory Commission (NRC), serious, health-jeopardizing errors were committed in 92 out of 116 prostate brachytherapy treatments performed at the Philadelphia VA between February 2002 and May 2008. In 57 of those 

cases, patients received less than 80 percent of the prescribed radiation dose, and 

in 35 cases, patients received excessive doses to other organs. 

When this disturbing pattern came to light in June 2008, the leadership of the 

Philadelphia VA acted appropriately to terminate the prostate brachytherapy program and to contact the affected veterans. However, two questions remain: Why did 

it take so long for this disturbing pattern of substandard care to come to light? And 

are there other areas of the veterans’ healthcare system that also lack necessary 

quality safeguards? 

Our Nation’s veterans deserve to know that they are receiving the highest quality 

of care from the VA health system. It is my hope that the scrutiny of Congress will 

help to ensure that the Department of Veterans Affairs offers an honest accounting 

of what happened in prostate cancer care in Philadelphia, and even more importantly, to take steps to make sure that no similar pattern of error is allowed to take 

place again. 

Thank you. 

Æ