subcommittee is called to order and today we are meeting to discuss the topic medical of radiation and overview of the issues by now i'm sure many of read or at least heard of the new york times article series on medical radiation errors in the patient's henri's highlighted in those articles are heart wrenching and it raises huge concerns and questions for me as well as from many of my fellow members in the house of representatives i actually was just reading now of today's new york times where there's a front page story about a group of radiation oncology group in melbourne florida that raised a lot of the issues i mean the article today raised many of the issues that we're going to bring out today but particularly disturbing was the fact that this group practice apparently had to physicians who were not present who were actually overseas and  billing on the assumption that those physicians were present and i guess had to be president of the rules and yet they were not so those are some of the problems that they're highlighted in today's new york times and have been in a whole series i want to start however by saying that medical radiation undoubtedly saves the lives it has reshaped the world of diagnostics and has offered patients less invasive alternatives for treating complex and life threatening conditions personally i don't want to express any concern that in having this hearing that we're sending the message that medical radiation is bad i want to assure you that that's not the case it's important that patients do not stop going to their scheduled treatments or getting their see their c their cat scans when they need them and we're not here today to make the statement that medical radiation should not be used but we are here today to learn more about the field and to examine what the driving factors are when things go wrong due to the dangerous nature of these technologies when things do go wrong the effects on patients are horrendous as mentioned the benefits that we as a society have gained from these advances are enormous but we often forget the fact that we're still dealing with something that is toxic to the human body when it is delivered correctly a single cat scan can deliver as much radiation as three hundred chest x rays with operating technology is powerful and dangerous says this is even more crucial that quality and safety are always front and center but tragically as highlighted in these new york times articles this is not always the case a procedure was such a small margin of error should be stripped stringently overseen and monitored but these critical steps appear to be lacking in many cases with all the advancements the industry has made these technologies technologies have become more complex and complicated to operate it's shocking to me that in many states individuals who operate these devices do not need to be license are therefore not regulated at all in terms of education and expertise even states where there are licensing requirements requirements to report errors and the penalties for making errors are basically nonexistent or not enforced as a result we have no idea how often these errors occur and have no good data on where the weaknesses in the system truly are and to stand mr barrow has legislation that deals with training and possibly accreditation as well so you know obviously when we have these hearings we're looking at the possibility of legislation and mr barrels a certainly one of those that we would be looking at i think part of the problem could be the fact that no single agency has authority over the entire spectrum of issues related to medical radiation and because of this things are more likely to fall through the cracks and i'm eager to hear from our witnesses today about this and what problems are present in addition to the lack of oversight from a regulatory perspective there also appears to be very little guidance to physicians on the appropriateness of these technologies especially with respect to radiation dosage and lifetime exposure of radiation one of our witnesses today will go into more detail on this issue but for example dosing for the same cats can can vary by huge amounts between and within the silicates in addition there are questions as to the preakness abuse of the scans i know from personal experience that health care providers are over very quick to order yet another cat scan without talking to patients about the health risks let alone the cumulative effects of multiple scans when i say my own experiences from my mom my mom passed away last december and the reality not this december but the previous one and i remember she had pancreatic cancer when we were going around to different hospitals and we ended up i think it four different hospitals every time i would go to a new hospital i would bring the scan with me you know the disk i guess and i would  give it to him and they'd say oh we can't use that and i would say well why and they'd say well you know our machines don't operate that way or maybe it's a good idea to have another one and i wasn't concerned i mean frankly i wasn't addressing it from a cost perspective although that's a big factor but i was worried about the health implications and you know frankly most no one said to me that there was a problem it was always like oh that's not a problem you know she can have it done again and nobody actually would use the previous one i was never able to get them to use the disk that i had brought with me they always had a reason why they couldn't use it and maybe that was a good reason but it just seems that maybe the lack of interoperability or you know one of those things that needs to be addressed many in congress who question the over use of medical imaging for the most part those conversations that centered on cost implications i have to wonder though if there are not also health implications as well and i'm eager to hear from our witnesses today about this issue and what's being done to study the long term cumulative effects of medical radiation  witnesses today are all intimately familiar with these types of technologies the possibilities they hold and the dangers they can present and i'd like to welcome especially can ms rock who is where is can he's always or he's on the next panel i guess who has traveled here from my home state of new jersey and also mr parks who's son story featured in one of the new york times articles and we appreciate your taking the time to speak to the committee on this very important issue and i think we're going to have some interesting conversation before i recognized mr whitfield though i did want to say that you know just reading the today's new york times article there's so many different factors here you know how much radiation what type of  technologies are used whether we should have doctors present how long they should be present whether they should be nearby or there the whole time it is a very complex issue and i and i don't mean to be simplistic about it but we should also get to the particularly important subject matter and medical radiation involves both radiation therapy and medical imaging the medical community uses radiation therapy to treat cancerous tumors including brain cancer breast cancer lung cancer and prostate cancer just to name a few they use medical imaging like c t scans and mammograms to find those tumors and identify other problems it clear that the overwhelming majority of americans who really receive radiation therapy and medical imaging benefit greatly and thousands of lives are saved each year because of these treatments and procedures hearing will also however focus in part on tragic events associated with radiation therapy these events raise legitimate questions that we need to explore and my hope is that the members of the committee and the public will listen to the witnesses who are experts in this field and not proceed with preconceived notions we must examine the issues associated with radiation therapy and medical imaging and if there are problems to be addressed we need to work with the manufacturers and the healthcare providers to do so however as we examine these issues it is important that no one comes away from this hearing thinking radiation therapy and medical imaging are too dangerous to use because too many lives are at stake i am particularly interested to hear from the manufacturers how these life saving techniques devices work i'm also interested in hearing from the various provider groups on the training associated with operating these complex devices and how the different professional societies develop criteria so these devices can be operated safely radiation treatment is a complex issue and so we welcome the witnesses here today to help and are excited that you can help educate us on what if anything and what steps  we need to take and i would yield back the balance of my time thank you  the gentleman from ohio ms sutton this next for an opening thank you mr chairman and i appreciate you holding this hearing today it's an important and complex issue that deserves our attention and all of us know someone who life has been saved by medical radiation whether a tumor was discovered with a c t scan and treated before grow into something on manageable or whether someone we love be prostate cancer through the help of radiological seeds there's no doubt that medical radiation has allowed people to stay on this earth with their loved ones much longer however as we've learned terrible tragic heartbreaking events can occur and have occurred when something goes awry with medical radiation therapy primarily in cancer patients i was greatly saddened to read the stories in the new york times which included a tragic story about a breast cancer patient from my district who suffered a radiation overdose in two thousand and six when a physicist entered incorrect information into the treatment planning computer her name was my regina garment and she was in so much pain from the radiation overdose and the resulting side effects that she eventually committed suicide according to the ohio department of health there have been eighteen incidents reports with respect to medical radiation over the past two years obviously we want to reach a place where there is no need to file any incident report because there are no incidents patient safety must always be our primary concern and patient safety and radiation therapy as well as patient safety and diagnostic radiation are critical we're here today to learn about the best way to ensure patients are protected to ensure that patients are given the right test at the right time and that no patient ever suffers through a radiation overdose to ensure that our medical quitman is safe and that our workers are well trained and i look forward to learning about the issues surrounding medical radiation from our witnesses today and i thank the witnesses from being here to deal with this very complex issue and i yield back my time thank you we are going to have votes and i know there are quite a few and i think the last ones of the day i'll find out soon but we're just so that we're probably not going to get to the panel before the vote so try to do this many openings this weekend and then we'll have to wait around probably an hour or so for us to come back unfortunately next is the gentleman from illinois mr shimkus thank you mr chairman i want thank the parks family for their attendance and being and we know it's not easy i want to concur with the comments of the the chairman radiation therapy has been very successful in saving lives early diagnosis in airlie treatment has prong the lives of thousands americans and this should be in no way an  attempt but we don't want to scare people away from doing this and some of these stories are starting to do that and we just have to be careful you know cancer survival rates five years so i rates have gone from fifty percent to upwards of ninety five percent in many cancer cases and that is because of this technology and this we have to address identify the problem encourage people to move forward so these mistakes don't occur in this case would be software applications and training in talking with health care professionals and the like a scalpel in the hands of a trained professional does great good scalp on the hands of someone who's on train does great harm and that i hope the focus of this hearing and we look forward to testing what we do think the parks families and those who have suffered chairman and thank you for holding this hearing to call attention to the serious problem of access in errors in the delivery of radiological services while we can expect either the people or the technology to be perfect when you go in a doctor's office you know the hospital you have the right to expect a certain level of competence and training from the people taking care of you on the lead sponsor of the care bill which will set minimum educational and certification requirements for the technical personnel who perform the imaging and radiologic therapy most people are surprised to find that many states don't license or regulate radiologic technologist at all common sense tells us that properly educated a certified personnel will produce better medical outcomes now and that but more efficient delivery and duplicate is testing and waste will also cut costs i recognize that the problems highlighted by recent media reports are likely to require a multifaceted solutions but i'm convinced that we must start by ensuring that the workforce is properly trained and certified without chairman thank you mr brown the other gentleman from georgia mr gingrey mr chairman thank you whether used in the detection or treatment of patients medical radiation has become an important part of medical care in this country latter half of the twentieth century through today we have seen this technology evolve and added the quality of healthcare in our country as an o b g y n physician for nearly thirty years i have seen firsthand the benefits of this technology for the health and the are my patients the chances of survival for a cancer patient as already mentioned are increased exponentially the earlier can't take there in this congress were heard from patients and indeed members of congress alike who credit the and their welfare to the early detection of cancer for others radiation treatments like chemotherapy proved the decisive factor in life or death ms langley is one such patient who credit selective internal radiation therapy with saving her life and thank you for coming before this committee and sharing your story with us today ms ling unfortunately for all of the benefit that patients see from such technology there are also troubling stories of trauma and sorrow the story of james parts is one such case and the trauma his son indeed his whole family and do it because of radiation accidents is a sobering tell you his story reminds us how important it and to proper safety protocols is as well as a review of adverse medical advance can be to the overall health of all of our patients earlier this month the food and drug administration announced a new initiative to reduce unnecessary radiation exposure from medical imaging therefore this is a very timely hearing and i would like to thank chairman polonca for calling it today however i would like to say on one note of caution remember the fear that surrounded the united states preventative services task force recommendations on my margraf the screenings that had this information of course is not faded from the psyche of this country that incident and the congressional hearings that followed outlined for this committee the importance of protecting the rights of patients and their physicians to decide what medical treatments are appropriate medicine is an art form it can be taught from a book but it must be practice with medical experience and yes balance judgement with that thought matt i want to thank all of you witnesses becoming before the committee today i look forward to hearing from you and the question period in your back german thank you i'm trying to get i'm going to try to get two more members in so i guess that would be ms issue mr green and then we're going to have to break but we'll continue after if any for those who come back the gentleman from california thank you m  were really stunned by it that's number one number two i can really track over just the period of time that i've been a member of congress this is my eighth year and  the co chair of the medical device caucus the tremendous improvements in this area which holds out so much hope for especially cancer patients in our country but clearly something needs to be done in the area of supervision the area of licensing and that we in my view we need national standards in this area because it's right now it's kept as catch my i'll submit my full statement for the record i look forward to hearing from the witnesses this is an important hearing if we need more information i will certainly participate in all of the hearing so that we come up with a framework that really fits what the what the problems are so that no one is subjected to the over radiation that we've read about i also would like to ask for a unanimous consent for the record that the relative to a fifty two year old father who is constituent of his three and the father of three children in los angeles and what happened to him relative to excessive radiation at cedars sinai medical center in los angeles without objection so thank you mr chairman thank you i think we can get two more in done is this christianson wants to stay we will start with mr green and then go to ms christians about a problem and i did a scan of my heart of the image of my cardiovascular system and that was great i went back to years later with staff and the equipment had already changed because we're seeing better equipment every day and we don't want to lose that ability to diagnose and to treat in the case of cancers the problem is if we don't deal with this we will scare both practitioners but also patients away from it so that's why they're hearing so important today mr chairman thank you for doing it we need to get it right because the next generation the treatment can be less invasive than what it is now but we surely don't want to stop it because people are scared they're going to be over  not trained to use the equipment they're using or that is not the proper dosage so mr chairman thank you and look forward to working with you and see what we need to do to deal with it thank  see the benefits that the diagnostic and therapeutic radiology have and i'm sure every one of us on this committee either ourselves or in our family have seen those benefits but we always have the better balance the benefits and the risks in favor of the benefit to the patient and minimizing the risk so we've seen some instances lee where and this is what happened over the years where people have been over radiated and have had severe  repercussions because of it and we have a vehicle at least one vehicle before us that can rectify this and it's something that we must do and i look forward to working with my colleagues to ensure that when individuals go for either diagnostic diagnostic reasons or therapeutic reasons that they are not harmed by by the machinery and the radiation and so i look forward to hearing the testimony  witnesses this morning and your comments on how we can improve the safety of these of radiation for our patients thank you thank you mr chairman thank you i think we have at least an hour of so come back after that if we if anybody else comes back we'll let them do an opening statement otherwise we'll go right to you but we're talking i'm sure no earlier than eleven thirty thank you subcommittee hearing is reconvened and we still have some opening statements starting on our side with our chairman mr waxman from california thank you chairman for holding this important hearing and i know we're anxious to hear from our witnesses and i regret that we had the votes that interrupted our hearing but we are looking today at the extraordinary benefits and examining the possible risk associated with the use of radiation in medicine and let me be clear at the outset diagnostic technologies like cat scans that identify tumors and therapeutic procedures such as radioactive seeds to treat prostate cancer are potentially life saving they are important interventions in our medical toolbox and our health care system is a question of the much better because of them but recent reports and studies have raised questions about the relative safety of these technology technologies no medical intervention is one hundred percent safe and patien individual tolerance for risk in being exposed to such procedures varies as well these are dangers generally cannot be avoided altogether but the purpose of this hearing is to learn more about those risks and hazards from radiation that would appear to be preventable and there's been a recent examples as reported in the press investigators at the n r c found that a cancer unit at the virginia hospital and the v hospital in philadelphia botched ninety two out of one hundred sixteen procedures using radioactive seeds to treat patients with prostate cancers over two hundred patients were in the stake in the exposed to up to eight times the normal dose of radiation during brain scans at cedars sinai hospital in los angeles because of a computer error that went undetected scott jerome parks the son of one of today's witnesses was blasted with excess radiation on three consecutive days during his treatment for tongue cancer scott died from his radiation exposure at the age of forty three despite these patients need and consent for the life saving technology used the end result clearly is not what they signed up for alarmingly as we will hear from a number of today's witnesses these are not isolated cases the mistake it's made in these instances well perhaps not widespread we hope not widespread appeared to be more than just random and rare they are occurring all across the country and in hospitals and physician offices alike the reasons for this poor quality of care would seem to be multifaceted whether it's a lack of standardization of equipment or lax and even non existing state licensing requirements for machine operators or outdated federal oversight authority experts tell us that more can and should be done to reduce unnecessary radiation exposure and medical errors indeed action has already been called for by the medical imaging manufacturers and some radiation provider groups whom we will hear from today as we move forward i would hope that we can all agree on two basic premises first is the enormous medical value of our various radiologic techniques as i mentioned earlier we want to underscore the point again both diagnostic and therapeutic radiology radio radiology interventions save lives if we want them we need them second is the obligation to ensure that these interventions are as safe as they can be and that everything is being done to make that a reality patients are entitled to nothing less with these principles in mind i believe our job today is simple and straightforward to understand how to lower the risks associated with radiation and medicine to make it as safe as possible without reducing its many benefits to patients and researchers we have an outstanding group of witnesses is no longer this morning this afternoon they're here to help us learn more about these issues i think each of them in advance for their testimony and i look forward to hearing from them but in my case from reading their testimony because i'm compelled to go to a meeting with the speaker on health care which will require me to miss the testimony but we'll have a chance to review what i think the witnesses for being here thank you chairman waxman the gentlewoman from north carolina misfired thank you mr chairman in the state for the sake of time i'm going to submit my statement for the record along with a letter from the society for radiation oncology administrators without objection so ordered thank you thank you and so i think we've had opening statements from everyone else so we'll move to our  panel and let me introduced each of the panelists if i could beginning on my left is mrs mr james and ms stop mrs donna parks from gulfport mississippi thank you for being with  today and suzanne lindley from canton texas and then we have dr rebecca smith binman who's professor in residence of radiology and epidemiology and biostatistics  washington university in st louis and then we have dr cynthia h mccullough who is director of clinical innovation at the c d c clinical innovation center department of radiology at the mayo clinic and professor of radiological physics at the college of medicine at the mayo clinic that's our panel we asked you to give us a five minute opening statements if you can limit it to that please and your statements your full statements become part of the record then we'll have questions from the panel i should mention that beyond this you may get additional written questions from the panel within the next ten days or so is well let's start with you mr parks thank you for being here let's make sure that your microphone is on it should be a green light and maybe bring that a little closer to mr park so that we can mr chairman and committee members we want to thank you for the opportunity of coming here to talk and we are here to testify on behalf of our son scott who died from an extreme overdose radiation mayenne very inept team of therapist using  procedure turned out to be a two year nightmare for the whole family especially he and his wife they were in new york city and that's for monster this occurred we were we were doing the right thing he had not wanted a surgical procedure which would have been very bad my hearing aid just went down so he chose what he called the laser treatment and we thought it would be very quick after the implant we thought that was just sort of an inconvenience it would be temporary  it didn't work out that way  of every day for two years and suffered all of the things he suffered but she can't speak because of a gag order and it's tied to her financial settlement she's the one who should be here and is and she knows everything that's happened each time we would go visit about every three or four months that we would see him  i'm not sure all patients do this but he rapidly became blind and deaf and he had constant pain and vomiting he became extremely weak and sleepy really couldn't hardly he could last for about fifteen minutes but he  always kept his interest in carmen he said he would keep himself alive to make sure that she was alright and he did that martin for suffering so much until the process was ran as its course in he was finally taken care of we met him for the last time at christmas when he friends had sent a big box and in the box with sand and two pails any on the video that he made he said just lay and his teeth were falling out he couldn't eat he didn't eat anything from the chairman got the stomach implant until he died and he used to like t became retching his wife was there and she got alarmed and asked them to stop the treatment but they ignored her and this went on for a second time and then a third time when the machine was wide open any got blasted with unguarded amounts of radiation  d the hospital i think made an error and told scott that this is never ever happened before and that there must be something with him because the machine always works perfect thing and of course they found out that wasn't true and that's when scott went into this he knew he was go dying cause for him to live to live for as long as he could and he stayed all to all the suffering and until finally there was a financial settlement and he told me that carmen was the reason he was staying alive and at the christmas party i remember hugging him raft very rapidly got much worse and soon died it was traumatic for all of us particularly his wife carmen and she was  wanting to testify and of course you can't do that and it's a shame that this is a secret that we aren't supposed to talk about and that's why we're here i told him i would do what i would what i could and what i did is wrote a scathing obituary for him which didn't do any good and i wrote a letter to the editor  didn't do any good and by some miracle i don't know how it happened but the new york times picked up on this whole issue and has gone and it snowballed i think it's making  impact and that's exactly what scott wanted looking down and he's very pleased i would like to say  that we are impressed with the machines and they're not as good as they could be and they must be improved to where they are we have made a couple  recommendations on life quickly read them we must develop a strong mandatory database that we don't have and all medical institutions should report to the database and it could become or jory for evaluating trends and identifying medical problems all medical problems not just radiation the veterans administration has developed reporting system reports and response to medical accidents called and c p s that's all i know about it but it works in the v a system very well and i think it would be nice if the whole country would adopt such a thing we're very encouraged that the s b a has taking a regulatory ask the medical equipment manufacturers to develop a fail safe interactive expert system that can interact with human technicians to reduce and eliminate human errors so i think that's what really scott was human error and that is the machines must talk to the technicians and of course the technicians should be very trained  oncologist and supervising physicist must learn to micromanage their radiology departments that's the only way they will work if you don't do that you're to have people dying it's outrageous to us that trained in unskilled workers can get anywhere near this dangerous equipment that they do in th and in scott's thank you thank you very much mr parks and also mrs parks for being here i mean i i know how tough i shouldn't know it had to be tough for you to be here and give us your testimony but it's really important because this is the very thing that we're trying to prevent in the future so i don't know what to say but to say that at least your being here in some way  you know can maybe make up in some way for for your loss but at least you're trying to prevent it from happening to others thank you thank you miss linds as a patient i too want to make sure that i'm in safe qualified hands when i have treatment and it's hard to follow a story like your specialty when mine is been the complete opposite thank you for having me today and patient advocate i'm here because of cancer research because of medical imaging technology because of radiation therapy i was thirty one years old when i was diagnosed with cancer it was eleven years ago it was then that i was diagnosed with stage four colon not only for stage is my was a very most advanced with found out that i had tumors that had already spread to my live and i was told that i had about six months to live we were scared we were sad and we planned our first thanksgiving as though it would be my last vacation with my vacation a holiday with family my daughters were eight and eleven years old we focused on the fact that i was going to die and we very much lost all of the fact that i would live i posted a note online list serv asking for guidance from other cancer patients on how to prepare my two young daughters for life without me and instead of answering my question a gentleman wrote back shelley wilder and said that he too was going through stage four colon cancer and i should look for some hope and that's what we did i started with the only chemotherapy that was available was five if you have been around for thirty years i was fortunate that colon cancer research was rampant and it's my cancer progressed i was able to benefit from each new treatment that was developed that worked for about six years and then the cancer began to spread there were no more approved options so i went in the clinical trial and those bought me a little bit of time then my liver became laced with tumors they were multiplying to the point where it looked like the stars lit up the sky at night my stomach is full and my skin was yellow and i was tired every breath every move was hard and the doctor said that there was nothing else that they could do and that basically i should call in hospice and that my condition was terminal we're preparing my family again and it's not up for an e mail to friends letting them know that i was at the end of the line then after calling hospice planning a funeral and picking out a casket i got a phone call from one of the friends i written a letter to and he told me about his daughter and what constant it was using selective internal radiation therapy and their little radioactive beads that are implanted internally and they attack the liver tumors and they leave a healthy tissue healthy it sounded too good to be true and so at first i was hesitant to call the doctor and then he kept calling me a dozen times that day and finally i picked up the phone and i call the doctor and we talked for a while and it turned out that i was a good candidate for the treatment i went  just not told him about the procedure and thought he would be really really excited for me and instead he said you know i help you and then he turned around and said what do you have to lose no one knew how much i had to gain i receive the outpatient treatment call radio embolization in january two thousand and five and i call them little magic b after six month period we saw sixty five percent of shrinkage and then after a while we started seeing the process of those tumors so they were literally dying from the inside out my belly started to get back to where there wasn't fluid in it my color came back and i began to live again i learned how to scuba dive a diving i started telling my private story in very public places i connected with other people and i met and shared experiences that i never seen it and i had been for this disease or these treatments i continue to assist them in therapy and i've also received additional toward radiation returning liver tumors and i've had cyberknife for a long time and they've all given me a little bit more time with my kids when you start anything and especially in the treatment you hope for the strain you pray for the best you prepare for the worst and you don't really know what's going to happen but all you have is hope these events radiation therapy technologies have given me that hope they will allow me to watch my daughter grow up to see them walk across the stage for graduation to start college to become adults that are nineteen and twenty two now you know both in college these treatments allow me to walk hand in hand with has been and hopefully will have more of these treatments and we'll be able to spend our rocking chair days together i still have tumors here there and everywhere systemic the therapy after eleven years is just now part of my normal retraining along with that i'll continue to use the target a radiological therapies when needed they allow me to live a colon cancer is a chronic condition and not a terminal one there's existing treatments  medical innovations will be a part of my life until there's a cure for this disease what they've been able to give me is nothing short of miraculous the grandest miracle is a realization that i'm not dying from cancer i'm living fully in spite of  hundred americans that will lose their lives today and each and every day after this for our close i want to leave you with this one thought as my perfect personal story makes painfully clear there are barriers out there already and i realize that you're not dr smith binder bind bind them in i guess the name of i'm sorry so that's how we spell about mine men thank you chairman poland ranking member whitfield and members of  subcommittee thank you for the opportunity to testify today my name is dr rebecca smith fineman professor of radiology epidemiology and statistics at the university of california san francisco school of medicine i'm a clinical radiologist and my research focuses on assessing the risks and benefits of medical imaging my testimony today focuses on c t because it's one of the most common imaging tests we use and it's a test with the greatest potential for causing harm c two uses x rays to obtain extremely detailed images of internal organs and the development of c t is widely considered one of the most important advances in medicine allowing a more timely and accurate diagnosis of disease across every area of medicine it is simply an extraordinary t and currently one in five individuals in the united states undergoes a c t scan every year although c t scanning is useful it delivers much higher doses of radiation than do conventional x rays and exposure to radiation can lead to the development of cancer to help put this into context when you go to the dentist and you're offered dental x rays some of you may pause to consider any potential harm from those x rays the most common type of c t scan that patients undergo in the us an abdominal c t delivers approximately the same amount of radiation as getting fifteen hundred dental x rays all at the same time additionally newer applications of c t such as those used to assess blood vessels in the brain require even higher doses of radiation as much as five thousand or more dental x rays the increase in the number of c t s and the higher dose for some c t s has resulted in a large increase in the population's exposure to radiation from medical imaging the national council on radiation protection a group dedicated to ensuring that the u s population is a safe as possible as it relates to radiation has estimated that the u s population's exposure to radiation from imaging has increased dramatically the risk of exposure to radiation increases a person's risk of getting cancer the national academy of sciences national research council reviewed all of the published literature on the health risks of radiation they found people who received doses in the same range as a single c t were in s risk of developing cancer further many patients in the us receive multiple seized c t scans over time and their wrist reason hire the doses that we experience every day as part of routine c t scanning are potentially dangerous to cancers may not develop for five ten or twenty years even though we can't see the harms immediately we must take them seriously oversight for c t radiation dosing is very fragmented the f d a oversees the approval of the c t scanners and medical devices but does not regulate how the test is use in clinical practice radiologist determine how the c t tests are performed however there a few national guidelines on how the study should be conducted and therefore has great potential for practice variation that could introduce unnecessary harm for excessive radiation dosing the american college of radiology has established a voluntary accreditation process to try to standardize practice and collects dosing permission but only on a very small sample of tests this approach is promising but at this point in time the data collection is extremely limited making it difficult if not impossible for the college to monitor facilities comply with their guidelines the manufacturers a c t equipment have begun work to establish standards of how radiation dose information should be measured and reported however the manufacturers have not adopted or implemented these standards my research team u c s f conducted a study to assess the doses associate with typical c t scans we collected radiation dose on over a thousand patients and found that for nearly every type of c t scan the radiation doses were much higher than commonly reported that the dose is very substantially between different facilities and even within the same facility the doses vary dramatically between patients as part of the study we also quantified the risk of c t we found that for some patients the risk of a single test to be as high as one in a hundred that means of one hundred patients who undergo a c t one of them could get cancer from the test this is an extremely high risk for a test opposed to find cancer not cause that what needs to happen to improve the safety of imaging given the importance of c t and yes the potential for causing cancer it's imperative that we make c t scanning the safest possible to do this we need to do two things firstly we need to lower the dose from routine c t scans and second we need to ensure that we use this technology only when necessary to lower the doses several steps are important we need very clear standards for what are acceptable levels of radiation exposure and there should be regulatory oversight for setting of the standards doses used in actual patients need to be monitored despite the potentially high radiation dose he can deliver there is no regulation of c t practice in the united states the dose information should be prominently displayed when c t s are done so the technologist can easily make adjustments of needed if the doses are too high and lastly the dose associate with each c t examination should be documented and recorded in each patient's medical record and this information should be tracked over time recording and tracking dose information would help educate patients and providers about radiation exposure and would lead to activities to minimize there are currently private businesses that offer full body c t screening to healthy individuals the f d a and most professional organizations have voiced concerns that using c t as a screening test could cause more cancers and they find for diagnostic c t these are tests that are done in patients with a clinical problem who have a symptom it's generally been thought that if the patient is sick enough to get a c t scan that the benefit of that test will outweigh any risk however we have started to u scanning so often and in patients who are really not very sick at all that we need to really think about whether the test is necessary and whether it could cause more harm than benefit me to physicians or patients are aware of the risks associated with c t nor the importance of limiting exposures in summary consensus is growing that efforts needed are needed to minimize radiation dose from c t and to ensure that patients receive the minimum dose necessary to produce medical benefit these efforts must include reducing unnecessary studies reducing the dos reducing the variation in dose across patients episode despite the frequency importance of c t imaging there are no resources available to the research community to study or improve the quality of creation of an academic consortium to study and make it a chairman and members of the committee thank you very much for the invitation to come and speak here today my name is eric cline i'm a professor of radiation oncology a washington university and have been a clinical medical physicist for twenty eight years accuracy we can now customize how doses are delivered to tumors by performing sophisticated calculations allowing physicians to escalate dose to increase cure aids simultaneously we can reduce doses to critical organs even tho close to a tumor the delivery technique of intensely modulated radiotherapy i am artsy which provides superior treatment delivery customization comes with an increase in complexity in the radiation time compared with conventional radiation therapy thereby increasing the risk thousands of hospitals and private treatment facilities all over the country have purchased by us he machinery often for a competitor purposes and far too often with our properly trained staff in place hospitals need to ensure staffing levels are adequate not only a number but an expertise there should be on testing methods before therapist begin to treat patients with testing on a frequent basis the training for all staff involves and with should include the consequence of something is incorrect there can be as many as one hundred steps in each process and each step must be understood by everyone involved especially those stats with greatest volatility we do a good job teaching people otherwise should be instituted in order for the community to learn from such errors or even near misses the second problem with this low in a dual report a rate is that is still too high hospitals need to encourage patterns to allow for time outs before each event begins to allow for cross checking of all parameters by therapists related to this the time leading up to a patient's first treatments chillon for careful review by the physicist of all parameters to be used in addition the manufacturer's testing of radiotherapy delivery and treatment plan equipment should include fall testing and compatibility between systems your guides to medical physicists we are the vital interface between physicians orders and the eventual treatments we are responsible for many things including the accuracy of the images used for the treatment plan the validity of the calculations the quality of the resultant patient treatment plan the accuracy of the lyrics all writers delivery systems and the overall and validation that each patient will be treated accurately but having the intuition and wisdom to detect the potential our underlying problem only occurs with rigorous training medical physicists are educated in many important areas and after proper training ideally in the credit residency program may become certified by the american board radiology a b r starting in two thousand and fourteen the a v r will only allow physicists w completed a residency program to sit for the boards this will raise the bar for the exam thereby raising the coppin c of all medical physicists in a very few near future but the a v r has to wait until two thousand and fourteen to allow the growth for the number of credit programs for this to take place the growth has been hampered by lack of funding there are some funny mechanisms but the most assured balance method would be for the center for medicare services to provide reimbursement for training physics residents similar to the method that's in place for training physician residents and finally there is an ironic situation regarding oversight of radiation treatment equipment to operate a mammography unit and to be a reimburse for the procedure a robust quality assurance program must be in place with oversight by a qualified medical physicist and most importantly programatic overview by the f d a an american college of radiology this model of requiring a quality program and qualified personnel to be in place with review by an agency in order to be reimbursed for providing radiotherapy treatments should strongly be considered for radiotherapy as a profession in closing approximately a million patients per year are safely and accurately treated with radiation therapy receiving outstanding vital treatments but further steps to ensure patient safety can and must be made thank you thank you d thank you i do have visual aids for some of the points i want to thank you very sincerely for having this meeting today it's an honor to be here and i want to speak to you about the safety of  on the right there at the extreme high doses such as what's required to effect a retreat cancer radiation can cause severe biological facts in this high dose region the effects are predictable based on the dose it's delivered and can result  cell death skin injuries skin reading hair loss next place in contrast let's look at medical imaging which uses a factor of a thousand times lower radiation doses at the doses used in medical imaging there is a chance an effect might occur but there is considerable controversy about the level of risk in developing cancer from these low doses next effect if we look at the risk level as the blue line here is a relative risk of one meaning no increase in measure next please so with regards pacifically to c t technology modern systems are equipped with feedback systems that will monitor the amount of radiation passing through patient and reaching the detectors and then to do just that radiation output throughout the patient and throughout the tree throughout the scan to adapt the amount of radiation so you get the image quality that is needed at the lowest dose these systems automatically adapt the dos across within the patient but across the spectrum of patient sizes from children all the way up to morbidly obese patient so here's an example of the automated setting taking the dose from the adult level which would be about one sixty five and it tailored it automatically down to a child level  i'd also like to point out that the patient goes for a single exam of the abdomen and chest and pelvis is a factor of two or three times lower now than it was two decades ago the current technical innovations continue to drive doses lower next click even though throughout the years the image quality keeps getting better these numbers here the section with the nanny represented by one image and we continue to get center which gives higher detail better image quality however c t is a sophisticated medical device and with any device or procedure human errors or electrical mechanical errors can happen and that's why i'm very grateful for the interest of the committee the f d a and the whole imaging community in ensuring that medical imaging is performed safely as possible whether or not the exams involve izing radiation i believe that the technology is not our fundamental problem i believe that the concern is of education for the technologists that operate the equipment the medical test equipment optimizing it and the radiologists who prescribe the exam protocols the education has not been able to keep up with the rapidly growing changes in technology and the single most important factor to make this more safe for patients is to ensure that all personnel involved in operating medical imaging systems meet nationally prescribed minim levels of training camp and the needed accreditation and certification programs already exist but without mandatory requirements for a consistent level of education we are allowing in some cases inappropriately trained personnel to operate advanced medical equipment one of the examples of the educational efforts being made by the imaging community is a dose summit by the american association of physicists medicine we're having this in april this year we organize this to teach users how to adapt the scan protocols to make sure that they're appropriate for the diagnostic task and for the specific patient the faculty and attendees includes businesses radiologist technologists and regulators and the meeting is being contributed to by a large number of professional organizations in the imaging community of note the registration is capped at two hundred percent two hundred participants and the meeting was sold out within one week of registration going live in summary today's medical imaging if you as you've heard as you're well aware has some absolutely amazing technology it can manage basically diagnose and guide treatment for injuries and diseases that couldn't be accomplished in the other way without c t there would be more unnecessary surgeries such as for suspected appendicitis that didn't turn out to be appendicitis more invasive diagnostic tests and less effective treatments before the advent of exploratory surgery was not uncommon but clearly medical tests where there has ionizing radiation are not only before and when they're medically appropriate when they are the benefit far outweighs any potential risk and that there is a very real risk to the patient's h if the necessary medical information is not obtained unfortunately right the patients are being frightened by the media reports about the dangers of radiation we are seeing patients come into the senate with symptoms  potentially severe illness or needing life saved three surgeries or treatments who have refused them because they've heard on t v or in the papers about this cancer causing stuff they are being harmed because of not getting the needed not the image exam is being done properly we should take care of that with training base should be concerned about whether they needed my loving year old daughter ended up in the emergency room and the ultrasound showed attention lacerated spleen they went to c t for the definitive diagnosis it was normal thankfully and i don't think that was an unnecessary exam it saved us from having unnecessary surgery thank you thank you doctor and i agree with you i'm going to paris and have  the witnesses starting with mr and mrs parks i'm a parent and it just should not be the case where parents bury their own child so what you have done and coming forward today is enormously helpful to us and it's painful for you but i think that what you are doing in the name of your son is an enormous contribution for us to really address and get to articulated so well what these technologies bring forward and the hope that they represent and your own example and by no means does anyone on this committee want to put a dent in what we have produced in our country that is in so many cases second to none in terms of the application of the technologies that are lifesaving and life extending and i think that what you said really points to that to the professionals to the doctors that are here it's wonderful to have someone from from our region from u c s f absolutely terrific let me just make a couple of observations we have it seems to me and in looking at all of this that we have safety procedures and oversight that need to be addressed that we have obviously fifty states and we have a patchwork quilt of of regulations there isn't any consistency that i can find in terms of what i've read there's the whole issue of proper supervision radiation is lifesaving and it can kill someone so i mean this this is something that needs to be supervised and there have to be proper super supervision but there also has to be education and training in that and we don't really have any national standards on that one of the doctors mentioned the the the practice variations that exist  and there are really no standards across the manufacturing field a credit cation i mean i i don't think there is any national standard relative to accreditation what i'm is of the professionals of the doctors a would you recommend national standards in these areas i can't help but think of the the mammography quality standards act that one of the staffers and it's been our staff report here that many years ago we were facing with mammography and the congress stepped up and put that law on the books and it addressed many of the issues that we're talking about here today  do any of you disagree about national standards needed to be addressed so you all agree do you believe that there should be accreditation in this area and licensure of those that administer the radiation in c t the american college of radiology has an accreditation program that's not mandatory by regulators but is become mandatory in a defacto sense because the insurance companies started requiring it in order to get reimbursed and so the program actually has thousands of units that are credited the program does address dos we measured those we have a database of those and as part of their creation program i have seen it continue to raise the bar of quality in c t since its inception in two thousand and one when i was again from the from the doctors what responsibility do you believe the manufacturers have in this what positive role can may play where do you i mean maybe this is a sticky wicket for you to be telling us but i'm not on a hunt against anyone but it seems to me that we've got to examine each facet of this and if you think that there is an important role for them to play in this and what that would be i think in the area of diagnostic metal medical imaging we have very little data about what higher than that on average and for one patient the doses range for one type of problem range from five to one hundred millisieverts for the kind of test that's supposed to have a dose of ten so in fact we don't know what's currently going on the doses in general could be much higher than we think and more variable part of the problem is there's no organization collecting those documenting those and part of the difficulty in that is the standards for reporting does vary across the board so there's no consistent way the dose is reported that a radiologist could easily look at the information on an individual scan and understand so you asked about the role of the manufacturers there are several very important committees that over the last several years have agreed upon standards for reporting those information for putting that information in the medical records the standards have not been adopted by the manufacturers if the standards were adopted by the manufacturers we could could quickly know what's going on and then determine how closely different facilities abide by those guidelines that we put out there so we need guidelines about what's allowable and we need data to decide if places are within those guidelines so i think the manufacturers could enormously move this field forward by adopting the standards immediately and having this data that's very helpful i know they're going to they're going to testify at the on the next panel but i won't be here and we definitely need to to work with them dr klein did you want to add to that ok great and then i i do have a slightly different value on this there's an organization called the international electric technical commission and it's a trade organization that's worldwide that the council it's mandatory that it be shown to the whole reads that it's right for the technologists and they do read that before they use it really isn't it's in front of them it well and one of the things is the tend to be prescribed for a given patient and diagnostic task and the variation that you're hearing about radiation gets stopped kind of quickly in tissue so every four centimeters of extra brilliant you know this better than anyone that's why you're the expert one of the experts in terms of testifying but to suggest that that the knowledge is somehow transferred through the system because there's a sticker or something in the equipment doesn't do it for me i have to say that but thank you very much mr chairman and this is going to require the work of our committee but it's what we're here for and i think that the people that you have assembled and we need all of you to to be part of the i'm sure legislation that we will draft and pass and it should be bipartisan this is this is in regards to radiation oncology equipment and manufacturing responsibility certainly the machinery goes through quite a bit of testing before as well as in the factory and as it gets delivered what could be done better is the training for the users  training to demonstrate if this message shows up this is exactly what it means and some of the manufacturers are inconsistent on some of the testing that they perform with the users with the physicist one company does a very good job for example of forcing errors to happen and then watching them that the machine will stop and show you what that error is but it's not consistent and the other problem that is a wide variation is problem reporting how errors or how machines that aren't functioning properly how that information gets to all the users it varies again how we get that information unfortunately sometimes it's an old old list servers rather than direct communication to any potential user of this equipment it might be better to do overkill communication right now which is scant and irregular thank you thank you mr wood feel mr ms parks i also wan thank you for being here today and sharing your son's ordeals with us we appreciate that and his landlady thank you for being here as well when we talk about medical imaging  travel limited i mean we talk about cat scans m r i s x rays and that's primarily yet but then when we talk about radiation therapy i'm assuming that there was a brief hundreds of radiation therapies are i know we have linear accelerators we have galvanized we have dr klein would you help me with that about the different kinds of also the use of actual radioactive sources directly placed in the tumour for a technique called breaking therapy which again was the was what happened with the v a hospital was a form of breakage therapy so there are  days or five days sometimes left in permanently well let's take a linear accelerator for just a moment of course we have the manufacturer involved because they made typically how many people would be required to be on the site when the linear accelerator is being used as it was on the parks and i would say for the most part two to ration therapists are at the console there can be three hopefully not one although i have witnessed that on some occasions so there's radiation therapy yes now our radiation therapist medical doctors know that there were therapists or people off these are radiation technologists have had the education to become ration therapists in treating patients but they go by the name therapist well i know that from reading about mr ms parks son it appears that his injury was the stain because of  the filters the filters were not calibrated or adjusted in the proper way that some what happens with regular radiation therapy conventional is that there is an open beam that treats a patient with intensely modulating radiation therapy there are devices little collimation devices that move in and out of the beam which gives it this very customized way of delivering therapy and so if those aren't in place  then the results of can can be can be problematic well from the testimony and that's because the irradiation time the time it takes to deliver i am r t as i mentioned testimony is longer than conventional therapy because the being for the most part is being blocked creates extra time from the testimony you all can correct me if i'm wrong but it appears that the recording of error as the dose is being used the sharing of information to the people that should know what it appears to be a really a fragmented system that i'm assuming would vary greatly with every institution would  correct in that assumption certainly would an institution does from institution to institution of how they handle errors what type of database they have and how they examine and report back to the entire staff i know i know a very consider obviously from state to state and and so forth well you know i'm really glad we're having this hearing because all three of you had indicated that you do feel like there does need to be some national standards  to assist in this area when we're dealing with the equipment like this that can certainly provide healing powers and do miraculous work it can certainly destroy a person as well so  your testimony is really been helpful and i do thank you all three of you for being here and let me ask one question just out of curiosity you know this is not anything technical that i noticed the either in your testimony or in your resume that it talks about college of medicine and i was it i guess i should have been aware but i wasn't anywhere there was a college of medicine at mayo clinic i mean i know you have residency programs and  technologists and allied health so you have the whole gamut and we try ok thank you thank you mr whitfield i'm going to ask some questions now i wanted to first again i don't know how i could thank the parks and i for being here and you know relating the story of your son it's just it's really a sobering reminder you know why we're here today frankly that you that you're relating to i just ask mr parks you mentioned the error reporting why is that so important if you what you mentioned the error reporting you know that when they report the errors you mentioned that why do you think that's so important the reporting again i got a i should turn that yeah my understanding is that machines  have like a focus and ordinarily they it seems to me they should be shut so that they can't over they can't kill anybody that in this case it was wide open and it was wide open attitude three days in a row where the physicists didn't check the machine nobody did and in a little we know about it there were four unauthorized and trained people who fiddled with that machine during those three days and that's i can't explain that i don't know why that happened ok so your view you're basically saying is that if this if if if there was more supervision and these things were reported that we might prevent it yes the physicist it's our understanding nobody can run it but they did and there needs to be enough staff to where there's somebody all the time watching that machine also we found that the ones that were there were watching them on a chair and apparently they give them some sort of medication that makes patients vomit sometimes and his face was covered with a mask and they were watching to make sure he didn't vomit into the mask and aspirate they weren't watching the monitor that was telling them that something is wrong you thank you so much miss lindsay miss lindley you know i think it's i mean obviously you said and i've said that it's critical that these technologies be available but you also do you also think that more needs to be done to make them safer maybe let me get the mike again there better safe hands and i think that especially with the selective internal radiation therapy that i had which was plan planet radiation they did after i had the procedure they actually took me back and did a spec scan to ensure that the radiation was in my liver and that everything was good and so i was i was very confident after i read their article i know that the next time i have a s gets a little complicated but if we look at ways to improve the system there are two major models that i know of one is that my graffiti quality standards act which i guess i'll call em q s a and then the changes in the medicare and movement for patients and provider rock which is nipa i guess i hate to use these acronyms but i have no choice and my understanding is that the m q s a is much more detailed and sort of aggressive that's sort of a general statement on my part there's no there's no accreditation required for radiation treatment facilities no licensing requirement for personnel so let me start with d mentioned the mammography standards in your testimony i guess that's the usa you know i believe in the importance of these standards but the question is you know is radiation therapy too complicated or too diverse for congress to regulate it the way we're doing with the m q s a i mean would you think that we could go that route or are you think we should just leave it up to the practice of medicine i think because of  complication conflict complexity it's even more necessary to have oversight and to have accreditation for facilities so you would would you use the m q s a model not exactly that model but what it's trying to accomplish yes uniformity that all mammography centers are giving the lowest office possible to get the best images and i think that philosophy should be can to be carried force that every facility before it turns on a beam has been checked and the personnel know exactly what what they're doing ok now can i make a distinction between you know the mammography standards the m q essay and the myth in your mind and not familiar as much with the middle but my understanding is that it's not got as in depth and prescriptive credentialing requirements for the staff for example certainly not going into the detail with the quality assurance so you would be more inclined to use the more detail your aggressive model of the usa i hate to you know i'm using my own terms here to describe it but you would be inclined that way i think it's been a very good program  there's a lot of overhead that comes with it so we would just want to be very cautious as we move forward that we do the best without adding too many levels of extra steps do you want to comment dr smith been i'm i do a lot of my research focuses on breast cancer so i know the m q s a rules and regulations in detail and i know the impact they have had on the quality of mammography cannot be overstated mammography has improved profoundly since the enactment and q s a regulation and one of the things that's so wonderful about this is they actually follow what happens at the patient level in terms of what they're likely to get when they go from mammogram to ensure that it's of a high quality so i think there's probably a role for both of those in oversight but n q essay has improved both the technical quality of mammography and it's also improved the interpretation of mammography by having agreed upon standards by which these exams are done and interpreted across the country and so the impact has been really phenomenal on the quality and improving women's access to high quality mammography  example i think it's very important to think about what accreditation is going to do and i think if accreditation is going to put some general standards that's absolutely a move in the right direction but what you really want to make sure i that every patient and every facility is safe and getting the best quality examine can and i'm not sure an overview of accreditation will give you that so i think it's certainly a place to start it makes no sense to have to say that are not accredited as long as we make sure that accreditation actually gets that quality but i think in addition to that we also need some safety measure to make sure they're actually getting the highest possible quality out of these tests as possible all right thank you very much interpreter talk since we're both from texas but thank you for bringing us up and i've watched him because some of us have served on the committee for many years and healthcare is much part of my life as it is physicians i think because we as it was being built but also their laser treatment facility there it's amazing what done today that used to couldn't be done simply because surgery couldn't do it and that's why i'm so concerned about making sure we get it right so we don't take away that growth in the technology that makes us healthier people dr klein can you describe the latest advances in radiation therapy and like i said having been m d anderson a number of  times i know my local one but i know there's also great facilities all over the country as i mentioned before there are numerous variations on later accelerators and what's been the most exciting addition to these lyrics  ability as the addition of imaging devices actually within the treatment room and this has had a huge impact because now we can capture exactly how the patient is setting up and for that matter being maintained in the right position during treatment and this is very important so this is what's known as image guidance radiation therapy so this is help us improve our accuracy of set up and also how the patients are being treated throughout the course of a given treatment the other new technology that's starting to boom of course is proton radiation therapy these are large facilities that deliver a very different type of radiation therapy very customized and idealize for pediatric radio radiation therapy for example so these are some of the new things that are coming and nothing should ever stop these from happening again but the people trained to use them and how they're used again needs to be looked at with scrutiny well i know there's a difference for you radiation that maybe we all but it cuts through for decades but compared to what's happening today with whether it be proton or even high thin usage of radiation can use talk about that the difference between what has happened in the last few years treating particular cancer customized for example not every patient is a great candidate for intensely modulators there are some that still benefit from conventional therapy but certainly for the most cases i m r t has improved our ability because a lot of these tumor sites are in locations that happen to be right next to a critical organ that we don't want to give any dose to and lately we've been able to give again the curative doses we need to those those tumors while not giving the dosage that would cause problems for the organs nearby and that has only been improving over the last five or ten years well and i know having heard mr parks and again what happened to the park son just seems like we ought to be able to prevent it  but can we do better on reporting the error although we know there is reporting because otherwise we would be here today because we see it in lots of different very so it is around the country even to be a facility so is it do we need to do better on reporting there so we can make changes or corrections sooner so that i was thinking of reporting in two flavors one is anonymous reporting reporting that someone sends in that it happens with this particular machinery and does an analysis of why it happened but they do it anonymously so that they are so they're more likely to do that because of there wouldn't be any direct liability now the airline industry learned that that was a great way to go for learning about incidents and near misses to not just instance that happened but once it almost happened and everyone learns from that and then the course of the other error reporting for an actual damage to a patient and they sort of both have to happen but again you can learn something from both but anonymous reporting is something that that we need to consider a lot of facilities are reticent to do so because they're afraid they can clearly submit an anonymous report without getting into trouble and  know from other members questions on both sides of the aisle that it's not something we may be able to do voluntarily you know the industry to regulate itself it sounds like we actually need legislation to deal with it is that correct i think if we if we go to the step of having your report ever ever ever reported as mandatory then obviously has to come from an agency the nuclear regulatory commission does that right now if you're in a state that is where the isotope use use of the right after cereals is still governed by the nuclear regulatory commission not every state has that two thirds do not but if an error were to happen with the use of an isotope for any therapy such as gamma knife we absolutely have to report that well thank you very much chairman for calling this important hearing and thank you every one of you for being here today there have been such tremendous technological advances in medical treatment but all agree that it's imperative that everything possible be done to minimize the risk of something going wrong and there was a terrible case in my hometown at the premier cancer center that has a reputation problem wasn't discovered until inspectors from the radiological physics center a federally financed testing service came in for an inspection and the director of the radiological physics center said that if the inspection occurred so i know you all of called for greater training broader accreditation but on this narrow topic what about the folks that come in and install the manufacturer's representatives  into the facility to actually have one of their own physicists or a hired physicist or something to test as an independent measure because equipment manufacturers make sure it's operating according to specifications but then there's to happen in this case the secondary texts that then that the people measure and calibrated and set it up for their uses so i think duplicate systems are always good checks and balances so the wasn't until the radiological center came through again that they noted there i think that it's very important to know how the machines are used in actual practice not how they're used before they leave the factory and the manufacturers when they come in to set up every c t scan for diagnostic imaging at least they work with the local physicians to figure out how to set up those dams and it turns out it's a complicated topic but you get pretty your pictures if you turn the dose up higher and those default settings are crucial in terms of what most patients receive and if those default settings are set in such a way that you get the most beautiful pictures then it turns out the patients are getting higher radiation doses than they need to to support those pictures so one of the things that the manufacturers are on the ground doing is setting up those protocols with the physicians and there should be guidelines for how those default settings the settings that most patients experience are set up so i'd say that's one way the manufacturers could help ensure most patients receive the lowest dose possible second this awareness of the potential harm for radiation is currently getting a lot of attention and the manufacturers actually have a lot of ways to lower dose so the doses for the most typical scans that patients undergo could be reduced by fifty percent without reducing quality at all and there are lots of ways to make that happen dr mccall is an expert on how you make those parameters as low dose as possible but the manufacturers have a lot of expertise around that area as well they have algorithms that you can apply to existing machinery to lower dose and i would really push for the manufacturers to make those software products available to everyone who currently owns a c t scan at a reasonable price so that we can get those dose reduction algorithms out there in active practice i think on the newer machines that will be sold over the next five years this problem may be dressed to a greater degree but i think we really need to ensure the current stands that are out there are done and there are ways to lower dose dramatically in regards to radiation therapy and in particular maybe to the what happened in florida that the manufacturer didn't not have any control over the training of the individual who would have been who was responsible for determining how the machine was designating the dose rate and that's what the problem was lying to the manufacturer not have control that the physicist who was responsible would have demanded and i we drive our manufacturers crazy to do extra tests to validate that everything was going correctly however if the manufacturer had said you're buying this various expensive piece of equipment is complex and potentially dangerous we are going to supply an expert physicist to come in from the outside to validate what you're when we talk about the federal guidelines for accreditation in the reporting of their eyes and so forth i would want to ask you three physicians do we have to be concerned about hipaa regulations when we i think one of the problems in usually collecting data are that you don't want to release information about the patient privacy information that would be concerned as it turns out for the area that we're talking about you don't need to release any patient information to understand you need to know a little bit about the patient such as their age and their sex none of those are covered by hapa and the dose that they received and that's all you need and none of that data are protected under have to so i think we use that sometimes as an excuse for not collecting the data but in this particular area for diagnostic imaging we don't need any of that personal data to understand quality  there are some databases right now that have data bank of areas that have been reported and there's also an interesting group european group called roast s r o s a s and i can supply that information later it's all voluntary and everything is  anonymous terms the patient information and it works very well to learn from that system so i don't think it's an issue ok i mentioned chairman for long that he's going in for radiation he had his own checklist to look at and then we started doing that that little bit more and i think that's one of the problems with our medical system today is frequently patients go in and they just make themselves totally compliant to whatever is going on in there and that they should be focused on as they go through their treatment what we're basically asking is is there anything you can do proactively as a patient to check what's going on if you go in can i can i ask some questions about what's going on here to make sure that i don't get overexposed one of the things we encourage we have a patient information check after you've agreed with your physician that this is an important exam just to make sure your physician is aware if you've had exams recently because perhaps the one you have you today isn't necessary but also we encourage in general the topic of just making sure that is too she knows that they need to right size the dose so to speak is this exam be tailored for my particular  illness or diagnostic question and for my particular body size we all come to different shapes and sizes whistling i think is that when it's not somebody holding a whistle it's a win situation although th e diagnostic imaging if you went in as an informed patient and said to the technologist of the physician can you tell me what my doses on this exam the answer currently would be i don't know i've  received dozens of e mails and letters and phone calls from patients who are really very concerned about this and one described his experience of asking his physician about the radiation dose and he was told by the hospital that he could hire a private physicist if you wanted that information and that information is in the c t scan will be a little tricky to get out but i think that information belongs in that patient's radical medical records so if you as a patient go to the emergency department and they need to give you a medication is a big sticker that goes on your chart if you have an allergy to a medicine and we've tried to put checks and balances in place to make sure that if you've analogy you don't get that medication i think around the issue of radiation safety we need to start thinking about that way so when a doctor orders a test they know if you've had fifteen others of those tests in the last two weeks they might still get that test but that information would be very important so if information is in the medical records i think doctors can make more informed choices certainly a patient should keep track of everything they've had done and ask the right question but we need to have a system in place at the other end that there are answers and information that they can get back to if i c of the difficult things about saying the dos is that the equipment with the manufacturers can do is say what is this machine putting out the actual dose to the patient then gets much more complex because it's this interaction of the patient their body size with what the machine is putting out and so the data is very clear as to how the machine set up and then physicists can go back and make estimates the models of what that patient got but unless you went to the extent of them with radiation therapy treatment planning on each and every patient you really can't tell them what your liver dose or your long doses without actually having a full c t of their body and then modeling what the scanner gives with them i don't think they did a great job answering the question about is this information available and the number that's available is what the scanners set up to give for a standard patient are technologists look at that radiography because the math involved in figuring how much is getting through the patient or that is something you can't kind of do on the side on a calculator so most radiographic systems actually have that feedback loop and that's where you can't explicitly say what mrs smith is going to get in her liver because it will take the scale of mrs smith and give the feedback of just how big she is at the dose all right thank hearing today decide that we need additional hearings or get back to you and you may get some additional written questions within the next ten days or so so thank you all we appreciate it and thank you in particular the parks and miss lindley as well thank you tim williams who is chair of the board of directors of the american society for radiation oncology and then we have dr michael herman who is president of the american association of physicists in medicine and then we have sandra hayden who is vice peaker of the house of the american society of radio radiologic technologist and then dr steven amos who is former chair of the board of chancellors for the american college of radiology and then from new jersey is kenneth ms wreck who is director of the v a new jersey health care system and it's in the department of veterans affairs and then we have david fisher who is executive director of the medical imaging technology alliance and finally john donnelly you who is vice chairman of medic callus inc thank you all for being here and i think you will he before when i said five minutes and your full statements become part of the record and then we'll have questions now i have to identify the apologize i mean i know when it's a friday of course it's the votes are over we don't have as many people participate but you know we had originally scheduled this for a day when it snowed when we had all the stuff snow so when we tried to reschedule it we didn't have a lot of options so that's why we here on friday and we'll start with dr williams thank you chairman for loan representative whitfield members of this distinguished committee good afternoon and thank you for the opportunity to testify at today's hearing i'm a practicing board certified radiation oncologist and i've been in my location for over twenty years and i personally taking care of almost seven thousand cancer patients i care deeply about the health and safety of my patients astro wants patients to have peace of mind when it comes to safety quality and efficacy of radiation therapy we are committed to stronger error reporting enhanced accreditation better use of health information technology patient centered educational tools and federal advocacy to help protect patients i was not involved in any of the tragic situations described by the new york times but i want to offer my own personal sympathies to those families and particularly the family of scott jerome parkes whose father shared his story with us earlier his wish was that no one else would go through what he did we agree no medical error is acceptable cancer patients have enough to worry about i have personally witnessed the great benefits of radiation therapy for cancer patients says the medical director of the department of radiation oncology at the land cancer institute the boca raton community hospital i currently service chair of the board of directors of the american society for ideation oncology for whom i'm representing here today radiation oncology is important tool in the fight against cancer contributing over the past twenty five years to steady increases in survival rates for cancer patients in the mid one nine hundred seventy s for example the five year survival rate for breast cancer was seventy five percent prostate cancer was sixty nine percent today that survival rate has increased to ninety eight percent for breast cancer and ninety nine percent for prostate cancer these are important games more needed astro's highest priority is ensuring that patients receive the safest most effective treatments a culture of safety and quality control is woven into the fabric of our field with many checks and balances to assure that safe and effective care is delivered to our patients well after was alarming concern by the errors described in recent press reports we do not believe that there are widespread radiation mistakes leading to patient harm across the country however the reports do highlight that there is more work to do any error no matter how small must be reported understood and utilized as a tool to reduce the potential for future errors failing to report known errors is unacceptable this moment is an opportunity to further improve our efforts to strengthen the practice of radiation oncology we have developed a six point action plan we call target safely number one work to strengthen error reporting and to create a national database for the reporting of medical errors number to advocate for new and expanded federal initiatives to help protect patients from radiation errors this includes supporting passage of the care act that requires national standards for radiation treatment team members supporting increased funding for the radiological physics center at the m d anderson cancer center and the quality assurance activities of the advanced technology consortium supporting congressional inquiry into self referral aster was concerned that self referral of radiation therapy services may result in shortchanging essential quality control assurance and patient safety protections number three work with cancer support organizations to help patients know what to ask their doctors about radiation therapy empowered patients who actively engage in their care are important members of our team fighting to be cancer number four enhanced the joint astro a c r radiation oncology practice accreditation program asked for recommends that all radiation oncology practices undergo accreditation number five expand educational training programs to include an intensive focus on quality assurance and safety astro strongly encourages that all radiation oncologist participate in maintenance of certification number six accelerate our ongoing health information technology interoperability effort we want device manufacturers to implement standards that allow the transfer of treatment information from one machine to another seamlessly to reduce the chance of a medical error astro has been developing and refining many of these programs for years in today's environment medical technology and decision making are increasingly complex the above plan holds the promise of ensuring patient safety in this challenging atmosphere finally i would like to illustrate the benefits of radiation by telling you the story of one of my patients from south florida i treated a fifty year old woman fifteen years ago who presented with bilateral breast cancer at that time the standard therapy was bilateral mastectomy and the idea of a lump y and radiation for both sides at the same time was considered a very advanced form of therapy she didn't want both of her breasts removed and they went ahead and proceed with a lumpectomy on both sides and simultaneous radiation to both breasts she is now alive fifteen years later i have been following her for the entire part time period and she spends time with the family enjoys a good quality of life and is a true success story for today this is what keeps me hopeful and looking forward to answers in the field my hope is that patien across the country will recognize these incentives for what they are isolated acts and that these reports will not dissuade patients who need radiation therapy from receiving needed treatments we support the committees we have view of these issues and we look forward to working with you to further enhance the quality of care patients receive thank you for the opportunities testify thank you dr williams dr herman s chairman pallone distinguished members good morning good afternoon thank you for the opportunity to testify my name's michael herman and i'm president of the american association of physicists and medicine medical physicists are responsible for accuracy quality and safety of the radiation producing technology and diagnostic imaging and radiation therapy although rare medical errors can be devastating we all wish that no one ever made a mistake but errors still can and do occur due to a combination of unlikely events occurring sequence chillier simultaneously many times under unusual circumstances that involve complex systems the use of medical radiation occurs in radiation oncology and in radiology practices with millions of people receiving that radiation annually to their benefit each patient procedure is a complex multisystem process which combines technology and human actions to make the process work requires coordination participation of a team of humans physicians medical physicist symmetrix radiation therapist radiation technologists all focused on the treatment of each patient one of a p m s primary goals is to identify and implement improvements in patient safety for the medical use of radiation we do this through our associations activities and in cooperation with other societies and regulatory and government bodies some of these include the development of procedures and guidelines producing detailed scientific educational and practical reports guidance to regulatory and accrediting bodies oversight of quality assurance and calibration processes facilitating medical information says communication and providing education and medical errors a p m believes that the position of qualified medical physicist should be recognized nationally for anyone practicing clinical medical physics a qualified medical physicist is an individual who has completed a unique combination of graduate education rigorous clinical training and board certification in medical physics all of these efforts mentioned move us toward more effective patient care and in achieving the absolute minimum  rate however some challenges remain there is no consistent national recognition of qualified medical physicists medical physicists are licensed in only four states in this country and regulated it widely varying levels in the other states the reports in guidelines that a p m and others publish have only the force and effect of professional and scientific guidelines there are no consensus national staffing guidelines for qualified medical physic services nor are there consistent standards established for accrediting practices that utilize medical physic services so what can we do while much effort in progress is being made to improve quality of care and increase patient safety but we can and we must do more together medical radiation team members professional associations manufacturers and government must strive for nationally consistent recognition of the qualified medical physicist and equivalent competency for all medical radiation team members by passing h r thirty six fifty two that can assist in ca accuracy responsibility an excellence in medical imaging and radiation therapy act of two thousand and nine and specifically requiring that all medical physicist involved in medical imaging and radiation therapy be included in this bill provide consistent procedure specific consensus minimum standards for national practice guidance and radiation oncology and medical imaging that recognize qualified individuals for specific responsibilities defined communication of the team stablish minimum staffing levels and receive timely review an amendment establish a rigorous minimum standard for all bodies that are credit clinical medical radiation practices based on the previously mentioned established national guidance that includes additional credit requirements for highly specialized procedures link c m s reimbursement to rigorous practice accreditation for all medical imaging and radiation therapy practices create a national data collection system to learn from actual and potential adverse events in the medical use of radiation that allows complete and consistent reporting by medical staff manufacturers and others improve the review effectiveness of product quality in the equipment clearance process and summary we believe that patient safety in the use of medical radiation will be increased through consistent education and certification of medical team members whose quote qualifications are recognized nationally and who follow consensus practice guidelines that meet the stablished national accrediting standards we have been working together for years on many of these issues we must do more and we need some help together we will continue to make the use of medical radiation safer and more effective for the people that need it thank you for the opportunity to speak to you today thank you dr herman ms ha it sounds like it's working good mr chairman and members of the committee my name is sandra hayden and i am a radiation therapist at m d anderson cancer center in houston i also serve on the board of the american society of radiologic technologist and it is in that role that address you today on behalf of the heirs are to use one hundred thirty four thousand members thank you for the opportunity to contribute to this dialogue on the quality of radiation therapy and other medical procedures that use radiation radiation therapy is the cornerstone of cancer management programs worldwide it can contain control and cure cancer for however radiation therapy must be precise to be effective accuracy is equally important during medical imaging exams that diagnose cancer x ray exams c t scans and other imaging tests use radiation and radiation comes with some risk errors although rare can cause devastating side effects they s r t believe the best way to ensure quality and safety of medical radiation procedures is to establish national educational and certification standards for technical personnel who perform them c t scanners gamma cameras and then eric celebrators are some of the most complex medical equipment in the world however this technology is ineffective in the wrong hands that's because the quality of any medical radiation procedure is directly linked to the skill and competence of the person performing it individuals must have extensive education and training to perform the exam correctly patient safety is in the hands of these individuals yet they remain largely unregulated radiographer is and that license in eight states radiation therapist such as myself are not regulated in seventeen states including the district of columbia medical services have no oath oversight in thirty one states and no states regulates medical dosimeter s even in states with some type of regulation the rules are sometimes so weak they offer patients little protection and some states hairdressers are better regulated than people who perform medical radiation procedures on qualified personnel are danger to patients and underexposed x ray can't reveal a malignant tumor and accurate radiation therapy treatment can't stop it spread even worse when medical radiation is used pollie it can harm the very patients it was meant to help as you've heard from earlier the solution is the consistency accuracy responsibility and excellence in medical imaging and radiation therapy bill the cure bill introduced by reparative then a barrel as h r three six five two and pending before congress since two thousand uses a three tiered approach to improving quality and safety first individuals who perform medical imaging and radiation therapy would require be required to graduate from a specialized educational program second they would be required to pass a national certification exam and third they would be required to maintain competency by obtaining continuing education only qualified personnel should be allowed to perform medical imaging a radiation therapy the care bill will ensure a minimum level of education knowledge and skill for those who are responsible for medical radiation procedures for patient safety the s r t encourages congress to cat passed the care bill the s r t also calls for consistent imaginary methods of reporting medical radiation  mistakes must reported and investigated so others may learn from them by learning how errors occur we can implement safeguards to prevent them currently state and federal or oversight of radiation errors is inconsistent regulatory bodies do not share information even worse some states do not require that errors be documented at all the s r t calls for mandatory reporting of medical radiation errors and also for consistent system of data collection and tracking a medical a model to consider is the f d a as med watch program which takes a systemic approach a reporting system such as med watch would build and alex based on patient safety and help reduce errors thanks to medical imaging and radiation therapy millions of americans are cancer survivors the vast majority of medical radiation procedures are administered safely and successfully however any mistake is unacceptable a t recommendation will lead to safer care and will help more patients when the battle against cancer thank you again for inviting me to speak on this important issue thank you ms hayden dr in new york a past president of the american college of radiology and i'm testifying today in my capacity as chair of a blue ribbon panel on radiation dose and medicine which represents more than thirty six thousand radiologists radiation oncologist nuclear medicine physicians and medical is committed to ensuring appropriate use of radiation and medicine one message i must highlight today is that the proper use of radiation in medicine whether diagnostic or therapeutic saves lives and improves the quality of care for millions of patients please consider the following advances in medical imaging have rendered exploratory surgery virtually obsolete interventional radiologic procedures often replace more invasive surgery call options resulting in improved outcomes and reduced hospitals and over one million patients cured or experience relief of pain treatment of their tumors with radiation therapy still as has been known for the past one hundred years recent media reports remind us that the medical use of radiation is not without risk we can and must do a better job of preventing error has long been involved with numerous radiation related quality improvement and there these include development of guidelines to ensure that patients get the right exam or treatment performed in the right way creation of registries and other tools to help physicians compare their outcomes with those of their peers and education of radiologists all of physicians and the public about the risks and benefits of both diagnostic and therapeutic radiation of particular note are strongly supports image gently and educational initiatives by pediatric radiologist to promote safe imaging of children to help prevent further adverse radiation related events a c r asked that congress seriously consider the following recommendation and we're not pulling any punches of formal accreditation process must be mandatory for all diagnostic imaging services and radiation therapy practice in this process hospitals and free standing facilities should be held to the same standards such as image quality monitoring phantom testing equipment calibration and maintenance and the qualification all involve personnel as a corollary ensure ongoing compliance with accreditation baseline a c r has been working with the industry to develop such a registry but a congressional mandate would facilitate this process congress has already recognized the importance of credit taishan m q essay requires accreditation of mammography practices and has helped save tens of thousands of lives a similar approach is seen and met already been described which requires accreditation of non hospital based imaging practice both m q m offer important lessons on how to design an optimal accreditation process further it is essential that the accrediting bodies have proven track record in imaging and radiation therapy accreditation a c r is the nation's oldest and most recognized medical imaging and radiation therapy accrediting body and is the only nation wide f d a approved accrediting body for m a c r accreditation designed to be educational in nature isn't a fish a process of both self assessment by the practice being reviewed and independent audit by physicians and medical physicists who are recognized experts in the specific type of practice being evaluated we recognize there is a desirable middle ground between accreditation process that is overly burdensome and one that lacks a substance to ensure quality and safety we stand ready to work with members of this committee to find the right balance thank you for the opportunity to a new jersey health care system i will describe for you our three year journey that includes how we identified a problem in the quality of care for ration radiation oncology patients how we responded and how we rebuilt the program to make sure that these circumstances would not happen again transparency was a constant focus throughout this process and guided our decisions to ensure that we acted in the best interests of all patients as soon as we determine that patients did not receive the quality of care they deserved we disclose this information to fifty three patients and their families consistent with the veterans health care administration policy of the fifty three patients we determine that two patients were harmed we inform the other fifty one patients that they experience errors that created a risk for the future we are following these patients for any subsequent signs of injury resulting from the identity of any of these areas prior to december of two thousand and six the east orange campus of the v a new jersey health care system radiation oncology program was accredited by a nationally recognized external agency outpatients was satisfied staff members had no complaints and all indications suggest that our program was delivering quality care in december of two thousand and six we first heard that two radiation therapy contract technicians unexpectedly were no longer reporting to work at our facility when we inquired as to why this happened we learned that they had raised concerns about the quality of care being provided resulting in a conflict with the supervisory staff we immediately initiated a review that included a series of increasingly detailed investigations of the quality of care in radiation oncology the first review by a quality manager validated that the concern raised by the technicians w credible in response we made the decision to close the program down until a thorough review was complete and we were certain our program provided safe quality care for our veterans patients in the need of radiation therapy have conceived through fee basis arrangements with local accredited facilities in their communities subsequent reviews by external v h a teams of experts and final comprehensive review by the american college of radiology confirmed deficits in our programs these include issues of staff qualifications and communication implementation of new technology without adequate education and training gaps and procedures for managing patients and the lack robust quality assurance program these findings became the framework for rebuilding our radiation oncology program we need to be sure we would deliver the highest standard of care possible and implement corrective actions to rectify all deficits identified by the a c r during the course of the investigation the clinical staff we've been working on programs designed as the same time the contract for radiation therapy technicians and for contract physicist expired we then made a decision that it would not be renewed we had guided improving our program by hiring new staff members including a nationally respected experienced and board certified chief of radiation oncology we also h properly trained and credentialed physicists dose amateurish radiation therapy technicians as radiation therapy is a complex and rapidly changing we established a program of continuous education for all staff and a major component  ongoing training of new technology and equipment we next established policies and procedures to guide patient care and instituted a comprehensive quality management program such a program includes meeting the standards established by the american college of radiology this entails identify quality controls for every state of radiation therapy including the dosing technique prescribe the energy the machine delivers the dose of radiation the patient receives and how the patient responds to the therapy we are continuing the routine tests of our machines simulating patient encounters checking those calculations tracking patient outcomes and instituting routine quality reviews of care including peer review a culture of open fundamental to patient safety this means an environment where all staff members are considered an equal part of the health care team to this and we established multi disciplinary team meetings prior to during and after treatment to review all aspects of care we encourage our staff members at all times to raise questions of concern about that care being provided the most important lesson we learned through this process was that staff members must be able to communicate openly to feel comfortable about raising issues and to feel confident that leadership will respond to their concerns thank you again for the opportunity to share my experience i am now available for questions at a later time thank you mr mr i thank you for being here to today i appreciate it mr fisher mr chairman congressman whitfield congresswoman castor thank you for the opportunity to be here today i serve as the executive director of the medical imaging and technology alliance the leading association representing the manufacturers innovators and developers of medical imaging and radiation therapy systems we are here today because of a tragic situation and as an industry we are committed to doing our part to prevent such things from occurring in the future at the outset it's important to note the computer tomogra utilizes a focused beam of radiation to kill cancer cells due to their distinct purposes the amount of radiation associated with these modalities differs by orders of magnitude these two modalities are have revolutionized health care delivery new the new england journal of medicine recently called medical imaging one of the top health care innovations ever likewise radiation therapy offers highly personalized noninvasive and cost effective care for up to sixty percent of all diagnosed cancer patients in the u s my day has a long history of working with its members physicians physicists technologists regulatory bodies and other stakeholders to track and reduce medical radiation our members continue to introduce new products and system innovations that reduce radiation dose for many procedures while continually improving image quality new technologies like weight and age based protocols automatic exposure control software improvements and improved interfaces with operators all enabled those production might is also working collaboratively with other stakeholders on issues related to medical radiation in the use of radiation many equipment for example in november of last year not in my to convene a meeting including physicians physicist industry and food and drug administration officials to discuss ways to prevent future medical errors that involve ionizing radiation might is also co sponsoring an upcoming c t dose summit and is also considering a radiation therapy summit to work with the a p a pm on a radiation therapy summit to further the education of providers business and others on the new technologies dose reduction technologies in particular our company's manufacture as part of the access to medical imaging coalition might help to develop appropriate as criteria for advanced medical imaging including the medicare medicare improvements for patients and providers act or method more recently m announce its support for the president's proposal in the fiscal year two thousand and eleven budget to develop a national dose registry we also welcomed the f d a as recent actions regarding radiation dose and support many of the policies proposed in their initiative to reduce unnecessary radiation expos exposure for medical imaging might intend to participate fully with f d a as they work to implement those production policies and might also has recently made two and two announcements in the area of radiation dose that may be of interest to this committee yesterday might announce a new dose second manufacturers are committed to including a dose warning feature to prevent c t scanning at higher potentially dangerous radial radiation levels this feature designed to prevent hazardous levels of radiation that could lead to injuries this feature can also be configured by hospitals or imaging facilities to prevent scans at these higher radiation levels third manufacturers will also stand will also standardize dose reporting to help better understand dose levels and facilitate facilitate the development of the national dose registry proposed by the president several weeks ago might reduction plan including the development of radiation dose reference levels to assist clinicians to understand the relative amount of radiation associated with the scan expansion of the appropriateness criteria mentioned earlier to ensure that patients receive the right test at the right time the development of training standards for hospitals and freestanding imaging facilities that purchase imaging equipment that involves the use of radiation radiation therapy equipment efforts to develop safety checklist to reduce medical errors and to incorporate those new standards into our training offerings efforts to ensure standardize reporting across stakeholders in a manner that is transparent for patients their families and physicians and examination of whether the myth accreditation policy should be expanded to include additional facilities or radiation therapy medical devices are in use and the establishment of minimum standards for radiologic technologist who perform diagnostic medical imaging exams and deliver radiation therapy treatment and each of these cases might in our member companies stand ready to work with professional organizations regulatory bodies individual clinicians and other stakeholders on these features lastly my continued to work with all of our members whose companies manufacture products then it ionizing radiation to develop new ways to reduce dose and reduce medical errors and i am hopeful we will continue to make strides in this area as we look to the future of health care in this country we cannot see our way to better outcomes and lower costs without the lens that medical imaging imaging provides the medical technologies might a member companies research develop and manufacture are the future of delivering better health outcomes at lower costs thank you for this opportunity today the legislation process proceeds my to look forward to continuing to work with congress and the administration to ensure appropriate use of and access to medical imaging and radiation therapy thank you mr fisher mr donahue thank you chairman plone congressman whitfield my name is john donoghue and i am grateful to be here to discuss the issues surrounding ionizing radiation and medicine i want to begin by expressing my profound diagnostic imaging we're a company founded by the radiologist an information technologist at the brigham and women's hospital in boston we provide physicians at the point of ordering with web based radiation safety and clinical appropriateness decision support by way of background i've been in the health care the international health care industry for over twenty five years and pharmaceutical vaccine in the radiology industry in the late one nine hundred ninety s i co founded an act of his presiden of one of the nation's first in the largest radiology management companies i have had the opportunity to interact extensively with c m s med pac the g a o congressional offices and many of the stakeholders in this area on an array of imaging  issues diagnostic imaging is rife with many health policy and federal legislative opportunities i am hopeful that after today's hearing we will all agree that radiation safety in imaging is a measurable and very serious issue but there are specific steps that we can take to mitigate the risk radiation safety has been very much in discussion since eight hundred ninety five when a new kind of light the x ray was discovered in july of two thousand and five the national academy of sciences issued a seminal study that examined health risks from exposure to low level ionizing radiation today the study is commonly referred to as the beer seven report or the biological effect of ionizing radiation report the water induced cancer to one in one thousand times further and importantly cumulative dosage totaling one hundred millisieverts can ratchet up this carcinogenic risk to one in one hundred times is also important to note that although radio sensitivity values vary dramatically by body tissue as well as by gender and by age studies have shown that there are meaningful dose estimates that can be measured for example the cleveland clinic submit six i helped lead a radiation safety doses initiative in awareness program the results were startling and they were highlighted extensively in the wall street journal firstly some individuals receive radiation exposure more than one thousand percent higher than recommended guidelines and secondly one patient received three hundred forty one c t scans over the eighteen month period bring the radiation exposure level to almost one thousand in two thousand and seven i presented yet another radiation safety initiative focused on the medicare population in this particular study over a twelve month period almost twenty percent of the medical population of the  medicare population received radiation exposure that exceeded the beer seven radiation recommended levels diagnostic imaging is an extraordinary clinical tool we want to encourage and expand the appropriate in the safe use of diagnostic imaging but the evidence appears to be incontrovertibly that patients are all too often exposed to unnecessary levels of ionizing radiation i believe the the solution is to do fo things firstly to ensure that every advanced imaging study is clinically proven by evidence and it is not redundant secondly to measure report on individual cumulative  present this ionizing history to physicians at the point of ordering thirdly i believe we should require recommendations of viable clinical alternatives to enhance radiation risk when they exist for example could an ultrasound a lab test or some blood work be sufficient for an initial diagnosis finally the fourth is i believe that once these tests pass these three criteria that they should be performed by in facilities by physicians and by rad techs who are are accredited and trained and that the equipment is assured to be said at the correct specifications my company made a callous is able to deliver a clinical appropriate as and radiation safety today we continuously survey and present available patient information to physicians at the point of ordering including individual specific radiation history dosage we also evaluate the clinical appropriateness of the test and present alternative recommendations if radiation safety sparks a concern in two thousand and ten we have no excuse but to leverage available clinical evidence innovative technology and regulatory policy to assure that all americans receive clinically appropriate and safe advanced diagnostic imaging i would respectfully suggest that congress encourage c m s to encourage web based or to include a web based clinical decision support and radiology safety program in the upcoming radiology pilots in addition and finally i want to commend the food and drug administration's unveiling of its recent radiology initiative specifically to underlying principles of appropriate justification of a radiation procedure and the optimization optimization of the radiation dosage these two issues addressed many of the concerns that i have raised in th testimony and we look forward to working with the f d a and other imaging stakeholders as this effort moves forward i want to thank the chairman i want to thank the entire committee for your focus on this issue and i'll be pleased to answer any questions you mr donahue thank all of you take some questions now let me start out by saying that that dr michael hagen i guess is here to accompany mr misery that's you dingell without objection so ordered i'm going to start the questioning and i want to start with with ken ms rock if i could again the reason why your testimony is so valuable in my opinion is because you at the v a hospital in new jersey went through a situation where there were problems you close of the syllabi you came back and corrected them and so i think that example is sort of a good one and in part what i'm what i'm asking is whether these changes that you have made you know could be utilized at other facilities and that's really what i'm trying to get down to but let me just say mr misery you mentioned in your testimony that you will require continuous education for all staff pacifically with respect to the technology and equipment can you elaborate on this in more detail and explain how you think this is going to work in practice and i guess also whether it would be useful for other hospitals  think there needs to be a constant continuous education on any new piece of equipment in a medical center whether it's in radiation oncology or radiology department or what the ology in speech there are programs available nationwide constantly being offered we need to make sure that our specialists a certified and trained before they have any opportunity to use the equipment recently as we're getting ready to open our program we brought in the manufacturers to work with our staff to observe simulations and that was part of the process and before we get the green light to open we need to make sure that everyone is equipped i want to know that my airline pilot is ready to fly that new piece of equipment before i get on that plane and that should be no difference in being treated in a medical center now you mentioned conducting routine tests of the machines to make sure the therapy you're providing is correct and safe one of the recent articles in the new york times highlighted a hospital that has been over radiating patients for the past five years and their regular system checks did not catch the error so can you just elaborate a little more on this aspect of the quality assurance plan and how these types of tests work and again how they would be you know help prevent situations in other hospitals i would really like to defer that to dr hagen who really has the expertise in the all right so i don't have to come up i guess and take your place there i don't know where or use one of the m accreditation for all radiation oncology facilities within the v a nationally fewer than twenty percent of radiation oncology practices are a c r credited this requirement for accreditation comes with some  signal signature by the principal deputy undersecretary in the finding by a surveyor at the v a site now must be corrected and the authority for that correction goes up to the network director and the network directors required to report through my program office to the undersecretary that each item has been corrected so that puts the quality control loop to answer your specific question about the i sponsored trials and so they fall under quality assurance program for the radiologic to six and you've heard that mentioned by a couple of panelists today that safe federally funded undergrad center out of and so they have been surveyed with almost thirty six hours of continuous operation with a physicist going through each of the planned operations and actually it's a result of that  initial evaluation that we're continuing to hold on treatment of the first patient until all of the issues that were found by the r p c have been resolved i guess going back to my initial statement to what extent is what you're doing now is something that you would see that we should apply nationwide or to other hospitals not in the v a system that's an excellent question and r p c is mandated to support with onsite evaluations all centers place patients on n c i sponsored drives to be able to expand that kind of service nationwide would require an order of magnitude increase in the size of the cell to like our p c actually would jeopardize their ability to perform their mandate which is to support clinical trials but to use r p c as a model and then fund a separate organization  in one of the new york times articles in order to qualify for a clinical trial radiation therapy the institution has to submit to enhance testing to make sure that they were delivering therapy properly and i guess a lot of the institutions failed those tests according to new york times but in the report by your association dr herman the also said this was a sobering statistic and i agree and that the tests are quite rigorous but still when our nation's top institutions apply to a clinical trial an fail we should wonder what's happening so i want to should you or you think that this is a sign of a larger problem and i don't know do i just wanted someone to respond to that about if you i guess it could be your doctor i'm sure  only indication that that it's difficult to carry out i am i t treatments one of the things that the sense that follows the part about the sobering statistic in that same report suggests that there's a larger consideration with the commissioning portion of the systems that comes before the clinical use so the details of the algorithm and some of the other things that can create additional variations and some of the some of the results some of the cases that didn't pass in the first the r b c phantoms were also due to not using the entire team to to do the treatment so i think one thing that would be helpful is is to have the phantom go through the entire identical process to what a patient goes through as opposed to sometimes having physicists try to do the whole thing because you're not taking advantage of the entire team component ok ms hayden you know you talked about all these variations in terms of education standards accreditation from from one state to the probably being one of the most important things to do because the technicians are such an important part of this so i just i just i don't know if you want to come in any more about you know the importance of national standards but i have to say that  it was really disturbing to me to read that there was so much variation from state to state and if you want to have anything more about it but i just thought that that was really sobering more than anything else of course you're up a lot and i appreciate this opportunity to speak again on behalf of the s r t as well as on behalf of the radiologic technologist that it minister radiation therapy and do the radiologic technology medical imaging exams there is it is very sobering the radiation therapist in my case which is what i am we're the last line of defense for the patients we are the safety net for the patients we are the ones that are counting on that machine we work in collaboration and we follow the prescription from the physician we work hand in hand with physics i feel like i want to hold hands at the table but certainly the care bill itself is just common sense to have educationally prepared clinically competent practitioners radiologic technologist is what we like to be referred to as to actually deliver this care for patients patients should be the number one focus of this and i'm awfully forward you couldn't make it retroactive presumably how long would it would it take before you know you'd be able to have enough people to perform these tests that would meet the standards of the careful i mean are we in a position that would have to say you know two three four years from now before we could actually have enough people that would be there would meet the standards yes sure we actually have time frames there will not be a shortage in regards to the people that will actually be performing examinations with the care bill or the passage of the care bill as it's all obvious it also will help save money in regards to not having repeated images and things that nature and in addition to that there's effect of dates to the care bill and so you would you know definitely follow that i have it in my hand here for you but we just want to be sure the s r t that the people providing care to patients that deliver radiation therapy and medical imaging have minimal education requirements and are competent makes perfect sense to me we do all the time i work at night with physics all the time and then tell me you have to help me have a little better understanding of this you're at m d anderson yes sir ok so the team that have an undergraduate degree and then you ask my personal credentials if i have a back a lawyer a science degree or radiation therapy technology from michigan wayne state university and so but there is different different qualifications for radiation therapist now as you heard within seventeen states i received registry in my certification exam i passed through the american registry a radiologic technologist which then makes me able to then be a qualified radiation therapy professional you know in some states could you be a radiation therapist was just an undergraduate degree yes you can be a radiation therapist with any sort of  qualification in the states or don't regulate it i worked in michigan in practice there for over ten years sir and i work side by side by people because michigan is an unregulated state for radiation therapy that did not have credentials and i must say it was very painful and i made sure that our patients were cared for but it is very it's not a good practice to be able to have practitioners that have all sorts of varying credential or non credentials delivering exact numbers are but there are a number of states that don't require a license for what so so then the hospital our facility that hires them they just have the free reign to hire whoever they want  and increasingly are working with health insurers throughout the country who are and very focused on clinical appropriateness and radiation safety yeah i remember in your testimony you talked a little bit about believe that individual radiation history is correct and does your company actually do that now yes sir we do it there are metrics available readily available that can create  very accurate measure of radiation dosage when it's applied and it's critically important to track this over a long period of time to assure that cumulative dosage doesn't put a patient into carcinogenic risk so we as a company perform that service we track dosage we measure it and we embed that information into the electronic medical record of the patient so it is there for the life of the patient irregardless of the ensure they move into a medicare we do for our health insurers for example is this is such a concerning issue we do a forensic analysis based on their claims data and based on any available clinical data to try to create a history of ionizing radiation so for example we can delve into a multi million data set of claims data and put together how many c t s what body part and what the cumulative exposure would be for a patient so we feel strongly enough about the safety issue that it's worth the effort to go back in to do this and then on an ongoing basis every new imaging procedure gets measured and tracked and importantly if there is a situation where a patient becomes  risk that next incremental study could present a carcinogenic risk the physician is immediately alerted electronically and provided with alternative action to consider and how many facilities the all manage we're a relatively required at m d anderson that the medical record the dosage of radiation given to a patient the medical record sir i respectfully in regard to diagnostic imaging which is not a department that i work in i can get back that answer to you in regards to my own facility in regards to radiation therapy yes the dosage is recorded for radiation therapy ok for radiation not for y unanimous consent however to enter into the record a letter from the society of interventional radiologist and simply on their views on this issue and also from the radio wakefield did you want to add something mr donahue now let me say this i mean this is been incredibly useful and thought provoking as i mentioned to the previous panel we will undoubtedly get back to you with additional written questions usually about ten days from now and then we'll issue it back but i have to be honest and i this is in no way meant to be offensive as much as valuable as your responses were in many ways i felt that quote that we ended up with more questions as a result of your responses and other words i think it's very likely that we're going to have to have an additional hearing on this subject because so many questions came up today that you know that i do need to think about initially and if we are going to develop legislation why should say developed we already have the care legislation i think before we move on that or you know have a hearing legislative hearing or draft something else we probably will need to have an additional hearing because i just had so many questions that came out of this today and but really you are extremely helpful and i was trying to get to the bottom of some of the problems out there and not to suggest that again when i suggesting that we don't want people to proceed with cat scans or or other diagnostic tools or other forms of radiation because we know how important that is but there are just a lot of questions i think that need to be answered so thank you very much and we'll conclude the hearing today but i can't emphasize enough how valuable this was  and without objection the hearing is concluded