SPEAKERS       CONTENTS       INSERTS    
 Page 1       TOP OF DOC
VHA'S RISK MANAGEMENT POLICY AND PERFORMANCE

WEDNESDAY, OCTOBER 8, 1997
House of Representatives,
Subcommittee on Health,
Committee on Veterans' Affairs,
Washington, DC.
    The subcommittee met, pursuant to call, at 10:05 a.m., in room 334, Cannon House Office Building, Hon. Cliff Stearns (chairman of the subcommittee) presiding.
    Present: Representatives Stearns, Bilirakis, Moran, Cooksey, Hutchinson, Gutierrez, Kennedy, and Peterson.
    Also Present: Representative Evans.
OPENING STATEMENT OF CHAIRMAN STEARNS

    Mr. STEARNS. Good morning, everybody. The subcommittee will come to order and I welcome my colleagues. Over the course of the last two years, the VA health care system has undergone dramatic change. In many respects, the change has been beneficial for veterans with establishment of systems for providing veterans' routine outpatient care, opening of community-based clinics and greater emphasis on improving customer service.
    With an accompanying emphasis on the part of VA health care managers on cost-cutting and improved efficiency, however, VA employees have faced unsettling times with hospital downsizing reorganization and threats of reduction in force. These sweeping changes have made all the more important the need to ensure that the quality of VA care remains high.
    This morning we examine one aspect of that obligation, VA's effort to prevent injury to its patients. Patient safety is by no means simply a VA issue. We are fortunate this morning to hear from a national expert on the prevention of error in health care delivery.
 Page 2       PREV PAGE       TOP OF DOC
    Dr. Leape's estimate that approximately one million Americans are injured by errors in hospital treatment each year and that 120,000 die as a result thereof is chilling. Our concern certainly is to be sure that VA is doing all it can to ensure veterans' well-being in its care delivery. VA has sadly experienced some tragic mishaps resulting in unexpected patient deaths.
    One can only react with horror at the image of a Miami VA nurse interrupting the start-up of a patient's blood dialysis to take a personal phone call, returning to find the patient's blood flowing from the dialysis machine on to the floor and then attempting to cover up the incident, rather than seeking emergency help.
    Cases like that lead me to wonder whether a new risk management policy is really the answer. I raise that question with the knowledge that VA has had risk management policies for some time. For years, a key element of VA policy has been to require both system-wide reporting of unexpected patient incidents and national review of that rolled up data to identify trends and institute remedial changes.
    I was astounded to learn, however, that until the committee asked and recently received tabulated national data on adverse incidents, for years, no VA official had compiled the data, let alone analyzed it. If VA headquarters ignores its own policy directives, I have to wonder how much trust to place in, quote, ''new policy pronouncements,'' however enlightened they might be.
    It is clear that this hearing raises some uncomfortable questions for the department. It has also become apparent that since we began to take a close look at these issues, VA has given the subject far more attention and concern. I approach this hearing, therefore, with cautious optimism that patient safety has become a critical VA issue but, also, with the resolve that this committee will be vigorous in its continued oversight of this area. It goes without saying that this is a most important hearing and I very much appreciate the efforts of those who came such a distance to be with us this morning. I look forward to their testimony. But before calling on our first witnesses, I am pleased to recognize our Ranking Member, my colleague and friend, Congressman Gutierrez for his opening remarks.
 Page 3       PREV PAGE       TOP OF DOC
OPENING STATEMENT OF HON. LUIS V. GUTIERREZ

    Mr. GUTIERREZ. Thank you very much, Mr. Chairman. Allow me to reiterate the importance of the subject matter of this hearing today. Improved patient safety and the prevention of unplanned clinical occurrences is a goal we all wish to achieve. In this regard, the Department of Veterans Affairs, our Nation's largest health care provider, is no different than nongovernmental health care providers. However, the VA serves a unique patient base and thus carries a unique responsibility to address patient safety.
    The VA as a Government provider is also under the budgetary constraints imposed upon it by the Congress and because this committee is responsible for oversight of veterans' health issues, we are also responsible for the health of veterans who use the VA for medical purposes.
    I believe this hearing is particularly timely. Unanticipated deaths at a number of VA medical facilities have raised our awareness of patient safety issues and the adverse medical effects that occasionally result from medical treatments. The statistics do not point to a greater number of unanticipated deaths at VA hospitals nationally for this year, but cases in Ohio and in upstate New York demonstrate the need for new approaches to be developed and implemented to address this problem.
    I am pleased to see the VA start this process. The VA has recently announced a partnership to address these important issues in conjunction with other national health care organizations, such as the American Hospital Association and the National Patient Safety Foundation of the American Medical Association is certainly a positive step. The implementation of a comprehensive risk management strategy with concrete proposals for preventing injuries to patients, visitors and VA employees is also a useful endeavor that should help the VA synchronize its efforts throughout the system.
 Page 4       PREV PAGE       TOP OF DOC
    Ensuring the quality of care throughout the VA is vitally important. Dr. Kizer has admitted that health care quality varies from hospital to hospital; that some hospitals are better than others and that some facilities have more reports of adverse events than others. For me, this variance from place to place means we are letting some veterans down and I believe by failing to offer the best quality care to all veterans, regardless of their location or network, we in turn let all veterans down.
    To address this problem, the recent actions of the VA must be followed up by more tangible steps. Access to information must be improved, the reporting of adverse events in VA hospitals is even more inconsistent than health care. A formal structure should be established to ensure that incidents of this nature are reported promptly throughout the system. In addition, the number of adverse events facility-by-facility, year-by-year, must be chronicled.
    We cannot determine if the VA health care has improved unless we have reliable statistical evidence that VA must make this an urgent priority if it is to address the issue in a responsible manner. Allow me once again to express my support for what the VA is currently doing to improve patient safety. These are positive steps worth commendation and they should help us all understand the true nature of this problem and assist in the creation of innovative solutions. I thank you all for joining us here today on this important issue and I look forward to questioning the witnesses later this morning. Mr. Chairman, thank you so much.
    Mr. STEARNS. Thank you. My colleague from Florida, Mr. Bilirakis.
OPENING STATEMENT OF HON. MICHAEL BILIRAKIS

    Mr. BILIRAKIS. Thank you, Mr. Chairman. I ask unanimous consent my entire statement be made a part of the record. And Mr. Chairman, I would like to commend you for scheduling this hearing. I do want to thank you for postponing it from the prior date. As you know, I had FDA reform at that time and I wanted to be here. I also would like to join you and others in welcoming Dr. Doherty, the Director of the Miami VA Medical Center, here to Washington.
 Page 5       PREV PAGE       TOP OF DOC
    Earlier this year, Mr. Chairman, as we all know, one of my district newspapers printed a series of articles on VA health care. These articles chronicled the stories of a number of patients who died unexpectedly because of adverse events. That paper reported that at least 23 veterans have died under unusual or avoidable circumstances at 17 VA hospitals and nursing homes around the country since 1993. These articles also recounted a series of mistakes that resulted in the deaths of 23 veterans in Florida and I won't go into those specific adverse events, Mr. Chairman. I suppose in our hearing today, it will go into those, but it is tragic.
    I think it is important we realize as tragic as these events are, the purpose of today's hearing is not to condemn the VA health care system. In fact, I have always believed that the VA health care system is a national asset that provides high quality care to our Nation's veterans. I am concerned, obviously, that events such as this sort of lessen the credibility in veterans' minds of the VA health care system, and I think that is the biggest problem with it all.
    Over the years, I visited, as have many others, VA health care centers. I have also heard from many veterans who have taken the time to share their positive experiences at VA medical facilities with me. Moreover, Mr. Chairman, it is important we realize adverse events are not unique to the VA.
    A 1993 Harvard study estimated one million preventable injuries and 120,000 preventable deaths occurred at American hospitals in a single year. While we would obviously prefer that adverse events never occur at any hospital, it is unrealistic to think that such events can be completely eliminated. After all medical providers are human and mistakes will occur if only by human error. So rather than set an unachievable goal, it is the responsibility, I think, of this subcommittee to ensure that when an adverse event does happen, it is properly investigated by the VA in a timely manner. Moreover, it is important that the VA establish appropriate risk management policies, as you indicated, to prevent such events from occurring.
 Page 6       PREV PAGE       TOP OF DOC
    We must also conduct proper oversight to ensure the risk management policies are being followed by VA medical personnel. This is particularly important because of the significant changes that have taken place within the VA health care system over the last couple years. These changes were designed to reduce health care costs and increase the timeliness of care provided to veterans.
    As the reorganization of the VA health care system continues, we must monitor the impact that these changes have on the quality of care veterans receive in VA medical facilities. Simply put, Mr. Chairman, veterans deserve to know they will receive the highest quality of care of VA medical facilities, and it is our job to make sure they do. I thank you, Mr. Chairman, for scheduling this hearing and, hopefully, we can get to the problems.
    Mr. STEARNS. I thank my colleague. The Ranking Member of the full committee, Mr. Evans.
OPENING STATEMENT OF HON. LANE EVANS, DEMOCRATIC RANKING MEMBER, COMMITTEE ON VETERANS' AFFAIRS

    Mr. EVANS. Thank you, Mr. Chairman. I guess I want to associate myself with the remarks just made by our colleague from Florida. You all know that this issue is a very important one. We congratulate you for holding this hearing. We know it goes to the heart of the basic issue of providing quality health care to our Nation's veterans, and when we have preventable mistakes occurring, it is often sensational and graphic in the media reports we receive, but I think as shocked as we all are, we need to keep these events in perspective as the gentleman from Florida indicated. Every system has its problems.
    One of our committee staff members shared an experience about the potentially life-threatening mistakes in her father's health care under one of the Nation's most preeminent health care organizations, so we must not characterize the VA by the number of unfortunate incidents that have occurred. We need to be practical and make sure they don't occur again and I completely associate myself with the remarks made by the gentleman from Florida.
 Page 7       PREV PAGE       TOP OF DOC
    Mr. STEARNS. Mr. Moran.
OPENING STATEMENT OF HON. JERRY MORAN

    Mr. MORAN. Mr. Chairman, thank you. I appreciate the opportunity to hear the testimony today and I congratulate you on having this subcommittee hearing. I think all Americans have a right to expect quality health care when they are admitted to a health care system, and it is especially true for veterans who have served our country and who are receiving medical care provided by the United States Government, so I think this is a very important topic and I appreciate the opportunity to participate in today's subcommittee meeting.
    Mr. STEARNS. Mr. Peterson.
    Mr. PETERSON. Nothing.
    Mr. STEARNS. Without objection, all Members' opening statements will be made a part of the record.
    And now we will start with the first panel, Dr. Leape, from the Harvard School of Public Health. Welcome, this morning, and we will have your opening testimony.

STATEMENT OF LUCIAN LEAPE, M.D., HARVARD SCHOOL OF PUBLIC HEALTH

    Dr. LEAPE. Mr. Chairman, members of the committee, thank you very much for the opportunity to come and testify before you. Although I am currently at the Harvard School of Public Health, I want to make sure you know that I am a real doctor; that for 25 years I was a practicing pediatric surgeon, so I think I have some understanding of these problems from the trenches as well as from academe. I also am a veteran so I have an interest in what is going on.
 Page 8       PREV PAGE       TOP OF DOC
    I have not, however, studied the Veterans' Administration hospitals, but I have no reason to think they are any different from the rest of the hospitals in the country in terms of the nature of the problems and the way they are approached. As the Chairman has pointed out, we have a serious problem. We have far too many injuries and deaths as a result of treatment that is designed to help people, and it is very important to try to understand why that occurs so we can do something about it.
    Clearly, health care is a high hazard industry. It has not thought of itself that way. We think of ourselves as a highly effective industry and, indeed, in the last 10 or 20 years, the improvements in medical science have, indeed, been breathtaking. We are highly effective. We are now, of course, also highly technological and highly complicated and complexity breeds opportunities for error and that is how injuries happen.
    But other industries are also high hazard, highly effective, high technology industries but have much lower injury rates. I think, first off, of aviation and nuclear power. Nobody questions the fact that these are very risky enterprises and yet they go wrong very seldom. What do they know that we don't know? Why is it that when you enter a hospital, your chances of dying from an accident are one in 200, but when you climb on an airplane, your chances of dying in an accident are one in 2 million?
    Clearly, we can learn a lot from what has been done in industry and it is time we apply these lessons to health care. Why haven't we done something before this? I would submit there are three basic reasons: The first is that the leaders in our hospitals have been unaware of the severity of the problem. It has only been in the last few years that these reports have come out that show the high incidence of injuries and accidents and errors, and the other reason is they don't receive the reports within the hospital.
    The reason we don't get voluntary reporting is that we punish people when they make errors, and, therefore, no one is going to report an error they can hide. These egregious incidents you have heard of already increase the fear that is so present in our hospitals among personnel concerning errors, and until we change that, we are not going to get good reporting. We may be able to snoop around as policemen, but we won't be getting the voluntary reporting.
 Page 9       PREV PAGE       TOP OF DOC
    The second is that our method for dealing with errors is misguided and ineffective. Our focus, traditionally, since time immemorial, has been on the individual. We attempt to get perfection in care by training doctors and nurses and pharmacists to be perfect and then punish them when they fail. The ''train and blame'' approach has been shown to be ineffective and the results speak for themselves.
    The high hazard industries that have low risks, such as aviation, do not get there that way. They have found, as we have learned from human factors experts over the years, that errors are not made on purpose, and that errors don't occur out of the blue, but that human beings make errors because of the situations, the processes, that they are functioning in; that is, defective systems make errors more likely and more difficult to pick up. Pilots aren't any better than doctors, but they make fewer errors because their systems make errors more difficult and when errors do occur, and they make errors also. They can identify them and correct them before an accident happens. So we have to think in terms of systems terms, rather than individual terms.
    When something goes wrong, we always want a head to roll, we look for somebody to blame, we cry negligence and abuse and so forth. Very, very few of our errors, I would say less than 1 percent, are due to real negligence. Most are made by good conscientious people that make a dumb mistake, just like you and I do every day. Errors are part of human experience.
    What we need to do is to have systems that keep them from hurting patients. For example, two medications that have similar looking labels are an accident waiting to happen. Two medications with similar sounding names are an accident waiting to happen. Nurses and doctors who work double shifts and have increased patient loads, who are tired and under stress, those are accidents waiting to happen. We all know that stress makes you more likely to make a mistake and yet doctors and nurses and pharmacists are often under great stress.
    The recent tendency to substitute less trained people for highly skilled nurses in our care of patients is absolute idiocy at a time when the intensity of illness in hospitals has gone up, as more and more patients are taken care of outside. At a time when care has become increasingly more complicated, we are reducing the level of expertise of people delivering the care. This is absolute madness. It is a setup for errors and it is not surprising they occur.
 Page 10       PREV PAGE       TOP OF DOC
    Illegible handwriting has long been a big joke. Doctors' handwriting has always been known to be something you can't read. It is not a joke when it leads to the wrong medication or wrong dose. This is something we should eliminate. And so it goes. So we have a lot of things in our system that, if you will, set up people to make mistakes.
    In fact, I would say the nurses and the pharmacists and the doctors are our best defense against these defects. They don't make mistakes most of the time. They keep from doing the things they are being set up to do.
    The third reason, in addition to the fact that our efforts have been misguided, is that hospitals and health care organizations have not made safety a number one priority. I think it is quite evident the time has come to do that. We have to stop reacting to crisis events and start being proactive in thinking about how to design our systems. It has already been mentioned there has been some recent progress. I think I should take one minute to mention that.
    Last October, there was an exciting conference sponsored by the Annenberg Center in which we brought together members from the health professions as well as industry and academics to talk about error prevention. At that time, the AMA announced its formation of the National Patient Safety Foundation, specifically committed to improving information dissemination, education and sponsoring research in error prevention. I think this is a significant step forward by the AMA, and they ought to be commended for it.
    At the same time, the Joint Commission on Accreditation of Health Care Organizations announced it was changing its reporting policy, to make it less punitive and more constructive. The American Society of Health-Systems Pharmacists published a list of eight or nine major features that hospitals should incorporate to prevent errors. If these were adopted by all hospitals in the country, errors in the medication process would be significantly reduced. And hospitals are beginning to do something about it.
 Page 11       PREV PAGE       TOP OF DOC
    We had a collaborative effort to reduce medication errors run by the Institute for Healthcare Improvement. We had 41 hospitals signed up and another 20 that we couldn't take, so there is an interest and demand; hospitals are trying to do something about it. We need to help them as much as we can. However, it is going to take a major culture change. It is going to take hospitals beginning to look upon errors as what they are, which is symptoms of a disease, not the disease itself. The disease is faulty systems. Until we concentrate on the system faults, we are not going to stop the errors. It is time to shift the target away from the people and on to the process.
    There are several things we could do right up front. It is time to move ahead with the electronic medical record. It is madness that we have medical records that nobody can read. It is time to move to computerized physician order entry so when doctors make an error, the computer picks it up and corrects it before it gets executed. It is time to implement bar coding of medications. We do it in our supermarkets, but we don't do it in our hospitals.
    The pharmaceutical industry ought to be called upon to bar code every drug and to bar code all unit doses, and hospitals should have bar coding of medications and bar coding of patients to prevent error. I am optimistic. I think what the VA has done with its new risk management policy is a step in the right direction and I think hospitals throughout the country are making a lot of progress, but we have a long way to go. Thank you.
    [The prepared statement of Dr. Leape appears on p. 93.]

    Mr. STEARNS. Thank you, Dr. Leape. I have an article in front of me from the Washington Post, dated October 7, and, basically, Dr. Kizer, who is the VA Under Secretary for Health, indicated that despite all the incredible advances in medical science of the past several decades, the simple fact is too many adverse events happen as a result of medical treatment, which pretty much corroborates what you have just said.
 Page 12       PREV PAGE       TOP OF DOC
    Obviously, the statistics of 1 in 200 in a hospital, versus one in two million in an airline is something we have to work harder on and it is scary, frankly, to think about it. Further on in this article, near the end, you say that basically you hail the VA for taking, quote, ''a giant step forward,'' end quote, by joining the effort to improve patient care.
    My question is, while your testimony or your comment in the newspaper praises the VA's, quote, ''new risk management policy'' and the potential it holds, in terms of measurable outcomes or results, how could this committee best assess the effectiveness of that policy, particularly in the absence of baseline data?
    Dr. LEAPE. It is going to be very difficult. They are no different from any other hospital. We don't have good baseline data anywhere because we have had very limited reporting in the past. We estimate that fewer than 5 percent of significant errors get reported and I have no reason to think the VA is any different from any other hospitals in that regard, so it is difficult to assess improvement.
    What can be done, however, is to take some baseline measurements now. This can be done in the form of focused audits. One can identify certain specific kinds of errors that are known to occur. One can do a survey of one or two units, nursing units in a hospital, and get a fix, if you will, on what the baseline rate is, so it is possible with intensive review of records and discussion with personnel, to get a good idea of where you stand and then reassess it by the same method a year or two later. But you do not have baseline data, you are absolutely correct, and neither does anyone else.
    Mr. STEARNS. So let me review. You know, it was disappointing for us in the committee to realize that this information was not regularly sent, and if it got there, it was just put into a room and it was not looked at on a periodic basis. So this baseline data is absent, and we don't have any way to evaluate it. Is there any difference between what is being done—what occurred in the VA and in the private sector.
 Page 13       PREV PAGE       TOP OF DOC
    Dr. LEAPE. Not to my knowledge and as a matter of fact, one of the disturbing things is most hospitals have incident reporting systems and we found, number one, they miss 95 percent of the events. Number two, usually nothing happens after a report goes in.
    One of the frustrations of medical personnel, nurses and doctors is they file a report and never hear anything back and nothing happens and that is unfortunately all too typical now. I obviously can't speak for all hospitals, but in the ones we have looked at that has been characteristic and this has got to change. I think it is changing, and that is why I complimented the VA on trying to change it, but it is not surprising it wasn't there before.
    Mr. STEARNS. So you are saying that what occurred in the VA system is typical of what occurs in the private sector.
    Dr. LEAPE. I believe so.
    Mr. STEARNS. So the nurses will offer the information, but low and behold, no one looks at it. There is no one who studies the baseline data and comes up with any conclusions.
    Dr. LEAPE. Of course, that is not a blanket statement that applies to all hospitals in the country because some do, but in general it tends to be more that way than the reverse, unfortunately.
    Mr. STEARNS. Well, how do we know that once we institute the new system that Dr. Kizer is talking about, and I commend him for it, that we are going to have any new results. That is really a question for Dr. Kizer. But my concern is, in your testimony you counsel against blame and punishment as tools to minimize clinical tools. In the private sector, if there is not performance, if there are continued adverse problems, they make change, they do something about it. This whole idea of blame and punishment in a medical center, should we use that as a means to implement new procedures, if we find, for example, one institution, one VA hospital, that has an enormous or adverse risk that is out of the norm, I mean, should there be some type of management reform, new safety measures done at that institution? I mean, we can collect all this information, but if you have an institution that is managed in such a way that safety is not preeminent, I mean, I guess what I am saying is what is the enforcement mechanism and is blame and punishment a motivator?
 Page 14       PREV PAGE       TOP OF DOC
    Dr. LEAPE. Well, I think what you are suggesting is what most regulators suggest. In other words, what is the rule and how do we enforce it? The evidence is that that is not the way you reduce errors. You have a fiduciary responsibility to monitor what they are doing and therefore you need to have data and you need to follow it, but that alone is not going to get you where you want to go.
    We really have to have a climate where people feel free to talk about their errors and where people think of errors as systems problems, not people problems. You still think of them as people problems. I was that way. When I had residents, I would chew them out when they made a mistake. It never occurred to me when I made a mistake it was something in the system; I always thought it was me. But experts say that isn't the way it is and again I come back to aviation.
    They have been fantastically successful and they have been successful because they have looked beyond the individual and said let's try to figure out what is going wrong so we can prevent it from happening again. So if you want to improve safety in the VA, you have to change the climate. That won't be easy. It will take time and, number two, you can legitimately expect each hospital to have in place features that we know reduce errors.
    For example, every hospital should have, I assume they do, but I don't know this, should have the unit dosing system, which reduces medication dose errors by 80 percent. Every hospital should have within 5 years computerized physician order entry. Every hospital should have within 5 years electronic medical records. Every hospital should have a full-time pharmacist and so forth and so on. So there are a number of things that we know make a difference and there is no excuse for them not being done and you can certainly monitor that. You certainly want to get a fix on what the incidence of adverse events is, but if you really want to have errors drop, it is going to require culture change and that isn't going to happen overnight.
    I think this policy sounds as if that is what they are trying to do. They are trying to be proactive. They are trying to put an emphasis on involving people and getting every individual thinking safety. They don't think that way now, and if the VA could get its people in the trenches, the people in the units, thinking safety and realize when they have an idea, it is responded to and people make changes, then things will improve. I think you need to keep the heat on them to do that, but it seems to me they are trying to do that from what I read here. I have no, you know, firsthand knowledge.
 Page 15       PREV PAGE       TOP OF DOC
    Mr. STEARNS. I think that is a significant point and at this point I turn over to the Ranking Member, Mr. Gutierrez.
    Mr. GUTIERREZ. Thank you. Doctor, could you share with us some specific examples that you might know of hospitals, medical institutions, things that have happened there and actions that particular institutions have taken?
    Dr. LEAPE. You mean specific awful events? They have been in the newspapers.
    Mr. GUTIERREZ. No.
    Mr. LEAPE. You don't mean that.
    Mr. GUTIERREZ. Specific actions that have been taken by the medical institutions, like a medical institution, things that have already been done. Here is what was going on; here is how they addressed it so that we can get a sense of what is happening.
    Dr. LEAPE. Sure. We got very interested in the whole business of computerized physician order entry because if the doctor has to order the medication in a computer, the computer will remember that the patient is allergic, which the doctor might forget, the computer will remember the patient is on another medication which interacts badly with it, so you can prevent errors by computerized prescription entry. And of two major hospitals we studied, one was going to implement that, the other hospital was not all ready to do that yet. They weren't set up. They didn't have the money and so forth.
    As an alternative, what they did was they got their pharmacist to come out of the basement and come up on the floors and make rounds with the doctors and nurses. Well, the pharmacist is a gold mine of information about drugs, I mean, that is what he knows, and they found with the pharmacist there that the physicians would ask them for advice and so forth. The pharmacist would see something going wrong and he would make an offer, and in a 6-month period, we found that the pharmacists had made 394 recommendations of changes, and the doctors had accepted 390 of them.
 Page 16       PREV PAGE       TOP OF DOC
    I mean, there wasn't much question that this was well-accepted. The nurses thought it was wonderful because, of course, they didn't have to go get the orders changed and so on. So the simple device of having a pharmacist make rounds with the team is a great step forward. Others have worked on the handwriting problem. They have sent the orders back to the doctors and said, you know, we can't read this. That sounds pretty obvious, but it wasn't being done and they have standardized their procedures to make sure that orders are correctly written.
    Chemotherapy is a hazardous form of treatment, as you know. People can die from their medications, and it is too easy to give an overdose because it's so complicated to compute these. Every drug has a different system and they give so much per day for how many days and so forth. Well, you can reduce errors greatly in that by merely having a pre- printed form in which the person is led through the calculations in which the weight and height and all those things are in, so they are less likely to make a mistake than if they just remember the dose and write it down. So some of the things are exceedingly simple. Bar coding is exceedingly simple.
    Mr. GUTIERREZ. What does bar coding exactly do, Doctor? Tell me the benefits of bar coding.
    Dr. LEAPE. Well, with bar coding, with a simple wand, you can identify that the medication you are about to give a patient is the right medication and that it is for that patient and then you can bar code the patient and make sure it is the right patient. You can link up the drug to the right patient, right drug, right patient, right dose, and this has been done in some institutions with significant reduction in errors.
    Mr. GUTIERREZ. And what can the VA do to encourage its clinicians to report quickly adverse—what kinds of things have been done in other settings. You said it is a systems problem, and that it takes time to change, so what have people done, and what can you recommend they do, to encourage a change and more honesty in coming forward.
    Dr. LEAPE. This is a leadership issue, isn't it, so the chairman of the department of medicine or surgery has to believe in this and he has to communicate it down. So if you want to change the culture, you have to change it from the top down, and this hearing today may help start it. But you have to have the heads of the hospitals understand and believe—it is not a religion, but it sounds like it. You really have to believe the way to make improvements is to take the focus off people and put it on the system.
 Page 17       PREV PAGE       TOP OF DOC
    Once you believe that, it gets transmitted readily. So if the chairman of surgery at the weekly morbidity and mortality conference, we always had weekly morbidity and mortality conferences, if it is quite clear to everybody there that the name of the game is to try to understand why it happened, not try to figure out who to blame, the information will pour out. We had one nurse supervisor at our training sessions who went home and decided she was going to try this out because she really thought it made a lot of sense. She convinced the other nurses she was sincere that they were not going to be punished. She said ''I really want to know what has been going on.''
    The number of reported errors in that unit were approximately eight per month for the preceding year. In the month after this happened, they had 160 reported, a 20-fold increase from merely the nurse saying we are going to change the way we do business here. We think errors are symptoms. We think you are good people. The errors are made by good people trying to do a good job, but we all make mistakes every day. If you really say let's get the focus off the individual and onto the systems, miracles happen.
    Mr. GUTIERREZ. So unless you change the leadership, you are not going to get the information and until you get the information, you can't correct the situation.
    Dr. LEAPE. Absolutely.
    Mr. GUTIERREZ. Mr. Chairman, thank you very much. I agree with you. I go to the hospital, I relax, I get on an airplane, I tense up.
    Dr. LEAPE. You've got it backwards.
    Mr. GUTIERREZ. According to Dr. Leape, I got it kind of backwards. But that is the way I think most of us probably feel. You have a sense of confidence and here is your doctor—not that I don't confide in the airline pilots, but I just feel like I don't get on an airline and get help. I go to my doctor and hospital to get help and there are professionals there. And you are right, we do have to do some things, even in the private sector. And if you visit even a manufacturing site, there are signs that say so many days without an accident, and they do have recommendation boxes, at good plants, you know, where people put their recommendations for safety and there is a safety box and there are all kinds of incentives to give workers so they can tell and take pride and actually report what is going on so they can do that. Thank you very much, Doctor, I really appreciate your testimony this morning.
 Page 18       PREV PAGE       TOP OF DOC
    Mr. STEARNS. Thank you. Mr. Bilirakis.
    Mr. BILIRAKIS. Thank you, Mr. Chairman. Dr. Leape, you have been very helpful and all of us really appreciate you taking the time to be here. Let me go back, and I don't want to spend very much time on this, but that 1993 Harvard study that estimated, that one million preventable injuries and 120,000 preventable deaths occurred in American hospitals in a single year. When the study came up with that figure, and I realize the word ''estimated'' is in there, this is versus how many total preventable injuries and versus how many total injuries and how many total deaths occurred.
    Dr. LEAPE. Those numbers were extrapolated from a study that was done in New York State in which 30,000 hospital records were looked at, random sample, all kinds of hospitals, and tried to get a population estimate. Most studies come out of one hospital, and they are often teaching hospitals and, you know, they are not representative. So we think it is reasonably representative. You may come from Idaho or Mississippi, you may not think what happens in New York is representative, in which case you can adjust, but we extrapolated.
    From that we found there were 1.3 million injuries and 69 percent were related to an error, so 69 percent times 1.3 comes out to be approximately 1 million. We estimate a total of 1,180,000 deaths. Two-thirds of that is 120,000. So two-thirds of all the injuries, 69 percent, we found, were due to errors.
    Mr. BILIRAKIS. Preventable.
    Dr. LEAPE. And therefore preventable, yes, right, by definition preventable, potentially preventable.
    Mr. BILIRAKIS. Well, you know, Doctor, you are right. I know Mr. Gutierrez mentioned a change in leadership. I don't know about changing the leadership, but I think everybody meant and he meant changing the culture, changing the thinking, if you will. I know we have had many instances in our hearings over the years here where there is great concern expressed by veterans, and I think we have all seen it if we visit enough centers, that a lot of the personnel there—I don't necessarily mean the medical doctors and what not, but a lot of the personnel have a feeling of, oh, well, the people here are on welfare. In other words, they don't treat the veterans with the respect that they certainly deserve, so that is a culture, even though it may be a lower level of clerk or whatever the case may be, it is very important.
 Page 19       PREV PAGE       TOP OF DOC
    I know that a few years ago, maybe the 2 or 3 years before the series of articles on VA health centers appeared, there was an article in the local newspaper in Florida, of a particular local hospital, where a doctor was involved in deaths. I think it was during open heart surgery and the articles indicated that that doctor had been involved in other incidences prior to these immediate deaths that the article referred to. The reason why he wasn't let go by the hospital is because the doctor threatened to sue them, and they were concerned about a lawsuit. They would go bowing out of the culture and that is really a part of it, is it not?
    Dr. LEAPE. The whole malpractice situation overlays this. You see, doctors are told by their lawyers not to tell the patient anything. You can't even say I'm sorry. All of that is designed to focus on a bad apple. All the best surgeons I know, and a lot of the best surgeons are my personal friends, every one of them has been sued. Now, they are not negligent, they are not bad apples, but the system does that and therefore doctors are inhibited and they are reluctant to participate in this. They don't want to report errors. Why should they incriminate themselves? That is a very major issue. It may be less of a problem in the VA, I don't know, but it is a very major issue we have to deal with.
    Mr. BILIRAKIS. Reform is something you feel is a major issue and is required.
    Dr. LEAPE. Absolutely, yes.
    Mr. BILIRAKIS. You also mentioned, and I guess this goes maybe to cultural thinking, cultural changes, but my oldest son is now a physician and part of his residency was included at the VA hospital in Tampa. I think back 3 or 4 years ago. I think back to the hours the people worked. You talked about the stress. Is that changing, these fantastic hours that these residents work and certainly it has to result in some problems taking place.
    Dr. LEAPE. You may remember that New York State passed regulations a few years back in reaction to the Libby Zion case to restrict the hours. There was a tremendous resistance to change, particularly in the surgical community, because, again, the culture, really what I grew up in, is that you have to be there and be with the patient day and night to really understand what is going on and to develop your sense of responsibility.
 Page 20       PREV PAGE       TOP OF DOC
    One of the most important things we want to develop in young doctors is a sense of responsibility and it certainly does that. It also makes you so tired that if you have an operation the next day, you may have trouble keeping your eyes open. That is a long way of saying there have been some efforts, but they haven't been very successful, and people who look at this from the outside are aghast.
    Health care is the only industry in this country that doesn't seem to believe that fatigue degrades performance. If you are a pilot, you are forced to take hours off between flights at night and the idea that surgeons and anesthetists can be up all night doing an emergency operation and then at 8 o'clock the next morning start a new case, that is madness, yet it happens in every hospital.
    Mr. BILIRAKIS. So the bottom line of what you are basically telling this committee is the problems at the VA are similar to the problems in health care throughout America and probably throughout the world.
    Dr. LEAPE. Absolutely.
    Mr. BILIRAKIS. And the way they are going to be correctable is not just at the VA, but throughout the entire—really, throughout the medical world.
    Dr. LEAPE. But you, of course, can be part of this process and things like this new policy, I think, are a leadership move. If it can be implemented, if you can do the things there that is moving ahead and if the VA does some exemplary things, other hospitals will learn from that, so I think you have an opportunity for leadership here, I really do.
    Mr. BILIRAKIS. Thank you, Mr. Chairman.
    Mr. STEARNS. Mr. Evans.
    Mr. EVANS. Thank you, Mr. Chairman. Picking up on the gentleman from Florida again. Based on your knowledge of the VA and other health care systems, are VA patients more likely than patients of other systems to experience an adverse event that results in serious injury or death.
 Page 21       PREV PAGE       TOP OF DOC
    Dr. LEAPE. I have no idea. I don't have any data on that.
    Mr. EVANS. All right. Well, VA has obviously been influenced by your work in developing their current risk management guidance. Do you have any views on the adequacy of their new policy and does it compare to policies used by other major health care systems? Are there good models that it might follow?
    Dr. LEAPE. As I look at this policy, and I haven't looked at VA hospitals or their data, but I have looked at this policy; there are several features of it that strike me as really exemplary, and as I say, if they are implemented will be a real move in the right direction.
    First of all, it is a proactive policy. Most error programs, error prevention programs, or what are often called risk management programs are reactive. Somebody does something awful and we have a big shake-up and try to change the system. This policy is an attempt to get the frontline people: nurses, doctors, pharmacists, to identify accidents waiting to happen and redesign the system before that happens.
    If you can do that, you are really on the right track. We have to do more than just react to disasters and this attempts to do that.
    Secondly, it attempts to—it sets as a goal—to incorporate the concepts of continuous quality improvement into the everyday routine of the nurses and doctors in the hospitals. That is, thinking of themselves as part of a team to ensure safety, to be thinking about how to make the process better. That has to do with reporting and then getting some feedback and some response when you report.
    If that can be done, that is going to be one of the most important things you can do to improve quality. Third, they are setting up an Intranet, not an Internet, an Intranet, a computerized Internet within the VA hospital system, which not only nurses or doctors or any personnel can report things they have learned about a way to prevent a certain kind of error, but the results from the review by the Office of Performance and Quality and by the Medical Inspector will be distributed through this.
 Page 22       PREV PAGE       TOP OF DOC
    Aviation has this and pilots read these things avidly. If we could learn from each other's mistakes, which is what this tries to do, clearly that would be helpful. You know, you have 173 hospitals. You have 173 potential laboratories for improving the way things are done and if that information is disseminated, clearly that will be a good thing. So I think these are very important and impressive features.
    Also, the emphasis on promptly informing patients, that doesn't happen in most hospitals. That is one of the reasons lawsuits happen, but patients are often the last to know that there has been an error, so one of the policies listed here is that patients will be promptly informed of what is going on.
    It has a lot of bureaucratism in it and it has a little too much regulation for my way of thinking. It reminds me of my days in the Navy, but on the other hand, the goals are good and what they are trying to do makes a lot of sense, and I think if you can implement it, it will be a giant step forward.
    Mr. EVANS. Thank you.
    Thank you, Mr. Chairman.
    Mr. STEARNS. Mr. Hutchinson.
OPENING STATEMENT OF HON. ASA HUTCHINSON

    Mr. HUTCHINSON. Thank you, Mr. Chairman, and I apologize for coming in late, but I want to assure you, doctor, that I have read your testimony and I very much appreciate your participation in this hearing, and I thank the Chair for conducting this very important hearing.
    I was intrigued with some of your comments and the emphasis upon systems to help correct errors and a different approach to it. Even under a systems approach, though, errors will still occur, but the whole object is to provide more training, positive reinforcement, and systems to correct or define the errors and prevent them.
 Page 23       PREV PAGE       TOP OF DOC
    Dr. LEAPE. Right.
    Mr. HUTCHINSON. Am I getting the gist of that?
    Dr. LEAPE. That is right. It is not possible to make things perfect, but you approach perfection and part of your approach is two-pronged. One is to make it much more difficult for errors to occur and, secondly, to make it possible to intercept them before they cause harm. That is the goal, and you are right now say at a 50 percent level. Get to the 90 percent level in 5 years and 5 years later get it to the 95 percent level, and keep on closing in until we get to a 99.9 percent perfection.
    Mr. HUTCHINSON. Which is exactly where we want to go, but there is always going to be some errors that sneak through and injuries as a result of that. I was intrigued by your comments on the tort system and in your written testimony, you talk about the tort system focus on the individual who made the error causing an injury, assuming that punishment will make the person less likely to err again.
    The concept of a systems cause is really considered. Just a comment on the tort system, though. The tort system is not designed for punishment, but it is designed for compensation, and even if you have a good systems approach, there are still going to be some errors that happen, some injuries that occur and compensation is still going to be important, would you agree?
    Dr. LEAPE. You are touching on a subject that is dear to my heart. I happen to think we should compensate everybody for their injuries. I think hospitals should be required to pay the cost of health care for everybody that is hurt by treatment because right now the health insurance mechanisms, among people outside the government hospitals, only pay about three-fourths of the cost, and the patient ends up picking up the rest of it, and those costs are sometimes substantial.
    Insurance doesn't cover it, they can't get insurance for that and so the patient is left holding the bag. If hospitals had to pay the cost of injury, they would have a tremendous incentive to reduce injuries and that is probably the single thing we could do to make the most difference, and I don't think the chances of that happening are very great.
 Page 24       PREV PAGE       TOP OF DOC
    Mr. HUTCHINSON. Yes, I think you answered my last question, which you raised the question in your written testimony about should hospitals and health care organizations, instead of physicians, be held responsible for adverse events. I think your answer is that should be looked at very affirmatively.
    Dr. LEAPE. Resoundingly, yes.
    Mr. HUTCHINSON. Now, a follow-up question would pain and suffering be included in your compensation?
    Dr. LEAPE. That is a sticky one. In Sweden and other countries where they have attempted to do things like this, they have not included that. Interestingly enough, if you talk with patients who have been injured, they want two things. They like to hear the doctor say I'm sorry and they like to see that the health care system is going to do something to keep that from happening again. Money is a distant third objective and I think the pain and suffering thing is all part of the anger that comes from a doctor that won't talk to them and a system that won't do anything. That may turn out not to be very important if we really had a good system of dealing with errors.
    Mr. HUTCHINSON. I think that is a good observation. I am not sure I agree 100 percent, but it is a good observation. And in regards to the admission of error, if the doctor says I'm sorry or whoever is responsible, and I am sure as part of your job you have reviewed medical records, is there hesitancy now for doctors to put in medical records all of the facts that might make them look bad.
    Dr. LEAPE. Absolutely. I have never seen a record that said I made a mistake.
    Mr. HUTCHINSON. I am not sure I have either.
    Dr. LEAPE. I certainly never wrote that.
    Mr. HUTCHINSON. Is there any system that can be developed that would help in that regard.
 Page 25       PREV PAGE       TOP OF DOC
    Dr. LEAPE. Sure. What we are talking about: If the physician is functioning in a hospital, in a department, where the understanding is that he or she is trying to do a good job and made a mistake, didn't make it on purpose. Let's see if we can figure out how to keep anybody from making the same mistake again. We are really sincere about it and the discussions are confidential and, of course, under the peer review statutes they are nondiscoverable in most States, so we don't need a law to do this. But if we had that kind of a system, then the physicians would be very interested in doing that, because all health workers want the same thing as patients want. They want to figure out a way to keep the mistake from happening again and the way you do that is to start talking about it. I don't think there is any question they would participate.
    Mr. HUTCHINSON. Doctor, thank you very much.
    Mr. BILIRAKIS. Will the gentleman yield for a minute?
    Mr. HUTCHINSON. Certainly.
    Mr. BILIRAKIS. Getting back to the immediate conversation, Doctor, you would have a strict liability type of a thing insofar as health care is concerned.
    Dr. LEAPE. Yes, this is very controversial obviously. We have had a couple States that have had some interest in implementing this and whether it will come to pass, I don't know. We should try it out at a State level to see what the problems are. But if you think about it, if you really believe systems failures are the cause of errors, you need to put the responsibility on the party that can do something about the systems.
    Doctors can't change the systems by themselves; the hospital has to do that. So if the hospital were responsible for the consequences of the injuries, the hospital would have a strong incentive to try to reduce that and would think about changing systems instead of just fingering the individual.
    Mr. BILIRAKIS. You would have, then, a process where it would have to be determined whether this was a preventable injury versus a nonpreventable one; isn't that correct.
 Page 26       PREV PAGE       TOP OF DOC
    Dr. LEAPE. Well, I would make it for all injuries caused by treatment, as opposed to caused by the disease. I mean, not complications of the disease, but all complications of treatment, yes, because the nonpreventables hurt just as bad as the other.
    Mr. BILIRAKIS. Give me an example of a nonpreventable, that is not the cause of disease.
    Dr. LEAPE. Sure. You wouldn't have to compensate for this but a rash from a drug, a person is allergic to a drug, it was not known before, they got the drug for the first time, they had an allergic reaction. At the present time, we have no way of preventing that. It could be fatal, all the way from a simple thing like a rash to being fatal. It is not the doctor's fault that happened and we don't have any mechanism for compensating them, so I think that the hospital should pay that and then the hospital would work on it. They obviously couldn't do anything about those, but they would work on the ones that are preventable, which are two-thirds of them.
    Mr. BILIRAKIS. Thank you, Mr. Chairman.
    Mr. STEARNS. Mr. Peterson.
    Mr. PETERSON. Thank you, Mr. Chairman, and thank you, Doctor, for giving us some compelling testimony here. I just wonder, how realistic it is that we can get to some of the places you want. You talk about a change in leadership. It seems to me that maybe people sitting around this table might be a key component of that. Right now, we have a situation where everybody is beating the heck out of the IRS because they are doing what we told them to do. Listening to what you are saying, it makes a lot of sense to me, but it just seems that your solutions are going to cost a lot of money. And the VA system is under a lot of pressure. They don't have enough money to do what they are doing now. I think to some extent, you have the same thing happening in the regular health care system where it is driven by costs, it is not driven by safety.
 Page 27       PREV PAGE       TOP OF DOC
    Dr. LEAPE. Right.
    Mr. PETERSON. And what you are suggesting is going to cost more money. If you are going to tell people they can't work 80 hours, they can only work 40 like an airline pilot—and I am totally persuaded computerizing records, bar coding would save a significant number of errors—that is going to cost money.
    I assume Dr. Kizer is going to tell us that they don't have the money to do that, to the extent because they can't take care of the patients they have. I would imagine you have people in the regular health care system that are not doing it because of the same reasons, am I right or wrong on that? Have you studied that whole aspect of this?
    Dr. LEAPE. Two answers, one theory and one reality. In theory, quality pays. That is, most studies done in the past show improving quality cuts cost.
    Mr. PETERSON. It costs more money at the beginning— —
    Dr. LEAPE. It costs less money to make a perfect car than to make one with defects and have to redo it.
    Mr. PETERSON. But how do you get there?
    Dr. LEAPE. Yes, right, in general. Now, specifically, I will give you one example. The Brigham and Women's Hospital recently put in a computerized physician order entry system, all orders have to be put in the computer. By doing that, it looks as if we have reduced adverse drug events by a sizable percentage, probably as much as 40 percent.
    Every preventable adverse drug event in that hospital costs $4,685 to the hospital. The hospital is spending $2.8 million a year by our estimate on preventable adverse drug events. If we cut that in half, they will save $1.4 million a year, that's every year. That will pay for a lot of computers. That may be more dramatic than most. Putting bar coding in would certainly save money, because if you eliminated 100 adverse events a year because it was the wrong dose and so forth. The business about reducing hours is a little stickier.
 Page 28       PREV PAGE       TOP OF DOC
    People are getting paid by the hour, the nurses and pharmacists are. The house officers are not, but nurses working double shifts get double pay. In fact, they get more than double pay, so it isn't necessarily more expensive. I think it is up front going to be more expensive, but in the end it will save money.
    Mr. PETERSON. Well, if it is saving all this money, why isn't everybody doing it?
    Dr. LEAPE. Well, they haven't known about it. It hasn't been self-evident up until now. I mean, computerized entries are a new thing just coming down the line.
    Mr. PETERSON. Are you kidding me?
    Mr. LEAPE. No, I'm not kidding you.
    Mr. PETERSON. I was in the hospital in my District 5 or 6 years ago and I think some of the people in the hospital understood if they could computerize, they would save a lot of money. They couldn't get their people running the hospital to do it.
    Dr. LEAPE. Yes.
    Mr. PETERSON. So it is hard for me to believe the whole industry didn't know about this, about bar coding. Bar coding has been around for 15 years.
    Dr. LEAPE. It is hard to believe, isn't it? I am with you. I mean, seriously, why haven't they done it yet?
    Mr. PETERSON. And I would guess, there is no money in the VA budget to bar code every VA hospital, to computerize every VA hospital so they can have an order entry system. I am totally convinced if we did that, it would save us money, probably a lot of money and a lot of problems.
    Dr. LEAPE. Well, see, in the private sector, it is the patients who have been paying, you know.
    Mr. PETERSON. Well, the patients have no idea what they are paying for. That is part of the problem, and the media is part of the problem with this, too. They don't put the right message out about what is going on with it.
 Page 29       PREV PAGE       TOP OF DOC
    Dr. LEAPE. The other answer to your question is if it costs more, so be it.
    Mr. PETERSON. I agree.
    Dr. LEAPE. I mean, we are talking about lives. If it is going to cost us a little more to do it safe, we have to pay a little more to do it safe. You wouldn't begrudge the airlines increasing the price of your ticket by 20 percent if it reduced your chances of having a crash. It is the same thing here. I really believe that in the long run it will save money. All the evidence from industry indicates that. But if it costs more up front, then we should pay that.
    Mr. PETERSON. I totally agree with you, but the reaction out of Congress might be, because of the media, to put more regulation on, to punish people more, which would have the exact opposite effect.
    Dr. LEAPE. We are starting to turn that around this morning. It is time to change and it starts in one room on one day and then it goes on.
    Mr. PETERSON. Amen. You need to go to talk to the appropriators I think, too.
    Dr. LEAPE. I appreciate your help.
    Mr. STEARNS. Dr. Leape, before you go, the staff pointed out to me there is a provision in VA law that the VA hospitals, in fact, have to compensate when an event occurs not reasonably foreseeable. Disability or death caused by hospital care, including carelessness, negligence, and lack of proper skill and error.
    Dr. LEAPE. Well, see, you are ahead of all the rest. You are already a leader.
    Mr. STEARNS. Before you go, you cite one in 200. But then you go on to say that doctors don't want to report their errors. Nurses don't want to report it. No one ever tells the patient, but in the airline industry we get good reporting. In all candidness, is this one in 200, maybe it is 1 in 100 or 1 in 70. How do we have any confidence in this 1 in 200 when we have doctors not reporting, nurses not reporting, no one across the hospital industry looking at the baseline information? I mean, how do we have any confidence in this?
 Page 30       PREV PAGE       TOP OF DOC
    Dr. LEAPE. I am going to make it worse. That number came from our study which was a review of medical records. Every doctor knows—every doctor and nurse knows what is not in medical records.
    Mr. STEARNS. So medical records have really already been diluted.
    Dr. LEAPE. What I am saying is when we say it is one million and 120,000 deaths, that is based on data from medical records. The number is almost certainly higher than that, maybe two or three times as high. I don't think we need to get everybody all shook up, but I think it is clearly a lower bound. It is clearly worse than that.
    Mr. STEARNS. But you are just saying for the record, you said two or three times so if I took three into 200, I am at 70, so 1 in 70 is probably a limit you are indicating for the record.
    Dr. LEAPE. It might be. I mean, we don't have that kind of data, but it certainly might be.
    Mr. STEARNS. Okay. Well, I thank you for your time.
    Mr. GUTIERREZ. Mr. Chairman, I ask unanimous consent that the Members be allowed to submit follow-up questions and responses for the hearing record.
    Mr. STEARNS. Without objection. We thank you for your time and we will now hear from the second panel. We have Dr. Kizer, Under Secretary for Health, Department of Veterans Affairs, accompanied by Dr. Wilson, Director, Office of Performance and Quality Department of Veterans Affairs, Dr. McManus, Medical Inspector, Office of Medical Inspector, Department of Veterans Affairs; Dr. Mather, Assistant Inspector General for Health Care Inspections, Office of the Inspector General, Department of Veterans Affairs.
    Let me again welcome our panelists and particularly Dr. Kizer for his valuable time and for coming here this morning and we await your opening statements.
 Page 31       PREV PAGE       TOP OF DOC

STATEMENTS OF KENNETH W. KIZER, M.D., M.P.H., UNDER SECRETARY FOR HEALTH, DEPARTMENT OF VETERANS AFFAIRS ACCOMPANIED BY NANCY WILSON, M.D., M.P.H., DIRECTOR, OFFICE OF PERFORMANCE AND QUALITY, DEPARTMENT OF VETERANS AFFAIRS; JAMES MCMANUS, M.D., MEDICAL INSPECTOR, OFFICE OF MEDICAL INSPECTOR, DEPARTMENT OF VETERANS AFFAIRS; JOHN MATHER, M.D., ASSISTANT INSPECTOR GENERAL FOR HEALTH CARE INSPECTIONS, OFFICE OF THE INSPECTOR GENERAL, DEPARTMENT OF VETERANS AFFAIRS

STATEMENT KENNETH W. KIZER., M.D., M.P.H.

    Dr. KIZER. Good morning, Mr. Chairman, members of the subcommittee. You have my written statement. I am not going to repeat that now. Instead, in the interest of time, I would like to take these few minutes to make just five points. First, I hope that Dr. Leape's comments made clear that the problem of adverse events resulting from medical treatment is a problem affecting health care everywhere, public and private hospitals, nursing homes, clinics, doctors' offices throughout the country.
    The size and dimensions of the problem are far greater than commonly realized. Indeed, investigators in this area have repeatedly stated that the statistics arising out of studies probably indicate only the lower bounds of the problem; that is, it is a problem much larger than the chilling numbers cited by the Chairman and Mr. Bilirakis earlier and those which Dr. Leape noted.
    The second point I would make is that as a former regulator of over 5,000 health care facilities in the State of California for quite a few years; as a physician who has practiced in a number of settings, ranging the gamut from university teaching hospitals to small rural hospitals; and as a consultant on quality of care issues, I can tell you, without any question, that the type of medical treatment problems seen in the VA are the same types of problems that occur every day in non-VA facilities throughout the Nation.
 Page 32       PREV PAGE       TOP OF DOC
    The major difference is that these problems elsewhere rarely receive the public scrutiny that events in the VA do.
    Third, while the quality of care provided by the veterans health care system overall is as good, and often better, than that provided in the private sector, as attested to by various objective indices, the system is far from perfect, and the quality of care is not as uniform throughout the system as it should be.
    We truly regret that treatment mistakes and some tragic errors have occurred. I personally consider even one death or injury resulting from medical treatment to be too many, and I concur with the Chairman, or at least with the statement that is attributed to the Chairman in the media, that the VA is and should be held to a higher standard than the private sector.
    The fourth point is that as part of the veterans health care system reengineering effort that we have discussed before this committee and other committees on a number of occasions, we have implemented a very comprehensive quality care framework, one element of which is a new risk management policy that will routinely identify and analyze adverse events that may be related to medical care.
    Our approach to this has been reviewed by a variety of entities, and we have gone to other health care systems to seek their critique and input on this policy, and I can tell you they have been uniformly very complimentary. In fact, to date, we have not been able to identify any other health care system in the country that is taking as rigorous approach to ferreting out this information as the VA is in its new policy.
    I should note, though, that as we actively seek out these problems in the months and years ahead, I would not be surprised to see the number of identified untoward incidents grow; in fact, that is something we should expect to see.
    The last point I would make, and as will be discussed by the third panel in more detail, I believe VA hospitals have generally done a good job of analyzing and correcting facility specific circumstances that may have contributed to untoward treatment-related outcomes. However, VA has done less well in taking those individual lessons learned and generalizing the findings to the system overall; that is, in fact, a focus of much of our efforts at present and underlies much of the thinking behind the new risk management policy. I can cite perhaps a couple of examples of how we are trying to approach this.
 Page 33       PREV PAGE       TOP OF DOC
    In the last 3 years, we have had three deaths due to errors in blood transfusions. We are now moving forward with a bar coding system that will be used when any blood transfusion or blood product is to be given. I think Mr. Peterson asked about the cost of that. Part of any of these things we talk about doing is what it costs for one facility, and then we have to look at the entire system. We think this particular intervention will cost about a half a million dollars, of which, I believe, we can readily absorb. We have to write some software programs and other things to incorporate it into the system, but that is moving forward.
    As another example in a similar vein, we have had an institution who has been looking at bar coding for pharmaceuticals or the administration of drugs. We are now looking at this for the implications, fiscal and otherwise, for system-wide implementation. When we flush that out we will be either moving forward with it or coming back and seeking funds to implement it. We are hopeful we can do it with the savings that we are generating by doing other things within the system. Let me stop here.
    I would just conclude by saying that I think we have set the stage for changing the way that we do business, and I think this will have a salutary effect on the way health care is provided throughout the entire Nation. I would say, though, that, frankly, we need your help.
    We need a change in the atmosphere and the environment in which these things are approached, as Dr. Leape spoke so eloquently about. We welcome your oversight, and we enlist your assistance in trying to solve this very major national problem. That is by no means solely a VA problem. It is a problem affecting health care everywhere in this country.
    [The prepared statement of Dr. Kizer appears on p. 107.]

    Mr. STEARNS. Dr. Mather.

 Page 34       PREV PAGE       TOP OF DOC
STATEMENT OF JOHN MATHER, M.D.

    Dr. MATHER. Good morning, Mr. Chairman. I appreciate this opportunity to appear before you today and discuss VA's policy and performance in the area of risk management and also the role of the Office of Medical Inspector. With your permission, Mr. Chairman, I request my written prepared statement be entered into the record and I will use this opportunity to summarize key issues.
    Mr. STEARNS. Without objection.
    Dr. MATHER. Veterans receiving their medical care through the VA can expect the health care professionals who treat them to do it well without inflicting serious harm. Even so, over the past 5 years, there have been instances where this has not been so and there have been a dozen or so widely publicized and apparently avoidable deaths.
    The Veterans Health Administration, with its system of medical centers, has long had policies which were intended to minimize risks to their patients of inadvertent error in medical care. Actions have been taken which, if consistently and properly applied, would have prevented serious disability and deaths under unusual or apparently avoidable circumstances.
    The risk management policy focused on achieving effective VA medical center programs, with appropriate oversight by regional networks offices (the VISNs), and headquarters offices including the Inspector General. Over the past several years, whenever there have been incidents of serious disability and avoidable deaths under unusual adverse circumstances, VA medical centers have taken the situations very seriously. Their staffs have conducted in-depth investigations, determined the nature of the error, assigned individual culpability, devised mechanisms to prevent similar incidents and filed reports with senior management.
 Page 35       PREV PAGE       TOP OF DOC
    Over the past 5 years, the VA has issued a series of policy directives on risk management. It has recently published a strong and comprehensive risk management policy. This latest directive fully addresses the criticisms we have previously raised concerning omissions and weaknesses. The present policy has the potential for significantly strengthening the VA's present procedures and mechanisms for coordinating an effective risk management program.
    VA's risk management policies have always had reporting requirements for the VA medical centers with defined procedures for oversight by regional components (the VISNs), and headquarters. Over the past couple of years, it seems that issues related to resource allocation, strategic planning and the implementation of a performance measurement system have been dominant on their agendas. Consequently, components in Central Office have not given careful attention to reviewing aggregate information on adverse events. This new risk management policy seeks to remedy this deficiency by assigning more definitive roles to VISNs and Central Offices.
    Eventually, throughout the VA's health care system, the information on adverse events can be appropriately standardized to insure that comparable data and information are collected and available for review. In this regard, the risk management directive gives broad guidance and each VISN is required to appoint a statistical consultant who can provide some consistency. Once data and information on risk management are collected, it is essential that it be tracked and regularly examined for trends. This requires assignment of clear roles and responsibility in the VISNs and for Central Office components.
    Here, the new policy provides the specific guidance for the organization of an Adverse Events Registry and the establishment of a Central Office Risk Management Oversight committee. The VA's Medical Inspector is a member of the committee, but his participation is likely to be compromised as long as questions persist about the role and staffing of the Office of the Medical Inspector.
    The Risk Management Oversight Committee needs to regularly review the Adverse Events Registry and identify relevant information for prompt dissemination to VA medical centers. This communication is an essential feature of a risk management policy for a health care system as large and complex as the Veterans Health Administration.
 Page 36       PREV PAGE       TOP OF DOC
    My Office of Health Care Inspections is the primary office in the Inspector General's office, with direct clinical and quality assurance oversight responsibilities. In fulfilling this role, we have generally reviewed as paramount the VA's need to revise its risk management policies and significant progress has been made in correcting several previously deficient areas.
    My office will continue to actively monitor the implementation and effectiveness of these risk management policies. Mr. Chairman, this completes my oral testimony. I will be pleased to answer any questions or provide written commentary in the future.
    [The prepared statement of Dr. Mather appears on p. 117.]

    Mr. STEARNS. Thank you, Dr. Mather. As I understand, Dr. Kizer, those are the two only opening statements, or are there additional?
    Mr. KIZER. No sir.
    Mr. STEARNS. Okay. I think the big question I have is, how big a problem is safety with the veterans' hospitals? You are quoted, again, in the Washington Post saying, quote, ''we really do not know the complete dimensions of what we are dealing with.'' You know, that is a very candid statement, and I commend you for what you are doing here in issuing a new directive and, as you pointed out in the press, your joint effort to improve hospital care and get an understanding of the safety.
    But, Dr. Kizer, until we made a request to see the systemwide patient incident reports, that data had not been systematically reviewed for several years, and as I understand, this is contrary to your own policy directive of April of 1995, chapter 35, of VA manual M-2. I guess the first question is how do you explain that, and how do we know it is going to occur after your new directive?
    Dr. KIZER. I think there are probably a lot of things that can be said on why it was not occurring. I would just sum it up by saying some things that I had thought were being done were not being done. I think the focus and the attention has significantly changed, and I know that one of the reasons why you can have confidence that things will change is because you are going to ensure that they do, in addition to our efforts.
 Page 37       PREV PAGE       TOP OF DOC
    But I think within the organization there is now a commitment to our risk management progress. As Dr. Leape alluded to, much of the problem here is a cultural problem in medicine, and medicine everywhere, as far as a willingness to identify and openly talk about and thoughtfully analyze errors and mistakes that occur—some of which are preventable, some of which may not be. VA health care practitioners are like what you would find elsewhere in that there is often a reluctance to do that, either because of fear of litigation or other concerns, because of the way things typically get sensationalized in the media with anecdotes getting blown out of proportion, and a whole host of other things. The bottom line is there have been changes put in place, and they are going to be carried through on.
    Mr. STEARNS. You know, when I heard Dr. Leape talk about underreporting, it comes to my mind the staff has shown me statistics that the number of reported incidents in 1994 were 5,063; and in 1996, it was 3,622; and this year the number of incidents is shrinking further. I mean, I don't know, but just looking at that report makes you concerned.
    Then when you go to look at the patient incident reports at particular networks, through 1997, mid-September, there are some very low numbers here. Some are reporting 13 incidents, 15, 21. So, I mean, this would sort of corroborate what you have been saying and what Dr. Leape has been saying. I mean, I would suspect, there seems to be underreporting from the data we have here.
    Do you want to comment on the fact that there appears, from the data here, that things are going down, and that the different networks are reporting very, very small incidents, and based upon what we have heard from Dr. Leape, it gives you a question of underreporting?
    Dr. KIZER. I think you are absolutely correct; that is a very legitimate question. It is one that we are looking at as well. The nonuniformity of this across the system is certainly one that we are looking at to see if we can better explain it.
 Page 38       PREV PAGE       TOP OF DOC
    The nature of the drop in reported incidents may well be due to underreporting. It may well be due to other things as well, including shorter hospital stays and the shift in care to outpatient settings. We have other data, for example, that shows significant improvements in care. For example, 3 years ago, we began tracking specific types of patients—i.e., specific vulnerable cohorts of patients—and looking at their longevity and clinical outcomes; we now see that over that period of time, there have been statistically significant increases and improvements in their 1-year survival rates.
    There are some other indicators that also would suggest that the quality of care is improving. For example, in surgery the numbers show fewer deaths and complications related to surgery. So at this point, I think underreporting is certainly a potential problem and may well account for some or indeed much of lower counts. But we also have data that suggests that quality of care is improving, and the actual numbers of complications are dropping.
    I am not going to stand before you and say that it is one or the other. I think we need to continue to look at this. I also would note that no matter how much we look at what has happened historically, we will probably never be able to ferret it out completely. What we are trying to focus on is where we go from here and how we move forward and get the sort of baseline data and ongoing mechanisms in place that can answer the questions you have, and also provide our patients with the sorts of assurances they need, and how we can demonstrate leadership to the rest of the health care community.
    Mr. STEARNS. I think that is good. And you are pointing out, as Mr. Bilirakis pointed out, about setting the culture.
    Let me just suggest or comment that your new policy, as I understand it, calls for a headquarters committee meeting once monthly to review all adverse events and all Board of Investigation reports. Now, considering there are thousands of cases, and you have this backlog of information, doesn't the headquarters committee have a responsibility to meet daily to look at this, rather than monthly, to carry out this responsibility, particularly in light of the fact that what appears here, we have all the information collecting, we are not doing anything with it, it seems to me you should jump on this and do it daily. Am I wrong?
 Page 39       PREV PAGE       TOP OF DOC
    Dr. KIZER. The frequency of review is certainly not set in stone, and if it turns out we need to meet weekly, biweekly, daily, then will do so. These are all things that as we move forward with implementing this policy, are subject to change, according to what the data and our results show.
    Mr. STEARNS. My last question is for Dr. Mather. Would you elaborate on the concern you have expressed in your testimony, and we sent out the letters to all the administrators of the hospital, as a result of the articles that were in Congressman Bilirakis' congressional district. We read these articles, and we were concerned, just as he was. And then we sent these letters to all the administrators, and they came back, and you, as I understand it, looked at these letters.
    The VA's new risk management efforts—let me just read it to be very clear. Would you elaborate on the concern expressed in your testimony that VA's new risk management efforts may be compromised to the extent that its Medical Inspector's Office is understaffed; that is the key, is it understaffed.
    Dr. MATHER. Mr. Chairman, in the Under Secretary's written statement, and also in mine, there is an elaboration there of some of the roles that have been performed by the Office of the Medical Inspector over the past few years. I know Dr. Kizer has a contract to review that role and function, which he anticipates will be completed later this year.
    If you look at this risk management policy, there is clearly a very key role for the Medical Inspector, Dr. McManus, to perform. Not only is it the receipt and review of those Boards of Investigation and the focus reviews, but to be very much of an active participant in that particular oversight committee, the Risk Management Committee. I think it is a dilemma he has, and that is while all the scopes of responsibilities he has, his staff over the last 3 years is down under half what it was. He did have a staff of some 20, and with what I see as the scope of what Dr. Kizer has in mind for that office, I do not see how Dr. McManus, with his small staff, and also with, generally speaking, a nonclinical staff, has really the wherewithal to be a complete and active participant in that oversight committee, the Risk Management Oversight Committee.
 Page 40       PREV PAGE       TOP OF DOC
    Mr. STEARNS. Thank you. Mr. Gutierrez.
    Mr. GUTIERREZ. Thank you very much, Mr. Chairman.
    Welcome to the panel. Welcome, Dr. Kizer. I guess we have a great opportunity for the VA to set a standard for the rest of the Nation, and I guess—I don't guess, I know that apart from your comment, Dr. Kizer, that this committee won't allow it to happen, I think we also have a responsibility to deal with everybody at the VA to ensure that you have the resources.
    So we would also like to hear, if you are going to issue a report back to us and you are going to be communicating to us, I think that is just as important as everything you are doing is everything you need to get it done so that the Members can be fully aware so that in the future, I think it is very fair for someone to be able to say, well—for me to be able to add, well, Dr. Kizer, you know, this is what you did; and for you to be able to say, yes, this is what I asked you in order to get there. And I think if we are going to do that, I certainly would like to have a complete list of the things you need to get it done.
    Having said that, if you could just share, Dr. Kizer, with us some specifics and reiterate just exactly what you intend to do, but not in general terms, but in specific terms. What can we expect to happen at VA hospitals that they are going to make the system better?
    Dr. KIZER. I think what you can expect is that as we analyze these incidents, we will be looking at all of them for systemwide improvements, and what you will see is a succession of systemwide implementations of interventions that are identified at the local level as being successful. Patient identification by bar coding, in the case of blood transfusions, is one example. Bar coding for pharmaceuticals is another.
    But as these are identified, the focus here is how can we implement those from a systemwide perspective. I wouldn't be surprised if there were resource needs associated with these interventions as we move forward. And as the committee knows, because of budgetary reductions, our headquarters operation has been reduced by about 30 percent of its staff in the last 3 years. As we have tried to look at the staffing needs for the Office of the Medical Inspector, that has to be done within the context of overall, very substantial reductions that we are forced to live with, in addition to some particular issues regarding the overlap in law, as well as in policy and operations, of the Office of the Medical Inspector and the Office of Health Care Inspections within the Inspector General's Office. As was commented on, or has been identified in other sources, there is overlap there, and that results in some confusion as far as exactly who is responsible for what.
 Page 41       PREV PAGE       TOP OF DOC
    We have also—as Dr. Mather noted—hired a consultant to review the functions of this office because this is unique; there is no such entity as the Office of Medical Inspections elsewhere in the health care system. That function simply doesn't exist anywhere in the private sector, and there are notable differences between how that office has operated in the past in the VA, as opposed to the Department of Defense, where there is an analogous office. To help with that, we have contracted with a consulting group to try to help ferret out some of those things. We have some preliminary information, and we expect to have their final report within the next couple months. Based on that, we will be looking at what the staffing needs may be for that department.
    But I would also add, as I have reiterated to Dr. McManus on a number of occasions, that while his office may have only a certain number of people, there are approximately 15,000 physicians in the system that are at his disposal should he need them; there are tens of thousands of nurses and other personnel. All he has to do is tell me what type of person he needs, and we will make those available to his office to conduct reviews or inspections, as needed.
    Mr. GUTIERREZ. Thank you very much, Dr. Kizer.
    Thank you, Mr. Chairman.
    Mr. STEARNS. Mr. Bilirakis.
    Mr. BILIRAKIS. Thank you very much, Mr. Chairman.
    A lot has been made of the underreported adverse incidents, and we can't belittle that. Because if we don't know what the problems are and we don't know what the occurrences are. How in the world are we even going to possibly try to address them and to solve them?
    One of you, it might have been Dr. Mather, I am not sure, said something about we need your help. Exact three words: We need your help. I guess Dr. Kizer said it. And I think that is good. Although, unless you tell us what you want us to do, I mean, other than more money, I am not sure that we can help, and I would hope that more would come from you all here today in that regard.
 Page 42       PREV PAGE       TOP OF DOC
    But let me go to a couple specifics here, because this cultural thing is very important, and we talked a lot about it, if you recall, when we had the sexual harassment hearings surface. There is a culture there. There is an accusation of good old boys culture and culture at the VA, and it is just very important.
    I am going to refer to a June 15 article in the St. Petersburg Times and ask two questions regarding that article. The Times reported the VA was forced to rehire a doctor that an assistant U.S. attorney called, ''a menace to his patients' well-being.'' This doctor, who worked at the Beckley, WV, VA Medical Center had four malpractice complaints against him and eventually had his license suspended by the West Virginia Board of Medicine. His license was formally revoked in January of 1997. And the article also went on to report that one VA physician had to take the medical examination 10 times, 10 times before passing.
    So the questions are, first, how big of an impairment is this for you as you try to effectively manage the VA health care system?
    Dr. KIZER. Let me say two things. First, you cited a couple of instances, and just should the people sitting immediately behind me generalize that to the rest of the physicians in the VA, I would note that 70 percent of physicians in the VA are university faculty, and you won't find that at any other health care system in the country. These are what we generally consider the best physicians in the country.
    Mr. BILIRAKIS. But we want as close to 100 percent as we can get, don't we, Dr. Kizer? I don't think we should be sitting on 70 percent. I mean, it is a good statistic, and I appreciate that.
    Dr. KIZER. Seventy percent are university faculty, and you are mixing two things there. The point, or specifically the point you raise, and I will respond to it the way I responded at a number of other hearings and settings as well, whether it is sexual harassment or whether it is some of the issues related to how we deal with physicians who we would like to—or other professionals we feel aren't serving the system well, the civil service laws and rules are a major impediment. I understand they are well-intended and that they are certainly derived by good motivations, but the personnel system has become so complex and so difficult and unworkable that it is creating many of the problems that you are now focusing on.
 Page 43       PREV PAGE       TOP OF DOC
    Mr. BILIRAKIS. You are attributing some of the problems to the fact that you can't fire, let go, or maybe in another way reprimand a Federal employee because he or she is a Federal employee.
    Dr. KIZER. There are so many levels of appeal and other mechanisms to circumvent disciplinary action that the system is exceedingly difficult to work with. The case you cited is one particularly egregious example of that where we tried to terminate the person, but the system forced us to rehire the individual.
    Mr. BILIRAKIS. All right. But have you come to the Congress, or has anyone at the VA come to the Congress and said to the Congress, look, you know, the laws mean well, we don't want to hurt innocent people, et cetera, but these are some changes that we recommend to allow us to be able to serve the veterans better?
    Dr. KIZER. We have discussed this, I would say, informally. But if I could take that as an invitation, we will come back with some more specifics.
    Mr. BILIRAKIS. Sure, you can take it as an invitation. I can't really speak for the committee, although the chairman is shaking his head yes.
    Mr. STEARNS. I agree completely.
    Mr. BILIRAKIS. Then it goes on to what type of standards does VA have for hiring of physicians and other medical personnel. Now, why would this physician who had to take the medical examination 10 times before passing have been hired by the VA?
    Dr. KIZER. If he is a licensed physician, the law doesn't allow us to discriminate against him because he had to take it 10 times. Once he passed and was licensed, by statute we cannot discriminate.
    Mr. BILIRAKIS. But you don't have to take everybody who applies, do you, just because they happen to be a licensed physician, and there happens to be an opening? I mean, isn't there some criteria there, whether it be subjective or otherwise, which allows you to not hire this one individual because the person might have something wrong with him or whatever the case might be?
 Page 44       PREV PAGE       TOP OF DOC
    Dr. KIZER. Well, I think it is not that simple.
    Mr. BILIRAKIS. It isn't?
    Dr. KIZER. No, it is not. We would certainly be willing to engage in further discussions on specifics.
    Mr. BILIRAKIS. I know this is a public hearing, and there might be sensitivity to some things that might be said and all that, but darn it, we are talking here about veterans. You know how I feel about the veterans health care system, but problems are there, and we can say that those problems are no worse there than they are in the regular health care system in America or maybe in the world. That doesn't make any of us feel any better because we are talking about treating veterans, who are special people. And so it seems like we ought to be confronting some of these things head on, because when we are talking about culture and cultural changes, I think these things are part of all that.
    Dr. KIZER. And I agree.
    Mr. BILIRAKIS. And there is something in the law that precludes you from being able to make a decision when more than one person applies for a job that you take this person versus the other person or whatever; is that right?
    Dr. KIZER. Without being able to focus on the specific circumstances, it is pretty hard to talk about that in the abstract. All I can—I would go back that the prohibitions against discriminating against somebody are very strong and very explicit in the law.
    Mr. BILIRAKIS. But, sir, excuse me, forgive me, Doctor—Mr. Chairman, with your indulgence—but you use the word ''discriminating.'' I am talking about making a decision. I mean, you know, we are human beings, and when we hire people, I don't think we should be discriminating. Are we saying that this particular individual had to take the examination 10 times, it would have been considered discrimination if we hadn't hired that person?
 Page 45       PREV PAGE       TOP OF DOC
    Dr. KIZER. It might well have been, yes. That is the nature of the law and how it is being interpreted.
    Mr. BILIRAKIS. So if I am not hired, the law will protect me in terms of they can say, hey, they don't like Greeks, or something of that nature; is that right?
    Ms. WILSON. Or someone with an anxiety disorder, and the reason they took the test 10 times was because of that, we would be discriminating against someone with a psychiatric illness.
    Mr. BILIRAKIS. I am sure the veterans love to hear that.
    Dr. KIZER. Well, we don't write the laws, but the way they are interpreted in the real world, in interpreting these things, they are not always used to the advantage of the employer or in the way they were intended; they do not work to the advantage of the system all too often.
    Mr. BILIRAKIS. Thanks, Mr. Chairman.
    Dr. KIZER. I would, if I might, mention one of the new policies that we put in effect a few months ago was the requirement that any new physician that is hired into the VA system must be board certified in the specialty that he or she will be practicing in. While this requirement is present in some other health care systems, that is not the norm in the community at large.
    Mr. STEARNS. Dr. Cooksey.
OPENING STATEMENT OF HON. JOHN COOKSEY

    Mr. COOKSEY. Thank you, Mr. Chairman. Well, this, no doubt, is a problem, and it is a problem that needs to be addressed. And in defense of the VA, the veterans' hospitals have received some cuts, I think oftentimes too many cuts will ultimately lead to the reduction in quality of care, because when you cut and cut personnel, it is going to create a problem. I happen to personally believe that when you have the best physicians, the best health personnel, nurses and so forth, you are going to get the best quality of care. But too often we make decisions based on the cost of care instead of quality of care, and as long as we are making decisions, health care decisions, based on cost of care and not quality of care, we are not going to get good quality care.
 Page 46       PREV PAGE       TOP OF DOC
    But in this current climate, these decisions are dictated by politicians, and now that I have changed from being a physician to being a politician, I assume I am part of the problem. They are made by bureaucrats, they are made by numbers crunchers, and they are influenced by the media and the tort system, which is greatly distorted, and it is a shame.
    And I agree with my colleague, Congressman Bilirakis, that it is a shame that physicians who have failed an exam 10 times can be brought in, because there are physicians out there. I happen to serve on the ethics committee of our State medical board for about 8 years, and it is the worst job ever—I realize there are people out there that probably should not be working, and too often they can end up in a State hospital because they have had their license jerked, and the only thing they can get is an institutional license, which means they can work at a State hospital or a veterans' hospital. I think the veterans deserve better than that. So it is a problem.
    Dr. KIZER. Let me just interject, just to clarify one point. They may well be able to work at the State hospital, I can't comment on that, since there are 50 different sets of laws dealing with the States; but if they have had their license revoked, they cannot work in a VA hospital. They have to be licensed to work for the VA.
    The other thing I would comment on is your comment about the malpractice and tort system in this country being a major barrier to addressing this problem of adverse events related to medical treatment. It is an absolute major contributing factor to why these things aren't talked about openly and why they aren't dealt with in health care overall.
    Mr. COOKSEY. Sure, no question about it. But, unfortunately, the trial lawyers carry the day. In case you didn't know, Dr. Kizer, I am sure you know this, there are 172 lawyers in Congress, and I think 52 or 53 in the Senate, and that is part of the problem, and there are too many in State legislatures. But anyway, I am obviously biased, and I do discriminate against trial lawyers and relish it.
 Page 47       PREV PAGE       TOP OF DOC
    But, you know, I think we are all here to make sure we get the right health care for veterans because there are good veterans out there. I had a retired physician, a veteran, World War II, good guy, tell me about some concerns at a local veterans' hospital in my District, and we checked it out, and there really was some misinformation there. There is still a lot of misinformation and this particular veterans' hospital is doing top quality work with good physicians, and I am pleased to be affiliated with it. There is another veterans' hospital in the general area that perhaps does not—has not addressed all these problems, but it does get back to quality of care, and that is what I think we are all about. And I applaud your efforts in moving in the right direction.
    And this is the type of flowchart that you need to find these problems, and it is one we deal with in the private sector as well, but we can do it—these problems will best be solved by properly motivated health personnel making the decisions, instead of politicians, lawyers, and the media trying to make these decisions or influence these decisions to their own advantage.
    Thank you, Mr. Chairman.
    Dr. KIZER. If I can make one final comment, please. One of the ways you can help is exactly what Dr. Leape mentioned as far as the climate and how these issues are perceived. There was an excellent article in the New York Times a few months ago about the need to change the mindset around this problem; it specifically dealt with medical treatment errors in private institutions. Insofar as starting at the top, the culture can change to facilitate open and thoughtful discussion of these things, and anything Congress can do in that regard certainly would be beneficial and would translate probably very tangibly into ultimately better care for our veterans.
    Mr. STEARNS. Let me just thank you for your candidness, and towards this idea of the culture that we want to improve the system, may I suggest, and we would welcome, if you would follow up, perhaps, with suggestions for us to improve the selection, the management of these facilities, because in the end, if we could together work to do that, we would provide immeasurable benefit to the veterans in this country.
 Page 48       PREV PAGE       TOP OF DOC
    The last sort of question I have is when it is all said and done, what will this committee get from your Department in the way of records showing that you have increased effectiveness, you have determined that these records are not underreported, and so forth and so on? So I am just asking you as a management policy, what will this committee see from your Department?
    Dr. KIZER. Obviously, in general terms, you will see whatever you want, whatever we can provide, and if the information that we do provide you as far as the statistics and numbers and the specific examples of things that have changed is not adequate, then we will increase that to give you, the committee and the Congress a level of comfort that it needs to be confident that the problem is being addressed and that improvements are being made.
    Mr. STEARNS. Again, I want to thank all of you.
    Mr. KENNEDY. Mr. Chairman, can I just make one point?
    Mr. STEARNS. Absolutely, Mr. Kennedy.
OPENING STATEMENT OF HON. JOSEPH P. KENNEDY, II

    Mr. KENNEDY. I apologize, Dr. Kizer, and other members of the panel for being late. I had, as you know, another conflict up here at the same time.
    But I just wondered if you might comment generally, Dr. Kizer. I think that the fear that people have, generally speaking, after a movie a couple years ago, I think it was called Article 99, that sort of demonstrated, you know, kind of a cannibalistic health care system within the VA, where parts of the VA health delivery system had to be robbing from other parts in order to be able to provide any kind of reasonable amount of care. And the real concern, I think, goes back to hearings that we have had in this committee room over the course of the last several years, where we have had, for instance, VA directors come before us, tell us everything was in fine shape within their own regions, and then I have walked out the door and had a VA director grab me and say, listen, I can't, in fact, tell you the truth within that committee because it will mean my job, but the truth of the matter is that underneath we are really in trouble in terms of having enough money to be able to actually create the kind of health care system that will provide the basic protections.
 Page 49       PREV PAGE       TOP OF DOC
    I apologize for missing your testimony, but do you have concerns that you just don't have enough resources to actually get the job done to be able to provide the kinds of assurances that you would actually see within the private health care system?
    Dr. KIZER. Let me just say, on the movie, that I have heard of it, but I have never seen it.
    Mr. KENNEDY. You got to catch it. It is worth the rental.
    Dr. KIZER. I have heard contrary views.
    Mr. KENNEDY. I am sure where you work you have.
    Dr. KIZER. Resources are always an issue. I think that many of the changes we are putting in place, as we have discussed at other hearings, are showing that we can take the limited and constrained resources that we do have and make them go a lot further. We really are able to do this; this year we have treated more veterans than have ever been treated in the VA before, and we are able to show very tangibly that the quality is better.
    Are there issues? Yes. And we are going to have to continue to focus on those.
    Mr. KENNEDY. All right. But I guess what I am really trying to deal with is—I understand that, and I think everybody gives you great high marks for revamping the VA health care system and kind of bringing it into the 21st century. But I am asking a slightly different question, and I am making a different point.
    There have been a number of instances where there—and these are always pointed out to be individual circumstances—where bodies have been found in hallways, where they were—where body parts, I believe, were found at a VA health facility in the Midwest, out buried in different parts of the facility. In my own district I am certainly aware of VA health facilities that were in very, very bad condition with plaster falling down into the mouths of dental patients and the like. I mean, these are the kinds of—where an individual had died in a hallway and had been left for a couple of days, you know.
 Page 50       PREV PAGE       TOP OF DOC
    I mean, these are circumstances that could, in fact, be isolated incidents. On the other hand, they could be circumstances that portray a pattern that I don't think, you know—the last thing we want to do is have you feel defensive about the system and feel that it is an automatic response to come in and just say, oh, we are getting better, if, in fact, there is a major problem below that is just not getting the kinds of resources that are necessary to deal with creating an adequate health care delivery system.
    So I just want to make—I want to make it very clear that nobody, I think, is interested in seeing any kind of whitewash of serious problems that exist because of a lack of resources. If that is an issue, I think, you know, we should just know it and understand it, rather than just be told that, and have you or anybody else feel that this is going to be a reflection on the kinds of changes that you have brought about, which I think, as I said earlier, people I think are generally very supportive and complimentary to the leadership that you have shown. But I am and have always been concerned that below the surface there is a great deal of need within all sorts of the VA health facilities that maybe we just aren't even, you know, coming close to the kinds of adequate resources that are necessary to deal with the problem.
    Dr. KIZER. Well, you know, I think you cite some specific anecdotal things that hopefully wouldn't be generalized in the system, because I don't think they accurately characterize the nature of the care, the physical plant or other aspects of the system.
    But I would go back, again, to note that resources certainly are and will continue to be an issue. The VA budget over the past 15 years has gone up each year, generally, 2 or 3 percent. Medicare and Medicaid are going up 8, 9, 10 or 12 percent each year. I mean, unquestionably the funding support for the veterans health care system is not on par and has not kept up with other government health care programs as far as the funding they are receiving.
    Mr. KENNEDY. And it is your opinion, then, that that has created serious shortfalls in terms of the kind of quality care that is necessary to provide—you know, just the adequate health care to the veterans?
 Page 51       PREV PAGE       TOP OF DOC
    Dr. KIZER. I don't think the funding is at the root of this. I think there are other things we have talked about at some length this morning that really will help, but I don't think that resources are the root cause of the problems that have been cited.
    Mr. KENNEDY. Thank you, Doctor.
    Mr. Chairman, I appreciate your indulgence.
    Mr. STEARNS. Sure. We are going to take a recess now before the third panel, which is very important, that is the directors from three major hospitals who have answered our request. So the committee is in adjournment until we have two votes, and we should be back perhaps in about 15 minutes, or I should be back after the two votes in about 15 minutes.
    Dr. KIZER. Mr. Chairman, it was my intent to sit through the third panel, but I do have a speaking engagement that I need to go to.
    Mr. STEARNS. I understand. Is there anything you would like to add before we conclude?
    Dr. KIZER. No, that is fine.
    Mr. STEARNS. Okay. Thank you all for your time.
    [Recess.]
    Mr. STEARNS. The committee will come to order, and we will resume with the third panel: Dr. Elwood Headley, Director of Boston VA Medical Center, Department of Veterans Affairs; T.C. Doherty, Director, Miami VA Medical Center, Department of Veterans Affairs; and Billy Valentine is Director, Muskogee VA Medical Center.
    Gentlemen, I want to thank you for coming, and I know, having been in business myself, you have to take time in your busy schedule to come here; so we appreciate your taking your time and sharing with us your opening statements.
    So at this point you can begin.

 Page 52       PREV PAGE       TOP OF DOC
STATEMENTS OF ELWOOD HEADLEY, M.D., DIRECTOR, BOSTON VA MEDICAL CENTER; T.C. DOHERTY, DIRECTOR, MIAMI VA MEDICAL CENTER, ACCOMPANIED BY DOUGLAS BRADSHAW, ASSISTANT GENERAL COUNSEL; AND BILLY VALENTINE, DIRECTOR, MUSKOGEE VA MEDICAL CENTER, DEPARTMENT OF VETERANS AFFAIRS

STATEMENT OF ELWOOD HEADLEY, M.D.

    Dr. HEADLEY. Thank you very much, Mr. Chairman, members of the committee, thank you for the opportunity to present the details regarding this incident. Written testimony has already been submitted and this will be a brief summary of that testimony. I will present the circumstances of the case, the nature and findings of the investigations which occurred, and remedial steps which were taken.
    The patient was a 60-year-old man with cancer of the esophagus. He had previously undergone surgery for this and was taken back to the operating room for reexploration of the surgical site and drainage of fluid accumulation from the right side of his chest. He was seriously ill prior to the surgery and judged to be a high-risk surgical candidate.
    During the surgical procedure, he suffered a cardiac arrest and attempts at resuscitation were unsuccessful. In the process of reviewing the events surrounding his death, it was discovered that he had received two units of packed red cells, typed and cross-matched for another patient.
    Needless to say, the staff was devastated. Fact-finding was begun immediately, the patient's family was promptly notified of the incident, and of their rights, appropriate internal VA and external notifications were immediately accomplished. An administrative board of investigation was charged to review the incident. And if I might just add, a typographical error in the submitted testimony states that the administrative board of investigation was begun March 8, 1997, it was 1996; I apologize for that. It was an immediate board of investigations.
 Page 53       PREV PAGE       TOP OF DOC
    Mr. STEARNS. Unanimous consent, so corrected.
    Dr. HEADLEY. Thank you.
    Findings of the board. The identification of the patient prior to and during the surgical procedure was an area that was looked at. Each discipline in the operating room independently identified the patient, but there was no interdisciplinary process in place to verify this identification. Another finding was that blood was stored in a refrigerator in the operating room by room number, this is a relatively standard practice in operating rooms. This patient was in operating room number 7. He received the blood prepared for the patient who preceded him in operating room number 7.
    The arm band identification of the patient was not verified against the blood product prior to administration. This was clearly in violation of policy and procedure.
    The conclusion of the administrative board of investigation was that the transfusion error had both a human error and a system component. Had the verification process included the confirmation of patient identification, as reflected on the wrist ID band, the incident could have been avoided. While the transfusion error was the result of human error, there were also opportunities to improve systems and existing policies and procedures.
    The remedial steps that were taken: In addition to the administrative board of investigations summarized above, a root-cause analysis was undertaken of our entire blood administration process. This is a method of reviewing processes as an aid to restructuring them. Based on the findings of the administrative board and the root-cause analysis, it was decided to reengineer our blood and blood products policies and procedures totally, in order to prevent this from ever happening again.
    The following were implemented: Letters of reprimand were issued to the anesthesiologist, the certified nurse anesthetist and the nurse involved. There was a total redesign of the process of blood administration to assure interdisciplinary verification of patient identification prior to the initiation of anesthesia or procedures, and prior to the administration of blood or blood products. There was a redesign of the process to a uniform system of dispensing blood to the operating room by individual patient, rather than in bulk, and eliminating storage of blood in the operating room and outside of the blood bank, minimizing risk to patients. Blood is now individually dispensed to the patient in the operating room, directly from the blood bank.
 Page 54       PREV PAGE       TOP OF DOC
    There was a change in policy to require documented, informed consent for blood transfusion, medical center-wide to facilitate active involvement of patients in the treatment decisionmaking process.
    Educational programs addressing all of the above were instituted hospital-wide with special emphasis on the operating room. Educational programs on risk management were presented hospital-wide with emphasis on the operating room.
    Ongoing monitoring of all the steps in the blood administration process were instituted and are being followed by the transfusion committee of the Boston VA. An annual review of blood and blood product administration was instituted in the hospital's ongoing clinical staff education program.
    The Joint Commission on the Accreditation of Health Care Organizations paid us an unannounced visit for cause to review our blood administration program. While we were in compliance with their standards at the time of the visit, we were placed on accreditation watch, pending implementation of the recommendations from the administrative board and the root-cause analysis.
    We were revisited several months after this initial visit and the watch was lifted. We were re-reviewed as a part of the triennial survey 3 weeks ago and were found to be in total compliance with Joint Commission standards.
    Thank you very much.
    [The prepared statement of Dr. Headley appears on p. 135.]

    Mr. STEARNS. Dr. Headley—I guess we got the name tags mixed up.
    Mr. BILIRAKIS. Change around the name plates in front of you. Which one is Dr. Headley?
 Page 55       PREV PAGE       TOP OF DOC
    Mr. STEARNS. Okay. So, Mr. Doherty.
    Mr. DOHERTY. Sorry about that.
    Mr. STEARNS. No problem.

STATEMENT OF T.C. DOHERTY

    Mr. DOHERTY. Mr. Chairman, members of the subcommittee, you have my statement, and if acceptable, I would just like to enter the statement into the record and give you a brief statement regarding the untimely death of Mr. Martin.
    I would like to say in the beginning, Mr. John Martin was more than a patient of ours, he was a personal friend. John came out of the military after a very brief stint and became a patient of the VA. We cared for him for more than 25 years before his untimely death. John was noncompliant, he was in the end stages of renal disease, and we did everything humanly possible to encourage him to change his dietary and other habits. Prior to John's death, there have been no—there had been no adverse effects related to staff performance in our dialysis program.
    The Miami VA Medical Center instituted the first dialysis treatment program in 1966. There were more than 135,000 treatments provided our veterans and, absolutely, this was the first untoward incident that had occurred. Mr. Martin's death was because the dialysis nurse, who had cared for him for a number of years and who was an experienced nurse, 16 years service, connected Mr. Martin to the dialysis machine, and she failed to connect the venous dialysis line to the return port. Instead, the line was left and his blood went into a container. This resulted in a loss of more than 1,800 cc's of blood.
    A brief overview of the events is as follows: As the dialysis nurse began the dialysis connection process for Mr. Martin, she encountered a problem with the venous transducer, which is a center unit that indicates blood pressure; she was unable to correct the problem and she called the nurse, a dialysis technician. While they were working, the dialysis nurse, his principal nurse, was called to the telephone. The dialysis technician continued to troubleshoot the transducer and the machine and determined the transducer needed to be replaced.
 Page 56       PREV PAGE       TOP OF DOC
    After she replaced the transducer, the technician proceeded to leave the patient's bedside. At this point, she heard the hissing of blood going out of his body.
    The dialysis nurse returned—she was on the phone for approximately 2 minutes—she and the technician immediately began to replace the blood that had been lost by Mr. Martin with large amounts of saline solution. The technician also began to clean up the blood spill. In the process of cleaning up, the technician showed a second dialysis nurse the amount of blood that had been spilled. The second nurse then began to assist with Mr. Martin's care.
    He appeared to stabilize, he spoke to the nurse, he spoke to the dialysis technician, but shortly after, his stability began to deteriorate, and an emergency code was called. The code team responded promptly. The team, however, was not informed of the blood loss; instead they were told the patient had developed abdominal pain followed by low blood pressure.
    Resuscitation measures were attempted, but not successful. Mr. Martin was pronounced dead at 8:25, June 22, 1996.
    Upon learning of this event, I immediately convened a three-person board of investigation to thoroughly investigate all the circumstances surrounding Mr. Martin's death; and I would like to say at this point that I am a former Staff Investigator for the House Veterans Affairs Committee, and when we conduct an investigation, my medical center, I usually assist in all investigations to make sure that they are thorough and complete.
    I then contacted his family. Mr. Martin had been separated from his wife for more than 23 years. His sister was identified as his next of kin. I nevertheless contacted the widow and the sister, and invited them to come to the medical center. They came to the medical center, and I informed them that an investigation was under way, because I was not satisfied with the events leading up—the circumstances leading up to Mr. Martin's death.
    At the same time I had directed the investigation be conducted, I also ordered that the two dialysis nurses, the dialysis technician, the dialysis unit nurse manager be removed from the dialysis unit pending the outcome of the investigation.
 Page 57       PREV PAGE       TOP OF DOC
    After the board of investigation was completed, the following actions were taken. The employment of the primary nurse assigned to Mr. Martin was terminated, and the nurse was reported to the State licensing board. She immediately left the country and I believe is somewhere in either Puerto Rico or Guam.
    The second dialysis nurse was suspended for 30 days and reassigned. She resigned from the VA.
    The nurse manager of the dialysis unit was suspended for 14 days, and was permanently reassigned. The dialysis treatments were moved to newly constructed dialysis units, which had been planned prior to the incident.
    The nursing staff of the dialysis unit was redesigned to ensure a more uniform approach among all staff members and with all patients. All the nursing leaders within the dialysis unit were given formal leadership training. All dialysis staff members have been engaged in ongoing training procedures relating to administrative and clinical problems and procedures. Plans are under way for all members of the interdisciplinary dialysis team to participate in a team-building program in order to advance a positive, cohesive team spirit that has been developed since this tragic accident.
    In conclusion, let me say—and I am a retired Marine Corps paratrooper, and I saw a lot of combat and I had multiple gunshot wounds; believe me, I have empathy for my patients, my veterans, and I relate to them. And as I indicated earlier, this was a tragedy that affected me very personally.
    We pride ourselves on providing the best possible care to our patients, and to have something of this nature occur has required us to humbly sit back and take a look at ourselves, asking how we can ensure that something like this never happens again. We have learned many lessons from this tragedy and have emerged from the incident with a renewed sense of mission to do everything we can to provide the very best for our veterans, which they deserve.
 Page 58       PREV PAGE       TOP OF DOC
    And we thank you very much for being able to come before you today.
    [The prepared statement of Mr. Doherty appears on p. 141.]

    Mr. STEARNS. Thank you. Mr. Valentine.

STATEMENT OF BILLY VALENTINE

    Mr. VALENTINE. Yes, sir. Mr. Chairman, members of the subcommittee, I have submitted written testimony that explains in detail the events that occurred at Muskogee VA Hospital. I will briefly take a minute to recap the events of May 24 and 25.
    I am pleased to be here this morning; it is just unfortunate it is under such tragic circumstances, that in 30 years in the VA I have but one opportunity to appear before a subcommittee, and it is under these tragic circumstances.
    Mr. STEARNS. That is a good point.
    Mr. VALENTINE. Our staff at Muskogee was saddened by the untimely death and also disappointed that this isolated accident so overshadowed the compassionate care that has been provided day to day at Muskogee VA Medical Center for over 60 years. The patient in question was a 65-year-old veteran admitted on May 22 with a diagnosis of gastrointestinal bleeding with other complications. From the time of his admission, he had progressively improved medically. He exhibited appropriate interaction with staff, was judged to be oriented and competent to make his own decisions. He was receiving no sedatives, relaxants or psychoactive medications.
    On May 24, at approximately 10:30 p.m., the patient left the ward without telling the staff or signing out. We can only assume he left the ward to go for a smoke, as he had done that several times that day. The staff noted that he was missing about 15 to 20 minutes after he departed the ward, and immediately began our search policy.
 Page 59       PREV PAGE       TOP OF DOC
    At approximately 8 a.m. the next morning, May 25, the VA policemen found the body of the missing patient in the construction site adjacent to the medical center. Investigations were conducted by the Muskogee Police Department, the Board of Investigation and the Office of the Medical Inspector. The death was ruled an accident which was precipitated by the actions taken by the patient. We will never know why the patient went to such a seldom used, isolated smoking area, nor will we know why he disassembled a chain-link fence to enter the construction site, why he walked 40 or 50 feet, over piles of bricks and construction debris, to the point that he fell to his death.
    What we have learned from this is that we have a commitment to continually analyze and redesign our systems to assure that our patients, employees and visitors are provided a safe environment.
    [The prepared statement of Mr. Valentine appears on p. 148.]

    Mr. STEARNS. Thank you, Mr. Valentine.
    Let me just echo your point about it is unfortunate that perhaps the one time you are coming in front of the committee, the subcommittee here, would be under these circumstances. But I think the larger issue is, how can we develop this culture that we have talked about, that we have a system-wide program to stop these and help out. So if all of us can work towards that, I think the larger goal will be immensely helpful to the VA hospital, and that is sort of the imprint we are trying to do here.
    So you are here obviously to try and improve the system and that is why—so towards that end, I understand that something happened in Muskogee, and then a year later, the same thing happened in the Miami hospital; and if there had been actual reporting of this incident, perhaps the procedures could have been placed so that in the Miami hospital, it would not have occurred.
 Page 60       PREV PAGE       TOP OF DOC
    To your knowledge, Mr. Valentine, did the Central Office prominently notify other VA medical centers of the lessons learned as a result of the incident to which you just testified?
    Mr. VALENTINE. No, not to my knowledge.
    Mr. STEARNS. Now, there is a good example, where if that was put on a bulletin board and notified, then Mr. Doherty and Dr. Headley could all look at it and say, by golly, here is something we should do to prevent something happening.
    Mr. Doherty, when the press reported that particular example, the kidney dialysis—and I used that in my opening statement—you went into the system-wide problems, the clinical problems. But the press has identified other patient deaths at the Miami hospital; I understand there have been four more cases involving failure to treat a veteran's bladder cancer, for example.
    So my question is, have all of these cases prompted a broader review of the systems of care delivery at your hospital, and is this a change in philosophy that is just starting now, or what can you say?
    Dr. DOHERTY. I think, number one, we regret—as Dr. Kizer indicated, one death is one too many, and we regret that any deaths occurred—untimely and unwarranted deaths—and I think that each case has to be viewed separately.
    And I think that, yes, we have instituted a system whereby—and Dr. Kizer, I think, alluded to that in his statement—the VA is going to have a database system whereby all of this stuff will be funneled in to headquarters. When anything occurs at our medical centers, we immediately notify our VISN director, and he in turn notifies our headquarters, Central Office, of the incident; and immediate steps are always taken at the medical center level to determine what happened, how did it happen, why did it happen, and what steps can be taken to prevent it from happening again.
 Page 61       PREV PAGE       TOP OF DOC
    And not all of these things that happened can be blamed on the medical center or the failure of medical center personnel to act properly. For example, you mentioned the case of the missing patient.
    Mr. STEARNS. Right, which you talked about.
    Dr. DOHERTY. The patient was brought to our hospital, he had a fire in his home, his wife brought him to the hospital and asked if we would hospitalize him because he could not get along with his mother-in-law and we agreed to take him in. He had been a patient previously in our nursing home and we had had the gentleman on the locked ward, secured unit, of the nursing home. His wife was determined that he was not going to be placed on the secured unit, locked ward of the nursing home; she felt this would be counterproductive and that he would lose all the confidence that he had, and that he was able to take care of himself.
    A conference was held at the nursing home, and it was determined they would go along with the wife of the veteran, and they placed the veteran in an unlocked ward. Four days later, he wandered away from the ward.
    Mr. STEARNS. And we looked at the Dillmore case in November of 1996, where wheelchair brakes failed and the individual toppled from the bus and was killed.
    Dr. DOHERTY. Yes.
    Mr. STEARNS. The Ribler case in 1995, the patient died after VA failed to—well, what I am saying is, all these things should have prompted a system-wide— —
    Dr. DOHERTY. Well, I think we are continually in a system-wide investigative posture to make sure that there are no accidents or untoward events that are occurring in our medical center. I think this is a daily occurrence, and I think that we take great pride in our medical center, in ensuring that our veterans not only receive quality care, but we take every measure to ensure their safety.
 Page 62       PREV PAGE       TOP OF DOC
    In the case of Mr. Dillmore, sir, I can assure you, we took Mr. Dillmore out for an outing to buy some stuff at a local shopping center. Upon his return, he was loaded onto the elevated wheelchair lift. Mr. Dillmore was a quadriplegic and he operated his wheelchair by his chin. When he was loaded onto the wheelchair, he put his wheelchair into motion, and it was a very heavy wheelchair, electric-powered wheelchair, and the attendant was unable to stop the wheelchair from moving forward. Mr. Dillmore had full control of that wheelchair, and he toppled over and fell 4 feet to the pavement.
    He indicated he was all right, and we immediately rushed him to the Parkway Medical Center; and unfortunately, he did expire, but I don't think it was a system failure. As—again, as in Mr. Martin's case, it was not a system failure; it was a case of failure of one individual to properly perform their duty.
    But in answer to your question, sir, yes, we are daily evaluating and measuring what steps can be taken to prevent any untoward incident from happening in our hospital. We are constantly putting systems into effect.
    Mr. STEARNS. I would submit, though, Mr. Doherty, if a person is controlling the wheelchair with his mouth, he should not be in control of the wheelchair when he is on that kind of structure.
    Mr. DOHERTY. You are absolutely right, sir.
    Mr. STEARNS. But be that as it may, here is something that I have no feel for and this is a general question for all of you.
    There were some $53 million paid in malpractice cases in 1996, fiscal year. And I read earlier that the hospitals have an obligation—as opposed to the private sector, they have an obligation to pay for negligence and errors and so forth. How has that impacted your hospital, the fact you have malpractice—and I might ask Mr. Headley, and I will move from my left to my right—because, you know, we have records of malpractice insurance claims and, obviously, in which hospital it occurred.
 Page 63       PREV PAGE       TOP OF DOC
    For example, in Mr. Doherty's hospital, it is my understanding, more than 4.4 million was attributable to cases involving your facility, and so I think just my question is not specific to any individual. And I don't even have a feel if 53 million is a lot. But just tell me, from your standpoint, this malpractice, is this a concern of yours at all; and is there something that the committee should know in reference to these claims?
    Dr. HEADLEY. Well, I think malpractice is always a concern because it indicates that there has been a failure of the system. It indicates that something has been done wrong. It indicates that there is something that we can improve.
    And indeed we use tort claims as part of our performance improvement activities. At the Boston VA, we do have a very mature performance improvement system, which has been in place probably for 20 years now which tracks and indeed does trend all of the various components of our quality management program. We look at tort claims, we look at patient incidents, we look at minor patient incidents, we look at medication errors, we look at all of the errors in our hospital. We trend these quarterly, we put them together annually, we share them with clinical staff, we take lessons from these; we use the tort claim data in order to improve performance. Financially, this is an impact; I don't know exactly how to compare this $53 million versus the private sector.
    Mr. STEARNS. I don't either.
    Dr. HEADLEY. And the amounts that go on there.
    Mr. STEARNS. Yes, sir, Mr. Doherty.
    Mr. DOHERTY. I would piggyback on Dr. Headley's statement. We are doing all of the same things that he indicated. To me, today it is very—you know, we get many frivolous claims that we have to entertain, and some of our—when you look at the malpractice suits that are filed, you wonder why there are so many. As I indicated, many of them are frivolous in nature, and the majority of the suits, claims that are filed against VA Medical Center of Miami, are denied.
 Page 64       PREV PAGE       TOP OF DOC
    I personally encouraged the widow and the sister of Mr. Martin to file a claim, and that was the only claim that was filed in the five deaths, and I assisted them in filing that claim because I felt in this case that they were deserving of something.
    Mr. STEARNS. Mr. Valentine.
    Mr. VALENTINE. I share in the concerns, any time you have a tort claim filed, there is a perception by the patient or his family, that the care that they have received was inappropriate, and that is the last message any health care facility would want to send. We do trend and track the filing of tort claims regardless of whether they are accepted or whatever action happens on them just so that we can get some tracking process into what may be hot spots in the facility; and I would certainly feel that $53 million is a significant amount of money. That is enough money to actually fund one small hospital for a year's operation. So we do have a concern.
    Mr. STEARNS. Okay. Mr. Kennedy.
    Mr. KENNEDY. Thank you very much, Mr. Chairman.
    First of all, I was struck by the testimony that the three of you gave in terms of just how it seemed as though you all cared very deeply about the loss of life that took place in your facilities, and I think that is an important demonstration for not only the people here, but for your staff, as well, to understand, you know, just how important these lives are that you are taking care of.
    I think, you know, it is also important to point out, as I understand, that there are about a million cases each year of patients that are injured by mistakes in treatment and that over 120,000 of them across the United States die, so I don't think that we are here to just try the three of you based on the fact that there are incidents in each one of your facilities where people have been killed as a result of inadequate or wrong medical treatment.
    I do think what we are trying to do is determine whether or not appropriate steps are being taken by your facilities, and whether or not there is a systemic problem that needs to be fixed, and I think there are enough incidents that have taken place around the country over the course of just in the last 10 years or more, since I have been serving on this committee, that would lead one to believe that there is, in fact, some kind of underlying problem that needs to be dealt with. And I think that I would like to just pursue that and get your thoughts on whether or not there is in fact, you know, a deeper issue that needs to be examined by this committee and dealt with either legislatively or administratively.
 Page 65       PREV PAGE       TOP OF DOC
    First and foremost, I mentioned in my opening statement, when I was talking to Dr. Kizer, I remember—and I don't have a listing in front of me, but I remember, I believe it was in Columbia, Missouri, there was an incident in the last couple of years where there was sort of a rogue individual running around killing a whole rash of different patients.
    I remember there was another incident where there were patients' bodies that were found buried on VA grounds. There were all these kinds of cases, you know, in terms of bodies being lost in various exits and horror story after horror story after horror story.
    We are told that these are sort of different, isolated incidents that have no reasonable relationship to one another. On the other hand, we have heard, I think, enough of them to, for instance, have the chairman of the subcommittee call all three of you here to ask you what is going in your facilities; and the real question is whether or not there is a systemic problem that either requires additional resources—I mean, Dr. Headley, I noticed you brought up the JCOA. Now, as you may recall, we had to bring in the Joint Commission to inspect the Court Street Clinic, going back several years ago. When they came in and looked at Court Street, they condemned the place. Subsequent to that we got a very nice new temporary facility where the veterans are very, very happy in terms of the quality of care they received. But it did take bringing JCOA in to condemn an older clinic in order for us to move on and get the kind of funding that was required, and I am wondering whether or not—you know, what brought JCOA into your situation.
    You indicated, I thought, according to your testimony, that they had come in and given you some sort of status that was not exactly adequate, and you then made some improvements to get yourself into the adequate category. So can you just explain what happened there, please?
    Dr. HEADLEY. Yes, certainly. The Joint Commission is routinely—let me back up one step. When there is an incident involving blood administration, it automatically gets reported to the FDA as a part of the external reporting mechanism. The FDA notifies the Joint Commission and the Joint Commission does go in and investigate each case of this nationally. So this was a routine visit of the Joint Commission for an incident. It is called a visit for cause, and it is for death involving blood administration.
 Page 66       PREV PAGE       TOP OF DOC
    The surveyor who came to us said that they investigate three to five of these nationally a year—not in VA hospitals, but nationally. At the time that the investigator came in, we had already done our administrative Board of Investigation, and I believe had already done our root-cause analysis.
    The Joint Commission surveyor who came in said that, indeed, you have basically done all of the things, you are basically in compliance, but we will put you on what is called ''accreditation watch'' until you implement all of the recommendations that you came up with.
    Mr. KENNEDY. Does that indicate that, in fact, you were below their standards prior to their arrival?
    Dr. HEADLEY. It means we had an incident.
    Mr. KENNEDY. If it is on some sort of temporary status, after they arrived, doing the investigation, it would imply that you were not operating at the status that JCOA requires.
    Dr. HEADLEY. I am not sure what accreditation watch exactly means. It is something that they implemented about a year and a half ago. They made organizations conditional; they rendered them conditional accreditation if they came in and investigated an incident, until they took some remedial steps.
    Mr. KENNEDY. Well, it bothers me a little bit to hear you say you don't know what that means. I mean, I am not trying to be unnecessarily hard on you there, Doc, but you know, you are the administrator of the hospital, and if the accreditation board is coming in and you are saying that they are not giving you an adequate—you are saying to us before the committee they didn't give you an adequate appraisal, they put you on temporary status, and you are saying to me you don't understand what they really meant by--
    Dr. HEADLEY. I understood exactly what they meant for us. What I am saying is, I am not quite sure what ''accreditation watch'' means in terms of Joint Commission accreditation, it doesn't have an official sort of—it means that they detected in our blood administration program some areas that could be improved.
 Page 67       PREV PAGE       TOP OF DOC
    For instance, we had said that we felt that having the refrigerator in the operating room and blood delivered to that refrigerator was a potential cause of error in the administration of blood in the operating room; and we had determined that we were going to remove that refrigerator, we were going to replace it with blood being delivered directly to the operating rooms from the blood bank. We instituted that as part of our systems process. We changed—the Joint Commission surveyor said and felt that an interdisciplinary identification of patients in the operating room was better than having each discipline identify the patient separately, having physician identify, having nurse identify, and we changed that procedure in our operating room.
    Mr. KENNEDY. And I appreciate the Chairman to just give me a minute to wrap up here.
    But I heard in your testimony these changes you made, and I think the question before the committee is whether or not these are changes that should have been imposed as a result of normal oversight by an administrator of a situation involving a life-threatening procedure.
    Dr. HEADLEY. Yes, they are.
    Mr. KENNEDY. And whether or not these are, you know, where people aren't looking to, you know, just come in and sort of gratuitously whack you around here Dr. Headley.
    What I think it is our responsibility is to make certain that, in fact, proper oversight of administrative procedures is going on within the VA; and I am still, to be honest with you, Mr. Chairman, somewhat unclear as to how that has occurred here.
    Mr. STEARNS. I will tell my colleague, we can go another round if you like. Let me call on my colleague, Mr. Bilirakis, who, I might point out, is the Chairman of the Commerce Health Subcommittee, which deals with Medicaid and part of Medicare, so he has large jurisdiction. My colleague.
 Page 68       PREV PAGE       TOP OF DOC
    Mr. BILIRAKIS. Thank you, Mr. Chairman.
    I want to welcome the gentlemen, and particularly Mr. Doherty, who comes from our State, even though it is not our congressional district. And really, Mr. Kennedy hit upon it, and before you came in, Joe, we talked about the need for cultural change. I mean, there is an atmosphere there that really many of us think results in a lot of these problems and you hit upon it.
    Let me ask you, Mr. Doherty, in the case of Mr. Martin, who bled to death while receiving the dialysis, the St. Petersburg Times reported it took ten-and-a-half months to report the nurse responsible for the incident to the State licensing authorities and the national data bank that collects the names of medical professionals who err; is this correct?
    Mr. DOHERTY. Yes, sir, but I think it needs explanation.
    It wasn't a delay; we had to conclude the investigation and the other processes that are necessary before reporting to the national data bank.
    Mr. BILIRAKIS. Is this a process?
    Mr. DOHERTY. This is a process, Mr. Bilirakis, that we have no control over; it is something that is imposed upon us.
    Mr. BILIRAKIS. By whom?
    Mr. DOHERTY. By the data bank and by the system, the system being the— —
    Mr. BILIRAKIS. By the data bank, in other words, the national data bank?
    Mr. DOHERTY. We have to furnish certain documentation, including a report of investigation and other matters, meaning that this case is finished by the VA and has been investigated by our peers and everything else.
    Mr. BILIRAKIS. But in the meantime, during this almost 11-month period of time—this nurse is no longer in the VA system?
 Page 69       PREV PAGE       TOP OF DOC
    Mr. DOHERTY. She immediately left the VA. We suspended her immediately and then terminated her. Upon completion of the investigation, she returned to her home in Puerto Rico. As I understand, now she is in Guam, but her license was pulled.
    Mr. BILIRAKIS. Well, you know, there is a period of time there; in other words, during this approximately 11 months, she could have gone out, and maybe she did go out and get a job as a nurse someplace.
    Mr. DOHERTY. You are absolutely right, sir, and this happened with the young lady we suspended for 30 days, she resigned and went to work immediately for the Cedars of Lebanon Hospital, directly across the street from us—at higher pay, I might add.
    Mr. BILIRAKIS. Well, and then what happened, did you plug her into the national data bank ultimately?
    Mr. DOHERTY. Her offense was not reportable to the national data bank.
    Mr. BILIRAKIS. It was not reportable?
    Mr. DOHERTY. No, sir. There are certain parameters that we have to follow and requirements for reporting to the national data bank.
    Mr. BILIRAKIS. By ''the national data bank,'' they are not VA requirements, they don't come from headquarters in Washington?
    Mr. DOHERTY. Right.
    Mr. BRADSHAW. Excuse me.
    Mr. BILIRAKIS. Yes, sir.
    Mr. BRADSHAW. Mr. Bilirakis, I am Doug Bradshaw, Assistant General Counsel in the VA, and just to clarify the reporting to the data bank, for adverse personnel actions, the data bank takes reports on licensed physicians and dentists, but not nurses. For malpractice payments, we can report any licensed provider.
 Page 70       PREV PAGE       TOP OF DOC
    Mr. BILIRAKIS. For malpractice payments?
    Mr. BRADSHAW. Yes, and in this case there was a malpractice claim filed, it was settled and upon settlement and payment of the claim, the data bank procedures went into effect at that stage and the nurse was reported for the malpractice payment. That is what the time lag was.
    Mr. BILIRAKIS. Due process is very important and we don't want to watch a person, just because of a particular event which maybe has not been proven yet, that is a result of his or her negligence, to suffer. On the other hand— —
    Mr. DOHERTY. I think the unusual delay in this case, sir, was because of the tort suit claim that had been filed.
    Mr. BILIRAKIS. And you felt—in other words, you didn't want to interfere with the legal process is what you are basically saying, I guess.
    Mr. DOHERTY. Not exactly, not with the VA.
    Mr. BILIRAKIS. Well, you know, Mr. Doherty—let me ask, do you hire your physicians? Who hires physicians, who hires nurses; do you have the kind of authority to hire people?
    Mr. DOHERTY. Are you asking me?
    Mr. BILIRAKIS. Yes, I am asking all three of you.
    Mr. DOHERTY. Yes, sir. But our physicians—we have—naturally they go through a clearance, and the chief of staff and his staff and the credentialing of people, I mean, to make sure— —
    Mr. BILIRAKIS. The ''chief of staff,'' meaning up here in Washington?
    Mr. DOHERTY. No. The Chief of Staff at the Medical Center have the final say in the matter.
 Page 71       PREV PAGE       TOP OF DOC
    Mr. BILIRAKIS. Mr. Doherty, you indicated you were a paratrooper, you were wounded in action, et cetera, so you care about the veterans; and Mr. Kennedy talked about the strong feeling all three of you showed as far as caring is concerned.
    If a person who is a medical doctor applies, and you find out that this person failed the test 10 times in succession, would you still hire them, him or her?
    Mr. DOHERTY. I would probably stand to run the risk of losing my job, but I don't think I would, no, sir.
    Mr. BILIRAKIS. Well, there has to be some courage, some guts here somewhere, for crying out loud.
    Mr. DOHERTY. I would be very suspect of anybody that failed because, like with the bar exam, if you failed the bar exam seven or eight times— —
    Mr. BILIRAKIS. The bar exam is probably not life and death either, but here we are talking about life and death and we are talking about veterans besides.
    Mr. DOHERTY. Yes, sir, I understand.
    Mr. BILIRAKIS. And it kind of blows my mind to see these things happening. You know, perception, as we find out up here, sometimes is more significant than facts.
    Let me get back to some of the cases. George Dillmore, the metro Dade police say unfortunately they have been uncooperative, we have not gotten anywhere with them. I don't understand what the big deal is; all we want to do is talk to the people who were there. Accidents do happen. Apparently they were stonewalled, right?
    Mr. DOHERTY. Mr. Bilirakis, the metro Dade police know they have access to my office, to our security and police office. They did not contact us. They contacted a clerk in our Medical Release Bureau, and the young lady— —
    Mr. BILIRAKIS. She was unauthorized probably to talk to them.
    Mr. DOHERTY. Yes. After reading about the article in the St. Petersburg Times, we contacted the officer. It took us 7 days to make contact with him.
 Page 72       PREV PAGE       TOP OF DOC
    Mr. BILIRAKIS. You tried to contact him?
    Mr. DOHERTY. Then he finally contacted us and we are cooperating with him, we told him, you know, all the years we have been in business, the police department comes to us, police and security, we cooperate fully, but we have to be very careful of the Privacy Act.
    Mr. BILIRAKIS. And I can understand, things happen and there is some sensitivity to them, and just anybody doesn't have the authority to talk to—whether it be law enforcement or whatever. But these things take place.
    You know, the case of the American Legion commander, Mr. Fincham, I believe it was.
    Mr. DOHERTY. Yes, sir, Fincham.
    Mr. BILIRAKIS. Well, Mr. Fincham. The names off the top of other x rays were cut, the x rays involving Mr. Fincham's situation disappeared. No one owned up to altering the missing and defaced x rays. The hospital's associate director said Friday the x rays later turned up.
    You know, it doesn't sound right.
    Mr. DOHERTY. I can understand, Mr. Bilirakis, and I fully appreciate what you are saying. In the teaching setting that we—we are an affiliated medical school—the identity of the patient is removed from the x ray when it is used for teaching purposes. This probably happened. I am not saying it did, but this probably happened in the case of Mr. Fincham.
    And in the case of Mr. Fincham's death, I would like to say this. Mr. Fincham, God bless him, was a very, very heavy man, it took four or five nurses to get him back in bed when he fell out. He kept putting his side rail down, and he was always pulling his IVs out and pulling his tubes out; and we had a sitter with him, and there was no clear-cut evidence, but it is highly believed that he removed the tracheal tube himself and it was put back in by the sitter. We have no evidence to indicate otherwise, but we have no evidence to indicate that this actually happened. But I think it should be known.
 Page 73       PREV PAGE       TOP OF DOC
    Mr. BILIRAKIS. Thank you, Mr. Chairman.
    Mr. STEARNS. I just have two questions, I guess.
    One, Mr. Doherty, I mentioned earlier, there is $53 million in malpractice insurance in fiscal year 1996; $4.4 million was attributed to your facility. No other facility had more than $3 million.
    Can this be explained? Is this just an aberration?
    Mr. DOHERTY. We are one of the most active medical centers in the State of Florida, and one of the busiest; and many of our patients come to us, believe me—I mean, we take care of very, very sick patients. I am not saying these cases were not legitimate, but I can cite one case that I have very strong, serious doubts about. I don't think anyone wants me to go into that, but I deeply regret that this kind of money has been paid out in the settlement cases, Mr. Stearns.
    Mr. STEARNS. I understand.
    Let me just conclude my questions, and Mr. Kennedy and Mr. Bilirakis can ask another series of questions afterwards.
    Dr. Kizer has instituted new policy procedures. The Washington Post had an article yesterday where he says, basically, the simple fact is that too many adverse events happened as a result of medical treatment, and he says he is going to do all this new system—new policy.
    What specific steps have been or will be taken at your facility to carry out that policy, and how will it be different if we come back here in 1998 and we are talking. And this is for each one of you.
    Mr. DOHERTY. I would think the system—we are in a tracking mode now; we track everything that happens in hospital medication—errors and untoward incidents, everything else that occurs, this is tracked and documented, this is reported, and the database is set up so that we will know instantly, and all the care-givers will be given access to know, so that we can identify areas that have—that are suspect and that people can look into and find out just what is happening here, that we have so many errors, medication errors and other things.
 Page 74       PREV PAGE       TOP OF DOC
    So I think that Dr. Kizer is on—I think he is taking a very aggressive role in this thing. And he indicated to us in our meeting yesterday that he intends to set up a database where all of this stuff will be funneled into headquarters, and the medical centers, everyone will have access to know where things are occurring, why they are occurring, how can we prevent them, how can we stop them, what is necessary to change the system.
    I think it is a wonderful step that he is taking.
    Mr. STEARNS. Mr. Valentine.
    Mr. VALENTINE. Well, I agree with Mr. Doherty. I think the VA handbook, 1051, is probably the most cutting-edge document that I have seen on risk management in health care for some time. Many of the issues covered in the handbook are activities that are going on within facilities at this time. I think the most significant area that must be put into place, if we are really going to reap any benefits from the changes, is that we need to be able at the facility level to learn very rapidly what has occurred at other facilities, what caused sentinel event to occur and what actions were taken to prevent a reoccurrence of it.
    I think the failure in the system in the past has been that we don't find out about these things in a timely manner, like was said earlier in the panels, that information may sit in a room for 2 years with no follow-up action; and if the steps that are outlined in the VA handbook in fact are implemented, and that that processing house and headquarters in fact do disseminate the information to the facility, I think the facility will benefit from this.
    Dr. HEADLEY. I would like to agree with the previous two speakers. I think that the VA has an opportunity to lead the way in the improvement of errors in medical care and the damages that occur, because we do have an integrated national system that is capable of pulling the information together and sharing it throughout the system.
    I think that many of us have had very active quality improvement, performance improvement, risk management programs at our facilities, but we have not necessarily had the benefit of findings at other facilities. There have been times in the past when this information has been shared, but it has not been continuous. I think that the plan that is currently in place makes this a very real possibility, and makes us have the potential to really make some significant contributions to the national effort, not just the VA, but to the national effort of reducing errors in health care and deaths secondary to those errors.
 Page 75       PREV PAGE       TOP OF DOC
    Mr. STEARNS. When you mention the responsibility, we probably have a moral responsibility, even more so, than the private sector because these are veterans. Mr. Kennedy.
    Mr. KENNEDY. Thank you, Mr. Chairman.
    I want to come back to the issue we were discussing, Dr. Headley. I mean, I think that if you look at any profession where there are life-threatening situations, whether you are talking about a military situation, which has reasonably well-defined rules of engagement, if you look at the rules that police officers and fire departments or other people that are involved in the setting of health and safety of the American people, there are fairly strict rules and regulations which folks have to follow.
    Now, as I understand, in the Boston situation where this fellow received the wrong blood, the two nurses that were involved in the transfusion still work at the VA facility. The anesthesiologist quit, so they took this on themselves to deal with what their future was, and the situation where the VA fired the anesthesiologist; no one going up the management scale in any way was penalized that I am aware of.
    Is it your opinion that this was simply a situation where a procedure was in place that was inadequate, that had no—where there was no demonstrable responsibility by any health care provider to anticipate the risk that the patient was being put in?
    Or, in fact, is this the kind of situation where, when the monitoring body of the government came in and looked at it and said, hey, wait a minute, this thing is not—you know, you guys aren't following the procedures that you ought to be here, and therefore we are putting you on hold and not giving you, you know, the sort of gold star or the green light on your current procedures, and you have got to bring your procedures up to a certain standard, and then you were going to then give them the kind of—the checkoff saying, you are in good shape? And if, in fact, it is the latter, is it your opinion that no one should have been fired, no one should have been in any way held accountable for this loss of life?
 Page 76       PREV PAGE       TOP OF DOC
    Dr. HEADLEY. Mr. Kennedy, we did a thorough Board of Investigation; at the time that this incident happened, reprimands were issued to the physician and to the two nurses involved in this.
    Mr. KENNEDY. What does that entail, Doc?
    Dr. HEADLEY. A reprimand is a letter and a counseling to an individual that there has been a problem with their performance, it is expected that this performance will improve, that they are being monitored for performance in this area, and that this letter goes into their personnel file.
    Mr. KENNEDY. Permanently?
    Dr. HEADLEY. It goes in for I believe a period of a year and it goes—it can be removed after a year.
    Mr. KENNEDY. Were these removed?
    Dr. HEADLEY. I don't believe they have been at this point in time.
    Mr. KENNEDY. But you don't know?
    Dr. HEADLEY. I don't know if they have been removed yet.
    Mr. KENNEDY. Do you think that is appropriate? Do you think it is appropriate?
    Dr. HEADLEY. That they be removed?
    Mr. KENNEDY. I am trying to understand. You know, somebody died in this case.
    Dr. HEADLEY. Yes.
    Mr. KENNEDY. I am not an expert on what hospital emergency room or operating room procedures are, so I feel somewhat uncomfortable in trying to understand exactly whether or not there was greater risk and responsibility than is being owned up to here. And as I said before, it sounds like there is the possibility that that is the case, and I am trying to get a better understanding of whether or not this was simply a situation where, you know, year in and year out, we followed these certain procedures. It has always worked before and, gosh, nobody ever anticipated that this particular situation would occur; and therefore, somebody accidentally died, and now we have to go fix up what had been accepted, reasonable procedures.
 Page 77       PREV PAGE       TOP OF DOC
    This is a very different circumstance than, look, you know, there was a procedure set up over in this particular operating room that was half-baked, harebrained, and people were putting patients at undue risk, and as a result, an individual died.
    You know, we have got two letters of reprimand that go into a file for a year; they are then withdrawn. And the anesthesiologist quits, and I don't know if he went off and got a better job, like the nurse did, but you are leaving open the possibility that accountability was not placed in order here, right, and that is what I am trying to get at.
    Dr. HEADLEY. Yes, I think that we do take this very seriously. I think that we have policies and procedures in place in the operating room, in the administration of blood, that we expect people to follow.
    We have a transfusion committee— —
    Mr. KENNEDY. I understand all that. I don't want to hear about all of the—I am just trying to understand whether or not the procedures that were in place were, in your opinion, adequate, given the historical record; or whether or not they were, in fact, inadequate.
    Dr. HEADLEY. Yes, I believe that the procedures that were in place were adequate, given the historical record. The procedures of checking an arm band before you administer blood and checking it against the blood, for some reason, this procedure was not followed.
    There was another procedure— —
    Mr. KENNEDY. So the procedure that was acceptable was not followed?
    Dr. HEADLEY. It was not followed.
    Mr. KENNEDY. And even though the procedure that was acceptable was not followed, the only thing that occurs in terms of disciplinary action is a letter of reprimand.
 Page 78       PREV PAGE       TOP OF DOC
    Dr. HEADLEY. That is correct.
    Mr. KENNEDY. Do you think that is adequate?
    Dr. HEADLEY. I don't know; I have thought a great deal about that.
    We heard this morning from Dr. Leape about the need to change the way we approach errors of this sort to become less punitive, so that people will be forthcoming in discussing errors when they are made and trying to improve systems so that these will not occur; and Dr. Leape made some very compelling arguments about this this morning.
    When we approached this, we approached it in a twofold manner; we approached it in looking at individual performance and we approached it in looking at systems problems.
    Mr. KENNEDY. Well, if we have gotten to a point where we are now saying we are going to forgive, you know, just blatantly, sort of inadequate procedures and the performance of those procedures in order to have a greater amount of openness, you know, we are entering the realm of the bizarre.
    I am all for having procedures where people aren't going to be hurt by coming forward with problems that exist in a system, but that should never get in the way of creating adequate responsibility on behalf of individuals to do their jobs properly, and—I mean, you know, if somebody isn't following procedures, and it ends up that a patient is killed—I mean, it is up—that is your job, to determine what is the proper way of handling it.
    You can get a bunch of Congressmen to come up here and try to tell you that, but ultimately you are the VA administrator.
    Dr. HEADLEY. That is correct.
    Mr. KENNEDY. All right.
 Page 79       PREV PAGE       TOP OF DOC
    Mr. STEARNS. The gentleman's time has expired.
    We have a vote, but I think we have enough time for Mr. Bilirakis.
    Mr. BILIRAKIS. I will just hustle through this, Mr. Chairman.
    Gentlemen, some Members of Congress claim that the VERA, the new resource allocation method, of course, which has not been in place all that long—and a lot of these problems occurred long before VERA—is the cause of poor patient care in areas of the country which receive under VERA less funding.
    Do you, Dr. Headley, believe that VERA is having an adverse impact on those areas of the country, such as yours, for instance?
    Dr. HEADLEY. I can't really say at this point in time. I don't believe that, as yet, we have experienced the full impact of VERA.
    Mr. BILIRAKIS. There is one particular delegation that is very vocal here who are maintaining that and your delegation is not in that category, but I appreciate your honesty.
    Mr. Doherty and Mr. Valentine, I don't know if you have any quick comments regarding that.
    Mr. DOHERTY. I think VERA has enabled us to provide quicker access and faster delivery of service by opening up community-based outpatient clinics; and we have opened up two of them, and our veterans, I think, are now being better served. We get a lot of snowbirds down in Miami, so we are very grateful for the extra money we get.
    Mr. BILIRAKIS. I am going to go on here, Mr. Valentine; if you will forgive me, I am going to finish it up. We have heard about new procedures put into place, and if you all were in the room, you heard my opening statement.
    I think that VA health care is pretty darn good in general, but we have heard about some of the things that have taken place, we have heard that cultural changes need to take place, we have heard about how existing civil service laws make it very difficult, sometimes almost impossible, to fire Federal employees and how that is a problem—and, boy, I would like to spend a little more time on that with you, but time doesn't permit because of the vote. And we have heard that on October the 6th, a couple of days ago, VA announced a national effort designed to improve the safety of patients at its hospitals.
 Page 80       PREV PAGE       TOP OF DOC
    I guess some of you all, in responding to the Chairman and to Mr. Kennedy, you talked about certain ideas put into place. It seems to me practically every one of those ideas are common sense, and I sit here and I sometimes wonder, well, hell, why haven't they been in place all along anyhow? Does it take a newspaper article to kick this thing off? Does it take then Mr. Kizer—Dr. Kizer to basically maintain these things are put into place? It seems like good gentlemen, caring as much as you do, would have probably put some of these things into place all along.
    We have heard during sexual harassment about, as I said before, a good old boys network and protecting one another and things of that nature. I tell you, the image is not as good as I think it deserves to be, because I don't think that health care in general is a bad system of health care or a bad quality of health care—maybe that is the best way to put it—through my experience with the VA; and I have had some experience.
    But we have got to do something about these things, and we invited Dr. Kizer—and I know the Chairman was going to reiterate the invitation, Dr. Kizer, to kind of tell us how Congress can help in terms of the changes that maybe can be made in the laws to be of some help. And I would strongly urge you—and we don't have the time now because of the vote—I would strongly urge you to submit your inputs to Dr. Kizer, and if Dr. Kizer ignores some of them, if you want to get them to some of us around the bend, so to speak, we certainly would welcome that.
    But if we are going to help out here, we have to change, I think, our mental outlook, starting at the top and going all the way down to that clerk in the lobby when the VA member or when the family first comes in; and some of them are just not as courteous as they should be.
    Having said all that, Mr. Chairman, thanks very much.
    Mr. STEARNS. I want to thank my colleagues for their second round of questions, and I want to thank our panelists for their patience and waiting between votes and everything.
 Page 81       PREV PAGE       TOP OF DOC
    We now call the subcommittee of health adjourned.
    [Whereupon, at 1:32 p.m., the subcommittee was adjourned.]