[Senate Hearing 108-89] [From the U.S. Government Publishing Office] S. Hrg. 108-89 PATIENT SAFETY: INSTILLING HOSPITALS WITH A CULTURE OF CONTINUOUS IMPROVEMENT ======================================================================= HEARING before the PERMANENT SUBCOMMITTEE ON INVESTIGATIONS of the COMMITTEE ON GOVERNMENTAL AFFAIRS UNITED STATES SENATE ONE HUNDRED EIGHTH CONGRESS FIRST SESSION __________ JUNE 11, 2003 __________ Printed for the use of the Committee on Governmental Affairs 88-254 U.S. GOVERNMENT PRINTING OFFICE WASHINGTON : 2003 ____________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpr.gov Phone: toll free (866) 512-1800; (202) 512�091800 Fax: (202) 512�092250 Mail: Stop SSOP, Washington, DC 20402�090001 COMMITTEE ON GOVERNMENTAL AFFAIRS SUSAN M. COLLINS, Maine, Chairman TED STEVENS, Alaska JOSEPH I. LIEBERMAN, Connecticut GEORGE V. VOINOVICH, Ohio CARL LEVIN, Michigan NORM COLEMAN, Minnesota DANIEL K. AKAKA, Hawaii ARLEN SPECTER, Pennsylvania RICHARD J. DURBIN, Illinois ROBERT F. BENNETT, Utah THOMAS R. CARPER, Delaware PETER G. FITZGERALD, Illinois MARK DAYTON, Minnesota JOHN E. SUNUNU, New Hampshire FRANK LAUTENBERG, New Jersey RICHARD C. SHELBY, Alabama MARK PRYOR, Arkansas Michael D. Bopp, Staff Director and Chief Counsel Joyce Rechtschaffen, Minority Staff Director and Chief Counsel Darla D. Cassell, Chief Clerk ------ PERMANENT COMMITTEE ON INVESTIGATIONS NORM COLEMAN, Minnesota, Chairman TED STEVENS, Alaska CARL LEVIN, Michigan GEORGE V. VOINOVICH, Ohio DANIEL K. AKAKA, Hawaii ARLEN SPECTER, Pennsylvania RICHARD J. DURBIN, Illinois ROBERT F. BENNETT, Utah THOMAS R. CARPER, Delaware PETER G. FITZGERALD, Illinois MARK DAYTON, Minnesota JOHN E. SUNUNU, New Hampshire FRANK LAUTENBERG, New Jersey RICHARD C. SHELBY, Alabama MARK PRYOR, Arkansas Joseph V. Kennedy, General Counsel Elise J. Bean, Minority Staff Director and Chief Counsel Mary D. Robertson, Chief Clerk C O N T E N T S ------ Page Opening statements: Senator Coleman.............................................. 1 Senator Levin................................................ 5 Senator Pryor................................................ 26 Senator Durbin............................................... 33 Senator Carper............................................... 50 WITNESSES Wednesday, June 11, 2003 Roxanne J. Goeltz, Burnsville, Minnesota......................... 8 James P. Bagian, M.D. P.E., Director, National Center for Patient Safety, U.S. Department of Veterans Affairs, Ann Arbor, Michigan....................................................... 15 Carolyn M. Clancy, M.D., Director, Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services, Rockville, Maryland............................................ 18 Dennis S. O'Leary, M.D., President, Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace, Illinois....................................................... 20 David R. Page, President and Chief Executive Officer, Fairview Health Services, Minneapolis, Minnesota........................ 38 Dianne Mandernach, Commissioner, Minnesota Department of Health, St. Paul, Minnesota............................................ 41 Robert E. Krawisz, Executive Director, National Patient Safety Foundation, Chicago Illinois................................... 44 Suzanne Delbanco, Ph.D., Executive Director, The Leapfrog Group, Washington, DC................................................. 48 Alphabetical List of Witnesses Bagian, James P., M.D. P.E.: Testimony.................................................... 15 Prepared statement........................................... 61 Clancy, Carolyn M., M.D.: Testimony.................................................... 18 Prepared statement........................................... 66 Delbanco, Suzanne, Ph.D.: Testimony.................................................... 48 Prepared statement........................................... 128 Goeltz, Roxanne J.: Testimony.................................................... 8 Prepared statement........................................... 53 Krawisz, Robert E.: Testimony.................................................... 44 Prepared statement........................................... 113 Mandernach, Dianne: Testimony.................................................... 41 Prepared statement........................................... 110 O'Leary, Dennis S., M.D.: Testimony.................................................... 20 Prepared statement........................................... 84 Page, David R.: Testimony.................................................... 38 Prepared statement........................................... 92 Exhibit List 1. Materials from Roxanne J. Goeltz: a. GThe Last Word: Be a Partner in Your Health Care, by Roxanne J. Goeltz, FDA Consumer Magazine, May-June 2003.... 132 b. GTrial and Error in My Quest to be a Partner in My Healthcare--A Patient's, by Roxanne J. Goeltz and Martin J. Hattie, Esq................................................ 134 2. GEnsuring Correct Surgery in the Veterans Health Administration, chart produced by the Department of Veterans Affairs National Center for Patient Safety..................... 158 3. GMaterials from David R. Page, President and Chief Executive Officer, Fairview Health Services: a. GFairview Health Services--At a Glance................... 159 b. GBio of David R. Page.................................... 160 c. GFairview Health Services, Patient Rights and Organization Ethics, Communication/Disclosure Policy....... 161 d. GFairview Performance Excellence System-wide Scorecard... 167 4. GMaterials from Dianne Mandernach, Commissioner, Minnesota Department of Health: a. GBio of Dianne Mandenach................................. 168 b. GBackground Information: Minnesota MDH of Health, Adverse Health Care Events Reporting Act of 2003................... 169 c. GDocuments related to the Minnesota Alliance for Patient Safety (MAPS), including A Call To Action: Roles and Responsibilities for Assuring Patient Safety; Operating Guidelines; Strategic Direction for MAPS; and Patient Safety Participation List.................................. 171 d. GMDH press release regarding Adverse Health Care Events Reporting Act of 2003 signed by Minnesota Governor Pawlenty 197 e. GMinnesota Adverse Health Care Events Reporting Act of 2003....................................................... 199 5. GStatement for the Record of the Alliance of Specialty Medicine....................................................... 206 6. GStatement for the Record of the American College of Obstetricians and Gynecologists................................ 210 PATIENT SAFETY: INSTILLING HOSPITALS WITH A CULTURE OF CONTINUOUS IMPROVEMENT ---------- WEDNESDAY, JUNE 11, 2003 U.S. Senate, Permanent Subcommittee on Investigations, of the Committee on Governmental Affairs, Washington, DC. The Subcommittee met, pursuant to notice, at 9:05 a.m., in room SD-342, Dirksen Senate Office Building, Hon. Norm Coleman, Chairman of the Subcommittee, presiding. Present: Senators Coleman, Levin, Durbin, Carper, and Pryor. Staff Present: Joseph V. Kennedy, General Counsel; Mary D. Robertson, Chief Clerk; Kristin Meyer, Staff Assistant; Caroline Lebedoff, Intern; Elise J. Bean, Democratic Staff Director/Chief Counsel; Laura Stuber, Democratic Counsel; John Myers (Senator Specter); Marianne Upton and Krista Donahue (Senator Durbin); Wendy Want (Senator Lieberman); and Tate Heuer (Senator Pryor). OPENING STATEMENT OF SENATOR COLEMAN Senator Coleman. This hearing is called to order. I will begin my opening statement and then turn to the distinguished Ranking Member of this Committee, Senator Levin, and then we will go to the testimony of the witnesses. Good morning and welcome to today's hearing. In the 19th Century, Edward Jenner's discovery pushed the boundaries of germ theory and disease. The use of antiseptics and anesthesia in surgery increased public health levels and sanitation. And in the end, the simple act of washing one's hands transformed modern medicine by saving lives by preventing the spread of disease. The topic that we are dealing with today deals with how we can reduce errors that negatively impact patient safety. It is not just about systems. In fact, it is a basic discussion of how do human beings interact with the systems that are created to underscore the primary obligation of medicine, to protect the safety of patients. I want to repeat that we are going to talk a lot about systems today, but in the end, we are talking about people's lives. We are talking about lives being lost and there is a human component that sometimes when we talk about systems in an antiseptic way we forget about, and that has to be at the forefront, that we are dealing with people's lives and we are dealing with lives, deaths that could be prevented, and accidents that shouldn't have happened. To be sure, there must be strong, dynamic, and rigorous systems in place to ensure the safety of the patient from the moment they enter our Nation's hospitals to the time they leave. There is an opportunity for us to discuss that today, and even more importantly, for us to implement systems that will accomplish this task. This opportunity was pointed out in a study issued by the Institutes of Medicine 3 years ago entitled, ``To Err is Human: Building a Safer Health System.'' Today's witnesses are at the forefront of the effort to achieve these improvements. However, before we get to the discussions of systems, we need to recognize the one of the key ingredients of the future of our health care system in a single word, and that is confidence. Americans must have complete and total confidence in their health care systems if we are to ensure progress is made in this Nation, keeping our people not only safe but healthy. Americans must have confidence that not only is medical technology among the best in the world here, but that the people who are using it are the most highly trained and skilled. Americans must have confidence that their health care providers, doctors, nurses, and others are not only equipped to manage their care, but they are committed to the highest standards of medical professionalism and ethics. Finally, Americans must have confidence in the institutions of health care. We must be certain beyond a shadow of a doubt that every possible attempt is being made to ensure that we emerge from a health care experience at a hospital or clinic in a better condition than when we entered it. The basic premise of the Hippocratic Oath, to do no harm, must reflect not just the deliberate efforts of health care providers, but must also extend to the practices and procedures they implement to ensure the totality of the health care experience is safe, from beginning to end. From the onset of washing hands to the discovery of drugs to prevent disease and pestilence, medicine has been constantly improving and always innovating. Such improvements must continue to be the hallmark of our health care system. First, it is obviously a critical component of patient safety and health. Improved care saves lives. Second, it increases the quality of care, of speeding recovery and improving outcomes. Third, it reduces cost, allowing more individuals to afford quality health care. Fourth, it eases the acute shortage of health workers, such as nurses and lab technicians that many areas face. This subject could not be timelier for Minnesota. Last week, the Minneapolis paper reported the tragic death of 2- year-old Brianna Baehman. Brianna died as the result of a hospital error. Ironically, this mistake happened in one of Minnesota's best hospitals, a hospital with an excellent record of quality improvement and a firm commitment to improving patient safety. Our first witness today will also remind us that the consequence of error can often be fatal. They will also do something else that they have done repeatedly since this great tragedy: Help us recognize that a failure occurred and that improvements must be made. I applaud them for not only accepting those failures, but for admitting that there is a critical need for improvements. Today's hearing is not meant to focus blame or to concentrate on tragedies for the sake of sensationalism. On the contrary, these tragedies are painful reminders that human error is a function of human growth. We must learn from our mistakes. Unlike most of us, doctors and nurses are in the unenviable position where their mistakes can easily have fatal consequences. While we can never achieve perfection, the good news is that we can do much better. We can develop a system in which errors are prevented and the consequences minimized. However, the reality is that we will never conquer human fallibility. As I said, today's experts are at the forefront of the Nation's efforts to install a culture of quality and implement a system of continuous improvement. I believe that their success or failure will determine the level of confidence Americans have in the health care system and, thus, the future of our health care system. At its most fundamental level, today's topic is the key to the future of our medical system. How do we ensure confidence and patient safety in our health care system through better performance from the Nation's health care system, especially its hospitals? There are proven management practices that have many names, including lean manufacturing, balanced scorecards, and Six Sigma. Although Japanese companies such as Toyota and Sony made many of these practices famous, they were originally developed by American experts, such as W. Edward Demming. Today, most of the world's leaders in productivity are American companies, such as GE, 3M, and Honeywell. The experts we hear from today will tell us that we can get these same improvements from the health care sector if we adopt some of the same management practices. Like any other institution, hospitals are basically human endeavors. While we cannot legislate away human error, we can develop systems for minimizing the chance of error by improving communication, standardizing practice, and learning from mistakes. Doing this depends on a number of things, however. One is the willingness to study and eliminate barriers to better performance. These barriers may take the form of human resistance to change, the lack of a team culture, or liability concerns about sharing information. By themselves, each barrier may make sense, but when they stand in the way of better health care, we need to examine their usefulness. Second, we need to work with those institutions or organizations and agencies that are prepared and committed to go that next step towards ensuring ongoing confidence in the safe care of patients in our health system. I am pleased that one of those people who are here today to talk about what they are doing to ensure a system that will provide for monitoring and improvement of patient safety in Minnesota is the Commissioner of the Department of Health, Dianne Mandernach. The State of Minnesota is one of the first in the Nation to begin implementing a system of data collection, working with the Minnesota Hospital Association to ensure accurate reporting of information related to patient safety. I want to thank the Commissioner for being here today and for the work and leadership she has provided on other issues, including SARS, in the State of Minnesota. In the end, in every area such as long-term care, medical practice, and product development, we need to and can do better, and the tools for doing so are already at hand. The health care industry can and must undergo the same type of transformation toward a culture of quality and system for continuous improvement that the manufacturing sector has recently experienced. Our experts are here today to tell us that this is being done, and with our help, it can be done faster. [The prepared statement of Senator Coleman follows:] PREPARED OPENING STATEMENT OF SENATOR COLEMAN Good morning and welcome to today's hearing. In the 19th Century, Edward Jenner's discovery pushed the boundaries of germ theory and disease. The use of antiseptics and anesthesia in surgery increased public health levels and sanitation. And, in the end, the simple act of washing one's hands transformed modern medicine by saving lives by preventing the spread of disease. The topic today deals with how we can reduce errors that negatively impact patient safety. It is not just a discussion about systems--in fact, it's a basic discussion about how do human beings interact with the systems that are created to underscore the primary obligation of medicine. To protect the safety of patients. That is, in my mind, the premise of our discussion today, and the testimony of our witnesses. To be sure, there must be strong, dynamic and rigorous systems in place to ensure the safety of a patient fromt he moment they enter our Nation's hospitals--to the time they leave. There is an opportunity for us to discuss that today, and even more opportunity for us to implement systems that will accomplish this task. This opportunity was pointed out in a study issued by the Institutes of Medicine 3 years ago entitled, ``To Err is Human: Building a Safer Health System.'' Today's witnesses are at the forefront of the effort to achieve these improvements. However, before we get to the discussion of systems, we need to recognize the one of the key ingredients to the future of our health care system in a single word: Confidence. Americans must have complete and total confidence in their health care systems if we are to ensure progress is made in this Nation to keeping our people not only safe, but healthy. Americans must have confidence that not only is medical technology among the best in the world, but that the people who are using it are the most highly trained and skilled. Americans must have confidence that their health care providers-- doctors, nurses, and others--are not only equipped to manage their care, but they are committed to the highest standards of medical professionalism and ethics. Finally, Americans must have confidence in the institutions of health care. We must be certain, beyond a shadow of a doubt, that every possible attempt is being made to ensure that we emerge from a health care experience at a hospital or clinic in a better condition than when we entered it. The basic premise of the Hippocratic Oath, to do no harm, must reflect not just the deliberate efforts of health care providers, but must also extend to the practices and procedures they implement to ensure the totality of the health care experience is safe from beginning to end. From the onset of washing hands, to the discovery of drugs to prevent disease and pestilence, medicine has been constantly improving and always innovating. Such improvements must continue to be the hallmark of our health care system. First, it is obviously a critical component of patient safety and health. Improved care saves lives. Second, it increases the quality of care, of speeding recovery and improving outcomes. Third, it reduces cost, allowing more individuals to afford quality health care. Fourth, it eases the acute shortage of health workers, such as nurses and lab technicians that many areas face. This subject could not be timelier for Minnesota. Last week, the Minneapolis paper reported the tragic death of two-year-old Brianna Baehman. Brianna died as the result of a hospital mistake. Ironically, this mistake happened in one of Minnesota's best hospitals, a hospital with an excellent record of quality improvement and a firm commitment to increasing patient safety. Our first witness today will also remind us that the consequence of error can often be fatal. Today's hearing is not meant to focus blame, or to concentrate on tragedies for the sake of sensationalism. On the contrary. These tragedies are painful reminders that human error is a function of human growth. We must learn from our mistakes. Unlike most of us, doctors and nurses are in the unenviable position where their mistakes can easily have fatal consequences. While we can never achieve perfection, the good news is that we can do much better. We can develop a system in which errors are prevented and their consequences minimized. However, the reality is that we will never conquer human fallibility. As I said, today's experts are at the forefront of the Nation's efforts to install a culture of quality and implement a system of continuous improvement. I believe that their success or failure will determine the level of confidence Americans have in the health care system, and thus, the future of our health care system. At its most fundamental level, today's topic is the key to the future of our medical system: How do we ensure confidence and patient safety in our health care system through better performance from the Nation's health care system, especially its hospitals? There are proven management practices that have many names including lean manufacturing, balanced scorecards, and Six Sigma. Although Japanese companies such as Toyota and Sony made many of these practices famous, they were originally developed by American experts such as W. Edward Demming. Today most of the world's leaders in productivity are American companies such as GE, 3M, and Honeywell. The experts we hear from today will tell us that we can get these same improvements from the health care sector if we adopt some of the same management practices. Like any other institution, hospitals are basically human endeavors. While we cannot legislate away human error, we can develop systems for minimizing the chance of error by improving communication, standardizing practice, and learning from mistakes. Doing this depends on a number of things, however. One is the willingness to study and eliminate barriers to better performance. These barriers may take the form of human resistance to change, the lack of a team culture, or liability concerns about sharing information. By themselves, each barrier may make sense, but when they stand in the way of better healthcare, we need to examine their continued usefulness. Second, we need to work with those institutions, organizations and agencies that are prepared and committed to go that next step towards ensuring ongoing confidence in the safe care of patients in our health system. I am pleased that one of those people who are here today to talk about what they are doing to ensure a system that will provide for monitoring and improvement of patient safety in Minnesota is Commissioner of the Department of Health Dianne Mandernach. The State of Minnesota is one of the first in the Nation to begin implementing a system of data collection, working with the Minnesota Hospital Association, to ensure accurate reporting of information related to patient safety. I want to thank the Commissioner for being here today, and for the work and leadership she has provided on other issues, including SARS, in the State of Minnesota. In the end, in every area such as long-term care, medical practice, and product development, we need to and can do better. And the tools for doing so are already at hand. The health care industry can and must undergo the same type of transformation toward a culture of quality and system for continuous improvement that the manufacturing sector has recently experienced. Our experts are here to tell us that this is being done and with our help it can be done faster. Senator Coleman. With that, I would like to turn it over to the Ranking Member of this Committee, Senator Levin. OPENING STATEMENT OF SENATOR LEVIN Senator Levin. Thank you, Mr. Chairman. Thank you for convening this hearing. It is a very important subject and your intense interest in it is critical to continuing progress in the area. Health care in the United States is among the most advanced in the world. Our doctors are trained in the newest techniques and medications. Our nurses undergo rigorous training, and our hospitals provide life-saving emergency care, diagnostics, medical equipment, and sustained support to return patients to health. But even top-caliber hospitals cannot escape medical mistakes that sometimes result in irreparable damage to patients. We have all heard the painful stories. A few years ago, a man in Tampa had the wrong leg amputated. Last summer, a young Dallas woman died because she got the wrong liver transplant. A North Carolina teenager died earlier this year after receiving transplanted organs that did not match her blood type. A young man in Texas underwent surgery for a stomach ulcer and continued to experience severe pain afterwards and learned during an emergency room visit some time later that a 13-inch surgical instrument had been left inside of him during the original surgery. The Centers for Disease Control estimates that over the last 5 years, as many as 15,000 people have had foreign objects left inside their bodies after surgery. The problem of medical errors is an old one. The Chairman has referred to a major milestone, a report that was issued in 1999 when the Institutes of Medicine, a federally chartered research agency, released the report called ``To Err is Human,'' and that report estimated that between 44,000 and 98,000 Americans die each year as a result of preventable medical errors, including diagnostic mistakes, equipment failures, infections, injury related to blood transfusions, and misinterpretation of medical orders. The report said that hospital deaths due to preventable adverse medical events are the eighth leading cause of death in the United States, exceeding deaths attributable to motor vehicle accidents, breast cancer, and AIDS. The report estimated that those medical errors cost the American health system between $37 and $50 billion a year. I remember when the report came out, it was information that shocked not only the public, but the health care profession in terms of the scope of the problem and how hidden it was and how little was being done to address it, and to their credit, the health care profession responded, not by denying the problem but by taking up its call to action, and there was a real break from the past that resulted due to concerns that ranged from patient suffering, professional pride, liability admissions, and legal costs. Many in the health care field could not or would not admit to individual or systematic or systemic medical errors, but the fact is, it took courage then and now for any medical professional to admit that mistakes happen. By making it acceptable to admit the truth, the health care professions have been able to move into a new era of identifying problems and designing best practices to overcome them. The key first step in this process has been to conduct a root cause analysis of a troubling incident to determine what happened and why, not to assign blame, but to find out what went wrong and what can be done to avoid similar problems in the future. The resulting best practice recommendations cover a wide spectrum of hospital procedures. Some of those recommendations are high-tech solutions. Some of them are very low-tech, just to avoid patient identity mix-ups by requiring patients to provide a very clear name, birth date, and doctor, which sounds awfully simple, but until recently has not been done in many places. All three types of information being required have led to fewer cases of mistaken patient identity. And read-back requirements, to read back to the patient the information that patient gives over the phone, has been important to reducing errors. One of the leaders in this effort is the National Center for Patient Safety, a small Federal program that began operation just a few years ago, to improve patient care at the 173 hospitals run by the U.S. Department of Veterans Affairs. This program focuses on prevention, not punishment, to eliminate system vulnerabilities, and it has become a model for both public and private hospitals. I welcome testimony from the Director of the center, Dr. Bagian, who lives and works in Ann Arbor in my home State of Michigan. The Chairman is right. We are dealing here with real people, real victims. We are not just dealing with statistics, although we all use them, and we are not just dealing with processes, although we must study them. But his point is the real one. We are dealing with real people who hurt, and major errors not only hurt particular patients who suffer the immediate effects, but their families, their loved ones. They hurt the doctors and hospitals that have to deal with the consequences of those errors. They increase overall medical and hospital costs. Those errors divert taxpayers' funds from other Medicare and VA health needs. They contribute to medical malpractice costs. They burden our legal systems. So it is in everybody's interest to improve patient safety, and again, I commend Chairman Coleman for convening this important hearing. Senator Coleman. Thank you very much, Senator Levin. I would now like to welcome our first witness to today's hearing, Roxanne Goeltz from Burnsville, Minnesota. I want to thank you for your attendance today and thank you for your courage in speaking out. I have had a chance to read some of your writings. I can only imagine how difficult it is, how great the pain is. But your courage in speaking out, describing the circumstances of your brother's death and your insights into how patients can participate more effectively in their own health care is important and we certainly want to hear your testimony today. Before we begin, pursuant to Rule 6, all witnesses who testify before this Subcommittee are required to be sworn. At this time, I would ask you to please stand and raise your right hand. Do you swear the testimony you will give before this Subcommittee will be the truth, the whole truth, and nothing but the truth, so help you, God? Ms. Goeltz. I do. Senator Coleman. Thank you. We will be using a timing system, Ms. Goeltz. Please be aware that approximately 1 minute before the red light comes on, you will see the lights change from green to yellow, giving you an opportunity to conclude your remarks. While your written testimony will be printed in the record in its entirety, we ask that you limit your oral testimony to no more than 5 minutes. Ms. Goeltz, you may proceed. TESTIMONY OF ROXANNE J. GOELTZ,\1\ BURNSVILLE, MINNESOTA Ms. Goeltz. Good morning, Mr. Chairman and Members of the Subcommittee. Thank you for the opportunity to speak to you today. --------------------------------------------------------------------------- \1\ The prepared statement of Ms. Goeltz appears in the Appendix on page 53. --------------------------------------------------------------------------- I am in front of you today because of the love I have for my brother, Mike, who died in September 1999 of medical error. One week later, a Minneapolis newspaper ran a three-part series on errors in hospitals. One-and-a-half months later, the IOM report came out stating 98,000 people a year die of medical errors in hospitals alone. In my profession as an air traffic controller, that would equate to crashing an airliner with 250 people in it every day. I needed to get involved for my brother, for myself, and for all the other loved ones being harmed needlessly. I want to share with you the story of my brother, Mike. Before September 22, 1999, I did not have a clue what the term medical error meant or that such a thing existed. Almost 4 years later, I still do not have a clear definition of what it means. What I do know is that needless harm is coming to people that enter the health care system. On September 21, 1999, my brother had gotten up, showered for work, and as he was getting ready to leave became light- headed and then experienced severe pain in his stomach. Mike went over to my parents and asked if he could spend the day, that he thought he had the flu. By 4 p.m., he was in so much pain that he could not speak and agreed to go to the emergency room. My dad took him, and after Mike was checked in, Dad went home. That was the last time my dad saw his son alive, and he will never forgive himself for leaving. But he had always been taught that you are safe and cared for in a hospital. Dad called around 6 p.m. to see how Mike was doing, but he was still in so much pain, he could not speak. Mike was eventually admitted to the hospital and given a self-drip morphine infusion for his pain, even though they were not sure what was causing it. Around 3 a.m., the next morning, my parents received a phone call telling them that Mike was not doing so well and would they come to the hospital. On the way there, they decided to take him somewhere else, not realizing he was already dead. When the elevator door opened on the second floor, the whole staff was standing there whispering. They stopped abruptly and my mom looked into the eyes of one of the nurses and she knew. She turned to my father and said, ``He is dead, Ray.'' This is the part of my story I have the hardest time getting through. It is the picture my parents have of their son every morning as they get up and every evening as they go to bed. Screaming, my parents ran down the hall to Mike's room. They stood in the doorway, staring at him lying in the bed, his arm hanging over the side with the IV still in it. My mom and dad traveled that space from the doorway to their son with a horrific feeling of failure, the failure every parent fears that they will not protect their child from harm. They felt guilt for trusting someone else with this task and now they experienced the ultimate mistake that could not be undone. My dad tried to put Mike's arm under the sheet, but was unable to bend it. They leaned over their six-foot, 200-pound son and hugged and kissed him. He was so cold. Mike was never cold, and he certainly could not be dead. When people die in airplanes, their families are brought to a site where the parts of the plane are gathered so they can attempt to begin the process of closure. They have grief counselors and supporting family members with them. An investigative process is begun immediately to try and find answers as to why the tragedy occurred. The families are kept informed and told what is found. My parents were allowed to go to the body of their dead son with no one there to support them. They were made to feel they deserved no answers as to what happened to their son, as if dying under the care of the medical profession relieves the profession of any accountability. No one would talk to them about their son's last hours alive. My parents were treated with silence and compassionless statements. The death of my brother was a tragedy, but the treatment of my family is what makes that tragedy horrific. I am often asked, what was the error that Mike died from? Mike was given a drug for pain, left alone, unmonitored and unchecked for over 4 hours. He died during this time. Is this the error, or was the misdiagnosis the error, or the treatment of my parents after he died the error? Mike died because we had been taught to trust our health care system and all will be well. This is not the reality of our system now. I can give another example. A friend put her mother in a care home after she had brain surgery. My friend was concerned about whether the facility could care for her mother and stated so to the floor nurse. The response was, ``Don't worry. We will take good care of your mother.'' In the next 36 hours, her mother sustained three separate falls which resulted in brain damage. The caring words said by the nurse have become a blatant lie to this family. What could the nurse have said? How about the truth. How about, ``We will do the best we can to care for your mother, but we cannot watch her all the time. Falls are a danger for patients and I can show you what we do to minimize them. If you would like to stay or have other family and friends stay with her, we welcome your help.'' As a family, we take part of the responsibility for Mike's death. We left him alone and we should have been there to speak for him when he could not. Maybe he would have died anyway, but he would not have died alone. I envision in the new world of health care that Mike would have taken a more active part, as well. He would have known of the aneurysm history in our family and how his own history of high blood pressure could contribute to his risk of having one. He would have been more aware of the risks and educated to the symptoms. When I began to understand the enormous task of patient safety, I became overwhelmed by it and had to decide what contribution I could make. I believe in the need of involving the consumer in whatever directions the industry takes. Consumers are key players on the team and all the efforts attempted in health care will be for naught if the consumer is not educated in their role. We need to help the public understand it is the system that is failing them and not the health care workers. The individuals here today represent the movement that is taking place that will make our health care not only the best in the world, but the safest in the world. AHRQ has already made important contributions to patient safety in general and in the role of consumers in particular. Among other projects, AHRQ is supporting a workshop in October that will bring consumers who are frequent flyers in the system together to mine our experience for lessons learned in being constructive, proactive partners in our care. Facilitated by the Institute for Alternative Futures and the Partnership for Patient Safety, I am involved in the development of this grant and want to commend Carolyn Clancy for her agency's commitment to the notion of a patient and consumer-centered system. AHRQ's work in this area has just begun, and as a consumer, I urge the Committee to support it with appropriate resources so this kind of work can continue. I hold a special place in my heart for the National Patient Safety Foundation, since it was their outreach to a nagging family member that allowed consumers to be at the table by establishing the Patient and Family Advisory Council, on which I have the privilege to serve. I want to commend Robert Krawisz's leadership and NPSF's efforts in creating a national database of patient safety information, which is crucial to the education needed about this issue. I believe the Leapfrog Group, through its call for patient safety reforms and advocacy on the behalf of employees, is one of the most important patient-centered forces in health care today. Among other resources, the Leapfrog Group's ability to use its member companies' human resource departments to educate consumers about their roles and responsibilities is enormous. The Office of Personnel Management is an honorary member of Leapfrog and should step up to the plate to support this group's efforts of reform. I have personal knowledge of the Fairview Health System's dedication to patient safety under Dr. Page's leadership because I had the opportunity to bring to his attention a family who had experienced a system failure and were very angry about it. While I cannot discuss the details, I witnessed how his staff agreed to meet with this family, listen to them, and responded by telling them what Fairview had learned from them and was going to investigate. It was not an easy meeting for Fairview, but the difference between this approach and the way my family was handled after Mike's death was night and day. Consumers are ready to work with leaders like Dr. Page who respect us and show it in the way their organizations operate. I think we can accomplish great things by working together in partnership. There are several things I believe could be done to further the culture changes needed in health care and society. The first would be to require disclosure in a reasonable time frame of any bad outcomes. Since facilities are required to sign contracts for care to receive Medicare and Medicaid funds, I urge you to consider whether this could be a condition of participation. Another important step would be to prohibit the confidentiality agreements that seal the records when a medical liability claim is settled. One of the great disparities between aviation safety and patient safety is that we widely publicize our lessons learned and use them as safety tools. Allowing the facts that produce accidents to be hidden, as health care routinely does, means health care repeats the same mistakes over and over again, as each hospital and clinic climbs its own carefully hidden learning curve. Finally, let us start educating the public about the true cause of errors. We need to stop scapegoating individuals and look at the system that is failing them and us. We should inform health care consumers not only of their rights, but just as importantly, their responsibilities as partners in care. My own experience has led me to join with these allies in a movement that can make patient safety a reality rather than a dream. We could use help from Congress and Medicare, and I have a number of suggestions about what our government can do to further the culture needed in health care society. The first is to require disclosure of medical errors, as I have said. Finally, there is a need to educate the public about the sources of medical errors. These occur because our systems fail and the corrections will need to be systemic. Rather than a ``blame system'' that seeks to find individuals and hold them responsible, we need a learning system. The Institutes of Medicine has published two reports showing how we can create systems changes. I would like to leave you with a short story about a friend who learned I was coming here today, and we have had my conversations about patient safety in the past 4 years and her daughter was in the doctor's office getting a dosage of medicine for an illness that she had. It was being measured in grams. This woman, who has never spoke up before, asked them to double-check the dosage and to show them how they came up with the information. This is not a difficult mother. As family members, we are often labeled that we are when we ask questions. What we are trying to be is partners in our care. Our government can and should help educate people about their responsibility. Thank you. Senator Coleman. Thank you very much, Ms. Goeltz. When you talked about the death of Mike in the early part of your testimony with great sadness and a little anger, and as I listened to your testimony, maybe it is your own personal journey, but there seemed to be a bit of hope that if individuals can be treated with greater respect, if there is a cultural change, if there is more information, that we can make progress. Are you hopeful today? Ms. Goeltz. Very hopeful. I, in the last 4 years, would never have imagined the attention and the dedication that has come about this issue. Senator Coleman. Talk to me a little bit about responsibility for culture change. There are two parts to that. On the one hand, I listened to you talk about the system culture, which I think you are talking about, but then you also quite often make reference to patient responsibility, or family responsibility. Talk to me about both those cultures. Ms. Goeltz. Well, more of my heart is in the patient responsibility. As a consumer, I feel that on my own journey in health care after Mike died, I was diagnosed with cancer, and the struggle that I had in getting the people in the health care system to listen to my input and give credence to what I was saying was evidence that they felt they needed to be the only ones to care, that I didn't have the information to provide. I think that we need to educate the consumers about how important it is that we have rights as patients, but with those rights, we also have responsibilities, such as knowing if you have a history of aneurysms in your family, as my brother did not, knowing if you are a diabetic what kind of medications might react with the insulin that you are taking, and not just rely on the individual that is caring for you in health care to have that information or be aware of it. Senator Coleman. Last question. On a couple of occasions, you have referred to the difference between aviation safety, something you are familiar with as an air traffic controller, and patient safety, obviously from the tragic death of Mike as well as your own journey, do you have any insights as to why the difference? It appears to me as I look at aviation safety, when an accident occurs, everything, from the first step of dealing with families to the investigation, is thorough, complete, every detail checked out, and then report published. And yet in hospital safety, we don't seem to have the same thing. Help me understand from your perspective why we are not there. Ms. Goeltz. I believe in aviation, about 12 years ago when they started to look at the cockpit management and how it used to be the captain was always the last word when things were happening in the airplane, they grew from that and anybody that was in that cockpit had input, and if the lowly engineer in the back said, ``We are not taking off,'' they wouldn't take off. That was the start, where aviation started to look at it as a team effort rather than an individual who ends up being totally responsible. In health care, they are taught both in school, and as they are going through their training, that they are responsible and that it can only be one person to be responsible because if they have numerous people giving input, there would be mass confusion and nothing would--the patient would die as they were arguing, basically. The importance is not necessarily to take away one person making a decision, but ensure that that person is listening to all the input around him to make that decision and not just basing it on his own experience, because there is a lot of experience in the room, for example, in a surgery room when you are doing something, than just that one individual. And so it is the team effort that is important, and I believe that attitude towards that has to change. Senator Coleman. Thank you, Ms. Goeltz. I appreciate your very insightful perspective, as well as the great compassion that you bring today. Thank you very much. Senator Levin. Senator Levin. Thank you, Mr. Chairman. Let me add my thanks for coming forward. It is very difficult for you to do that, to recount a very painful chapter of your life. You have obviously used it for constructive and positive purposes, to help others, and we thank you for that, as well, because you tried to turn a tragedy into something which would have a positive impact. I am interested in your thoughts about holding people responsible or accountable for failures, errors, or mistakes. There is great emphasis on that in our world. I am wondering both about you individually, how you personally feel about that--I gather from what I know that you did not bring a lawsuit against the hospital, for instance, and if you feel comfortable talking about your thoughts about why not. I am also interested in your thoughts about whether there is too much emphasis on blaming or holding people accountable or holding people responsible for errors and whether or not that has a negative effect on what we are trying to do, which is to have people admit mistakes, and whether the organization that you are a member of or associated with, the National Patient Safety Foundation, has any views on that. I know you are not here representing them, but if you are aware of their position on that issue, it would be helpful for us to know that. Ms. Goeltz. First, the fact that we did not pursue suing the hospital, it is not that we didn't do that initially. Initially, the anger and the hurt that came out of what happened to my brother and the fact that no one would talk with us, I did go with my parents to a lawyer to see if we could get answers for what had happened to Mike. Basically, what he told my parents after many weeks of encouragement that he was going to be able to get answers for them was that it wasn't worth his time. He could not make enough money. That was another slap in the face for my parents. At that point, I realize that was not the route that I wanted to pursue and I ended up finding the National Patient Safety Foundation on the Internet and attended a forum where I heard them compare aviation safety to health care safety, and that was my connection with looking at it from a system standpoint rather than trying to blame the doctor or the nurses that were involved, because I started to learn what they were working with and in, with staff shortages and an attitude of complacency. It was a small rural hospital, which is also a factor in the possibility for medical errors. Because of that, of my knowledge of how I do things in my work, and I have been in air traffic control since I was 20 years old, it is the way I think. I don't blame individuals. I try to look at it from a standpoint of what is their background. As an example, I had a trainer when I was an air traffic controller. No one else could work with him. It was very difficult to work with this man, but I tried to understand what it was about his information that he was providing me, and he had been a sole survivor of a unit that came out of Vietnam and he viewed things very differently than other people. And it was by trying to understand that background that I was able to work with him, and I believe that is what I do when I look at errors. I try to understand what is behind the error, not the individual that was there when it occurred. As far as NPSF, they have always been about not blaming and punishing. That was the message I heard when I first met with them in October 1999 and they continue to support that. Blaming individuals does not get us anywhere. It is what we have been doing in health care for years and this is where we are at. It is time to change and look at what we can do to help the individuals work better in a system that is failing them. Senator Levin. Thank you very much. If you have a chance to either stay for the panels, or if you are not able to, to perhaps read some of the testimony, I think there may be at least some reassuring testimony that things, indeed, are happening in the field along the lines, I think, that you are talking about, which is openness and acknowledging mistakes rather than trying to assign blame. So I think some of the later testimony this morning could be reassuring to you that there is movement in the direction that you indicate. Thank you very much for coming. Ms. Goeltz. Thank you. Senator Coleman. Thank you. I would like to call our second panel of witnesses at this time. We welcome our second panel at this time, Dr. James Bagian, Director of the National Center for Patient Safety for the U.S. Department of Veterans Affairs in Ann Arbor, Michigan; Dr. Carolyn M. Clancy, the Director of the Agency for Healthcare Research and Quality at the U.S. Department of Health and Human Services in Rockville, Maryland; and finally, Dr. Dennis O'Leary, President of the Joint Commission on Accreditation of Healthcare Organizations based in Oakbrook Terrace, Illinois. I thank all of you for your attendance at today's important hearing. I look forward to hearing your testimony this morning and your unique perspectives on what the Federal Government and accreditation agencies are doing to foster a climate of continuous improvement in our Nation's hospitals. As I noted earlier, pursuant to Rule 6, all witnesses who testify before the Subcommittee are required to be sworn. At this time, I would ask you all to please rise and raise your right hand. Do you swear the testimony you will give before this Subcommittee is the truth, the whole truth, and nothing but the truth, so help you, God? Dr. Bagian. I do. Dr. Clancy. I do. Dr. O'Leary. I do. Senator Coleman. Thank you. Dr. Bagian, we will proceed first with your testimony. We will then hear from Dr. Clancy and finish up with Dr. O'Leary. After we have heard all of your testimony, we will turn to questions. Dr. Bagian. TESTIMONY OF JAMES P. BAGIAN, M.D., P.E.,\1\ DIRECTOR, NATIONAL CENTER FOR PATIENT SAFETY, U.S. DEPARTMENT OF VETERANS AFFAIRS, ANN ARBOR, MICHIGAN Dr. Bagian. Thank you. Thank you, Senator Coleman. It was a pleasure to hear both your comments and Senator Levin's because I think it really set the stage, as did Ms. Goeltz's. --------------------------------------------------------------------------- \1\ The prepared statement of Dr. Bagian appears in the Appendix on page 61. --------------------------------------------------------------------------- What I would like to talk about is kind of reemphasis some of the things that were said and talk about some of the experiences we have had at the VA as we have done some of these things, because I think there are some useful lessons, both as barriers to be overcome and avoid and maybe successful ways to go about looking at this. As you have already stated, the problems of patient safety are significant and we know worldwide, not just in the United States, that anywhere from 4 to 9 percent of all patients who come into a hospital end up being a hurt incident to their care. That is quite a huge number. In 1997, well ahead of either of the IOM reports, the VA embarked on the quest to try to improve patient safety and Dr. Kizer, who was the Under Secretary for Health, really is responsible for getting the ball rolling. In 1998, I was first involved with the VA as we looked at this and it became clear to me from my background as an engineer and a pilot and an astronaut for over 15 years and being a member of the Challenger Accident Investigation Board and now even on the Columbia Accident Investigation Board that the culture in aviation was much different than it is in medicine. It is like night and day, as you heard from Ms. Goeltz. I can't agree more. The real point was culture and how do we look at things differently, and I think one of the things, and maybe a slight clarification of what has been said to now, is that people talk about it is about preventing errors, and I would say that is not what it is about. That is a tool. That is not the goal. The goal is to prevent harm to patients. That sounds like a subtle difference, but it is important because many things that harm patients are not traditionally viewed as errors, and yet they need to be corrected, and if we have time during the question period, I will be glad to give you some concrete examples of that. But we find that preventing harm is the big deal. It is about preventing harm and how do you do that. We will all agree what harm is. We might not all agree on errors. The barriers are several. One is leadership in this area. For a number of reasons, in many places, leadership has been lacking. Our leadership has been viewed as if we write an e- mail, make a policy, that is going to change things. Things don't change by e-mails and policies. They change by leading people. You manage things, you lead people, I think that is a very important thing. Another is the difference, and you heard it already, it is about having a learning system, not an accountability system. We have numerous accountability systems. They play a role. They play a vital role. They are not sufficient. They are necessary, but not sufficient. We need a way that people can learn. People don't learn at the point of a gun. They don't. By saying, we are going to subject you to penalties if you don't learn, that doesn't make people do it better. These are accidents. These are not deliberate acts. Caregivers do not start out to hurt patients. They don't. That is the worst thing that can ever happen to a provider, but yet it happens, and we heard some examples this morning already. The fact is, how do we set it up so they can learn from these? It has to not be viewed as a punative system. It has to be looked at as a fair system. If the people involved in delivering health care, and this includes the patients, as well, if they look at the system as punative, they are not likely to candidly participate. Aviation has shown this. Going back over 25 years ago, an accident approximately 40 miles from where we sit killed 92 people on TWA 514. It came out that the information what caused that accident, had been known 6 weeks prior and was never adequately disclosed because of fear of punishment. That led to the confidential reporting system that NASA runs, the Aviation Safety Reporting System. It is very important that they have confidentiality for reporting. If they don't, people don't report things because they are afraid they will be unfairly treated. One of the things we need to change, and it is not just medicine that does it, the first question people often ask is, ``Whose fault is that?'' and I call fault the ``f'' word in medicine. It is not whose fault is that. The question is, what happened, why did it happen, and what do we do to prevent it? These are the things, and if you don't end up with what do we do to prevent it, then you have really done very little. We think what you have to do is look at how to get people comfortable with that. How do people get comfortable with saying, things went wrong, things aren't just right? We know from surveys there is a difference in culture between aviation, for example, and medicine. When a cohort of pilots were asked, if you were told by your superior to do something you thought was wrong, would you question it? Ninety-seven percent said yes. I am surprised it wasn't 100. Among physicians, less than half said yes--quite a difference. It is a different culture. The big question is, how do we get there? How do we change this? And we think there are a number of things. One, you need to develop a systems approach. People have to understand what is blame-worthy. We have done this in the VA and we have shown that by clearly establishing what was blame- worthy, that is: Criminal acts, things that are criminal, purposely unsafe acts, and acts involving substance or alcohol abuse on the part of the provider; these acts deserve to have boards of investigation with full disclosure, discoverable, and possible punishment, if that is appropriate. If it is not one of these type of acts, then we look at it in a confidential way to come out with what real systems solutions are and then implement them. By doing this, we have seen reporting in the VA, which was always thought, even by the Joint Commission in the past to be good, went up 30-fold. Our close call reporting went up 900- fold. That is 90,000 percent. Close calls are reported in very few facilities in the United States today outside the VA today. We require investigation of those. Close calls are things that almost happened but didn't actually result in injury. That is a way to learn. That is the way human beings learn, yet institutionally in medicine and many other industries, we just mop our brow and say, whew, glad nothing happened, and then we go and do it again the next day until somebody is hurt. That is the foolish way to proceed. We need to look at things differently. We provide tools to people, where we have actually embedded systems approaches, because the changing culture doesn't happen overnight. We develop tools that are human factors engineered that teach people how to look at systems very thoroughly. When they find these tools are successful, they adopt these behaviors as their own, not as some artifice, as their own, and then that changes their attitudes. And then when attitudes change, then culture changes. We have done this. We have seen this now being adopted, like Australia has done it, taken our tools and converted it into Australian, changing words that we think are English that they don't, for example, change schedule to roster. We see here it is translated into Danish. Australia has adopted our system for the whole country. So has Denmark. Sweden is in the process. So is Singapore and Japan. Canada has looked at it, New Zealand, and others. We believe, along with these tools, it is not just giving people tools, it is involving the whole system, which includes the patient. You see on this poster how we ensure correct surgery. We have pamphlets go to the patient to do the same exact thing. The bottom line is that what we need to do is get away from the misconception or fallacy that it is just reporting. We have reports. It is also good to have people feel safer with reporting. The important thing is what we do about it, without creating an environment where it is safe for people to report, to really examine these thoughtfully and candidly, nothing will change and without creating, and that is what I think Congress can do. And while the VA has the ability to do that and some States do, it is inconsistent across all States. Federal legislation which has already passed out of the House in H.R. 663 and is in the Senate under consideration needs to be acted on, I think. There are some changes that need to be made. It does not let local facilities be their own patient safety organization. If you remove the ability to improve things from the front line, you remove the ability to be tightly coupled and fix things. You need both central and at the front line where the work really happens, and I would strongly encourage you to look at that, because creating that environment will allow it to go forward at a meteoric rate, I believe. Thank you. Senator Coleman. Thank you very much, Dr. Bagian. Dr. Clancy. TESTIMONY OF CAROLYN M. CLANCY, M.D.,\1\ DIRECTOR, AGENCY FOR HEALTHCARE RESEARCH AND QUALITY, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ROCKVILLE, MARYLAND Dr. Clancy. Good morning, Mr. Chairman and Members of the Subcommittee. I am very pleased to be here today to discuss the important issue of supporting hospitals and other health care organizations in their efforts to build and sustain a culture of continuous quality and patient safety improvement. --------------------------------------------------------------------------- \1\ The prepared statement of Dr. Clancy appears in the Appendix on page 66. --------------------------------------------------------------------------- Hospitals and other health care delivery systems provide millions of Americans each year with important and frequently life-saving care. But as we all know, medical errors and patient safety issues are an epidemic. And as we have seen from recent news headlines, no institution is exempt and everyone who uses the health care system is at risk. This is about all of us. However, there is good news. Our health care system is committed to improving the quality and safety of care provided to our Nation's citizens. This issue is a very high priority for Secretary Thompson and for the Agency for Healthcare Research and Quality, or AHRQ. Thanks to the vision of the U.S. Congress, over the last 3 years, AHRQ has had the opportunity to invest $165 million in patient safety research and is now the leading funder of this research in the world. My written statement describes how we have invested that $165 million and also describes the lessons we have learned from other industries which have made major strides in safety. I would like to mention very briefly an exciting proposal that we have for fiscal year 2004. AHRQ is requesting a total of $84 million dedicated to patient safety activities, of which we propose to invest $50 million to help hospitals invest in information technology, or IT, designed to improve patient safety with a special emphasis on the needs of small community and rural hospitals. Today, I would like to focus on how AHRQ translates the findings of the research we support into the information and tools that help hospitals, health care professionals, patients, and others improve the safety of health care. The research funded by AHRQ addresses two major challenges facing the health care system as it deals with patient safety. One, the key message we have heard again and again this morning from the Institutes of Medicine report and its sequel, ``Crossing the Quality Chasm,'' is that it is the system. Health care professionals, as you mentioned, Mr. Chairman, are human. Humans are prone to mistakes. We need to make sure that these professionals work in systems that are designed to prevent mistakes and catch problems before they occur. The second is that we need to shift away from naming, blaming, and shaming as a way of responding to errors. The correct response is to learn so that they don't happen again. If you punish people for reporting, they won't. This is not an easy thing to do, to learn from errors so that they don't happen again, but it is what we need to do. Related to this is the need to create a system that allows people to discuss and report errors without fear of recrimination or being sued. I would like to give you a quick example of an organization that could teach us all a lot in health care about preventing mistakes. The next time you go to Starbucks for a latte, notice how many people read your order back to you after you place it. Then look at the checkmarks on the cup made to back-up the verbal order. In health care, this is called read-back. Obviously, making a latte isn't nearly as complex as health care. On the other hand, many of the lessons from Starbucks apply. We need to build that kind of redundancy into health care and it isn't there right now. To meet these challenges, AHRQ has funded an ambitious patient safety research agenda that was formed through extensive consultation with the users of our research, consumers, health care providers, hospitals, and others. We feel very strongly that supporting research that meets the needs of its ultimate users is what will make a difference in patient safety. As you pointed out, Mr. Chairman, when you welcomed the National Patient Safety Foundation to Minneapolis in May 2001, in the end, success will not be about what leaders and CEOs do. They provide direction. Success will be tied to folks on the front line who have the vision and incorporate the message and carry it out well. That is how you will be successful. The goal of our patient safety initiative is to develop the information and tools that can be put to use immediately to improve health care safety and quality. For example, the health care system has long decried the lack of good measurement tools to identify where problems exist and solutions for solving them. So to fill this gap, AHRQ has developed a free web-based tool that can help hospitals enhance their patient safety performance by quickly detecting potential medical errors in patients who have undergone medical or surgical care. This tool is called patient safety indicators and it will be a tool that is ready and waiting for the proposed patient safety organizations if the pending patient safety legislation that Dr. Bagian just mentioned is passed by this Congress. We also know that health care professionals need information based on the latest scientific evidence and strategies and techniques to improve patient safety. In health care jargon, this is best practices. AHRQ supported the development of an evidence report titled, ``Making Health Care Safer: A Critical Analysis of Patient Safety Practices.'' This report identified 79 potential practices and rigorously reviewed the evidence underlying those. We then turned that report over to the National Quality Forum, a private consensus- building organization, which then developed 30 patient safety best practices, which were released 2 weeks ago in Los Angeles. However, providing information on best practices and patient safety is important, but certainly not enough. Therefore, AHRQ is poised to begin two exciting new programs under our patient safety initiative. The first, in which we will be working very closely with Dr. Bagian, is the development of a Patient Safety Improvement Corps. This initiative was developed in response to States who say that they needed more people to help them actually address the problem of medical errors and patient safety. The Patient Safety Improvement Corps will be a cadre of specially trained patient safety experts who can provide technical assistance to States, local governments, and health care institutions, learning from errors and helping to prevent them from happening again. The second program is a series of Safe Practices Implementation Challenge Grants. These grants are intended to help hospitals and other health care institutions assess safety risks to patients and devise ways to prevent them, as well as to implement safe practices that show evidence of eliminating or reducing known risks and harms. I would like to tell you about an exciting AHRQ-funded project that is helping to promote learning from medical errors and near misses so they don't happen again. We have developed a website modeled on the format of morbidity and mortality conferences that are routinely held within individual hospitals across the country. The AHRQ web M&M site is an online, peer- reviewed patient safety journal aimed at improving patient safety through analysis and discussion of submitted cases. These are submitted anonymously and these are near misses and also include an analysis of why this occurred and what could be done to prevent it. We also offer training and education about errors and patient safety to policy makers through our User Liaison Program, or ULP. Patient safety has been a big feature of our ULP workshops recently. For example, we had one in Minneapolis in July 2001 and recently had one in Seattle last week on patient safety. This is a great deal of interest among State and local policy makers in this topic. I would like to thank you again for giving me the opportunity to discuss the very important issue of medical errors, patient safety, and furthering a culture of continuous quality improvement in hospitals and health care organizations. Working together, we can improve the patient safety, enhance health care quality, and give the American people the best, safest health care system possible. Thank you. Senator Coleman. Thank you very much, Dr. Clancy. Dr. O'Leary. TESTIMONY OF DENNIS O'LEARY, M.D.,\1\ PRESIDENT, JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS, OAKBROOK TERRACE, ILLINOIS Dr. O'Leary. Good morning. Thank you, Mr. Chairman and Members of the Committee, for inviting the Joint Commission on Accreditation of Healthcare Organizations to testify this morning. --------------------------------------------------------------------------- \1\ The prepared statement of Dr. O'Leary appears in the Appendix on page 84. --------------------------------------------------------------------------- The Joint Commission, like others, is deeply concerned that the number of serious medical errors remains unacceptably high, despite the focus of significant national attention on patient safety in recent years. As part of our own intensified efforts to improve patient safety, we have created a Sentinel Event Database that today is this country's most complete record of the full range of serious medical errors and their underlying causes. This database, combined with knowledge gained from working directly with health care organizations to address their patient safety problems, has given us a deep understanding of the interplay of factors that contribute to health care errors. In this testimony, I would like to briefly outline six strategies for addressing the medical errors problem. First, health care organization leaders must be encouraged to create cultures of safety in their own settings. A culture of safety is characterized by an open atmosphere for reporting and addressing errors. Adopting such a culture is the overarching strategy that is necessary to the support of all other solutions to the problem. The culture of an organization emanates from all of its leaders, particularly the CEO. However, investments in patient safety, while a moral obligation, usually provide financial benefits predominately to payers and purchasers rather than to the organization. Further, it is a hard reality that public payers pay the same reimbursement for unsafe care as they do for safe care, a point not lost on stressed organization leaders. If there is no business case to drive the creation of cultures of safety, as most would now agree, a new pay-for- performance business case needs to be established, as we later recommend. Second, one of the Joint Commission's most important contributions to patient safety improvement efforts has been to incorporate into its accreditation requirements a systems approach to managing risk that is borrowed from engineering and quality control principles used in the manufacturing world. Individuals will always make errors. However, adverse events usually occur when internal systems fail to keep human mistakes from reaching patients. The Joint Commission now requires accredited health care organizations to engage in both after-the-fact and prospective risk analyses that assess weak points in their systems of care and then to redesign these systems ``to build safety in.'' Third, we need to educate and train health care professionals who are proficient in systems thinking. Today, we educate physicians at length on content unrelated to patient safety and lead them to believe that they will know how to do everything by themselves. By contrast, nurses, who are on the front line of the most complex health care, are educated for 2 to 4 years and receive brief postgraduate supervision that averages 30 days before they assume full responsibility for patient care duties. As a result, many nurses leave patient care because they feel unprepared to deal with today's high- acuity patients and actually fear that they will make critical mistakes in caring for patients. So today, we have a severe nursing shortage and a corresponding severe patient safety problem. Data from the Joint Commission's Sentinel Event Database demonstrates that in 24 percent of unanticipated deaths and serious patient injuries, inadequate numbers of nurses is a contributing factor. Last year, the Joint Commission published a major white paper on the nursing shortage which urged Federal funding for post-graduate nurse training. This is a de minimis investment in patient safety. Additional funding is also needed to supplement the extremely modest dollars allocated to last year's Nurse Reinvestment Act. Appropriations under this act are essential to the funding of faculty in nursing schools, which today must turn away hundreds of qualified nursing applicants. This is an untenable situation in the face of a major and growing nursing shortage. Fourth, information technology can become a vital asset in reducing medical errors. Unfortunately, the health care industry lags far behind most other industries in the use of information technology, and there remain significant impediments to broad-scale adoption of available technologies. Therefore, we are particularly pleased that Secretary Thompson has made the attainment of a National Health Information Infrastructure a priority of his Department. Now, the Congress, too, must prepare to make the capital investments necessary to facilitate rapid adoption of appropriate information technologies by health care organizations and to rapidly close the gap between what is possible and where this country is today. Fifth, I would observe that behavior change is best achieved when there are incentives that reward desired actions. I would like to mention two powerful incentives briefly. The first incentive lies in targeting the expectations of the health care oversight framework. To this end, the Joint Commission has now set a series of discrete national patient safety goals around documented safety problems and has incorporated assessment of compliance with these goals into the accreditation process. The second type of incentive involves rewarding behaviors through payment. There is now a growing imperative to determine how payment incentives can be aligned amongst payers, purchasers, provider organizations, and practitioners toward the goal of improving the quality and safety of care. Patient safety improvement must be part of the ``pay-for-performance'' equation. Finally, the passage of patient safety legislation must become an urgent priority of this Congress. Federal confidentiality protections for reported adverse events and their underlying causes are inextricably linked to the efforts to create a culture of safety inside health care organizations. Such protective legislation would establish a solid foundation for leveraging the sharing of information and mutual problem solving. Thank you for the opportunity to testify today. Senator Coleman. Thank you very much, Dr. O'Leary. Let me ask first a general statement for the panel and then some very specific questions. Both the distinguished Ranking Member and myself made reference to the Institutes of Medicine report, ``To Err is Human.'' It made recommendations for a 10- year program to reduce adverse events in the medical system, the medical industry. Just a brief comment. How are we doing? We talk about reports, reports are out there, but are we making--talk to me about the level of progress. Dr. Bagian. Dr. Bagian. Well, I think I can certainly speak from the VA's standpoint. We had adopted--not adopted, we had already done the things when the IOM report came out, so we read it and said, well, this is an affirmation of what we were doing. I think one of the things that was not correct about that report, quite frankly, was the 50 percent reduction, and I always kid about 50 percent of what? The reports you have are not reality. You have to understand that self-reports will never absolutely and accurately represent what happens. That would be like saying the number of speeding tickets issued today on the Beltway around D.C. is indicative of the number of people that speed. It isn't true. What reports do is they identify vulnerabilities that you need to then attack and solve, and we can show one. For instance, we found pacemakers that are used in intensive care units that have been out 8 years and the most widely used pacemaker in the world had a problem where they were having numerous problems a month where they would lock up and not work. We looked at it based on just a close call. No one looked at it as an error. They thought it was just a close call. We actually looked at it, understood it, talked to the manufacturer, worked with the manufacturer to change how they trained, how they labeled, and ultimately change the software so it can't occur. A much more effective solution than just telling people to be careful. So there are a number of concrete ones we can show. We can look at things like preventing incorrect surgery. We showed by thorough root cause analysis that it is not just the wrong side. In fact, approximately 36 percent of cases the wrong patient is operated on. That means the solution is slightly different. And yet by very small things, and you alluded to some of them, about how to identify people and things of that nature, are small, critical things and yet make a big difference and show the incidence goes down dramatically. So yes, I think there are definite advances. But, we can do better. Senator Coleman. Dr. O'Leary. Dr. O'Leary. I think we have made huge advances in our knowledge about why these things happen and steps that can be taken to prevent them. But I think the reality is also that we are running behind the power curve. This is a moving target. We have addressed a lot of the issues identified in 1999, but each day, we are introducing new drugs, new technologies, and new procedures. As they are introduced into our health care settings, there is no mindset as to how the systems involved in their use can be designed so that bad things won't happen. This is all about the need for a culture of safety in health care organizations. It is just not the No. 1 or No. 2 priority of the leadership that it must be. I don't think you can underestimate the importance of the Federal legislation that is working its way into the Senate now, nor the importance of pay-for-performance incentives. If you want to capture the attention of the leadership, major change is essential. Jim is right. Fifty percent of what. Some people have said that the IOM were far too high, but some of us believe those were substantially underestimated. We have a very big problem, and we have not gotten on top of it yet. Senator Coleman. I am interested, and Dr. Clancy, as you respond, I just want to add another question to that, because you talked about a number of reports. There is a lot of reporting going on, a lot of stuff that AHRQ is doing. But I am interested in translating that data into reality, into what does it take to--you have got best practices, identified them. How do you ensure that those best practices are instituted? Dr. Clancy. Well, first of all, just let me build on the comments of my colleagues. I agree that the VA has been doing a terrific job and the Institutes of Medicine report was probably a serious underestimate. It doesn't, for example, address avoidable harms in outpatient care, in nursing home settings and all kinds of settings, or in children and so forth. I think the awareness has increased dramatically and that is a good thing. We have now begun to pull together information about best practices, and I wanted to reinforce just for a moment why that is so important. In the wake of any highly-publicized error with a tragic outcome, what happens is that health care institutions do something immediately. Now, they don't necessarily have a lot of knowledge about whether that is effective or not, but it stimulates great action. I think the strides that AHRQ and others have been making is to give health care institutions and leaders a sense of where the evidence is, where it makes sense to make those types of efforts, and where we maybe need to learn more. Having said that, I think that a big focus of our research initiative this year is to challenge institutions to work with us. They actually do have to contribute to these Patient Safety Practices Implementation Grants, to take what we know already and put it into practice because it is urgent that we do so. And the last reason I am a little bit optimistic is that there are more and more consumers knowing that they have to ask questions, that their role is vital. Senator Coleman. Great. Thank you. With that, I will turn it over to the Ranking Member, Senator Levin. Senator Levin. Thank you, Mr. Chairman. I would like to talk about the reporting questions, as to whether or not medical errors should be reported, whether that ought to be a voluntary or mandatory issue, and then the bill which I have just been looking at for the first time, I must confess, that passed the House, H.R. 663, which I think a number of you referred to, relative to patient safety. But first, on the reporting issue, Dr. Bagian, tell us about your views on mandatory versus voluntary reporting of errors. Dr. Bagian. Yes, sir. I think we have to define the term. By mandatory, we think by having legislation or rules that way you must report. If we interpret that to mean that everything will be reported, I think we are delusional, quite frankly. There are numerous examples in aviation and other industries where there have been mandatory reporting and things don't get reported. For example, the one I mentioned a little bit earlier briefly, about the accident on TWA Flight 514, not far from here, where 92 people were killed. It came out that 6 weeks before that particular accident, another crew had had the same problem, did not report it. This came out in the investigation and they realized that while they were supposed to report, it was mandatory, it didn't get reported. Once they furnished a safe harbor to talk about honest mistakes, those things helped and it is due to confidentiality. Places that have tried to do this and then gone back on the confidentiality, for instance, New Zealand is a classic example. That happened over a decade ago. They promised the confidentiality and then violated that promise. They got no more reports, zero. During my testimony before the Senate, Arlen Specter's Committee back in January 2000, he asked the same question about mandatory versus voluntary and I quoted Dr. Charles Billings, who started the NASA Aviation Safety Reporting System. He said, in the final analysis, all reporting is voluntary. You can legislate whatever you want, but if you think that means everybody reports, that is not the way it is. People report either what they can't get away not reporting, or they report the things they altruistically think are worthwhile reporting. We disagreed a little bit on opinion during that hearing and I wrote a little essay for Senator Specter. He went and looked at so-called mandatory systems in his own State of Pennsylvania and came back and said, ``I agree with you. It doesn't work.'' So if we are really interested about learning, mandatory isn't the issue. It is how do you have an environment where people tell you what vulnerabilities exist, and then how do you then implement, as I think both my colleagues here at this panel have said, how do you then act on those reports, because that is the key. There is not a lot new under the sun, I must tell you. You can look at incidents that happened today and they happened last year and they happened 10 years ago and nobody--I won't say nobody, but seldom have they been effectively dealt with, and I think the key is how do we create an environment by which they can do that. And I think there are ways and we have to get past the solution that we often see, and I think Dennis and Carolyn can probably verify. Very often in the past, people will say, ``Tell the nurse to be more careful.'' You know, duh. There is a Nobel Prize winning suggestion. Yet, you see it again and again, rather than here is how we design a system so even when somebody makes an error it does not translate to the patient being hurt. So I think it is critically important not to worry about mandatory versus voluntary for accidental acts but worry about how do you deal with it. How do you disclose, not the report, disclose what the problem was so other people can learn from it and what the solution is, which is vitally important to actually help the patient. Senator Levin. Do either of you have a comment on the voluntary/mandatory reporting question, how we define it? Dr. O'Leary. Like Jim, I think you are kind of kidding yourself about a voluntary system. The fact is, people will report what they are going to report, and you don't know what you don't know. Even in places like New York that have strong systems, there is clear evidence of underreporting. Most importantly, mandatory systems create a confrontational stance. However, we are trying to solve enormously complicated problems. If we don't work together-- that is the Congress, accrediting bodies, the private sector, payers, everybody--if we are not working together, we are not going to get there. Let us take wrong site surgery as a case in point. We have issued two sentinel event alerts on this, and we just held a wrong site surgery national summit to draw additional attention to this. We know what the problems are. But the Joint Commission, on a voluntary basis, receives five to eight new reports of wrong site surgery every month--something that should never happen. Now, I think there is probably an answer to this. We are going to advocate for the development of a universal protocol, and we are going to get the surgical societies to buy into this and urge their members, the surgeons, to do this. The point is that everybody has to play in the solutions, and if we have confrontational or adversarial systems, we are just not going to get there. We will just drive reporting underground. Senator Levin. When we talk, or you talk about mandatory versus voluntary, this is a report to whom? We are not talking about legislation. We are just talking about internally, inside of a medical facility. Don't you all believe---- Dr. O'Leary. Oh, well---- Senator Levin. Define the word ``mandatory.'' Dr. O'Leary. We all ought to have a common understanding. Senator Levin. Right. Dr. O'Leary. I completely agree with you. We do have requirements in our standards that the organizations define serious adverse events and report them internally. That is an accreditation requirement. That is very different from requiring reporting to a State agency or to a Federal agency, with or without public disclosure. That is where we get into the adversarial situation. Senator Levin. I just wanted to get that on the record. My time is up, so I had better pass. Thank you, Mr. Chairman. Senator Coleman. Senator Pryor. OPENING STATEMENT OF SENATOR PRYOR Senator Pryor. Thank you, Mr. Chairman. Thank you for having this hearing today on this very important subject matter. Let me try to get inside the numbers, and I think I am following up on some of Senator Levin's questions here, and that is in preparation for this hearing today, I have reviewed a few statistics. In 1991, two reports in the New England Journal of Medicine found that adverse events occurred in 2.9 percent of the hospitalizations in Colorado and Utah and 3.7 percent of the hospitalizations in New York. And then some follow-up statistics based on that. I also have a statistic that says in January 2000, a GAO study said it was uncertain how many deaths occurred as a result of adverse drug reactions, but one study projected that it was as many as 106,000 deaths that occurred in 1994. I guess what I am asking the panel is, do we really know the scope? Do we really have a handle on the numbers and what is really going on out there? Dr. Bagian. I would say the answer is no, absolutely not, and I think when they have done prospective studies, which are different than the ones you have cited--they were chart reviews. We know doing chart reviews, that is inaccurate. Everything that occurs doesn't appear on the chart. I think we all know that, and that causes underreporting. We do know by prospective studies that the complexion can be much different. However, I think to try to take a bookkeeping view of it, to say exactly what it is, we can spend a lot of effort doing that and that is not helping patients directly. What is really important is the things we know about we haven't even corrected, which is really the inadequacy we first need to deal with. As we have more trust in the system, and I think we have seen that in the VA system, where we have seen a 30-fold increase in reporting, that it gives the ability to identify problems. And I would say that we have seen examples of a report where we have had only one in our reporting system. We go out and prospectively look and it is happening in every hospital, and yet people become so inured that that is just the way things are, instead of saying, why don't we change it and we change it and the thing goes away. And yet, if you looked at reports, you would say, not an issue at all. So I think the reports aren't the primary issue. People have to feel safe and you have to show them the report has resulted in improvement, and that is what primes the pump to get people to help you. That is the key. If you don't translate the results, you are dead in the water. Senator Pryor. Do you two agree with that? Dr. O'Leary. Absolutely. Dr. Clancy. Yes. Senator Pryor. Do you have any follow-up comments you would like to make on that? Dr. Clancy. I would just want to underscore the comment that Dr. Bagian made earlier, which is that we can all agree when there are harms. There is some legitimate controversy at times about which of those harms are avoidable, but the aim of medicine should be to do no harm. That is a fundamental tenet of the Hippocratic Oath. In addition to that, I would say that there are two broad areas of avoidable harms. One is all about systems that has nothing to do with the knowledge problem, and you can pick any publicized incident you want. This is not about we didn't know that the donor and the recipient were supposed to match. We didn't have a system in place to double-check and make sure that it couldn't possibly happen that that mismatch occurred. Then there are some knowledge issues that I think the Chairman spoke about at the beginning of this, and we have a lot to learn in both areas. Senator Pryor. Dr. O'Leary, would you like to add anything to that? Dr. O'Leary. No. I agree. Senator Pryor. OK. That is a great answer. [Laughter.] I am not trying to say that we have to have tempirical data on this, but do we have a sense at least of, say, the numbers of wrong site surgeries or incidents related to the wrong dosage of medication? I mean, do we have any sort of sense of-- -- Dr. Bagian. I would say what Dennis said before. You don't know what you don't know. We can look at the New York data, we can look at our data, and it shows us what we think are incidence of reporting rates, but we know that is the floor. It is probably more than that. There are some that are missed because it is not realized that it is a problem, or frankly, people are embarrassed or ashamed or afraid for whatever reason to report. But I think the big thing is, there are so many things we know about today, that if we could fix just those, we would be a long ways along. And I think more than that, it is sort of the thing, do you teach people to fish or do you give them fish? It is one thing to say, do this, this, and this. That tells us about the problems we know. But if we are talking about systemic change, it is how people think, how they solve from a systems approach. You need to give them that, because then as new unanticipated things come up, they are solving problems right there and they are nipping them in the bud. Senator Pryor. That is good. Let me ask one last question, and I am almost out of time here, but that is I understand the paradox that health care professionals are in where if they do report, they may get punished in some way. They may get sued. Their insurance premiums may go up. There are a lot of bad things that can happen when people are genuinely trying to make health care better. We have some proposals here in the Congress relating to medical malpractice tort reform. We have a lot of people in my State, rural hospitals and other hospitals are concerned about how much their liability and exposure is when things go wrong. But they are, I think, trying to do their best to try to provide the quality health care they should. But where is the balance there? I mean, how do we, I hate to say expose the problem, but I will use that word. How do we expose the problem and address it, but at the same time not punish the people that sometimes do, and we all admit, I think, cause real harm to people? I mean, there is no question that some of these medical malpractice problems cause very severe harm, even death, and cause great hardship. So where is that balance? Dr. O'Leary. Well, let me make a couple of comments. First of all, I think this is, oddly enough, one of these true-true unrelated kinds of issues. Of all of the medical errors and serious adverse events, something in the range of 3 percent of people sue, and of the cases in which there are lawsuits, most of those are probably not with merit. Those are well- established figures. Now, that does not in any fashion excuse the delivery system and all of us who participate in it from paying attention to medical errors and doing everything we can to address them. That will help the problem, and at the very least is a good faith effort if we are going to deal with tort reform on the other side. One of the places in which this interdigitates is the issue of sharing information with patients and patients' families when adverse events occur, a point very poignantly made by our first panelist this morning. We now have a requirement, and it is based on studies out of the Veterans Administration system, that requires the organization and the physician, in particular, to tell patients and patients' families when something bad has happened. And the interesting aspect of this, and Jim knows more about this than I do, is that the liability exposure goes down and the overall expense is much less. There are legitimate settlements, but you are not spending a lot of money on legal costs and so on. Dr. Bagian. May I follow up to that? I think that Dennis has hit the nail right on the head. It is too true and unrelated. The fact is that the specious argument is made that by having confidentiality for safety system, that you take away the ability for the patient to have adequate redress for damage done to them, and I think nothing can be further from the fact. The fact is that we need to do things in a different way. It is sort of the Einstein quote about insanity, doing the same thing over and over again but expecting different results. If we don't allow there to be a learning system in parallel to the accountability systems, little will change. In the VA, for well over a decade, we have had where you inform the patient that they have been injured, or their family, whatever is appropriate, tell them how they can have redress financially both for pension and tort, and do that. We show overall, which is not really important, that our losses are less, but that wasn't why we did it. We did it because it was the right thing to do. That goes on one side. We take no arrow from the quiver of the plaintiff's attorney or the patient. However, the other data that would never be available, that is where people say, hey, here is what happened, here is how we can prevent it, that will never come forward if you stay the way it is in most places right now. So we will continue to hurt people, we will continue to pay them, and then we will do the same darn thing tomorrow because we think it was Dr. X, and if we fix Dr. X, that is the problem. Well, you know what? There are thousands of Dr. X's and there are millions of Nurse Y, and to think that we are the only individual and we are the only one that made that mistake is not true. We have to say, what are the systems issues to help well- meaning Dr. Xs and Nurse Ys not cause the problem, and I think the parallel thing, we have confidentiality for safety, and make it clear that is different from the other accountability system. For one, they still get all the stuff they get today, all of it. It is to give us another tool to make things better. If you don't, then things will be like they have been, which I believe we all think is unsatisfactory. Dr. Clancy. Just a quick comment. Fear does not actually follow rules of logic. [Laughter.] Even though, as Dr. O'Leary said, most of the times when people are harmed, they don't sue, that doesn't mean that fear of malpractice doesn't have a very chilling effect on people's ability to come forward and say, look what happened here, I can save you from doing this. I believe that is what we really need to turn around to make a positive culture. Our research has shown in the experience of the VA that when patients are harmed, they want an apology, they want an explanation, what happened, and they want to know, what are you going to do to make this better? Doctors want to provide that information, as well, and they are terrified because of fear. Senator Pryor. That is one reason I asked the question, because it is hard to find that balance on the best approach, I think. Mr. Chairman, can I ask just one more very brief follow-up? Senator Coleman. Absolutely. Senator Pryor. Back on the statistics and the numbers and the reporting, do you all have any sense about whether the problems with patient safety are more pronounced in rural areas versus urban areas? Do you all have any sense of that? Dr. Clancy. We don't, but we are actually funding some research in rural areas right now with the Health Resources and Services Administration. Senator Pryor. Thank you. Senator Coleman. I want to do a second round of questioning, a follow-up to Senator Pryor talking about the paradox. I certainly understand the fear of liability, but one of the things that I am sorting through here is, on the one hand, Dr. Bagian, you have a system of close calls, I mean people reporting those, and that needs to be done in a way in which there is no fear of some kind of retribution. On the other hand, and I use the wrong site surgery, something that should never happen. There is no reason for it to happen. There should be a protocol to prevent it from happening. If folks aren't following that protocol, then how do you punish them? What do you do? Dr. Bagian. Dr. Bagian. Well, I can talk about our own system. We talk about, as I mentioned before, the intentionally unsafe act. Violation of a rule by itself doesn't mean there is wrongdoing. We all know that there are rules that, under certain circumstances, aren't appropriate. If you make people lockstep, do the policy like an automation, then we don't need people, we will have computers do it. The fact is, we pay health care professionals to use judgment. If somebody has done something in basically a reckless or a careless manner and basically said, well, I don't believe in marking the site, so I am just not going to do it, there will be sanctions about that and we consider that an intentionally unsafe and that will be dealt with in a discoverable way where discipline can and probably would be meted out. On the other hand, if there is an accident, when you examine it and say, this could happen, there is some judgment there, but I think you have to look at, is this a systemic issue? If it is something you can see, here is what is set up under this particular circumstance, you can understand why it happened. There are a number of examples. I can give you one. It is not a VA. It was a trauma, a motor vehicle accident. You don't have time to talk to the patient. The patient can't talk to you. So the normal things where you ask the patient to tell you who they are and the site isn't appropriate. They went and actually operated on the wrong side of the chest--this wasn't a VA. Do you think they deliberately did it? No. When you looked at it, you understood the set-up, and that was so unique and idiosyncratic that the fact they couldn't follow the procedures is understandable and we had to say, how can you do that better? The fact is, while it theoretically can happen, sir, it is not the major issue and I think it is not a problem to deal with that. Dr. O'Leary. Our six new National Patient Safety Goals, which we implemented for the first time this past January, each have two specific requirements and one has one. We now survey organizations for compliance with those requirements. Of the 11, three relate to wrong site surgery prevention. Organizations not in compliance with any of these can lose their accreditation. So we do have some teeth in these expectations for the first time. These are stand-alone steps. However, the universal protocol that I talked about rolls several of these requirements into a series of interrelated expectations that organizations will be held accountable to meet. In a sense, that is a punishment-oriented mentality, but I think at some point, you have to tell people that you mean it and they really need to do these things. Senator Coleman. And that is my question. On the one hand, we are talking about systemically wanting people to understand that if something went wrong, you ought to report it. In part, and it was a good point, it is not just, by the way, for what you are doing there, but 20 times over somewhere else. But how do you develop that system when, in fact--I will use the simple stuff, again, the wrong site, obvious, basic. This is stuff we know. This is not chemical interactions. There should be a protocol, like pilots, before they start or get on a plane, every time, they walk through the protocol. How do you encourage reporting of something that you know is going to lead to some sort of sanction? Dr. Bagian. I would say it doesn't always lead to the sanction. It depends. I mean, it really does depend. But I think what the Joint Commission does is correct, just like they do for root cause. You don't have to report it, but you are expected to act on it. If it comes out you haven't, you pay the piper. We have done the same thing, and we have written in Annals of Internal Medicine about this, is where the ultimate buck stops is at management and leadership. Leadership either creates an environment where you are expected to follow the protocol, and if I am the CEO of a corporation and we have physicians that are privileged at my hospital that aren't doing it, then it is not just them. It is, who is the captain of the ship? If the leadership does not make sure it is done, there is where the primary responsibility is. If you ask me, I think a CEO responsibility has to be very up front about this. Dr. O'Leary. Let me give you a case in point here. I am going to talk to you about the American Academy of Orthopedic Surgeons, and I don't think I am speaking out of school here. They have had a ``sign your site'' program for several years now. Until recently, 40 percent of orthopedic surgeons refused to ``sign your site,'' just refused to do it. Now, if you are the hospital CEO and the orthopedic surgeons who bring a lot of your business to your hospital are blowing you off, what are you going to do about that? So they came to us and said the Joint Commission needs to get on board on this. Help us lean on our members. And that was really a lot of the thrust of the wrong site surgery summit that we hosted, to get all of the surgical societies on board. It is a way of linking hands together to deal with a problem. At the end of the day, we expect to have a universal protocol that is going to be signed off on by organization after organization saying this is the right thing to do. That is how we advance the ball down the field. Senator Coleman. Let me ask one last question. It is really in follow-up to, I believe it was Senator Pryor asked the question of whether greater incidence in rural hospitals of concern here. Each of you talked about technology, and I am wondering, is technology the great equalizer? I mean, the reality today is, no matter where you are, you have got access to all the information you need. Talk to me a little bit about how you are using technology to better educate, to cut down the incidence of these kinds of problems. Dr. Clancy first. Dr. Clancy. Well, I guess I will brag for Dr. Bagian on behalf of the VA. A week or two ago in the New England Journal, there was a terrific article showing how the VA's efforts to reengineer health care, which included a substantial focus on information technology, led to quantum leaps in quality of care that the rest of the health care system has simply not been able to achieve. This is a good news story and actually underscores that IT is an important part of the solution. It is not the whole solution, and people do get a little carried away in their enthusiasm at times. We have some very exciting projects underway right now looking at a variety of technologies, everything from the proper use of bar codes--and I am told by the folks in Wal-Mart that health care is way, way behind in our use of this fairly straightforward technology--to hand-held devices for electronic prescribing and so forth. I think the trick is making sure that it gets used. The software and hardware is pretty easy. There are some excellent examples of times when organizations were given software and hardware free, but weren't given any support in terms of how to use it. I think the challenge is how to incorporate information technology into the culture of work and making sure that it works for you rather than giving other health professionals another job to do. Dr. O'Leary. It is not a panacea, but very simple things like access to just-in-time information about a patient are very important. A patient comes to the emergency unit; he's never been seen before; no one knows anything about him or what medications he is on. The patient may not be mentally clear. Being able to tap into that patients information is really critically important in being able to provide safe, high quality care. Also, having computerized systems that identify medication interactions and inappropriate medicines and dosages, which is basically the thrust of computerized physician order entry, obviously reduces errors and saves lives. It is not a panacea, but it gets us further along than we have been before. Dr. Bagian. If I could just echo some of the things that have been said, it is not a panacea. We are very fortunate at the VA to have a very robust electronic medical record so when a patient shows up, you can see all their outpatient information, you can see their chest films right on the screen. Just click, click, click, there is a chest film, there is a biopsy specimen, whatever. The thing is, though, I think one of the barriers for most folks is that we don't have yet well-recognized standards. So if you go with one vendor and things change, it is not transportable, and I think that is where there can be help. Where there are standards that are standards for the United States, then it is like tires. Suppose tires for all cars were different, so you have to have a special tire for a Ford and a special one for the Chevy. It would be much tougher. We know that 15-inch tires are 15-inch tires. If we had the same thing for our patient data sets, that would really, I think, jumpstart people to go to electronic medical records. The single biggest thing I would say in the VA, the results that Dr. Clancy talked about, having an electronic medical record to be able to identify problems and really know, this diabetic isn't on the right dose of insulin, whatever, that allows us to see oversights and deal with them very directly, to have decision support, as Dr. O'Leary said. But right now, I think it is not conducive. If I were a CEO of a private hospital, the investment I would have to make for electronic medical records, not knowing if I would be orphaned next year, I think would probably be imprudent in most cases. It would be heroic to do it, but probably imprudent. And I think by having standards, you can make it the prudent thing to do. It is good patient care. It is actually good economics. It is good all the way around. Dr. Clancy. I also would just add that rural institutions are one particular challenge, which is why we are very excited about our investment for 2004 which will be giving them a particular emphasis. Another area is outpatient care, in general. The number I have heard thrown around is about 8 percent of outpatient practices have electronic medical records. Having practiced in an institution that had computerized physician order entry, which is now one of the pioneers in the area. I can tell you that you still have significant challenges with transitions in care if you don't have something in the outpatient setting or a way to address those gaps. Senator Coleman. Thank you. Very helpful. Senator Pryor, any questions of this panel? Senator Pryor. I will defer to Senator Durbin. Senator Coleman. Senator Durbin. OPENING STATEMENT OF SENATOR DURBIN Senator Durbin. Thank you, Mr. Chairman. I apologize to you and the panel, I'm trying to juggle committees, and it is not fair. I wish I could park myself here, because I am really fascinated and am trying to focus on what you have to say. Dr. O'Leary, thank you for coming out from Illinois to join us today with Mr. Krawisz, also from my home State. Thank you, Mr. Chairman, for inviting them. Over the Memorial Day break, I flew overseas and ran into the bookstore and picked up a book and started reading and it was one of the best books I have read on this subject and I recommend it to you if you haven't seen it yet. It's called ``Complications.'' It was a National Book Award finalist. Dr. Clancy. Yes. Senator Durbin. Written by Dr. Gawande, who is a surgical resident in Boston. I don't think I have ever read a book that gave me as much insight into the practice of medicine and learning the practice of medicine and all of the challenges associated with it. It is, I think, extremely insightful and well-balanced. Every Member of Congress interested in this issue should read this book, and I commend it to you if you haven't. I just think it says so many things that are so meaningful and give such great perspective. Let me tell you one or two things that he said that stuck with me. He dedicated an entire chapter to what he called bad doctors. He said, it is not the bad doctors who engage in criminal behavior or make egregious mistakes that are the big problem. It is what he calls the everyday bad doctors. He talks about one doctor who everyone long admired, a hard working surgeon, did good work until 1990 when he started making mistakes, ignored obvious symptoms, declined to do surgery when it was necessary, refused to fix his mistakes when patients returned to the office. It took 5 years of injured patients, ignored reprimands, and malpractice lawsuits before he was finally suspended in 1995. Why? Here is how he explains it. There is an official line about how the medical profession is supposed to deal with these physicians. Colleagues are expected to join forces promptly to remove them from practice and report them to the medical licensing authorities, who in turn are supposed to discipline or expel them. It hardly ever happens that way, he says, for no tight-knit community can function that way. When a skilled, decent, ordinarily conscientious colleague whom you have known and worked with for years starts popping Percodans or becomes preoccupied with personal problems or neglects the proper care of patients, you want to help, not destroy, the doctor's career. There is no easy way to help, he writes. In private practice, there are no sabbaticals, no leaves of absence, only disciplinary proceedings and public reports of misdeeds. As a consequence, when people try to help, they do it quietly and privately. Their intentions are good. The results aren't. As is often the case, the people who were in the best position to see how dangerous this doctor actually was were in the worst position to do anything about it--junior physicians, nurses, and ancillary staff. He describes the research of Marilyn Rosenthal, a sociologist at the University of Michigan, who has examined medical communities around the world. She gathered data on what had happened in 200 specific cases, ranging from family physicians with a barbiturate addiction to a cardiac surgeon who continued operating despite permanent cerebral damage from a stroke. The dominant reaction, Dr. Rosenthal found, was uncertainty, denial, and feckless intervention, very much like a family that won't face up to the fact that Grandma needs to have her driver's license taken away. How do we change the culture? He talks about a lot of things, but I want to really come to this point with you. Over and over again, each of you have told us we have a serious problem with medical errors and patient safety, and I think we look at it in terms of the global issue, and I think Dr. Clancy said medical errors and patient safety issues represent a national problem of epidemic proportion. And then we take a look at it from the viewpoint of the victim, the patient victim. What is the recourse for the patient victim? If they are one out of 50 that decides to file a lawsuit, they have their day in court. But 49 out of 50 don't file lawsuits. They are victims and either don't know it, or knowing it, decide not to pursue their legal recourse. Now we are in a debate about whether to limit the opportunity for a patient victim to recover in court. That is our debate now. And let me ask you this. If the current threat of litigation has not forced reform in the medical system and doctor conduct, how can insulating those doctors and hospitals and medical providers from liability in court do anything but encourage further bad conduct? Dr. Bagian. Can I try first? I mean, it is an interesting question. We talked about it a little before you stepped back in the room, but to repeat, I think the evidence is fairly clear, certainly from the aviation industry, when they thought that by mandatory reporting and public exposure was a way to make it safer, it didn't happen and there were many deaths because of that. When they went to having a parallel, not a replacement, and I will emphasize that, you have your accountability system and ability to redress, which we think is appropriate, but when you have a parallel learning system, it gives you a place where you might learn other information that otherwise will never be reported, period. And if you look at over 500,000 reports in aviation by ASRS, many things that were never, ever recognized by the so- called mandatory system, like runway incursions, like wings that sweep over the main runway as a 747 taxis back to the ramp and they would never report because that is the only way they could get back to the ramp, and if they reported they did, it was a violation and they would lose their license, so instead, they just did it. Look, nobody is looking, let's do it because I need to get the job done. When they made that available, for instance, in the ASRS, those things were then addressed and the problems were fixed. Senator Durbin. Let me follow through, then, because we often hear that. That is not an unreasonable conclusion you have reached based on the evidence you presented to us. But then we hear the other side of it. Oh, the threat of lawsuits has created all of this defensive medicine. Doctors are ordering tests they never would have ordered to make sure they cover themselves. So at one point, you are arguing--not you, but the profession is arguing that there is a consciousness of the threat of litigation which is literally affecting the practice every single day, and then the opposite conclusion is being argued, but wait a minute, to be honest with you, the threat of litigation isn't causing people to reform the system. How can it have such an impact, if it does, to create defensive medicine and not have an impact to create this appetite for reform? Dr. Bagian. Well, I think partly it is the dislocation of penalty versus reward in the way the system is set up among the profession. I think as Dr. Clancy pointed out, fear is not necessarily based on reality. People's perception of their risk, and I am talking about physicians as well as the patient, affects their behavior. However, I think the big issue is not the malpractice issue here. There needs to be--certainly, malpractice is important. That needs to be available. But I think when you look at solutions, as you talked about the bad doctor, as you classified it from this book, the fact is that if you have systems in place and encourage those, and we deal with these and I can give you examples, where you see, for instance, the physician popping Percocet, as you gave as a hypothetical or whatever, if you look at that, the question is, how does your privileging and credentialing work within the hospital? How do you show proficiency? How do people demonstrate that have had a stroke, as you made the example of a cardiac surgeon? How do you make sure they are proficient? I think right now in many of our hospitals, we don't do it as in aviation, where pilots have to demonstrate their proficiency on an ongoing basis. It is not once you are a pilot, you keep flying. You come back and you fly in a simulator. We give you challenges and you pass or you don't. We don't do that in a methodical way in medicine. I think if you do that and hold the organizations responsible, not just the individual but the people that manage them, to say, hey, what is it, and it is not just Dr. X. The fact is, I would challenge you when you find one of these bad doctors, if you look in a systematic way through your whole staff, there are many others that have the same problem, and that is where you get the leverage to really make a difference in patient care. Senator Durbin. I am sorry to cut you short. I thank the Chairman for giving me a few extra minutes. Let me just say a couple things in closing. One is, this does not create a situation--this book does not create a situation in the mind of the reader that is anti- doctor. I mean, there are heroic things that this surgical resident describes that he has done on a daily basis, and any one of us who has had a loved one or family member in a hospital or doctor's office wants the best and the brightest right there feeling that they can help us. But I do believe that we have to try to come to some balance here. When a hospital administrator in Decatur, Illinois, tells me that their hospital pharmacy writes 50,000 prescriptions a year, and when they went in looking for errors they only found 20, it just boggles the mind. Human error is going to argue there are many more than 20 in the course of a year. They are afraid to even talk about it. When a system is built so that colleagues, junior colleagues have to report on a bad doctor to stop him from malpractice, the system is not working. I really think that we have to look at the medical malpractice insurance crisis from the perspective not only of what happens in the courtroom, but what happens in the operating room and what happens in the board room of the insurance company. All of these things have to come together for an honest appraisal. Thank you very much, Mr. Chairman. [The prepared statement of Senator Durbin follows:] PREPARED OPENING STATEMENT OF SENATOR DURBIN Thank you, Mr. Chairman, for holding this hearing. The debate over how to best ensure patient safety has been going on for 4 years and I hope this hearing will help move the process along. Rarely is there an opportunity in the health policy arena to help prevent so many injuries and deaths. I am very pleased to see that there are two folks from Illinois here today: Dr. Dennis O'Leary from Oakbrook Terrace and Mr. Robert Krawisz from Chicago. Welcome to both of you. There is a fascinating book called Complications: A Surgeon's Notes on an Imperfect Science by Atul Gawande. Dr. Gawande is a surgeon in Boston who took time off during medical school to work on Clinton's health care reform plan. He brings a unique perspective to this issue and I want to read you some excerpts from his book because I think it illustrates how complex and multi-layered the challenge of ensuring patient safety is. He dedicates an entire chapter to what he calls ``bad doctors.'' He says that it is not the bad doctors who engage in criminal behavior or make egregious mistakes that are the big problem. It is what he calls the ``every day bad doctors.'' He describes a doctor named Hank Goodman whom everyone long admired. He was a hard working surgeon who did good work . . . until 1990 when he began making mistakes. He ignored obvious symptoms, declined to do surgery when it was necessary and refused to fix his mistakes when patients returned to his office. It took 5 years of hurt patients, ignored reprimands and malpractice lawsuits before he was finally suspended in 1995. Five years of dubious outcomes before he was stopped. Why? In trying to explain why, Dr. Gawande gets to the heart of the challenges we face. He writes: ``There is an official line about how the medical profession is supposed to deal with these physicians: Colleagues are expected to join forces promptly to remove them from practice and report them to the medical-licensing authorities, who, in turn, are supposed to discipline them or expel them from the profession. It hardly ever happens that way. For no tight-knit community can function that way.'' ``When a skilled, decent, ordinarily conscientious colleague, whom you've known and worked with for years, starts popping Percodans, or becomes pre-occupied with personal problems and neglects the proper care of patients, you want to help, not destroy the doctor's career.'' ``There is no easy way to help, though. In private practice, there are no sabbaticals to offer, no leaves of absence, only disciplinary proceedings and public reports of misdeeds. As a consequence, when people try to help, they do it quietly, privately. Their intentions are good; the result usually isn't.'' ``As is often the case, the people who were in the best position to see how dangerous Dr. Goodman had become were in the worst position to do anything about it: Junior physicians, nurses and ancillary staff.'' Dr. Gawande describes the research of Marilynn Rosenthal, a sociologist at the University of Michigan who has examined medical communities around the world. She gathered data on what happened in more than 200 specific cases ranging from a family physician with a barbiturate addiction to a cardiac surgeon who continued operating despite permanent cerebral damage from a stroke. The dominant reaction Dr. Rosenthal found was uncertainty, denial and feckless intervention--very much like a family that won't face up to the fact that grandma needs her drivers license taken away. How do we change this culture? How do we encourage doctors to help each other but know when their help is not enough? Dr. Gawande talks about more than bad doctors. He describes the pressure of the profession and how human his colleagues are. He says, ``Plain old mistakes of execution are not uncommon. We have only begun to recognize the systemic frailties, technological faults and human inadequacies that cause them, let alone how to reduce them.'' He goes on to describe another layer of the problem: Consistency in procedure. He says ``important knowledge has simply not made its way far enough into practice. Among patients recognized as having heart attacks, for example, it is now known that an aspirin alone will save lives and that even more can be saved with the immediate use of a thrombolytic--a clot dissolving drug.'' ``Yet, a quarter of those who should get an aspirin do not, and half who should get a thrombolytic do not. Overall, physician compliance with various evidence-based guidelines ranges from more than 90 percent of patients in some parts of the country to less than 20 percent in others.'' According to a study by a Dartmouth physician, the likelihood of a doctor sending you for a gallbladder-removal operation varies 270 percent based on the city you live in; for a hip replacement, the variation is 450 percent, and for intensive care during the last 6 months of your life, it varies a whopping 880 percent. A patient in Santa Barbara is five times more likely to be recommended back surgery for back pain than someone in the Bronx. All of these things demonstrate how complex this problem is. It's not just about bad doctors. It's about consistently practicing evidence-based medicine, and it's about changing the culture of medicine. I'm very interested in hearing the solutions our witnesses will present today. Thank you. Senator Coleman. Thank you very much, Senator Durbin. I would like to excuse the panel, then, at this time. Thank you. I would like to call our final panel of witnesses. We welcome our final panel, David Page, President and Chief Executive Officer of Fairview Health Services of Minneapolis, Minnesota; Dianne Mandernach, the Commissioner of the Minnesota Department of Health, St. Paul, Minnesota; Robert E. Krawisz, the Executive Director of the National Patient Safety Foundation of Chicago, Illinois; and I anticipate that we will have a final witness, Dr. Suzanne Delbanco, the Executive Director of the Leapfrog Group for Patient Safety in Washington, DC. I understand Dr. Delbanco is coming from another engagement in the city and hopefully will join us soon. I want to thank all of you for your attendance at today's important hearing. I look forward to hearing your testimony this morning on how the private sector is working to improve the performance of our Nation's hospitals. As you have heard, pursuant to Rule 6, all witnesses who testify before this Subcommittee are required to be sworn. I would ask you now to please stand and raise your right hand. Do you swear the testimony you are about to give before the Subcommittee will be the truth, the whole truth, and nothing but the truth, so help you, God? Mr. Page. I do. Ms. Mandernach. I do. Mr. Krawisz. I do. Senator Coleman. Thank you. We will be using a timing system. Please be aware that approximately 1 minute before the red light comes on, you will see the lights change from green to yellow, giving you an opportunity to conclude your remarks. While your written testimony will be printed in the record in its entirety, we ask that you limit your oral testimony to no more than 5 minutes. Mr. Page, we will have you go first, then we will hear from Ms. Mandernach, then Mr. Krawisz, and if Dr. Delbanco comes, we will finish up with Dr. Delbanco. After the panel has testified, we will then turn to questions. Mr. Page, if you will begin. TESTIMONY OF DAVID R. PAGE,\1\ PRESIDENT AND CHIEF EXECUTIVE OFFICER, FAIRVIEW HEALTH SERVICES, MINNEAPOLIS, MINNESOTA Mr. Page. Thank you, Chairman Coleman. Thank you for this opportunity to speak to this important subject. I am President and CEO of the Fairview Health Services, which is a system of 18,000 employees serving seven separate communities in the State of Minnesota. I am also on the board of the National Patient Safety Foundation, an organization dedicated to improving the safety of patients all across this country. And I am here to talk about cultural change and process improvement. --------------------------------------------------------------------------- \1\ The prepared statement for Mr. Page appears in the Appendix on page 92. --------------------------------------------------------------------------- As we have heard before, there is no institution, no matter how gilded its quality reputation is, that is immune from the sorts of issues that we are talking about this morning. I have an example here of yesterday's New York Times Science section where the headline is, ``When Her Heart Failed, A Pump Gave Her Life.'' This is a headline of yesterday's Times Science section featuring one of the Fairview institutions. I also have a newspaper here of less than 2 weeks ago where the headline reads, ``Hospital Error Cited in Report on Two-Year-Old's Death.'' We recently had a tragic loss at one of our facilities, the one that was cited in the second newspaper I just shared with you. A 34-month-old girl named Brianna received a ten-fold overdose of a powerful blood thinner called heparin. This was following her liver transplant. She later died. We are not certain how or whether the overdose may have contributed to her death. We are certain that our systems allowed a ten-fold overdose and failed a conscientious staff, a patient, the patient's family. We are incredibly sorry for this event and I would be pleased to tell you what we have done to make sure that the event doesn't reoccur. We have standardized heparin concentrations throughout that hospital. We have instituted a safety checklist that occurs at each shift change, citing certain particular drugs that are on the medical administration list. And we have implemented another double-check on the signing off on drug administration on high-risk drugs, of which heparin is one. We have committed ourselves to make sure that this particular episode does not reoccur. I am here today to describe to you what Fairview is doing and must do to make health care safer, and we need your help and the help of the other organizations here this morning. But if you remember anything from my conversation with you this morning, I would have it be this. To become safer in health care, we must learn from other industries that have confronted similar safety issues, and they have created cultures that focus on high standards, on safety in a compulsive fashion. They have created open communication atmospheres where all can be reported without fear of reprisal or threats to income. And finally, and of equal importance to the other two, they have embraced continuous process improvement. Our goals at Fairview, and I think reasonably transferred for goals for the health care system in general, we need to do three things. We need to embrace a bold vision and focus of the sort Paul O'Neill did at Alcoa Aluminum, where employee safety was a daily issue, and he brought safety records down to the lowest in the industry by leadership from the top and focus. We have a history of that focus at Fairview. We have made it part of our vision. We have created senior executive positions focused solely on that. We have made safety part of executive goals on an individual basis. And we are developing a culture of process improvement where we can continually take a look at how we perform the systems and processes that serve our patients. I would point out to you that the State of Minnesota was the first State in the Union to have 100 percent of its hospitals reporting in the Leapfrog website of what their record is on patient safety, in patient safety systems. We also have in our State a medical database, and you will hear later from testimony on this panel about an adverse health care event reporting system recently passed in the State. Second, teamwork and open communication is the second piece of where we must go on this, including anonymous reporting. I know of institutions that over a decade ago had the capability of having anyone in their care system or the family write down a concern and, almost like a suggestion box, put the concern into a system that was available throughout the hospital that would say, ``I wonder about this,'' and it might be a physician, a nurse, a drug administration. That is an open process. It did work. And Congress can help us here by helping to support an atmosphere of full and open disclosure, not only to the patients, their families, but in and amongst the systems as we try to learn from our mistakes and see that they don't happen again. Last, we must implement a rigorous process improvement system of the sort 3M, Motorola, Toyota, and others in the industry have in place. After Fairview's management visited Motorola in 2001, we came back and started to work on implementing a scorecard system that would give us the ability to track and, most importantly, measure the things that we had that surround the delivery of care, our systems and processes. If you don't understand the capabilities of your processes and systems, you will not be able to measure them and measure their performance. If you can't measure them and their performance, you will not be able to change their outcomes. It has been said earlier this morning on previous panels, more often than not, by a large factor, what has failed to protect human failure has been our systems and our processes. These challenges are larger than any one institution or delivery system can address, and I encourage you from the public policy to support the things that have been mentioned by others here, certainly the open and faultless reporting, I think the reimbursement for quality of care. It was said earlier this morning that from the standpoint of payment, there is no difference on bad quality and good quality and that should not be. I think insofar as the largest purchaser of health care in the country, the government, we really ought to have a distinction made for when quality is present, can be identified and measured, and have a payment that recognizes that. In winding down, I will tell you that Fairview has implemented and is in the process of continuing to implement an electronic medical record. This electronic medical record allows us to bring to bear clinical data about patients at all sites in our system, in our clinics, in our emergency rooms, in our intensive care units, and depending upon the physician's capability at home, in his home, on a concurrent basis, including in-line, on time lab reporting. We are spending about 4 percent of our top-line revenue in information systems. The health care industry's average is 2 percent, and industry in general ranges between 5 and 15 percent. You can help us with this area by helping support this investment, this capital investment, by something of the sort that might be a capital pass-through of the sort that was in the reimbursement system for major capital investments. Have a capital pass-through for investment in information systems that are in the clinical environment. Senator Coleman. Mr. Page, I will have you please sum up your testimony. Mr. Page. I will close by saying, we must work together to create the culture of relentlessly high standards for patient safety. We must create an atmosphere of open communication and disclosure without fear of reprisal that encourages error reporting. And most importantly, I think from my standpoint, we must measure and consciously improve our systems that support those individuals who are at the bedside, and your help in this will be indispensable for us. I thank you for this opportunity to meet with you here this morning. Thank you. Senator Coleman. Thank you very much, Mr. Page. Commissioner Mandernach. TESTIMONY OF DIANNE MANDERNACH,\1\ COMMISSIONER, MINNESOTA DEPARTMENT OF HEALTH, ST. PAUL, MINNESOTA Ms. Mandernach. Thank you, Mr. Chairman and Members of the Committee, for providing the opportunity to participate in this very important hearing. --------------------------------------------------------------------------- \1\ The prepared statement for Ms. Mandernach appears in the Appendix on page 110. --------------------------------------------------------------------------- Today, I am pleased to share with you some very exciting steps that the State of Minnesota has recently taken to establish a process for the mandatory reporting of serious adverse events, commonly referred to as medical errors. These efforts go beyond the mere reporting of the events to include the review of information on the underlying cause of the events, the review of corrective actions taken by the reporting hospital, dissemination of information regarding these events, and public reporting by type and location of the event. This law integrates many of the recommendations of the Institutes of Medicine, but more importantly, the law provides for accountability within hospitals and to the public. Before discussing the specifics of our legislation, however, I would like to make a few general comments on the issue of patient safety. Since the 1999 release of the Institutes of Medicine's landmark report on patient safety, ``To Err is Human,'' we have been flooded with information on this issue from a variety of sources. However, the issue of patient safety has been one of my core values for many years. As a former CEO of a small hospital in Northern Minnesota, I was very aware of the need for assuring that systems were in place to promptly and accurately identify both errors and potential errors, the ones referred to as near misses. It was my responsibility to assure that steps were taken quickly, fairly, and objectively to review any incident and then make sure that corrective actions were implemented to minimize the occurrence of similar events. The need for ongoing, continuous quality improvement within every institution is a theme that we have heard repeated today. I strongly support the initiatives that are being undertaken by the groups represented here today. However, as the topic of the hearing suggests, instilling hospitals with a culture of continuous improvement, we must understand that the efforts taken within the hospital will always be the most important, the most direct, and the most timely to truly minimize and prevent the occurrence of medical errors. As Commissioner of Health, I am ultimately responsible for assuring that the care and services provided in State-licensed facilities protect the health and safety of our patients. Every media story reporting on serious consequences of medical errors reinforces this need to assure that there is public accountability and follow-up on these serious events. The formation of the Minnesota Alliance for Patient Safety, MAPS, was one of Minnesota's key responses to the IOM report. MAPS was jointly established by the Minnesota Department of Health, the Minnesota Hospital Association, and the Minnesota Medical Association, with a mission to promote optimum patient safety through collaboration and supportive effort among all participants of the health care system. MAPS now consists of over 50 health care-related institutions. MAPS has become a collaborative forum to discuss the implications of medical errors in the health care system, to provide education and training programs, to disseminate the successful efforts undertaken by hospitals to reduce errors. The public-private makeup has provided opportunities for frank but open discussion on many of the sensitive issues, many of which were referred to this morning. Without this collaborative process, passage of our mandatory reporting law would have been much more difficult, if not impossible. As Chair of the Hospital Association, David Page played a pivotal role in convincing other hospitals to actively participate in MAPS. The need for and development of a mandatory reporting system was one of the more controversial discussion topics undertaken by MAPS. Concerns were raised about the benefits of mandatory versus voluntary reporting, types of events to be reported, the ability to analyze information to identify trends, the ability to provide appropriate follow-up and recommendations for change. A subgroup of MAPS was established to review the provisions of Minnesota's current law and then to move forward to include any reporting system and make recommendations to be introduced in the 2003 legislative session. I am very pleased that these efforts led to the bipartisan sponsorship and passage of our Senate File 1019, the Minnesota Adverse Health Care Events Reporting Act of 2003. One of the key attributes of this law is the inclusion of the reportable events recommended by the National Quality Forum. This list of 27 ``never events,'' that is, events that should never occur in a hospital, such as wrong site surgery, represented a consensus of many interested parties as to what should be included in any mandatory reporting system. This list provides an effective starting point for a medical error reporting system. It is our understanding that Minnesota's law is the first ever in the Nation to specifically incorporate the NQF recommendations. This list was and is consistent with the criteria established by the IOM, that a mandatory reporting system focus on serious adverse events and that the events reported be defined as clearly as possible. However, in order to take steps to provide patient protection, any reporting law must go beyond the mere collection of statistics. We have heard that repeatedly this morning. Our reporting law mandates that information be reported as to the cause of the error as well as the corrective actions taken by the facility. These crucial elements address our concerns as to the internal and external accountability and assure that appropriate actions are taken in the facility to protect patient health and safety. In addition, the law directs the Commissioner to review the information to determine whether trends or system problems are being identified and to also furnish information to all providers to assist in the improvement of their patient safety system. While Senate File 1019 made significant changes to the reporting law, the legislation was discussed, debated, and enacted in an environment of consensus. As with every piece of legislation, the fine points of the law were debated, but there was no serious opposition to the need for the law or the value of its enhancement to patient safety. There was one major stumbling block and that was the fiscal impact at the time that we were attempting to address a major budget deficit. That allowed for a transition plan. So the key provision was the agreement that the Department would not be required to implement the law until sufficient non-State funds were obtained. The bill proponents and especially the Minnesota Hospital Association believed that the initial start-up funds of approximately $125,000 could be obtained either from private sources or through grants. The willingness of the hospitals to secure the necessary funds to implement the transition fees was strong recognition of their commitment to this process. There are some recommendations and suggestions that I would like you to consider in the future. We would encourage a national system that would focus on the mandatory reporting of these specific events. I realize that this will generate some problems for States with existing reporting systems. However, this is the only way that we can get a national perspective on the true extent of this problem. The collection of clearly identified events across State lines will also assist in the identification of trends, the identification of system problems, and will encourage more collaborative responses to improving patient safety. As part of this recommendation is a request to obtain funding to support the efforts. We realize that funding is always a concern, but if steps can be taken to minimize the extent of medical errors, the price paid for these systems will be money well spent. Funding could be directed at the development of demonstration projects or pilot programs to allow for an analysis of the effectiveness of various State systems. However, we are well past the time for continued discussion and debate and systems need to be put in place as quickly as possible. There is one final thing and that is, we would encourage that steps be taken through Medicare and Medicaid survey and certification programs to address both the internal and external reporting of medical errors. Regulations and regulatory agencies should balance the need for public accountability and safety with the need for internal quality improvement efforts. Consistent expectations for the reporting and monitoring of these events and funding for these activities is a critical component to provide accountability to the public we represent. Thank you. Senator Coleman. Thank you very much, Commissioner Mandernach. Mr. Krawisz. TESTIMONY OF ROBERT E. KRAWISZ,\1\ EXECUTIVE DIRECTOR, NATIONAL PATIENT SAFETY FOUNDATION, CHICAGO, ILLINOIS Mr. Krawisz. Thank you, Mr. Chairman and Members of the Committee. I am Executive Director of the National Patient Safety Foundation in Chicago, and prior to that, I served as a senior manager for the National Safety Council and also the American Society for Quality. My comments today will focus on instilling hospitals with a culture of continuous improvement. --------------------------------------------------------------------------- \1\ The prepared statement for Mr. Krawisz appears in the Appendix on page 113. --------------------------------------------------------------------------- In a recent study, the Juran Institute indicated that the cost of poor quality and safety exceeds 30 percent of all health care outlays. With the national health care expenditures of $1.4 trillion, the 30 percent figure translates into $420 billion spent each year as a result of poor quality and safety. Performance improvements can provide important benefits, such as greater patient satisfaction, significant improvements in patient safety, and dramatic cost reductions that can be shared with purchasers and consumers. A question that is often asked is, how long does it take to change the culture and performance of an industry? Are we making progress in patient safety? We heard that just a little while ago with the other panel. I think we can turn to the transformation of occupational safety and quality in the United States for part of the answer. The change cycle consists of five stages: Problem recognition, the introduction of solutions, growth, maturity, and integration. The problem recognition phase usually lasts about 10 years as an industry struggles with denial. Once there is a commitment to find solutions, the length of the change cycle depends on the amount of support that is provided and on the strength of the economic business case. It took about 25 years after the formation of OSHA to change the culture in occupational safety and secure dramatic performance breakthroughs. The quality transformation in the United States was faster, with major improvements in place in the mid-1990's following the Baldridge Act of 1987. We simply can't wait that long in health care. The stakes are too high. With your support, we have the ability to complete the change process a lot faster. Where are we today? We are near the end of the search for solution phase. The patient safety movement is gathering steam and moving into the growth stage of the change cycle. We know what to do to start the improvement process, but we need resources to get the job done. The National Patient Safety Foundation established the Patient and Family Advisory Council to provide guidance and patient perspectives on all of its activities. In March, we released a national agenda for action to support patients and families. It provides a high-level road map for action in four areas: Education, culture, research, and supportive services. The first step is to raise awareness of these issues. The second step is to address how these actions should be implemented and funded. A detailed agenda is included in my written testimony. There are several evidence-based strategies that are starting to produce dramatic quality and patient safety improvements. I think the challenge is to close the gap between what is known and what is being practiced in most hospitals. The National Patient Safety Foundation's dissemination strategy plays an important role in closing the performance gap. Examples of breakthrough strategies include the following. The Baldridge health care criteria provides an excellent framework for managing the enterprise and securing performance improvements. Hospitals can set their sights on winning the award or simply following the criteria. SSM Health Care in St. Louis is the first award recipient in health care. Results include significant improvements in safety and quality, cost reductions, and improvements in their market share. A full disclosure policy provides the information essential for identifying problems and developing breakthrough solutions, and we have heard a lot about that today. There are two axioms of disclosure. No one makes an error on purpose, and no one admits an error if you punish them for it. Full disclosure provides data to analyze problems and find solutions, improves patient and family satisfaction, and reduces malpractice litigation. SSM Health Care, the Baldridge winner, established a blame- free zone for staff to report errors and near misses. This has led to numerous system improvements. Many other hospitals have also adopted effective disclosure policies. Another important strategy is engaging patients and families to develop new perspectives. They experience the gaps and fragmentation in the health care system. Patients and family advisory councils help health care professionals and leaders, keep them honest and grounded in reality, and they provide timely feedback, new ideas, and additional creativity. The result is improved quality and safety and reductions in malpractice allegations. There are also numerous process improvement tools that hospitals can use to evaluate processes and identify solutions. Examples include process mapping and analysis software, failure mode and effect analysis, root cause analysis, design of experiments, and comprehensive Six Sigma programs. Six Sigma has set a new standard for organizations in a variety of industries that are reducing errors to only 3.4 per million opportunities. Froedtert Hospital in Milwaukee utilizes the Six Sigma methodology extensively to reduce process variation. Successes include improving outcomes with high-risk medication and reducing the variability of PCA infusion pumps, cycle times, and analyzing lab specimens, and reductions in patient falls. The Joint Commission released 6 goals and 11 evidence-based requirements in January. The National Quality Forum released 30 evidence-based safe practices in May of this year. Hospitals can secure dramatic improvements in quality and safety by adopting these practices now. What can hospitals do to close the gap between what is known and what is being practiced today? I think a major lesson learned at Occupational Safety and Health is that organizations need a formal program to organize and focus their activities before rapid improvements can take place. The elements of an effective patient safety program are also included in my written testimony. In closing, there are a number of ways Congress can encourage greater effort at continuous improvement in health care. These include the following: (A) providing funding to support the national agenda for action for patients and families, including development of a patient and family resource center; (B) supporting a central role for the Agency for Health Care Research and Quality and coordinating a multi- faceted, multi-industry national patient safety initiative-- this should include sufficient funding to carry out research and development activities to support and advance public and private patient safety initiatives across the Nation; (C) creating financial incentives for hospitals to support the business case for safety; and (D) supporting patient safety legislation aimed at protecting confidentiality and promoting disclosure, such as H.R. 663, which passed the House by a near- unanimous vote in March, and also S. 720, which currently awaits Senate action. Thank you. Senator Coleman. Thank you very much, Mr. Krawisz. Mr. Page, when we invited Fairview to be here, it was a number of weeks ago that we put this together and invited Fairview because they are acknowledged as one of the leading institutions in Minnesota and your leadership in this area. Certainly, the very tragic circumstances of last week probably bring to mind that we can do all the things that we intend with systems, but there is still human error. Are we looking at training issues? Are there workload issues? I am trying to understand the nature of human error, and when we are talking about life or death, which we are talking about here, how do we make sure that we are doing everything possible to minimize it? Mr. Page. Chairman Coleman, I appreciate that question because I think it is one of the key questions. A very short answer to that is that within the circle of institutions and people trying to deal with patient safety, we developed a graphic, a concept. It is called the sharp end and the blunt end and it is literally a sidewise-drawn arrow, a big broad- band arrow with at the very sharp end of the arrow, a patient, nurses, physicians, and technicians. That is the sharp end. And everything behind that in a widening gap are the systems that support the delivery that occurs at the sharp end. We have the knowledge that the vast majority, and I am talking about the 95 percent-plus of occurrence, of failure to protect from human error, occurs in the blunt end in our systems. And in the event that recently occurred and one of our institutions reported on last week, we looked at the sharp end and the blunt end and find most of our learnings are on the blunt end. But the good news is, those learnings allow us to do things with the processes around that sort of care that will keep that from happening again. So training, yes. I think, really, the investigation of the cause of the factors, root cause analysis that has been mentioned here this morning, the learning from that and then the realization of those learnings into your other systems and processes. Senator Coleman. Thank you very much, Mr. Page. Commissioner Mandernach, I am interested, you talked about the ease of the bipartisan manner in which Minnesota enacted its particular statute, I think you said Senate File 1019. Was the issue of liability raised during the course of this discussion? Ms. Mandernach. It was raised during the course of the discussion, but I give credit to the MAPS group that really championed this and brought it forward. There had been a great deal of work done around the issue of liability and in the final analysis, it was looked at again as the right thing to do in the interest of patient safety. Knowing that, there are still going to be issues of liability and we are not taking away the patient's ability to exercise their options. This is to make tragic situations not just reportable but that we all learn to make sure that it doesn't happen again. Senator Coleman. Thank you. Mr. Krawisz, in your written testimony, I know you talked about the Internet. Internet use is the second-leading force inhibiting hospitals from installing management practices designed to improve patient safety and quality, but then you also talk about the power of the Internet to inform. Mr. Krawisz. Yes. Senator Coleman. I am interested in this area of technology and are we using it and particularly in dealing with rural areas, where I always see it as a great equalizer, the opportunity to get whatever information you want no matter where you live. Can you talk about patients who use the Internet, what does the National Patient Safety Foundation recommend? Mr. Krawisz. Well, I think the Internet is a fabulous resource. If you look at the numbers, last year, more than 20 million people went online to research medical conditions and their treatment. I think that this perhaps is a double-edged sword. A danger might be of the patients making their own decisions on their treatment. It is certainly good for them to use the information and then to go to their physician and to ask a lot of questions. Those are the things that we are recommending. We also recommend they use the Internet to communicate a lot of information to patients on the extent of the problem and what they can do to protect themselves. As an example, on our website currently, we are receiving more than 400,000 visits each month. Most of those are from patients that are researching what they can do to protect themselves and to be safe. We have a number of fact sheets for patients, and these can be easily downloaded for their use. So I think it is a valuable tool, and another thing that we are doing, we have a grant from AHRQ to produce web-based education for physicians, nurses, and also patients, and this will be offered free and it will be on our website by the end of the year. Senator Coleman. Thank you very much. Dr. Delbanco, we indicated that you had another engagement and would hopefully join us. I am going to forego swearing you in. I do want to turn to my colleagues for questioning, but I will give you an opportunity for a very brief statement, just a summary, and then I will come back to you after my colleagues have had a chance to raise some questions. But I will give you this opportunity right now to make a very brief statement. Ms. Delbanco. Thanks. And when you say brief, can you specify so I---- Senator Coleman. Two or three minutes. Thanks. TESTIMONY OF SUZANNE DELBANCO, PH.D.,\1\ EXECUTIVE DIRECTOR, THE LEAPFROG GROUP, WASHINGTON, DC. Ms. Delbanco. I think that I will just talk. Rather than read from my notes, I will just speak and then I can hand in my written testimony. --------------------------------------------------------------------------- \1\ The prepared statement for Ms. Delbanco appears in the Appendix on page 128. --------------------------------------------------------------------------- The Leapfrog Group is an organization of about 140 large employers and other large health care purchasers, like State agencies and labor unions and others, who have come together to try and make big breakthrough improvements in the safety, quality, and overall value of health care for Americans. What brought the group together was really frustration about seeing how much health care costs were rising, learning about how health care quality varies tremendously from provider to provider, and feeling like from the buy side of the market there was very little control over what it was that purchasers were actually purchasing. So the group felt the need to look in the mirror as purchasers and ask themselves how they could reform their own practices and behaviors to start sending a stronger signal to the health care system that quality improvement and safety improvement is actually incredibly important, not just cost containment; although, of course, that is a primary concern to employers today. So the group came together about 3 years ago, received sponsorship and founding from the Business Roundtable and has grown from its initial 7 founding members to 140. What brings the members of Leapfrog together is a common commitment to two major activities. One is to informing and educating employees, so the 33 million Americans that our 140 members represent understand about how quality can vary and how important it is to make informed decisions. We are starting very specifically with some recommendations around improvements that hospitals can make in the area of patient safety. They are largely process improvements where we are advocating a change in the way that health care is delivered, first through the use of computerized physician order entry systems, where doctors make medication errors via computers that are linked to error-prevention software. Second, through particular staffing in the intensive care units where patient care is managed by doctors with special training in critical care, known as intensivists. The research suggests that when you have this kind of staffing, the odds of dying in the intensive care unit are reduced by 29 percent, which is quite tremendous. And then last, we advocate that patients who need certain high-risk surgeries or who have certain high-risk neonatal conditions, be referred to hospitals who we know, based on a variety of sources of evidence, are going to produce better outcomes for those patients, because these are elective situations where patients are going in for procedures that actually can be very dangerous. So that is the focus of our employee education and information. In order to actually provide relevant data to consumers that they can use, we have a voluntary online hospital survey where we invite hospitals to report their progress towards implementing these practices, which today are still quite rare. To reinforce the efforts of providers who try to implement these practices, which are not easy to do, we also are working on helping employers find ways to reinforce in the marketplace, through positive incentives and rewards, the efforts of health care providers who have fully implemented these practices or who have made significant progress. So whether those approaches include trying to shift market share by educating patients to seek care at those institutions or by directly providing financial bonuses or different payments to hospitals that have these practices in place, we are trying to start aligning the incentives properly so that there is a difference between how we pay health care providers who do a very good job versus those who may not be trying as hard. So together, we have gathered data from about 810 hospitals across the country. Those data are available publicly on our website, www.leapfroggroup.org, and are disseminated by many other partners, health plans, and others. Our philosophy about what it is the private sector can do and what even Congress could help us do is: We need to have a more transparent health care system, where we have an ability to gauge health care performance, whether it is along safety or quality or efficiency measures or others, so that we can know about how to educate consumers and we can know what should be the basis for rewarding providers differentially. And in addition to that, we need to experiment a lot more with how to create positive carrots and even sticks in some cases so that we can reinforce the efforts to continuously improve the way that health care is provided. So I will just stop there. Senator Coleman. Great. Thank you very much, Dr. Delbanco. Senator Pryor. Senator Pryor. Thanks, Mr. Chairman. I know we have a vote going on right now, so I am going to keep my questions very short. I guess this is mostly for you, Mr. Page, but I would like to hear everyone else's analysis of this. What impact on patient safety has the advent of managed care had? It seems to me that it is one of the great developments in health care in the last several years here in this country. I just wonder if there is any correlation to managed care and patient safety. Mr. Page. That is a good question. I am not sure I have a clear answer. I can opine two things. Managed care, in its process to trade off the economics of premium and the cost for control of the delivery in a more rigorous fashion, gate keepers and those sorts of things that HMOs would have, I think has at least given the promise of having control of the sorts of clinical sets and check lists and things that would be used in the delivery of care. From that standpoint, I think it could be viewed as a positive element. Unfortunately, I think the down side of the managed care is that often when it has a profit motive, the delivery of care becomes second to serving the interest of the investors if it is publicly held, and from that standpoint it has probably not been a very positive impact. Senator Pryor. Do you all have any other comments on that, managed care? Ms. Mandernach. I would agree with David. Mr. Krawisz. I would, also. It has not had a very positive impact and I think people are moving away to looking at different systems, incentive-based systems. Ms. Delbanco. I would just add maybe a slightly different comment, which is that employers who designate a lot of their responsibilities to health plans, whether they are managed care plans or less restrictive plans, have had more success with managed care plans in terms of their ability to educate patient members about making informed choices. We have seen a lot more uptake among those types of plans when it comes to sharing performance data and reinforcing the role of consumers making informed decisions. Senator Pryor. Thank you, Mr. Chairman. Senator Coleman. Thank you, Senator Pryor. Senator Carper. OPENING STATEMENT OF SENATOR CARPER Senator Carper. Thank you to our witnesses. Welcome. Thanks for being with us today. I have one question, and the question involves, if you will, an intersection, not like an intersection of streets but the intersection of policy issues that confront us here pretty regularly. One of those is health care safety, which you have been kind enough to speak to for us. Another is health care cost containment. A third is all those folks in this country, 40 million or so, who don't have any health care coverage. A fourth is the advent of new technology, some of which Dr. Delbanco has spoken to. And the fifth is the Medicare reform legislation which we are going to take up in the Senate next week. I am wondering if any of you would just share with us your thoughts. I picked up on some of what Dr. Delbanco was talking about in terms of automated prescriptioning of meds, not through written prescriptions but electronically. It may be less expensive, lead to fewer errors, and fewer negative outcomes for patients. That is the kind of solution I am looking for. We are going to have a chance to, not reinvent Medicare, but to change it rather significantly. One of the ways I hope we will do it is by the use of technology to help us on the health care cost containment side, help us on the safety side, and maybe if we do a good job there, then we can have a few dollars to address those folks who don't have any coverage at all. Do you have any thoughts, advice for us, if you will, as we take up this legislation in the Senate next week? Mr. Page. I would offer two points. One is that the computer application information systems in the clinical context does have tremendous capability to reduce error and make safer care, which has real costs. Now, the costs aren't always attended to the institution, but I think from the national policy standpoint, the emphasis on moving towards systems that can reduce the error rate can save a tremendous amount of cost. I think one of the other issues that you mention is the intersection of those who don't have access to the system and that has real costs to the system, because oftentimes they come to the system late in their health care issues and are a much more difficult problem clinically to deal with. It is logical for the national policy on a cost basis to try and get these people into the system rather than have them on the fringe of the system taken care of by what we now call the safety net hospitals. I think that is a reasonable, appropriate, cost- driven public policy approach to take. Last, I think the Congress should probably recognize that the demographics of our population are changing. People have, almost one in five in this population have chronic illnesses, defined by being an illness that persists longer than 3 months, and this will change how we will take care of health problems going forward in the future. Ms. Mandernach. The only comment that I would add, and I would wear my former hat as a hospital CEO of a smaller facility in smaller Minnesota, as you talk about the policies, I would ask for a sensitivity to the rural structure that is very fragile at this point in rural hospitals. As we talk technology, it is not a lack of desire, it is a lack of funds available, and as we begin to establish standards, we need to be very sensitive that there are great sums of people who live in Northern Minnesota, in rural areas across the country, in addition to the fact that we are a very mobile society. And so even if we live in big cities, we often travel in rural communities and we need that infrastructure. Mr. Krawisz. I think technology certainly works. The VA under Ken Kizer has really proven what can happen with both bar coding and computerized physician order entry. However, it is very expensive. I think we should find a way to allow all hospitals to be able to participate. As you all know, many hospitals are plagued with significant financial losses and low margins and they really don't have the money, especially I would believe in rural areas, to adopt these sophisticated technological solutions. So I think maybe with your help and the right incentives, we can move in that direction, and which I believe is the proper direction. Ms. Delbanco. I will speak again from the employers' perspective. I think employers, especially those, let us say, who are manufacturers, are frustrated with the processes that are being used in the health care system and see a lot of waste. One of the reasons why the Leapfrog Group initially started by advocating structural or process improvements is because the feeling is that if we root out the defects, if we get rid of the mistakes that are made, we will be much more cost effective in terms of the health care dollars, the limited health care dollars that we use. And so I think the two points that I would make, which are similar to what I said at the end of my remarks, are that we believe it is incredibly important to have publicly available health care performance information so we can gauge how effectively our health care dollars are being used, and that one of the only ways to collect that information or report it in a cost-effective manner is to have an underlying clinical information system that hospitals and other caregivers put in place across the country so it is economical to gather data and to report it. So it is a little bit of a catch-22 situation, but our goal, at least as private sector purchasers and some public sector purchasers working together, is to try to jump-start that process and not sit back and wait for incremental improvements. Senator Carper. Thank you all. Thank you. Senator Coleman. Senator Carper, thank you. We have to go vote. I do want to thank the panelists. I want to note that due to time constraints, the Subcommittee was unable to invite all of the parties affected by this issue to present oral testimony. This week, we have received written statements from the American College of Obstetricians and Gynecologists and the Alliance of Specialty Medicine. Without objection,\1\ these statements will be included in the written record, as well as the prepared statements of all the witnesses. --------------------------------------------------------------------------- \1\ These statements will appear in the Appendix as exhibits. --------------------------------------------------------------------------- Again, I want to thank you, and this hearing is adjourned. [Whereupon, at 11:34 a.m., the Subcommittee was adjourned.] A P P E N D I X ---------- [GRAPHIC] [TIFF OMITTED] T8254.001 [GRAPHIC] [TIFF OMITTED] T8254.002 [GRAPHIC] [TIFF OMITTED] T8254.003 [GRAPHIC] [TIFF OMITTED] T8254.004 [GRAPHIC] [TIFF OMITTED] T8254.005 [GRAPHIC] [TIFF OMITTED] T8254.006 [GRAPHIC] [TIFF OMITTED] T8254.007 [GRAPHIC] [TIFF OMITTED] T8254.008 [GRAPHIC] [TIFF OMITTED] T8254.009 [GRAPHIC] [TIFF OMITTED] T8254.010 [GRAPHIC] [TIFF OMITTED] T8254.011 [GRAPHIC] [TIFF OMITTED] T8254.012 [GRAPHIC] [TIFF OMITTED] T8254.013 [GRAPHIC] [TIFF OMITTED] T8254.014 [GRAPHIC] [TIFF OMITTED] T8254.015 [GRAPHIC] [TIFF OMITTED] T8254.016 [GRAPHIC] [TIFF OMITTED] T8254.017 [GRAPHIC] [TIFF OMITTED] T8254.018 [GRAPHIC] [TIFF OMITTED] T8254.019 [GRAPHIC] [TIFF OMITTED] T8254.020 [GRAPHIC] [TIFF OMITTED] T8254.021 [GRAPHIC] [TIFF OMITTED] T8254.022 [GRAPHIC] [TIFF OMITTED] T8254.023 [GRAPHIC] [TIFF OMITTED] T8254.024 [GRAPHIC] [TIFF OMITTED] T8254.025 [GRAPHIC] [TIFF OMITTED] T8254.026 [GRAPHIC] [TIFF OMITTED] T8254.027 [GRAPHIC] [TIFF OMITTED] T8254.028 [GRAPHIC] [TIFF OMITTED] T8254.029 [GRAPHIC] [TIFF OMITTED] T8254.030 [GRAPHIC] [TIFF OMITTED] T8254.031 [GRAPHIC] [TIFF OMITTED] T8254.032 [GRAPHIC] [TIFF OMITTED] T8254.033 [GRAPHIC] [TIFF OMITTED] T8254.034 [GRAPHIC] [TIFF OMITTED] T8254.035 [GRAPHIC] [TIFF OMITTED] T8254.036 [GRAPHIC] [TIFF OMITTED] T8254.037 [GRAPHIC] [TIFF OMITTED] T8254.038 [GRAPHIC] [TIFF OMITTED] T8254.039 [GRAPHIC] [TIFF OMITTED] T8254.040 [GRAPHIC] [TIFF OMITTED] T8254.041 [GRAPHIC] [TIFF OMITTED] T8254.042 [GRAPHIC] [TIFF OMITTED] T8254.043 [GRAPHIC] [TIFF OMITTED] T8254.044 [GRAPHIC] [TIFF OMITTED] T8254.045 [GRAPHIC] [TIFF OMITTED] T8254.046 [GRAPHIC] [TIFF OMITTED] T8254.047 [GRAPHIC] [TIFF OMITTED] T8254.048 [GRAPHIC] [TIFF OMITTED] T8254.049 [GRAPHIC] [TIFF OMITTED] T8254.050 [GRAPHIC] [TIFF OMITTED] T8254.051 [GRAPHIC] [TIFF OMITTED] T8254.052 [GRAPHIC] [TIFF OMITTED] T8254.053 [GRAPHIC] [TIFF OMITTED] T8254.054 [GRAPHIC] [TIFF OMITTED] T8254.055 [GRAPHIC] [TIFF OMITTED] T8254.056 [GRAPHIC] [TIFF OMITTED] T8254.057 [GRAPHIC] [TIFF OMITTED] T8254.058 [GRAPHIC] [TIFF OMITTED] T8254.059 [GRAPHIC] [TIFF OMITTED] T8254.060 [GRAPHIC] [TIFF OMITTED] T8254.061 [GRAPHIC] [TIFF OMITTED] T8254.062 [GRAPHIC] [TIFF OMITTED] T8254.063 [GRAPHIC] [TIFF OMITTED] T8254.064 [GRAPHIC] [TIFF OMITTED] T8254.065 [GRAPHIC] [TIFF OMITTED] T8254.066 [GRAPHIC] [TIFF OMITTED] T8254.067 [GRAPHIC] [TIFF OMITTED] T8254.068 [GRAPHIC] [TIFF OMITTED] T8254.069 [GRAPHIC] [TIFF OMITTED] T8254.070 [GRAPHIC] [TIFF OMITTED] T8254.071 [GRAPHIC] [TIFF OMITTED] T8254.072 [GRAPHIC] [TIFF OMITTED] T8254.073 [GRAPHIC] [TIFF OMITTED] T8254.074 [GRAPHIC] [TIFF OMITTED] T8254.075 [GRAPHIC] [TIFF OMITTED] T8254.076 [GRAPHIC] [TIFF OMITTED] T8254.077 [GRAPHIC] [TIFF OMITTED] T8254.078 [GRAPHIC] [TIFF OMITTED] T8254.079 [GRAPHIC] [TIFF OMITTED] T8254.080 [GRAPHIC] [TIFF OMITTED] T8254.081 [GRAPHIC] [TIFF OMITTED] T8254.082 [GRAPHIC] [TIFF OMITTED] T8254.083 [GRAPHIC] [TIFF OMITTED] T8254.084 [GRAPHIC] [TIFF OMITTED] T8254.085 [GRAPHIC] [TIFF OMITTED] T8254.086 [GRAPHIC] [TIFF OMITTED] T8254.087 [GRAPHIC] [TIFF OMITTED] T8254.088 [GRAPHIC] [TIFF OMITTED] T8254.089 [GRAPHIC] [TIFF OMITTED] T8254.090 [GRAPHIC] [TIFF OMITTED] T8254.091 [GRAPHIC] [TIFF OMITTED] T8254.092 [GRAPHIC] [TIFF OMITTED] T8254.093 [GRAPHIC] [TIFF OMITTED] T8254.094 [GRAPHIC] [TIFF OMITTED] T8254.095 [GRAPHIC] [TIFF OMITTED] T8254.096 [GRAPHIC] [TIFF OMITTED] T8254.097 [GRAPHIC] [TIFF OMITTED] T8254.098 [GRAPHIC] [TIFF OMITTED] T8254.099 [GRAPHIC] [TIFF OMITTED] T8254.100 [GRAPHIC] [TIFF OMITTED] T8254.101 [GRAPHIC] [TIFF OMITTED] T8254.102 [GRAPHIC] [TIFF OMITTED] T8254.103 [GRAPHIC] [TIFF OMITTED] T8254.104 [GRAPHIC] [TIFF OMITTED] T8254.105 [GRAPHIC] [TIFF OMITTED] T8254.106 [GRAPHIC] [TIFF OMITTED] T8254.107 [GRAPHIC] [TIFF OMITTED] T8254.108 [GRAPHIC] [TIFF OMITTED] T8254.109 [GRAPHIC] [TIFF OMITTED] T8254.110 [GRAPHIC] [TIFF OMITTED] T8254.111 [GRAPHIC] [TIFF OMITTED] T8254.112 [GRAPHIC] [TIFF OMITTED] T8254.113 [GRAPHIC] [TIFF OMITTED] T8254.114 [GRAPHIC] [TIFF OMITTED] T8254.115 [GRAPHIC] [TIFF OMITTED] T8254.116 [GRAPHIC] [TIFF OMITTED] T8254.117 [GRAPHIC] [TIFF OMITTED] T8254.118 [GRAPHIC] [TIFF OMITTED] T8254.119 [GRAPHIC] [TIFF OMITTED] T8254.120 [GRAPHIC] [TIFF OMITTED] T8254.121 [GRAPHIC] [TIFF OMITTED] T8254.122 [GRAPHIC] [TIFF OMITTED] T8254.123 [GRAPHIC] [TIFF OMITTED] T8254.124 [GRAPHIC] [TIFF OMITTED] T8254.125 [GRAPHIC] [TIFF OMITTED] T8254.126 [GRAPHIC] [TIFF OMITTED] T8254.127 [GRAPHIC] [TIFF OMITTED] T8254.128 [GRAPHIC] [TIFF OMITTED] T8254.129 [GRAPHIC] [TIFF OMITTED] T8254.130 [GRAPHIC] [TIFF OMITTED] T8254.131 [GRAPHIC] [TIFF OMITTED] T8254.132 [GRAPHIC] [TIFF OMITTED] T8254.133 [GRAPHIC] [TIFF OMITTED] T8254.134 [GRAPHIC] [TIFF OMITTED] T8254.135 [GRAPHIC] [TIFF OMITTED] T8254.136 [GRAPHIC] [TIFF OMITTED] T8254.137 [GRAPHIC] [TIFF OMITTED] T8254.138 [GRAPHIC] [TIFF OMITTED] T8254.139 [GRAPHIC] [TIFF OMITTED] T8254.140 [GRAPHIC] [TIFF OMITTED] T8254.141 [GRAPHIC] [TIFF OMITTED] T8254.142 [GRAPHIC] [TIFF OMITTED] T8254.143 [GRAPHIC] [TIFF OMITTED] T8254.144 [GRAPHIC] [TIFF OMITTED] T8254.145 [GRAPHIC] [TIFF OMITTED] T8254.146 [GRAPHIC] [TIFF OMITTED] T8254.147 [GRAPHIC] [TIFF OMITTED] T8254.148 [GRAPHIC] [TIFF OMITTED] T8254.149 [GRAPHIC] [TIFF OMITTED] T8254.150 [GRAPHIC] [TIFF OMITTED] T8254.151 [GRAPHIC] [TIFF OMITTED] T8254.152 [GRAPHIC] [TIFF OMITTED] T8254.153 [GRAPHIC] [TIFF OMITTED] T8254.154 [GRAPHIC] [TIFF OMITTED] T8254.155 [GRAPHIC] [TIFF OMITTED] T8254.156 [GRAPHIC] [TIFF OMITTED] T8254.157 [GRAPHIC] [TIFF OMITTED] T8254.158 [GRAPHIC] [TIFF OMITTED] T8254.159 [GRAPHIC] [TIFF OMITTED] T8254.160 [GRAPHIC] [TIFF OMITTED] T8254.161 [GRAPHIC] [TIFF OMITTED] T8254.162