    [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

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                                WASHINGTON : 2003
    ____________________________________________________________________________
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                       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.
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        \1\ The prepared statement of Ms. Goeltz appears in the Appendix on
    page 53.
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        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.
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        \1\ The prepared statement of Dr. Bagian appears in the Appendix on
    page 61.
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        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

                                  ----------

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