[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.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Goeltz appears in the Appendix on 
page 53.
---------------------------------------------------------------------------
    I am in front of you today because of the love I have for 
my brother, Mike, who died in September 1999 of medical error. 
One week later, a Minneapolis newspaper ran a three-part series 
on errors in hospitals. One-and-a-half months later, the IOM 
report came out stating 98,000 people a year die of medical 
errors in hospitals alone. In my profession as an air traffic 
controller, that would equate to crashing an airliner with 250 
people in it every day.
    I needed to get involved for my brother, for myself, and 
for all the other loved ones being harmed needlessly. I want to 
share with you the story of my brother, Mike.
    Before September 22, 1999, I did not have a clue what the 
term medical error meant or that such a thing existed. Almost 4 
years later, I still do not have a clear definition of what it 
means. What I do know is that needless harm is coming to people 
that enter the health care system.
    On September 21, 1999, my brother had gotten up, showered 
for work, and as he was getting ready to leave became light-
headed and then experienced severe pain in his stomach. Mike 
went over to my parents and asked if he could spend the day, 
that he thought he had the flu. By 4 p.m., he was in so much 
pain that he could not speak and agreed to go to the emergency 
room.
    My dad took him, and after Mike was checked in, Dad went 
home. That was the last time my dad saw his son alive, and he 
will never forgive himself for leaving. But he had always been 
taught that you are safe and cared for in a hospital.
    Dad called around 6 p.m. to see how Mike was doing, but he 
was still in so much pain, he could not speak. Mike was 
eventually admitted to the hospital and given a self-drip 
morphine infusion for his pain, even though they were not sure 
what was causing it. Around 3 a.m., the next morning, my 
parents received a phone call telling them that Mike was not 
doing so well and would they come to the hospital. On the way 
there, they decided to take him somewhere else, not realizing 
he was already dead.
    When the elevator door opened on the second floor, the 
whole staff was standing there whispering. They stopped 
abruptly and my mom looked into the eyes of one of the nurses 
and she knew. She turned to my father and said, ``He is dead, 
Ray.'' This is the part of my story I have the hardest time 
getting through. It is the picture my parents have of their son 
every morning as they get up and every evening as they go to 
bed.
    Screaming, my parents ran down the hall to Mike's room. 
They stood in the doorway, staring at him lying in the bed, his 
arm hanging over the side with the IV still in it. My mom and 
dad traveled that space from the doorway to their son with a 
horrific feeling of failure, the failure every parent fears 
that they will not protect their child from harm. They felt 
guilt for trusting someone else with this task and now they 
experienced the ultimate mistake that could not be undone.
    My dad tried to put Mike's arm under the sheet, but was 
unable to bend it. They leaned over their six-foot, 200-pound 
son and hugged and kissed him. He was so cold. Mike was never 
cold, and he certainly could not be dead.
    When people die in airplanes, their families are brought to 
a site where the parts of the plane are gathered so they can 
attempt to begin the process of closure. They have grief 
counselors and supporting family members with them. An 
investigative process is begun immediately to try and find 
answers as to why the tragedy occurred. The families are kept 
informed and told what is found.
    My parents were allowed to go to the body of their dead son 
with no one there to support them. They were made to feel they 
deserved no answers as to what happened to their son, as if 
dying under the care of the medical profession relieves the 
profession of any accountability. No one would talk to them 
about their son's last hours alive. My parents were treated 
with silence and compassionless statements. The death of my 
brother was a tragedy, but the treatment of my family is what 
makes that tragedy horrific.
    I am often asked, what was the error that Mike died from? 
Mike was given a drug for pain, left alone, unmonitored and 
unchecked for over 4 hours. He died during this time. Is this 
the error, or was the misdiagnosis the error, or the treatment 
of my parents after he died the error? Mike died because we had 
been taught to trust our health care system and all will be 
well. This is not the reality of our system now.
    I can give another example. A friend put her mother in a 
care home after she had brain surgery. My friend was concerned 
about whether the facility could care for her mother and stated 
so to the floor nurse. The response was, ``Don't worry. We will 
take good care of your mother.'' In the next 36 hours, her 
mother sustained three separate falls which resulted in brain 
damage. The caring words said by the nurse have become a 
blatant lie to this family.
    What could the nurse have said? How about the truth. How 
about, ``We will do the best we can to care for your mother, 
but we cannot watch her all the time. Falls are a danger for 
patients and I can show you what we do to minimize them. If you 
would like to stay or have other family and friends stay with 
her, we welcome your help.''
    As a family, we take part of the responsibility for Mike's 
death. We left him alone and we should have been there to speak 
for him when he could not. Maybe he would have died anyway, but 
he would not have died alone.
    I envision in the new world of health care that Mike would 
have taken a more active part, as well. He would have known of 
the aneurysm history in our family and how his own history of 
high blood pressure could contribute to his risk of having one. 
He would have been more aware of the risks and educated to the 
symptoms.
    When I began to understand the enormous task of patient 
safety, I became overwhelmed by it and had to decide what 
contribution I could make. I believe in the need of involving 
the consumer in whatever directions the industry takes. 
Consumers are key players on the team and all the efforts 
attempted in health care will be for naught if the consumer is 
not educated in their role. We need to help the public 
understand it is the system that is failing them and not the 
health care workers.
    The individuals here today represent the movement that is 
taking place that will make our health care not only the best 
in the world, but the safest in the world. AHRQ has already 
made important contributions to patient safety in general and 
in the role of consumers in particular. Among other projects, 
AHRQ is supporting a workshop in October that will bring 
consumers who are frequent flyers in the system together to 
mine our experience for lessons learned in being constructive, 
proactive partners in our care.
    Facilitated by the Institute for Alternative Futures and 
the Partnership for Patient Safety, I am involved in the 
development of this grant and want to commend Carolyn Clancy 
for her agency's commitment to the notion of a patient and 
consumer-centered system. AHRQ's work in this area has just 
begun, and as a consumer, I urge the Committee to support it 
with appropriate resources so this kind of work can continue.
    I hold a special place in my heart for the National Patient 
Safety Foundation, since it was their outreach to a nagging 
family member that allowed consumers to be at the table by 
establishing the Patient and Family Advisory Council, on which 
I have the privilege to serve. I want to commend Robert 
Krawisz's leadership and NPSF's efforts in creating a national 
database of patient safety information, which is crucial to the 
education needed about this issue.
    I believe the Leapfrog Group, through its call for patient 
safety reforms and advocacy on the behalf of employees, is one 
of the most important patient-centered forces in health care 
today. Among other resources, the Leapfrog Group's ability to 
use its member companies' human resource departments to educate 
consumers about their roles and responsibilities is enormous. 
The Office of Personnel Management is an honorary member of 
Leapfrog and should step up to the plate to support this 
group's efforts of reform.
    I have personal knowledge of the Fairview Health System's 
dedication to patient safety under Dr. Page's leadership 
because I had the opportunity to bring to his attention a 
family who had experienced a system failure and were very angry 
about it. While I cannot discuss the details, I witnessed how 
his staff agreed to meet with this family, listen to them, and 
responded by telling them what Fairview had learned from them 
and was going to investigate. It was not an easy meeting for 
Fairview, but the difference between this approach and the way 
my family was handled after Mike's death was night and day.
    Consumers are ready to work with leaders like Dr. Page who 
respect us and show it in the way their organizations operate. 
I think we can accomplish great things by working together in 
partnership.
    There are several things I believe could be done to further 
the culture changes needed in health care and society. The 
first would be to require disclosure in a reasonable time frame 
of any bad outcomes. Since facilities are required to sign 
contracts for care to receive Medicare and Medicaid funds, I 
urge you to consider whether this could be a condition of 
participation.
    Another important step would be to prohibit the 
confidentiality agreements that seal the records when a medical 
liability claim is settled. One of the great disparities 
between aviation safety and patient safety is that we widely 
publicize our lessons learned and use them as safety tools. 
Allowing the facts that produce accidents to be hidden, as 
health care routinely does, means health care repeats the same 
mistakes over and over again, as each hospital and clinic 
climbs its own carefully hidden learning curve.
    Finally, let us start educating the public about the true 
cause of errors. We need to stop scapegoating individuals and 
look at the system that is failing them and us. We should 
inform health care consumers not only of their rights, but just 
as importantly, their responsibilities as partners in care.
    My own experience has led me to join with these allies in a 
movement that can make patient safety a reality rather than a 
dream. We could use help from Congress and Medicare, and I have 
a number of suggestions about what our government can do to 
further the culture needed in health care society.
    The first is to require disclosure of medical errors, as I 
have said. Finally, there is a need to educate the public about 
the sources of medical errors. These occur because our systems 
fail and the corrections will need to be systemic. Rather than 
a ``blame system'' that seeks to find individuals and hold them 
responsible, we need a learning system. The Institutes of 
Medicine has published two reports showing how we can create 
systems changes.
    I would like to leave you with a short story about a friend 
who learned I was coming here today, and we have had my 
conversations about patient safety in the past 4 years and her 
daughter was in the doctor's office getting a dosage of 
medicine for an illness that she had. It was being measured in 
grams. This woman, who has never spoke up before, asked them to 
double-check the dosage and to show them how they came up with 
the information.
    This is not a difficult mother. As family members, we are 
often labeled that we are when we ask questions. What we are 
trying to be is partners in our care. Our government can and 
should help educate people about their responsibility. Thank 
you.
    Senator Coleman. Thank you very much, Ms. Goeltz.
    When you talked about the death of Mike in the early part 
of your testimony with great sadness and a little anger, and as 
I listened to your testimony, maybe it is your own personal 
journey, but there seemed to be a bit of hope that if 
individuals can be treated with greater respect, if there is a 
cultural change, if there is more information, that we can make 
progress. Are you hopeful today?
    Ms. Goeltz. Very hopeful. I, in the last 4 years, would 
never have imagined the attention and the dedication that has 
come about this issue.
    Senator Coleman. Talk to me a little bit about 
responsibility for culture change. There are two parts to that. 
On the one hand, I listened to you talk about the system 
culture, which I think you are talking about, but then you also 
quite often make reference to patient responsibility, or family 
responsibility. Talk to me about both those cultures.
    Ms. Goeltz. Well, more of my heart is in the patient 
responsibility. As a consumer, I feel that on my own journey in 
health care after Mike died, I was diagnosed with cancer, and 
the struggle that I had in getting the people in the health 
care system to listen to my input and give credence to what I 
was saying was evidence that they felt they needed to be the 
only ones to care, that I didn't have the information to 
provide.
    I think that we need to educate the consumers about how 
important it is that we have rights as patients, but with those 
rights, we also have responsibilities, such as knowing if you 
have a history of aneurysms in your family, as my brother did 
not, knowing if you are a diabetic what kind of medications 
might react with the insulin that you are taking, and not just 
rely on the individual that is caring for you in health care to 
have that information or be aware of it.
    Senator Coleman. Last question. On a couple of occasions, 
you have referred to the difference between aviation safety, 
something you are familiar with as an air traffic controller, 
and patient safety, obviously from the tragic death of Mike as 
well as your own journey, do you have any insights as to why 
the difference? It appears to me as I look at aviation safety, 
when an accident occurs, everything, from the first step of 
dealing with families to the investigation, is thorough, 
complete, every detail checked out, and then report published. 
And yet in hospital safety, we don't seem to have the same 
thing. Help me understand from your perspective why we are not 
there.
    Ms. Goeltz. I believe in aviation, about 12 years ago when 
they started to look at the cockpit management and how it used 
to be the captain was always the last word when things were 
happening in the airplane, they grew from that and anybody that 
was in that cockpit had input, and if the lowly engineer in the 
back said, ``We are not taking off,'' they wouldn't take off. 
That was the start, where aviation started to look at it as a 
team effort rather than an individual who ends up being totally 
responsible.
    In health care, they are taught both in school, and as they 
are going through their training, that they are responsible and 
that it can only be one person to be responsible because if 
they have numerous people giving input, there would be mass 
confusion and nothing would--the patient would die as they were 
arguing, basically.
    The importance is not necessarily to take away one person 
making a decision, but ensure that that person is listening to 
all the input around him to make that decision and not just 
basing it on his own experience, because there is a lot of 
experience in the room, for example, in a surgery room when you 
are doing something, than just that one individual. And so it 
is the team effort that is important, and I believe that 
attitude towards that has to change.
    Senator Coleman. Thank you, Ms. Goeltz. I appreciate your 
very insightful perspective, as well as the great compassion 
that you bring today. Thank you very much.
    Senator Levin.
    Senator Levin. Thank you, Mr. Chairman.
    Let me add my thanks for coming forward. It is very 
difficult for you to do that, to recount a very painful chapter 
of your life. You have obviously used it for constructive and 
positive purposes, to help others, and we thank you for that, 
as well, because you tried to turn a tragedy into something 
which would have a positive impact.
    I am interested in your thoughts about holding people 
responsible or accountable for failures, errors, or mistakes. 
There is great emphasis on that in our world. I am wondering 
both about you individually, how you personally feel about 
that--I gather from what I know that you did not bring a 
lawsuit against the hospital, for instance, and if you feel 
comfortable talking about your thoughts about why not.
    I am also interested in your thoughts about whether there 
is too much emphasis on blaming or holding people accountable 
or holding people responsible for errors and whether or not 
that has a negative effect on what we are trying to do, which 
is to have people admit mistakes, and whether the organization 
that you are a member of or associated with, the National 
Patient Safety Foundation, has any views on that. I know you 
are not here representing them, but if you are aware of their 
position on that issue, it would be helpful for us to know 
that.
    Ms. Goeltz. First, the fact that we did not pursue suing 
the hospital, it is not that we didn't do that initially. 
Initially, the anger and the hurt that came out of what 
happened to my brother and the fact that no one would talk with 
us, I did go with my parents to a lawyer to see if we could get 
answers for what had happened to Mike. Basically, what he told 
my parents after many weeks of encouragement that he was going 
to be able to get answers for them was that it wasn't worth his 
time. He could not make enough money. That was another slap in 
the face for my parents.
    At that point, I realize that was not the route that I 
wanted to pursue and I ended up finding the National Patient 
Safety Foundation on the Internet and attended a forum where I 
heard them compare aviation safety to health care safety, and 
that was my connection with looking at it from a system 
standpoint rather than trying to blame the doctor or the nurses 
that were involved, because I started to learn what they were 
working with and in, with staff shortages and an attitude of 
complacency. It was a small rural hospital, which is also a 
factor in the possibility for medical errors.
    Because of that, of my knowledge of how I do things in my 
work, and I have been in air traffic control since I was 20 
years old, it is the way I think. I don't blame individuals. I 
try to look at it from a standpoint of what is their 
background.
    As an example, I had a trainer when I was an air traffic 
controller. No one else could work with him. It was very 
difficult to work with this man, but I tried to understand what 
it was about his information that he was providing me, and he 
had been a sole survivor of a unit that came out of Vietnam and 
he viewed things very differently than other people. And it was 
by trying to understand that background that I was able to work 
with him, and I believe that is what I do when I look at 
errors. I try to understand what is behind the error, not the 
individual that was there when it occurred.
    As far as NPSF, they have always been about not blaming and 
punishing. That was the message I heard when I first met with 
them in October 1999 and they continue to support that.
    Blaming individuals does not get us anywhere. It is what we 
have been doing in health care for years and this is where we 
are at. It is time to change and look at what we can do to help 
the individuals work better in a system that is failing them.
    Senator Levin. Thank you very much. If you have a chance to 
either stay for the panels, or if you are not able to, to 
perhaps read some of the testimony, I think there may be at 
least some reassuring testimony that things, indeed, are 
happening in the field along the lines, I think, that you are 
talking about, which is openness and acknowledging mistakes 
rather than trying to assign blame. So I think some of the 
later testimony this morning could be reassuring to you that 
there is movement in the direction that you indicate. Thank you 
very much for coming.
    Ms. Goeltz. Thank you.
    Senator Coleman. Thank you. I would like to call our second 
panel of witnesses at this time.
    We welcome our second panel at this time, Dr. James Bagian, 
Director of the National Center for Patient Safety for the U.S. 
Department of Veterans Affairs in Ann Arbor, Michigan; Dr. 
Carolyn M. Clancy, the Director of the Agency for Healthcare 
Research and Quality at the U.S. Department of Health and Human 
Services in Rockville, Maryland; and finally, Dr. Dennis 
O'Leary, President of the Joint Commission on Accreditation of 
Healthcare Organizations based in Oakbrook Terrace, Illinois.
    I thank all of you for your attendance at today's important 
hearing. I look forward to hearing your testimony this morning 
and your unique perspectives on what the Federal Government and 
accreditation agencies are doing to foster a climate of 
continuous improvement in our Nation's hospitals.
    As I noted earlier, pursuant to Rule 6, all witnesses who 
testify before the Subcommittee are required to be sworn. At 
this time, I would ask you all to please rise and raise your 
right hand.
    Do you swear the testimony you will give before this 
Subcommittee is the truth, the whole truth, and nothing but the 
truth, so help you, God?
    Dr. Bagian. I do.
    Dr. Clancy. I do.
    Dr. O'Leary. I do.
    Senator Coleman. Thank you. Dr. Bagian, we will proceed 
first with your testimony. We will then hear from Dr. Clancy 
and finish up with Dr. O'Leary. After we have heard all of your 
testimony, we will turn to questions. Dr. Bagian.

TESTIMONY OF JAMES P. BAGIAN, M.D., P.E.,\1\ DIRECTOR, NATIONAL 
CENTER FOR PATIENT SAFETY, U.S. DEPARTMENT OF VETERANS AFFAIRS, 
                      ANN ARBOR, MICHIGAN

    Dr. Bagian. Thank you. Thank you, Senator Coleman. It was a 
pleasure to hear both your comments and Senator Levin's because 
I think it really set the stage, as did Ms. Goeltz's.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Bagian appears in the Appendix on 
page 61.
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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.
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    \1\ The prepared statement of Dr. Clancy appears in the Appendix on 
page 66.
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    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.
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    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.
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    \1\ The prepared statement for Mr. Page appears in the Appendix on 
page 92.
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    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.
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    \1\ The prepared statement for Ms. Mandernach appears in the 
Appendix on page 110.
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    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.
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    \1\ The prepared statement for Mr. Krawisz appears in the Appendix 
on page 113.
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    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.
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    \1\ The prepared statement for Ms. Delbanco appears in the Appendix 
on page 128.
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    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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