[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]



                 PATIENT SAFETY AND QUALITY INITIATIVES

=======================================================================

                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION

                               __________

                              JUNE 9, 2005

                               __________

                           Serial No. 109-17

                               __________

      Printed for the use of the Committee on Energy and Commerce


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house


                               __________

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                    ------------------------------  

                    COMMITTEE ON ENERGY AND COMMERCE

                      JOE BARTON, Texas, Chairman

RALPH M. HALL, Texas                 JOHN D. DINGELL, Michigan
MICHAEL BILIRAKIS, Florida             Ranking Member
  Vice Chairman                      HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio                EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia                 FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky               SHERROD BROWN, Ohio
CHARLIE NORWOOD, Georgia             BART GORDON, Tennessee
BARBARA CUBIN, Wyoming               BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
HEATHER WILSON, New Mexico           BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona             ELIOT L. ENGEL, New York
CHARLES W. ``CHIP'' PICKERING,       ALBERT R. WYNN, Maryland
Mississippi, Vice Chairman           GENE GREEN, Texas
VITO FOSSELLA, New York              TED STRICKLAND, Ohio
ROY BLUNT, Missouri                  DIANA DeGETTE, Colorado
STEVE BUYER, Indiana                 LOIS CAPPS, California
GEORGE RADANOVICH, California        MIKE DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire       TOM ALLEN, Maine
JOSEPH R. PITTS, Pennsylvania        JIM DAVIS, Florida
MARY BONO, California                JAN SCHAKOWSKY, Illinois
GREG WALDEN, Oregon                  HILDA L. SOLIS, California
LEE TERRY, Nebraska                  CHARLES A. GONZALEZ, Texas
MIKE FERGUSON, New Jersey            JAY INSLEE, Washington
MIKE ROGERS, Michigan                TAMMY BALDWIN, Wisconsin
C.L. ``BUTCH'' OTTER, Idaho          MIKE ROSS, Arkansas
SUE MYRICK, North Carolina
JOHN SULLIVAN, Oklahoma
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee

                      Bud Albright, Staff Director

        David Cavicke, Deputy Staff Director and General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

                         Subcommittee on Health

                     NATHAN DEAL, Georgia, Chairman

RALPH M. HALL, Texas                 SHERROD BROWN, Ohio
MICHAEL BILIRAKIS, Florida             Ranking Member
FRED UPTON, Michigan                 HENRY A. WAXMAN, California
PAUL E. GILLMOR, Ohio                EDOLPHUS TOWNS, New York
CHARLIE NORWOOD, Georgia             FRANK PALLONE, Jr., New Jersey
BARBARA CUBIN, Wyoming               BART GORDON, Tennessee
JOHN SHIMKUS, Illinois               BOBBY L. RUSH, Illinois
JOHN B. SHADEGG, Arizona             ANNA G. ESHOO, California
CHARLES W. ``CHIP'' PICKERING,       GENE GREEN, Texas
Mississippi                          TED STRICKLAND, Ohio
STEVE BUYER, Indiana                 DIANA DeGETTE, Colorado
JOSEPH R. PITTS, Pennsylvania        LOIS CAPPS, California
MARY BONO, California                TOM ALLEN, Maine
MIKE FERGUSON, New Jersey            JIM DAVIS, Florida
MIKE ROGERS, Michigan                TAMMY BALDWIN, Wisconsin
SUE MYRICK, North Carolina           JOHN D. DINGELL, Michigan,
MICHAEL C. BURGESS, Texas              (Ex Officio)
JOE BARTON, Texas,
  (Ex Officio)

                                  (ii)




                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Bornstein, William A., Medical Association of Georgia........    38
    Clancy, Carolyn M., Director, Agency for Healthcare Research 
      and Quality, U.S. Department of Health and Human Services..     7
    Griffen, F. Dean, American College of Surgeons...............    33
    Loewenson, Jane, Director, Health Policy, National 
      Partnership for Women and Families.........................    44
    O'Leary, Dennis, President, Joint Commission on Accreditation 
      of Healthcare Organizations................................    24

                                 (iii)

  

 
                 PATIENT SAFETY AND QUALITY INITIATIVES

                              ----------                              


                         THURSDAY, JUNE 9, 2005

                  House of Representatives,
                  Committee on Energy and Commerce,
                                    Subcommittee on Health,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:06 p.m., in 
room 2322, Rayburn House Office Building, Hon. Nathan Deal 
(chairman) presiding.
    Members present: Representatives Deal, Shimkus, Myrick, 
Burgess, Barton (ex officio), Waxman, Capps, and Baldwin.
    Staff present: Nandan Kenkeremath, counsel; Brandon Clark, 
health policy coordinator; Eugenia Edwards, legislative clerk; 
Puwee Kempf, minority professional staff member; Bridgett 
Taylor, minority professional staff member; and Voncille Hines, 
minority research assistant.
    Mr. Deal. I will call the meeting to order and I will 
recognize myself first for an opening statement. First of all, 
I am pleased to tell you we have two panels today of 
distinguished individuals to talk to us on the general issue of 
patient safety. We look forward to hearing their testimony.
    The purpose of today's hearing is to focus on public and 
private sector initiatives to reduce the number of medical 
errors to improve patient outcomes and to improve overall 
quality.
    In 1999, the Institute of Medicine released a report on the 
problem of medical errors and their impact on health in 
America. In this report, they estimated that at least 44,000 
Americans die each year as a result of medical errors and that 
this number may be as high as 98,000.
    If these numbers are accurate--and they rank medical errors 
as the fifth overall leading cause of death--and I think all of 
us understand that this is just unacceptable. There is no 
question that we should be doing more to protect patients from 
unnecessary medical errors. This hearing can serve as a 
springboard for moving forward on finding a solution to this 
pervasive problem.
    A broad list of agencies and stakeholders are working on 
efforts to improve patient safety and reduce the number of 
medical errors. Many of these groups are represented here 
today.
    I applaud your efforts and look forward to continuing to 
work with you in the future. I firmly believe that we have the 
necessary technological resources and understanding of the 
problem to be able to reduce the number of deaths caused by 
medical error by at least half in the next 5 years. I am 
committed to achieving this goal and I ask each of the members 
of this committee to join me in that event.
    As an important first step, I want to work with my 
colleagues on both sides of the aisle and in both houses of 
Congress to pass a bipartisan patient safety bill before the 
August recess. That is my goal.
    Again, I welcome our witnesses, and I thank them for their 
participation. I now recognize Mrs. Capps for her opening 
statement--are you going to defer to Mr. Waxman? Go ahead.
    Mr. Waxman. No, go ahead.
    Mrs. Capps. Thank you, Mr. Deal. I commend you for your 
goal before recess of legislation. Addressing patient safety is 
a broad and intricate issue that could be the subject of a 
dozen hearings and addressed by at least as many separate 
witnesses and initiatives. I want to thank the witnesses today 
for taking the time to be with us.
    I am going to focus on the national shortage of nurses in 
my opening remarks, and I hope that we will be able to discuss 
this topic, because it has a direct effect on patient safety. 
Several reports have concluded what many health care 
professionals have known for years, that there is a direct link 
between the number of registered nurses and the quality of care 
provided in our Nation's hospitals.
    A study in the New England Journal of Medicine in May of 
2002 linked higher levels of nursing care to better patient 
care and outcomes in hospitals. Another study in 2002 by the 
Joint Commission on the Accreditation of Health Care 
Organizations, JCAHO, found that nearly one-quarter of all 
unanticipated events that result in death, injury or permanent 
loss of function are caused by inadequate nurse staffing 
levels.
    Research published in October 23, 2002, Journal of the 
American Medical Association, concluded that a patient's 
overall risk of death rose roughly 7 percent for each 
additional patient above four on a nurse's workload.
    Health Affairs article in 2004, based on research funded by 
the Agency for Healthcare Research and Quality and the Robert 
Wood Johnson Foundation, linked the prevalence of nursing 
shifts longer than 12 hours to increased risk of medical 
errors.
    It should not take us this many studies to understand that 
overworked, overstressed medical professionals make more 
mistakes.
    There are a number of steps that we can and need to 
address--that we need to take to address this part of the 
problem. In the 107th Congress, this committee took the lead in 
addressing the nursing shortage by passing the Nurse 
Reinvestment Act. But funding for nurse education programs is a 
paltry $150 million, while we spend billions on training our 
physicians. I am not saying we shouldn't spend this money on 
training our physicians, I am just making the contrast.
    In 1974, during the last serious nursing shortage, Congress 
appropriated $153 million for nurse education programs. In 
today's dollars, that would be worth $592 million, 
approximately four times what we are spending now.
    But new funding alone will not solve this problem. We must 
also make significant changes to the nursing workplace. Proper 
staffing levels allow nurses the time they need to make patient 
assessments, complete nursing tasks, respond to health care 
emergencies and provide the level of care that their patients 
deserve.
    The Robert Wood Johnson Foundation is taking a lead on this 
issue by funding a program called Transforming Care at the 
Bedside, which has assisted hospitals to redesign themselves to 
provide more effective, less stressful care. This is the kind 
of effort we need to encourage and enhance.
    We also need to make sure nurses are not overworked by the 
practice of mandatory overtime and requiring adequate staffing 
levels for patients. The Safe Nursing and Patient Care Act of 
2005, H.R. 791, would deal with the issue of mandatory 
overtime.
    I have introduced the Quality of Nursing Care Act, H.R. 
1372, to direct hospitals to work with their nursing staff and 
develop staffing level standards that will be enforced by 
Medicare. These bills, among other approaches and along with 
other efforts to transform the health care workplace, would 
have a real impact on patient safety. If this committee wants 
to adequately address patient safety, we have to take up bills 
like this and look seriously at the nursing shortage.
    I yield back the balance of my time and thank you for the 
extra time.
    Mr. Deal. I thank the gentlelady.
    Dr. Burgess, do you have an opening statement?
    Mr. Burgess. Thank you, Mr. Chairman. Yes, I will make a 
brief statement. Of course, I want to thank you for calling the 
hearing today. Having practiced medicine for over 20 years, I 
think I can say without being too immodest that patients in the 
United States are treated to the highest quality of medical 
care than anywhere else in the world.
    But that doesn't mean that improvements aren't necessary or 
aren't achievable. I believe that there are many elements that 
hold back medicine in the United States from making that next 
leap in quality. Setting quality benchmarks and dissemination 
methods for best practices are important elements of any 
legislation developed by this committee. Creating portals for 
patients to access this data will be critical as well.
    I will just have to tell you too, on a side note, I was a 
practicing physician in 1999 when the Institute of Medicine 
came out with that book, ``To Err Is Human.'' I read through 
their data development. I was astounded that anything that was 
put together that sloppily, for want of a better word, ever 
found its way into print.
    We take two studies, one from a hospital in one part of the 
country in 1984, another from another part of the country in 
1992. Get a data set from each one, and, in fact, the error 
rate went down between 1984 and 1992--but you never hear about 
that--and then we extrapolate that to the whole country, come 
up with a number, 44,000. Just to be sure we have got it right 
we double it and then add 10 percent. When you figure it out 
for yourself.
    But that doesn't mean that the problem isn't real, because 
it is. We all know it is. We can argue about the number, but if 
one patient is injured, that is too many. One dollar that is 
spent correcting a medical error is a dollar that is not spent 
buying a child vaccine or providing someone prenatal care.
    It is in fact a major contributing factor to the litigious 
environment that doctors have been forced to work under, the 
fear of being sued. Because of the fear of being sued some 
doctor errors never come to light and are not adequately 
reviewed by peers in medicine.
    Because of this, best practices can at times be hard to 
come by, because doctors feel disinclined to draw a target on 
themselves if they provide care in minor variance of those best 
practices.
    To fully address patient safety in this country, we also 
need to look at the legal environment that suppresses, 
suppresses self-reporting and stanches quality peer review.
    I am pleased that we are joined with our witnesses today 
and I would be especially interested in hearing from all of 
you, but Dr. Griffen about the work that is being done by the 
thoracic surgeons to improve the quality of thoracic care.
    I yield back the remainder of my time.
    Mr. Deal. Thank you, Mr. Burgess.
    Mr. Waxman.
    Mr. Waxman. Thank you, Mr. Chairman, for holding this 
hearing. I want to associate myself with your opening comments. 
There is nothing partisan about the issue of trying to stop 
medical errors. Those of us who want to see if we can give 
attention to this issue and some focus on it should try to work 
together to see if there is some legislative proposal that 
would try to avoid the errors before they take place.
    So much of our time is often taken up in Congress about how 
to put limits on pain and suffering and how to have lawsuits in 
one court jurisdiction or another, State court, Federal or 
however. If we could avoid these errors, that should be our 
goal.
    I think the Institute of Medicine did us a real service in 
their report. They pointed out the errors, so many of which 
could have been prevented. I would hope that we could look at 
some of their recommendations, and I am looking forward to 
hearing from the testimony of our witnesses today.
    One group that I didn't see on the list are representatives 
from the nurses. Because I have a constituent in Los Angeles, a 
man by the name of Dan Sandell, who has done a lot of work 
developing medical technologies and devices and simple 
procedures based on extensive conversations with nurses and 
hearing from them about some things that would just make it 
less likely--or some of the errors that we hear about taking 
place.
    I think we have to be mindful that it is not so easy to 
develop standards, developing and measuring quality standards 
is pretty complicated, but also very important. Here we have a 
very critical issue. Not only do we need to know what we are 
measuring, but to be sure we are measuring the right things. We 
have to be sure the information is available to the public and 
available in a way that allows people to make informed 
judgments about the quality of care being provided.
    I understand hospitals internally keep records and keep 
track of medical errors of one sort or another. We might try to 
see whether we can incorporate some of their information into a 
broader data base that would be helpful without causing 
intrusion into the privacy of hospital internal procedures.
    We don't want people in the medical professions to fear 
telling us about medical errors. We want to work in a way that 
will give assurances to everybody that we all want to work 
together to accomplish the same goal, and that is to try to 
prevent medical errors.
    I think fear of litigation is one way that medical errors 
are often prevented, because medical professionals want to be 
sure they take all the steps necessary so they won't be 
questioned later. In doing so, they probably do a much better 
job and the patients are better served.
    These are all factors that go into this whole mix. I would 
look forward to the testimony, because this will be useful to 
us in figuring out what is best to do. Thank you.
    Mr. Deal. Mr. Shimkus, do you wish to make an opening 
statement?
    Mr. Shimkus. Just briefly, Mr. Chairman. I want to welcome 
our witness. Illinois just passed, and the Governor has not yet 
signed----
    Mr. Waxman. Is your mike on?
    Mr. Shimkus. I am attempting to.
    Mr. Deal. An electrical error.
    Mr. Shimkus. I may try. I will be the chairman. No, I 
won't.
    Illinois just passed medical liability reform. It had other 
provisions in there too that I think, when we addressed 
consensus, that I have worked with the chairman on, does talk 
about the tort issue and caps. But it also--there is some 
insurance issues, and there is also some safety concerns and 
technology addressing issues that I think are all part of it.
    For those of us who have been ravaged by the medical 
liability issue, we also understand that we have got to do a 
better job using technology to help us in patient records, in 
addressing medicine and tracking that.
    I, fortunately or unfortunately, have just come out of a 
major medical procedure. The good hospitals have, you know, 
computers, not only in the operation rooms, but they have them 
in your recovery rooms.
    Others are slower to do that, because there is a cost 
incurred. I think we will do well if as we address how to start 
talking about errors and reforms that being able to have good 
data that is--that people can plan on and count on would be 
helpful. So I hope that we will also look at that as we move 
forward in our hearings.
    I thank our guest and I look forward to her testimony. I 
yield back, Mr. Chairman.
    Mr. Deal. Thank you. Ms. Baldwin.
    Ms. Baldwin. Thank you, Mr. Chairman. I also want to thank 
our witnesses who will join us this afternoon. I am glad to 
have this opportunity, Mr. Chairman, to explore the topic of 
patient safety. To me, the issue of medical errors is in many 
ways similar to the issue of the uninsured. Everyone recognizes 
the problem, and we agree that even one instance is one too 
many. Yet Congress remains stuck and has not passed legislation 
to address the problem. I am hopeful, Mr. Chairman, that 
today's discussion will open a new dialog and move us toward a 
constructive way of reducing the number of medical errors. 
Maybe we can have a similar hearing on the uninsured at a later 
point in time to move that issue forward, too.
    Regarding medical errors, I am interested in exploring ways 
that we can use health care information technology, IT, to 
address this issue. Part of why I find health care IT to be so 
promising is that effective use of IT systems could potentially 
reduce medical errors in multiple ways.
    For example, IT systems can prevent medical errors from 
ever occurring. IT systems can provide built-in safeguards to 
double-check for adverse drug reactions prior to a prescription 
even being written. IT systems can prevent medical errors 
through information gathering and sharing.
    With a national health care IT system, we can potentially 
have access to incredible amounts of information for research 
purposes. Think of how much sooner we might have been able to 
know about Vioxx and its negative side effects if information 
had been collected through an IT system.
    I don't want to focus on IT to the exclusion of our human 
resources in medicine. Clearly, there is more that we can and 
must do to support them in their mission to care for our 
health. Certainly, the doctor's Hippocratic oath says first to 
do no harm, and there are additional things we can do in that 
regard.
    I look forward to hearing our witnesses' views on health 
care IT and the ways in which we can help our practitioners, 
and again thank the witnesses for joining us today and yield 
back.
    Mr. Deal. Thank you. I might add to you and Mr. Shimkus 
both, we are looking at the possibility of holding a hearing on 
the issue of information technology, because it definitely has 
a relationship.
    Yes, Mrs. Capps.
    Mrs. Capps. Thank you. I would like to ask unanimous 
consent to submit Mr. Dingell's statement for the record.
    Mr. Deal. Without objection.
    Mr. Waxman. For all members?
    Mr. Deal. Yes, we will extend that to any member who wishes 
to do so.
    [Additional statement submitted for the record follows:]

 Prepared Statement of Hon. Joe Barton, Chairman, Committee on Energy 
                              and Commerce

    Thank you, Mr. Chairman, for holding this hearing on the important 
topic of patient safety and quality.
    Thousands of Americans die needlessly every year as a result 
medical errors. The great shame in that statistic is that many of these 
errors were ultimately preventable. These deaths also highlight the 
failure of our health systems to address the problem of patient safety 
and medical errors.
    The challenge we face is how to design and pay for health systems 
that substantially reduce the risk of medical errors. There is no one 
single answer, or silver bullet, that will miraculously solve the 
problem. Nor do I believe the answer is (as is too often the case here 
in Washington) to simply throw more money at the problem. First, we 
should do no harm. Second, we need to consider how to come up with 
smarter, more efficient ways to keep patients safe.
    Since the 1999 release of the groundbreaking Institute of Medicine 
study on medical errors, hospitals, doctors and health plans have all 
worked to develop innovative initiatives to reduce medical errors. The 
witnesses today will describe some of the boldest of these new 
initiatives.
    These initiatives reflect three core issues that need to be 
addressed if we are to ever substantially reduce medical errors. These 
issues include: 1) the need to better educate providers, 2) improving 
systems to detect and address medical errors, and 3) promoting greater 
accountability.
    The Committee has already done important work to address some of 
these needs. We worked closely with Mr. Dingell and his staff to draft 
a bipartisan patient safety bill to promote the development of patient 
safety organizations and encourage providers to use these organizations 
to identify and eliminate medical errors. I intend to do everything I 
can to resolve the outstanding issues we have with the Senate, so we 
can pass this bill and send it to the President for his signature soon.
    I also look forward to hearing from the witnesses today about the 
lessons we can learns from their initiatives. There is likely much more 
than could be done beyond the modest goals we set out in our patient 
safety legislation. I believe we owe it to patients, their families, 
and the American taxpayers to better prevent the needless loss of lives 
and taxpayer dollars due to preventable medical errors.
    Thank you again Mr. Chairman for holding this hearing.

    Mr. Deal. We are pleased to have as our first panel Dr. 
Carolyn Clancy, who is the Director of the Agency for 
Healthcare Research and Quality. Dr. Clancy, thank you for 
being with us today. It is your floor.

      STATEMENT OF CAROLYN M. CLANCY, DIRECTOR, AGENCY FOR 
HEALTHCARE RESEARCH AND QUALITY, U.S. DEPARTMENT OF HEALTH AND 
                         HUMAN SERVICES

    Ms. Clancy. Thank you, Chairman Deal, distinguished members 
of the subcommittee. Thank you for inviting me to this 
important hearing on initiatives to improve patient care and 
safety in America. I would ask that my written statement be 
entered in the record.
    Improving patient safety is a high priority for President 
Bush and Secretary Leavitt and an important statutory 
responsibility for the Agency for Healthcare Research and 
Quality. Your timing in calling this hearing couldn't have been 
more perfect, for you have chosen the week of AHRQ's first 
joint meeting of patient safety and information technology 
grantees. They are over at the Convention Center now. That 
meeting is open to the public, so the potential for discourse 
and learning has been great, our grantees from each other and 
the public and the public from our grantees.
    There is great excitement about our successes to date, but 
we also recognize that we have a lot more work to do to achieve 
the goal of a safe, high quality health care system. Our 
grantees are committed and dedicated to this goal, and they are 
very pleased to have your support for their efforts.
    The Institute of Medicine report ``To Err Is Human'' is a 
critical turning point in the awareness of the issue of patient 
safety. It changed the way the public sees the health care 
community and the way the health care community sees itself. It 
reminded us that safety and quality in health care were no 
longer something to be taken for granted, nor did the current 
state have to be accepted, whether good or bad, as the best 
that could be done. We can measure how we are doing and 
improve, and the tools to do that job should be developed.
    It essentially changed the conversation in two essential 
ways. First, it suggested that a fundamental change was needed 
in how the health care system should react when an error 
occurs. It suggested that we shelve the traditional name, blame 
and shame response in favor of openness and an opportunity of 
learning from mistakes.
    Second, the Institute of Medicine also reminded us that 
health care is a highly collaborative enterprise. As my 
predecessor John Eisenberg used to say, patient safety is a 
team sport. Providing high quality, safe health care requires 
ongoing communication, collaboration and teamwork.
    In many ways, your subcommittee led the charge on improving 
patient safety in the Nation before the Institute of Medicine 
report was published in November 1999. Earlier that summer, the 
subcommittee included a mandate to address medical errors in 
the bill reauthorizing the agency. Appropriations followed a 
year later, and direction from the Senate Appropriations 
Committee, for AHRQ to lead a national effort to combat medical 
errors and improve patient safety. As a result of your mandate, 
AHRQ has made improving patient safety and reducing medical 
errors a top priority.
    Since fiscal year 2001 we have funded over 225 patient 
safety and related health information technology projects. 
These projects fall into four broad approaches. One is 
identifying medical errors and other threats to patient safety 
so we can understand why they occur.
    The second is advancing our knowledge and practices that 
will effectively reduce or eliminate the occurrence of medical 
errors or minimize the risk of patient harm.
    A third is developing, assembling and widely disseminating 
information on how to implement patient safety best practices.
    Fourth is enabling providers to continually monitor and 
evaluate threats to patient safety and the progress they are 
making.
    In the spirit of patient safety as a team sport, I would 
like to note that our colleagues at the FDA, CMS and the 
Centers for Disease Control and Prevention are also supporting 
efforts to improve patient safety. My written statement has 
more detail on our and the other agencies' activities.
    I would like to make several brief observations from our 
work that I hope will prove useful as you think about the 
issues related to improving patient safety and reducing medical 
errors.
    First, this culture of patient safety that the Institute of 
Medicine and others have recognized is critical on two levels. 
Health care professionals need to feel safe to acknowledge 
errors or near misses within the institutions in which they 
practice.
    Second, as a culture of safety develops within an 
individual institution, it is important to recognize that the 
number of reported errors is likely to rise as previously 
hidden errors are disclosed.
    For this reason, an initial increase in the number of 
reported errors is actually a sign of success, not failure. 
What we would expect to see is that the overall volume would 
increase, but ultimately the severity of those mistakes would 
decrease.
    Third, while an increasing number of hospitals are 
developing the capacity to analyze the causes of medical 
errors, we need to recognize that the ability to conduct these 
analyses is uneven, both in terms of experience and skill 
level.
    Fourth, knowing the right thing to do to improve the 
quality and safety of patient care is only the first step. To 
increase the pace of improvement, the emphasis on 
implementation research--that is step-by-step guidance on 
implementation, and tools to facilitate the use of effective 
interventions--is critical. AHRQ has already begun to shift its 
emphasis within our existing resources in this direction.
    Fifth, there is a significant amount of information on how 
to improve the safety of hospital care, but the evidence base 
is less robust for other settings of care.
    Finally, as a nonregulatory agency, I believe that AHRQ can 
make effective use of voluntary collaboratives that bring 
together health care organizations at different stages of 
development in the application of health care interventions. By 
providing an opportunity to learn from the experience of 
organizations on the cutting edge, we can eliminate the 
inherent delays that occur while each institution reinvents the 
wheel and learns the same lessons on their own.
    In fact, yesterday I announced that AHRQ had just awarded 
over $8 million in funding for 15 projects that are designed to 
help clinicians, facilities and patients implement evidence-
based patient safety practices. These grants, called 
Partnerships in Implementing Patient Safety, will use existing 
knowledge in partnerships to improve the safety of patient 
care. Over half the projects focus on reducing medication 
errors, an area known to be in need of patient safety 
solutions. Many of the projects will apply interventions to 
improve health care communications, also a well-known source of 
errors.
    Mr. Chairman, thank you for the opportunity to present 
these remarks, and I would be delighted to answer any 
questions. Let me also say that the administration remains 
supportive of passing patient safety legislation, has looked to 
this subcommittee as an essential partner and encourages error 
reporting without fear of litigation and looks forward to 
continuing to work with you.
    [The prepared statement of Carolyn M. Clancy follows:]

     Prepared Statement of Carolyn M. Clancy, Director, Agency for 
 Healthcare Research and Quality, U.S. Department of Health and Human 
                                Services

    Chairman Deal, Congressman Brown, distinguished Subcommittee 
members, thank you for inviting me to this important hearing on 
initiatives to improve the safety of patient care in America. Patient 
safety is a high priority for President Bush and Secretary Leavitt; it 
is a statutory responsibility for my agency, the Agency for Healthcare 
Research and Quality (AHRQ); and it is a key area of emphasis for 
agencies across the Department of Health and Human Services and other 
Federal Departments. The Administration remains supportive of passing 
patient safety legislation that protects and encourages error reporting 
without fear of litigation and looks forward to continuing to work with 
the Committee on this important issue.

                        CONGRESSIONAL DIRECTION

    It is now more than 5\1/2\ years since the Institute of Medicine 
(IOM) elevated national awareness of the issue of patient safety with 
its landmark report, To Err Is Human. Since then, the issue of patient 
safety has become almost inescapable. Nearly every week, newspaper 
articles, reports on the radio and television, and articles in the 
medical literature keep issues of patient safety in the national 
spotlight.
    The IOM report was a critical turning point. It changed the way the 
public sees the health care community, and the way the health care 
community sees itself. It essentially ``changed the conversation'' in 
two essential ways. It made us realize that when medical care goes 
badly, the traditional response of ``name, blame, and shame'' not only 
does little to improve safety for the next patient, it may actually put 
the next patient at greater risk by encouraging mistakes to be hidden. 
The IOM also reminded us that safe, high quality care requires a team 
effort; patient-centered care requires tremendous ongoing communication 
and collaboration, requiring adjustment in our ongoing trend to greater 
specialization.
    It is worth noting that congressional action to promote patient 
safety actually preceded the November 1999 release of the IOM report. 
During the summer of 1999, Mr. Chairman, your Subcommittee included a 
mandate to address medical errors in the bill reauthorizing and 
renaming my agency. Appropriations followed a year later, with a 
directive from the Senate Appropriations Committee for AHRQ to lead a 
national effort to combat medical errors and improve patient safety.
    Mr. Chairman, this hearing is especially well-timed. It coincides 
with the annual patient safety conference AHRQ hosts for the 
researchers we fund, health professionals and the public. These annual 
conferences are designed to assess progress and accomplishments, 
promote better coordination and foster mutual learning. Because we made 
a significant number of health information technology awards last year, 
many of which were related to patient safety, we expanded this 
conference to include a dual focus on patient safety and health 
information technology. We focused on patient safety on Monday and 
Tuesday, had a general plenary session on Wednesday that was keynoted 
by Secretary Leavitt, and today and tomorrow will highlight health 
information technology.

                       DEPARTMENT-WIDE COMMITMENT

    I will address how AHRQ has responded to congressional direction in 
a moment. It is important to note at the outset that the response to 
the challenge of improving patient safety is shared Department-wide. 
For example, MedWatch, the Food and Drug Administration's (FDA's) 
Safety Information and Adverse Event Reporting Program, provides 
important and timely clinical information about safety issues involving 
medical products, including prescription and over-the-counter drugs, 
biologics, devices, and dietary supplements. FDA has issued a final 
rule requiring the bar coding of most drugs to promote electronic 
prescribing and to reduce the number of medical errors that occur in 
hospitals and health care settings. FDA's MedSun program of 2-way 
communication between FDA and health care facilities is improving the 
identification, understanding, and sharing of information about medical 
device problems. It is currently being used to pilot tissue 
surveillance. In addition, FDA is working on an integrated reporting 
system to allow reporters to submit an adverse event report about any 
FDA-regulated product through a single gateway and website. FDA is also 
working on human factors engineering to make medical devices more user-
friendly and to eliminate device errors that cause harm.
    The Centers for Medicare & Medicaid Services (CMS), in 
collaboration with the Centers for Disease Control and Prevention 
(CDC), AHRQ, and many private sector partners, has launched a major 
patient safety initiative, the Surgical Care Improvement Project, to 
eliminate surgical complications, such as post-operative pneumonia and 
surgical site infections. This work builds on the National Surgical 
Improvement Project begun in the Department of Veterans Affairs (VA), 
tested in civilian hospitals through support from AHRQ, and now being 
implemented nationwide through Medicare's Quality Improvement 
Organizations (QIOs).
    The CDC maintains a sentinel network of hospitals, the National 
Nosocomial Infection Surveillance (NNIS) System, and has launched a 
Campaign to Prevent Antimicrobial Resistance in Health Care. Monitoring 
infections, antimicrobial resistance, disease-specific screening and 
preventive healthcare practices, and other health events is a proven 
prevention strategy. In addition, CDC funds Prevention EpiCenters 
(academic medical centers) to conduct research to prevent healthcare-
associated infections and improve patient safety.

                             AHRQ RESPONSE

    Since FY 2001 AHRQ has funded over 225 patient safety and related 
health information technology projects. These projects fall into four 
broad approaches:

 Identify medical errors and other threats to patient safety and 
        understand why they occur;
 Advance our knowledge of practices that will effectively reduce or 
        eliminate the occurrence of medical errors and minimize the 
        risk of patient harm;
 Develop, assemble, and widely disseminate information on how to 
        implement patient safety best-practices; and
 Enable providers to continually monitor and evaluate threats to 
        patient safety and the progress they are making.
    Our projects address a broad array of issues linked to preventing 
risks to patient safety: advancing the effective use of health 
information technology, an issue of particularly high importance to 
President Bush and Secretary Leavitt; medication safety; communication 
issues within the health care team and availability of patient support; 
error prone clinical practices; problems that arise because of an 
institution's internal culture or organization; provider fatigue; 
unique safety issues in intensive care units, issues related to 
education and training; and reporting of adverse events or near misses.

                        ADVANCING PATIENT SAFETY

    Increasingly, our projects have emphasized the development of 
skills to undertake patient safety improvement, development of 
practical tools to facilitate the use of what is now known, and working 
in voluntary partnership with public and private sector groups to 
actually implement that knowledge. I will briefly describe projects in 
these three areas.
Developing Skills to Implement Patient Safety Initiatives
    AHRQ has created a Patient Safety Improvement Corps, a training 
program that brings together teams of state officials and private 
sector providers to learn and work together and undertake joint patient 
safety initiatives. The VA has partnered with us in carrying out the 
training sessions. Thirty-three states and the District of Columbia, 13 
of which are represented on this Subcommittee, have participated in the 
first two years of the program. In recruiting for the third class we 
are giving preference to applications from States that have not 
participated.
    Some teams have been successful in developing projects involving a 
large number of providers. For example, the Georgia team involved 28 
hospitals and health systems across the state to develop and adopt 
strategies to ensure that the correct site has been verified before a 
surgical procedure is begun on a patient.
    Another initiative, with the Department of Defense (DoD), is built 
on the recognition that teamwork is a critical aspect of patient 
safety. Poor team coordination is a major cause of preventable patient 
harm. The DoD and AHRQ have developed a public domain curriculum for 
training health care professionals to improve teamwork. This curriculum 
has been extensively field-tested and will be made available to all 
health care institutions nationally in the fall of 2005. AHRQ and DoD 
will be working with CMS and the QIOs to set up a national training 
program in teamwork using the new curriculum. The curriculum will also 
be available on the AHRQ PSNet (http://psnet.ahrq.gov/).
    It is important to increase the skill level for analyzing patient 
safety threats at the hospital level. The most common approach in 
hospitals is known as Morbidity and Mortality, or M&M, conferences to 
assess what went wrong in cases where a patient was harmed. We have 
built upon that approach with a popular web site, known as the AHRQ Web 
M&M (http://www.webmm.ahrq.gov/) in which new cases are shared, along 
with expert commentaries on how to think through such cases, identify 
problem areas and potential solutions. Each month a ``spotlight'' case 
is presented, accompanied by an educational slide set that health 
professionals can download and use as an educational tool in their own 
institutions. More than 10,000 health care professionals are now 
ongoing registered users of Web M&M, and 28,000 visited the site in a 
recent month. This approach is bringing lessons learned about patient 
injury and medical error outside the confines of individual hospitals, 
and the users include nurses, pharmacists, physician assistants and 
other allied health professionals in addition to physicians.
    Communication with patients is another important skill, especially 
when an error has occurred. One of our grantees, the Partnership for 
Health and Accountability, comprised of the Georgia Hospital 
Association (GHA) and Emory University, has developed a video, 
Discussing Unanticipated Outcomes and Disclosing Medical Errors, to 
assist providers on effective approaches for disclosing medical errors. 
The videotape was evaluated and refined and distributed to all GHA 
members. Over two dozen workshops were held throughout Georgia, to 
discuss the content of the video and to distribute a questionnaire to 
ascertain hospital disclosure practices. Distribution of the video is 
available at no cost through the PHA website (http://www.gha.org/pha/).

Developing Tools to Improve Patient Safety
    In response to requests by state hospital associations, state data 
organizations and others, AHRQ developed a set of indicators that any 
hospital can run against its hospital discharge data set to evaluate 
how it is doing in terms of safety and quality. --The AHRQ Patient 
Safety Indicators are being used by a variety of hospitals and other 
organizations to screen for suspiciously high rates of potentially 
preventable complications from surgery and medical care, such as 
complications of anesthesia or postoperative infection.
    Because the AHRQ indicators can allow for comparisons between 
hospitals, they are being used by a variety of organizations for public 
reporting and private and public sector pay-for-performance initiatives 
and demonstrations, in addition to internal hospital quality 
improvement. Many State and regional hospital associations, including 
the Georgia Hospital Association and the Dallas-Fort Worth Hospital 
Council, have integrated the AHRQ indicators into their quality 
improvement programs. --A number of Blue Cross plans are using these 
indicators to align financial incentives with achievement of specific 
performance objectives, and some of the indicators are being used by 
CMS as part of their pay-for-performance demonstration.
    Public and private sector organizations, such as Premier, Inc., 
have recognized the importance of measuring organizational conditions 
that can lead to adverse events and patient harm. To assist in that 
effort, AHRQ developed and recently released, in collaboration with DoD 
and Premier, another tool, known as the Hospital Survey on Patient 
Safety Culture. This public domain tool is being rapidly adopted across 
the country. For example, Catholic Health Partners has 70 hospitals in 
their system. They are using the survey and have received so far about 
3,000 responses. DoD anticipates using it in all of its facilities 
world-wide and AHRQ has made it available on our patient safety website 
PSNet.

Voluntary Partnerships to Improve Patient Safety
    The largest initiative, developed by the Institute for Health 
Improvement and cosponsored by AHRQ, CMS, and CDC, is the 100,000 Lives 
Campaign. This campaign has enlisted more than 2,200 hospitals to 
commit to implement changes in care that have been proven to prevent 
avoidable deaths. The initiative is starting with six interventions: 
deployment of Rapid Response Teams, delivery of evidence-based care for 
acute myocardial infarction, prevention of adverse drug events, 
prevention of central line infections, prevention of surgical site 
infections, and prevention of ventilator-associated pneumonia. The goal 
is to save 100,000 lives annually that would otherwise have been lost 
without these changes in the delivery of care. In addition to saving 
lives, the benefits of preventing complications are significant. For 
example, patients on ventilators are very susceptible to pneumonia 
because it is easy for bacteria to get into the lungs. If they develop 
pneumonia, they are likely to spend an extra week in the hospital, and 
the extra cost of care can easily reach $40,000.
    An AHRQ grantee at Johns Hopkins University is paving the way for 
success of the 100,000 Lives Campaign by working to prevent deaths 
resulting ventilator associated pneumonia and blood stream infections 
related to central lines. The Hopkins team is now working with 127 
Intensive Care Units (ICUs) in Michigan, 30 in New Jersey, 45 in 
Maryland, and recently expanded into Rhode Island. Michigan's 
experience suggests the significance of what can be accomplished. An 
Associated Press story last week noted that Michigan hospital officials 
estimated that they had saved 77 patients' lives: 73 from pneumonia and 
4 from blood infections. In addition, a small number of ICUs have 
actually gone as long as 9 months without one of these two 
complications. This project has developed implementation tool kits to 
assist other hospitals in putting these safety improvements into 
practice.
    Building upon our research investment over the last 5 years, this 
week AHRQ awarded over $8 million in funding for 15 projects that are 
designed to help clinicians, facilities, and patients implement 
evidence-based patient safety practices. These grants, Partnerships in 
Implementing Patient Safety, will use existing knowledge to improve the 
safety of patient care. They are projects that will have both an 
immediate and a long-term impact. Over half the projects focus on 
reducing medication errors, an area known to be in need of patient 
safety solutions. Many of the projects will apply interventions to 
improve health care team communications, also a well-known source of 
errors.
    There are two key elements to these projects. First, the 
interventions are generalizable; they will work in a wide array of 
other settings of care. Second, like the Johns Hopkins grant described 
previously above, these projects will develop implementation toolkits 
that will share lessons learned on how to best implement patient safety 
practices, identify the barriers they are likely to face as well as 
ways to work through them. The implementation toolkits will be 
available on PSNet.

                        CONCLUDING OBSERVATIONS

    Mr. Chairman, we have made significant progress since the Congress 
and the IOM highlighted the importance of patient safety. But we are 
still a long way from the lofty goals reflected in the IOM report. So 
there is more to be done. I am reminded of the final slide of the 
Patient Safety Improvement Corps team from Georgia, during a 
presentation reviewing their experience, which said: ``Patient safety 
is a never-ending process.''
    I would like to conclude with several brief observations from our 
work that I hope will prove useful.
    First, a culture of safety is critical on two levels. Health care 
professionals need to feel safe to honestly acknowledge errors or 
``near misses'' within the institutions in which they practice. 
Institutions also need to feel safe to seek help in identifying and 
resolving organizational and system-based threats to patient safety 
without retribution.
    Second, as a culture of safety develops within an individual 
institution, it is important to recognize that the number of 
``reported'' errors is likely to rise as previously hidden errors are 
disclosed. For this reason, an initial rise in the number of reported 
errors is a sign of success, not failure.
    Third, while an increasing number of hospitals are developing the 
capacity to analyze the causes of medical errors, we need to recognize 
that the ability to conduct these analyses is uneven, both in terms of 
experience and skill level. One of our state Patient Safety Improvement 
Corps teams determined that, after excluding a large hospital with a 
pro-active patient safety program, most hospitals in their state 
completed only four root cause analyses per year. State teams that 
focused on the skills needed to undertake such analyses found that the 
need for better skill development was significant. Moreover, few 
institutions have any experience with other pro-active risk assessment 
methods. Moving to a system in which hospitals routinely undertake 
analyses of the causes of errors will require significant skill 
development and technical assistance.
    Fourth, knowing the right thing to do to improve the quality or 
safety of patient care is only the first step. To increase the pace of 
improvement, the emphasis on implementation research, step-by-step 
guidance on implementation, and tools to facilitate the use of 
effective interventions is critical. AHRQ has already begun shifting 
its emphasis within our existing resources in this direction.
    Fifth, there is a significant amount of information on how to 
improve the safety of hospital care, but the evidence base is less 
robust for other settings of care.
    Finally, as a non-regulatory agency, I believe that AHRQ can make 
effective use of voluntary collaboratives that bring together health 
care organizations at different stages of development in the 
application of effective health care interventions. Collaboratives 
provide a natural setting for shared learning which accelerates the 
pace of improvement and innovation. By providing an opportunity to 
learn from the experience of organizations on the cutting edge, we can 
eliminate the inherent delays that occur while each institution 
reinvents the wheel. This approach also enables AHRQ to better focus 
its technical assistance and short-term implementation research.
    Mr. Chairman, that concludes my prepared remarks. I would be 
delighted to answer any questions.

    Mr. Deal. Thank you. We will begin the questioning process, 
and I will start it off.
    Would you tell us what intervention methods or measures you 
have chosen for the 100K Lives Campaign and how those 
intervention methods would work, if you could?
    Ms. Clancy. The 100,000 Lives Campaign is actually led by 
another group called the Institute for Healthcare Improvement 
that is based in Boston, Massachusetts. But they have many, 
many partners, of which AHRQ is one, as is the Centers for 
Medicare and Medicaid Services and the Centers for Disease 
Control.
    As I understand it, the rationale for the areas chosen were 
to focus on areas where there was a significant amount of 
momentum, where there was a good evidence base about what to do 
to address the problem. For example, ventilator-associated 
pneumonia. This is an area where we supported a very large 
demonstration project, with the expectation that that project 
team would team up with others, and indeed they have. They have 
teamed up with many, many others that they didn't plan to 
because there is a great deal of interest in it.
    It was also done because there was some way that they could 
calculate how many lives they might save over an 18-month 
period. Hence the 100K lives. I am told by Don Berwick, who 
couldn't be here today, that about 2,300 of the Nation's 
hospitals have signed up to be part of that campaign.
    Mr. Deal. You are making grants and supervising and 
overseeing those awards. What is the plan to try to consolidate 
and learn from all of these experiences that are gained, a so-
called best practices or suggested methodologies? Is that going 
to be the responsibility of your agency to do?
    Ms. Clancy. We regard that as an essential part of our 
responsibility. For example, the concept of a culture within a 
health care institution sounds nice. But the question is, what 
does that really mean? So the past year we actually developed a 
survey tool that hospitals can actually use.
    So a hospital leader who says that he or she is committed 
to having a culture of safety within that institution can 
actually use this survey to find out if that is the experience 
within his or her institution. So if I as a leader am committed 
to a culture of safety, but indeed some of my employees are 
fearful for making note of when there are errors--and this is 
to make a culture of safety, you really need to do that. So 
that would be one example.
    A number of our reporting demonstrations have partnered 
with others. Another part of the 100K Lives Campaign focuses on 
errors in medications that are made at the time that someone is 
discharged from the hospital. It sounds almost self-evident. 
But it turns out that a lot of patients have a group of 
medications that they take. They are admitted to the hospital. 
Sometimes those change. They go home with a new set.
    Oftentimes there is insufficient checking to make sure that 
the patient knows how to reconcile the new set of medications 
with what they are taking at home. The consequences can be 
fairly disastrous. Sometimes people are effectively taking 2 or 
3 kinds of the same medication or taking medications that have 
adverse interactions and so forth. And that has been part of 
the 100K Lives Campaign. But many States have stepped up to 
join and be part of that.
    In your State, in Georgia, there has been a very nice 
Voluntary Hospital Reporting Initiative, which has been very 
successful. We are also training a group of individuals called 
the Patient Safety Improvement Corps. These are individuals 
from across the country--and we were actually inspired to do 
this by States, who said to us, you know, we have a lot of 
data. What we don't have are people to analyze that. 
Periodically you see this in the newspaper where some incident 
was reported but the health department or no one else actually 
had the time or capacity to do that.
    So these individuals are nominated by their States and 
hospitals and come and attend a program for about 3 weeks of 
intensive learning. The rest is done back at their home 
institution to try to understand why errors occur, what 
strategies can be put in place to prevent them and so forth.
    So those are just a few examples, and I think you are 
getting the sense. I could probably keep on going but I will 
stop here.
    Mr. Deal. Thank you very much.
    Mrs. Capps.
    Mrs. Capps. Thank you, Mr. Chairman, and Dr. Clancy, thank 
you for your testimony. I have been impressed with the work 
that your agency has done on medication errors and the lessons 
that you have drawn from health care providers. Can you tell me 
what kind of research your agency is currently conducting 
regarding the relationship between the nursing workforce and 
patient safety?
    Ms. Clancy. Yes. Interestingly, one of the first 
publications looking at the relationship between what some 
people refer to as nursing sensitive outcomes--that is to say 
patient outcomes that you would expect to be influenced by 
nurses directly and nurse staffing--was done by someone who was 
a visiting scholar at the agency. That was about 7 or 8 years 
ago. Since then, we have funded some of the research that you 
cited in your opening remarks.
    An important part of our initial patient safety portfolio 
has been a group of projects that we call working conditions. 
Now, these projects look at such issues as nurse staffing, 
nurse perceptions of how often they are called or mandated to 
work overtime. They have also looked at resident work hours. 
One of the new projects that we are funding, that we just 
announced, is actually going to test ways to make sure that 
residents can work for work hours. It turns out that the nurse 
staffing is both about how many nurses there are, which is 
obviously an issue of great urgency, but also how those nurses 
are organized. That is the research that is still ongoing.
    Mrs. Capps. Some of the results have been published?
    Ms. Clancy. Yes.
    Mrs. Capps. Are there more then that we can expect to see?
    Ms. Clancy. Yes.
    Mrs. Capps. And a timeframe for that.
    Ms. Clancy. I could follow up on that for you with details.
    Mrs. Capps. Thank you very much. I am including this in 
your--I guess you could say culture of safety. I was interested 
to how you responded to Chairman Deal on some of these topics. 
You talk about developing this culture of safety in health care 
facilities. For the most part, I have heard medical error 
reporting as being one of those issues. It is certainly a very 
important one. I am wondering if the culture of safety--you are 
designing projects also to look at medical professionals, the 
way that they safely deal with patient loads in terms of their 
own numbers, as a part of this fostering of the culture of 
safety?
    Ms. Clancy. Some of our projects deal very specifically 
with that. One of the projects includes a national survey of 
nurses to see their perceptions about work and what are people 
hearing in terms of what they have to say about patient load 
and so forth and how does that affect their perception that 
they are at higher risk of providing unsafe care and so forth.
    Mrs. Capps. Okay. How about making sure that the same 
medical professionals are sufficiently well rested on the job, 
the number of hours that they have been working, their ability 
to be cogent and really attentive to patients' needs? Do you 
consider this--you could lump it all into mandatory overtime 
but you could also talk about shift length and other times?
    Ms. Clancy. The area where we have the greatest amount of 
information actually relates to medical interns and residents. 
But I think that the findings are likely to be generalizable. I 
think many of you may be aware that, unlike when I was 
training, the interns and residents are now limited to 80 hours 
a week of working. Some people believe that actually it matters 
how that 80 hours is divided up.
    So there were two studies published this past year in the 
New England Journal. One looked at the rate of medication, 
serious medical errors made by medical interns in an ICU at 
Brigham and Women's Hospital in Boston. Those interns who 
worked a 30-hour shift had significantly higher rate of serious 
medical errors than those who worked a shorter shift.
    In addition to that they looked at car accidents incurred 
by those interns on their way home after a long shift. It turns 
out they were twice as likely to be involved in a serious motor 
vehicle accident. The same grantee is now following up working 
with that institution to design ways to make sure that they 
eliminate those longer shifts, and the Accreditation Council on 
Graduate Medical Education that regulates how the hours for 
interns and residents is actually taking this issue up this 
summer.
    Mrs. Capps. I would submit that, yes, you can extrapolate 
on the basis of interns. I would commend you because not until 
these kinds of studies were done did people actually begin to 
realize the great risk that they were providing both for the 
intern but also certainly for the patient. I am convinced that 
until specific research is done on the population that we are 
very concerned about----
    Ms. Clancy. I would agree.
    Mrs. Capps. So we really need to, and I would urge you to 
take that on. I am sure you are concerned about it as well.
    I wonder, just finally, if you would talk a little bit more 
about skill development, for a better analysis, which 
hospital--you mentioned that. But I am wondering which hospital 
personnel you anticipate needing this training and what kind of 
skill development you think is needed among medical 
professionals like doctors and nurses to make this work.
    Ms. Clancy. Well, I think there are two parts of it. Most 
hospitals now have someone who is designated as the lead 
patient safety officer who works with quality professional 
officers and others across the organization. Some hospitals 
have the capacity to have more people with that kind of 
expertise than others. So that was actually the focus of our 
Patient Safety Improvement Corps. We are doing this jointly 
with the VA because I think they have been acknowledged leaders 
in the field of developing some of these techniques.
    The other part of skill development, which I think is more 
of a research area, is actually building on the techniques that 
we currently have to create others that may be more specific 
and useful for certain circumstances.
    Mrs. Capps. I am going over my time, but I do look forward 
to continuing to be in touch with you and thank you for the 
work that you doing.
    Mr. Deal. Thank you. Dr. Burgess.
    Mr. Burgess. Thank you, Mr. Chairman. Well, let us continue 
on Mrs. Capps' line with the resident work hours, something I 
have some familiarity with, having trained at Parkland Hospital 
back in the 1970's when resident work hours were thought to be 
not long enough.
    Are you working with the Council on Resident Education to 
be certain there is exposure to an adequate amount of clinical 
material? If you cut residents down to a maximum of 80 hours a 
week--and we probably worked a little more than that back in 
the 1970's--should an internship now be 14 months or 16 months 
or 18 months instead of 12 months? Should other parts of the 
training program be similarly extended?
    Ms. Clancy. We have not gotten into whether the length of 
time for training should be expanded, but I know that is very 
much on the minds of leaders in medical education. The specific 
issue they will be taking up this summer as a result of the 
work we funded is within 80 hours a week.
    Do they need to make recommendations or guidelines about 
how that 80 hours is allocated? For example, could 72 of it--
which you probably did quite often at Parkland in the 1970's--
can you work 72 hours in a row or not? Right now I believe that 
the current rules allow people to work up to 36 hours.
    Having seen the results of this study, I think they feel 
compelled to go back and do that. One of the other areas that 
was inspired by the Institute of Medicine report is to actually 
include some training about systems and team practices. So, for 
example, one of the modules that they have developed focuses on 
why can't we get thrombolytic treatment to patients who are 
coming into the emergency room with a heart attack.
    It has to be done in a very timely fashion. That is an 
exercise that people go through. It is not because no one knows 
to actually administer the treatment. The issue is how do you 
make the decisions in a fast enough fashion that you can get 
the medication from the pharmacy and the cardiologist who is on 
call comes in, and so on and so forth. So that is now a part of 
residency training. I expect that we will continue to be in 
touch with them.
    Mr. Burgess. Let me move on to the issue of information 
technology. We hear a lot about that up here. I will have to 
tell you, I worry that your information technology may be like 
hyperbaric oxygen. It may be the last refuge of the uninformed. 
I remember when we got--well, there has been some significant 
breakthroughs in technology since I started in medicine. The 
pulse oximeter was one of those that I think saved a tremendous 
number of lives. The fetal monitor has arguably saved a great 
number of lives.
    But I still remember the morning that Dr. Pritchard, my old 
residency chairman, walked into the room, and there were eight 
or nine of us huddled around the monitor, no one paying any 
attention to the patient and her baby at the bedside. That was 
a lesson that will probably stay with me the rest of my life. 
We had a good few good laughs over that afterward, as you might 
imagine.
    But the IT part is only as good as the people who put the 
data in and then the people who analyze the data. If we just 
simply throw a bunch of IT or IT dollars at that time problem, 
I can see the opportunity for some spectacular failures in that 
avenue.
    Ms. Clancy. I couldn't agree with you more. Our grantees 
generally tend to agree that using information technology to 
improve the safety and quality of health care is one part 
technology and two parts work processes and getting people to 
collaborate and be very clear about what they are doing. Simply 
installing computers with a magic wand everywhere is not going 
to address these problems if it is not linked with a work flow 
and doesn't actually enhance what physicians, nurses and other 
health care professionals do in terms of patient care. All of 
the grants that we are making in this area are focused 
explicitly with evaluating applications of health information 
technology to see their impact on safety and quality, including 
when they don't work as intended.
    Mr. Burgess. Just from my own experience with a trial of e-
prescribing, it adds 1 to 2 minutes per patient encounter, if 
you do it accurately, which was the whole idea, I think, of e-
prescribing, that we will be more accurate. But in a typical 
doctor office where you see 35 or 45 patients or more, and 
almost all of those patients walk out with a prescription of 
some sort, we are adding an hour, conservatively, to that 
practitioner's day. Do we have a plan in place for compensating 
that practitioner for that hour?
    Ms. Clancy. Well, that would specifically be within the 
jurisdiction of the Congress and CMS and other payers. We do 
have a couple of trials ongoing right now examining the use of 
electronic prescribing to reduce medication errors.
    We are finding out a lot about the limitations of the 
current existing technologies. We think it is very important to 
feed that back to the vendors and others who develop them, 
because if you add time to a physician's day the likelihood 
that they are going to use that technology as often as intended 
seems to me to diminish.
    Mr. Burgess. It does diminish rather strikingly in my 
experience.
    My time is up, Mr. Chairman. I would just ask, would there 
be the possibility of submitting written questions as well?
    Mr. Deal. Yes.
    Mr. Burgess. All right. Thank you.
    Mr. Deal. We will do that. Mr. Waxman.
    Mr. Waxman. Thank you, Mr. Chairman.
    Dr. Clancy, thank you very much for your testimony. All of 
us want to work very closely with you. The idea of patient 
safety and quality initiatives are important, and the work that 
you are doing has shown many different ways to lessen medical 
errors, some big and some small. I would hope that you would 
continue to dedicate significant time and resources toward such 
initiatives.
    My concern is that since 2004 much Federal funding for 
patient safety research has been diverted to health information 
technology. Although information technology is an important 
component of improving quality of care, other research actions 
and implementations are also necessary. Could you tell us what 
portion of your budget is going to health information 
technology and how much is going to other patient safety 
initiatives?
    Ms. Clancy. This year we are investing a total of $84 
million in patient safety, including those projects that are 
labeled patient safety and those that are labeled health 
information technology. It turns out the break isn't quite as 
clean as you think. But $50 million this year is focused 
explicitly on evaluating selected applications of health 
information technology for their impact on quality and safety.
    This may sound a little bit more verbose than I would like, 
but the point is that many of the people who have been the 
early adapters making investments in IT, quality and safety is 
on the list but it is not actually one of the top two reasons 
they are making those investments. So we think there is a lot 
to learn and a lot of good lessons to share about how to make 
sure these applications work well for the clinicians using them 
and have the desired impact on safety and quality.
    Mr. Waxman. Do you think that more resources are necessary 
to implement and continue patient safety initiatives, including 
health information technology improvements? Can you talk about 
what else we need to be doing to attain a safer health care 
system in terms of patient safety?
    Ms. Clancy. I think that we need to continue on both 
fronts, both on the smart, if you will, use of health 
information technology as well as all of the system supports 
around that. This includes identifying and testing better ways 
for evaluating what happens when a medical error does take 
place, continuing to learn from how to report errors in a way 
that is meaningful, rather than simply making long lists of 
mistakes or errors that occurred, so that people can learn from 
them and prevent them in the future. We need to learn a lot 
about how we can standardize safe practices.
    I know you will hear a lot more about that from Dennis 
O'Leary a little bit later this afternoon.
    Mr. Waxman. How about the intersection between health 
information technology and the patient safety?
    Ms. Clancy. It is huge. In fact, I would say of that 
portfolio there is probably a good quarter of the projects that 
I would not know, even though I could probably tell what year 
they were funded, which portfolio they actually came out of. So 
from the outset of patient safety we funded a group of projects 
that looked at specific applications of information technology. 
All of the IT investments we are making now are focused. All of 
the grantees have to evaluate the impact on patient safety and 
quality.
    Mr. Waxman. Do you have some kind of systematic way of 
getting information from the people on the front lines? I 
generally think of operating room nurses and general care 
nurses. They must have a wealth of information. How do you make 
sure you get the benefit of their experience?
    Ms. Clancy. To some extent this survey tool that I 
mentioned a little bit earlier on culture of safety, one of the 
series of questions in there, the items in there actually 
examine whether or not people who are working on the front 
lines in hospitals have the opportunity to bring their concerns 
forward. Are they heard or are they actually punished or told 
to stop doing that? But we think advice from people on the 
front lines is critically important. They are an important 
component of all of the meetings that we have. We think it is 
very important to hear from consumers or recipients of care, 
also.
    Mr. Waxman. Do you recommend structures for hospitals so 
that the hospital and administration has a way to continually 
get information on what is being done and it is in fact being 
done?
    Ms. Clancy. I wouldn't make a specific recommendation for 
any hospital. What I think is that we have seen that those 
leaders who are committed to safety and quality and have boards 
of trustees who are very interested in this topic tend to keep 
it on the front burner. I don't know if you had something more 
specific in mind.
    Mr. Waxman. I am just wondering if there are systems 
approach in a hospital--all hospitals I would think would want 
to have decent patient care to try to avoid errors, but is 
there some kind of systematic approach that hospitals have in 
place, not that they all have to be uniform, but is there 
something they could be doing to get the information and 
figuring out what advances there are in patient safety and how 
to avoid medical errors?
    Ms. Clancy. We are making all of the tools from our 
research available to hospitals as rapidly as we can. I think 
the response to the 100K Lives Campaign, about 2,300 of the 
Nation's hospitals having volunteered to participate--they are 
not getting paid--this is just part of what they are doing--is 
a strong reflection of how interested hospitals are, which I 
think is a good sign.
    Mr. Waxman. Thank you. Thank you, Mr. Chairman.
    Mr. Deal. Mr. Shimkus.
    Mr. Shimkus. I have great respect for Dr. Burgess, but he 
cut me to the quick when he said the debate on information 
technology was the last refuge of the uninformed, because in my 
discussions with--not just on patient safety, but with driving 
down cost, I kind of concur. I think we are going to reap great 
benefits. I have seen a couple of doctors' handwritings, Dr. 
Burgess.
    Mr. Burgess. What is your point?
    Mr. Shimkus. Type those babies in. They may be easier to 
read. I just think the great institutions around our country 
are doing it themselves, are putting money into information 
technology so that they can follow the file. Instead of going 
to the bedside and pulling out the chart and going through 
paper on paper, they can readily access it. I think you are 
making a strong investment in that, and I would encourage you 
to continue to do so.
    I want to address--talk to me about the issue--again, I am 
from southern Illinois. We have a medical crisis, medical 
liability. 160 doctors have left in a two-county area. The 
State legislature has just passed reforms that we think are 
going to be very, very helpful, if the Governor signs it.
    One thing that is driving patient safety issues is this 
whole--a small percentage of bad doctors who practice, cause 
problems and then cross State lines and cause problems and 
cross State lines and cause problems. It is a minority. It is a 
vast minority.
    So that brings up the debate of a list per State or 
nationally. I would like to hear your comments on how do we 
track the issue of bad doctors who are causing great cost and 
escalation in this whole debate?
    Ms. Clancy. I think there is a fair amount of information 
that would suggest that not all doctors who are sued have 
actually provided poor or negligent care. In fact the studies 
that Dr. Burgess referenced as contributing greatly to the 
Institute of Medicine report are looking at to what extent are 
malpractice suits attributable to poor care. The overlap is 
smaller than you think. Many of the victims of poor care don't 
sue, and many people who sue have not received negligent care. 
So that is one problem.
    From our recent research we know that when patients are 
injured they really want three things. One is they want an 
apology. They want an explanation. They would like some 
assurance that the institution and others involved are going to 
do something to prevent it from happening again. The doctors 
agree with them. But they are terrified. They are terrified 
that if they surface, errors or near misses, that they will be 
punished.
    That is something people figure out right away. So I think 
that in many, many areas, many specialties, liability is a huge 
barrier to our making progress on patient safety.
    Mr. Shimkus. But you didn't address the question on a bona 
fide listing of--you know, I concur. I have been living this 
medical liability crisis ever since I have been a public 
official in my State. So I know that those--both issues of 
people suing, not suing who are harmed and those who aren't 
harmed suing. But the issue is, what if you do have a 
poorlytrained bad doctor who practices, harms someone, then 
moves across the State line? I mean, we know the cases, we know 
that they are doing it. How do we address that issue?
    Ms. Clancy. Yes. I would like to defer that to the general 
counsel for the Department, if that is okay with you. We can 
get back with a response.
    Mr. Shimkus. I would love it. Thank you. The last thing, 
what is the patient's role on patient safety?
    Ms. Clancy. It is interesting there have been a number of 
surveys of the public that show between 30 and 40 percent say 
that they or a family member have been injured or believe they 
have been injured as a result of a medical error. The 
proportion of doctors is about the same.
    Both doctors and members of the public think that patients 
have an important role to play. Based on that, based on the 
best information that we could develop, we actually launched a 
campaign with the American Medical Association and American 
Hospital Association, about five steps that individuals could 
take to make sure that they get the safest health care 
possible.
    This is not about telling patients it is your fault that an 
error is committed, but simply alerting them to opportunities. 
One is to ask questions if you don't know what is happening. 
Another is to make sure that you get the results of any lab 
tests. The third is to make sure that you understand that you 
always have all the medications that you take with you. The 
fourth is to, if necessary, bring someone in with you. I can 
send you a copy of the five steps. It has been very, very 
popular.
    We are also working closely with a couple of consumer 
advocacy organizations, usually led by people who themselves 
have had a family member who has been the victim of a medical 
error. They want very, very much to work with others in health 
care to make positive changes.
    Mr. Shimkus. Mr. Chairman, I will end on this. I like that 
idea of asking questions. A lot of us, we love our doctors and 
we trust them. Seeking second opinions, when there is a 
question, would probably be very, very helpful. So I think that 
is also an important role.
    Thank you, Mr. Chairman.
    Mr. Deal. Thank you. Ms. Baldwin.
    Ms. Baldwin. Thank you, Mr. Chairman. I am going to follow 
along the lines that Mr. Shimkus was just asking about in terms 
of patients' role in all of this. I think that public reporting 
of errors and quality data is important if we are to empower 
patients.
    Would AHRQ support the public reporting of things like 
infection rates at hospitals and process measurements such as 
has every person with a heart attack received an aspirin and a 
beta blocker within the appropriate amount of time? These are 
the types of measures that the National Quality Forum develops 
through the consensus building process.
    I think public reporting of these types of measures helps 
prompt entities to improve by allowing the public to choose 
quality providers. In my home State of Wisconsin, we have a 
system that does this. It is called QualityCounts, which 
provides health care consumers with various hospital 
performance measurements. QualityCounts seems to have been very 
effective in informing consumers. So I am wondering if this is 
something that you are supporting and trying to further?
    Ms. Clancy. Yes, we work very closely with the Quality 
Forum as well as the Joint Commission of the American Hospital 
Association and so forth. In fact, I think, as all of you were 
aware, almost all of the Nation's hospitals right now are 
reporting publicly on 10 clinical measures of quality, starting 
in 2005. Our role in that has actually been to develop a 
consumer survey called HCAHPS, which will assess the patient's 
perspectives on their care in the hospital. That should be up 
and running later this year.
    I was literally at a meeting with some other colleagues 
from the Hospital Association, the Joint Commission and other 
organizations before coming here, trying to think about what 
are the next measures that need to be added to those 10, 
because I think it is very, very important that people have 
good information.
    A critical issue with respect to infections and some other 
dimensions of errors or bad outcomes that we don't necessarily 
want, is making sure that we know what we are counting is fair. 
So, for example, right now it is often difficult to know 
whether higher infection rate means worse care, more infections 
in a hospital or more attention being paid to counting 
infections. We are still struggling with that. That did not 
make it through the National Quality Forum endorsement process. 
But we are still struggling to find out how to make it easier 
to do that because obviously a lot of information that is 
important to consumers.
    Ms. Baldwin. Great. One of the things that I am curious 
about is making sure that any new Federal involvement in 
patient safety and quality improvement is synchronized with our 
efforts in this area. As I understand it, currently the most 
significant Federal investment in patient safety and quality is 
the Medicare Quality Improvement Organization Program, QIO. 
Again in Wisconsin our QIO is called MetaStar. In my experience 
they have done really great work in our State, playing a 
central role in Wisconsin's patient safety initiative since it 
was first created.
    So in light of the work that QIOs are doing, what 
assurances can you offer us that any additional resources for 
AHRQ's effort in patient safety and quality are not duplicative 
or lacking in coordination with the substantial investment of 
Medicare and programs in the same area?
    Ms. Clancy. We worked actually very closely with the QIO 
program and consider them pretty vital partners. For example, 
this year in the eighth scope of work, one of their priorities 
will be focusing on helping small physician practices adopt 
health information technology. Many of those practices don't 
have--well, they are certainly not going to have their own IT 
staff, for example, or a host of computer guys. We are looking 
to partner with them whenever possible, to make sure that we 
were as focused on alignment and coordination as we could be. 
We actually have a joint employee with CMS that makes sure that 
our activities with the QIOs and other aspects of quality 
improvement are aligned as close as possible.
    Ms. Baldwin. Great. Thank you.
    Mr. Deal. Thank you.
    Ms. Myrick.
    Mrs. Myrick. Thank you. I appreciate the fact that you are 
here today to share with us. I am delighted to hear that there 
is more going on in the area of when we talk about patient 
safety and errors in the area of cleanliness relative to staph 
infection, because it is so hard for me to understand in this 
day and age when we have got something that is so simple that 
can be solved, like washing your hands, and people in the 
medical field are not doing it.
    In our area, I know that, you know, it seems like every 
third or fourth person that comes out of the hospital says they 
have a staph infection. I mean, we have experienced it too. It 
is very frustrating. I know some hospitals have been very 
successful in their programs, and I just hope that that stays a 
major part of what you all are doing relative to the quality 
improvements, and so forth, with the hospitals that you are 
going to be working with.
    Then the other thing I wanted to say was I know, just again 
from working with them at home, the anesthesiologists, when you 
are talking about different specialty groups in safety, started 
back in the 1980's in trying to really improve their error 
rate, because it was like 1 in 10,000 back then. It is now 1 in 
200,000, which is a huge improvement. But they did it through 
training and increased technology and other means.
    Are other specialties taking this on, as far as you know? I 
mean, are other people actively really looking at their own 
areas, not just the hospital but specialties?
    Ms. Clancy. Yes, what the anesthesiologists did I think was 
groundbreaking for the field of medicine. They took some 
lessons from aviation and other industries so that any time an 
anesthesiologist walked into an operating room, all the 
cylinders of gas and things like that, all the different 
technology and equipment they used always worked the same way. 
So that tragic errors wouldn't be made because someone didn't 
mention to you that in this OR we turn it the other way.
    So that I think was really terrific. Interestingly in 
Wisconsin, the Department of Anesthesiology at the medical 
school has actually expanded on that work to now focus on 
quality of care in the operating room, which is the 
anesthesiologist, it is the surgical nurses, it is the surgeons 
and so forth.
    Mrs. Myrick. Good.
    Ms. Clancy. What they have done I think is incredibly 
encouraging. Of great interest a few years ago we reached out 
to the American Board of Internal Medicine. The boards are 
those entities that provide certification for physicians in 
different specialties. Right now, all of the medical boards, 
medical and surgical boards are doing two things. One is that 
they are requiring that all physicians be periodically 
recertified. So you don't just take a test once and then you 
are done. They are referring to this as maintenance of 
certification, but they are all making efforts to link 
maintenance of certification with your efforts to improve 
safety and quality wherever it is that you practice.
    Mrs. Myrick. Very good.
    Ms. Clancy. So it isn't just that you read a lot and take a 
test, but it is actually linked to the application and the work 
that you are already doing in trying to improve patient safety 
and quality.
    Mrs. Myrick. Well, I appreciate very much what you are 
doing. Thanks.
    Ms. Clancy. Thank you.
    Mrs. Myrick. I yield back.
    Mr. Deal. Thank you. Well, Dr. Clancy, thank you so very 
much. That is been very helpful and informative. There probably 
will be some written questions submitted and we would 
appreciate your response to you. Thank you for being with us 
today.
    I would ask our second panel if they would please come to 
the table. Let me introduce our second panel.
    First of all, Dr. Dennis O'Leary is President of the Joint 
Commission on Accreditation of Healthcare Organizations; Dr. F. 
Dean Griffen, who is representing the American College of 
Surgeons; Dr. William A. Bornstein, who is representing the 
Medical Association of Georgia and Emory Healthcare System; Ms. 
Jane Loewenson, who is the Director of Health Policy for the 
National Partnership for Women & Families.
    Gentlemen and gentlelady, we are happy to have you with us.
    Dr. O'Leary, I will start with you.

 STATEMENTS OF DENNIS O'LEARY, PRESIDENT, JOINT COMMISSION ON 
  ACCREDITATION OF HEALTHCARE ORGANIZATIONS; F. DEAN GRIFFEN, 
  AMERICAN COLLEGE OF SURGEONS; WILLIAM A. BORNSTEIN, MEDICAL 
 ASSOCIATION OF GEORGIA; AND JANE LOEWENSON, DIRECTOR, HEALTH 
      POLICY, NATIONAL PARTNERSHIP FOR WOMEN AND FAMILIES

    Mr. O'Leary. Thank you, sir. I am Dr. Dennis O'Leary, 
President of the Commission on Accreditation of Healthcare 
Organizations. As the Nation's principal health care 
accrediting body, the Joint Commission has long been dedicated 
to improving the safety and quality of care provided to the 
public.
    In recent years the Joint Commission has worked intensely 
on public awareness and safety issues and to promulgate a range 
of workable and necessary solutions. The Joint Commission's 
successful efforts in this regard have been recognized in 
articles recently published in Health Affairs, and the Journal 
of the American Medical Association.
    Today I would like to highlight some of the initiatives in 
which the Joint Commission is engaged and to suggest some areas 
of merit for their exploration.
    The most compelling need is for provider organizations to 
adopt broad-based systems approaches to managing and actually 
reaching patients. More to the point, we need organization 
environments where safety is always in mind and in which 
identified errors are viewed as opportunities for improvement, 
in which apology, honesty and transparency characterized the 
relationship of patients who have been harmed with error and 
which there is constant vigilance for emerging risks. With this 
framework in mind, the Joint Commission has created a 
substantial portfolio of patient safety initiatives.
    Taken together, they constitute a road map for improving 
patient safety. Let me highlight some of these efforts.
    First, the Joint Commission earlier this year launched a 
new International Center For Patient Safety. The center will 
initially focus on the identification, gathering, analysis, and 
dissemination of patient safety solutions both in this country 
and abroad, and upon the creation of cultures of safety and 
health care organizations. The center will obtain input and 
guidance through an international steering committee of patient 
safety experts and five global regional advisory councils.
    In addition, the center will shortly convene this country's 
10 principal patient safety organizations to explore 
opportunities to collaborate in promulgating patient safety 
solutions. This domestic collaboration will set the stage for 
creation of a worldwide network of patient safety leadership 
organizations. Indeed, the World Health Organization last year 
launched a World Alliance For Patient Safety, and the Joint 
Commission is soon expected to be designated as a WHO 
international collaborating center for patient safety solutions 
as a part of this initiative.
    A second critical effort involves the annual setting of 
national patient safety goals and associated requirements. The 
purpose of the national patient safety goals is to focus the 
attention of accredited organizations on obvious, 
straightforward, inexpensive patient safety solutions. 
Compliance with the specific requirements is evaluated during 
each onsite accreditation survey and the organization's 
performance with respect to each national patient safety goal 
is publicly reported.
    Third, this past winter the Joint Commission joined with 
the centers for Medicare and Medicaid services to partner with 
the Institute For Health Care Improvement in a national 
campaign to save 100,000 lives by June 2006. This initiative is 
enlisting thousands of hospitals across the country in a 
commitment to implement specific evidence-based patient care 
interventions to prevent avoidable deaths. This campaign is 
viewed by the growing number of partners and participants as an 
outstanding opportunity to realize some of the Institute of 
Medicine's major goals through a concerted effort.
    The last set of issues I would like to mention is framed in 
the Joint Commission's recently released policy report, 
Strategies for Improving the Medical Liability System and 
Preventing Patient Injury. This particular initiative was 
spurred by the chilling effect that the current system has on 
reporting adverse events in health care by the high, 
exorbitantly high cost of defensive medicine and by the 
fundamental lack of fairness of the current system in 
compensating injured patients. The Joint Commission believes 
that the debate over medical liability reform must be broadened 
to encompass the patient safety issues that fuel litigation at 
the front end.
    Of the almost two dozen recommendations in the report, two 
are especially relevant to the hearing today. First, more 
should be done to encourage appropriate adherence to clinical 
guidelines and other desired performance. Adherence to clinical 
guidelines is known to be an effective way in which to improve 
quality, reduce variation in care, and improve financial 
performance. Adherence to the guidelines can also have a 
substantial role in reducing legal risk. One way to promote 
greater use of clinical guidelines and accepted patient safety 
solutions is to pursue strategies that provide incentives for 
their use.
    Second, we need to encourage clear and honest communication 
between practitioners and patients when an adverse event 
occurs. Specifically, patients and their families need a prompt 
explanation of what happened, a commitment that an 
investigation will be done to understand what went wrong, 
assurance that steps will be taken to make it unlikely that 
such an event will happen again, and, most importantly, an 
apology.
    The Joint Commission's accreditation standards require the 
disclosure of unanticipated outcomes to patients and their 
families when they occur. However, a recent study confirms that 
half of hospitals are reluctant to comply with this standard 
for fear of liability suits.
    In a very real sense, the health care industry is a victim 
of the rapid and continuing advances and its capabilities and 
sophistication. Much progress has been made in improving 
patient safety since the IOM issued its report To Err Is Human, 
but we may actually be falling further behind as new drugs, 
procedures, and technologies are introduced every day. Each of 
these has inherent safety risks that have not been identified, 
and they are usually introduced into care delivery systems 
where patient safety and systems thinkings are not constantly 
top of mind. The knowledge of what to do differently and how to 
do it exists, but we are far closer to the beginning of the 
journey than we are at the end. We as a society must ramp up 
our efforts if we are to successfully bridge the chasm between 
the current state of health care and what is truly safe, high 
quality care.
    [The prepared statement of Dennis O'Leary follows:]

 Prepared Statement of Dennis O'Leary, President, Joint Commission on 
               Accreditation of Healthcare Organizations

    I am Dr. Dennis O'Leary, President of the Joint Commission on 
Accreditation of Healthcare Organizations. I appreciate the opportunity 
to testify on new patient safety and quality initiatives that are 
currently underway in this country and, in some instances, around the 
world.
    Founded in 1951, the Joint Commission is a private sector, not-for-
profit entity dedicated to improving the safety and quality of health 
care provided to the public. Our member organizations are the American 
College of Surgeons; the American Medical Association; the American 
Hospital Association; the American College of Physicians; and the 
American Dental Association. In addition to these organizations, the 
29-member Board of Commissioners includes representation from the field 
of nursing as well as public members whose expertise spans such diverse 
areas as ethics, public policy, insurance, and academia.
    The Joint Commission currently accredits over 15,000 organizations 
in the United States. These include hospitals (both general acute care 
and specialty), critical access hospitals, laboratories, health care 
networks (including integrated delivery systems, HMOs and PPOs), 
ambulatory care, office-based surgery, assisted living, behavioral 
health care, home care, hospice, and long term care organizations. 
About one-third of accredited organizations are hospitals, comprising 
the 80% of hospitals that contain 96% of U.S. hospital beds.
    Accreditation is voluntary for all types of accredited 
organizations. However, both federal and state government regulatory 
bodies recognize many of the Joint Commission's accreditation programs 
and rely upon its accreditation findings and decisions for Medicare and 
licensure purposes. Furthermore, the Joint Commission standards are 
widely utilized by private sector organizations even where 
accreditation is not the objective. The Joint Commission also has a 
large international presence working with major leadership 
organizations such as the World Health Organization and the World Bank; 
accrediting individual hospitals in multiple countries; and providing 
consultation to foreign governments that are seeking to create similar 
accrediting bodies.
    This country has been engaged in a highly visible national dialogue 
on patient safety for over five years. For an even longer time, the 
Joint Commission has been working diligently on a number of fronts both 
to raise professional and public awareness of safety issues and to 
identify and promulgate a range of workable and necessary solutions. We 
believe that some notable progress has been made, and the Joint 
Commission's successful efforts in this regard have been recognized in 
recent articles by Robert Wachter in Health Affairs and by Lucian Leape 
and Don Berwick in the Journal of the American Medical Association. In 
point of fact, there has been a remarkable change in how leaders in 
health care organizations talk and think about patient safety issues 
and how they approach medical errors when they occur. Moreover, there 
is broad support across the health care industry and among policy-
makers for creation of blame-free environments that foster increased 
reporting of patient safety events. Nonetheless, we have a long way to 
go to reach our shared goals. This is because the root causes of 
medical errors and quality problems are numerous, complex, and hard-
wired into the way we deliver health care. We therefore need a 
multifaceted, multi-stakeholder approach to ensuring that high quality, 
safe care is provided on a consistent and predictable basis in this 
country.
    Today, I would like to highlight some of the initiatives in which 
the Joint Commission is engaged in its continuing efforts to improve 
care, and to also suggest some areas that merit further exploration.
    The Joint Commission's efforts to improve patient safety are based 
upon a fundamental recognition of the need for provider organizations 
and practitioners to adopt a ``systems approach'' to managing risk and 
keeping inevitable human error from reaching patients. The systems 
approach idea is borrowed from engineering and quality control 
principles which have been successfully applied in manufacturing and 
other industries to mitigate the effects of human error. The growing 
awareness of practices used in other high risk endeavors (e.g., in the 
nuclear power and airline industries) to create safety, makes clear 
that a name, blame, and shame approach to safety will fail, and that 
the end goal must be the design of safe systems--systems that are 
designed to anticipate human error and prevent the occurrence of 
adverse events.
    This approach to safety--``systems thinking''--requires tools such 
as retrospective root cause(s) analysis when adverse events occur and 
prospective failure mode and effects analyses to identify and eliminate 
risks in identified vulnerable processes before actual adverse events 
can occur. This approach also requires a learning environment in which 
errors and preventable harms are identified (rather than hidden) so 
that they can become learning experiences for the organization.
    Also required is an organizational environment that is safety-
focused; that is, one in which safety is always top of one's mind; in 
which reporting of errors and unsafe conditions is rewarded, not 
punished; in which apology, honesty, and transparency characterize the 
relationship with patients who have been harmed through error; and in 
which there is constant vigilance for emerging risks. This type of 
organization environment--often called a ``culture of safety''--only 
develops when the organization's administrative and clinical leaders 
collaboratively and intentionally create it.

                            TOOLS FOR CHANGE

    With this framework in mind, the Joint Commission has created a 
substantial portfolio of initiatives, practical tools, and solutions 
for patient safety over the past decade. Taken together, they 
constitute a roadmap for organizations that are seeking ways to improve 
their performance and enhance patient safety. Concepts and tools are 
critical ingredients for any type of sea change. If we are to truly 
achieve improvements in patient safety, we must give health care 
organization leaders, clinicians and patients the information, tools 
and potential solution they need to effect such changes.
    The patient safety initiatives that I would like to highlight today 
are: 1) our new International Center for Patient Safety, 2) new 
accreditation standards, 3) the Sentinel Event Policy and Alerts, 4) 
the National Patient Safety Goals and Universal Protocol, 5) the Speak-
Up Campaign, 6) the Patient Safety Event Taxonomy, 7) the 100 Thousand 
Lives Campaign, and 8) selected recommendations from our initiative to 
link potential improvements in the medical liability system to the 
prevention of patient injury.

International Center for Patient Safety (ICPS)
    In March of this year, the Joint Commission launched a new 
International Center for Patient Safety (ICPS). The Center will 
initially focus on the identification, gathering, analysis, and 
dissemination of patient safety solutions, both in this country and 
abroad, and upon the creation of organization cultures of safety which 
embrace continuous attention to safety-focused, systems improvement 
efforts. These are seen as the most significant near-term opportunities 
for achieving major advancements in patient safety. The center will 
also serve as a focal point for research and related efforts to develop 
additional patient safety-related solutions. The center will obtain 
input, feedback and guidance through an international steering 
committee of patient safety experts, five global regional advisory 
councils, and strategic domestic and international.
    The Patient Safety Center recently launched a new Web site which 
will serve as a central repository of resources and information related 
to all aspects of patient safety. Its content is relevant to patients, 
provider organizations, purchasers, physicians, nurses, and other 
practitioners. Health care organizations and health professionals will, 
for example, be able to use the Center's Web site to find information 
on the most frequent types of identified sentinel events and their root 
causes and resources for understanding and meeting the Joint 
Commission's National Patient Safety Goals. Patients and their 
families, as well as purchasers, will be able to use the Center's Web 
site to obtain quality-related performance information on health care 
organizations, become familiar with public education campaigns on 
patient safety such as the Joint Commission's Speak Up Campaign, and 
become knowledgeable about public policy issues that impact patient 
safety. Online discussion groups will provide an interactive forum for 
international dialogue on critical patient safety issues and topics.
    The Center's Web site will also become the focus of the Center's 
efforts to create a worldwide collaborative network of patient safety 
leadership organizations. The international context is particularly 
significant, because patient safety is a universal problem. In fact, 
the World Health Organization launched its own World Alliance for 
Patient Safety in October 2004, and the Joint Commission and Joint 
Commission International are now involved in several of the Alliance's 
major initiatives. These include the lead role for creation of an 
International Patient Safety Events Taxonomy and designation as the WHO 
International Collaborating Center for Patient Safety Solutions, to 
coordinate the work of the Alliance's Solutions Initiative. A WHO 
collaborating center is a national institution designated by the 
Director-General of the World Health Organization to participate in an 
international collaborative network that carries out activities in 
support of WHO's mandate to promote international health.
    The World Alliance for Patient Safety has been charged to conduct 
six initiatives over the next two years:

 Global Patient Safety Challenge--to focus on the reduction of health 
        care-associated infections through the promotion of hand 
        washing and other preventive efforts.
 Patients for Patient Safety--to identify and create a network of 
        patient and consumer groups interested in identifying and 
        promoting constructive patient safety solutions.
 International Patient Safety Events Taxonomy--to utilize the Joint 
        Commission's Patient Safety Events Taxonomy to create a high 
        level international umbrella taxonomy that accommodates 
        taxonomies already in existence in other countries.
 Research for Patient Safety--to undertake prevalence studies of 
        adverse events in selected developed and developing countries 
        and to pursue other patient safety research initiatives.
 Solutions for Patient Safety--to identify, gather, evaluate and 
        disseminate patient safety solutions that are tailored to the 
        needs of developing and developed countries.
 Reporting for Learning--to identify best practice guidelines for 
        reporting systems that facilitate learning from adverse events 
        and analyses of their underlying causes.
 The Joint Commission's International Center for Patient Safety will 
        shortly convene the principal patient safety leadership 
        organizations in the United States to explore opportunities to 
        collaborate in coordinating the identification and 
        dissemination of patient safety solutions and in pursuing other 
        opportunities to improve patient safety. Those organizations 
        that have agreed to participate are the Agency for Healthcare 
        Research and Quality, United States Pharmacopeia, VA National 
        Center for Patient Safety, ECRI, Institute for Healthcare 
        Improvement, Institute for Safe Medication Practices, the 
        Leapfrog Group, the National Patient Safety Foundation and the 
        National Quality Forum.

Patient Safety Related Standards
    One of the key elements in the Joint Commission's commitment to 
patient safety is the development, updating, and deployment of state-
of-the-art patient safety standards. Over half of Joint Commission 
standards are directly related to safety --addressing such issues as 
medication use, infection control, surgery and anesthesia, blood 
transfusion, restraint and seclusion, staffing and staff competence, 
fire safety, medical equipment maintenance, emergency management, and 
security, among other areas.
    In recent years, new and revised standards now require the internal 
definition, reporting and in-depth analysis of serious adverse events; 
internal systems improvements based on these analyses; the 
implementation of comprehensive virtual patient safety programs that 
actively engage organization leaders; the prevention of accidental harm 
through the prospective analysis and redesign of vulnerable patient 
systems (e.g. the ordering, preparation and dispensing of medications); 
and transparency in the communication of outcomes of care--whether good 
or bad--from the organization (usually through the responsible 
physician) to the patient. The Joint Commission has also taken steps to 
ratchet up the performance expectations respecting medication 
management and infection control and has introduced patient flow 
standards to mitigate the impacts of emergency department overcrowding 
on patient safety. Under development are major standards revisions that 
will substantially increase the stringency of current processes for 
credentialing physicians and licensed, independent practitioners and 
assessing their competency in the performance of various clinical 
procedures. These enhanced expectations anticipate increasing greater 
use of performance data as part of both the privileging and performance 
monitoring process.

Sentinel Event Policy
    In 1995, the Joint Commission developed and implemented a Sentinel 
Event Policy that encourages the voluntary reporting of serious adverse 
events and requires the performance of root cause analyses that meet 
pre-determined criteria for thoroughness and credibility. Soon 
thereafter, the Joint Commission began to characterize and organize the 
reported events and their underlying causes for all identified 
occurrences (whether self-reported or otherwise), into a learning 
database. The resulting Sentinel Event Database is now this country's 
most complete record of the full spectrum of serious medical errors and 
their underlying causes. This database, combined with knowledge gained 
from working with health care organizations on a daily basis to address 
their patient safety problems, has given us a deep understanding of the 
interplay and complexity of factors that contribute to serious adverse 
events. It has also helped us craft solutions to some common safety 
issues. The solutions represent a range of actions--both low and high 
cost--that can be taken at various levels of the health care system and 
in which different stakeholder groups can participate.
    The Sentinel Event Policy and its resultant database have proven 
their value. However, we would have many more reports and a more robust 
understanding of root causes of error if there were federal protection 
for reporting adverse events and near-misses. This Subcommittee has 
previously shown strong leadership in this area, and we hope it will 
continue to work toward passage of such safe harbor legislation this 
year.

Sentinel Event Alerts
    For the past seven years, patient safety solutions from the 
Sentinel Event Database have been disseminated in the periodic 
publication, Sentinel Event Alert. Since its creation, over 30 issues 
of Sentinel Event Alert have raised awareness in the health care 
community and the federal government about the occurrences of adverse 
events and the ways in which these events can be prevented. By 
distributing Sentinel Event Alert, the Joint Commission encourages 
organizations to implement the suggestions found with the publication 
to prevent errors and enhance patient safety. The most recent topics 
covered in Sentinel Event Alerts have been patient controlled analgesia 
by proxy and anesthesia awareness.

National Patient Safety Goals
    Based upon the data from the Sentinel Event Database and other 
patient safety databases, and the advice of a national panel of patient 
safety experts, the Joint Commission now annually establishes and 
issues a set of National Patient Safety Goals and associated 
Requirements. The purpose of the Joint Commission's National Patient 
Safety Goals is to focus attention on obvious, relatively straight-
forward, inexpensive patient safety solutions that all accredited 
organizations are expected to adopt. The goal-related requirements are 
specifically surveyed during the onsite accreditation survey, and the 
organization's performance with respect to each National Patient Safety 
Goal is reported in an organization-specific Quality Report on the 
Joint Commission's public website (www.qualitycheck.org). This public 
disclosure is not of errors or adverse events, but, rather, of whether 
the organization is performing the specific safe practices described in 
the Requirements.
    Last month, the Joint Commission Board affirmed its required ``do 
not use'' list of abbreviations. The list was originally created in 
2004 by the Joint Commission as part of a National Patient Safety Goal 
which mandates identification of a list of abbreviations, acronyms and 
symbols that are not to be used throughout the organization. 
Participants at a 2004 Summit convened to address this issue supported 
the ``do not use'' list. During the ensuing four-week comment period, 
the Joint Commission received 5,227 responses that included 15,485 
comments. More than 80 percent of the respondents supported maintenance 
of the ``do not use'' abbreviation list.

Universal Protocol
    In 2003, the Joint Commission's Board of Commissioners approved a 
separate Universal Protocol for Preventing Wrong Site, Wrong Procedure 
and Wrong Person Surgery as a supplement to the National Patient Safety 
Goals. The Universal Protocol was created to staunch the continuing 
occurrence of a specific type of adverse type that should simply never 
occur. The Universal Protocol became effective July 1, 2004 for all 
accredited hospitals, ambulatory care and office-based surgery 
facilities. The Universal Protocol drew upon, and expanded and 
integrated, a series of previous requirements under the Joint 
Commission's 2003 and 2004 National Patient Safety Goals and is 
applicable to all operative and other invasive procedures. The 
principal components of the Universal Protocol include: 1) the pre-
operative verification process; 2) marking of the operative site; and 
3) taking a ``time out'' immediately before starting the procedure. The 
protocol has been endorsed by nearly 50 professional associations and 
societies.

Speak-Up Campaign
    Several years ago, the Joint Commission, together with the Centers 
for Medicare and Medicaid Services, launched a national program to urge 
patients to take an active role in preventing adverse events in health 
care by becoming involved and informed participants on the health care 
team. The program utilizes various media to reach patients and 
consumers, including incorporation into selected purchaser employee 
benefits strategies, and has been embraced by a number of provider 
organizations and practitioners. The original Speak Up initiative was 
subsequently expanded to Help Prevent Errors in Your Care for Surgical 
Patients. This campaign provided tips to help patients prepare for 
surgery and assure their involvement in making certain that the correct 
procedure is performed at the correct body site. The two campaigns 
launched in 2004 included Preparing to be a Living Organ Donor which 
urges individuals to think through the risks and realities of becoming 
a living organ donor, and Three Things You Can Do To Prevent Infection 
which highlights a series of easy to steps anyone can take to avoid 
contagious respiratory diseases like the common cold, strep throat, and 
influenza. This year, the Joint Commission launched Things You Can Do 
To Prevent Medication Mistakes. This provides important tips for 
preventing medication mistakes and outlines key questions that the 
patient may want to pose to the doctor, pharmacist, nurse or other 
caregiver. Additional patient safety topics--such as discharge planning 
and pain management--stroke will be addressed in the future.

Standardized Patient Safety Events Taxonomy
    It is no small irony that the progressively expanding national 
discussions on patient safety over the past several years are not based 
on a common language. For example, there are no agreed upon definitions 
of ``medical error'' or ``adverse event,'' making it extremely 
difficult, if not impossible, to aggregate safety data across various 
types of reporting programs. This critical missing element has hindered 
our collective ability to collect patient safety data in a consistent 
fashion, analyze process failures, mine data (e.g., trends, pattern 
analysis), and disseminate new knowledge about patient safety. In 
response to this challenge, the Joint Commission has created the 
framework for a comprehensive Patient Safety Event Taxonomy. This 
taxonomy is currently in the final stages of the National Quality 
Forum's consensus development process. Having a standardized taxonomy 
will facilitate the management of patient safety data and the 
development of patient safety reporting systems. It should eventually 
have broad potential utility for consumers, provider organizations, 
health care practitioners, purchasers, researchers and other audiences.
    As noted previously, this taxonomy is being used as the starting 
point for a WHO-led project to create an international Patient Safety 
Events Taxonomy. The development of a common international framework 
for classifying, measuring, and reporting adverse events and near 
misses is one of the principal technical components of the WHO's global 
strategy to improve health care delivery systems, product safety 
(devices, drugs, biologics, and vaccines) and the safety of services 
(medical decision-making, diagnosis, and laboratory analysis). The 
intent is to create a scalable, portable framework that can be used to 
classify patient safety incidents reported through different systems in 
different countries with varying levels of technology.
100,000 Lives Campaign
    Much of what the Joint Commission does and achieves is realized 
through partnerships with other health care leadership organizations. 
This past winter, the Joint Commission announced that it was joining 
with the Centers for Medicare and Medicaid Services to partner with the 
Institute for Healthcare Improvement in the national campaign to save 
100,000 lives by June 2006. The campaign aims to enlist thousands of 
hospitals across the country in a commitment to implement changes to 
prevent avoidable deaths. The 100,000 lives campaign is viewed by the 
growing number of partners and participants as an outstanding 
opportunity to realize some of the Institute of Medicine's major goals 
through a concentrated effort. Hospitals that choose to participate in 
the campaign will specifically commit to implement one or more of the 
following six quality improvement changes:

 Deploy Rapid Response Teams at the first sign of patient decline
 Deliver reliable, evidence-based care for Acute Myocardial Infarction 
        to prevent deaths from heart attack
 Prevent adverse drug events by implementing medication reconciliation
 Prevent central line infections by implementing a series of 
        interdependent, scientifically grounded steps called the 
        ``Central Line Bundle''
 Prevent surgical site infections by reliably delivering the correct 
        perioperative antibiotics at the proper time
 Prevent ventilator-associated pneumonia by implementing a series of 
        interdependent, scientifically grounded steps called the 
        ``Ventilator Bundle''

Strategies for Improving the Medical Liability System and Preventing 
        Patient Injury
    Through its Public Policy Initiatives, the Joint Commission 
periodically tackles tough patient safety and health care quality 
issues that would benefit from an independent voice. This year, the 
Joint Commission released a public policy report called ``Strategies 
for Improving the Medical Liability System and Preventing Patient 
Injury.'' The initiative was spurred by the chilling effect that the 
current system has on identifying and reporting adverse events in 
health care; by large jury awards; the exorbitantly high cost of 
defensive medicine; and by the fundamental lack of fairness of the 
current system in compensating injured patients. The Joint Commission 
wanted to broaden the debate over liability reform to encompass the 
patient safety issues that fuel litigation at the front end.
    To address this issue, the Joint Commission convened a roundtable 
of experts in law, medicine, health care policy and related research, 
as well as patient safety advocates to frame the issues and create 
recommendations for action. The basic finding of the Roundtable was 
that there is a fundamental dissonance between the medical liability 
system and patient safety. Patient safety depends upon the transparency 
of information on which to base improvement, while medical liability 
drives information underground and out of reach to those who could most 
benefit from it. Of the more than a dozen recommendations from the 
recently issued report, several are relevant to this hearing today.
    1) Encourage appropriate adherence to clinical guidelines and 
performance recognitions. Adherence to clinical guidelines has long 
been touted as an effective way in which to improve quality, reduce 
variation in care, and improve financial performance. However, there is 
also a significant relationship between medical liability and clinical 
guidelines. A new study has shown that adherence to guidelines can have 
a substantial role in reducing legal risk. One way to promote greater 
use of clinical guidelines and consensus approaches to patient safety 
solutions is to pursue strategies that provide incentives to focus on 
improvements in patient safety and health care quality.
    Pay for performance programs, for example, hold great promise for 
transforming the health care system to achieve the Institute of 
Medicine's six aims (safety, effectiveness, patient-centeredness, 
timeliness, efficiency, and equity.) Indeed, only small, symbolic 
rewards may be needed to achieve desired behavior changes. Also on this 
point, pay for performance opens a larger opportunity to reform. 
Reimbursement systems today usually fail to recognize, let alone 
compensate for necessary investments by provider organizations and 
practitioners in patient safety.
    2) Encourage communication between practitioners and patients when 
an adverse event occurs. One of the basic principles of patient safety 
is to communicate with and listen to patients. Several elements are 
fundamental to any disclosure effort when an adverse event occurs. 
These include a prompt explanation of what is understood about what 
happened and its probable effects; assurance that an analysis will take 
place to understand what went wrong; follow-up based on the analysis to 
make it unlikely that such an event will happen again; and an apology. 
The Joint Commission's accreditation standards require the disclosure 
of sentinel events and other unanticipated outcomes of care to patients 
and to their family members when they occur. A recent study nonetheless 
confirms that half of hospitals are reluctant to comply with this 
standard for fear of liability suits. But there is growing consensus 
that this openness has the potential to heal, rather than harm 
relationships between practitioners and patients.
    3) National Practitioner Data Bank. One of the ways through which 
health care organizations seek to assess competencies of their 
physicians and other practitioners with clinical privileges is to query 
available data sources about disciplinary actions or medical liability 
judgments and settlements. However, such information is impossible to 
obtain from any one source. We need a centralized repository, or a 
network of linked sources, to make such information available. The 
Department of Health and Human Services, through the Health Resources 
and Services Administration, operates the National Practitioner Data 
Bank (NPDB) to permit hospitals and licensing boards to track physician 
performance issues. However, since its inception, the reliability, 
validity, and completeness of the NPDB's information have been 
questioned. A 2000 GAO report pointed out the need for reform of the 
NPDB. We believe that pursuit of these reforms is long overdue. The 
only reliable alternative is to create an alternative resource to house 
this information in the private sector.

                           CONCLUDING REMARKS

    In conclusion, there remains much work to be done to truly change 
the culture of our complex health care delivery system to fully embrace 
patient safety and health care quality. The health care industry is a 
victim of its rapid success in the explosion of biomedical science, 
sophisticated technologies, and trained personnel who have highly 
specialized knowledge. Much progress has been made in improving patient 
safety since the IOM issued its report, To Err Is Human, but we may 
actually be falling further behind as new drugs, procedures and 
technologies are introduced every day. Each of these have inherent 
safety risks that have not been identified, and they will, for the most 
part, be introduced into care delivery settings where patient safety 
and systems thinking (``to keep the error from reaching the patient'') 
are not constantly top of mind. In addition, the absence of electronic 
information exchange capabilities to provide decision support makes it 
virtually impossible for practitioners to maintain a current clinical 
knowledge base.
    The knowledge of what to do differently and how to do it exists but 
we are we are far closer to the beginning of the journey than we are to 
the end. We as a society must ramp up our efforts if we are to 
successfully bridge the chasm between the current state of health care 
and what is truly safe, high quality care.

    Mr. Deal. Thank you. Dr. Griffin.

                  STATEMENT OF F. DEAN GRIFFEN

    Mr. Griffin. Thank you. My name is Dean Griffin, and I am a 
practicing general surgeon in private practice in Shreveport, 
Louisiana. I am pleased to be here today representing the 
American College of Surgeons and its 67,000 fellows and their 
patients. The College commends the subcommittee for undertaking 
this important hearing. We are pleased to have this opportunity 
to present testimony detailing some of the surgical programs 
that have been developed to improve surgical patient safety and 
quality of care.
    While the American College of Surgeons has had a long 
history of involvement in patient safety and quality efforts, I 
would like to focus today on those things that are currently 
rather new.
    The National Surgical Quality Improvement Program is the 
first nationally validated, risk adjusted, outcome based 
program that has been demonstrated to measure and improve the 
quality of surgical care. The program was initially developed 
by the Department of Veterans Affairs in the early 1990's. In 
the VA system, this group had impressive results with a 27 
percent decline in postoperative mortality, a 45 percent drop 
in postoperative morbidity, a reduction in average 
postoperative length of stay from 9 to 4 days, and an increased 
patient satisfaction level.
    In 2001, the College developed its own NISQIP, which 
expanded the program to the private sector through a grant from 
the Agency of Health Care Research and Quality. The program 
employs a prospective, peer controlled, validated data base to 
qualified 30-day risk adjusted surgical outcomes, allowing 
valid comparisons of outcomes among the hospitals now in the 
program. Medical centers and their surgical staffs are able to 
use the data to make informed decisions about their continuous 
quality improvement efforts.
    Of particular interest to hospitals is the generation of a 
risk adjusted observed to expected outcome ratio from each 
center which could be compared to other participating centers 
on a blinded basis. Statistical analysis of the preoperative 
data identifies risk factors, and further analysis calculates 
the expected outcome for each hospital's patient population. So 
far, the College has expanded the NISQIP program to over 30 
hospitals, and applications are under development for dozens of 
others who want to be involved.
    In 2002, the Institute of Medicine named the NISQIP the 
best in the Nation for measuring and reporting surgical quality 
outcomes.
    The College is one of 10 organizations on the Surgical Care 
Improvement Project Steering Committee. SCIP is a national 
partnership of organizations dedicated to improving the safety 
of surgical care by reducing postoperative complications. This 
summer, the SCIP partnership will launch a multi-year national 
effort to reduce surgical complications by 25 percent by 2010. 
SCIP quality improvement efforts are focused on reducing 
perioperative complications in the area where the instance and 
costs of complications is significant.
    Recently, the College has developed a Bariatric Surgery 
Center Accreditation Program to foster high quality care for 
patients undergoing bariatric surgery for morbid obesity by 
setting, monitoring, and reporting appropriate standards. 
Because the number of surgeons and hospitals providing 
bariatric surgery has grown so quickly, the College decided 
recently to place high priority on establishing this new 
accreditation program.
    The ACS has recently issued a patient safety manual titled 
Surgical Patient Safety: Essential Information for Surgeons in 
Today's Environment. This publication provides information and 
guidance for surgeons and others involved in surgical patient 
safety. It describes a variety of practical resources and 
provides a broad overview of key issues, such as the scientific 
basis of surgical patient safety. Issues such as decision 
support, electronic prescribing, and area detection, analysis, 
and reporting are all analyzed. Legal challenges for surgeons 
participating in patient safety activities are also reviewed. 
Broad error prevention methods and strategies for preventing 
wrong-site surgery and for safe blood transfusions and handling 
are also included.
    The College last year initiated an extensive analysis of 
closed general surgery malpractice claims in order to generate 
data that will help guide its patient safety educational 
efforts and perhaps maybe some research and standard setting as 
well.
    The College is a sponsor of the National Time Out Day, 
which highlights the JCAHO universal protocol and other 
initiatives that have been developed to reduce medical and 
surgical errors. The surgical time out is an opportunity before 
a surgical procedure begins for all members of the operating 
team to review the case for the patient's benefit.
    In conclusion, the College is proud of its many important 
innovations and quality improvement and patient safety, and it 
has plans for sponsoring additional programs. We welcome 
initiatives by Congress that would create an environment that 
will facilitate the developments of these private sector 
innovations and initiatives that hold such promise for 
improving the quality and safety of surgical patient care.
    Thank you, Mr. Chairman, for allowing me to testify on 
behalf of our fellows and their patients, and thanks to all of 
the members of the subcommittee for their ongoing efforts to 
help us help our patients.
    [The prepared statement of F. Dean Griffen follows:]

   Prepared Statement of F. Dean Griffen, Chair, Patient Safety and 
     Professional Liability Committee, American College of Surgeons

        ``The American College of Surgeons is dedicated to improving 
        the care of the surgical patient and to safeguarding standards 
        of care in an optimal and ethical practice environment.''
    This mission statement of the American College of Surgeons can be 
found in the lobby of its building in Chicago. But this is not just a 
statement; elevating the standards and safety of surgical patient care 
are goals that the College has been putting into action since its 
founding in 1913.
    My name is Dean Griffen, MD, FACS, and I am a general surgeon in 
private practice from Shreveport, Louisiana. I am pleased to be here 
today representing the American College of Surgeons and its 67,000 
members. The College commends the House Energy and Commerce 
Subcommittee on Health for undertaking this important hearing. We are 
pleased to have this opportunity to present testimony detailing some of 
the surgical programs that have been developed to improve surgical 
patient safety and quality of care.
    Patient safety and quality improvement depend on a composite of 
factors within the broad scope of the American health care system. In 
surgery, safety relies on the presence of competent and trained 
surgeons, on a ``safe'' institution, and on systems of good practices 
with which the surgical care is rendered.

     ACS HISTORY OF INVOLVEMENT IN QUALITY IMPROVEMENT INITIATIVES

    In 1918, the College initiated a Hospital Standardization Program 
in an effort to ensure a safe environment and effective system of care 
for surgical patients and others who are hospitalized. That program 
ultimately led to the establishment of what is known today as the Joint 
Commission on the Accreditation of Healthcare Organizations (JCAHO). 
This commitment continues through the participation of three College 
JCAHO commissioners, as well as through other programs and initiatives 
conducted by College committees and programs.
    In 1922, the College established the multidisciplinary Commission 
on Cancer to set standards for high-quality cancer care. Today, the 
commission is comprised of more than 100 individuals representing more 
than 39 national professional organizations. Among other initiatives, 
the Commission on Cancer has established cancer program standards and 
conducted the accreditation of nearly 1,500 hospital cancer programs. 
It also provides clinical oversight for standard-setting activities and 
for the development and dissemination of patient care guidelines; and 
it coordinates national cancer site-specific studies on pattern of care 
and patient management outcomes through the annual collection, 
analysis, and dissemination of data for all cancer sites.
    Shortly thereafter, the Committee on Fractures was formed, later to 
evolve into the Committee on Trauma, which develops the standards that 
most states employ to designate trauma centers. The trauma program also 
includes a National Trauma Data Bank that facilitates studies and the 
development of treatment guidelines for optimal care of injured 
patients.
    While the American College of Surgeons has had a long history of 
involvement in patient safety and quality efforts, I would like to 
focus my testimony on some of our most recent initiatives, including:

 National Surgical Quality Improvement Program (NSQIP)
 Surgical Care Improvement Project (SCIP)
 ACS Bariatric Surgery Center Network Accreditation Program
 Committee on Emerging Surgical Technology and Education (CESTE)
 Surgical patient safety manual
 Closed claims analysis project
 National Surgical Time Out Day
 Various patient safety guidelines and principles

             NATIONAL SURGICAL QUALITY IMPROVEMENT PROGRAM

    The National Surgical Quality Improvement Program (NSQIP) is the 
first nationally validated, risk-adjusted, outcomes-based program that 
has been demonstrated to measure and improve the quality of surgical 
care. The program was initially developed by the Department of 
Veteran's Affairs (VA) in the early 1990s, as an outgrowth of the 
National VA Surgical Risk Study. In the VA system, NSQIP had impressive 
results, with a 27 percent decline in post-operative mortality, a 45 
percent drop in post-operative morbidity, a reduction in average post-
operative length of stay from 9 to 4 days, and increased patient 
satisfaction. In 2001, the College developed its own NSQIP, which 
expand the program to the private sector through a grant from the 
Agency for Healthcare Research and Quality.
    The program employs a prospective, peer-controlled, validated 
database to quantify 30-day risk-adjusted surgical outcomes, allowing 
valid comparison of outcomes among the hospitals now in the program. 
Medical centers and their surgical staffs are able to use the data to 
make informed decisions about their continuous quality improvement 
efforts. The program involves the following key components:

 Data Collection
 Data Monitoring
 Validation Report Generation
 Data Analysis
    Of particular interest to hospitals is the generation of a risk-
adjusted, observed-to-expected outcome ratio for each center, which can 
be compared to other participating centers on a blind basis. 
Statistical analysis of the pre-operative data identifies risk factors 
and further analysis calculates the expected outcome for each 
hospital's patient population.
    The NSQIP program involves a number of mechanisms to provide 
feedback to the participating hospitals and to the program as a whole. 
These mechanisms include annual data audits, site visits, and the 
sharing of best practices. This structured and careful feedback by 
program staff ensures the consistent reporting of data across sites and 
the rapid dissemination of information about successful surgical 
practices and about the environments that produce the highest quality 
of care.
    So far, the College has expanded the NSQIP program to over 30 
hospitals, including Partners HealthCare hospitals (the Harvard Medical 
School system), and applications are under development from dozens of 
others who want to be involved. In 2002, the Institute of Medicine 
named the NSQIP ``the best in the nation'' for measuring and reporting 
surgical quality and outcomes.

                   SURGICAL CARE IMPROVEMENT PROJECT

    The College is one of the 10 organizations on the Surgical Care 
Improvement Project (SCIP) steering committee. SCIP is a national 
partnership of organizations dedicated to improving the safety of 
surgical care by reducing post-operative complications. Its steering 
committee reflects the range of public and private organizations that 
must work together to reduce surgical complications, and includes 
groups representing surgeons, anesthesiologists, perioperative nurses, 
pharmacists, infection control professionals, hospital executives, and 
others who are working to improve surgical patient care.
    The program was initiated in 2003 by the Centers for Medicare and 
Medicaid Services and the Centers for Disease Control and Prevention. 
This summer, the SCIP partnership will launch a multi-year national 
effort to reduce surgical complications 25 percent by 2010.
    SCIP quality improvement efforts are focused on reducing 
perioperative complications in the following four areas, where the 
incidence and cost of complications are significant:

 Surgical site infections
 Adverse cardiac events
 Venous thromboembolism
 Postoperative pneumonia
    SCIP stresses that surgical care can be improved significantly 
through better adherence to evidence-based recommendations and by 
giving more attention to designing systems of care with thorough 
safeguards. Other evidence-based programs such as NSQIP, the National 
Nosocomial Infections Surveillance (NNIS) system, and the Medicare 
quality improvement organizations, have demonstrated this time and 
again. The College is proud to play a leadership role in the 
development of the SCIP performance measures, and our organization will 
continue to play a significant role in further developing SCIP 
initiatives.

       ACS BARIATRIC SURGERY CENTER NETWORK ACCREDITATION PROGRAM

    Recently, the College has developed a Bariatric Surgery Center 
Network (BSCN) Accreditation Program to foster high-quality care for 
patients undergoing bariatric surgery for morbid obesity. The program 
describes the necessary physical resources, human resources, clinical 
standards, surgeon credentialing standards, data reporting standards, 
and verification/approvals processes required for designation as a 
``bariatric surgery center.''
    Severe obesity has reached epidemic proportions and because weight-
reduction surgery provides an effective treatment for the condition--
and because the number of surgeons and hospitals providing this care 
has grown so quickly--the College decided recently to place high 
priority on establishing this new accreditation program. The College 
contracts with hospitals and outpatient facilities that agree to 
implement its facility and other resource standards by reporting 
outcomes data on all their bariatric surgery patients, by submitting to 
site visits, and by completing annual status reports. By reviewing 
existing studies and consulting with experts in the field, the College 
has developed standards, defined necessary resources, organized the 
means to collect data, and organized the processes for conducting site 
visits to accredit hospitals and outpatient facilities in order to 
improve patient safety within this accredited network.

        COMMITTEE ON EMERGING SURGICAL TECHNOLOGY AND EDUCATION

    Indeed, this whole area of disseminating new surgical technology 
into the broader world of surgical practice is one of great concern to 
the College generally. The College established its Committee on 
Emerging Surgical Technology and Education to study the implications of 
new technology and to suggest best methods of developing policies that 
will accelerate education in this area and so protect surgical patient 
welfare.
    Through the work of this committee, the College has approved a 
process by which its Fellows can be verified for the use of emerging 
surgical technologies. It also has created a voluntary verification 
process for surgeons performing ultrasound to ensure that these 
surgeons are, in fact, qualified and that their facilities and 
equipment are appropriate for medical application and that they meet 
and maintain quality standards.

SURGICAL PATIENT SAFETY: ESSENTIAL INFORMATION FOR SURGEONS IN TODAY'S 
                              ENVIRONMENT

    ACS has recently issued a patient safety manual titled Surgical 
Patient Safety: Essential Information for Surgeons in Today's 
Environment. This publication provides information and guidance for 
surgeons and others involved in surgical patient safety. It describes a 
variety of practical resources and provides a broad overview of key 
issues, such as the scientific basis of surgical patient safety.
    Specifically, this manual analyzes the human factors, systems 
analyses, and processes affecting surgical patient safety. Issues such 
as decision-support, electronic prescribing, and error detection, 
analysis, and reporting are analyzed. Legal challenges for surgeon 
participation in patient safety activities are also reviewed. Broad 
error prevention methods such as the use of surgical simulation, 
educational interventions, and quality improvement initiatives are 
covered. In addition, the manual provides strategies for preventing 
wrong-site surgery and for safe blood transfusion and handling.

                     CLOSED CLAIMS ANALYSIS PROJECT

    The College last year initiated an extensive analysis of closed 
general surgery malpractice claims in order to generate data that will 
help guide its patient safety educational efforts--and perhaps some 
research and standard setting efforts, as well. The Patient Safety and 
Professional Liability Committee, which I chair, is in the process of 
completing this pilot project to determine if we can replicate the 
success realized by the American Society of Anesthesiologists. The 
anesthesiology program, which has been in place for about 20 years, has 
led to engineering and practice changes that have had remarkable impact 
on reducing surgical patient injury and improving the quality of care.
    The program promises to help us better identify and prioritize 
patient safety concerns. It will also allow the College to report to 
its members on the most common events leading to the most severe 
injuries, and help the surgical community develop the processes that 
will help correct these problems and avoid preventable maloccurrences.

                     NATIONAL SURGICAL TIME OUT DAY

    The College is a sponsor of the National Time Out Day, which 
highlights the JCAHO universal protocol and other initiatives that have 
been developed to reduce medical and surgical errors. All JCAHO 
accredited hospitals, ambulatory surgical centers, and office-based 
surgery facilities were required to adopt the universal protocol 
starting July 1, 2004. And, beginning last year, a coalition of 
physicians, hospitals, nurses, and other health providers partnered in 
a yearly coordinated effort to reduce medical errors in the future.
    The surgical ``timeout'' is an opportunity before a surgical 
procedure begins for all members of the operating room team to review 
the case of the patient before them. Not only does the timeout provide 
an opportunity to identify inconsistencies and so prevent errors in the 
operating room, but by improving overall communication it helps empower 
all members of the team to continue the dialogue during the operation 
if things do not seem to be going according to plan.

            VARIOUS PATIENT SAFETY GUIDELINES AND PRINCIPLES

    Over the past few years, there has been a noticeable increase in 
the number of invasive procedures being performed in the office 
setting. Recognizing that these settings are largely unregulated and 
very few have sought accreditation, the College called on the American 
Medical Association to work with it in convening a work group of 
relevant specialty societies and state medical associations to develop 
a set of principles for optimal office-based surgery.
    In addition, the College, like others, has set forth guidelines for 
correct patient, correct site, and correct procedure surgery. In these 
guidelines, the College urges the surgical team to conduct a detailed 
final verification process on each of these crucial areas, and it calls 
for confirmation of the consent form by the patient or the patient's 
designated representative. If a patient is scheduled for multiple 
procedures performed by different surgeons, all the items on the 
checklist are to be verified for each planned procedure. If any 
verification process fails to identify the correct site, the process 
must be immediately halted until verification is completely accurate.
    This coming weekend, the College's Board of Regents will be 
reviewing the draft of a new statement on ``Prevention of Retained 
Foreign Bodies After Surgery.'' These proposed guidelines provide for 
consistent application and adherence to standardized counting 
procedures and the use of X-ray, radiofrequency, and bar coded items 
during surgery.

                               CONCLUSION

    The College is proud of its many important innovations in quality 
improvement and patient safety, and it has plans for sponsoring 
additional programs. For example, we currently are conducting a pilot 
test of a hand-held case log system that surgeons in practice can use 
to record and report their operative experience. This system could, in 
turn, provide a quality benchmarking tool and help surgeons engage in 
practice-based learning and quality improvement. We also are 
considering the development of new network accreditation programs 
according to the model set by our bariatric center program. We welcome 
initiatives by Congress that would create an environment that would 
facilitate, rather than hinder, the development of these private sector 
innovations and initiatives that hold such promise for improving the 
quality and safety of surgical patient care.
    Thank you Mr. Chairman and Mr. Brown for allowing me to testify on 
behalf of our Fellows, and thanks to all the Members of the 
Subcommittee for their ongoing efforts to promote patient safety and 
quality.

    Mr. Deal. Thank you. Dr. Bornstein.

                STATEMENT OF WILLIAM A. BORNSTEIN

    Mr. Bornstein. Thank you. On behalf of the physician 
members of the Medical Association of Georgia, I want to thank 
Chairman Deal for your initiative in calling this hearing today 
to discuss the important issue of patient safety and quality 
initiatives. I am particularly grateful to have the opportunity 
to present testimony on the innovative work in this area by 
physicians on the State level.
    1999, as others have pointed out, represents a tipping 
point for patient safety and quality in the United States. That 
was the year the IOM published its seminal report To Err Is 
Human. Interestingly, although the IOM report had a galvanizing 
effect on the health care provider community, as Dr. Burgess 
has pointed out, the bulk of the data contained is really quite 
old.
    I would argue that the powerful influence of the IOM report 
was partly a result of its clear, incisive message, but equally 
a result of superb timing. After several decades of 
extraordinary advances in therapeutic and diagnostic 
technology, health care providers in 1999 were developing a 
growing sense that improvements in the quality and safety of 
the delivery of this care were lagging behind. Thus, the 
powerful message of the IOM report fell on receptive ears.
    Not coincidentally, 1999 is also the year I became Chief 
Quality Officer at Emory Crawford Long Hospital in Atlanta. 
This was a new role for us at Emory and a relatively new role 
in the country. In the 6 years since then, my responsibility 
has grown to encompass Emory Health Care System. Emory Health 
Care is the clinical arm of Emory's Woodruff Health Sciences 
Center and is the largest, most comprehensive health care 
system in Georgia. Emory's Woodruff Health Sciences Center is 
one of the Nation's leading academic medical centers, and my 
full-time job is improving the quality and safety of care in 
the Emory system.
    In the 6 years since the IOM report, the physicians of 
Georgia have accomplished a great deal to improve the quality 
and safety of the care we deliver. I would like to share with 
you some of those accomplishments as well as some of the 
challenges we face.
    In 2001, the Medical Association of Georgia, MAG, formed 
the MAG Institute for Excellence in Medicine. I have the 
privilege of serving on the board of directors of the MAG 
Institute, whose mission is to improve patient safety and 
clinical outcomes. The MAG Institute is focusing on educational 
activities and applied studies to assess the effectiveness of 
care in the outpatient setting. For example, we are working to 
improve the detection and treatment of diseases such as 
colorectal center, asthma, and kidney disease.
    Perhaps the most exciting aspect for the work that is being 
done by the MAG Institute is the application of information 
technology to patient safety and improved clinical care. The 
MAG Institute is currently partnering with Blue Cross/Blue 
Shield of Georgia in a study to determine whether the use of 
hand-held computers to access important clinical data at the 
bedside will improve patient outcomes. We are also very excited 
about the variety of projects that are designed to help Georgia 
physicians adopt and use health information technology to 
provide safer and more effective care.
    At Emory Health Care, a major focus has been on enhancing 
our culture of safety. We agree with the IOM that the highest 
levels of quality and safety can only be achieved through 
systemic approaches in addition to individual efforts. This is 
a paradigm shift for physicians as we were trained that quality 
and health care resulted from individuals striving for solo 
perfection. When errors occurred, they were reviewed as 
individual failures, resulting in a culture of blame and shame. 
Physicians were felt to be a special breed that could and 
should aspire to error-free performance even under adverse 
circumstances such as sleep deprivation.
    Today, we are changing this paradigm at Emory in a number 
of ways. We now survey our employees, nurses, technicians, 
everyone, on the culture of safety issues, and in fact helped 
develop the culture of safety survey tool that AHRQ is now 
promulgating. We and others have started weekly senior 
executive patient safety rounds to talk to the staff and ask 
them what can we do to improve the safety for our patients and 
to enhance the culture of safety. We have made a total 
commitment to disclosing errors to our patients and did so 
before the Joint Commission requirement, and to apologizing for 
their occurrence.
    I would like to point out that the new tort reform law 
recently enacted in Georgia prohibits such apologies from being 
introduced as evidence in a medical malpractice case. This is 
extremely important. A critical aspect of a culture of safety 
is the encouragement and indeed rewarding of reports of errors 
and near misses. The blame and shame approach has the 
inevitable effect of discouraging such reporting.
    A corollary of this insight is that reported error rates 
are an extreme underestimation of true error rates. 
Benchmarking therefore has the unintended consequence of 
reducing reporting. Therefore, virtually all patient safety 
experts, including myself, oppose such error rate benchmarking, 
whether it is between units within a hospital or between 
hospitals. What we do need is to be able to report and analyze 
individual occurrences and to share lessons learned under a 
protected and nonpunitive umbrella.
    Let me turn to what we believe is the absolutely critical 
role of information technology. The extraordinary increases in 
the complexity of clinical care of the past two decades reflect 
remarkable advances. This is a wonderful thing, but managing 
that complexity is difficult. The dramatic increase in clinical 
complexity has been further compounded by a parallel increase 
in administrative complexity. I am referring here to such 
things as complex billing codes, various documentation 
requirements, and managed care formularies that vary from plan 
to plan and moment to moment based on the best available deal 
of the moment. Administrative errors at best create the need 
for rework and, at worst, elicit a visit from the Office of the 
Inspector General. It is no wonder that physicians often seem 
preoccupied during patient visits as our heads spin trying to 
manage this complexity.
    The simple truth is that this level of complexity cannot be 
optimally managed without the support of information 
technology. These health care IT systems are extremely complex 
and expensive. Like any therapy, these systems carry risks 
along with their benefits, and it is no surprise to us that 
recent studies are showing that, if implemented incorrectly or 
suboptimally, they can cause more harm than good.
    At Emory we are spending $50 million over 10 years on our 
system, and have made it one of our top organizational 
priorities. Successful implementation of such systems requires 
expertise in addition to money. As mentioned earlier, the MAG 
Institute has recognized this need and has several innovative 
projects under way to help Georgia physicians incorporate 
information technology into their practices. These initiatives 
enable folks like us at Emory who have the resources to be a 
little ahead of the curve to work with our colleagues across 
the State to help them work through these hurdles.
    However, most health care in Georgia and the rest of the 
United States is delivered by practitioners in solo or small 
group practices. At Emory, the investment of money and expert 
resources we are making in our electronic medical records 
system is a severe strain and competes with important other 
investments and needed diagnostic and therapeutic equipment. 
Physicians in small group practices will not be able to afford 
such investments without help.
    The achievement of optimal quality and safety is also 
critically dependent on the ability of these systems to share 
information. This in turn requires the development of data 
standards. In order to protect physician investment in these 
systems, it is very important that these standards be developed 
as rapidly as possible. To this end, we applaud the goals and 
early efforts of the National Health Care IT Initiative under 
the leadership of Dr. David Brailer and the announcement this 
week by Secretary Leavitt of the creation of the American 
Health Information Community, which Secretary Leavitt himself 
is planning to chair.
    Through the efforts like those I have described, we have 
made substantial progress in the 6 or so years since the 
publication of the IOM report To Err Is Human. We still have a 
long way to go. In the meantime, despite our understanding that 
the system approaches that are in progress are essential for 
optimal quality and safety, our doctors and nurses are 
continuing to do what they need to do and what they have been 
doing all along, working heroically to deliver the best quality 
and safety with the tools they have.
    With the remarkable progress of the last several decades, 
we are in what could be a golden age of health care. All the 
Institute of Medicine reports now have on their frontispiece a 
quote from Goethe that begins: Knowing is not enough; we must 
apply. Physicians need financial and administrative support 
from Congress to succeed in implementing the systems to apply 
the remarkable knowledge base that we have accumulated. I 
believe that with efforts like those I have described and with 
your help and support we can deliver on this promise of a 
golden age of health care in this country.
    Again, I would like to thank Chairman Deal and the members 
of the committee for the opportunity to share these thoughts 
with you, and I would be happy to answer any questions at the 
conclusion.
    [The prepared statement of William A. Bornstein follows:]

  Prepared Statement of William A. Bornstein, Medical Association of 
                                Georgia

    On behalf of the physician members of the Medical Association of 
Georgia (MAG), I want to thank Chairman Deal for his initiative in 
calling this hearing today to discuss the important issues of ``Patient 
Safety and Quality Initiatives.'' I am particularly grateful to have 
the opportunity to present testimony on the innovative work in this 
area by physicians on the state level.
    1999 represents a tipping point for patient safety and quality in 
the U.S. That was the year the IOM published its seminal report ``To 
Err is Human.'' Interestingly, although the IOM report had a 
galvanizing effect on the health care provider community, the bulk of 
the data it contained were really quite old. I would argue that the 
powerful influence of the IOM report was partly a result of its clear 
and incisive message but equally a result of superb timing. After 
several decades of extraordinary advances in therapeutic and diagnostic 
technology including remarkable imaging and image guided interventional 
technology, pharmaceuticals, fiberoptics, genomics and proteomics, 
health care providers were in 1999 developing a growing sense that 
improvements in the quality and safety of the delivery of care were 
lagging behind. Thus, the powerful message of the IOM report fell on 
receptive ears. The evidence for this is that when the IOM report was 
released, despite some debate about the numbers, there was remarkably 
little disagreement about the message itself.
    Not coincidentally, 1999 is also the year I became Chief Quality 
Officer, a new role, for Emory Crawford Long Hospital in Atlanta. In 
the six years since then, my responsibility has grown to encompass the 
Emory Healthcare system. Emory Healthcare is the clinical arm of the 
Woodruff Health Sciences Center and provides patient care to millions 
of Georgians each year. As the largest, most comprehensive health care 
system in Georgia, Emory Healthcare includes The Emory Clinic, Emory 
Children's Center, Emory University Hospital, Emory Crawford Long 
Hospital, Wesley Woods Center of Emory University, the jointly owned 
Emory-Adventist Hospital, and EHCA, LLC, a limited liability company 
created in collaboration with HCA-The Healthcare Company. Emory 
Healthcare has 9,000 employees, $1.2 billion in net patient service 
revenue, and 1,184 licensed patient beds. In addition to Emory's own 
primary and multispecialty health care centers located throughout metro 
Atlanta, the Emory Healthcare Affiliate Network comprises 45 hospitals 
representing 65 communities and more than 6,000 physicians throughout 
Georgia, Alabama, North Carolina, and South Carolina. Emory Healthcare 
also is an owner of 1st Medical Network, Georgia's largest PPO network 
of physicians and hospitals, serving more than 700,000 lives. It is 
designed to serve as a delivery system for HMOs, PPOs, insurers, and 
others with a managed care network of hospitals and physicians in the 
state. The Woodruff Health Sciences Center is a top-ranked research 
institution with an annual budget is $1.85 billion. We have over 1,752 
full time faculty, plus 1,391 adjunct or volunteer faculty and 
collaborative scientists, and close to 3,500 students and medical 
residents in training.
    In the six years since the IOM report the physicians of Georgia 
have accomplished a lot to improve the quality and safety of the care 
we deliver to our patients. I would like to share with you today some 
of those accomplishments. I would also like to share my thoughts about 
challenges and threats to progress.
    In 2001, the Medical Association of Georgia, Georgia's largest 
physician organization, formed a separate 501 (c) 3 organization, the 
MAG Institute for Excellence in Medicine. I have the privilege of 
serving on the Board of Directors of the MAG Institute. The mission of 
the MAG Institute is to improve patient safety and improve clinical 
outcomes for the patients of Georgia physicians. The MAG Institute is 
focusing on educational activities as well as sponsoring applied 
studies to assess the effectiveness of practices and processes in the 
outpatient setting, primarily in physician's offices. For example, we 
are working in areas such improving the detection and treatment of 
diseases such as colorectal cancer, asthma and kidney disease. Perhaps 
the most exciting aspect of the work that is being done by the MAG 
Institute is the application of information technology to patient 
safety and improved clinical care. The MAG Institute is currently 
partnering with Blue Cross Blue Shield of Georgia in a study to 
determine whether the use of handheld computers to access important 
clinical data at the bedside will improve patient outcomes. We are also 
very excited about the variety of projects that are designed to help 
Georgia physicians adopt and use health information technology to 
provide safe and more effective care. We are pleased to be working with 
the Georgia Medical Care Foundation (GMCF), the Medicare Quality 
Improvement Organization (QIO) on a series of initiatives sponsored by 
the Centers for Medicare and Medicaid Services. MAG and GMCF together 
will work with physicians to promote the adoption of health information 
technology (HIT) to improve the quality and efficiency of care--with a 
focus on e-prescribing, registries and deployment of full electronic 
health record systems. This project will help physicians select HIT 
products, reorganize their workflow and care processes to effectively 
use HIT, and undertake quality improvement projects to realize the 
benefits of HIT.
    MAG also participated with the Georgia Hospital Association and 
other statewide organizations to form the Partnership for Health and 
Accountability (PHA) in 2000. Whereas, the MAG Institute has focused on 
patient safety in the outpatient setting, the PHA has focused its 
efforts on the hospital or inpatient setting, which was the primary 
focus of the IOM report. Through the PHA, hospitals confidentially and 
with peer review protection share lessons learned from adverse events, 
outcome and process data and best practices.
    At Emory Healthcare, we have been taking a multi-pronged approach 
to improving quality and safety. A major focus has been on enhancing 
our ``culture of safety.'' Fundamentally, this means a culture that 
emphasizes a systemic rather than an individual approach to quality and 
safety. This represents a major paradigm shift in health care. 
Traditionally, most of us were trained that quality in health care 
resulted from individuals striving for solo perfection. When errors 
occurred, they were viewed as individual failures, resulting in a 
culture of ``blame and shame.'' Health care workers were felt to be a 
special breed that could and should aspire to error-free performance, 
even under adverse circumstances such as sleep deprivation. We thought 
ourselves exempt from the ``laws'' of human performance. This may have 
been a reasonable approach decades ago when the complexity of health 
care was orders or magnitude less. However, it has not been reasonable 
for at least the past 20 years. One of the major accomplishments of the 
IOM report ``To Err is Human'' was to send that message loud and clear.
    A critical aspect of a culture of safety is the encouragement and 
indeed, rewarding of reports of errors and near misses. The blame and 
shame approach had the inevitable effect of discouraging such 
reporting. A corollary of this insight is that reported error rates are 
an extreme underestimation of true error rates. Benchmarking on error 
rates therefore has the unintended consequence of reducing reporting. 
Therefore, virtually all patient safety experts, including myself, 
oppose such benchmarking whether it is between units within a hospital 
or between hospitals. This in no way disputes the public's right to 
know. Rather it is a statement that outside of research settings, 
reported error rates do not convey meaningful comparative information, 
that public reporting of such rates has negative impacts on safety, and 
that for now, we need to focus on increasing internal reporting of each 
occurrence so that we can analyze and learn from each such event. When 
we are successful at creating such a culture of safety, one of the 
signs of success is a paradoxical increase in error rates due to an 
increase in self-reporting. I should emphasize that I am talking here 
about error rates. I do favor reporting of individual occurrences under 
a protected and non-punitive umbrella so that lessons learned can be 
shared. This has worked well for aviation. In Georgia, the Partnership 
for Health and Accountability has created a peer review protected 
mechanism for reporting and mutual learning throughout the state. I 
also support the reporting of quality process measures such as the 
Joint Commission National Quality Measures.
    There are many ways we are working on creating a culture of safety 
at Emory. We have begun surveying our employees on culture of safety 
issues and in fact helped develop the culture of safety survey tool 
that AHRQ is now promulgating. PHA is facilitating such surveying for 
all hospitals in the state. We and others have started weekly senior 
executive patient safety rounds to ask our staff about what we can do 
to improve the safety for our patients and to enhance the culture of 
safety. We have made a total commitment to disclosing errors to our 
patients and apologizing for their occurrence. It should be noted that 
the new tort reform law recently enacted in Georgia prohibits such 
apologies from being introduced as evidence in a medical malpractice 
case; this is extremely important. At Emory we have a national expert 
on medical error disclosure, Dr. John Banja. Dr. Banja is working with 
both the MAG Institute for Excellence in Medicine and PHA to teach 
physicians and other health care providers in Georgia how to improve 
their skills in such empathic communications.
    As we are succeeding at creating a culture in which our staff 
reports more errors and near misses, we are committed to analyzing each 
error, learning from each error and sharing what we learn through peer 
protected channels both internally and with other providers in Georgia. 
These activities are critically dependent upon the continuation of peer 
protected reporting options.
    We also learn through these activities where to focus our quality 
and safety improvement efforts. Over the past several years, Emory 
Healthcare has won patient safety and quality awards from PHA for our 
``Medication Error Prevention Initiative,'' our ``Correct Site Surgery 
Initiative,'' and our ``Skinsational Program'' to reduce pressure 
ulcers.
    Let me turn to what we believe to be the absolutely critical role 
of information technology. The extraordinary increase in the complexity 
of clinical care over the past two decades reflects the remarkable 
advances that I have previously cited. This is a good thing but 
managing that complexity has created challenges. The dramatic increase 
in clinical complexity has been compounded by a parallel increase in 
administrative complexity. I am referring here to such things as 
complex billing codes, various documentation requirements, and managed 
care formularies that vary from plan to plan and moment to moment based 
on best available deal on a particular drug. Administrative errors at 
best create the need for rework and at worst elicit a visit from the 
OIG. It is no wonder that physicians often seem preoccupied during 
patient visits as their heads spin trying to manage this complexity. 
The simple truth is that this level of complexity cannot be managed 
without supporting information technology any more than flights in and 
out of Atlanta's airport could be. Like any therapy, this technology 
will have some adverse effects, much as looking at instruments rather 
than out the window may have occasional undesired effects in aviation. 
Recent reports, like the one from the University of Pennsylvania which 
appeared earlier this year and highlighted new errors caused by such 
systems, raise appropriate cautions. However, it is very clear that 
done right, these systems will improve safety and quality. These 
systems are becoming the most important tools in our quality and safety 
improvement toolboxes. They are, however, just that--tools. We must 
learn from one another as we go along about how to start right and how 
to continuously refine these tools to continuously improve quality and 
safety. These systems must also be able to share information between 
one another. To both these ends, I applaud the goals and early progress 
of the National Healthcare IT initiative under Dr. Brailer's able 
leadership and the announcement this week by Secretary Leavitt of the 
creation of the American Health Information Community, which he will 
personally chair.
    These systems are extremely complex and expensive. At Emory we are 
spending around 50 million dollars over 10 years on our system and have 
made it one of our top organizational priorities. We have project 
leaders who are highly sophisticated and dedicated to this project. We 
are doing this to improve the quality and safety of the care we 
deliver. However, most care in the state of Georgia, and throughout the 
United States, is delivered by physicians in solo or small group 
practices. How are they going to make this transition and how are they 
going to do so safely? Clearly, funding support is crucial. Even at an 
organization of Emory's size, our 50 million dollar investment in this 
technology is a severe strain and competes with other crucial capital 
investments in the latest diagnostic and therapeutic equipment. 
Expertise is also a critical success factor. As mentioned earlier the 
MAG Institute has recognized this need and has several innovative 
projects under way to help Georgia physicians incorporate information 
technology into their practices. These initiatives enable folks like us 
at Emory who have the resources to be a little ahead of the curve to 
work with our colleagues in the state to help them work through these 
hurdles.
    When I look back to when I was in medical school and residency 30 
or so years ago, I am amazed at how much better we can care for our 
patients now than then. We health care providers should be ecstatic 
about the progress, yet by and large we are a stressed out and often 
unhappy bunch. I think that's because we are keeping our patients safe 
through heroic individual efforts that can't be sustained. We 
desperately need these systemic approaches such as electronic medical 
records and others including those I've mentioned in order to be able 
to truly appreciate and deliver on what could be viewed as the 
beginning of a golden age of health care. As part of the ``tipping 
point'' phenomenon that is underway, that realization is bubbling to 
the surface of consciousness for the great majority of providers.
    The other thing I realize looking back to when I started my medical 
training is that I thought then that knowledge was both necessary and 
sufficient to deliver outstanding patient care. I thought that if I 
could just learn everything about what needs to be done, it would get 
done. What we have learned from the IOM reports and the other emerging 
literature on these topics is that knowledge is, in fact, not enough; 
we have to learn how to more reliably apply this knowledge. Indeed, 
each IOM report now has on its frontispiece a quote from Goethe that 
begins, ``Knowledge is not enough; we must apply.'' Through efforts 
like those I've described, we are intensely focusing on increasing the 
reliability and safety of the application of our knowledge. I believe 
that with such efforts and with your help and support, we can achieve 
what will truly be a golden age of health care in this country.
    However, as with any great opportunity, there are challenges and 
risks that must be overcome. As I have mentioned these efforts are 
expensive and labor intensive. We need to find ways to fund and 
incentivize them and we must do so quickly. Meaningful measurement of 
quality and especially safety is challenging and still fairly 
primitive. Electronic medical record systems will help us collect and 
report better data. In the meantime, we need to be able to report 
individual errors in a protected non-punitive environment so that we 
can share lessons learned. Benchmarking of error rates must be avoided. 
The latter would undermine our efforts to enhance reporting and the 
culture of safety and would not help anyone identify which health care 
providers are safer. Finally, we must strive for a more rational 
approach to health care financing that deals with coverage for all 
Americans and that rewards health rather than disease.
    Again, I want to thank Chairman Deal and the members of the 
committee for the opportunity to share these thoughts with you and I 
will be happy to answer any questions you may have.

    Mr. Deal. Thank you. Ms. Loewenson.

                   STATEMENT OF JANE LOEWENSON

    Ms. Loewenson. Good afternoon, Chairman Deal, 
Representative Baldwin, and Representative Burgess. My name is 
Jane Loewenson, and I am the Director of Health Policy for the 
National Partnership for Women and Families. Thank you for the 
opportunity to testify before you today.
    The National Partnership is a nonprofit, nonpartisan 
advocacy organization that has fought for economic, employment, 
and health security for women and families for more than 30 
years. We are committed to improving the quality of our health 
care system because health care is central to the vitality and 
economic security of women and their families. The 
responsibility to make health care decisions often falls to 
women, yet there is very little meaningful information to help 
them with such important decisions as choosing a doctor or a 
hospital.
    Consumers are left to hope that they receive optimal care 
in a health care system where there are reports that as many as 
98,000 people die of preventable medical errors in hospitals. 
And, according to a recent RAND study, the likelihood of 
getting the right care at the right time is about 50/50.
    The Institute of Medicine has called for both a national 
and mandatory reporting system for serious medical errors and a 
voluntary system for more minor errors or near misses. The 
National Partnership strongly supports those recommendations. 
Though it is only part of the equation, we also strongly 
supported passage of patient safety legislation during the last 
Congress that would create only a voluntary reporting system. 
We believe this could be an important step forward. However, it 
should address several key issues that I have laid out fully in 
my written testimony. They include the need for a clear 
definition of patient safety information, protection of 
existing and future reporting requirements, and a rigorous 
certification process. The legislation also should not preclude 
information, where appropriate, from use in criminal 
proceedings.
    We appreciate all the work this committee has done on 
patient safety legislation, and are pleased that the bill will 
be moving forward this summer.
    Now let me turn to the primary focus of my testimony today, 
the critical need for the public reporting of comparative 
information on how well physicians, hospitals, and other 
providers are delivering care. Right now, it is easier to get 
information about stocks and cars than doctors and hospitals. 
At the National Partnership, we believe it is not only possible 
but imperative to evaluate and publicly report providers' 
performance on standardized quality measures that will enable 
people to have meaningful information to guide their health 
care decisions.
    There are multiple efforts to measure and report quality 
and safety information in both the private and public sector. 
One of the oldest public reporting efforts is in New York 
State. Since 1989, the New York State Department of Health has 
published annual data on risk adjusted mortality following 
coronary artery bypass graft for each hospital and surgeon. 
Between 1989 and 1992, mortality from bypass surgery fell 41 
percent statewide in New York. By 1992, New York had the lowest 
risk adjusted mortality rate of any State in the Nation for 
bypass surgery and the most rapid rate of decline in any State 
with below average mortality.
    A second example of public reporting is Minnesota's adverse 
health event reporting law that was passed during the 2003 
legislation session. The law mandated hospitals to report the 
occurrence of any of the 27 ``never events'' endorsed by the 
National Quality Forum. The purpose of the law is to learn from 
serious medical errors so that harm to patients can be 
prevented. Examples of ``never events'' include: Retention of a 
foreign object in a patient after surgery; wrong-site surgery; 
and acquisition of a very serious pressure ulcer or bed sore 
after admission.
    Hospitals are required to report information on the event 
along with their determination of why the event happened and 
what they are doing to prevent the event from happening again. 
The fact that health care providers in Minnesota's hospitals 
are now reporting serious errors and identifying ways to 
prevent harm is a major step forward. From the examples I have 
described as well as others, we have learned that quality can 
be measured, that what gets measured gets improved, and what 
gets measured and publicly reported gets improved even more.
    The National Partnership co-leads and provides the 
organizational home for the Consumer-Purchaser Disclosure 
Project. The Disclosure Project is a coalition of large 
employers, business coalitions, consumer organizations, and 
labor unions that have united around a common goal of making 
our health care system more transparent by championing 
performance measures to the National Quality Forum consensus 
based endorsement process, encouraging the implementation and 
public reporting of NQF endorsed measures, and encouraging the 
development of new standardized quality measures to create a 
more complete and meaningful picture of the quality of care.
    Going forward, the National Partnership welcomes the 
opportunity to provide you with further information on our 
activities and perspective as you consider the issues of 
patient safety and quality improvement. We appreciate the 
subcommittee's interest in these issues, and thank you for the 
opportunity to testify this afternoon.
    [The prepared statement of Jane Loewenson follows:]

   Prepared Statement of Jane Loewenson, Director of Health Policy, 
               National Partnership for Women & Families

    Good afternoon, Chairman Deal, Ranking Member Brown, and other 
members of the Committee. My name is Jane Loewenson, and I am the 
Director of Health Policy for the National Partnership for Women & 
Families. Thank you for the opportunity to testify before you today on 
patient safety and health care quality. I appreciate the opportunity to 
share the National Partnership's views.
    The National Partnership for Women & Families is a non-profit, 
nonpartisan advocacy organization that has long fought for economic, 
employment and health security for all women and families. The 
Partnership has more than 30 years of experience promoting fairness in 
the workplace, policies that help women and men meet the competing 
demands of work and family, and access to quality health care.
    Over the past six years, the news about the quality of our health 
care system has been grim. The Institute of Medicine's (IOM) reports, 
To Err is Human and Crossing the Quality Chasm, document the wide gap 
between the health care that Americans are getting and what health care 
could and should be. In fact, more people die in hospitals from 
preventable medical errors than from breast cancer and AIDS combined. 
The IOM reports also document pervasive misuse, under-use and overuse 
of treatments and diagnostic tests. A recent study by the RAND 
Corporation found that an American's likelihood of getting the right 
care at the right time was about 50/50, no better than the toss of a 
coin. The evidence is clear: medical errors and poor quality take an 
enormous toll on our health and our lives.
    The National Partnership is committed to improving the quality of 
our health care system, because health care is central to the vitality 
and economic security of women and their families. The responsibility 
to make health care decisions for their families often falls to women. 
Yet there is very little meaningful information to help with such 
important decisions as choosing a doctor or hospital. No tool exists 
that provides a complete picture of the quality and safety of the care 
delivered by providers. Consumers are left to hope that they receive 
optimal care in a health care system that fails patients far too often.
    At the National Partnership for Women & Families, we believe that a 
critical strategy for reducing medical errors and improving the quality 
of our health care system is to enable Americans to select hospitals, 
physicians, and other providers on the basis of publicly reported, 
standardized performance information.
    My testimony today touches briefly on the patient safety 
legislation that was under consideration during the last Congress. 
However, it will primarily focus on the critical need for greater 
transparency in our health care system.

            PATIENT SAFETY LEGISLATION IN THE 108TH CONGRESS

    In response to the finding that as many as 98,000 people die of 
preventable medical errors in hospitals, the Institute of Medicine 
called for a both a national mandatory reporting system for serious 
medical errors, and a voluntary system for more minor errors or near 
misses. The National Partnership strongly supports those 
recommendations.
    While creating a mandatory reporting system for medical errors is a 
key goal for the National Partnership, we also strongly supported 
passage of patient safety legislation during the last Congress that 
would create patient safety organizations to collect and analyze 
voluntary, confidential reports of medical mistakes. Creating such a 
mechanism would be an important step forward, although only part of the 
equation. To make a voluntary system as effective as possible and to 
avoid undermining other efforts to improve health care quality, we 
believe that patient safety legislation should address several key 
issues.
    The legislation should provide a clear definition of patient safety 
information. A certain level of confidentiality and protection from 
legal discovery is needed to encourage the voluntary reporting of 
medical errors and near misses. This protection, however, should not 
shield information from a patient that they otherwise would have access 
to, nor should it preclude information, where appropriate, from use in 
criminal proceedings. Legislation should also protect federal, state, 
and local reporting requirements, such as those for public health.
    Public reporting is a powerful incentive for quality improvement, 
and patient safety legislation should not undermine it. The 
confidential reporting of information to patient safety organizations 
should not hide from public view information that otherwise would be 
subject to public reporting. It should preserve the reporting of 
performance information that increasingly has been required by 
purchasers, states and accrediting organizations.
    An effective voluntary reporting system also depends on having 
qualified independent organizations to collect and analyze the data 
reported by providers. We believe the legislation should include a 
rigorous certification process for patient safety organizations, 
evaluation of the qualifications and operations of these organizations 
including the ability to maintain the privacy of patient records, and 
clear requirements for what they should do with the data they collect. 
The process for certifying patient safety organizations should protect 
against conflicts of interest.
    The National Partnership appreciates all the work this committee 
has done on patient safety legislation and hopes that a bill moves 
forward during this session of the Congress.

              PERFORMANCE MEASUREMENT AND PUBLIC REPORTING

    Now let me turn to the primary focus of my testimony today: the 
critical need for the public reporting of comparative information on 
how well physicians, hospitals, and other providers are delivering 
care. We support the IOM definition of quality as care that is safe, 
timely, effective, efficient, equitable, and patient-centered, and 
agree that these elements should be measured.
    Right now, it is easier to get information about the performance of 
a company's stock than the performance of a doctor. And consumers have 
more information about the safety record of a car than the safety 
record of a hospital. It is our view that this reality must change. 
People should have access to objective, comparable information that 
allows them to choose the best surgeon for their bypass surgery, the 
safest hospital for giving birth, the physician who will do the best 
job of keeping their diabetes under control, or the pediatrician who 
will best treat their child's asthma so that they can avoid trips to 
the emergency room.
    At the National Partnership, we believe it is not only possible, 
but imperative, to evaluate and publicly report providers' performance 
on standardized quality measures. This will enable people to have 
meaningful information to guide their health care decisions. Not only 
do we believe people have a right to this information, there is strong 
evidence that measurement drives quality improvement and that quality 
improves even more dramatically when information is publicly reported.
    There are multiple efforts to measure and report quality and safety 
information in both the private and public sector. I will describe 
three concrete examples:

1. New York
    One of the oldest public reporting efforts is in New York State. 
Since 1989, the New York State Department of Health has published 
annual data on risk-adjusted mortality following coronary artery bypass 
graft (CABG) for each hospital and surgeon. Between 1989 and 1992, 
mortality from bypass surgery fell 41 percent statewide in New York. By 
1992, New York had the lowest risk-adjusted mortality rate of any state 
in the nation for bypass surgery and the most rapid rate of decline in 
any state with below-average mortality. This example clearly 
demonstrates the relationship between public reporting and better 
health outcomes.

2. Wisconsin
    A second example of the impact of public reporting and performance 
measurement is Wisconsin's QualityCounts Report. This report, released 
in the fall of 2001, reported 24 hospitals' performance across five 
categories: surgery, non-surgery, hip/knee surgery, cardiac care, and 
maternity care. QualityCounts was the first public report on hospital 
quality issued in this region and it generated substantial interest. Of 
the 24 hospitals, eight performed poorly in obstetrics and three had 
poor scores in cardiac care.
    An evaluation of the QualityCounts experience, published in Health 
Affairs in 2003, found that public reporting of performance led to 
greater quality improvement activities. The evaluation compared the 
hospitals that had their performance publicly reported with those that 
received a private report of their performance and those that received 
no report. The study found clearly demonstrates that hospitals that 
publicly reporting their performance undertook the greatest number of 
quality improvement activities.

3. Minnesota
    Minnesota's Adverse Health Event Reporting Law was passed during 
the 2003 legislative session, and mandated hospitals to report the 
occurrence of any of the 27 ``never events'' endorsed by the National 
Quality Forum (NQF). The purpose of the law is to learn from serious 
medical errors, so that harm to patients can be prevented. Examples of 
``never events'' include:

 Retention of a foreign object in a patient after surgery;
 Wrong-site surgery; and
 Acquisition of a very serious pressure ulcer (or bed sore) after 
        admission.
    Minnesota is the first state to fully implement the ``never event'' 
reporting. Hospitals are required to report information on the event, 
along with their determination of why the event happened and what they 
are doing to prevent the event from happening again. This past January, 
the Minnesota Department of Health reported that, over the course of 15 
months, there were 99 incidences of ``never events'' and named the 
hospitals in which they occurred. Findings from the report include:

 31 patients had foreign objects left in them after surgery;
 24 patients acquired a serious pressure ulcer (or bed sore) after 
        admission;
 13 patients had surgery on the wrong part of their body.
    Some examples of corrective action plans that hospitals have 
submitted include: 1) purchasing surgical sponges and other materials 
that are easier to track and count; 2) marking the surgical site prior 
to surgery; and 3) setting up physicians orders to make sure patients 
at risk for bed sores are re-positioned on a regular basis. The fact 
that health care providers in Minnesota's hospitals are reporting 
serious errors and identifying ways to prevent harm to patients is a 
major step forward in patient safety.
    From the examples I have described, as well as others, we have 
learned that:

 Quality can be measured;
 What gets measured gets improved; and
 What gets measured and publicly reported gets improved even more.
    The National Partnership recognizes that measurement and public 
reporting are powerful mechanisms to address the safety and quality 
crisis in the health care system. We have embraced a vision of a 
transparent health care market, one in which standardized, comparative 
information on provider performance is available to the public. To 
advance this vision, the National Partnership has forged a 
groundbreaking collaborative--the Consumer-Purchaser Disclosure 
Project. The National Partnership co-leads and provides the 
organizational home for this effort. The Disclosure Project is a 
coalition of large employers, business coalitions, and consumer 
organizations and labor unions that have united around a common goal of 
making our health care system more transparent by:

1. Championing performance measures that reflect consumer and purchaser 
        needs through the National Quality Forum's (NQF) consensus-
        based endorsement process;
2. Encouraging the implementation and public reporting of NQF-endorsed 
        measures by public and private purchasers, accreditation 
        bodies, health plans, and other key stakeholders; and
3. Encouraging the development of new standardized quality measures 
        such as infection or complication rates, or patient experience 
        with providers, so that consumers and purchasers have a more 
        complete and meaningful picture of the quality of care.
    Through our work on the Disclosure Project, we recognized the need 
for additional consumer engagement around the issues of patient safety 
and quality improvement. Consumers are the ultimate stakeholder in 
health care, yet their voices can be lost among the multitude of other 
interests in a complex health care system. In response, the National 
Partnership recently launched a major initiative, with support from the 
Robert Wood Johnson Foundation, to engage consumer advocates at the 
local, state, and national level in these issues.
    Going forward, the National Partnership welcomes the opportunity to 
provide you with further information on our activities and perspective 
as you consider the issues of patient safety and quality improvement. 
We appreciate the Subcommittee's interest in these issues and thank you 
for the opportunity to testify this afternoon.

    Mr. Deal. Thank you. We will now begin the questioning. Dr. 
Bornstein, are you aware of any medical schools that are 
actually teaching classes on patient safety? And, if so, how do 
they approach the subject?
    Mr. Bornstein. Yes, sir. There are a number of efforts 
under way to begin to incorporate this kind of information into 
the curriculum both at the medical student level and also at 
the level of interns and residents. And fundamentally it is 
about training and systems thinking, ideally it involves 
participation in actual projects to improve safety and quality. 
We actually think that a lot of this training should occur at 
the level of interns and residents, and we have applied at 
Emory for grants to do this kind of training. Nothing is simple 
in health care, as the members of the committee know better 
than anyone, and part of the unintended consequence of some of 
the workweek restrictions relate to how much time is available 
for this critically important training. But we think that is 
very important for the future of safety of health care.
    Mr. Deal. Ms. Loewenson, some people have argued that 
simply making the public aware of serious events that have 
occurred during their treatment doesn't really improve the 
quality of care overall. How would you respond to that?
    Ms. Loewenson. Well, I guess I would point to the examples 
in my testimony and others as well. In the New York experience 
where the mortality rates were published, mortality following 
bypass surgery actually went down. In Minnesota, in the 
Minnesota example, the serious events are not only being 
reported but corrective action plans are as well.
    Mr. Deal. Dr. O'Leary, I think one of the two suggestions 
that you had was to encourage clear communications between the 
doctor and the patient. And Dr. Bornstein has alluded to the 
fact that in my State of Georgia, our State of Georgia, that 
our legislature included in its medical liability reform 
package the provision for simply saying I am sorry and not 
having that being allowed into evidence in a trial proceeding. 
Is that something that you are seeing take place at the State 
level in other places as well?
    Mr. O'Leary. There are actually, to our knowledge, only a 
handful of States that have done that so far. But this is one 
of the recommendations in our public policy white paper, that 
that be done. It is a relatively simple but very important step 
I think to encourage real apologies. I think we all understand 
that, even without the medical liability specter, apology is a 
hard thing to do and we need to do everything we can to 
encourage that.
    Mr. Deal. I certainly hope, if this committee revisits the 
issue of another medical liability reform bill, that we will 
take into consideration perhaps the addition of that particular 
provision. I think it has some real therapeutic value in the 
overall scheme of things.
    I have been impressed with your testimony. I appreciate the 
fact that all of you have taken the time to be with us. As you 
know, we are just piercing the veil on many of these issues, 
and they certainly do interrelate to the IT issue that we have 
all alluded to and trying to make sure that whatever we 
accumulate by way of information is useful information that is 
going to achieve a goal, that of protecting patients in the 
future, and that we can learn from that. So as each of you look 
at this issue on an ongoing basis, we will appreciate your 
continued funneling to us of information or thoughts or ideas 
because we are hopeful that we will have some legislation that 
will be forthcoming before our recess.
    I would add, however, I do not view that whatever we will 
do as the end of the course on that subject matter, because I 
think it would be impossible for us to formulate in any 
particular piece of legislation everything that perhaps is 
going to have to be addressed down the line. We probably will 
have to at some point in the future consider such things as 
building in to reimbursement formulas money for the development 
of the IT systems that will be necessary and making sure that 
those do talk to each other so that information is not just 
collected and put in a box somewhere or in a computer disk and 
doesn't go any further and is not of any use.
    So it is a challenge that I think our committee faces, and 
your testimonies here today have been very helpful and we 
appreciate that very much.
    Our ranks have dwindled. Ms. Baldwin.
    Ms. Baldwin. Thank you, Mr. Chairman. First I have more of 
a comment than a question for Ms. Loewenson. I was happy to see 
in your written testimony that you also referenced Wisconsin's 
QualityCounts report as an example of the impact of public 
reporting and performance measurement. And as I mentioned 
earlier, one of the important features of Quality Counts is 
that the results are a part of the public domain. And I just 
wanted to emphasize that part of your testimony, that this data 
could be collected and used certainly for internal quality 
improvement purposes. But including it in the public domain 
really enhances the power of the data collected and the power 
of patients to make wise decisions about their health care.
    Dr. Bornstein, I was pleased to see and hear in your 
testimony the emphasis you placed on health care information 
technology, and I certainly believe it is a powerful and very 
important tool in reducing medical errors, and it was 
interesting to hear about your work with physicians in Georgia 
to promote the adoption of health care information. The doctors 
that I speak to at home are very excited about information 
technology, and the promise it holds, but they also frequently 
mention their concerns. You raised several of them in your 
testimony: The barriers that are keeping them from adopting 
health care IT, including the cost of the system obviously, the 
ongoing need for software and technology support services, the 
fact that we are not yet at a point where we have national 
interoperability standards. And you can certainly understand 
why a doctor especially in a small practice might hesitate 
before investing very significant sums of money into an IT 
system when the system could become obsolete in the future if 
they--you know, as the national processes continue.
    I guess I would like to hear if you are hearing similar 
feedback in Georgia, and what specifically you are helping 
these doctors, especially in the small practice settings, maybe 
one doctor or a small number, to overcome these barriers.
    Mr. Bornstein. Thank you for that question. Those are all 
very important points. First, on the matter of cost. As you 
were speaking, and I think you captured it exactly right and 
not only for cost. Doctors, many doctors are enthusiastic about 
the promise, fearful about the price they are going to have to 
pay both in terms of dollars but also in terms of change and 
how they deliver care and the learning curve that is involved. 
I think, you know, part of what we can do is organizations like 
Emory that partly are funded to help develop these things 
through grants from AHRQ and others, we need to be able to 
share that information. And the Institute, the MAG Institute is 
a vehicle for doing that.
    So one of the things that we are looking to do at the 
Institute is create some sessions where physicians of Georgia 
can come together, meet with us and other experts from within 
the State and from around the country to hear tips about how to 
make this easier, how to make it work better, how to be able to 
incorporate it into their practice.
    Ms. Baldwin. Just a quick followup, and I don't know if you 
have had further chance to study the initiative that you were 
talking about, the initiative that Secretary Leavitt announced 
this week, the four grant programs. Do you remember the time 
line of that, when we can actually expect results out of those 
various?
    Mr. Bornstein. No. I am sorry. I would love to know the 
time line myself.
    Ms. Baldwin. Maybe we can hold further hearings on 
information technology and electronic medical records so we can 
get further detail on that. Thank you for your time.
    Mr. Bornstein. I think it was Secretary Leavitt who made 
the comment that what we don't want to get into a situation 
where it is sort of last vendor standing becomes the vendor of 
choice. You know, with our $50 million investment, you know, we 
are taking some risk in that regard.
    Ms. Baldwin. Thank you.
    Mr. Deal. We are pleased to have the chairman of the full 
committee here, Mr. Barton. I would recognize you at this time.
    Chairman Barton. Mr. Chairman, I don't have any questions. 
I have missed the hearing, basically. I just came to show 
support and to thank our panelists for attending. This is an 
important issue and, as you pointed out, something that we hope 
possibly to legislate on later in the year.
    Mr. Deal. We appreciate your coming. Dr. Burgess for 
questions.
    Mr. Burgess. Thank you, Mr. Chairman. Dr. O'Leary, on the 
back page of your printed testimony you talk, have a paragraph 
here talking about the National Practitioner Data Bank, which I 
think is what Mr. Shimkus was asking about during the earlier 
round. Would you share your thoughts with us on what you think 
the shortcomings of what the National Practitioner Data Bank 
are and how that might be improved to improve the environment 
and patient safety?
    Mr. O'Leary. Well, the Practitioner Data Bank, as you are 
all aware, is probably 15 years or so old. It has probably 
never met its full expectations, and I think those are probably 
best articulated in the 2000 GAO report on the subject. For 
instance, there has been an ongoing problem about 
underreporting of disciplinary actions, you know, the 30-day 
rule, and if it is not 30 days it doesn't count. But there has 
really been very little texture in there so that the data bank 
tends to be weighted toward information on settlements and 
actual judgments, probably more heavily on settlements. And yet 
in the data bank it turns out, of all of the settlements, fewer 
than 10 percent have any--put any information about whether a 
standard of care was violated. This starts to be relatively 
unhelpful information. What is I think most troubling to us is 
that nothing has been done about the recommendations in that 
GAO report. It is 5 years later now, and we feel very strongly 
that this, if it were properly designed and utilized, could be 
a helpful resource because, amongst other things, it crosses 
State lines. But it is falling well short of that now. And if 
HIRS and HHS are not going to fix it, maybe we need to be 
looking at other alternatives, which might, for example, even 
include a network of data bases. I mean, I think we have to be 
thinking creatively as to how we meet this need which is not 
being met right now.
    Mr. Burgess. You mean like a network of State boards of 
medical examiners?
    Mr. O'Leary. It could be that, yes.
    Mr. Burgess. Very well. Thank you. Dr. Griffin, you talk 
about your effort in compiling the data base and the 15-year 
effort that you put forth, and I really appreciate all the hard 
work that the American College of Surgeons has put into that. 
Now, we are likely to copy you to some extent and may in fact 
even be providing somewhere along the line some effort at 
relief of liability for people who are willing to set up those 
same types of programs. Do you think it would be fair to do a 
look-back and incorporate already standing programs such as 
yours in any future endeavor that we undertake?
    Mr. Griffin. Yes.
    Mr. Burgess. I just wanted to get that on the record.
    Mr. Griffin. Interestingly, the Thoracic Society has been 
very influential in taking the bull by the horns. In the 
absence of the wonderful protections that you all have written 
into your drafts of current legislations that has been proposed 
as the Patient Safety Improvement Act, there is other examples 
of this. The cardiology groups up in New England have tackled 
their problems in the same way. And just like Ms. Loewenson 
says, if you measure something, it gets better. And they have 
shown that, as have the thoracic surgeons. And so measurement 
is so critical. And that is what we are trying to achieve in a 
very dense milieu of frustration. Measurement of outcomes gives 
something concrete that can be used by hospitals and by 
patients to see where they are, if they are outliers in there. 
In other words, if their observed versus expected outcomes fall 
below one, they have got a problem that patients will find out 
about for sure, because the hospital that has an outcome above 
one is going to advertise in the paper and then therefore--and 
through this process we are going to be able to help those 
below one improve.
    Reporting of errors is so critical. And if we can get that 
data base with error reporting, then we can not only help the 
good hospitals advertise and get the patients, we can also then 
help the lesser hospitals improve to keep the patient base 
spread out. One doctor who is the best one can't see everybody, 
and so everybody needs to perform well.
    Mr. Burgess. I couldn't agree more. Thank you.
    Mr. Chairman, I will just point out, too, you talked about 
getting the IT systems to the point where they can talk to each 
other and there be complete interconnectability between the IT 
systems. And, unfortunately, with the HIPPA legislation that 
you all passed before I got here that may be a detriment.
    And, finally, Ms. Loewenson let me ask you. One thing I 
have been impressed with in Congress is that science moves a 
lot faster than legislation. How do you propose that mere 
performance measures will keep up with science?
    Ms. Loewenson. Well, we think that they should, No. 1. But 
we support measurements being endorsed through the National 
Quality Forum and having all of the relevant players involved 
in the consensus building as to whether it is an appropriate 
scientifically based measurement, and then I think that we need 
to revisit them on a regular basis.
    Mr. Burgess. And how regular? What is regular? Is that 
yearly, is it quarterly?
    Ms. Loewenson. I guess it would depend on the situation and 
what it was. Maybe certain things would have to be revisited 
more quickly than others.
    Mr. Burgess. I just have been impressed with my visits to 
the NIH. The types of things that they are working are 
lightyears ahead of where anyone is in the actual practice of 
medicine today. And you are right, we are going to have to keep 
up. But we have got to make certain that our performance 
indicators don't hinder us delivering the best science and the 
best medicine.
    Thank you, Mr. Chairman. My time is up. I yield back.
    Mr. Deal. I thank the gentleman, and once again, I thank 
the panel members. Your testimony has been very useful. It has 
been distributed to those members who weren't present at the 
hearing today and it is a part of this record and certainly is 
something that we will be reviewing as we go forward. Thank you 
again for your attendance.
    [Whereupon, at 3:50 p.m., the subcommittee was adjourned.]

                                 
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