[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.]