[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
MEDICAL ERRORS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH
of the
COMMITTEE ON WAYS AND MEANS
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
__________
FEBRUARY 10, 2000
__________
Serial 106-101
__________
Printed for the use of the Committee on Ways and Means
U.S. GOVERNMENT PRINTING OFFICE
69-818 WASHINGTON : 2001
_______________________________________________________________________
For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC
20402
COMMITTEE ON WAYS AND MEANS
BILL ARCHER, Texas, Chairman
PHILIP M. CRANE, Illinois CHARLES B. RANGEL, New York
BILL THOMAS, California FORTNEY PETE STARK, California
E. CLAY SHAW, Jr., Florida ROBERT T. MATSUI, California
NANCY L. JOHNSON, Connecticut WILLIAM J. COYNE, Pennsylvania
AMO HOUGHTON, New York SANDER M. LEVIN, Michigan
WALLY HERGER, California BENJAMIN L. CARDIN, Maryland
JIM McCRERY, Louisiana JIM McDERMOTT, Washington
DAVE CAMP, Michigan GERALD D. KLECZKA, Wisconsin
JIM RAMSTAD, Minnesota JOHN LEWIS, Georgia
JIM NUSSLE, Iowa RICHARD E. NEAL, Massachusetts
SAM JOHNSON, Texas MICHAEL R. McNULTY, New York
JENNIFER DUNN, Washington WILLIAM J. JEFFERSON, Louisiana
MAC COLLINS, Georgia JOHN S. TANNER, Tennessee
ROB PORTMAN, Ohio XAVIER BECERRA, California
PHILIP S. ENGLISH, Pennsylvania KAREN L. THURMAN, Florida
WES WATKINS, Oklahoma LLOYD DOGGETT, Texas
J.D. HAYWORTH, Arizona
JERRY WELLER, Illinois
KENNY HULSHOF, Missouri
SCOTT McINNIS, Colorado
RON LEWIS, Kentucky
MARK FOLEY, Florida
A.L. Singleton, Chief of Staff
Janice Mays, Minority Chief Counsel
______
Subcommittee on Health
BILL THOMAS, California, Chairman
NANCY L. JOHNSON, Connecticut FORTNEY PETE STARK, California
JIM McCRERY, Louisiana GERALD D. KLECZKA, Wisconsin
PHILIP M. CRANE, Illinois JOHN LEWIS, Georgia
SAM JOHNSON, Texas JIM McDERMOTT, Washington
DAVE CAMP, Michigan KAREN L. THURMAN, Florida
JIM RAMSTAD, Minnesota
PHILIP S. ENGLISH, Pennsylvania
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Ways and Means are also published
in electronic form. The printed hearing record remains the official
version. Because electronic submissions are used to prepare both
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converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
current publication process and should diminish as the process is
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C O N T E N T S
__________
Page
Advisory of February 3, 2000, announcing the hearing............. 2
WITNESSES
U.S. Department of Veterans, James P. Bagian, M.D., Director,
National Center for Patient Safety, Veterans Health
Administration................................................. 72
National Aeronautics and Space Administration, Moffett Field,
California, Linda J. Connell, Director, Aviation Safety
Reporting System............................................... 13
______
American Health Quality Association, William E. Golden, M.D...... 92
American Hospital Association, and Cedars-Sinai Health System,
Michael Langberg, M.D.......................................... 45
American Medical Association, Thomas R. Reardon, M.D............. 55
Institute of Medicine, Mount Sinai School and Medicine, and
Veterans Affairs Medical Center, Christine K. Cassel, M.D...... 7
Joint Commission on Accrediation of Healthcare Organizations,
Dennis S. O'Leary, M.D......................................... 86
National Quality Forum for Health Care Measurement and Reporting,
Kenneth W. Kizer, M.D.......................................... 79
SUBMISSIONS FOR THE RECORD
American Academy of Orthopaedic Surgeons, and American
Association of Orthopaedic Surgeons, joint statement........... 107
American College of Physicians-American Society of Internal
Medicine, statement............................................ 110
American Osteopathic Association, and American Osteopathic
Healthcare Association, joint statement........................ 112
Association of Women's Health, Obstetric and Neonatal Nurses,
statement...................................................... 114
Health Care Liability Alliance, statement........................ 116
Healthcare Compliance Packaging Council, Falls Church, VA,
statement...................................................... 123
Honeywell, Annette Guarisco, statement........................... 124
New Medical Concepts, Inc., Fort Lauderdale, FL, Raymond T.
Hersh, statement............................................... 125
Shands Healthcare, Gainesville, FL, J. Richard Gaintner,
statement...................................................... 127
MEDICAL ERRORS
----------
THURSDAY, FEBRUARY 10, 2000
House of Representatives,
Committee on Ways and Means,
Subcommittee on Health,
Washington, D.C.
The Subcommittee met, pursuant to notice, at 9:40 a.m., in
room 1310, Longworth House Office Building, Hon. Bill Thomas
(Chairman of the Subcommittee) presiding.
[The advisory announcing the hearing follows:]
ADVISORY FROM THE COMMITTEE ON WAYS AND MEANS
SUBCOMMITTEE ON HEALTH
Contact: (202) 225-3943
FOR IMMEDIATE RELEASE
February 3, 2000
No. HL-11
Thomas Announces Hearing on Medical Errors
Congressman Bill Thomas (R-CA), Chairman, Subcommittee on
Health of the Committee on Ways and Means, today announced that
the Subcommittee will hold a hearing on the prevalence and
nature of medical errors in the health care system.
Additionally, proposed strategies to ensure patient safety
through the reduction of errors will be discussed. The hearing
will take place on Thursday, February 10, 2000, in room 1310
Longworth House Office Building, beginning at 9:30 a.m.
In view of the limited time available to hear witnesses,
oral testimony at this hearing will be from invited witnesses
only. However, any individual or organization not scheduled for
an oral appearance may submit a written statement for
consideration by the Committee and for inclusion in the printed
record of the hearing.
BACKGROUND:
Since Medicare's inception, a variety of measures have been
utilized to help ensure the quality of medical care received by
Medicare beneficiaries (e.g., Peer Review Organizations).
Recently, the Institute of Medicine (IOM) released a report, To
Err is Human: Building a Safer Health System, that has brought
the issue of patient safety to the forefront of health policy
discussion. This report cites studies that estimate the annual
number of deaths resulting from medical errors in the United
States to be at least 44,000, and possibly as high as 98,000.
This number equates to the eighth leading cause of death in the
nation and is more than the amounts attributed to auto
accidents, cancer, or AIDS.
The statistical data included in the IOM study were derived
from the hospital inpatient environment. As the country's
largest insurer, Medicare Part A is the primary source of
funding for services provided in these locations. Authors of
the IOM study recommend several potential strategies for
government, industry, consumers, and health providers to reduce
medical errors. Additionally, the authors encourage Congress to
create a national patient safety center to develop new tools
and systems in order to address persistent problems.
In announcing the hearing, Chairman Thomas stated, ``As
Congress prepares to act on patient protection legislation, we
must examine the problem of medical errors this year. After
all, isn't the ultimate patient protection to prevent deaths
from medical errors? Congress should not complete patients'
rights legislation without examining potential solutions to
prevent patients from dying due to medical errors. I look
forward to this hearing to learn how Congress might develop
solutions that will help protect seniors and all other patients
in the health care system.''
FOCUS OF THE HEARING:
The hearing will provide the opportunity to hear from the
administration, advisory bodies, and providers on why medical
errors occur and what possible solutions could be utilized to
prevent them.
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label, by the close of business, Thursday, February 24, 2000,
to A.L. Singleton, Chief of Staff, Committee on Ways and Means,
U.S. House of Representatives, 1102 Longworth House Office
Building, Washington, D.C. 20515. If those filing written
statements wish to have their statements distributed to the
press and interested public at the hearing, they may deliver
200 additional copies for this purpose to the Subcommittee on
Health office, room 1136 Longworth House Office Building, by
close of business the day before the hearing.
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Chairman Thomas. The subcommittee will come to order. I
want to thank everyone and apologize in advance for the
unusually small room. This is the committee hearing room for
House Administration. I am chairman of that committee and we
rarely see this many people. It went from the District of
Columbia, where you had no one. House Administration at least
filled some of the seats.
For centuries, healers have taken the Hippocratic oath, and
we will hear this a number of times today. First, do no harm.
Based upon the Institute of Medicine's report, not necessarily
a significantly new report, but for some reason, either timing
in a slow news cycle or the reaction or overreaction of some
institutions to its presentation, it has become front-page
news.
This committee, and I believe this chairman and the ranking
member, are not always interested in being the first with a
piece of legislation. The rush to legislation has begun in this
particular area. I have always been an advocate of get it right
rather than get it first. However, it seems to me in reading
the report and in reading the testimony today, there are
clearly some steps that can be taken of an organizational or
structural nature that would create a more fertile field for
the continued development of error correction structures or
systems. To the degree that the patient protection conference
continues to be delayed, there may very well be an opportunity
to present in a measure that will move relatively rapidly
through the system.
I was amazed to find that after I suggested this at the
Hospital Association last week at their convention, that a
member, not of this committee but a colleague of mine from
California, suggested that dealing with procedures to reduce
the number of patients killed would be a poison pill in the
patient protection legislation, and I just find that ironic,
because if there is anything fundamental to first do no harm,
it is first do not kill. If there is something that can be
done, I do not know why we do not move as expeditiously as
possible.
This morning, I really want to have as clear an
understanding as we can bring to the issue about what is being
done to prevent errors, but more importantly, what we can do to
prevent these mistakes, and a know a number of folks are going
to tell us that there has been a flurry of activity in recent
years, while at the same time I have heard criticisms of the
IOM report that the data is old, it has been around a long
time. If that is the case, then why was there not a flurry
earlier? My assumption is it is because it got more news than
it ever has before.
So in the course of this hearing, I hope we will learn why
the current medical error reporting systems apparently are not
working and what changes need to be made. Our objective,
obviously, should be to make changes that result in more
effective, accurate, and timely systems for reporting medical
errors.
We are going to start with Dr. Christine Cassel, who will
provide an overview, given her unique history on the Institute
of Medicine's recommendations, and then we will hear from Ms.
Linda Connell, who directs the Aviation Safety Reporting System
at NASA and who, coincidentally, is a nurse and may be able to
provide some cross-fertilization between what is usually used
as an example of an extremely successful model, based on her
experience and involvement in the other world.
We also want to learn about the characteristics of the
internal reporting system used by the Veterans Health
Administration, followed by witnesses that will describe other
approaches that are currently being used or that should be put
in place to correct medical errors.
I look forward to the session. As I said, our goal is to
see if there are not some initial steps that can be made
relatively briefly. I do not think we need to wait until we
reinvent an entire national system, but I will be very
sensitive to the statements made about what should not be done
or cannot be done, because even if the number of accidental
deaths is not 100,000, even if it is 50,000, even if it is
40,000, i.e., you pick the number, the current system is and
will be unacceptable without fundamental and systematic change.
With that, I will yield to the gentleman from California
for any opening remarks he might wish to make.
[The opening statement of Chairman Thomas follows:]
Opening Statement of Hon. William M. Thomas, a Representative in
Congress from the State of California
For centuries, healers have taken the Hippocratic Oath to
``first do no harm.'' Yet, it seems that patients have reason
to question their safety as they participate in today's health
care system.
Last November, the Institute of Medicine issued a report on
patient safety and the staggering number of medical errors that
occur in our nation's hospitals. As Congress prepares to act on
patient protection legislation this year, I can think of no
better reason to examine why these errors occur and how we can
reduce the number of people who die from them. Some of my
colleagues on the other side of the aisle have called this
issue a ``poison pill''in patients' rights legislation but,
isn't reducing medical errors the ultimate patient protection?
This morning, I want to learn why people are suffering and
dying from medical errors and what can be done to prevent these
mistakes. We are not here to debate the number of errors, or
the methods for calculating them. Even one death from a medical
mistake is one too many. In the course of this hearing, we will
learn why the current medical error reporting systems
apparently are not working and what changes need to be made to
prevent people from dying due to medical errors. Our objective
should be to make changes that result in more effective,
accurate, and timely systems for reporting medical errors.
We will start with Dr. Christine Cassel, who will provide
an overview of the Institute of Medicine's recommendations.
Then we will hear from Ms. Linda Connell, who directs the
Aviation Safety Reporting System at NASA, which has been cited
by many in the quality field as a model system for reporting
medical errors. We also will learn about the characteristics of
the internal reporting system used by the Veterans Health
Administration, followed by witnesses who will describe
possible approaches to drive down the number of medical errors.
I look forward to an informative session that helps us
understand how we can protect and improve the safety of the
health care system for all patients.
Mr. Stark. Thank you, Mr. Chairman, for calling this
hearing. As the Institute of Medicine report tells us, medical
errors result in injury and death to thousands of patients each
year and billions of dollars in wasted costs. It is time for
the health care industry to catch up with the rest of the world
in preventing errors.
Much information reported by the IOM, as you point out, has
been known for some time. This recent report focuses our
attention and helps us realize that it is time now to address
the problem.
We find, for example, that the dialysis program is the MD-
80 of the medical world. In 1997, we called for quality
standards and HCFA is still working on the standards. That is
three years. It is way past time for these standards to be
implemented.
Some dialysis centers are needlessly killing people today,
and we have the data to show it, and yet HCFA and other
regulators were not doing anything about it. So how many
airplane crashes do we need to have in the medical delivery
system before they wake up?
The quality of care has never been a priority in Medicare,
Mr. Chairman, and it certainly is not a priority in any of the
managed care plans outside of Medicare. I believe that it is
time that we make it a priority, and improving quality and
preventing errors ought not to be partisan. I doubt if it will
be. We want to improve that, and I look forward to working with
you on this issue and I hope we can act on it this year. Thank
you.
Chairman Thomas. Thank you. I would now ask Dr. Cassel and
Ms. Connell to come forward. There are a number of medical
professionals who are concerned about this, and I will tell you
only that some of us may even have to apologize ahead of time
in terms of our terminology, because we may use the vernacular
in discussing what is going on, and if the reference is that
people are dying and being killed, there may be some terms that
are used which somehow insulate you. I know in the spy business
they used to talk about it as termination.
It is, I think, partly necessary to confront the fact that
what is happening in the system is that people are dying from
medical errors. The argument that if they are being killed,
there is some willfulness to it, is a concern I have because a
willful refusal to change procedures when people are dying
reaches a very interesting philosophical debate point about
whether or not the system is killing people.
Mr. Stark. Mr. Chairman?
Chairman Thomas. The gentleman from California.
Mr. Stark. By way of, I guess, apologizing for a harsh
word, I would like to describe it in layman's terms. Going to
the hospital, for example, is a dangerous trip. The difference
in my mind, at least, is that if people are allergic, as I am,
to penicillin, and if the person at the hospital asks me before
I have an operation and I say, no, I am not, or I forget to
tell them, or I am not wearing that little wrist bracelet, and
I have a reaction, that is not the medical delivery system's
fault; it is mine. Now, if I do not know whether I am allergic,
that is different.
Also, if the medical system forgets to ask, that, to me, is
negligent or wrong. That is something in the system that is
wrong, and I think those kinds of errors could be fatal. We
certainly should be able to eliminate the errors where they
forget to ask. What we can do to educate the populus, I think
that is beyond our ability, but I would like to draw that
difference. Thank you.
Chairman Thomas. I appreciate it. An educated consumer is a
goal that all of us want because that would help significantly.
[The opening statement of Mr. Ramstad follows:]
Opening Statement of Hon. Rep. Jim Ramstad, a Representative in
Congress from the State of Minnesota
Mr. Chairman, thank you for calling this important hearing
today to discuss the issue of medical errors within our health
care system.
Like all of my colleagues here, I was troubled to hear of
the high number of medical errors that occur in our nation
every year. The amazing and hard-working people who make up the
health care industry in America--these people who have
dedicated their lives to the health and welfare of those around
them--are human and that means errors will happen. But the
sheer numbers of errors is staggering.
I know every physician, nurse and health care provider at
any level is ready and willing to help us combat the prevalence
of errors in the system. That's why we do not seek to blame
anyone for these errors at this hearing today, and why we need
to carefully identify ways to reduce the number of errors and
establish a system for analyzing the problems and learning how
to prevent future mistakes.
I still believe the answers to these tragic issues lie
within the health care industry itself, but I look forward to
hearing the testimony of those coming before us today on how we
can work together in an appropriate fashion to ensure errors
and near-misses are reported, analyzed and prevented.
Mr. Chairman, thanks again for calling this critical
hearing.
We have your written testimony, and without objection, it
will be made a part of the record and you can address us in any
way you see fit in the time you have available. Dr. Cassel?
STATEMENT OF CHRISTINE K. CASSEL, M.D., MEMBER, QUALITY OF
HEALTH CARE IN AMERICA COMMITTEE, INSTITUTE OF MEDICINE,
PROFESSOR AND CHAIRMAN, HENRY L. SCHWARTZ DEPARTMENT OF
GERIATRICS AND ADULT DEVELOPMENT, MOUNT SINAI SCHOOL OF
MEDICINE, NEW YORK, NEW YORK, AND DIRECTOR, GERIATRIC RESEARCH
EDUCATION AND CLINICAL CENTER, VETERANS AFFAIRS MEDICAL CENTER,
BRONX, NEW YORK
Dr. Cassel. Thank you. Congressman Thomas, Congressman
Stark, and members of the committee, I am pleased to be here
with you today to address this important topic.
Chairman Thomas. Dr. Cassel, let me tell you that although
it is a pretty room, the acoustics are not real good and these
microphones are very unidirectional. You need to speak directly
into it. Thank you.
Dr. Cassel. I am an internist and geriatrician and
professor and Chairman of the Henry L. Schwartz Department of
Geriatrics and Adult Development at the Mount Sinai School of
Medicine and Director of the Geriatric Research Education and
Clinical Center at the Bronx Veterans Affairs Medical Center. I
tell you this because in my field of geriatric medicine, it is
an area that is one of the highest risks for complications of
medical care. Errors are a small part of those kinds of
complications.
Today, I am pleased to be here representing the Institute
of Medicine's Committee on the Quality of Health Care in
America and our recently released report, ``To Err is Human:
Building a Safer Health System.''
Our committee concluded that medical mistakes rank eighth
among the leading causes of death, ahead of traffic accidents,
breast cancer, and AIDS. The good news is, we strongly believe
that it is possible to achieve at least--at least--a 50 percent
reduction in errors over the next five years. The knowledge and
technology exists to prevent many of these mistakes.
No physician or nurse wants to hurt patients, and doctors,
nurses, and other health workers are highly trained to be
careful and take precautions. They are held and they hold
themselves to high standards. Paradoxically, it is precisely
this exclusive focus on the individual as the source of
mistakes that makes health care so unsafe.
Errors are seldom due to carelessness in the sense of lack
of trying hard enough. More commonly, they are caused by faulty
systems, processes, and conditions that lead people to make
mistakes or fail to prevent them. They can be prevented by
designing systems that make it hard for people to do something
wrong and easy for them to do it right.
Safe industries, such as aviation, chemical manufacturing,
and nuclear power learned this lesson a long time ago. While
insisting on training and high standards of performance, they
recognize that these alone are insufficient to ensure safety.
They also pay attention to factors that affect performance,
such as work hours, work conditions, information technology,
team relationships, and the design of tasks so that errors are
difficult to make. They create safety by design. Health care
must do the same.
To address this serious issue, our report puts forth a
comprehensive strategy for government, industry, consumers, and
providers all to take action. The strategy calls for four major
things.
One, the creation of a Center for Patient Safety within the
Agency for Health Care Research and Quality to provide
leadership, invest in research on medical errors, and build
prototype systems to improve safety, and disseminate this
information on best practices.
Two, establishment of mandatory and voluntary reporting
systems. A nationwide, State-based mandatory reporting system
is needed to collect information on the most serious errors
that result in death or permanent harm and to use this
information to better understand the factors that contribute to
errors, to encourage health care organizations to take
necessary steps to prevent future errors, and to keep the
public informed about safety issues. Voluntary reporting
systems focusing on errors that result in lesser or no harm,
what the aviation industry calls near misses, should be
encouraged by extending peer review protections to the data and
information in these systems.
Third, strengthening the standards and expectations for
improvements in safety that are set by accrediting and
licensing organizations, group purchasers, and professional
groups.
And fourth, creating safety systems inside health care
organizations, including integrated health plans, hospitals,
nursing homes, and outpatient facilities.
As you said, Mr. Chairman, the response to the IOM report
has been phenomenal. This report received nearly saturation
coverage in the national media. There were more than 100 live
and taped appearances of committee members on local television
and radio stations. In a recent survey conducted by the Kaiser
Family Foundation, 51 percent of Americans closely followed the
news of this release. Steady news coverage of this critical
issue continues.
Since the release of this report, questions have been
raised regarding the recommendation, especially regarding two
of our recommendations, one pertaining to the Center for
Patient Safety and the second pertaining to mandatory and
voluntary reporting systems. I would like to focus a few more
words of my testimony in these two areas, but I would be happy
to answer your questions about any part of the report.
The Center for Patient Safety. Meeting this safety
challenge, we feel, requires leadership and action at a
national level. Attention and resources are critical to making
safety the number one priority of other health care industries.
Unless something like the Center for Patient Safety is created
to keep attention focused on these issues and to enhance the
base of knowledge and tools, meaningful progress is going to be
very difficult.
The Center for Patient Safety is not intended to be a
regulatory or standard-setting body. It is expected to track
progress and issue an annual report to the President and to
Congress on patient safety and to enhance knowledge of safety
by funding research into the application of safety sciences to
health care and the development of prototype systems.
At present, there is no national visibility for this issue
outside of this alarm in the recent press. There is no stimulus
or encouragement for health care organizations to get better at
implementing safe practices. We will not achieve safety unless
we know what we are striving for. We, therefore, need to set
national goals like the U.S. Preventive Services Task Force or
Healthy People 2000.
The need for research is enormous. This is a new kind of
research for the health care world to take on. The funding for
this research has to be at a meaningful level in order to make
a difference, and this is the agency that is responsible for
our nation's health care quality information. It is an
appropriate place to do that.
Let me say a couple more words about the reporting of
errors. Our committee believes there should be both mandatory
and voluntary reporting systems. We understand many of the
problems that have been raised about mandatory reporting
systems, but we believe that without some kind of mandatory
system, we will not know the rate of errors and we will not
know if we have improved them. We must also be responsible to
the public in this sense. The mandatory reporting will give us
this information, will make us responsible to the public, and
as importantly, will require that all health care organizations
make some level of investment in this important area which will
create a level playing field for health care so that people who
spend money on this will not be penalized.
The voluntary reporting is equally important, and I want to
just say that these kinds of less-harmful errors are much more
difficult to identify, and if we encourage voluntary systems,
we can find ways like the aviation industry has to identify the
so-called near misses and to improve our performance in the
absence of harm to patients. These voluntary systems should be
afforded legal protections from data discoverability in order
to allow the free exchange of information within those systems.
In conclusion, let me just say that the core message from
safety experts that our committee heard and that I believe you
will hear today is to avoid a system that is punitive towards
individuals. That will inhibit accurate reporting and it will
not reduce errors. The key is creating an environment where
teams can be creative about reducing errors, where they have
the information to work with, and where the health care systems
are accountable to the public. Thank you very much.
Chairman Thomas. Thank you, Dr. Cassel.
[The prepared statement follows:]
Statement of Christine K. Cassel, M.D., Member, Quality of Health Care
in America Committee Institute of Medicine, Professor and Chairman,
Henry L. Schwartz Department of Geriatrics and Adult Development, Mount
Sinai School of Medicine, New York, New York, and Director, Geriatric
Research Education and Clinical Center, Veterans Affairs Medical
Center, Bronx, New York
Good morning, Congressman Thomas and members of the
Committee. My name is Christine K. Cassel. I am an internist
and geriatrician, and Professor and Chairman of The Henry L.
Schwartz Department of Geriatrics and Adult Development at The
Mount Sinai School of Medicine in New York and Director of the
Geriatric Research Education and Clinical Center at the Bronx
Veterans Affairs Medical Center. I am here today representing
the Institute of Medicine's Committee on the Quality of Health
Care in America which recently released the report To Err is
Human: Building a Safer Health System.
The IOM Committee on the Quality of Health Care in America
concluded that medical mistakes rank eighth among the leading
causes of death--ahead of traffic accidents, breast cancer, and
AIDS. The good news is that we strongly believe that it is
possible to achieve at least a 50 percent reduction in errors
over the next five years. The knowledge and technology exists
to prevent many of these mistakes.
No physician or nurse wants to hurt patients, and doctors,
nurses, and other health workers are highly trained to be
careful and take precautions to prevent mistakes. They are held
and hold themselves to high standards. Paradoxically, it is
precisely this exclusive focus on the individual as the source
of mistakes that makes health care so unsafe.
Errors are seldom due to carelessness or lack of trying
hard enough. More commonly, errors are caused by faulty
systems, processes and conditions that lead people to make
mistakes, or fail to prevent them. They can be prevented by
designing systems that make it hard for people to do something
wrong and easy to do it right. Safe industries, such as
aviation, chemical manufacturing, and nuclear power, learned
this lesson long ago. While insisting on training and high
standards of performance, they recognize these are insufficient
to insure safety. They also pay attention to factors that
affect performance, such as work hours, work conditions,
information technology, team relationships, and the design of
tasks to make errors difficult to make. They create safety by
design. Health care must do likewise.
To address this serious issue, our report puts forth a
comprehensive strategy for government, industry, consumers, and
providers all to take action. The strategy calls for:
The creation of a Center for Patient Safety within
the Agency for Healthcare Research and Quality to provide
leadership, invest in applied research on medical errors, build
prototype systems to improve safety, and disseminate
information on ``best practices'' throughout the health care
system.
Establishment of mandatory and voluntary reporting
systems. A nationwide, state-based mandatory reporting system
is needed to collect information on the most serious errors
that result in death or permanent harm, and to use this
information to better understand the factors that contribute to
errors, to encourage health care organizations to take the
necessary steps to prevent future errors, and to keep the
public informed of safety issues. Voluntary reporting systems,
focusing on errors that result in lesser or no harm (what the
aviation industry calls ``near misses''), should be encouraged
by extending peer review protections to data and information in
these systems.
Strengthening the standards and expectations for
improvements in safety that are set by accrediting and
licensing organizations, group purchasers, and professional
groups.
Creating safety systems inside health care
organizations, including integrated health plans, hospitals,
nursing homes and outpatient care facilities.
The response to the IOM report on errors has been
phenomenal. The report received near saturation coverage in the
national media, including front page and leading news coverage
in most of the major national newspapers and television news
programs. There were also more than 100 live and taped
appearances of Committee members on local television and radio
stations. In a recent survey conducted by the Kaiser Family
Foundation and Harvard School of Public Health, it was found
that 51% of Americans closely followed news of the release of
the report. Moreover, steady news coverage of this critical
issue continues.
Since the release of the report, questions have been raised
especially regarding the recommendations pertaining to the
creation of a Center for Patient Safety and the mandatory and
voluntary reporting systems. I would like to focus my testimony
on our Committee's thinking in these two areas, but I would be
happy to answer questions about any part of the report.
Center for Patient Safety
Meeting the patient safety challenge will require
leadership and actions at all levels, but national leadership,
attention and resources are absolutely critical to making
safety the #1 priority of every health care institution.
Experience from other industries, such as aviation, suggests
that unless a Center is created to keep attention focused on
patient safety and enhance the base of knowledge and tools,
meaningful progress is not likely.
The Center for Patient Safety is not intended to be a
regulatory or standard-setting body, but it is expected to
track progress and issue an annual report to the President and
Congress on patient safety, and to enhance knowledge of safety
by funding research into the application of safety sciences to
health care and the development of prototype systems. The
Center would also be responsible for dissemination of
information on ``best practices.''
Goal-setting. At present, there is no national visibility
for patient safety, and no stimulus or encouragement for health
care organizations to implement safe practices. We cannot
achieve safety unless we know what we are striving for. By
setting national goals, much like the U.S. Preventive Services
Task Force, or Healthy People 2000, the Center for Patient
Safety can ``raise the bar'' for achievement by all
organizations.
Research and development. While much is known from prior
research and industrial experience about theories of error
causation and prevention, relatively little is known about the
application of those theories and methods in medical practice.
Because principles of safety have been so sparsely used in
health care, their usage needs to be studied in a number of
applications (medication safety, surgical operations, new
technologies, etc.) and in a variety of settings (e.g.,
emergency rooms, intensive care units, and doctors' offices).
The Center for Patient Safety would set a research agenda and
fund both intramural and extramural research projects to
address those needs. The need is enormous. The funding should
be at a meaningful level in order to make a difference.
For its development role, the Center for Patient Safety
would lead and facilitate the application of known principles
and research findings in the definition of best practices and
processes. These would apply to both clinical care and
management, and are needed for virtually all systems in health
care organizations: medication systems, operating rooms,
emergency departments, diagnostic testing, care of the elderly,
etc. Some of these activities can, and should, be led by
professional societies who can mobilize the expertise and
commitment of their members. The Center would also develop
methods for consumer education and be responsible for
disseminating safety information widely.
The need to develop these research, education,
dissemination, and facilitation activities is the principal
reason for recommending that the Center for Patient Safety be
lodged in the Agency for Healthcare Research and Quality. These
functions are similar to those that the Agency has
traditionally carried out over the past decade under its
quality improvement agenda. It can easily provide both the
leadership and the expertise needed by the Center for Patient
Safety to establish new programs.
Evaluation. The Center for Patient Safety could also
perform the valuable function of coordinating, collecting and
analyzing data provided by both voluntary and mandatory
reporting systems. It would monitor national progress in
improving patient safety and provide an annual report to
Congress, including recommendations to health care
organizations and the various agencies and associations for
improving patient safety. Part of this function might also be
served by the newly established National Forum on Health Care
Quality Measurement and Reporting.
Reporting of Errors
The IOM Committee also believes there should be mandatory
and voluntary reporting systems. Mandatory reporting systems
should focus on detection of errors that result in serious
patient harm or death. While safety experts recognize that
errors resulting in serious harm are the ``tip of the
iceberg,'' they represent the small subset of errors that
signal major system breakdowns with grave consequences for
patients.
Mandatory systems serve three purposes. First, they provide
the public with a minimal level of protection by assuring that
the most serious errors are reported and investigated and
appropriate follow up action taken. Second, they provide an
incentive to health care organizations to improve patient
safety in order to avoid the potential penalties and public
exposure. Third, they require all health care organizations to
make some level of investment in patient safety, thus creating
a more level playing field.
We recommended that a nationwide, state-based system of
mandatory reporting be established that provides for the
collection of standardized information about the most serious
errors. Congress should provide funds and technical expertise
for state governments to establish or adapt their current error
reporting systems to collect the standardized information,
analyze it and conduct follow-up action as needed with health
care organizations.
The committee believes there is a serious problem of
accountability for safety in health care and that current
mechanisms for holding health care organizations accountable
for safety are inadequate. We use the phrase ``holding
accountable'' not as code for blame and punishment, but to mean
insuring responsibility, i.e., making sure that health care
organizations are doing everything they reasonably can for
patient safety. If mandatory reporting systems are perceived as
unfairly punitive, or embarrassing for the organization,
compliance will be reluctant and incomplete. But, improvement
cannot happen in the absence of reliable data. Reporting,
alone, does not improve safety or reduce hazards. Unless
reporting is followed by understanding and change, safety will
not improve. Investigation of the circumstances surrounding
incidents is required to determine the underlying causes.
Improvements only occur if the analysis identifies systems
failures and they are corrected. Success of the investigation
and analysis depends in large measure on the degree to which
individuals feel it is safe to participate. Systems that have
been most successful in bringing about changes for safety
combine mandatory reporting with some degree of confidentiality
and protection of individual providers.
Although state governments would be responsible for the
mandatory reporting program, this does not mean that a state
would have to collect and analyze the data themselves. A state
may choose to rely on an accrediting body, a peer review
organization or other private sector oversight entity to
perform this function. Twenty states already have mandatory
error reporting systems. Since the release of our report, a
number of others are exploring this option. Flexibility and
innovation in implementation is important at this stage of
development because states that have existing adverse event
programs have used different approaches to implement their
programs and a ``best practice `` or preferred approach is not
yet known.
The IOM Committee believes that voluntary reporting systems
play a valuable role in encouraging improvements in patient
safety and are a complement to mandatory reporting systems. The
focus of voluntary systems is usually on errors that resulted
in no harm, or very minimal patient harm. Voluntary reporting
systems are particularly useful for identifying types of errors
that occur too infrequently for an individual health care
organization to readily detect based on their own data, and
patterns of errors that point to systemic issues affecting all
health care organizations. The continued development of
voluntary reporting systems should be encouraged, and voluntary
reporting systems should be afforded legal protections from
data discoverability. The core message from safety experts in
other fields is to avoid a system that is punitive towards
individuals--it will inhibit accurate reporting and won't
reduce errors. The key is creating an environment where teams
can be creative about reducing errors, where they have the
information to work with, and where the health care systems are
accountable to the public.
Thank you for this opportunity to testify. I would be happy
to answer any questions the Committee may have.
Chairman Thomas. Ms. Connell is the Aviation Safety
Reporting System Director at the National Aeronautics and Space
Administration Ames Research Center, Moffett Field, and, of
course, the FAA and the reporting procedure associated with
that is held up as a model. But something that some folks may
not know, Ms. Connell is also a nurse, so that she has an
opportunity to have a comparison of two different worlds, one
in which many folk wear blue uniforms with epaulets and the
other world in which they have a stethoscope around their neck
and a white coat, one which has an open structure of reporting
errors, the other one seems to have a degree of secrecy about
the fact that errors even occur. Ms. Connell?
STATEMENT OF LINDA J. CONNELL, DIRECTOR, AVIATION SAFETY
REPORTING SYSTEM, NATIONAL AERONAUTICS AND SPACE
ADMINISTRATION, MOFFETT FIELD, CALIFORNIA
Ms. Connell. Mr. Chairman and members of the subcommittee,
I thank you very much for the invitation to provide information
to you on the Aviation Safety Reporting System, which I will
call the ASRS from here on. This system in aviation is a
voluntary, confidential, non-punitive safety reporting system
that has been contributing to aviation safety since 1996. As
the Director of the ASRS for NASA, I will attempt to highlight
some of the aspects of this system that may be applicable to
the current efforts in health care safety.
The ASRS is a highly successful and trusted program that
has served the needs of the aviation community for 24 years.
The ASRS was established as a result of a very tragic accident
in 1974, not far from here, when TWA 514 collided with a
Virginia mountaintop on approach to Dulles. It was discovered
in the ensuing NTSB accident investigation that a United
Airlines crew had very narrowly escaped the same fate only six
weeks prior.
As a result, the NTSB provided a recommendation to the FAA
and the ASRS began operation in 1976 under an agreement between
the FAA and NASA. This cooperative safety program invites
pilots, air traffic controllers, flight attendants, maintenance
personnel, and others to voluntarily report to NASA any actual
or potential hazard to safe aviation operations.
As the medical community begins to consider the value of
reporting systems within their discipline, there are several
constructs that are a part of ASRS which could be beneficial.
The guiding principles of the ASRS are that it is voluntary, it
is non-punitive, and it is confidential. It is voluntary in the
sense that any person involved in the daily operations of the
system can report to NASA by their choice and describe any
event they determine to be important. Although the system
solely excludes accident and criminal event reporting, it was
decided that the system should not restrict or influence what
the people wanted to say about safety or their experiences.
This was an opportune decision and has helped to expand the
insights into human performance.
The ASRS is considered non-punitive in that the reporters
to the ASRS are guaranteed limited immunity by the FAA. The FAA
will not use, nor will NASA provide, any information that has
been filed with the ASRS in an enforcement action. The FAA will
also waive fines and penalties for unintentional violations of
any Federal Aviation regulation as long as those violations are
reported within ten days to the ASRS and that all criteria
written in an advisory circular are met.
All the reports submitted to the ASRS are held in strict
confidence. More than 470,000 reports have been submitted since
the beginning of the program without a single reporter's
identity being revealed in those 24 years. Currently, the ASRS
program is receiving approximately 36,000 reports annually.
I would like to point out that the ASRS is a unique safety
information system. No other such system, voluntary or
mandatory, offers and delivers the complete standard of
confidentiality and subsequent anonymity provided by the ASRS
program. The successful longevity of this system and its
continuing trust and strength arises almost solely from the
proven ability to protect the identity.
It is important to remember that the ASRS is not an
investigative system. There are two main purposes under the
ASRS function. One is to identify any deficiencies or
discrepancies in the system and alert the system. Two is to
provide data for planning and safety improvement.
The ASRS has released numerous alert messages concerning
potential hazards and important occurrences and they are paid
attention to. We also hold biweekly telecons with the FAA in
order to highlight any significant report information. These
discussions involve information that is fully de-identified by
the NASA expert analysts, who are retired airline pilots, air
traffic controllers, mechanics, flight attendants.
The long-term purpose for the ASRS is met by the database,
which provides de-identified reports that include an extensive
narrative section which is a very complete description of the
event. Due to the style of reporting and our ability to contact
the reporters while processing their report, we are able to
find out the ``why'' of the event, not just a terse
description. Once this data is placed into the database, it is
accessible to the public.
The ASRS has accomplished over 5,800 database searches for
the government, students, research organizations, international
organizations, aircraft manufacturers, as well as others not in
our discipline, as in nuclear power. The FAA is the top
requester of this ASRS information.
There are several factors that could be described as
components for success. Briefly, some of these factors are the
independence, perceived and actual independence, of the
operating organization; the involvement of an advisory group
representing the reporter community from the beginning; the
availability of expert analysts for the report processing;
continuous feedback of information to the reporter communities;
and ongoing research utilizing this data.
It is noteworthy as people consider the application of the
aviation model to medicine that the ASRS model has generally
been accepted in international aviation systems. There are
currently seven countries that have operating voluntary
systems.
This concludes my remarks, and I would close in stating
that we at the ASRS firmly believe that the collection of
voluntary reports and the subsequent database provide the most
authoritative source of human performance information that
exists in aviation. I thank you.
Chairman Thomas. Thank you very much.
[The prepared statement follows:]
Statement of Linda J. Connell, Director, Aviation Safety Reporting
System, National Aeronautics and Space Administration, Moffett Field,
California
Mr. Chairman and Members of the Subcommittee,
I am pleased to respond to your request for information on
the Aviation Safety Reporting System (ASRS). The ASRS is a
model for voluntary, confidential, non-punitive safety
reporting that has been contributing to aviation safety since
1976. Some aspects of its applicability to the current efforts
surrounding the improvement of healthcare have been addressed
in the December 1999 Institute of Medicine report, ``To Err is
Human: Building a Safer Health System.''
The ASRS is a highly successful and trusted program that
has served the needs of the aviation community for 24 years. It
is available to all participants in the National Aviation
System who wish to report safety incidents and situations. The
ASRS was established in 1976 under an agreement between the
Federal Aviation Administration (FAA) and the National
Aeronautics and Space Administration (NASA). This cooperative
safety program invites pilots, air traffic controllers, flight
attendants, maintenance personnel, and others to voluntarily
report to NASA any actual or potential hazard to safe aviation
operations. The FAA, Office of System Safety, provides most of
the program funding. NASA Ames Research Center administers the
program, assures confidentiality, receives all reports
submitted to the program, and sets policies in conjunction with
the FAA and a fifteen member industry Advisory Committee.
The ASRS collects and responds to these voluntarily
submitted incident reports to lessen the likelihood of aviation
accidents. The ASRS data are used to identify aviation system
deficiencies for correction by appropriate authorities, support
aviation system policy, planning and improvements, and
strengthen the foundation of aviation human factors safety
research.
The ASRS reporters are protected when they report to this
system. NASA and the FAA offer those who use the ASRS program
two important reporting guarantees: confidentiality and limited
immunity. These guarantees as expressed in Federal Aviation
Regulation 14 CFR 91.25 and FAA Advisory Circular 00-46D are
offered because this type of safety information is unique and
its value can only be obtained as a result of the confidence
and trust placed in the program by the reporters. The NASA
preaddressed and postage-free form, NASA ARC 277A-D, is used by
the aviation reporters to submit information. The reports sent
to the ASRS are held in strict confidence. More than 470,000
reports have been submitted since the program's beginning
without a single reporter's identity being revealed. The ASRS
removes all personal names and other potentially identifying
information before entering reports into its database.
Currently, the ASRS program is receiving 36,000 reports
annually.
The reporters to ASRS are guaranteed limited immunity by
the FAA. This means that the FAA will not use, nor will NASA
provide, information that has been filed with the ASRS in an
enforcement action, and will waive fines and penalties for
unintentional violations of Federal Aviation Regulations, as
long as violations are reported within 10 days. However,
accidents and criminal activities are not protected from
enforcement actions, and should not be submitted to the ASRS.
In addition to the immunity provisions associated with the ASRS
program, reporters often mention other equally important
motivations for using the program. The reporters feel increased
satisfaction in knowing that they are helping to improve the
aviation system by giving safety information to the ASRS and
increased understanding of the factors contributing to their
safety incident.
I would like to point out that the ASRS is a unique safety
information system. No other such system, voluntary or
mandatory, offers and delivers the complete standard of
confidentiality and anonymity provided by the ASRS program. An
indication of the importance of confidentiality is provided by
the fact that over 70% of the reports in the ASRS database
contain statements revealing human error information. It is not
unusual for reporters to discuss their own operational
mistakes, mistakes they won't tell others (like other
government agencies or organizations), let alone the reasons
why it happened. Confidential incident reporting provides an
insight into events from the human perspective that can rarely
be obtained through other methods.
The successful longevity of the ASRS and its continuing
trust and strength arises from several factors. First and
foremost is the promise of confidentiality which is further
reinforced by the 24-year history of proven ability to protect
the identity of a reporter. The next important factor is the
program's independence, both actual and perceived. NASA, as the
``honest broker'' between the regulator and the reporter, has
been a significant reason the ASRS is trusted and the reports
received are honest appraisals of the reporter's performance
and that of others in the aviation system. NASA is a research
organization with no regulatory authority and, therefore, is
perceived as a safe place to report sensitive, possibly self-
incriminating, information. NASA's distinct position as an
independent government agency with a strong influence on
aviation safety policy and practice has been invaluable in
instilling trust in the ASRS.
Another important factor is the creation of the ASRS
Advisory Committee. This body has assisted the ASRS by
providing substantial advocacy, guidance concerning ASRS
policy, assurance to reporter communities of bona fide
confidentiality, and support for safety change as a result of
incident reports. This Advisory Committee has been very crucial
from the initial steps of the creation of the ASRS and
throughout its history. The Advisory Committee attempts to
represent all potential reporter communities, as well as other
industry organizations and government. Currently, this group
exists under the NASA Aero-Space Technology Advisory Committee
as the ASRS Advisory Subcommittee.
The Advisory Committee has substantially assisted the ASRS
in providing another crucial factor important for its success.
The importance of feedback to the reporter communities cannot
be underestimated. The ability of the ASRS program to convert
the aviation community's report input into constructive output
is evidenced by the many products produced by the ASRS (see
Attachments A & B and http://asrs.arc.nasa.gov).
The ASRS has released 2,500 alert messages concerning potential
hazards and important occurrences. Approximately 42% of the
alert addressee responses indicate that a follow-up action was
taken as a result of the safety alert message. A monthly
newsletter, CALLBACK, is distributed to over 88,000 recipients
which captures and presents safety information from the
incidents received by ASRS. The participation of ASRS at
significant safety organizational meetings, conventions, and
workshops continues to reinforce the participation by these
communities. The reporters can see evidence that information
provided is utilized for constructive changes to improve
safety.
It is noteworthy as people consider the application of the
aviation model to medicine that the ASRS model has generally
been widely accepted in international aviation systems. There
are currently seven countries that have operating voluntary,
confidential incident reporting systems. These countries are
United Kingdom, Australia, Canada, Russia, Taiwan, Korea, and
the United States. Each country has preserved the concepts of
voluntary and confidential as the necessary structure to
accomplish the receipt of reports. Most countries have
provisions for ``use immunity'' (i.e., prohibition from use in
enforcement action), but none have ``transactional immunity''
(i.e., waiver of disciplinary action). But all countries are
very aware of their survivability in relation to
confidentiality. As an example to all systems, one country's
first system was completely destroyed due to lack of reporting
after a breach of a reporter's identity.
As part of the process to protect a reporter's identity,
methods for de-identification of the report are crucial. The
ASRS employs aviation experts as its report analysts. These
people are, in fact, retired aviation professionals who analyze
each report and maximize the pertinent safety information
available within the report. This analysis process is performed
by pilots, air traffic controllers, flight attendants, and
mechanics who have each had lengthy careers in aviation. Our
system (as opposed to one which has anonymous reporting) has
the capability of calling incident reporters and obtaining
additional information as well as discussing the safety event
with the reporter. When these interactions occur, you have
pilots talking to pilots and controllers talking to
controllers, etc. This process produces an increase in the
validity of the data. We are able to find out the ``why'' of
the event, not just a terse description. The narrative section
of the report record is quite complete in its description of
the event, as well as the inclusion of key words and coding for
retrieval from the electronic database.
The ASRS analysts, as well as providing their expertise and
quality assurance, are able to reliably remove information that
might identify a reporter. The ASRS places its highest priority
on this protection. The goal is to remove enough information to
protect the reporter and preserve the safety message from the
actual words of the person reporting. This process of de-
identification also relates to other topics of interest which
include the public release of information and legal discovery.
The ASRS database includes the data that has been determined to
be most important. Due to limited resources, the ASRS performs
a type of triage to determine which reports will be fully
analyzed for inclusion in the database. Once this data is
placed into the database it is accessible to the public through
the ASRS Search Request process, an internet site managed by
the FAA (http://nasdac.faa.gov/safety--data) or by a private
CD-ROM product on the market. The ASRS has accomplished over
5,800 database searches for government agencies, students,
research organizations, international organizations, aircraft
manufacturers, etc. The FAA is the top requester of the ASRS
information. Often, we are asked for information through the
Freedom of Information Act (FOIA), but this is not needed, as
NASA's ASRS database is openly available.
In relation to legal issues, incidents rarely give rise to
the issues of negligence and liability inherent in more serious
events, like accidents. The reports are rapidly de-identified,
the narrative may be altered when analysts add additional
clarifying language, and a report from one reporter (e.g., a
Capt.) will be paired with other reports (e.g., a First
Officer) describing the same event, etc. These policies and
procedures subsequently alter the original report content to
some extent. ASRS has been informed that due to this the
database report becomes hearsay evidence due to its lack of an
identifiable source, which appears to be of less interest in
legal cases. The ASRS has been told that in some cases the
database reports have been used to defend a pilot, for example.
Instead of the information being used against a person, it has
been used to illustrate a potential system flaw that numerous
humans have been victim to. Therefore, if the event's reporter
does choose to share their experience with the ASRS, they are
not faced with the added threat of complicating their own, or
their employer's legal position. The de-identification process
tends to drive out the fear of reporting.
It is important to note that the ASRS is not an
investigative system. The information contained in reports is
evaluated carefully by experts, but the confidentiality
requirements of the system prevent us from obtaining third
party verification. The information relating to the existence
and character of the phenomenon is relayed to the appropriate
organizations in a manner that permits and encourages them to
investigate the safety issue further and seek a solution, or
implement interim procedures to accommodate the phenomenon
until a solution can be identified and instituted. We firmly
believe that the ASRS incident database is the most
authoritative source of human performance information that
exists in aviation today. This program is a paradigm that can
be utilized in many other disciplines.
Thank you for providing me with this opportunity to present
information on the Aviation Safety Reporting System regarding
our efforts and activities associated with improvements in
safety. If the ASRS can be of any further assistance to the
Subcommittee or its members, please feel free to call upon us
at your convenience.
Mr. Chairman, Members of the Subcommittee, this concludes
my testimony.
Aviation Safety Reporting System Significant Program Safety Products
The following is a listing of the variety of safety
products that were accomplished by the NASA ASRS staff:
General Accomplishments
Since the implementation of the Aviation Safety
Reporting System (ASRS) in 1976, over 474,000 reports have been
submitted by pilots, mechanics, air traffic controllers, cabin
attendants, and other aviation personnel.
The ASRS is the largest repository of aviation
human factors incidents in the world.
The ASRS has an unblemished record of never
breaching reporter confidentiality.
The ASRS has accomplished over 5,800 database
searches for government agencies, students, research
organizations, international organizations, aircraft
manufacturers, etc.
Since 1976, the ASRS has issued over 2,500 safety
alert messages in the form of Alert Bulletins & For Your
Information Notices. Approximately, 42% of the addressee
responses indicated that a follow-up action was taken as a
result of the safety alert message.
Operational Impacts
Identified and alerted the FAA Office of Aviation
Safety & the NTSB to the wake vortices caused by B757 aircraft.
Consequently, the FAA issued a directive requiring increased
separation behind B757 aircraft and the issuance of wake
turbulence advisories. Identified and alerted the FAA Office of
Aviation Safety & the Air Transport Association to the affects
of passenger electronic devices on air carrier communication &
navigation systems.
Issued an ASRS Alert Bulletin to the aircraft
manufacturer that concerned an L-1011 electrical fire. The
manufacturer subsequently issued a Flight Operations Advisory
Bulletin to all L-1011 operators.
Issued an ASRS Alert Bulletin to the air traffic
managers at Los Angeles Control Tower and the Southern
California TRACON concerning close-in instrument approach
changes. The FAA collaborated with various manufacturers to
implement a flight management system (FMS) program modification
that would promptly display transitions to newly assigned
runways.
Issued an ASRS For Your Information Notice
concerning the airport lighting and general conditions of the
Pickens County Airport, Jasper, GA. The local FAA Flight
Standards office conducted an on-site inspection of the airport
and issued a warning notice to the Pickens County Commissioner
to take corrective actions within 30 days of the notice.
Issued an ASRS For Your Information Notice to the
Airport Manager of Mitchell International Airport, Milwaukee,
WI concerning an unsafe runway incursion incident. The airport
authorities subsequently completed a project to install
flashing warning lights at key runway intersections.
Issued an ASRS Alert Bulletin to FAA Headquarters
concerning a smoldering passenger's bag in a DC-10 aircraft
that was caused by animal-shaped butane cigarette lighters. The
FAA subsequently issued a notice to airport security personnel
on the toy-shaped lighters.
NTSB Accident Support
A database search of Jetstream-31 aircraft failure
incidents was forwarded to the NTSB in conjunction with the
Jetstream-31 accident at Raleigh-Durham, NC.
A database search of EMB-120 aircraft engine
incidents was forwarded to the NTSB in conjunction with the
EMB-120 accident near Carrollton, GA.
A database search of Colombian airspace incidents
were forwarded to the NTSB in conjunction with the B757
accident near Cali, Colombia.
Accomplished a database search request for the
NTSB in support of the investigation of the MD-11 accident near
Halifax, Nova Scotia.
NASA/ASRS RESEARCH IMPACT: A PARTIAL LISTING
----------------------------------------------------------------------------------------------------------------
NASA/ASRS Research Regulatory/Operational
Product or Data Year Effects Cited In
----------------------------------------------------------------------------------------------------------------
Human Factors 1978 Used as resource in NTSB Runway
Associated with and FAA studies of runway Incursions at Controlled
Runway Incursions, transgressions; 1991 FAA Airports in the United
C.E. Billings, study resulted in new States, NTSB special
NASA TM 78540 procedures and improved Investigation Report,
(ASRS QR#8). An runway/taxi marking (NTSB.SIR-86/01).
analysis of ASRS systems Runway Incursion
incident data. Plan, DOT/FAA Associate
Administrator for System
Engineering and
Development, ARD-100,
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----------------------------------------------------------------------------------------------------------------
Chairman Thomas. We have a vote on now and we are running
short of time, given the distance from the floor that this
hearing room is, so I would ask for our witnesses to allow us
to recess and I would like to reconvene at 10:25.
[Recess.]
Chairman Thomas. I want to thank you both for your
testimony. During the debate on patient protection, which has
passed both houses and is now in conference, there was a common
reference to a movie, I think it was ``As Good As It Gets,''
and the throw-off lines about HMOs. It was obviously art and a
work of fiction, but somehow, it was representative of the
truth.
I was struck by another movie called ``Malice'' in which
Alec Baldwin plays a surgeon and there is a discussion going on
in which there was great concern about the question of life
hanging in the balance and the comment was that, well, they had
better pray to God, and Alec Baldwin said that they had better
pray to me because I am God.
Now, that was as much a fictional script as ``As Good As It
Gets,'' but I think it also focuses, as art often does, in a
non-statistical way, on a general belief that, to a certain
extent, one of the reasons there has been some great difficulty
in getting the kind of error structure in place in the medical
community is because of that type of an attitude. Is there any
truth, any relevance to that? Is there any indication that the
argument is that, after all, medicine is primarily an art and
great artists have to be left alone so that they can do the
best they can in a difficult environment?
Dr. Cassel. Well, there is--I do not know so much about the
art component. I think medicine is a skill and it deals with
uncertainty and it deals with science and technology. It also
deals with human beings, as we were talking about earlier.
Chairman Thomas. I believe all of those are true in the
aviation industry.
Dr. Cassel. That is right.
Chairman Thomas. Would you say, Ms. Connell, that that is
probably a good profile of some fairly egotistical pilots who
think they are really good at what they do?
Ms. Connell. They are highly trained and highly skilled.
Chairman Thomas. Yes.
[Laughter.]
Ms. Cassel. But, Mr. Thomas, I think it is also true that
the culture of medicine has held physicians and nurses
accountable as individuals for getting it right all the time.
It has not been so much a systems approach. One specialty----
Chairman Thomas. So if you do not get it right, do not talk
about it?
Ms. Cassel.--it is your fault. Do not talk about it,
because it is your fault, and do it better next time. One
specialty has begun to address this with remarkable success,
and that is anesthesiology, which has recognized the high-risk
environment in which they work and has begun actually to take
some lessons from aviation to look at team interaction, to look
at identifying----
Chairman Thomas. Is there not a real world result, and that
is the----
Ms. Cassel. And there is a real world result.
Chairman Thomas.--the insurance costs for that specialty
have dropped dramatically because of the structure.
Ms. Cassel. Dramatically, right. So it can be done.
Chairman Thomas. Now, I understand there was some complaint
or difficulty about that because what they really did was try
to do a look-back dealing with history in trying to shape where
they go forward. That may be difficult, but obviously, it is
not impossible.
Ms. Cassel. That is right.
Chairman Thomas. And by stating that it is there does not
mean other specialties could not adopt exactly the same
procedure?
Ms. Cassel. Probably not exactly the same procedure,
because----
Chairman Thomas. Roughly?
Ms. Cassel.--other specialties operate in a different
context. For example, my specialty, geriatric medicine, is not
in the operating room. We are in the community. We are in
nursing homes. But the same principles of being willing to sit
down with your colleagues and talk about potential mistakes and
how to prevent them can be applied just as well.
Chairman Thomas. Ms. Connell, obviously, the statement that
I made that you had an organization that is always used as an
example of how to do it right, but you also have been
historically involved in the medical community. Based upon your
knowledge, is there no transferability, is there modest
transferability, or is there significant transferability in
what you have been doing in aviation to a medical model?
Ms. Connell. My experience in medicine basically finished
in 1986 and I have been inactive since that time. But when I
became involved in the ASRS, I just intuitively saw ways in
which this kind of information could transfer into medicine. I
think it could significantly contribute to information systems
that can help health care look at the human factor component.
Chairman Thomas. Dr. Cassel, you indicated in your opening
statement and kind of emphasized that you think you can have at
least a 50 percent reduction over five years, but in the
report, there was an allusion to what occurred in the aviation
industry, that, in fact, since the middle of the century, it
has been reduced by more than a third. That is a 40-year
period.
Are we in danger of creating a self-fulfilling failure if
we are talking about we are going to get a culture structure
reculturalized as well as a reporting system in place and do it
so that you can reduce them by 50 percent, or is the opposite
true, things are so sloppy and so disorganized with no
structure whatsoever that any structure at all could produce a
50 percent reduction in five years?
Dr. Cassel. Well, it is not so much that the situation is
as bad as you describe, but there is some very low-hanging
fruit in this area. There are some things that could be done
fairly easily that could achieve quite dramatic reductions in
errors.
Chairman Thomas. Then why have they not been done?
Dr. Cassel. In part, they have not been done because the
goals have not been so clearly articulated and because the
resources have not been there, and let me give you an example.
Medication is a place where a lot of error occurs. As Mr. Stark
said----
Chairman Thomas. Do we have any ability to quantify that,
what percentage of the deaths occur from the medicine side
versus operating room, for example?
Dr. Cassel. There are hundreds of studies looking at error
rates, and particularly problems with medications, and they
come up with different numbers and some of our extrapolations
used in the report come from those studies.
Chairman Thomas. My concern is I do not necessarily want to
quantify to simply look at a number and then compare where the
greatest failure is, but it seems to me that if we are going to
try to put some structure in place, you would kind of like to
go to where, as you say, the low-hanging fruit orchard is.
Dr. Cassel. Let me tell you a story. Last week, I was a
consultant to a major academic health center in the country
that wanted to do something. It was a senior management
retreat. They wanted to do something about this errors issue.
And their debate in looking at the medication issue was, should
we think about in the current competitive environment spending
huge amounts of money on big new information systems, or should
we simply put a pharmacist on rounds with the medical team
every morning, because that has been shown to be very
effective, as well.
Now, those are the kinds of discussions that I think we
ought to be encouraging people to have, and we quite frankly, I
think, need to try out both models. It is very clear that
computerized order entry helps this problem, but it is also
very clear that those are huge expenditures in the current
environment and the same improvement can be achieved other
ways.
Chairman Thomas. I will tell you, it is kind of frightening
to read some of the stories that we are beginning to focus on.
You will recall the number of infant deaths because of the
failure to keep household cleaning items away from children and
where you place them on the shelves and keeping latches closed,
and it sounds like hospitals are just now discovering that
concentrated potassium chloride kept at a lower shelf level
will result in deaths.
This seems incredible, based upon all of the other safety
discussions in the home, in the workplace. I mean, you go to
any area that requires you to wear a hard hat and there is a
sign on the wall that proudly says, we have had no accidents
for X number of days. Now, the problem is, in hospitals today,
it would be we have a sign that says, we are proud to say there
have been no deaths for X number of hours, but they do not talk
about that in terms of a culture of trying to get it right.
Dr. Cassel. The potassium chloride issue has now been
widely addressed because it was so obvious and such a quick
fix, if you will, that made a lot of sense, similar to things
that the anesthesiologists learned when they looked at their
practices.
One of the differences here is the liability environment
and the fact that a hospital internally may decide to do some
of these things, but they are sure not going to write articles
about it for the popular press and say, look what we
accomplished by reducing these errors because of that liability
environment.
I just want to say that that is a very complex area that
our committee recognized we did not have the capability to
address, but I think that should be another major step that we
address----
Chairman Thomas. Well, my concern is I do not think the
liability is all that difficult. I think we may get into a
discussion in terms of mandatory versus voluntary scope of
information circulation, but Ms. Connell, do you not think that
that was absolutely critical to the success of your structure,
that whole ability to depersonalize the information and create
an environment in which people had a comfort level that when
they reported it, and I imagine at the beginning, it was fairly
difficult. It is a chicken and an egg. How do you do it?
Ms. Connell. I do not see large disparities over what I am
hearing and what I know of the history of the ASRS. The
extensive history is published in a NASA publication, and you
can read in here some of the dilemmas that were being
considered at that point in time, and one of them is this legal
liability issue and how to get beyond it. The other is how do
you encourage people to report and take the chance kind of
thing. Even with the promises, how will they know?
And one of the strategies used by the founders, Dr.
Billings, Dr. Renard, Cheney, and Harding, is that they involve
the trusted individuals in the industry, so they are union
heads and representatives, they are pilot organizations, they
are traffic organizations, flight attendant organizations, that
went to their communities and said, we have looked at this
thoroughly and in depth and we bona fide it as a system that
will work. We have great promise for it. We would encourage you
to support it by submitting. And if you have any difficulty
with the program, I am the person you can talk to.
Chairman Thomas. Just a couple of examples and then I will
yield to my colleague. Everybody is familiar with a pilot and
copilot getting ready, say, to take off, and notwithstanding
the fact that they have spent thousands of hours in that seat
and perhaps hundreds and even thousands of hours in that
particular aircraft, they have a checklist and they go down the
checklist systematically on items that you would think were old
hat to them, and, in fact, they are, but they go down in a
systematic way.
That seems to me something that could be carried to a
number of areas in which you think you are following a
procedure, but perhaps it is not as structured. Let me give you
a more controversial example.
I am quite sure that the question of installing a device
which would monitor not only all of the telemetry in the
aircraft but the actual voices of the pilots in a stress
situation was not universally accepted. Nevertheless, one of
the more dramatic aspects of this amazingly public effort to
find out what went wrong was recovering the black box and
analyzing what occurred.
Could you not talk about an analogous situation of having a
black box in the operating room which would collect all of the
telemetry and perhaps video cameras, so that instead of trying
to recreate an event from hearsay or third-party testimony
after the fact, you would have a medical black box that you
could examine to determine exactly what happened. But most
importantly, you would have a graphic teaching tool to show
firsthand what you do not do. Is that an idea that might be
transferrable to medicine?
Ms. Connell. It is difficult for me to say. The black
boxes--
Chairman Thomas. I am going to ask Dr. Cassel in just a
minute, so----
Ms. Connell. Okay. Accident investigation with the NTSB is
a very intensive and in-depth investigation, and I am just not
familiar with what depth investigations occur on the medical
side and whether that is a cost that would provide a large
benefit. That is something they would have to assess. But in
aviation, it was resisted and it was resisted by the pilots who
are sitting up front, having every word recorded and every
change in throttles recorded.
But they did adopt it eventually as the accident prevention
mentality. In other words, if we do, you know, have an accident
and we do not survive, at least someone will know what has
happened and we can prevent the next one. So it was an
altruistic professional kind of argument that basically won
over the day. It has still and is still remains a controversial
issue in aviation in terms of it getting in public hands and
getting outside of the walls of the accident investigation.
Chairman Thomas. Dr. Cassel, I know that as well as being
on the IOM, you are professor and Chairman at Mount Sinai
Medical Center in terms of a well-respected teaching hospital.
As I mentioned to you earlier, there were indications that
doctors were not as adequately trained in a bedside manner in
terms of the way in which they addressed patients, and there
was some discussion of changing the curriculum to make sure
that they were a bit more responsive in their communications.
Has there been any change in the teaching curriculum about
the Alec Baldwin syndrome and that there needs to be a
commitment in an altruistic and a professional way to let
people know what happened when errors are being made, or is
there still this cult of secrecy developed and promoted in
these teaching hospitals?
Dr. Cassel. There have been a number of changes in medical
curriculum to try to teach the students to interact on a whole
range of scales in a better way with the patients, and as
importantly, with the other members of the team, and that is
part of what we have learned from these lessons from the
aviation industry.
There are probably specific environments, such as trauma
units or operating rooms, where models like the black box might
be useful, but in general, I think they are more useful for
teaching purposes. We, for example, have some experience at
Mount Sinai in using videos of medical students and residents
interviewing patients and then talking with their colleagues
about the management of the case, and then we do sort of a
post-mortem on that interaction. We say, well, look how you
were putting down that nurse and that nurse could not tell you
what really needed to be said about that patient.
So that kind of sort of an autopsy of the behavior, if you
will, and taking it apart and having the faculty, the teachers,
examine that with the students can really help. I have seen
some very helpful videos of cockpit interactions when I was
Chairman of the American Board of Internal Medicine saying
doctors could learn a lot from how they sort of break down and
examine the hierarchial behaviors in those settings.
Chairman Thomas. I am just slightly concerned about your
use of terms, post-mortem and autopsy in those situations.
Dr. Cassel. I am sorry.
[Laughter.]
Chairman Thomas. The gentleman from California.
Mr. Stark. Thank you, Mr. Chairman.
Dr. Cassel, Ms. Connell, thank you for your testimony. I
wanted to ask you, Dr. Cassel, in the IOM report, there is
discussion about a national center to fund research and conduct
analysis of the data, and I do not find any mention of a plan
or a suggestion that we require hospitals to take action. We in
Congress are now talking about education. We are forcing
schools and principals to have a plan of action to improve the
results of training kids.
Ought we not to require, not just suggest, I think, a
hospital to have a plan? The plan might be more intensive or
less intensive, depending on the hospital's record, of how they
are going to reduce errors and have targets to achieve that.
Should we not, as part of that plan, include investigations
where there is a serious or fatal accident to find out why the
accident happened and add corrective measures to the plan and
then follow up to make sure the corrective actions are taken?
In other words, without the question of mandatory or
voluntary reporting, ought there not to be some kind of
required system? If hospitals already write up errors and get
A-pluses, obviously, it would not be as much of a burden. If a
hospital is way behind the curve, it might be more of a burden.
Could you discuss how you think that would work and would it be
helpful?
Dr. Cassel. I think it would be very helpful. I would just
also want to add that whatever we are thinking about for
hospitals, we should also be thinking about for nursing homes--
--
Mr. Stark. Okay.
Dr. Cassel.--another very high-risk environment that
actually has more beds in the United States than hospitals do
any given day.
Mr. Stark. I will lump them all together, as well.
Dr. Cassel. Secondly, I think what you are describing is
not what we envision as being a function of the Agency for
Health Care Quality, which is to support research and setting
some goals for the nation, but, in fact, could be done by any
number of means. Some of the accreditation processes that are
currently in place, perhaps Medicare standards and
expectations.
But the most important thing about requiring institutions
to document their approaches to improving the rate of errors,
or not the rate of errors, but the occurrence of errors and to
learning from those is that there be a level playing field,
that this not be something that is held against the system. The
example you are going to hear later about the Department of
Veterans Affairs, that there was a front page article in the
New York Times that the VA has more errors than any other
system, well, it is because they are doing a better job of
reporting.
Mr. Stark. Right.
Dr. Cassel. But the public does not understand that, and so
we need to make sure that the playing field is level if we are
going to require all of the institutions to do the same thing.
Mr. Stark. Or universal? Would you say----
Dr. Cassel. Yes, even that. That is right.
Mr. Stark. Why has the industry not done it up until now?
Dr. Cassel. Well, that is----
Mr. Stark. The hospital and nursing home. Why----
Dr. Cassel. Why has the hospital industry not?
Mr. Stark. Yes.
Dr. Cassel. I think the answer to that is a very complex
one and it is analyzed in some detail in our report. It has to
do in part, as Mr. Thomas suggested, with the culture of
medicine and the emphasis on the individual. I believe that the
liability environment is a big, big piece of this, and I also
believe that the competitive marketplace in which no hospital
wants to go public saying, we are doing our best to prevent
errors, that is not a big selling point in the marketplace. So
until we require everybody to do the same thing, it is not
going to happen.
Mr. Stark. Let us switch to your profession. Several years
ago, many years ago, it was suggested that we require
physicians to recertify, be tested, say, every seven years.
Now, most of the specialty groups do require that. The AMA came
off the wall and said, oh, my God, you cannot do that. We will
do it voluntarily. Well, you know what voluntarily means.
We require pilots to be tested. We require lawyers to be
tested. We require real estate brokers to be tested. Cops have
to go out and shoot their guns every so often. We in Congress
are tested, good point.
[Laughter.]
Mr. Stark. Is there anything so awful about suggesting that
a physician, because of the rapid change in technology, ought
to go back periodically and be recertified? Would that help?
Dr. Cassel. We did not address this in detail in the
report, but I will tell you my personal opinion is not only is
there not something so awful about it, I think it is essential
for our health care to be accountable to the public, as you
point out, in this current environment of rapidly advancing
science and also requiring physicians to know something about
the systems that they work in and how to improve those systems.
Certification boards do now require episodic
recertification, but having just finished a year as chairman of
one of those boards, I can tell you that we did not feel that a
sit-down paper and pencil test every seven to ten years is
really enough, either. We need more performance measures. We
need what--the aviation industry does it every six months, I
believe, in simulators. We need much more practice performance
evaluation in addition to cognitive knowledge.
Mr. Stark. One quick question, Ms. Connell.
Ms. Connell. Yes.
Mr. Stark. The VA system has a voluntary reporting system
that permits employees and patients to report occurrences and
protects them. Should any error reporting system permit
confidential reporting by employees and patients or anybody
else without fear of action being taken against them?
Ms. Connell. I am not sure I could answer that question
without knowing deeply the VA system.
Mr. Stark. You have it in your system? Do you have a
confidential reporting system----
Ms. Connell. Ours is a confidential reporting system at the
national level.
Mr. Stark. And there is no fear of action being taken
against somebody who reports, right?
Ms. Connell. Not now. We have proven over 24 years that
that is impossible with the structure the way it is.
Mr. Stark. So you say that is important to your structure?
Ms. Connell. It has been important in keeping the flow of
information increasing and continuing.
Mr. Stark. Thank you.
Chairman Thomas. I thank the gentleman. We may need to do
two rounds, so we will try to maintain the clock as we move
through, not withstanding the chairman's unwillingness.
Does the gentlewoman from Connecticut wish to inquire?
Mrs. Johnson. Thank you, Mr. Chairman, and my apologies to
some of the later speakers. I have to chair a hearing at 11:00,
so I will not be able to stay through the whole hearing.
I was very interested, Dr. Cassel, in your comment that
errors are seldom due to carelessness or lack of trying hard
enough and that, in fact, what we are looking for is safety by
design. I think that is very, very important. I represent a
manufacturing part of the country. I have seen what has
happened as a result of system change, first through total
quality management and then due to this ISO 9000. I had one of
my hospitals say to me recently, why are you doing this? Do you
not understand, we are going through ISO 9000. We have to
because GE wants every one of its contractors to be ISO 9000
and we take care of GM employees. I did not know that.
So there are a lot of systems changes going on
institutionally, and for us to adopt a mandatory reporting
system, and I have never seen one that does not get to be
punitive and does not, especially on top of malpractice and
competition, foster as much cover-up as is possible.
I think we have an enormous opportunity here to use the
certifiers, the system, the office to help gain an
understanding of what systems do improve safety, which has been
something we have not been willing to look at and have not put
the resources in, and then there are many ways in which we can
get them to design it. The thing I hear most often in my
hospitals is, do you understand that we have to reimburse for
this drug, not because you require it but because it is the
state of medical practice and we have to do it, and when is
Medicare going to notice that we have to do this and up their
reimbursements.
So I worry about the emphasis on mandatoriness when there
is so much we have not done, and I think this issue of
reporters being absolutely free to just talk about something
they saw--I saw a hospital go from individual insurance to the
institutional self-insurance and then physicians did say, I do
not think the way you are dealing with that case is really so
hot.
So I think we have an enormous opportunity here, but I
think the confidentiality is terribly important. Someplace to
report is very important, an office. How do we get visible some
of the systems demands that, frankly, are being made in every
other sector of the economy for quality, and safety is just a
part of quality, but remember, OSHA made this mistake. OSHA
came in--the original OSHA law was X, Y, Z. When it began to
work was when we got OSHA consultation and without danger, you
could get an OSHA person to come into your workplace and say,
what are the problems here, and they were not allowed to come
back and penalize you if you changed it within six months.
So there is just such an enormous void here and the systems
are so lacking because so many of our laws discouraged system
views, and these are not bad people and we are never going to
wipe out all mistakes. So I do not want--we found this out when
we reported death rates in hospitals, and I had a VA hospital
in my district and the director had the good sense to come to
every one of the members of the Congressional delegation and
make an appointment and sit down and say, I am going to provide
services to very disturbed veterans and we are going to have
problems. He said, the reason we do not have problems now is
nobody will take care of them. So he opened his doors to the
most severely distressed soldiers with very serious psychiatric
problems and so on. Yes, he had a couple of batteries. Over the
years, he had a couple of hangings and those kinds of things.
But, boy, the lives he saved, the stories he can tell.
I will be interested to look at your report and see more
clearly where you want mandatory reporting and why, but there
is just such a wide-open opportunity here for rapid improvement
if we are able to integrate systems and approaches and spread
the knowledge of them, and I worry about that.
Dr. Cassel. I very much agree with your concerns and I
would really welcome your input on this process. The committee
spent a lot of time examining this issue and it is very aware
of the potential for mandatory reporting having a negative
effect, a silencing effect, if you will, and that is why we
keep emphasizing this level playing field aspect of it.
But we already have more than 20 States that have some form
of mandatory reporting. There is experiments, if you will, out
there at the State level that the Agency for Health Care
Quality could, in fact, look at, see what seems to be working,
what does not seem to be working, and follow that, and that is
another reason why we call for this at the State level rather
than in some uniform Federal way and then to learn from those
individual experiences.
The last thing in the world that you want is for a health
care institution not to take care of the high-risk people, not
to engage in a trauma unit because they are afraid that they
are going to get in trouble for doing that.
Mrs. Johnson. Right. I thank you and I thank the chairman
for inviting you and also you, Ms. Connell, from the aviation
system, because your system is very, very interesting and I
always sort of wondered, how is it that we are able to have
quite as safe an air traffic system as we do, a remarkable
record, when people are people and errors happen, so thank you
for your good work.
Ms. Connell. Thank you.
Mrs. Johnson. Thanks, Mr. Chairman.
Chairman Thomas. I thank the gentlewoman.
Does the gentleman from Washington wish to inquire?
Mr. McDermott. Thank you, Mr. Chairman. Sitting here
thinking about having practiced medicine, it seems to me that
the issue we are discussing here has really two parts. One is,
what do you do about the individual who has had a medical error
occur in their treatment, and then what do you do about the
system?
I think that it is important for us in trying to fashion
any kind of government response to that that we keep those
clearly in mind, because my remembrance of the AMA
responsibility for a doctor, I mean, it is that a doctor is
required to be honest with his patient in spite of the fact
that there may be, in fact, a legal responsibility or a
liability may come out of it. Is that correct?
Mr. McDermott. I believe that is part of the code of
ethics.
Mr. McDermott. Yes, it is, Section 8.12. I just want to get
it in the record, that a doctor does not have the luxury of not
telling a patient just because he is afraid of a lawsuit, and
that is a responsibility that he or she has to deal with.
[The information was not received at the time of printing.]
Dr. Cassel. And that gets at another response to
Congressman Johnson's question of why did we make this
recommendation for mandatory reporting, understanding all of
the challenges inherent in that, but that there is
fundamentally this responsibility to the public which we felt
was the overriding concern.
Chairman Thomas. Would the gentleman yield on that point,
since you are a practitioner and you are discussing this as two
doctors and those of us who are watching, do you believe that,
notwithstanding whatever number point subsection that is, that
it is, in fact, working, that people do follow it?
Mr. McDermott. I have no way of telling. I suspect that it
goes on a lot more than we know because I suspect that in most
cases where there is not a lawsuit brought, it is because the
physician said to the patient, we made a mistake here. We did
this, we did that, and we are going to correct it. Then the
patient does not have to go to the legal system to get it
corrected. So I do not know how you would--it would be very
hard to say what the statistics are. I am sure there are
physicians who do not tell.
Chairman Thomas. I am sorry to interrupt, but my biggest
concern is that I know we are going to hear from folk that, you
know, we are professionals. We are on top of it. We have
written statements. We have rules. Did you not have those five
years ago and ten years ago and do you not have them today, and
here this report comes out. My concern is that if we do not
really look at it systematically this time, we may not get the
impact of publicity that has occurred and we will not be able
to make the changes that need to be made. That is one of my
concerns about citing items that are already on the books and
have been there for some time.
I thank the gentleman for yielding.
Mr. McDermott. What I said at the outset was, you had to
talk about individual responsibility as physicians and then you
have to talk about how you bring about systemic change. I,
actually, early in my career when I was in the State
legislature, worked in a PRO, so I pulled charts out of
hospitals all over the State of Washington and looked at them
and looked at what was going on. We looked at all the deaths in
hospitals during a given period to see. So I have been in that
process.
The question, I think, is in the mandatory reporting. Do
you then publish that this happened and this happened, or do
you design a system by which you make the PRO deal with this
both in investigating the root cause, why are there infections
in the operating room or why are there whatevers going on, and
then have a corrective action? Do you give that responsibility
to them and say, it is your job to do this and see what
happens?
My view is that I am reluctant--the first rule of medicine
is, above all things, do no harm, and I am afraid that if you
start posting on the wall of every hospital everything that has
gone on in the hospital, you will do neither the patients nor
the physicians nor the hospital any good. So I am curious about
if you think, from looking at your study, whether giving the
responsibility for this, mandatorily reporting to the PRO every
problem and then make them go out and do an investigation and
do a corrective action, would that solve the problem or at
least come at the problem in a reasonable way?
Dr. Cassel. I do not know if it would solve it, but it
seems a reasonable strategy to examine because the PROs are in
place and they are charged with quality. They do not, however,
by and large, have the technical analytical expertise to do the
kinds of root cause analysis that aviation gives us as a model.
That is why your example exactly, of why listing a list of
something on the wall of any institution is not going to be
what matters here. What is most valuable from the aviation
example are these complex stories. These are complex issues
involving lots of different people, communication, packaging,
every dimension of a very complex industry, and so if you are
going to ask the PROs or any other body to do this, there would
really have to be the resources to get the analytical strength
to make sense out of these stories so that they can be learning
experiences to improve the situation.
Mr. McDermott. Simply mandatorily reporting and publishing
a great book of medical errors for the country----
Dr. Cassel. That will not do, no.
Mr. McDermott.--would not move the issue forward?
Dr. Cassel. No, and in general, quantitative reporting is
not going to tell us much about this because we never can know
what the denominators are. So to try to measure how many we
have got this month and how many we have a year from now of
some sort of error in some geographic location is not really
going to tell you what you need to know. You really need to dig
down deeper and look at the human factors involved.
Mr. McDermott. Let me just ask, if you indulge me for just
a second longer----
Chairman Thomas. I will indulge you.
Mr. McDermott. Thank you. I like to be indulged.
Chairman Thomas. The gentleman's time has expired.
[Laughter.]
Mr. McDermott. The question of medicine has changed
dramatically since I began practicing in 1963, and what one of
the changes is, that there are not three nurses on every floor,
as there used to be. There is one nurse perhaps covering a
couple of floors with some nurse assistants or licensed
practical nurses or whatever and technicians operating at all
sorts of levels. In your study, was there any attempt to refine
where the errors occurred, what kind of categories they fell
into, besides medication errors? I mean, the idea of putting a
pharmacist on the team going around is a cost to the hospital,
and under the present conditions, no hospital is going to pay a
pharmacist to walk around for following 20 doctors going
through rounds.
Dr. Cassel. Well, some actually are because it costs less
than the kinds of information systems that use computers to
identify drug-drug interactions or somebody's handwriting, the
nurse made a wrong interpretation of what the medication was.
Those kinds of problems can be avoided by information systems,
but for some hospitals, they think they are better off having
human beings interact in teams. Ideally, of course, you would
like to have both, but what you are describing with the change
in the kinds of staffing in hospitals is a response to this
very competitive environment that we are in and people trying
to deliver much more high-tech care and to do it with as few
people as possible.
And that, to my mind, is an environment in which we should
be even more interested and more concerned about these kinds of
errors and hold ourselves more accountable, because there is
all this reengineering going on. Now, we have seen this
happening in industry and much of it has actually been for the
better. They have gotten more efficient and produced better-
quality products. So it is not necessarily a bad thing, but if
you are not following and reporting what you are doing, you are
not going to know whether you are getting better or not.
Mr. McDermott. I guess, Mr. Chairman, the reason I raised
this whole thing is that having watched the change in
hospitals, it is hard for me to know how you can train somebody
at the community college for 30 days or 90 days or maybe a
semester or maybe even a year to then come in and give one
little slice of the treatment without looking at the whole rest
of what is going on. I mean, that person cannot possibly know
because they have only been trained to look at the thing they
are to do.
Dr. Cassel. Right.
Mr. McDermott. That is where I have the----
Dr. Cassel. That is where we need to look at the human
investment the same way that industry does, to say these people
are not widgets to be inserted into a health care system. They
are a valuable part of the team and you invest in their ongoing
education and in their ongoing communications with the other
people involved.
Mr. McDermott. Thank you, Mr. Chairman.
Chairman Thomas. All that may be true, but it is rather
frustrating when I continue to hear that one of the problems is
that someone cannot read someone's handwriting. Now, I rent a
car and I pull up, and by the time I have turned the auto off,
opened the trunk, and retrieved my luggage, someone who is
probably being paid pretty close to the minimum wage can hand
me the totalization of the time, the mileage, the dollar
amounts. There is a little computer that they use to assist
them.
Now, someone better not tell me that this world is so
complicated and so difficult that you cannot create a palm-held
interactive drug relationship of what is on that chart and that
any of those very simple requirements like, hey, guy, type the
Rx, the computer can do it for you today. To sit here at this
level on the seriousness of this issue and say the problem is
somebody's handwriting on an Rx tells me exactly how far we
have to go with this culture that we have been talking about.
Dr. Cassel. And what you describe does exist in many
places. It just does not exist everywhere, and----
Chairman Thomas. And the problem is, there is no systematic
collection of data, there is no systematic confidentiality, and
there is no willingness to share in a confidential way as there
is, for example, in the aviation industry.
Does the gentleman from Louisiana wish to inquire?
Mr. McCrery. Thank you, Mr. Chairman. In fact, that is part
of what I was going to pursue, is the use of technology and why
we are not making greater strides in the use of technology in
terms of patient protection, if you will. It seems to be a word
or phrase that is bandied about a lot in Washington these days,
so let us talk about patient protection.
Is it necessary for the Federal Government to intervene
here and mandate the use of certain technologies like these
hand-held machines that are available, I believe, in which you
type in, or actually just push a few numbers or letters and the
prescription pops up, the interactions pop up, the patient's
records are on there for other drugs that he or she is taking.
Should we mandate that those things be used by doctors on their
rounds in hospitals? It is for patient protection.
Dr. Cassel. It certainly is, and the broader answer that I
believe to your question about should the Federal Government do
something is yes. Now, as Mr. Thomas said, I think the very
important question is what exactly would really make the most
difference and be the most productive role for government
intervention, and there are a number of different approaches to
that.
Let us remember that the computer process is also not
infallible, as we have been actually learning about Internet
activities just this week. But even the thing about pushing the
button, people also do push the wrong button. So the human
factor--you can never escape the need for the human factor's
dimension of this kind of work.
But I think that information technology is very promising
for reducing errors and improving quality of care, but it is
expensive. I have been sitting at the table at a number of
different health care organizations with discussions about the
competitive environment, how many hundreds of millions of
dollars they spend on information technology, and where is that
going to come out of. So that is where part of the tension, the
inevitable tension will be.
Mr. McCrery. What is the role of the government, the
Federal Government, in establishing a system of reporting
disclosure of errors and near misses? Do we have a role? Should
we implement a nationwide system of mandatory or voluntary
disclosure?
Dr. Cassel. Our reports suggest that there be a nationwide
expectation or standard of reporting from every State and that
the States get help from the Federal Government in implementing
these systems and evaluating them and improving them going
forward.
Mr. McCrery. Only about a third of the States, as I
understand it now----
Dr. Cassel. Currently have that.
Mr. McCrery.--have those, so why should we not mandate it
from Washington?
Dr. Cassel. Our reports suggest that you do that, but that
you not mandate exactly the same system for every State because
we do not know yet how best to do this and we can learn from
what the States have been doing.
Mr. McCrery. Since you are at a teaching hospital, one
thing that I get from people often, Mr. Chairman, is why do
doctors in residency programs have to stay up so many hours? Is
that not dangerous? Why do you force them to work hours on end?
Nobody else does that. Pilots cannot do that. In fact, pilots
have just the opposite. They have to take off. They have to
take off from their job. They also have to take off, but----
[Laughter.]
Ms. Connell. In order to land, they must take off.
Mr. McCrery. Yes. But why is that? I am just curious, so I
can answer all these people that bug me about this.
Dr. Cassel. Now here, you will get my personal opinion. I
think that medical training has been unreasonable and actually
dehumanizing in those dimensions. It is getting better. The
State of New York has very clear rules about how many hours a
resident can work. But we still get arguments from physicians
who say that the most important thing for the physician is to
learn to work under stress and to learn the continuity of care,
so you are responsible for one patient over a period of time in
the illness.
Chairman Thomas. Dr. Cassel, I am sorry to interrupt you,
but on that basis, do you think it is primarily driven by
economics, that is, it is cheap labor----
Dr. Cassel. No.
Chairman Thomas.--or it is part of the hazing process to
join the culture?
Dr. Cassel. Those are my two choices, those answers?
[Laughter.]
Dr. Cassel. I do not think it is because of economics. I
think it is part of the culture of being a tough guy and
getting it right no matter how stressed you are. I think this--
--
Chairman Thomas. And learning how to not report it if you
do not get it right.
Dr. Cassel. Well, that probably has been part of that, and
that is why I think this is something else we can learn from
aviation, exactly what you suggest, that we probably do need to
recognize that to err is human and that humans are fallible and
that humans need to go to sleep periodically.
Mr. McCrery. In conclusion, Mr. Chairman, I just want to
say that I agree with Mrs. Johnson that, or at least I think
this is what she concluded, that much of the problem is
systemic and we really have to look at the reasons for the
system, if not promoting errors, certainly putting in place
systems that do create errors and afford the possibility for
errors in greater numbers than we should.
I really do not think that it is the individuals' faults.
It is not the doctors' faults as individuals. But it is a
systemic problem, but I do think that it is a culture, as part
of the system, that has grown up over the years and the
teaching hospitals, the medical schools, I think, are going to
have to play a large role in correcting this culture and
reversing some of these things that have been put in place by
the system.
Mr. Chairman, my time has expired, but this is very
interesting. I appreciate the testimony.
Chairman Thomas. I thank the gentleman. We may do a second
round, but I did want Ms. Connell to respond, because as I
understood your testimony on the structure that you oversee, it
is just kind of open-ended and whoever wants to report gets to
report. You were talking about, what was it, 36,000 reports.
My guess is, if it were an open-ended reporting system in
the medical structure, you would probably be overwhelmed and so
perhaps there is a question of volume. But to what extent do
you believe it has been fundamentally important in building the
system to let every individual in the system believe that they
can make a difference if they choose to make a difference?
Ms. Connell. There definitely is a human concept there that
people need to feel empowered, to feel engaged, to feel they
can make a difference, and this system has provided that.
Now, in all honesty, of all the information I receive,
there is some percentage I cannot use because it does not fit
into what we can do something about. But that does not mean I
do not accept it.
Chairman Thomas. I will go to the gentleman from Florida,
but it seems to me that the reporting of information which is
not all that useful is a minor problem compared to the enabling
position of people believing that they can inform. I hear
immediately, oh, we cannot do that because it is just going to
be too much volume, and you immediately then begin a
hierarchial structuring of who is important, what is important,
who counts in the system and who does not, and I think that has
been one of the fundamental problems in medicine, that there is
this hierarchial structure and I do not think folks realize it
when they begin saying, oh, there is no way we can create a
system like the FAA where everybody reports.
Just create a system of dealing with that volume, because
one of the fundamental enabling aspects of a system, I think,
is to be able to say, hey, anybody in this structure who feels
strongly enough, on a confidential basis, let us have it. I
think that probably would break down the culture of medicine
almost as fast as anything else we could do.
Ms. Connell. And we have learned a lot by taking that
perspective, because--
Chairman Thomas. I understand the volume problem, but boy--
Ms. Connell.--you cannot anticipate what you are going to
hear, but you have to be ready to listen.
Chairman Thomas. You can if you can judge who is important
and who is not to the system.
Ms. Connell. But some rather innovative solutions to
problems have come from an Embry Riddle student looking at an
issue. So it is pretty wide open.
Chairman Thomas. But it is the mental concept, the
willingness to accept even the least in the system's report
that there may be of some value. That, again, is part of that
culture that has been built into medicine, that is not going to
work.
Ms. Connell. And I have to say, the support at the highest
levels. The FAA under David Hinson made it very clear that all
organizations would have safety departments that report
directly to the CEO. They elevated safety as something very
important, and there are, and we have managed to translate this
to people. The economic advantage of putting money into safety
far outweighs the accidents.
Chairman Thomas. I thank the gentleman.
The gentlewoman from Florida.
Mrs. Thurman. Thank you, Mr. Chairman.
Dr. Cassel, I am interested to know, is this the first time
that this medical error issue has really hit this country?
Dr. Cassel. Well, that is a wonderful question. No. Nothing
in this report is new information. We did a very thorough
examination of existing literature, and actually, we did not
even go as far back as some other studies that have been done
in the 1980s or 1970s that we were aware of. So it is not new
information.
Mrs. Thurman. Okay.
Dr. Cassel. And that is why it is interesting that it has
gotten the response that it has. I think some of that has to do
perhaps with the current concern about the quality of care and
the so-called managed care backlash and the environment of
concern about patient protections, but I think it also has to
do with having an organization like the Institute of Medicine
look very systematically at this issue and package it in a way
that sort of makes sense of it.
Mrs. Thurman. The reason I asked is because in Florida, and
I am going to tout Florida here a little bit because I think
Florida has been a real leader in this issue. We were the first
state to implement any kind of adverse incident reporting
programs. We did that in 1975 and then we expanded it again in
1985.
I guess part of the question, with the recommendations that
have been made and the fact that there are some 20 States that
have actually put some kind of review system in place; what
have we learned from those? Are we analyzing the information
from those States that have implemented reporting programs? Has
this been included as part of the proposal that is being put
forward to us? Have we looked at the statistics of what
happened before they did this to what they are doing today to
what works in those States in reducing errors?
I am just a little concerned that we are going to get so
overpowered with some new regulatory something this, something
that, when we have some models out there that potentially might
be working. Because I think this is an issue that you have to
move quickly on to make something happen and why would we
reinvent what are we doing if it is similar to some of these
States in their reporting mechanisms and what can we do quickly
that can make a difference?
Dr. Cassel. Some of our data did come from State-level
studies exactly as you described, but there has not been an
attempt at a national level to really follow over time what has
occurred in those States, for example, that have some sort of
mandatory reporting or that have other kinds of error reduction
or patient safety strategies in place. That is one of the
functions that we think that the Agency for Health Care Quality
could take on, is to figure out how most accurately to really
study those things.
This is not traditional health care research. That is the
other thing we need to learn from these other industries, that
our approaches to even looking at quality of care research do
not have the same dimensions that some of these other
industries do in looking at the root cause analysis, for
example, and sort of qualitative analysis. So that why I think
we do need some very concerted research to exactly draw those
lessons from people who are doing the right thing and are
making progress, but we really do not know how to study it or
explain it.
Mrs. Thurman. Maybe to the chairman and others, we know
that there are some things working out there. Are there things
legislatively? For example, I think Florida is the only one now
that through the practice acts makes risk managers in hospitals
go through classes and have to be accredited for their
practices. So we have done some things in those areas and those
seem to be working. It just seems to me that we need to learn
from some of those things.
I know that talking about some of the technology issues, in
Florida, for example, they are putting information on the Web.
For example, information about medication safety is already up
and running. And yet we are sitting here talking today that
this is a major problem in this country. Wrong site surgery,
restraint injury, these things are happening.
I think part of it is that we need to make sure that some
of this information is getting out. I think we also need to be
talking to our State legislators who can put some of these
quality boards in place immediately to take care of some of
these situations. It is a pretty dismal thing to think that we
have been talking about this for a long time and only 13 States
have even looked at anything at this point.
Dr. Cassel. I think it is actually more 20 or 22 at this
point, so it is a little bit more promising, but I think there
are things to learn from the States. You are absolutely right.
Mrs. Thurman. Thanks.
Chairman Thomas. I thank the gentlewoman.
Does anyone have a burning desire to ask another question?
The gentleman from California is burning first.
Mr. Stark. Thank you, Mr. Chairman.
Dr. Cassel, I have a hunch that we are going to hear some
complaints during the course of the day about the costs of any
program that we may encourage or require, and it is my sense
that the health care costs due to preventable events is
somewhere between $8 and $15 billion a year, or something like
$2 billion a year, I have heard even, just through
inappropriate or adverse drug events which have to be
corrected.
The National Quality Forum on its Internet site estimates
that 30 percent of the acute care patients and 20 percent of
the chronically ill patients receive care that is
contraindicated. I guess that means unnecessary, or may be
unnecessary.
So ought the savings to the hospitals from preventing
errors which may cause them to have to keep people longer--they
are only getting a DRG payment, so if they do it wrong,
obviously, it will cost them more than getting it right the
first time--can you comment on the costs versus savings of any
kind of program we might undertake to require all of the
providers to be more involved in a system of reporting and
corrective action?
Dr. Cassel. I certainly can comment on that. But before I
do that, I think we always have to remember that cost is not
the first reason for addressing this issue. That first do no
harm has to do with protection of patients first and foremost,
and even if it did cost more it would be worth doing.
But having said that, I think the cost issue is one that
needs examination, but it is not quite as straightforward I
believe as you describe it. For example, a hospital as a unit
may gain or lose money if it improves its error rate depending
on how that plays out in the DRGs. Because some patients who
become very ill from a medication complication then may go home
or may go to a nursing home and the hospital itself may not end
up bearing the cost burden of that.
The entity that is likely to save is Medicare when you look
at the whole picture of patient care. I think it is harder to
know whether a single individual hospital would gain or lose in
a single year let us say from implementing some of these
strategies.
Mr. Thomas. The gentleman from Washington.
Mr. McDermott. Thank you, Mr. Chairman. I am sitting here
trying to figure out how to design this, because I think
everybody wants to make it better. I remember the difficulty
that the Agency for Healthcare Quality, they went through a
sort of near-death experience here in the Congress around their
analysis of certain procedures and whether or not they were
effective and so forth.
So as I think about putting this issue in their box and
saying, this is something new we would like you to do, I would
like you to distinguish something or at least talk about it,
the whole question of confidentiality protections versus
medical liability.
If we require mandatory reporting, every hospital in the
United States must report to the Agency for Quality Health
Research any incidents of medical errors. Can that information
then be used in a lawsuit against the hospital or the doctor or
whoever? Or is it in fact--would it be possible to make it
confidentially protected in such a way that it could be used
for the purpose of systemic analysis and recommending changes?
Or would it simply be a repository from which whoever would
say, I think there is some information over there we need for
the lawsuit?
Dr. Cassel. Several important points. First, we do not
recommend that the Agency for Healthcare Research and Quality
become the regulatory agency because they need to, exactly as
you say, to be free to really examine all of the data and set
some goals for the Nation, and look ahead and invest in the
research necessary to know how best to do this. So that is not
a regulatory function that makes sense to place there, and as
you point out it puts their most important function at risk,
which is to support learning or about how to improve quality.
Secondly, I think that a serious look at the liability
environment is essential in really trying to answer this
question. As I say, our existing IOM committee does not really
have the capability to do that. But something like an IOM study
about the whole environment of liability and how does it relate
to quality or how does it inhibit quality. I tend to think that
some very interesting strategies such as no-fault approaches to
adverse events that happen in health care would compensate more
people who are harmed at less cost, and it would get the money
to the people who have been harmed rather than to the attorneys
who are trying to find the cases.
As you probably know, in one of the important studies here
it was identified that only something like 1 percent of people
who were harmed by negligence actually ever even were involved
in a lawsuit. And the ones who did get compensated got
compensated 10 years later. So that does not seem to me to say
that our current liability environment is really protecting the
patients. So from my point of view I think we need a much more
expansive look at this whole situation.
Mr. McDermott. Thank you, Mr. Chairman.
Mr. Thomas. The gentleman from Louisiana.
Mr. McCrery. That would be a great hearing for us to have,
Mr. Chairman. I would like to pursue that, but I will not
today.
The matter that Dr. McDermott brought up earlier is an
interesting one, this issue of cost savings that have been
implemented by health care institutions, whether it is
hospitals or health care plans or whatever. And if I am not
mistaken, the data that you studied is 10 years old; is that
right?
Dr. Cassel. Much of it is.
Mr. McCrery. Much of it is 10 years old?
Dr. Cassel. Yes, eight to 10 years.
Mr. McCrery. I do not know when all this cost saving took
place but it is possible that it had not really reached its
zenith 10 years ago and you still might have had two nurses on
duty instead of one and those kind of things. So it may be hard
to tell. It may be useful to do a new study or collect new data
and study that in light of the changes that have taken place.
But I wonder if you have, upon going through all that
material, have you reached any conclusions or even developed
any opinions on the quality of care today as opposed to say 10
years ago because of cost-saving matters that have been brought
into play in the health care institutions? Do you have any
comments on that? And if you did not look at that and you did
not develop any----
Dr. Cassel. We did not specifically look at trends over
time in this study and I think that the data does not really
exist to allow us to do that. That is one of the reasons we
think that the research in this area is so vitally important,
and that we have some ability to look at trends over time and
set some goals for ourselves as a nation. So that would be, to
my mind, one of the most important things we can do. If we do
not know whether it is getting better or worse, it is going to
be hard to fix it.
Mr. McCrery. So your panel did not reach any conclusions as
to the deleterious effects, if any, of the various cost-saving
devices that have been implemented by health plans?
Dr. Cassel. That was not one of the things that we looked
at. There is some literature in the health services research
arena trying to look at changes in health care financing and
the effects on quality. It requires very sophisticated studies
so there are not a lot of really definitive ones in that area.
But the current environment of concern about health care
quality I believe is going to allow us to really make much
better use of that kind of research.
Mr. McCrery. Thank you, Mr. Chairman.
Mr. Thomas. The gentlewoman from Florida have any
questions?
Mrs. Thurman. No.
Mr. Thomas. I did want to just briefly follow up. Ms.
Connell, you heard the statement that they have the goal of a
50 percent reduction in five years. Do you think that that is
really a realistic target based upon your experience in
changing a culture, which I think is probably more sympathetic
to resolving errors? That is not the right way to say it, but
you know what I mean.
Ms. Connell. You have got a large system, there is no doubt
about it. It is real hard to say. We have a goal at NASA under
a NASA safety program right now which was driven by the Gore
Commission goal to reduce aviation worldwide accidents 80
percent in 20 years. We are looking at that in terms of how are
we going to do that when we have an accident rate that is
already pretty low and we have a lot of data.
Mr. Thomas. I certainly do not want to discourage anyone,
but I also think if we are going to go into this we have to set
some realistic targets so that goals are met in a realistic
way. For example, the only legislation that has been introduced
so far is a piece of legislation on the Senate side that is
setting up three demonstration projects, vanilla, chocolate,
and swirl, and they are going to report in five years. So good
luck on voluntary compliance to meet your 50 percent if that is
the direction that we are going to be going.
My other really big concern, especially when we are talking
about mandatory and the role of Government and the rest is that
I have found that Government is really good being the sovereign
at requiring people to report what.
And what I am hearing, and I hope as we move into this next
panel that what is not going to get us there. It has got to be
an analysis structure that goes into the why with as much data
available as possible, and that that is not always conducive
when you want to, even in a non-punitive or litigiousness
situation, point the finger at people and reward those who do
well and try to stop those who do not do well. That tends to be
the direction, notwithstanding the desire, of a mandatory
system and a structure of, we have got to get data.
Qualitative analysis thoughtfully done may in fact produce
better results in my opinion than a whole lot of quantity
mandated because somebody wants to do something about the
problem. Any reaction to that?
Dr. Cassel. I would just heartily endorse the emphasis on
the qualitative aspect of the data.
Ms. Connell. So would I.
Mr. Thomas. Notwithstanding the fact that you want
everybody to participate in the system because, one, you do not
know where the qualitative data is going to come from. But
secondly, in my opinion, the openness of that system is what
creates the willingness to, within the quantity, get the
quality.
Dr. Cassel. Yes.
Mr. Thomas. I want to thank the panel very much. We took
some time, but I just thought the unique backgrounds of both of
you and the perspective that you might bring to this would set
the tone and I appreciate very much your willingness.
Now I would ask the defendants to approach the bench.
[Laughter.]
Mr. Thomas. Oh, I am sorry. The next panel is Dr. Michael
Langberg, senior vice president of medical affairs, chief
medical officer of Cedars-Sinai in Los Angeles, on behalf of
the American Hospital Association. And Dr. Thomas Reardon,
president and executive committee member of the American
Medical Association.
We have a vote underway. It is a 15-minute vote. If we can
get both of your testimony in, your written testimony will be
made a part of the record, and if you will address us in the
time that you have, which if both of you take five minutes we
will have enough time to vote. I believe it is going to be
difficult to do, and if we are not successful in doing it then
we will recess and come back.
Dr. Langberg, do you want to start?
STATEMENT OF MICHAEL LANGBERG, M.D., SENIOR VICE PRESIDENT OF
MEDICAL AFFAIRS, AND CHIEF MEDICAL OFFICER, CEDARS-SINAI HEALTH
SYSTEM, LOS ANGELES, CALIFORNIA, ON BEHALF OF THE AMERICAN
HOSPITAL ASSOCIATION
Dr. Langberg. Mr. Chairman, and members of the committee,
my name is Dr. Michael Langberg. I am the senior vice president
for medical affairs, chief medical officer for Cedars-Sinai
Health System in Los Angeles. The Cedars-Sinai Medical Center
is the largest not-for-profit acute care hospital in the
western United States, and together with more than 2,000
physicians associated with our system, Cedars-Sinai provides
care to an urban population of considerable diversity.
I have spent almost all of my professional career at
Cedars-Sinai as a general internist. Since 1996, I have served
as its chief medical officer and am responsible for overseeing
systemwide quality initiatives and information systems. I have
developed a deep knowledge of the complexity of modern health
care and have a broad background in improving the quality and
safety of the patient experience.
I am here today on behalf of the American Hospital
Association. The AHA realizes that the entire health community
has to address the serious issues raised in the Institute of
Medicine's report on medical safety. I also want to share with
you some of what hospitals and health systems are doing in this
critical area.
To begin, I would like to remind the committee and the
American public that hospitals provide care to millions of
patients safely every year. The people who deliver health care,
the doctors, the nurses, and others, are highly trained,
receive continuous education, and strive every day to deliver
safe and compassionate care. They do believe in the dictum,
first do no harm. But health care today is extraordinarily
complex and even our best intentions can have unwanted and
unintended consequences.
The IOM report, To Err is Human, points out that as good as
our systems are for preventing and reducing medical errors of
all kinds, we can and we must do better. We applaud the members
of the IOM committee for developing a report that shines a
bright light on the problem of medical errors and are heartened
by the quick response this has received.
We agree with the report in urging all to avoid blaming
individuals for past errors, and instead to focus on preventing
future errors by designing safety into the system. It stresses
two principles that we have learned, reduce errors and increase
patient safety.
First, to err is human. We must understand and improve the
systems in which people work to make errors less likely. As a
result, reducing errors requires us to design and implement
more error-resistant systems.
Second, we have to create an environment where caregivers
feel they can come forward when an unfortunate mistake is made.
We need to create a non-punitive environment that allows for
the candid discussion of errors, their sources, their causes.
If we cannot discuss our mistakes, we cannot learn from them or
prevent them in the future.
The AHA also agrees that stepped-up efforts are needed.
There are many organizations today that specialize in the area
of reducing and preventing medical errors. We at the AHA are
working with some of these experts.
In December, the AHA announced an initiative to target and
improve medication safety. Why? Because medication related
errors are one of the most common sources of all medical
errors.
As part of this initiative, the AHA formed a partnership
with the highly respected organization in this field, the
Institute for Safe Medication Practices. This non-profit
research and educational organization and its president,
Michael Cohen, have been dedicated for over 25 years to the
continual reduction of medication errors throughout the health
care system. We are pleased that they will provide leadership
as well as technical expertise for the AHA's initiative.
As part of our effort we will share with every one of our
members successful practices for improving medication safety.
We have already sent out a quality advisory on improving
medication safety to our 5,000 hospital and health system
members. This advisory includes background on the issue,
resources our members can turn to for help, and a three-page
list of successful practices for improving medication safety.
We will follow up on how these successful practices are
being implemented with a medication safety awareness
assessment. We will also serve as a clearinghouse for
information and resources, and are planning a national summit
involving other organizations and hospital leaders to discuss
widespread efforts to improve medication safety.
In summary, Mr. Chairman, the IOM's report is timely. It
brings together a number of stakeholders all at the same time
to collectively address this important issue. As the report
notes, large, complex problems require thoughtful, multifaceted
responses. The AHA has pledged and committed to help its member
hospitals and health systems respond to this critical issue.
I will be happy to answer questions.
[The prepared statement and attachments follow:]
Statement of Michael Langberg, M.D., Senior Vice President for Medical
Affairs and Chief Medical Officer, Cedars-Sinai Health System, Los
Angeles, California, on behalf of the American Hospital Association
Mr. Chairmen, I am Michael Langberg, M.D., senior vice
president for medical affairs and chief medical officer of
Cedars-Sinai Health System in Los Angeles. I am here today on
behalf of the American Hospital Association's (AHA) nearly
5,000 hospital, health system, network, and other health care
provider members. We are pleased to have the opportunity to
testify on an issue of critical importance for hospitals and
the patients and communities they serve: the Institute of
Medicine's (IOM) report on medical safety, and what hospitals
and health systems are doing to improve patient safety.
The Cedars-Sinai Health System includes a number of
physician officers distributed across the Los Angeles
metropolitan area. Cedars-Sinai Medical Center is the largest
not-for-profit acute care hospital in the western United
States. Together with the 2,000 physicians associated with our
system, Cedars-Sinai provides care to an urban population of
considerable racial, ethnical, social, linguistic, religious
and economic diversity.
I have spent almost all my professional career at Cedars-
Sinai on the faculty in General Internal Medicine, originally
as Director of Medical Education. In 1996, I assumed the role
of chief medical officer overseeing system-wide quality
initiatives and information systems. I have developed a deep
knowledge of the complexity of modern health care, and have a
broad background in improving the quality and safety of the
patient experience. I believe that much of what is outlined in
the IOM report is accurate. The report has focused attention at
a time when many other activities are under way to address
these issues, which many of the members of the IOM panel first
brought to national awareness several years ago.
BACKGROUND
For thousands of years, healers have lived by the motto
primum non-nocere--first, do no harm. The nurses, doctors, and
others on the patient care team in hospitals strive every day
to deliver the safe, compassionate care that patients deserve.
But in today's complex, high-tech world of medicine, our best
intentions can have unwanted and unintended consequences. The
IOM report, ``To Err is Human: Building a Safer Health
System,'' points out that, as good as our systems are for
preventing and reducing medical errors of all kinds, we can and
must do better.
THE IOM REPORT AND HOSPITALS
We applaud the members of the IOM Committee on Health Care
in America for developing a report that shines a bright yet
objective spotlight on the problem of medical errors. The IOM
report is important, outlining the significance of the medical
error problem in this country.
It acknowledges that medicine is delivered by people who
are highly trained and receive continuous education to stay on
top of their respective areas of discipline. Hospitals and
caregivers already work under strict internal quality control
procedures, in addition to federal, state, local and
independent oversight. Hospitals have important systems in
place--checks and balances to reduce the potential for human
error. For example, they have quality teams, physicians and
nurses who examine unexpected deaths, treatment errors and
accidents, to identify and correct the cause. And most
hospitals have teams of experts whose sole focus is to develop
and oversee safety policies to prevent accidents before they
happen.
In addition, there are many organizations that specialize
in the area of reducing and preventing medical errors. The AHA
is working with several of these organizations so that we can
help hospitals and health systems benefit from their knowledge
and expertise. Among them: the National Patient Safety
Partnership--a public/private partnership of organizations; the
National Coordinating Council for Medication Error Reporting
and Prevention; and the American Medical Association National
Patient Safety Foundation. We're doing this because, as the IOM
report points out, a vigilant, ongoing, stepped-up effort to
improve patient safety is needed.
We agree with the report that we need to avoid ``blaming
individuals for past errors'' and instead ``focus on preventing
future errors by designing safety into the system.'' We also
agree that, as the report states, ``professional societies and
groups should become active leaders in encouraging and
demanding improvements in patient safety.'' The AHA is
committed to being just that kind of leader, so that America's
health care system does indeed focus not on blame, but on
prevention.
The IOM report focuses on the broad issue of medical
safety. The AHA, at a White House event in December with
President Clinton, announced an initiative to improve
medication safety, because medication errors are one of the
most common sources of overall medical errors. We used the
opportunity to point out that whatever happens at the national
level will only be valuable if it helps the women and men like
me and those I work with at the Cedars-Sinai Health System--
people who are on the front lines of health care--do their jobs
even better.
Speaking of action at the national level, we understand the
committee's interest in determining whether further legislation
is needed to address medication errors. But before moving to
consider new legislation, we urge Congress to consider the
reporting mechanisms currently in place--by organizations like
the Veterans Administration, the Joint Commission on the
Accreditation of Healthcare Organizations, and the Institute
for Safe Medication Practices--to collect and use information
on errors. Congress should know how these current mechanisms
work and consider ways to improve them, if necessary, before
proposing new reporting systems.
The AHA believes we need to be clear about what our
objectives are in collecting information on events that may be
related to errors. Reporting should be a tool for reducing and
preventing errors. It should be designed to stimulate
organizations and practitioners to analyze what went wrong and
make the necessary changes to ensure that the mistakes do not
happen again. In addition, lessons learned from one error
should be widely shared with others. Provider accountability
should be tied to these objectives.
The quantity of reports is not nearly as important as the
quality. One need not read 500 reports of workers mixing up two
similar sounding medications, before it becomes obvious that
the two medications need better labeling. Our goal should not
be to ensure that every provider report every event, but rather
to encourage dialogue to learning.
AHA ACTIVITIES
More than a year ago, the AHA board and many of our
hospital leaders attended a national forum in Cleveland. The
topic: improving patient care. Though we have long been
involved in improving the quality of care provided in the
nation's hospitals, we came away from that particular meeting
with a strong sense from hospital leaders that, on a national
level, we could do more … we needed to address these
issues head on.
But the issue of medical error is very broad in scope. We
set our sights specifically on improving medication safety--
reducing and preventing medication errors that result from
things like different drugs being packaged in similar
containers, use of confusing abbreviations on labels and
prescriptions, illegible doctor handwriting, and more.
Against the backdrop of all this activity came the IOM
report, which led overnight to increased awareness of the
importance and seriousness of this issue. The release of the
report came as we were preparing to kick off our initiative to
take a comprehensive look at hospitals' ability to prevent
medication errors and help them make improvements where needed.
As part of our initiative, we formed a partnership with a
highly respected organization in this field, the Institute for
Safe Medication Practices (ISMP). This non-profit research and
education organization is dedicated to reducing the incidence
of medication error throughout the health care system, and will
provide leadership and technical expertise for the AHA's
initiative. ISMP provides independent review of errors reported
through the Medication Errors Reporting Program (MERP), which
ISMP was instrumental in founding. Through MERP, health care
professionals across the nation voluntarily complete pre-
addressed mailers or dial a toll-free number (800-23-ERROR) to
report actual and potential medication errors with complete
confidentiality. As an official MedWatch partner, ISMP shares
all information and prevention ideas with the U.S. Food and
Drug Administration (FDA) and other professional and policy
organizations. Working with practitioners, regulatory agencies,
health care institutions, professional organizations, and the
pharmaceutical industry, ISMP provides timely and accurate
medication safety information and works toward improvements in
drug distribution, naming, packaging, labeling, and delivery
system design.
The following four objectives are key to our medication
safety campaign with ISMP.
Develop a non-punitive process for discussing errors
Most of what has been learned in recent years about how to
reduce errors and increase patient safety is based on two
principles. First, individuals, by the very nature of being
human, are vulnerable to error. Although they are the focus of
the error, errors happen because of the systems in which these
individuals work. As a result, reducing errors will require us
to design and implement more error-resistant systems.
Second, we have to create an environment in which we learn
from failure. This requires us to identify an effective
mechanism for candid discussion of errors. This cannot be
achieved in an environment of punishment or fear. Doctors,
nurses and other caregivers should not be penalized for
stepping forward after an unfortunate mistake is made. A more
open environment can only occur when health care providers are
afforded adequate legal protections.
Today, when health care providers are required to disclose
confidential internal information to health care oversight
agencies, they may jeopardize state law that protects internal
quality analysis discussions and expose themselves to crushing
legal liabilities. There is no incentive to share this
information with others to prevent similar events in other
institutions. We believe protections that currently apply to
such information should also apply when it's disclosed. We
believe that evidentiary, confidentiality and other legal
reforms should be considered to help foster an environment that
promotes candor.
Candor is absolutely critical if we are to be truly
successful in identifying, learning from and reducing not only
medication errors, but all medical errors, and making the
health care system safer. We need to create a non-punitive
culture at all levels that supports the collection of
information about errors, along with candid discussion of
errors, their causes, and ways to prevent them from happening
again. A safe, non-punitive environment will encourage people
to report and discuss errors--the first step in lessening the
chance they will happen in the first place and making sure they
do not happen again.
Share successful practices with every hospital and health
system
We sent to every AHA member the attached ``Quality Advisory
on Improving Medication Safety.'' The advisory includes
background on the issue, a long list of resources our members
can turn to for help, and a three-page list of ``successful
practices'' for improving medication safety. Some of these
practices can be adopted easily and quickly, such as providing
staff with information about ordering, dispensing,
administering and monitoring medications, not storing certain
concentrated solutions on hospital wards, and helping patients
better understand what they are talking, why, and how to use it
safely.
Others are longer-term practices that, with time and money,
can create significant changes throughout our members'
organizations. Among these are the development of a voluntary,
non-punitive system to monitor and report errors that might
occur within hospitals, and the computerization of medication
administration systems.
We compiled the list of successful practices with the help
and advice of some of the best experts in the field--including
the ISMP, the Institute for Healthcare Improvement, the
Massachusetts Coalition for the Prevention of Medical Errors,
the National Coordinating Council for Medication Error
Reporting and Prevention, the National Patient Safety
Partnership and many others.
Develop a ``medication safety awareness test'' for use by
hospitals
To follow up on how the successful practices are being
implemented, we are working with ISMP to develop a ``Medication
Safety Awareness Test'' to help our members assess their
progress. This tool will also help the AHA get an idea of what
other help its members may need, and help us track and
demonstrate hospitals' success at improving medication safety.
Serve as a clearinghouse of information and resources for
hospitals
The AHA will continue making available to its members up-
to-date information on improving medication safety. We will
gather information from outside sources and work with other
national organizations to develop information and data. We are
planning a medication safety ``summit,'' gathering other
organizations and hospital leaders together to discuss
widespread efforts to improve medication safety. And we will be
adding to our Web site (www.aha.org) a special area containing
all the information, data, best practices, and other resources
we compile in our medication safety improvement campaign.
CONCLUSION
Mr. Chairman, the IOM report is very timely. It comes as
America's health care system enters a new century of caring for
people. It marks an opportunity for us to rebuild the public's
confidence and trust in the health care system they rely on
every day. And it reminds us that, despite setbacks, we still
deliver the greatest health care in the world.
But it also notes that ``large, complex problems require
thoughtful, multifaceted responses.'' Reducing and preventing
medication errors, and improving the overall safety of the
health care system, will demand the thoughtful collaboration
and participation of everyone involved in the health care
field: hospital leaders, pharmacists, drug manufacturers,
doctors, nurses, government agencies, other organizations, and
consumers. America's hospitals and health systems are committed
to this effort.
AHA Quality Advisory
A Message to AHA Members:
Primum non nocere. Above all, do no harm. Healers have
lived by this motto for thousands of years. The minimum our
patients expect from us is safe and compassionate care when
they enter a hospital. And they deserve to get it.
But in today's complex, high-tech world of medicine, our
best intentions can have unwanted consequences. And those
consequences are contributing to the public's eroding
confidence and trust in the health care system.
While the recently released Institute of Medicine study has
drawn a lot of attention to medication errors, we have been
working on this issue for some time. Following up on
discussions with the AHA Board of Trustees and Regional Policy
Boards on improving hospitals' accountability to their
communities, the AHA is developing an initiative to help you
improve patient safety by reducing and preventing medication
errors. To provide leadership and technical expertise in this
effort, we have formed a relationship with the Institute for
Safe Medication Practices (ISMP), a not-for-profit research and
education organization dedicated to reducing the incidence of
medication error throughout the health system.
This is what you can expect from us in the coming months.
First, we will provide you with strategic and practical
advice to reduce the potential for and incidence of medication
error. To jump start this initiative, we are attaching several
successful practice recommendations compiled from respected
sources.
Next, together with ISMP, we are developing a ``Medication
Safety Awareness Test'' that will help you assess your progress
on implementing recommendations in your hospital, and that will
enable us to track and demonstrate your success at improving
medication safety.
The recommendations that follow can greatly improve patient
safety. The first set can be implemented immediately; they
focus on standardization and simplification of processes that
will likely reduce the potential for human error. The second
set require changes to existing organizational systems; they
will likely require a longer-term implementation plan and may
rely on computerization of the physician order-entry and
pharmacy dispensing processes.
Here are some ways to get started:
Consider organizing a senior management team to
review and discuss the attached recommendations. This team
could include the CEO, chief medical officer, chief operating
officer, chief nurse executive, director of pharmacy, risk
manager, director of information systems, and others. Some
organizations also include patients on this team. Assess your
organization's processes as they compare to the recommendations
and track your progress on implementing changes.
Review your policies and procedures for reporting
and investigating errors. Create an open, non-punitive culture
that evaluates and corrects errors.
Review information about incidents that occur
within your institution and use it to find opportunities for
improvement. Consider personally investigating an adverse event
yourself, including talking directly with those involved.
Help your organization's physicians, nurses, and
other patient care staff be prepared to respond to patients'
questions about adverse medical events and about the general
quality of care in your organization.
Make sure your staff is aware of the tremendous
amount of information available from organizations like the
ISMP, the Institute for Healthcare Improvement, the Food and
Drug Administration, the U.S. Pharmacopeia, the Massachusetts
Hospital Association, the National Coordinating Council on
Medication Error Reporting and Prevention, the National Patient
Safety Partnership, the National Patient Safety Foundation, the
American Society for Health-System Pharmacists, and the
American Society for Healthcare Risk Management.
Lead the way with executive behavior: Declare the
goal of safety to be a specific priority of you and your board.
Be certain to keep your board and organized medical staff up to
date on all the actions you're taking.
Look for more from us in the near future. We'll provide
strategic and practical advice on reducing errors, and we'll be
your clearinghouse for information and resources. The AHA is
committed to helping you create a safer, more effective, and
more efficient health care system.
Dick Davidson President
AHA Quality Advisory
Improving Medication Safety
Background
Most of what has been learned in recent years about how to
reduce medication errors and increase patient safety is based
on two principles. First, individuals, by the very nature of
being human, are vulnerable to error. Although individuals are
the focus of the error, errors happen because of the systems in
which those individuals work. As a result, reducing error will
require us to design and implement more error-resistant
systems. Second, we have to create an environment in which we
can learn from failure--a safe, non-punitive environment that
supports open discussion of errors, their causes, and ways to
prevent them.
These principles have a common denominator--they require
the leadership and commitment of senior executives, medical,
nursing, and clinical staff to create change within our
organizations.
Common Sources of Error
Medication systems in hospitals are complex and multi-
layered, involving many steps and many individuals. This
complexity increases the probability of failure. While many
errors are caught before they can cause harm, it can be tragic
whenever a patient's safety is compromised. Error can occur at
any stage--prescribing, ordering, dispensing, administering, or
monitoring the effects of a medication. According to the
Institute for Safe Medication Practices, some common sources of
medication error in health systems include:
Unavailable Patient Information:
Critical patient information (diagnoses, lab values,
allergies, drug contradictions, etc.) is often unavailable to
pharmacy, nursing, and medical staff prior to dispensing or
administering drugs.
Unavailable Drug Information:
Pharmacists often are not readily available on patient care
units and written resources may not be up-to-date, which can
lead to dose miscalculations or ignorance of drug interactions.
Because errors occur most often during the prescribing and
administration stages, accessible drug information must be
readily available and close at hand for all staff who prescribe
and administer drugs.
Miscommunication of Drug Orders:
Failed communication is at the heart of many errors. This
includes poor handwriting, confusion of drugs with similar
names, careless use of zeroes and decimal points, confusion of
metric and apothecary systems, use of inappropriate
abbreviations, ambiguous or incomplete orders, and, sometimes,
conflicts between practitioners.
Problems with Labeling, Packaging and Drug Nomenclature:
Most drugs are dispensed through unit dose systems that
parse medications into smaller-sized doses. These systems,
however, do not always provide for thorough preparation,
packaging, and labeling of medications, with screening and
checking by both nursing and pharmacy personnel, and they may
not be available throughout every unit in the hospital (e.g.,
ERs and ICUs). Drug administration procedures often do not
ensure that medications remain labeled until they reach the
patient's bedside, a frequent source of error.
Drug Standardization, Storage, and Stocking:
Stocking multiple concentrations of the same drug, or
storing drugs in look-alike containers or in ways that obscure
drug labels, may contribute to error. Lack of safety procedures
for use of automated dispensing technology or inadequate check
systems may also contribute to errors.
Drug Device Acquisition, Use and Monitoring:
Lack of standardization in drug delivery devices, improper
default settings, unsafe equipment (e.g., free-flow infusion
pumps), and the lack of independent check systems for verifying
dose and rate settings can all contribute to device-related
errors.
Environmental Stress:
Environmental factors like lighting, heat, noise, and
excessive interruptions, can affect individual performance. The
process of transcribing orders is particularly vulnerable to
distractions in the environment, as staff transcribing orders
are exposed to noise, interruptions, non-stop unit activity,
and too-long or double shifts.
Limited Staff Education:
Many practitioners are not as aware as they should be of
situations within their own organizations that have been
reported as error-prone, or of similar information published in
professional literature.
Limited Patient Education:
Medication use is a multi-step, multidisciplinary process
that begins and ends with the patient. Patient education about
medications--what they are taking, why they are taking it, and
how they should take it--is essential to successful medication
administration. Patients can be partners in the prevention of
error while hospitalized and need to be educated to safely
self-administer medications when they go home.
Quality Improvement Processes and Risk Management:
Health facilities need systems for identifying, reporting,
analyzing, and correcting errors and identifying trends, and
measurement systems for tracking the effect of system changes.
Also, organizations need to take into consideration information
from outside sources about errors that have occurred elsewhere.
But above all, health organizations need to cultivate a non-
punitive approach to error that will encourage frank
identification and analysis of errors when they occur.
Steps for Improving Medication Safety
These potential sources of error can be controlled if we
design safer systems. With this in mind, the AHA has attached
to this advisory a list of successful practices for improving
medication safety and for improving overall patient safety
within our hospitals and health systems. We encourage your team
to review this list of recommendations, plan for
implementation, and begin to track your progress.
Our Sources
The recommendations were culled from several reliable
sources that are leaders in the effort to reduce and prevent
medication errors, and we are grateful for their pioneering
efforts. This list includes those organizations, as well as
other resources for your organization's efforts.
American Society of Health-System Pharmacists
(www.ashp.org)
American Society for Healthcare Risk Management
(www.ashrm.org)
Institute for Healthcare Improvement (www.ihi.org)
Institute of Medicine (www.national-academies.org)
Institute for Safe Medication Practices
(www.ismp.org)
Joint Commission on Accreditation of Healthcare
Organizations (www.jcaho.org)
Massachusetts Hospital Association
(www.mhalink.org)
Massachusetts Coalition for the Prevention of
Medical Errors (www.mhalink.org/mcpme)
National Coordinating Council on Medication Error
Reporting and Prevention (www.nccmerp.org)
National Patient Safety Foundation (www.npsf.org)
U.S. Pharmacopeia (www.usp.org)
Books
1. Cohen, Michael R., Ed. Medication Errors. Washington,
D.C. American Pharmaceutical Association. 1999. (Contains a
special chapter on high-alert medications and dangerous
abbreviations; rich with insight and practical advice on
reducing the risk of error.)
2. Corrigan, Janet, et al. To Err is Human: Building a
Safer Health System. Washington, D.C. National Academies Press.
1999. (Comprehensive overview of medical error, containing many
practical suggestions and recommendations from several trusted
sources.)
3. Leape, Lucian, et al. Reducing Adverse Drug Events.
Boston, MA: Institute for Healthcare Improvement. 1998.
(Concepts to reduce adverse events and a model for
improvement.)
Patient Information Brochures
1. Your Role in Safe Medication Use: A Guide for Patients
and FamiliesgT1 is available from the Massachusetts Hospital
Association at www.mhalink.org
2. Partners in Quality: Taking an Active Role in Your
Health Care is available from the Hospital & Healthsystem
Association of Pennsylvania at www.hap2000.org
3. How to Take Your Medications Safely is available from
the ISMP at www.ismp.org
4. Just Ask! is available from the U.S. Pharmacopeia at
www.usp.org
Information on Safe Medication Practices
From the Institute for Safe Medication Practices
ISMP Medication Safety Alert!
Urgent Error Advisories
From the U.S. Pharmacopeia
Dangerous Abbreviations
Practitioner Reporting Alerts
Drug Quality Alerts
Look-alike Sound-alike Name Lists
From the Joint Commission on Accrediation of Healthcare
Organizations
Sentinel Event Alerts
Successful Practices for Improving Medication Safety
Easily implemented changes (process redesign)
The following steps can be implemented immediately by
hospitals and health systems. They focus on standardization and
simplification of medication system processes.
Fully implement unit dose systems
Maintain and systematically use unit-dose
distribution systems (either manufacturer-prepared or
repackaged by the pharmacy) for all non-emergency medications
throughout the hospital. Unit dose systems should include, in
addition to packaging, systems for labeling and order
screening.
Stress the need for dose adjustment in children,
older persons, and patients with renal or hepatic impairment.
Limit the variety of devices and equipment
For example, limit the types of general purpose
infusion pumps to one or two.
Develop special procedures and written protocols for high-alert drugs
Use written guidelines, checklists, dose limits,
pre-printed orders, double-checks, special packaging, special
labeling, and education.
Remove concentrated potassium chloride/phosphate
from floor stock.
Limit the number of possible concentrations for a
drug, particularly high-alert drugs like morphine and heparin.
Such standardization will allow the use of premixed solutions
from manufacturers or centralized preparation of IV medications
in the pharmacy.
Review JCAHO Sentinel Events Alert #11, Nov. 19,
1999. Also, review Chapter 5 of Michael Cohen's 1999 book,
``Medication Errors,'' published by the American Pharmaceutical
Association.
Ensure the availability of up-to-date drug information
Make updated information on new drugs,
infrequently used drugs, and non-formulary drugs easily
accessible to clinicians prior to ordering, dispensing, and
administering medications (e.g., have pharmacists do rounds
with doctors and nurses; distribute newsletters and drug
summary sheets; use computer aids; and provide access to
formulary systems and other internal resources).
Review error potential for all new products,
including a literature review, before any drug or procedure is
approved for use; reassess six months to one year later.
Educate staff
Provide physicians, nurses, pharmacists, and all
other clinicians involved in the medication administration
process with orientation and periodic education on ordering,
dispensing, administering, and monitoring medications.
Distribute information about known drug errors
from outside organizations like the Institute for Safe
Medication Practices (ISMP) and the U.S. Pharmacopeia (USP).
Educate patients
Patients should be educated in the hospital, at
discharge, and in ambulatory settings about their medications,
what they are taking, why they are taking it, and how to use it
safely.
Encourage patients to ask questions about their
medications.
Encourage health care providers to work with
pharmacists on patient education when patients receive certain
classes of medications or are discharged on more than five
medications.
Ensure the availability of pharmacy expertise
Have a pharmacist available on-call when pharmacy
does not operate 24-hours a day.
Make the pharmacist more visible in patient care
areas--consider having pharmacy personnel make daily rounds on
units, or enter orders directly into computer terminals on
patient care units.
Standardize prescribing and communication practices
Avoid certain dangerous abbreviations (see ISMP
and USP for examples); identify a list of unacceptable
abbreviations that will not be used in your institution.
Include all elements of the order--dose, strength,
units (metric), route, frequency, and rate.
Use full names (preferably generic).
Use computerized reminders for look-alike and
sound-alike drug names.
Use metric system only.
Use preprinted order sheets whenever possible in
non-computerized order systems.
Standardize multiple processes, such as:
Doses
Times of administration (for example, antibiotics)
Packaging and labeling
Storage (for example, placing medications in the
same place in each unit)
Dosing scales (for example, insulin, potassium)
Protocols for the use and storage of high-alert
drugs
Longer-term changes (systems redesign)
The following steps will require substantial changes to
existing organizational systems; they will likely require a
longer-term implementation plan and a continual focus on
improvement. Many of the recommendations rely on
computerization in the physician order-entry and pharmacy
dispensing processes.
Develop a voluntary, non-punitive system to monitor and report adverse
drug events
Review policies for how your organization
encourages reporting and analyzing errors throughout the
institution.
Encourage open communication and feedback.
Ensure no reprisals for reporting of errors.
Reports will increase if you make it safe to report.
Increase the use of computers in the medication administration system
Encourage the use of computer-generated or
electronic medication administration records.
Plan for the implementation of computerized
prescriber order entry systems.
Consider the use of machine-readable code (i.e.,
bar coding) in the medication administration process.
Use computerized drug profiling in the pharmacy.
Be a demanding customer of pharmacy system
software; encourage vendors to incorporate and assist in
implementing an adequate standardized set of checks into
computerized hospital pharmacy systems (e.g., screening for
duplicate drug therapies, patient allergies, potential drug
interactions, drug/lab interactions, dose ranges, etc.).
Institute 24-hour pharmacy service if possible . . .
. . . alternatively, use night formularies and careful drug
selection and storage procedures. To facilitate medication
distribution after hours, develop policies and procedures to
ensure access to consultation with a pharmacist if a pharmacist
is not available on-site.
AMERICAN HOSPITAL ASSOCIATION
December 6, 1999
Mr. Thomas. Thank you very much, Dr. Langberg.
Dr. Reardon, welcome once again. Your testimony will be
made a part of the record, and if you could do it slightly
under five minutes we would be greatly appreciative because we
are going to ask questions.
STATEMENT OF THOMAS R. REARDON, M.D., PRESIDENT, AMERICAN
MEDICAL ASSOCIATION
Dr. Reardon. I will do my best. Good morning, Mr. Chairman,
and members of the committee.
The AMA appreciates your initiative in calling this hearing
to focus attention on the major concern to all of us, the
safety and quality of care for patients in our health system.
The elimination of health system errors is not only a high
priority for the AMA, it is an important ethic of the medical
profession. We believe that any error that harms a patient is
one error too many.
In short, the AMA believes that Congress, States, and the
private sector together can achieve significant advances in
health system safety and quality without delay. We recommend
that Congress do the following.
One, fund research to analyze existing data. This would
have an immediate impact on patient safety and provide guidance
on designing future data collection methods. Two, fund the
Agency for Healthcare Research and Quality, AHRQ, to provide
grants for new private sector patient safety research centers
across the country.
Three, extend peer review liability and confidentiality
protections to those involved in patient safety improvement
initiatives. And four, fund AHRQ to disseminate effective
patient safety strategies nationwide.
Congress has already taken steps consistent with these
recommendations. For example, in the Healthcare Research and
Quality Act of 1999 which was just enacted in December,
Congress directed the AHRQ to conduct and support research and
build public-private partnerships to first of all identify the
causes of preventable health care errors and prevent injury in
the health care delivery; develop, demonstrate and evaluate
strategies for reducing errors and improving patient safety;
and disseminate such effective strategies throughout the health
care system.
AHRQ is also directed to coordinate all research,
evaluations, and demonstrations related to quality measurement
and quality improvement activities undertaken and supported by
the Federal Government.
In addition, in the BBA 1997, Congress directed the
Medicare Payment Advisory Commission to look at issues related
to quality of care for Medicare beneficiaries. Accordingly, the
Medicare Payment Advisory Commission's 1997 report to Congress
contains a chapter and seven recommendations to Congress
addressing the issue of health care errors under Medicare.
One Medicare Payment Advisory Commission recommendation was
noted in the IOM is for Congress to pass legislation to protect
the confidentiality of individually identified information
relating to errors in health care delivery, and that when that
information is reported for quality improvement purposes.
The AMA strongly supports the principle under the IOM
report that the health care system must be transformed from its
existing culture of blame and punishment which suppresses
information about errors into a culture of safety that focuses
on an openness and information sharing to improve health care
and prevent adverse outcomes.
This does not mean that negligent actions should be
protected. Accountability for negligent or incompetent actions
is already well-established in our health care and judicial
systems for physicians and other health care providers. State
and Federal courts, State licensing boards, and accrediting
bodies such as the JCAHO all function to maintain
accountability and standards. Along with accountability though,
we must have a system whereby medical professionals can convene
to discuss patient safety issues and potential solutions
without having their discussions, findings, or recommendations
become the basis for lawsuits.
The IOM report recommends a mandatory reporting system for
deaths or serious outcomes. However, investing in expensive
data collection without clear objectives may in fact divert
resources from other, more productive approaches to improve
patient safety. We believe that mandatory public reporting
could have unintended consequences and elicit less information
than a well-designed, well-run voluntary program. In fact,
there is no evidence that patients in States that have a
mandatory reporting system are any safer than those in States
that do not have that mandatory reporting system.
Congress can assist by providing funding to establish
extramural research programs that would be administered by AHRQ
with centers for patient safety established throughout the
country to analyze available data on errors, deaths, and other
adverse outcomes. Thus, the AMA strongly supports the IOM
report recommendation for Congress to provide the funds and
technical support necessary to analyze the information obtained
from current error reporting systems and conduct follow-up
actions.
The AMA has been working in a concerted effort to
accomplish many of the objectives outlined in the IOM report.
For example, in 1996 and 1998, the AMA joined with other health
care leaders to convene the Annenberg conferences which have
already resulted in several initiatives in patient safety that
are being undertaken at the State and national level, such as
preventing injuries due to medication errors.
In 1997, the AMA established the National Patient Safety
Foundation, an independent, not-for-profit organization that
convenes forums to discuss patient safety matters and provides
grants to stimulate patient safety research. The NPSF was cited
several times in the IOM report for its work and is well-
positioned to utilize its diverse group of health care leaders
and other stakeholders to continue improving patient safety.
I thank you for the opportunity to testify and look forward
to your questions.
[The prepared statement follows:]
Statement of Thomas R. Reardon, M.D., President, American Medical
Association
Good morning, Mr. Chairman and members of the Committee, my
name is Thomas R. Reardon, MD. I am the President of the
American Medical Association (AMA) and a general practice
physician from Portland, Oregon.
The AMA greatly appreciates Chairman Thomas' initiative in
calling this hearing today to discuss the issue of patient
safety and the recent report released by the Institute of
Medicine (IOM). This IOM Report, entitled To Err is Human:
Building a Safer Health System, has focused the nation's
attention on a major concern to us all--the safety and quality
of care for patients in our health care system. We commend the
IOM for its efforts in examining the issues of patient safety
and quality of care, and welcome the opportunity to work
cooperatively with the IOM, Congress, and health care leaders
to further advance the quality and safety of patient care.
The elimination of health system errors is not only a high
priority for the AMA, it is an important ethic of the medical
profession. As an association founded on the commitment of
physicians to improve the quality of medical care, we believe
that any error that harms a patient is one error too many.
And, clearly, the public shares the AMA's concerns. For
example, the November/December 1999 Kaiser Family Foundation/
Harvard Health News Index reported that 51% of Americans
closely followed news coverage on the IOM Report. While much of
the information in the IOM Report is not new, there is much
that is new and exciting in the private sector's response to
the issues raised in the IOM Report. For instance, the AMA has
a longstanding commitment to improving patient safety and
quality of care, and has been working in a concerted manner,
especially in recent years, towards many of the objectives
outlined in the IOM Report. Several recent examples of these
efforts are the AMA's creation of the American Medical
Accreditation Program, the National Patient Safety Foundation,
and the Performance Measurement Coordinating Council, and our
active participation in the President's Advisory Commission on
Consumer Protection and Quality in the Health Care Industry and
the new National Quality Forum.
We believe that Congress can make a significant positive
impact on reducing health systems errors by:
Funding research to analyze existing data to
determine ways to improve patient safety and provide guidance
on the advisability and potential design of future data
collection methods;
Funding the Agency for Healthcare Research and
Quality (AHRQ) to provide grants for new private sector patient
safety research centers around the country;
Extending peer review liability protections to
those involved in patient safety improvement initiatives, and
confidentiality protections for individually identifiable
information reported for health system safety and quality
improvement purposes; and
Funding AHRQ to disseminate effective patient
safety strategies nationwide.
Creating a Culture of Safety
The AMA strongly supports the principal underlying the IOM
Report that the health care system needs to transform the
existing culture of blame and punishment that suppresses
information about errors into a culture of safety that focuses
on openness and information sharing to improve health care and
prevent adverse outcomes. The AMA also supports the IOM's focus
on the need for a system-wide approach to eliminating adverse
outcomes and improving safety and quality, instead of focusing
on individual components of the health system in an isolated or
punitive way.
What can Congress do to help create a culture of safety?
Congress has already taken several steps to help create a
culture of safety. In fact, Congress recently passed specific
legislative language to reduce errors in the health system. In
December 1999, the Healthcare Research and Quality Act of 1999
(P.L. 106-129) was enacted into law to reauthorize the AHRQ
(formerly AHCPR). In Section 912(c) of this law, Congress
clearly showed its commitment to reduce errors in the health
care system by, inter alia, directing AHRQ to conduct and
support research and build private-public partnerships to:
``(1) identify the causes of preventable health care errors and
patient injury in health care delivery; (2) develop,
demonstrate, and evaluate strategies for reducing errors and
improving patient safety; and (3) disseminate such effective
strategies throughout the health care industry.'' (emphasis
added) Further, by separating this bill from the Senate's
patient protection legislation (S. 1344), Congress has sent a
clear message on the way to ensure patient safety and quality.
Also, when Congress passed the Balanced Budget Act of 1997
and created the Medicare Payment Advisory Commission (MedPAC),
it directed MedPAC to look at issues related to quality of care
for Medicare beneficiaries. Accordingly, MedPAC's June 1999
Report to Congress contains a chapter and seven recommendations
to Congress addressing the issue of ``health care errors under
Medicare.'' In its report, MedPAC recommends that the Secretary
of Health and Human Services establish patient safety as a
quality improvement priority for Medicare and take steps to
minimize preventable errors in health care delivery.
One area where we believe Congress additionally could be
helpful would be to enact legislation to expand peer review and
confidentiality protections for those seeking to identify
safety problems and their solutions, as recommended by the IOM
Report. Legislation excluding from liability those engaged in
patient safety improvements, similar to the exclusions for
biomaterials suppliers contained in the Biomaterials Access
Assurance Act of 1998, could be an important step toward a new
culture of safety.
MedPAC and the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) have made similar
recommendations to Congress. The June 1999 MedPAC Report
recommends that Congress enact legislation ``to protect the
confidentiality of individually identifiable information
relating to errors in health care delivery when that
information is reported for quality improvement purposes.'' The
IOM Report states that MedPAC's recommendation is a ``promising
alternative.'' Likewise, JCAHO recently testified that it has
been seeking federal legislative protection to protect from
disclosure information developed in response to a sentinel
event and shared with an accreditor.
The matter of accountability for negligent or incompetent
actions is already well established in our health care and
judicial systems for physicians and other health care
providers. State and Federal courts, state licensing boards,
and accrediting bodies such as JCAHO all function to maintain
accountability and standards. However, the very fear of
existing legal liability or its misapplication are the greatest
hurdles to pioneering patient safety efforts.
For example, when the Anesthesia Patient Safety Foundation
was founded, legal liability was a major concern. The creative
approach employed by the anesthesiologists was to start by
looking at claims that have already been settled or closed.
Unfortunately, waiting for a case to settle or close before a
problem can be discussed without the fear of litigation
needlessly delays important feedback that otherwise could
result in an immediate solution. Congress can help create a
culture of safety by allowing medical professionals to convene
to discuss patient safety problems and potential solutions
without having their discussions, findings, or recommendations
become the basis for class action or other lawsuits. If the
fear of litigation continues to pervade efforts to improve
patient safety and quality, our transformation into a culture
of safety on behalf of our patients may never be fully realized
The IOM Report recommends a mandatory reporting system for
deaths or serious adverse outcomes. However, the AMA agrees
with the AHRQ, the VA, and many leading organizations and
experts on health care matters that mandatory public reporting
could have unintended consequences and elicit less information
than a well-designed, well-run voluntary program. We believe
that other recommendations in the IOM Report offer more
fruitful avenues for Congress to consider at this time. Past
federal efforts to collect data on physicians and other health
care providers in the name of quality improvement have had a
negative effect on efforts to create an environment that
fosters trust and open communication. Simply focusing on
finding the individuals who contribute to an error completely
ignores the epidemiological and health services research
approaches that have produced many notable advances in the
quality and safety of patient care.
Any approach to improving patient safety should, at a
minimum, include a non-punitive mechanism for reporting
incidents, post-incident evaluations for identification of
system changes to prevent subsequent occurrences, and federally
guaranteed legislative protection from discovery for all
aspects of information gathered to improve patient safety.
System-wide trust and communication are fundamental elements
for successful reform.
Non-punitive approaches have yielded useful results in
related contexts. For example, Congress should consider the
experience of the past several decades in preventing hospital-
acquired infections. With the scientific support of the Centers
for Disease Control and Prevention and AHRQ, hospital
epidemiologists and physicians specializing in hospital-based
infectious diseases have systematically undertaken thousands of
investigations of endemic and epidemic infections. These
studies have been done in a blame-free environment in which
learning was the major goal. The infection controllers observed
that spontaneous reporting of infections and broad, voluntary
surveillance provided misleading information. They recognized
the need for targeted surveillance and focused objectives for
the infection control program, as well as for simple, clear
definitions of infections. Hospital-acquired infection rates
have declined precipitously as a result of these efforts.
There is a great danger in oversimplifying the task of
assuring patient safety. Like infant mortality, teen pregnancy,
and flu virus, patient safety must be approached using the same
epidemiological and health services research methods that we
use to address other public health problems. Truly effective
quality improvement requires intensive surveillance with
monitoring, tracking, analysis of variations, assessment of
interventions, feedback, and education. Organizations must
focus on studying and improving the entire process of care, not
just identifying blame. Enumeration of errors without sound
scientific analysis is futile, and diversion of scarce
resources to cataloguing all errors could be cost inefficient
and unproductive.
In other words, more data collection for the sake of having
more data, absent specific goals and scientifically designed
studies, is unlikely to yield real improvements in patient
safety Indeed, investing in expensive data collection without
clear objectives may in fact divert resources from other more
productive approaches to improve patient safety. As MedPAC
stated in its June 1999 Report, ``In devising error-reduction
initiatives, the program should conduct small-scale tests of
approaches that have been developed for other industries as
well as for health care before adopting approaches for
programwide use.''
The AMA's approach to reducing medical errors is similar to
that recommended by the IOM in its report. In fact, when the
IOM Committee on Quality began to examine this issue, we were
pleased that the National Patient Safety Foundation (NPSF)
(which shares the AMA's goals to improve patient safety) was
invited to discuss its efforts and provide information that
contributed to the report. Thus, the AMA welcomes the IOM
recommendation for a system-wide approach to reducing medical
errors in which punitive efforts are rejected and instead,
efforts to create a culture of safety are recommended.
Health Services Research for Patient Safety
The AMA has been a pioneer in the effort to reduce health
care system errors and ensure that our patients receive safe,
quality health care. For example, in 1996, the American
Association for the Advancement of Science, JCAHO, and the AMA
joined with the Annenberg Center for Health Sciences to convene
the first multidisciplinary conference on errors in health
care. The outcome includes several initiatives in patient
safety that are being undertaken at the state and national
level, such as preventing patient injuries due to medication
errors.
Given the importance for this agenda and the imperative for
physician leadership, the AMA established in 1997 the National
Patient Safety Foundation (NPSF), a broad-based partnership of
health care clinicians, consumer advocates, health product
manufacturers, public and private employers and payers,
researchers, regulators, and policymakers. The NPSF is an
independent not-for-profit organization that now serves as the
forum for a diverse group of concerned individuals to think and
talk about the issues and impediments to patient safety.
The initiatives undertaken by the NPSF are similar to those
recommended in the IOM Report. For example, the NPSF has
convened a group of national authorities concerned with
reducing medication errors. This group has identified 41
challenges for improvement and is now in an implementation
phase. Also, the NPSF has developed an agenda for research that
seeks to identify the core issues that should be targeted by
the broader research community, and has awarded eight research
grants to advance patient safety. Further, with the support of
the AHRQ, the NPSF is cataloging patient safety research
projects that will document the extent of patient safety
research as well as identify gaps in existing knowledge.
Congress can further assist with these private sector
efforts to reduce health system errors and adverse outcomes by
providing funding to private sector organizations to analyze
available data on errors, deaths, and other adverse outcomes.
This will help identify their root causes and potential
solutions.
Although the IOM has recommended a nationwide mandatory
reporting system for deaths or serious adverse outcomes, we
fail to see any linkage between the mandatory reporting systems
established to date and real improvements in patient safety and
quality of care. The IOM Report states, for example, that at
least one-third of states already have adverse event reporting
systems, and the IOM interviewed 13 of these states. However,
there is no data to indicate that patients accessing the health
care systems of states with mandatory reporting systems are any
safer than those in states without reporting systems. Indeed,
the IOM Report makes no such claim.
The AMA strongly supports the IOM recommendation for
Congress to provide the funds and technical support necessary
to analyze the information obtained from current error
reporting systems and conduct follow-up action as needed. A
focus group that the IOM conducted with 20 states identified a
clear need for resources, tools, methods, and protocols to
allow them to constructively address this issue. In addition to
the states and the FDA, private sector organizations such as
JCAHO, NCQA, U.S, Pharmacopeia, as well as private health
insurance companies, have a wealth of data that has yet to be
mined for information that could be used to improve patient
safety.
The IOM Report does not describe how a nationwide mandatory
reporting system--or even the state reporting systems that are
in place right now--would lead to elimination of errors and
improvements in patient safety and quality. The appropriate way
to target the nation's scarce resources to improvements in
health system safety is to fund research in the private sector
to determine how best to utilize data to improve quality of
care. What data elements are useful? How should these data be
analyzed, tabulated, and evaluated to identify root causes,
system problems, and safety problems? How can they be used to
identify solutions and prevent future errors? How can such
information be integrated into educational curriculums,
practice guidelines, accreditation programs, and performance
measurement? These are some of the questions upon which we must
focus.
As the IOM Report notes, the sheer volume of reports to a
system does not determine the success of that system. To the
contrary, obtaining data on all deaths or adverse outcomes in a
national mandatory reporting system would represent an
unnecessary and inefficient allocation of resources. Programs
that collect larger numbers of error reports are unlikely to
yield much new information beyond what can be learned from a
comprehensive analysis of a limited sample of error reports.
To date, the approaches that have been most successful in
health services research provide government funding for
targeted studies and demonstration projects conducted in the
private sector or with private sector partners. Extramural
research programs such as the Multipurpose Arthritis and
Muskuloskeletal Disease Centers funded by the National
Institutes of Health, the Veterans Administration's Health
Services Research and Development Field Programs, and the
Evidence-based Practice Centers (EPC) funded by the AHRQ are
excellent examples. Similar extramural research centers could
be established with AHRQ grants to focus on research in patient
safety. As an alternative to establishing a Center for Patient
Safety within the AHRQ, the EPC model could be used with AHRQ
administering a program of grants for research and pilot
projects to be conducted in several different patient safety
centers. The nation's leading health systems, for example,
could be funded to establish their own internal reporting
systems and conduct research on patient safety problems and
solutions using their own data. In addition, the activities of
non-profit organizations, such as the NPSF, could be advanced
considerably with new government funding.
Conclusion
The AMA believes that true reform must include all
components of the health care system and not focus only on
individual components. Hospitals, physicians, nurses,
pharmacists, drug and device manufacturers, nursing homes, and
others must all work together and be encouraged to work
together to identify, study, and solve system-wide problems
that could cause errors or adverse outcomes. Our common goal
must be to detect errors and system barriers to make
corrections before a patient is harmed.
Simply adding more regulation and more mandates are not the
answer to improve patient safety and quality. The AMA strongly
urges Congress to advance with the same caution and
deliberation as the medical community in its efforts to create
a culture of safety for patients in all health care settings.
Congress must understand the efforts already being implemented
in both the public and private health care delivery systems
before passing legislation. When and if legislation is enacted,
we must all be certain that it will support and enhance the
initiatives already underway, and not set back these efforts.
As stated in the IOM Report, a system must be designed to
detect, prevent, and minimize health care system hazards to
reduce errors. This can be achieved best by first acknowledging
that the vast majority of health care system errors are not
intentional and must be distinguished from truly negligent
behavior. The focus must remain on reforming the system, not
punishing the individual. We must collectively focus our
efforts on identifying solutions that benefit patients.
Nationwide dissemination of the identified solutions would
do a great deal more to improve the safety of the nation's
health care system than would a nationwide mandatory reporting
system. As it has done with dissemination of practice
guidelines, Congress should direct the AHQR to disseminate
current information on patient safety and prevention of adverse
events, and provide grants to research currently available
data.
The AMA is committed to continuing and redoubling our
efforts to work with Congress and our partners in the medical
care system to achieve a health system in which patients are
assured of safe, quality health care. We appreciate having the
opportunity to be here today to support the IOM's efforts to
reduce health system errors. Thank you.
Mr. Thomas. Thank you, Doctor, and I am sure your
handwriting is legible as well.
[Laughter.]
Mr. Thomas. We are going to recess until 12:15.
[Recess.]
Mr. McCrery. [presiding] The committee will come to order.
Mr. Thomas has been unavoidably detained for a few minutes and
he has asked me to reconvene the hearing, which I am pleased to
do.
Dr. Reardon, let me begin with you, if I may. As you know,
I am very interested in this topic of liability. The AMA and
members of Congress have talked for years about the liability
system in this country and the flaws in the liability system,
and we have tried mightily to correct some of those flaws
through medical malpractice reform here at the national level,
but not successfully. So we have depended on the States to go
forward, and many have, with very reasonable reforms to their
medical liability systems.
I noticed in your testimony that you talked about the
failure or the culture of blame and punishment. You were
speaking a little fast, which we appreciated, but it sounded as
if you were saying that this culture of blame and punishment
was producing bad results. That it inhibited the discovery of
errors, omissions, that could be corrected or addressed. Was
that the implication of those remarks?
Dr. Reardon. Yes, it was. Let me expand, if I may, just a
moment. I think what I was talking about is that we need to
change to a system of openness where we have open discussions
and feel free that the information is not going to be
discoverable, for instance, for medical malpractice.
For instance, I made a statement that we do have a system
of accountability which is the court system, and if there is a
medical error for instance and there is a lawsuit on one side,
at the same time we need to be able to have an open discussion
and what went on with that medical error, what happened, why it
happened, and what we can put into place so it will not happen
again. Those discussions we would like to see protected. They
could be peer review discussions of a medical error. But we
would like to have those confidential and protected so that
they could not be discovered and used against the physician in
a lawsuit.
We think if we do not have that, as was pointed out I think
for the anesthesiologists when they first started their system,
they sometimes put off the discussion of the medical error for
three or four years until the suit was settled. I think you
lose an opportunity there to talk about it when it is immediate
and fresh and the information is fresh in everybody's mind and
you can, I think, do a much better job.
Mr. McCrery. Does the liability system itself and this
culture of fear or blame and punishment account at all for the
fact that very few doctors around the country have been brought
up before voluntary licensing groups around the country? I have
got some data here that says that in a typical year the number
of physicians who are brought before State boards of medicine
is less than 5,000 around the country. Whereas, the report that
we got recently from the IOM estimates that between 44,000 and
98,000 patients die a year from medical errors. I know that it
not all doctors, but there does seem to be a disparity there.
Is that culture of blame and punishment and the liability
system partly to blame for the lack of enforcement in your
licensing boards?
Dr. Reardon. I think there are two issues here. First of
all, many of the medical errors we are talking about are system
errors, oftentimes not attributable to any particular
individual but a fault in the system. The other issue I think,
Congressman, is that a malpractice suit does not mean you are a
bad doctor. You can provide the best care, do the best that you
can and have an adverse outcome. So that the best doctors can
get sued over the course of a lifetime.
So this does not ordinarily come to the attention of a
State licensing board unless there are a series of errors on an
individual doctor, and then a licensing board may feel inclined
to step in and review that particular physician. So I think
there are two different issues there.
Mr. McCrery. Yes, they are two different issues but why--
let me just ask you. Why are there so few doctors brought
before licensing boards for discipline? I mean, I am concluding
that it is few. It seems to me to be a few. Maybe you disagree
and you can explain why. But it seems to me to be a few in
comparison to the number of physicians we have and the number
of instances of medical delivery.
Dr. Reardon. I think the most common reason a physician is
brought up before the licensing board is substance abuse,
either alcohol or drugs. Probably the other issues can be
sexual involvement with patients, sexual abuse, if there is a
pattern of egregious medical practices, and those issues do
come up. Now I think it also depends on the individual State. I
come from the State of Oregon, which I think we have a very
active board. There are probably 80 to 100 physicians on
probation at any one time, being monitored by the State board.
But also the State board of medical examiners are limited
by two things. One is the powers invested in them by the State
legislatures through the medical practice acts; and two, their
funding. So I think those are the two issues that we look at,
as we have criticism of boards and some boards are more active
than others, they have some limitations based on what the
legislature invests.
I cannot really comment whether 5,000 is a lot or not a
lot, but I can tell you what the most common investigations
are.
Mr. McCrery. If in fact most of the investigations are not
related to the delivery of health care but rather with personal
problems with the physician, that underscores to me the need to
at least question whether the licensing procedures and the
disciplinary procedures that are in place are effective.
Again, I want to try to relate it to this culture of blame
and punishment. Is it in fact part of the culture among
physicians not to expose fellow physicians that they know may
be guilty of errors, omissions in their practice because they
do not want someone to put the finger on them in this liability
system that we have for fear of being punished?
Dr. Reardon. I can only comment on my own experience, and
that is that I think it behooves all of us if we see a pattern
with a physician of aberrant practice, of poor quality, to
report that, and I think that is reported from time to time.
But the fact of a medical error does not mean that he is a bad
physician. We are taught in medical school to try and be
perfect, to do everything right. And yet, because it is a
complex system, patients are not--are different. You sometimes
treat the same condition differently in different patients. So
there is a lot of variation in that care.
But an adverse outcome or a malpractice suit does not mean
that is a bad doctor. I think there needs to be a pattern of
behavior.
Mr. McCrery. I agree, and I certainly do not mean to imply
that every doctor who is guilty of some error or omission is a
bad doctor. We all make mistakes, and unfortunately doctors are
human too and they do make mistakes. But again, I think that we
need to examine all the systems that we have put in place to
try to exact quality care and reexamine those in light of the
data that has come to light in the last few months. Certainly
the disciplinary procedures that are in place are one of those
systems that we need to look at.
I am a lawyer. We have the same kind of similar
disciplinary boards and so forth as the medical profession and
ours probably does not work very well either, to tell you the
truth. So maybe we should take a look at that, among other
systems that we have in place.
Now our chairman is back, and I am pleased to turn it back
over to the chairman since I have to go to another function
across the way. Mr. Chairman, I am going to return it to you.
And before that, Mr. Stark, are you prepared to inquire of the
witnesses?
Mr. Stark. I am not really prepared, but I am ready.
[Laughter.]
Mr. Stark. I guess I would ask both Dr. Langberg and Dr.
Reardon, my sense is that you both--I do not know whether you
object to running a reporting system and improvement system
through the PROs (Peer Review Organizations) or prefer to do it
through the AMA or the AHA. But I think that is a basic theme
that I am getting, that somehow you want to do it yourself--I
mean, the organizations you represent--and not do it through an
independent agency.
But I think both of your constituencies have worked with
PROs for 18, 20 years now, and the information I think is
confidential, and I think the incentives are right. The AMA
does not have half the doctors in the country. The AHA probably
has all the hospitals or 90 percent of them. So if the AMA does
it, we are not dealing with half the doctors, and that seems
ineffective. The AHA would be investigating the people who pay
their salaries, and that does not seem very productive.
So what would be wrong with having the PROs run a system of
supervising and setting up error reduction plans and dealing
with it? Dr. Langberg? Dr. Reardon?
Dr. Langberg. I think the fundamental question to any
reporting system is what is the purpose of reporting and--
Mr. Stark. We have talked about that this morning. We are
all trying to reduce errors.
Dr. Langberg. And in that light, the question is whether
reporting to a PRO and having the PRO be responsible for
improving errors within hospitals is the best way to get errors
to be reduced. Working to improve care at my facility and
watching the way in which people come together to address
difficult, complex clinical circumstances and move forward.
Mr. Stark. Doctor, you are missing the point. Cedars has a
good plan. Let us stipulate to that. But there are some
hospitals--the San Leandro Hospital that is owned by Columbia
in San Leandro, California is not worth poop. They do not have
a good plan. Now how are we going to get them to have as good a
plan as you have? And what is wrong with having PROs say,
``look, you have got to have a plan''? Then go ahead and let
them review and report back. That is what I am getting at.
I mean, what you are talking about is the plan in your
hospital. Let us stipulate that that is excellent. Now how do
we get the--you are suggesting the AHA is going to get other
hospitals to do it? Well, I do not know. I think that the PRO
groups would do it more efficiently and not be captive to the
people who pay their salaries, which is the problem with the
AHA.
Dr. Langberg. I thank you for the stipulation about the
quality of my institution's program. What I want to try to
describe is that in our experience and in the hospitals'
experience generally there already exists organizations to whom
we report in one form or another our programs and plans to
improve care around these kinds of issues.
As you know, Congressman Stark, in California the
accreditation process for hospitals involves a tripartite
review of the California Medical Association, the State
Department of Health, and the Joint Commission. They do a very
thorough review not only of our outcomes, but of our internal
processes and systems which identify and improve errors.
Having recently gone through that experience in the last
six months, it is a highly detailed, exhaustive experience. Our
obligation is to respond to recommendations and improve any
deficits that were found by that review within specific
timeframes we face financial consequences if the recommended
improvements aren't implemented and adhered to.
So I guess the response I am making is, firstly, that I
believe there already are in place organizations that can be
engaged to assist hospitals in developing those programs if
they do not already exist.
Secondly, if I can make a couple comments about PROs. I
agree with all the comments you made regarding our experience
with them. My colleague, Dr. Golden, will be testifying later.
I have a great deal of respect for the PRO. However, the PROs
are generally viewed by practitioners as governmental agencies.
I know they are technically not, but they are viewed as
governmental agencies.
Mr. Stark. Okay, that answers that. Let us try this,
Doctor. We have had 500 reports of workers mixing up two
similar sounding medications, and before you get around to
saying it it becomes obvious, we need to label it.
Each year we have 800,000 accidental needle sticks to
health workers, some of which lead to death from AIDS and
hepatitis. So it would seem that we need to reengineer needles
for the safety of the workers, and in California, which you
mentioned--I happen to be from there--we have legislated that
that be necessary. Yet the AHA is still resisting doing that
nationwide. Tell me how you are helping us there.
Dr. Langberg. The AHA is working with OSHA--
Mr. Stark. No, they are resisting it, not working with. Let
us get that straight.
Dr. Langberg. As I understand it, the AHA is at least in
dialogue with OSHA about ways in which to look at this
nationwide. I hesitate to go back to my own experience in my
hospital, however, at this point needles will not go away, and
sharp things will not go away. I do not mean--
Mr. Stark. Okay, Doctor, thank you.
Dr. Reardon, what does the AMA say about working with PROs
to accomplish some kind of review and collection of data and a
system for helping to reduce errors?
Dr. Reardon. Mr. Stark, I think in my testimony I mentioned
that we were supportive of the Agency for Health Research and
Quality as being an agency potentially for doing that, with
patient safety centers across the country for gathering data.
Quite frankly, the answer I think from the physicians' point of
view is that PROs, which are under HCFA, I think, are looked at
by many as governmental and somewhat punitive in the past, and
this I think would bother the physician community that they
have been punitive. We would like to do this as an open
process, to change the culture to one of safety away from
punitive and punishment.
Mr. Stark. Can you give me an example of punitive actions
that PROs have taken against physicians?
Dr. Reardon. I am not sure I can give you--I can give you
in general terms----
Mr. Stark. No, no, I would challenge that.
Dr. Reardon. I cannot give you a specific example, I am
sorry.
Mr. Stark. I think what you are both saying then is, you
have both said you do not want Government to do this, you want
to do it yourselves basically, or through some voluntary
means--which is what we have had for the past 20 years or more
and you have not done it. The docs have resisted, the AMA has
resisted recertification. The hospital association has resisted
safe needle requirements.
The indication is that the professional organizations are
not willing to really do much on their own unless there is some
requirement. Now I would be perfectly willing to let the courts
do it, but then you want to be absolved from any chance that
anybody will sue you.
So in the absence of anybody being able to sue you, and the
absence of anybody being able to require you to do it except
the guys paying their dues where you are all in the same club,
I am just a little worried that it will not get done without a
little more incentive. It does not have to be Government, as
long as it is independent. It is my understanding the PROs are
independent. We happen to pay them.
But the problem with JCAHO, which is a lousy organization,
is that you guys pay them in the hospital community, so they
cave in to you. And about every five years we have to threaten
to fire them, and then they get tough and go look at some
hospitals. But the rest of the time they just go out and have
lunch with the hospital administrators and do not do poop.
Well, we are back to the same-old, same-old, Mr. Chairman.
I mean, if we do not have laws, then I do not think we will get
anything done. But these guys do. Thank you, gentlemen.
Chairman Thomas [presiding]. Thank the gentleman.
Someone who has highlighted particular areas in medicine in
a rather dramatic way is a doctor who also happens to be a
fairly successful author by the name of Robin Cook. He has a
penchant for one-word titles: Fever, Brain, Toxin. I read one
called Coma, which was I guess, for wont of a better word, a
diatribe against managed care, and that there was in essence at
this one hospital a criminal conspiracy to kill people. You can
imagine my reaction after having read that novel and looking at
the IOM report, that those people who were consciously doing it
are pikers.
Now I anxiously await a novel by Robin Cook, and I would
even be so bold as to suggest a title: Oops. But I do not think
he is going to write one, because I think when you have a
centristic view of the universe and that all planets orbit
around you, it is extremely difficult to address the fact that
problems may, in fact a majority of problems may initiate with
you. Part of the gentleman from California's frustration is the
fact that if we are going to do something in this area, the
same-old, same-old is probably not going to be acceptable.
Now I am willing to go along with you, and I would like to
ask you a series of questions so that you can increase my
comfort level that what you are advocating will in fact produce
results. Dr. Langberg, in your testimony in fact you said that
the American Hospital Association is working with several
organizations--I think it was three, as a matter of fact--to
help improve patient safety and reduce medical errors. Have you
got any specific data to show that medical errors have been
reduced?
Dr. Langberg. The AHA's partnership with the Institute for
Safe Medication Practices was announced in December, so I do
not have any information in the last six weeks.
Chairman Thomas. Do you know when we might get some
evidence that the structure that you have initiated that you
wish us to allow to self-nurture will produce changed behavior;
i.e., fewer medical errors?
Dr. Langberg. I can, Mr. Chairman, give you the timeframe
for the program the AHA has created afterwards.
Chairman Thomas. Okay. And you oppose mandatory reporting?
Or are there conditions under which you would accept mandatory
reporting?
Dr. Langberg. Keeping in mind that the purpose of reporting
is to improve care, I know from my own direct experience that
virtually every meeting of physicians and other caregivers,
every peer review meeting, every root cause analysis meeting
generally starts off with a discussion about confidentiality,
non-disclosability. In California we have an evidence code that
goes by the number 1157 that allows for peer review to take
place without fear of civil litigation, and that has been an
extraordinary aid to open up discussions in our institution.
My fear about mandatory reporting is along the lines of
chilling what in my experience has been dramatically productive
discussions among colleagues, inclusive but not only with
physicians, as we try to improve things.
Chairman Thomas. You mentioned California, and obviously
Cedars-Sinai is in California, and California has a mandatory
reporting law on particular events. I am reading from the back
of the IOM book which is invaluable to give me a State by State
analysis. Do you believe that the mandatory reporting structure
in California has had an ongoing chilling effect in the
collection of data and the correction of medical errors since
it has been in place since like 1972?
Dr. Langberg. No, I do not believe it has had a chilling
effect.
Mr. Thomas. So if we use a model kind of like California
has then it would be okay?
Dr. Langberg. I think the practice in California and the
kind of things that have to be reported, to the best of my
recollection, tend to be move of catastrophic in nature,
epidemic kinds of issues that may be occurring in a hospital,
in contrast to the output of individual peer review root cause
analysis looking at what may have gone wrong or close calls in
a given case.
Chairman Thomas. It has as a list of reportable events,
disappearance or loss of a patient. I assume that means not
having them expire, but you simply lose track of them. So lost
patients are critical to this reporting structure, but not
patients who have been terminated by medical errors. Do you
know of the California law and why maybe it would not include
that as a reportable event? And would you then be adamantly
opposed to the California law if it were amended to include
that kind of an item as a reportable event?
Dr. Langberg. I confess ignorance on the legislative intent
of the California law, having been in place as you point out
for a couple decades. The question of reporting a death due to
medical error is obviously a complex one, and my earlier
comments went back to the effect of having to report, and what
in which settings that would hamper our ability to surface
concerns about a case and the detailed analysis required to get
the answers.
Again from my direct experience, Mr. Chairman, the
causality in any case of unexpected outcome is always complex.
I have yet to be involved in an analysis of a case----
Chairman. Thomas. As is the case of an airplane crash. As
is the case in many other instances. Let me try to explain the
situation we are in. I am trying to let you make your case. I
want to turn to the gentleman from California on my left and
say, I have a high comfort level that your push to get a
mandatory structure is not one that I can support, and you guys
have got to help me.
The question is this, if we could show that mandatory
reporting reduced deaths due to medical errors, is not the
ultimate thing to make sure that people do not die through
medical errors? And if a mandatory structure could show that
would you be in favor of a mandatory structure? Or are you just
philosophically opposed to the idea of mandatory? That is what
I am trying to understand here.
Dr. Langberg. For me it is not a matter of philosophy. For
me it is a matter of direct experience with people going
through this.
Chairman Thomas. So I cannot create a comfort zone, change
the liability laws, utilize that FAA total confidentiality
structure? I have got a clean sheet of paper. What is it that
you believe you need in place to have a minimal comfort level
with a mandatory reporting system? Is there no list that we can
write that would create a comfort level for you on a mandatory
reporting system?
Dr. Langberg. Given the context of a mandatory reporting
system----
Chairman Thomas. No, we write the context.
Dr. Langberg. Right. No, given the question, which is given
a mandatory reporting system, what would be required to make me
more comfortable with that. That is the question.
Chairman Thomas. Make you minimally acceptable of it.
Dr. Langberg. Right. Even though, as I know you know
already, our position is to support a voluntary system. But in
the context of a mandatory system, our biggest, first concern
would have to be on the protections of peer review and its
discoverability, disclosability in any kind of public and legal
setting.
The ability to extend what are perhaps best practices in
States and other locations that provide confidentiality
protections resulting in full dialogue. These kinds of things I
think ought to be identified and perhaps replicated on a
national basis. They exist already in some locations. So that
would be the first issue that I would want to put before you.
Chairman Thomas. If we could come to an agreement over the
next month on that, Dr. Reardon, if the conference on patient
protection had not concluded and we were able to present that
as an additional item, which after all on patient protection if
you are going to reduce the number of patients that are being
killed that would seem to be a useful location and a very
timely vehicle. Would the American Medical Association consider
that a poison pill?
Dr. Reardon. Mandatory reporting are you asking me, Mr.
Chairman?
Chairman Thomas. No, all of the criteria that you folks
write that you need to have acceptable mandatory reporting. Or
better yet, your vision of voluntary reporting. If we offered
that in the conference so that it could move through the House
and the Senate expeditiously and be put in place, because I am
quite sure the President would not veto something that would
reduce medical errors and therefore accidental deaths; would
that be a poison pill to you?
Dr. Reardon. May I respond, Mr. Chairman, about my concerns
about mandatory reporting?
Chairman Thomas. No, I asked voluntary. We will do
voluntary.
Dr. Reardon. We would certainly be willing to look at a
voluntary system and work with you on that.
Chairman Thomas. Do you know how high a comfort level that
is? Zero. You write it and give it to me, and then I put it in.
Would you call that a poison pill in the patient protection
bill?
Dr. Reardon. I am sorry, sir, you are asking me that we
would write it and give it to you?
Chairman Thomas. Sure. I will put in what you write. Would
that be a poison pill?
Dr. Reardon. I would not look at that as a poison pill, no.
Chairman Thomas. You would not.
Dr. Reardon. No.
Chairman Thomas. Okay, that is a starting point. Now we
will work on it.
Dr. Langberg, in your testimony you briefly mention JCAHO,
the Joint Commission on the Accreditation of Hospitals. The
commission has an external sentinel event reporting system in
which hospitals participate. I believe that was started in
1996. Was there general acceptance and willingness to go with
that system when it was first put in place or did hospitals
resist it?
Dr. Langberg. There are two components to the sentinel
event system and I actually would like to go on record as
acknowledging the Joint Commission for coming up with this, and
Dr. O'Leary personally for his role in advocating this.
Chairman Thomas. And that was the basic position of
virtually all hospitals, going on record, thanking, supporting,
and willing to go forward?
Dr. Langberg. I do not know what the former positions were
in previous testimony. The two components had to do with the
creation of a sentinel event system. The second component had
to do with the reporting of the outcome of those systems.
In my institution we have taken that direction to heart and
have created, I think, an outstanding sentinel event--we call
it significant adverse event system that tries to capture what
might be sentinel events as defined by the Joint Commission as
well as near misses, and encouraging all kinds of people in the
institution from volunteers, nurses, transporters, to
physicians, and administrators, to report anything they might
see through a process that leads to a rapid root cause analysis
and an identification of problems and attempts to fix them.
That has been a great boon to our process to improve care.
The question of reporting got a lot of evaluation at the
hospital level, and from my recollection there were two primary
considerations. The first consideration was that the
protections under our State's non-disclosability law would only
be valid if the discussions were taking place between
designated peer review bodies within the State. So going to an
out-of-State reporting peer review, according to legal
evaluation, punch holes through the very protection in peer
review that we were hoping to maintain.
The second issue had to do with issues around liability and
malpractice considerations, if again this information was
reported out of State. Those two considerations, not the
reporting concept but the concept of chilling the atmosphere
where the good work was in fact able to be done, was what the
general objections were about.
Chairman Thomas. I will just tell you that my guess is that
there is probably not a comfort level that the only response
that we would make would be three five-year demonstration
projects under HCFA as our only response to this problem. There
will be a contest as to the question of mandatory versus
voluntary, and I believe you people will have a significant
role to play in whether or not someone such as myself look
seriously at mandatory reporting.
To the degree you are forthcoming, to the degree we
actually set up a structure which does what we believe needs to
be done, to the degree you minimize the arguments which I
believe to have less merit than you attempt to present, since
time I think they do not have merit, then we can try to put a
fairly hefty voluntary structure. I still do not know that
there may not need to be some mandatory.
I will tell you that there is no question in my mind that
there has to be an absolute guarantee of the privileged nature
of the information, the confidentiality. And I am more than
willing, since I have tried to offer six times in the past and
I did on this bill which the AMA called medical malpractice
reform a poison pill on the patient protection legislation, an
opportunity to change the liability question.
But somewhere in this matrix, looking a bit at the VA
because they do, I believe, have a liability issue and I want
to talk to them about that. Looking at what has occurred in
aviation, notwithstanding all the differences that are involved
in these two areas, there is, in my opinion, something that is
going to be done.
To the degree it is something that you would rather live
with than not live with is basically up to your folks in your
willingness to have positive input in the process. By positive,
that is not to continue a dialogue of great concern, upset by,
unwilling to. Otherwise we will just write it without your
input.
I would value your input in a constructive way in setting
up a procedure which significantly--I would love to say 50
percent in five years--which significantly reduces medical
errors for which I can see no conceivable reason for
continuing. You people are eminent professionals, both in the
institutional area and in the personal practice area. And you
cannot sit here and tell me your professions on their own,
pledging a professional commitment to do no harm, have produced
a significant shift.
If you believe things are better than 10 years ago, show
me. If you believe the things that you have done in the last
three years are showing concrete results and we should wait for
them to show more concrete results, show me.
But if you cannot, then we are going to move. It is
absolutely unacceptable, especially given the beginning of
every statement by every medical person, our pledge is to do no
harm. You are. Through errors and failures to set up a
systematic procedure of examining why things went wrong. We
have got a lot of what. If we do not get to the why we will
never change the what.
I want to thank you very much. I look forward to working
with you. Apparently the conference on patient protection is
going to extend longer than we thought. I have got a nice
little slot available for a number of what I believe to be
appropriate items that we could fit in there and expeditiously
move them to the signature of the President. I would hope that
you would examine your medicine chest and carefully reevaluate,
Dr. Reardon, what you think is or is not a poison pill.
Thank you very much.
The gentleman from California.
Mr. Stark. I just want to say that thus far I think you and
I can work together on this. Whether there will be a conference
to get it into or not is a question. I suppose it depends on
the health of the Democrats at this point.
But I am struck also by the Chair's interest in changing
the way, for instance, the way we reimburse teaching hospitals.
Now I have never heard any complaints from the American
Hospital Association when we spend all that money to help them
run their teaching hospitals. They like Government then, do you
not, Dr. Langberg?
Dr. Langberg. I think the teaching hospitals--
Mr. Stark. It is kind of helpful, is it not?
Dr. Langberg.--appreciate the reimbursement that is given
them.
Chairman Thomas. Like the recent readjustment which gave a
couple of bucks to California, versus New York.
Mr. Stark. They love us when we are paying them money. But
when we suggest that maybe we get quality results and pass a
law, then they do not want Government interfering.
Chairman Thomas. Excuse me. Is the gentleman suggesting
that they are in the human condition?
Mr. Stark. I may be. I just want to remind you that the
next time you come in to ask for money, that you were here
today saying do not get in our way, in terms of passing laws
that would require higher quality. We would just make a note of
that, because we will remind you of that again the next time
the AHA wants to come and ask for help.
Chairman Thomas. Again, thank you and I look forward to
working with you. We do have some opportunities here and I
believe it is incumbent upon us to do what we can as much as we
can, not just in the current framework but moving forward.
Thank you very much.
Now, thanking them for their indulgence, I would like to
ask the last panel to come forward. There obviously was a
reason why we did the panels in the order that we did, because
I was anxious to have some interactive comment from some
individuals who I think are actively involved in trying to make
it happen in reflection of those to whom it is happening to.
Our panel consists of Dr. James P. Bagian, Director,
National Council for Patient Safety, Veterans Health
Administration, U.S. Department of Veteran Affairs; Dr. Kenneth
Kizer, recently from that environment, now President and Chief
Executive Officer, National Quality Forum for Healthcare
Measurement and Reporting; Dr. Dennis S. O'Leary, President on
the Joint Commission on Accreditation of Health Care
Organizations; and Dr. William Golden, President, American
Health Quality Association.
Thank you all. Your written testimony will be made a part
of the record and, in the time that you have, you can address
us in any way you see fit.
Why do we not start with you, Dr. Bagian, and then move
across the panel.
STATEMENT OF JAMES P. BAGIAN, M.D., PE, DIRECTOR, NATIONAL
CENTER FOR PATIENT SAFETY, VETERANS HEALTH ADMINISTRATION, U.S.
DEPARTMENT OF VETERAN AFFAIRS
Dr. Bagian. Thank you, Chairman.
It is a pleasure to have been asked to come here today. You
already have my record, as you mentioned. I will not talk
directly about that, but try to address some of the issues you
brought up earlier in the morning, because I think we have a
number of things we can concretely point to that might be a
source of discussion.
To start out with one thing I would like to point out, and
I know when Ms. Connell was up here she referred to it as well,
about aviation. The problem in aviation was not much different
from medicine 50 years ago. In fact, my father was a fighter
pilot during World War II and stories he would tell me as a
boy, it did not seem much different.
He would talk about in the afternoon, at training command,
you could look around the horizon on any given afternoon and
see a pillar of smoke somewhere from a crash. In fact, if you
look at the statistics during World War II, more planes were
lost in training and non-combat than in combat. That is no
longer the case. It is because aviation looked at it in a
different way. They could not just keep doing the same thing,
they had to do it differently.
I think medicine is at the same point now, too, and that
can refer to the comments that were made before, what has
changed? I think things do need to change.
In the VA, we think reporting is important. The purpose for
reporting, as has been mentioned, is not just to report. I
think you were the ones that mentioned about the qualitative
versus quantitative. Just counting does not do it. If Linda
Connell was here, she would tell you, or Charlie Billings, her
predecessor, that it is not about counting. It is about
identifying vulnerabilities and then what you do about them.
To just know that they are there and do nothing serves no
purpose. It might keep somebody employed, but that is not the
point. The point is what do you do to make it better, and how
do you test that.
Along those lines, the VA looked at this system, and we
have several systems. One of the ones I will talk about is an
internal mandatory reporting system. When we say mandatory, I
think there has been a lot of talk about mandatory and
voluntary----
Chairman Thomas. Dr. Bagian, as a backdrop, and if you are
going to get to it then I apologize, but I have not been able
to research it enough. If you would just give a brief overview,
not necessary to come out of your time, about the legal
difference, if there is any, of a physician or a medical
employee of the VA versus the private sector. Because I do
think you have some kind of a liability shield that we would
have to take into consideration, while you describe your
system, and that we would have to do something in the private
sector if we like some of the things that you were doing. Is
that true?
Dr. Bagian. There is a difference, yes. The difference is,
you might look at ours as enterprise liability. If a physician
or caregiver is acting within their scope of practice, what
they are privileged and supposed to do, then any error or
anything that would result in a malpractice claim, the
Government is responsible. The individual is not financially
responsible.
They still can sue the Government. In fact, there are
pension benefits as well as tort redress they can take. So
while you cannot come against the individual, it is not that
much different. It might play a factor. I do not think it is
the largest role. In fact, I will talk about that, if you will
allow me. That is a good point.
With the mandatory and voluntary reporting, one thing I
would point out is it is not just a difference between
mandatory reporting and voluntary. You also have to look at
what is the purpose, accountability or to learn? And then you
have to look at issues of is it going to be confidential once
it is reported, whether it is mandatory or voluntary, or not?
You could have mandatory systems that are confidential that
you can get reporting to, whereas if it was mandatory and not
confidential, it would be quite different. I think that is
important. It is like a matrix. It is not just mandatory or
voluntary, it is a little bit more complex than that.
With ours, we have a mandatory internal system that we use
and we first started it back in 1997 and we have revised it
most recently at the end of last year, and we have started to
roll out that change beginning in November in VISN 8, our
Network 8 in Florida, South Georgia, Puerto Rico. And we
started last week in Southern California, Nevada. We tried to
learn as we went along, because we are kind of in uncharted
waters, if you will.
One of the things we found was that you have to make it
very clear what people are reporting and why, so there is no
ambiguity about whether they are sticking their head in the
lion's mouth and not knowing. Because if people's perception is
that it is a gotcha game, if they get surprised, they are not
going to come back and talk to you again.
So we made it very clear. The way we made the distinction,
and we did this in conjunction with the Office of Medical
Inspector, with the Office of Health Inspection which is kind
of like our IG, with legal, and with the unions as well, and in
our professional groups. We said look, we think what the whole
point is here if someone reports an event, and I will not go
into definitions of that, but an event and it is not thought to
be the result of an intentionally unsafe act--and we define
that as something that appears to be intentionally unsafe--
substance abuse on the part of the physician, which you heard
about earlier; a criminal act, a frankly criminal act; or
alleged patient abuse, then we think that goes in the safety
system. And then it gets a confidentiality shield, if you will.
We use it internally. We know what we need to do, but it
will not result in individual discipline.
However, if it falls in one of those other categories, the
intentional acts if you will, then it goes the administrative
route where we still want to find out what happened, why did it
happen, how do we prevent it, but we know there is an inkling
there could be discipline required here, that it was not just
stuff happened. And then we take whatever appropriate action is
required.
By doing that, it appears that it has relieved some of the
anxiety on the part of reporters to report, because they say we
understand that. Everyone came forward and the various groups
said that no one had a problem with intentionally unsafe acts
getting more severe or a blame type of thing. So we have gone
that way.
I know my light is up, may I go on if that is okay, sir?
Chairman Thomas. I used some of your time, so you can keep
going.
Dr. Bagian. Thank you.
When we put ours in place, we realized that the point was
protecting confidentiality, accepting reports from all comers.
Not just physicians, not just nurses. I mean, if a patient
turns a report in, we look at it. It is not like we say oh,
that is not the right status. We look at all information as
good. We do not want to censor it. It is for us to then look at
it and decide what we do.
Then we put a whole system, a very comprehensive system
together, where we put teams together that will investigate
whatever the particular event is and they not only say what
happened, why did it happen, but then they come forward and
also say what is the corrective action? What is the plan for
implementing it? When will you check to make sure it worked?
I mean, we can have great ideas about how to make things
better but without testing them, we do not know that they work.
And then we have one final thing, to have this
accountability piece, if you will, that the facility director
has to concur on not concur at each individual corrective
action. If they non-concur, and they may. There may be a
suggestion that is fiscally not possible or there are a number
of things, they might have to make a risk-benefit analysis and
then might say no, I do not think that is the right thing to
do, we will do this. There has to be final concurrence before
it is signed off.
But that is part of the official record. It does not get
buried somewhere. It is not like a year from now we wonder how
did that happen? We know how it happened. We think that is
important. It keeps it all in the bright light of day, people
know how it happened, it is not like it is some secret thing,
we do that. And we concentrate on system solutions.
Another thing I will point out is, and it was mentioned I
think by Mr. Stark and yourself in the last panel, is some of
the tools we have had in the past in medicine, they have been
available to others and that we just did not know were there or
maybe were not generally appreciated. There are things about
human factors, about things you have to look at. It is not
enough to tell somebody, with the look-alike medications, to
tell them to be more careful.
I cannot tell you how many reports we have seen
historically that say ``tell the nurse to be more careful.'' So
does that mean they were not careful before? Oh, be careful,
this is a new policy. Well no, that does not work. You have to
do something different in systems.
One of those things, when you mentioned about the rental
car thing earlier today, actually in 1994 one of the nurses at
Topeka came back from being on a trip and she says how come--
just what you said--they have this thing where a guy has a
computer on his leg or whatever, and he does this.
They actually went ahead and developed a prototype of bar
code reading and everything else, which we are now in the
process of rolling out. And they showed in their studies that
they reduced medication administration error by about 67
percent through using that. And now the VA is in the process of
rolling that out nationwide in all of our facilities, and every
one of our facilities should have that in place by June of this
year, if not before.
So we absolutely agree that there are uses for technology
to design the system to make it harder to make an error. You
want to recognize that people can make errors, people are
people, and make them fault tolerant.
From my previous life as an astronaut, we talked about
fault tolerance all the time. We knew that errors can occur,
whether it is equipment failures or personal failures. So you
kind of have belt and suspenders. You do not just go out single
string and take your chances.
We think medicine has to think more proactively about that,
and we think we are doing that.
We have a number of other things. You mentioned about the
black box. We actually have a medical simulator. In fact, at
Palo Alto, Dr. Dave Gava is one of the pioneers in this area.
We have a full operating room simulator with a mannequin that
does everything like a real person. It changes the kind of gas
it expires, CO2, O2 and the anesthetic agent. You actually can
put a regular blood pressure cuff on its arm and you can change
the blood pressure or anything you want. We run very
sophisticated simulations to train people. We video them and
use them for training.
It helps not only in the evaluative process, but also as a
learning process. And the interaction, somebody talked about
the arrogance and why people do not work in teams. Many of the
exercises are set up just to demonstrate that. That if you do
not all get along together and realize that the OR tech might
have the key, and not just the surgeon, that you are missing
the boat. You are not using your people correctly.
Aviation realized that, in the mid-1980s, and instituted it
on a widespread basis. We are doing the same thing. In fact, at
the center in Palo Alto, people come from around the country
and the world, literally, to come train and learn how to do it.
We are very aggressive in that area.
You talk about other changes, KCL, potassium chloride was a
problem. We realized it was a systems thing. I was heartened by
what you said earlier about even if it is 40 or 50 deaths a
year, that is too many. We agree. We do not think you have to
count the numbers. We know we do not want to have a death. And
if we identify a vulnerability and see a systems way, or any
way, to correct it then we want to do it. We do not say oh, let
us wait until we have 50 more deaths and then it is time. We do
not need to do that.
We did not do that with KCL, and we took that off the
shelves. Dr. Kizer can say for sure, I think it was in the
middle of 1998 we put out the--it was before I joined the VA.
It was put out as a directive that KCL would not be kept in a
concentrated manner on the floor, to take away this thing about
telling the nurses to be careful. That old practice was
foolish. That is not the way to do it.
So anyway, that is just the highlights of some of the
things we have done, and I would be happy to entertain
questions.
[The prepared statement follows:]
Statement of James P. Bagian, M.D., PE, Director, National Center for
Patient Safety, Veterans Health Administration, U.S. Department of
Veterans Affairs
Mr. Chairman and Members of the Committee,
I am pleased to appear before you to discuss VA's ongoing
activities and initiatives to ensure the safety of patients who
receive care from VA. In December 1999, the Institute of
Medicine (IOM) released a report ``To Err is Human: Building a
Safer Health System.'' The report reviewed existing studies and
concluded that as many as 98,000 preventable deaths occur each
year in United States' healthcare due to error. The IOM
recommended creating a new National Center for Patient Safety
that would focus on research and policy related to errors in
healthcare, improved error reporting systems, improved
analysis/feedback methods, performance standards for healthcare
organizations and individuals, and other specific governmental
actions. Importantly, they cautioned that the focus must be on
creating a culture of safety that will require improving
systems, not assigning blame.
VA interpreted the IOM report as a validation of our
commitment to improving patient safety in our healthcare
system. All of the IOM recommendations applicable to VA have
either been in place or were in the process of being
implemented prior to the release of the report. While VA has
had quality and safety related activities ongoing for many
years, it was in 1997 that our formal patient safety program
was launched (see Attachment 1). Leaders in the field of
patient safety and medical error outside VA have participated
in the design of our system and recognize VA as a pioneer in
these efforts.
During 1997, VA intensified its already extensive efforts
in quality improvement by launching a major initiative on
patient safety. We recognized that programs to improve quality
and safety in healthcare often share purpose and corrective
actions. However, we believed that patient safety required a
new and different approach. We set out to create a new culture
of safety in which our employees detect and tell us about
unsafe situations and systems as part of their daily work. Once
we know about unsafe situations and systems, we are committed
to design and implement new systems and processes that diminish
the chance of error.
Highlights of Patient Safety Activities at VA: 1997-Present
VA recognized that patient safety is not a VA-specific
issue, therefore we asked other health care organizations to
join us in an effort to understand the issues and to act for
patient safety. As a result, the National Patient Safety
Partnership (NPSP), a public-private consortium of
organizations with a shared interest and commitment to patient
safety improvement, was formed in 1997. The charter members, in
addition to VA, included the American Medical Association, the
American Hospital Association, the American Nurses Association,
the Joint Commission on Accreditation of Healthcare
Organizations, the Association of American Medical Colleges,
the Institute for Healthcare Improvement, and the National
Patient Safety Foundation at the AMA. Five additional
organizations have subsequently joined the charter members in
the Partnership: the Department of Defense--Health Affairs,
National Institute for Occupational Safety and Health, the Food
and Drug Administration, Agency for Healthcare Quality and
Research, and the Health Care Financing Administration. This
group addresses high impact issues that are of importance to a
broad cross section of the healthcare industry. An example of
the Partnerships activity was the establishment of a
clearinghouse for information related to the effect of Y2K
computer issues on medical devices. The NPSP also called public
and industry attention to Preventable Adverse Drug Events and
promulgated simple actions that patients, providers, purchasers
and organizations could take to minimize their chance of an
adverse drug event. (See Attachment 2) The partnership serves
as a model of what a private-public collaboration can do to
improve patient safety.
In 1998, VA created the National Center for Patient Safety
(NCPS) to lead and integrate the patient safety efforts for VA.
As the IOM report advises, VA created this center as a
commitment to patient safety as a corporate priority with a
direct reporting relationship to the Under Secretary for
Health. The NCPS employs human factors engineering and safety
system approaches in its activities. The first task for the
Center was to devise systems to capture, analyze and fix
weaknesses in our systems that affect patient safety.
We sought to design reporting systems that would identify
adverse events that might be preventable now or in the future.
In addition, we sought systems to identify and analyze
situations or events that would have resulted in an adverse
event if not for either luck or the quick action of a
healthcare provider--we call such events ``close calls.'' We
believe that ``close calls'' provide the best opportunity to
learn and institute preventive strategies, as they will unmask
most system weaknesses before a patient is injured and avoid
the liability issues implicit in investigation of injury. This
emphasis on ``close calls'' has been employed by organizations
outside of healthcare with great success.
VA consulted with experts (Expert Advisory Panel for
Patient Safety System Design) obtaining advice to enhance the
design of VA's reporting systems. These experts in the safety
field included Dr. Charles Billings, one of the founders of the
Aviation Safety Reporting System, as well as other experts from
NASA and the academic community. They advised us that an ideal
reporting system a) must be non-punitive, voluntary,
confidential and de-identified; b) must make extensive use of
narratives; c) should have interdisciplinary review teams; and
d) most importantly, must focus on identifying vulnerabilities
rather than attempting to define rates of error. VA has used
these principles to design the patient safety reporting systems
we have in use or in development.
Based on the expert advice and on lessons learned from our
first generation mandatory adverse event reporting, the NCPS
has developed a comprehensive adverse event, close call
analysis and corrective action program which includes an end-
to-end handling of event reports. This system not only allows
for the determination of the root causes, but also captures the
corrective actions as well as the concurrence and support of
local management for implementation. The system includes a
number of innovations such as algorithms and computer aided
analysis to determine the root cause of adverse events and
close calls. The Joint Commission on Accreditation of
Healthcare Organizations and the American Hospital Association
are currently evaluating parts of the system for use.
The improved event reporting system is being pilot tested
in VA's VISN 8. Extensive training is used as the new system is
introduced to assure full understanding of the search for the
root cause and redesign of the system. To date, response from
the pilot site is positive. The quality managers and clinicians
using the system believe that the new methods analysis of error
will make a significant difference in the care of veterans.
A complementary, de-identified voluntary reporting system
is in the process of being implemented. It is patterned after
the highly successful Aviation Reporting System that NASA
operates on behalf of the FAA. It will be external to VA and
will allow employees and patients to report unsafe occurrences
without fear of administrative or other action being taken
against them.
Based on lessons learned, VA has promulgated specific
procedures and policies aimed at reducing risk of error. These
include such things as restricting access to concentrated
potassium chloride on patient care units, use of barcode
technology for patient identification and blood transfusions in
operating rooms, and for verification procedures prior to
injection of radio-labeled blood products. (Attachments 3-6)
Based on the observation of a VA nurse when she returned a
rental car, VA developed a system for using wireless bar coding
to improve medication administration. That system was piloted
at the Topeka VA Medical Center and will be in all VA hospitals
by June of this year. At least two-thirds of medication errors
can be prevented with this system.
In 1999, VA established four Patient Safety Centers of
Inquiry. These Centers conduct research on critical patient
safety challenges. Activities at the Centers of Inquiry range
from fall prevention and operating room simulators to
understanding the role of poor communication in patient safety.
The Center in Palo Alto, which is affiliated with Stanford
University, is a recognized leader in the area of simulation
and has been featured prominently in the media. Their simulated
operating room allows surgeons and anesthesiologists to train
and do research without endangering a patient. VA expects to
create additional simulation facilities to train its physicians
and other healthcare professionals. One simulator with
appropriate staff could train about 600 anesthesiologists and
residents-in-training per year. This means that virtually all
VA anesthesiologists/anesthetists can be trained in a year on
clinical situations that could not be simulated safely in
patients. As a result of analyzing common variations during
simulated operations, the center has developed a checklist card
of facts that should be kept close at hand. These checklist
cards will be attached to all anesthesia machines across VA.
VA is partnering with the Institute for Healthcare
Improvement to build learning collaboratives aimed at reducing
medication errors, a major issue identified in the Institute of
Medicine report. IHI collaboratives will affect several hundred
VHA personnel each year. Other IHI collaboratives have resulted
in measurable improvements and similar results are anticipated
with medication errors.
Another key VA strategy to reduce medical errors involves
the development of a new curriculum on safety. VA is moving
forward with plans to provide education and training relevant
to patient safety not only to those already in practice but
also at the medical, nursing, and health professional school
level. This will be the first time an extensive safety
curriculum will be developed and broadly implemented. VA is
particularly well situated to lead the educational effort due
to the extensive role it plays in the education of healthcare
professionals in the United States. (VA is affiliated with 105
medical schools and up to one-half of all physicians train in a
VA facility during medical school or residency.) Additionally,
we have instituted a performance goal and measure to provide VA
employees 20 hours of training on patient safety this year.
VA instituted a Patient Safety Improvement Awards Program
to focus interest on and reward innovations in identifying and
fixing system weaknesses. Not only does this produce ideas for
patient safety improvements that might otherwise go unnoticed
but it further reinforces the importance that VA places on
patient safety activities. (Attachment 7)
In 1995, VA instituted a Performance Measurement System
that uses objective measures of patient outcomes to set goals
and reward achievement. Since 1998, VA has incorporated a
performance goal and measure for its executives for
accomplishment in patient safety activities. Last year, each
network had to implement three patient safety initiatives to be
fully successful and six initiatives to be outstanding.
Other performance goals and measures assess the use of
Clinical Practice Guidelines. By holding entire medical centers
and geographic networks responsible for measured outcomes, we
are able to institute reminder systems and redundancies that
lead to dramatic improvements in performance. For example,
patients who receive medications known as``beta-blockers''
following a heart attack are 43 percent less likely to die in
the subsequent two years and are rehospitalized for heart
ailments 22 percent less often. A goal of providing this
therapy to 80 percent of eligible patients has been set in the
private sector, and recent medical literature reports rates of
use as low as only 21 percent in some settings. In the VA, over
94 percent of heart-attack patients receive this life-saving
medication.
Another example of the power of using systems rather than
relying on individual adherence to clinical guidelines is in
immunization. It is estimated that 50% of elderly Americans and
other high-risk individuals have not received the pneumococcal
pneumonia vaccine despite its demonstrated ability to minimize
death and hospitalization. VA's emphasis on preventive
healthcare has led to achieving pneumonia vaccination rates
that exceed standards set for HMOs by almost 20% and nearly
double published community rates. Similar accomplishments have
been achieved in providing annual influenza vaccinations.
We believe that patient safety can only be achieved by
working towards a ``culture of safety.'' Patient safety
improvement requires a new mindset that recognizes that real
solutions require an understanding of the ``hidden''
opportunities behind the more obvious errors. Unfortunately,
systems thinking is not historically rooted in medicine. On the
contrary, the field of medicine has typically ascribed errors
to individuals and embraced the name-blame-shame-and-train
approach to error reduction. Such an approach by its very
nature forecloses the opportunity to find systems solutions to
problems. Other industries such as aviation have recognized the
failings of this approach and over many years have succeeded in
transitioning from a similar blame and faultfinding approach to
a system-based approach that seeks the root causes of errors.
VA realized how pivotal culture is to improving safety and in
1998, conducted a culture survey of a sample of employees. Of
interest, the shame of making an error was a more powerful
inhibitor of reporting than was fear of punishment. Employees
readily forgave mistakes in others but were intolerant of their
own. We plan to survey culture broadly in VA for several years
to track the progress of our efforts.
VA created a database of adverse events and asked our
Medical Inspector to review it. The report has been widely, yet
often inaccurately, quoted or critiqued in the media. The
database was created to discover common and important adverse
events in order to focus our efforts in patient system
redesign. Commonly, the media assumed that all the adverse
events (and deaths) were due to error. They were not. Neither
the report nor the database cataloged which adverse events were
preventable with today's state of knowledge and therefore could
be characterized as errors. For example, most of the adverse
events were falls, suicides and parasuicidal events (attempted
suicides, suicide gestures), or medication errors. It is not
possible with today's knowledge to operate a national system of
nursing homes and acute-care hospitals treating the elderly and
chronically ill without a number of falls. Yet, we know that it
is important to look for common factors to allow us to reduce
the frequency of falls in the future. Similarly, psychiatrists
have tried unsuccessfully to predict which patients will commit
suicide. By looking at our data we hope to be able to predict
high-risk patients in the future and therefore be able to
prevent suicides. We have already learned that men with a
recent diagnosis of cancer, who live alone and who own a gun,
are more likely to commit suicide. We plan to study the use of
additional interventions in this subgroup of patients at high
risk of suicide.
Conclusion
With no successful models in large healthcare systems to
guide us, VA turned to other high risk, high performance
industries to learn principles for safety. We have borrowed
both methods and people from safety-conscious settings such as
aviation and space travel and from underutilized disciplines
like human factors engineering. These efforts have already
produced significant improvements in VA, and we believe will do
the same in all healthcare settings.
We would prefer that all of healthcare had begun to address
the issue of patient safety long ago. For too long, the
emphasis has been on holding individuals accountable and hoping
that well-intended and well-educated professionals wouldn't
make human mistakes. As the IOM aptly states in the title of
its report: ``To err is human.'' We are pleased to be on the
leading edge as healthcare takes a systems approach to patient
safety. We are anxious to discover new ways to make VA and all
healthcare safer. We appreciate your support of these efforts
and intend to keep you fully informed of our progress.
[Attachments are being retained in the Committee files.]
Mr. Thomas. I appreciate it and we will have some
questions. Dr. Kizer?
STATEMENT OF KENNETH W. KIZER, M.D., M.P.H., PRESIDENT AND
CHIEF EXECUTIVE OFFICER, NATIONAL QUALITY FORUM FOR HEALTH CARE
MEASUREMENT AND REPORTING
Dr. Kizer. Thank you and good afternoon, Mr. Chairman, Mr.
Stark. It is a pleasure to be here. I am Dr. Kenneth W. Kizer.
I am currently the President and CEO of the National Quality
Forum. This is a new private, non-profit organization whose
mission is to improve the quality of U.S. health care by
improving the mechanisms and technology of measuring and
reporting of quality.
I am pleased to appear before you this afternoon to discuss
the urgent need to improve patient safety. I think for too long
the topics of medical error, patient safety and therapeutic
adverse events, if you will, have escaped public scrutiny.
At the outset, I think we should acknowledge, and indeed I
am probably reiterating what has been said before by others
today, that it really should not come as a surprise that health
care has errors. In the latter part of the 20th century health
care has become one of the most complex, if not the most
complex, of all human activities. It involves hundreds or
thousands of interactions among scores of caregivers and myriad
complex technologies that can cause harm as well as help
patients. If there ever were a high risk, high hazard activity,
modern health care certainly qualifies as such.
While it should not be surprising that modern health care
is a high risk, high hazard, and error-prone activity, I think
what is perhaps surprising is that health care has lagged so
far behind other high hazard industries in systematically
implementing risk reduction and error reduction strategies.
In my written testimony, Mr. Chairman, I comment about the
state of health care quality in the U.S. overall. I describe
the genesis and the operation of the National Quality Forum,
which I head. And I outline 10 areas of action which should be
pursued to improve patient safety in the United States. In the
interest of time, I am not going to repeat those things here. I
would like to take the remaining three minutes or so that I
have in these opening comments to stress at least a few of
those points.
Despite the prevalence and the cost of medical errors, most
health care executives, clinicians and consumers have largely
been unaware of the magnitude of the problem, although aware
that errors certainly occur. Many factors account for this lack
of awareness, including especially the systematic
underreporting of such events and the prevailing blame and
punishment culture that discourages reporting and open
discussion of errors, and that has been the focus of
considerable comment already today at this hearing.
One of the most pressing needs in reducing medical errors
is getting more complete data on the occurrence of such.
Indeed, fundamental to any improvement effort is defining and
measuring the extent of the problem. At present, medical errors
are grossly underreported and there is very limited data about
their occurrence.
The Institute of Medicine has recommended that a national
reporting system be established that provides for the
collection of standardized information about adverse events
that result in death or serious harm to patients. They have
also recommended that the National Quality Forum be tasked with
promulgating and maintaining a core set of reporting standards.
The IOM further recommends that Congress pass legislation
to extend peer review protections to data related to patient
safety and quality improvement that are collected, analyzed,
and used solely for the purposes of improving safety and
quality.
I support those recommendations and I would strongly
underscore the need for having a non-punitive approach to
gaining these data.
I would also emphasize a second needed area of action, and
that is of making patient safety a priority. Government health
programs, health care organizations, and health care executives
should make reducing medical errors and improving patient
safety key strategic priorities. This should occur at all
levels of Government and at all levels of health care
organizations or institutions.
If patient safety is, indeed, to be a priority, it has to
have a home within those health care organizations and within
the relevant Government agencies and there must be individuals
that are responsible for managing the data and the associated
programs.
The National Quality Forum supports the Institute of
Medicine's recommendation that there be a national center for
patient safety, although we defer to the Congress and the
Administration as to where such a center should be housed
within the Government.
Finally, I would emphasize the need to implement medical
error prevention best practices where such have been
identified, and quite a few best practices have been identified
and were referred to by others earlier today as the ``low
hanging fruit'' that could be harvested quite readily. This is
especially so in the area of medication safety practices, where
a number of things have been identified and shown to be able to
reduce errors in the short term.
In closing, Mr. Chairman, I would just note that too often
Americans equate high technology health care with high quality
health care. In many situations, this nexus is true. But in
other cases, more sophisticated technology simply creates a
delusion of higher quality and increases the risk of medical
error.
With that, I will be happy to answer your questions.
[The prepared statement follows:]
Statement of Kenneth W. Kizer, M.D., P.H., President and Chief
Executive Officer National Quality Forum for Health Care Measurement
and Reporting
Mr. Chairman and Members of the Subcommittee, I am pleased
to appear before you today to discuss the urgent need to
improve patient safety in U.S. healthcare. For too long, the
topics of medical error and therapeutic adverse events have
escaped public scrutiny.
It should come as no surprise to anyone that errors occur
in healthcare, for in the past fifty years healthcare has
become one of the most complex of all human activities,
typically involving hundreds or even thousands of interactions
between people and technology during even ``routine''
treatment. Today, medical care is typically provided by teams
of healthcare professionals, each of whom is responsible for a
part of a patient's care; myriad diagnostic tests are routinely
performed, many of which may be hazardous to the patient; and
treatment often involves complicated invasive procedures that
could injure a patient in multiple ways. If ever there were a
high risk, high hazard activity, modern healthcare certainly
qualifies as such.
Therefore, Mr. Chairman, I commend you and the Subcommittee
for focusing on this important issue, and I welcome the chance
to share with you some thoughts about policies and practices
that might be employed to improve patient safety and, in turn,
the quality of U.S. healthcare, as well as possible roles that
the National Quality Forum might play in such efforts.
Healthcare Quality in the U.S.
The quality of healthcare in the United States presents a
paradox. On the one hand, the generally high level of training
of U.S. healthcare practitioners today, our extensive and
highly sophisticated biomedical research program, the rapid
dissemination of new medical knowledge, the extent of
government funding for healthcare, and the widespread ready
availability of state-of-the-art diagnostic and treatment
technology have brought life-saving treatments to more
Americans than ever before, and are the envy of much of the
world. On the other hand, a number of studies in recent years
have documented serious and widespread quality of care problems
in U.S. healthcare. Overuse, underuse and misuse of medical
care occur too frequently in all types of healthcare delivery
systems and with all types of healthcare financing.
While tens of millions of Americans reap the benefits of
modern medicine each year, millions of others are exposed to
unnecessary risks or are denied opportunities for improved
health. Likewise, too many patients are injured, disabled or
killed as a result of medical errors and treatment-related
mishaps.
Quite simply, as good as American healthcare is, it could
be markedly better!
Further, some experts believe that U.S. healthcare, which
is by far the world's most expensive healthcare, could be
significantly cheaper, if as much attention were focused on
improving its quality, as was done in a number of other U.S.
industries in the latter part of the 20th century. Higher
quality healthcare may well cost less.
It is notable that interest in rigorously determining the
quality of healthcare in America is only of relatively recent
origin, arising largely in response to the managed care
revolution and concern that the new healthcare organizational
structures and reimbursement strategies brought by managed care
might be creating incentives that were deleteriously affecting
the quality of care. In evaluating this situation, however, the
most striking finding is how little is really known about the
quality of healthcare in America. (Not that it is known better
any place else.) There is no mandatory national reporting or
surveillance system, nor any regular systematic review of the
state of healthcare quality to determine whether it is getting
better or worse. Likewise, few healthcare systems or provider
organizations even have rudimentary organized data systems that
routinely inform them about the quality of care they provide.
Overall, it is highly ironic and quite remarkable that we
know much more about the quality of airlines, automobiles,
televisions and toasters in America than we do about
healthcare, the nation's largest enterprise, accounting for
more than $1 trillion in annual expenditures and some 15% of
the gross national product.
In recognition of these problems and in response to growing
consumer and purchaser demands for greater healthcare
accountability, numerous efforts have been launched in the last
10 to 15 years to promote quality improvement in American
healthcare. And while incremental progress has been made, in
the aggregate, and despite the good work of many dedicated
individuals and organizations, healthcare quality has not
progressed to where it can and should be. There continues to be
large gaps between the care people should receive and the care
that they actually do receive.
This sentiment was clearly expressed in three independent
reports published in 1998--i.e., reports by the National
Academy of Sciences Institute of Medicine's National Roundtable
on Health Care Quality, by investigators at RAND after an
extensive review of the literature, and by the President's
Advisory Commission on Consumer Protection and Quality in the
Health Care Industry. Indeed, 1998 will probably come to be
viewed as a watershed year for healthcare quality improvement
because of these reports and actions they spawned.
The National Quality Forum
One of the sequels to the 1998 reports and one of the most
notable of recent efforts to improve the quality of American
healthcare has been the establishment of The National Forum for
Health Care Quality Measurement and Reporting, a private, non-
profit, membership organization proposed by the President's
Advisory Commission on Consumer Protection and Quality in the
Health Care Industry.
The concept of the National Quality Forum arose in
recognition of a strong American sentiment against government
regulation and control of healthcare quality. Of note, the
Commission proposed a public-private partnership involving two
new organizations--a private-sector entity they referred to as
the National Forum on Health Care Quality Measurement and
Reporting (better known now as The National Quality Forum
[NQF]) and a public entity they called the Advisory Council for
Health Care Quality. The Commission's original vision was that
the Advisory Council would identify national goals for quality
improvement and provide oversight on the accomplishment of
those goals, while the NQF would devise a national strategy for
measuring and reporting healthcare quality that would advance
the identified national aims for improvement. This paired
public-private relationship seemed to reasonably balance
concerns about the capacity of a private organization to meet
important public needs against the prevailing negative
sentiment towards vesting healthcare quality control with the
government.
The NQF was birthed in the fall of 1999, following the work
of the Quality Forum Planning Committee that had been launched
in June 1998.
With in-kind support from the United Hospital Fund of New
York, the Planning Committee drafted an initial mission
statement for the NQF, proposed a governance structure and
sought funding from selected foundations. Start-up funds were
subsequently obtained from the Robert Wood Johnson, California
HealthCare and Horace W. Goldsmith Foundations and the
Commonwealth Fund. A president and chief executive officer was
hired in the fall of 1999, and the NQF started to operate in
late 1999.
Of note, no action has been taken, so far, to establish the
proposed Advisory Council for Health Care Quality, and some of
its envisioned functions are now being reviewed by the NQF for
implementation.
The NQF sees its fundamental mission as being the
improvement of healthcare quality--e.g., to promote delivery of
care known to be effective; to achieve better health outcomes,
greater patient functionality or a higher level of patient
safety; or to make care easier to access or a more satisfying
experience. The primary strategy the NQF will employ to
accomplish its mission is to improve quality measurement and
reporting mechanisms--i.e., to improve the technology for
measuring and reporting quality. In doing so, however, the NQF
does not envision itself developing quality indicators or
measures de novo. There are myriad research, accreditation and
oversight organizations and commercial interests already
involved with developing measures.
The NQF has identified five key enabling objectives. These
include:
(1) Developing a national strategy for measuring and
reporting quality for the U.S. that is consistent with
identified national goals for quality improvement;
(2) Standardizing the measures of and processes for
reporting quality-related data so that data collection is
consistent and less arduous for healthcare providers, and so
that the data are of greater value;
(3) Promoting consumer choice by building consumer
competence in using quality measures;
(4) Enlarging the healthcare system's capacity to evaluate
and report on the quality of care; and
(5) Increasing the overall demand for healthcare quality
data.
While there is much that needs to be done in each of these
areas, the NQF sees a particularly acute need to reduce the
burden and increase the value of quality reporting methods.
The NQF has convened a group of highly respected quality
improvement, healthcare delivery and policy experts to help
craft a strategic framework for healthcare quality measurement
and reporting. This group is known as the Strategic Framework
Board (SFB), and its essential mission is to determine the
principles, intellectual framework and criteria for quality
measurement and reporting.
In pursuing its mission, the NQF will seek to provide a
clear, coordinated and coherent over-arching strategy and a set
of guiding principles to inform the choice of measures that it
will ultimately endorse. The NQF will strive to endorse
measures that are compelling and causally related to better
outcomes, and especially outcomes related to processes or
activities that improve something that actually happens to
patients. Indeed, the NQF believes that the true test of a
quality indicator or measure is how well, and for what cost,
the measure and its reporting actually helps improve care. The
more ways that a measure promotes better outcomes, the better.
The NQF will also strive to ensure that its over-arching
strategy has a sound theoretical framework that will inform and
guide a strategic and proactive research agenda.
In approaching its work, the NQF will explore issues of
quality across the entire spectrum of healthcare and will seek
to coordinate quality measurement between and among the various
levels or elements of the system--e.g., health plan, hospital,
medical group, nursing home, individual practitioner, home care
etc.
Likewise, the NQF believes that it must always ensure that
the consumer's perspective is heard during the discussion of
quality measures. In an effort to continuously actualize this,
the NQF's Board of Directors is designed to have a majority of
its members representing consumers and purchasers. This is an
important structural precept that should facilitate keeping the
consumer's perspective ever present.
Finally, in approaching its work, the NQF is committed to
working constructively with the many other parties involved in
the healthcare quality measurement and reporting area,
including especially the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) and the National Committee for
Quality Assurance (NCQA), to make certain that its work is not
duplicative, but rather collaborative and helpful to the
important work already begun by these entities. Improving
healthcare quality is a matter of national importance that
requires all of us to work together; there is neither time nor
resources to pursue any strategy other than one of complete
cooperation.
Medical Errors and Patient Safety
Recently, as a result of the Institute of Medicine's
seminal report on the subject in November 1999,\1\ considerable
public attention has been focused on medical errors and other
diagnostic or treatment-related mishaps that endanger patient
safety--these will be further referred to here collectively as
``therapeutic adverse events.'' The evidence is clear that
therapeutic adverse events kill tens of thousands and injure or
disable hundreds of thousands of Americans every year. They are
a major public health problem that warrants immediate and
decisive action, and the urgency for action is heightened by
the fact that, for many problems, solutions to prevent their
occurrence are known. In other cases there is a need for
research to find the best practices that would prevent their
occurrence.
---------------------------------------------------------------------------
\1\ Institute of Medicine. To Err is Human: Building a Safer health
System. Washington, DC. National Academy Press. 1999.
---------------------------------------------------------------------------
Despite their prevalence and cost, most healthcare
executives, clinicians and consumers are largely unaware of the
burden of therapeutic adverse events. Many factors account for
this lack of awareness, including especially the systematic
underreporting of such events and the prevailing ``name and
blame'' culture that discourages reporting and open discussion
of the issue. This ``name and blame'' culture causes fear of
punishment, fear of reprisal and/or fear of peer disapproval
when an adverse event does occur; this has been particularly
counter-productive in dealing with the issue in a forthright
manner.
It is widely known that error is inherent to anything that
humans beings do, and substantial evidence exists that errors
are the result of poorly designed processes and systems that
fail to account for the inherent limitations of human
performance. Indeed, because medical errors typically involve
problematic processes or systems rather than the incompetence
or malice of individual practitioners improvement strategies
that punish clinicians for reporting errors are misguided.
In my opinion, ten things, at a minimum, must be addressed
if medical errors are to be reduced. These include the
following:
1. Get more complete data on the occurrence of therapeutic
adverse events.
Foundational to any improvement effort is defining and
measuring the extent of the problem. At present, medical errors
are grossly under-reported, and there is extremely limited data
about their occurrence. Creating a data collection system is
essential to the success of efforts to reduce their occurrence.
Likewise, sharing information about errors with frontline
clinicians is needed to further their understanding of the
issues, as well as to promote collaboration and a sense of
shared mission.
The Institute of Medicine recommended that a national
mandatory reporting system be established that provides for the
collection of standardized information about adverse events
that result in death or serious harm to patients, and that the
NQF be tasked with promulgating and maintaining a core set of
reporting standards. The IOM further recommended that Congress
pass legislation to extend peer review protections to data
related to patient safety and quality improvement that are
collected, analyzed and used solely for the purposes of
improving safety and quality. I support those recommendations,
and I would strongly underscore the need for having a non-
punitive approach to gaining this data.
In considering the data, it is important to remember that
reporting such events is for both public accountability and
quality improvement purposes, and not everything reported for
quality improvement purposes warrants public reporting. There
is a set of adverse events or untoward situations about which I
believe we could obtain widespread consensus on the need for
reporting for public accountability purposes (e.g., maternal
death during childbirth, restraint-related strangulation,
wrong-site surgery, to name a few), but there is a larger pool
of events or circumstances that, at least at this time, should
be maintained confidential for quality improvement purposes.
2. Make patient safety a priority.
Government health programs, healthcare organizations and
healthcare executives should make reducing medical errors and
improving patient safety key strategic priorities. This should
occur at all levels of government and at all levels of
healthcare organizations or institutions.
Patient safety work should be built into the schedule of
managers and should be a defined executive responsibility.
Patient safety issues should receive as much attention by
healthcare facility governing boards as do issues like
financial performance, market share and strategic planning.
Healthcare facility management should be held accountable for
patient safety performance just as they are held accountable
for other performance.
3. Create a patient safety infrastructure.
If medical error data are to be collected and if patient
safety is to be a priority, then it must have a ``home'' within
healthcare facilities, healthcare organizations and relevant
government agencies, and there must be individuals who are
responsible for managing the data and associated programs. The
NQF supports the notion of there being a national Center for
Patient Safety, although we defer to the Congress and the
Administration where such a center should be housed. Wherever
it is located, though, it must be provided with adequate
resources to accomplish its mission.
4. Create a culture of safety
Healthcare executives and managers should strive to create
a culture of safety in their institutions or organizations.
A healthcare culture of safety can be defined as an
integrated pattern of individual and organizational behavior,
and the associated underlying philosophy and values, that
continuously seeks to minimize hazards and harm to patients
that may result from diagnosis and/or treatment-related
processes. A culture of safety identifies safety as a priority
and aligns organizational objectives and rewards accordingly.
A number of characteristics define a healthcare culture of
safety. For example, in a culture of safety there is open
acknowledgement that modern healthcare is a high risk activity
and that everyone in healthcare has a responsibility for risk
reduction and error prevention. Errors are recognized and
valued as opportunities for improvement, and there is a non-
punitive and safe environment in which errors can be learned
from. There is honest and open communication about safety
issues with well known mechanisms for reporting and learning
from errors, and confidentiality of information. Likewise, in a
culture of safety there are mechanisms for restitution and
compensation for injuries that result from errors, and clear
organizational commitment, structure and accountability for
safety improvement.
5. Implement patient safety best practices.
Healthcare leaders and organizations should implement
medical error ``best practices'' when such have been
identified--e.g., such as those identified by the Massachusetts
Hospital Association, National Patient Safety Partnership and
Institute for Safe Medication Practices. This is especially so
for medication safety practices, where a number of practices
have been shown to definitely reduce errors.
6. Professional misconduct must be recognized and dealt with.
Gross negligence, malfeasance or unethical behavior should
be recognized as a grave threat to patient safety and should be
dealt with accordingly. Licensure, credentialing and
privileging bodies should more aggressively discipline
practitioners who have demonstrated impaired performance of
this nature.
7. Healthcare regulators and accreditation organizations should
embrace measures that enhance patient safety.
Regulations and guidelines should encourage root cause
analysis and facilitate non-punitive reporting. Similarly,
pharmaceutical and medical device manufacturers should be
required to complete and disclose human factors testing of
naming, packaging and labeling of medications and post-market
surveillance of adverse events.
8. Patient safety self-assessments should be conducted.
All healthcare facilities should routinely conduct self-
assessments for risk reduction and error prevention. When
available, structured and standardized self-assessment
instruments should be utilized--e.g., the self-assessment
instrument developed by the Institute for Safe Medication
Practices for medication safety practices.
9. Patient safety research should be funded and otherwise
supported.
While a number of interventions are available that could
improve patient safety in the short term, there is a need for
additional research in the area of medical error reduction and
patient safety. Research is needed in ways to make care
processes safer, in how to make reporting systems optimally
useful, and in ways of communicating information about
healthcare hazards that do not unduly alarm patients, to name
some fertile areas of research. Likewise, while basic research
is needed in many areas, there is a need to investigate
technology transfer and the application of safety lessons from
other industries to healthcare. A good model for the latter are
the Veteran Health Administration's Patient Safety Centers of
Inquiry.
10. Medical education should address patient safety.
Patient safety needs to be incorporated into the fabric of
health professional training at all levels. Indeed, a
significant part of the problem regarding the failure of
physicians to report medical errors stems from attitudes and
beliefs instilled during medical school. The fact that everyone
makes mistakes, regardless of how well trained or how smart one
is, and that modern healthcare is an inherently high risk, high
hazard activity should be promoted throughout one's training,
along with how mistakes should be managed.
Professional organizations and credentialing bodies should
also give consideration to requiring continuing education
specifically in patient safety, such as is required of
practitioners in the veterans healthcare system.
Conclusion
In closing, Mr. Chairman, I would emphasize that even
though improving patient safety in U.S. healthcare presents
many challenges, improvement is eminently achievable, as has
been demonstrated in the veterans healthcare system.
I would further note that too often Americans equate high
technology healthcare with high quality healthcare. In some
cases, this nexus is true, but in many other situations more
sophisticated technology simply creates a delusion of higher
quality, while actually increasing the risk of medical error.
As healthcare becomes more and more reliant on complicated
technology there will be increasing need for vigilance against
errors. Many actions need to be taken to ensure that such
vigilance is actualized and that healthcare in the 21st century
becomes safer than it is today. The ten action areas described
above would be a good beginning in this regard.
Again, thank you for the opportunity to testify before you
this morning. I would be pleased to answer your questions.
Mr. Thomas. Thank you very much. Tools of diagnosis do not
replace diagnosis. Dr. O'Leary?
STATEMENT OF DENNIS S. O'LEARY, M.D., PRESIDENT, JOINT
COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS
Dr. O'Leary. Thank you, Mr. Chairman.
I am Dr. Dennis O'Leary, President of the Joint Commission
on Accreditation of HealthCare Organizations. I am pleased to
address you today concerning medical errors. This is perhaps
the most pressing health care quality issue of our time.
The Joint Commission accredits over 18,000 organizations
whose services include acute care, long-term care, ambulatory
care, behavioral health care, laboratory services, and home
care. This broad experience gives the Joint Commission a
panoramic view of the strengths and weaknesses inherent in our
health care delivery system.
My testimony will focus on the tasks that must be carried
out to reduce errors nationwide. Dramatically reducing the
numbers of errors will take a concerted effort by all
responsible parties who participate in and oversee the delivery
of health care. This coordinated approach must necessarily
bridge the public and private sectors.
Medical error reduction is fundamentally an information
problem. The solution to reducing errors resides in developing
mechanisms for collecting, analyzing, and applying existing
information. With this in mind, there are five critical
information-based tasks that are essential to an effective
error reduction strategy.
The first task is the creation of a blame-free protected
environment that encourages the systematic surfacing and
reporting of serious adverse events. Fear of reprisals, public
castigation, and loss of business will continue to impede the
reporting of serious errors unless we provide incentives for
making mistakes known to accountable oversight bodies.
Today, the blame and punishment orientation of our society
drives errors underground. Indeed, we believe that most medical
errors never reach the leadership levels of the organizations
in which they occur. If we are to get a handle on the
epidemiology of medical errors, we must create a protected
blame-free environment that will lead to an active
understanding of their scope and nature.
Further, it is imperative that any medical error reporting
program operate under a pragmatic and carefully crafted
definition of what constitutes a serious adverse event.
The second task is the production and credible root cause
analyses of serious adverse events. When a serious error
occurs, there must be an intensive, no holds barred vetting of
all of the causes of the underlying event. These root cause
analyses, which we believe hold the critical answers to future
error reduction, focus primarily on organizations, systems and
processes.
Unfortunately, most reporting systems, both voluntary and
mandatory, fail to require or encourage the performance of root
cause analyses. Not surprisingly, organizations are hesitant to
share these root cause analyses with the Joint Commission or
anyone else. We must recognize that preparing a document that
lays bare the weaknesses in the health care providers systems
is akin to writing a plaintiffs' brief. Therefore, we cannot
expect uniform preparation of these documents without Federal
protections against their inappropriate disclosure.
The third task is to implement concrete planned actions to
reduce the likelihood of similar errors in the future. The
principal derivative of a root cause analysis is an action plan
that focuses on improving the organization's systems which
related to the serious adverse occurrence. It is essential that
implementation of this action plan be monitored and confirmed
by an independent oversight body. The response to an error does
not simply terminate with the report itself, or even an
analysis of what went wrong. We view the monitoring of planned
systems changes in organizations as a key element of public
accountability.
The fourth task is the establishment of patient safety
standards which health care organizations must meet. The Joint
Commission has recently established explicit patient safety
standards for health care organizations. These standards were
specifically created to establish patient safety as a high
priority in these organizations. The new standards require that
the leadership of a health care organization establish
processes for identifying and managing sentinel events and put
these into practice.
The last task is dissemination of experiential information
to all organizations at risk for adverse events. To have a
positive national impact on patient safety, information gleaned
from the analyses of errors must be disseminated so that all
organizations may reduce the likelihood of adverse events.
The Joint Commission does this through its series of
sentinel event alerts. To date, we have issued alerts on
medication errors, wrong site surgery, restraint related
deaths, blood transfusion errors, inpatient suicides, infant
abductions, and post-operative complications.
Finally, it must be understood that access to error related
data and information underride and drive this overall system of
accountability and oversight. Therefore, we believe that any
national reporting program must ensure appropriate data sharing
amongst all of the responsible oversight parties.
In conclusion, we believe that the work of the Joint
Commission over the last four years provides significant
lessons learned for policymakers grappling with solutions to
the medical errors problem. Our sentinel event program has
identified the critical information-based tasks that need to be
carried out. But the sentinel event program also illustrates
the harsh realities of the litigious atmosphere in health care
that creates major barriers to the surfacing and reporting of
error related information.
It is abundantly clear that no reporting system for serious
errors can fulfill its objectives without Congressional help.
Without Federal legislation, the Joint Commission's error
reporting program, and others like it, will continue to fall
significantly short of their intended goals.
Thank you.
[The prepared statement follows:]
Statement of Dennis S. O'Leary, M.D., 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 am pleased to
have the opportunity to address the House Ways and Means
Subcommittee on Health regarding medical errors. The frequency
and nature of medical errors is perhaps the most pressing
quality of care issues we face in the health care today.
The Joint Commission is the nation's oldest and largest
standard-setting body for health care organizations. We
accredit over 18,000 organizations that provide a wide range of
services, including hospitalization; long term care; ambulatory
care; behavioral health care; laboratory services; managed
care; and home care. Based on its broad experience, the Joint
Commission has a panoramic view of the strengths and weaknesses
inherent to our health care delivery system. We believe that
the problem of medical errors is endemic to the way health care
is carried out, but that the health care providers have the
tools and the commitment to sharply reduce their incidence.
My testimony will focus on the activities that we believe
must be carried to reduce errors nationwide. The release of the
Institute of Medicine's report, ``To Err is Human: Building a
Safer Health System,'' has galvanized the professional and
policy making communities around this critical set of quality
issues. Such synergy of purpose among stakeholders is a
prerequisite for successfully addressing complex,
multifactorial problems whose solutions depend upon information
sharing among the parties. Dramatically reducing the numbers
and types of errors will take a concerted effort by all who
participant in and oversee the delivery of health care.
The goal for the country should be to find ways to increase
knowledge about why errors occur and to apply that information
in a manner that will enhance patient safety. On the surface
this sounds simply, but success, will in fact, require a
cultural shift in how our society views and treats medical
errors. Success will also require a coordinated approach, among
responsible parties, particularly in the development and
application of constructive information regarding medical
errors. This coordinated approach must necessarily bridge the
public and private sectors.
Medical error reduction is fundamentally an information
problem.
The solution to reducing the number and types of medical
errors resides in developing mechanisms for collecting,
analyzing, and applying existing information. If we are going
to make significant strides in enhancing patient safety, we
must think in terms of what information we need to obtain,
create, disseminate and apply to the problem. With this in
mind, there are five critical, information-driven activities
that must be supported in the overall system. In theory, a
single organization could perform all of these functions, but
in fact, multiple public and private sector organizations will
have roles to play.
1. Creation of a blame-free environment to encourage the system
surfacing and reporting of serious adverse events.
Fear of reprisals, public castigation, and loss of business
will continue to impede the reporting of serious errors unless
we provide incentives for making mistakes known to accountable
oversight bodies. Today, the blame-and-punishment orientation
of our society drives errors underground. We believe that most
medical errors never reach the leadership levels of the
organizations in which they occur. For the typical caregiver
involved in a medical error that leads to a serious adverse
event, the incentives to report are all negative--potential job
loss, humiliation, shunning. It is a small wonder that we know
so little about this terrible problem. If we are to get a
handle on the epidemiology of the problem, we must create a
climate that will led to an accurate understanding of its scope
and nature.
An important feature of the Joint Commission's Sentinel
Event Program (Attachment A) is the non-punitive reporting
environment it seeks to create. Hoping to foster a positive
culture that will promote error reduction efforts, the Joint
Commission has designed its policies not to penalize the
accreditation status of an organization that surfaces an error
and performs the appropriate due diligence required under the
policy. The resulting atmosphere provides incentives that favor
the surfacing of information about errors that eventually
contributes to error reduction strategies that can be used by
other organizations.
Despite the incentive to report errors to the Joint
Commission, the fear of litigation is a significant impediment
for the majority of health care providers. Therefore, we have
experienced only limited reporting to the Joint Commission's
database since it was established in 1996. Indeed, our Sentinel
Event Program has found it necessary to create procedureal
accommodations to protect sensitive error-related information,
such as having our surveyors review reported errors onsite
rather than having information sent to the Joint Commission's
central office. But these manipulations are only stop gap
measures that we believe must be replaced by federal
protections for error-related information.
Further, it is imperative that any medical error-reporting
program operate under a pragmatic and carefully crafted
definition of what is a reportable event. Standardization of
the information to be collected is an important prerequisite
for aggregating events in a consistent and meaningful fashion.
Further, without a pragmatic definition, a reporting program
would be flooded with hundreds of thousands of lesser injuries
that would overwhelm the system. With this in mind, the Joint
Commission has identified a subset of sentinel event*--
including their nomenclature and taxonomy--that should be
reported to the Joint Commission on a voluntary basis.
Our definition of a reportable event minimizes the external
reporting burden for health care organizations while focusing
on the most serious occurrences that have a high likelihood of
being preventable. The fact that the Sentinel Event program
seeks to collect data on the most serious errors, or
``crashes,'' distinguishes the Joint Commission's reporting
program from the voluntary programs encouraged in the IOM
report, which would collect information only on the ``near
misses.''
2. Production of credible ``root cause'' analyses following the
occurrence of serious adverse events.
When a serious error occurs, there must be a requirement
for an intensive, no-hold-barred vetting of all of the causes
underlying the event. We call these responses ``root cause''
analyses--a term borrowed from the engineering world's reliance
on a systems approach to both solving problems and producing
desired outcomes.
A root cause analysis focuses primarily on systems and
processes, as opposed to individual performance. While an
individual is invariably the proximal cause of error relate to
systems failures distal to the error itself. For example,
systems may fail to provide simple checks and balances; or they
may be missing critical safeguards; or may have design flaws
that actually promote the occurrence of errors.
These intensive analyses are rich learning processes that
can elucidate multiple factors that ultimately contributed to
the error. Many of these are not readily apparent until the
root cause analysis is undertaken. Therefore, the analysis must
be comprehensive and thorough, and engage the personnel
involved in all aspects of the care giving and support
processes. These are also time consuming investigations, and
their complexity may require external technical assistance. The
Joint Commission has developed several comprehensive guides on
how to conduct a ``thorough and credible'' root cause analysis,
and continues to be the leading source of guidance for health
care organizations in this area.
Unfortunately, the majority of reporting systems--both
voluntary and mandatory--fail to require or encourage the
performance of these intensive assessments. This was evident
during our recent review of many state reporting programs. A
reporting system that ends with the report of the event itself
is not a credible program and will not contribute to error
prevention. Root cause analyses also offer extraordinary
insights into how processes must change to control unwarranted
variations, and they tell stories of what systems must be
developed to guard against the occurrence of similar human
error. Root cause analyses hold the promise of prevention. They
are also the necessary substrate from which risk reduction
action plans are created.
While reporting is voluntary under our Sentinel Event
Program, the production of a root cause analysis following a
sentinel event is mandatory. Not surprisingly, organizations
are hesitant to share these root cause analyses with the Joint
Commission or anyone else. Although many organizations have
done so, we must recognize that preparing a document that lays
bare the weaknesses in a health care provider's system is akin
to writing a plaintiff's brief for purposes of litigation.
Therefore, we cannot expect uniform preparation of these
documents without federal protections against their
inappropriate disclosure.
3. Implementation of concrete, planned actions to reduce the
likelihood of similar errors from happening in the future.
Monitoring is an critical element of the strategy for
preventing errors, to ensure that the response to an error does
not terminate simply with the report itself or a discussion of
what went wrong. The Joint Commission monitors the action plans
of accredited organizations which have experienced serious
medical errors, in a manner similar to the way it monitors any
quality of care area in need of improvement. This ensures that
there is an independent review of the milestones associated
with planned systems changes. We expect to see an
organizational response that results in preventive actions.
We view the monitoring function as a key element of public
accountability. The public must have confidence that there is
an external body overseeing patient safety issues in the
organization that are delivering their care. We believe that
the public views safety as a threshold concern. While citizens
probably do not wish to have detailed data about safety
prevention in each health care organization, they should
reasonably expect that responsible oversight bodies are acting
conscientiously and effectively on their behalf. This includes
aggressive and timely follow-up to the occurrence of a serious
medical error and holding the organization accountable for
making necessary systems improvements.
At the same time, it is error-related data and information
that undergird and drive this system of accountability and
oversight. Therefore, we believe that any national response to
the IOM report must ensure appropriate data sharing among all
of the responsible oversight bodies which perform any of the
functions discussed in this testimony. The health care quality
oversight system involved a variety of private sector and
public sector players today. Efforts should at least be made to
better utilize existing structures through improved data
sharing, and encourage the broad dissemination of what has been
learned from medical mistakes. We do not want to end up with a
fragmented, ineffective system where, for example, a single
body is privy to reports of errors, yet organizations with
public accountability for patient safety are not made aware of
or do not have access to this information.
4. Establishment of patient safety standards which health care
organizations must meet.
The Joint Commission has established developed explicit
patient safety standards that became applicable to accredited
organizations beginning in January 1999. These new standards
were specifically created to establish patient safety as a high
priority in provider organizations.
The new standards require that the leadership of a health
care organization establish processes for identifying and
managing sentinel events and put these into practice. The
standards also require that the organization monitor the
performance of particular processes that involve risks or may
result in sentinel events, and intensely analyze undesirable
patterns or trends in performance. The standards make patient
safety a visible responsibility of health care organizations
and a requirement for accreditation. Compliance with these new
patient safety standards is evaluated through our periodic
onsite inspection process.
We would like to see other accreditors and quality of care
oversight bodies include meaningful patient safety standards in
their requirements. Further, it may be valuable to explore ways
for oversight bodies to better inform the public and purchasers
as to how well organizations are doing in terms of meeting
these performance expectations.
5. Disseminating of experiential information learned from
errors to all organizations at risk of similar adverse events.
To have a positive national effect on patient safety,
information gleaned from errors must be aggregated, analyzed
and disseminated to the health care community at large. In
1997, the Joint Commission began to issue periodic Sentinel
Event Alerts Alerts to share the most important lessons
learned--known risky behaviors as well as best practices--from
its database of error-related information. To date we have
issued Alerts in a number of areas, including medication
errors; wrong site surgery; restraint-related deaths; blood
transfusion errors; inpatient suicides; infant abductions; and
post-operative complications.
We are confident that these Alert have saved lives.
Unfortunately, we cannot calculate real decreases in error
rates with scientific certainty, because the full scope and
frequency of serious adverse events is simply not known.
However, we have some data, which illustrates the effects of
our Sentinel Event program in selected areas. For example, we
have seen a notable significant effect from our first Alert
(Attachment B) dealing with the importance of appropriate
storage and handling of potassium chloride (KCl)--a substance
that is deadly when given in concentrated form and is easily
mistaken for less benign substances. In analyzing the causes of
KCl-related deaths, it became evident that accidental injection
of KCl stored on hospital floors was an important cause of
unanticipated deaths. The Joint Commission issued its Alert on
the subject in February 1998. The number of reported deaths has
dropped from 12 in 1997 to only one in 1998 and one in 1999.
We also believe that significance should be attached to how
information is disseminated and by whom. The risks associated
with potassium chloride have long been known to practitioners.
But when the principal accreditor of provider organizations
issued a major alert, it caught the attention of organization
leaders and health care practitioners. Moreover, it was clear
to the recipients of the information that the Joint Commission
would be paying attention to this particular issue and
following up during onsite evaluations of the organization's
performance. This program of Alerts is an example of the type
of vehicle necessary to achieve behavior change in health care
organizations.
There is also a need for more research to inform health
care evaluators on how to identify ``risk'' in organizations.
We have some knowledge about the relationship of organizational
structure to outcomes--for example, team approaches appear to
be more effective than hierarchical structures--but the
information is very limited. It may be useful to determine
whether there are key characteristics of organizations that
makes them more or less prone to errors such as how well they
handle new information, communicate among their component
services, etc. Investing in demonstrations of shared decision
making may also prove fruitful. Shared decision-making tools
that bring the latest information to both practitioner and
patient could lead to reduced medical errors through more up to
date medical knowledge, increased patient compliance, and other
factors.
Conclusions and Need for Congressional Action
We believe that the work of the Joint Commission over the
last four years provides significant ``lessons learned'' for
policy makers grappling with solutions to the medical errors
problem. The Sentinel Event Program has identified the critical
information-based functions for solving the medical error
problem. In carrying out these functions, the Joint
Commission's efforts have assuredly prevented additional errors
and saved lives.
But, the Sentinel Event program also illustrates the harsh
realities of a litigious atmosphere in health care that creates
major barriers to the surfacing and reporting of error-related
information. It is abundantly clear that no reporting system
for serious errors can fulfill its objectives without
Congressional help. Without federal legislation, the Joint
Commission's error reporting program and others like it
continue to fall significantly short of their intended goals.
This is true whether the reporting framework is public or
private; mandatory or voluntary; national, state, or local.
We urge, therefore, that Congress create statutory
protections from disclosure and discoverability of the in-
depth, causal information which must be gathered in any
mandatory or voluntary reporting program for serious adverse
events.
*The Joint Commission defines a reportable sentinel event
as an event that has resulted in an unanticipated death or
major permanent loss of function, not related to the natural
course of the patient's illness or underlying condition, or one
of the following: suicide of a patient in a round-the-clock
care setting; infant abduction or discharge to the wrong
family; rape; hemolytic transfusion reaction involving
administration of blood or blood products having major blood
group incompatibilities, or surgery on the wrong patient or
wrong body part.
Mr. Thomas. Thank you very much, Dr. O'Leary. Dr. Golden?
STATEMENT OF WILLIAM E. GOLDEN, M.D., FACP, PRESIDENT, AMERICAN
HEALTH QUALITY ASSOCIATION
Dr. Golden. Thank you, Mr. Chairman, and good afternoon.
As medical director for quality improvement at a Medicare
peer review organization, I am pleased to be here today to talk
about medical errors. I am also a professor of medicine at the
University of Arkansas Medical School. The Arkansas PRO has
extensive experience doing quality improvement, HEDIS
measurement patient satisfaction surveys for Medicare as well
as Medicaid.
Today I am here as President of the American Health Quality
Association. This organization represents quality improvement
organizations in this country which are private, community
based, and work in all health care settings, hospitals,
physicians offices, nursing homes, home health agencies in all
50 states, the District of Columbia, and U.S. territories.
Unifying our activities is the Medicare peer review
contract. Over the last 10 years, the PRO system has evolved
into a national network of quality improvement experts that
systematically evaluate the delivery of health care in a region
and institute projects to educate and alter the clinical
behavior of institutions, health professionals, and patients.
Today's PRO system is and can be a core element of a national
system for improving patient safety.
We are already doing extensive work in this area to reduce
errors. Our staffs have changed over the last 10 years to
accomplish these goals. We currently have on staff clinical
experts, nurses and physicians, who are trained in quality
improvement techniques. We have data and statistical
professionals on staff, medical record abstraction teams, an
extensive infrastructure of community relationships to get
change in the community structure and to communicate this
information, as well as expertise in public relations and
outreach strategies.
Indeed, in the major study on errors out of Colorado and
Utah, the data collection was subcontracted to PROs by the
teams out of Harvard to get the research performed.
The Institute of Medicine points out there are two kinds of
errors, errors of omission and errors of commission. Much of
the PRO system currently works to reduce errors of omission in
prevention, diagnosis, and treatment. We are doing such things
as increasing rates of mammography, increasing the use of
pneumovax, pneumococcal vaccine, influenza vaccine. Appropriate
drugs after the treatment of heart myocardial infarction
improve the receipt of those drugs by appropriate patients.
Timely administration of the correct antibiotics for the
treatment of pneumonia. ACE inhibitors for heart failure,
making sure patients receive this medicine to improve function
and survival. Better monitoring of potential diabetic
complications.
We are even doing studies on errors of commission, such as
the elimination of a dangerous drug in the treatment of stroke.
I have a list of 22 performance measures attached to my
testimony that goes into the areas we are currently working on
to reduce errors.
The strengths of these activities reflects the fact that
they affect a large number of older Americans. They have strong
scientific support. And they are standardized, so we can
compare treatments and progress across states, within regions,
and also within our own program.
Given our experience over the last 10 years, we have seven
recommendations to improve the system and improve patient
safety. One is to expand the current performance monitoring
system the PROs are using. We currently measure and improve
medical errors. Our list of clinical topics could be expanded
with new performance measures to improve care. Indeed, if we
improve care for Medicare patients we often improve care for
all patients, because once you have improvement for myocardial
infarction, all patients with MI tend to benefit.
Many of these recommendations are consistent with what was
in the Medicare Payment Advisory Commission report in June 1999
and was recommended by the Medicare Payment Advisory
Commission.
We could work on things like adverse drug events, hospital
acquired infections, post-operative hemorrhage, et cetera. We
agree that the Agency for Healthcare Research and Quality,
HCFA, and other stakeholders should get together and work on
new performance measures to reduce errors.
It is important to note that this system would not increase
burden to the hospitals because most of this could be done by
using administrative databases, record abstraction, and does
not require reporting. It can be done by data abstraction teams
and rates of errors could be determined and improvements
designed to improve safety.
We believe that there should be a mandatory reporting of
some catastrophic errors. Much of this, as I said, can be done
by abstraction, but there are some random events which break
through safety systems in hospitals, and the reporting of those
errors to a regional entity would allow for many institutions
to learn from these rare events so that additional patients
would not be harmed by recurrences at other settings.
We believe there needs to be accountability of this system
and that this kind of activity should be handled by a qualified
expert organization who can do root cause analysis, can
communicate the information and can get behavior change.
The PRO program right now is under agreements with the
Health Care Financing Administration to actually improve care
in their areas and make it measurable.
We believe there needs to be confidential treatment of
reported errors. It is very important that we do not punish
people for reporting mistakes in their environment if it is
under the rubric of improving patient safety. Right now the
PROs have much of that confidentiality in place, so we can go
forward. That is much in keeping with the protections as
outlined by the Institute of Medicine report.
We believe there also needs to be a mechanism for finding
unreported errors. PROs, like Utah and Colorado did for their
study, can do chart surveillance for either targeted errors or
random errors, depending on the topics under review. That way,
we can see whether there are additional events going on in the
system that need to be addressed.
The system must promote best practices with good
collaboration between institutions and the entity that is
collecting the information, collect best practices and promote
quality improvement in the communities.
And finally, we need to separate malpractice reform from
error reduction programs. Malpractice is a very difficult topic
and I believe we are here today to talk about how we can
improve patient safety and reduce errors. That is our
fundamental intent, and the malpractice reform, we will leave
to other experts.
At this point, I will stop and welcome questions. Thank you
very much for the time.
Chairman Thomas. Thank you.
[The prepared statement follows:]
Statement of William E. Golden, MD, FACP, President, American Health
Quality Association
Good morning, Mr. Chairman. Thank you for inviting me to
testify today.
I am the Principal Clinical Coordinator for one of
Medicare's Quality Improvement Organizations, or QIOs, called
the Arkansas Foundation for Medical Care. I am also a Professor
of Medicine and Director of General Internal Medicine at the
University of Arkansas Medical School. My QIO has extensive
experience in performance measurement and conducts quality
improvement, HEDIS measurement, and patient satisfaction
surveys for the state Medicaid program. We are also a
recognized vendor for the Oryx Program of the Joint Commission
on Accreditation of Healthcare Organizations (JCAHO). In fact,
we created three of JCAHO's thirty performance measures in the
proposed national core program.
I am here, today, as President of the American Health
Quality Association (AHQA), a national membership association
of organizations and individuals dedicated to health care
quality improvement. Our member QIOs are private, community-
based organizations that promote health care quality in all
health care settings. QIOs work in all 50 states, the District
of Columbia and the U.S. Territories.
The QIOs have several lines of business including work with
state governments and private health plans. The work that
unites them all, however, is their 3-year, competitively
awarded contracts from HCFA to evaluate and improve the quality
of care delivered to Medicare beneficiaries. For this work, our
members are more commonly referred to as Medicare Peer Review
Organizations, or PROs.
Congress established the PROs in 1983 to look for single
case problems. During the 1990s, the PRO system evolved to
become a national network of quality improvement experts that
systematically evaluate the delivery of health care in a region
and institute projects to educate and alter the clinical
behavior of institutions, health professionals and patients.
QIOs are staffed with clinical experts, communication experts,
and data and statistical professionals who work together to
analyze and collaborate with the health care system in their
communities.
Today's PRO system is uniquely qualified to serve as the
core of a new national system for improving patient safety. One
of the greatest strengths of the PRO system is its extensive
infrastructure of relationships in every region of the country.
PROs work individually with hospital staffs and physicians
offices. They are also increasingly engaged with home health
care systems, nursing homes, academic health centers, and
community groups such as heart associations and cancer
coalitions.
In addition to technical expertise, they have developed
public relations and outreach strategies with professional
associations, public health authorities and state officials.
This is critical for helping hospitals and other facilities
implement improvement strategies as well as tailoring messages
to the public about improving their health (e.g. public
awareness of receiving pneumococcal vaccinations or getting
regular eye examinations to reduce the risk of diabetes-related
blindness). This is also critically important for the
effectiveness of the PROs' required projects with underserved
and disadvantaged populations. These projects often require
forms of outreach and communication that are culturally
appropriate.
The Institute of Medicine (IOM) report released last
November targets both medical errors of omission--care not
provided that should have been--as well as errors of
commission. In addition, the IOM Committee also states that
errors occur and should be detected in all phases of medical
care: prevention, diagnosis and treatment.
The Medicare PRO Program as a Model Error Reduction Program.
Medicare's national PRO system has been identifying,
measuring and reducing error rates for several years. The PRO
program is now embarking on an expanded three--year mission to
identify and eliminate medical errors. The new program is
focused largely on errors of omission--such as prescriptions
that were not ordered for prevention of heart attack--and on
errors in all three categories mentioned by the IOM. For
example, in the prevention area, PROs are working to promote
immunizations to prevent the most common fatal infection,
pneumococcal disease. In the area of missed diagnoses, the PROs
will be working to increase mammography screening and diabetic
retinopathy testing. An example of PRO work to reduce treatment
errors is that PROs will be emphasizing timely administration
of antibiotics for newly hospitalized pneumonia patients.
I have attached a complete list of the 22 performance
indicators in each of six clinical topic areas for which the
PROs must reduce error rates. These PRO performance indicators
serve as a useful model for a new medical error reduction
system for several reasons. These clinical topics were
carefully chosen because they affect a large percentage of
older Americans and because the scientific basis for the
desired therapy or action is well established. A national error
reduction program should also focus on high priority problems
and adopt a science-based approach.
In addition, the standardized national set of performance
indicators assures national comparability of data within and
between all states, which is critical to accurately measure
improvement. We believe this is a sound model for a national
system of identification and reduction of medical errors.
Recommendations.
Based on our experience working within a national system to
identify quality problems and work collaboratively with
providers to bring about improvement, here are our
recommendations for a new system for improving patient safety.
1. Expand Monitoring System for Error Prevention.
Congress should expand the current system utilized by
Medicare to monitor a targeted list of health care processes
and patient conditions known to be associated with a
disproportionate amount of medical errors. This system will
identify many errors and adverse events, which have not yet
resulted in dramatic or catastrophic patient outcomes. The
published literature identifies some categories of preventable
adverse events that are both relatively frequent and frequently
preventable, and might be targeted by a national monitoring
system. Some examples include adverse drug events, hospital
acquired infections, deep venous thrombosis, postoperative
hemorrhage. The Agency for Healthcare Research and Quality
(AHRQ) and the Health Care Financing Administration (HCFA)
should collaborate with representatives of our national network
of Quality Improvement Organizations (QIOs), as well as
professional and provider groups to define the highest priority
areas of scrutiny for error-prone health care processes, and to
develop a standardized system for measurement.
Congress will be asked to consider the burden of error
reporting. The system of monitoring that I have described can
be accomplished without imposing significant additional
reporting burdens on hospitals or other providers. PROs can
accomplish much of the data gathering necessary by expanding
their current mechanisms for review of medical records and
abstraction of key data for analysis. Quality improvements
based on this kind of monitoring will probably continue to be
the major method by which patient safety is enhanced. Because
the PRO program has already established the relationships with
hospitals necessary to perform this function, there is very
little new work that hospitals must do to facilitate an
expanded program to address errors in patient care planning and
execution.
2. Mandatory Error Reporting.
We have recommended that Congress devote substantial
resources to monitoring and educating providers about the
adverse events that have strong potential to harm patients,
rather than wait for patient harm to occur. But the smaller
number of more dramatic events that result in patient harm must
also be addressed by an error reduction system because the
results of such errors are so often tragic and irreversible.
This subset of adverse events often captures the attention of
local health professionals and often results in demands for
system changes to eliminate recurrence.
Health facilities should report the rare and seemingly
random adverse events that result in patient harm to a regional
entity to create a database. Monitoring and analysis of such a
database can offer insight into better system design for all of
our communities. The reporting of such errors allows for
hindsight analysis to be available throughout the health
system, so that more people can benefit from the analysis than
just those in the local environment that witnessed the adverse
event. The PROs are well qualified to manage and interpret such
a database in each state, and have proven adept at educating
providers and practitioners about ways to avoid errors in the
future.
3. Ensure Accountability.
Congress should hold providers accountable for measurably
reducing the incidence of errors. A qualified expert
organization, completely independent of hospital providers,
should analyze the incidence of errors and judge whether
improvements are being made. The PRO program is already
performing this function on a more limited scale. For the
period 2000-2002, PROs will be accountable under their Federal
contracts for measuring and reducing the frequency of missed
prescriptions to prevent strokes and heart attacks, or missed
lab tests to help control diabetes. If a PRO cannot accomplish
sufficient measurable improvement, it may lose its Federal
contract. In a new medical error system, Congress can rely on
the QIOs to measure error rates and identify providers that
have made no progress in eliminating errors. Providers that are
making no progress on errors could be reported to a federal or
state regulatory agency, or to the Joint Commission for
Accreditation of Healthcare Organizations (JCAHO).
4. Assure Confidential Treatment of Reported Errors.
Reports identifying specific providers and individuals
should generally not be disclosed. Part of the reason for this
is that ``naming names'' tends to fix blame, even when this is
inappropriate. The IOM report [page 45] noted, ``Complex
coincidences that cause systems to fail rarely have been
foreseen by the people involved.'' This suggests that it is
more important to understand system failures than to attempt to
affix blame on one or more individuals involved in a system
failure.
It is critically important to not to discourage, let alone
punish, the active search for errors. Several studies
demonstrate that errors are much more numerous than anyone can
know without actively digging to find them. The IOM relied on
two large studies of the prevalence of medical errors. PROs, in
fact, did the medical record abstraction for the second study,
based in Utah and Colorado. Both studies found a large number
of preventable adverse events through careful review of the
medical record. But these researchers also noted that many
other errors could not be found in the medical record alone.
When researchers at the LDS Hospital in Salt Lake City wanted
to find out the true incidence of adverse drug events in their
institution, they started by counting the incident reports
filed by doctors, nurses, and pharmacists. They came up with
about 20 reports a year. But after extensive mining of lab
data, prescription records, and interviews with hospital
personnel, they found the true incidence of adverse drug events
was over 580 events a year. The hospital then tracked down the
causes of these problems and reduced their true error rate
below the original apparent rate.
The LDS project puts the idea of public reporting in
context. If hospital personnel know that any error they find
involving patient harm will be subject to public reporting, few
will undertake the costly and difficult investigations that are
necessary to discover errors. If public disclosure and
punishment await those who dig effectively to find the true
extent of errors, few errors will be found, and fewer still
will be eliminated.
Congress has repeatedly recognized the importance of
maintaining confidentiality for sensitive internal hospital
quality improvement activities. For example, Federal law
ensures that confidential data reported to PROs shall not be
disclosed. Congress can ensure confidential treatment of this
information by requiring that error reports be sent to the PRO
in each state. The current PRO statute protects such
information from unauthorized disclosure. Public reporting of
errors should be reserved for those institutions identified by
the PRO that cannot or will not improve error rates.
At the state level, aggregate information without
identifiers for individuals or institutions could be released
to the general public. Data reported at the national level
would first be encrypted for aggregate public reporting and
would then be considered a publicly accessible dataset.
5. Establish a Mechanism to Find Unreported Errors.
Experience with other mandatory reporting systems for
errors and health quality problems reveals that no mandatory
reporting system will receive all appropriate reports. A
separate mechanism to identify unreported errors is needed. One
such system is already in place nationwide. Individual PROs
periodically request records and analyze them for indicators of
errors such as delayed administration of antibiotics in newly
hospitalized pneumonia patients, and missed opportunities to
prescribe medications to heart attack and heart failure
patients. In addition, the national PRO program also utilizes
clinical data abstraction centers (CDACs) to accomplish this
task. These centers also observe strict confidentiality in
managing the records, and have achieved a high degree of
reliability in finding and reporting errors to PROs, which then
work with the hospitals to prevent their recurrence. This
system can be utilized to find many more types of errors.
Institutions should be required to provide information in
response to a PRO request to actively identify or pursue
information that may not be readily identifiable in
standardized reports. This mechanism will help to ensure the
integrity of the mandatory reporting system, as it may uncover
reports that should have been filed with the PRO but were not.
6. Promote Best Practices.
Once errors are found, their causes must be understood, and
solutions must be implemented. This is now accomplished through
the national Medicare PRO program by collecting from each PRO
their successful interventions to improve care, and then
sharing it with all the rest. In this way, every PRO can
approach local institutions with the benefit of the best
knowledge of all the PROs and providers that have previously
tried to solve a problem. By assisting hospital personnel in
finding best practices, the PROs go far beyond merely holding
hospitals accountable for their failures.
7. Separate Malpractice Reform from the Error Reduction
Program.
Tort reform and facilitation or limitation of litigation is
a matter for a separate set of public policy deliberations. All
information should be reported to the PROs for the purpose of
assuring that measurable quality improvement is accomplished.
Neither regulatory remedies nor liability law need be affected
by reports to the PRO or by the confidentiality protections
afforded such reports.
AHQA believes these are the basic elements necessary for
creating a systematic approach to reducing medical errors that
will assure both medical professionals and patients that the
problem is being addressed fairly and effectively. The key to a
successful solution to this problem will be giving the medical
community the opportunity to fully identify the possible extent
of their errors and do the work necessary to systematically and
measurably improve. Without this measurable improvement, the
problem will continue to be discussed but never solved and
consumers will never be assured that the quality of their
medical care will become any better. The nation's QIOs can
provide the accountability and results that the system will
require.
Thank you again for the opportunity to share this
information with Congress. I look forward to continued
discussion as you work to improve the safety of patients across
America.
National Health Quality Improvement Projects of Medicare PROs 1999-2002
----------------------------------------------------------------------------------------------------------------
Quality Indicators (proportion of Data Sources (Medicare
Clinical Topic beneficiaries receiving:) FFS Only) Expected Health Outcomes
----------------------------------------------------------------------------------------------------------------
Acute MI Early administration of Hospital medical Inpatient
aspirin on admission records for AMI patients mortality rates
Early administration of beta Mortality rates
blockers on admission at 30 days
Timely reperfusion Mortality rates
ACE inhibitors for low left at 1 year
ventricular ejection fraction Readmission
Smoking cessation counseling rates with AMI CHF
during hospitalization
Aspirin at discharge
Beta blockers at discharge
CHF Angiotensin-related drugs Hospital medical Inpatient
for left ventricular ejection records for heart failure mortality rates
fraction when appropriate patients Mortality rates
at 30 days
Mortality rates
at 1 year
Readmission
rates w/CHF
Pneumonia State Influenza vaccination Flu and Hospital
rate pneumonia immunizations-- admission rates
State Pneumococcal Claims or survey similar Hospital
vaccination rate to CDC's BRFSS readmission rates
Inpatient Influenza Other Inpatient
vaccination (or screening) indicators: Hospital mortality rates
Inpatient Pneumococcal medical records for Mortality rates
vaccination (or screening) pneumonia patients at 30 days
Blood culture before Readmission
antibiotics are administered rates with Pneumonia
Appropriate initial empiric
antibiotic selection
Initial antibiotic dose
within 8 hours of hospital arrival
Stroke/TIA and Discharged on warfarin, Hospital medical Inpatient
Atrial aspirin or other antiplatelet drug records for stroke, TIA, mortality rates
Fibrillation (stroke or TIA only) and chronic atrial Mortality rates
Discharged on warfarin fibrillation patients at 30 days
(chronic atrial fibrillation only) Readmission
Avoiding inappropriate use rates with stroke/TIA
of sublingual nifedipine (stroke or
TIA only)
Diabetes Biennial retinal exam by an Claims for all Mortality rates
eye professional diabetic beneficiaries at 1 year
Annual HbA1c testing Rate of
Biennial lipid profile development of diabetic
retinopathy
Rate of
development of ESRD
Breast Cancer Biennial mammography Claims for all Percent of new
screening female beneficiaries cases of breast cancer
detected at stage 1
----------------------------------------------------------------------------------------------------------------
Chairman Thomas. With all due respect, Dr. Golden, a major
portion of your testimony sounded like a job interview.
Dr. Golden. Sure.
Chairman Thomas. You mentioned doing root cause analysis.
Dr. O'Leary mentioned that they were engaged in root cause
analysis. That sounds like a deep ``why'' probe is what it
sounds like. Is that what it is?
Dr. O'Leary. Why, yes.
Chairman Thomas. Okay, a deep ``why'' probe, root cause
analysis. Did you say, Dr. Golden, that you do it or that you
need to have an agency that does it? Do you do root cause
analysis?
Dr. Golden. We facilitate it. As I said, most----
Chairman Thomas. What does facilitate versus do it mean?
Dr. Golden. As I said, we are doing data analysis to find
rates of errors. We are suggesting improvement mechanisms to
eliminate those errors. Some of these projects, we give to our
collaborating institutions, and I will say right now that the
average project we do attracts two-thirds of the hospitals in
our State. We give them turnkey projects to effect fundamental
system changes within those facilities.
Now, every now and then, you run into an institution--I
will give you an example--which is an outlier that has a unique
set of problems. We had one hospital that had a very high rate
of bypass mortality. We--
Chairman Thomas. You have lost me to a certain extent.
Dr. Golden. Sorry.
Chairman Thomas. My question was, do you do deep root
analysis? Do PROs do deep root analysis?
Dr. Golden. We do not do analysis of single-case events. We
find experts to assist. What we do do is evaluate systematic
reforms.
Chairman Thomas. That is fine.
Dr. Golden. So that is a different issue, different kind of
errors.
Chairman Thomas. I understand.
Dr. Golden. Right.
Chairman Thomas. You do a lot of other things, but one of
the concerns I have is that there may be a drive to provide a
one-basket approach, and my concern is that if, in fact, there
is expertise out there in a number of different areas, one, I
do not want to duplicate or reproduce it----
Dr. Golden. Absolutely.
Chairman Thomas.--and two, I want to make sure that we
maximize the opportunity of the information flow so that those
who are performing functions can continue to perform them.
Dr. O'Leary, you----
Dr. Golden. We facilitate that deep root analysis and get
the experts.
Chairman Thomas. Right. I will not ask the obvious
question. But Dr. O'Leary, the question I do want to ask is,
did you find the hospitals as receptive as the statement that
Dr. Langberg kind of intimated, that they had no problem at all
accepting the sentinel reporting structure? Did you have any
difficulty getting that system up and running? Were the
hospitals fully cooperative, in your opinion?
Dr. O'Leary. Well, I do not think it is any secret that
there were a broad base of concerns, that those concerns were
driven primarily over the potential waiver of confidentiality
if they shared that information with us, and in fairness, there
are now some State laws that protect that sharing. But there
had been very little testing of existing peer review statutes.
I will tell you that there are a large number of organizations
who said that they would be pleased to share with us the
occurrences and the root cause analyses if such protections
were in place, and I accept that on good faith.
Chairman Thomas. Does it make sense to go ahead, as was
indicated by several others, that we need to continue to have a
State-based structure? I mean, it is going to remain, given the
police powers of the State in terms of health and welfare, but
would it not facilitate things if we provided a shield at the
national level for the confidentiality, the collection of data,
so that you would have a uniform structure nationwide,
notwithstanding what may or may not be done in the State?
Dr. O'Leary. I think that is absolutely crucial. The time
it would take to pass----
Chairman Thomas. Now, let me get this straight. You are a
private sector operation?
Dr. O'Leary. Yes.
Chairman Thomas. And I am a Republican?
Dr. O'Leary. Yes.
Chairman Thomas. And we just both came to agreement on the
idea of a national uniform structure?
Dr. O'Leary. There are certain compelling needs, and this
is one of them.
Chairman Thomas. I think somebody is going to come to the
conclusion that that is what should be driving this process. It
is too important to get down into the gutter of politics or
anything else, and we are going to do everything we can to do
it as best we can.
I just have a lot of confusing information and I want to
ask, Dr. Bagian, did I hear you say that you really have kind
of like the FAA system, where it is kind of an all-comers
reporting, that you accept voluntarily, although you do have
the mandatory? Do you find that to be an information overload
in your structure?
Dr. Bagian. No, sir, at least not yet. One of the things we
have, we have a mandatory system. We also have a voluntary
system that we are in the process of putting in place. It is
not fully in place. If you would ask Linda, I mean, I have
known Linda for 20 years and Charlie Billings back when I was
at NASA, so I am familiar with their program. They sometimes
see different things from the mandatory systems as opposed to
the voluntary system. For example, there is mandatory
reporting. And then there is the ASRS you heard about. They in
certain cases can compare reports from the different systems; I
mean, it is the same event. The stories are not always the
same. It is the same incident we are talking about, but the
story you tell the cops----
Chairman Thomas. Between the mandatory and the voluntary?
Dr. Bagian. Yes, sir.
Chairman Thomas. The coerced and the uncoerced?
Dr. Bagian. I do not know if that was the term I would use.
Chairman Thomas. Okay.
Dr. Bagian. The one where you are more fearful than the
other. Let us put it that way. At any rate----
Chairman Thomas. That is better, yes.
Dr. Bagian. I think what they found, and you should ask
Linda to tell you about that, the issue is that you get
valuable things from both. That is not to say that the
mandatory system, where you are in fear because it is
disclosable, you do not get anything valuable. You do. But they
are synergistic. You learn different things from both, and they
both are essential.
One thing I might point out that I did not mention before
is about close calls. You heard many comments about the need to
get those severe, you know, the deaths, the severe thing. We
think that misses the point by a lot.
Chairman Thomas. Yes. You do not learn----
Dr. Bagian. That is right. I mean, if we have to stack up
the bodies like cordwood to learn, that is kind of like the
hard way to learn. That is not really very progressive. What
you want to do is you want to look at close calls, the risk
thereof, as they talk about in the Joint Commission's
definition of single event, and we think that is very powerful,
because several things have been shown in the aviation world.
Often, you can learn as much or more from close calls, because
people are more likely to be candid because it is kind of--this
is not a word--not tortable, right, if there was no damage. But
yet, people can talk about it more candidly----
Chairman Thomas. There are more of them around to talk
about it.
Dr. Bagian. And there are also more around to talk, that is
correct. So we have emphasized very heavily to do the whole
thing. The IOM report segregates it and says mandatory is just
the real serious ones and voluntary is the other, and we
disagree with that. We think you want to look at both, the
whole thing, because you weave them together to learn even more
than just saying that you want to look at one versus the other.
We think that close calls are a very important thing not to
lose sight of.
Chairman Thomas. Okay, because that is one of the concerns.
Now, have you had a breakdown of your system yet where
information has been leaked, or have you been able to keep a
lid on it?
Dr. Bagian. So far, no problem yet, and we emphasize it
very clearly that that is an integrity violation and it will
not be tolerated.
Chairman Thomas. I mean, it is very difficult sitting here
when one of the first arguments is that you cannot have
everybody reporting, that humans always make mistakes, and that
even if you go to a computerized structure, you are going to
push the wrong button. At some point when you go through those
explanations, they quit being explanations and they start
becoming excuses. My concern is that I am already hearing what
I consider to be some excuses as to why you cannot do a
relatively broad-based approach.
Dr. Kizer, what I really liked in the ten points that you
had in your written testimony was that you addressed what we
have been alluding to and sometimes specifically referred to,
and that is going back to the education structure and getting
into the teaching hospitals and into those support, both the
professional and quasi-professional, and figuring out how to
change the curriculum so that you can begin to do that
systematically.
I find, interestingly, that the first thing I get out of
most of these folk is we have to spend more money, we have to
set up additional structures, and if, in fact, we are dealing
with behavior and systems, there is a mental approach to
behavior which allows the system to function that you do not
necessarily have to spend a lot of money on, and that is
basically behavioral alteration.
So if we have to write off today's current professionals,
we ought to at least make sure that as we make these changes,
we get down in there early, and I am not just anxious to set up
a Federal agency to collect data to get the why and begin to do
that. I am very anxious to get some help in exactly where there
are people who are doing this.
Do you do any kind of, and notwithstanding the fact that
you are no longer there, do you do any in-service training in
the VA? Have you found that you have to set up a parallel
program for those that are there to do training, to get people
to understand, notwithstanding the fat that you put up a
voluntary system and you can report? Even if it is voluntary,
there are people who will be hesitant to do it because they
have not been in that situation before. You have to create an
environment of support, not just here is the environment.
Dr. Kizer. It goes beyond that. The VA actually put in
place a requirement, a continuing education requirement for our
existing practitioners, not the usual continuing medical
education but a requirement specifically on quality improvement
and patient safety that went beyond what is required, and as
far as I know, that is unique in the nation.
But they also----
Chairman Thomas. Now, was that an integral component of
putting this plan in place or did you realize you had to have
it as you were going along?
Dr. Kizer. It was one of the areas where we knew that we
had to change the behavior of the existing cadre of folks. You
also have to look at the next generation and put in place
things to deal with them, so it requires a multi-faceted
approach. Recognizing the culture and the barriers that exist,
VA also has a financial rewards system where practitioners can
actually get financially rewarded for identifying problems and
solutions. But it is trying to change the dynamics from one of
hiding the information to one were it is the norm that you come
forward and you are as forthright and open as possible.
Chairman Thomas. But can you not at least get into that
aspect of this readjustment we need to make on a carrot and a
stick basis? That is, you reward those institutions and other
places that are doing those sorts of things, not the question
of the transmission of the data itself, which has to be in a
positive, supportive structure.
But it seems to me that one of the problems, and we have
not really talked about it, is that we do not have the ability
to collect the data, or we are beginning to get the ability,
and even if we have it, we still do not have in place, except
for maybe structures like yours that can impose it, kind of a
best practices procedure so that once you get the data, it can
get out there and actually be converted into a workplace
change.
In that sense, we ought to be able to reward and withhold,
if not punish, for people who are picking up and making the
changes that clearly have been indicated are the appropriate
way to go. I think the medical culture causes problems there
again, because now you are telling me how to practice the art
of medicine for which I am my own best definer.
Dr. Kizer. There is no question that there is much that
could be done in reimbursement strategies and how health care
is compensated that could get at the issues that you are
talking about.
Chairman Thomas. I am actually going to be looking, and I
know you folks do not have a lot coming out the other end of
the pipe yet, but from what I have heard, it sounds to me like
we have got a little bit of a microcosm here that has got a
number of pieces in place. Now, obviously, the liability
question is different and that is something we have to look at
over in the other area.
But one of the things I hope people realize on this, and I
hope in terms of the legislation, if we do move legislation
this year or whenever we move legislation, is that it is not to
do something simply to react to the publicity that occurred,
and I am always concerned about that. But I do think there are
some overdue at least first steps or positive steps about the
control of information, the flow of information, the assisting
in the collection of information, that certainly would lay a
foundation for us to move forward, where governmental agencies
or quasi-governmental agencies, although they may be thought of
that way, and private commissions and agencies are going
forward.
Now, I know that some people are going to be suspicious of
the IOM report and its data and most of the beginning dates of
a lot of activities and they seem awfully close to what is
occurring now, and my assumption is that it is just the
timeline of the awareness. As you indicated, maybe the aviation
industry was in the 1970s, the 1980s, and the medical
community's time period is in the 1990s and the first few years
of 2000. If that is the case, we will accept the very
interesting coincidence of the movement in this area.
My hope is that as much on a voluntary basis as we can,
that we could move forward, but I am having a difficult time
now accepting the belief that a totally voluntary structure
will produce anywhere near 50 percent reduction in the time
frame or a mandatory will create the climate which will allow
us to build on what we are doing and move it forward as an
ingrained culture rather than as another structure over which
we are going to fight in terms of whether it helps or hurts.
The gentleman from California.
Dr. Golden. Mr. Chairman, can I give you a piece of good
news, at least?
Chairman Thomas. Yes, Dr. Golden. I am looking for it.
Dr. Golden. I know you had concerns when you had talked to
Dr. Cassel about the physicians' attitude toward data and
changing performance, and I have been giving physicians' data
for seven years in my State and I can tell you that when they
see clinically pertinent data, they do respond. I have gotten
two unsigned hate letters in seven years, and I can tell you
now I send data to----
Mr. Stark. Did they have a big red crayon?
Chairman Thomas. Could you read the handwriting?
Dr. Golden. No. Actually, one was from the east side of the
State, one was from the West, but that was when we first
started mailing to doctors' offices directly performances, and
we get on average over 150 offices responding back to us now
saying they were going to implement things in response to data
on performance Statewide. So I think things are better than you
think.
Chairman Thomas. But also, in listening carefully to the
aviation field structure, what was said if we were listening
carefully was that when you are dealing with this data, they
have pilots talk to pilots, air traffic controllers talk to air
traffic controllers. They find a relationship in which there is
a common understanding that you are in my business and we are
all in this together, which is not always the case in the
hierarchial structure of medicine. To the degree that we can
learn from that, that also would be helpful.
The gentleman from California.
Mr. Stark. Thank you, Mr. Chairman, and I thank the panel.
I guess, just quickly, Dr. Bagian, can you just very quickly
give us some indication of whether on a dollars and cents
basis, your program for quality in the Veterans Administration,
has it saved you money, cost you money? What has been the
result? Can you document that for us?
Dr. Bagian. That is one of the things we are looking at, to
look for the business case, if you will. We do not have enough
data to give you that answer, but we suspect for a whole host
of reasons when we do the whole accounting, but we do not have
any data to supply at this time.
Mr. Stark. If you save money, let us know. If you do not,
shred it, okay?
Dr. Bagian. We certainly think that is important. We will
look at it. But it is the right thing to do, too. We do not
think you can do anything but do it. We think you cannot lose.
Mr. Stark. Dr. Kizer, your organization has got some, I
guess, 29 standard performance measures that you have
identified, maybe more now, I do not know, and my question, I
guess to the panel, is does anybody feel that we should not try
and develop and use standard performance measures for various
aspects of quality control, that a single set of those
performance measures should be used nationwide, and that the
hospitals should be required to make public their progress in
meeting these standard performance measures? Does anybody find
anything wrong with that?
I mean, I think that is different from reporting serious
errors, but some way to measure--I guess I do not know whether
they do it with airlines. They do it with passenger complaints.
I am not sure that is a very good standard.
Dr. Kizer, do you think that mandatory reporting has a
place in this whole system? I mean, that is what IOM
recommends. Do you want to comment?
Dr. Kizer. I believe there is a set of events we can define
that that are important both from a quality improvement and a
public accountability point of view; there are certain things
that just should not occur in health care today and that the
public has a right to know about them.
It is a fairly short list of things. I think some have
alluded to them already, things like wrong-site surgery or
perhaps medication error deaths or death during childbirth,
things that just are not what one would expect today. I think
that it would actually be quite possible to garner consensus
among the health care professionals about that list of things
that would be mandatorily reportable.
I think the list of things that one might want to maintain
confidential is a much longer list, things involving judgment,
particularly professional judgment, was it a premature death,
was it unexpected, those type of things. But there is a set of
information that really should be available for public
accountability purposes.
Mr. Stark. Dr. Golden, I suggested earlier to the Hospital
Association and the AMA that they might like to use PROs as the
group that would oversee any kind of a reporting system, and I
got the sense that they dismissed the PROs as merely another
bureaucratic governmental agency. It is my understanding that
your funding comes as a government contractor, but do you want
to differentiate yourself from Lockheed or other government
contractors?
Dr. Golden. All the PROs are independent corporations, if
you will. Some of them have different structures. But we have a
contract with HCFA to perform tasks in our environment.
As a member of the AMA House of Delegates off and on for 20
years, I know that the approach, the quality improvement
approach of PROs over the last seven years, has been very
positively reviewed, and, in fact, the AMA House with their
reports have said so. They have found the educational approach
to be very much to the liking of the organization and its
members.
I think that they get nervous about government, but there
is no question that in terms of relationships locally between
PROs and physicians and hospitals, we have seen a great
improvement over the last several years and it is a very
collaborative and constructive relationship at this point.
Mr. Stark. JCAHO, Dr. O'Leary, was set up in 1965 to create
the oversight of quality in the hospital structure, was it not?
Dr. O'Leary. Yes, sir. The Joint Commission was established
in 1951. The Medicare Act created the deeming relationship in
1965.
Mr. Stark. Why did it take you until 1999, according to
your testimony, January of 1999, to develop explicit patient
safety standards?
Dr. O'Leary. Well, let me clarify.
Mr. Stark. That was 35 years, if you do not count going
back to 1951, which even makes it longer. What was the problem?
What were you doing all that time?
Dr. O'Leary. Let me clarify that a large number of Joint
Commission standards are patient safety standards in the sense
that they reduce the risk of untoward occurrences, whether we
are talking about credentialing and privileging standards or
environmental safety standards or patient assessment standards.
The particular standards that we referred to are standards
specific to error identification or reporting inside
organizations, where we now require organizations to set up
processes or a plan, in line with your previous question.
Mr. Stark. What was the problem in getting that done? What
took you so long?
Dr. O'Leary. I think it was the realization that the
problem that we were experiencing had probably less to do with
organizations not reporting errors to us than the fact that
they were not--errors inside organizations were not made known
to the leaders within organizations and it dawned on us that we
had not really created a requirement that organizations create
systems to identify serious adverse events and require internal
reporting and internal root cause analyses and the development
and implementation of action plans.
So those specific standards to which that refers are those
standards. You are requiring an internal plan, which was the
question you asked earlier, inside organizations to surface
these events and deal with them.
Mr. Stark. So it took you 35 years to figure that out?
Dr. O'Leary. At least that, yes.
Mr. Stark. Thank you, Mr. Chairman.
Chairman Thomas. Thank you. I do not remember whose
testimony it was off the top of my head when I read it, but it
may have been on this panel. It was an example of the Salt Lake
City hospital situation, where there were 20 reported, and then
when you went back and did an analysis inside the structure,
there are actually 582. And by going back and doing it in a
more systematic way, they actually wound up reducing it below
the original 20 that were reported.
That, to me, in a nutshell, is kind of where we want to go,
and that is we have got to set up a structure that allows us to
systematically address what is really there because we can make
the corrections. It has been proven over and over again. It is
just that cracking this nut of the culture of medicine and
truly putting in place structures which provide a comfort level
for all, in my opinion, to report and then deep root analysis
so that you can make the kinds of changes.
But what scares me the most is, and I guess it is the
phrase low-hanging fruit, that low-hanging fruit has been
hanging there for a long time and maybe this publicity will
allow some folks to pick it. But my fear is, picking the fruit
makes it look like movement has been made. There has been no
systemic change, and we will have lost the opportunity to get
in, and I am very, very nervous about that. That is why I want
to make sure that we put at least some structure in place
fairly quickly on, for want of a better term, an exoskeletal
aspect of it, which would be liability or data collection that
will allow the forces that seem now to be working to work in an
environment in which they can actually perform better.
I do not know that I want to put in place a total
structural approach which will do government mandatory, deep
root, and the rest of it, but I do think we have to, I think
sometime this year, create an environment which is nurturing
and supportive of clearly, whether it started in 1999 or not,
the willingness apparently to go forward. We have got to give
you some of those tools.
I want to thank you folks. We are going to be back to you.
Do not want for me. If you have got any additional information
or direction or if you are alarmed by some of the legislation
that is moving, I would appreciate a candid analysis of what is
out there as legislation forms in terms of whether or not it is
actually a help or a hindrance or if there are pieces of it
that are better than not. We desperately need your help, your
expertise, and your experience.
The gentleman from California.
Mr. Stark. I agree, and just a couple of anecdotes that may
be helpful--just this last week, we heard about a report in
Charlotte, North Carolina, where they found 28 questionable
deaths in JCAHO-accredited mental health facilities, and yet
JCAHO only knew about two of them. Now, that may not be their
fault, but it indicates that it does not sound like people are
stepping right up to report.
Then in our own State, we must have at least twice the New
York State population, both of our States have mandatory
reporting, New York and California, yet we reported in 1998
4,337 reports of serious events, and New York had some 15,000
to 20,000 reports. Now, we have to come to some kind of closure
on what is different and why this huge difference in reporting.
Chairman Thomas. It may very well be the definition of a
serious event.
Mr. Stark. Yes, there may be a lot to it, but I think that
is the problem.
Chairman Thomas. But the point is, we have got to get to
the bottom of it.
Mr. Stark. Somehow, we need to find a way that we are
collecting these data and then we can act on it, I think, or
the institutions can act on it. So I look forward to working
with you.
Chairman Thomas. Based upon the statement you just made, I
do not think I have to make the following statement, and that
is what we heard, if we did not hear anything, was not to set
up a system which is punitive, accusatory, but rather open,
voluntary, looking for professionals to be able to operate.
Stating any kind of evidence based upon the current lay of the
land, to me, is relatively less useful than to begin to figure
out how to set up a structure in which we can move forward.
Personally, I am not interested in jettisoning anybody off
of this vehicle of trying to reduce the staggering number of
medical errors that produce deaths greater than what occur on
the highway from cancer or from AIDS. I am enlisting everybody
in both a voluntary and a mandatory effort to turn this around.
Thank you all. The subcommittee stands adjourned.
[Whereupon, at 2:06 p.m., the hearing was adjourned.]
[Submissions for the record follow:]
Statement of the American Academy of Orthopaedic Surgeons, and American
Association of Orthopaedic Surgeons
The American Academy of Orthopaedic Surgeons and the
American Association of Orthopaedic Surgeons (AAOS),
representing 18,000 members, appreciate Chairman Thomas'
initiative in holding this hearing to address patient safety
and the recommendations of the recent Institute of Medicine
(IOM) report, entitled To Err is Human: Building a Safer Health
System. We would like to offer our perspective on the report
and welcome the opportunity to work with you and other members
of the Subcommittee as you consider appropriate policies with a
goal toward reducing medical errors. We would also like to
share with you some highlights of our work over the past
several years to reduce or eliminate specific types of surgical
errors.
We share your concerns and those expressed in the IOM
report that ensuring patient safety in hospitals, as well as
other practice settings, must be given appropriate attention.
AAOS is committed to the elimination of medical errors and has
designated this as a high priority in the policies and
practices of the AAOS. High quality patient care is the crux of
AAOS' Principles of Medical Ethics in Orthopaedic Surgery and
we have strived to create an expectation of high quality care
and to assist our members in the practice of safe care by
making this an important focus of our education program.
More than a decade ago, the AAOS Board of Directors decided
to commit significant financial and clinical resources into the
development of a Continuous Quality Improvement Program (CQI)
to help provide ``Best Care'' for our patients. The ``Best
Care'' philosophy has been a cornerstone of the strategic plan
of AAOS. Accordingly, clinical guidelines have been developed
to serve as common treatment protocols for a number of
musculoskeletal conditions. Corresponding outcomes instruments
allow for the evaluation of patient outcomes, by identifying
factors, including medical errors, associated with positive or
negative patient outcomes in order to initiate change in the
treatment guidelines. This process of Continuous Quality
Improvement thus drives treatment towards optimum or ``Best
Care.'' The AAOS is a recognized leader in this area.
AAOS also has developed programs to address specific
medical errors. In September 1997, AAOS established a task
force to examine surgical errors and recommend prevention
safeguards for the operating room. The task force developed
``Sign Your Site,'' a protocol whereby before surgery, the
surgeon checks the patient's chart and any radiographs, the
patient identifies the correct site and side to be operated on,
and then the site is marked with the surgeons initials using a
permanent marking pen. The surgeon then operates through or
adjacent to the initials. AAOS launched a major educational
program among its members to eliminate wrong-site surgery, and,
by mid-1998, AAOS mailed information to 19,000 operating room
supervisors and surgeons in other specialties.
Numerous hospitals throughout the country have responded
positively to this campaign, and mandatory ``Sign Your Site''
programs have been initiated at an increasing number of
hospitals. The AAOS has provided information on the ``Sign Your
Site'' program at the request of the Joint Commission on the
Accreditation of Hospital Organizations (JCAHO), the Physician
Insurers Association of America and other organizations
committed to reducing medical errors. AAOS believes that a
unified effort among surgeons, hospitals and other health care
providers to initiate pre-operative and other regulations is
helping to prevent surgical error.
Like many similar initiatives, feedback from the ``Sign
Your Site'' campaign offers invaluable insight into the
administrative operations of hospitals and other provider
institutions to study how to reduce medical errors. What we
have discovered in launching this campaign is that such efforts
require long-term commitments and resources involving ongoing
communication and research to ensure success. From our
experience, we would caution you that policies cannot
underestimate the planning involved. A comprehensive campaign
requires intensive ongoing communication, networking,
surveying, monitoring, research, feedback and education. That
is one reason that the AAOS campaign was conceived as a multi-
year effort.
Since 1990, the AAOS Committee on Professional Liability
also has conducted a series of closed-claim professional
liability insurance studies, through on-site retrospective
review of the records of insurance companies across the
country. Most major orthopaedic diagnoses and procedures have
been studied, including foot and ankle surgery, spine surgery
and spine fusion, total hip and knee replacement, knee
arthroscopy, fractures of the hip, femur and tibia, and
pediatric problems, in order to assist orthopaedic surgeons in
providing optimum patient care. Many articles and two books
have resulted from these studies--the purpose and result have
been to identify trends in unexpected outcomes and medical
errors, to provide risk management, and to promote safe and
appropriate surgical practice. This guidance emphasizes
thorough patient consent discussions about treatment options
and alternatives, risks of treatment, non-treatment, and
patient expectations regarding eventual functional ability
after treatment.
We commend the IOM for undertaking such an important study.
Several critical points have been raised in the report that
must not be overlooked when defining appropriate policies.
Medical error is a multifaceted, complex issue. The
comprehensiveness of the report alone illustrates the daunting
task required to determine how to proceed. AAOS believes that:
Policies must first determine, by supporting
research, whether and how current medical error reporting
programs, as well as prevention initiatives, have lead to
reduction in medical errors.
Funding must be available to redesign systems
based on research findings and costs to hospitals and other
providers for implementing these systems must be considered.
Access to medical error data under the current
liability system must be carefully and thoroughly analyzed and
mechanisms for reporting must ensure patient and provider
confidentiality and expand peer review liability protections.
Resources must be available to communicate
information on patient safety practices to hospitals, other
institutional providers, health care professionals and
consumers.
Promotion of a system of Continuous Quality
Improvement is among the best ways to provide patients ``Best
Care'' and to eliminate medical errors. The traditional Quality
Assurance (QA) method is a judgmental, confrontational and
punitive approach, which is likely to negatively impact
relations between physicians, patients and government.
Patient safety is paramount and medical error reporting
should lead to improvements in patient safety. As the IOM
report points out, the underlying objective is to prevent
patient harm. An important focus of legislation should be to
examine existing mandatory and voluntary reporting systems
across the states to determine if and how this information can
be utilized constructively to prevent and reduce the number of
medical errors. The progress of prevention programs and
demonstration projects in reducing medical errors should also
be examined. Follow-up is critical. Without some clear
direction on how to integrate the results of the research into
the health care system, you risk prematurely raising
expectations that reporting will lead to a reduction in medical
errors. It is disconcerting that, as the IOM report points out,
while approximately one-third of the states have implemented
mandatory adverse event reporting systems, there is no
indication that these systems have resulted in safer
environments for patients and this data has not been utilized
to assist in reducing medical errors.
The AAOS is encouraged by the IOM report's discussion of
the need to create a culture of safety in reporting. If new
reporting requirements, whether mandatory or voluntary, are
legislated, then the approach should encourage open and candid
discussions and disclosures through non-punitive mechanisms for
reporting that ensure patient and provider confidentiality and
expand peer review protections. Even if the reporting is
institution-based and not individual-based, or just voluntary
and not mandatory, implications for the availability and use of
such data may result in unintended consequences. Discovery
rules and statutes governing access, entitlement and use of
such information must be carefully scrutinized. Policies must
require appropriate definition of the type and use of data
necessary for a successful medical error reporting program, as
well as the process for reporting. A successful effort will
require careful planning of the many critical components of a
reporting mechanism.
The difficulty in finding the right balance to prevent a
punitive approach is evident in the IOM report itself. The
report seems to send contradictory messages by expounding on
the importance of creating a safe reporting environment on the
one-hand, yet maintains that confidentiality is not appropriate
for mandatory reporting systems. The impact of such reporting
systems on patient confidentiality rights and provider peer
review laws requires careful scrutiny. The AAOS is particularly
concerned with the report's recommendation to proceed with
reporting requirements, including mandatory reporting, while
recognizing that the current liability system is not conducive
to reporting and analysis.
AAOS also believes that physicians and other health care
professionals are already held accountable through a well-
established punitive-based judicial system, as well as
licensing structures and ever-more-complicated accrediting
processes. These systems are designed to substantially serve to
prevent patient injuries and ensure good quality patient care.
We believe all entities involved in making medical decisions
should be equally accountable. But additional systems with
punitive undertones could defeat efforts to foster an open
dialogue on medical error and patient safety.
Federal legislation should recognize the need to proceed
with caution and with careful planning before medical error
reporting is required or encouraged of hospitals and other
health care providers. Consideration should be given to funding
studies of existing data of mandatory and voluntary reporting
systems, demonstration and prevention projects, and
dissemination of information on patient safety. Funding should
encourage private/public partnerships in these efforts. Careful
consideration of the legal and statutory requirements governing
the use of medical information should be required prior to
implementation of any reporting systems, regardless of type or
scope.
We appreciate the leadership of Chairman Thomas and other
members of the Subcommittee in drawing attention to the
findings of the IOM report, To Err is Human: Building a Safer
Health System. Please consider consulting with a broad range of
the medical community, recognizing expertise in specific areas,
and examining and involving efforts already underway through
private funding.
Thank you for taking the time to consider our comments. We
look forward to working with the Members of the Subcommittee
and other Members of Congress as you assess the need for
legislation to address medical error reporting.
Statement of American College of Physicians-American Society of
Internal Medicine
The American College of Physicians-American Society of
Internal Medicine (ACP-ASIM), representing over 115,000
physicians who specialize in internal medicine and medical
students with an interest in internal medicine, appreciates the
opportunity to comment on the report of the Institute of
Medicine (IOM), To Err is Human: Building a Safer Health
System. Our membership includes practicing physicians, teaching
physicians, residents, students, researchers, and
administrators who are dedicated to assuring high quality
medical care.
The IOM report highlights unacceptable quality and safety
problems in the nation's health care system. The report reveals
that more people die each year as a result of medical errors
than from motor vehicle accidents, breast cancer, or AIDS. It
notes that medication errors alone account for over 7,000
deaths annually. This is a dismal record that exceeds the 6,000
deaths each year due to workplace injuries. Significantly, the
IOM report finds that ``the problem is that the system needs to
be made safer'' and indicates that the ``problem is not bad
people.''
The IOM report concludes that the U.S. health care industry
lacks a systematic way of identifying, analyzing, and
correcting unsafe practices. In order to achieve this end, the
report states: ``Preventing errors means designing the health
care system at all levels to make it safer. Building safety
into processes of care is a more effective way to reduce errors
than blaming individuals. The focus must shift from blaming
individuals for past errors to a focus on preventing future
errors by designing safety into the system.'' The report lays
out a comprehensive strategy for addressing these problems. It
challenges the profession to make significant changes to
achieve a safer health care system. We accept this challenge.
ACP-ASIM offers the following comments regarding specific
recommendations in the IOM report:
Creation of a Center for Patient Safety (IOM Recommendation
4.1):
ACP-ASIM agrees with the IOM recommendation that a highly
visible center is needed with secure and adequate funding to
set national goals, evaluate progress, and develop and
coordinate a research agenda to achieve improvements in patient
safety. We firmly believe that such an effort should involve
the many private sector initiatives that are also now underway.
We concur with the IOM that a coordinated national effort is
needed and that adequate and stable funding must be assured. If
the center is to be housed in a federal agency, it should be in
a non-regulatory agency such as the Agency for Healthcare
Research and Quality (AHRQ). A coordinated program for research
and achievement of national goals for improvements in patient
safety should be as objective as possible and should not be
tied to a federal agency with regulatory responsibilities. AHRQ
has the expertise and an existing infrastructure for funding
research and coordinating activities concerning health care
quality. ACP-ASIM, therefore, supports increased funding for
AHRQ to accomplish these expanded functions.
Mandatory Reporting (IOM Recommendation 5.1):
The IOM report recognizes the need for both mandatory and
voluntary error reporting systems. It explains that mandatory
reporting systems are needed to hold providers accountable for
their performance. It further advises that mandatory reporting
should focus on the identification of serious adverse events
(deaths or injuries resulting from medical interventions). The
IOM notes that the focus of a mandatory reporting system should
be narrowly defined. It recommends that the Forum for Health
Quality Care Measurement and Reporting (The Quality Forum), a
recently formed public/private partnership charged with
developing a comprehensive quality measurement and public
reporting strategy, should be responsible for promulgating and
maintaining
The IOM report also calls for licensing and accreditation
bodies to expand the scope and magnitude to which patient
safety is reviewed and evaluated in rendering licensing/
accreditation decisions.
ACP-ASIM agrees with the intent of this recommendation, but
is concerned about its possible implementation. We strongly
agree that physicians have a professional obligation to
patients and society to report serious errors resulting in
adverse events. It is appropriate that information on serious
adverse events be reported to appropriate authorities and that
a uniform, national reporting format be developed. We further
agree that a public/private sector body, such as The Quality
Forum, should be responsible for clearly defining what should
be reported and developing the uniform reporting format.
However, we are apprehensive about the possible role of the
federal government in mandating what is to be reported and what
will be done with the data. We urge Congress and federal
agencies not to define reporting requirements too broadly or to
be overly inclusive. We are concerned that mandatory reporting
requirements could be excessively burdensome to institutions
and individual physicians. We, therefore, agree with the IOM
that a more narrowly defined program has a better chance of
being successful.
We also wish to highlight that the IOM calls for devoting
adequate attention and resources for analyzing reports of
adverse outcomes to identify those attributable to error. The
IOM notes that it is only after careful analysis that the
subset of reports attributable to error can be identified and
follow up action taken. We agree with the IOM that the results
of the analyses, not all data that are required to be reported,
should be made available to the public.
ACP-ASIM emphasizes that licensing and accreditation bodies
considering patient safety issues in making licensing/
accreditation decisions should not review every case patient
record, but should review representative samples of patient
care. Patient safety reviews should be completed within a
reasonable time and with minimal disruption or additional
administrative burdens for physicians or institutions.
Voluntary Reporting Systems (IOM Recommendation 5.2 and 6.1):
The IOM calls for voluntary reporting systems to collect
information on errors that cause minimal or no harm. It notes
that voluntary reporting of less serious errors can identify
and remedy patterns of errors and systemic problems. It notes
that the aim of voluntary systems is to lead to improvements in
patient safety and that the cooperation of health care
professionals is essential. The IOM clearly recommends that
voluntary reporting systems must be protected from legal
discovery. IOM further recommends that Congress pass
legislation to extend peer review protections to data related
to patient safety and quality improvement that are collected
and analyzed by health care organizations for internal use or
shared with others solely for purposes of improving safety and
quality.
ACP-ASIM supports voluntary reporting of incidents that do
not result in fatalities or major errors, but could be
symptomatic of systemic problems. However, protection of the
confidentiality of data is essential to ensure that events
involving medical errors or other incidents adversely effecting
patient safety are reported and acted upon. Physicians and
other health professionals have a responsibility to patients
and the public to assure that all actions adversely affecting
the quality and safety of patient care are reported and acted
upon through a system of continuous quality improvement.
However, ACP-ASIM recommends that voluntary quality improvement
systems must protect individual confidentiality. The
confidentiality of reported data must be protected so that
physicians and other health care professionals are encouraged
to report all adverse incidents without fear that their
cooperation will increase their exposure to law suits for
professional liability or other sanctions. Any potential
increased exposure to fines, loss of hospital privileges, or
even possible loss of medical licensure will discourage
physicians from voluntarily reporting ``near misses'' and other
adverse incidents. Consequently, we strongly suggest that any
voluntary reporting system must be primarily educational rather
than punitive.
Nevertheless, ACP-ASIM acknowledges that physicians have a
professional obligation to disclose to patients information
about procedural or judgment errors made in the course of care
if such information is material to the patient's well-being.
Errors do not necessarily constitute improper, negligent, or
unethical behavior, but failure to disclose them may. (ACP-ASIM
Ethics Manual, 1998, p.8-9)
The President's Executive Order
In response to the IOM report, President Clinton announced
on December 7, 1999, that he had signed an executive order
directing a task force to analyze the report and report back
within 60 days about ways to implement its recommendations. He
also directed the task force to evaluate the extent to which
medical errors are caused by misuse of medications or medical
devices, and to develop additional strategies to reduce these
errors. He further directed each of the more than 300 private
health plans participating in the Federal Employee Health
Benefits Program to institute quality improvement and patient
safety initiatives. He also signed legislation reauthorizing
the Agency for Healthcare Research and Quality and providing
$25 million for research to improve health care quality and
prevent medical errors. The AHRQ will convene a national
conference with state health officials to promote best
practices in preventing medical errors. In addition, the
President announced that he was directing his budget and health
care teams to develop quality and patient safety initiatives
for next year's budget.
ACP-ASIM applauds all of these actions by the Executive
branch to address the problems identified in the IOM report.
Issues for Further Review
The IOM report raises many questions that will require
further examination. We urge Congress to consider the
following:
What should be required for mandatory reporting?
Should reporting be required only for the most egregious errors
involving death or serious injury? How will ``serious errors''
be distinguished from ``less serious'' errors? Will mandatory
reporting be cumulative, by institutions or by individual
physicians?
To whom should data be reported? Should it be
reported to state agencies only, to states and the federal
government, or to private agencies?
What data should be released to the public? For
errors causing serious injury or death, what should be the
extent of data released? Should everything be reported or just
the final analysis? Does the public have a right to know the
number of adverse incidents reported by a physician?
What happens to the information that is reported?
Will there be follow-up actions, and if so, will these be
released to the public? Who will have access to the raw data,
and will there be adequate protections of confidentiality?
Should licensing bodies use data on errors to deny
or revoke physician licenses? Should data on physicians be
available to hospitals for consideration in granting or denying
hospital privileges?
How can reporting requirements avoid creating
excessive costs and administrative burdens for physicians and
health care organizations?
Conclusion
ACP-ASIM is strongly supportive of the recommendations of
the IOM report, To Err is Human: Building a Safer Health
System. The College agrees that far too many preventable errors
are committed that do not get reported and that solutions are
needed to improve the quality and safety of patient care. ACP-
ASIM concurs with the IOM's conclusion that the focus must be
the reform of the system, not the punishment of individuals.
ACP-ASIM encourages the profession to take up the challenge
raised by the IOM to improve the quality and safety of patient
care. The College supports setting a national goal of reducing
medical errors by 50% within five years. Such an achievement
will require substantial commitment of resources and effort.
Substantial financial costs will be involved, but these may be
largely offset by benefits in improved patient care and better
health outcomes. Regardless of the costs, the public has a
right to expect health care that is safe and effective. The
profession is responsible to individual patients and to the
public to continuously seek to improve the quality of medical
care and make sure that health care services are provided as
safely as possible.
The College applauds the prompt initiatives instituted by
the President and will look forward to working with Congress in
addressing issues requiring legislative action. However, as we
have indicated, there are many questions that need to be
addressed before a national plan with mandatory and voluntary
reporting requirements can be implemented. ACP-ASIM appreciates
the deliberation that the Committee is giving to the IOM report
and the opportunity to submit testimony. We are prepared to
work with the Congress and the Administration to reduce the
number of medical errors.
Statement of American Osteopathic Association, and American Osteopathic
Healthcare Association
This statement is presented on behalf of the American
Osteopathic Association (AOA) and the American Osteopathic
Healthcare Association (AOHA). The AOA represents the 44,000
osteopathic physicians throughout the United States who
practice medicine and are committed to ensuring the highest
standards of patient care. The AOA is the national professional
organization for osteopathic physicians, and is the recognized
accrediting authority for colleges of osteopathic medicine,
osteopathic postdoctoral training programs and osteopathic
continuing medical education. The AOHA represents the nation's
hospitals and health systems that deliver osteopathic
healthcare or osteopathic graduate medical education. Through a
for-profit subsidiary, the AOHA provides its members with
access to risk management assistance, among other products and
services.
Osteopathic medicine is one of two distinct branches of
medical practice in the United States. While allopathic
physicians (MDs) comprise the majority of the nation's
physician workforce, osteopathic physicians (DOs) comprise more
than five percent of the physicians who practice in the United
States. Significantly, D.O.s represent more than 15 percent of
the physicians practicing in communities of less than 10,000
and 18 percent of physicians serving communities of 2,500 or
less.
The AOA and the AOHA are deeply concerned about the
frequency of adverse events cited by the Institute of Medicine
in its recent study, ``To Err is Human.'' The Institute
reported that between 44,000 and 98,000 patients died or were
injured in 1984 and 1992 as a result of these adverse events.
The members of the osteopathic medical profession have long
supported efforts to improve patient care by drastically
reducing medical errors. In 1945, the AOA's Healthcare
Facilities Accreditation Program (HFAP) was established. The
HFAP is authorized by the Health Care Financing Administration
(HCFA) to accredit osteopathic and allopathic hospitals and
healthcare systems for Medicare purposes. The HFAP assists
hospitals and their staffs in reducing or eliminating medical
errors by developing Quality Monitoring and Improvement
programs that monitor patient safety. On January 27, the AOHA
held its first seminar on improving patient safety and reducing
medical errors. Additional seminars are planned for March 24,
and will be held throughout the year.
The AOA and AOHA generally support the IOM's
recommendations to bolster nationwide efforts to improve
patient safety. We support forums that explore ways in which
healthcare organizations can participate in the effort to
reduce medical errors. The healthcare community can, and
should, expand current activities to identify and address
system failures that lead to medical errors.
The osteopathic medical community will continue its efforts
to strengthen existing quality improvement activities at every
level, including the education and training of medical
professionals and administrative personnel. We do not believe
that the way to improve healthcare is to increase federal
mandates, regulation, and administrative burdens, which could
suppress reporting and inhibit open discussion of adverse
events and medical errors.
The AOA and the AOHA agree with the IOM that it is
important to have reliable information about adverse events
that healthcare professionals can use to assess, analyze and
correct systemic and other failures that lead to such events.
There is potential for such information to enhance the
understanding of medical errors, while preventing future
errors. Unfortunately, there is scant proof among the
approximately 20 states currently reporting such data that the
healthcare systems are any safer in those states than in states
that do not have such reporting.
We do believe, however, that state medical error reporting
programs already in place may offer models for a federal effort
to compile similar data. These should be closely reviewed and
considered before federal action is taken. For instance, the
data now being collected should be analyzed to determine
whether or not the data used in the IOM study is reflective of
the current state of affairs. Additionally, consideration ought
to be given to the development of pilot projects designed to
collect adverse event data. Finally, federal agencies should
use the data compiled by states with mandatory reporting
programs to determine whether their data is comparable with the
IOM's data, which may be outdated.
Outdated data may have distorted the IOM's conclusions
about the alleged epidemic of medical errors. Accurate data
could help federal agencies determine which areas of healthcare
experience the most errors and are most in need of
restructuring. Accordingly, the AOA and AOHA would recommend a
revised study using more current data than 1984 or 1992 as
reported by the IOM.
Mandatory reporting of adverse events presents a number of
serious problems. Healthcare facilities may be reluctant to
cooperate with mandatory (or even voluntary) data reporting if
they perceive that they will be disciplined. It will be
difficult to learn from errors and to improve systems if
facilities and individuals fear that the information will be
used against them. Only after the IOM study and its supporting
data have been analyzed fully and pilot projects established,
should policymakers consider the establishment of a national
database, with either voluntary or mandatory reporting.
If a national effort to gather and analyze adverse event
data goes forward, the information should not be solely
available to federal healthcare agencies. Stripped of its
identifiers, it also must be available to healthcare
facilities, researchers, accreditation organizations, and other
healthcare entities that, in turn, could use the data to
benchmark and monitor changes in the occurrence of medical
errors. In this way, the database would serve as a tool to
promote higher standards of patient care. Healthcare facilities
and providers who report and assess medical errors can attempt
to rectify particular problems by monitoring their data and
comparing it with federal, state and local trends. Identifiable
data is not necessary for this function to be met.
Identifiable data should not be available to the public
because to do so would inhibit reporting due to a natural fear
of punishment and litigation. Healthcare professions
continuously work to correct medical errors. The AOA and the
AOHA believe that the American healthcare system operates well
on the whole. Public confidence in that system should not be
undermined while healthcare providers seek to increase patient
safety.
Another reason that the AOA and the AOHA recommend national
data remain confidential and secure is that such data could be
used as background information for litigation. Any national
data that is gathered should be considered information only for
peer review. Since peer review protections vary greatly from
state to state, at a minimum, any federal data gathering
initiative must provide protection from discoverability and use
in malpractice litigation. The data must be used only for the
purpose of improving the safety standards of American
healthcare.
The AOA and the AOHA stand ready to support the IOM in
improving patient safety in the United States. We welcome the
opportunity to work with this committee and others dedicated to
patient safety. Our members and staff are available to assist
in the development of legislation that would lead to the
continued improvement of the American healthcare system.
Statement of Association of Women's Health, Obstetric and Neonatal
Nurses
AWHONN is a membership organization of 22,000 nurses who
manage the complex health needs of women and newborns. Our
membership includes registered and advance practice nurses who
work in a variety of settings including clinical, research and
academic.
AWHONN's Commitment
As the IOM report indicates, the scope of the problem is
massive, and AWHONN is committed to working with other health
care provider organizations to develop solutions to help nurses
combat the problem of medical errors. As an initial expression
of our concern with the issue of medical errors, AWHONN has
signed on to the following statement circulated by the American
Nurses Association:
The Institute of Medicine report, To Err is Human: Building
a Safer Health System, shines a bright light on a significant
problem within the U.S. health system. The patient care
environment--across all health settings--is NOT conducive to
the delivery of safe, quality nursing care despite the best
efforts of dedicated nursing professionals. It is time to shine
that same bright light on those qualities which create an
environment that promotes the highest standard in patient care
and excellence in nursing services. Qualities like sufficient
nurse staffing, adequate support services; an appropriate skill
mix of qualified providers that reflects patient acuity and
needs; and dedicated nursing leadership in administration.
Enhancing these qualities will result in better patient
outcomes, fewer errors, and a stronger nursing profession
emboldened to speak out on behalf of our patents.
Over the years, AWHONN has been committed to promoting
excellence in nursing practice to improve the health of women
and newborns. Nurses can play a critical role in the prevention
of medical errors, as they are often the first and last level
of communication with the patient. Because of their
comprehensive education and experiences, registered nurses are
capable of providing both highly skilled technical care and
complex emotional care. Furthermore, professional registered
nurses are able to effectively implement patient management
strategies for both low-risk and high-risk patients.
Support of System Solutions
We strongly agree with the report's overall goal to look
beyond using individual culpability as a means of correcting
the significant problem of medical errors. Instead, the report
places a great deal of weight on problem-solving across
disciplines and developing various mechanisms to reduce the
number of medical errors. Research has shown that because we
are humans, we will commit errors...we are not perfect.
Unfortunately, we cannot eliminate all medical errors, but we
can strategize on ways to dramatically reduce them. We have
learned that even the experts can commit errors--it is not
simply a matter of lack of knowledge.
AWHONN agrees with many of the study's recommendations,
including the creation of a center for patient safety within
the Agency for Healthcare Research and Quality that would set
national safety goals, track the progress and report to the
President and Congress on the achievement of those goals, and
research methods for identifying and preventing errors. It is
important to create one central location where information can
be shared on findings and trials.
Need to Address Nursing Shortage
While we support many of the recommendations of the report,
we believe one critical component was not addressed. The report
ignores the issue of inadequate and inappropriate nurse
staffing, which increases the likelihood of medical errors,
regardless of competency. In the managed care era, we have seen
hospitals replacing highly qualified and educated nurses with
less qualified technicians. AWHONN is greatly concerned with
the growing nursing shortage and we challenge healthcare
facilities to continuously evaluate the impact of patient-to-
nurse ratios on patient outcomes, patient satisfaction,
resource utilization and overall operating expenses.
Approximately 80% of our members provide bedside maternal/
child care on maternity floors and neonatal units. Hospital
admissions for infant births account for more than twice the
admissions for any other medical condition or procedure.\1\ We
view the childbirth experience as an intensely physical and
emotional event with lifelong implications. Only the registered
nurse combines formal nursing education and clinical patient
management skills with experience in providing emotional and
psychological support and physical comfort measures to laboring
women.
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\1\ Agency for Health Care Policy and Research. (1999). Most Common
Diagnoses and Procedures in U.S. Community Hospitals, 1996 Health Care
Cost and Utilization Project, Research Note. (AHCPR Publication No. 99-
0046). Rockville, MD: Author.
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AWHONN supports evaluation models that would measure the
impact that a registered professional nurse has on indirect
cost savings, such as savings resulting from lower cesarean
section rates, shorter labors and fewer technologic
interventions. With fewer qualified nurses available, it will
be more difficult to ensure that quality patient care is being
delivered. Knowing that this shortage will gradually increase
and peak around 2010, we must be prepared to address their
impact on patient safety.
Recertification is Not the Answer
While we agree with the report's recommendation for health
professional licensing bodies to work with certifying and
credentialing organizations to develop more effective methods
to identify unsafe providers and take action, we are concerned
with the recommendation to require licensing bodies to
implement periodic re-examinations and re-licensing of doctors,
nurses, and other key providers, based on competence and
knowledge of safe practices. Research has not proven that this
intervention is any more effective than current strategies
employed by the profession. The nursing profession is committed
to ensuring competent practitioners through proven methods,
such as appropriate education and competency validation. By
including the re-examination component, the report contradicts
its concept of not focusing on individual competency. Before
determining a strategy, AWHONN urges true research to develop
an evidence-based approach to professional certification.
Commitment to Providing Resources for AHWONN Members
AWHONN has a long history of providing resources to our
members to support them in expanding their knowledge in order
to deliver quality nursing care. AWHONN recognizes that
delivery of safe patient care is directly associated with
appropriate education and competency validation, creation of
evidence based policies and procedures and proper equipment
management. AWHONN also promotes safe patient care practices
through its journals, practice reference service, research-
based practice projects and legislative activities.
In providing quality of care to pregnant women and newborns
we know that:
Proper fetal assessment is vital to the care of
obstetric patients. AWHONN therefore addresses this area
through its Fetal Monitoring Workshops, Fetal Heart Monitoring
Principles & Practices book, videos, CD ROM, Antepartum and
Intrapartum Fetal Heart Rate Monitoring Clinical Competencies
and Education Guide and Fetal Heart Rate Auscultation symposia.
Appropriate and timely patient assessment can
elicit important information about potential risks. Proper
assessments and subsequent interventions can promote positive
patient outcomes. AWHONN resources which enhance nursing
assessment skills include a presentation package targeting
domestic violence, a compendium of postpartum care, tapes on
mother-baby postpartum assessments, videos on critical-care
obstetrics, cross training and compromised neonates.
Safe medication administration contributes to safe
clinical practice. AWHONN's Perinatal Medication Administration
Competence Assessment Tool tests staff's current medication
administration knowledge and critical thinking skills.
Once training has been completed validation of
competence is imperative. AWHONN resources which address
competency validation include a reference book entitled
Competence Validation for Perinatal Care Providers as well as
numerous clinical competencies and education guides on such
topics as perinatal education, home care and limited ultrasound
examination. AWHONN's Assessment of Fetal Well-Being Competence
Assessment Tool is designed to measure nurses' knowledge and
application of perinatal facts and principles.
Effective patient care guidelines, policies and
procedures can guide quality patient care. AWHONN resources to
assist our membership in this include the AWHONN handbook
entitled Achieving Consistent Quality Care: Using Evidence to
Guide Practice, AWHONN's Standards & Guidelines (5th Edition)
and the AWHONN publications High Risk & Critical Care
Intrapartum Nursing and Perinatal Nursing both of which contain
actual guidelines and/or care paths.
Equipment malfunction and misuse contributes to
medical errors. AWHONN includes a section in its Fetal Heart
Monitoring Principles & Practices book on instrumentation
troubleshooting. The video series on OB/GYN limited ultrasound
includes an orientation to the machine's instrumentation and
controls. In AWHONN's Liability Issues in Perinatal Nursing, a
section is devoted to the appropriate use of technology and
equipment.
Summary
AWHONN believes that nurses have the education and
experience to deliver quality health care services, while
monitoring the care their patient receives over the entire
health care system. Nurses have long been known as strong
patient advocates, working to ensure their patients receive
access to the most appropriate care in a timely fashion. We
would urge Congress to consider that the health care community
needs to evaluate solutions that help address the issue of
medical errors across the health care system.
AWHONN appreciates the opportunity to offer our comments on
this very important issue. We will continue to work with the
members of AWHONN to ensure that they have the resources
available to them to make decisions about the care their
patients receive and we look forward to working with Congress
on developing possible solutions to this problem.
For further questions, please contact Melinda Mercer Ray,
RN, MSN, Director, Health Policy/Legislative Affairs at 202-
261-2405 or Kristen LaRose, Senior Legislative Specialist at
202-261-2402.
Statement of Health Care Liability Alliance
The Health Care Liability Alliance (HCLA) is a coalition of
more than 30 organizations committed to reform of the health
care litigation system to enhance its fairness, timeliness, and
cost-effectiveness. HCLA's members are organizations and
associations of physicians, hospitals, blood banks, health
device manufacturers, health care insurers, pharmaceutical
manufacturers, and biotechnology companies.
HCLA applauds the Chairman's timely leadership in
connection with the issue of patient safety. We appreciate the
opportunity to submit our views regarding the report of the
Institute of Medicine (IOM) entitled ``To Err is Human:
Building a Safer Health System.'' We look forward to working
with the Chairman, members of the Committee, and their staff as
Congress debates this important issue.
Because of its concern for the effect the tort system has
on the quality of care, HCLA welcomes the IOM Report. The
Report makes a significant contribution by recognizing that the
tort system is a major barrier to improving the quality of
care. That underlying conclusion provides the basis for
meaningful tort reforms.
INTRODUCTION
The tort system as it now operates in this country
increases health care costs by forcing providers to practice
defensive medicine and by imposing inordinate litigation costs
on the health care system. These costs are borne by patients,
people with insurance, people who are trying to buy insurance,
people who need care, and taxpayers--through higher health care
costs, higher insurance premiums, higher taxes, and reduced
access to care.
The tort system does not provide benefits that justify
these costs. It does not carry out its intended functions. It
does not establish a rational standard of care. Findings of
liability, made in court with hindsight and with the benefit of
leisurely contemplation that rarely are possible in the actual
delivery of care, often do not provide an accurate standard of
medical conduct. As one expert on the tort system has
summarized this situation, ``The fundamental problem of tort
liability, especially in the areas of products liability and
medical malpractice, stems from the unpredictability of its
imposition.'' \1\
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\1\ Jeffrey O'Connell, ``Two-Tier Tort Law: Neo No-Fault & Quasi-
Criminal Liability,'' 27 Wake Forest Law Review 871 (1992).
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This retroactive, case-by-case, and arbitrary standard
making has caused doctors to practice defensive medicine--to
order medical procedures out of a perceived need to have a
defense available if there should be an adverse event. Cesarean
delivery rates provide one example. Because juries awarded
large recoveries for birth injuries where obstetricians did not
perform a Cesarean section, doctors have performed them more
often than they otherwise would have. Cesarean rates rose from
4.5 per 100 births in 1965 to 24.1 in 1986.\2\
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\2\ Richard E. Anderson, ``Billions for Defense,'' Archives of
Internal Medicine. 1999; 159: 2401
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The essentially unlimited power of juries to award non-
economic damages results in verdicts that are not just and that
when publicized whet the appetite of trial lawyers and
traumatize providers. In many cases, (enough to engender
disdain for the litigation system and fear on the part of the
provider), there is no logical or medical connection between
the provider's action and liability or between the injury and
the amount of damages awarded.
The Harvard Study of hospital care in New York itself
demonstrated that the filing of claims was not correlated to
negligence.\3\ In a follow-on study of claims of malpractice
filed by patients in the Study, several of the authors
concluded that ``the severity of the patient's disability, not
the occurrence of an adverse event or an adverse event due to
negligence, was predictive of payment to the plaintiff.'' \4\
In other words, the amount patients recovered through the tort
system was a function of their health condition, not any
negligence by the health care system. The authors concluded
more generally, therefore, that ``the standard of medical
negligence performs poorly in malpractice litigation.'' \5\
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\3\ Paul Weiler et al., A Measure of Malpractice. Cambridge:
Harvard University Press; 1993.
\4\ Troyen A. Brennan et al, ``Relation Between Negligent Adverse
Events and the Outcomes of Medical-Malpractice Litigation,'' N Engl J
Med 1996; 335:1963-7.
\5\ Ibid.
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The tort system thus presents a provider with the random
risk of catastrophic financial injury. This causes some
providers to quit practice and others to limit their practice,
reducing patients' access to care, particularly in inner-city
and rural areas. Most of those who continue to practice are
forced to engage in defensive medicine. This results in more
medical interventions for patients, as the increased rate of
Cesarean deliveries demonstrates, thereby adding costs and
putting patients at greater risk. It is estimated that
defensive medicine costs at least $50 billion per year.\6\
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\6\ David Kessler and Mark McClellan, ``Do Doctors Practice
Defensive Medicine,'' QJ Econ. 1996; 111: 353-390.
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At the same time, the litigation system does not provide
fair and timely compensation for injured patients. They must
wait on average 3\1/2\ years for resolution of their claims by
the litigation system. If they prevail, they typically must
give 33-60% of any recovery to their lawyers in contingency
fees. Only 28 percent of the amount spent to provide insurance
coverage actually goes to victims; the rest is spent in
transaction costs and in operating the tort litigation
system.\7\ The tort system imposes a 72% tax on patients and
providers.
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\7\ Jeffrey O'Connell and C. Brian Kelly, The Blame Game. Lexington
Books; 1987:127.
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Because of the threatening and contentious climate it
creates, the litigation system, rather than protecting
patients, is actually impeding efforts to improve the quality
of care. It makes it difficult for providers to acknowledge
mistakes. It deters open discussion of possible errors. And it
discourages providers from filing reports, seeking assistance,
and collaborating with other providers and experts to improve
quality.
The money spent on defensive medicine and litigation
expenses could be better used to improve the quality of care
and access to it. The energy and focus that the present system
channels into litigation-related and litigation-induced actions
should be redirected into developing better quality control
systems and innovative ways of delivering care.
INSTITUTE OF MEDICINE REPORT
With one exception, the IOM Report avoids inflated
rhetoric. The exception is its statement that as many as 98,000
people may die annually because of medical error. This figure
is extrapolated in ways that are not explained from 71 deaths
that the Harvard Study of the medical records of 31,429
patients discharged from 51 New York hospitals in 1984 said
were attributable to negligence.\8\ This extrapolation has no
scientific basis, as the authors of the Study themselves have
recognized.\9\
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\8\ Berkeley Rice, ``Do doctors kill 80,000 patients a year?''
Medical Economics. November 21, 1994; 1(discussing extrapolation to
80,000 deaths).
\9\ Troyen Brennan et al., ``Incidence of Adverse Events and
Negligence in Hospitalized Patients: Results of the Harvard Medical
Practice Study,'' N Eng. J Med 1991; 324: 370-6.
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The Harvard Study, moreover, suffered from methodological
flaws, and its results have not been duplicated. The reviewers
who determined which records reflected negligence agreed in
only 10% of the cases. In an effort to confirm findings that
rest on this shaky foundation, a second set of reviewers
examined a subset of 318 of the records. Apparently they did
not reach the same conclusions on individual records that were
attributed to the primary set of reviewers.\10\
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\10\ ``Billions for Defense'' at 2400. The second set of reviewers
found the same incidence of adverse events and adverse events due to
negligence, but not in the same charts. Rather than confirming the
reliability of the methodology used, this provides further
demonstration of the uncertainty of what is an adverse event and what
is negligence.
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The authors of the Harvard Study also applied their
methodology to patients in Colorado and Utah hospitals in 1992.
Extrapolating the results of this study, the authors concluded
that 44,000 deaths were caused nationwide by medical error. The
IOM Report finds this, and the unexplained figure of 98,000
deaths, to represent a range.\11\ The more recent study,
however, could equally be seen as an indication that health
care improved in the 8 years after the New York study, that
better care is provided in Colorado and Utah, or, since the
results of the Harvard Study could not be duplicated, that the
parameters of the Study are vague and the methodology is
flawed.
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\11\ ``To Err is Human'' at 1, 22.
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It is not our purpose here to discuss the weaknesses of the
Harvard Study or the exaggerated extrapolations that have been
made from it. Patient safety and quality care should not be a
numbers game. We should, as a health care system and as a
society, endeavor to eliminate avoidable injuries. In doing so
we must remember, as the Harvard Study reminds us,\12\ medical
intervention is inherently risky and is provided by people.
People are only human, and the title chosen for the IOM report
reflects the reality this presents; ``To Err is Human.''
Because we are dealing with medical intervention by human
beings, we must focus on what we can do together to reduce the
number of unnecessary injuries suffered during the delivery of
health care services.
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\12\ A Measure of Malpractice at 138.
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The IOM Report makes a vital contribution to this effort by
its recognition and discussion of the three interrelated
factors that now impede efforts to improve patient safety.
First, it emphasizes that the problem is not ``bad
apples,'' \13\ although there are some ``bad people'' and they
must be weeded out. Mistakes are often caused, or are not
prevented, by system (both technical and organizational)
failures. As the Report suggests, because providers are only
human, they need systems to help them avoid mistakes; but we
cannot let reliance on systems dull the special intelligence
that humans posses or lull them into lethargic complacency.
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\13\ ``To Err is Human'' at 42.
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The focus must be on developing systems that avoid future
mistakes and not on attempting to pin blame for past conduct on
an individual. This important observation leads the Report to
balance public policy in favor of error prevention and away
from faultfinding: ``When an error occurs, blaming an
individual does little to make the system safer and prevent
someone else from committing the same error.'' \14\ ``Although
a punitive response may be appropriate in some cases (e.g.,
deliberate malfeasance), it is not an effective way to prevent
recurrence.'' \15\
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\14\ Id. at 4.
\15\ Id. at 47.
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Secondly, the Report emphasizes the need to report
information about adverse events or potential adverse events in
order to identify patterns of conduct that threaten safety and
to assess the success of corrective actions. It correctly
recognizes that reporting is essential to the primary goal of
prevention. The Report provides a comprehensive summary of the
numerous and varied reporting systems that are currently in
effect.
Thirdly, and most importantly, the Report recognizes that
there is a critical and common element or impediment that
prevents all the reporting systems, regardless of how they are
structured, from collecting the information they need. That
impediment is the tort system.
Participants and witnesses to an adverse event are
reluctant to report it (even if required by law to do so) out
of fear that doing so will trigger or support a tort claim. The
irrationality of the litigation system and the randomness of
its results trigger a defensive reaction. Fear of being
enmeshed in that system, even if one is ultimately found not to
be liable, deters reporting.
As the Report concludes, ``Patient safety is also hindered
through the liability system and the threat of malpractice,
which discourages the disclosure of errors. The discoverability
of data under legal proceedings encourages silence about errors
committed or observed.'' \16\
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\16\ Id. at 37.
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As a result, it finds ``All reporting systems, whether
mandatory or voluntary, are perceived to suffer from
underreporting. Indeed, some experts assert that all reporting
is fundamentally voluntary since even mandated reporting can be
avoided. . ..The volume of reporting is influenced by more
factors than simply whether reporting is mandatory or
voluntary. . ..One factor is related to confidentiality.'' \17\
``Thus,'' the Report concludes, ``the prominence of litigation
can be a substantial deterrent to the development and
maintenance of the reporting systems discussed in this
report.'' \18\
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\17\ Id. at 85.
\18\ Id. at 94.
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It is refreshing that the IOM Report recognizes this
problem. It is important to the debate that it does so. The
tort system impedes efforts to improve health care by deterring
the reporting of data needed to make improvements in the health
care system. Recognition of this fact by The IOM should provide
the needed impetus for addressing this basic problem.
As the Report recognizes, the tort system deters reporting
even where confidentiality is promised. There is concern that
confidential data will leak. There is also fear that what is
confidential today may not be protected tomorrow. The Report
cites the powerful example of the continuing political pressure
to ``open up'' the National Practitioner Data Bank.\19\
Providers are concerned that the constant political pressure
eventually will be successful, leading to a breach not only of
a particular data source but also inserting the opening wedge
for a more general release.
---------------------------------------------------------------------------
\19\ Id. at 105.
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Confidentiality of adverse event reports, therefore, is
necessary to develop an effective reporting system that will
permit identification of safety problems and permit assessment
of remedial actions. But there is on-going concern that even
confidential reports will be fed into the litigation system--by
leaks or by surrender to political pressure to remove the
confidentiality protection. Confidentiality of reports is
necessary to improve reporting, but it is not sufficient. The
tort system also must be reformed.
Two reforms that are needed
The findings of the IOM Report, therefore, confirm the need
for a combination of two reforms: confidential protection for
adverse event reports and a reformed tort system.
Confidential reporting
It is important that Congress act on the findings of the
Report by protecting the confidentiality of reports made of
adverse events or of problems that could lead to adverse
events.
The Report in several places emphasizes the need for
reporting to be confidential. It appears, in fact, to call for
Federal legislation to protect confidentiality of all reports
although it also makes an inconsistent recommendation that
would deny confidentiality to reports of adverse events leading
to serious injury. The Report recommends Federal legislation to
``extend peer review protections to data related to patient
safety and quality improvement that are collected and analyzed
by health care organizations for internal use or shared with
others solely for purposes of improving safety and quality.''
\20\
---------------------------------------------------------------------------
\20\ Id. at 9.
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As the Report's discussion of peer review protection
reflects, the nature and the scope of the current protection
varies widely from state to state.\21\ Not only does the scope
of the protection afforded by each state differ greatly, but in
some instances the sharing of peer review materials with third
parties engaged in health care quality efforts, such as The
Joint Commission on Accreditation of Healthcare Organizations
(JCAHO), has been held to waive any confidentiality
protection.\22\ Moreover, the efficacy of these state
protections is further undermined by uncertainty surrounding
the application of the peer review privilege should the parties
be drawn into federal court. This occurs, for instance, in
actions brought under a Federal statute with related medical
malpractice claims under state law (i.e., pendent state
claims).
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\21\ Id. at 103-104.
\22\ As the Report recognizes, ``One legal fear is that disclosure
of internal quality data to outside reviewers not under a peer review
statute will lead to discovery from JCAHO in lawsuits; indeed, many
fear that disclosure to JCAHO would invalidate even the
nondiscoverability protections each hospital enjoys for its own data
under its state peer review statute.'' Id. at 108.
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As the Report recognizes, health care providers must have
confidence that the peer review privilege will be applied with
consistency and predictability if they are to come forward with
information regarding medical errors.\23\ The discussion in the
Report focuses on immunity and protection of peer review
materials and deliberations from discovery. In urging that the
protection be expanded, the Report at a minimum recommends that
quality and safety information derived from reports or from
investigation (the main areas now protected in different ways
by peer review statutes) be protected from use in litigation
and from public dissemination. The information derived through
the peer review process may involve the ``most serious adverse
events"; thus this recommendation calls for the appropriate
confidential treatment of such information.
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\23\ Id. at 96.
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However, the Report also says that such information should
be available for public consumption and that only reports of
events other than the ``most serious adverse events'' should
have confidentiality protection.\24\ We discuss this misplaced,
and internally inconsistent, position below. The important fact
is that the Report finds that confidentiality is necessary for
effective reporting and patient safety improvements and
recommends in, at least one place, across-the-board
confidentiality.
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\24\ Id. at 9.
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Tort reform
Even where confidentiality would be provided, but
particularly where it would not, reporting and improvements in
the health care system quality can best be advanced by
reforming the tort system to protect providers from random and
excessive judgments. HCLA urges Congress to enact the tort
reforms embodied in its proposed legislation which is modeled
on the MICRA reforms enacted in California in 1975.
These reforms would preserve the ability of injured
patients to obtain compensation for their economic injury and
to recover reasonable non-economic damages. They would: 1)
encourage non-judicial resolution of claims and ensure that
plantiffs' lawyers did not capture an excessive contingency fee
from their clients; 2) prevent plaintiffs from obtaining double
recovery (collateral source rule); 3) limit non-economic
damages to a reasonable amount ($250,000); 4) require
plaintiffs to bring any action in a reasonable time after the
injury occurs or is recognized (statute of limitations and
statute of repose); 5) protect any particular defendant from
paying a larger percentage of any recovery than is warranted by
his/her conduct (joint and several liability).
Passage of these measures will restore a measure of balance
to the tort system, give providers more faith in the system,
and therefore facilitate reporting--which ultimately will
result in greater patient safety.
As the IOM Report recognizes, patient safety is not
adequately served by the present system. If the tort system in
its current state were adequately protecting patient safety,
the Report would not have been necessary. The tort system is
not only not the answer; it is the barrier to the enhanced
quality systems that the Report correctly finds are the best
way to improve safety. The underlying, if unarticulated, theme
of the Report, therefore, is that tort reform is necessary to
improve the quality of health care in this country.
Actions that should not be taken
The Report correctly concludes that the barrier to systems
improvements in health care is not the lack of reporting
mechanisms but the tort-induced reluctance of participants to
provide data through the existing avenues. There is no
indication that there are not enough reporting requirements.
The Report describes them comprehensively. The need is to make
the changes necessary to encourage more reporting, and for the
agencies and institutions to which reports are made to analyze
the information and act on them more vigorously.
HCLA questions, therefore, whether any purpose would be
served by adding new reporting requirements or creating new
agencies to collect or coordinate reports. In fact, adding new
reporting requirements would only distract attention from the
need to make the essential tort changes to support the existing
reporting requirements.
No new reporting requirements without confidentiality
While recognizing that the barrier to existing reporting
requirements is a lack of confidentiality and fear of the tort
system, the Report does not address this barrier, except in its
recommendation that peer review protections be expanded.
Instead it recommends that mandatory reporting of serious
adverse events be expanded by federal statute, without
corresponding confidentiality protection. Indeed, while it
offers a gesture toward the states' role, it would make
mandatory reporting a federal requirement in any state that did
not on its own come to the conclusion that mandatory reporting
is needed.\25\ Although The Report recognizes that the absence
of confidentiality is impeding compliance with existing
reporting requirements, it would make mandatory reporting a
national requirement while providing no confidentiality
protection.
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\25\ Id. at 8.
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The Report would permit confidentiality protection only for
voluntary reporting of events that are not serious--where it is
least useful. If an event results in little or no harm, there
may be less concern about tort litigation. The Report offers
confidentiality protection here, where it is worth less, but
would deny it in the serious cases, where it is important to
elicit reporting. Recommending confidentiality for voluntary
reports is not a sufficient response to the problem identified
by the Report itself--that lack of confidentiality deters
reporting.
Drawing a line, moreover, on when reporting is required and
when it is confidential on the basis of whether the action
resulted in ``serious'' harm will bog down the health care
system in line-drawing and hair-splitting. What is serious
harm? Who defines it? Suppose the event could have had a
serious harm if it had not been caught? How long is serious? Is
an extra day in a hospital serious? Is a false positive that
leads to patient concern serious? Suppose the patient was not
able to understand the test result; is a false positive serious
in that case? \26\
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\26\ Unintentionally demonstrating the problem, the Report also
refers to the kinds of acts that would fall under the voluntary (and
confidential) reporting scheme as ones that resulted in ``no
harm...(near misses) or very minimal patient harm.'' (p. 74) What is
supposed to be done with respect to injuries that fall between serious
and minimal?
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Rather than trying to impose reporting by regulation and
mandates, and varying the protection for different types of
reports, Congress should provide protection for all safety and
quality reports, and for consideration of them. This is the
best way to advance patient safety efforts.
No centralization of safety efforts
It would be both unnecessary and harmful to create the new
Federal Center proposed in the IOM Report. The Report envisages
various roles for this new Center. HCLA believes these are
unnecessary and would actually detract from efforts to improve
patient safety.
The Report sees a need for the Center to establish a
``national focus to create leadership, research, tools, and
protocols to enhance the knowledge base about safety.'' \27\
The premise that only the creation of a government Center can
create a national focus and provide leadership is disturbing.
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\27\ ``To Err is Human'' at 5.
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As the Report indicates, efforts to enhance patient safety
are being undertaken in different ways by a variety of
individuals and institutions: insurers, manufacturers,
providers, academic institutions, trade associations, etc. It
may look messy and confused, but the pursuit of knowledge often
is, particularly in an area as complex and varied as the design
and manufacture of health care products and the delivery of
health care.
Commissions, meetings, and public awareness can all
contribute to a national focus. So can efforts by political
leaders, if conducted without demagogy and finger pointing. A
new Center is not necessary to do this. This proposal is really
symbolic; concern would be demonstrated by creating a new
Center and spending more money.
An approach based on centrally developing and collecting
safety-related data could in fact impair safety research and
promotion of safety activities. A centralized agency for safety
research could well become hitched to a particular view or
approach, subordinating all others. It is more effective for
different people to try different approaches.
Creating a ``highly visible [governmental] center'' is
likely not only to diminish the diversity of research and views
but to politicize patient safety. Once there is a ``highly
visible'' government agency tasked to provide leadership and
develop research and recommendations, every interest group will
descend on it in an effort to gets its agenda adopted. Congress
will inevitably be drawn in. It would be far more effective, if
more research is needed, to provide funding to a variety of
researchers on a scientific, non-political basis.
The Report also has another role in mind for the new
Federal safety Center. It would not be limited to research. It
would receive and analyze reports (from the states)--apparently
the mandatory reports of ``serious adverse events'' discussed
above. The Center would become a national data bank for at
least some kinds of reports. But it is unclear how the
information would be used and who would have access to it. The
Center apparently would ``identify persistent safety issues
that require more intensive analysis and/or a broader-based
response.'' \28\ In other words, it would use the data to do
more studying. But would the agency act on the information? To
whom would it give its findings?
---------------------------------------------------------------------------
\28\ Id. at 76.
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What is needed is not central collection of information,
nor more analysis and dissemination. Needed information should
be given to those in a position, and with the most powerful
incentive, to use it to improve patient safety. Instead of
funneling data through a centralized, and possibly politicized,
government agency, the focus should be on doing what is
necessary to get the information to those who will actually use
it to improve patient safety.
Hospitals need more information about errors that are made
there. Licensing boards need more information about their
licensees. It is far simpler, and more effective, to inform a
device manufacturer that the labeling is confusing than to
report this to Washington. With this information,
manufacturers, providers, and insurers would have the greatest
incentive and the best ability to use it to improve safety.
Instead of creating a centralized, nation-wide, government-
led reporting system, we should focus on doing what is
necessary to get more information to the people on the front
lines of health care quality.
Compliance will be enhanced if reporters know they are
reporting to an entity that will use the information
effectively. A nurse is far more likely to report an error to
her nursing supervisor or to report a problem with a device to
its manufacturer than to file a form destined for a distant
Federal bureaucracy. Health care providers are the people who
are most concerned with quality of care and patient safety.
They are more personally and directly concerned than is a
distant government bureau. They strongly want to avoid adverse
events. They want to provide good care.
There is another practical factor that must be considered.
Providers function under conditions of considerable stress.
They are quite astute in distinguishing between what is real
and what is more government make-work. They are more likely to
report when they believe it will do good (particularly if they
have protections of confidentiality) than where they are told
to fill out another government-imposed form that seems to bear
little or no relation to their real world--patient care.
Providers, manufactures, suppliers, employers who sponsor
health plans, and insurers, deal with each other and with
various licensing and quality institutions on an on-going
basis. They should be encouraged to report potential or
existing problems and discuss improvements among themselves.
This can best be achieved by protection of confidentiality for
reports and discussions, and by reform of the tort system.
Requirements that they file reports with a state agency for
forwarding to Washington, D.C., will not encourage reporting or
enhance collaborative efforts to improve the quality of care.
CONCLUSION
The IOM Report documents the obstacles to greater patient
safety efforts: the difficulties in securing more reporting
that result from the lack of confidentiality and the shadow
cast by the litigation system. But rather than addressing these
problems, it recommends more reporting (but without
confidentiality) and centralizing the reporting system.
The problem, however, is not a lack of centralized
reporting; it is the barriers to reporting and to safety-
improvement measures posed by the tort system.
The problem is not a lack of reporting mechanisms, but a
lack of assured confidentiality and fear on the part of the
people who would report that they will be enmeshed in the
litigation system.
The primary need is not more data and more studies; it is
for those in the field attempting to improve patient safety to
have confidence that cooperating in safety-improvement measures
will not result in involvement in burdensome tort litigation.
The fears induced by the tort system cannot be resolved by
expanding the already unsuccessful requirements to report. The
problems of the tort system itself must be addressed.
The solution should not be centralized or governmental; it
should be private and dispersed. Medical errors, when they
occur, happen at the local level, and local solutions are best
crafted to solve local problems.
The quality of health care, consequently, can best be
improved by reforming the tort system to: 1) reduce the number
of lawsuits, 2) make the system more fair and efficient, and 3)
reduce its costs. Reforms in this direction would lessen the
pressures to practice defensive medicine, lower health care
costs, and increase access to care. At the same time, a fairer
and less random tort system, and assurances of confidentiality,
would reduce the barriers to reporting and enhance the ability
of the field to identify problems and to make corrections.
Statement of Healthcare Compliance Packaging Council, Falls Church, VA
Falls Church, Virginia, February 10, 2000--The Healthcare
Compliance Packaging Council, a not-for-profit trade
association established in 1990 to promote the many benefits of
superior pharmaceutical packaging, today commended the Health
Subcommittee of the House Committee on Ways and Means for
holding a hearing on the important national issue of medical
errors. ``We are especially encouraged,'' noted Peter G.
Mayberry, HCPC Executive Director, ``by the attention that is
being paid to medication errors that take place in hospitals
and other in-patient settings. Hopefully, these hearings will
serve as a catalyst for change.'' Considering that, on average,
an estimated seven percent of all hospitalized patients--some 2
million people--experience an adverse drug event each year, the
HCPC believes that inquiry by the Health Subcommittee is
critical and timely. Moreover, in light of the fact that
proven, cost-effective steps have already been identified to
address the problem, the HCPC is hopeful that attention to the
problem by the Health Subcommittee will lead to adoption of in-
patient pharmaceutical distribution systems that can reduce
adverse drug event incidents by fifty percent or more. ``One
element of such systems,'' Mr. Mayberry noted, ``is the
adoption of unit dose pharmaceutical packaging by drug
manufacturers, hospitals, and other inpatient facilities
throughout the country.''
Most people are familiar with unit dose formats, or blister
packs and strips, through over-the-counter medications and
prescription birth control pills. With solid oral dosages such
as pills or tablets, these formats separate each dosage unit in
its own compartment or blister cavity. As Mr. Mayberry
explained, ``What many people may not know, is that unit dose
formats can be combined with bar code technology such that no
medication could be dispensed unless the doctor's prescription,
the patient's medical chart, and the drug itself all match up
correctly. These dispensing systems are already available, and
are considered state-of-the-art when it comes to ensuring that
the right drugs are given to the right patients at the right
time.''
``As far as we know,'' Mr. Mayberry continued, ``every
group that has examined the problem of in-patient adverse drug
events has recommended the use of unit dose formats as a
solution.''
Indeed, in its list of recommendations released on May 12,
1999, the National Patient Safety Partnership urged hospitals
to ``Use unit dose drug distribution systems for inpatient
care; also use such systems for outpatient care, where
appropriate.'' Similarly, in its November 1999 report, To Err
is Human: Building a Safer Health System, the Institute of
Medicine (IoM) recommended that ``If medications are not
packaged in single doses by the manufacturer, they should be
prepared in unit doses by the central pharmacy.'' (page 166).
The IoM report further stated that ``Unit dosing can reduce
errors by eliminating the need for calculation, measurement,
preparation, and handling on the nursing unit and by providing
a fully labeled package that stays with the medication up to
its point of use.'' The IoM report also noted that unit dosing
has been recommended by the American Society of Health-System
Pharmacists, the Joint Commission on the Accreditation of
Health Care Organizations, the National Patient Safety
Foundation of the AMA, and the Massachusetts Hospital
Association as a means of reducing adverse drug events.
Lucian L. Leape, M.D., Adjunct Professor of Health Policy
at the Harvard School of Public Health, is also a proponent of
unit dose packaging as a means of reducing adverse drug events.
As Dr. Leape--who testified before the Senate Health Committee
on January 26, 2000--told the FDA on January 8, 1998 during its
workshop entitled ``Minimizing Medical Errors: A Systems
Approach,'' distribution of drugs in unit dose formats is the
``right thing'' for pharmaceutical manufacturers to do.
Despite this widespread support, however, certain hospitals
and other inpatient facilities have been directed to abandon
unit dose formats in an effort to reduce pharmacy expenses. As
the IoM explained in To Err is Human: Building a Safer Health
System, ``As a cost-cutting measure, unfortunately some
hospitals have recently returned to bulk dosing, which means
that an increase in dosing errors is bound to occur.'' (page
167). This is a penny wise/pound foolish approach that, as the
IoM predicts, will surely lead to even greater numbers of
adverse drug events. It is primarily for this reason that the
HCPC lauds efforts by the Health Subcommittee to focus on such
an important healthcare issue. Hopefully, by conducting this
inquiry, the Health Subcommittee will help to underscore the
importance of unit dose packaging, along with other recommended
practices, as a systematic approach that can be immediately
adopted to prevent adverse drug events.
Mr. Mayberry may be contacted in care of the Healthcare
Compliance Packaging Council at 7799 Leesburg Pike, Suite 900N,
Falls Church, Virginia, 22043.
Statement of Annette Guarisco, Honeywell
We appreciate the opportunity to present the views of
Honeywell on the important issue of medical errors in the
health care system.
As policymakers consider ways to reduce medical and
medication errors, such as adverse drug effects, modernize the
Medicare system and promote safety for children and adults, the
promotion of unit dose/unit of use (known as blister packs)
should be considered:
Blister packs are inherently child resistant
Blister packs are tamper-resistant and tamper-
evident
Drugs packaged in unit dose formats are protected
against cross-contamination
Efficacy of the drug is maintained for a longer
period of time without being compromised when unit dose formats
are used
Special labeling, color coding, is available to
designate when and if the drug has been taken when unit dose
formats are used
Blister packaging provides for greater individual
product barrier protection against moisture, light and oxygen
The rate of compliance with unit dose packaging is
significantly higher, resulting is fewer and less serious
adverse health consequences:
Contraception--92% compliance rate, vs. 70% for
anticoagulants, 82% for organ transplant rejections drugs, 60%
for hypertension medication, 80% for asthma, 50-70% for
epilepsy, 50-60% for diabetes and 53% for estrogen deficiency
drugs
It was estimated in 1990 that nearly 10% of
hospital admissions were the result of pharmaceutical non-
compliance and up to 23% of nursing home admissions were
primarily due to an inability to manage medications at home.
When drug regimens are not taken as prescribed,
taxpayer dollars are wasted on drugs paid by Medicare,
Medicaid, and VA programs, and unnecessary and longer hospital
and nursing home stays.
Unit dose packaging takes less pharmacist time to
prepare and reduces the chance for errors, leaving them more
time to consult with patients on the proper use of medications.
The recent Institute of Medicine Report, To Err is Human:
Building a Safer Health System, called for implementing unit
dosing:
If medications are not packaged in single doses by the
manufacturer, they should be prepared in unit doses by the
central pharmacy. Unit dosing--the preparation of each dose of
each medication by the pharmacy--reduces handling as well as
the chance of calculation and mixing errors. Unit dosing can
reduce errors by eliminating the need for calculation,
measurement, preparation, and handling on the nursing unit and
by providing a fully labeled package that stays with the
medication up to its point of use.
Unit dosing was a major systems change that significantly
reduced dosing errors when it was introduced nearly 20 years
ago. Unit dosing has been recommended by the American Society
of Health-System Pharmacists, JCAHO, NPSF, and the MHA in their
``Best Practices Recommendations.'' As a cost-cutting measure,
unfortunately some hospitals have recently returned to bulk
dosing, which means that an increase in dosing errors is bound
to occur. Page 166-167.
Honeywell urges the Committee to consider ways to encourage
drug manufacturers, hospitals, nursing homes, and other
inpatient facilities to utilize unit dose formats, and to
promote unit dosing in the Medicare and Medicaid systems as
well as in the federal employee health benefit system.
We appreciate the Committee's consideration of these
recommendations and applaud the Committee for deliberating on
the important subject of reducing medical errors.
Annette Guarisco
Corporate Director, Public Policy and Government Relations,
Honeywell (202) 662-2644
Statement of New Medical Concepts, Inc., Fort Lauderdale, FL
SAFE MEDICATION USE IN THE OUTPATIENT SETTING: THE PROBLEM OF
MEDICATION NON-COMPLIANCE
New Medical Concepts, Inc. (NMC), a telecommunications and
healthcare information company headquartered in Fort
Lauderdale, FL is pleased to present this statement for the
hearing record to the House Committee on Ways and Means
Subcommittee on Health it examines medical errors. We believe
the Institute of Medicine's Report To Err Is Human: Building A
Safer Health System and the report to Congress issued last week
by the General Accounting Office on Adverse Drug Errors provide
a strong basis for Congressional action on one of the most
serious problems in our healthcare system: the need to improve
patient safety.
Our comments focus on problems associated with one of the
most significant aspects of this problem in terms of impairment
of quality of care and unnecessary costs: the need to assure
safe prescription drug use by patients in the outpatient
setting.
New Medical Concepts, Inc.
NMC was founded in 1997 by a group of business, healthcare
and telecommunications professionals with recognized expertise
in innovative technology, medicine, pharmacy and healthcare
operations. The firm has developed RxAlerts,gT1 a unique voice
and text messaging alert system, using automated, personalized
wireless and wired communications, which has the potential for
dramatically reducing patient medication non-compliance and
fostering more effective communications between healthcare
providers and their patients.
Most would acknowledge that drug therapy is often the most
effective and cost-efficient way to achieve desired therapeutic
outcomes in the treatment of patients. But drugs cannot work if
they are not taken or are taken improperly. All drugs have side
effects; some known, some unknown; some serious, some not.
Because of the potential for harm and the increased
significance of drug therapy as a treatment modality, safe
medication use must be a priority objective in today's
healthcare system. The problem of medication non-compliance is
very real and demands practical solutions, the kind that foster
integrated communication between patient and provider and which
our company has developed.
Adverse Drug Events
An adverse drug event (ADE) would typically be defined as
any undesired effect associated with drug therapy such as
harmful reactions (adverse drug reactions or ADRs), treatment
failure, medication errors, overdoses and non-compliance.
Consequences range from ineffective treatment to injuries, at
times resulting in death. The population that is most at risk
because of these events are the chronically ill patients of all
ages and the elderly. With an aging population, the use of
prescription drugs will rise and likewise, the risk of
medication misuse and ADEs will also increase.
Medication Non-compliance
We wish to emphasize to the Committee that the problems
associated with medical errors and adverse drug events are just
as significant (and probably more prevalent) in the outpatient
setting as in the institutional setting. Certainly the
overwhelming percentage of the several billion medications
dispensed per year are to patients who are not in hospitals,
nursing homes or other institutional settings, but who receive
their drugs from community pharmacies. Safe medication use and
the associated problem of medication non-compliance by patients
in the ambulatory setting deserve this Committee's serious
attention.
Indeed, the General Accounting Office report on ``Adverse
Drug Events'' released last week identified patient non-
compliance in the ambulatory setting as a major source of
adverse drug events. The report also described medication non-
compliance as a major source of emergency room and hospital
admissions. For example, the GAO cites a report finding that 58
percent of adverse drug events in patients visiting an
emergency room were caused by medication non-compliance.
Another study it cites found that 11 percent of all elderly
admissions to a hospital were related to medication non-
compliance. Among the proposals the GAO makes for reducing
adverse drug events is improving communication between patients
and physicians about the risks and benefits of medication.
Definition, Reasons, Those Most Seriously Affected
Medication non-compliance, or not taking a medicine as it
was prescribed, is a worldwide health issue. Non-compliance
includes taking too much medication, taking medication not
prescribed, not taking medication prescribed, altering the
prescribed dosage, or altering the time between doses. The
reasons for non-compliance vary and may include forgetfulness,
confusion over generic and brand names, unclear information
about how to take or how much to take of a medication,
disappearing symptoms of an illness, no perceived improvement
in a patient's condition or well-being and, for those with low
income, the difficult choice of having to select food or heat
over drug expenditures. As with ADEs generally, the elderly and
the chronically ill are particularly susceptible to the problem
of medication non-compliance. They usually take multiple
prescriptions, and they are more susceptible to memory problems
and confusion.
Relevant Statistics
Thirty years ago (1970) only 650 medications were
available; today the number approaches 10,000
Over 2.7 billion retail prescriptions were
dispensed in the U.S. in 1998.
30-50 percent of all prescriptions are not taken
correctly. (U.S. Food & Drug Administration)
More than a billion prescriptions are taken
incorrectly each year. (U.S. Chamber of Commerce)
The estimated annual cost of medication non-
compliance exceeds $100 billion. (National Pharmaceutical
Council)
Non-compliance kills 125,000 Americans each year.
(National Pharmaceutical Council)
Social and Economic Consequences
Non-compliance with the taking of medication has
significant implications not only in terms of poor health
outcomes for the patient but for the healthcare system itself.
Its full effect on morbidity, mortality, and the associated
healthcare costs are only beginning to be recognized. One
national study (Johnson, Jeffrey A. and J. Lyle Bootman.
``Drug-Related Morbidity and Mortality: A Cost-of-Illness
Model,'' Archives of Internal Medicine 155:1949-56, Oct. 6,
1995) revealed more than $75 billion in direct annual costs
(with variable assumptions, the range was from $31 to $137
billion) as a result of medication use problems in the United
States. It based its findings on preventable treatment
associated with increased admissions to hospitals and nursing
homes and increased visits to physician offices and hospital
emergency rooms which resulted from medication non-compliance.
The costs estimated in this study related only to the
direct cost of first time events and did not address
consequential adverse health events (i.e., new medical problems
resulting from the primary illness) or the indirect cost of
lost employee productivity/absenteeism and turnover. When
indirect costs due to non-compliance are added to the direct
cost figures, total economic costs exceed $150 billion.
(Johnson, Jeffrey A. and J. Lyle Bootman. ``Drug-Related
Morbidity and Mortality: A Cost-of-Illness Model,'' Archives of
Internal Medicine 155:1949-56, Oct. 6, 1995) Drug-related
morbidity and mortality costs are in the same range as
diabetes, cardiovascular disease and obesity--leading some
experts to suggest that drug-related problems should be
considered a major category of disease.
Failure to Address the Problem
Medication non-compliance has reached the forefront of the
medical community's awareness, but efforts to focus on safe
medication use and the problem of medication non-compliance
have been limited. While there have been major efforts made in
developing technologies to detect and minimize adverse drug
reactions, essentially sophisticated computer systems utilized
by pharmacies and hospitals, these innovations do not address
the more complex and subtle causal factors associated with non-
compliance, notably communications between patient and
healthcare professionals. Patient counseling requirements,
consumer information sheets that accompany prescriptions,
public service announcements, educational brochures and the
specialized educational programs that are part of ``disease
management'' programs are all positive developments, but have
not proven sufficient to assure appropriate and safe medication
use by patients. There have been few efforts made,
technological or otherwise, to develop programs or products to
assist health professionals and individual patients in dealing
comprehensively with the problem.
Conclusion: Innovation That Addresses Medication Non-Compliance Must Be
Encouraged
The inescapable conclusion is that if patients are non-
compliant with medication therapy, desired outcomes (whether it
be a cure, relief of symptoms or improved quality of life) are
impaired. Indeed, it is clear that many emergency room and
physician office visits and hospital and nursing home
admissions could be prevented with interventions targeted at
improving medication compliance. There can be little doubt that
non-compliance is a significant health and economic burden on
the healthcare system; that interventions directed at improving
compliance will result in improved health outcomes; and that a
significant cost savings will be realized through interventions
directed at improving compliance.
NMC believes our product RxAlerts is an effective and
practical tool which will assist the healthcare system in
addressing the problem of medication non-compliance. RxAlerts
is a comprehensive medication compliance and support product/
program which uses sophisticated state-of-the-art software,
utilizing proprietary computer time-clocking engines, to
provide personal, customized health-related information to
patients from their health providers through wired and wireless
communication media--alphanumeric and voice paging, facsimile
transmission, cellular telephony, the internet, wired
telephones and television (pending). The product applications
have two-way communications capability and are encrypted to
assure patient confidentiality. NMC is initially focusing on
disease states like HIV, asthma, diabetes, post-organ
transplants and certain pulmonary and heart conditions where
medicine regimens are difficult, where there is a criticality
of maintaining consistent medicine levels, where there is a
need to modify or enhance behavior and where there is an
overall need to communicate with patients on a regular basis.
New Medical Concepts is encouraged that the Committee is
examining the issue of medical errors, and we pledge to work
with Congress, federal and state health agencies and the
healthcare community in finding real world ``Patient
Connectivity'' solutions which will foster safe medication use
and improve the quality of care patients receive.
Statement of J. Richard Gaintner, Shands Healthcare, Gainesville, FL,
Dear Mr. Chairman, Members of the Committee:
I am writing as CEO of Shands HealthCare, with its mission
of providing excellent patient care, improving community
health, and supporting education and research for the State of
Florida. Shands HealthCare is an integrated clinical delivery
system, which offers the most comprehensive range of services
in North Central Florida. The not-for-profit enterprise
encompasses six acute care hospitals, two specialty hospitals,
a home care company, and manages the University of Florida
clinic operations as well as an extensive physician network.
Shands at the University of Florida, the system's flagship
hospital, is the academic medical center for the University of
Florida Health Science Center and is recognized as one of the
Southeast's leading tertiary care centers, and as such receives
the majority of its patients from every county of Florida and
Southeast Georgia. Shands at the University of Florida is
closely linked with the College of Medicine at the University
of Florida resulting in the development and delivery of cutting
edge technology for the delivery of patient care.
In addition, Shands HealthCare, the University of Florida,
and University and Methodist Medical Centers have joined forces
to form Shands Jacksonville, of which I am the Chairman of the
Board of Directors.
I also have the honor of serving as Chairman of the Council
of Teaching Hospitals (COTH), a PO Box 100326 Gainesville, FL
32610-0326 352.395.0421 352.395.0177 fax
[email protected] of the Association of American
Medical Colleges (AAMC), representing over 400 teaching
hospitals across the nation. In addition, I serve on the Boards
of the American Hospital Association and the Florida Hospital
Association, and was recently elected Chair of the Florida
Statutory Teaching Hospital Council. As a member of the Board
of the National Committee for Quality Health Care, I have been
directly involved in the promotion of quality for health care
teams.
We believe that we have a fundamental responsibility to
continually improve the quality of care and services provided
to our patients. As part of their mission, teaching hospitals
provide a disproportionate share of the most complex health
care services. This translates to patients entering the health
system who are sicker and more complicated, yielding health
needs greater than those traditionally seen elsewhere.
Hospitals have long recognized their role in improving the
care provided to patients. Initiatives already in place at
teaching hospitals include, but are not limited to: leadership
commitment to improving the care provided; internal reporting
of incidents for the identification of possible opportunities
for improvement; teaching conferences where cases are subjected
to detailed review; use of external benchmarking; proactive
attention to improving processes through the use of quality
improvement tools and techniques; and, sharing of information
related to trends and successes.
Shands HealthCare participates in each of these, as well as
required external reporting to the State of Florida for
specified serious incidents. These reporting processes have
only been successful because of the protections put in place by
the Florida Legislature to maintain the confidentiality of the
information reported. This is a crucial step to ensure that the
process remains non-punitive and successful.
One of the keys to success has been the focus of the
Quality Committee of the Board of Directors on quality
improvement, of which reducing errors is but one component.
Reporting of issues and involvement of the Board has reinforced
the commitment at all levels of the organization to improving
and maintaining the health of people in the State of Florida
and the Southeastern United States.
Thank you for your consideration and response to our desire
to work closely with Congress as it pursues ways to continue to
improve the quality of health care services.
Sincerely,
J. Richard Gaintner, MD