Table Of ContentS. HRG. 106–847
MEDICAL MISTAKES
JOINT HEARINGS
BEFORETHE
SUBCOMMITTEE ON
LABOR, HEALTH AND HUMAN SERVICES,
AND EDUCATION, AND RELATED AGENCIES
COMMITTEE ON APPROPRIATIONS
THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
ANDTHE
COMMITTEE ON VETERANS’ AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SIXTH CONGRESS
FIRST AND SECOND SESSIONS
SPECIAL HEARINGS
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Labor, and Pensions, and Veterans’ Affairs
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COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington FRANK R. LAUTENBERG, New Jersey
MITCH MCCONNELL, Kentucky TOM HARKIN, Iowa
CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HARRY REID, Nevada
JUDD GREGG, New Hampshire HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
JON KYL, Arizona
STEVEN J. CORTESE, Staff Director
LISA SUTHERLAND, Deputy Staff Director
JAMES H. ENGLISH, Minority Staff Director
SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin
TED STEVENS, Alaska PATTY MURRAY, Washington
JON KYL, Arizona DIANNE FEINSTEIN, California
ROBERT C. BYRD, West Virginia
(Ex officio)
Professional Staff
BETTILOU TAYLOR
MARY DIETRICH
JIM SOURWINE
AURA DUNN
ELLEN MURRAY (Minority)
Administrative Support
KEVIN JOHNSON
CAROLE GEAGLEY (Minority)
(II)
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
JAMES M. JEFFORDS, Vermont, Chairman
JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut
MIKE DEWINE, Ohio TOM HARKIN, Iowa
MICHAEL B. ENZI, Wyoming BARBARA A. MIKULSKI, Maryland
TIM HUTCHINSON, Arkansas JEFF BINGAMAN, New Mexico
SUSAN M. COLLINS, Maine PAUL D. WELLSTONE, Minnesota
SAM BROWNBACK, Kansas PATTY MURRAY, Washington
CHUCK HAGEL, Nebraska JACK REED, Rhode Island
JEFF SESSIONS, Alabama
MARK E. POWDEN, Staff Director
SUSAN K. HATTAN, Deputy Staff Director
J. MICHAEL MYERS, Minority Staff Director and Chief Counsel
COMMITTEE ON VETERANS’ AFFAIRS
ARLEN SPECTER, Pennsylvania, Chairman
STROM THURMOND, South Carolina JOHN D. ROCKEFELLER IV, West Virginia
FRANK H. MURKOWSKI, Alaska BOB GRAHAM, Florida
JAMES M. JEFFORDS, Vermont DANIEL K. AKAKA, Hawaii
BEN NIGHTHORSE CAMPBELL, Colorado PAUL W. WELLSTONE, Minnesota
LARRY E. CRAIG, Idaho PATTY MURRAY, Washington
TIM HUTCHINSON, Arkansas
CHARLES BATTAGLIA, Staff Director
JIM GOTTLIEB, Minority Chief Counsel/Staff Director
(III)
CONTENTS
MONDAY, DECEMBER 13, 1999
Page
Opening statement of Senator Arlen Specter ........................................................ 1
Statement of Dr. John Eisenberg, Director, Agency for Healthcare Research
and Quality, Department of Health and Human Services ............................... 2
Statement of Mary Wakefield, Ph.D., member, Quality of Health Care in
America Committee, Institute of Medicine; director, Center for Health Pol-
icy, Research and Ethics, George Mason University......................................... 8
Statement of Ray McEachern, president, Association for Responsible Medi-
cine, Tampa, FL ................................................................................................... 14
Statement of Patricia McEachern .......................................................................... 16
Statement of Diane Artemis, Falls Church, VA .................................................... 19
Statement of Debra Malone, Vail, CO ................................................................... 23
Statement of Dr. Nancy Dickey, immediate past president, American Medical
Association ............................................................................................................ 28
Statement of by Anne Shea, acting executive director and chief operating
officer, National Patient Safety Foundation ...................................................... 28
Summary statement ......................................................................................... 29
Statement of Mary Foley, R.N., first vice president, American Nurses Associa-
tion ........................................................................................................................ 33
Statement of Stanton Smullens, chief medical officer, Jefferson Health Sys-
tem, Philadelphia ................................................................................................. 38
Statement of Martin D. Merry, M.D., associate professor of health manage-
ment, University of New Hampshire .................................................................. 41
Prepared statement of Hon. Pete Stark, U.S. Representative from Califor-
nia.......................................................................................................................... 47
Prepared statement of the United States Pharmacopeia ..................................... 48
Prepared statement of Salvador Castro, Professional Engineer .......................... 52
TUESDAY, JANUARY 25, 2000
Opening statement of Senator Arlen Specter ........................................................ 55
Prepared statement of Senator John D. Rockefeller IV ....................................... 57
Statement of Molly Joel Coye, M.D., member, Institute of Medicine, Com-
mittee on Quality of Health Care in America.................................................... 65
Statement of Thomas L. Garthwaite, M.D., Acting Under Secretary for
Health, Department of Veterans Affairs ............................................................ 75
Prepared statement .......................................................................................... 77
Statement of Joseph Donahey, Circuit Court Judge, Pasco County, FL............. 90
Statement of Ralph Specken, M.D., New York, NY .............................................. 93
TUESDAY, FEBRUARY 22, 2000
Opening statement of Senator Bill Frist ............................................................... 99
Prepared statement of Senator James Jeffords .................................................... 101
Opening statement of Senator Edward M. Kennedy ............................................ 102
Prepared statement .......................................................................................... 104
Opening statement of Senator Arlen Specter ........................................................ 104
Opening statement of Senator Tom Harkin .......................................................... 105
Opening statement of Senator Susan M. Collins .................................................. 106
Opening statement of Senator Jack Reed.............................................................. 107
Opening statement of Senator Jeff Bingaman ...................................................... 107
Opening statement of Senator Christopher J. Dodd............................................. 107
Prepared statement .......................................................................................... 107
(V)
VI
Page
Statement of Dr. John M. Eisenberg, Director, Agency for Healthcare Re-
search and Quality, Department of Health and Human Services, and Oper-
ating Chair, Quality Interagency Coordinating Task Force ............................. 108
Prepared Statement ......................................................................................... 113
Statement of Dr. Thomas Leonard Garthwaite, Deputy Under Secretary for
Health, Department of Veterans Affairs ............................................................ 116
Prepared statement .......................................................................................... 118
Statement of Dr. I. Steven Udvarhelyi, senior vice president and chief medical
officer, Independence Blue Cross, Philadelphia, PA, on behalf of the Amer-
ican Association of Health Plans ........................................................................ 165
Prepared statement .......................................................................................... 166
Statement of Dr. Thomas R. Russell, executive director, American College
of Surgeons ........................................................................................................... 170
Prepared statement .......................................................................................... 172
Statement of Dr. Dennis O’Leary, president, Joint Commission on Accredita-
tion of Healthcare Organizations, Chicago, IL .................................................. 176
Prepared statement .......................................................................................... 178
Statement of Dr. Arnold S. Relman, professor Emeritus of Medicine and
of Social Medicine, Harvard Medical School, Boston, MA ................................ 187
Prepared statement .......................................................................................... 189
Prepared statement of the American Academy of Orthopaedic Surgeons and
the American Association of Orthopaedic Surgeons.......................................... 205
Prepared statement of the American College of Physicians—American Society
of Internal Medicine............................................................................................. 207
Prepared statement of the American College of Radiology .................................. 211
Prepared statement of Healthcare Provider Credentials Verification Associa-
tion ........................................................................................................................ 212
Prepared statement of the National Association of Chain Drug Stores.............. 214
MEDICAL MISTAKES
MONDAY, DECEMBER 13, 1999
U.S. SENATE,
SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN
SERVICES, AND EDUCATION, AND RELATED AGENCIES,
COMMITTEE ON APPROPRIATIONS,
Washington, DC.
The subcommittee met at 10:30 a.m., in room SD–138, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman) presiding.
Present: Senator Specter.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator SPECTER. Good morning. The hour of 10:30 having ar-
rived, the Committee on Labor, Health, Human Resources, and
Education of the Appropriations Committee will proceed with our
hearing.
On November 29, the Institute of Medicine issued a report enti-
tled ‘‘To Err is Human: Building a Safer Health System,’’ which
cataloged an enormous number of medical errors which occur at
our health care delivery system hospitals and doctors offices. Now,
this had followed some rather dramatic disclosures about medical
errors.
A prominent health reporter in the Boston Globe, Betsy Layman,
died from an overdose during treatment in Florida. Mr. Willy King
had the wrong leg amputated. Two large studies, one conducted in
Colorado and another in Utah, found adverse events occurring in
about 3 to 4 percent of hospitalizations, respectively, and the pro-
jected estimates are that as many as 44,000 Americans may die
each year from medical errors. These errors comprised the fifth
leading cause of death in the United States, with the costs esti-
mated in the range of $20 billion a year.
The study of the Institute of Medicine recommended that the
Agency for Health Care Research and Quality receive an appropria-
tion initially of some $30 million. That agency is funded by this
subcommittee, and it was decided that we should push ahead with
the hearing at an early date, even though the Congress is in recess
at this time, so that we may investigate the issue and proceed with
the dialogue, hopefully being in the position to introduce legislation
on this subject when the Congress reconvenes in late January.
There are a number of agencies, really, to be heard from on this
matter, and today’s hearing will really just begin the dialogue, but
the issue has been raised. In addition to the Agency for the Health
Care Research and Quality, a number of other agencies funded
through the initiation of this subcommittee may also have an im-
(1)
2
portant role to play, such as the Health Care Financing Adminis-
tration, the National Institutes of Health, which received an enor-
mous increase in funding, some $2.3 billion this year, to a total of
almost $18 billion a year, the Centers for Disease Control, the
Health Resources and Services Administration, the Administration
on Aging, Substance Abuse, and Mental Health Administration,
and also the surgeon general’s office.
I might say parenthetically, I talked to Dr. Satcher last week
about that very important report on mental health, which is to be
released today, and the advanced billing show that to be a matter
of enormous concern, and, again, a subject which has been funded
through this subcommittee, having enormous implications, which
we may have a hearing on later and address those issues.
STATEMENT OF DR. JOHN EISENBERG, DIRECTOR, AGENCY FOR
HEALTHCARE RESEARCH AND QUALITY, DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Senator SPECTER. A fuller statement will be admitted for the
record, but to proceed at the earliest moment with our very distin-
guished panel of witnesses, I would like to call at this time Dr.
John Eisenberg and Dr. Mary Wakefield to be our initial witnesses.
Dr. Eisenberg is the Administrator of the Agency for Healthcare
Research and Quality, the agency called upon by this study to take
the lead in addressing these serious issues. Dr. Eisenberg was
chairman of the Department of Medicine of Physicians, and Chief
at Georgetown University, and before that was the Chief of Gen-
eral Internal Medicine at the University of Pennsylvania, a grad-
uate of Princeton, Washington University, St. Louis School of Medi-
cine, and the Wharton Business School. That is quite a varied
background, Dr. Eisenberg. Thank you for joining us here today,
and the floor is yours.
Dr. EISENBERG. Thank you, Senator Specter. Mr. Chairman,
when I read the Institute of Medicine’s report on patient safety and
errors in the health care system, I, like every physician, had some
reminiscences. It brought back some memories.
I recall the woman whom I took care of; we had had a pap test
done to screen her for cervical cancer. The result was suspicious,
but I never knew that, because I never got the report back, and I
did not realize that I had not gotten the report back until she
called me and asked about the report.
I tracked it down. I found out it was suspicious. We followed it
up, and fortunately, it turned out not to be anything serious, but
that was a near miss, and it was a near miss that could have been
a tragedy, had she not called me, had she not taken part in detect-
ing and preventing errors. That happened at the University of
Pennsylvania, when I headed the General Internal Medicine Divi-
sion there. It is a great hospital, as you know, but even at the best
institutions, errors happen.
Senator, when I spoke at three medical school graduations last
spring, I asked all of the students who were graduating, and I
asked all of the faculty to raise their hands if they had ever made
a mistake in taking care of a patient, and every single student
raised his or her hand, and every faculty member raised his or her
hand. So we have established the fact that these errors exist; we
3
have established that the best physicians at the best institutions
make mistakes.
What the Institute of Medicine’s report has done, has been to
alert us to the magnitude of this problem, to point out to us that
if it were a disease, it would be the eighth leading cause of death
in the United States. But if it were a disease, Senator Specter, I
think we would call it an epidemic.
Senator SPECTER. Dr. Eisenberg, did you say the eighth leading
cause of death——
Dr. EISENBERG. The eighth leading cause.
Senator SPECTER [continuing]. Not the fifth leading cause of
death?
Dr. EISENBERG. Not the fifth. The eighth. It is somewhere be-
tween 44,000 and 98,000 deaths per year, is what the IOM has es-
timated. Now, that is bad news, but there is some good news, and
the good news is that these errors can be prevented.
If this were a disease, then let us think about what we would do.
We would attack it with the best research that we could muster,
we would put resources into translating that research into im-
proved practices, and it is going to take resources, and it is going
to take teamwork in order for us to respond to this problem.
I want to commend you, Mr. Chairman, and the other Members
of the Senate and the House of Representatives for recently taking
what I think is a significant and very timely step in November to
reauthorize our agency and to rename it from the Agency for
Health Care Policy and Research to the Agency for Healthcare Re-
search and Quality, or AHRQ, as we will call it.
The name quality in our name is very important, because this is
an issue of health care quality. Errors and even near misses, like
the one that I had, are not new problems, but they have finally got-
ten the attention that they deserve.
Congress did show foresight in raising the awareness of medical
errors as an important part of the health care quality agency
through that legislation that reauthorized our agency and renamed
it. You gave AHRQ not only the authority, but you gave us the re-
sponsibility to carry forward many of the error prevention rec-
ommendations in the Institute of Medicine’s report.
Now, while an investment is going to be required to make system
improvements to reduce medical errors, I think we can be confident
that it will also reap substantial benefits. In the long run, when
these medical errors are prevented, the IOM estimates that we
could save as much as $8.8 billion that is spent on health care
today. The research we have sponsored shows that many adverse
drug reactions and events can be prevented if appropriate systems
are put in place.
I recall, for example, in the mid-1980s, when at Penn, our faculty
developed with the Philadelphia College of Pharmacy and Science,
one of the first systems to detect adverse drug reactions, and these
kinds of systems are now being computerized, but Senator Specter,
it is more than just about drug errors.
In fact, the Institute of Medicine found that while about 10 per-
cent of the errors clearly involve drugs, 12 percent of them were
the failure to prevent an injury, and 17 percent were diagnostic
mistakes, like the one that I almost made.
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While the statistics of errors are astonishing to many and they
are distressing to all of us, it is very important for us to remember
that the IOM emphasized that this is a problem of the health care
system, not incompetent careless individuals.
Our approach to medical mistakes has to change from the old
mode of name them, blame them, and shame them, to one of look-
ing at systems, finding out what the root causes of these errors are,
and then sharing information so that those errors are not repeated.
Like the patients that they care for, health care professionals are
human, and we humans are not perfect. As the IOM report recog-
nized, to err is, in fact, human.
Now, research has shown us that errors exist, and we need to
understand the dimensions of those errors, but we cannot stop just
by counting the errors. We have to evaluate why they occur, and
then we have to develop systems in order to prevent them. Our
new name, AHRQ, is symbolic of the need to develop an arc or a
bridge between the problem and its solution, between what we
know and what we actually do in health care.
Let me give you one example. Our agency funded a study that
tested whether emergency rooms could put together dedicated chest
pain observation units, which could reduce the number of people
who are mistakenly sent home even though they have had a heart
attack. These units have specially trained staff, they have dedi-
cated equipment, and they have validated treatment protocols that
have led them to reduce the number of people who are sent home
mistakenly by as much as 100-fold, says the research.
We can learn from the aviation industry, as we know, and we
know that in health care more can be done as well. Some of the
earliest research, in fact, in error reduction in health care was done
in anesthesia. Applying the lessons of that research has allowed
anesthesiologists, the people who provide anesthesia for surgery, to
reduce their error rate by about seven fold.
We have seen, in the Department of Defense and in the Depart-
ment of Veterans Affairs, programs that show that improvements
can be made in reducing errors, but if we are going to reduce errors
in health care, Senator Specter, we are going to have to share in-
formation on those practices and share information on effective so-
lutions, but we cannot share information if we do not have informa-
tion. What the Institute of Medicine’s report told us is that we can
help change the culture of secrecy surrounding medical errors into
a culture of education and improvement.
I want to thank you and your colleagues for providing our agency
with the funding that you mentioned earlier in fiscal year 2000.
That, combined with our new authorizing language, is going to
allow us to make a down payment on research in this critical area.
We have already expanded our commitment to research in reduc-
ing medical errors. We are going to fund about $2 million in re-
search on medical errors and patient safety this year, identify op-
portunities for further research that we can carry out in the future,
and continue supporting a very exciting new initiative, the Centers
for Education and Research in Therapeutics (CERTS). You may
have seen the article about CERTS in the Wall Street Journal on
Friday, which will help to reduce adverse events from drugs, and
