[Senate Hearing 106-847]
[From the U.S. Government Publishing Office]
S. Hrg. 106-847
MEDICAL MISTAKES
=======================================================================
JOINT HEARINGS
before the
SUBCOMMITTEE ON
LABOR, HEALTH AND HUMAN SERVICES,
AND EDUCATION, AND RELATED AGENCIES
COMMITTEE ON APPROPRIATIONS
the
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
and the
COMMITTEE ON VETERANS' AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SIXTH CONGRESS
FIRST AND SECOND SESSIONS
__________
SPECIAL HEARINGS
__________
Printed for the use of the Committees on Appropriations, Health,
Education, Labor, and Pensions, and Veterans' Affairs
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
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_____________________________________________________________________
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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)
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
FRANK H. MURKOWSKI, Alaska Virginia
JAMES M. JEFFORDS, Vermont BOB GRAHAM, Florida
BEN NIGHTHORSE CAMPBELL, Colorado DANIEL K. AKAKA, Hawaii
LARRY E. CRAIG, Idaho PAUL W. WELLSTONE, Minnesota
TIM HUTCHINSON, Arkansas PATTY MURRAY, Washington
Charles Battaglia, Staff Director
Jim Gottlieb, Minority Chief Counsel/Staff Director
C O N T E N T S
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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 Policy, Research and Ethics, George Mason
University..................................................... 8
Statement of Ray McEachern, president, Association for
Responsible Medicine, 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 Association............................................. 33
Statement of Stanton Smullens, chief medical officer, Jefferson
Health System, Philadelphia.................................... 38
Statement of Martin D. Merry, M.D., associate professor of health
management, 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, Committee 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
Statement of Dr. John M. Eisenberg, Director, Agency for
Healthcare Research and Quality, Department of Health and Human
Services, and Operating 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 American 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
Accreditation 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 Association....................................... 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
arrived, 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
entitled ``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 projected 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 estimated 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
appropriation 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 important role to play, such as
the Health Care Financing Administration, the National
Institutes of Health, which received an enormous 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
distinguished 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 General Internal Medicine at the
University of Pennsylvania, a graduate of Princeton, Washington
University, St. Louis School of Medicine, 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 detecting and preventing errors. That
happened at the University of Pennsylvania, when I headed the
General Internal Medicine Division 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 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
between 44,000 and 98,000 deaths per year, is what the IOM has
estimated. 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 improved 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 Research 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 gotten 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 responsibility to carry forward many of the error
prevention recommendations 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 percent 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.
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
looking 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 recognized, 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 dedicated 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
Department 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 information on those practices and share
information on effective solutions, but we cannot share
information if we do not have information. 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
reducing medical errors. We are going to fund about $2 million
in research on medical errors and patient safety this year,
identify opportunities 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 we are going to support
activities to translate that research into better practice.
We are going to continue to collaborate with the American
Medical Association, with the National Patient Safety
Foundation, and with many other colleagues who have been
providing leadership in this area. Last week, as you know,
President Clinton directed the Quality Inter-agency
Coordination (QUIC) Task Force to review existing medical
errors and patient safety issues in Federal health programs,
and to test the feasibility of our implementing the Institute
of Medicine's recommendations.
Secretary Shalala co-chairs the QUIC, and she has made a
personal commitment to improving health care quality. Secretary
Shalala and Secretary Herman have directed me as the operating
chair of the QUIC, and as the head of the lead agency in
quality, to focus our attention on this issue. At 8:30 this
morning, when we had members of every Federal agency involved
in this issue come together to talk about what we can do. We
have already begun to take steps toward reducing medical
errors.
We are going to work with the Institute of Health Care
Improvement to look at ways of reducing errors in Federal
programs, and we are going to continue to recognize and to
emphasize that the issues of reducing medical errors and
improving patient safety are critical and timely. We need to be
sure that the proposed solutions address the real problem, the
problem at its root, which is the system, rather than blaming
individuals.
We need to improve the system, so that health care
providers can have an opportunity to provide high-quality
health care that they were trained to provide in a safe and an
effective environment. We look forward to working with the
Congress to gain control of this epidemic of medical errors,
and to improve the quality of health care for the American
people.
Mr. Chairman, I want to thank you for this opportunity to
discuss this important issue and to continue to work with you
and your staff in the area. Thank you.
Senator Specter. Thank you, Dr. Eisenberg.
With respect to the listing as to eighth highest or fifth
highest, the statistics which I have from the Institute of
Medicine and Centers for Disease Control put the medical
errors, with as many as 98,000, in fifth place behind heart
disease, cancer, stroke, and obstructed lung disease, and ahead
of pneumonia, influenza, diabetes, auto accidents, suicide, and
kidney disease, which round out the top ten. So whether the
figure is five or eight, it is----
Dr. Eisenberg. That is right.
Senator Specter [continuing]. An enormously significant
figure.
Dr. Eisenberg. I think one of the reasons we do not know
exactly how many there are is because we do not have systems to
understand how many errors are occurring and to understand
where they are occurring as well as we should. If we could do
better research in this area, we could probably clarify for you
whether it is number five or number eight.
Senator Specter. I had a chance meeting at New York City
with Dr. Eugene Flam, a very distinguished surgeon formerly
from the University of Pennsylvania, and somebody that I have
had personal contact with, and we were discussing the range in
statistics, and a question was raised as to whether they may be
inflated, if we cannot put a more precise tabulation on them.
Do you think that that is a possibility?
Dr. Eisenberg. I know Gene well, having worked with him
when we were both at Penn, and I suspect that from his
perspective these estimates of errors may be more frequent than
he sees himself, but I think for the nation as a whole----
Senator Specter. Because he makes fewer errors?
Dr. Eisenberg. I would not be surprised. But I think for
the nation as a whole, these numbers, if anything, are
conservative. The numbers that I have heard would suggest that
the numbers of the IOM, the 44,000 to 98,000 deaths per year,
are, if anything, on the low side.
Senator Specter. One suggestion has been made that as a
result of the legislation which was signed into law just last
week by the President, the omnibus appropriation bill, which
gave you clear authority, your agency, that it might be
unnecessary to have additional legislation, that you might be
able to handle it within the existing framework of established
law. What is your view about that?
Dr. Eisenberg. We can certainly do more than we have done
in the past, and I think the authorizing language that we have
gives us just that authority.
It gives us authority to conduct a more aggressive program
of research; it asks us to create a national report on health
care quality by the year 2003, and we have to respond, and we
look forward to responding to that authorizing language.
Whether we should do more than the authorizing language already
allows us to do is something that our department and the entire
administration is looking at very, very seriously. Over the
next several weeks we are going to look at it carefully, get
back to the President about what we should do and what we can
do even beyond the authorities that we already have.
Senator Specter. Well, when there was a call on the part of
the Institute of Medicine to start off with an additional
funding source of $30 million, and then to elevate that to $100
million, I think it likely that to get that kind of additional
congressional support there is going to have to be a lot more
concern in Congress, which may require some additional
legislation and some additional congressional focus.
Dr. Eisenberg. We look forward to talking with you about
that legislation, what it might allow us to do, and the kinds
of resources that it would require.
Senator Specter. When you talk about mistakes, and then say
that they are systemic, it is almost a suggestion that they are
not individual matters, and you used the illustration of
someone coming into the hospital with chest pains, the errors
of not knowing when there is a heart attack, and then a system
change led to a significant reduction in those errors, tell us
a little bit more about that. What exists before you have a
system change that the people who examined patients for chest
pain would not be aware of the criteria to make a determination
as to whether it is or is not a heart attack?
Dr. Eisenberg. When errors occur, they sometimes occur
because of the fact that people are not aware or they are not
knowledgeable of what they might want to do. The first step
would be to be sure that we translate to them the information
that has been made available about what works and what does not
work.
Sometimes it helps for them to have guidelines that are
written by professional societies or other knowledgeable
groups, based upon the research about what they----
Senator Specter. Well, do not the people who conduct those
examinations have guidelines?
Dr. Eisenberg. Sometimes they have guidelines. We----
Senator Specter. Sometimes they do not.
Dr. Eisenberg. Sometimes they do not.
Senator Specter. Why not?
Dr. Eisenberg. Sometimes they are not easily accessible.
Senator Specter. Guidelines are not easily accessible.
Dr. Eisenberg. Sometimes they are not. We, in fact, have
just started----
Senator Specter. What is their basic training before you
get to the guidelines?
Dr. Eisenberg. The first step is to understand the
pathophysiology, the cause of the problem, and the treatments.
Senator Specter. If somebody comes into the hospital and
has a chest pain, who customarily sees that person, somebody in
the emergency room?
Dr. Eisenberg. Somebody in the emergency room almost always
would see that person if they show up in the emergency room.
However, they may go to their personal physician's office, and
that physician, or the person in the emergency room, may not
see very many patients with this problem.
If we can make a guideline readily available, which we have
done that through AHRQ's a National Guideline Clearinghouse (on
the web), then that will help. But even with the guideline, you
need to have a system in place whereby the laboratory result
comes back quickly and accurately.
Senator Specter. Is the EKG standard in an emergency room,
where somebody comes in and complains of chest pain?
Dr. Eisenberg. If the suspicion on the part of the
clinician is high enough, an EKG would be standard, yes.
Senator Specter. How do you define suspicion high enough on
the part of the physician?
Dr. Eisenberg. What the average physician will do will be
to use what he has read, or she has read and experienced, and
say, ``this seems likely enough to me that I better look into
this and get a cardiogram. '' If that physician has a decision
support system, which is a fancy way of saying a mechanism of
helping the physician not just rely on his own memory, or what,
then I think with that kind of system in place, we can get the
best information to the doctor right away, rather than relying
on our remembering everything in the frenzy of an emergency
room setting.
Senator Specter. Can you generalize on the quality of the
physicians available at emergency rooms across America?
Dr. Eisenberg. I think that the physicians who work in
emergency rooms around this country are remarkable clinicians,
working in very difficult and unpredictable situations. They do
not know what is going to come in, and they know that it may be
very important.
Their job is to figure out whether it is a very important
problem or a problem that can be taken care of easily. That is
the remarkable task of judgment that exists in an emergency
room, and anything we can do to put systems or support programs
in place to help them make those judgments better, will help
improve the quality of care patients receive.
Senator Specter. Well, would you say that the hospitals
customarily take very strong measures to be sure that the
physicians in the emergency rooms are up to the wide variety of
problems that they see?
Dr. Eisenberg. I think they do what they can with the
resources that they have available.
Senator Specter. Well, actually, that is different, to do
what they can with the resources that they have available. How
frequently are they left to medical personnel who are in
training, as opposed to experienced physicians?
Dr. Eisenberg. The requirements of the Joint Commission of
Accreditation of Health Care Organizations and the requirements
of all the residency review groups require that any physician
in training be supported and backed up by a physician who is
fully trained and experienced in this area.
Senator Specter. On the spot?
Dr. Eisenberg. Immediately available. As well as having
nurses and other health professionals with experience. What I
mean by the hospitals doing what is within their resources is
the other support that they could provide them.
For example, a computer system. We know that we have the
capacity to develop computer systems that would provide support
to clinicians making decisions that exceeds the capacity of
many hospitals today.
What we need to understand is why those computer systems
have not spread more rapidly, which ones work, and which ones
really make a difference in the issue that you are addressing.
We need to understand how we can make computers more available
in emergency rooms and hospitals around the country more
quickly.
Senator Specter. Well, that is just the beginning, Dr.
Eisenberg. There are just so many questions and so many issues,
but thank you for those observations.
STATEMENT OF MARY WAKEFIELD, Ph.D., MEMBER, QUALITY OF
HEALTH CARE IN AMERICA COMMITTEE, INSTITUTE
OF MEDICINE; DIRECTOR, CENTER FOR HEALTH
POLICY, RESEARCH AND ETHICS, GEORGE MASON
UNIVERSITY
Senator Specter. We turn now to Dr. Mary Wakefield, the
Director of the George Mason University Center for Health
Policy and Ethics. She served on the Institute of Medicine
Committee, which issued the report on medical safety, and is
here to discuss the findings and implications of that report.
Previously, she served as a commissioner to the Medicare
Payment Advisory Commission, and prior to her current position
at George Mason she worked as Chief of Staff for Senators
Quentin Burdick and Kent Conrad, from North Dakota.
Welcome, Dr. Wakefield. I also note an R.N. beside your
name, registered nurse. Thank you for being here, and we look
forward to your testimony.
Dr. Wakefield. Thank you. Good morning, Mr. Chairman. My
name is Mary Wakefield, and I direct the Center for Health
Policy, Research, and Ethics at George Mason University, in
Fairfax, Virginia.
As an aside, as you noted, many years ago I was sitting on
the other side of the dais as a staff member to one of your
former colleagues, and even though I am appearing on this side
of the table, I just want to tell you it is a privilege to be
back here in a room that I had actually spent a great deal of
time as a staff member.
Today, however, I am here 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.'' Joining me today is Dr. Janet
Corrigan, Director of the IOM Quality of Health Care in America
Project.
Patient safety is a tremendously important issue, and one
that deserves urgent attention. Our health-care system in this
country is the best in the world. We are living longer and are
healthier than at any time in the history of humankind, but our
health-care system is also under enormous strain, made evident
by the number of medical errors plaguing us. The human cost is
high. Based on the findings of one major study, 44,000 hospital
patients die each year as a result of medical errors, and
another study puts the number even higher, at 98,000. Even
using the more conservative figure, medical mistakes, as you
and Dr. Eisenberg indicated, would rank eighth among the
leading causes of death, ahead of traffic accidents, breast
cancer, and AIDS.
It is important to note that while errors may be more
easily detected in hospitals, they afflict every health care
setting: day-surgery and outpatient clinics, retail pharmacies,
nursing homes, as well as home care. Moreover, some 7,000
patients die each year from medication errors that take place
both in and outside of hospitals, and that number exceeds the
annual rate of death from workplace injuries. These stunningly
high rates of medical errors are simply unacceptable in a
medical system that promises first to do no harm.
So, it is against this discerning backdrop that our
committee undertook its study, and having spent substantial
time reviewing the literature and examining the data, we have
determined that no single entity is at fault, and furthermore
that finger pointing and placing blame would be a pointless
exercise.
Instead, we emphasize that reducing the high rate of
medical errors will require rigorous changes throughout the
entire health care system. Here, we are talking about system-
wide change. Our report puts forward a comprehensive strategy
for government, industry, consumers, and providers all needing
to take action.
Taken together, our recommendations represent a systematic
way to design safety into the process of care. They should be
evaluated after five years to assess progress in making the
health system safer. With adequate leadership, attention, and
resources, improvements can be made.
To quote the report: ``It may be part of human nature to
err, but it is also part of human nature to create solutions,
to find better alternatives, and meet the challenges ahead.''
In order to meet those challenges, we must first face
facts. Our health care system is a decade or more behind other
high-risk industries in its attention to ensuring basic safety.
The risk of dying in a domestic airline flight or at the
workplace has declined dramatically in recent decades, in part
because of the creation of Federal agencies that focus on
safety. Drawing on that model, we urge Congress to create a
center for patient safety within the U.S. Department of Health
and Human Services.
This center would set national safety goals, track progress
in meeting them, and invest in research to learn more about
preventing mistakes. It also would act as a clearinghouse, an
objective source of the latest information on patient safety
for the nation.
For example, if a health care organization improves safety,
its practices should be shared with a broad audience, and the
center would help provide the needed channel to distribute that
information. This center would not have regulatory authority.
Administratively, Congress would need to spend between $30
million and $35 million to set up the center, and it should be
housed within the Agency for Health Care Research and Quality
of HHS. Funding would need to grow to at least $100 million
annually, or put another way, one percent of the $8.8 billion
in health care costs attributable to preventable adverse
outcomes.
At the same time, we recommend that a nationwide, mandatory
public reporting system be established at the Federal level and
implemented by State governments. Currently, only about a third
of the States have mandatory reporting requirements, and yet
this information is critical if we are to learn, in any
systematic way, about medical treatments that lead to serious
injury or death.
We also believe that the public has a right to know about
errors resulting in serious harm, and that this information
should be made available to the public with appropriate
safeguards for protecting patient and provider confidentiality.
Health care organizations should also be encouraged to
participate in voluntary reporting systems. These systems focus
on medical mistakes that do not result in serious consequences.
The IOM Committee does recommend Federal legislation to protect
the confidentiality of these data when the information is
collected and analyzed solely for the purpose of improving
safety.
This would encourage the growth of voluntary, confidential
reporting systems so that practitioners and health
organizations can correct problems before serious harm occurs.
Without such legislation, fears that reported information might
ultimately be subpoenaed and used in lawsuits could discourage
participation by practitioners and health care organizations.
A top-down system will not be enough to bring about the
kind of fundamental changes needed to improve patient safety.
Pressure from all directions will be necessary. That is to say
public and private purchasers of health care insurance,
including businesses buying coverage for their workers, should
make safety a prime concern in their contracting decisions.
Doing so will create financial incentives for health care
organizations and providers to make needed changes.
One reason consumers do not push harder for patient safety
is that they assume accrediting and certifying organizations
and local and State regulators do it for them. Regulators and
accreditors should make patient safety a key component of their
oversight programs. For most health care professionals, for
example, there is no assessment of clinical performance once
they get their licenses to practice. Licensing and certifying
bodies should implement periodic reexaminations of doctors,
nurses, and other key providers, based on both competence and
knowledge of safety practices.
At the same time, the U.S. Food and Drug Administration
also should increase its attention to public safety. As the
agency that regulates prescriptions and over-the-counter drugs,
it should make every effort to eliminate similar-sounding drug
names, and confusing labels and packaging that foster mistakes.
Numerous studies have documented errors in prescribing
medications and dispensing by pharmacists as well as
unintentional mistakes on the part of patients.
Reducing medication errors also will require that all
hospitals and health care organizations implement proven safety
practices, such as the use of automated drug ordering systems.
Medication errors occur frequently in hospitals, yet many have
not implemented known methods for improving safety.
Health care organizations must create an environment in
which safety becomes a top priority. This culture of safety
means designing systems geared to preventing, detecting, and
minimizing hazards and the likelihood of error, not finding and
attaching blame to individuals.
This requires creating and adequately funding systems to
monitor safety. We urge the adoption of well-understood safety
principles such as designing jobs and working conditions for
safety; standardizing and simplifying equipment, supplies, and
processes; and avoiding reliance on memory.
Because the know-how exists to prevent many of these
mistakes, we strongly believe it is possible to achieve at
least a 50 percent reduction in errors over five years. The
majority of medical errors do not result from individual
recklessness, but from basic flaws in the way the health care
system is organized. Equipment controls that differ from one
manufacturer to another, or from year to year, can contribute
to errors.
Stocking patient care units in hospitals with drugs that
are potentially lethal unless diluted before being administered
has resulted in deadly overdoses. Illegible writing in medical
records has resulted in the administration of a drug for which
the patient has a known allergy.
More generally, medical knowledge and technology advance so
rapidly that it is difficult for practitioners to keep up, and
the health care system itself is evolving so quickly that it
often lacks coordination. For example, when a patient is
treated by several practitioners, those practitioners often do
not have complete information about the medicines prescribed or
the patient's illnesses.
Mr. Chairman, our report emphasizes there are no ``magic
bullets.'' No one part of this plan will be sufficient to bring
about the degree of change needed. Dramatic improvement
requires comprehensive change involving all parts of the
system.
Thank you for this opportunity to testify. I would like my
statement put in to the record. I would be happy to answer any
questions the Committee may have.
Senator Specter. Thank you, Dr. Wakefield.
When you state a 50 percent reduction within 5 years, that
is a very tall order. Where do you get that? That is just not a
figure pulled out of the air. What statistical base do you have
for that expectation?
Dr. Wakefield. Well, we base that on having reviewed the
research that identifies both errors that have been committed,
their sources, and what we know about how improvement in
systems of care can actually occur. So in other words, a lot of
the errors that are already occurring within health care
delivery systems could be solved by the use of procedures that
some facilities already have in place.
So in some cases, in many cases, as a matter of fact, a lot
of the solutions to these problems are simply not disseminated
throughout the health care delivery system. So part of what we
looked at were the causes of those errors, and whether or not
with the investment of a number of different organizations and
initiatives, those that we identified in our series of
recommendations, once brought to the table, we think that that,
in fact, could result in at least half of those errors being
eliminated within 5 years.
Senator Specter. Well, that is a good statement as to what
you hope to do methodically, but how do you get to a 50 percent
figure?
Dr. Wakefield. It is an aim that, after a deliberation
across the members of the committee, we thought was a tall
order, a challenge, but an aim that if the resources of
stakeholders with an interest in solving these problems are
brought to bear, that it should be an achievable order.
Senator Specter. It is more than an aim, it is your
expectation----
Dr. Wakefield. Yes, it is.
Senator Specter [continuing]. That is what you say will
happen.
Dr. Wakefield. Yes, it is.
Senator Specter. To the extent that you could document
that, we would be very interested. When you talk quantifiably
about a success rate, and then we can turn that into dollars
and cents when you have the figures as to how many billions of
dollars it costs by these medical errors, that would be very
helpful.
One of the items that you enumerate is well known to just
about everybody, and that is the illegible writing issue. How
are you going to handle that? It is a very common experience
for all of us patients to hear doctors brag about how illegible
their writing is when we get a prescription and go off to the
pharmacy. How are you going to do that?
Dr. Wakefield. It is a problem. There are systems that have
been put in place in some health care delivery organizations.
They operate on the use of computerized order entry systems. So
rather than having to rely on Dr. Eisenberg's handwriting, for
example----
Senator Specter. How is your handwriting, Dr. Eisenberg?
Dr. Eisenberg. It needs help.
Dr. Wakefield. Assuming that Dr. Eisenberg needs help with
his handwriting, we would ask him to actually enter that
prescription on a computer, so that you eliminate the
possibility of a nurse, a pharmacist, or some other health care
provider misreading what he has written.
Senator Specter. To what extent is that done now,
prescriptions entered on computers?
Dr. Wakefield. There are hospitals, for example, that have
incorporated those kinds of computer systems within their
health care facilities, but there are many health care
facilities that have not.
Senator Specter. Well, regrettably, I have been in a few
hospitals, but I have never had a prescription entered on the
computer, but that is done----
Dr. Wakefield. Yes, that is correct.
Senator Specter [continuing]. To a significant extent?
Dr. Wakefield. Yes, there are hospitals that have purchased
and incorporated computerized order entry systems. There are
many hospitals, as I mentioned, and other health care delivery
systems that have not, even clinics, for example.
Senator Specter. Mandatory reporting requirements seems to
me to be a very salutatory, very good idea, because if there is
mandatory reporting, then the hospital, doctor, has to identify
where a mistake is being made, and that is the first step to
correcting it, if there is a report on it. People do not like
to report mistakes, for good reason, so there is a real
incentive to not have to report it, not to make it to have
something that you do not have to report to start with.
What kind of resistance do you expect from hospitals, the
American Hospital Association, the American Medical
Association, the people who would be called upon to really face
up to significant errors on that kind of a mandatory reporting
system?
Dr. Wakefield. Well, I guess perhaps, Senator, since I
believe you have some representatives from those organizations
they will probably be telling you what they think of that
particular provision, but I would say that from the committee's
perspective we thought it was an extremely important one.
We felt that mandatory reporting of very serious errors,
errors and errors that result in patient death, ought to be
operationalized, and that that mandatory reporting will help to
hold the systems of health care accountable for the care that
they provide and the safety that they ensure for their
patients.
Senator Specter. Following hearings by this subcommittee,
which also has jurisdiction over education funding, legislation
was enacted fairly recently requiring colleges and universities
to report campus crime.
There was enormous resistance to that, so that if the crime
occurred on the sidewalk within the university complex, it was
excluded, and we had to pass supplementary legislation to
correct that and put some teeth and some fines into action by
the Department of Education, but that, I think, is a core issue
and one which there is going to be resistance. We are going to
have work on that one very carefully.
Your first recommendation was the creation of a center for
patient safety within the Agency for Health Care Policy and
Research. Do we really need another bureau?
Dr. Wakefield. Well, we are not recommending establishing a
brand new agency, we are recommending the establishment of a
center within an already existing agency to provide a very
sharp focus to addressing issues around patient safety and
error reduction.
Senator Specter. When we looked at the proposal for the
national health policy in 1993 we had a chart that was more
complicated than the New York subway system. We had about 100
new agencies and new jobs for about 50 agencies, even a new
sub-box.
Do we really need that, Dr. Eisenberg? Do you have enough
bureaus, agencies, without creating another center for patient
safety within your agency?
Dr. Eisenberg. Well, we are looking at the IOM's
recommendation to determine what we ought to recommend within
the administration about the creation of a new center. I think
there are certain elements about what the IOM has recommended
that go undisputed.
The first is that there ought to be a place in government
that has the responsibility for sponsoring the research and
analyzing the data that exists. The second is that it ought to
be an agency that has a focus on research, and it is not a
regulatory agency. The third is that it not be separated from
the rest of the quality agenda.
I agree with those three criteria, so I am comfortable with
the idea that the responsibilities that the IOM has laid out
rest within the Agency for Health Care Research and Quality,
and we are going to look at what the right organizational
framework for that vesting of responsibility ought to be.
Senator Specter. Well, you have a very impressive report,
Dr. Wakefield. Where can people get a copy of this report if
they want to pursue your recommendations?
Dr. Wakefield. The Institute of Medicine will be making
those reports available, within the National Academy of
Science. It will also be on the Web, www.nap.edu.
Senator Specter. Well, it is very interesting, you start
off at the top first, ``Do no harm,'' and I just asked Dr.
Chatta to find out where that comes from, and it is in the oath
of Hippocrates, that even before you start to help you seek to
avoid hurting, which is very interesting. When we patients go,
that should be our first area of concern.
Well, thank you very much for your testimony. That gives us
a good launching pad, and we will doubtless be talking to some
more.
STATEMENT OF RAY McEACHERN, PRESIDENT, ASSOCIATION FOR
RESPONSIBLE MEDICINE, TAMPA, FL
Senator Specter. I now call our second panel. Our first
witness on this panel is Mr. Ray McEachern, President and co-
founder, with his wife, Patricia, who is joining us on the
panel, of the Association for Responsible Medicine, based in
Tampa, FL.
Mrs. McEachern suffered permanent disability as a result of
a medical error, bringing them to found the organization to
inform patients about the need to protect themselves from such
injuries.
Mr. McEachern served in the Peace Corps, at the Office of
Economic Opportunity, and worked with former Secretary of
Defense Dick Cheney at the Cost of Living Council, and is a
graduate of Florida State University. Welcome, Mr. McEachern,
we look forward to your testimony.
Mr. McEachern. Thank you, Mr. Chairman. I appreciate the
opportunity to testify. As you said, my name is Ray McEachern.
My wife and I, Patricia, founded the Association for
Responsible Medicine about five years ago. As a report from the
IRM says, ``To err is human.'' Of course, the second corollary
of that statement is ``To cover up is a crime.'' That is the
message I am here to deliver.
I have heard the phrase, ``It is not about fixing blame. It
is about fixing the system,'' so often it appears to have
become a mantra. I agree that it is not about fixing blame, but
unless our first concern is the patient instead of the
provider, we will never fix the system. Human beings make
errors. Human beings can at times be negligent. Human beings
sometimes lack the skill or concern that can lead to unintended
outcomes. Systems for preventing human beings from making
deadly mistakes must be designed with a focus on human nature.
When the system is to blame, then no one is responsible. I
reject that notion. Health care providers are responsible
adults. The concern should not be to protect the health care
providers, or more precisely, their insurance companies, the
concern must be to find ways to prevent injuries from being
covered up.
When mistakes are covered up, no system can be designed to
prevent them. An effective system for preventing error must
recognize the human tendency to deny our own responsibility
when things go wrong, it must provide an incentive to learn the
humility that comes from admitting our own errors, and it must
get rid of those who do not learn.
My wife and I learned about medical injury the hard way in
1992 when a catheter got tangled inside her carotid artery.
There was no report made of that error, as was required by law,
because as the doctor testified a few years later in a
deposition, and I quote, ``No one gave me the report form.''
The nightly news is filled with reports of automobile
accidents and diseases like breast cancer and AIDS, but when a
human being suffers a perforated artery during an angiogram or
a perforated bowel during a C-section, there are no reports on
the nightly news or anywhere else for that matter.
In fact, the Florida Hospital Association had the Florida
law changed in 1998 so that mistakes like perforations of
organs would no longer have to be reported. That change was
just another example of how the foxes are allowed to guard the
hen house.
If anyone doubts my analogy about the foxes in the hen
house, just take note of the fact that the speaker of the
Florida House of Representatives is none other than the former
general counsel and chief lobbyist for the Florida Medical
Association.
For several years, my wife and I have argued that a
national hospital safety board should be established with the
power to audit hospital reports of adverse incidents,
infections, and mortality, and publish those reports by
hospital name. A system for reporting errors is long overdue,
but we must not let those foxes that have been guarding the
henhouse, because that would just give the public a little thin
chicken soup. That is the kind of reporting system we are going
to have if we leave it in the hands of the hospital and doctor
associations.
The reporting system must be mandatory and its results must
be open and accessible to the public. There must be penalties
for failure to report that are meaningful and more to be feared
than the financial consequences or the public outcry of the
mistake itself. There must be a mechanism for informing the
public that allows us to select those providers that have the
best records.
Let the marketplace reward those hospitals which have the
best patient care records and they will, I assure you, make
sure that their staffs include only the best trained and the
most concerned health care professionals.
Florida's mandatory error reporting system is designed to
protect the reputation of the doctors, and the hospitals, and
the bank accounts of their insurance companies. After more than
14 years of confidentiality that is supposed to encourage
reporting, the reporting system is a virtual scofflaw.
As an example, one Florida hospital, whose name I am not
privileged to know, because of the confidentiality laws,
changed its annual report in 1996 from the 10 or 20 they
probably reported to approximately 1,700 medical injuries after
a training audit was conducted by the agency in Florida that
licenses hospitals. Because that hospital was required to
report accurately, they had, that one hospital, reported 37
percent of al the iatrogenic injuries reported by all Florida
hospitals that year.
The other 200 hospitals in Florida were involved in a
massive coverup of human injury that the Harvard study would
estimate to be at least 60,000 people. The State government is
aiding and abetting the cover-up by hiding the identity of the
wrongdoers, by allowing the same doctors to repeatedly make
error after error without losing there license, by dismissing
our complaints without any investigation, and by passing so-
called tort reform laws that slam the courthouse door to the
people who would dare to question the care they have received.
If I could somehow give voice to the hundreds of thousands
of tongues that have been silenced forever by medical injuries,
or if I knew how to give motion to broken bodies that no longer
have the capability to fight for themselves, I think there
would be a demonstration in the streets of Washington that
would rival the demonstration that was recently held in
Seattle.
The people who were medically injured are silent, and it is
not because they do not care, it is because they are in
despair.
Now, I have made some specific recommendations, Mr.
Chairman, and I hope this committee will seriously consider
those, and I thank you for the opportunity to speak.
STATEMENT OF PATRICIA McEACHERN
Senator Specter. Well, thank you very much, Mr. McEachern.
If you are willing to do so, we would be interested to know
more about the specific situation about Mrs. McEachern, which
has obviously motivated you to be very, very active on this
line. Mrs. McEachern, we welcome you here----
Mrs. McEachern. Thank you.
Senator Specter [continuing]. And look forward to your
statement. We do not want to pry, obviously, but to the extent
you feel comfortable telling us what happened to you, we are
interested to know that.
Mrs. McEachern. OK. The doctor that I gave approval to run
a catheter up, he is the doctor that committed the same thing
that happened to me 6 or 7 months prior to somebody else. I did
not know it. What he did was he let a resident do the procedure
without my approval. The resident did not know what he was
doing. He had never done it before.
He got the catheter tangled and it caused my knee to be
paralyzed on the right-hand side, my leg and my arm. There are
other things, my speech, and things like that.
Senator Specter. Was the doctor present when the intern
performed the catheterization----
Mrs. McEachern. He said he was.
Senator Specter [continuing]. Or the resident, rather.
Mrs. McEachern. The resident was the one that performed it,
and the doctor said he was present, but I do not know for sure
that he was.
I do not think that a person should be allowed to have
somebody do the work on them that you have not approved. The
doctor was the one who I had approved to do it, and the
resident did it. I did not give the approval.
Senator Specter. When did you find out that the resident
rather than the doctor had performed that procedure?
Mrs. McEachern. My husband was the one that found out.
Mr. McEachern. Actually, it was learned later that evening
from another doctor that what had happened, that she had been
stroked, that is a term in the hospital industry, they talk
about stroking their patients as if they were stroking a cat,
but they do not mean that kind of stroking.
``They stroked your wife,'' he said, ``during the
angiogram.'' Several weeks later, of course, I found out the
doctor was who was supposedly supervising the angiogram, and
then talked with him. He admitted that he had allowed a
resident physician to do it.
Senator Specter. Did he say he was present at the time?
Mr. McEachern. He did not say that--he did not deny that he
was there. In other words, I did not ask him on that particular
issue. I do want to observe, though, that while I was talking
to him in the hospital he was outside an operating suite, and
operating room suite, where another patient may have been
undergoing the same kind of procedure.
In other words, I do not know for a fact what he was
supervising or supposed to be supervising at that time, I do
know that 6 months prior he had been sued for the exact same
kind of error that had occurred with my wife, because he let
another resident physician perform it, and since then he has
been sued for several other things. I might also admit, even
with Florida's mandatory reporting system of errors, he did not
report the error, he also has recently falsified records that
were submitted to our Department of Health for entry on the
Internet concerning his malpractice record.
So what I am saying is that doctors are just like the rest
of us, we do not like to admit our mistakes, and if there is
any way we can get away with it, denying them or keeping them
from becoming public, they will do so, unless we have an
effective system with teeth in it.
Senator Specter. Mrs. McEachern, what damages or injuries
did you sustain?
Mrs. McEachern. My right leg is paralyzed and my right arm
is paralyzed. I have a numbing sensation in my face. I am going
to have to be on medicine the rest of my life, so I will not
have seizures. I am also on Prozac, a depressant.
What I would like to say is that this is so hard for a
person to have something like this happen. I was fortunate to
have a family to care for me, but there are so many people out
there to have this done to them that have absolutely nobody,
and the medicine that they put you on is so expensive that the
people have to go on Social Security, and they just do not have
the money to buy, so they are, you know----
Senator Specter. Did you institute legal action against the
doctor?
Mr. McEachern. We were very, very fortunate, sir. As the
Harvard study reports, only 2 percent of the people who were
negligently injured ever file a lawsuit, by medical mistakes.
That was an observation, based on research in the Harvard
study.
Senator Specter. What was the result of that lawsuit?
Mr. McEachern. We won our lawsuit. It took 4 years. We were
only able to find a lawyer to accept our case after visiting
many different lawyers that turned us down.
We, by perhaps the grace of God, found a lawyer, who for 25
years had been a radiologist, a doctor, in other words, before
he became a lawyer. He understood exactly what happened to my
wife as soon as he saw the X-rays. He never batted a eye when
he saw that and accepted the case.
Senator Specter. Was the case settled, or did you have to
go through the----
Mr. McEachern. Well, as is common, the insurance company
and the doctors denied it until about 2 weeks before a trial
was scheduled. The doctor settled just before that, the trial
began. The medical school, which was also in the lawsuit,
because of the intern, continued to deny it and went to trial,
and we got a jury award of $1.7 million in damages from the
jury.
Of course, there is a cap, very common in all of medical
malpractice throughout the country. There was a cap on awards
for medical malpractice for the medical school of $200,000. In
our case, it is $100,000, where if there were two injured
parties, myself and my wife, then it is $200,000.
So that is one reason it is so hard to get a lawyer. With
the caps that tort reform has instituted nationwide, and, of
course, sovereign immunity-type caps, which are also very
common, most people, even if they know they are negligently
injured in a hospital, are not able to find a lawyer.
Senator Specter. Thank you very much, Mrs. McEachern, and
thank you, Mr. McEachern.
STATEMENT OF DIANE ARTEMIS, FALLS CHURCH, VA
Senator Specter. We now turn to Ms. Diane Artemis, of Falls
Church, VA, currently a senior business process engineer,
specializing in international organizations. She suffered from
a hip joint disease, and endured problems as a result of--well,
she will describe it herself. She has over 25 years of
experience in managing technical projects. She was a captain in
the air force, and holds a B.A. in English and a master's
degree in public administration.
Thank you for joining us, Ms. Artemis, we look forward to
your testimony.
Ms. Artemis. Thank you, Mr. Chairman. In the interest of
saving time, I would like to skip the details of what happened
to me, and instead, merely summarize that in May of 1993, I----
Senator Specter. That is fine, Ms. Artemis. Do it any way
you like.
Ms. Artemis. In May of 1993, I had total hip replacement
surgery, due to left hip dysplasia. What followed was a sad
comedy of errors that resulted in five trips into the operating
room to correct surgery.
This had started when, after surgery I was being escorted
to the toilet by a med tech, which is someone who does night
duty at many hospitals without LPN or RN credentials. The med
tech caught me, a freshly operated hip replacement patient, and
somehow got me back into bed, and afterwards I underwent
spasms, the hip replacement prosthesis tore through my sutured
tissue, and lodged in the muscle tissue of my left thigh.
Over the next 3 months it formed heterotopic ossification,
which was caused by the breakdown of traumatized muscle tissue
into calcium shards, and this hardened around my left hip. I
eventually underwent total reconstructive surgery of my left
hip, and I would have, had I not been young, athletic, and fit,
been left crippled or probably dead from what had happened to
me.
I would respectfully mention that there was a Journal of
American Medical Association magazine report on December 4,
1994, that estimated the amounts of deaths per year in this
country, upwards of 180,000, rather than 98,000, and many, many
more from injuries.
I will skip to some of my conclusions that I made after
what happened to me, and I respectfully submit them to the
chairman and subcommittee for your consideration.
In addition to the multiple surgeries and the 3 months lost
from work that the medical errors caused me, please consider
that the cost of a routine hip replacement with rehabilitation
and implant included is normally $12,000. The total cost to my
insurance company for these multiple surgeries,
rehabilitations, and out-patient treatments was nearly
$200,000.
Did the surgeon or hospital administrator responsible for
training and hiring staff have any incentive to do it right the
first time? No. Apart from the personal integrity and
competence a patient would they would have, both doctor and
hospital profited from every mistake which required repeated
surgeries, stays, drugs, equipment, X-rays, and therapies.
Please remember, this was not an HMO or managed care medicine,
this was private, fee-for-service medicine all the way.
Did my insurance company have an incentive to contest the
charges? No. When I contacted them, they claimed that
contesting the charges would be more expensive than simply
paying whatever was billed.
So, to whom is a doctor or a hospital administrator
accountable? To you? To me? To the government? To other
doctors? No one, really, I found. On paper they may be
accountable to a State medical board or the Joint Commission on
the Accreditation of Health Care Organizations, the JCAHO, but
these boards and the JCAHO are merely doctors and
administrators policing their own.
JCAHO inspections are announced several months in advance
and well-prepared for by a hospital staff. In the case of a
medical board investigation of a patient complaint, unless
there is evidence of drunkenness or egregious social
misconduct, a doctor or administrator will usually be
vindicated by his peers.
Can an individual gain access to complaints lodged with the
medical board or State insurance corporation to judge for
herself whether to take a chance on a particular doctor or
hospital? Not in your life? Had I been able to review patient
comments about my surgeon, I never would have chosen him.
Although technically competent, with superb credentials, his
history of incompetent aftercare made him a poor choice.
It is remarkable to me that I can find out more about a
plumber by contacting the Better Business Bureau and viewing
its open file of consumer comments than I can about a doctor
who is going to cut open my body. Choose a doctor by word of
mouth? How many people did I know who had had a total hip
replacement? Even if I were to find and ask a prior patient,
how could I evaluate his opinion or circumstances without
viewing the doctor's or hospital's performance in the
aggregate?
Does the individual fare any better when she wants to
research a hospital's safety record, protocol for handling hip
replacement patients; that is, an X-ray required when a patient
falls, and assess the level of staff training provided to
ensure that a hospital's staff is qualified to treat someone,
in my case, recovering from hip replacement surgery? I was
placed in a ward whose primary service was head trauma, head
trauma rehabilitation, rather than hip replacement
rehabilitation.
It is my experience that the hospital administrator, if he
responds to such requests for information at all, will quote a
list of legal citations a mile long prohibiting the release of
this information. Other industries which impact human health,
safety and the environment are compelled by disclosure laws to
provide such data to the public, as well as to State, local,
and Federal inspectors.
The chemical, pharmaceutical, automobile, manufacturing,
aviation, et cetera, et cetera, industries all must submit to
OSHA and EPA inspections and share their safety records and
operating procedures with the public.
How has the medical industry and its personnel obtained
these exemptions? Do they impact our health and safety any
less? Are they more prone to be sued than are the chemical,
aviation, or other regulated industries?
Tort reform is another issue; we are talking public safety
here, but as previously mentioned, only 2 percent of these
cases ever make it into court, and for a variety of reasons, it
is difficult to find attorneys willing to take on these cases.
As the shocking statistics of 100,000+ deaths per year--and
several hundred thousand more injured by negligence or
inadequate staff training--show, it is time the medical
industry opens its books to public scrutiny of its patient-
handling protocols, safety records, and training requirements.
Additionally, any citizen ought to be able to obtain a copy
of any complaints filed against a doctor or hospital. Let the
consumer have the right to know and judge for herself. After
all, our lives are often in their hands and our salaries and
insurance costs pay their bills.
I would respectfully add that we have to get beyond an us
versus them mentality with doctors and hospitals covering up
their mistakes and refusing to acknowledge them. In the
chemical industry, for example, unless one causes egregious
loss of life and property, an error in operations is not
penalized if (1) it is properly recorded and (2) corrective
action immediately taken.
Unless doctors and hospital officials are willing and able
to admit their mistakes, learn from them, and promptly correct
them, we will widen the chasm of distrust between them and us,
and watch the percentage of our Gross Domestic Product spent on
medical care skyrocket.
I sincerely hope that these hearings help foster a culture
of public service and safety in the medical community. I would
respectfully suggest the subcommittee consider the creation of
medical industry best practices, enabling doctors and hospitals
to benchmark their performance against other countries, other
industries, and each other. The consumer would benefit by being
able to make an informed and objective choice.
Our Nation would benefit by lower overall medical costs to
repair damages caused by negligence or carelessness, and less
time lost from work. If we work together with our doctors and
hospitals to define and improve the standard of care, combined
with our technological know-how, we will finally achieve a
medical system that can be the envy of the world.
Thank you, Mr. Chairman.
Senator Specter. Thank you very much, Ms. Artemis. You say
that you had expenses of some $200,000 for what should have
cost $12,000.
Ms. Artemis. Yes, sir, close to it.
Senator Specter. How many separate operations did you have?
Ms. Artemis. I was in the OR five times, and three times
was cut open.
Senator Specter. That was on a procedure, which according
to your understanding, should have been accomplished with a
single operation.
Ms. Artemis. Yes, sir. Mine was very uncomplicated. The
original surgery took less than an hour. Very simple.
Senator Specter. Did your insurance company pay all of
these charges?
Ms. Artemis. My insurance company, I was extremely blessed
to have a very generous insurance company, also provided for 12
weeks of rehabilitation care and nursing home care, because I
do not have family members to care for me.
Senator Specter. Have you had any permanent disability or
permanent problems resulting from the operations?
Ms. Artemis. Yes, sir. I have lost most of my major muscle
tissue in the left hip sockets. The reconstructive surgery I
had was to put together my hip in a new way to allow me
movements, and also when I inevitably need replacement of the
prosthesis head, the plastic prosthesis head, I may at that
time be a cripple.
Senator Specter. But you did not consider any legal action
against anyone.
Ms. Artemis. No, sir. Actually, I did. My treatment surgeon
volunteered to be an expert witness for me, but because both he
and my surgeon who performed the operation were adjunct
professors at the same medical university, he would only go to
court and testify that there was negligence, but he would not
name my provider by name. There is a statute of limitations of
2 years, and it expired at the end of the 2-year term.
Senator Specter. What efforts had you made to determine the
qualification of the doctor who performed the initial
operation?
Ms. Artemis. The doctor who performed the surgery was the
chief of orthopedic surgery at a very prestigious university
hospital. He had done thousands of these procedures. He was
well known, well published. I asked to speak to several of his
previous patients, and they all thought he was a wonderful,
wonderful surgeon.
Senator Specter. Well, we will be getting into this subject
in great detail. When a doctor or a hospital is obligated to
report mistakes, there is a little different issue as to
reporting lawsuits or claims which were filed, which were not
determined to be mistakes. If there is a judgment issued, and
if there is a verdict, then there is a conclusion of an error.
If there is a claim made, that does not prove an error until
the matter is investigated further.
Your point is you would like to see--or what would you like
to see? What would you like to see reported so that you would
have a better idea? What could you have found out about the
doctor in your case, had you had a range of possibilities?
Ms. Artemis. Well, the original surgeon I chose was from a
very prestigious practice specializing in joint replacement
surgeries, so I presumed that he was superbly qualified. His
credentials were excellent.
Senator Specter. Have you heard after the fact that he had
been sued----
Ms. Artemis. Yes, I have.
Senator Specter [continuing]. In the past?
Ms. Artemis. In searching for attorneys to take on the
case, I came across--because I was not crippled, dead, or brain
damaged, I had attorneys do underwriting of what they could
potentially gain in a case, and I was--because I was young, and
healthy, and walking again, I was of low value, so I was
interviewing various attorneys, and found in talking to them
that they, indeed, had been approached by patients for this
particular surgeon, but for various reasons did not go any
further, but I did learn that he had had a track record of this
sort of behavior.
In addition, one of my neighbor's father was an
anesthesiologist who practiced with this surgeon, and I had
heard that he had had a number of disciplinary actions for
throwing equipment across the operating room. So I had heard
over the months that he had this reputation.
Senator Specter. The insurance company took no action
either to recover their $200,000 in losses.
Ms. Artemis. No, sir. They claimed that fighting,
litigating, going to court potentially would ultimately cost
them more time and resources than just paying the bills.
Senator Specter. Thank you very much, Ms. Artemis. Thank
you.
STATEMENT OF DEBRA MALONE, VAIL, CO
Senator Specter. We now turn to Ms. Debra Malone, an
intensive care nurse from Avon, CO, 11 years of experience in
her profession. Her father, Dr. Karl Shipman, was an internal
medicine specialist in Denver whose medical situation was a
resulting death from a series of errors in his care, and was
extensively chronicled in their local press.
We welcome you here, Ms. Malone. I note that you are a
graduate of the University of Colorado at Boulder. Thank you
for joining us, and we look forward to your testimony.
Ms. Malone. Thank you. My name is Debra Malone, and I am
honored to speak to you today. I am here to tell you about my
father's death. My 64-year-old father, Dr. Karl Shipman, broke
his wrist when he fell off a ladder in 1997. The fracture
required surgical repair with an external fixator. His death
was as a result of a staph infection that began in his healing
wrist and spread into his spine, eventually causing multi-
system failure. What should have been routine treatment became
a series of medical missteps and misdiagnoses that resulted in
the death of a wonderful man.
There were opportunities for medical intervention that
could have saved my father's life that went unrealized. The
spreading infection in his wrist and spine was misdiagnosed as
back strain during several office visits. The swollen wrist was
characterized as normal.
Physical therapy was the prescribed treatment. The
orthopedic physicians never took vital signs or conducted basic
lab tests that could have indicated the presence of an
infection.
Under the care of these physicians, my father's condition
worsened. When I insisted that he be admitted to the hospital,
he was admitted to the 600-bed hospital in Denver, where he
practiced internal medicine for 35 years. The day he entered
the hospital he still had a fighting chance to recover from the
infection that was now becoming critical. Unfortunately, the
errors were to continue for another 22 hours. Time had proved
crucial.
Even with lab tests indicating a very sick man, diagnosis
and treatment were slow, at best. He spent the night in the
intensive care unit under the care of a float nurse, who was
not trained in the IC setting. This unqualified nurse was
working with a medical intern who was only months out of
medical school. Together, they failed to recognize the severity
of my dad's deteriorating condition.
Important changes in his cardiac rhythm were not addressed.
Medication errors occurred. Antibiotics were missed. Haldol, an
anti-psychotic medication, was inappropriately given to my
father for his new onset of confusion. He was, in fact,
severely hypoxic from impending respiratory failure. The
tending physician was never notified.
I was at my father's bedside during this nightmare. In the
middle of the night, when my initial questioning turned to
adamant concern, I was removed by the nursing staff and told to
get some rest. By the morning, my father was in decompensated
shock, cardiovascular collapse, and respiratory failure.
At this time, the intensivist, who was a board-certified
critical care physician, immediately intervened. He rapidly
recognized the dire situation and began heroic efforts to save
my father's life. After this night, my father never spoke
again. He died 18 days later.
The pain of our loss is compounded by the knowledge that
his death was probably preventable. As a nurse, I was extremely
disturbed by the entire sequence of events. Because of my
expertise within the ICU, I live with the feeling of having let
my father down by not more forcefully challenging the
inadequate care given that first crucial night.
What became even more upsetting was the stonewalling,
defensive posture the hospital took when I attempted to address
these issues with them. The risk management office assured me
that they had reviewed the case and found nothing wrong with
the care my father received.
After this, HCFA investigated and found several areas of
deficient care, and has placed the hospital under continued
investigation for the next year. This action was just short of
revoking over $100 million in Medicare funding.
Medicine is complex. We cannot expect perfect outcomes in
every situation, but our profession is not doing everything it
can to assure the best possible outcomes at all times. My
father's case illustrates the need for better supervision of
medical residents, better nurse staffing, and better guidelines
for appropriate nurse assignments.
An important change that I have been advocating is the
reorganization of physician resources in an intensive care
unit. The Society of Critical Care Medicine supports what is
commonly referred to as a closed or highly structured ICU
system.
In this system, a board-certified critical care physician,
otherwise known as an intensivist, is the team leader for every
patient admitted to the ICU.
They are in the ICU to oversee patient care and education
of house staff 24 hours a day, 7 days a week. They coordinate
the plan of care with the other physicians on the case, thus
eliminating fragmentation that often results in inefficient and
unsafe care.
It is well documented that this system significantly
increases staff efficiency, decreases patient mortality, and
lowers hospital costs. Unfortunately, despite this evidence,
many hospitals, including the one my father was admitted to,
failed to utilize this invaluable system.
Thank you for listening to my story and for your dedication
to improving patient safety.
Senator Specter. Thank you very much, Ms. Malone. When you
testified about what you concluded to be the inadequate care
given to your father, you described a float nurse and an
intern. Precisely, what is a float nurse?
Ms. Malone. A float nurse is a nurse who works on another
unit, has another specialty of care, and is brought into
another unit to work that night. They are floated into another
unit.
Senator Specter. Was your father in the intensive care unit
at that time?
Ms. Malone. Yes. I believe a lot of this is resulting, and
I say it frequently, is the result of nursing staff shortages.
They are minimally staffed, and if someone is sick, or patients
are moved to the ICU, or to the OB unit, or whatever unit it
is, managed care, or many hospitals now, will, instead of
paying bonuses or overtime for nurses, or seeking more
qualified nurses from an agency, maybe an intensive care nurse
from an agency that is more costly, they will bring in another
nurse from another unit, which is not their specialty.
I believe that nursing is very highly specialized now,
which is, you need to be cross-trained, but you cannot move as
easily from one unit to another.
Senator Specter. Well, when your father was in the
intensive care unit and you were there with him, how much
attention did he receive from the float nurse and the intern?
How much could they care for him, considering the other
responsibilities they had at the same time?
Ms. Malone. I believe my father was probably that nurse's
only patient. In the intensive care unit, it is usually one-to-
one nursing--one patient to one nurse, possibly two patients to
one nurse.
Senator Specter. How about the availability of the doctor?
Ms. Malone. The medical intern was called at one point, and
did come in to see him at one point, but it was never
supervised by an attending physician or somebody else that
could have directed more appropriate care for my father's
condition.
Senator Specter. Well, was there an attending physician?
Ms. Malone. The attending physician was at home sleeping.
The problem at this hospital, and at many institutions
throughout the country, is that the attending physician will
directly supervise the medical intern or resident.
Direct supervision is a pretty loose term, because I failed
to see how direct supervision occurs when an attending
physician is at home sleeping, or 30 minutes away seeing office
patients.
Senator Specter. Well, the question that I had raised with
Dr. Eisenberg to start, we were just on the point about the
emergency room, was the adequacy of the care. We were talking
about the situation with chest pains, and how familiar the
emergency person would be there, and there have been some grave
problems about reductions in funding for the Federal Government
under certain of our legislative initiatives.
We just made an adjustment to legislation 2 years ago,
adding some $10 billion to hospital reimbursements, and there
is no question about the escalating costs of medical care, but
these are all parts of the issue which the Congress has to
consider, and the Congress has a significant responsibility
here, but the question in my mind is, what is the quality of
care there and how good are the people.
An intern is obviously limited as to the training, and
background, and professionalization. You did raise an objection
in the middle of the night----
Ms. Malone. Yes.
Senator Specter [continuing]. And they told you, in effect,
to go home. Tell us a little bit more about what happened.
Ms. Malone. Well, I was quite upset. I was very exhausted.
I had just flown in from an international trip. I did not know
that it was a medical intern just months after medical school.
I did not know that this nurse had never been oriented to the
ICU. I was in a very large ICU. Most of my nursing experience
is in small rural areas. This hospital had been a part of my
life since I was a year old. I have trusted this hospital. I
placed all my trust in them. I was a daughter at the bedside.
Senator Specter. How old was your father?
Ms. Malone. He was 64 years old, still practicing medicine
full time, married for 40 years.
Senator Specter. You say HCFA had the capacity to have----
Ms. Malone. Right.
Senator Specter [continuing]. Taken action to----
Ms. Malone. Well, after a year of grieving and despair, I
finally contacted a patient advocacy group. Even as a nurse, I
did not even know--in your grief you do not even know how to
report anything. I finally contacted a patient advocacy group,
and they gave me instructions.
So I went through the reporting process. I reported it to
the nursing board, to the medical board, and to the health
board. HCFA investigated, and it received quite a bit of media
attention, and quite a bit of change was effected from this.
Senator Specter. Tell us about the change, if it did lead
to improved procedure. What exactly did happen?
Ms. Malone. It was mostly administrative procedures for
showing nurse competencies, reporting of medical errors for
medical residents. I did not see necessarily a huge change to
prevent it from happening, it was almost more in the reporting
thing. I would like to see changes, system changes that prevent
it from happening so we do not even get to the reporting phase.
It is interesting to note--the medical board and the
nursing board are still reviewing the case. It is interesting
to note that in the State of Colorado, the Colorado State
Medical Board has no jurisdiction over medical interns or
residents.
Senator Specter. Was any consideration given to legal
action in your merit?
Ms. Malone. Yes. This is not a decision taken lightly by my
family. My mother is a nurse, I am a nurse, and my father was a
doctor. These were all colleagues and friends that we were
pursing legal action. We took almost 2 years to file a wrongful
death suit. We went up almost to the statute of limitations.
It was difficult to find competent attorneys that you felt
comfortable with taking this case. The cap for wrongful death
in Colorado is $250,000.
For a medical resident, it is only $150,000, and you had to
file within 6 months, because a medical resident is a
government employee, and we did not know this at the time. So
the medical resident is under government immunity from a
lawsuit and from disciplinary action from the medical board.
Senator Specter. What happened to the lawsuit?
Ms. Malone. We are just in the starting stages of it. Two
years ago my father died on November 8.
Senator Specter. So the lawsuit is pending at this time.
Ms. Malone. It is pending. We just filed, and we are
starting the proceedings. The procedure, to go down that
painful road, we had to fight tooth and nail for restitution
for pain, suffering, and death.
Senator Specter. Well, thank you very much, Ms. Malone, Ms.
Artemis, Mr. and Mrs. McEachern. The subcommittee would be
interested if you would take the time to read this report, and
we can get you copies, and tell us from your own experience
what you think of these recommendations, or what else you would
recommend from your own experience.
This is the sort of a matter where there ought to be broad
public comment to see what remedial action ought to be taken.
People who have been a part of the system and have had problems
are very important, and we are going to be hearing from the
professionals at all levels, but we would be very interested in
your thinking.
Do you have a final comment, Mr. McEachern?
Mr. McEachern. I just wanted to ask, Mr. Chairman, if you
saw the recommendations that we have submitted. We submitted
seven recommendations with our presentation.
Senator Specter. I have seen them, and they will be shared.
My colleagues could not be here, so Senator Harkin, who is the
ranking member, is very much concerned about this, as are all
the colleagues. We do have them and we will circulate them, and
we are considering them.
Mr. McEachern. I would just like to make one final
observation that there is a gentleman in the audience here
today who is the president of a company here in Gaithersburg,
MD. The name of the company is HT Medical. They make patient
simulators.
We should not be training and maintaining the staff of
physicians on human beings, not at least until they have been
qualified on some other non-human object, and patient
simulators are the way to go. We would not send a man to the
moon without his knowing how to fly there and back. We should
not allow a doctor to operate on a patient without his having
taken all the steps necessary on a patient simulator.
Senator Specter. Well, if that gentleman would contact my
office, we would be interested to talk to him. Thank you all
very much.
STATEMENT OF DR. NANCY DICKEY, IMMEDIATE PAST
PRESIDENT, AMERICAN MEDICAL ASSOCIATION
Senator Specter. I now turn to our final panel, Dr. Nancy
Dickey, Ms. Anne Shea, Mary Foley, Dr. Stan Smullens, and Dr.
Martin Merry. Dr. Nancy Dickey is immediate past president of
the American Medical Association, family physician from College
Station, Texas. During her presidency of the AMA, Dr. Dickey
helped create the National Patient Safety Foundation and
currently serves on the executive committee of the foundation.
She earned her medical degree from the University of Texas
Medical School at Houston. Thank you for joining us, Dr.
Dickey. You are our lead witness.
Dr. Dickey. Thank you, Mr. Chairman. Good morning.
The AMA appreciates the opportunity in your calling this
hearing, and for us to talk about the IOM report. The
elimination of errors is a high priority for the AMA, and we
have been a pioneer in the effort to reduce errors and improve
the quality of the nation's health care.
For example, in 1996, the AMA joined with other leaders to
convene the Annenberg conference, which was the first multi-
disciplinary conference on errors, and in 1997, we established
the National Patient Safety Foundation, which is an independent
not-for-profit organization that brings virtually all of the
stakeholders together.
We fund research, have tried to write curricula, and so
forth. We are pleased, in fact, that the NPSF was acknowledged
in IOM report as a leader in this area.
I assure you, as I assure my patients, that the AMA will
continue our efforts to eliminate health care errors, and as an
association founded on the commitment to improve the quality of
medical care, any error that harms a patient is one error too
many.
We believe that true reform has to include all components
of the health care system, hospitals, nurses, pharmacists,
manufacturers of drugs and devices, physicians, and others all
have to work together to identify, study, and solve system-wide
problems that could cause errors.
Equally important is the necessity to transform our culture
of blame and punishment, a culture being one that tends to
suppress information, to a culture of openness and information
sharing, and one that says that the right thing to do is put
the information on the table.
We are pleased that the IOM report recommends such an
approach to reducing errors, in which punitive efforts are
rejected, and efforts to create a culture of safety are
recommended.
The IOM report, however, recommends a mandatory reporting
system. We have serious concerns with this approach. 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.
Like the successful FAA model for reporting errors, we
believe that guidelines for a national reporting system should,
at a minimum, include a non-punitive mechanism for reporting
incidents, post-incident review, and federally guaranteed
protections from discovery for all aspects of voluntarily
reported information.
System-wide trusts and communication are fundamental
elements for successful reform. This can be achieved first by
acknowledging that the vast majority of health care system
errors are not intentional and have to be distinguished from
truly negligent behavior. The focus should be on reforming the
system, not on punishing the individual.
I thank you for the opportunity and will share my time, if
I can, with Ms. Shea, from the Patient Safety Foundation.
SUMMARY STATEMENT OF ANNE SHEA
Senator Specter. Ms. Shea, welcome.
Ms. Shea is the Chief Operating Officer and Acting
Executive Director of the National Patient Safety Foundation.
First some background. Her MBA is from Lake Forest Graduate
School of Management. Welcome, and we look forward to your
testimony.
Ms. Shea. Good morning. My name is Anne Shea, and I am the
Chief Operating Officer and Acting Executive Director of the
National Patient Safety Foundation. The mission of the 2\1/2\-
year-old nonprofit foundation is to measurably improve patient
safety in the delivery of health care.
In order to do this, the NPSF concentrates on four
principle areas: Research, communication, education, and
applications in learning. We try to cover the full range from
analysis of what the problem is, to practical solutions.
Therefore, the NPSF is a forerunner and a companion to the
concerns expressed in the IOM report.
In fact, in ``To Err is Human,'' the National Patient
Safety Foundation is often mentioned as an example of what is
needed. Quote, ``The National Patient Safety Foundation may be
able to serve a resource and dissemination role, and NPSF is
well positioned to translate concerns and findings about
patient safety between many different parties.''
This evaluation coincides with our own self understanding.
We are well positioned to contribute significantly to our
common goal of patient safety. In particular, we are well
positioned to become one of the centers for excellence that the
report recommends. Our initiatives connect very closely with
the overall direction of the IOM report.
Let me give you a sense of what we are doing. We have
convened a group of national authorities concerned with
reducing medication errors and have identified 41 challenges.
We are now in phase two, which focuses on implementation. We
are initiating a national call for solutions that is scheduled
to be announced in the next 30 to 45 days. This initiative is
in conjunction with the Joint Commission on Accreditation of
Health Care Organizations.
With the support of the AHCPR, now called AHRQ, we are
conducting a cataloging patient safety research project that
will document the extent of patient safety research, as well as
identify the gaps in existing knowledge. We have in place a
clearinghouse of multi-disciplinary literature relevant to
patient safety. This brief overview provides some idea of what
we are doing.
With committed leadership, a strong infrastructure, and
diversified programming, we are looking forward to working with
the IOM and other interested parties to increase patient
safety. Thank you.
Senator Specter. Thank you, Ms. Shea. Dr. Dickey, in your
prepared statement, and you covered this part of it, and your
full statement will be made a part of the record, you talk
about guidelines for a national reporting system, which should,
at a minimum, include a non-punitive mechanism for reporting
incidents, and a federally guaranteed legislative protection
from discovery for all aspects of this information.
Now, we have heard testimony from a number of witnesses
here today who wanted to have access to find out about their
doctors and their hospitals. Would this information be
available to such prospective patients, as you see it?
Dr. Dickey. I think part of the problem that we see today
can be highlighted by looking at the successful FAA reporting.
When that system combined the regulators and the reporting, and
did not promise to be non-punitive, it was used very little. It
was only when----
Senator Specter. It was used for what?
Dr. Dickey. It was used very little by pilots. It was only
when they were guaranteed confidentiality, and when there was a
promise that if you called and reported a potential problem,
there would not be a punitive action, that it began to
accumulate the kind of data that has led to a great deal of the
safety progress in aviation.
One of the problems that occurs today is that when an error
or even a near miss, as Dr. Eisenberg talked about, occurs,
getting people to talk about it openly is difficult, because it
is an invitation to a liability lawsuit, which is time-
consuming, expensive, and oftentimes encumbers somebody's time
and money, even when there was not any negligence or intent of
harm there.
We believe that a reporting system that allows us to
investigate near misses has to encourage people to come forward
openly and not threaten that if, indeed, they put issues on the
table, the first likelihood is that they will go to court, and
then they may or may not get around to what happened at the
near miss or even at the error that occurred.
Senator Specter. So your answer is no.
Dr. Dickey. Well, clearly, the information needs to be
available at some point to patients, because we believe
patients ought to be able to make a choice, but we believe that
the information has to be put in the proper format.
I think if we looked at Massachusetts, where the medical
association partnered with the State board to create a profile
of information about physicians, when there is an opportunity
to put information into a format that gives patients full
information, that physicians have supported making information
available to patients, but to do it in a piecemeal fashion, to
suggest that because a physician has been sued it is an
incompetent physician is not fair information for patients to
be making a hundred percent of their judgments on.
Senator Specter. Well, when you talk about punishment, I
structured the question as the people who testified here today,
who wanted to know about how their doctors performed. Ms. Diane
Artemis wanted to know about the quality of her medical
service. Now, she is not going to sue. She has not been
treated.
So when Ms. Artemis is looking to see what this hip
replacement doctor, she is looking at it for preventative
measures, she is not about to sue. Why not have that available
to Ms. Artemis.
Dr. Dickey. We believe that you should have available
information about whether your physician has performed the
procedure, what the outcomes of the procedure are, that is,
successes of that procedure. In fact, the AMA has a program
called AMAT that would, when fully developed, make information
about outcomes and performance of individual physicians
available to patients, but----
Senator Specter. If the reporting requirement called upon
the hip replacement physician to report mistakes, should not
the prospective patient have access to that information about
those mistakes?
Dr. Dickey. I think it depends on what you call mistakes,
Senator, because I think the problem here is----
Senator Specter. Well, help us define it. That is what we
are looking to you to do.
Dr. Dickey. I agree with you, and I think part of my
concern, and my heart goes out to each of the people we heard
from today, and I am obviously responding only to a brief
summary of what I have heard happen, but the surgery appeared
to have gone well, if I heard the story correctly.
It was a fall after surgery that created this series of
problems for the patient. Now, was the surgeon responsible for
the fall that happened afterwards? Does he or she have to
report that error, despite the fact that Ms. Artemis had a
different outcome than she should have rightly expected?
Those are the kinds of questions that I think are terribly
important to physicians, to hospital administrators, to nurses
who want to be sure our patients get safe care, but at the same
time want to be sure that our patients get good information.
Senator Specter. Well, if the case has gone all the way
through litigation, and a judgment, and a jury's determination
that a doctor was at fault so that it is established as to
liability, how about that information? That is not just a
claim. That is not just a speculation. That has already been
traditionally determined. Do you think that ought to be made
available to prospective patients?
Dr. Dickey. The AMA policy is that that information ought
to be available only if it is within a package of information
that helps explain it. In other words, we are not supportive of
opening up things like the national data bank.
Senator Specter. Well, I am on a specific issue now. You
raised a question about whether it is proved, whether something
else is involved, whether it is just a claim. I am talking
about something that has been litigated and decided, there has
been a judgment through the court process, a final judgment,
appeals if any are or in order, or any sought to be taken.
What kind of package would you need beyond that sort of a
factual statement be made available to a prospective patient?
Dr. Dickey. I think patients would need to know how often
physicians in that particular specialty get sued, that the fact
that your physician had been sued successfully once would
perhaps be put in the information that says 98 percent of
physicians in that specialty have been sued successfully once,
and if they have been sued 12 times, that may raise your level
of concern.
I think that patients need good information to make
decisions. I think, unfortunately, piecemeal information may
lead them in the direction of bad decisions, because they are
not getting the right information to make a decision.
Senator Specter. So if there were a fuller picture or a
background, a package, do you think under those circumstances
we could structure that kind of disclosure?
Dr. Dickey. I believe and the AMA believes that the
patients need to be given information on which to make choices
about physicians, hospitals, and procedures, but it needs to be
full information. Part of the concern we have expressed in the
past, for example, has been that many times the hospitals that
have the highest number of bad outcomes are those facilities
that take care of the very sickest patients, patients that only
a few years ago might not have even been offered the
opportunity of a particular operation or a particular potential
for cure, because their rate of complications was going to be
so high.
Do we want to punish those entities that take on the care
of the sickest patients when it may be my spouse or my mother
who needs the care, but has a very complicated medical history?
Senator Specter. Well, if the hospital chooses to have that
information, I think we can structure a reporting system which
would give them that opportunity, but if you so delimit it with
a level of proof which is unrealistic, then information is not
going to be forthcoming to patients.
You have not dealt specifically with the concept of a
Federal mandate on risk reporting, or do you support a Federal
mandatory reporting system?
Dr. Dickey. At this time we would not support a Federal
mandate. We believe that collecting of information may well
advance the ability to do the kind of research that Dr.
Eisenberg talked about, that the NPSF attempts to fund, but do
not believe at this point that we need a Federal mandate either
to have that occur, nor that Federal mandates in the past for
that kind of reporting have demonstrated that they improve the
situation or improve the quality of the care.
Senator Specter. Well, I would respectfully disagree with
you about the need for a Federal mandatory reporting system. I
think the evidence is on the table for it. To the extent that
it could be structured in a way which will give a fuller
picture, and not distort the picture, or explain how many
doctors in a similar situation have this consequence, or that
they treat the sickest people so that the explanations are
present to give the doctor's side of it and the hospital's side
of it I think is fair.
If you start analogizing it to the Federal Aviation
Administration, where you are really dealing with very, very
different quantities and qualities, much more than apples and
oranges, they are both fruits, but if you deal with FAA and
doctors, I think they are just different, but to the extent
that we could accommodate your concerns, I think Congress would
want to do that.
We fought this battle on mandatory reporting of crime on
college campuses. There was a lot of resentment to that,
because it is very embarrassing, and all sorts of efforts were
made to hide it away, but as soon as the requirement came into
effect, all sorts of precautionary measures were taken to
prevent crime, because colleges and universities did not want
to report it. We are well aware in the Congress about the
undesirability of too many mandates coming out of Washington.
We do not want a mandate, there are too many of them from
Washington's bureaucracy, but you are talking about a problem
here which has been pretty well recognized nationally, and my
sense is that my colleagues will be looking at some sort of a
mandatory system, but we want to accommodate the concerns you
raised to give the fuller picture and allow hospitals and
doctors to say what is on the other side of it, to give an
explanation, so that the consumer, prospective patient, knows
the full picture, and can say, well, okay, that happened, but
this fellow, this woman, et cetera, is okay.
Dr. Dickey. Senator, I think it is important that we
realize the IOM report, and I know you do, is far bigger than
physician interactions with patients. In fact, we have
mandatory reporting of those issues that have been adjudicated.
It is the National Practitioner Data Bank, where all
lawsuits are ultimately kept. I think here we are talking about
where a doctor, or a nurse, or a hospital administrator
identifies something, may have not resulted in harm, because
something intervened to stop the problem before the patient was
hurt.
If we can put that near miss or even the error on the table
and talk about how did that happen without fear of spending a
half-a-million dollars to defend one of those players in a
court of law, we may be able to prevent hundreds of other
hospitals, or doctors, or nurses from that error, which may not
be stopped the next time.
Senator Specter. Well, where you deal with those cases
where there have not been damages, you are not going to be
sued, if it is a mistake which has not resulted in an error.
Well, these are all things that we have to talk about, and this
is a very important dialogue.
On this side of the table we are trying to figure out what
the facts are and what the public policy ought to be. You men
and women know the specifics. You are the experts. Now, we have
a pretty good document here to start to work from, so we want
to push the envelope.
STATEMENT OF MARY FOLEY, R.N., FIRST VICE PRESIDENT,
AMERICAN NURSES ASSOCIATION
ACCOMPANIED BY ANNE SHEA, ACTING EXECUTIVE DIRECTOR AND CHIEF OPERATING
OFFICER, NATIONAL PATIENT SAFETY FOUNDATION
Senator Specter. Our next witness is registered nurse, Mary
Foley, the First Vice President of the American Nurses
Association, Director of Nursing at St. Francis Memorial
Hospital in San Francisco, earned her nursing degree from
Boston University and her master's degree from the University
of California, San Francisco.
Thank you for joining us, Ms. Foley, and we look forward to
your testimony.
Ms. Foley. Thank you, Mr. Chairman, and thank you for this
opportunity. I am Mary Foley, First Vice President of ANA.
In the last 3 years I have had the privilege of working as
a staff nurse, a director of nursing, and a clinical nursing
faculty person, so I feel well rounded. I am proud to represent
the American Nurses Association, which is the full-service
professional organization representing our 2.6 million
registered nurses in the country. We include staff nurses,
nurse practitioners, clinical nurse specialists, certified
nurse mid-wives, educators, managers, and nurse anesthetists in
all of our 53 States and territories.
The ANA appreciates the opportunity to discuss our concerns
regarding the topic of patient safety and medical errors. The
issue of health care error is one of great importance to the
nursing profession. Nurses have substantial contributions to
make to the efforts to reduce health care error, and it is
critical for us to share our perspectives.
The American Nurses Association agrees with the Institute
of Medicine Reports' assertion that the majority of errors
result not from human recklessness, but from failures in the
health care system, and believes the report reinforces the need
to address all systems' issues, including staffing, though the
report itself lacks important information on the relationship
between system errors and appropriate staffing.
``To Err is Human'' describes a fragmented health care
system prone to errors and detrimental to safe patient care.
This problem is not new to registered nurses or to the American
Nurses Association.
In nursing practice, the scope of responsibility,
independent judgement, and decision-making has been expanded,
while nurses' autonomy and decision-making abilities are more
constrained, as management systems focus on bottom-line profits
over patient safety and quality.
Nurses are the single largest labor cost for a hospital,
and, therefore, a likely target for cuts. Slashes in operating
budgets have resulted in reduced utilization of professional
nurses and nursing management oversight positions. These
traditional management positions have been most directly
responsible for assuring that adequate safety and quality
systems are in place.
Let me add as well, we are beginning to see shortages of
nurses in areas such as critical care, operating room, and
emergency room staff, and that will be another consideration
for future discussion, I am sure, as we try to provide adequate
numbers of nurses, in addition to addressing the systems and
the financial systems that have interfered with adequate
staffing.
Therefore, one of ANA's major concerns in the health care
delivery system relates to the prevention of adverse events,
and we must speak to the adequacy and the appropriateness of
staffing.
For some time, ANA, the State Nurses Associations, and
nurses throughout the country have identified elements of these
troubling workplace trends. Separate studies by ANA, the
Princeton Survey Research Associates, the American Hospital
Association, and the National Coalition of Health Care all
reveal that patients and families were concerned about the care
they were receiving in acute care institutions.
Adequate numbers of staff are necessary to reach a minimum
level of quality patient care services. In 1994, ANA launched
its safety and quality initiative to investigate the impact of
health care restructuring on the safety and quality of patient
care and the nurses who provide that care.
Central to this initiative is the development of nursing
quality indicators, the nursing report card for acute care, and
the national data base of nursing sensitive quality indicators.
ANA has advocated and participated in the collection of this
information, and beleives that this information must be
disseminated to be effective.
Therefore, the ANA supports many of the IOM
recommendations, including the creation of a center for patient
safety. The ANA also supports a call for nationwide mandatory
reporting systems. ANA would argue, however, that such a system
of reporting and tracking adverse events must not only maintain
data on when the errors are occurring, but include information
on what organizational valuables are responsible for the
errors.
Staffing should be such that the quality of patient care is
maintained, the quality of organizational outcomes are met, and
that the quality of nurses' work life is acceptable. This focus
represents a safety system that was referenced in the IOM
report, and it is an example of safer practices at the delivery
level.
We have been working hard to pursue strategies that protect
patients from preventable errors, and that move organizations
away from the traditional search and destroy missions that
frequently follow serious health care errors. In addition to
our safety and quality initiative, ANA has participated in the
President's advisory commission on consumer protection and
quality in the health care industry. We are a founding member
of the National Coordinating Council for Medication Error
Reporting and Prevention, and we are actively involved in the
National Patient Safety Foundation, sponsored by the American
Medical Association, and the Veterans Administration's National
Patient Safety partnership.
We believe that nurses are the quality and safety monitors
of health care. We worry about systems that put providers and
patients at risk. Today's environment demands that the nursing
profession assert its powerful voice in a time-honored role as
patient advocate by supporting public policies that protect
consumers, enhance accountability for quality, and promote
access to a full range of health care services.
ANA will continue to increase hospitals' awareness of and
participation in the national data base of nursing-sensitive
quality indicators, and will work for the dissemination of that
information.
By working together we can further document the link
between nurse staffing and patient outcomes in order to make
informed data-driven decisions that will allow safe quality
patient care to be the norm in all patient care settings.
We appreciate the opportunity to participate in this
discussion, and welcome the opportunity to work with you as we
address these issues.
Senator Specter. Well, thank you very much, Ms. Foley.
Initially, what is your evaluation of the adequacy of nurse
staffing? It is a big, broad question, but would you care to
make a comment on it?
Ms. Foley. We are very concerned, as a professional
organization. We would be remiss in not saying aloud that we
think there have been forces in the health care system,
financially based many times, in terms of reimbursement,
inadequacy of reimbursement, decision making that may focus
unfortunately on the bottom line of operations.
As an administrator in a facility, I want my facility to
continue to operate and to be in existence for another 95 years
in the City of San Francisco, and yet, some of that focus I
think has been detrimental, I know has been detrimental, to the
adequacy of nurse staffing.
I think Ms. Malone spoke very eloquently and personally
about an observation that she realized, that nurses, while they
may be in short supply perhaps through supply, we know that
there have been efforts to reduce the overall budgeted
positions of registered nurses in some cases.
I think Ms. Artemis spoke of a med tech who substituted for
a professional registered nurse. Perhaps a nurse may not have
assisted her to the bathroom that evening, but perhaps it might
have been a nurse close by to assist in some of the immediate
follow-up care.
I am not sure if that would have changed the outcome, but I
would like to believe that the presence of adequate numbers of
registered nurses, and the right number, and in the right
qualifications will, indeed, make a difference. So we are
concerned.
We think the report touches on the delivery level issues,
and the fact that staffing is part of the safety system, we
think there is a great deal of relevance, and we appreciate the
linkage.
Senator Specter. Well, here again, if there has to be a
disclosure of mistakes, errors, attributable to insufficient
staffing, that is motivation not to have insufficient staffing.
The cost factor always is very much front and center with the
practical problems we are facing.
I am interested to have your views on a mandatory reporting
system. We have had a little different view from Dr. Dickey. Is
it your thought that there would not be a conclusively chilling
effect, but that there would be a reporting of mistakes and
errors, even where the reporting person is going to be
admitting some potential liability?
Ms. Foley. I think as long as there is an avoidance of a
blame approach to the individual who has the courage and I
believe the professionalism to report, then it would be
absolutely appropriate, and we do support it as an
organization.
Nurses are often the individuals making out reports. I am
sure somebody, I hope somebody documented the fall, for
example, of Ms. Artemis. I mean I think that is an example of
reporting that we have done. Now, many times those reports go
into the risk management file and are internally evaluated.
I know as a nurse administrator I carefully watch the
trends of medication errors and falls, and I do not believe
that all of them are reported. I am concerned, not just at my
own facility, but through out the country, that individuals are
fearful of a disciplinary approach, as opposed to a supportive
process improvement approach.
If there is an individual who really should not be
practicing, I would never hesitate to pursue that as an
individual case, but if there is a system failure, not enough
staff, staff who have not been properly cross-trained, an
opportunity to be oriented well to the very particular
techniques of post-operative total hip care, I mean I think
those are very serious system problems.
Yes, the individual might have made the error, but there
were individuals such as the administrator and the supervisors
who contributed to that error by not allowing the support
systems to work.
Senator Specter. Well, when you talk about mandatory, so
long as it does not involve blame, it is a little difficult not
to cross the line.
Ms. Foley. It is.
Senator Specter. That is what we want to try to do. When we
are talking about letting prospective patients know what the
doctor has done in the past, then the patient simply does not
choose the doctor. So the doctor does have a disadvantage in
being ruled out of the case, but not being sued, not being
disciplined.
When you talk about disciplinary matters within the
hospital, you can encourage the hospital not to discipline, but
if the hospital knows that an individual has done something
which is egregious, should their hands be tied and not taking
some sort of direct action which might involve discipline?
Ms. Foley. No, by no means, and I do not mean to mix
reporting of events that would help paint the picture of some
system problems with those egregious errors. I by no means want
to commingle those situations. I think individuals will need to
be addressed.
I think the nursing approach is, we have been trying to
measure some of the patient outcomes, those indicators that we
believe have changed, because of some of the support systems,
and those includes falls, and medication errors, and patient
satisfaction.
Nurse injury, we are finding, has a close correlation to
the number of adequate numbers of staff. We have supported not
just the collection of this information, but public disclosure,
and dissemination of this data, so that the next time an
individual is pursuing the outcome of post-operative care for
total hip patients, they may understand more accurately what
facilities they might want to select, because nursing believes
that only with sharing in the public arena will the consumer be
able to make an informed decision.
So we support the reporting. I think we need to work,
perhaps, on the detail of what, as you said, gets to that line
of egregious individual error and responsibility versus those
reports that would help us draw the bigger picture.
Senator Specter. Well, when we talk about liability, it is
going to be a challenge to try to have mandatory disclosure
which is not going to involve some admissions as to legal
liability. There is certainly a tremendous amount more that
hospitals and supervising within the medical system can do
before the case gets to court at all.
The cases which get to court are usually very protracted
and with extraordinary discovery, which could be short
circuited by administrators to find the problems long before it
gets to that kind of judicial determination, a very, very small
percentage of matters.
STATEMENT OF STANTON SMULLENS, CHIEF MEDICAL OFFICER,
JEFFERSON HEALTH SYSTEM, PHILADELPHIA
Senator Specter. We now turn to Dr. Stanton Smullens, Chief
Medical Officer for the Jefferson Health System in
Philadelphia. He is here representing the American Hospital
Association, has served in a variety of leadership posts at
Thomas Jefferson University Hospital, including committees on
quality improvement, clinical professor of surgery at
Jefferson, won the Leon Paris Memorial Award for superior
patient care, graduate of Harvard College and Jefferson Medical
College, and a personal friend of mine, as is wife, Sarah Case
Smullens, seated behind him. Welcome, Dr. Smullens. We look
forward to your testimony.
Dr. Smullens. Thank you, sir.
Senator Specter. It is a great opportunity to have an
opportunity to question you, Dr. Smullens.
Dr. Smullens. My name is Stanton Smullens. I want to tell
you who I am, why I am here testifying today, and why I welcome
this opportunity.
Until 2 years ago I was a surgeon and teacher at Thomas
Jefferson University in Philadelphia, where I went to medical
school, trained, and practiced for many years. I became
involved in medical administration, because I felt that doctors
and other health care professionals had to work together with
hospitals to address the problems confronting health care in
America.
In June of this year I became the first Chief Medical
Officer of the recently formed Jefferson Health System. The
Jefferson Health System is very diverse, and includes over
3,000 physicians, most of whom are in private practice. In many
ways, it is a cross-section of the hospitals in the American
Hospital Association, and the issues confronting health care.
I am here today on behalf of the AHA, because they realize
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.
First, I want to reassure the committee and the American
public that hospitals safely provide care to millions of
patients every year. The people who deliver health care, the
doctors, nurses, and others on the health care team are highly
trained, receive continuous education, and strive every day to
deliver safe and compassionate care. They truly believe in the
dictum, ``First, do no harm.'' But health care today is
extremely complex, and even 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.
We applaud the members of the IOM committee on quality of
health care in America for developing the report that shines a
bright light on the problems of medical errors, and outlines
their significance in this country, and are heartened by the
quick response this has received.
We agree with the report that says we need to avoid blaming
individuals for past errors, and instead, focus on preventing
future errors by designing safety into the system. It stresses
two principles that reduce errors and increase patient safety.
First, individuals, by the very nature of being human, are
vulnerable to error. Although, individuals are the focus of the
error, we have to understand and improve the systems in which
people work that make errors more likely. As a result, reducing
errors will require us to design and implement systems that are
more error resistant.
Second, we have to create an environment where care givers
feel they can come forward after an unfortunate mistake is
made. There needs to be a non-punitive culture that allows the
candid discussion of errors, their causes, and ways to prevent
them from happening again. If we cannot discuss our mistakes,
we cannot learn from them.
The AHA also agrees with the recommendation that stepped up
vigilance is necessary. There are many organizations that
specialize in the area of reducing and preventing medical
errors. The IOM report focuses on the broad issue of medical
safety. This past week the AHA announced an initiative to
improve medication safety, since it is one of the most common
sources of overall medical errors.
As part of this initiative, the AHA formed a partnership
with a highly respected organization in this field, the
Institute for Safe Medication Practices. This non-profit
research and educational organization is dedicated to reducing
the incidents of medication error throughout the health care
system, and will provide leadership and technical expertise for
AHA's initiative.
In summary, Mr. Chairman, the Institute of Medicine's
report is very timely, and causes us to refocus on basic
issues.
At a time when great technological change and increasing
complexity of health care, I am glad to raise my voice in the
efforts to improve the overall safety of our health care
system, and as the report notes, the large complex problems
require thoughtful, multi-faceted responses that will demand
the thoughtful collaboration and participation of everyone
involved in the health care field, hospital leaders, doctors,
nurses, other health professionals, pharmacists, business,
government agencies, other organizations, and the public. The
AHA is pledged and committed to help its member hospitals and
health systems respond to this critical issue.
Thank you, Mr. Chairman.
Senator Specter. Well, thank you very much, Dr. Smullens.
You are a key official at one of the world's greatest
hospitals, Jefferson Medical College. Problems of hospitals
everywhere are staggering, in terms of the demands put on you,
the medical education, care of indigents, reduced Federal
payments, et cetera.
Years ago my oldest sister advised me never to go to a
hospital. She really stated do not go unless it is imperative.
What goes on in the hospitals which leads to the common problem
of infection? When you go into a hospital and you are sicker
after you get into the hospital than you were before? That is a
very broad question----
Dr. Smullens. It is.
Senator Specter [continuing]. And one which is on many,
many minds when they think about going to hospitals.
Dr. Smullens. Well, it is a complicated question,
obviously. One of the problems, of course, is that the patients
are very sick when they get there, their resistance is lowered,
and that in itself is a major problem.
The other problem is that there are a lot of sick people
with infections in hospitals, so that the hospital environment
does have infection, so that it is very important that policies
are in place and that they are followed appropriately to reduce
the transmission of infection between patients, and that the
infections when they are discovered are treated appropriately.
Senator Specter. To what extent are you doctors exposed to
this infectious atmosphere, to undesirable consequences?
Dr. Smullens. Well, I think that everyone in the health
care field, who are treating patients, is involved. There are
policies and procedures about isolating infectious patients,
treating infectious materials, wearing the appropriate gowns,
care of any type of equipment that comes in contact with
infected patients. There are policies in place to try and
handle this, but it is a constant ongoing problem.
Senator Specter. We have heard from Dr. Dickey being
opposed to mandatory requirements and Nurse Foley being in
favor of them. We are going to hear from Dr. Merry in a few
minutes. How do you vote?
Dr. Smullens. Well, Pennsylvania has mandatory reporting. I
think the real question is how it is used. The recommendation
is that the errors be analyzed and that they be looked at in a
way that information can be learned from them.
In the case of the fall that was described, the nurses have
taken a leading position in having what they call falls
assessment for patients, so that if you have a patient who is
admitted to the hospital, every patient is analyzed as to what
the chances are that they will fall. Certainly, a patient who
has just had a hip replacement is at risk for a fall, so that
patient would be treated differently than a patient, say, who
comes in for some other routine problem.
So that every patient, elderly patients, patients who are
frail, there is a false assessment that is made, and,
hopefully, hospitals are implementing that. There are
categories that you can rate one through four. I think that is
the categorization. But the point is, there is this type of
system approach to that very problem, so that the
understanding--the way that came about was looking at falls,
understanding why they occurred, and then setting up these
policies in place.
Senator Specter. To what extent are consumers able to have
access to the mandatory system in Pennsylvania to evaluate a
prospective doctor?
Dr. Smullens. I do not know the answer to that. I suspect
that it is limited. I think that for any consumer, anyone going
to a physician, they have to ask. One of the concerns is what
Dr. Eisenberg raised, every doctor in that audience raised his
or her hand that they had made a mistake. If you set up the
situation where people are afraid to seek appropriate care,
then you are going to hurt more people than you are going to
help by the reporting, so that it is only if the reporting
gives information that is helpful in making those decisions
that we can go forward, so that I personally think that anybody
going to have any kind of procedure has to open their mouth,
ask the doctor have you been sued, have you done this before,
will you do the operation. If they do not want any of the
training physicians to be involved then say I do not want the
training physicians involved.
There is a problem, though, about training the next
generation of physicians, and nurses, and other health care
professionals. Jefferson has just opened a medical simulation
laboratory, and I would be glad to have you come down and see
it.
Senator Specter. Well, it would be an extraordinary patient
who would ask those questions----
Dr. Smullens. I know. I know.
Senator Specter [continuing]. An extraordinary patient, and
it is not an easy line to draw to get the information for the
consumer to adequately inform the consumer without opening
Pandora's box, but that is what we are going to be wrestling
with here.
The considerations of privacy are very, very critical, but
I would be interested, and we will pursue it further as to what
the impact has been with Pennsylvania's statute, as to how that
has worked with respect to a chilling effect or what has
happened.
Do you think it is possible--well, you have already said we
have that in Pennsylvania. We will have to work from that step,
forward.
STATEMENT OF MARTIN D. MERRY, M.D., ASSOCIATE PROFESSOR
OF HEALTH MANAGEMENT, UNIVERSITY OF NEW
HAMPSHIRE
Senator Specter. We now turn to Dr. Martin Merry, South
Portland, Maine, Associate Professor of Health Management at
the University of New Hampshire, where he teaches quality
management, is a private consultant on medical quality, and was
medical director at St. Joseph's Hospital in Elmira, New York,
as well as project director for the Department of Defense
Civilian External Peer Review Program.
He earned his college degree at Cornell and his medical
degree from McGill University in Montreal. Thank you for
joining us, Dr. Merry, and the floor is yours.
Dr. Merry. Thank you, Mr. Chairman. As you indicated, my
focus upon health care quality as part of my career path is
about 25 years old, and from this perspective, I would say to
its great credit, the Institute of Medicine has finally brought
to center stage the question that has troubled many of us
working in health care quality for years; specifically, how can
a health care system that achieves literal miracles of cure
also generate such stark statistics on errors of medicine.
My intention today is both to address this question and
suggest how we might use this moment to launch a renewed, and
this time, more effective quality transformation for health
care. In my view, Senator Specter, quality legend W. Edwards
Deming got it precisely right with his famous 95-5 rule, the
notion that 95 percent of quality problems relate primarily to
system deficiencies, only 5 percent to people issues.
In keeping with this notion, I can assure the committee
that the root cause of errors in medicine is not incompetent
doctors, nurses, and health care administrators. These errors
are the inevitable result of an incredibly complex enterprise,
namely, modern health care, still structured in a totally
inadequate, obsolete, craft model of service delivery.
Fortunately this obsolete model is imploding as we meet,
but unfortunately, this implosion is accompanied by a painful
cacophony of insurers bleeding red ink, slash-and-burn hospital
and health system cost cutting, angry and depressed physicians,
burned out nurses, fired administrators, and, yes, inexcusable
and intolerable amounts of harm to patients.
Is there any way that we might better understand the
seeming chaos that now afflicts health care? I say yes.
Approximately 200 years after it began in this country, the
industrial revolution has finally arrived in health care. In
fact, I agree with a growing number of people who acknowledge
that health care is experiencing a simultaneous industrial and
information revolution, and this double revolution is asserting
itself with vengeance.
During such a profound transformation, there is no neutral
ground, we are all either part of the problem or part of the
solution. I and my colleagues at the Northland Health Group
define being part of the solution as focusing our knowledge and
energy on Deming's 95 percent. We seek to address the
inadequate systems that now so poorly serve health care
professionals, and are the root cause of errors in medicine.
This means commitment to transformation, and specifically
to measurement systems that better define quality, information
systems that truly support clinicians and managers who wish to
actualize evidence-based health care practice, learning systems
that help us change our mental models and our behaviors, and
finally, payment systems that genuinely reward, and in any case
do not penalize performance excellence.
Perhaps most importantly, we are encouraging new form of
collaborative leadership. To paraphrase Albert Einstein, we
cannot master today's leadership challenges with yesterday's
tired and increasingly ineffective leadership models.
All of this requires infrastructure investment among health
care provider organizations, even as they witness the
disappearing operating margins. My frustration is that we
already possess a vast array of underutilized systems tools for
addressing these infrastructure issues, as well as many
sparkling examples of twenty-first century world class quality
in health care.
Let me illustrate. In communities where open surgical
biopsy remains the standard practice, craft-model scheduling
and operational inefficiencies are such that a woman can
experience as many as 30 sleepless nights between the moment
she learns of her suspicious mammogram, then finally has a
definitive diagnosis. This is not error in medicine.
This is simply a wholly inadequate craft-model health
system doing its normal thing, but if the same woman happens to
receive her care through Health System Minnesota, the
suspicion-to-definitive diagnosis time gap is 2 hours.
Let me be sure we heard the quality message of this
example. Using known elements of modern quality management
science, Health System Minnesota has reduced sleepless nights
for its patients not from 30 days to 2 days, it reduced the
time line to 2 hours, zero sleepless nights.
As Michael Millenson documents in ``Demanding Medical
Excellence,'' which I have here, and I think should be the
companion volume to the committee's excellent report,
information-age health care can and does generate superb
quality today.
I reemphasize that we already have the tools to accomplish
the transformation revolutionary improvement. A tragedy that
outstrips even that of errors in medicine is our failure to
disseminate and actualize the knowledge we already possess. In
this context, I urge the committee to push even harder for the
industrial/information revolution that our health care system
must inevitably transit. The report is long on traditional
regulatory approaches, such as mandatory reporting, and these
all certainly have a role, but it is short on its recognition
and support, in my opinion, for leading-edge quality management
science.
I urge the Federal Government to elevate its vision beyond
that of this report, to move beyond fighting errors, to
embracing the best that modern quality management science might
create.
Nearly 10 years ago, Paul Starr, author of the Pulitzer-
winning, Social Transformation of American Medicine, stated,
``No matter how dramatically you think health care has changed
in the last decade, now is the time before the revolution. Year
by year, the existing system is coming unstuck.'' He made that
statement in 1990.
Error in medicine is a tragic phenomenon of a system now
deeply unstuck. We will not solve this problem by attacking it
though regulation alone. We will not fix the errors problems
until we change health care's culture, and changing culture is
not a technical problem, it is a leadership imperative.
We must all work together to foster a transformation that
elevates the whole system to a quality culture that simply will
not tolerate error. If both the space program and the airline
industry can nearly eliminate human errors as a source of
injury, can we in health care aspire to anything less?
I applaud the efforts of this committee, Senator Specter,
and thank you for this opportunity to share my experience and
outlook.
Senator Specter. Well, thank you, Dr. Merry. When you used
the illustration of 30 sleepless nights awaiting an X-ray for
somebody who has some indication of possible breast cancer----
Dr. Merry. It is actually awaiting a diagnosis, the time
between I may have cancer, and I know one way or another.
Senator Specter. Well, why so many intervening sleepless
nights? It is not a complicated matter to have to test, is it?
Dr. Merry. It is because we have never really designed our
systems around patients. The system heretofore has been
designed around physicians primarily.
When I was practicing primary care internal medicine, I
would have my primary care patients, we would learn about the
diagnosis from the X-ray that there was a suspicion, and I sort
of narrowly defined my role as that of getting her to the
surgeon, and quite frankly, during those years, this was the
seventies, I would like to think I would be more sensitive now,
I really did not think a lot about what happened in my busy day
thereafter until we got the diagnosis, and I did not have the
sensitivity, until I learned what Health System Minnesota had
done, to really be thinking about what that experience was
like----
Senator Specter. Health Systems in Minnesota got it done in
2 hours.
Dr. Merry. In 2 hours.
Senator Specter. What is at Jefferson, Dr. Smullens, 1
hour?
Dr. Smullens. The problem is that, a lot of it is that it
is a fragmented system. There is not really a system to deal
with it, so the individual----
Senator Specter. It is not fragmented at Jefferson, is it?
Dr. Smullens. If the patient gets to the surgeon, I would
hope it would get done very quickly, but unfortunately, there
is a time frame between when the primary care physician gets
the report of the X-ray, which may be several days after the X-
ray is done, then has to get to the appointment with the
surgeon to get the biopsy done, or perhaps with the
radiologist.
So it is a sense that there is a time between when the
diagnosis is suspected and the patient actually gets to someone
who can make the diagnosis.
Senator Specter. You are a management specialist, Dr.
Merry, so give Dr. Smullens some advice as to how to solve that
for Jefferson.
Dr. Merry. First of all, you would have to really broadly
conceive what our duty to our patients really is. In the
seventies, when I was in practice, getting the diagnosis was
the big thing, but we are now in the 1990s and the time lag,
the sleepless night factor, is a part of what we owe to our
patients at this level. If we have the capability of producing
that, we need to do it.
Interestingly enough, it is higher-value health care, too.
It is cheaper to do it faster. That old way of getting them to
the surgeon, scheduling the surgery and open biopsy, that is
actually more expensive than stereo-technic biopsy, which is
one of the technical pieces by which you can get that lag down
to 2 hours, but we have to conceive it in a very sensitive and
much deeper way than we ever have before, building a system
around our patients rather than the physicians and the
hospitals.
Senator Specter. Well, your suggestion, Dr. Merry, is that
quality management is vastly underutilized in American
medicine.
Dr. Merry. That is my statement, yes.
Senator Specter. Are there enormous financial savings, too,
if the management processes were improved? Must be.
Dr. Merry. Yes. If we define, as Deming did, quality
improvement as process improvement, getting waste out of the
system, as designing more efficient systems, as the breast
biopsy suggests, that actually is lowering the cost through
process improvement, and producing higher quality
simultaneously.
I think that that notion has been so jargoned in health
care that we do not believe it is really true, but some of
your--the members of this committee, specifically Don Berwick,
as well as Brent James, have demonstrated that.
Ten years of leadership at Intermount Health System and
IHI, that is the truth, we just have not been able to spread
that word through the system adequately.
Senator Specter. Does this report deal with the issue you
raise about improving health management?
Dr. Merry. To me, it begins to touch on it in the notion of
a culture of safety. A lot of this stuff strikes me as being
kind of, a little more regulation, and I think it--better
regulation I am all for at this point, but it is not the
creative challenge, and it is not the kind of stuff that
leaders will aspire to.
The culture on safety comes to the closest to what I think
are the directions that the Federal Government could do to pull
the whole system away from the error problem. Yes, deal with it
effectively here, but just establish a higher bar, so to speak,
for a cultural shift, that is why I like the word, culture of
safety, the problem being that if you have a culture of safety,
it makes a big difference whether it is a culture of fear
versus a culture of excellence, because the two are
incompatible, as Deming very well stated.
Senator Specter. Well, tell us a little bit more about how
you would approach a culture of excellence.
Dr. Merry. It is first and foremost a leadership problem.
CQI came into health care in 1987 through the national
demonstration project. Again, Brent James and Don Berwick were
leaders in that movement, and we looked upon it as a technical
issue.
If we would learn enough of the tools and techniques, we
will do it. We did not understand it the first time around in
the late eighties and early nineties. It was a cultural shift
of major magnitude.
One of Deming's 14 points was adopt a new philosophy, and
we did not fully understand the new philosophy back in the
early 1990s, so we went through that wave. I am very
encouraged. About the last 6 months I am getting more
opportunities to speak about quality, I am getting a receptive
ear to quality as a business strategy.
I think it is beginning to sink in, as this kind of
industrial information revolution goes through health care. I
think we are in a new position of potential receptivity of this
message.
Senator Specter. Dr. Eisenberg, how does this dichotomy
strike you, culture of excellence versus culture of fear?
Dr. Eisenberg. I agree with just about everything that has
been said. I think one of the most striking aspects of what Dr.
Merry has said is the gap between what we know we can do and
what we know we ought to be doing, and our ability to deliver
it. In many ways, it is like much of what you know about the
science of medicine. We know that mammography works, but we do
not know why more women do not receive them.
If we could learn more about what works in developing this
culture, and in developing more information about what produces
errors, and then see that we could translate that into improved
practices, then I believe we would answer the problem that
these folks have laid before you today.
Senator Specter. Well, I am sort of struck, here we are in
Congress seeking to legislate on this report on a culture of
fear where we might have some standing, but do we have any
standing to legislate on the culture of excellence?
Dr. Eisenberg. We certainly do. In fact, I will go back to
what I had mentioned when I had started, which is I think you
did legislate on a culture of excellence when you changed the
name of our agency to the Agency for Health Care Research and
Quality. It was a clear statement by the Congress that you
think this is high priority.
Senator Specter. Also legislature on the culture of
excellence when we handed $2.3 billion to NIH this year----
Dr. Eisenberg. I would agree with that.
Senator Specter [continuing]. And $2 billion last year, and
a billion the year before.
Dr. Eisenberg Senator Specter, what I appreciate is the
fact that you appropriated funds to AHCPR (now AHRQ) to allow
us to translate some of the new knowledge gained from the
research of the NIH into improved practices. I think the
culture is going to require a team effort.
It is going to require the patients and the consumers to
come up and speak and have the courage that these folks did
today, and it is going to require the courage of the profession
to say that we can do a lot better than we have been doing.
Senator Specter. Well, I think the Congress is going to
legislate on the issue of mistakes, from this report. Senator
Kennedy has announced his intention to do so, and Senator
Jeffords is the chairman of the authorizing committee, and we
are going to be moving toward it here.
When you talk about a culture of excellence, it is a
broader range as to whether there is competency here. We can
appropriate money, as we have for your agency, or we have for
the National Institute of Health, or the Center for Disease
Control, but whether we ought to go beyond that, leaving the
implementing decisions to you professionals, whether we have
anything more to say is a much tougher question.
Well, thank you all very much. This is a very provocative
and a very, very important subject. It is obviously life and
death, and we wanted to have this hearing as soon as we could,
and stay tuned.
CONCLUSION OF HEARING
Thank you all very much for being here, that concludes our
hearing. The subcommittee will stand in recess subject to the
call of the Chair.
[Whereupon, at 1:03 p.m., Monday, December 13, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
MATERIAL SUBMITTED SUBSEQUENT TO THE CONCLUSION OF THE HEARING
[Clerk's note.--The following statements were received by
the subcommittee subsequent to the conclusion of the hearings.
The statements will be inserted in the record at this point.]
PREPARED STATEMENT OF HON. PETE STARK, U.S. REPRESENTATIVE FROM
CALIFORNIA
Mr. Chairman: I would like to congratulate you for your quick
action in holding today's hearing, which will educate Members and the
public concerning the need to reduce medical errors and improve the
quality of care in our nation's health care system.
We too are busily looking into this matter. I am currently drafting
legislation to establish a comprehensive quality system--including a
provision to curb medical errors. This legislation will require the
Secretary of Health and Human Services to establish and maintain a
comprehensive system for monitoring, improving, and safeguarding the
quality of care for Medicare beneficiaries and to reduce medical
errors. Providers will have to join in this effort as a Condition of
Participation in Medicare.
The recent Institute of Medicine (IoM) report raises public
awareness concerning the need to prevent medical errors and to promote
public safety. This also opens the door to a number of critical
issues--such as safeguarding health care professionals from accidental
needlestick injuries and protecting patients from the improper use of
restraints and seclusion. I have introduced legislation this Congress
to reduce medical errors in both of these areas and I hope you will
include these proposals in whatever legislation you develop and
advance.
Earlier this year, I introduced H.R. 1899, the ``Health Care Worker
Needlestick Prevention Act'' with my colleague Rep. Marge Roukema (R-
NJ) to ensure that those who care for us don't have to risk their lives
to save our lives. Last year, an estimated 800,000 accidental
needlesticks occurred in medical facilities from needle-bearing
devices. Accidental needlesticks produce the single greatest risk of
blood exposure to the HIV virus for health care workers. And infection
with the hepatitis B and C viruses may also be transmitted through
needlestick. Technology exists to greatly reduce these injuries. Such
preventable medical errors involving health care workers must be
brought to an end.
In addition, I joined Rep. Diana DeGette (D-Colo.) this year to
introduce legislation addressing the use of restraint and seclusion in
Medicare and Medicaid psychiatric treatment facilities, facilities for
the developmentally disabled, and residential treatment facilities for
children. A series of Hartford Courant articles from October 1998
highlighted the misuse of restraint and seclusion in residential
facilities over the course of ten years and found that 142 cases of
patient deaths were related to the improper use of restraint or
seclusion. A General Accounting Office (GAO) September 1999 report on
restraints and seclusion identified 24 deaths during fiscal year 1998
related to improper use of restraint or seclusion. Due to currently
inadequate reporting requirements, the GAO estimates that the number of
deaths is likely to be significantly higher.
This past August, the Administration came forward with new
conditions of participation for hospitals concerning the use of
restraints, and I commend the Administration for their important, major
step forward. Yet, as the GAO notes, we still have further to go.
Current Federal regulations do not limit the use of restraint and
seclusion in all settings such as residential treatment centers and
group homes, and there is no comprehensive reporting system to track
injuries, deaths and use of restraint and seclusion.
The ``Patient Freedom From Restraint Act of 1999'' (H.R. 1313) sets
strict requirements for the use of restraints and seclusion and
requires treatment facilities to document and report on restraint and
seclusion use. H.R. 1313 also requires facilities to report cases of
severe injury and death to the state's Protection and Advocacy Board,
and the Secretary of Health and Human Services. By establishing such a
reporting framework, the bill intends to reduce medical accidents
related to restraint and seclusion use.
The IoM report should prove a catalyst for Congress to take overdue
action on preventing deaths by accidents in our nation's health care
system. I look forward to working with you and our colleagues on this
timely, important issue. Let's work together to end these senseless
injuries and deaths.
______
PREPARED STATEMENT OF THE UNITED STATES PHARMACOPEIA
The United States Pharmacopeia (USP) is pleased to have the
opportunity to provide this statement in conjunction with the Senate
Subcommittee on Labor, Health and Human Services, and Education Hearing
on Medical Mistakes. USP strongly supports Congressional consideration
of actions it might take to ensure the significant reduction of
preventable medical mistakes that occur throughout the continuum of the
prescription, dispensing, administration, and use of medicines. USP
further believes that development and execution of federal legislation
and regulatory policies, which will direct and guide public and private
initiatives at the national, state, and local levels, must be achieved
to ensure patient safety from medical mistakes, and to reduce
substantively the multi-billion dollars that such mistakes currently
cost the health care system each year.
USP comments, offered for Subcommittee consideration, cover the
following:
--Information about the U.S. Pharmacopeia's 30-year record of
stimulating voluntary health care practitioner reporting and
using the analysis of those reports to improve patient safety.
--Background on USP's ability to affect change in drug product
labeling, packaging, and nomenclature when such is identified
as contributing to medication errors.
--An explanation of USP's new MedMARxTM program--a
national, Internet-based, anonymous medication error reporting
system, introduced in July 1998, and now used by over 100 U.S
hospitals.
--A recommendation for Congressional action that can directly and
quickly remove one of the most significant barriers to hospital
and practitioner reporting of medication errors.
usp's medication error reporting experience
Background
USP, founded in 1820, is a private not-for-profit organization
whose sole mission is to promote the public health by establishing and
disseminating officially recognized standards of quality and
authoritative information for the use of medicines and related articles
for professionals, patients, and consumers. It is composed of
approximately 500 members representing state associations and colleges
of medicine and pharmacy, ten agencies of the federal government, and
about 75 national professional, scientific and trade organizations, and
members-at-large who include members from other countries that
recognize USP standards. The USP's expertise as a standards-setting
body has been recognized by Congress in the enactment of the Pure Food
and Drug Act of 1906, by the Federal Food Drug and Cosmetic Act in
1938, and by the Food and Drug Modernization Act in 1997. USP standards
are also referenced in most state pharmacy laws governing practice.
USP began developing drug information, in 1970, as support to its
standards-setting activities. The USP DI, the compendia of
USP drug information, is today recognized by the Federal Omnibus Budget
Reconciliation Acts of 1990 and 1994 as a reimbursement resource for
Medicaid Agencies considering issues associated with off-label uses of
medicines and guidance for patient counseling. Based upon its federal
recognition, and its reputation as a credible, authoritative, and non-
biased source of information developed by approximately 800 volunteer
experts, USP DI also serves as a reimbursement resource for insurers
and third party payers, and as the basis for drug formulary decisions.
USP practitioner reporting programs
Because of our concern with the quality of drug products on the
market, in 1971, the USP co-founded the Drug Product Problem Reporting
Program--national program in which health professionals were asked to
voluntarily report problems and defects experienced with drug products
on the market. Often the product problems or defects had to do with
inadequate packaging or labeling--labeling that could lead to confusion
on the part of health professionals or lead to errors; for example,
similarity in color or design of the label, or look-alike, sound-alike
drug names.
Eight years ago, in 1991, USP decided to focus more intensely on
the problem of medication errors and what it could do to prevent them.
Our focus today is on both the product and on the system in which the
product is prescribed, dispensed, administered, and used. USP does not
set practice standards per se, but admittedly many of our standards do
indirectly affect professional practice and many practice standards are
based on USP standards. The USP learned that The Institute for Safe
Medication Practices (ISMP) was seeking support of a national
organization to bring its program, The Medication Errors Reporting
(MER) Program, to the national level. USP agreed to coordinate the
national program for ISMP. The MER Program is now one of four USP
voluntary, spontaneous reporting programs for health care
practitioners. The Program is operated under the umbrella of the USP
Practitioner and Product Experience Division.
Since late 1991, the MER Program has received more than 4,000
reports of actual and potential medication errors. We also continue to
receive medication error reports through USP's other reporting
programs. These reports have identified errors in various health care
delivery environments, including hospitals, nursing homes, physicians'
office, pharmacies, emergency response vehicles, and home care. By
these reports, we have seen that errors are multidisciplinary and
multi-factorial. They can be committed by experienced and inexperienced
staff, by health professionals, support personnel, students, and even
patients and their care givers. Errors can occur anywhere along the
continuum from prescribing to transcribing to dispensing and
administration. The causes of errors may be attributed to human error,
to product names or designs, or to the medication handling and delivery
systems in which the products are used and individuals operate and
interact. For purposes of voluntary reporting, USP does not seek to
limit the types of errors that may be reported, because all information
received may have some future value. We do not, however, actively
solicit reports of adverse drug reactions.
We recognize that an actual error may be reported as a potential
error because of liability concerns, or a facility's risk management
policies, so each report is treated with the utmost seriousness by USP,
no matter how it is characterized by the reporter. As each MER report
is received, it is shared with the product manufacturer and with the
Food and Drug Administration. USP does not require, in the MER Program,
that the name of the reporter, patient identity, or facility be given.
If given, however, USP respects the desire of the reporter to keep
their identity confidential and will purge the identity of the
institutions or individuals named in the report in accordance with the
instructions of the reporter. Reporters are advised of any actions
resulting from their report either individually or through USP's
Quality Review publications, which are disseminated to all individuals
who have reported to the MER Program and are publicly available on
USP's web site.
USP'S ABILITY TO AFFECT CHANGE
Encouraging the reporting of errors is only one aspect of USP's
efforts to promote safety of the medication use system. USP evaluates
and implements, through its standards-setting authority, changes in
drug products to prevent the recurrence of errors. The following
examples describe some of the changes or other steps taken by USP in
response to MER Program reports.
--Death reported due to the accidental misadministration of
concentrated Potassium Chloride Injection led to (1) changing
the official USP name to Potassium Chloride for Injection
Concentrate to give more prominence to the need to dilute the
product prior to use; (2) labels must now bear a boxed warning
``Concentrate: Must be Diluted Before Use;'' and (3) the cap
must be black in color (the use of black caps is restricted to
this drug only), and the cap must be imprinted in a contrasting
color with the words, ``Must be Diluted.''
--Deaths reported due to the confusion and resultant injection of the
anticancer drug, Vincristine Sulfate for Injection, directly
into the spine instead of into the vein, resulted in changes in
the requirements for packaging by pharmacies and manufacturers
preparing ready-to-use doses. Each dose, whether prepared by
the manufacturer or the pharmacist, now must be wrapped in a
covering labeled ``FOR INTRAVENOUS USE ONLY'' and that covering
may not be removed until the moment of injection.
--Deaths reported due to the name similarity of Amrinone and
Amiodarone have lead USP and the United States Adopted Names
(USAN) Council to consider changing the official and
nonproprietary names of one, or both, products.
--Deaths reported due to the inadvertent mix-up of neuromuscular
blocking agents (which paralyze the respiratory system) with
other drugs, have led to recommended changes in standards for
labeling and packaging of the therapeutic class of
neuromuscular blocking agents.
--MER reports of deaths identified the need to establish dosing
limitations for the sedative-hypnotic Chloral Hydrate for use
in children, and for the anti-gout drug Colchicine. These
dosing limitations have been incorporated into USP DI
information in a special section in each drug monograph to
caution health professionals on each drug's proper use based
upon reports of errors received through the program.
Reported medication errors also have brought about other changes in
USP standards and guidance to practitioners. For example, USP has
ceased to recognize use of the apothecary system, a centuries old
system of measurement, in favor of the metric system in order to avoid
misinterpretations that have led to overdoses. USP has made changes in
general label requirements for marketed drug products. For example,
strengths less than one must be expressed as a decimal preceded by a
zero (e.g. 0.1 grams, not .1 grams) to avoid ten-fold-overdoses. USP
standards also require that the strength of a product when expressed as
a whole number be shown without a zero trailing the decimal to avoid
ten-fold overdoses by the lack of recognition of the decimal point
(e.g. 1mg, not 1.0 mg).
Prior to the formation of the Food and Drug Administration Office
of Post Marketing Drug Risk Assessment, FDA developed a formal
mechanism for receiving and evaluating MER reports--the Subcommittee on
Medication Errors. USP and FDA also created a joint advisory panel on
the Simplification and Improvement of Injection Labeling to reduce
medication errors. The Food and Drug Modernization Act of 1997
recognizes product labeling recommendations of that joint initiative.
In 1991, to expand the scope of the MER Program, USP developed a
joint program with the National Association of Boards of Pharmacy. The
database is maintained by USP and assists each Board of Pharmacy to
determine the relative extent of errors in its state and contributes to
the overall incident collection effort.
In addition to using the MER program to stimulate changes in
enforceable standards and information, USP has used the MER information
to develop educational tools for the health professions. In 1993, a
curricular resource entitled--Understanding and Preventing Medication
Errors--was distributed at no charge to colleges of pharmacy throughout
the U.S. USP also has attempted to reach the public directly to teach
patients how to protect themselves from medication errors through the
development of a public service campaign--Just Ask . . . About
Preventing Medication Errors.
USP has worked diligently during the past eight years, particularly
in the standards-setting area, to build coalitions among health care
organizations and to provide health care expert review of medication
errors. In 1995 USP spearheaded formation of the National Coordinating
Council for Medication Error Reporting and Prevention (NCC MERP). USP
is the founding organization and continues to serve as NCC MERP
Secretariat. To date, NCC MERP comprises 17 national organizations and
agencies that share a common mission to promote the reporting,
understanding and prevention of medication errors. Member organizations
include practice organizations of medicine, nursing, and pharmacy, the
licensing boards of pharmacy and nursing, organizations of the
pharmaceutical industry, the Department of Veterans Affairs, USP, FDA,
Joint Commission on the Accreditation of Healthcare Organizations
(JCAHO), and the American Hospital Association. In the four years since
its inception, the Council has produced internationally recognized work
products, such as:
--A standardized definition of ``medication error''
--A categorization index to classify medication errors by the
severity of the outcome to the patient
--Recommendations to reduce the error prone aspects of prescription
writing; product labeling and packaging; and broad
recommendations related to the dispensing and administration
phases of the medication use process.
The Council is now examining issues of process failures in the use
of verbal orders, benchmarking, inter-organizational comparisons, and
error rates.
In 1996 USP appointed an Advisory Panel on Medication Errors, an
interdisciplinary group of health care practitioners who: review
reports submitted to the USP Medication Errors Reporting Program; make
recommendations for USP standards-setting; and make recommendations and
participate in the activities of the NCC MERP.
In 2000, USP will constitute a new expert committee on ``Safe
Medication Use'' that will fulfill a broader scope of responsibilities
of the Advisory Panel that it will replace. The new expert committee
will review MedMARx data and provide guidance for the development of
best practice solutions that will result in the reduction and
prevention of medication errors.
USP'S MEDMARX PROGRAM
In early 1998, USP developed a program for hospitals to report
medication errors to a nationwide program. Hospitals were eager to
submit reports to USP if it could be done anonymously and in a
standardized format that would allow hospitals to track, trend, and
compare their data to other participating hospitals. USP's goal was to
develop a model for hospitals first, ensure success of the model, then
broaden the model to include other health care settings and other types
of reporting such as medical error and adverse drug reactions.
On July 27, 1998, USP made MedMARx available to hospitals
nationwide. MedMARx (pronounced med marks) is an internet-accessible,
anonymous reporting program that enables hospitals to voluntarily
report, track and trend data incorporating nationally standardized data
elements (i.e., definitions and taxonomy) of the USP Medication Errors
Reporting Program, the National Coordinating Council for Medication
Error Reporting and Prevention (NCC MERP), and the American Society of
Health-System Pharmacists. MedMARx is structured to support an
interdisciplinary systems-approach to medication error reduction and
fosters a non-punitive environment for reporting.
Hospitals use the program as part of the organization's internal
quality improvement process, thereby extending the ``peer-review''
group to the group of hospitals in the program. Hospitals review the
errors entered by other institutions in ``real time'' and also can view
any reported action taken by another institution in response to the
error or to avoid future similar errors. This feature affords
institutions the opportunity to examine errors in a proactive manner.
For example, the institution can review the error profile of a drug or
class of drugs before a product is added to the institution's formulary
to determine if certain risk prevention measures or training programs
should be instituted prior to the drug's purchase or if the error
profile is so serious that the decision to stock the drug is rejected.
MedMARx also supports the performance improvement standards of the
Joint Commission on the Accreditation of Healthcare Organizations
(JCAHO), which requires institutions to look outward at the experiences
of others in order to reduce risk.
Currently 110 hospitals have enrolled in the MedMARx program and
other progressive hospitals and health systems are joining rapidly.
Profiles of the participants show that hospitals of various types and
sizes spanning fewer than 50 beds to approximately 1000 beds are
enrolled. MedMARx hospitals include institutions of the Department of
Veterans Affairs and the Department of Defense, and state-owned
facilities.
The USP commitment to MedMARx is broader than merely collecting
data. In the coming year, USP will enroll champion hospitals
participating in MedMARx in a long-term project to propose indicators
of quality in the medication use process and to identify best practice
standards and best process standards for the medication-use system.
A recommendation for congressional action
USP is heartened by the national attention resulting from release
of the Institute of Medicine Report--To Err is Human--Building a Safer
Health System. USP is particularly gratified at the immediate action
being taken by Senators Spector and Stevens through the Subcommittee on
Labor, Health and Human Services, Education.
Among the IOM Report discussions and recommendations is recognition
that the lack of federal and/or state protection of medication error
reported information poses a major barrier to voluntary reporting of
errors, or potential errors. Health care practitioners are concerned
about reprisals and practitioners and systems are concerned about
liability. USP believes, therefore, that Congress can make a
significant contribution to the development of systems that facilitate
voluntary medication error reporting and tracking through immediate
consideration of legislation that would protect information developed
in connection with error reporting by hospitals and other institutions
and health care settings. USP currently is developing such legislative
language to present for Senate and House consideration.
CONCLUSION
In closing, we wish to assure Subcommittee members that USP shares
with Congress the goal of a safe medication use system. USP has made a
public and long-term commitment to working proactively with all
stakeholders toward that goal. We particularly look forward to working
with Congressional leadership on the issue of confidentiality and other
policy issues that will result in greater voluntary reporting,
analysis, and system changes to prevent medication mistakes.
______
PREPARED STATEMENT OF SALVADOR CASTRO, PROFESSIONAL ENGINEER
I am writing you about another facet in the recent disclosure of
deaths and injuries caused by medical errors.
It involves dangerous medical devices. It also involves the cover
up of ineptness of some of the people in the FDA. There is also the
dilemma of a whistleblower.
I am a Whistleblower who stuck his neck out and, like the other
whistleblowers, I also paid the price. I was fired. In this case it
involved a medical device that could harm the weakest of our society,
infants.
As a licensed professional engineer, I am required by law and the
code of ethics of an engineer to protect the health and safety of the
public.
Late In 1995 I discovered that the company I worked for, Air-
Shields/Vickers located in Hatboro, PA, was making an infant transport
incubator that had the potential of causing injury or death to a
newborn infant. I brought this to the attention of my supervisor, Joe
Lassard. I pointed out what the problem was and how it could easily be
corrected. I also told him that the FDA should be informed of the
situation. He told me that the company knew of the problem but was
hiding the information from the FDA. I was appalled at the unexpected
response. The modification would actually reduce the cost of the
device.
My response was that if the FDA was not informed by the company of
this problem, I would. Big mistake! Within a few weeks I was fired as
being ``Incompetent''. In the letter of discharge the Director of
Engineering, Jan Wenstrup, stated that ``It became very clear that Sal
is not able to function in a progressive product environment . . .''
Built into the incubator is a hand ventilation system. It is used
to resuscitate an infant in respiratory distress. This hand ventilation
system is dangerous because the design is flawed. A pressure relief
valve in the system was improperly located in the circuit. It did not
protect the infant's lungs from being ruptured. As a result, the
pressure displayed on the pressure gage did not indicate the actual
pressure being applied to the infant lung.
A few days after being fired, I notified the FDA of the dangerous
design. In my letter I explained the problem and its solution.
Two weeks after I was fired, tests were run by Quality Assurance
Engineer Joe Bagnell to check my concerns. The data from the test
proved that the design was flawed.
Around December 1995, Dr. Mickler, Head of the dept. of Anesthesia
at Montgomery County Hospital in Norristown, PA received an infant care
unit with the identical hand ventilation system. He informed Air-
Shields/Vickers that the hand ventilation system was dangerous. A team
from the company was sent to talk with the doctor. Dr. Mickler was able
to demonstrate his concerns to the team. The team was not convinced
that the design was dangerous. The doctor, frustrated with the
company's refusal to admit that there was a problem, called the FDA.
The doctor also notified Emergency Care Research Institute (ECRI). The
staff members at ECRI are experts in the evaluation of medical
equipment. They reported in June 1996 their findings to the hospital
industry. They agreed that the hand ventilation system was dangerous.
ECRI published its findings in their magazine. In the article they make
recommendations on how to correct the problem. The very same
recommendations I had made to my supervisor six months earlier. The
same information I had sent to the FDA.
The FDA sent investigators, John S. Shea and James P. McEvoy to
collect information on the breathing circuit. The two FDA investigators
interviewed me in my home. I provided them with a sworn statement of
the facts.
The FDA investigators spoke to the company's ``experts''. The
``experts'', who had no engineering background, insisted that the
circuit was safe. The ``experts'' told the FDA investigators that the
company would not make any change in the breathing circuit design.
A report of the investigation was sent to FDA headquarters outside
of Washington, DC. I was able to get an edited version of this report.
I inquired as to what the FDA was going to do about having the
problem corrected. I was told, over the phone but not in writing, that
the case was closed. FDA determined this based on the fact that they
did not have any record of injuries or deaths. The FDA also decided it
was not going to insist that the company correct the dangerous
breathing circuit.
Under the Freedom of Information Act (FOIA), I requested from the
FDA the documentation that involved the 510(k) approval of this medical
device. The letter was sent in April 1996. In spite of numerous calls
and follow up letters, to this date I have not received the requested
information.
Someone in the FDA eventually went back and reviewed the
information they had. The FDA came to the conclusion that I was right
after all. A recall on incubator was issued October 11, 1999.
It has taken the FDA 43 months to get the company (Now known as
Hill-Rom Airshields) to correct the dangerous breathing circuit.
The FDA estimates that the retrofits will not be completed until
the end of January 2000.
The horrible fact is that the FDA originally approved this
dangerous design in 1989. The FDA 510(k) approval number is K985550.
This product has been on the market for 10 years. How could the FDA
allow infants to be exposed to this dangerous device for so long?
I can not believe that someone in the medical field did not report
this to Airshields or the FDA. This product had been on the market for
six years before Dr. Mickler and I brought it to their attention.
Who knows how many babies' lives will be saved because I blew the
whistle on my employer and continuously badgered the FDA to have the
error corrected..
In the light of the recent disclosures of the cover up of medical
errors in hospitals, one has to wonder how many of these victims were
helpless infants. We may never know.
The FDA was created to enforce the laws passed by our legislators
to protect the public. It is impossible for the limited number of
investigators to ferriet out the illegal activities of a few corrupt
corporate managers. Who is more qualified to expose shoddy products
than the company employees who work with these products?
New Jersey has a law that is called the Conscientious Employee
Protection Act (CEPA). The American public would be best served with a
similar national law to protect whistleblowers. Employees would be
protected from unscrupulous employers who callously break the law.
Employers who put Bucks before babies!
I am a member of Institute of Electrical and Electronic Engineers
(IEEE). Our organization of 347,000 members has a commitment to ethics
in engineering. I have presented my case to two ethics committees, the
Member Conduct Committee (MCC) and the Society on Social Implications
of Technology (SSIT). They fully support my position. One of the
members of the committee sent a letter to the Director of Engineering,
Jan Wenstrup for his side of the story. The response of the lawyer is
typical of the double-speak one can expect from corporate management.
It is reminiscent of the rubbish put out by the CEOs of the tobacco
industry.
If you wish, I am willing to talk to anyone in your office in
greater detail regarding this matter. It can be here in Philadelphia or
in Washington.
MEDICAL MISTAKES
----------
TUESDAY, JANUARY 25, 2000
U.S. Senate, Subcommittee on Labor, Health and
Human Services, and Education, and Related
Agencies, Committee on Appropriations, and
Committee on Veterans' Affairs,
Washington, DC.
The subcommittee and committee met at 9:37 a.m., in room
SD-192, Dirksen Senate Office Building, Hon. Arlen Specter
(chairman) presiding.
Present: Senator Specter.
Opening Statement of Senator Arlen Specter
Senator Specter. Good morning, ladies and gentlemen. The
hearing of the Appropriations Subcommittee on Labor, Health and
Human Services, and Education will now convene.
As we meet this morning at 9:37, a snow storm is raging in
Washington. And word came in that the Government was closed.
Some of us had notice that it had been opened, but it was
officially closed today. And word also came that the Senate was
closed.
Yesterday began the second session of the 106th Congress.
But we have had a good response and a turnout for the witnesses
scheduled for this hearing. And the witnesses have come from
long distances: California, Florida. Dr. Specken drove 8 hours,
coming in last night. Only one witness, a Washingtonian, was
unable to get out of the driveway. So we will proceed.
It may well be that this will not be the last hearing on
the subject of medical errors. Senator Harkin, who could not be
here this morning because he was engaged in the Iowa primaries,
which were held last night, had wanted to be here. And we have
prepared legislation in the field, and the hearings will enable
us to flesh out the legislation and perhaps make some
modifications. Since we are going to be circulating it in the
course of the next several days and hope to introduce it in a
week to 10 days, we want to get some comments. And I shall
discuss the legislation in due course.
The issue of errors in hospitals has been brought into
sharp focus. And I ask unanimous consent--which is not hard to
get for two reasons: one, I am the chairman and the other is
nobody else is here--that my full statement be included in the
record, and I will summarize.
The report of the Institute of Medicine on medical errors
has caused quite a reaction in the United States. This
subcommittee held its first hearing on December 13 even though
we were in recess at the time, because of our consideration of
the urgency of addressing the issue.
The Institute of Medicine report chronologed that an
estimate between 44,000 and 98,000 hospitalized Americans die
each year due to avoidable medical mistakes. The national cost
of preventable medical errors is between $17 billion and $29
billion. And the IOM estimates that there could be a 50 percent
reduction in errors over the next 5 years.
The Institute of Medicine recommended a mandatory reporting
system, which has caused a large number of objections. And we
heard them in our December 13 meeting. My own view is that
there has to be mandatory reporting if we are to have any
results. My own State of Pennsylvania has a reporting system.
And we threw a big party in Pennsylvania and nobody came. We
require reporting and almost no one is reporting. If there is
to be a chance to succeed in identifying these errors and
preventing them, I believe, personally, there must be mandatory
reporting.
The Joint Commission of Accreditation of Health Care
Organizations has recommended voluntary reporting. So the issue
is joined and there will be plenty of debate on that subject.
This is a joint hearing with the Veterans Affairs
Committee, which I Chair. And I am pleased to note that the
Veterans Administration has responded to this problem with a
substantial degree of diligence. The Veterans Administration
has been plagued with a great many problems. So it is
especially pleasing--frankly, refreshing--to find that there
has been action here.
Last month, the Veterans Administration Medical Inspector
published a report on data from the Patient Safety Registry for
events from June 1997 through December 1998. Almost 3,000
adverse events in hospitals and almost 600 of them were
sentinel events, classified as loss of life, limb or permanent
loss of function. And the VA has already instituted a mandatory
reporting system.
Senator Harkin and I have prepared legislation which will
call for 15 demonstration projects to report to HHS, to give us
some insights as to what will work. On five of the
demonstration projects there will be mandatory reporting, with
the errors to be held confidential. On five of the other
demonstration projects there will be voluntary reporting, with
the information to be confidential. And five other
demonstration projects will call for mandatory reporting and
will mandate that the hospital, the physician who made the
mistake, must report that to the patient.
Now, that may appear to some as a rather extreme, drastic,
unusual procedure, but Senator Harkin and I have discussed this
matter at length, and discussed it with others, and it is our
judgment that there is a professional responsibility on the
part of the hospital or a doctor, where an error is made which
affects the patient, that the patient ought to be notified.
That is a professional responsibility.
Beyond the medical profession, it is my personal view that
that would apply professionally generally. It is not done
because of the obvious human frailty of not wanting to admit an
error, which may open up the party to civil liability, or more.
But there is no doubt that if the injured party has an attorney
and an inkling as to what has happened, that through litigation
and discovery, the professional must and the hospital must make
those disclosures.
We have seen a fair number of lost records, missing pages,
an intolerable situation, giving rise to the inference of
deliberate concealment. Of course we do not find that only in
hospitals and medical reports, we find it in corporate papers.
We find it in government papers. Our Government Affairs
Committee had an extensive inquiry and found key Department of
Justice documents with missing pages. But that is an
intolerable situation in our so-called civilized society.
So our legislation will be looking for these demonstration
projects to give us insights as to how to identify these
problems as the first indispensable step toward correcting the
problems. The legislation will further provide for an analysis
as to how to solve the problems of Federal funding.
For example, there are computers available which can track
complex medicines taken by a patient, so many that it is hard
to figure out what will cause a problem and hard to figure out
what the patient is taking. And that can be reduced, with our
modern technology, to the computers to find out. That is just
one illustration. And there needs to be an assessment as to
what can be done and what its cost will be.
So those are issues which are of vital importance. They are
life and death matters. And as chair of the Veterans Committee,
we intend to pursue the VA health system, which is one of the
largest in the country. And as chairman of the subcommittee
having jurisdiction over funding of HHS and HCFA and the health
system, we intend to see to it that adequate resources are
devoted to identify the problems and to move ahead with the
solutions.
I believe it is necessary to get tough on medical mistakes
and hospital mistakes with the mandatory reporting. And it is
necessary to get tough on requiring professionals to report
their errors to their patients. Because where it is life and
death, that kind of a resolute sense of urgency and toughness I
think has to be followed.
At this point I will submit a statement from Senator
Rockefeller IV, ranking minority member of the Committee on
Veterans' Affairs.
[The statement follows:]
PREPARED STATEMENT OF SENATOR JOHN D. ROCKEFELLER IV
I applaud the Chairman's leadership on this important issue, but I
am sorry this hearing has been scheduled at a time when I have another
longstanding commitment away from the Capitol. I ask that this
statement be inserted in the hearing record following the Chairman's
opening remarks.
The problem of patient safety is staggering--between 5 to 18
percent of hospitalized patients are affected by medical errors; an
average of 7 percent of hospitalized patients are affected by
medication errors; and there are approximately 2 million hospital-
acquired infections per year.
We now know that treatment errors and other problems most often
result from imperfections in the health care system--how medical
personnel interact with each other, with technology, and with
medications. Rarely is a lapse in patient safety caused by a single
error, by a health care professional working independently. It's much
more complicated than that. Fortuitously, an Institute of Medicine
report entitled ``To Err is Human: Building a Safer Health System''
lays out a blueprint for developing better ways to care for patients.
Late in 1997, I issued a Committee minority staff report on
shortcomings in VA's quality management program. That report found that
although VA has many good programs and talented personnel, it did not
have the systems in place to determine whether or not quality care is
being provided, uniformly, at all facilities. I want to remind you that
we were looking at the systems in place, not the quality of care
provided. A VA Inspector General's report on the same subject included
many of the same findings as the Committee minority staff report. Given
this recent history, I am so proud that the VA has taken an enormous
step forward in dealing with patient safety.
Although this is just the beginning for some to mitigate the
potential for medical errors, I am enormously proud that the VA health
care system is already ahead of the curve. For each of the Institute of
Medicine (IOM) recommendations, the VA has either developed a response
or is actively pursuing programs to get at the heart of a very complex
problem. I include with this statement a comparison of the IOM
recommendations and VA current activity.
For example, the IOM recommends establishing a research agenda,
Centers of Excellence, and a method to disseminate lessons learned. The
VA has a distinct research program in place and will be kicking off
research efforts by focusing on anesthesia issues, human-machine
interface, patient falls, and medication errors. VA is also funding
Centers of Inquiry at four sites. And the VA updates field personnel
with Internet postings and safety alert updates.
And while the IOM recommends a nationwide mandatory reporting
system for adverse events that result in death or serious harm, the VA
is already developing their own mandatory reporting system. VA has
adapted their current error reporting system to collect the
standardized information, to conduct an analysis of the data, and to
follow up with prudent solutions.
Clearly, the VA is doing much in this area. Generally, I question
the need for taking legislative action to force VA to comply with IOM
recommendations, which they are already doing.
I recently wrote to the Secretary of Veterans Affairs and asked for
the Department's views on the need for legislation. A copy of my letter
is attached. If legislation is necessary to enable the VA to do a
better job at identifying errors or fixing known problems, I certainly
will work with Senator Specter to do that.
While this is an excellent opportunity to tout the good work of the
VA, it also provides some cautionary lessons for other health care
systems.
First, the quality of the data must be examined. Far too often,
faulty data have led VA to incomplete or incorrect conclusions.
Sufficient resources must be pumped into data collection activities.
Second, health care groups must find a balance between overly
prescriptive and more lax approaches. The VA's Patient Incident Program
of old, which was designed to identify the underlying causes of adverse
incidents, originally permitted VA hospitals to develop unique lists of
events to be tracked. There was no requirement to use any predetermined
categories or uniform methods in collecting data. Obviously, this
limited what could be learned about the system as a whole. VA has
evolved past this more free-flowing approach and is now revising and
expanding this system to develop a National Patient Safety Reporting
System, which will include specific data elements. It will be based on
NASA's successful aviation safety reporting system.
And finally, simply designating a program will not provide the
answers. While the glory seems to come with the promise of new and
innovative programs, lip service will not help patients. Real results
follow implementation, and successful implementation requires adequate
funding and staffing. There is no getting around this. Management must
also be willing to commit to the future, as results will not be
instantaneous.
Again, I thank Senator Specter for his leadership on patient
safety. I hope that we can work together to get VA the needed tools.
Improving the health care system for veterans, and for all Americans,
must be a priority.
A copy of my letter to Secretary West follows.
January 14, 2000.
Hon. Togo D. West, Jr.,
Secretary of Veterans Affairs,
Washington, DC.
Dear Secretary West: Your efforts to implement a Patient Safety
Initiative, as part of an overall approach to quality, are to be
applauded. VA seems to be on the right track to avoiding medical errors
in the future. I am pleased VA is in the the process of implementing
most of the recommendations included in the recent Institute of
Medicine (IOM) report on medical errors. Of course, much remains to be
done.
As you are aware, there seems to be Congressional interest in
requiring other Federal health care systems to comply with IOM
recommendations. I do not believe legislation is necessary at this time
regarding VA compliance. I solicit your views on this.
Clearly, all health care systems have significant error rates, and
providers from all settings generally underreport medical errors.
Establishing a National Patient Safety Center, the Patient Safety
Centers of Inquiry, the reporting system and registry--together with
your plans to provide training in the field--should provide a sound
basis for the Patient Safety Initiative to move forward.
Mr. Secretary, VA's plans are truly admirable, and I look forward
to learning more about this initiative as it continues to move from the
drawing board to VA's medical centers. I strongly believe, however,
that for this effort to be successful, the necessary resources--in
staffing and in dollars--must be devoted to it. For example, I
understand that the National Center has nearly a dozen authorized staff
positions yet to fill. I hope this process will be completed quickly.
I would like to know more about your plans to encourage voluntary
reporting and to improve the quality of the information included in the
registry. The Office of Medical Inspector's report on the registry
indicates significant problems with data validity and reliability. As
you are well aware, incomplete and questionable data is a longstanding
problem within VA. Nevertheless, the OMI has provided several concrete
recommendations to improve the registry. Please keep me updated on your
progress in this area.
Finally, the Patient Safety Initiative is a positive and
potentially effective approach to risk management. However, it will
fail, in my view, if it is used to attempt to shield poor quality
health care providers from the necessary review and sanction that
follow the provision of poor and harmful treatment.
Mr. Secretary, I am pleased with your focus on patient safety. With
sufficient resources and improved data, I believe we can look forward
to dramatic reductions in the medical errors which cause unexpected
injury or death. I look forward to hearing about your latest advances.
Sincerely,
John D. Rockefeller IV,
Ranking Minority Member.
COMPARISON OF IOM RECOMMENDATIONS ON PATIENT SAFETY AND VA'S CURRENT STATUS
----------------------------------------------------------------------------------------------------------------
IOM Recommendations VA Actions
----------------------------------------------------------------------------------------------------------------
4.1 Congress should create a Center for Patient VA led the way in setting up the National Patient Safety
Safety (CPS) with the AHCPR. This Center should: Partnership. In 1997, the partnership began with 8 and
now has 13 health care organizations as members.
Set national goals for patient safety, track VA has set four comprehensive goals, noted in the VHA
progress in meeting these goals, and issue an National Patient Safety Improvement Handbook. (being
annual report to the President and Congress. piloted) (Draft 10-29-99) (VHA NPSIH). It addresses
identification of errors, study of errors, safety
alerts, and prospective analysis.
VA is tracking, by means of a Mandatory and Voluntary
Reporting System. (IL 10-99-010, June 29, 1999).
VA will provide an annual report, per conversation with
Dr. Bagian, the Director of the Center for Patient
Safety.
Develop knowledge of errors in health care by VA has research agenda. The first four issues are
developing research agenda, funding Centers of anesthesia, human-machine interface, patient falls, and
Excellence, evaluating methods for identifying/ medication errors. (These will be applied research).
preventing errors, and funding dissemination VA is funding Centers of Inquiry for research. Those
activities to improve patient safety. identified are at VA Palo Alto, CA; Cincinnati, OH;
White River Junction, VT; and Tampa, FL.
VA is evaluating and is developing a VHA National Patient
Safety Improvement Handbook, an Advisory Panel, an
oversight committee, and is redesigning its Performance
Measurement System for the organization. Evaluations of
the program have been done by the Chief Network Office,
the Office of the Medical Inspector, the Office of
Quality Performance, Patient Care Services, etc.
VA has put lessons learned, from patient errors, on its
website and updates it with safety alerts.
----------------------------------------------------------------------------------------------------------------
5.1 A nationwide mandatory reporting system should VA is performing this function for all VISNs as described
be established that provides for the collection of in the VHA NPSIH (Draft 10-29-99).
standardized info by state govts about adverse
events that result in death or serious harm.
Reporting should initially be required of hospitals
and eventually of other institutional and ambulatory
care settings. Congress should:
Designate the Forum for Health Care Quality VA is collecting standardized information as described in
Measurement and Reporting as the entity VHA NPSIH (Draft 10-29-99).
responsible for promulgating and maintaining a
core set of reporting standards to be used by
states, including a nomenclature and taxonomy
for reporting;
Require all health care organizations to report VA is requiring that all care, whether given in
standardized info on a defined list of adverse hospitals, ambulatory care, or other settings is to be
events; reported. (VHA NPSIH)
Provide funds and technical expertise for state VA has adapted their current error reporting system (risk
govts to establish or adapt their current error management) to collect the standardized information,
reporting systems to collect the standardized conduct root analysis, and do followup. Actions to
info, analyze it, and conduct followup action as correct errors will be taken as required and lessons
needed with health care organizations. Should a learned will be published on the Web.
state choose not to implement the mandatory A mandatory reporting system is under development. VHA
reporting system, HHS should be designated as NPSIH
the responsible entity; and designate the Center The National Center for Patient Safety is located at 2215
for Patient Safety (CPS) to: Fuller Road, Ann Arbor, MI, 48105--Tel (734) 930-5890;
Fax (734) 930-5899.
(1) Convene states to share info and VA is already involved in initiatives to identify best or
expertise, and to evaluate alternative model practices and has shared information and expertise
approaches taken for implementing reporting with health consumers, patient advocacy groups, the
programs, identify best practices for pharmaceutical industry, health care practitioners and
implementation, and assess the impact of organizations, etc. (National Patient Safety Partnership
state programs; and Statement, May 12, 1999).
(2) Receive & analyze aggregate reports from VA has a system under development to gather reliable data
states to identify persistent safety issues and to analyze aggregate reports from all VISN and
that require more intensive analysis and/or medical facilities in order to find prudent solutions to
a broader-based response. identified problems.
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5.2 The development of voluntary reporting efforts A VA Expert Advisory Panel on Patient Safety Design is
should be encouraged. The Center for Patient Safety establishing a voluntary reporting system that is
should: confidential, de-identified, and nonpunitive. (Briefing
by the Deputy Under Secretary for Health to Senate and
House Staff from the Committee on Veterans Affairs,
January 4, 2000)
Describe and disseminate info on existing The VA Lessons Learned Program, which is on the Web, as
voluntary reporting programs to encourage well as the use of the VA Performance Measurement System
greater participation in them and track the and the VA National Patient Safety Reporting System will
development of new reporting systems as they all be used to encourage participation in reporting.
form; The National Patient Safety Partnership and the National
Center for Patient Safety will track the development of
new reporting systems. (VHA NPSIH)
Convene sponsors and users of external reporting The National Patient Safety Partnership program, which is
systems to evaluate what works or doesn't work made up of 13 members, has held meetings with other
well in the programs, and ways to make them more health care organizations, pharmaceutical companies,
effective; etc. to see what works and what does not work.
Periodically assess whether additional efforts VA has identified 12 major steps or milestones to address
are needed to address gaps in information to gaps in patient safety. VA firmly supports voluntary
improve patient safety and to encourage health reporting or errors. (Significant Milestones in VA
care organizations to participate in voluntary Patient Safety Improvement, VA Office of Congressional
reporting programs; and Affairs, December 20, 1999)
Fund and evaluate pilot projects for reporting VA is funding and evaluating ( through pilot projects)
systems, both within individual health care reporting systems throughout the VA and is collaborating
organizations and collaborative efforts among with other health care organizations such as JCAHO, AHA,
health care organizations. AMA, ANA, AAMC, NPSF at AMA, and IHI-Charter Members, as
well as with NASA and ASRA (Aviation Safety Reporting
Systems).
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6.1 Congress should pass legislation to extend peer For the VA, information from confidential sources or
review protections to data related to patient safety documents are protected by Title 38 (U.S.C.) Section
and quality improvement that are collected and 5705 and restrictions dictated by the Privacy Act--Title
analyzed by health care organizations for internal 38 ( U.S.C.) Section 7332 grant additional protection.
use or shared with others solely for purposes of
improving safety and quality.
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7.1 Performance standards and expectations for The VA has had organizational and executive detailed
health care organizations should focus greater performance standards for about 5 years and has had
attention on patient safety. specific safety standards for the past 3 years.
Regulators and accreditors should require health VA's health care facilities are accredited by JCAHO,
care organizations to implement meaningful CARF, NRC, CAP etc. All of these bodies have patient
patient safety programs with defined executive safety requirements for the organization and its
responsibility. executives.
Public and private purchasers should provide This does not apply to the VA as written, but VA does
incentives to health care organizations to have safety standards so that it can compete for and
demonstrate continuous improvement in patient provide services to private and public purchasers such
safety. as in sharing agreements, and for providing care for
those eligible for TRACER, etc.
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7.2 Performance standards and expectations for For the past three years, VA has had patient safety
health professionals should focus greater attention performance standards for all health care professionals.
on patient safety. This also includes health care executives.
Health professional licensing bodies should-- VA has an excellent certification and privileging
program. This has been attested to by GAO and JCAHO.
(1) Implement periodic reexaminations and VA requires reprivileging of all physicians and those
relicensing of doctors, nurses, and other that require privileges every two years. All those with
key providers, based on both competence and licenses must maintain primary verification of up-to-
knowledge of safety practices; and date licenses. Re-privileging is based on both the
competence and knowledge of staff medical practices as
well as on quality of care considerations. These
considerations include safety.
(2) Work with certifying & credentialing VA has been working with the U.S. Public Health Service
organizations to develop more effective since 1996 to develop a Federal Credentialing Program
methods to identify unsafe providers and that will be an electronically accessible health care
take action. practitioner credentialing data base consisting of
primary source verification. (Bureau of Health
Professions, Health Resources & Services Administration,
Public Health Service, HHS, January 13, 2000.--VetPro
and FCP) This is one of the first methods used to assure
the provision of safe health care. This program will
also evaluate the peer review organization.
Professional societies should make a visible VA took the lead in establishing the National Patient
commitment to patient safety by establishing a Safety Partnership Initiative in 1997.
permanent committee dedicated to safety
improvement. This committee should--
(1) Develop a curriculum on patient safety The VA, working with the National Patient Safety
and encourage its adoption into training and Partnership Program, gave birth to a VA Patient Safety
certification requirements; Improvement Oversight Committee, a VA Patient Safety
Registry, a VA Patient Safety Improvement Awards
Program, a VA National Patient Safety Center, a VA
Patient Safety Center of Inquiry, a VA Expert Advisory
Panel on Patient Safety, a VA National Patient Safety
Improvement Handbook (draft), etc. All of these programs
will assist in the development of the foundation of a
curriculum for training, planned for every VISN and VA
health care facility.
(2) Disseminate info on patient safety to VA is frequently cited in various journal articles,
members at special sessions at annual editorials, newspapers, and other publications
conferences, and in journal articles, concerning its efforts to improve safety. (During the
editorials, newsletters, other publications, last two weeks of December 1999, I collected 18
and websites on a regular basis; clippings.) VA has a website to disseminate information
about lessons learned from patient safety information.
The VA, in November 1998, helped to fund and was a
participant in the International Patient Safety and
Reducing Errors in Health Care Conference at Rancho
Mirage, CA.
(3) Recognize patient safety considerations VA has developed patient guidelines on numerous health
in practice guidelines and in standards care issues which have set the standards for new
related to the introduction and diffusion of technologies, therapies, and drug usages. The whole
new technologies, therapies, and drugs; purpose of these guidelines is the provision of quality
care that is safe, above all.
(4) Work with the CPS to develop community- Once the Center for Patient Safety has been established,
based, collaborative initiatives for error VA will work with it, as it has continued to work with
reporting and analysis, and implementation all the members of the National Patient Safety
of patient safety improvements; and Partnership and other pioneers in this field.
(5) Collaborate with other professional VA will participate and in fact may be one of the leading
societies and disciplines in a national group of professionals with considerable experience in
summit on the professional's role in patient this field.
safety.
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7.3 The FDA should increase attention to the safe VA agrees that FDA should increase attention to the safe
use of drugs in both pre- and post-marketing use of drugs and is a continuous collaborator with the
processes through the following actions: FDA in pre- and post-marketing processes.
Develop and enforce standards for the design of VA routinely provides information to the FDA on a
drug packaging and labeling that will maximize systematic basis for these types of issues.
safety in use;
Require pharmaceutical companies to test (using While this recommendation is under the purview of the
FDA-approved methods) proposed drug names to FDA, VA notifies the FDA about proposed sound-alike drug
identify and remedy potential sound-alike and names and look-alike drug names as part of it current
look-alike drug names to identify and remedy safety program. This has been in effect as part of the
confusion with existing drug names; and older Risk Management Program that has been renamed the
Patient Safety Program.
Work with physicians, pharmacists, consumers and After problems have been identified through postmarketing
other to establish appropriate responses to surveillance, VA notifies the FDA and all of its health
problems identified through postmarketing care facilities and requires immediate action to
surveillance, especially for concerns that are eradicate the identified problem and to prevent errors.
perceived to require immediate response to
protect the safety of patients.
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8.1 Health care organizations and the professionals VA has been the leader in establishing the Patient Safety
affiliated with them should make continually Partnership Program in 1997.
improved patient safety a declared and serious aim It is evident from the VA National Patient Safety
by establishing patient safety programs with a Improvement Handbook (Draft 10-29-99) (currently being
defined executive responsibility. Patient safety piloted) that the VA is providing visible attention to
programs should: (1) provide strong, clear, and safety and is implementing a nonpunitive system. VA is
visible attention to safety, and implement developing a system to analyze errors and is
nonpunitive systems for reporting and analyzing standardizing and simplifying equipment, supplies and
errors within their organizations; (2) incorporate processes. The Center for Patient Safety is planning a
well understood safety principles, such as training program for all VISNs and VA health care
standardizing and simplifying equipment, supplies, facilities at individual sites in the field. The
and processes; and (3) establish interdisciplinary training is planned for small groups so that there can
team training programs, such as simulation, that be simulations and one-on-one training.
incorporate proven methods of team management.
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8.2 Health care organizations should implement VA is not waiting for any law or development of a Center
proven medication safety practices. for Patient Safety as recommended by the IOM. It has its
own center and is implementing the program now!
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STATEMENT OF MOLLY JOEL COYE, M.D., MEMBER, INSTITUTE
OF MEDICINE, COMMITTEE ON QUALITY OF HEALTH
CARE IN AMERICA
ACCOMPANIED BY LUCIAN LEAPE, M.D., MEMBER, INSTITUTE OF MEDICINE,
COMMITTEE ON QUALITY OF HEALTH CARE IN AMERICA
Senator Specter. We turn now to our first witness. As a
matter of informality, I am going to ask all the witnesses to
come forward at the same time and sit at the dais together. Our
first witness is Dr. Lucian Leape. He serves as a member of the
Institute of Medicine, Committee on Quality of Health Care in
America, and is an Adjunct Professor at the School of Public
Health at Harvard University. Dr. Leape did the original
research, published 10 years ago, that first called the issue
of medical errors to the public's attention.
And we have Dr. Molly Joel Coye, who serves as a member of
the Institute of Medicine, Committee on Quality of Health Care
in America, and Senior Vice President of the West Coast office
for the Lewin Group, a health care strategic planning, policy
research and managing consultant firm. Dr. Coye has previously
served as Director of the California Department of Health
Services and Commissioner of Health for the State of New Jersey
and head of the Division of Public Health at Johns Hopkins
School of Hygiene and Public Health.
Welcome, Dr. Leape and Dr. Coye. We look forward to your
testimony.
Dr. Coye. Thank you.
Dr. Leape. Mr. Chairman, I think it would be nice to have
Dr. Coye go first and set the stage, and then I will pick up
after that. She originally planned to testify. I am a pinch
hitter, but I am happy to do anything I can.
Senator Specter. Well, as you like it.
Dr. Coye.
Dr. Coye. Dr. Leape is, as usual, much too modest. He is
really the father of work on patient error and patient safety
in this country.
I, however, am also here representing the Institute of
Medicine and the Committee on the Quality of Health Care in
America, which recently released the report, ``To Err is Human:
Building a Safer Health System.'' We realize that you have
already held a series of hearings--this is the second in a
series of hearings--and that my colleague, Mary Wakefield, has
testified on behalf of the IOM committee in the past. For that
reason, we will only briefly review the IOM's recommendations,
and really focus our remarks on the frequently asked questions
that have ensued in the last month or so, or two months, since
then.
But let me reiterate, first of all, because it is really
core and central to our concern that our review of the
literature underscores the fact that medical mistakes rank
eight among the leading causes of death, ahead of traffic
accidents, breast cancer, and AIDS. Furthermore, we believe
strongly that it is possible to achieve at least a 50 percent
reduction in these errors over the next 5 years.
For that reason, we welcome your interest and support and
attention to these concerns. Most importantly, we have
knowledge and technology available now, which 10 or 15 years
ago was not available, in order to address these problems.
Based on those findings, we offered four major recommendations.
The first was to create a National Center for Patient Safety
within the Agency for Health Care Research and Quality, to
provide leadership, invest in applied research, build prototype
systems, and disseminate information on best practices. That is
not intended to be a regulatory agency, but a national center
for learning and research and dissemination.
Our second recommendation is for the establishment of
mandatory and voluntary reporting systems, which is central to
the discussion today. We recommended the creation of a
nationwide system, which is State based, as a mandatory
reporting system to collect information on the most serious
errors that result in death or permanent harm in order to use
that information to better understand the factors that
contribute to errors and to encourage health care organizations
to take the necessary steps in order to prevent them in the
future. We also encourage the growth of voluntary reporting
systems, analogous to the near-miss systems in the airline
industry.
Senator Specter. How do you distinguish between the
mandatory and the voluntary reporting systems?
Dr. Coye. The mandatory system is intended to collect
information on serious errors which lead to serious injury or
death. The voluntary is for either lesser injury or essentially
no injury at all. We learn an awful lot from the errors in
which nobody was particularly hurt but we almost hurt someone.
The third recommendation is to strengthen standards through
accrediting and licensing organizations and also to encourage
group purchasers and professional groups to raise their
expectations. And I hope you will hear from, if you have not
already, the Leapfrog Alliance of Purchasers, as an example,
which includes many large purchasers which are moving rapidly
to try to incorporate requirements in their negotiations with
health plans for the assurance of patient safety. And creating
safety systems inside health care organizations.
Now, the response to our recommendations has been pretty
phenomenal. You probably have seen the Kaiser Family Foundation
and Harvard School of Public Health poll that found that 51
percent of Americans closely followed news of the release of
the report. And coverage continues. We believe, because of
that, there is a tremendous opportunity to act. And we would
like to take the opportunity today to address some of the
concerns and questions that have arisen.
I would like to stress, having not only been health
director and commissioner in two States, but a member of the
committee over the last year as we reviewed all of the
literature in this area, that it is hard to overstate the lack
of public understanding of the impact of these errors in
medical mistakes. We know a great deal about this, but there
has been very slow progress. There is a great need for action
in this area. Our recommendations call for national leadership,
national attention and resources, to make safety the number one
priority of every health care institution.
I would like to turn to Dr. Leape to talk about the
mandatory reporting requirements in detail. But before I do so,
I would like to speak specifically to aspects of our report on
mandatory reporting that relate also to State health
Departments and public health officers interests. The IOM
committee believes very strongly that the public has a right to
be informed about unsafe conditions and a right to expect
health care organizations to respond to evidence of safety
hazards by taking whatever steps they need to in order to
remedy the situation.
We said in our report that only the institution itself--the
hospital, the clinic, the physician's office--can redesign its
systems for safety. The majority of effort in improving safety
should focus on safe systems, and the health care organization
itself should be held responsible. This does not mean that
State governments must be responsible for actually operating
the mandatory reporting program. The State could delegate to an
accrediting body, a peer review organization or another private
sector entity the collection and analyzing of data.
So we do not believe that this would be an onerous burden
on the States, and it is an important role in experimentation
and innovation, because we do not yet know what the best
practice for a national system would be.
Let me turn to Dr. Leape, who has spent the last several
decades working on this issue.
Senator Specter. Is that true, Dr. Leape?
Dr. Leape. Thank you, Dr. Coye. And thank you, Mr.
Chairman.
Senator Specter. Is that true, Dr. Leape, several decades?
Dr. Leape. It just seems like it.
Senator Specter. If so, how many?
Dr. Leape. Well, I was a practicing pediatric surgeon for
20 years and, about 12 years ago, got interested in this
subject and have been working since then.
Senator Specter. We welcome you here, Dr. Leape. We know of
your work and look forward to your testimony.
Dr. Leape. Well, thank you, sir.
I want to reinforce what Dr. Coye has said. The committee
feels the Center for Patient Safety is the most important thing
we can do to advance safety. But I think the focus of the
hearing today is on the mandatory reporting requirement, and so
we wanted to give you whatever help we could in that area.
I would like to clarify one thing. There are three levels
at which reports are made. The first and I think still the most
important one is to the patient. And I could not agree more
with your statement that this is an unequivocal, clear and
important professional obligation.
The first obligation a physician or nurse has is to be
honest with the patient, and patients have a right to know. It
is part of our ethical canon in medicine, and this is certainly
a principle that is upheld and specifically stated by the
American Medical Association, the American Nursing Association
and the American Hospital Association. They all believe that we
have an obligation to be honest with our patients, full stop,
period.
The second level of reporting is internal within an
institution. And most of us believe this is where real
improvement takes place. Tip O'Neil used to say: All politics
is local. I think all improved safety is local. Hospitals and
health care institutions have to create safe environments for
the people to work in. They have to make sure that the
procedures they follow are safe.
So internal reporting is a key feature for that, and we
know a lot about that. We know that internal reporting does not
happen if it is not safe. That is, if we punish people for
reporting errors, they do not report. We know that internal
reporting does not happen if it is not productive. That is, if
nothing happens. Because reporting alone does not improve
safety. Reporting only improves safety if it leads to a
response, if it leads to an investigation, if it leads to an
analysis on what is found that leads to change. And only when
people see that that is what has happened do they feel that it
is worth while to report.
This has been the experience of the most impressive and
most successful reporting system in the world, which is the
aviation safety reporting system. They receive over 30,000
reports a year. And they analyze these reports and they feed
back.
I hope you will hear from Charles Billings, if you have not
already, the architect of that system. Because what he says is:
All reporting is voluntary. People can find ways to get around
it if they have to. But they will report and they want to
report when it is safe and when it is productive. The success
of the aviation safety reporting system I think is eloquent
testimony to the validity of Dr. Billing's comments.
The final kind of reporting, in addition to internal
reporting within hospitals is external reporting, such as the
aviation safety reporting system--voluntary systems which get
information to improve safety, and mandatory systems which are
used for a very different purpose--accountability. And I think
that is where a lot of the confusion has come.
Most of us feel it is very difficult to get both
improvement and accountability from the same system. It can
work, and it does in some instances. But most of the time it is
very difficult. But we think it is absolutely crucial to have a
system of accountability. And the committee felt that the way
to do this was to require reporting of sentinel events. A
sentinel event to us is a bad thing, an injury--not an error--
an injury or a death that should not have happened, that we all
agree really should not have happened--suicide in a hospital,
removal of a wrong leg, maternal deaths.
These are the kind of things that really should not happen.
And when they do, they may not mean that anybody has done
anything wrong, but they certainly raise the question. They
raise the question as to whether the hospital has adequate
safeguards to prevent these kind of really serious injuries.
The committee felt that these need to be clearly defined and
that we need to be quite clear about what we are trying to do
with it.
Reporting of sentinel events is after all a very minimal
level of safety assurance. We want our regulators, we want our
hospitals to do much, much more. But the least we can do is
make sure we are finding out about these terrible breaches in
our safety mechanisms.
We would suggest that there are several characteristics of
such a system. The first is it should focus on events, not
errors. Second, reports should be by institution and not by
individuals. Individuals can report, but the point is to hold
the institutional accountable. Because only the institution can
change the systems. We think that it should be a relatively
short list of clearly defined, unambiguous, unfudgeable,
unhideable, serious events that everybody knows need to be
reported and that are hard to conceal.
They may require investigation from an external body. It
turns out, in practice, about a third do and about two-thirds
do not. And they may require some significant changes. They
rarely require punishment. Most effective external reporting
systems do not have to punish; they just have to make it clear
they will. And we find that in systems that work, there is no
question about the authority, but there is also no question
about a constructive, cooperative arrangement that leads to
improvement.
And, finally, I think they need to be confidential with
regard to individuals, both patients and providers, if we are
to make them safe and if we are to make them effective. Now,
there are three issues here. One is mandatory notification.
Does a health care organization report? And our feeling on that
is unequivocal--yes, absolutely, there should be no question
about that at all. There is really no legitimate reason to not
report these types of things.
The second issue has to do with the response--what do you
do when you report? And there we think it is important that the
system be such that both the health care institution and the
regulator or accreditor respond in an appropriate way. And they
should be held accountable to make a response. As I indicated
before, only about a third of them probably require a full-
scale investigation, but they all need to be notified, and we
all need to know what was done.
Finally is the issue of disclosure. And that is a sticking
point--which of this information should be disclosed to the
public? Hospitals, of course, do not want any of it disclosed
because it damages their reputation. This is a very real and
important consideration that we should not ignore.
On the other hand, the public has a right to know. And we
think the balance is that there needs to be public access to
this information both in terms of the fact that the event
occurred and in terms of what was found and how it was
resolved. We do not think there is much to be served by making
available all the details of the investigation and specifically
names of individuals. So we would like to see a responsible
system. And we think the health care institutions in this
country want to do that. And there are good examples out there
of how regulators are doing it. But there is not any question
in our minds that we need to have this, and I am quite happy to
answer any questions you may have.
Senator Specter. Thank you very much, Dr. Leape.
Beginning with the basic issue of mandatory versus
voluntary, as I said earlier, I believe the mandatory
requirements ought to be imposed. But what, Dr. Leape, was the
best argument on the other side for limiting it to voluntary
disclosures?
Dr. Leape. Well, I would go back to Dr. Billings' comment
of all reporting is voluntary. And that is, people have
tremendous reluctance to report when they get punished. I have
spent the last 10 years trying to convince people that we have
to quit punishing people for making errors. Because errors are
not sins. People are not bad when they make errors. Errors very
rarely result in misconduct. But there may be bad systems and
those systems that cause the errors. But the reason people do
not want to report of course is because it makes them look bad
and they get punished for it. Even if you leave out the whole
risk of litigation, I think that is greatly overblown.
Senator Specter. That is to say that a voluntary system
does not work. People do not want to report if it is a matter
of their option. And if it is voluntary, then they will not
report, as you outlined, human nature on the point, basic human
nature. So what is the strongest argument that can be made for
those who want to have it on a voluntary basis? Do they
structure a rationale that there will be more information or
enough information to correct the errors?
Dr. Leape. May I show you an illustration? I would be glad
to make these available to the committee.
Senator Specter. Sure.
Dr. Leape. People will report voluntarily when it is safe.
And when it is safe means when they do not get punished. What
you have here is an example from a single nursing unit in a
single hospital in the Midwest, in which the nurse decided to
quit punishing people when they reported medication errors. And
they had information for the previous year, they had reports in
their voluntary system of approximately eight reports a month.
It varied, but it was about eight reports a month.
In the month after, she said two things. One is we are not
going to punish people. And secondly, we want to find out about
our errors so we can do something about them. The next month
she received 160 reports--20 times more.
Senator Specter. And what punishment had been imposed in
the earlier period?
Dr. Leape. Well, the punishment is often very subtle.
Sometimes, if it is a serious error, people can be fired. If it
is less serious, they are reprimanded. If it is less serious,
they are cautioned and warned that it should not happen again
or they are retrained. Or even if none of those happen, it is
made quite clear that they are looked down upon for having made
a mistake. There is a social ostracism in health care often.
And that has been the single major barrier to improvement.
Because we treat errors as sins, because we treat people who
make errors as bad people, they hide and they conceal.
And all I am saying to you is when you quit doing that,
they will talk about it. And the interesting thing is they want
to talk about it, because they want to do something about it,
too.
Senator Specter. Well, if you have a system which requires
that the patient be advised of the mistake, then that opens the
door to litigation. The door may be opened later, or may be
opened in any event by the patient seeking an attorney who will
make inquiries and get compulsory disclosure through the
litigation discovery. You support the proposition that there is
an obligation, a professional obligation, to notify the patient
who has been injured. But does not that involve the principle
of punishment, which discourages reporting as you articulate
it?
Dr. Leape. Well, I do not think there is any way around our
fulfilling our ethical obligations. I think we have to do that
regardless of the consequences.
Senator Specter. Dr. Coye, you had commented about the
technology which is available. We would be interested to know
what you have in mind. One example which I mentioned was the
computerization of a patient's medicine so those who are
providing it know what is going on. What other suggestions in
the technological field do you have in mind?
Dr. Coye. I can give you two examples, and I think probably
that Dr. Leape can give you some examples as well. The first
example has to do with the computerized physician order entry
systems, which is what you are referring to. And I am not sure
if someone has presented this before, but there are actually
small hand-held machines, a Palm Pilot or analogous machines,
which can have on it enough about the patient's medical history
and about the available drugs, about the interactions between
drugs, that a physician can write a prescription essentially
right there during the interview with the patient and
immediately find out if they have made an error.
They do not have to send it to the pharmacy and have the
pharmacist catch the error. They immediately can see a screen
that pops up and says: This dosage is not the recommended
dosage. Or: Are you aware that this patient is also taking
these other three medicines, and there is a drug-drug
interaction here?
So there are very practical means--some of them have other
platforms other than this--in order to alert the physician in
real time and prevent some of these errors, as well as the fact
that it is then transmitted by computer from the Palm Pilot or
from a PC to the pharmacist. And the whole process is from
machine to machine, so the opportunity for human error in there
is reduced.
Senator Specter. Do you have any examples of technology on
any other issue than prescriptions?
Dr. Coye. Right now what we have most of what I am aware of
is in the prescription area, because that is so critical. One
of the big problem areas is that a lot of the work has been
done in hospitals. And one of the things we wrestled with is
how do get a handle on the size of the error potential in
ambulatory.
Most people do not go to the hospital most of the time;
they are seeing a doctor in a private office. But there is very
good technology now that can analyze the medicines that are
prescribed for those patients and that they take and their
clinical conditions to show where there are patterns of
prescribing that are probable errors and that can actually
intervene and reduce those rate of errors.
Senator Specter. That is more on prescribing prescriptions.
What other errors might be attacked by technology?
Dr. Leape. The field that has done the most in improving
safety has been anesthesia. And over the years they have made a
number of changes, both technological and otherwise. They have
looked a lot about how they work together. They have done a lot
in terms of team training and how people interact. But they
have also put a lot of emphasis on technology.
One thing, for example, is they now require the use of the
pulse oximeter, which is a little device that attaches to the
finger that continuously records the blood oxygen level. And by
doing this and having alarms on that system, the anesthetist
gets an early warning if the patient's ventilation is not
adequate. They also measure the carbon dioxide coming out in
the ventilators. And they have a number of monitors they use.
Anesthesia has set up a whole battery of safety procedures that
they now routinely follow. They have been an excellent model
for this.
Another area that again anesthesia started but is now going
into surgery and internal medicine is the use of simulation, in
which doctors learn to do procedures on a dummy, so they have
their first crash or their first disaster on an artificial
patient. And this has greatly improved safety we believe. So I
think there is a whole host of things coming down the line.
Senator Specter. Dr. Leape, you made one statement that I
would like to ask you about. You say that a lot of these
errors, these are errors which should not have happened, but it
does not mean anyone has done anything wrong. I question the
juxtaposition of those two statements. If an error occurred, if
an injury occurred which should not have occurred, does not
that necessarily mean that if somebody had not made a mistake
that would not have occurred?
Dr. Leape. It seems that way, does it not?
Senator Specter. Well, I am trying to understand your
profession, your application. Because your approach is
obviously very thoughtful, and I know you have something
specific in mind.
Dr. Leape. Well, the thing that is impressive when you
investigate a serious accident and so forth is the complexity
of what is going on and the multiplicity of factors. A case in
point that you may have heard of is the death of a child in the
Denver Hospital who got the wrong form of penicillin injected
intravenously. When that case was investigated, they found 55
system failures. All kinds of things had not worked the way
they should. And this is what you invariably find.
You find a physician takes out the wrong kidney, for
heaven's sake. But how did that happen? How is it possible that
the rest of the team did not realize what was going on? How is
it possible that it was not properly marked on the x-ray? How
come it was not marked on the patient? Et cetera, et cetera.
And what we are saying is we want to substitute
responsibility for blame. They are not the same. We hold
everybody responsible. And we want to substitute systems
analysis for personal punishment. And the reason for that is
really very simple. I am a surgeon. And one thing about
surgeons is they are pragmatists. They can have all the
theories in the world, but if they do not work and a patient
dies, that theory is no good.
So you learn very quickly in surgery to not fool around and
to be honest because you get tested every day. And
pragmatically, the system of blaming and punishing people and
holding individuals responsible has not worked. It has got us
what we have today, which is an incredibly unsafe system. Even
if you do not agree with our theory, you have got to admit we
have got to do something different. And something different is
not only soundly based on theory, it works.
And so when you have an egregious accident, what you have
to say is: What are all the things that have caused this to
happen? One of them may be that that doctor was on for 24
hours. That is a systems failure. No other industry would
permit that.
One of the problems may be that for that doctor it was only
the procedure for which he was not adequately trained. Right,
he should not do that. But what is the system that lets that
happen? And that is what we are getting at. These problems are
not simple, but they are not because of bad people. We do not
have very many bad people in medicine. We have a few, but not
very many.
Senator Specter. Dr. Coye, one final question for you. It
was recently called to my attention that at a major hospital
there was a review of a doctor's failure to file an honest
report on a procedure. And it was thought that he did so to
avoid malpractice liability. And the review board suspended
him, saying that had he candidly stated that he had falsified
the records to avoid malpractice liability, they would have
retained him on the staff. But because he was not candid in
admitting that he had falsified the records, that they were
going to discharge him from the staff.
What do you think of that kind of a judgment?
Dr. Coye. In the committee, we recognize that the
malpractice system is a tremendous barrier in fact to the kind
of improvements that are needed. We have a malpractice system
that is very, very strong and is not going to be dismantled
simply to solve the problems of patient safety. It is not an
important means of ensuring the safety of the public, however,
in medicine.
Senator Specter. It is not?
Dr. Coye. It is not. And it is very important that we not--
I am getting into too many double negatives--we not be
prevented, as a nation, from doing what we ought to do to
reduce patient errors because of the malpractice system. The
malpractice system we took in our committee as somewhat of a
given. Given that we have a malpractice system, we still have
to put in the programs of reporting that are going to be needed
to find out more about and track progress in the work on
patient safety.
Senator Specter. Do you think the medical malpractice
system contributes to keeping the medical profession on its
toes to avoid mistakes and to avoid malpractice liability?
Dr. Coye. Very minimally I think is the most accurate
statement I could make. Again, I would just like to invite Dr.
Leape to comment on this. We wrestled with this for quite a
long time in the committee. It is quite clear that--I also was
COO of a large hospital system in California, and I regulated
hospitals for a long time--that we know, and I am sure that you
do, too, that a very small proportion of all errors ever wind
up in malpractice cases. And so physicians who are worried
about legal liability are not necessarily forced to do much
about these patterns. And frankly, a lot of it is not something
an individual physician can do much about.
Senator Specter. Do you think there should be more
malpractice cases, then?
Dr. Coye. That is not what we see as the solution.
Senator Specter. I thought you would not see it that way.
Well, you did not quite come to grips with my question. And it
seems to me--and not to belabor the point and we have taken a
lot of extra time on the first panel because these are such
difficult questions--that you cannot justify falsifying a
report because there is an understandable personal interest in
avoiding malpractice.
Dr. Coye. Oh, I think we completely agree with that. I am
sorry if I did not say that.
Senator Specter. That is what the hospital concluded, that
if the doctor had said it is a false report because he did not
want to be liable for malpractice, he could have stayed on.
Dr. Leape, I have one final question for you. When you went
through the enumeration of the various organizations which say
there is a duty on the part of the professional to tell the
patient about a mistake, are those reduced to codes of ethics
among the nurses, among the doctors, among the hospitals?
Dr. Leape. My knowledge of these is merely as a recipient,
as a practitioner, and you should inquire of those
organizations their specifics. But certainly that is my
understanding, that hospitals have codes of ethics based on
these.
Senator Specter. We will do that. I have an instinct that
the thought of Federal legislation, mandating doctors and
hospitals to tell the patient about a serious mistake is going
to create an enormous outcry. And I think it is time that
professionals faced up to what you and I and--Dr. Coye, let the
record show, is nodding in agreement--that is an adoptive
admission, Dr. Coye, you agree with Dr. Leape?
Dr. Coye. I am very comfortable with agreeing.
Senator Specter. OK. That professionals have a duty to tell
their patients when they have made a mistake. But to mandate
that is going to I think cause a great hue and cry. And I think
that your quotation of Charles Billings, that all reporting is
voluntary because there is a way to avoid it, it all depends
upon, if you will pardon me, the punishment at the other end.
And I may have a predisposition to that because I spent so long
as a prosecuting attorney.
The Federal income tax system is voluntary, but reporting
goes way up when the prosecutions go up. White collar crime has
a very heavy aspect of deterrence. Barroom killings do not. The
punishment is not a deterrent there. And spousal disputes are
not. But where people are thoughtful, if there is a consequence
and a punishment at the end of it, that kind of a mandate at
the end promotes the reporting.
We very much appreciate your being here, Dr. Coye and Dr.
Leape. We will study carefully what you have said. And we may
be back to you for some more answers. Thank you.
Dr. Leape. Thank you.
STATEMENT OF THOMAS L. GARTHWAITE, M.D., ACTING UNDER
SECRETARY FOR HEALTH, DEPARTMENT OF
VETERANS AFFAIRS
ACCOMPANIED BY JAMES P. BAGIAN, M.D., P.E., DIRECTOR, NATIONAL CENTER
FOR PATIENT SAFETY, VETERANS HEALTH ADMINISTRATION
Senator Specter. I call now panel number two: Dr. Thomas
Garthwaite and Dr. James Bagian. Dr. Garthwaite is the acting
Under Secretary of Health, the highest official in the Veterans
Health Administration, responsible for the management of the
Nation's largest health system, that serves more than 3 million
veterans each year and has an annual budget of more than $17
billion. In addition to providing medical care, the VA's health
system is the Nation's largest provider of graduate medical
education and one of the Nation's largest research
organizations.
Welcome, Dr. Garthwaite. It says here that you have served
the VA for 25 years, which means you started at a very early
age, from your appearance at least. We will not ask you how old
you are. We will not mandate a disclosure on your age, but
anything you want to volunteer on that subject will be printed
in the record.
Dr. Garthwaite. Thank you, Mr. Chairman. It is a pleasure
to be here to discuss what can be done in patient safety and
what the VA has already done.
I think the first thing I might do is read from our Patient
Safety Handbook, because of what has been brought out in the
previous panel. It says that networks will ensure that their
facilities have a process in place to promptly inform patients
and their families about pertinent clinical facts associated
with injuries resulting from adverse events. It goes on to
describe various processes and our responsibility to inform
them about their rights both under the Tort Claims Act but also
under a separate set of benefits, 1151 benefits. We believe
strongly that a frank and open discussion about any medical
errors that we discover must start with the patient.
In fact, one of our medical facilities has recently written
up their experience, in which they proactively have done this
for many years, and track their litigation experience versus
other VA's who have done that perhaps less formally. And it
indicates that in fact their malpractice payments seem to be
somewhat less. They have removed, in a way, the need to punish
the health care system for failure to admit that something
happened.
I would like to make just a couple of points. The first is
about the difference between accountability systems and
learning systems. And I think that really speaks to the issue
about mandatory and voluntary reporting to some degree.
We have multiple systems in place to try to understand
whether a given provider is a bad provider and to take action.
We have credentialling systems to understand their training. We
have privileging systems to understand if they are currently
clinically competent to do what they do. We have administrative
investigations when we think there has been an intentional
unsafe act. And we have personnel and performance systems in
which we can take actions against individuals.
So we have in place many systems, and I think, by and
large, they work effectively where we need to use them to take
action against practitioners. That, however, is not the major
issue in understanding mistakes. We believe, as Dr. Leape
stated, that most people come to work every day to help
patients, not to harm patients. And it is a systematic view
that is necessary in order to change that.
Let me just give you one example of systems versus people.
The prescription prescribing practice involves a series of
steps, from a clinician writing an order for a medication--in
older systems, handwritten; in newer systems, computerized--and
then the transcription of taking that order off the chart, sent
to the pharmacy, the filling of that prescription, sending it
to the ward, a nurse taking the prescription to the beside and
assuring the patient gets that either orally or by injection.
Timing is important. Dose is important. Reading the
handwriting is important. Some drugs sound a lot alike. Getting
the right drug to the right patient. Some patients have similar
sounding names. There are a host of opportunities along that
process for error to occur.
If you went today to the Washington VA Medical Center, you
would find that 100 percent of their inside orders, their
hospital orders, are entered on the computer. No chance for
handwriting error. No chance to prescribe a drug that they do
not carry. No chance for ordering a dose that they do not
carry.
Then, as the drug comes back and is administered by the
nurse, instead of the nurse looking visually at the patient and
trying to read the arm band, and sometimes at a difficult angle
in an imperfectly lit room, they have hand-held devices which
they can use--to scan the bar codes both on the patient's wrist
band and on the medication. And so at the bedside with this
technology today, they can compare what was ordered, which
patient is getting the drug, the time of the drug, the dose,
and the actual drug. So any potential errors related to the
administration of medication are significantly decreased by
this new process.
Nurses say: I definitely would not want to go back to the
old way of passing out medicines. I like the fact the system
will stop me when there is a discrepancy.
So I think it is really about systems. And that is what we
have really been about in the VA over the last 3 to 4 years. In
1997, we set out on a mission to improve patient safety in our
health care system. The first step was to reach out to others
in the health care system. And we were the energy behind
forming the National Patient Safety Partnership, which now has
13 very large organizations across health care, where we can
get together and discuss what generically should be done.
Then we have added a series of things, and I am not going
to bore you with a long list. It is part of our written
testimony. But one of the key things we did was to set up a
Center for Patient Safety that reports directly to the Under
Secretary of Health. So there is no question about who is
accountable for setting a system in place. There is no
plausible deniability that we did not know that things were
unsafe. We want to know at the very highest levels what we can
do to make health care safer for veterans.
In fact, what we really would like to do is, first, see a
weakness before anything happens. If we cannot do that, then
maybe there is a close call. We catch it. We would like to
learn from that.
And finally, the worst way to learn, but the one that we
want to dedicate ourselves to learn from the first and only
mistake, is when we have harmed a patient. And so that is what
the system is designed to do, to learn the maximum amount with
the least harm to anyone, and then to put into place systems
that do not ever let it happen again.
With me today is Dr. Jim Bagian. Dr. Bagian is a two-time
astronaut, an engineer and a physician. And he has joined us as
the head of patient safety. And as you will see, he has given
this a lot of thought and has good ideas about how we can
continue along our journey to make VA the safest health care
system in the world.
[The statement follows:]
PREPARED STATEMENT OF DR. THOMAS L. GARTHWAITE
Mr. Chairman and Members of the Committees, I am pleased to appear
before you to discuss VA's ongoing activities and initiatives to re-
engineer its patient ensure the safety of patients who receive care
from VA programs. 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. 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
The 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 Nursing
Nurses Association, the Joint Commission on Accreditation of Healthcare
Organizations, the American 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 field in a
crosscutting wayindustry. An example of the Partnership's activity was
the establishment of a clearinghouse for information related to the
effect of Y2K computer issues on medical devices medically related
issues. 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. 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. 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.
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 percent 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
percent 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 hope 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.
Senator Specter. Dr. Bagian, Dr. Garthwaite has pretty much
made my introduction of you unnecessary, but that will not stop
me from doing it. You are the Director of the Veterans Health
Administration's National Center for Patient Safety, a
Diplomate of the American Board of Preventive Medicine with a
specialty in aerospace medicine. And you chair the VA Expert
Advisory Panel on Patient Safety System Design. You were a NASA
astronaut for over 15 years. You have extensive experience in
aviation-related safety programs.
You have a very impressive background, Dr. Bagian. We look
forward to your testimony.
Dr. Bagian. Thank you, Mr. Chairman. It is a honor to be
here today to have the chance to speak with everyone here.
As Dr. Garthwaite said, the VA has, for quite some time,
taken a very proactive role at looking at patient safety and
errors and their role. I could not agree more with many of the
things that were said by the previous panel about the IOM
report. We in fact feel like we have either done or have in the
process of implementation virtually everything that is
applicable in that report, and we could not applaud it more.
I thought I would go over some of the high points of what
we are doing right now and maybe some of the rationale. And
then, if you have questions, certainly we would answer them.
The way I first became involved with the VA and doing this
was chairing the Expert Advisory Panel on Patient Safety System
Design you mentioned. And with my background, I have often
recognized that medicine did not necessarily take advantage--
not just the VA, medicine in general--with many of the systems
designs for safety that occur in other industries, both in the
industrial world as well as aviation and space flight, where
quite a bit has been done. And you have already heard about the
aviation safety reporting system.
Our job when we first were tasked was to come and look at,
how will we construct reporting systems to really learn what is
going on? And one of the primary things there is what barriers
might exist there. Because you cannot really begin--and it is
not reporting, I should say, in itself. Reporting is kind of
worthless if you do not do something about it.
If it just goes into a black bureaucratic hole, where
people fill out reports and they do not see the benefit of what
they have reported in their system, they see improvements made,
changes being made, feedback that it has even been read, people
do not want to continue to report. And it is not just to have a
requirement. People want for things to be better. They want to
have an effect. But when they feel like it is fruitless, they
tend to be discouraged and you do not really glean the best
that you can from your folks.
When they talk about high performance organizations in the
organizational psychology world and when they talk about
industries, they talk about mainly space flight and aviation
which are two of the ones that standout. They do not talk about
medicine. They talk about industries. We are not talking about
individual companies. These are the ones that do it well. And
they talk about how people feel free to talk about the
unthinkable, the things that people would be embarrassed about.
And they try to remove that.
So we had a panel. And Dr. Charles Billings, who you heard
mentioned before, who is basically the architect or one of the
fathers of the aviation safety reporting system, was on that
panel, as were others, from NASA and from other institutions.
And we asked them to identify, what are the characteristics of
a reporting system that makes it successful? And in aviation,
up until about the mid-seventies, there was not a lot of
reporting. When a report was made, basically it was responded
to by fine, suspension, things like that. So many things did
not get reported.
When they put what is called a de-identified system in
place, where you do not identify the individual reporter but it
is used for systems-level stuff, as Dr. Leape mentioned, they
have over 33,000 reports a year, that have been going on for
close to 25 or 30 years now. And it is because the individuals
do not worry about individual punishment. They think that they
can actually report something that they have concern about.
Now, in that particular program, it is only open to close
calls, essentially, not actual accidents. That was because of
the situation that evolved at the time. It was not because they
would not like to look at everything.
In our system, we have a mandatory system that you have
heard briefly about and we have a voluntary component as well.
And we think mandatory is important. And you have to look at
what you are using it for. Is it for accountability or
improvement? And we realize both are important, very important.
You cannot ignore one versus the other.
In our mandatory system, we look at it. And if we see that
an act is even thought to be what we call an intentional unsafe
act--and in our handbook you can read the definition if you
would like, but it basically is those things that appear to be
intentionally unsafe--not proven beyond a shadow of a doubt. If
on first review it appears it was a deliberate, unsafe act, if
it was a criminal act, if it was an act that involves substance
abuse, alcohol abuse on the part of the care-giver or if there
was alleged patient abuse, those are not covered in our safety
system. They go in our administrative system where they are
thoroughly investigated, so that if punishment is required or
other administrative action can be taken. However, if it does
not meet that hurdle--and most do not--they are on the other
side. And that is where we look for the true systems issue,
where we try to correct the systems. But it is not about who
did what.
And if you go in the aviation world in an accident
investigation, for example, the first words out of somebody's
mouth are not: Whose fault is it? And I kiddingly call it the
``f'' word. We do not use the ``fault'' word. That is not how
you start. Because if you begin the investigation by saying,
Whose fault is it, you tend to look for whose fault it is and
you miss the richness of what else went on--the long chain of
events that you heard Dr. Leape refer to a few moments ago.
But if we look at systems, you may find individuals. And if
we do at any time, we can throw it back over that way. We
worked with our Office of Medical Inspector, the Office of
Health Inspection, unions, everyone else. And everyone thought
that was a very fair and equitable way to do it, to really give
us both pieces. But it is not enough just to have a voluntary
system, because that gives you large systems-level things. But
also the mandatory does that. But you want voluntary, because,
as we found, the culture is very important.
And you have heard that referred to in some ways. And it is
really the essence of the organization. You can have a number
of rules and procedures, which are all very important and we
would not want to minimize their importance, but it is
important that the people want to do the right thing and feel
that it is safe, as you heard Dr. Leape mention, safe that they
feel that they can do it.
We did cultural surveys and published them. And one of the
first ones published in the Annenberg proceedings, the safety
meeting in 1998. And we found, for instance, that they talk
about the punitive aspect. Punitive is not strictly that you
will be fired or suspended or anything like that. It is also
embarrassment, shame. We found that about half the people--and
this is not just within the VA--half the people feel that if
they make a mistake that they are ashamed.
Yet only 4 percent say that they would hold it against
someone else if they make an innocent error. So it says we have
a long way to go. Because it is the shame and the embarrassment
that really stands in our way.
So we have put both systems in place. We have put in a
voluntary system in place because it has been shown--and that
was in the news in the last couple of weeks, when you heard
there was a statement by the President about trying to change
the way aviation safety systems are going to report. That was
not talking about the ASRS, that was talking about another
system that was identified, but how to take the punishment out
because you get different messages from both. And if you only
have a mandatory system, you will get information that is good.
But if you do not have the voluntary, you will miss some. So
that one cannot operate absent the other. They both are
complementary.
And one final thing is in these systems, it is not about
the numbers. Because you are never really sure of the
denominator. It is about identifying the vulnerabilities of
your system. Because once you identify a vulnerability, you do
not have to say, are there a thousand cases of this? Once you
see one that is wrong, that you think is wrong, you correct it.
I will give an example of potassium chloride that you may
have heard, where patients may have inadvertently had it
injected--not just in the VA, but anywhere. It is a problem
that is known. And the VA went out, over a year ago, and we
said, we recognize that it is a problem. We did not say we have
to do some study about what percentage got it.
We said, this is a systems problem. Take it off the floor
and put it in the pharmacy so this cannot occur. Make it easier
for people to do the right thing and not that they have to
remember to be careful. That is a bad system. So we have
changed that and we think that is the essence of reporting, to
identify vulnerabilities, so we can then actually take actions.
And that is what we hope to do.
Senator Specter. Thank you very much, Dr. Bagian and Dr.
Garthwaite.
Dr. Bagian, you talk about de-identifying on near misses,
where that encourages the party to come forward and say what
has happened. But you reject that for actual mistakes. Why do
you reject it for actual mistakes?
My instinct is to be in favor of identification. But when
you make the point that the de-identifying stimulates reporting
because nobody knows who did it, then the question arises in my
mind as to whether it might be better to have all this
information to improve the system than to be able to identify
the person who made a mistake. So why not carry the de-
identification system beyond near misses to actual mistakes?
Dr. Bagian. Thank you for that question. I need to clarify
what I said. Actually, the system we have is slightly different
than the IOM's, where they take the actual sentinel event,
which is the serious injury, permanent injury, death, versus
the near misses, close calls. We say both our mandatory system
and our voluntary system take all comers, that we do not just
segregate and say, oh, if it is a close call, it is less
important.
In fact, it has been shown I think in many places that
close calls are often the best way to learn about things, to
prevent things. The whole point is prevention. And we often say
that experience is the best teacher, but it is also the most
expensive. If we can learn in a way that did not require an
injury, but we knew one could have occurred, we then foreclose
the possibility of one.
In our system, we look at both. So what happens is, in the
mandatory side, we do have the identification. We have a system
where we know who reported what.
Senator Specter. Well, the question is, why not have the
identification? Because you might get more information if you
did not identify even where there have been the serious errors.
Dr. Bagian. Yes, we have, too. We have a de-identified
system that is being planned and which is not fully rolled out
yet, the voluntary system, which is de-identified. We have the
mandatory system which is. And we realize that there are some,
you are right, that may be deterred from reporting. And I
certainly expect that we will not get a report of everything
that goes on, for a number of reasons. But we think you have to
have both.
The identified system lets you focus very specifically on
that particular area and understand it in great depth. The de-
identified voluntary system gives you other information which
you may learn things from. And FAA can give you numerous
examples where, in their identified system, they have learned
certain things, but in the de-identified, their voluntary ASRS
system, they learn other things. And they are complementary.
And one does not repudiate the other, but they reinforce each
other.
Senator Specter. They might learn more if they had all de-
identified.
Dr. Bagian. Well, I will give you an example. Suppose you
knew in a de-identified system that--we will take one outside
of medicine--but suppose you knew that there was a system at
the high school where your children go to school, and they
said, we know that 55 percent of high school juniors are
drinking after school. We do not know if it was your high
school junior, but we know 55 percent. You go back and you look
at your kids and you go--if you do not like them drinking after
school; I would not--and you try to figure out, well, is it
them or not and what do you do? You are not sure exactly the
corrective action or if one is even needed for your child.
On the other hand, if you know that your child did that,
you would do something different. You might say, hey, Brian, I
know you have been using some of what I think is questionable
judgment. Let us talk about this and let us deal with this.
On the one hand, you might miss the opportunity to improve
something or try to put pressure on somebody to behave in a
different way which is inappropriate. So one focuses your
attention and allows you to do certain things, but because of
the bright spotlight they may not be reported in all cases. On
the other hand, the other one gives you the chance to see those
ones that nobody wants a spotlight on, but they kind of would
like the thing to be handled generically. And you can learn
from both.
That does not mean it does not also cause you to look, even
from the de-identified, to look more closely at the particular
individuals that you even wonder, are we prone to vulnerability
in an area, and then you can further, in a prospective manner,
inspect those. So it identifies vulnerabilities, which is the
real key.
Senator Specter. Well, these considerations call into
question the basic philosophy of where the best public policy
lies. Dr. Coye testified that the malpractice system helps only
minimally. There are many people who believe that, and perhaps
most of them are doctors and hospital officials who believe
that.
As a practicing lawyer who has been on both sides of the
plaintiffs and defense work--happily not too much because I was
successful in getting out of the practice of law--and for a
long time chose to be a prosecuting attorney as opposed to
being in private practice--but in the experience I have had, as
I say, both representing plaintiffs and defendants in personal
injury cases, has persuaded me that the system is a deterrent.
That when there are major errors disclosed on manufacturers of
a variety of products, they change the way they do it. They do
not want to be hit with big liability verdicts.
It may be that however big the verdicts are they are
minuscule compared to the corporate profits. And that brings in
the big argument about punitive damages which rages in these
halls all the time.
And on medical malpractice, my sense has been that the
awards do focus the attention of the doctors and the hospitals
on the problems and that it does have therapeutic effect, it is
a deterrent, there is a real value in it. But when we start to
talk about turning the system upside-down, so to speak, and
trying to correct the big problems on systems changes--so if
you had a lot of reporting, you might be able to have better
public policy at the end of the rainbow--it still does not take
care of the individual who was injured and how you compensate
that individual for the loss that individual has suffered.
And in the medical malpractice field, catastrophic injuries
occur all the time. So that it is a matter of millions of
dollars to provide for somebody who has been injured that way
for the balance to compensate their injuries. But that is why I
push on the de-identification issue which you talk about.
Dr. Garthwaite. Mr. Chairman, if I might. As we look at it
internally, we keep it identified under a quality assurance
protections. But then there is a point at which we attempt to
de-identify it and share it broadly. We have a Web page that
has every small and large lesson we have learned locally. And
then we have a committee that reviews those and decides which
things are absolutely system issues versus local issues and
need to be implemented in the system.
So as we attempt to communicate the things that we learn
broadly, we do not feel it is about punishing a person who had
the honesty to bring it forward. It is really about what is the
issue and how do we fix it. And so I think that is a key piece.
Senator Specter. Let me ask you a specific question related
to that. In the context of VA self-reporting of medical errors,
it is my understanding that VA hospital names are not revealed.
Which leads to the question as to why not, if the VA patients
should know that a particular hospital had reported errors?
This goes to Dr. Bagian's point about which school has the high
school drinking. Parents would like to know that.
Dr. Bagian. Just to clarify the way it works. It is
complex, but not that complex.
Senator Specter. Try us. We might understand it.
Dr. Bagian. Absolutely, Mr. Chairman, I know you will. The
way it works in the mandatory system, and let us just talk
about that. When it is reported, it has the institution's name
on it. There is an identifier. So if we need to go back and get
more information, we know who the people involved are. That is
the people, and I mean people from practitioners, care-givers.
Senator Specter. We identify the VA hospital?
Dr. Bagian. Internally, absolutely, yes, sir.
Senator Specter. No, but for the patients?
Dr. Bagian. Yes, for the individual patients, as Dr.
Garthwaite said, it is our policy and requirement that if a
patient is injured through a medical error or in any way,
suffers untoward effects, we will do that.
Senator Specter. But suppose somebody is not injured, if
you have a very bad result at the Veterans Hospital in
Tuscaloosa--which is outside of Pennsylvania so I can speak
freely--should the veterans who are going to Tuscaloosa know
that there are a lot of errors so they can choose to go
somewhere else?
Dr. Bagian. On the safety side, we do not post the errors
that way.
Senator Specter. Why not?
Dr. Bagian. There are several reasons. One is that unless
you get down to the point where you risk--we risk adjust for
errors. And I will give you an example. One of the things I
know--I have talked to Dr. Leape about this earlier--is one of
the things people think for mandatory reporting, you know, you
might pick certain types of things, like say maternal death
during labor, or whatever you might want to report, and if you
looked at something like that and you just looked at the box
score, like how many deaths occurred in Tuscaloosa, if that is
the one you want to use as the illustration, and they just give
you a number--and we had four in the last year--is four a lot?
Is four too many?
If Tuscaloosa was the regional high-risk maternity care
place, you might expect there might be more deaths because the
acuity, the severity of the illness with those people is much
higher. Whereas the ambulatory care clinic down the street does
not really see women in labor. And they would say, oh, we have
not had any. Would that mean you should go there?
Senator Specter. Wait a minute. You are saying you are not
going to tell which hospital it is because there may be
extenuating circumstances?
Dr. Bagian. Well, we think that there are two things. In
the safety--and we tried to draw this thing about the
intentionally unsafe act versus not--in order to build trust in
the system--and trust is really paramount for people being
willing to come forward to address the problems--safety has to
be looked at that it is looking for systems changes. To
publicly say, from the safety--I am telling the safety side;
Dr. Garthwaite can talk about the VA in total--but from the
safety side, we felt it was very important that we not be
looked at as we are the stick.
If it is looked at like that, on the one hand, they do not
know--it is like they are flipping a coin--and we report this--
--
Senator Specter. OK. So you keep it confidential to get
better reporting you suppose is a higher value than letting
them know for the prospective patients?
Dr. Bagian. We think so for big systems, yes, sir.
Senator Specter. Let me move on to a couple of other
questions which I want to cover here, because we are running
very late. And these are very important and complex subjects.
Dr. Garthwaite, you identify the specific language--and we
are going to be tracking that with other organizations--which
has a mandate that the errors be reported. Would you repeat
that?
Dr. Garthwaite. What I read?
Senator Specter. Yes, read that to us again, please.
Dr. Garthwaite. We have a whole chapter.
Senator Specter. Do not read the whole chapter.
Dr. Garthwaite. So networks will ensure that their
facilities have a process in place to promptly inform patients
and their families about pertinent clinical facts associated
with injuries resulting from adverse events, assuring them that
measures have been taken to maintain life and minimize
disability and discomfort.
Senator Specter. Adverse events being defined as hospital
or doctor errors?
Dr. Garthwaite. And beyond.
Senator Specter. Dr. Garthwaite, do you think there is any
greater response for doctors and hospitals to report their
errors because they are not liable to suit because of the
Federal Tort Claims Act and the individual doctor and the
hospital and the Federal Government is not liable? You have a
very different system of liability for confessing error.
Dr. Garthwaite. Yes, I think we do. And we enjoy a greater
degree of public scrutiny, which is appropriate for a federally
funded health care system.
Senator Specter. Public scrutiny?
Dr. Garthwaite. I mean in terms of oversight that we have.
Senator Specter. Oversight by the Veterans Affairs
Committee? Piercing oversight by the congressional committees?
Dr. Garthwaite. One of our goals is to be an organization
characterized by exceptional accountability. And we have not
shied away from that. I think that is why we have a patient
safety system.
Yes, there is a difference. You can sue the United States
Government. We do report individuals for their role when
payments are made. Not all the time, but about half the time,
after a peer review panel looks for their contribution. There
is a disincentive for us, I think, to admit publicly when bad
things happen, just as there is in the private sector. We are
trying extremely hard to improve the image of the VA health
care system in terms of quality.
Senator Specter. Dr. Bagian, let me ask you one final
question. Yesterday's New York Times reports your saying,
quote: There needs to be some level of national reporting. But
to allow disclosure of hospital names and practitioner names
would be counterproductive. It would inhibit reporting and
drive the problems further underground.
First, were you accurately quoted?
Dr. Bagian. I think that is the general gist. They were not
using a recorder at the time, but I think it is reasonably
accurate. Contextually, I think that is true.
Senator Specter. Are you not saying there that you are
against mandatory reporting of errors, identifying the specific
hospital and practitioner?
Dr. Bagian. No. What I said was I think we have to have our
eyes open and that it can have a chilling effect. You have to
decide, is the need for people to know worth maybe the
unintended side effect that you drive things underground and
therefore do not learn? We can look at other systems. In
aviation that was the case and they learned very little.
Senator Specter. You say it is counterproductive. Overall,
do the advantages outweigh the disadvantages in your mind?
Dr. Bagian. The advantages of?
Senator Specter. Of reporting specific hospital errors and
practitioner errors.
Dr. Bagian. Yes, sir. If our goal is to increase patient
welfare and minimize injuries due to error, I think if we
create fear in people, they are going to be less candid about
coming forward. That is human nature. And I think there is
ample evidence in reporting systems in this country and others,
especially in aviation, that would show that to be true.
Senator Specter. So are you in favor of reporting?
Dr. Bagian. I am in favor of reporting, yes, sir.
Senator Specter. With specific names of the practitioners
and the hospitals?
Dr. Bagian. In the case where it was not what we would call
an intentionally unsafe act, we would think that that is
counterproductive. I will speak for myself.
Senator Specter. Well, the rabbit is in the hat. If you
call it an intentionally unsafe act, that is subject to
generous interpretation by the doctor.
Dr. Bagian. Well, it is not the doctor that makes the
judgments.
Senator Specter. Oh, yes, it is, if there is a report. The
doctor either reports or does not.
Dr. Bagian. But other people also report things. When a
report is reported, there are very complex issues that many
people are involved in. It is not just the reporter that is
involved.
Senator Specter. But others do not have access to the same
knowledge that the person who makes the mistake does. The
language which Dr. Garthwaite read imposes an obligation on the
doctor to tell a patient where there has been something that
has been wrong.
Dr. Bagian. That is true. Yes.
Senator Specter. So that is in variance with your quoted
statement that it is counterproductive to disclose the names of
hospitals and practitioners.
Dr. Bagian. The point there was that if you disclose those
things--it is not saying that one may not, but it is saying you
have to have your eyes open. That if the goal is to try to have
greater candor so we can understand what is going on, to change
it, we might have a chilling effect. And I think that has been
shown in other places. And it was just a statement of opinion
borne out by other experience with similar reporting systems.
That when you make it where it becomes public
embarrassment--as was pointed out, it is not the fact of saying
that we would write some legislation that says you could not be
liable for tort or whatever else. It is actually the whole
shame issue, which probably weighs at least as large overall as
anything. And public ridicule is not necessarily a strong
inducement.
Going back to what you said before, sir, I think you are
exactly right--the issue about tort and liability as far as
motivation, there certainly is some motivation there. But I
think there is also information that would argue that, besides
the motivating factor, that people practice in some cases
defensive medicine----
Senator Specter. I would like you to supplement your oral
testimony with a memo to the committee on your ultimate
conclusion, whether you do or do not favor disclosure of
hospital names and practitioner names or not.
Dr. Bagian. I would be happy to do that.
Senator Specter. Because I do not think the record is clear
on this point.
Dr. Bagian. I would be happy to do that.
[The information follows:]
At the hearing of the Senate Committee on Veterans Affairs and the
Committee on Appropriations, Subcommittee on Labor, Health and Human
Services, and Education on January 25, 2000, the question posed was
whether I thought that the public ``disclosure of hospital and
individual practitioner names in conjunction with some form of national
reporting would be counterproductive.'' Specifically, did I think that
such action would tend to ``drive problems further underground.'' I
appreciate the opportunity to provide further information in this
regard.
If the purpose of the reporting that is contemplated is to provide
knowledge that can be used to improve systems design and prevent future
errors and injuries; then I believe that public disclosure of
identities related to errors that were not of a malicious or
intentionally unsafe nature is counterproductive. I say this because
public disclosure does little to improve the systems level type issues
and will appear and be perceived as punitive on some level. The
punitive atmosphere that this would create would be in line with the
traditional ``train and blame'' approach that has been the standard
operating procedure in medicine for too long and has given us the
system that we are currently trying to change.
Studies that have been done about safety culture in medicine have
indicated that fear of shame plays a substantial role in people's
reticence to report. The experience of the aviation industry has
indicated that protection of individual and corporate identities has
been vital to the success of their programs, most notably the Aviation
Safety Reporting System (ASRS). A real world example exists where
another country tried to emulate the ASRS system and inadvertently
divulged the identity of one of the reporters. The result was that the
system ceased to function and was disbanded due to lack of
participation for years.
Therefore, if the purpose of national reporting is to gather
information for improvement, we should not publicly disclose
identities. On the other hand, if the purpose is to mete out some sort
of punishment then disclosure will facilitate that. It must be
recognized that such disclosure will probably result in the drying up
of most meaningful reporting.
I appreciated your questions on the day of the hearing as inquiries
to fully understand the issues and I offer this in the spirit of
conveying that the options available are about more than whether
reporting is mandatory or voluntary. If there is any other information
that you or your staff desire, please do not hesitate to contact me.
This is a vitally important issue and I am happy to assist in whatever
way is useful.
Senator Specter. One final question for you, Dr.
Garthwaite. The medical inspector's report was dated June 15,
1999, but the committee was not notified of it or provided
copies until December 13th, which was the same date that U.S.
News & World Report published a story of its report in its
edition dated the 13th. So it must have been out before the
13th. Why did the committee get such late notice?
Dr. Garthwaite. I do not know. We will examine that and
tighten up our distribution.
[The information follows:]
Medical Inspector reports have been routinely treated like the
internal working documents that they are. They are used to fix local
and/or systemic issues in the delivery of care. We have not routinely
distributed them to our oversight committees. We have supplied them
when requested and the Medical Inspector routinely meets with SVAC and
HVAC staff. The Medical Inspector's report, entitled ``Special Report,
VA Patient Safety Event Registry: First Nineteen Months of Reported
Cases, Summary and Analyses, June 1997 through December 1998,'' was
issued on July 15, 1999. Copies of the report were distributed to the
Office of the Under Secretary for Health at that time. In August and
September 1999, copies of the report were sent to each facility and
Veterans Integrated Service Network (VISN) in the VHA system. The
Medical Inspector presented the report at VHA's monthly Quality
Management Integration Council meeting on September 1, 1999.
At an October 27, 1999 meeting with Senate Veterans Affairs
Committee staff, the Medical Inspector mentioned the report. At that
meeting, it was agreed that staff from both the Senate and House
Veterans Affairs Committees should be briefed on the contents of the
report. The Medical Inspector's briefing for the two Committees took
place on December 13, 1999. 1 am sorry that this briefing did not occur
sooner.
Senator Specter. Were you aware that the committee got
notice after the fact?
Dr. Garthwaite. No, I was not aware of that. I apologize
for that.
Senator Specter. Well, I think you are moving in the right
direction. It is not without its complications and
difficulties. And these are issues we are going to be wrestling
with for some time. But I am glad to see the VA moving ahead.
We fought very hard to get the extra money last year. We
finally succeeded. But it was a hell of a battle.
Dr. Garthwaite and Dr. Bagian, if you would wait around
until after the hearing, I want to have a private word or two
with you on another subject.
Dr. Garthwaite. I would be happy to.
Dr. Bagian. Yes, sir.
STATEMENT OF JOSEPH DONAHEY, CIRCUIT COURT JUDGE, PASCO
COUNTY, FL
Senator Specter. Our third panel is Judge Joseph Donahey
and Dr. Ralph Specken. Judge Donahey is a Circuit Court Judge
for the Sixth Judicial Circuit in Florida since 1995. He is a
former criminal defense attorney. He spent 38 years in the
justice system as a lawyer and judge. He is a member of the
Florida, American and Federal Bar Associations. The
introduction says: Although a true Floridian, Judge Donahey was
born in State College, Pennsylvania, where his father started a
strip coal mining business.
Judge Donahey, I think that this is undue editorial license
for my staff to call you a true Floridian, when I would say you
are a true Pennsylvanian. The place of birth governs. You can
dissent from that, but that may be the official committee view.
Judge Donahey. Senator, I bleed blue and white when Penn
State plays.
Senator Specter. I am glad you made my point so
effectively.
Would you introduce the beautiful woman to your left? And I
am looking forward to your testimony.
Judge Donahey. Yes, sir, this is my wife Tina, who is in
fact a true Floridian.
Senator Specter. Okay, 50/50. That is not too bad.
Thank you very much for joining us, Judge, and we look
forward to your testimony.
Judge Donahey. Thank you, sir. Very simply, or as simply as
I can make it. On January the 11th, 1999, I was fully sighted.
I went in as a patient to Tampa General Hospital for lower back
surgery. I had disks virtually gone between L-2-3, 3-4, 4-5, L-
5 and S-1. It was major surgery. I had done quite a bit of time
checking out, trying to find out where to go.
I had been referred by one of my former law partner's
husband, who was a physician in Clearwater, to a neurosurgeon
with a wonderful reputation, who refused to touch me, referred
me to another neurosurgeon at Tampa General Hospital with a
reputation for having just magnificent hands and wonderful
technique and who could solve my problem, if anybody could. I
went to see him. I consulted with him. I was assured that he
felt they could deal with the problem, that they could resolve
it, and that I could get back to going back on the tennis court
and doing things that I enjoyed doing physically, like chopping
wood at my cabin in North Carolina, et cetera.
Very confident. I was very pleased. And I went into surgery
again January the 11th, fully sighted. Ten hours, I came out
blind. Never had I ever heard from anybody anywhere that loss
of vision was a potential side effect or a potential result of
such surgery.
In the informed consent that preceded the surgery I was
told that I could die. I was told that I might end up a
paraplegic. I was told that I might have drop-foot in my left
leg or something like that. These things rarely occurred, but
never, ever a mention of loss of vision.
I emphasize that because post-surgery I learned that in
fact this physician had had this similar result three times
prior to mine. One of those results was just within 30 to 40
days prior to my surgery. In fact, the day I consulted with him
and he was giving me--predicting prospectively what was going
to occur, I have since learned that he had a meeting with his
last patient, who suffered an impairment of vision from surgery
a month before.
Obviously, when the anesthesiologist and I came out of the
anesthesia were saying, how many fingers do I have up, and I
could not see fingers, it was quite an experience.
Several things that I think are important to what you are
doing here today. No. 1, this doctor did not inform me that he
had had these results in three cases before. And by the way, my
loss of vision is bilateral, both eyes--his previous three
cases were only loss of vision in one eye, which they seem to
feel was far less significant. I was not told that they had had
that result. I have since learned that risk management at Tampa
General Hospital did not know that he had had these results.
Now, he is the lead neurosurgeon on that hospital staff,
and yet risk management/quality assurance assures me that they
have never heard of these results at their hospital before. And
we know that that simply is not true.
Post-surgery I have learned some other interesting things.
The first is that he did not perform my surgery. And I went to
him because of the buildup and the recommendation and because
of the assurances he gave me personally of how he developed the
technique, of how he has trained other physicians around the
country to do this rather unique surgery, but that he felt it
could be done. As it turns out, he did not do it. It was a
resident who performed the surgery. He was supervising.
The interesting part of it is that he was not supervising
just my surgery, but he was supervising surgery in an adjoining
surgical suite. He was floating back and forth between the two.
In this type of surgery, with the length of the surgery--
and by the way, he told me that the surgery would last from 5
to 6 hours. His physician's assistant told me that the surgery,
the actual surgery, would only last about 4 and a half hours.
The other hour or so that he talked about was with the
anesthesia, preparation and coming out of the anesthesia. The
surgery actually lasted 10 hours.
My suggestion would, or my suspicion would be, that the
fact that he did not do it himself but had a resident do it and
the fact that he was floating back and forth, supervising two
suites, may well have lengthened the procedure. That is very
important because my loss of vision is directly attributable to
their failure to maintain the oxygen and red blood cell level
during the course of the surgery, depriving my optic nerves of
oxygen, resulting in the neuropathy and the loss of vision.
Were there warning signals? Yes, absolutely. We have now
had this situation reviewed. Warning signals, there were big
flags waving everywhere. I now know that when they initially
administered the anesthesia that my blood pressure dropped
dramatically. They did nothing. The anesthesia was not being
administered by the anesthesiologist that I was told would be
doing it, but by a resident.
So the anesthesiologist was floating back and forth between
the same two surgical suites. It turns out that the resident
surgeon and the resident anesthesiologist apparently did not
know what to do. I do not know whether they were cowered by the
fact that they had these sages that were supervising them, that
they did not want to approach them, they did not want to tell
them.
I do not know what caused them to not react as they should
have, but they did not. And as a consequence, after I was
strapped in, the blood pressure had recovered. When they
flipped me over, the blood pressure dropped again. All during
this time the red blood cell count--or when the surgery
started, I started losing blood.
By the way, I had provided two pints of my own blood for
them to give me the transfusions during the course of the
surgery if it became necessary. I was assured that it would
not, but if it became necessary. As it turned out, they did not
give me the blood during the surgery even though the blood cell
count went below acceptable levels. They did not give it to me
until post-surgery, when they found out I was blind.
I sat here and I listened to this testimony about reporting
and whether it should be reported and whether or not it should
be identified. Let me assure you, Senator, I have had my wife
in Rochester, Minnesota, at Mayo for surgery. I was seeking the
best place to go to get my surgery done. It was complex. I knew
that. It was difficult. I would not have hesitated for a moment
to go to Rochester or to Duke or to a number of other places--
all of which were available to me. I chose this doctor and this
facility because of what I was told and, as it turns out,
because of what I was not told.
And what I was not told was that this physician, this
surgeon, had had three cases of vision impairment in the 18
months preceding my surgery.
Senator Specter. Well, Judge Donahey, thank you for sharing
your experience with us. It was a very poignant and unfortunate
story.
Before asking any questions, I just want to turn to Dr.
Specken. But I would be interested to know what your status now
is with respect to your eyesight.
Judge Donahey. I cannot see.
Senator Specter. You cannot see.
Judge Donahey. There is a bright light up here. And there
is another one over here. I every now and then get just a bit
of form of where you are. I think you are right there.
Senator Specter. Well, you appear to have eye contact, but
that is deceptive from my view, not from yours.
Judge Donahey. I do that in the courtroom. I try to follow
voices.
Senator Specter. What is the prognosis?
Judge Donahey. This is it.
STATEMENT OF RALPH SPECKEN, M.D., NEW YORK, NY
Senator Specter. Well, I have some questions for you, but
first we are going to turn to Dr. Specken. He is a Consulting
Psychiatrist for the New York City Human Resources
Administration, Attending Psychiatrist at Hollisford Hospital.
He is here to give us his own medical expertise, but also
testify about his harrowing experience with losing his 23-year-
old son because of an information breakdown within the medical
system.
Thank you for joining us, Dr. Specken, and for what I
understand was a harrowing drive down here, some 8 hours from
New York City. We appreciate your being here. Would you
introduce your companions?
Dr. Specken. To my left, Ms. Pearl Korn. Pearl is known as
one of the deans of the photojournalist community, doing some
of the early work in Rumania and Northern Ireland. She was
damaged by medical malpractice.
To my right is my life partner, Stephanie, the brains of
the family. I am the mouth, so I will talk. I am very persuaded
by this systems notion. In all seriousness, it is an honor to
be in the same room as Dr. Leape. In the history of the 20th
century, he is going to go down as one of the giants in
medicine, really. So it is an honor to be here.
Thank you for your concern about our 8-hour drive down. But
since I am persuaded by systems theory, I have to tell you
something. I ran a couple of red lights getting over here. I
did not do it intentionally. I did not want to do it, but it
happened. I assume I will suffer no punishment for this, and I
promise I will not do it again. If I do it, I will tell about
it and we will try to work out a better system so that this
sort of thing does not happen.
Senator Specter. You have not been sufficiently specific to
identify jurisdiction or venue. Judge Donahey is going to
counsel you.
Dr. Specken. You will see that I am very well aware of
this. I am not completely convinced of the indemnity, but I am
trying to break new ground here. After all, with the 21st
century and systems. But, with all seriousness, it is very
important to very careful with that word, and not to abrogate
personal responsibility to the world of the computer disk and
whatnot.
It was almost 6 years ago today that Seth's mother walked
into his bedroom where the chart from the hospital lay and
figured out how he died. I am going to mention the name of the
hospital, since it is the world's largest and wealthiest and
most important in many ways--New York Presbyterian Hospital,
then Columbia Presbyterian Hospital, in the City of New York.
Seth died essentially from an act of what should have been
called second-degree homicide. It was not intentional, but the
acts that were taken against him were such that the prudent
physician would have known better. Stephanie's reading of the
chart set upon a whole series of motions, set about a lawsuit,
set about our Web site, which was known as medmalpractice.com.
I will give Ms. Taylor a copy of that if she has the fortitude
to read through it.
From that Web site, as far as I know, came the first
analogy between medical error and the situation in the airline
industry. We found, Stephanie and myself, that the risk of
dying in an airplane is something like 1 and 1 million. The
risk of dying from a cause unrelated to your illness in a
hospital in New York is approximately 1 in 323. Few of us would
get on airplanes gingerly if we faced that sort of risk, 1 in
323.
But, in any case, time has moved on. I am abbreviating this
section of my talk, because it is not my main interest in
speaking to you, Senator. But I wanted to fill you in on what
has happened with the case. Shortly prior to trial,
mysteriously, one of the lawyers resigned, thereby ending the
trial. In a very Byzantine series of events, the chief lawyer
coerced us into signing a general release, which incidentally
put the lie to one of the hospital's charges against me.
And then a further series of Byzantine events--I took on
the role of being a pro se lawyer and defeated the aim of the
chief lawyer, who was actually one of the best litigators in
New York, to have a guardian appointed over me, to enforce the
settlement. And we have submitted a pro se motion to have this
settlement vacated--not on the grounds of the money, but on the
grounds of the fact that we have been forced into silence about
what happened to Seth.
In all of this I have made great connections with folks
around the country, such as Pearl. You should know, and
probably do know, that there are groups developing around the
country. You met with Ray McAetrin. Our group in New York City,
founded by Irene Corrina, who has been on national television,
is called Pulse of New York, is attempting to get mandatory
disclosure of a physician's malpractice history. It is meeting
great resistance in the State legislature.
Through all of this I have become a minor expert in medical
malpractice law and, really, I can speak about it with some
expertise. I can totally support Dr. Coye's perception. It is a
very poor system. I do not want to use extreme, inflammatory
words. It is a broken system. It is a system which must be
replaced. The average medical malpractice victim in this
country is impoverished, living on welfare, in great poverty.
That is the average medical malpractice victim.
One out of seven cases, from Dr. Leape's work, come to the
law. A minimum of those come to trial--oftentimes the wrong
cases. It is a very bad system. And all of this is in preface
to what I wanted to say today. And here is what I want to say.
It is very important that the members of the committee
become aware of the fact that there are other countries that
are well ahead of us in the study of this problem. Three
specifically come to mind--Sweden, Germany, and New Zealand.
And I am going to give some references to the staff that should
be explored. The predominant thinker in this area was a German
professor, now passed on, Dieter Deeson, who, in 1988, put
together a compendium of comparative malpractice law around the
world, which should inform the committee of other vistas in
this area. It is very important for your future deliberations.
Because, as I say, our malpractice system essentially is
broken and should be discarded. It benefits the insurance
companies. It benefits the medical malpractice lawyers. To the
victims, it presents a sort of casino environment, where a
handful are rewarded handsomely, the bulk receive nothing, and
even those that are rewarded oftentimes are coerced into
silence.
So I would like to give a brief proposal in this whole
area. Contrary to the National Academy--and, incidentally, as
far as I know, I was the first one to propose this National
Patient Safety Board on our Web site 3 years ago--but in any
case, this National Patient Safety Board, in what I think
should be the system of the future, must become a regulatory
agency analogous to the National Transportation Safety Board.
This agency should adopt systems that encourage accountability,
regulation and strict enforcement. People are people. They are
going to respond to these issues.
The current system of regulation is State-based, with
various medical boards in the State. Ours is called the Office
of Professional Medical Competency. Other States have medical
boards. These are, as you will hear from the victim
communities, very problematic organizations in many ways.
As one of our State board directors told me recently in the
committee meeting, they are receiving literally thousands and
thousands of complaints that they cannot field. They do not
have the staff to deal with these complaints. They are
backlogged for years. And overlying all of this, these boards
are largely dependent on the physicians making the ultimate
decisions. In other words, in our board, the decisions as to
malpractice are made by three people, two of them who are
physicians.
These medical boards should be altered to become
subsidiaries of the board in Washington. And then something
that will make the doctors happy in my proposal, I am for
strict tort reform. I think we have to move into a system of
strict tort reform, moving into the German and Swedish system
of schedules of payments, that victims are compensated
essentially by the government with a payment schedule--not as
much as they receive in the malpractice system, but something.
So that once a malpractice is identified, the issue of medical
malpractice lawyers is not present. The payment is made for the
medical misadventure.
Where I will come to blows with my colleagues, however,
comes from my understanding of the German system, in which it
is their experience that fully 22 percent of what is called
negligence is deemed criminal negligence and immediately goes
into what amounts to a criminal medical system of jurisprudence
in which there are specially trained judges with knowledge and
interest in medicine who deliver true criminal penalties when
it is due. And this is approximately 22 percent of the time.
Medicine to be practiced in Germany therefore becomes
somewhat of a high risk profession, but with much better
safety.
Senator Specter. Dr. Specken, your suggestion is that
medical malpractice cases result in criminal sanctions?
Dr. Specken. No. No. I am saying that looking at negligent
cases, over the spectrum of negligent cases, 22 percent of them
would fall into what they perceive as their criminal realm. It
has to do with their concept of due diligence.
Senator Specter. Are those cases then prosecuted
criminally?
Dr. Specken. They all are. And doctors go to jail in
Germany, something which is unheard of here. But I spoke to a
German lawyer, and he was aghast when I explained our system to
him. He could not understand why we tolerated this system of
indemnification of doctors. And I could bring to you something
Ray McAetrin said when he came before the committee, if the
anger in the victim community ever gets unleashed, Seattle, the
experience in Seattle, will become a mild thing compared to
what could happen with that anger.
Senator Specter. Dr. Specken, what happened to your son, if
you are comfortable telling us? I do not want to press you, but
if you would tell us what happened to your son with his medical
treatment, we would be interested to know.
Dr. Specken. Yes. Seth was restrained illegally for a
period of over 60 hours in an inappropriate withdrawal from
Zanax medication, which I had been prescribing to him for panic
disorder. The hospital staff, which was largely run by trainees
and interns, did not know how to withdraw an individual and
used restraints.
Senator Specter. And you lost your son?
Dr. Specken. And Seth died in a bathroom, naked and alone.
Senator Specter. Judge Donahey, you have had a fair sized
criticism of the medical malpractice system today. You have had
a lot of experience in the judicial system obviously as a
jurist, a lawyer. Do you have litigation pending against the
doctor?
Judge Donahey. Well, you would be interested in knowing
that another thing that I did not know prior to my surgery was
that my surgeon was a full-time professor at the University of
South Florida Medical School and therefore is covered by
sovereign immunity in the State of Florida, both the hospital
and him.
Senator Specter. Covered by immunity for what he does in
the operating room?
Judge Donahey. Yes, sir sovereign immunity in the State of
Florida protects you. So yes, there is litigation. I am going
to pursue the litigation not because I have the potential of
recovering some amount of money, but more because I think this
matter needs to be brought to light. I was really appalled when
I found out that quality assurance and assigned risk at the
hospital did not know that he had three prior patients that had
suffered vision impairment.
You might be interested in knowing also that since then I
know that there has been a debate going on in the quality
assurance at Tampa General Hospital to determine whether or not
they should add to the informed risk statement for patients
that are undergoing lower back surgery the loss of vision or
the impairment of vision as a potential result.
This doctor who is in charge of the department refuses to
permit that to be added. And the justification that he gives is
that if you were to put it in the informed risk to be read to
patients, that patients who legitimately need this surgery
would choose not to have it.
Senator Specter. Judge, did you consider asking this doctor
any questions about what the worst result he ever had was or
had he been sued or something which a direct question might
have drawn some information for you?
Judge Donahey. No, I did not ask that question. I should
have. Hindsight certainly suggests that I should have.
Senator Specter. Well, it is a tough question to ask as a
patient. No matter how much prescience you have or how much
experience you have, that is not an easy question to ask.
Judge Donahey. Well, let me tell you what I have found out
post-surgery. Post-surgery, there is no recordization, no suit
that has ever been filed against him as a result of the
previous three cases, or of any other cases. He does not have
any cases. Now that tells us what? It tells us real simply that
if there have been claims, they have been settled. They have
been settled quietly prior to the filing of suit and a
stipulation and condition of that settlement is that the
settlement not be revealed. And you know that occurs all the
time.
In Florida, our medical malpractice system requires that
you do your investigation before filing the suit. You have to
give notice of intent to file the suit. You have to have
affidavits by other physicians supporting the finding of
medical malpractice before you can file a suit. If you do not
do all of that, first of all, your suit is subject to being
dismissed; and, second, the lawyer who files the suit is
subject to a counterclaim himself for liability.
Senator Specter. Judge Donahey, I would be interested in
your views. We are going to have to terminate this hearing
shortly.
Judge Donahey. Yes, sir.
Senator Specter. I would be interested in your views as to
whether you agree with the Institute of Medicine that there
ought to be mandatory reporting?
Judge Donahey. Absolutely.
Senator Specter. And mandatory disclosure to the patient of
anything that went wrong?
Judge Donahey. Absolutely. Senator, it is a patient's right
to be informed. It is a patient's right to make a fully
informed decision as to where to go and where to seek his or
her medical treatment. And you can only do that if you have
available to you a full disclosure of the history and the
background and the performance of the particular facility and
physician that you are talking to.
Senator Specter. Dr. Specken, do you favor mandatory
disclosure by hospitals and doctors of their errors?
Dr. Specken. This dimension of the discussion is putting
the cart before the horse. What we need first is a new system
of regulation, which has to do with a well-functioning local
medical board that in turn, in a hospital, manages a quality
assurance office.
Now, I am in full agreement with Dr. Leape and Dr. Coye and
Dr. Garthwaite and Dr. Bagian on a certain point--definitely
there are cases which are true accidents that happen to
doctors, although I was the first to bring up the analogy to
the airline industry in medical mistakes. I am also the first
to say it is a poor analogy. Doing medicine is infinitely
different than flying a plane. It is infinitely more difficult.
The best of doctors is going to make a mistake. It should be
the determination ultimately of what is served by releasing
that information.
Senator Specter. You may be right about a restructuring of
a great many things, but that is unlikely to happen. We are
going to be faced with a narrower question as to whether we are
going to mandate hospitals and doctors to report their
mistakes.
Dr. Specken. And in that case, do it now. It is overdue.
Senator Specter. How about reporting to the patients?
Dr. Specken. Absolutely. It is overdue. There is so much
death because of this, it should be done.
Senator Specter. We are going to have to conclude now. And
you have my thanks, Judge Donahey and Dr. Specken, for coming
from Florida and from New York. I am very sorry to hear about
your son, Dr. Specken; I have a couple of my own. And I am
sorry to hear about your blindness, Judge Donahey. You seem to
comport yourself well when you look at the chairman. And you
probably have a bead on some of the witnesses in your
courtroom. I think they will not know you cannot judge their
demeanor by your presentation.
Your wife is nodding in the affirmative, so you are making
the best of a very tough situation.
The subcommittee will be pursuing this matter further.
There will be additional hearings. Senator Harkin asked me to
announce that he will be cosponsoring the legislation which I
have described. There is a great deal more we have to find out,
but we are determined to take a strong stand against these
kinds of errors.
That concludes the hearing. And Dr. Garthwaite and Dr.
Bagian, if you would step forward, I would appreciate it.
Thank you all very much.
Dr. Specken. Thank you for the opportunity, Senator.
Judge Donahey. Thank you, Senator.
CONCLUSION OF HEARING
Senator Specter. Thank you all very much for being here,
that concludes our hearing. The subcommittee and committee will
stand in recess subject to the call of the Chair.
[Whereupon, at 11:29 a.m., Tuesday, January 25, the hearing
was concluded, and the subcommittee and committee were
recessed, to reconvene subject to the call of the Chair.]
MEDICAL MISTAKES: ADMINISTRATION RESPONSE AND OTHER PERSPECTIVES
----------
TUESDAY, FEBRUARY 22, 2000
U.S. Senate, Committee on Health, Education, Labor,
and Pensions, and the Subcommittee on Labor,
Health and Human Services, and Education,
Committee on Appropriations,
Washington, DC.
The joint hearing convened at 9:36 a.m., in room SD-430,
Dirksen Senate Office Building, Senators Frist and Specter,
presiding.
Present: Senators Frist, Specter, Hutchinson, Collins,
Kennedy, Dodd, Harkin, Bingaman, and Reed.
OPENING STATEMENT OF SENATOR BILL FRIST
Senator Frist. Good morning, and welcome to this joint
Senate hearing of the Committee on Health, Education, Labor,
and Pensions, and the Appropriations Subcommittee on Labor,
Health and Human Services, and Education, on the topic of
``Medical Errors: Administration Response and Other
Perspectives.''
Today's hearing, as most of you know, is the fourth and
last in a series on the finding of an Institute of Medicine
report entitled ``To Err is Human: Building a Safer Health
System.''
I would like to thank Dr. John Eisenberg for appearing
before the committee on behalf of the administration to offer
the response of the Quality Interagency Coordination Task Force
on Federal Actions to Reduce Medical Errors and their Impact.
We will also hear from the Veterans Administration on their
implementation of a National Patient Safety Program and from
other health care professionals who have spent a great deal of
time and effort studying the issue of quality improvement.
I applaud the Institute's efforts to highlight patient
safety as a major concern in America's health care system. The
report states that medical errors are the eighth leading cause
of death in the United States, with as many as 98,000 people
dying per year. More people die from medical mistakes than from
motor vehicle accidents, AIDS, or breast cancer.
There are several schools of thought on how to prevent
these mistakes. Some say that sanctioning those health
professionals who are not doing their job is the answer. But
even the best-trained, the best doctors and nurses, make
mistakes during even the most routine of tasks.
Clearly, the root cause of medical errors is more systemic,
and examining and improving the systems that ensure patient
safety would seem to be more effective in reducing the number
of medical errors than solely reprimanding any one individual
or group.
One implication of a system view of error reduction is that
the responsibility for safety lies with the people who organize
and run those systems. This also implies that in order to
achieve systemic improvements, we must facilitate and encourage
communication between the different disciplines within the
health care delivery system. Doctors, nurses, pharmacists,
hospitals, researchers, regulators, accreditation bodies and
health plans must all be involved in systems improvement.
The report calls for strong mandatory reporting efforts in
order to identify these errors, analyze the patterns, and
discover ways to prevent the problems from recurring, as well
as a system of voluntary reporting. Standards and expectations
should be raised, the report states, to encourage health care
professionals and organizations to focus on and develop patient
safety programs.
The report also recommends creating a new Center for
Patient Safety through the Agency for Health Care Quality and
Research, and providing initial funding of $35 million for the
Center. While the President's budget calls for an additional
$20 million in funding for patient safety research and pilot
projects, more may be needed in order to address a problem of
this magnitude.
We also need to allow for confidentiality through peer
review protections for information that is voluntarily
submitted regarding medical errors. I believe the Federal
Government is uniquely positioned to provide the necessary
protections against the inappropriate disclosure of data
collected for the purposes of error reduction.
I am pleased that the report of the Quality Interagency
Coordination Task Force supports the extension of peer review
protections to facilitate reporting of errors in a blame-free
environment.
Once the information is collected and analyzed, either
through AHRQ--we will be hearing that acronym over the course
of the day--or another deemed institution such as the Joint
Commission on Accreditation of Health Care Organizations,
recommendations on ways to prevent errors need to be developed
and disseminated throughout the health care industry. It is my
hope that the recommendations will be incorporated into future
survey instruments by organizations such as the Joint
Commission, the accrediting body responsible for hospitals and
other inpatient health care settings.
We are especially fortunate to have with us today a witness
from the Veterans Administration. As they indicate in their
testimony, all of the IOM's recommendations applicable to the
VA have either been in place or are in the process of being
implemented. Based on their findings, the ideal reporting
system must be nonpunitive, voluntary, confidential, and de-
identified.
I support their conclusion that patient safety can only be
achieved by root cause analysis and building a true culture of
safety. Our committees' common goal is to identify and support
approaches that increase knowledge about why medical errors
occur and to apply that knowledge to improve patient safety.
This series of hearings has provided the committee with an
understanding of the problems associated with medical errors
and the recommended solutions. I anticipate the development of
bipartisan legislation creating a health care system quality
improvement framework to address these problems. A number of
members of this committee, including Senators Kennedy, Jeffords
and Dodd, have already expressed interest in joining all of us
in that effort.
At this hearing, we will hear from health care
professionals and thoughtful leaders who have spent a great
deal of time studying this issue. They will speak to the
current State of patient safety, share with us recent
developments in improving the quality of care, and give us
their recommendations about what should be done.
I appreciate everybody coming. As you can see, Senator
Jeffords is not with us; his plane has not yet arrived, and
therefore, I am chairing this hearing. We will insert Senator
Jeffords' prepared statement at this point.
[The statement follows:]
PREPARED STATEMENT OF SENATOR JAMES JEFFORDS
Good morning, welcome to this joint Senate hearing of the Committee
on Health, Education, Labor, and Pensions and the Appropriations
Subcommittee on Labor, Health and Human Services, and Education on the
topic of ``Medical Errors: Administration Response and Other
Perspectives.''
Today's hearing is the fourth and last in a series on the findings
of an Institute of Medicine report entitled ``To Err Is Human: Building
a Safer Health System.'' I would like to thank Dr. John Eisenberg for
appearing before the committee, on behalf of the administration, to
offer the response of the Quality Interagency Coordination Task Force
on Federal actions to reduce medical errors and their impact. We will
also hear from the Veteran's Administration on their implementation of
a national patient safety program and other health care professionals
who have spent a great deal of time studying the issue of quality
improvement.
I applaud the Institute's efforts to highlight patient safety as a
major concern in America's health care system. The report states
medical errors are the 8th leading cause of death in the United States,
with as many as 98,000 people dying per year. More people die from
medical mistakes than from motor vehicle accidents, AIDS, or breast
cancer.
There are several schools of thought on how to prevent these
mistakes. Some say that sanctioning those health professionals who
aren't doing their job is the answer. But even good doctors and nurses
make mistakes during the most routine of tasks. Clearly, the root cause
of medical errors is more systemic. Examining and improving the systems
that ensure patient safety would seem to be more effective in reducing
the number of medical errors than reprimanding any one individual or
group.
One implication of a system view of error reduction is that the
responsibility for safety lies with the people who organize and run
those systems. This also implies that in order to achieve systemic
improvements, we must facilitate and encourage communication between
the different disciplines within the healthcare delivery system.
Doctors, nurses, pharmacists, hospitals, researchers, regulators,
accreditation bodies, and health plans must all be involved in systems
improvement.
The report calls for strong mandatory reporting efforts in order to
identify these errors, analyze the patterns, and discover ways to
prevent the problems from recurring, as well as a system of voluntary
reporting. Standards and expectations should be raised, the report
states, to encourage health care professionals and organizations to
focus on and develop patient safety programs.
The report also recommends creating a new Center for Patient Safety
through the Agency of Healthcare Quality and Research (AHRQ) and
providing initial funding for the Center of $35 million. While the
President's budget calls for an additional $20 million in funding for
patient safety research and pilot projects, more may be needed in order
to address a problem of this magnitude.
We also need to allow for confidentiality--through peer review
protections for information that is voluntarily submitted regarding
medical errors. I believe the Federal Government is uniquely positioned
to provide the necessary protections against the inappropriate
disclosure of data collected for the purposes of error reduction. I am
pleased that the report of the Quality Interagency Coordination Task
Force supports the extension of peer review protections to facilitate
reporting of errors in a blame-free environment.
Once the information is collected and analyzed, either through AHRQ
or another deemed institution, such as the Joint Commission on
Accreditation of Health Care Organizations, recommendations on ways to
prevent errors need to be developed and disseminated throughout the
healthcare industry. It is my hope that the recommendations would be
incorporated in future survey instruments by organizations such as the
Joint Commission, the accrediting body responsible for hospitals and
other inpatient healthcare settings.
We are especially fortunate to have a witness at today's hearing
from the Veteran's Administration. As they indicate in their testimony,
all of the IoM's recommendations applicable to the VA have either been
in place or are in the process of being implemented. Based on their
findings, the ideal reporting system must be non-punitive, voluntary,
confidential and de-identified. I support their conclusion that patient
safety can only be achieved by root cause analysis and building a
culture of safety.
I believe our committees' common goal is to identify and support
approaches that increase knowledge about why medical errors occur and
to apply that knowledge to improve patient safety. This series of
hearings has provided the committee with an understanding of the
problems associated with medical errors and the recommended solutions.
I anticipate the development of bipartisan legislation creating a
health care quality improvement framework to address these problems. I
am pleased that a number of members of the Committee, including
Senators Kennedy, Frist, and Dodd, have already expressed interest in
joining me in that effort.
At this hearing we will hear from health care professionals and
thought leaders who have spent a great deal of time studying this
issue. They will speak to the current state of patient safety, share
with us recent developments in improving the quality of care, and give
us their recommendations about what should be done. Thank you all for
coming.
Senator Frist. We will hear opening statements from Senator
Specter, Senator Kennedy, and Senator Harkin; then we will go
to the first panel and then give the other members the
opportunity to make opening statements after the first two
witnesses, if that is all right.
Senator Specter.
Senator Specter. Let me yield to Senator Kennedy. Today is
his birthday. And beyond it being his birthday, he is the
senior member here.
OPENING STATEMENT OF SENATOR EDWARD M. KENNEDY
Senator Kennedy. That is very kind. Watching what has been
happening on the national political scene, this kind of
hospitality and generosity is very welcome.
I have to recognize that it is Senator First's birthday as
well, so the stars are lined up in some particular way.
Senator Frist. We had better be productive.
Senator Kennedy. Senator Frist, I was born 200 years after
George Washington, and I have always tried to make something
out of that but have never been able to do much with it. In any
event, I thank the Senator and my chairman and also Senator
Specter.
As Senator Frist has pointed out, we are very fortunate to
have together the two committees, one the authorizing
committee, the other the appropriating committee, that have
worked very closely on health care policy issues. I think that
that is really the way that this process should work.
I think all of us are enormously impressed with the
Institute of Medicine recommendations, which are very powerful
and very thoughtful and very compelling. We received these just
several weeks ago and members are enormously interested and
concerned about the problem of medical errors. The
administration has responded in the last few days, giving us an
update on their own recommendations, which are extremely
thoughtful and have, I think, a great deal of substance.
Obviously, they will probably be the subject of differences in
how to approach this, but they really respond in a very timely
way to these issues which are of such great importance.
So at a time when perhaps there is some question about
whether the Congress is off to a shaky start in terms of how
much has been achieved and accomplished, I think that this area
of public policy is one where we have seen very substantial
recommendations from our colleagues on the various committees,
and we look forward, Mr. Chairman, to working with you and
those on the other committee in moving ahead with this
legislation.
We regret that Senator Jeffords is not here. But we can
talk in a bipartisan way, and I know that myself, Senator Dodd
and others look forward to working very, very closely.
I also want to welcome Dr. Arnold Relman from
Massachusetts, who will be appearing on our second panel. He
has had a very distinguished record in academic medicine, at
the University of Pennsylvania, as well as at Harvard and with
the New England Journal of Medicine. He has not only thought a
great deal about these issues but has also been instrumental in
working in our own State of Massachusetts at addressing how to
improve patient safety, so we have some practical guidance from
him, as well as from a very outstanding group of witnesses
today.
Mr. Chairman, I want to thank you at the outset. I think
you have outlined in a very important way some of the various
considerations we need to address. We have one approach that
has been employed by the Veterans Administration by
implementing a mandatory reporting system and developing a
voluntary reporting system to ultimately achieve the greatest
kinds of protections for American consumers. That is really
what we are trying to accomplish. This is an extremely
comprehensive and demanding subject matter, but it is one that
demands action.
PREPARED STATEMENT
I would like to put my full statement in the record.
I am somewhat disappointed with our friends at the American
Association of Health Plans. Instead of joining in a rather
thoughtful, productive discussion on how we can best act
together to reduce and prevent medical errors, the Association
continues to argue against accountability for patient abuse. So
I was very disappointed in their recommendations. However, the
other reports and suggestions have been, I think, enormously
thoughtful and productive. I look forward to working with you
and the other members to implement an effective medical error
reduction program to protect American families, which we know
is our charge and responsibility.
I thank you.
Senator Frist. Thank you, Senator Kennedy.
[The statement follows:]
PREPARED STATEMENT OF SENATOR EDWARD M. KENNEDY
I commend the Chairman for holding these important hearings on
medical errors. We have learned a great deal from our witnesses, and I
look forward to our efforts to improve the current system and prevent
as many medical mistakes as possible.
I particularly welcome Senator Specter to our hearing. He's been an
effective leader on this issue, and I look forward to his testimony.
After speaking with many providers and patients, it is clear that
we need better data on medical errors, why they occur, and how to
prevent them. It also seems clear that many providers will not take the
steps necessary to improve patient safety unless they are held
accountable in some way for implementing those steps.
Reporting offers one way to obtain needed information about medical
mistakes. The programs in existence today vary widely some are
voluntary and others are mandatory. Some have protections against
disclosure and others do not. The Veterans Administration has developed
a mandatory reporting system, and is implementing a voluntary system,
as well. It's likely that no single data collection method can provide
the broad range and depth of information we need to prevent as many
medical errors as possible.
Another major challenge is to commit the necessary resources to all
aspects of the problem, including research and education. The Institute
of Medicine set a goal of a 50-percent reduction in medical errors
within 5 years. That recommendation contemplates an initial increase of
$35 million in the budget of the Agency for Healthcare Research and
Quality, with progressive increases up to $100 million at 5 years.
Finally, any legislation put forward will not effectively reduce
medical errors unless it holds institutions accountable for
implementing practices and standards that improve patient safety. The
public deserves meaningful information about how well individual health
care institutions perform on patient safety measures, so that patients
can make informed choices.
Each of these aspects of the medical errors problem is important.
These issues must be given high priority by this session of Congress.
I also commend the President, the Vice President, and the members
of the Quality Interagency Coordination Task Force for an outstanding
job. The Administration's proposal is an effective plan to reduce
medical mistakes and improve patient safety, and it will allow progress
while Congress prepares to move forward.
Finally, I must also comment on the testimony by the American
Association of Health Plans. I am disappointed in both the tone and
content. Instead of joining in a thoughtful and productive discussion
on how we can best act together to reduce the occurrence of preventable
medical errors, the Association continues to argue against
accountability for patient abuse.
Nevertheless, I'm optimistic that Congress will act quickly to
solve the glaring problem of medical errors, and I look forward to
working closely with my colleagues to meet this urgent challenge.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Frist. Senator Specter.
Senator Specter. Thank you very much.
This is a very important hearing by the authorizing
committee, the Senate Committee on Health, Education, Labor,
and Pensions, and also our Appropriations Subcommittee on
Labor, Health and Human Services, and Education, tackling this
issue of enormous importance.
On November 29, the Institute of Medicine came down with
its report that there are almost 100,000 deaths annually due to
mistakes in hospitals, and there has been very, very prompt
action. A series of hearings has already been held in our
subcommittee in December, as well as in this authorizing
committee. Senator Harkin and I introduced legislation on
February 8. The President has acted with an Executive Order,
and today, we will have the report of the Quality Interagency
Coordination Task Force as directed by the President, and later
today, President Clinton will hold an event in the Executive
Office Building, and many of us will be present at that time to
really tackle this matter of overwhelming importance, as well
we should in light of the fact that more than 300 people die
each day from hospital mistakes. So this is something that we
ought to be working on and working on expeditiously.
The issue as to how it is going to be handled is not an
easy one. My own view is that mandatory reporting is necessary.
There is considerable resistance to mandatory reporting, but
the President's Task Force has made a suggestion that the
mandates be by category and not identifying institutions or
individuals. There may be a way to accommodate mandatory
reporting without having a chilling effect to discourage people
from reporting.
The legislation which Senator Harkin and I have introduced
calls for demonstration projects along three lines. One is
voluntary reporting with confidentiality, with five
institutions doing that; five more institutions would have
mandatory reporting with confidentiality; and a third group of
five institutions would have mandatory reporting with
disclosure to the injured patient.
It is my own view that there is a professional
responsibility by doctors and hospitals to tell people when
they have been injured. I would extend that to lawyers and
architects and professionals of every sort. I think that is a
professional responsibility. It may be that in the long run,
the disclosure of errors can lead to a way to deal with this
problem which would be different from the current tort system
of medical malpractice, and perhaps those who are injured could
be compensated in some other way, like perhaps workmen's
compensation without respect to fault. That is a long way down
the road, but the business of identifying the mistakes is
really very, very important.
I agree with Senator Kennedy about the cooperative nature
of what we are doing here, not only the committees, but both
sides of the aisle, Republicans and Democrats. I was a little
bit concerned to see in the morning's press that the president
of the American Hospital Association, which had been invited to
the White House event, has decided not to attend. I think that
that is not proper. I think we all ought to participate, and we
all have our views, but they are not necessarily in concrete.
Our duty is the American people and to the patients who are
entitled to medical care without being victimized by mistakes.
And toward that goal, we are pledged to move ahead.
I am delighted now to yield to my very distinguished
colleague from Iowa, my partner on the subcommittee, Senator
Harkin.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Thank you very much, Senator Specter. I
want to thank you and of course, Chairman Jeffords, Senator
Kennedy, and Senator Frist for holding this important hearing
on medical errors. I really think everything has been said, and
I do not know how much I can add, other than to just reiterate
for emphasis' sake that this is costing us a lot in our
society--estimates of $17 to $29 billion a year just in terms
of monetary cost. But how do you estimate the cost for patients
and their families when a diagnostic test is misread, a drug is
given that is known to cause an allergic reaction, or a surgery
goes awry? These costs are inestimable, and they also further
erode the trust that Americans have in our health care system.
It is bad enough to have to go into a hospital for surgery--and
Dr. Frist can probably speak to this a heck of a lot better
than I can--but all of us who have gone through that or who
have had family members go through it know the apprehension,
the fear of the unknown. When you add to it the knowledge that
so many errors are being made compounds, I think, the anxiety
that people have when they seek medical help.
I just want to make one thing clear from my viewpoint. That
is, as I have looked at this along with Senator Specter, I am
convinced that no one individual and no one institution is at
fault. I do not think you can put a finger on something and say
this is it. We have the best-trained and most sophisticated
health care work force in the world; we have skilled,
conscientious doctors and nurses and pharmacists, many of whom
are working under tremendous pressure and time constraints. I
believe the problem is very complex, and I believe it is a
systemic problem--it is something in the way the system works--
so I think we are going to need some comprehensive solutions
and rigorous changes that will address this in a very
comprehensive manner.
As Senator Specter said, he and I recently introduced the
Medical Errors Prevention Act of 2000. The one thing I would
say about the administration's approach--and I will be asking
the witnesses about this--there is no money provided in the
President's budget to go out to the States to help them set up
these reporting systems. Senator Specter and I provide for that
in our proposed legislation. We provide grants to the States. I
do not see that in the administration's proposal.
Finally, I will just say that some years ago, we had a
similar problem facing us in the aviation industry. The level
of errors was unacceptably high. But we had a major national
initiative; we put sufficient resources into research and
training and systems solutions. I think we have altered the
culture and processes of aviation so that the errors and risks
have been dramatically reduced. That does not mean that
airplanes do not crash--of course they do--but it is nothing
like it used to be. And now we know how to pinpoint and find
the errors more rapidly than we did, say, 20 years ago.
I think that that same kind of approach must be applied
here, and that is what Senator Specter and I have tried to do
in our legislation.
Thank you very much, Mr. Chairman.
Senator Frist. Thank you, Senator Harkin.
Senator Collins.
OPENING STATEMENT OF SENATOR SUSAN M. COLLINS
Senator Collins. Thank you, Mr. Chairman.
Mr. Chairman, I am very pleased to participate in this
fourth hearing today on how we can reduce the number of medical
errors in this country. I am particularly interested in hearing
from representatives of the Veterans Administration. In my home
State of Maine, we have a Veterans Hospital at Togas that
recently received a lot of publicity in regard to two serious
medical errors that occurred there, including one case where a
very unfortunate gentleman had his prostate inappropriately and
unnecessarily operated on.
So we know that these problems and errors do occur, whether
in VA hospitals or in other hospitals throughout our country.
In fact, the VA recently issued a report that showed nearly
3,000 cases of medical mistakes or adverse events involving
more than 700 patients who died while hospitalized or shortly
thereafter--those were the major findings of this report. In
contrast with the past VA practice of trying to cover up or
minimize such errors, however, the VA has adopted a new
approach of encouraging employees to come forward to fully
disclose the mistakes and to learn from them as a means of
enhancing patient safety.
So I think we can learn from the experience of the VA about
whether the actions that have been put in place are reducing
medical errors and whether they can serve as a model for other
hospitals as well.
I appreciate the opportunity to participate today. Thank
you.
Senator Frist. Thank you, Senator Collins.
Senator Reed.
OPENING STATEMENT OF SENATOR JACK REED
Senator Reed. Thank you, Mr. Chairman.
Mr. Chairman, let me just thank you for hosting this
hearing. It is an interesting topic, and I am eager to hear
from today's witnesses.
I yield back.
Senator Frist. Thank you, Senator Reed.
Senator Bingaman.
OPENING STATEMENT OF SENATOR JEFF BINGAMAN
Senator Bingaman. I agree with Senator Reed, Mr. Chairman.
Thank you for holding the hearing, and I am here to hear the
witnesses.
Thank you.
Senator Frist. Those were good, short opening statements by
the last two.
Senator Dodd.
OPENING STATEMENT OF SENATOR CHRISTOPHER J. DODD
Senator Dodd. Thank you, Mr. Chairman. Let us keep it
moving in your direction and keep this moving.
I will put an opening statement in the record, Mr.
Chairman, and when the time for questioning comes, I will make
some further comments.
Senator Frist. Thank you.
[The statement follows:]
PREPARED STATEMENT OF SENATOR CHRISTOPHER J. DODD
Mr. Chairman, I'd like to thank you both--Senator Jeffords and
Senator Specter--for convening this joint hearing, the final in a
series of three that the Health and Education Committee has held on the
topic of medical errors. I am pleased that the committee is looking
carefully and thoughtfully at this troubling issue and I'm delighted to
be working with the Chairman, Senator Kennedy, Senator Frist and other
members of this committee to draft legislation to address it.
As we are all now aware, a recent Institute of Medicine study has
revealed a major health crisis--not a deadly new virus or another tear
in the safety net--but a crisis of human error. According to the IOM,
medical mistakes, ranging from illegible prescriptions to amputations
of the wrong limb, are responsible for as many as 100,000 deaths a
year.
Most Americans feel confident that the health care they receive
will make them better--or at the very least, not make them feel worse.
And in the vast majority of circumstances, that confidence is deserved.
The dedication, knowledge and training of our doctors, nurses, surgeons
and pharmacists in this country is unparalleled.
But, as the IOM reports starkly notes, our health care system is
showing some cracks. If we are to maintain public confidence, we must
respond quickly and thoroughly to this crisis.
As we near the end of the series of hearings that the committee has
held on this topic, having heard from government officials, academic
experts and health care providers, the questions to be addressed are
now clearly outlined for the us: Should error reporting should be
mandatory or voluntary? Should reports, once made, should be disclosed
to the public, and, if so, in what form? Should information in the
reports be out of the reach of malpractice attorneys, and if so, how?
Who should collect the information? And how should the information,
once collected, be analyzed and disseminated to improve patient care?
The task before us is straightforward and I am hopeful that the
legislation we are drafting through the committee process will be ready
for introduction in the next few weeks.
I would like to end by stating my concern about continuing attempts
to use the medical errors issue to divert attention from the Patents
Bill of Rights (PBOR). I am surprised and disappointed by the arguments
being made that solving the medical errors crisis alone is all that is
needed to improve the quality of health care in this country. Doctors
inadvertently harming patients and insurers deliberately withholding
medically necessary care are equally important, but distinct, issues--
addressing one does not obviate the need to address the other. I think
the American people understand that and I hope those working on this
issue understand it as well.
Again, Mr. Chairman, I thank you for placing this issue high on the
committee's agenda. And, I thank Senator Specter and Senator Harkin for
their interest and leadership on this issue. I look forward to working
with you all in a bipartisan manner to find a solution.
STATEMENT OF DR. JOHN M. EISENBERG, DIRECTOR, AGENCY
FOR HEALTHCARE RESEARCH AND QUALITY,
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
AND OPERATING CHAIR, QUALITY INTERAGENCY
COORDINATING TASK FORCE
Senator Frist. I have the pleasure of introducing our first
panel this morning. Once again, we will be welcoming Dr. John
Eisenberg, who is director of the Agency for Healthcare
Research and Quality, or AHRQ. The reason I keep stressing that
is for those of us who have been around a little bit, we have
followed the agency, and in the reauthorization last year, the
name was changed, and with a lot of working together and a lot
of foresight, it was exactly for this reason, where the focus
is very much on quality and research.
Dr. Eisenberg has held his current post since 1997. His
agency is the lead Federal agency charged with conducting and
sponsoring research to improve the quality, the
appropriateness, the effectiveness of health care services and
to improve cost and access to care.
Dr. Eisenberg also serves as Senior Adviser to the
Secretary on Quality at the Department of Health and Human
Services. His career includes a variety of positions in
academia and Government. Prior to being appointed to AHRQ, Dr.
Eisenberg was chairman of the Department of Medicine and
physician-in-chief at Georgetown University. He has also been
chief of the Division of General Internal Medicine at the
University of Pennsylvania. He has held a number of key
positions in the research community, physicians' associations,
and in the clinical practice of medicine.
Dr. Eisenberg, we are pleased to have you with us once
again.
Dr. Eisenberg. Thank you--I suppose I should say ``Messrs.
Chairmen''--for the invitation to join you today. I am pleased
to be here to discuss the response of the Quality Interagency
Coordination Task Force, or QuIC, to the Institute of
Medicine's report entitled, ``To Err is Human: Building a Safer
Health Care System.''
I want to take a moment to make a personal comment about
what a pleasure it is to be in a hearing where Dr. Relman is
testifying. He was the chairman of medicine at the University
of Pennsylvania when I was a resident, and when I went to him
and said, ``I would like to be a clinician, but I also want to
do research related to health care improvement,'' he said,
``That is great--why don't you study at the Wharton School?''
As Senator Frist will attest, it is not always that you get
encouragement like that at that stage in your career when you
want to do something unorthodox, so I want to thank him for
that. Were it not for his encouragement, I would not be here
today. After the testimony, others can decide if that is a good
thing or not, but I do want to thank him for getting me started
in this area.
Senator Frist. Dr. Eisenberg, pull the microphone just a
little bit. These are very directional microphones, so during
the hearing, I will keep repeating that so people in the back
can hear as well.
Dr. Eisenberg. The QuIC was created by President Clinton in
1998 when he received the final report of his Quality
Commission in March of that year. This organization, the QuIC,
or Quality Interagency Coordination Task Force, brings together
every Federal agency that is involved in health care quality so
that we can collaborate and coordinate all of our efforts to
improve quality. It is chaired by Secretary of Health and Human
Services Donna Shalala and by Secretary Alexis Herman of the
Department of Labor. I serve as its operating chair, and Dr.
Garthwaite is one of its key members. I testify today not so
much in my role as director of the Agency for Healthcare
Research and Quality but as the operating chair of the QuIC.
Later today, as has been mentioned, Secretaries Shalala and
Herman will present the response of the QuIC to the President
at a White House ceremony.
What I would like to do now is submit for the record our
report--other copies are available here today--entitled,
``Doing What Counts for Patient Safety: Federal Actions to
Reduce Medical Errors and Their Impact.'' And doing what counts
is very important, because we think that not only should we
count what is happening, but we need to do what counts in order
to improve patient safety in response to that.
The Institute of Medicine report certainly shocked the
Nation. Newspapers and television nationwide covered the story;
they reported that 44,000 to 98,000 Americans were dying each
year as a result of preventable medical errors, in hospitals.
Clearly, those numbers reflect a problem of near epidemic
proportion.
The administration has had a longstanding commitment to
improving health care quality and to improving patient safety,
and my written testimony details at length a number of existing
Federal efforts that are underway to reduce the medical errors
that exist and to improve patient safety in this country. But
we do not think that that is enough; we think more needs to be
done.
The Institute of Medicine proposed a four-tier approach to
reducing medical errors and called for a national goal of
reducing the number of those errors by 50 percent in 5 years.
We agree with that goal, we fully endorse that goal, and we are
going to work to achieve it with the following steps which are
also, in a corresponding way, four steps, as a part of our
strategy.
The first step is to create a national focus on patient
safety. The Institute of Medicine recommended and we endorse
the establishment of a research center on patient safety within
the Agency for Healthcare Research and Quality, or AHRQ. This
new Center for Quality Improvement and Patient Safety will
support research, especially extramural research, and it will
support the kinds of centers of excellence in patient safety
research that we have sponsored in biomedical research. This
center is also going to support studies to determine the best
way to translate research findings into practice and will do
that in partnership with both the public and private sectors.
The center at AHRQ will also have the responsibility for
integrating these efforts into the Agency's broader quality
agenda, recognizing that patient safety is part of the broad
agenda of quality in this country. It will include support for
centers for education and research in therapeutics and the
National Report on Quality, which both of your committees have
urged us to do by mandating in our reauthorization and by
providing appropriations to get the program started. The
President's fiscal year01 budget includes $20 million to
support this center's initial activities.
The second step is to establish reporting systems
nationwide. This will help us to achieve complementary goals
of, first, accountability to the public, and second, a learning
environment for the health care industry. We firmly believe
that the American public has the right to know how safe its
health care system is and what is being done to make it safer.
So following the IOM's recommendations, we will work to promote
a nationwide system of State-based mandatory reporting programs
to gather this information.
We believe that this mandatory data should collect
information on errors that result in death or serious harm, and
we agree with the Institute of Medicine that this data should
be reported to the States by health care systems and then
reported to the public without identification of patients and
without identification of health care professionals.
But we think we should do more than that. We believe that
we should do more, especially to find the best way to be
accountable to the public which wants so much for its health
care system to be safe. The Health Care Financing
Administration, for example, will undertake several
initiatives. First, it will develop a pilot program with a
State that has a mandatory system to determine what the best
way is to report these preventable adverse events, the events
that should never occur. HCFA will also require as part of its
conditions of participation that hospitals participate in
mandatory programs and that the over 6,000 participating
hospitals in the Medicare program participate in those programs
and demonstrate that they have a patient safety program in
place. HCFA will also work with a peer review organization not
develop a mandatory reporting system that will remain
confidential in order to help hospitals and health
professionals learn how to prevent errors through improved
systems in up to 100 hospitals.
Now, similar to these activities from the Health Care
Financing Administration as a value-based purchaser, another
Federal value-based purchaser, the Office of Personnel
Management, will instruct the almost 300 health plans in the
Federal Employees Health Benefits Program to include error
reduction and patient safety initiatives beginning in the year
2001, so that its call for proposals this year will include
that requirement.
To fulfill both the learning objectives and the
accountability objectives, the Federal agencies that deliver
health care, like those that purchase health care, will make a
commitment to establish reporting systems and to be sure that
they do everything they can to improve patient safety. For
example, the Department of Defense will soon implement a
mandatory but confidential reporting system in its hospitals
and clinics that will be modeled after the ones developed by
the VA that Dr. Garthwaite will be describing.
Agencies other than the purchasers and providers of care
will also contribute to patient safety. The CDC and the FDA,
which currently run reporting systems that provide
opportunities for learning how to prevent adverse events, are
going to be able to ensure even more in the future that the
health care system is publicly accountable for safety. These
efforts are going to be strengthened by activities like the
FDA's extension of mandatory reporting requirements for blood
banks and establishments that deal with blood products, from
the 400 today to the entire 3,000 that are involved in blood
banking and the delivery of blood products.
In every one of these programs, no matter which part of the
Federal role in health care quality we are addressing,
partnerships are going to be key. Whether it is the researchers
or the providers or the purchasers or the regulators of health
care in the Federal Government, partnerships with hospitals and
health professionals and patients are going to be absolutely
critical.
To make these partnerships work, we believe that one of our
first steps should be to work with the National Forum for
Health Care Quality Measurement and Reporting, also known as
the Quality Forum, which is a private sector standard-setting
body that was launched by Vice President Gore and is now an
independent membership organization. It will identify a basic
set of patient safety measures and a set of proven patient
safety practices, based on good evidence about what works, that
should be reported by every hospital. The Quality Forum's
recommendations will be used to guide the Federal reporting
systems, such as the one that the Health Care Financing
Administration will develop.
We believe that these reporting systems should include just
the most serious events that are preventable, the deaths and
serious adverse events, in the mandatory and publicly disclosed
system, but we also believe that it is important for us to give
the public information on whether health care delivery
organizations are responding to those errors by adopting
patient safety practices.
We are going to work with the Forum closely to determine
how best to disseminate this data to the public and to asset
the States and others who want to do a better job in
understanding what the most effective data collection and data
dissemination methods are. The Agency for Healthcare Research
and Quality will lead a research and evaluation effort to study
those existing mandatory reporting systems and to develop
recommendations for their improvement.
We hope that these activities will inform and encourage the
State efforts as well as private efforts. It is our goal that
mandatory reporting systems should be in place in all 50 States
within 3 years. Within 3 years, the QuIC will review the
evaluations of the State programs that I have described, assess
their impact, see how they can work best, assure that the
reporting requirements help and do not hinder reporting and
patient safety, and recommend whether further Federal action is
needed.
In addition to these mandatory systems, both those on very
serious adverse events that are publicly reported as well as
those that remain confidential, the QuIC also agrees that there
is a place for voluntary reporting. This voluntary reporting
should focus on a broader array of information, including what
are called ``close calls'' which might have been intercepted in
time to prevent patient injury; to identify and to learn from
those close calls, and from the pattern of those errors. We
know from other industries like aviation that confidentiality
is a vital feature of this type of reporting system, and it is
critical in order to encourage widespread cooperation. We will
evaluate the effectiveness of these voluntary systems,
including the VA's soon-to-be-implemented voluntary system.
Also learning from the aviation experience, the QuIC
believes it is important that peer review protections that are
now available to the peer review organizations be extended to
others who are working on confidential reporting systems,
whether they are mandatory or voluntary; but these protections
should never deny an individual information from his or her
medical record, nor should it limit the normal process of
discovery of the original records. The QuIC believes that
patients and their families, as Senator Specter said, should be
told about serious events that occur to them or to their family
members, and we believe that the entire Nation should follow
the lead of the VA and the Defense Department, who are putting
that principle into practice.
In addition to these reporting and research initiatives by
Federal purchasers, the third step recommended by the Institute
of Medicine was to set performance standards and expectations
for safety at both the health care organization and individual
provider levels. We agree with the IOM's recommendation that
the States have a key role not only in reporting but also in
assuring the competence of health care professionals and the
licensing of institutions. The QuIC also recognizes the
critical role that professional societies play, as do
accrediting organizations, and we are prepared to offer
technical assistance and collaboration to professional
societies and accrediting organizations to be sure we promote
the models of best practices and patient safety. This year, for
example, the Department of Labor will work with private sector
employers and employees to incorporate patient safety into
purchasing decisions.
The administration also agrees with the IOM's
recommendation----
Senator Specter. Dr. Eisenberg, could you summarize at this
point, please?
Dr. Eisenberg [continuing]. I will--to increase the
attention to safe use of drugs. The FDA will expand its
programs of reporting in order to improve reporting of adverse
events and also to be sure they are safe.
Finally, we believe that the QuIC should make every effort
possible to join you in commending the Institute of Medicine's
panel for its excellent and thoughtful report. The Institute of
Medicine has challenged each of us to be safer, to build safer
systems of health care that prevent those human errors from
turning into human tragedies.
PREPARED STATEMENT
The QuIC and all of its participating agencies represent
the capacity of the Federal public sector's commitment to do
better--as researchers, as purchasers, as providers, as
regulators, and so on--and we stand ready to work with the
Congress so that we can work with our fellow public sector
agencies, with the States, and with the private sector to
reduce medical errors and make American health care safer for
everyone. That is the only way that we are going to meet this
challenge.
Thank you very much.
Senator Specter. Thank you very much, Dr. Eisenberg.
[The statement follows:]
PREPARED STATEMENT OF HON. JOHN M. EISENBERG
INTRODUCTION
I am very pleased to be here today to discuss the response of the
Quality Interagency Coordination (QuIC) Task Force to the recent report
of the Institute of Medicine on medical errors, To Err Is Human:
Building a Safer Health System. The QuIC is chaired by HHS Secretary
Donna E. Shalala and Labor Secretary Alexis Herman; I serve as its
operating chair, and I testify today in that capacity.
President Clinton has a longstanding commitment to improving health
care quality and protecting patient safety. In 1998, he created the
QuIC to focus Federal efforts to improve health care quality and
appointed Health and Human Services Secretary Shalala and Labor
Secretary Herman as co-chairs. When the IOM report was released, the
President requested that the QuIC evaluate its recommendations and
provide recommendations for further action to prevent medical errors.
Later today, Secretaries Shalala and Herman will formally present
the response of the QuIC to President Clinton at a White House
ceremony. I would now like to submit a copy of that report--Doing What
Counts for Patient Safety: Federal Action to Reduce Medical Errors and
Their Impact--for the record. Before I outline its details, I would
like to discuss briefly the issue of medical errors and ongoing Federal
efforts to improve patient safety.
The IOM report shocked the Nation. Newspapers and television
nationwide carried the story that anywhere from 44,000 to 98,000
Americans die each year as a result of preventable medical errors in
hospitals. Many more are permanently or temporarily disabled, and still
more experience minor or no ill effects, but nonetheless have been
victims of medical errors. In addition, because of limited data, we
don't know about the rate of medical errors that occur in health care
settings outside of hospitals.
Clearly, the numbers we do know reflect a problem of near epidemic
proportions.
Many of the findings described in the IOM report are not new.
Perhaps the most significant contribution of the report has been to
bring the information together in one place, draw it to the attention
of the American public, and issue a call for action.
FEDERAL EFFORTS
To say we know about the problem, begs the question, ``What have we
done to address medical errors?'' The answer is we've done quite a bit,
but much more can and should be done.
In early 1997, the President established the Advisory Commission on
Consumer Protection and Quality in the Health Care Industry, and
appointed Secretaries Herman and Shalala as co-chairs. The Quality
Commission released two seminal reports focusing on patient protections
and quality improvement. Also consistent with the Quality Commission's
recommendations, Vice President Gore launched the National Forum for
Health Care Quality Measurement and Reporting. The ``Quality Forum'' is
a broad-based, widely representative private advisory body that
develops standard quality measurement tools to help all purchasers,
providers, and consumers of health care better evaluate and ensure the
delivery of quality services. In addition to the work and significant
potential of the QuIC and Quality Forum, other Federal agencies have
made significant efforts to reduce medical errors and increase
attention on patient safety.
The Quality Commission, in its final report to President Clinton,
highlighted medical errors as one of the six quality challenges facing
the American health care system. On December 7th, he directed the QuIC
to evaluate the IOM report and present to him its own recommendations
for reducing medical errors and improving patient safety. Those
recommendations are in the report I've just submitted for the record.
I would like to note, however, that Federal efforts to improve
patient safety predated the Quality Commission's deliberations and the
IOM report. A few highlights:
--The Agency for Healthcare Research and Quality, which I direct,
sponsored landmark research into the frequency and causes of
medical errors and testing techniques designed to reduce them.
This research was used by the IOM panel in its deliberations.
--The Centers for Disease Control and Prevention (CDC) collect data
on such adverse events as hospital-acquired infections, and the
Food and Drug Administration collects data on errors related to
drugs and medical devices, one of the most frequent sources of
medical errors. These agencies then report findings back to
health care providers and medical manufacturers to assist them
in taking action to prevent similar occurrences.
--The Departments of Veterans Affairs and Defense have instituted
computerized physician order entry systems, a proven deterrent
to errors caused by drug interactions. The VA, which also has
one of the world's largest and most advanced computerized
patient record systems, has created an error reporting system
and is using bar code technology for medication administration
and blood transfusions, all in the name of reducing medical
errors.
--The Health Care Financing Administration's (HCFA) ``Conditions of
Participation'' for Medicare provider facilities addresses
quality of care. VA uses its purchasing power to demand safe
packaging and labeling of the drugs it buys. And the Office of
Personnel Management (OPM) announced it will require meaningful
patient safety programs in all health plans in the Federal
Employees' Health Benefits Program to implement patient safety
initiatives beginning in 2001.
But, as I stated earlier, more should be done.
QU IC RESPONSE
The IOM proposed a four-tiered approach to reducing medical errors
and called for a national goal of reducing the number of errors by 50
percent in 5 years. We fully endorse that goal, and we will work toward
achieving it with the following strategy:
The first step is to create a national focus on patient safety. The
IOM recommends, and we endorse, the creation of a Center for Patient
Safety within the Agency for Healthcare Research and Quality.
The President has included an additional $20 million in his fiscal
year 2001 budget for AHRQ to conduct research on medical errors
reduction, including creating a new Center for Quality Improvement and
Patient Safety. Those funds will be used to develop national goals,
invest in an aggressive research agenda, convert findings into improved
health care practices, and educate patients about their safety. The
Center--or CQuIPS will perform these functions in partnership with both
the private and public sectors and integrate these efforts into the
Agency's broader quality agenda.
The second step is to establish reporting systems nationwide. In
order for there to be an effective, coordinated approach to reducing
medical errors, we need much more information than we have now, in
comprehensive and useful formats. Our objective will be to achieve the
complementary goals of accountability to the public and a learning
environment for the health care industry. The IOM recommended
establishment of nationwide reporting systems that contain both
mandatory and voluntary components as the means to gather this
information.
We agree, and will pursue the development of a well-designed
patient safety program that includes reporting systems that hold health
care systems accountable for delivering high-quality care and provide
valuable information for decisionmakers to use in making our health
care system safer.
It is important to note that the QuIC believes that any legislation
or administrative intervention in this area should not undermine
individuals' rights to redress for criminal activity, malpractice, or
negligence. The QuIC does not support legislation that would allow
safety reporting systems to serve as a shield for providers engaging in
illegal or negligent behavior.
The American public has the right to know how safe its health care
is and what is being done to make it safer. We support the development
of standardized, State-level mandatory reporting systems that include
both mandatory and voluntary components. We believe the mandatory data
systems should collect information on errors that result in death or
serious harm to individuals. We also believe that the data should be
aggregated by the States and reported to the public grouped by health
system without identification of patients or health care professionals.
This should provide the public with information that it deserves about
the quality of care without compromising patient privacy.
To fulfill both the accountability and learning objectives, the
Federal agencies that deliver health care are also taking action to
establish reporting systems. The Department of Defense will soon
implement a reporting system in its hospitals and clinics modeled on
the one used by VA. Dr. Garthwaite will be describing VA's system in a
few minutes. Federal agencies such as the CDC and FDA currently run
reporting systems that provide opportunities for learning how to
prevent adverse events and ensure that the health system is publicly
accountable for safety. These efforts will be strengthened by the FDA's
requirement for blood banks and establishments dealing with blood
products to report errors and accidents.
In addition, we will ask the National Forum for Health Care Quality
Measurement and Reporting, the private-sector, standards-setting body
launched by Vice President Gore, to identify a basic set of patient
safety measures and proven patient safety practices. We will encourage
reporting systems to include information on whether health care
delivery organizations have adopted these practices in the information
made available to the public. We will work with the Forum to determine
how best to disseminate the data to the public. To assist States and
others in understanding the most effective data collection and use
practices, AHRQ will lead an effort to evaluate existing mandatory
reporting systems and develop recommendations for improvement.
HCFA, through its Peer Review Organizations (PRO) Program, will
test the effectiveness of developing a data collection and technical
assistance function to help hospitals identify error-prone practices
and modify their medical delivery systems to reduce or eliminate
errors. This will be tested in up to 100 hospitals that volunteer to
participate in this model mandatory reporting system. Funding for these
pilot projects will be derived from existing resources in the
President's fiscal year 2001 budget for PROs.
We hope these activities will inform and encourage State efforts to
implement reporting systems. It is our goal that mandatory reporting
systems be in place in all 50 States within 3 years.
We also agree there is a place for voluntary reporting systems
designed to collect a broader array of information, including close
calls that were intercepted in time to prevent patient injury,
identifying and learning from patterns of errors. We know from other
industries, like aviation, that confidentiality is a vital feature of
this type of reporting system, in order to encourage widespread
cooperation.
We will evaluate the effectiveness of current voluntary reporting
systems, including the VA's soon-to-be-implemented voluntary reporting
system nationwide that will identify, evaluate, and take steps to
prevent errors in its facilities.
If the first and second steps are to create a national focus on
patient safety, and to establish both mandatory and voluntary reporting
systems, the third step is to set performance standards and
expectations for safety at both the health care organization and
individual provider levels as recommended in the IOM report. We agree
with the IOM's conclusion that the States have a key role in assuring
the competence of health professionals. The QuIC also recognizes the
importance of professional societies and accrediting organizations, and
we will offer technical assistance, and as well as promote models of
best practices in patient safety.
We can, and will, however, take positive steps toward ensuring that
health care organizations implement patient safety programs. HCFA will
publish regulations requiring hospitals participating in the Medicare
program to have ongoing medical error reduction programs in place. That
alone will affect over 6,000 hospitals nationwide. The OPM will
instruct the almost 300 health plans in the Federal Employees Health
Benefits Program to include error reduction and patient safety
initiatives beginning in 2001. This year, the Department of Labor will
work with private-sector employers and employees to incorporate patient
safety into purchasing decisions by including information on medical
errors in the educational material disseminated through its Health
Benefits Education Campaign.
Third, the Administration also agrees with the IOM recommendation
to increase the attention given to safe use of drugs and medical
devices, and the President has increased the FDA's funding level for
pre- and post-marketing oversight in his fiscal year 2001 budget
request.
Finally, the IOM urged that health care organizations make a
commitment to continuous patient safety improvement. We couldn't agree
more. Within the Federal community, VA and DoD--leaders in the patient
safety area--have implemented a variety of innovations to enhance
patient safety, including enhanced safety training for staff, use of
computerized medical records, and adoption of automated prescription
order entry systems. This summer they will lead a QuIC initiative to
test strategies to improve patient safety in ``high hazard areas,''
like labor and delivery rooms, emergency rooms, operating rooms and
intensive care rooms.
CONCLUSION
I would like to commend the IOM panel for its excellent and
thoughtful report. Its recommendations are vitally important to the
safety of the American people. We agree with each of its
recommendations, and the QuIC report details how we will address them.
The QuIC and all its participating agencies stand ready to work hand in
hand and with our fellow public-sector agencies, States, and the
private sector in a collaborative effort to reduce medical errors and
make the American health care system safer for all. That's the only way
we will meet this challenge.
This concludes my prepared remarks. I will be happy to respond to
any questions you may have. Thank you.
Senator Frist. Senator Specter will introduce Dr.
Garthwaite.
STATEMENT OF DR. THOMAS LEONARD GARTHWAITE, DEPUTY
UNDER SECRETARY FOR HEALTH, DEPARTMENT OF
VETERANS AFFAIRS
Senator Specter. Dr. Thomas Garthwaite is Acting
Undersecretary for Health at the Department of Veterans
Affairs. He specializes in endocrinology and has served the
Veterans Administration for some 25 years. He has a bachelor's
degree from Cornell University and an M.D. from Temple in
Philadelphia.
Dr. Garthwaite testified at last month's hearing on medical
errors, held jointly by the Veterans Affairs Committee and the
Subcommittee on Labor, Health and Human Services, and
Education. The Veterans Administration implementation of the
National Patient Safety Program with the disclosure of medical
mistakes has been a forerunner in this field, and Dr.
Garthwaite had some important testimony to offer at last
months' hearing and I know is an important witness again here
today.
Senator Specter. Now we turn to Dr. Garthwaite.
Dr. Garthwaite. Mr. Chairman and distinguished members of
the committees, thank you for inviting us here today to testify
on the critical issue of patient safety.
In 1996, President Clinton demonstrated his leadership and
commitment to improving our health care system by establishing
the Advisory Commission on Consumer Protection and Quality in
the Health Care Industry. Actions taken by the President on
recommendations of the Commission have led to a new focus and
cooperation within the administration to improve health care
quality, and I believe Dr. Eisenberg has just detailed that
cooperation quite well.
In 1997, the Department of Veterans Affairs began a major
initiative to establish a system and a culture to improve the
safety of our health care system and, by sharing our results,
to improve health care safety for everyone. Our written
testimony details our extensive efforts to date. I would like
to comment on VHA's plans for the next couple of years.
First, we will continue to implement safety measures.
Medication errors are among the most common errors in medicine.
We anticipate that a bar code system for medication
administration will prevent over two-thirds of medication
errors. We plan to have this system in all VA medical centers
by this June.
In the high-risk and intensive environment of an operating
room, time can be of the essence. An anesthesia reminder list
of important facts has found to be helpful in emergency
situations. We will place such a check list on every anesthesia
machine in the VA this year.
We have found that suicide is among the most common
unexpected causes of loss of life during or immediately after
hospital discharge. We have developed new guidelines on the
treatment of depression and will promulgate their use
throughout the VA this year. We are also organizing a Suicide
Summit to bring together experts on depression and to spotlight
this altogether too common tragedy.
In addition to implementing these and other safety
measures, we will continue to expand and hone our comprehensive
safety program. We will expand our National Center for Patient
Safety. This Center leads our efforts in implementing and
improving our mandatory and voluntary reporting systems,
educating the work force in root cause analysis, in creating a
culture of safety, in analyzing the root cause of error and of
close calls, and in design and implementation of improved
systems of care.
We will continue to fund our four Patient Safety Centers of
Inquiry. These Centers currently target their safety research
on organizational issues and training, on fall prevention, and
the development of safer hospital rooms, on human factors
engineering, including the interactions among health care
workers and between workers and their machines, and on training
in safety with an emphasis on the use of simulators for
research and competency testing.
In addition, each of our Quality Enhancement Research
Initiatives will add patient safety to their goals and
objectives. These research initiatives seek to move health
services research to the bedside by targeting the effects of
providers and systems on patient outcomes.
We will add staff dedicated to patient safety. We estimate
adding 190 full-time-equivalent employees to our current
composite effort of 294. In addition, we have a goal that half
of all full-time staff will receive 20 hours of training in
patient safety this fiscal year. This represents a commitment
of over $39 million and 1.6 million man-hours of training.
We will continue to fund the VA Quality Scholars Program.
This unique fellowship in quality and safety is currently
available for 10 physicians per year at five VA facilities
affiliated with academic institutions. It is designed to
promote the academic awareness of safety design issues in
medicine.
Underlying our comprehensive program for patient safety are
several key principles. We believe that the institution
delivering care has a responsibility to assume that individuals
will make errors. Those institutions must find the systems that
allow the errors to occur and improve the design of those
systems. The new designs might either prevent error or minimize
the impact of error.
We also believe that those institutions must share their
lessons learned; otherwise, each system is doomed to harm a
patient to learn the very lesson previously learned in another
institution. All institutions have a responsibility to detect
the less common cause of error related to incompetent providers
and to take appropriate action.
In VA, we believe that we must, first, openly inform
patients or family about their errors; second, have a system of
mandatory, but not punitive, reporting and analysis of adverse
events within a process protected from public disclosure of
individual patients and practitioners; third, have a
complementary voluntary system of reporting which in other
systems, like aviation, has been shown to provide additional
important information; fourth, to analyze those adverse events
and close calls for possible systemic fixes and new standards;
fifth, and critically important, to implement new standards
rapidly and universally across our health care system; and
sixth, to share our important lessons and improvements with
other health care institutions in VA and outside.
VA has chosen to use its unique position as a publicly
accountable national health care system to lead in the effort
to ensure the safety of patients. We also will use our strength
as a major research and educational organization to conduct
research on safety and to add human factors and organizational
design to the curriculum of clinical and administrative
students in VA.
PREPARED STATEMENT
It is the opportunity to learn from a single mistake that
all health care must embrace and which underlies the need for
event reporting systems. VA has established such systems. We
believe that we must share our lessons learned broadly but also
hope to learn from the experience of others.
Thank you.
[The statement follows:]
PREPARED STATEMENT OF HON. THOMAS L. GARTHWAITE
Mr. Chairmen and Members of the Committees, 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. 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 Partnership's
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. 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 and VISN 22. 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 first
pilot site--VISN 8--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. 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.
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.
Attachment 1
NCPS Handbook
[DRAFT--Not For General Distribution]
VHA National Patient Safety Improvement Handbook
Foreword
It has been reported in the medical literature that as many as
180,000 deaths occur in the United States each year due to errors in
medical care, many of which are preventable. In order to take actions
that will improve this situation, it is necessary to have a clear
picture as to what is actually happening so that appropriate steps can
be taken that will prevent such occurrences. For this prevention effort
to be effective, it will be necessary to establish methods of gathering
and analyzing data from the field that will allow the formation of the
most accurate picture possible. It is believed that only by viewing the
health care continuum as a ``system'' can truly meaningful improvements
be made. A systems approach that emphasizes prevention, not punishment,
as the preferred method to accomplish this goal will be used. Armed
with this type of information the most appropriate conclusions can be
drawn from which prudent solutions can be formulated, tested, and
implemented. Ultimately, this effort can be successful only if emphasis
on safety and responsibility for improving it resides at all levels of
the organization. This activity requires a true team effort. People on
the frontline are usually in the best position to identify a number of
issues and their solutions while those in managerial roles are often in
positions that allow the implementation and wide dissemination of
lessons learned. Only by creating and/or maintaining open lines of
communication can the improvements developed be successfully
implemented. If we don't work together, real success will not be
possible. If we are not receptive to changing our way of doing things,
we can't succeed.
What we're talking about here is building a ``culture of safety''.
Such a cultural change does not happen over night. It can only happen
as a result of countless efforts on everyone's part to approach the way
we look at things differently. We must constantly question if we can do
the things in a better, more efficient, and safer manner. We must never
let ``good enough'' be good enough. We must be relentless in our
pursuit of finding ways to improve our systems. We don't believe people
come to work to do a bad job or make an error, but given the right set
of circumstances any of us can make a mistake. We must force ourselves
to look past the easy answer that it was someone's fault to answer the
tougher question as to why the error occurred. It is seldom a single
reason. Through understanding the real underlying causes we can better
position ourselves to prevent future occurrences. As has been said,
``Experience is the best teacher'' but is also one of the most
expensive teachers as well. To minimize that expense we must
communicate the lessons we learn throughout the system so that others
can learn from our experience without forcing them or our patients to
learn these same things unnecessarily through their own bitter
experience. While we do a good job now and should be proud of the
service we provide, there are always ways we can do it better in the
future.
The VA is in an exciting position in the field of healthcare. We
have the opportunity to lead the way in improving the overall care
patients receive through the Patient Safety Initiatives that exist now
and that will exist in the future. The impact we can have is enormous
but to do this requires courage on our part. I use the word courage
because to report events that not only resulted in actual problems but
also those situations, referred to as a ``close call', where problems
were averted but the potential for an actual incident did exist is not
the status quo in healthcare or most other industries. It will require
us to learn not to look to fix blame but rather to look to answer the
questions what, why, and how do we prevent it. This will require trust
on everyone's part and that won't and can't happen over night. It will
be the product of many small steps and small victories. But to happen
at all, we have to have the courage to take the first steps and remain
committed to the overall goal of improving safety in the way we provide
care to our patients and run our system. We are sailing into uncharted
waters and will no doubt have to make many changes as we learn. The
important thing is that we begin the journey or else we condemn
ourselves and our patients to the realm of ``good enough''.
James P. Bagian, M.D., P.E.
Director, VHA National Center for Patient Safety.
VHA National Patient Safety Improvement Handbook
1. Purpose
The Patient Safety Improvement (PSI) Handbook's purpose is to
provide a clear roadmap that can be used to guide the VHA in the
accomplishment of its goal of minimizing the chance of the occurrence
of untoward outcomes consequent to medical care. Through the use of
procedures, methods, clarifying examples, and appropriate feedback
loops at all levels of the organization (with accompanying rationale)
it is hoped that this overall goal can be achieved. Incorporation of a
widely understood methodology for dealing with these safety related
issues will allow for clearer more rapid communication of information
both up and down the organization thus speeding the process of safety
improvement. For this to occur, training must take place to complement
the contents of this handbook, reading it alone is not sufficient.
2. Scope
This handbook will delineate what type of events are to be
considered and how they should be dealt with as well as defining the
disposition of events not covered by this handbook. It will also
specify the method by which the need for conducting a root cause
analysis will be determined and what the procedure for communicating
related findings throughout the organization is. These procedures will
address the management component as well as the frontline needs.
3. Definitions
a. Adverse Events.--Adverse events are untoward incidents,
therapeutic misadventures, iatrogenic injuries or other adverse
occurrences directly associated with care or services provided within
the jurisdiction of a medical center, outpatient clinic or other VHA
facility. Adverse events may result from acts of commission or omission
(e.g., administration of the wrong medication, failure to make a timely
diagnosis or institute the appropriate therapeutic intervention,
adverse reactions or negative outcomes of treatment, etc.). All adverse
events require reporting and documentation in the National Patient
Safety Registry (NPSR), however, the type of review is determined
through the Safety Assessment Code (SAC) Matrix scoring process, as
outlined in Appendix SAC. Some examples of more common adverse events
include: patient falls, medication errors, procedural errors/
complications, completed suicides, parasuicidal behaviors (attempts/
gestures/threats), and missing patient events.
b. Sentinel Events.--Sentinel events are a type of adverse event.
Sentinel events, as defined by JCAHO, are unexpected occurrences
involving death or serious physical or psychological injury, or risk
thereof. Serious injury specifically includes loss of limb or function.
Major permanent loss of function means sensory, motor, physiologic, or
intellectual impairment not previously present that requires continued
treatment or life-style change. The phrase ``risk thereof'' includes
any process variation for which a recurrence would carry a significant
chance of serious adverse outcomes. Sentinel events signal the need for
immediate investigation and response. Some examples of sentinel events
include: death resulting from a medication error or other treatment
related error; suicide of a patient in a setting where they receive
around-the-clock care; surgery on the wrong patient or body part
regardless of the magnitude of the operation; and hemolytic transfusion
reaction involving the administration of blood or blood products having
major blood group incompatibilities. (Note: Events considered to be
JCAHO ``sentinel events'' are included in the catastrophic cells of the
SAC Matrix.)
c. Close Calls.--A close call is an event or situation that could
have resulted in an accident, injury or illness, but did not, either by
chance or through timely intervention. Such events have also been
referred to as ``near miss'' incidents. An example of Close Calls would
be: surgical or other procedure almost performed on the wrong patient
due to lapses in verification of patient identification but caught at
the last minute by chance. Close Calls are opportunities for learning
and afford the chance to develop preventive strategies and actions.
Close Calls will receive the same level of scrutiny as adverse events
that result in actual injury. All Close Calls require reporting and
documentation in the National Patient Safety Registry (often referred
to as ``the Registry''), however, as for adverse events, the SAC Matrix
scoring process and score determines the type of review.
d. Intentional Unsafe Acts.--Intentional unsafe acts, as they
pertain to patients, are any events that result from: a criminal act; a
purposefully unsafe act; an act related to alcohol or substance abuse,
impaired provider/staff; or events involving alleged or suspected
patient abuse of any kind. Intentional unsafe acts should be dealt with
through avenues other than those defined in this handbook (i.e.,
Administrative Investigation (AI) or other administrative channels as
determined by the Facility Director). Guidance on what to do when
criminal acts are suspected is described in paragraph 5.d. Intentional
acts will be entered into the National Patient Safety Registry along
with the results of any review or investigation as they pertain to
patient safety. (This will ensure that preventive patient safety
measures, where appropriate, can be shared and/or instituted across
VHA.)
e. Root Cause Analysis (RCA).--Root Cause Analysis is a process for
identifying the basic or contributing causal factors that underlie
variations in performance associated with adverse events or close
calls. This specific type of focussed review known as a Root Cause
Analysis will be the form of focussed review that is used for all
adverse event or close calls requiring analysis since it further
refines the implementation and increases the quality and consistency of
our focussed reviews. To avoid confusion, the term Root Cause Analysis
(RCA) will be used to denote this type of focussed review and will
adhere to the guidelines provided in this handbook (see Appendix RCA).
NOTE: The term Root Cause Analysis needs to be used in documents so
that they will be confidential under Title 38 United States Code
(U.S.C.) 5705 and its implementing regulations.
RCAs have the following characteristics:
1. the review is interdisciplinary in nature with involvement of
those closest to the process;
2. the analysis focuses primarily on systems and processes rather
than individual performance;
3. the analysis digs deeper by asking ``what'' and ``why'' until
all aspects of the process are reviewed and all contributing
factors are (progressing from looking at special causes to
common causes), and;
4. the analysis identifies changes that could be made in systems
and processes through either redesign or development of new
processes or systems that would improve performance and reduce
the risk of event or close call recurrence.
To be thorough, an RCA must include:
1. a determination of the human and other factors most directly
associated with the event or close call and the processes and
systems related to its occurrence; (there is rarely only one
underlying cause)
2. analysis of the underlying systems through a series of ``why''
questions to determine where redesigns might reduce risk;
3. identification of risks and their potential contributions to
the event or close call, and;
4. determination of potential improvement in processes or systems
that would tend to decrease the likelihood of such events in
the future, or a determination, after analysis, that no such
improvement opportunities exist.
To be credible, an RCA must:
1. include participation by the leadership of the organization
(this can range from chartering the RCA team, to direct
participation on the RCA team, to participation in the
determination of the corrective action plan) and by individuals
most closely involved in the processes and systems under
review;
2. be internally consistent (i.e., not contradict itself or leave
obvious questions unanswered), and;
3. include consideration of relevant literature.
Appendix RCA provides details about RCA structure, process and
outcomes.
4. Goals
The goals of the PSI Program are to prevent injuries to patients,
visitors, and personnel, and to manage those injuries that do occur to
minimize the negative consequences to the injured individuals. The way
this will be accomplished is by taking small steps in the way we do
things so that we establish the level of faith and trust in our system
to let these behaviors become a true part of us. This will and should
be a never-ending process. In this way a ``culture of safety'' can be
formed. The key building blocks for accomplishing these goals are:
a. Comprehensive identification and reporting of all adverse
events, Sentinel Events, and close calls (see paragraph 5).
b. Reviewing adverse events, Sentinel Events, and close calls to
identify underlying causes and system changes needed to reduce the
likelihood of recurrence (see paragraph 6). The determination of cause
will be aimed at the system issues not directed at use as a punitive
tool. The requirements for initiating a review will be determined by
the priority scheme as defined by the Safety Assessment Code (Appendix
SAC).
c. Disseminating patient safety alerts and lessons learned
regarding effective system modifications throughout VHA (see paragraph
6) in an effective manner.
d. Prospective analysis of service delivery systems before an
adverse event occurs to identify system redesigns that will reduce the
likelihood of error.
5. Identification and Reporting of Adverse Events, Sentinel Events, and
Close Calls
a. Each VISN will ensure that its designated facility manually or
electronically reports at least the following events:
1. Adverse Events (see Definitions, paragraph 3a).
2. Sentinel Events (see Definitions, paragraph 3b).
3. Close Calls (See Definitions, paragraph 3c).
b. Facility staff will also report any unsafe conditions of which
they are aware, even though the conditions have not yet resulted in an
adverse event or close call. These would include potential system
weaknesses that were identified through prospective hypothetical
analyses (``what if'' types of questions) using techniques such as
failure modes and effects analysis (FMEA).
c. Adverse events, Sentinel Events, and Close Calls shall be
reported within the facility to the risk manager (or other
appropriately designated party) within 24 hours of their detection. The
risk manager (RM) will then use the Safety Assessment Code Matrix (SAC)
to determine what action is required. This action could range from
reporting to the VISN, National Center for Patient Safety (NCPS), and
JCAHO with associated RCA performed and corrective action plan, to a
decision to do nothing at the present time due to the low priority
accorded the event from its SAC score. Appendix SAC details how the SAC
score is used and paragraph 6 shows the procedure that will be followed
for handling events that are reported along with the associated time
constraints and products required as well as to what organization
reports will be made. Events affecting personnel, visitors, and groups
of patients as well as individual patients are covered here as well. If
a safety alert to other facilities seems needed, this should be
indicated (this is covered in the Appendix RCA).
If in the course of conducting a RCA it appears that the event
under consideration is the result of an Intentional Unsafe Act the RCA
team will refer the event to the facility director for appropriate
further consideration as is described in paragraph 3.d. above. In such
a situation the RCA team will then discontinue their efforts, since the
facility director will have assumed the responsibility for any further
fact finding or investigation, while still maintaining the information
they have already collected confidential as per Title 38 United States
Code (U.S.C.) 5705. This means that members of the RCA team in question
could not serve on an AI team that might be convened by the facility
director to consider this particular issue.
d. If a crime is suspected to have been committed, appropriate
officials should be notified as soon as possible by management (see
Title 38 Code of Federal Regulations (CFR) Sections 14.560 and 14.563,
MP-1, Part I, Chapter 16 and MP-1, Pt. I, Ch. 2, subpar. 208.02). To
the extent possible the surrounding area should not be disturbed so
that evidence is available for review by the police and other
authorities. However, care needed by the patient should always be
provided as quickly as possible, regardless of its effect on the site.
As required by 38 CFR Sections 14.560 and 14.563, allegations of crimes
against the person or property, or other non-fraudulent criminal
matters shall be referred to the Regional Counsel, who will then refer
the matter to the appropriate law enforcement agency. Serious crimes
(felonies or misdemeanors) committed on hospital or domiciliary grounds
must be reported directly to the United States Attorney or local agent
of the Federal Bureau of Investigation. Allegations of fraud,
corruption or other criminal conduct involving VA programs and
operations must be referred to the Office of the Inspector General.
Notification should also be given to the Deputy Assistant Secretary for
Security and Law Enforcement and to the VISN office. The VISN office
will inform the CNO.
If a crime is suspected to have been committed, facility security
and medical staff may need to assist law enforcement agencies with
preserving evidence (e.g., blood alcohol levels, weapons, controlled
substances). Local policies and procedures for maintaining the chain of
custody of evidence apply in those instances.
e. Staff who submit close call and adverse event reports will
receive feedback on the actions being taken as a result of their
report. The feedback should be of a timely nature and come from the
risk manager (or other appropriately designated party). Prompt feedback
to reporters has been credited in other reporting systems with being
one of the cornerstones that establishes trust in the system in that it
demonstrates the seriousness and commitment on the part of the system
to the importance of the reporting effort. The bottom line here is for
the reporters to be made acutely aware that their effort of reporting
was not just a paperwork drill. The nature of this feedback can range
from a simple acknowledgement that the event is under consideration, to
providing information as to the corrective action that is planned or
has been accomplished.
f. Each VISN and facility will adopt strategies to motivate and
facilitate staff identification and reporting of adverse events and
close calls, even when staff errors contributed to the event. Emphasis
should be placed on the value of close calls in identifying needed
system redesigns. Identification and reporting of adverse events and
close calls, including those that result from practitioner error, need
to be a routine part of everyday practice. Employees need to understand
that human errors are commonly due to systems type problems. They
especially need to understand that the most conscientious,
knowledgeable, and competent professionals can make errors.
g. The National Patient Safety Registry will be used to track and
monitor reported events. The field will accomplish initial entry of
data into the Registry. This is so the accuracy of the data recorded
will be as high as possible and avoids translation and transcription
errors that could occur if this function was accomplished at some other
level in the organization. Further, it is intended that the data entry
should occur at the facility level, where technically possible, for the
same reasons as described above.
6. Review and Analysis of Reported Events
a. A procedure has been worked out so that the review and analysis
system for handling reports proceeds in an understandable manner and
takes into account the various requirements of the VHA and accrediting
organizations. The process is schematically outlined in Figure 1.
The following description will ``walk you through'' the chart
above. The first step taken by the RM after any required immediate
action is to assign a SAC score (see Appendix SAC) that then defines
the further actions that are necessary.
Events receiving a score of 2 or 1 will be acted on as thought
appropriate by the facility. You will need to either eliminate,
control, or accept the risks associated with these events. These
actions can range from performing an RCA to no further action required.
All events receiving a SAC score of 3 will receive either a
traditional RCA or an Aggregated Review as described below and the
initial report of the event will be entered into the Registry where it
can be accessed by the VISN, CNO, and the NCPS.
A quarterly Aggregated Review may be used for three types of
events. The three types of events are: falls; medication errors, and;
parasuicidal behavior (see Appendix Aggregated Reviews). The use of
aggregated analysis serves two important purposes. First, greater
utility of the analysis (i.e., trends or patterns not noticeable in
individual case analysis are more likely to show up as the number of
cases increases). Second, it makes wise use of the RCA team's time and
expertise. The NCPS will use this information to compare to other data
it has and determine if any immediate action as far as the issuance of
alerts, etc. is indicated. It must be noted that any event may be
subjected to a traditional RCA even though it is in a category that is
permitted to use the aggregated approach if this course of action is
thought to be appropriate. Further, events that are in those categories
that are eligible for Aggregated Review and have received a SAC score
of 3 based on what has occurred rather than a potential/risk thereof
will have a RCA performed and not be allowed to use the aggregated
approach.
If the event in question is an actual adverse event meeting the
JCAHO definition of Reviewable Sentinel Event the facility will then
make the determination if they will report it within 5 calendar days of
occurrence to the JCAHO (this may entail consultation with other
entities, such as the VISN, as is defined by local policy) as is
indicated by the first dotted line in the chart. In either case, the
event receives an RCA and results are reported to the Registry and if
previously reported to the JCAHO, to them as well. The report of the
outcome of the RCA will be completed within 45 calendar days and
forwarded as described above.
It is worthwhile noting that only two reports might result, that is
the one before the RCA is performed and that after the RCA is
completed. This was specified so as to reduce the burden on the
frontline folks to that which was already required of them to
prioritize (SAC score) and do their RCA.
To summarize, facilities have the option to report to JCAHO as
explained in JCAHO policy. The RCA report delineated in Appendix RCA
will be used and will be retained by the facility even after the
results have been entered into the Registry so that they can be made
available for future review as required.
The point where the real benefit of this entire process will be
realized is after the RCA is completed and the corrective actions that
can be taken to prevent the future occurrence of similar events are
defined and implemented. These corrective actions will fall into the
categories of eliminate, control, or accept and the rationale for
selecting one approach over another should be documented. Once
implemented, a plan for evaluating the effectiveness of the implemented
change must be enacted to insure that this change has the desired
effect and the subsequent results communicated to the VISN and NCPS
(see Figure 2) through entry in the Registry or other appropriate
means.
As noted above, all events will be entered into the Registry. In
this way all events reported will be captured in the Registry even if
they have SAC scores less than 3 while remembering that 3's will
receive RCA's as described above. Accordingly, the opportunity will
then exist to better understand the system and appropriately focus our
attentions in the future.
b. The NCPS will be responsible for disseminating the lessons
learned and alerts from the RCAs and the Registry. The NCPS will also
develop methods that the field may find advantageous to implement based
on this and other information.
c. The NCPS will chair the PSI Oversight Committee (PSIOC) which
will be comprised, at a minimum, of a representative of Office of
Quality and Performance (OQP), Office of Medical Inspector (OMI), Chief
Network Officer (CNO), and Patient Care Services (PCS). This committee
will meet monthly to:
1. Review data from the registry for trends.
2. Review RCAs and AIs of selected cases from the Registry where
indicated to guide future policy development.
3. Review selected process improvements for general applicability
and disposition.
4. Recommend topics that deserve further examination or issues
that require further action. This could include recommendation
of quality or performance measures to address issues that have
been identified.
5. Assign follow-up responsibility for issues identified in
activities (1) through (4). Note: The input of subject matter
experts will be obtained as needed.
d. The Office of Medical Inspector shall monitor RCAs and AIs to
assess their adequacy and to identify problems with processes of care
which warrant attention. The OMI may conduct reviews and site visits at
the request of the Secretary of Veterans Affairs, the Under Secretary
for Health, the Deputy Under Secretary for Health, the Inspector
General, veterans and their families, the VISNs and medical facilities,
and other stakeholders, such as Congress and Veterans Service
Organizations. The OMI also may conduct reviews and site visits based
on its own judgement.
7. INFORMING PATIENTS ABOUT ADVERSE EVENTS
a. Background Information
1. VHA is obligated to inform patients and their families, only
as authorized by applicable confidentiality statutes, about
injuries resulting from adverse events and the options
available to them. There is also evidence that patients desire
acknowledgment of errors from their caregivers and that doing
so reduces the likelihood that patients will take legal or
administrative action. Any information disclosed must not come
from documents and data protected by Title 38, United States
Code (U.S.C.), Section 5705. Also, in addition to the
restrictions dictated by the Privacy Act, certain information
generally cannot be revealed even after a patient's death under
38 U.S.C. Section 7332, and includes information related to the
patient's treatment for substance abuse (including alcohol),
sickle cell anemia disease, and HIV status.) Furthermore, the
patient's name and home address cannot be released under
certain circumstances to individuals other than the patient.
Questions about release of information to the patient and the
patient's family should be referred to the facility's Health
Information Service, who may consult with the Regional Counsel,
where applicable.
2. The two primary options available to injured patients or their
survivors are claims for compensation under 38 U.S.C., Chapter
11, Section 1151, and tort claims under the Federal Tort Claims
Act, Title 28 U.S.C., sections 1346 (b), 2671-2680.
(a) Claims under 38 U.S.C. Section can result in payment of
monthly benefits for additional disability or death
incurred as the result of VHA facility care, medical or
surgical treatment or examination, if the disability or
death was proximately caused by negligence or an unforeseen
event. Claims under section 1151 provide for the payment of
a monthly benefit based on the percentage of disability and
eligibility for VA medical care. Claims for 1151 benefits
are processed by VBA Regional Offices.
(b) Tort claims may result in a settlement by Regional
Counsels, General Counsel, United States Attorney, or in a
judgement if a Federal court determines that negligence by
medical practitioners caused injury or death (and
jurisdictional requirements are met). The claimant
frequently receives money in a lump sum payment, but
structured settlements, which can include annuities,
medical trusts, future payments, and reversionary
interests, are also used where appropriate. Tort claims can
result in monetary awards for pain and suffering, which are
not necessarily included in veterans benefits. Tort
settlements or judgements can also be used to provide for
family members in ways that veterans benefits statutes do
not allow. However, an attorney is usually retained, and
attorney fees capped at 20 (administrative settlements) to
25 (litigation) percent of the damages reduce the award the
veteran or survivors receive. Tort claims are processed by
the Regional Counsels.
(c) Veterans and survivors may pursue both section 1151 and
tort claims. However, if both claims are successful, 38
U.S.C. Section 1151 benefits will be offset until the
amount that would have been paid equals the amount of the
tort claim settlement or judgement.
b. Communication with Patients Regarding Adverse Events
1. VISNs will ensure that their facilities have a process in
place to promptly inform patients and their families,
consistent with the legal requirements and restrictions as
stated in paragraph 7.a. above, about pertinent clinical facts
associated with injuries resulting from adverse events,
assuring them that measures have been taken to maintain life
and minimize disability and discomfort. Typically the attending
physician or designated member of the treatment team will be
the ones to communicate with the patients or family initially.
2. VISNs and facilities will ensure that their staff provide
appropriate and timely communication with patients and their
families regarding adverse events that involve potential
organizational liability. Potential organizational liability
should be assessed based on discussions with practitioners and
the Regional Counsel. The patients and their families shall be
advised of appropriate remedial options. These options should
include locally available interventions (e.g., arranging for
second opinions, expediting clinical consultations, inpatient
admission) and referral of patients to the 38 U.S.C. Section
1151 claims process and the tort claims process.
3. One mechanism to facilitate such communication is a standing
PSI group, e.g., the Chief of Staff or designee, Regional
Counsel, Veteran's Benefit Counselor, patient representative,
and PSI staff, that assesses liability issues and coordinates
conferences with patients and families. To provide prompt
responses, the group needs to be able to meet on short notice.
Another approach is to have PSI staff assume these
responsibilities with support and consultation from facility
management and Regional Counsel.
4. A collaborative relationship between Regional Counsel and VA
medical center staff is necessary to ensure that appropriate
and timely communication with patients occurs. Each VISN should
ensure that their staffs develop an understanding with its
Regional Counsel regarding the procedures for obtaining
Regional Counsel input prior to discussing an adverse event
with a patient.
8. TORT CLAIMS
a. Each facility shall ensure that its staff conduct peer reviews
of all new tort claims and share the findings with their Regional
Counsel.
b. State licensing board and National Practitioner Data Bank issues
will be coordinated with the office of the Director of Medical/Legal
Affairs.
Appendix--Close Call System Definitions
WHAT IS A CLOSE CALL?
1. A close call is an event or situation that could have resulted
in an accident, injury or illness, but did not. Close calls can involve
patients, staff or visitors. Close calls can occur in patient care
settings and anywhere else in a VA facility.
2. We have all experienced close calls on the job. A few examples
are listed below.
--A nurse almost gives an overdose of insulin, but recognizes and
prevents the error when double-checking the order. (During the
double check, they realize that they had confused the ``U'',
for units, with a ``0''.)
--An environmental management employee notices a jug of industrial
strength cleaner mistakenly left in the shower stall on a
locked psychiatric unit. They return it to proper storage
before any patient can use it inappropriately.
--On the way to the parking lot, a motor pool employee notices that a
barricade, preventing anyone from using a sidewalk under
repair, has fallen down and been shoved aside. The employee
replaces the barricade and then notifies engineering service of
the hazardous situation before anyone trips and falls.
WHAT IS NOT A CLOSE CALL?
1. There are a few events or situations that are not close calls.
These events or situations are handled through administrative review or
investigation. These excluded events or situations are: Intentionally
unsafe acts; Criminal acts; Acts related to alcohol or substance abuse,
impaired provider/staff; and Events involving alleged or sustained
patient abuse.
Appendix--The Joint Commission on Accreditation of Healthcare
Organizations' (JCAHO) Definition of Reviewable Sentinel Events That
May be Reported to JCAHO
The following criteria define the subset of sentinel events that
are voluntary reportable, at the facility's discretion to the Joint
Commission. Only those sentinel events that affect recipients of care
(patients, clients, and residents) and that meet the following criteria
fall into this category:
1. The event 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,\1\ \2\ or
---------------------------------------------------------------------------
\1\ A distinction is made between an adverse outcome that is
related to the natural course of the patient's illness or underlying
condition (not reviewable under the Sentinel Event Policy) and a death
or major permanent loss of function that is associated with the
treatment, or lack of treatment, of that condition (reviewable).
\2\ ``Major permanent loss of function'' means sensory, motor,
physiologic, or intellectual impairment not present on admission
requiring continued treatment or life-style change. When `major
permanent loss of function' cannot be immediately determined,
applicability of this policy is not established until either the
patient is discharged with continued major loss of function, or 2 weeks
have elapsed with persistent major loss of function, whichever occurs
first.
---------------------------------------------------------------------------
2. The event is one of the following (even if the outcome was not
death or major permanent loss of function):
a. Suicide of a patient in a setting where the patient receives
around-the-clock care (e.g., hospital, residential treatment
center, crisis stabilization center).
b. Infant abduction or discharge to the wrong family.
c. Rape.\3\
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\3\ The determination of ``rape'' is to be based on the healthcare
organization's definition, consistent with applicable law and
regulation. An allegation of rape is not reviewable under the policy.
Applicability of the policy is established when a determination is made
that a rape has occurred.
---------------------------------------------------------------------------
d. Hemolytic transfusion reaction involving administration of
blood or blood products having major blood group
incompatibilities.
e. Surgery on the wrong patient or wrong body part.\4\
---------------------------------------------------------------------------
\4\ All events of surgery on the wrong patient or wrong body part
are reviewable under the policy, regardless of the magnitude of the
procedure.
---------------------------------------------------------------------------
Note: As JCAHO policies are dynamic, it is important to be sure
that the most recent JCAHO Sentinel Event Policies and definitions are
used in making any determination.
Appendix--Aggregated Reviews--Falls, Medication Errors and Parasuicidal
Behavior
Background.--Quarterly Aggregated Reviews, completed within 45 days
of the end of the quarter and conducted by a chartered RCA Teams, may
be used for three types of reported events or close calls (potential
3s). All actual SAC 3s require individual RCAs. The three types of
aggregated reviews are: falls; medication errors, and; parasuicidal
behaviors.
The use of Aggregated Reviews serves two important purposes. First,
greater utility of the analysis (i.e., trends or patterns not
noticeable in individual case analysis are more likely to show up as
the number of cases increases). Second, it makes wise use of the RCA
Team's time and expertise.
Of course, a facility may elect to perform an individual RCA rather
than an Aggregated Review on any of these three types of adverse events
or close calls that they think merits that attention, regardless of the
actual SAC score.
A tailored real-time minimum data set (Aggregated Review Log) will
be compiled for falls, medication errors and parasuicidal behaviors by
designated staff in follow-up to reported events or close calls, during
each quarter. Capturing this data may require medical record review,
medication administration record review, and brief discussion with
staff members most knowledgeable about the events or close calls. The
Aggregated Review Logs will be provided to the designated RCA Teams as
soon as they are convened, and will serve as their initial data source.
(By using these logs, the RCA Teams may not routinely need to
retrospectively consult individual patient profiles or individual
medical records.)
It is anticipated that by utilizing this aggregated approach and
building the reviews over succeeding quarters, common themes may be
more readily identified and the effectiveness of actions taken to
prevent these events or close calls from happening again may be more
easily evaluated.
Descriptions of each Aggregated Review Log are provided below, and
copies of the Logs are attached to this Appendix.
Falls.--Falls are defined according to local/facility definition.
An individual RCA will be performed for any reported inpatient or
outpatient fall occurring on facility property that results in an
actual SAC 3, for all enrolled patients.
Reported falls and close calls on facility property (potential 3s)
involving enrolled patients will be included in an Aggregated Review on
a quarterly basis (completed by the RCA Team within 45 days after the
end of the quarter). These Aggregated Reviews will be entered in the
Registry.
The following elements are included in the Falls Aggregated Review
Log:
--Case (1 . . . X)
--ID# (First Initial, Last Initial, last 4 SSN)
--Age
--Sex
--Event (Day, Date, Time)
--OPT or INPT/Unit (designation of inpatient or outpatient status at
time of event, and if inpatient, unit where the patient was
assigned at the time of the event)
--Functional & Cognitive Factors (a listing of factors related to
falls, requires a ``yes''/``no'' response for all applicable
items: prior fall; designation as ``high risk'' for falls;
needs assistance with ADLs mobility, transfer, toileting,
dressing, eating; gait or balance limitations; incontinent;
confused/memory limitations; related medical conditions;
medication effect, and; other)
--Assistive Devices (a listing of devices related to falls, requires
a ``yes''/``no'' response for all applicable items: cane;
crutches; transfer device; walker; wheelchair; bathing device;
mechanical lift; eye glasses; hearing aid, and; other)
--Communication Issues (a short list of areas where communication or
information exchange can break down, requires a ``yes''/``no''
response for all applicable items: staff to staff; staff to
patient, and; staff to family/other)
--Environmental Factors (a listing of physical plant issues related
to falls, requires a ``yes''/``no'' response for all applicable
items: use of restraints; use of protective devices; inadequate
footwear; bed siderails; floor condition; obstacles; fall while
the patient was reaching for a needed item; inadequate patient
or family/other education; unfamiliarity with the environment;
inadequate lighting, and; other)
--What Happened & Treatment Plan Changes (free narrative)
--Comments (free narrative)
Medication Errors.--Medication errors are defined according to
local/facility definition.
An individual RCA will be performed for any reported inpatient or
outpatient medication error that results in an actual SAC 3, for all
enrolled patients.
Reported medication errors or close calls (potential 3s) involving
enrolled patients will be included in an Aggregated Review on a
quarterly basis (completed by the RCA Team within 45 days after the end
of the quarter). These Aggregated Reviews will be entered in the
Registry.
The following elements are included in the Medication Aggregated
Review Log:
--Case (1 . . . X)
--ID# (First Initial, Last Initial, last 4 SSN)
--Age
--Sex
--Event (Day, Date, Time)
--OPT or INPT/Unit (designation of inpatient or outpatient status at
time of event, and if inpatient, unit where the patient was
assigned at the time of the event)
--Processes Related to Event (a listing of key steps in the
medication process, requires a ``yes''/``no'' response for all
applicable items: ordering; transcribing; dispensing;
administering, and; documenting)
--What Happened? (a listing of medication errors, requires a ``yes''/
``no'' response for all applicable items: medication given
despite known allergy; omission; overdose; incorrect patient
identification; incorrect medication identification; incorrect
dose; incorrect route; incorrect schedule, and; equipment
failure)
--Medication (name/dose/route/schedule for the correct medication,
and, the actual/close call medication)
--Treatment Plan Changes (free narrative)
--Comments (free narrative)
Parasuicidal Behaviors.--There are two primary categories of
suicidal events: completed suicides, and; parasuicidal events (i.e.,
any suicidal behavior with or without physical injury--short of death--
including the full range of known or reported attempts, gestures and
threats).
An individual RCA will be performed for any completed inpatient
suicide (at the time it occurs) and for any completed outpatient
suicide (at the time of facility notification) for all enrolled
patients. In other words, all actual known suicides of enrolled
patients will receive a RCA. And, all actual known suicides of enrolled
patients will be reported in the Registry.
All reported parasuicidal events or close calls (potential 3s)
involving enrolled patients will be included in an Aggregated Review on
a quarterly basis (completed by the RCA Team within 45 days after the
end of the quarter). These Aggregated Reviews will be entered in the
Registry.
The following elements are included in the Parasuicidal Aggregated
Review Log:
--Case (1 . . . X)
--ID# (First initial, Last initial, last 4 SSN)
--Age
--Sex
--Event (Day, Date, Time)
--OPT or INPT/Unit (designation of inpatient or outpatient status at
the time of event, and if inpatient, unit where the patient was
assigned at the time of the event)
--Date of Last OPT TX (date of most recent prior outpatient
treatment, this does not include an appointment that was
scheduled but was a ``no show'')
--Diagnoses (a listing of current/active diagnoses)
--Tx Team (a short list of treatment team options, for providers that
were assigned to the patient at the time of the event, requires
a ``yes''/``no'' response for all applicable items: mental
health/psychiatry; specialty/sub-specialty, and; primary care)
--What Happened? (free narrative)
--Family & Other Supports (free narrative)
--Treatment Plan Changes (free narrative)
--Comments (free narrative)
Appendix--Safety Assessment Code (SAC) Matrix
Severity Categories
Key factors for the severity categories are: extent of injury;
length of stay; level of care required for remedy, and; actual or
estimated physical plant costs. These four categories apply to actual
adverse events and potential events (close calls). For actual adverse
events, assign severity based on the patient's actual condition.
If the event is a close call, assign severity based on the most
likely ``worst case'', systems level scenario. (For example, if you
entered a patient's room before they were able to complete a lethal
suicide attempt, the event is catastrophic, because the most likely
``worst case'' is suicide.)
------------------------------------------------------------------------
Catastrophic Major
------------------------------------------------------------------------
Patients with Actual or Potential: Patients with Actual or
Death or major permanent loss of Potential:
function (sensory, motor, physiologic, Permanent lessening of
or intellectual) not related to the bodily functioning
natural course of the patient's illness (sensory, motor,
or underlying condition (i.e., acts of physiologic, or
commission or omission). intellectual) not related
Suicide (inpatient or outpatient) to the natural course of
Rape the patient's illness or
Hemolytic transfusion reaction underlying conditions
Surgery/Procedure on the wrong patient (i.e., acts of commission
or wrong body part or omission).
Infant abduction or infant discharge to Disfigurement
the wrong family Surgical intervention
Death or major permanent loss of required
function that is a direct result of Increased length of stay
injuries sustained in a fall; or of more than 3 patients
associated with an unauthorized Increased level of care
departure from an around-the-clock for more than 3 patients
treatment setting; or the result of an
assault or other crime
Visitors and Staff: Visitors
Death; or More than 3 visitors
Hospitalization of 3 or more (includes requiring evaluation and
outpatients) \1\ treatment
Staff
More than 3 lost time or
restricted duty injuries
or illnesses
Equipment or facility
Damage more than $100,000
\2\
------------------------------------------------------------------------
Moderate Minor
------------------------------------------------------------------------
Patients with Actual or Potential: Patients with Actual or
Increased length of stay for up to three Potential:
patients; or No increased length of
Increased level of care for up to three stay or increased level
patients. of care
Visitors Visitors
Evaluation and treatment for up to Evaluated and no treatment
three visitors. required or refused
treatment
Staff Staff
Less than three lost time or No lost time or restricted
restricted duty injuries or illnesses. duty injuries or
illnesses
Equipment or facility Equipment or facility
Damage more than $10,000 but less than Damage less than $10,000
$100,000.
------------------------------------------------------------------------
\1\ 29 CFR 1960.70 requires each federal agency to notify OSHA within 8
hours of a work-related incident which results in the death of an
employee or the in-patient hospitalization of 3 or more employees.
\2\ The Safe Medical Devices Act of 1990 requires reporting of all
incidents in which a medical device may have caused or contributed to
the death, serious injury, or serious illness of a patient or another
individual.
Probability Categories
Like the severity categories, the probability categories apply to
actual adverse events and close calls.
In order to assign a probability rating for an adverse event or
close call, it is ideal to know often it occurs at your facility.
Sometimes, the data will be easily available because it is routinely
tracked (e.g., falls with injury, medication errors, etc.). Sometimes,
getting a feel for the probability of events which are not routinely
tracked will mean asking for a quick or informal opinion from staff
most familiar with those events. Sometimes it will have to be your best
educated guess.
HOW THE SAC MATRIX LOOKS
------------------------------------------------------------------------
Severity & Probability Catastrophic Major Moderate Minor
------------------------------------------------------------------------
Frequent...................... 3 3 2 1
Occasional.................... 3 2 1 1
Uncommon...................... 3 2 1 1
Remote........................ 3 2 1 1
------------------------------------------------------------------------
Frequent--Likely to occur immediately or within a short period of time
(may happen several times in 1 year).
Occasional--Probably will occur in time (may happen several times in 1
to 2 years).
Uncommon--Possible to occur in time (may happen sometime in 2 to 5
years).
Remote--Unlikely to occur (may happen sometime in 5 to 30 years).
How the SAC Matrix Works:
When you pair a severity category with a probability category for either
an actual event or close call, you will get a ranked matrix score (3 =
highest risk, 2 = intermediate risk, 1 = lowest risk). These ranks, or
Safety Assessment Codes (SACs) can then be used for doing comparative
analysis, and, for deciding who needs to be notified about the event.
Notes:
1. All known reporters of events, regardless of SAC score (1, 2, or 3),
will receive appropriate and timely feedback.
2. The Risk Manager (or designee) will refer adverse events or close
calls related solely to staff, visitors or equipment/facility damage
to relevant facility experts or services on a timely basis, for
assessment and resolution of those situations.
3. A quarterly Aggregated Root Cause Analysis may be used for three
types of calls (this includes all events or close calls other than
actual SAC 3s, since all actual SAC 3s require an individual RCA).
These three types are: falls; medication errors, and; parasuicidal
behavior. The use of aggregated analysis serves two important
purposes. First, greater utility of the analysis (i.e., trends or
patterns not noticeable in individual case analysis are more likely to
show up as the number of cases increases). Second, it makes wise use
of the RCA team's time and expertise.
Of course, the facility may elect to perform an individual RCA rather
than Aggregated Review on any adverse event or close call that they
think merits that attention, regardless of the SAC score.
______
Attachment 2
National Patient Safety Partnership Statement Regarding Its Initiative
to Reduce Preventable Adverse Drug Events--May 12, 1999
Various studies have shown that adverse drug experiences or events
affect between 2 and 35 percent of hospitalized patients. Preventable
adverse drug events represent a significant subset of these, if not a
large majority of them. Little is known about the incidence of adverse
drug events in outpatients, although they have been shown to be a
significant cause of hospitalization and, consequently, increased
health care costs. Indeed, adverse drug events are a cause of increased
healthcare costs in all care settings.
For this initiative, a preventable adverse drug event (PDE) \5\ is
defined as an event that can be anticipated and forestalled and that
will cause or lead to inappropriate medication use or patient harm
while the medication is in the control of the healthcare professional,
patient, or consumer. Such events may be related to professional
practice, healthcare products, procedures, and systems, including
prescribing; order communication; product labeling, packaging, and
nomenclature; compounding or dispensing; distribution; administration;
education; monitoring; and use.\6\ Overall, PDEs are a serious public
health and medical care problem because of the large number of drugs,
doses, and drug treatment regimens currently available and the many
changes in the manner that healthcare is provided today.
---------------------------------------------------------------------------
\5\ The differences between a PDE and the Food and Drug
Administration's (FDA) broader statutory definition of an adverse drug
experience or event should be recognized. The National Patient Safety
Partnership's principal interest is advancing practices that prevent
adverse events whereas the FDA's principal interest is understanding
drug/drug interactions and the biologic activity of drugs so they are
fully labeled. At 21 CFR section 314.80 FDA defines an adverse drug
experience as any adverse event associated with the use of a drug in
humans, whether or not considered drug related, including the
following: an adverse event occurring in the course of the use of a
drug product in professional practice; an adverse event occurring from
drug overdose, whether accidental or intentional; an adverse event
occurring from drug abuse; an adverse event occurring from drug
withdrawal; and any failure of expected pharmacological action.
\6\ Adapted from the USP Quality Review--Definition of Medication
Errors.
---------------------------------------------------------------------------
The National Patient Safety Partnership is a public-private
partnership dedicated to improving healthcare in general and patient
safety in particular by reducing adverse events and untoward outcomes
of healthcare or healthcare-related processes. The members of the
Partnership believe there are significant patient safety improvements
that can be made through the prevention of avoidable adverse events
associated with the prescribing, dispensing and administering of
medications.
The members of the National Patient Safety Partnership believe that
prevention of medication-related adverse events will be maximized when
the outcomes of specific actions for improvement can be reliably
predicted based on a strong body of evidence. It realizes that the
current evidence base needs strengthening and believes that iterative
improvement accompanied by outcomes analysis can advance the state of
the science toward that goal. Based on current knowledge, the
Partnership has identified a number of ``best practices'' or ``model
practices'' that could substantially reduce the potential for
occurrence of PDEs, and the Partnership calls on healthcare consumers,
patient advocacy groups, the pharmaceutical industry, healthcare
practitioners and healthcare organizations to make a commitment to
adopt the practices listed below and to work together to implement
them, as well as to develop additional ways to reduce PDEs.
MODEL PRACTICES TO PREVENT ADVERSE DRUG EVENTS \7\
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\7\ The ordering of these ``Best Practices'' is not intended to
suggest relative importance. The ``Best Practices'' are identified on
the basis of eight techniques or criteria that have been shown to be
important in reducing errors in general and medication errors in
particular. The eight criteria are (1) ensuring timely access to
information; (2) standardization; (3) simplification; (4) reduced
reliance on memory; (5) reduced reliance on practitioner vigilance; (6)
broad application; (7) cost effectiveness of the intervention; and (8)
established success of the intervention. The 16 practices are used in
the Institute for Healthcare Improvement Breakthrough Series.
---------------------------------------------------------------------------
Current Best Practices For Patients/Consumers
The members of the National Patient Safety Partnership believe that
all patients should be actively involved in their care and decisions
concerning their care. There are many actions that patients can take,
but the following two are stressed as ways to ensure that medication-
related information is exchanged in a way that increases the
probability of safe care.
1. Patients (or their personal advocates) should always inform
their physician or other healthcare practitioner of all medications
they are taking (NB: This includes prescription medication, over-the-
counter medication and dietary supplements.) as well as about any and
all allergies or previous adverse drug experiences they have
experienced before accepting any new medication. Patients should not
assume that information previously provided has been communicated or
has been considered prior to a medication being prescribed or
administered.
2. Patients (or their personal advocates) should request
information about medications in terms that they can understand, both
at the time the medication(s) is/are being prescribed and when they are
received. This applies to prescription and over-the-counter
medications. Patients should ask for information about the intended use
or purpose of the drug, possible drug-drug interactions, potential
hazards associated with taking several medicines (e.g., more than 3
drugs at the same time), and about changes in the appearance of any
medications they have been taking (such as when a prescription refill
is a different color from what had previously been taken). Before
accepting or receiving a prescription, the patient should always ask
the following questions:
--Is this the drug my doctor (or other health care provider) ordered?
What is the trade and generic name of the medication?
--What is the drug for? What is it supposed to do?
--How and when am I supposed to take it and for how long?
--What are the likely side effects? What do I do if they occur?
--Is this new medication safe to take with other over-the-counter or
prescription medications, or dietary supplements, that I am
already taking? What food, drink, activities, dietary
supplements or other medication should be avoided while taking
this medication?
In addition, at the time prescription medications are received from
pharmacies, patients should ask if the drug they are receiving is the
one their doctor or other health care provider ordered and ask that
both the trade and generic names be listed on the prescription label.
Current Best Practices For Providing Organizations and Practitioners
The members of the National Patient Safety Partnership believe that
healthcare organizations and practitioners are committed to
safeguarding patients and call upon both organizations and individual
practitioners to further advance the following practices and to support
and advocate for these actions in areas and organizations in which they
are not utilized.
3. Educate patients, family members and other caregivers about all
medications (both prescription and over-the-counter, including dietary
supplements) that are used. (Emphasis should be placed on the hazards
of polypharmacy, drug-drug interactions and possible adverse effects.)
Patients and caregivers should be encouraged to ask for information
about all medications and dietary supplements, especially when new
medications are prescribed or changes in medications are made.
4. Prominently display critical patient information, such as drug
allergies and medication regimens, on every patient record.
5. Emphasize the need for dose adjustment in children and elderly
patients. In some elderly patients, a reduction in dose may be required
because of age-related changes in body mass and organ function.
6. Limit accessibility to and control the use of highly toxic or
other high-hazard drugs such as potassium chloride or concentrated
epinephrine.
7. Insist on the development and use of protocols for highly toxic
or hazardous drugs or those with a narrow therapeutic range.
(Computerized drug order entry systems can be especially important in
facilitating this with alerts, restrictions or suggestions for safer
substitutes.)
8. Computerize drug order entry whenever possible. If computerized
drug order entry is not feasible, then use pre-printed order forms for
drugs in inpatient settings and, where appropriate, in ambulatory care
settings.
9. Utilize pharmacy-based intravenous (IV) admixture programs.
10. Avoid the use of abbreviations whenever possible; if
abbreviations are used, they should be standardized throughout the
organization and their use minimized.
11. Standardize approaches and processes for drug storage
locations, internal packaging or labeling and delivery, and require use
of the standardized approaches and processes.
12. Use unit dose drug distribution systems for inpatient care;
also use such systems for outpatient care, where appropriate.
Current Best Practices For Purchasers
The members of the National Patient Safety Partnership believe that
while most of these practices advocated in this initiative would cost
little or nothing to implement, they do recognize that an investment
will be required for some and call upon healthcare organizations and
the pharmaceutical industry to make any needed investment in the
interest of patient safety.
13. Require machine-readable labeling, such as a barcoding system,
complete with pertinent information such as lot number and expiration
date.
14. Preferentially purchase products that have labels with name of
drug, concentration and warnings prominently displayed and that
otherwise incorporate human factors evaluation into naming, labeling
and packaging processes. (For example, the use of large type or
contrasting colors to avoid look-alike packaging or unheeded warnings.)
15. Preferentially purchase and utilize ``unit of use'' packaging
in inpatient settings; also use such packaging in outpatient
(ambulatory care) settings, where appropriate.
16. Preferentially purchase intravenous (IV) solutions with
contents and concentration prominently displayed on both sides of the
container.
Even Better Practices in the Future
Finally, the members of the National Patient Safety Partnership
believe it is imperative that the healthcare and pharmaceutical
industries launch and sustain collaborations directed toward systematic
approaches to the prevention of PDEs. The Partnership challenges these
industries to seek opportunities for research and to seek
collaborations to identify better practices in the future, to
prioritize practice interventions, and to define practices that can
predictably effect improvement in terms of increased safety and cost-
effectiveness. Integral to such an activity is a non-punitive culture
that encourages reporting of adverse or unexpected events to relevant
oversight bodies, including internal quality management systems and
regulatory agencies, and that provides feedback about resulting lessons
learned and system changes aimed at preventing future such events. To
be truly successful these activities must be ongoing since no solution
that is found to any problem can be thought of as the ``solution for
all time''. A spirit of continual and relentless examination and
reexamination will be necessary to insure that our processes and
techniques are appropriate today and that they continue to evolve as
necessary to be appropriate in the future as well.
______
Attachment 3
VHA Directive 99-031--July 14, 1999
THE AVAILABILITY OF POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE USP
1. PURPOSE: This Veterans Health Administration (VHA) Directive
establishes policy regarding the use of potassium chloride for
injection concentrate USP.
2. BACKGROUND
a. In recent years, numerous reports have been published in the
medical literature of adverse events and deaths caused by errors in the
use of potassium chloride for injection concentrate USP. This matter
has been discussed on numerous VHA Headquarters pharmacy conference
calls. Many facilities have already removed potassium chloride for
injection concentrate USP and other hypertonic injectables from patient
care areas.
b. VHA policy requires that a pharmacy-managed IV admixture program
be responsible for the labeling, preparation, and distribution of IV
admixtures. Understanding that some IV admixtures may not be prepared
by the Pharmacy Service, practices and policies must be in place to
ensure the IV admixtures not prepared by the Pharmacy Service are
compatible with the policies that govern the pharmacy-prepared IV
admixtures.
3. POLICY: VHA policy regarding potassium chloride for injection
concentrate USP is as follows:
a. Potassium chloride for injection concentrate USP will not be
stored on any wards, intensive care units, surgical suites and similar
sites as ward stock.
b. Potassium chloride for injection concentrate USP will only be
utilized as part of a pharmacy-managed IV admixture program; therefore,
storage of the medication will be in the pharmacy and is the
responsibility of the Pharmacy Service.
c. To meet patient needs, the use of manufactured ``pre-mixed''
large volume solutions, including those with potassium chloride, may be
used in conjunction with a pharmacy-managed IV admixture program.
4. ACTION
a. All Department of Veterans Affairs (VA) medical facilities will
ensure that any potassium chloride for injection concentrate USP is
removed from all wards, intensive care units, operating suites, and
clinics.
b. All VA medical facilities will establish medication use policies
that include guidance regarding safe handling of potassium chloride for
injection concentrate USP. Additionally, these policies shall
specifically state that it is VA policy not to have potassium chloride
for injection concentrate USP and other hypertonic injectable solutions
on the wards and similar sites, that normal or routine VA practice is
for IV solutions to be mixed centrally, that cardioplegic solutions are
prepared by, or supplied by, Pharmacy Service only, and that unit dose
drug distribution is required for inpatient areas.
c. At VA medical facilities that perform heart transplant and open
heart surgery, cardioplegic solutions are to be prepared by, or
supplied by, the Pharmacy Service.
(1) Those solutions prepared by Pharmacy Service will be hand-
delivered to the operating room (OR) by Pharmacy Service. These
solutions are to be clearly labeled, ``For Cardioplegia Only''
and contain the patient's name. They may be secured in one
location in, or adjacent to, the cardiac surgery suite, i.e.,
the OR automatic medication dispensing machine or the locked
perfusionist's cabinet. Access is to be limited to the cardiac
surgeon, cardiac anesthetist and/or cardiopulmonary bypass
technician (perfusionist) and the OR pharmacist.
(2) The Chief, Anesthesia Service is responsible for:
(a) Identifying the secure location in the cardiac surgery
suite;
(b) Assuring that access is limited to those individuals
requiring access to this highly concentrated therapeutic
agent;
(c) Ascertaining that the correct solution is used in the
correct patient (as in the use of blood or blood products);
(d) Providing for the disposition of any unused cardioplegic
solutions; and
(e) Developing, publishing, and maintaining a local policy that
assures the accountability and safety of the drug.
5. REFERENCE: None.
6. FOLLOW-UP RESPONSIBILITY: The Chief Consultant for Pharmacy
Benefits Management Strategic Healthcare Group (119) is responsible for
the contents of this directive.
7. RESCISSIONS: Directive 98-026, is rescinded. This VHA Directive
expires July 31, 2004.
Thomas L. Garthwaite, M.D.
Acting Under Secretary for Health.
______
Attachment 4
VHA Directive 98-049--November 5, 1998
BAR CODING PATIENT WRISTBANDS
1. PURPOSE: This Veterans Health Administration (VHA) Directive
defines policy for bar coding a patient's full social security number
on the patient identification wristband.
2. BACKGROUND: The requirements for a Blood Product Verification
function, in response to a working group review of ``system'' changes
which would reduce blood transfusion errors in the operating room, have
been developed. The group proposed that a universal identifier be bar
coded onto the patient identification wristband. A revision to the
Veterans Information Systems Technology Architecture (VistA) Surgery
software package necessitated that as of February 1, 1998, a bar code
that displays the patient's full social security number must be printed
onto the patient identification wristband.
3. POLICY: It is VHA policy to issue to each patient on hospital
admission a patient identification wristband on which there is a
printed bar code displaying the patient's full social security number.
4. ACTION
a. All patients reporting for hospital admission or ambulatory
surgery must be issued a patient identification wristband that contains
the patient's full name, social security number and a bar code that
displays the patient's full social security number.
b. Printers capable of generating wristband bar codes must be
installed in locations that process patients for hospital admission and
ambulatory surgery.
c. Additional information, e.g., ward designation, is optional. If
the ward designation is used, it will refer only to the ward
identification and will not reference the professional service
specialty.
4. REFERENCES: VHA Manual M-1, Part I, Chapter 4.
5. FOLLOW-UP RESPONSIBILITIES: The Director, Health Administration
Service (10C3), is responsible for the contents of this VHA Directive.
6. RESCISSIONS: VHA Directive 97-064 is rescinded. This VHA
Directive will expire on November 5, 2003.
Kenneth W. Kizer, M.D., M.P.H.
Under Secretary for Health.
______
Attachment 5
VHA Directive 98-033--July 16, 1998
TRANSFUSIONS PERFORMED IN OPERATING ROOMS
1. PURPOSE: This Veterans Health Administration (VHA) Directive
established policy for the identification process to be used in all VHA
operating rooms, (inpatient and ambulatory) prior to the administration
of blood or blood products.
2. BACKGROUND: VHA policy has established standard operating
procedures (SOPs) to be used when transfusing blood products. These
include specific visual verification by two individuals that the unit
of blood or the blood product is in fact the one that has been assigned
to this particular patient. The Standard Form (SF) 518, Blood or Blood
Component Transfusion, documents this process. Nevertheless, there have
been rare blood product transfusion related deaths in VHA Operating
Rooms (OR) due to patient and/or blood product identification errors.
As part of VHA's patient safety policy to provide high quality, safe,
appropriate health care, this policy introduces the requirement to
perform an additional independent mechanical verification of the
identity of the patient and the blood product. This mechanical process
utilizes the Veterans Health Information Systems Technology
Architecture (VistA) software to read the bar coded identification on
the blood product. This will be performed in addition to the current
visual verifications. The visual identification by two individuals and
this mechanical check will provide an error proof identification
process.
3. POLICY: All laboratories in facilities performing surgery must
have implemented and use the VistA Blood Bank Package. The identity of
each unit of blood and blood products will be entered into the VistA
Blood Bank files. At the time the blood product is assigned to an
individual, the assignment information must also be entered into the
VistA Blood Bank files. Each Veteran Integrated Service Network (VISN)
will ensure that all facilities performing surgery have implemented
this policy by August 1, 1998.
4. ACTION
a. All patient wristbands will be printed with the bar coded full
Social Security Number (SSN) of the patient.
b. All inpatient or ambulatory surgery operating rooms in which
procedures are performed which will, on some occasions, require the
transfusion of blood products shall be equipped with bar code readers
for direct interaction with the VistA Surgical package.
c. When a patient enters the OR, the patient's full SSN bar code on
the wristband will be machine read and entered into the VistA Surgical
files as a component of the surgical menu options.
d. Should the patient require blood or blood products, two members
of the surgical team will visually validate that the blood product is
correct for that specific patient. Specifically, they will match the
name and SSN on the patient's wristband to the information on the SF
518 and match the information on the blood product to the information
on the same SF 518.
e. Upon completing the visual validation, the blood product will
then have its identifying bar code mechanical scanned. If the resulting
computer message indicates that the database does not have an
assignment of this particular unit to this particular patient, a
warning message will be displayed indicating that the staff must
personally verify that the specific blood product unit is appropriate
for this specific patient prior to administration.
5. REFERENCES: None.
6. FOLLOW-UP RESPONSIBILITY: Agatha Francis, Enforcement officer
(115) is responsible for the contents of this directive. Questions may
be directed to (202) 273-8420.
7. RESCISSION: This VHA Directive expires July 16, 2003.
Kenneth W. Kizer, M.D., M.P.H.
Under Secretary for Health.
______
Attachment 6
VHA Directive 99-003--March 4, 1999
ADMINISTRATIVE PRACTICES FOR ENSURING SAFE INJECTION OF RADIO-LABELED
BLOOD PRODUCTS
NOTE: Changes have been incorporated into this directive so this
Change 1 to VHA Directive 99-003 stands as a complete document.
1. PURPOSE: This directive articulates Veterans Health
Administration (VHA) current policy regarding the administration of all
radio-labeled blood products (e.g., Indium-111 labeled white blood
cells, Technetium 99m--HMPAO labeled white blood cells, Chromium-51
labeled red blood cells, and Technetium 99m labeled red blood cells) to
patients.
2. BACKGROUND: The prevalence of blood-borne diseases such as
hepatitis and human immunodeficiency virus (HIV) require that specific
and controlled procedures be utilized to protect patients from needless
risk when blood samples are removed, tagged with radio-pharmaceuticals,
and re-injected for diagnostic or research purposes.
3. POLICY: According to Title 10, Code of Federal Regulations
(CFR), Parts 19, 20, 21, 30 and 35, and Department of Veterans Affairs
(VA) Manual MP-2, Part XX, responsibility for developing local policies
for the control and supervision of the administration of radio-labeled
blood products is assigned to the VHA medical facility's constituted
Radiation Safety Committee (RSC).
4. ACTION: To avoid misadministration of radio-labeled blood
products and ensure safe injection practices, the following procedures
are to be followed:
a. A written requisition from a physician shall be obtained for the
procedure, and the physician shall verify the request on the patient's
chart or computerized patient record.
b. The patient's identity shall be verified with the participation
of two healthcare personnel by two of the following measures when
obtaining a blood sample: by confirming the patient's name and Social
Security Number (SSN), examining the wrist and/or armband, and querying
the patient as to their identity by asking for spelling of their name.
NOTE: Do not merely ask if the patient is ``X'' and accept a ``YES''
response. If available, employ bar code verification should be
utilized.
c. The original blood product container shall be identified with an
adhesive label bearing the patient and/or recipient's full name, SSN,
date, and signature of the person drawing the blood. Where and when
available, bar code verification shall be utilized.
d. Prior to the administration of the prepared radio-labeled blood
product, the container that is clearly labeled with an adhesive
identification label, the patient's identity shall be again verified by
two individuals by two different measures, including bar code
verification, as appropriate. Ideally, one or both individuals who
initially identified the patient should be present at the time of
administration of the blood product.
e. A copy of VA Form 10-0130, Administration of Radio-Labeled Blood
Products, is attached for local reproduction. After the initial
distribution is received, additional stock may be obtained from the
Forms and Publications Depot through normal channels. This form
documents the preceding identification procedures and should be
completed in the sequence described and remain part of the patients
nuclear medicine record.
NOTE: The radio-pharmaceutical vendors may provide forms
accompanying the agent. Such forms do not eliminate the need for
Nuclear Regulatory Commission (NRC) records or VA Form 10-0130.
f. The performance plan for each nuclear medicine technologist
shall emphasize the importance of assuring patient safety by including
patient identification and verification prior to the administration of
all radio-labeled blood products by requiring 100 percent compliance in
the performance of this function.
g. Each nuclear medicine technologist shall receive a copy of the
policy, receive appropriate training, and sign to verify that the
policy and procedure have been reviewed and are understood. Annual
mandatory reviews of the policy and procedure with each employee shall
be documented.
h. Any misadministration of a radio-pharmaceutical product must be
reported via the facility Patient Safety Improvement Program mechanism
through the Quality Management office and, if criteria are met, the
NRC.
5. REFERENCES: Title 10 CFR, Subpart A, 35.1 and 35.33.
6. FOLLOW-UP RESPONSIBILITY: The Director, Nuclear Medicine and
Radiation Safety Service (115B) is responsible for the contents of this
directive. Questions should be directed to Deputy Director, Nuclear
Medicine Service, Ann Arbor, MI at (734) 761-7885
7. RESCISSION: Circular 10-93-005 is rescinded. This VHA directive
and change 1 will expire on February 3, 2004.
Kenneth W. Kizer, M.D., M.P.H.
Under Secretary for Health.
Attachment 7
Department of Veterans Affairs,
Veterans Health Administration,
Washington, DC, July 9, 1998.
IL 10-98-015
UNDER SECRETARY FOR HEALTH'S INFORMATION LETTER
VHA PATIENT SAFETY IMPROVEMENT AWARDS PROGRAM
1. The Veterans Health Administration (VHA) is committed to
improving healthcare quality in VHA treatment facilities and in the
healthcare industry overall.
2. One important element of the Department of Veterans Affairs
(VA's) healthcare quality improvement effort is its Patient Safety
Improvement Initiative. This initiative includes, among other things,
promulgating the Patient Safety Improvement Directive (formerly
entitled the Risk Management Directive, VHA Directive 1051);
establishment of the Forensic Medicine Strategic Healthcare Group;
inclusion of patient safety-related measures in the Veterans Integrated
Service Network (VISN) Directors performance agreements; creation of
the National Patient Safety Partnership; provision of funding and other
support for industrywide conferences and expert working groups on
patient safety; establishment of a new health system management
fellowship aimed at developing clinical leaders in healthcare quality
improvement; and funding new quality of care clinical research
projects.
3. Historically, the healthcare industry has not viewed itself as a
high-risk industry and has not utilized the same type of rigorous,
systematic review of each adverse event or untoward outcome as has been
done in other high-risk industries like aviation and nuclear power. For
example, there is no oversight entity for the healthcare industry like
the National Transportation Safety Board that deconstructs and analyzes
each airline accident to isolate the critical causative factors and to
develop approaches to minimize future occurrences through technical
design changes, system or process changes, or improved training.
Similarly, unlike the nuclear power industry, healthcare has not widely
used detailed process engineering that carefully analyzes alternative
scenarios to prospectively establish the safest, most risk-free method
to handle potentially hazardous situations. The aviation and nuclear
power industries have controlled the risk of adverse events by focusing
meticulous attention on the design of their operating systems to make
it difficult for personnel to make mistakes, and easy to correct
mistakes before they result in an untoward outcome. The result,
contrary to public perception, is that these high-risk industries have
reduced their risk of an adverse event 1,000 to 10,000 times lower than
what occurs in healthcare. Clearly, one of the major challenges facing
healthcare today is to become a ``high reliability'' industry such as
aviation and nuclear power generation.
4. While various indicators suggest that the veterans healthcare
system has a better record on patient safety than the healthcare
industry overall, adverse events or untoward outcomes resulting from
medical treatment occur too frequently at VHA facilities. VHA is
committed to systematically identifying and analyzing these occurrences
in an effort to reduce their frequency to the lowest level possible.
VHA is uniquely positioned in the United States to serve as a national
laboratory to find solutions to patient safety problems and to lead
national efforts to improve patient safety. Illustrative of VHA's
unique characteristics are the fact that VHA has medical treatment
facilities located in every state; is a fully integrated healthcare
system; has mechanisms in place to capture the relevant patient safety
data; is intimately involved with physician and other health
professional training; has a widely acclaimed research program; and is
open to widespread scrutiny by virtue of it being a public system.
5. As a further way of identifying the root cause(s) of adverse
outcomes and developing improved processes or procedures to minimize
potential patient safety risks, the VHA Patient Safety Improvement
Awards Program was established.
6. The Patient Safety Improvement Awards Program is designed to
increase the emphasis on this important aspect of clinical practice by
financially rewarding individuals, teams, services or institutions
which identify adverse events or potential patient safety situations
and improve processes or practices that minimize or eliminate the risk
of an untoward outcome. The awards are intended to provide an incentive
to employees to develop and document improved processes and to export
them as ``best practices'' throughout the veterans healthcare system,
and the healthcare industry.
7. The VHA Patient Safety Improvement Awards Program will provide a
financial reward ranging from $500 to $25,000, along with other
recognition, to recipients. The exact amount of the award will depend
upon the extent to which the improved process can be adopted in, or
adapted to, other patient care settings and the severity of the
potential hazard it reduces or eliminates. Larger rewards shall be
targeted for improvements that reduce or eliminate life-threatening
risks and have system-wide application. Award nominations will be
accepted in the following categories:
a. Direct Care Provider Category--Individual or Team
(1) This category recognizes submissions from individuals or teams
which provide direct, hands-on clinical care to patients, and which can
identify and implement steps to lessen the likelihood of medical
errors, adverse outcomes or anomalous clinical occurrences. It is
expected that this category will generate the largest number of award
submissions. Individual or team nominations in this category may
include persons who provide indirect care or support.
(2) Individuals and teams are eligible for awards of up to $5,000
in this category.
b. Indirect Care and Support Activities Category--Individual or Team
(1) This category recognizes submissions from individuals or teams
which provide indirect clinical support, such as pharmacists or
laboratory personnel, or which provide support activities making the
overall environment safer, such as safety specialists or bio-medical
engineers. It may also include activities which eliminate risk from the
various processes supporting the provision of patient care such as
Medical Records or Information Resources Management.
(2) This is established as a separate category in order to focus
attention on these indirect care and support activities as a potential
source of patient safety improvements.
(3) Individuals and teams are eligible for awards up to $5,000 in
this category.
c. Single Service or Product Line Category
(1) This category recognizes submissions from discrete
organizational entities, such as the Medical Service or Surgical
Service, or product lines, such as an Ambulatory Care Service Line,
which has developed and implemented policies, procedures, or training
which significantly improves the level of patient safety throughout the
organizational element. The specific processes, approaches, or
behaviors must be reflected in the overall operation of the service or
product line.
(2) Services or product lines are eligible for awards up to $10,000
in this category.
d. Multiple Service, Facility or Institutional Category
(1) This category recognizes submissions that involve two or more
services or that are from a complete entity on an organizational basis,
e.g. Medical Center or Outpatient Clinic. It recognizes programs that
permeate the entire operation of the facility, either through changes
in culture, total process engineering, or other systematic approaches.
The award submission would have to demonstrate significant, sustained
improvements to patient safety over a baseline, and also demonstrate
that accidents and misadventures were reported in a full, complete
manner.
(2) Institutions are eligible to receive awards up to $25,000 in
this category.
e. Equipment, Tools or Supplies Categories--Individual or Team
(1) This category recognizes individuals or teams which identify
equipment, tools or medical supplies which eliminate risk or otherwise
significantly improve patient safety. Given the widespread availability
of information on such items, awards under this category must
demonstrate a high level of initiative, i.e. locating and identifying a
very new or little known item, or recognizing that a modification to an
item currently available could make it safer.
(2) Individuals or teams are eligible for up to $2,500 in this
category.
8. Individuals, teams, services or institutions are invited to
submit descriptions of their safety improvements. Submit six copies of
each nomination to the VHA Headquarters Management Support Office
(10A2A), ATTN: Dot Brady, 810 Vermont Avenue NW, Washington, DC 20420.
Nominations from field activities are to bear the endorsements of the
Medical Center Director and Network Director. Submissions from VA
Central Office activities are to bear the endorsement of the
appropriate Chief Officer. Final approval of nominations will be made
by the Office of the Under Secretary for Health. Submissions should be
limited to no more than ten pages and should include at least the
following items:
a. Name of nominee, address, phone number and telefax number
b. Nomination category
(1) Direct Care Provider Category--Individual or Team.
(2) Indirect Care and Support Activities Category--Individual
or Team.
(3) Single Service or Product Line Category.
(4) Multiple Service, Facility or Institutional Category.
(5) Equipment, Tools or Supplies Categories--Individual or
Team.
c. Nominator's name, title, address, phone number and telefax
number
d. Description of the specific event or circumstance(s) that
triggered the process or system improvement
e. Description of the specific and/or general safety hazard
eliminated
f. Description of the approach used to develop the new process;
i.e., whether based on a retrospective review of a specific incident or
based on prospective review or process reengineering
g. Estimate of the potential number of untoward incidents that
could be avoided if adopted throughout the system, or assessment of the
applicability of the new process at other VA health care facilities and
its impact on patient injuries at those facilities
h. Listing of specific equipment, supplies, or staff training
required to implement the revised process or system improvement
NOTE: Photographs, flow charts or diagrams, floor plans, blueprints
or other materials that help illustrate the proposal are welcome, and
may be submitted with the narrative justification.
9. Proposals will be judged on the following criteria:
a. Severity of the safety hazard eliminated,
b. Potential frequency of the hazard eliminated,
c. Elegance of the solution, in terms of simplicity and investment
or maintenance required,
d. Clarity of the analysis of cause of incident or misadventure,
and
e. Evidence that solution was effective in reducing hazard
10. This is an on-going program with no limit on the number of
awards. Proposals which are not selected for national recognition but
which have merit will be referred back to the VISN or facility for
recognition at the local level.
11. For additional information, please contact Dot Brady (10A2A),
Management Support Office, on 202-273-8873.
Kenneth W. Kizer, M.D., M.P.H.
Under Secretary for Health.
Senator Frist. Thank you, Dr. Garthwaite.
Dr. Garthwaite, before coming to the U.S. Senate, I spent
10 years working in VA hospitals doing heart surgery. One thing
that was interesting to me in doing heart surgery in VA
hospitals, both in Tennessee and on the West Coast, was the
protection of an individual from the tort system--not
protection, but separation. It is unique, and as we talk about
the VA system and we talk about 5,500 other hospitals that are
outside that system, I think it is important for us to at least
address the issue.
First of all, the VA falls, correct me if I am wrong, under
the Federal tort system, and individual physicians working for
the VA cannot be sued for medical errors; is that correct?
Dr. Garthwaite. That is correct, as long as they are
operating within their job description and their assigned
duties.
Senator Frist. Which is very different from outside the VA
system. Could you comment, and again, this goes back to what
Dr. Eisenberg mentioned in the report about this blame-free
environment, how important is that different, more protected
environment, in terms of the willingness to participate in
reporting medical errors and mistakes, based on your experience
and what you have heard?
Dr. Garthwaite. I am sure it must play some role, although
if we do make a payment on behalf of a provider, we have the
responsibility, when we determine the care was substandard, of
reporting them to the National Practitioner Databank. So there
are some consequences for individual providers who are deemed
to have provided less than standard care.
I think an other distinct difference is that we employ most
of our physicians. Some are on contract, but most of our
physicians are employed directly by the VA. That sets up an
employer-employee relationship and a supervisor-supervisee
relationship which are relatively unique to the VA.
Senator Frist. And do you feel the blame-free environment
makes people more willing to come forward and report errors?
Dr. Garthwaite. I think it can and should, although I would
say that, for instance, in our report of 3,000 which Senator
Collins alluded to, those were in fact 3,000 adverse events;
many of them were not actual errors, but events which were
unanticipated which we felt demanded further investigation. The
same is true with the deaths associated with those adverse
events.
We received a fair amount of encouragement from the press
about that, but we also received some not so flattering
commentary about the number of errors occurring in the VA
health care system.
I only say that because it is not just whether or not there
is a tort action that really suppresses people from coming
forward; it is often the shame, in the sense that you have done
less than you set out to do, and the embarrassment for doing
less than you believe you can do. That is very important in
keeping people from bringing forward and discussing errors.
We did a survey of our staff, and in fact, shame
significantly outranked fear of punishment as a reason for not
sharing medical mishaps.
Senator Frist. I think you are exactly right. That sort of
peer pressure is something which cannot be understated in
medicine today, which means more disclosure can make the system
work better. It does not have to be just punishment and taking
people into the courtroom. I think that is very important; many
people do not understand that.
Dr. Eisenberg, as you know, we worked very hard in this
committee on the reauthorization of the Agency for Healthcare
Research and Quality, signed into law this past year. What we
attempted to do was refocus the entire Agency on quality
issues, quality improvement, recognizing that we do not have
the answers to all these difficult challenges; that the pace of
science and health care delivery is moving quickly, and
therefore, you have taken that charge, and it is now written
into law. Part of what we wrote into it was this reduction of
medical errors before the IOM report, and we granted the Agency
very broad authority, however, funding issues we must continue
to address. You were very clear in your opening paragraphs that
you were speaking today not primarily wearing your hat from the
AHRQ, but I am going to ask you to put it on and tell us what
effect the recommendations will have on your agency and
specifically, do you believe that we need to create a new
center within AHRQ to accomplish what has emerged--the IOM
recommendations or the recommendations that will be put forward
today by the administration.
Dr. Eisenberg. My AHRQ hat is on now. You are correct in
your comment about the fact that we have been thinking about
the issue of errors for some time. In fact, the Agency funded
investigators in Massachusetts looking at the issue of errors
as early as the first part of the preceding decade, in the
nineties, and it was much of the work that was funded by the
Agency which led to an understanding of what the risk is and
what the number of deaths is. So this is part of an ongoing
project for us, and it is also part of our ongoing quality
agenda.
I think, though, that the Institute of Medicine report has
had a very positive effect for all of us who are concerned
about the need for more research in health care quality,
because it has taken an issue which has been difficult to
explain and has made it feel more real to people. It has taken
a part of the quality challenge for this country and it has
made it very clear to Americans that while we have very good
health care, we could have better health care. It has also made
it clear to them that there is a lot that we do not know about
how we could have better health care, and that we need more
research in this area, both to understand the causes and to
understand how we can improve care.
I have often thought that if health care quality were a
disease, and it were listed as the fifth or eighth leading
cause of death, that people would not hesitate for a moment in
calling for a major research agenda. Now that the quality
agenda has taken more life through the issue of patient safety,
I think it is easier for us to explain the rationale for a
major national agenda in health care research.
Senator Frist. What about the new center?
Dr. Eisenberg. On the center, we applaud the Institute of
Medicine's recommendation and agree with it. We believe that a
new center can be created within the Agency, building on what
we have as the Center for Quality Improvement, so that it would
expand the scope of that center to become a Center for Quality
Improvement and Patient Safety, with a broader scope and a
broader set of responsibilities.
Senator Frist. Thank you.
Senator Specter.
Senator Specter. Thank you very much.
Dr. Eisenberg, starting with the good news, there has been
a recommendation of $20 million in funding from our
subcommittee, and I believe Senator Harkin and I will lead the
way in providing that funding for you.
I was pleased to hear you say that you agree with the
thought that I expressed that there is a professional
responsibility to tell the patient when an error has been made
by the hospital. My question is whether you agree with me that
there should be a mandatory requirement as a matter of law.
There is no doubt that a patient has a right to get the
information when an error has been made, or full disclosure if
a patient seeks to exercise that right in court. Would you
agree that there ought to be a provision that where there is a
patient who has suffered death or acute injury, that should be
disclosed to the patient or to the estate?
Dr. Eisenberg. The QuIC has taken the position that it is
the obligation of the individual clinician and the hospital to
tell the individual about that event. We really have not taken
a position on whether that requires a Federal law, or even
States laws, for that matter, but we certainly believe that at
a minimum it is a professional responsibility.
Senator Specter. Well, I would ask you to take a look
beyond. There is a mandatory requirement for reporting in
Pennsylvania, for example, by hospitals, but there is
relatively little. I note that you have called for reporting by
the States as opposed to the Federal Government, and I believe
that that is a matter which requires some analysis. You have
also noted that the 6,000 hospitals funded by HCFA would have a
mandate which goes pretty far on having a Federal
responsibility.
There is a little more of an inclination to report when it
is a Federal responsibility, a Federal mandate, perhaps backed
up by loss of payments from HCFA, for example. There is an
analogy in the campus reporting where we found that the
obligation of universities and colleges to report crimes on
campus was disregarded in substantial measure. That legislation
came through our subcommittee, and we have since added some
pretty tough penalties.
Do you think that ultimately, there will have to be a stick
as well as a carrot to get compliance by those who have an
obligation to report on a mandatory basis?
Dr. Eisenberg. I think that the State systems as they
currently exist demonstrate the fact that in their diversity,
we do not know enough about how to collect this data, and we do
not know how to report it at this point. What we need to do is
look at the States systems, and we need to work with the States
to demonstrate how this process can work best.
If in 3 years, we find that States have not adopted a
mandatory reporting system, we will have by that time learned
which of the States' programs work best, how they work best,
and the QuIC will report back to the administration with
recommendations about how to go beyond the current proposal if
that is necessary.
But we are optimistic that with Federal help through, for
example, the Quality Forum helping to standardize the kinds of
measures that ought to be used, the States systems can work.
Senator Specter. Perhaps the demonstration projects that
Senator Harkin and I have recommended, with five institutions
on voluntary confidential, five on mandatory confidential, and
five on mandatory with a statutory obligation to tell the
patient, will give us some insights there.
Let me ask you one final question, Dr. Eisenberg, before
turning to Dr. Garthwaite, if I have sufficient time. The
president of the American Hospital Association, Richard
Davidson, is reported in today's New York Times as saying they
were not going to attend the White House event today ``because
we thought that there was an agreement with the White House in
a public-private partnership, but there has been little or no
consultation.''
Before Senator Harkin and I introduced our legislation, we
consulted with many of the national agencies, including the
American Hospital Association, and while they did not like the
idea of mandatory reporting, they did have some good ideas on
technology.
When President Clinton proposed his national health plan
late in 1993, and we had the very heated debate in 1994, there
was considerable concern--really, criticism--by the private
sector of lack of consultation. My question to you is what do
you plan to do, if anything, to try to bring on board groups
like the American Hospital Association to try to get
cooperation from the private sector, which I think is going to
be necessary if there is going to be what Mr. Davidson calls
``a change in the culture in hospitals''?
Dr. Eisenberg. Well, we look at this process as beginning,
not ending, and we have stated very clearly in the report that
we want the consultation of the States, of the private sector,
including the hospitals, the medical community, and the nursing
community, as we lay out the implementation of the principles
that we have established. But a careful read of this report--
and I am sure the hospital community will read it carefully--
will demonstrate that these are principles that are
established, and we do not pretend to know exactly how these
programs ought to be implemented. In fact, that is the gist of
my response to you about the State programs. We think we have a
lot to learn from the States and from the hospitals about how
to implement a mandatory reporting system so that it encourages
and does not discourage the reporting process.
Senator Specter. My red light just went on, Dr. Garthwaite,
but I have you on the record from our last hearing. Thank you
for joining us.
Senator Frist. Thank you, Senator Specter.
Senator Kennedy.
Senator Kennedy. Thank you very much, and I thank the
panel.
At the outset, I listened to my friend Senator Frist talk
about what has happened in the military. We have what we call
the Feres doctrine, which is another way of stating what has
been reviewed earlier today about the limitations on the
ability of our servicemen and women to recover damages for
tort-related injuries. That is a longstanding doctrine that I
think may be worthy of review at some time--I do not know if we
want to get into it today, because we have had extensive
hearings in the Armed Services Committee over a period of time,
and I think there are some legitimate questions about that
doctrine. The protections that exist now were basically adopted
because we had a war situation and did not want to have people
involved in conflict having to think twice about how they were
going to treat servicemen and women. We have had a long period
of peace now, and, therefore, the continuation of liability
protections is a legitimate issue.
You also have in the military certain protections for
whistleblowers, which we do not have in the private sector at
the present time, which permit information to be brought
forward. Service personnel who report possible violations of
law or negligence are protected, which is enormously important.
The whistleblower protections for medical personnel have
not been included, although we attempted to include them in our
Patients' Bill of Rights. This remains an important issue.
Basically, in my limited time, I want to ask about the
prescription drug benefit program. One aspect of this issue
involves various adverse drug reactions that particularly
affect our elderly population. We know that our senior citizens
have a heavy utilization of prescription drugs. I am very
hopeful that we will get action in this Congress on an extended
prescription drug benefit. But we also want to make sure if we
are going to do that that we give adequate protections to our
seniors to avoid the kinds of adverse drug reactions that
various studies have reported.
Could you tell us how important you think making sure that
we provide at least some protection, perhaps along the lines of
a pharmacy benefit, for seniors? How important is that, and how
important will that be, as there is an increasing reliance on
prescription drugs? As a result of these studies, what are you
recommending we do in order to make sure we provide protections
for seniors, and how important is it that we pass a
prescription drug benefit program?
Dr. Eisenberg. The issue of patient safety and medications
in the elderly is a very critical issue. We know that as many
as 7,000 of the people who die each year from errors die
because of drug errors, and we think that about one out of
every ten hospitalizations occurs because of a prescription
drug-related issue.
There are three ways which we think we ought to approach
this issue. The first one does relate to your point about a
drug benefit, that is, when drug benefits are offered, they are
often managed by organizations like a pharmaceutical benefits
manager. If that is the way a drug benefit is organized, that
would provide us with an opportunity to have a safety program
embedded in the prescription and dispensing process.
We understand from pharmaceutical benefit managers that
they do have programs in place to enhance patient safety, to
provide utilization review to the clinicians as well as
education. But in addition to that, we think the FDA plays a
key role in its reporting systems, to enhance its reporting
systems, to develop standards so that drug packaging and
labeling and the naming of drugs is safer.
And third, we believe it is very important to understand
what the risks are of adverse events, and the Centers for
Education and Research in Therapeutics at AHRQ will provide us
with a mechanism for enhancing that knowledge.
So to your question, we believe it has to be a multifold
way of addressing it, and a drug benefit would give us an
opportunity to address it head-on.
Senator Kennedy. Dr. Garthwaite.
Dr. Garthwaite. I would just add that often we think of
errors as errors of commission, but errors of omission are
important in terms of patients' overall quality of care. The
use of beta-blockers and aspirin after a heart attack has a
significant effect on preventing the next heart attack and
preventing hospitalization and extending life. Some private
sector studies suggest that that happens as infrequently as 21
percent of the time. We have been able, though the use of
systems, reminders, and education of our providers, to get the
VA up into the 90 percent of administration of beta-blockers
and aspirin. So the availability of drugs can be critical.
Senator Kennedy. Dr. Eisenberg, you mentioned the
importance of educating patients so they can make informed
decisions. Will the Office of Personnel Management rate health
plans and institutions participating in the Federal Employees
Health Benefit Program on how well they perform in medical
error reduction and meeting patient safety standards and make
that information available to participants? We have about 10 to
11 million people involved in that program at the present time,
and I am interested in whether you have thought about that and
what suggestions you may have.
Dr. Eisenberg. Yes, we have thought about it. The Office of
Personnel Management intends to have a requirement that plans
describe the systems that they have in place and that that be
made available to individuals in the book that describes the
plans as Federal employees choose those plans.
OPM does not have a plan right now to rank or rate
programs, but rather, to report the degree to which they exist.
In addition to that, OPM uses the Consumer Assessment of Health
Plans Survey that was developed by AHRQ to educate Federal
employees about the satisfaction of other Federal employees and
people who use health plans, and we believe that patient safety
and the satisfaction with patient safety and the experiences
with patient safety could be embedded in that as well.
Senator Kennedy. Thank you.
I thank the chair.
Senator Frist. Thank you, Senator Kennedy.
Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
I want to focus on just two areas. Dr. Eisenberg, your plan
sets up 100 demonstration projects where reporting will be
mandatory for those institutions that volunteer to participate
in the demonstrations, but you do not require other hospitals
to do the same. I am just wondering, given the authority that
HCFA has to determine which providers can participate in
Medicare, why don't you go further? You have a big stick there
with HCFA, so why don't you go further?
Dr. Eisenberg. Well, HCFA has proposed several initiatives,
with one guiding principle, which is that it needs experience,
and it wants to get that experience as quickly as possible,
about how these systems work, when they work the best, and how
to design a system that might go beyond the first demonstration
project.
So the program to which you are referring is a program that
would be a demonstration project with a peer review
organization; it would have mandatory reporting, but it would
be confidential, and 100 hospitals would participate in it. We
believe that very soon after the institution of a program like
that, we would know more about how a broader system such as you
describe should be instituted so that it has more effect.
Senator Harkin. Why aren't you taking the approach that
Senator Specter and I have in our bill? We propose looking at
different types of systems rather than just the one system.
Dr. Eisenberg. We would be more than happy to sit down and
talk with you about expanding beyond the one program that the
Health Care Financing Administration has proposed at this
point, to explore whether more would be appropriate.
Senator Harkin. Second, we included in our bill a provision
for demonstrations on best practices, and I do not see that in
your proposal. Now, there is a lot of information out there,
and some places are doing really good work. I do not have all
the information at my fingertips right now, but I have been
informed of some unique approaches at the Latter Day Saints
Hospital in Salt Lake City--they are supposed to be faxing me a
lot of information. I understand they have really moved way
ahead in this area. I would hope again that you would expand
your request to include demonstrations on best practices.
Dr. Eisenberg. That is a critical issue for us. In fact, in
the proposal that we have before your committee, there is $11
million requested for the Agency for Health Care Research and
Quality to study whether the best practices really are best,
how they compare to their alternatives so we can prove that
they are best rather than just assert that they are best. That
$11 million will enable us to fund research like the research
at LDS Hospital, which in fact our agency had funded earlier,
demonstrating that programs can work. LDS tells us that eight
other hospitals are now coming to them, asking them for advice,
and we are proud of that because we funded the initial
research, and that shows that the research can be translated
into practice. So it is a large part of what we see as the
research agenda in this area, and we have requested $11 million
for what we call the ``translating research into practice''
part of the safety agenda.
In addition to that, we will have evaluations of programs
such as those that the VA and the Defense Department are
instituting.
Senator Harkin. So you have requested $11 million--run that
by me again--what are you going to do with that money?
Dr. Eisenberg. The total request for the Agency's patient
safety initiative is $20 million. Of that, $5 million would be
spent on new knowledge in this area, $4 million would be spent
in developing new tools to implement that new knowledge, and
$11 million would be spent in the area that you are describing,
which is evaluating best practices and getting those best
practices translated and disseminated and into the field, to
see how we can get them disseminated as quickly as possible.
We think the $11 million is a good down payment on the
suggestion that the Institute of Medicine has made.
Senator Harkin. Thank you very much, Dr. Eisenberg.
Thank you, Mr. Chairman.
Senator Frist. Thank you, Senator Harkin.
While we are talking about the money, could you just answer
one question for me. The $20 million, you walked through, and I
think that is very important. The Institute of Medicine
specifically said $35 million. What do they recommend that you
are not doing? The Institute of Medicine report said $35
million a year for 3 years; is that correct?
Dr. Eisenberg. That is right.
Senator Frist. And the President has recommended $20
million. What is the difference? Should we be doing more, and
what are we leaving out?
Dr. Eisenberg. Well, the Institute of Medicine's
recommendation was for $35 million in the first year and $100
million within 5 years in this area. We are currently spending
about $4 million in this area, so the total is about $24
million, not the $35 million that the Institute of Medicine had
recommended.
I do not think there is a major area that the IOM suggested
that we work on--whether it is understanding root causes or
developing measures or evaluating outcomes and effectiveness of
these programs--that we are not doing. It is simply an issue of
the magnitude of the investment and the degree to which we can
address those issues.
Senator Frist. I think that is something that Senator
Specter and we need to come back to--because if it is this big,
and as Senator Harkin said, there are more things that we need
to be doing, we need to do that.
Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Dr. Eisenberg, the emphasis in both the Institute of
Medicine report and your recommendations is on patient safety
and reducing medical errors in the hospital setting, and yet a
great deal of health care is now being delivered outside of
hospitals, whether in ambulatory care clinics or physicians'
offices. Have you taken a look at whether there are similar
problems in those settings--it seems to me we have every reason
to believe there are problems in these settings as well. Has
there been any attempt to address medical errors outside the
hospital setting?
Dr. Eisenberg. There has not been enough. We think, as you
do, that there are a number of adverse events which are
preventable which occur outside hospitals, and because of that,
we think we ought to take several steps. One of them is to
start with hospitals, because we know we have ways in which we
can institute improvement programs there. The VA and the DOD
have shown us that.
Second, we know that many hospitals are a part of broader
systems, and throughout our report, we describe a way of
addressing this challenge, not just from hospitals but systems
of care, so we can look at the system no matter where the
patient is--whether the patient is vertical or horizontal,
walking or in the hospital, we can address this issue.
And third, we place a major emphasis on the importance of
information systems, because whether a patient is in the
hospital or out of the hospital, we need to have data on what
is happening with that patient, and our information systems in
the health care industry lag far behind the information systems
that are available in many other industries like aviation or
even banking, where more data is available and more is known.
If we could have better information systems, then I think I
would be able to give you a more satisfactory answer to your
question, because we would know more about what is happening in
the outpatient setting.
I think Senator Kennedy's question gets to that as well
with regard to outpatient use of drugs.
Senator Collins. A second question that I have for you, Dr.
Eisenberg, concerns the burden on small hospitals versus large
hospitals of some of the new requirements that we are talking
about. My State is typical of many. We have the 600-bed Maine
Medical Center in urban Portland, and our smallest hospital is
a 14-bed hospital, the Charles A. Dean Hospital in rural
Greenville. Obviously, we want to have quality patient care no
matter where it is delivered. But those hospitals--that tiny
hospital versus the large--by Maine standards--hospital--face
very different challenges. As we look at this issue and how
best to address it, is there a way to take into account the
size of hospitals and the burden of certain reporting
requirements, so that particularly rural hospitals that are
fragile financially already are not pushed over the brink?
Dr. Eisenberg. There is, and we have thought about that
very seriously because we agree with you that it is an
important issue, and there are several ways of addressing it.
One is for us to emphasize how we are only asking that the
reporting that is mandatory and publicly disclosed reporting be
on those events which are preventable, very serious events, and
avoidable deaths. One of our concerns is that in small
hospitals like the ones that you describe, the number of those
events will be small, and the number of events occurring that
are not quite as serious will still be small.
Any single event that should never happen should never
happen, no matter how big or how small the hospital. But if we
are looking at events that might be related to more serious
events, like a wrong prescription that might be caught, what
Dr. Garthwaite called a ``close call,'' we are concerned that
if we were to require mandatory reporting on those, the
reporting burden could be substantial. Therefore, we think that
what we are proposing is doable and is feasible in the short
term. And second, we believe that for hospitals like that, we
need to put programs together, for example, with the Quality
Forum, that will help them understand what the measures are
that they should be measuring so they don't have to reinvent
the wheel in every, single hospital.
Senator Collins. Thank you.
Dr. Garthwaite, I have been concerned for some time, and I
know you are well aware of this, about the cutbacks at the VA
hospitals across this country, particularly in the Northeast
and particularly at Togas in Maine. I have been concerned that
the cutbacks are going to reduce veterans' access to care, but
they also threaten to jeopardize the quality of care. When you
have a situation as we do in Maine where there are currently no
oncologists, when physicians complain repeatedly to us about
the pressures of seeing ever greater numbers of patients in
ever shorter amounts of time, when there are long waiting
periods for treatment--it paints a picture that raises serious
questions in my mind as to whether we are creating the kind of
environment that is conducive to medical errors.
Aren't the kinds of staff reductions and cutbacks that we
are seeing at Togas and at other hospitals likely to increase
rather than reduce the kinds of medical errors that you are
working so valiantly to try to reduce at VA hospitals?
Dr. Garthwaite. Well, I certainly hope not. We are
attempting to reduce nondirect care providers in most of the
areas where we find our expenses exceed other areas of the
country in terms of how much it costs to give a certain unit of
care. But I think your point is a valid one both in the VA and
in the health care sector in general, and that is that as there
are increasingly intense pressures to decrease the cost of
health care, that can lead to staffing issues.
One of our Patient Safety Centers of Inquiry will look
specifically at staffing mixes and staffing ratios and others
and whether or not the number of staff and how busy they are
has contributed as a root cause to any of the adverse events
that we uncover.
So I think it is a very valid point. I think it is not just
a VA issue, but a general issue, and we think it is a very
important one to examine.
Senator Collins. Thank you, Mr. Chairman.
Senator Frist. Thank you, Senator Collins.
Senator Reed.
Senator Reed. Thank you very much, Mr. Chairman.
Dr. Eisenberg, in your testimony, you have indicated that
this summer, QuIC will begin to test strategies to improve
patient safety in high hazard areas. Are you aware of the
ongoing work between the Department of the Army and certain
military and civilian hospitals. I am aware of this program,
which is called med teams, because a lot of the research is
taking place at Rhode Island Hospital. Through med teams,
hospitals are taking the techniques the Army has used to
develop training for aviation crews and applied them to
emergency rooms, and it seems to be working quite well.
Could you comment on the med teams program and more
generally about the adaptation of some of military crew
training techniques to medicine? And one other point--medical
errors seems to be, following a point Senator Harkin made, more
of a systemic problem, but in many respects, it might be
similar to group crew training problem. In medicine today,
despite the skill and the extensive training of individual
physicians and nurses, the breakdown might arise from the fact
that they cannot work together as a cooperative crew or team.
Please comment Dr. Eisenberg, if you could.
Dr. Eisenberg. The QuIC has provided us a wonderful
opportunity for Federal agencies to learn from each other, and
the example that you give is a terrific example of just that.
We have learned from the Defense Department about how it is
learning from systems that have been put into place for other
purposes and how they can be applied to systems in the health
care system, and as opposed to having individuals independent,
that a well-organized, systematic approach that is goal-
oriented can help us to address those issues.
In fact, the Defense Department has the lead in helping us
to develop what is called a ``breakthrough series'' in reducing
errors in high-hazard environments. We are going to be doing
that with the Institute for Health Care Improvement in Boston.
There will be a number of Federal agencies--the VA, the DOD,
the Public Health Service agencies will all be participating in
this. It is a way we can learn from the Defense Department's
experience in the area that you described.
Senator Reed. And to elaborate, is it your sense that this
notion of crew training might be a way to handle some of the
problems, being experienced by our highly trained physicians,
technicians and nurses. I guess it begs the question: Are some
of these problems the result of poor teamwork rather than lack
of individual skills?
Dr. Eisenberg. Many of them are the result of poor teamwork
and poor systems that undergird the teams. In the best American
hospitals, both of those issues have been addressed. We have
teams that are working together in a very well-organized way.
In fact, team care and shared decisionmaking are themes in the
patient safety area in hospitals around this country. But even
that is not enough if they do not have the underpinning of an
information system to help them communicate with each other and
understand what the data is about their patients.
Senator Reed. Dr. Garthwaite, do you have a comment?
Dr. Garthwaite. I would just say that we have a simulator
for an operating room at the Palo Alto VA, affiliated with
Stanford University, and when they bring in a team and put them
through an emergency, they tape record from every angle and all
the communication and then play it back to get exactly what you
have suggested, in that people do not realize how imprecise the
communication is and what their actions are like when they are
taken out of that situation and they get to watch and critique
themselves.
So that whole human factors analysis is going to be
critical to solving some of these issues.
Senator Reed. And Dr. Eisenberg, I presume your plans are
to take this already existing knowledge and technique, the
simulations, and deploy it into the hospital setting--is that
at the core of what you are doing, or at least should it be?
Dr. Eisenberg. You have heard Dr. Garthwaite describe the
VA's intentions. We, as Federal agencies, do operate some
hospitals--those that we have talked about today, the VA and
the DOD, as well as the Coast Guard, the Bureau of Prisons,
Indian Health Service--all of whom are participating in this
program. In those institutions where we provide care, we intend
to implement these programs as quickly as we can. But we want
to do what we can to stimulate and help the private sector.
Senator Reed. And in that regard, your testimony also
suggests that OPM, for example, is going to urge all 300
private health plans in the Federal Employees Health Benefits
Plan to include error reduction and patient safety measures.
Urging, suggesting, persuading--at what point do you recommend
that they do things like put all of their surgeons and surgical
teams through this type of crew-oriented training?
Dr. Eisenberg. The Office of Personnel Management at this
point believes that by making the information available to
Federal employees and letting Federal Employees make decisions
about the choice of plans or hospitals and whether or not they
have patient safety programs in place, that will be a very
forceful incentive for those plans and those hospitals to put
those programs into place.
We will evaluate that, and if it does not work, we may come
back to you and say it did not work, we need something else.
But at this point, we believe that that is the right first
step.
Senator Reed. It just seems to me, reflecting the number of
hospitals in my State, and there are only a few, I suspect that
they will write in their brochure that they have these
techniques if they in fact do, and the question is whether or
not they are up-to-speed. I think it is hard for a layperson to
make the distinction along those lines, but at least it is a
first step.
Dr. Garthwaite, you have already done some work in VIS-8
and VIS-22 about close call reporting. I feel particularly
moved to ask this question today as the pilot of my plane this
morning came back with a flashlight to make sure the landing
gear was down, and as he walked back to the front of the plane,
I said, I wonder if they are reporting that as a close call.
Can you comment on the VA's close call reporting system?
Dr. Garthwaite. Yes. We learned from our initial forays
into adverse event reporting that it was not just sending out a
policy and hoping people read it and understood what it really
meant, or that our caregivers really had any intrinsic
knowledge about how to do a root cause analysis. So in rolling
out the new system, we have done extensive education and
targeted two pilot health care networks, one in Florida and one
in Southern California--I think that is what you are referring
to.
Senator Reed. Yes.
Dr. Garthwaite. The one in Florida has been up for about 3
months, and we have gotten very good feedback. In fact, other
networks have asked to move up their dates of implementation
somewhat, because this seems to work much better than the older
system.
I think the key is the total education, the immersion in
the computer-aided analysis system that walks people through
what a true root cause analysis is. We hope to learn even more
as we implement this, but we believe that it is going to make a
major difference.
Senator Reed. My time as expired, but just quickly--they
are in fact reporting close calls?
Dr. Garthwaite. Yes. We think we should hear about errors
and close calls both in our mandatory and in our voluntary
systems. We would rather have too much information and error on
that side at the present time until we begin to understand it.
I really only takes knowing about an error to learn from it.
You do not have to learn the same lesson six times or 12
times--it is not how frequently you learn it--you have got to
find it, design a fix, and implement that systematically.
Senator Reed. Thank you, Doctor.
Thank you, Mr. Chairman.
Senator Frist. Thank you, Senator Reed.
Senator Hutchinson.
Senator Hutchinson. Thank you, Mr. Chairman.
I would like to pursue the voluntary versus mandatory a
little bit, Dr. Eisenberg. My understanding was that the
administration initially had supported voluntary reporting
requirements and that now, the plan calls for mandatory, at
least in the case of death and serious injury. Am I correct
that there has been a switch in thinking in the administration?
Dr. Eisenberg. No, that is not correct. We did support
voluntary programs, and we still do, but we had not taken a
position prematurely, nor announced a position prematurely, on
whether we were supporting and how we were going to support
mandatory programs.
What you might have read was that at the time, we were not
prepared to announce what our findings were going to be because
we thought we ought to come to you and announce them here. So
that was not accurate.
Senator Hutchinson. From your statements today during the
questioning of Senator Harkin, I just wonder how strong is the
commitment to mandatory, because when he suggested a
multifaceted approach where there would be mandatory voluntary,
you indicated a willingness to negotiate that and discuss that,
so that seems to me to be somewhat of a retreat from a blanket
commitment to a mandatory system.
Did I misunderstand something there, or could you expand on
that?
Dr. Eisenberg. We think that a mandatory system is
necessary. We think, however, that the whole spectrum of
reporting activities should be undertaken and that we should
evaluate how they work best, and even within mandatory systems,
we believe that there should be confidential systems of
mandatory reporting and mandatory systems that should be
disclosed.
We have not retreated from anything--in fact, our position
on mandatory systems that are to be disclosed is that there
ought to be a nationwide, State-based system of mandatory and
disclosed reporting on major events that are either----
Senator Hutchinson. Wouldn't that preclude Senator
Harkin's, where you would have--obviously, if you are doing
voluntary, it is not mandatory, so if you are doing both----
Dr. Eisenberg. As I understand that proposal--and I should
say that the administration has not had a chance to review it
or take a position on it--but as I understand it, they propose
to go beyond the cautious approach of just having mandatory
reporting of major life-threatening or life-ending events, to
look at what more we can do than that and to evaluate those in
short order.
We agree with that, that we need to evaluate more than just
the mandatory reporting of major events.
Senator Hutchinson. The New York Times story today that was
referred to by Senator Specter earlier said that the
President's initiative leaves some important questions
unanswered, among those, what is the Federal role in the
proposed new reporting system, and will the States get
additional money to catalog and analyze reports of errors.
When you were talking about the $20 million and putting a
new mandate on the States regarding reporting and their role in
that, will there be any incentive or any assistance for the
States in this new obligation?
Dr. Eisenberg. There will. The $20 million that we were
describing is for the research part of this and not for the
implementation part. We do think it is very important, though,
that we assist the States in implementing these programs, first
through asking the Quality Forum to come up with a core set of
measures so there is some standardization, and the States do
not have to all struggle to find out what a good set of
measures ought to be.
We also want to help the States to evaluate what those
programs are, bring the States together in the convening role
of the Federal Government, and help them to learn from each
other. Once we know what works best, then we can help the
States to move forward and implement those programs that are
most effective.
Senator Hutchinson. You mean move forward in the sense of
assisting them with funding at some point?
Dr. Eisenberg. Well, we have not taken a position on that,
because we do not know what the best system would be. But I
trust that when we do know that, we will come back to work with
the Congress to evaluate how much it would cost to implement a
program like that and whether it should be funded federally or
not.
Senator Hutchinson. In that same New York Times article,
Dr. Nancy Dickey, former president of the AMA, is quoted as
saying that they are ``opposed to mandatory reporting and that
it may well drive underground the very information you need to
improve safety. A number of States have mandatory reporting,
and there is no evidence that they have greater safety or fewer
errors.''
Would you respond to that concern, both that it might drive
that information underground and that in States that have
mandatory reporting, there is no evidence that you have fewer
errors?
Dr. Eisenberg. I will. First, we do not think that having
mandatory reporting of events that the doctors and the
hospitals should disclose to the patients anyway is going to
drive anything underground, because they should have reported
it to the patient in the first place. So none of this should
have been secret. The kinds of events we are describing are the
events of deaths that were avoidable, or a major event that
causes the patient a lifetime or long-term problem, and as we
have already discussed, that should be disclosed. So we are
just talking about reporting those events which have already
been disclosed.
Second, in response to your question, do we know if these
programs work or not--no, we do not. We do not know how well
they work or when they work best. So the comment that is quoted
is on target. We need to know a lot more about these programs,
and there is no way we are going to learn more about them
unless we have them, and we can evaluate them very carefully.
The final thing I want to say is that the American Medical
Association should take great pride, I think, in the fact that
it has taken a very professional approach to this issue of
patient safety, raised the issue, and recognized the
responsibility of the profession for doing just what the VA and
the DOD have been doing and translating that to the Nation as a
whole to learn from errors as well as to make them available to
the public.
Senator Hutchinson. My time is almost up, but I would have
thought that in the States that have had mandatory reporting
requirements, there would be some indicators, some evidence,
that in fact we have a better track record there as far as the
serious adverse events than in States that do not have that.
Are you saying there has been no analysis, so there is no
evidence?
Dr. Eisenberg. It is not that there has been no analysis;
it has been that there is very little. Our agency, as you know,
is a small agency, and our research budget is likewise small,
but we have funded a few projects, one of which looked at the
New York system and demonstrated that in New York with
mandatory reporting of cardiovascular deaths, there was a
reduction subsequent to that in deaths from cardiovascular
surgery. In Pennsylvania, we found that the reporting system
existed, but it was not disseminated widely to the public, and
the public by and large did not know about it.
So those two research projects that we have sponsored tell
us that programs can work if you extrapolate from that
research; they do not work if you do not do anything with the
information. It is that kind of research that we think we need
to sponsor to look at other States' programs to find out how
they can work best.
Senator Hutchinson. Thank you.
Thank you, Mr. Chairman.
Senator Frist. Thank you, Senator Hutchinson.
Senator Dodd.
Senator Dodd. Thank you, Mr. Chairman.
This is very interesting, and I appreciate the opportunity
to listen to the witnesses and to our colleagues.
If I could jump ahead, since we have another panel coming
up. Someone has suggested that in fact there is not much need
for a Patients' Bill of Rights, that if we could deal with the
issue of proper reporting of medical errors, that would alone
suffice--that the pursuit of patients' rights is a misguided
effort in Congress. I disagree with that, but I would like to
ask you, Dr. Eisenberg, to comment on it because you may not
have the chance once you leave that microphone. And there is a
distinction in my view between a physician committing an
inadvertent error that causes serious injury or death and a
deliberate decision by a health care plan to deny health care
coverage. That is how I see it. I think there is a fundamental
distinction. I think both issues are very important, and I do
not see how one necessarily supplants the other. I wonder if
you might just take a moment and comment on a coming witness'
position on that issue.
Dr. Eisenberg. I cannot comment on his position because I
have not heard it, but I will comment on your statement. I
think it is so important for us to recognize that to get high-
quality care delivered to Americans, they need to have health
care insurance, and we in the administration have taken very
strong positions, as has the Congress, to improve access to
insurance. We also believe that once you have insurance, you
need to have access to care, and that is what the Patients'
Bill of Rights is all about--just because you have insurance,
you may not have access to the necessary care, and we want to
be sure that that happens.
But even if we have a Patients' Bill of Rights, and even if
people have access to care, what we are talking about today is
what happens when people do have access to care and to be sure
that they have access to high-quality care.
So the way we look at it is, in a sense, as three legs of a
stool. In order for us to have high-quality care, we have got
to have insurance so that people are covered; we have got to
have access to the necessary services; and then, once you get
access to those services, they have to be safe services, error-
free services, and high-quality services. So they are separate
issues, they are separate parts of the same story of trying to
get high-quality care to the American public.
Senator Dodd. And one does not replace the other.
Dr. Eisenberg. No. They are all necessary.
Senator Dodd. Dr. Garthwaite, I see you nodding your head,
but do you want to add anything to that?
Dr. Garthwaite. No. I would agree. We try to set the same
kind of system within the VA. It is very important that
decisions about what is a covered service are made openly and
publicly and are adequately disclosed to the patients.
Senator Dodd. Senator Hutchinson has left, but he raised
some good questions about the mandatory vs. voluntary
approaches--and I apologize as one of the last people to ask
you the question here, but it was still somewhat uncertain in
terms of what we mean by mandatory reporting.
First of all, I realize this is a work in progress as you
describe it, but I would like to try to get some clarity on
this if I could. Mandatory for whom? Mandatory for hospitals--
for doctors--for pharmacists? Who does that cover? When you use
the word ``mandatory,'' what is the universe that you are
talking about there?
Dr. Eisenberg. First, the universe is defined by what it is
that needs to be reported in a mandatory way. It is a system
responsibility to assure that those reports are being made. We
believe, as was the implication of the question earlier, that
this is a team issue, that it is not the responsibility of any
one group or any one clinician, but it is the responsibility of
the system to be sure that mechanisms are in place to be sure
these reports occur, and that people feel safe in doing that
reporting.
Some of the reporting will be confidential. Some of the
mandatory reporting will be confidential. But the definition of
who does the reporting is really driven by what it is that they
are reporting about, if it is surgery, or if it is a drug, or
if it is some other part of health care.
Senator Dodd. On the question of confidentiality, I think
there is an implication in the minds of some people, care, that
if you say ``mandatory,'' there is the question of
confidentiality--once something is mandatorily reported, there
is an assumption, and I do not think without some
justification, that once it has to be reported, you have no
assurance that that information is going to be held in
confidence. Once a larger universe has that information, to
what degree is there a sense that you are- not going to be
subjected to unwarranted lawsuits, for instance, which is a
concern that many have.
Dr. Eisenberg. That is a critical part of this proposal,
that the confidentiality be serious, that there be peer review
protections extended to those who are organizing and holding
these databases of errors or breaches of patient safety, and
that we not fear the discovery of those secondary databases.
They should not be discoverable. We do not want those databases
to be available to people who just want to go on a fishing
expedition to find examples of errors. The charts are
available, and they will always be available, I hope, to anyone
who has the right to look at them; but we do not think these
secondary databases where we are collecting the errors that
have occurred should be disclosed. There should be peer review
protections of those.
Senator Dodd. Are you recommending any penalties for
unwarranted disclosure of information for those who might do
so?
Dr. Eisenberg. We have not been so specific as to recommend
what the penalties are, and we recognize that that is an area
in which we are going to need to work very closely with you and
the Congress to develop a mechanism for implementing those peer
review protections.
Senator Dodd. Of course, the other side of that--and again,
I realize it is a bit of an unanswered question--is that if
there is a pattern--if it is an inadvertent mistake, that is
one thing--if it becomes a pattern that shows up, at what point
do you then decide that holding information confidential then
places patients at significant risk by protecting information
that should otherwise be in the public domain so that patients
and their families can make intelligent decisions about who
provides care?
Dr. Eisenberg. We believe that if the events are serious
enough that they need to be disclosed, as the ones that you
have described would be, that they ought to be disclosed to the
public, but that mostly, these events are avoidable errors that
will sometimes lead to an adverse event, but that not all
adverse events, of course, occur from an error. Some of them
occur despite the best medical care that could have been
provided.
Because of that, we want to emphasize the aspect of
learning from errors, whether it is a mandatory or a voluntary
system, and we do think that we need to count on the medical
profession, its accrediting organizations and professional
societies to do just what you have said, which is to act on
that information. But we do think that some of that information
needs to be held confidential so that the reporting is full and
complete.
Senator Dodd. My time is up, but Mr. Chairman, could I ask
just one other question of Dr. Garthwaite?
Senator Frist. Yes, go ahead.
Senator Dodd. On the bar-coding that you do at the VA, that
is a best practice method, and I just wondered how expensive
that is to do. Could an individual hospital bar-code? Is there
enough technology available today that you could do it at a
relatively low cost?
Dr. Garthwaite. Yes, I believe there is. It is never
completely free. We have 173 medical centers, and to implement
it in all of those, the actual hardware is probably $25
million. But it will save money, too, in the fact that a lot of
extended hospitalizations are due to giving the wrong dose or
the wrong timing of medication and so forth; a lot of
hospitalizations are the result of adverse administrations.
So we think there are some savings to be had. There is a
significant expense to training, but I think that overall, it
is such a common error, and the effects on our pilot study were
to dramatic in reducing the number of errors that it is
worthwhile. And I assume the price will come down, as it does
with everything else in electronics.
Senator Dodd. Thank you. I have overextended my time, Mr.
Chairman, and I thank you.
Senator Frist. Thank you very much.
I know we need to move to the second panel, but let me just
say, Dr. Eisenberg, that I appreciate your three-legged stool
approach to quality, and I think it is very important, because
in each of the medical errors hearings that we have had, we
have had the Patients' Bill of Rights come up, and then the
question of should you separate the two or not--and the real
answer is that you need to look at all these issues together.
I do think it is important for my colleagues as much as
others to understand that that approach to quality of medicine
was very much a part of the Patients' Bill of Rights bill that
was marked up by this committee, that was taken to the Senate
floor, that passed the U.S. Senate, that is currently being
talked about as the Patients' Bill of Rights in our conference.
I say that because the authorization for AHRQ, the emphasis on
quality, the only legislation last year to pass on medical
errors, which is part of AHRQ, started in this committee and
was debated. And when we looked at the bills that were on the
Senate floor last year for a Patients' Bill of rights, medical
errors was part of the Senate-passed bill; the reauthorization
for AHRQ was part of the Senate-passed bill and was not a part
of the other bills that were debated on the floor and was not a
part of the Patients' Bill of Rights in the House.
I say that because a lot of people do not know it.
Ultimately, we ended up pulling that out, passing it at the end
of last session so that we could keep moving ahead, and as
demonstrated today, I think that your leadership in AHRQ
addresses this larger picture of quality where, yes, we have a
Patients' Bill of Rights, we have insurance, we have access,
but we have got to address people who get into the system and
minimize the errors that are there.
Let me just ask one thing that I think will clarify things
for me, and then we will move to the second panel. I am a heart
transplant surgeon in Nashville, TN, and I have patients who
come in from all around Tennessee in a field that is pretty
new, transplantation. We are using drugs that people who are
going through medical school now are trained to use, but most
physicians are not accustomed to using cyclosporin, which is a
fairly new drug--15, 20 years old--and they certainly do not
know the interactions with other drugs. So I transplant a
patient, send him back to a small town in Tennessee, where they
go back to work and live a normal life--but they are on seven,
eight, nine, ten different medicines. The family practitioner
in that area sees a sore throat, starts erythromycin, does not
realize that cyclosporin and erythromycin interact, and all of
a sudden, the erythromycin drives the cyclosporin levels up,
the kidneys shut down, adverse reaction, possible death. There
is an 11-bed hospital there in the country--a typical small
rural hospital of 11 beds, as Senator Collins said. How would
the system under the recommendations being made today by the
President, and conceptually, based on your discussions, work?
Is it reported through hospitals, or who does the reporting? Is
that 11-bed hospital responsible for collecting that data? And
then you have the emphasis on States. Whom do they report it
to? Do they report it to the Department of Public Health in
Tennessee, which does not have the organization or the
administration or the focus now? And then, once it gets to the
State with this mandatory reporting, does it come to AHRQ, does
it come to you, where basically, we are talking about funding,
or does it go to the FDA or to the NIH? Where does this data
eventually go?
Dr. Eisenberg. First, that example that you gave is
certainly an avoidable error and one that should not have
occurred. The first question, then, is would that have been
defined by the Quality Forum as one of those select examples of
a reportable event that should be reported to the States.
Every State may want to choose the events that it decides
are reportable, but we are going to ask the Quality Forum to
help the States to look at those which have an evidence base.
Senator Frist. And that has not been defined, or do we have
definitions out there right now?
Dr. Eisenberg. That is right; we do not. And if you look
through the Institute of Medicine report, they describe every
State's definition, and they are all different.
The Quality Forum will be a special place for this to
happen, I think, because it brings the hospitals, the
hospitals, the physicians, the purchasers, the consumers, and
the providers all together to decide what the appropriate list
should be. So that would be the first question.
Second would be yes, the report would occur through the
hospital as we see this system developing. As I mentioned
earlier, perhaps when we see how well that system works and how
it can work best, that could be expanded to systems of care,
but right now, we think it should start with hospitals.
Senator Frist. Even if the patient is not hospitalized?
Dr. Eisenberg. If the patient is not hospitalized, the way
the reporting system would currently work, I do not think that
that would be picked up.
Senator Frist. That is fine. Please continue.
Dr. Eisenberg. I do not think any of us see that as where
we would like to end, but that is at least where we are
starting.
Where would it go? In each of the States, there is a
different mechanism for who collects the data in the State, so
each State would decide that independently.
What would happen to the data after that? I should say that
in addition to this reporting that you are describing, I think
you will hear later from the JCAHCO about a different kind of
reporting system which that hospital might want to report to
that would not go just through the State but would be through
the accrediting organizations, and Dr. O'Leary can comment on
that.
Then, finally, what would happen to the State data, you
asked. We believe that we should have a mechanism for polling
the data nationally so that we can help the States compare
their experiences with other States, but it should be de-
identified--it ought not to have the name of the individual
patient or the name of the individual clinician. And when it
comes to the national dataset, in fact, the hospitals ought to
be coded so that they are relatively de-identified, too, but
the State would be able to break that code and find out how the
States are doing, how the hospitals are doing.
We believe that that could be done at AHRQ in our research
role to help the States to analyze that information, but
without any regulatory responsibility for doing so.
Senator Frist. I know we have to move to the next panel,
but that really helps me walking through it, because there are
so many different points at the local level all the way up. On
the last one with AHRQ--and you said it in the last sentence,
but I want my colleagues to be aware--conceptually, I do not
think we want AHRQ to be in the regulatory business--and I do
not know, if this is the system that we decide upon, where is
the appropriate repository? We need to be thinking at least 5
years out or 10 years out where we want it to be. And then, is
it going to be mainly a research institution, or is it going to
be a regulatory institution, or is it both?
Dr. Eisenberg. That is a critical issue. In the aviation
area, the decision was made to split out the regulation from
the research role, and that information goes to the research
group, ont to the regulatory group, who then inform the
regulators about where the problems may be, but it is a
separated process.
Senator Frist. Thank you. We need to move to the second
panel----
Senator Dodd. Just one more question, Mr. Chairman.
You raised the issue earlier--and I appreciate your going
through this last issue step-by-step--we are losing 100,000
people each year, and I do not know what direction those
numbers are heading in and whether that is static or continues
to go up each year, but it is not an insignificant problem that
we are dealing with here. I am not interested in watching yet
another agency of the Federal Government become a regulatory
agency--I like to leave as much at the State level as
possible--but I can see a patchwork developing here that could
be very uneven in terms of what degree of confidence people
would have about whether or not they are going to be in good
hands in making decisions depending on what State they are in.
Particularly today, with the mobility of medical technology,
where people go to different places because, for example, it is
known that in Tennessee, there is a better heart surgeon, or in
Philadelphia, there may be a better brain surgeon, so people
move around a lot, and now, if you add to that that you have to
concern yourself with whether each State is going to have
better recordkeeping so I can make a good decision about
whether my brother or my sister or myself will be in good
hands, I get uneasy about that approach. I understand the
rationale for it, but----
Senator Specter. Senator Dodd, if you are going to talk
about Philadelphia, you are going to have to talk at greater
length.
Some of us have an obligation to be----
Senator Dodd. I know that, but just as to the last point on
the question of cost.
Senator Specter [continuing]. Let me just make one
statement here. Some of us have an obligation to be at the
White House at 12:10, and we have four more witnesses to hear
from as well as questions.
Senator Dodd. I understand.
You are not going to answer it here today, but on the point
that Senator First was raising, I would be very interested in
some cost analysis of what this is going to cost States,
because ultimately, I can see the issue coming back to us in
terms of what dollars we are going to provide States. I presume
you do not have the answer to that today. Senator Hutchinson
raised it, and Senator Frist did so implicitly, and I would
like to know what you are anticipating in terms of the cost of
this if the States are going to do it.
Senator Frist. OK. Thank you both very much. We appreciate
it.
Let us now call the second panel forward, and Senator
Specter, why don't you begin with the introductions? Let us go
through all four introductions and the move straight into the
testimony.
I will ask everyone to try to keep your testimony to 5
minutes and try to summarize. It will be made a part of the
record--and then we will continue with questioning, recognizing
that people do need to get to the White House.
Senator Specter.
STATEMENT OF DR. I. STEVEN UDVARHELYI, SENIOR VICE
PRESIDENT AND CHIEF MEDICAL OFFICER,
INDEPENDENCE BLUE CROSS, PHILADELPHIA, PA,
ON BEHALF OF THE AMERICAN ASSOCIATION OF
HEALTH PLANS
Senator Specter. Our first witness will be Dr. Steven
Udvarhelyi, senior vice president and chief medical officer for
Independence Blue Cross and its affiliated companies, Keystone
Health Plan East and AmeriHealth in Philadelphia. Dr.
Udvarhelyi has extensive experience in the managed health care
industry and serves on several panels concerned with quality in
health care. He received his M.D. from Johns Hopkins and his
B.A. from Harvard.
Senator Frist. Thank you, Senator Specter.
Dr. Udvarhelyi. Good morning, Chairman Frist, Chairman
Specter, and members of the committee.
My name is Dr. Steven Udvarhelyi, the chief medical officer
for Independence Blue Cross in Philadelphia, PA, and I thank
you for the opportunity to testify today on the very important
issue of patient safety. I am testifying on behalf of the
American Association of Health Plans, which represents more
than 1,000 HMOs, PPOs, and similar network plans that provide
health coverage to more than 150 million Americans.
Independence Blue Cross, my company, serves approximately
2.7 million individuals in Southeastern Pennsylvania and offers
a full range of health insurance products including Medicare,
Medicaid, and commercial health plans.
The Institute of Medicine report, ``To Err is Human,'' has
performed an important service by raising the public's
awareness about the longstanding problem of medical errors. But
it is important to not that preventable medical errors are
neither a new nor a newly-discovered phenomenon. For example,
in 1984, the Harvard Medical Practice Study looked at over
30,000 hospitalizations in New York and found that about 3,000
patients suffered serious complications from preventable
medical errors. Based on this, the authors estimated that over
27,000 individuals die each year in New York alone as a result
of preventable adverse medical events.
So if the evidence on the proliferation of medical errors
is not new, then why have we not been able to effectively
improve patient safety? The answer has to do with the
atmosphere in which physicians, hospitals, and other health
care providers function. When a mistake occurs, we are all
eager to point the finger at someone, and our current liability
system promotes this culture of blame.
Both the Institute of Medicine and President Clinton's
Advisory Commission have noted that fears of litigation
negatively impact error reporting. In fact, there is really no
doubt that the current culture of blame inhibits the
identification of medical errors and in so doing helps
perpetuate them.
Mandatory reporting of medical errors by itself will not
necessarily lead to a reduction of errors or better outcomes
for patients. We must first create an environment that
encourages the reporting of errors and then enables all
participants in the health care system to learn from mistakes
in an effort to prevent them from occurring. A central
characteristic of this environment must be malpractice reform
to reduce the punitive consequences of reporting. And I agree
with Senator Specter's earlier comments that such reforms
should address how to compensate injured individuals.
Other elements of the new environment that must be embraced
if we are to move away from the current culture of blame and
toward improved patient safety include confidentiality and a
nationally-based reporting system. There must be strong
confidentiality protections in place for any error reporting
system, whether voluntary or mandatory, again in part so that
reports cannot be used as a basis for initiating or pursuing
liability claims. Additionally, data should be reported and
analyzed in the aggregate wherever possible.
We need a national rather than a State-based system to
promote uniform reporting and to enable us to identify the
underlying systematic causes of medical errors. Only in an
environment with malpractice reform, strict confidentiality,
and nationally-based reporting do we believe that mandatory
reporting for medical errors is appropriate.
Implementation of an error reporting system also raises a
number of other important issues, including what type of errors
should be reported, who will be able to report those errors,
what type of information should be included in an error report,
and who will have access to the data and how will it be used.
In conclusion, the American Association of Health Plans
whole-heartedly supports the goals of the Institute of Medicine
committee to decrease errors and develop a systemic approach to
prevent their recurrence. We also believe that if the Institute
of Medicine report has shown us nothing else, it has
demonstrated that the current debate over patient protection
legislation needs to be viewed in a new light. As noted by the
IOM and President Clinton's Advisory Commission, the current
liability system deters the reporting of errors. Expansion of
such a system, as proposed by the Norwood-Dingell bill, would
do nothing to promote improved patient safety.
PREPARED STATEMENT
Chairman Frist and Chairman Specter, we are committed to
working with your committees and all the stakeholders involved
in this issue to develop an effective way to identify errors
and use that knowledge to improve patient safety.
Thank you for the opportunity to provide testimony today. I
would be happy to answer any questions at the end.
Senator Frist. Thank you, Dr. Udvarhelyi.
[The statement follows:]
PREPARED STATEMENT OF I. STEVEN UDVARHELYI
Good morning Chairman Jeffords, Chairman Specter, and members of
the committee. My name is Dr. I. Steven Udvarhelyi, and I am Chief
Medical Officer at Independence Blue Cross in Philadelphia, PA. Thank
you for the opportunity to testify today on the very important issue of
patient safety. I am testifying on behalf of the American Association
of Health Plans, of which Independence Blue Cross is a member. AAHP
represents more than 1,000 HMOs, PPOs, and similar network plans
providing care to more than 150 million Americans. AAHP member plans
are dedicated to a philosophy of care that puts patients first by
providing coordinated, comprehensive health care.
Independence Blue Cross serves approximately 2.7 million
subscribers and members in Southeastern Pennsylvania. Our company
offers a full range of health insurance products: fee-for-service
indemnity plans in conjunction with Pennsylvania Blue Shield; Personal
Choice, a Preferred Provider Organization; Blue Choice, another PPO;
Keystone Health Plan East, our commercial HMO; Keystone 65, our
Medicare HMO; Personal Choice 65, our Medicare PPO; and Security 65,
our Medicare Supplemental coverage. We also contract with the state of
Pennsylvania to provide HMO coverage for Children's Health Insurance
Program (CHIP) eligible children in our region, and in partnership with
Mercy Health Plan we offer Medicaid HMOs, Keystone/Mercy Health Plan
and AmeriHealth/Mercy Health Plan.
Mr. Chairmen, patient safety is an issue that must be addressed if
we are to improve the quality of health care in the United States. The
Institute of Medicine (IOM) report has performed an important service
by raising the public's awareness about the long-standing problem of
medical errors and we applaud the Committee's goal to improve patient
safety.
My testimony will address the issue of patient safety, focusing on
the following four areas:
(1) The historical context of errors in medicine;
(2) How our current environment prevents effective identification
of errors;
(3) Types of changes that must be made to create an environment
that is supportive of error identification and improved patient safety;
and
(4) Additional questions raised by error reporting initiatives.
historical context
Preventable medical errors are neither a new nor newly discovered
phenomena. Awareness of this issue dates back many years, with studies
documenting the problem reaching back as far as the 1950's. For
instance:
--In 1976, the U.S. House of Representatives' Subcommittee on
Oversight and Investigation of the Committee on Interstate and
Foreign Commerce issued its report, ``Cost and Quality in
Health Care: Unnecessary Surgery.'' The Subcommittee, in citing
the scientific literature, estimated that there were some 2.4
million unnecessary operations every year, with as many as
11,900 deaths attributed to these unneeded operations, and
thousands more seriously injured.
--The Harvard Medical Practice Study, which looked at over 30,000
hospitalizations in New York State in 1984, found that nearly
3,000 patients suffered serious complications from preventable
medical errors. This study projected that approximately 27,000
individuals die each year in New York hospitals alone as a
result of preventable medical errors. (Brennen et al, 1991)
--``Giving medication to the wrong patient or to the right patient in
an incorrect dosage or at the wrong time is commonplace in
hospitals, nursing homes and other health care settings.'' This
is based on findings from six different research studies
published between 1986 to 1990. (Bogner, Human Error in
Medicine, 1994)
With respect to patient safety, it is important to understand
what health plans can do. For example, health plans have
credentialing requirements so that only qualified providers
participate in our networks. Health plans provide information
to providers on ``exemplary practices'' that are based on
medical and scientific evidence, and perform technology
assessments to understand what the risks and benefits are of
new and emerging medical technologies and interventions. Health
plans utilize centers of excellence--hospitals and other health
care centers that have gained an expertise in a specific area
such as cardiac care--to promote patients' access to the
institutions and professionals who are leaders in their
respective fields.
However, it is important to note that health plans do not perform
the surgery, prescribe or administer the drugs, and are not in
the physician's office or the operating room when care is
delivered to patients. Accordingly, it is health care
professionals who know when an error has occurred and who are
in the best position to evaluate and decrease errors. This
sentiment is echoed in a 1994 book entitled, Human Error in
Medicine.
--``[T]o explore the operational context for error, it is necessary
to have information about the elemental unit of the provider,
the patient and whatever medical treatment device(s) or
medication were used at the time of the error. . . . Such a
system cannot be developed without input from those who
understand the situation and can identify the factors that
induce errors: the medical care providers.'' (Bogner, Human
Error in Medicine, 1994)
``CULTURE OF BLAME''
The question we all must ask ourselves based on the above examples
and the findings of the IOM report is why, when we have evidence of the
proliferation of medical errors, have we not been able to effectively
improve patient safety?
In order to answer this question, we need to look at the atmosphere
in which physicians, hospitals and other health care providers
function. When a mistake occurs, our society is quick to look for
someone at whom to point the finger, and, in the case of medical
errors, the finger is often pointed at the individual provider.
However, most medical errors result from a series of often subtle
events in the systems that deliver care, and not from the negligence of
individual practitioners or institutions. Obviously, a ``culture of
blame'' is not conducive to the identification and reporting of errors-
the essential precondition for understanding why an error has occurred
and what changes are necessary to avoid its repetition. This was noted
by both the IOM and President Clinton's Advisory Commission on Consumer
Protection and Quality in the Health Care Industry in 1998.
--Patient safety is ``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. Most
errors and safety issues go undetected and unreported, both
externally and within health care organizations.'' To Err Is
Human, Institute of Medicine, 1999
--[P]erhaps the most significant deterrent to the identification of
errors is the threat of costly, adversarial malpractice
litigation.'' President Clinton's Advisory Commission on
Consumer Protection and Quality in the Health Care Industry,
Final Report, 1998
Direct evidence of the impact of litigation on patient safety is
not hard to find. In considering Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) policy to require reporting of all
``sentinel events'' that occur in hospitals (defined as all unexpected
occurrences that resulted or could have resulted in a patient's death
or serious injury), the American Medical Association (AMA) House of
Delegates determined it could not support the requirement due to the
fear of lawsuits such reporting would generate. Clearly then, we need
to replace the ``culture of blame'' that inhibits the identification of
medical errors, and in doing so, perpetuates them. In its place, we
need to create an environment that encourages the reporting of errors
and enables all participants in the health care delivery system to
learn from mistakes in an effort to prevent them from recurring.
CREATING AN ENVIRONMENT SUPPORTIVE OF PATIENT SAFETY
Identifying medical errors is the first essential step to improving
patient safety. Mandating reporting in a vacuum, however, will not lead
to better outcomes. To again quote from Human Error in Medicine, ``It
is imperative that an atmosphere be created in which medical care
personnel can freely provide data about errors and near errors they
experience.'' As an example of how a supportive environment can promote
effective reporting, the federal Aviation Safety Reporting System has
established incentives and safe harbors that contribute to the
reporting of almost 20,000 errors each year. Aviation officials point
to a system that is viewed by workers as confidential and non-punitive.
What we can learn from the experiences in the aviation industry is that
there are many factors that will impact the success of measures to
improve patient safety and they must be considered in order to develop
an effective policy.
Accordingly, AAHP believes that the following elements must be
embraced if we are to move away from the culture of blame, encourage
health care providers to report medical errors, and put our health care
system on a path toward improving patient safety.
--Error reporting is tied to significant malpractice reforms. Fear of
litigation has interfered with efforts to identify medical
errors. The culture of blame pervades every aspect of medicine,
from affecting patient safety to increasing medical costs by
encouraging the practice of ``defensive medicine.'' In order to
promote a more positive environment for reporting and
identifying medical errors, we need to enact malpractice
reforms applicable to health care claims.
--Reported information is strictly confidential. While the IOM report
supports confidentiality for errors not defined as ``serious
adverse events'' we feel there must be strong confidentiality
protections for both mandatory and voluntary effort-reporting
systems, in part so that reports themselves cannot be used as a
basis for initiating or pursuing liability claims. It is
critical to recognize that failing to adopt a policy of strict
confidentiality for error reports simply means that errors will
not be reported, and therefore will go uncorrected, leading to
more unnecessary patient injuries. Precedent for maintaining
the confidentiality of reported errors already exists in state
peer review laws and regulations.
--Analyzed data is reported in aggregate. While researchers will need
access to the identity of the individuals and institutions who
have committed an error for the purpose of analyzing the data,
public reports should not use any individually or
institutionally identifiable information.
--Data is reported to a national entity. The IOM recommends that data
be collected on a state-by-state basis. However, this would
complicate the ability to easily access data and to identify
system-wide trends. A national system, based on uniform data
collection, is needed to identify the underlying systemic
causes of medical errors.
--Data is used and not warehoused. Error reports are useless if they
are not analyzed and if the resulting information is not fed
back to those providing for and delivering health care. The
entity that receives error reports should have the capability
to analyze them and to make the reports available to bona fide
research organizations for analysis.
Only under a new environment including malpractice reforms and
strict confidentiality do we believe mandatory reporting for serious
adverse events attributable to medical error is an appropriate and
effective way to begin to reduce medical errors. Such reporting must be
tied to incentives to change current behavior of under-reporting
errors, if we are to make headway in promoting patient safety. In the
absence of these changes our efforts to begin to address the problem of
medical mistakes will be hindered.
OTHER ISSUES RAISED
Error reporting raises a host of other issues that must be
addressed before policy makers move ahead. To list a few:
--What type of errors will be reported? Not all errors are of such
gravity to require mandatory reporting. The national entity
responsible for data reporting standards should set priorities
for errors subject to mandatory reporting.
--Who will be able to report errors? Will patients or their family
members, in addition to medical professionals, be viewed as a
source of error reporting?
--What other type of information would be included in an error
report? There will need to be clear parameters on what type of
information is necessary to track medical errors. Even with
confidentiality provisions in place, the error reports will be
based on material that may be extremely sensitive to all
involved parties.
--Who will have access to the data and how will it be used? There
will be broad interest in obtaining the data, and it is
critical to ensure that the data is only used for the purposes
of improving patient safety.
These are just a few the questions that would need to be addressed
before any error reporting system could be implemented.
CONCLUSION
In conclusion, patient safety remains a serious health care quality
concern and must be afforded proper attention. AAHP enthusiastically
supports the direction and goals of the IOM committee to decrease
errors and develop a systematic approach to prevent recurrence. But we
do question how Congress can promote the reporting of errors on the one
hand and support the expansion of a flawed liability system on the
other. If the IOM report has shown us nothing else, it has demonstrated
that the current debate over ``patient protection'' legislation has
been misguided at best. The current liability system, as noted by the
IOM and President Clinton's Advisory Commission, deters the reporting
of errors. Expansion of such a system, as proposed by the Norwood-
Dingell bill (H.R. 2990), would do nothing to promote efforts to
improve patient safety.
Health plans will continue to maintain their role of supporting
those who actually deliver care physicians, hospitals and other health
care providers. The commitment of providers is critical to this
undertaking, but the commitment of other stakeholders-patients,
purchasers, regulators and health plans-is also important. We must work
together to develop an effective way to identify errors and use that
knowledge to improve patient safety and prevent future errors from
occurring.
Mr. Chairmen, AAHP is pleased to continue to work with the
committee as you examine the issue of patient safety. AAHP and its
member plans remain committed to upholding high standards of patient
care, which include supporting efforts to decrease medical errors. We
welcome the Committees' interest in these issues, and we thank you for
providing us the opportunity to testify today.
STATEMENT OF DR. THOMAS R. RUSSELL, EXECUTIVE DIRECTOR,
AMERICAN COLLEGE OF SURGEONS
Senator Specter. I am happy to introduce Dr. Tom Russell,
recently named executive director of the American College of
Surgeons. Dr. Russell is a general surgeon who specializes in
colon and rectal surgery. Since 1980, he has served as chairman
of the Department of Surgery at California Pacific Medical
Center, with which he has been affiliated since 1975. He is
also a clinical professor of surgery at the University of
California San Francisco and has been affiliated with a number
of hospitals in the San Francisco area. Dr. Russell is a member
of many professional and medical societies and has published
extensively on scientific and educational topics in surgery.
It is a pleasure to have you with us, Dr. Russell.
Senator Frist. Dr. Russell.
Dr. Russell. Mr. Chairman, Senator Specter, it is a real
pleasure to be here. My name is Tom Russell, and until very
recently, 2 months ago, I was a busy practicing surgeon in San
Francisco, and I have recently been in the health care
environment personally, teaching residents.
I am now executive director of the American College of
Surgeons, and on behalf of the 62,000 Fellows of this College
representing all surgical specialties, I am honored to be here
to present to these two distinguished Senate committees.
Patient safety is not a new topic for our organization. I
am proud to say that for the entire 87 years of the College's
history, patient safety and quality of care have been of
paramount importance. Our work in this area is described in
some detail in my written statement--I will not bore you with
our past history or what our future plans are.
While we have done much in the past, we recognize that much
yet needs to be done. The recent Institute of Medicine report
gives us the impetus to re-look at what we are doing, and the
College leadership, the staff, and our committees are now
reviewing this report to see what additional steps our
professional organization must take to enhance patient safety
in this country's hospitals.
Let me now turn specifically for the sake of time to some
of the specific key recommendations of the IOM report. One
urges that the Congress pass legislation extending peer review
protections to data related to patient safety and quality
improvements. The College strongly supports this position. It
would greatly enhance the current peer review system's work in
evaluating errors, identifying patterns of poor care, and
addressing health care system problems--and I underline
``system problems.''
This was actually recognized even before the IOM report.
Last June, the Medicare Payment Advisory Commission, or MedPAC,
called upon Congress to ``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.''
In making this recommendation, MedPAC did not attempt to
distinguish between different types of adverse events. In fact,
MedPAC argued that ``reporting incidents of preventable errors
in health care delivery is unlikely to become routine practice
as long as providers fear that the information they disclose
can be used against them in a punitive manner.''
Therefore, the College believes that legislation extending
confidentiality protections to all data and work products
related to patient safety and quality improvements is a step
that is likely to bear immediate dividends, particularly in
creating the culture in the hospital and the health care
setting for reporting of events.
A second recommendation calls for a nationwide mandatory
reporting system. The College has some concerns about this and
wishes to know more of the details. We believe it is
unfortunate that the IOM committee concluded that the
information collected through mandatory reporting should not
receive the same level of confidentiality protection as that
received through the voluntary reporting process. This makes it
appear that the purpose of a mandatory reporting system may be
punitive in nature--a perception that seems unlikely to foster
the quality improvements that we are all looking for.
Second, the Institute of Medicine report calls for narrowly
defined mandatory reporting systems, but stops far short of
providing those important details. The College believes that
more work is needed to identify the data that should be
collected and how such data should be used. It will be critical
to ensure that the time and effort involved in submitting
information be used effectively and patient safety improvement
occur. Reporting of data alone will do nothing to improve the
system; the loop must be closed. Without this assurance, the
College believes it would be a waste of taxpayers' dollars to
create yet another mandatory reporting system and data
repository.
This cautious approach, I might add, should in no way
prevent progress on patient safety.
A third IOM recommendation stresses that voluntary
reporting efforts should be encouraged. We could not agree
more. In fact, we believe that a wide variety of voluntary
reporting systems should be encouraged. In this regard, the
Federal role could be one of providing the funding needed to
develop and test a variety of voluntary reporting systems and
other patient safety initiatives. The Agency for Health Care
Research and Quality, AHRQ, seems well-positioned to play a
role provided it is given adequate resources to do so.
To conclude, I want to assure Senator Specter that the
American College of Surgeons wants to participate in this
activity. The American College of Surgeons has a longstanding
history in patient safety, beginning in 1918, when it initiated
the Hospital Standardization Program, which you know today as
the JCAHO.
I could enumerate all of our activities as far as training
the young doctors in medical school and what we do in residency
training for all surgical specialties, how we relate to the
American Board of Medical Specialties, what we do for ongoing
CME education, what some of our committees do with respect to
trauma and cancer care in this country. We are forming a
framework to develop lifelong learning for physicians
throughout their professional lives so they can remain
competent, and we are obviously very interested in public
education and making certain the public knows about surgery and
how to select surgeons and what to expect from an operative
procedure.
PREPARED STATEMENT
We look forward to working with Congress, with these
committees and with the administration and other interested
professional groups to ensure that patients receive the highest
quality care possible.
Thank you very much.
Senator Frist. Thank you, Dr. Russell.
[The statement follows:]
PREPARED STATEMENT THOMAS R. RUSSELL
Mr. Chairman and members of the Committee, my name is Thomas
Russell, MD, FACS and I am the Executive Director of the American
College of Surgeons. On behalf of the 62,000 Fellows and other members
of the College, I would like to thank you for this opportunity to offer
the surgeon's perspective on the IOM report entitled ``To Err is Human:
Building a Safer Health System.'' The American College of Surgeons is a
scientific and educational association of surgeons that was founded in
1913 to improve the quality of care for the surgical patient by setting
high standards for surgical education and practice. The College has a
longstanding interest in patient safety and we look forward to working
with Congress, the Administration, and other interested parties to
assure that patients receive the highest quality of care.
ACS INVOLVEMENT IN THE ISSUE OF PATIENT SAFETY
Patient safety is an important issue, but certainly not a new one.
From its founding, the College has devoted considerable attention to
the issue of patient safety and we recognize that our work will never
be done. As others have said, any error that harms a patient is one
error too many. However, in discussing the issue of patient safety, we
believe it would be a mistake to act as if the issue has simply been
ignored. The IOM report itself takes note of a wide variety of programs
and initiatives, some of them of a longstanding nature, that have
focused on patient safety issues. For example, Appendix E of the report
acknowledges that ``[s]urgical morbidity and mortality (M&M)
conferences began early in the twentieth century as a standardized case
report system to investigate the reasons and responsibility for adverse
outcomes of care.'' As noted in the IOM report, the Accreditation
Council for Graduate Medical Education now mandates weekly M&M
conferences ``at which, under the moderation of a faculty member,
surgical residents and attendings present cases of all complications
and deaths.''
I thought it would be appropriate and useful, at the outset, to
outline briefly at least some of the College's own work on patient
safety and related matters. In 1918, the College initiated a Hospital
Standardization Program in an effort to ensure a safe environment and
an effective system of care for surgical and other hospitalized
patients. That program ultimately led to the establishment of what is
known today as the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO). This commitment continues through the College's
representation on the JCAHO board, as well as through other programs
and initiatives conducted by a number of College committees and
departments.
The College has been intimately involved in the education of
surgeons at the undergraduate, graduate and continuing medical
education levels. For example, the College's Committee on Emerging
Surgical Technology and Education studies the implications of
innovations in surgical methods and helps develop policies to promote
appropriate training for surgeons and protect the welfare of the
surgical patient. The College also sponsors a wide variety of courses,
specifically including those aimed at assuring the safe and effective
use of new technologies, such as stereotactic breast biopsy, diagnostic
breast ultrasound, and sentinel node biopsy in the management of breast
tumors.
Another innovative program is administered by the College's
Committee on Continuing Education to help surgeons maintain their
skills and stay abreast of current practice standards. This program is
the Surgical Education and Self-Assessment Program (SESAP) and provides
practicing surgeons the opportunity to stay abreast of current
standards in surgical practice by reproducing the diagnostic and
treatment challenges faced in the practice of surgery.
I might add that it is unfortunate that the rigor with which
surgeons and other physicians are trained, examined and board
certified, involving the oversight of Residency Review Committees
(RRCs), the Accreditation Council for Graduate Medical Education, the
American Board of Surgery and the other members of the American Board
of Medical Specialties, and other bodies, is generally unknown to the
general public. Fellows of the College are nominated to serve on these
various oversight and standard-setting bodies and play an active role
in their deliberations. Of special note is ongoing work to develop a
framework for evaluating a physician's continuing competence in the
areas of patient care, professionalism, interpersonal and
communications skills, medical knowledge, practice-based learning and
improvement, and systems-based practice. All of this is being
considered in the context of a physician's maintenance of board
certification.
For nearly 20 years, the College's Committee on Operating Room
Environment conducted a biennial symposium for operating room team
members. These education programs routinely emphasized the need for
team communications to ensure safety in the operating room environment,
as well as infection control practices, identification and elimination
of hazards in the operating room (e.g., electrical, fire), how to deal
with difficult behaviors in the operating room, uses of computer-based
technology to enhance patient safety in the operating room, training
and credentialing operating room team members and other personnel, and
data collection and quality improvement.
Additionally, the College has published a Patient Safety Manual as
a guide for implementing a systematic approach to quality assurance and
risk management in hospitals. The manual focuses on a systems approach
to patient safety that includes: analyzing quality of care data; peer
evaluation of data; determination of corrective action; and,
communicating the results with all affected parties. The College is in
the process of updating the manual yet again.
On the subject of trauma care, the College sponsors a number of
programs to improve the care of the injured patient. These include a
national trauma registry and advanced trauma life support (ATLS)
courses.
Another College-sponsored activity worth noting is the annual data
set collected as part of the National Cancer data base, which looks at
cancer care in approved hospitals and provides feedback to individual
institutions, allowing them to compare their practice with the national
aggregate. This is the largest cancer database in the country, and
operates without the benefit of any federal funding.
In an effort to collaborate with a variety of health care
professionals on the issue of patient safety, a representative from the
American College of Surgeons serves on the Board of the National
Patient Safety Foundation. As you know, the foundation is a broad-based
partnership that serves as a forum for addressing a wide spectrum of
patient safety issues through four core strategies: research,
prevention, communication and education.
In response to the IOM report, the College is planning to devote
special attention to the issue of patient safety during our next
Clinical Congress, an annual event attended by approximately 18,000
people.
Finally, in today's world, patients must become active partners in
their own medical and surgical care. In an effort to assist patients to
be as knowledgeable and informed as possible in choosing their
surgeons, the College has long supported an active public information
program. The purpose of the program is to provide the public with
information on what distinguishes surgeons from other physicians, what
to look for in examining a surgeon's credentials, questions to ask
before consenting to an operation, and so on. This long-standing
commitment to public education is a major priority of the American
College of Surgeons.
In short, for the last 87 years, the College has emphasized patient
safety and quality of care. We, therefore, strongly support
recommendation 8.1 of the recently released IOM report, which calls
upon health care organizations to make patient safety a priority.
ACS VIEWS ON THE RECOMMENDATIONS MADE BY THE IOM
The IOM report includes a wide variety of recommendations. For
purposes of this hearing, the College would like to focus upon several
of them.
Extending Peer Review Protections
I'd like to begin by discussing recommendation 6.1. This
recommendation urges the Congress to pass legislation extending peer
review protections to data related to patient safety and quality
improvements that are collected and analyzed by health care
organizations for internal use or shared with others solely for
purposes of improving safety and quality.
Peer review can be an effective tool in evaluating errors,
identifying patterns of poor care, and addressing health care system
problems. Unfortunately, the current peer review system is handicapped
in that peer reviewers are not consistently guaranteed the appropriate
confidentiality protections that are needed for them to effectively
complete their work. Health care professionals will not be receptive to
reporting errors to any reporting system if there is a belief that this
information could be used against them in future litigation. This
handicap will cause these systems to remain ineffective.
In its June 1999 report, the Medicare Payment Advisory Commission
(MedPAC) called upon the Congress to ``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.'' I think that it is important to note
that, in making this recommendation, MedPAC did not attempt to
distinguish between different types of adverse events, and went on to
observe that ``[s]uch a law would neither help nor harm individual
patients who are injured (compared with the status quo), but should
help patients collectively by fostering the reporting of data that can
be used to reduce the incidence of avoidable errors in the future.'' In
fact, MedPAC argued that ``[r]eporting incidents of preventable errors
in health care delivery is unlikely to become routine practice as long
as providers fear that the information they disclose can be used
against them in a punitive manner.''
To sum up, the College believes that if Congress is able to do only
one thing this year to address patient safety concerns, it should be to
adopt legislation that extends peer review protections (i.e.,
confidentiality protection and protection from discovery) to all data
and work products related to patient safety and quality improvements.
In our view, this is the step that is likely to bear immediate
dividends with respect to patient safety. Among other things, it should
encourage the development and successful operation of voluntary
reporting systems, another IOM-recommended step and one discussed a bit
later in these remarks.
National Center on Patient Safety
Recommendation 4.1 of the IOM report calls for the creation of a
new Center for Patient Safety. This center would set national goals for
patient safety, track progress in meeting these goals, issue an annual
report on patient safety, and accomplish other assigned tasks. While
the American College of Surgeons would not object to the establishment
of such a National Center, we would suggest that the Congress carefully
review the existing authority given to the recently reauthorized and
renamed Agency for Healthcare Research and Quality (AHRQ). We believe
that AHRQ might already be well positioned to address patient safety
issues.
In fact, several members of the Health, Education, Labor and
Pensions Committee have already pointed this out. For example, Senator
Frist, who is a Fellow of the College, has been quoted as saying that
the problem of medical errors can be addressed by the Congressionally
mandated Centers for Education and Research on Therapeutics,
university-based centers that would provide research and education
programs on drug safety issues and other issues involving therapeutics.
It may well be, then, that what is lacking is not a new center, but
rather, additional funding to permit AHRQ to support a wide variety of
patient safety research and pilot projects. In fact, given the current
state of our knowledge about patient safety, we believe that more
research and demonstration projects-conducted by a wide range of
organizations, including physician specialty societies--would be
extremely important.
We would, of course, encourage AHRQ or any other entity involved in
patient safety to ensure that the physician community has an
opportunity to provide appropriate input with respect to planned or
potential initiatives.
Mandatory Reporting
This brings me to recommendation 5.1, which calls for a nationwide
mandatory reporting system that provides for the collection of
standardized information by state governments about adverse events that
result in death or serious harm. Under the recommended approach,
hospitals would be the first entities required to report. Further, the
Forum for Health Care Quality Measurement would promulgate and maintain
a core set of reporting standards (including a nomenclature and
taxonomy for reporting). If a state did not implement the reporting
system, the U.S. Department of Health and Human Services would assume
the responsibility. Quite importantly, this recommendation assumes that
the reported information would not be protected from public disclosure.
The College has a number of concerns about recommendation 5.1.
First, we believe it is most unfortunate that the IOM committee chose
to recommend that the information collected through mandatory reporting
should not receive the same level of confidentiality as that received
through a voluntary reporting process. The purpose of collecting
information on adverse events should be to improve patient safety by
correcting system errors, not by punishing individuals who have
committed some unfortunate error. This systems approach would appear to
be the model followed in the case of airline safety, where the Aviation
Safety Reporting System is held out as a model for voluntary,
confidential, and non-punitive safety reporting. Curiously enough, in
its report, the IOM Committee itself emphasizes that non-punitive
systems for reporting and analyzing errors should be implemented. It is
unfortunate, then, that the IOM Committee did not follow this belief
throughout the entire report. This inconsistency makes it appear that
the chief purpose of the mandatory reporting system is punitive, a
perception that seems unlikely to foster quality improvement efforts.
Second, the IOM report notes that ``the focus of mandatory
reporting systems should be narrowly defined,'' but it stops short of
specifying what such systems should cover. As you know, there are
several reporting systems now in place, and the College believes that
much more work is needed to identify which data should be collected-
whether in a mandatory or voluntary reporting system. We would be
pleased to assist in such a study. We would, for example, be interested
in finding ways to minimize reporting burdens. Moreover, I am sure this
committee would agree that it will be critical to ensure, especially in
any mandatory reporting system, that the time and effort involved in
submitting information and doing something with it (e.g., providing
meaningful feedback to those who submit data) is likely to lead to
patient safety improvements. Without this assurance, the College
believes it would be a tragic waste of taxpayer dollars to create yet
another data repository.
Third, the College is concerned about the state-based nature of the
recommended mandatory-reporting system. This recommendation would lead
to 50 reporting structures and data repositories. These state-based
systems would by their very nature be ``different''. These differences
could include different reporting requirements and different public
disclosure policies. Moreover, in at least some cases, individual
states might not have the necessary resources to make effective use of
reported information or even to operate the data collection effort.
Given all these concerns, the College urges Congress to defer
adoption of recommendation 5.1. Our cautious approach to this
recommendation is predicated on the belief that overlaying the current
system with more regulation, restrictions, disclosures, and punishment
could, unfortunately, divert and dilute efforts to focus on systems
improvement and problem-focused education for well-meaning health care
providers who, by their very nature, are human. In particular, we
believe that it is premature, at best, to talk about whether any
mandatorily reported information should-or should not-receive
confidentiality protections until we know what this information is, its
validity, and so on.
Voluntary Reporting
Recommendation 5.2 stresses that the development of voluntary
reporting efforts should be encouraged. The College could not agree
more. The IOM Committee is absolutely right when it says that
``voluntary reporting systems are an important part of an overall
program for improving patient safety and should be encouraged.'' In
fact, we believe that a wide variety of voluntary reporting systems
should be encouraged. Some could be strictly internal to a particular
organization. Others could involve reporting to some independent
entity, which would analyze the data and help identify steps likely to
reduce or eliminate future errors, or ensure that the reporting entity
has conducted a disciplined process to understand the reason(s) for a
particular error and the ways to prevent its recurrence.
As the IOM report states, there are currently a number of voluntary
reporting entities including the sentinel event reporting system
conducted by the Joint Commission on Accreditation of Healthcare
Organizations, the Medication Errors Reporting Program, the MedMARx
program and the Department of Veterans Affairs Patient Safety
Initiative. In addition, a number of healthcare organizations have
developed their own internal voluntary reporting systems. Further, as
noted earlier, error reporting systems are found in other areas, such
as aviation safety. No doubt, these and other still-to-be-created
reporting systems have much to teach us.
In short, the College strongly supports recommendation 5.2 and
believes that the federal government can certainly play an important
role in encouraging voluntary reporting of adverse outcomes. However,
as we emphasized at the outset, we believe very strongly that the
confidentiality of reported information must be assured if the goal is
an effective reporting system. In addition, we believe that it would be
inappropriate, at least at this time, for the federal government to
dictate how these voluntary reporting systems should be conducted or
what information they should collect.
Role of Professional Societies
Among other things, recommendation 7.2 urges the creation of a
permanent committee devoted to patient safety by professional
societies, such as the American College of Surgeons. Such committees
would develop a curriculum on patient safety, disseminate patient
safety information through various channels, and take other actions. I
think this recommendation unfortunately makes it appear as if
professional societies have been ignoring patient safety issues, which
is certainly not true in the case of the College and many other
professional societies. For many years, the College has had a number of
committees addressing the issue of patient safety. Some of the fruit of
this work was alluded to at the beginning of this statement. However,
in response to the IOM's recommendations, the College will evaluate
whether it would be better to centralize patient safety-related work
into a single committee. It is quite possible, however, that we will
conclude that, due to the wide scope of patient safety issues, surgeons
and surgical patients are better served by having several committees,
rather than just one, responsible for this work. I have shared the IOM
report with several existing committees within the College as well as
our 12 advisory councils. Their review of the IOM report may well
suggest additional steps that the College should take to address
patient safety concerns.
Medication Safety Practices
The last recommendation I would like to address is 8.2, which calls
upon health care organizations to implement proven medication safety
practices. Among the practices highlighted in the IOM report is
physicians' use of a computerized order entry system for prescription
drugs. Such systems are already in use in many hospitals and have
generally been well received by physicians and proven themselves
effective and efficient in handling patients' prescription drug needs.
The College, therefore, supports their use. However, we believe that
the Congress should recognize that computerized order entry systems for
prescription drugs do involve considerable up-front costs for
hospitals, and that the current financial pressures being felt by most
hospitals could understandably dampen their enthusiasm for incurring
these costs.
CONCLUSION
As I stated in the beginning, the American College of Surgeons has
a longstanding interest in patient safety and we look forward to
working with Congress and other interested parties to ensure that
patients receive the highest quality care. I hope that you find our
input useful in shaping future policies. I would now be pleased to
respond to any questions you might have.
STATEMENT OF DR. DENNIS O'LEARY, PRESIDENT, JOINT
COMMISSION ON ACCREDITATION OF HEALTHCARE
ORGANIZATIONS, CHICAGO, IL
Senator Specter. Dr. Dennis O'Leary, also on this panel, is
president of the Joint Commission on Accreditation of Health
Care Organizations. Prior to joining that Commission, Dr.
O'Leary served as dean of clinical affairs at the George
Washington University Medical Center and vice president of the
University Health Care Plan. He has an M.D. from Cornell and a
B.A. from Harvard.
Thank you, Mr. Chairman.
Senator Frist. Dr. O'Leary.
Dr. O'Leary. Thank you.
I am Dr. Dennis O'Leary, president of the Joint Commission
on Accreditation of Health Care Organizations, and I am very
pleased to address you today concerning medical errors. This is
perhaps the most pressing health care issue of our time, and I
applaud the efforts of both of your committees in this area.
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. Since 1996, we have played a leadership role in
encouraging error reporting and analysis. This Sentinel Event
Program has provided us some unique lessons learned that we
would like to share with you today.
Dramatically reducing the number 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.
We believe that medical error reduction is fundamentally an
information problem. With this in mind, we suggest that five
critical, information-based tasks 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 better understand the epidemiology of medical
errors, we must create a protected, blame-free environment that
permits access to information about 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 the serious adverse event.
The second task is the production and protection of
credible root cause analyses of serious adverse events. When a
serious error occurs, there must follow an intensive, no-holds-
barred vetting of all of the causes underlying the event. These
root cause analyses, which we believe hold the critical answers
to future error reduction, focus primarily on organization
systems. 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 health care provider systems is akin to writing a
plaintiff's 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 systems related to
the serious adverse occurrence. It is essential that
implementation of this action plan be monitored and confirmed
by an independent oversight body. We view the monitoring of
planned systems changes in organizations as a key element of
public accountability. Therefore, we believe that any public
sector error reporting program must provide for the sharing of
relevant adverse information with responsible accreditors.
The fourth task is the establishment of patient safety
standards which health care organizations must meet. We believe
that all quality oversight bodies should have explicit
requirements that make the identification and management of
medical errors a high priority for organization leadership. The
Joint Commission implemented such standards in January 1999 in
order to bring both visibility and focus to the problem. These
standards expect organization action on both medical error
crashes and near misses in the delivery of patient care.
The last task is dissemination of experiential information
to all organizations at risk for adverse events. To have a
positive impact on patient safety, information gleaned from the
analyses of errors must be widely disseminated to help all
organizations reduce the likelihood of adverse events. The
Joint Commission does this through its continuing series of
Sentinel Event Alerts. To date, we have issued alerts on
medication errors, wrong site surgery, restraint-related
deaths, blood transfusion errors, inpatient suicide, infant
abductions, and postoperative complications. Such dissemination
activities are highly dependent upon having good information
and adequate resources to reach health care decisionmakers.
This is therefore an area where more effective public-private
sector collaboration is highly desirable.
Finally, it must be understood that access to error-related
data and information undergirds and drives this overall system
of accountability and oversight. The Congress should,
therefore, support coordination of error reduction strategies
and the sharing of relevant data amongst all of the responsible
public and private sector oversight bodies.
PREPARED STATEMENT
The Joint Commission's Sentinel Event Program has
identified the critical information-based tasks that are
essential to solving the medical error problem. But this
program also illustrates the harsh reality 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 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.
Senator Frist. Thank you, Dr. O'Leary.
[The statement follows:]
PREPARED STATEMENT OF DENNIS O'LEARY
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 Senate Committee on Health, Education, Labor
and Pensions regarding medical errors. The frequency and gravity of
medical errors is perhaps the most pressing health care quality issue
of our time.
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 in 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 health care providers have the
tools and the commitment to sharply reduce their incidence.
My testimony will focus on the task 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 the key
stakeholders is a prerequisite for successfully addressing complex,
multifactorial problems that we face today. Dramatically reducing the
number and seriousness of errors will take a concerted effort--
particularly including a willingness to share information--by all who
participate 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
simple, 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. This coordinated
approach must necessarily bridge the public and private sectors.
I would like to stress that medical error reduction is
fundamentally an information problem. The solution to reducing the
number 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 the information we need to obtain, create, and
disseminate. With this in mind, we suggest there are five critical,
information-based tasks whose completion is essential to an effective
error-reduction strategy. In theory, a single organization could
perform all of these tasks, but in fact, multiple public and private
sector organizations will have roles to play.
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 level 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 medical errors, we must create a
protected, blame-free environment that will lead to a more accurate
understanding of their scope and nature.
An important feature of the Joint Commission's Sentinel Event
Program is the non-punitive reporting environment it seeks to create.
Hoping to foster organization cultures that 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 which in 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, we have found it necessary to create procedural
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 stopgap measures that we believe must be
replaced by federal protections for error-related information. We urge
the Congress to enact such federal protections, because they are as the
sine qua non for any effective system of error reporting.
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 events \1\--including
their nomenclature and taxonomy--that should be reported to the Joint
Commission on a voluntary basis.
---------------------------------------------------------------------------
\1\ 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.
---------------------------------------------------------------------------
Our definition of a reportable event minimizes the external
reporting burden for health care organizations while focusing on the
most serious occurrences. 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, in a
protected environment, collect information only on ``near misses.''
The second task is the production of credible ``root cause''
analyses of serious adverse events. When a serious error occurs, it is
essential that there be an intensive, no-holds-barred vetting of all of
the potential causes underlying the event. We call these responses
``'root cause'' analyses--a term borrowed from the engineering world's
orientation to a systems approach both to solving problems and to
producing desired outcomes.
A root cause analysis focuses primarily on organization systems and
processes, as opposed to individual performance. While an individual is
invariably the proximal cause of a mistake in health care, the
fundamental causes of the error almost always relate to systems
failures distal to the error itself. For example, systems may fail to
provide simple checks and balances; or they may lack critical
safeguards; or there may be design flaws that actually promote the
occurrence of errors.
Root cause analyses are rich learning processes that often
elucidate multiple factors that contributed to the error. Many of these
are not readily apparent until the root cause analysis is undertaken.
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, most 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
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 undesirable 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.
The third task is implementation of 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 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 terminate simply with the report itself or even an
analysis 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 targeted review of the
milestones associated with planned systems changes. In the end, we
expect to see an organizational response that results in preventive
actions. This monitoring function is a key element of public
accountability. The public must have confidence that there is an
external body overseeing patient safety issues in the organizations
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 tasks discussed in this testimony.
Today's health care quality oversight system involves a variety of
private sector and public sector players. Efforts should at least be
made to better utilize existing structures through improved data
sharing, and to encourage the broad dissemination of what has been
learned to date from medical mistakes. We must avoid a fragmented,
ineffective system where, for example, a given entity is privy to
reports of errors, but oversight bodies with public accountability for
patient safety are not made aware of or do not have access to this
information.
The fourth key task is the establishment of patient safety
standards which health care organizations must meet. The Joint
Commission has recently established developed explicit patient safety
standards for health care organizations beginning. These new 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 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.
While most quality oversight organizations can point to existing
standards that should, in theory, have an effect on preventable error,
we believe that this particular emphasis on organization accountability
is critical. We would therefore like to see other accreditors and
health care quality oversight bodies include similar 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 meeting these heightened performance
expectations.
The fifth task is to dissemination of experiential information
learned from errors to all organizations at risk for serious 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. This can be done at
different levels in the health care system.
The Joint Commission has such a program for its accredited
organizations. In 1997, the Joint Commission began to issue periodic
Sentinel Event 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 Alerts have saved lives. Unfortunately,
because the full scope and frequency of serious adverse events is not
known, we cannot calculate real decreases in error rates with
scientific certainty. 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 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 more benign substances. In
analyzing the causes of KCl-related deaths, it became evident that
storage of concentrated KCl on hospital floors was an important cause
of unanticipated deaths. In the Alert that the Joint Commission issued
on this subject in February 1998, it was suggested that storage of
concentrated KCl be limited to hospital pharmacies to the extent
possible. 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. Our Sentinel
Event Program has identified the critical information-based tasks that
need to be carried out. In carrying out these tasks under its aegis,
the Joint Commission has assuredly prevented additional errors and
saved lives.
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. This is true whether the reporting framework is public or
private; mandatory or voluntary; national, state, or local.
Therefore, we urge that the 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.
______
FACTS ABOUT THE SENTINEL EVENT POLICY
The Joint Commission's Sentinel Event Policy is designed to
encourage the self-reporting of medical errors to learn about the
relative frequencies and underlying causes of sentinel events, share
``lessons learned'' with other health care organizations, and reduce
the risk of future sentinel event occurrences.
A sentinel event is any unexpected occurrence involving death or
serious physical or psychological injury, or the risk thereof. Serious
injuries specifically include a loss of limb or function. The phrase
``or the risk thereof' includes any process variation for which a
recurrence would carry a significant chance of a serious adverse
outcome.
Any time a sentinel event occurs, the accredited organization is
expected to complete a thorough and credible root cause analysis,
implement improvements to reduce risk and monitor the effectiveness of
those improvements. While the immediate cause of most sentinel events
is due to human fallibility, the root cause analysis is expected to dig
down to underlying organization systems and processes that can be
altered to reduce the likelihood of human error in the future and to
protect patients from harm when human error does occur.
A standard that creates explicit expectations regarding the
internal identification and management of sentinel events was added to
the Leadership chapter of all accreditation manuals and became
effective January 1, 1999.
The Sentinel Event Policy provides an opportunity to expand the
Joint Commission's database of sentinel events that occur with
significant frequency. The database also categorizes the most common
underlying causes of these events and strategies that accredited
organizations have used to reduce risk to patients. The Joint
Commission regularly distributes to health care organizations
information about sentinel events and how they can be prevented through
its newsletter Sentinel Event Alert.
Voluntary Self-Reporting of Sentinel Events
Under the Sentinel Event Policy, a defined subset of sentinel
events are subject to review by the Joint Commission and may be
reported to the Joint Commission on a voluntary basis. Only those
sentinel events that affect recipients of care (patients, clients,
residents) and that meet one of the following criteria fall into this
category.
--The event 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.
--The event is one of the following (even if the outcome was not
death or major permanent loss of function): suicide of a
patient in a setting where the patient receives around-the-
clock care (e.g., hospital, residential treatment center,
crisis stabilization center); 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.
An organization that experiences a sentinel event that does not
meet the criteria for review under the Sentinel Event Policy is still
required to complete a root cause analysis. However, the root cause
analysis does not need to be made available to the Joint Commission.
Sentinel Events That Are Not Self-Reported
Each accredited health care organization is encouraged, but not
required, to report to the Joint Commission any sentinel event meeting
the aforementioned criteria for reviewable sentinel events.
Alternatively, the Joint Commission may become aware of a sentinel
event by some other means such as from a patient, family member or
employee of the organization, or through the media.
Whether the organization voluntarily reports the event or the Joint
Commission becomes aware of the event by some other means, there is no
difference in the expected response, time frames or review procedures.
Joint Commission Response
If the Joint Commission becomes aware (either through voluntary
self-reporting or otherwise) of a sentinel event that meets the
definition of a reviewable sentinel event, the organization is required
to: prepare a thorough and credible root cause analysis and action plan
within 45 calendar days of the event, or of its becoming aware of the
event; and submit to the Joint Commission its root cause analysis and
action plan or otherwise provide for Joint Commission evaluation of its
response to the sentinel event under an approved protocol, within 45
calendar days of the known occurrence of the event. The Joint
Commission will then determine whether the root cause analysis and
action plan are acceptable.
A ``for cause'' survey will be conducted in immediate response to
learning about a sentinel event if the Joint Commission determines that
there is a potential ongoing threat to patient health or safety or
potentially significant noncompliance with major Joint Commission
standards. These surveys occur infrequently and are charged at a rate
of $3,500 per day.
Accreditation Watch
If the submitted root cause analysis or action plan is not
acceptable or none is submitted within 45 days, the organization is at
risk for being placed on Accreditation Watch by the Accreditation
Committee of the Joint Commission's Board of Commissioners.
Accreditation Watch is a publicly disclosable attribute of an
organization's existing accreditation status and signifies that an
organization is under close monitoring by the Joint Commission. The
Accreditation Watch status is removed once an organization completes
and submits an acceptable root cause analysis.
Failure to perform an acceptable root cause analysis and implement
appropriate actions can result in a change in accreditation status,
including loss of accreditation. Further, each sentinel event evaluated
under the Sentinel Event Policy will be reviewed at the health care
organization's next full accreditation survey. This review will focus
on how effectively the organization has implemented its risk-reduction
activities.
If an organization declines to share any information regarding a
sentinel event with the Joint Commission, the organization will be
placed on Accreditation Watch and, ultimately, risks the loss of
accreditation.
Advantages to Reporting a Sentinel Event
There are several advantages to the organization that reports a
sentinel event.
--Reporting the event enables the addition of the ``lessons learned''
from the event to be added to the Joint Commission's sentinel
event database, thereby contributing to the general knowledge
about sentinel events and the reduction of risk for such events
in many other organizations.
--Early reporting provides an opportunity for consultation with Joint
Commission staff during the development of the root cause
analysis and action plan.
--The organization's message to the public that it is doing
everything possible to ensure that such an event will not
happen again is strengthened by its acknowledged collaboration
with the Joint Commission to understand how the event happened
and what can be done to reduce the risk of such an event
occurring in the future.
Disclosable Information
If the Joint Commission receives an inquiry about the accreditation
status of an organization during the 45-day root cause analysis period,
the organization's accreditation status will be reported in the usual
manner without reference to the sentinel event. If an inquirer
specifically references the sentinel event, the Joint Commission will
acknowledge that it is working with the organization through its
sentinel event review process.
The Joint Commission will not disclose legally protected sentinel
event-related information to any other party and will vigorously defend
the legal confidentiality of this information, if necessary, in the
courts. If subpoenaed for sentinel-event related information, the Joint
Commission will not release this information, and again, after
notifying the health care organization, will vigorously defend its
position in the courts.
Submission of Root Cause Analysis and Resulting Action Plan
The Joint Commission has initiated a number of procedures to
protect the confidentiality of sentinel event information shared by
accredited organizations and in the Joint Commission's possession.
--The Joint Commission advises health care organizations not to
provide patient or caregiver identifiers when reporting
sentinel events to the Joint Commission.
--An organization that experiences a sentinel event should submit two
separate documents to the Joint Commission: (a) the root cause
analysis and (b) the resulting action plan. The root cause
analysis will be returned to the organization once abstracted
information is entered into the Joint Commission database. If
copies have been made for internal review, they will be
destroyed after the review. Also, once the action plan has been
implemented to the satisfaction of the Joint Commission, it
will be returned to the organization.
In addition, if the organization has concerns about increased risk
of legal exposure as a result of sending the root cause analysis
documents to the Joint Commission, the following alternative approaches
to review of the organization's response to the sentinel event are
acceptable.
--An organization brings root cause analysis documents to the Joint
Commission headquarters for review and then takes the documents
back on the same day.
--A specially trained surveyor conducts an on-site visit to review
the root cause analysis and action plan. The organization will
be assessed a charge sufficient to cover the average direct
costs of the visit.
--A specially trained surveyor conducts an on-site visit to review
the root cause analysis and findings, without directly viewing
the root cause analysis documents, through a series of
interviews and review of relevant documentation. For purposes
of this review activity, ``relevant documentation'' includes,
at a minimum, any documentation relevant to the organization's
process for responding to sentinel events and the action plan
resulting from the analysis of the subject sentinel event. The
latter serves as the basis for appropriate follow-up activity.
The organization will be assessed a charge sufficient to cover
the average direct costs of the visit.
--Where the organization affirms that it meets specified criteria
respecting the risk of waiving legal protection for root cause
analysis information shared with the Joint Commission, a
specially trained surveyor conducts an on-site visit to
interview staff and review relevant documentation to obtain
information about the process the organization uses in
responding to sentinel events, and the relevant policies and
procedures preceding and following the organization's review of
the specific event and the implementation thereof, sufficient
to permit inferences about the adequacy of the organization's
response to the sentinel event. The organization will be
assessed a charge sufficient to cover the average direct costs
of the visit.
Confidentiality of Information
A Sentinel Events Legal Issues Task Force was created to address
the potential remedial strategies that might be employed to minimize
the risk of discoverability of specific information pertaining to a
sentinel event. The task force assisted the Joint Commission in
pursuing federal legislation and developing model state legislation
that would reinforce existing protections for sentinel event-related
information that health care organizations may share with the Joint
Commission.
With the assistance of the Sentinel Event Legal Issues Task Force,
the Joint Commission also has identified two contractual arrangements
that should substantively address the legal concerns regarding
potential waiver of confidentiality protections in certain states.
These arrangements involve having the health care organization either
identify, through written agreement the Joint Commission as a
participating entity in the organization's peer review or quality
improvement activities; or appoint the Joint Commission to the
organization's peer review or quality improvement committee.
These arrangements clarify that the Joint Commission is not an
external third party in the limited context of an intensive assessment
of a sentinel event and, therefore, no waiver of confidentiality
protections has occurred by sharing sentinel event-related information
with the Joint Commission.
For More Information
The Joint Commission also has taken a series of steps to help
organizations better understand the revised Sentinel Event Policy.
A ``hot line'' is in operation to respond to questions regarding
sentinel events. The number is (630) 792-3700.
Sentinel Event Alert, a newsletter that is distributed periodically
to all accredited organizations, provides important information
relating to the occurrence and management of sentinel events in Joint
Commission accredited organizations. Sentinel Event Alert is published
as needed and appropriate (e.g., as suggested by trend data) and
provides communication regarding the Joint Commission's Sentinel Event
Policy, and, most importantly, information about sentinel event
prevention.
The Joint Commission's Web site provides additional sentinel event
information including the complete Sentinel Event Policy; how to
complete a root cause analysis; sentinel event reporting forms;
information about relevant publications and education programs; and
back issues of Sentinel Event Alert. Go to www.jcaho.org/sentinel/
sentevnt__frm.html.
______
Sentinel Event Alert
ISSUE ONE, FEBRUARY 27, 1998
New Publication
We are pleased to introduce the first issue of Sentinel Event
Alert, a periodic publication dedicated to providing important
information relating to the occurrence and management of sentinel
events in Joint Commission-accredited health care organizations.
Sentinel Event Alert, to be published when appropriate as suggested by
trend data, will provide ongoing communication regarding the Joint
Commission's Sentinel Event Policy and Procedures, and most
importantly, information about sentinel event prevention. It is our
expectation and belief that in sharing information regarding the
occurrence of sentinel events, we can ultimately reduce the frequency
of medical errors and other adverse events.
Initially, Sentinel Event Alert will be mailed to the organization
chief executive officers and Joint Commission survey coordinators,
however, it is expected that eventually Sentinel Event Alert will be
sent via broadcast fax. In the future, staff from the Joint Commission
will be contacting your organization to collect appropriate fax and E-
mail addresses.
While the topic of this first issue is particularly relevant to
acute care facilities, we will share information of relevance to all
accredited organizations in future issues.
Medication Error Prevention--Potassium Chloride
In the two years since the Joint Commission enacted its Sentinel
Event Policy, the Accreditation Committee of the Board of Commissioners
has reviewed more than 200 sentinel events. The most common category of
sentinel events was medication errors, and of those, the most
frequently implicated drug was potassium chloride (KCl). The Joint
Commission has reviewed 10 incidents of patient death resulting from
misadministration of KCl, eight of which were the result of direct
infusion of concentrated KCl. In all cases, a contributing factor
identified was the availability of concentrated KCl on the nursing
unit. In six of the eight cases, the KCl was mistaken for some other
medication, primarily due to similarities in packaging and labeling.
Most often, KCl was mistaken for sodium chloride, heparin or furosemide
(Lasix).
Issue For Consideration.--In light of this experience, the Joint
Commission suggests that health care organizations not make
concentrated KCl available outside of the pharmacy unless appropriate
specific safeguards are in place.
______
ISSUE TWELVE, FEBRUARY 4, 2000
Operative and Post-Operative Complications: Lessons for the Future
Since the Joint Commission began tracking sentinel events nearly
four years ago, the Accreditation Committee of the Joint Commission's
Board of Commissioners has reviewed 64 cases related to operative and
post-operative complications. For each of the events reviewed, a root
cause analysis was completed.
Eighty-four percent of the complications resulted in patient
deaths, while 16 percent resulted in a serious injury. All of the cases
occurred in acute care hospitals. Cases directly related to medication
errors or to the administration of anesthesia are not included in this
review.
Fifty-eight percent of the complications occurred during the post-
operative procedure period, 23 percent during intraoperative
procedures, 13 percent during post-anesthesia recovery, and 6 percent
during anesthesia induction. The types of procedures most frequently
associated with these reported complications included interventional
imaging and/or endoscopy, tube or catheter insertion, open abdominal
surgery, head and neck surgery, orthopedic surgery and thoracic
surgery. Ninety percent of the 64 cases reviewed occurred in relation
to non-emergent procedures.
The most frequent complications by type of procedure included the
following:
--Naso-gastric/feeding tube insertion into the trachea or a bronchus.
--Massive fluid overload from absorption of irrigation fluids during
genito-urinary/gynecological procedures.
--Open orthopedic procedures associated with acute respiratory
failure, including cardiac arrest in the operating room.
--Endoscopic procedures (including non-gastrointestinal procedures)
with perforation of adjacent organs. Liver lacerations were
among the most frequent complications of abdominal and thoracic
endoscopic surgery.
--Central venous catheter insertion into an artery.
--Imaging-directed percutaneous biopsy or tube placement resulting in
liver laceration, peritonitis, or respiratory arrest while
temporarily off prescribed oxygen.
--Burns from electrocautery used with a flammable prep solution.
Complications associated with misplacement of tubes or catheters
usually involved a failure to confirm the position of the tube or
catheter (usually radiographically), misinterpretation of the
radiographic image by a non-radiologist, or a failure to communicate
the results of the confirmation procedure.
Root Causes Identified by Hospitals Experiencing These Events
Hospitals identified eight root causes in the 64 cases. Two-thirds
of the hospitals identified incomplete communication among caregivers
as a root cause, while more than half mentioned failure to follow
established procedures.
The six other root causes included the following:
--Necessary personnel not being available when needed.
--Pre-operative assessment being incomplete.
--Deficiencies in credentialing and privileging.
--Inadequate supervision of house staff.
--Inconsistent post-operative monitoring procedures.
--Failure to question inappropriate orders.
Risk Reduction Strategies Identified by Hospitals Experiencing These
Events
Organizations that experienced complications identified risk
reduction strategies. Eighty percent recommended improving staff
orientation and training. Other strategies included the following:
--Educating and counseling physicians.
--Expanding on-call coverage, especially in radiology.
--Standardizing procedures across settings of care.
--Revising credentialing and privileging procedures.
--Clearly defining expected channels of communication.
--Revising the competency evaluation process.
--Monitoring consistency of compliance with procedures.
--Implementing a teleradiology program.
Experts' Recommendations
Experts emphasize that direct communication between physicians and
other health care providers is very important in preventing
complications. There should be more staff education, a more
conscientious style of practice, less emphasis on turf issues, and more
respect for all of the members of the surgical team, says Dorothy Fogg,
R.N. B.S.N., M.A., senior perioperative nursing specialist for the
Center for Nursing Practice, Association of PeriOperative Registered
Nurses in Denver.
Regarding complications associated with misplacement of tubes or
catheters, Mark Malangoni, M.D., a general surgeon at MetroHealth
Medical Center in Cleveland, says the correct placement should be
confirmed with a test or x-ray. For example, health care providers
could check the positioning of a venous catheter with a chest x-ray and
the placement of a feeding tube with an abdominal x-ray.
Malangoni, a member of the American College of Surgeons' Pre-
Operative and Post-Operative Care Committee, and Fogg recommend that
hospitals review their credentialing and privileging procedures to
ensure that physicians have proper training and expertise. Fogg says
this is especially important in an area like endoscopy where some
surgeons may have limited training and experience or where the
procedure to be done is relatively new. Those with less experience
should work in tandem with someone on staff who has extensive
experience in this methodology and has demonstrated competency in the
procedure to be performed.
STATEMENT OF DR. ARNOLD S. RELMAN, PROFESSOR EMERITUS
OF MEDICINE AND OF SOCIAL MEDICINE, HARVARD
MEDICAL SCHOOL, BOSTON, MA
Senator Frist. We also welcome Dr. Arnold Relman as the
fourth member of our panel. Dr. Relman is a professor emeritus
of medicine and of social medicine at Harvard Medical School
and also editor-in-chief emeritus of The New England Journal of
Medicine--which I receive weekly and keep reading, even in the
U.S. Senate. Dr. Relman has been professor of medicine at
Boston University School of Medicine, and he was the Frank
Worcester Thomas Professor of Medicine and chairman of the
Department of Medicine at the University of Pennsylvania School
of Medicine. Over a span of almost 30 years, he has published
numerous articles in original research, clinical studies, as
well as textbook chapters and in recent years has written
widely on economic, ethical, legal, and social aspects of
health care.
Dr. Relman, it is good to have you with us.
Dr. Relman. Thank you, Mr. Chairman.
Thank you for this opportunity to describe how
Massachusetts promotes the quality of medical care in its
hospitals. I am chairman of the unit in the State Board of
Medicine that is responsible for this program, and I will
briefly explain how it works.
All licensed hospitals in Massachusetts are required by
State law to have approved programs for quality assurance, the
most important element in which is a system for reporting all
serious mishaps in their medical care. By ``serious mishap,''
we do not necessarily mean mistakes, and we do not necessarily
mean mistakes that are preventable. We mean all serious,
unexpected outcomes in the course of medical care, whether they
are errors or not and whether they are deemed preventable or
not. So we cast a very broad net.
These reports are filed quarterly with the Board and must
include a full medical account of what happened along with the
results of the hospital's investigation into the cause of the
incident and the steps the hospital has taken to prevent any
recurrences. Each incident report is carefully reviewed by the
physician members of our unit with the assistance of our staff
nurses. We often request additional information, and sometimes,
when a hospital is in trouble, we meet directly with its staff
and its medical leadership. Before we close our file on a case,
we need to be satisfied that all appropriate remedial steps
have been taken where indicated.
Two crucial features of our program make it unique, I
believe, and promote its effectiveness. First, as noted
already, it is located in our State Board of Registration and
Medicine. The rationale for this arrangement is that medical
errors in hospitals or anywhere else, for that matter, cannot
be reduced without the full participation of physicians.
External regulators who are themselves physicians are most
likely to know when hospital physicians are meeting their
professional responsibility for peer review, and if the
regulators also hold the power of licensure, as we do, they are
likely to get the serious attention of the medical staffs of
the hospitals.
A second critical feature of our reporting program is that
while it is mandated by State law, its information is kept
totally confidential and protected by law from subpoena, legal
discovery, or introduction into evidence. Moreover, our unit
does not share any of its files with other parts of the Board.
The rationale for this policy is to encourage hospitals and
their medical staffs to be totally forthcoming in their reports
to us and to take responsibility for dealing with their own
problems without fear of adverse publicity or disciplinary
action simply for doing so.
Of course--and it should be understood--our program does
not preempt existing State laws and regulations requiring
disciplinary action under certain circumstances and disclosure
in cases of medical malfeasance, so it does not change our
State's policy on informing the public about such matters. And
we have, I think, one of the leading State programs in
informing the public about the performance of physicians.
We have accomplished a great deal in less than a decade
despite serious limitations on our resources and initial
suspicions from the provider community that were quite
profound. We are now gaining the trust and cooperation of
hospitals and doctors and, just as importantly, of their
lawyers. So the number and quality of reports that we receive
is steadily improving. Meanwhile, our analysis of these reports
has identified common causes of potential mishaps, and we are
feeding this information back to the hospitals, generally to
the State as a whole, or sometimes to a particular hospital.
It is too early to measure precisely the effect of our
program on the quality of hospital care. It has been working
for half a dozen or 8 years. It is too early to measure, but we
have anecdotal evidence that hospitals and doctors are learning
how to prevent mistakes. This evidence also supports our
conviction that prevention is more effective than discipline or
publicity in the reduction of medical mistakes.
Now, what can the Federal Government do to help? This is my
personal opinion and has nothing to do with the experience of
our Board. In general, I support the Institute of Medicine's
recommendation for the establishment of a national mandatory
reporting program in all States, and I believe the reports
should be anonymous and confidential; that is absolutely
crucial, and I echo what has been said before. I also support
the idea of creating a Center for Patient Safety within the
Agency for Health Care Research and Quality, to act as a
repository for standardized information from the States and to
study and do research and disseminate the anonymized
information.
In addition, I strongly recommend a program of Federal
grants-in-aid to the States to help them develop monitoring
programs like the one we have--or even better. Few States have
the resources to do this alone, and we are not getting the help
that we need from our State, although we are slowly persuading
our legislators that it is really worthwhile. I will be just
another few seconds, Mr. Chairman. But without the full
participation of State boards, no Federal reporting program
could succeed. Let me emphasize--you can pass all the laws that
you want; you can have all the Federal agencies that you want,
but the raw data and the information and the analysis that must
be made where the data are obtained--namely, in the health care
institutions--that must be at the State level. You cannot do
that at the Federal level.
I estimate that the total cost of these State grants might
be about $35 to $40 million annually. I am convinced that an
investment of this kind would pay huge dividends in improving
hospital care throughout the country, and when it is applied to
ambulatory institutions, much more broadly, and in reducing the
financial burdens of medical mishaps and substandard care.
PREPARED STATEMENT
Thank you for your attention. I have already distributed a
booklet to you describing the Massachusetts program in greater
detail, but I will be glad to take your questions. With me is
Elizabeth O'Brien, who is the nurse attorney in charge of the
staff work of our program, and she will make sure that I give
you correct answers.
Thank you.
Senator Frist. Thank you, Dr. Relman.
[The statement follows:]
PREPARED STATEMENT OF ARNOLD S. RELMAN
Mr. Chairman and distinguished members of this committee: I am Dr.
Arnold S. Relman, a physician certified in internal Medicine, and
Professor Emeritus of Medicine and of Social Medicine at the Harvard
Medical School. I am also a former editor-in-chief of the New England
Journal of Medicine, and currently a member of the Board of
Registration in Medicine of the Commonwealth of Massachusetts. On the
Board, I serve as Chairman of its Patient Care Assessment (PCA)
Committee, which is responsible for the program in quality assurance
and medical error reduction that I want to describe to you briefly.
Here, in bare outline, is how the program works:
All licensed hospitals in Massachusetts are required by state law
to have Board-approved program for monitoring and reporting on the
quality of their patient care. They submit regular reports on their
programs to the Board's PCA Committee, the most important of which is a
quarterly report of all major medical mishaps and unexpected serious
outcomes as defined in our regulations. I use the term ``mishap''
rather than ``adverse advent'', as used by the Institute of Medicine in
its recent report, because we take a somewhat broader view of the
incidents that need to be reported.
These quarterly reports must include a full, medically coherent
account of what happened, the results of the hospital's investigation
into the cause, and the steps taken to prevent any recurrences. Such
steps might include changes in hospital procedures and organization,
remedial education of its staff, or disciplinary actions against
individuals involved. All this information is then reviewed and
discussed by the four physician members of our PCA Committee, with the
help of a small but highly trained staff of nurses. This is, I believe,
a unique feature of our program. It is placed in the State Board of
Medicine because we believe physicians must be directly involved if a
hospital really is serious about monitoring and improving the quality
of its medical care.
Another critical feature of our reporting system is that it is
confidential and the involved individuals are anonymous. The reports
are not used for disciplinary purposes, or shared with the Board's
other units. This encourages hospitals to be totally forthcoming in
their reports to us, without fear of damaging publicity or disciplinary
action. Of course, our program does not pre-empt existing state laws
concerning the disciplining and public disclosure of medical
malfeasance, and hospitals are expected to comply with them.
On the other hand, this is not a voluntary program. In my opinion,
voluntary programs cannot work very well. The hospitals understand that
we have the legal authority to require compliance, although we have so
far depended largely on education and persuasion. The leadership of
recalcitrant or underperforming hospitals, including the leaders of
their medical staff, are invited to meet with our committee for
remedial conferences. Our staff are also available to help hospitals
with specific questions or problems. As a result, there has been a
steady increase in compliance and in the number and quality of the
reports we receive. Despite this improvement, we still have not gained
a complete picture of all the medical mishaps occurring in
Massachusetts hospitals, nor have all hospitals begun to review their
care as rigorously as we would like.
Nevertheless our program has clearly achieved some success. We have
gained the trust and cooperation of the physicians and administration
in most of our hospitals and they are now much more willing to take on
the responsibilities of self-regulation. They understand that more is
required of them than simply organizing new committees and producing
paperwork. Our type of monitoring cannot work unless physicians take
direct responsibility for meeting our requirements. That distinguishes
our reporting program from most other state reporting systems, which
usually involve hospital administrators and non-physician staff and
deal more with records than with the substance of medical care.
In the course of analyzing the hospital reports, our committee has
identified certain problems in hospital procedures and the organization
of medical care that have warranted the issuance of general advisories
to all hospitals, as suggestions for improving care and avoiding
mishaps. We have also helped numerous individual hospitals with their
own problems in quality assurance. It is too early to measure
quantitatively the effect of our program on the quality of hospital
care, but I believe it is already substantial, and will become
increasingly important. We should also be able to accumulate
statistical data on the incidence of certain types of medical mishaps
and their causes. At present, however, further exploration of these and
other possible benefits of our PCA program is prevented by limited
resources.
Could federal legislation help with this kind of program? I believe
so, and I think appropriate federal help and involvement would pay
great dividends in improving hospital care throughout the country and
reducing the human and financial burdens of medical mishaps and
substandard care.
In general, I support the recommendations in the IOM report for the
establishment of a nationwide mandatory reporting system that provides
for the collection of standardized information by state governments
about medical mishaps that result in death or serious harm. I also
agree that a Center for Patient Safety within the Agency for Health
Care Policy and Research should be established to administer the
collection, analysis and public dissemination of the information--but
it is crucial, I believe, that the transmitted information be anonymous
and non-identifiable. The IOM estimates of the initial cost of funding
the new Center (i.e., 30-35 million per annum) seems reasonable.
In addition to the Center, however, I think it is necessary that
there be funds to help states initiate and operate reporting programs
that would meet the Center's requirement. The state programs should be
mandated through Medicaid or Medicare regulations and should require
the full participation of physicians. Probably the best way to do this
is through state Boards of Medicine, as we do in Massachusetts. The
federal government should make grants available to the state Boards to
undertake this work, but it should continue to delegate the regulation
of medical care to the individual states, as is now the case. I would
guess that the cost of funding the reporting programs in all states
might be of the order of 35-50 million annually. This support is
essential if there is to be a national center that gathers information
from the states. Few states now have the resources to gather
comprehensive or reliable information and I do not believe the federal
government could or should attempt the task by itself without the
participation of the states.
The total cost of such a federal investment would be relatively
small and the dividends very substantial, indeed.
Senator Frist. Senator Specter.
Senator Specter. Dr. Relman, you talk about anonymous and
confidential. Would you agree that the hospital physician/
professional has an obligation to tell the patient about the
error?
Dr. Relman. Absolutely.
Senator Specter. How does that comport with the requirement
of confidentiality?
Dr. Relman. When the physician talks to the patient and
says, ``We have made a mistake, and this is what happened,''
that is the result--it comes back, Senator, to what I said
about the difference between unfortunate things that happen--
mishaps--and errors. There is a huge number of unfortunate
things that happen in a hospital, and our committee is just
beginning to get a mind-boggling idea of the variety of things
that might go wrong. Many of these are not mistakes, and many
of them could not be prevented. So that first, there has to be
some understanding of the cause of what happened. Sometimes it
is obvious, and the doctor can immediately say to the patient:
``We made a mistake''--the wrong medication, operated on the
wrong limb, or whatever--and there is no problem about that.
But to conclude that the hospital or the doctor was in
error in many other situations requires an analysis, and that
analysis takes time. And if it comes to the conclusion that the
hospital made a mistake in that case, the patient has a right
to know. That is a professional obligation. But there are many,
many things that happen that cannot be individualized that way,
and the cumulative results I think should be kept confidential
so that doctors and hospitals can work on this problem.
Senator Specter. Dr. Russell, you talked about a mandatory
requirement as being punitive. We are struggling with how to
get the information reported, and the President has come to the
conclusion that a mandate is necessary, as has his studying
task force.
In Pennsylvania, we have a requirement of mandatory
reporting, and there is a wide net on obligations of hospitals,
nursing homes, health agencies, ambulatory surgical facilities,
intermediate care facilities. A very extensive investigative
report by The Philadelphia Inquirer disclosed that there was
only one report in the course of a year. Now, we are at a
little bit of a loss to figure out how to get the reporting
done; if a mandatory system is only going to produce a single
report, what is the answer? How can we possibly think about a
voluntary system, and don't we need to go even beyond the
mandate to put some teeth in it--as, for example, the analogy I
used at the outset about reporting crimes on campuses, where we
found that the colleges and universities were not reporting
because they did not want to discourage students from coming to
their schools. We had to amend the law to put some sanctions in
there. How do we get the information?
Dr. Russell. I think that if mandatory has anything
punitive associated with it, it is going to really dampen the
ability to get the information.
I think, Senator, the best way to do it is internally. In
our hospital, we had a very free reporting system where things
surfaced very quickly, and we attempted to handle most of these
issues right on the spot. It is a local problem, and you need
to create a culture in hospitals, whether they are small or
large, or single hospitals or part of a big system----
Senator Specter. Let me interrupt you, Dr. Russell. The
words ``creating a culture'' have been used quite a bit. A
culture is generational. A culture is not something that you
can legislate. How do you create a culture?
Dr. Russell. I think you got to hospitals where it exists,
and it does. I think there are some hospitals that are doing a
very good job at this. There are some hospitals where all
patients are informed of an error, which we could not agree
more with you--this is a code of ethics that we have as a
profession.
Some hospitals are doing an excellent job. There are some
hospitals that need to improve. And we need to look to our
winners and our good systems to get advice on how to do this,
but a lot of it--and I am only speaking as an active practicing
surgeon, which I no longer am, but I am using my experience of
just a few months ago and of 25 years--if you have a good
internal system where you promote the information to get out
about problems, you have a very good system.
For example, in the sentinel event situation that we have
at our hospital, the problem is that too many sentinel events
are brought forward, and we have to have a committee to
determine which is truly a sentinel event. Not very many occur.
Senator Specter. Dr. Udvarhelyi, before my red light comes
on, let me direct a question to you. I am pleased to hear you
talk about an agreement with the mandatory system, if I
understood your testimony correctly. You talk about some
changes in the malpractice system as well. Is your endorsement
of a mandatory reporting system total, or would you condition
that on some pre-existing change in medical malpractice--
because candidly, it is unlikely that that is going to happen
very fast. That is an issue which the Congress has been
wrestling with for a long time, and the States have made some
legislative changes. But is your endorsement of mandatory
reporting unconditional?
Dr. Udvarhelyi. Senator, I think it would be conditioned on
changes in the liability, because if the mandatory reporting
were to lead to an increase in claims and became a vehicle by
which additional claims were brought, and that became the
primary use of the mandatory reporting, we think that that
would have a counterproductive effect on creating the correct
climate and culture to learn from these and to encourage the
reporting.
Senator Specter. My red light is on, so I will conclude
with just a very brief statement--and I am sorry, Dr. O'Leary,
that I did not have a chance to pursue with you the ``blame-
free'' issue, but the red lights go on very fast.
We would ask your assistance in our effort to draft
legislation or implement the administration of these
demonstration projects. Dr. Russell, you talked about
identifying data, how you use it, closing the loop. You have
been our experts, and we are going to have to rely upon the
experts to work with the Federal agencies, the active
practitioners, where those in the bureaus may not have the kind
of detailed knowledge you have. If we move ahead promptly with
demonstration projects, we can find a lot of answers.
The goal of having a mandatory system within 3 years is a
fine goal, but it is unlikely to happen if you are requiring it
of 50 States; but if we have some experience on the differences
between voluntary reporting and mandatory reporting, and even
mandatory reporting with some disclosures, we will then be in a
position to try to really understand and solve this problem.
Thank you all very much for coming.
Senator Frist. Thank you, Senator Specter.
Dr. Udvarhelyi, could you comment on the administration's
recommendation for mandating safety plans for all health plans
in FEHBP, the Federal Employees Health Benefits Program? Do you
support it, do you not support it?
Dr. Udvarhelyi. Senator, I have not yet seen the final
proposal that OPM is going to come out with, so it is a little
premature for me to comment on specifics. I think health plans
can play a supportive role in patient safety. Today we have
credentialing requirements to make sure that physicians and
hospitals in our networks meet certain requirements, and we
think that is an area where we can encourage physicians and
hospitals to do more in patient safety.
We also share best practices with them, and we think we can
do more there; and we promote patients going to centers of
excellence. As you well know, one of the best ways to get a
good outcome is to go to a center that has the requisite
experience and track record, as opposed to one that does not.
We think that these are all ways in which we can assist, but at
the end of the day, the care is provided in the physician's
office, or the drug is prescribed in the hospital, and we think
it is critical to have the support of physicians and hospitals
on the front lines to identify errors and to report them.
Without their support, a requirement on the health plans to do
something without the support of the physicians and other
providers is going to be difficult.
Senator Frist. One of the big challenges is educating
broadly. This is system-wide, and as we have talked about
today, you cannot point your finger at any one area and say,
``Let us fix this, and it will fix the system.'' The health
plans are in a unique situation in that the health plans
interact with doctors, nurses, providers, hospitals, rural
hospitals, urban hospitals, and I cannot help but think that it
is going to fall on your shoulders to take a leading role. It
can be accreditation, it can be individual States, it can be
Federal law, but we are going to need to look to you to see
how, in a way that is consistent with all the other things that
you are doing. I guess it is going to be important for you to
put certain pressures on there if voluntary is going to work--
and mandatory is going to be important, but limited in terms of
the full systemwide impact. I think the health plans can play a
very important role there, consistent with what you are already
doing, but probably reaching out more.
Would you object to in some way--and I know that new
mandates are the last thing you want to see--but having every
health plan out there at least put in writing to notify
patients, prospective patients, what is being done in terms of
medical error reduction?
Dr. Udvarhelyi. We would support the dissemination of
information about patient safety, certainly. But again, for us
to take an active role, one thing we cannot do is change the
liability issues ourselves. And if the information is exchanged
in ways that are not protected and are not confidential, and we
cannot change that, it may be problematic.
Senator Frist. Well, the confidentiality and the liability
everyone has said must be addressed, and to try to fix the
system and come out with a range of proposals that does not
include that, I think is irresponsible, and we hear that again
and again; so how we address it is tough.
Dr. Russell, on the medical errors, we hear the numbers,
and it is appalling, and people are surprised. It is
inexcusable, given the information systems that we have today
in contrast to 30 years ago, where you really can computerize.
We have pockets that are doing very well, hospital systems that
are doing well, medical centers that are doing very well--you
have been a part of many of those as I have in our own
practices. Therefore, we should not leave the impression that
nothing is being done. The point is we can do a lot more, and
we need to figure out how, together, we can do that, private
and public sectors.
For my colleagues, in regard to mortality and morbidity, or
M and M, rounds--at Vanderbilt for the 10 or 11 years I was
there, every week we had M and M rounds; at Stanford when I was
there, and at Massachusetts General when I was there, again, it
was standard. But I was in academic health centers. Are
mortality and morbidity or M and M rounds just at academic
health centers, training centers, where residents and fellows
are taught? How many hospitals have M and M rounds that might
be community hospitals that are not engaged in training? Could
you set the perspective for what M and M rounds are?
Dr. Russell. All right. M and M rounds is looking at your
results. Now, it is ideal for surgery, because we are doing
surgical procedures, and not always do you have good results.
But these are not necessarily errors; you have complications.
And it is very important, as Dr. Relman alluded, to
differentiate complications from an error.
M and M rounds is an effort in surgery to look at the
results of operations and at what problems or complications
occurred. These occur in teaching hospitals; it is a very
important culture to create in young surgeons to assume
responsibility, because in surgery, you know, we often make
patients sicker than to start with in order to get them well.
We set them back a little bit. So we have to be very critical
of our results.
I think the Morbidity and Mortality Conference is a great
learning tool for young surgeons to set, once again, the
culture of responsibility of results from the operations that
we do. This can easily be applied in private hospitals, and I
think a lot of private community hospitals do Morbidity and
Mortality Conference on a monthly basis, where they criticize
and critique their results with the idea that they are trying
to make the product better.
Senator Frist. And confidentiality there is not an issue,
because you are within a system, and it is mainly physicians
and nurses talking together, looking at systems, looking at
failure, errors, unexpected outcomes--but in truth, it is
pretty much limited to where training is going on--is that
right, or is that incorrect?
Dr. Russell. I think it is true that it is where training
is going on, but a lot of private hospitals where there is no
training get the staff together on a weekly or monthly basis
and go over complications that have surfaced in the last
reporting period. It is a very important part of the internal
reporting, and you need to create a culture of not just being
critical, but rather, a learning experience.
Senator Frist. Thank you.
Dr. O'Leary, what role do you think States should play in
the collection and dissemination of information at the State
level based on what you have seen through the JCAHO?
Dr. O'Leary. We would have no problem with a State-based
reporting system. I do worry about standardization of
reporting, something that was addressed in the Institute of
Medicine report that I did not hear quite as clearly in the
QuIC Task Force report. But I think we have to carefully define
what is going to be reported and seek to standardize that
across the State systems or we will have bad data, for openers.
I think it is also important that the States establish
requirements for root cause analyses for those hospitals and
other organizations that are going to be reporting to them. I
think one of the failures of the current mandatory reporting
systems in States to demonstrate improvement is that simply
counting cases does not cause improvement. You need to know
underlying causes, gather that information, and share the
lessons learned out of that. That has been very much the Joint
Commission's experience.
I think the other comment about the State reporting systems
is that the need for confidentiality is underscored by our
experience. If you look at the States that have confidentiality
protections, those are the ones that have pretty good numbers
of reports, although there is probably still underreporting
there. The States that do not have confidentiality protections
have very low numbers. That message is pretty clear, and we
need to learn from that experience.
I would finally hope that in any system that we create
there would be data-sharing amongst the responsible parties.
Many of the hospitals involved in my report to the States are
accredited by the Joint Commission. We have an active follow-up
program. I think the States and the responsible accrediting
bodies need to share information among themselves.
Senator Frist. Thank you.
Dr. Relman, for 6 to 8 years, things have been going pretty
well. How many hospitals are there in Massachusetts, roughly?
Dr. Relman. About 110.
Senator Frist. And how many reports do you get a year?
Dr. Relman. It is a rising number, which does not mean the
care is getting worse. It means that the cooperation is getting
better, and the system is really beginning to operate. It is
getting better all the time--it is a moving target.
Senator Frist. Is it 50; 100; 1,000; 10,000?
Dr. Relman. It is now between 500 and 600 a year, based on
about 15,000 beds. Our estimate is that that represents only
about 10 percent or 15 percent of what actually is going on.
Senator Frist. And it is mandatory.
Dr. Relman. Absolutely.
Senator Frist. And of the 110 hospitals, how many have not
reported any, just roughly?
Dr. Relman. Two. But they are going to be hearing from us,
and they already have. We watch that, and it is remarkable how,
if you sit down--our doctors on one side of the table and their
doctors and their president of the board of trustees and the
CEO on the other side of the table--and we look them in the
eye, and we say, ``What is going on here? Are you saying
nothing bad ever happens--no unfortunate outcomes--nothing is
unexpected?'' Then, there is a dialogue. As long as they know
that you are honestly telling them this is in confidence, and
it is not punitive, and we want to help you do what you know is
the right thing to do, you begin to get cooperation.
Senator Frist. And do you work for the Government--are you
a State employee?
Dr. Relman. Well, I would not call it that. I am
essentially a volunteer. The State of Massachusetts pays me $35
plus free parking for every day that I spend time working for
them.
Senator Frist. And how many doctors, realistically, out in
the field, basically looking at clinical errors for the most
part and interpreting them and looking across the table--how
many do you think you are going to get to do that for $35?
Dr. Relman. You have to be old and foolish, the way I am,
and a little idealistic. But I think that a lot of my
contemporaries who have had full careers in the practice and
teaching and research in medicine are available. It is not
full-time. It takes about 15 or 20 percent of my time to do--a
lot of nights and weekends. I have a lot of contemporaries, at
least in Massachusetts, who would like to do that because it is
a very satisfying thing to watch your profession get the
message and realize that they could really do much better if
they were reassured that this was going to be done in a
constructive, confidential way. And it does not interfere with
any of the existing laws about reporting on convictions and
malpractice litigation and so on. All those laws are in place.
Senator Frist. But it is important for people to understand
that when you are talking about medical errors and medical
mistakes and judgment, systemwide failure--we are probably
talking about some of the most sophisticated decisionmaking in
medicine today.
Dr. Relman. Absolutely.
Senator Frist. You are seeing the toughest, I think, when
you go from M and M rounds, and you sit there for hours and
dissect individual cases. And I guess I wonder, looking at
State Governments in all 50 States, whether you are going to be
able to pull that sort of expertise for $35.
Dr. Relman. If you want to recommend a raise, I would
appreciate it.
Senator Frist. I will. But it is sophisticated, and I
commend you for the success there.
But that goes to my next question--in Massachusetts, it is
6 years; you do not get paid very much; you are probably way
underfunded for what you are required to do.
Dr. Relman. Yes.
Senator Frist. You have compulsory reporting for not only
what we see at M and M rounds, but in every adverse or serious
unexpected outcome, which is thousands, I would think----
Dr. Relman. We think that in Massachusetts, there are
several thousand such episodes, and so far, we are looking at
about 500, or perhaps 600 this year.
Senator Frist. We are talking about the most sophisticated
of medicine that is going to require expertise. We are not all
going to be able to have Dr. Relman, with your long history.
Dr. Relman. We call on consultants, too, on an ad hoc basis
when we need them. We do not have all the expertise in our
office.
Senator Frist. And all this is done through the State
government.
Dr. Relman. The State Board of Medicine.
And the trick is that the doctors know that there are State
regulations which say licensees of the State Board of Medicine
in Massachusetts are not allowed to practice in an institution
that does not have an approved quality assurance program. And
we want you to convince us that we should approve your quality
assurance program. Furthermore, we can always report bad
performances in hospitals to the State Department of Public
Health.
Senator Frist. I had written down a question, and you got
to it at the end, about why do you need Federal laws coming in.
You have made this progress, and ultimately, you feel strongly
that it should be done at the State level, I assume.
Dr. Relman. But we need help, and the Federal Government
can give us guidelines.
Senator Frist. You need some money, and you heard me ask
earlier, if the administration is serious about mandatory
reporting of thousands of errors, making the most sophisticated
dissemination of information back, I am not sure it is not a
little disingenuous for them to come forward with tiny bits of
money, make this mandatory/compulsory reporting requiring the
most sophisticated expertise in medicine today at the table, if
you can really interpret the data that is coming forward. If
you just want to get it out there and disseminate it, that is a
different issue, then we are going to have to face the facts of
what the resources are going to be.
Your $40 million figure of grants, based on what you have
told me, is a nice start. We have not heard that requested by
the administration. We are talking about $20 million for
overall funding of all research for the 1,155 of Dr. Eisenberg,
which does not approach that. And again, it is important--the
$40 million----
Dr. Relman. This would go to the States.
Senator Frist. I understand, I understand. Right now, we
have how much going to the States--zero, probably, or a few
million dollars.
Dr. Relman. We do not get any Federal support.
Senator Frist. I know. We are going to give some to
Massachusetts. We need Senator Kennedy here. [Laughter.]
Anyway, I appreciate it, because the program is admirable
and demonstrates the overall complexity of it.
On public dissemination of information--in the transplant
field very early on, by Federal legislation, we were required
to report every transplant that we did. This was early on,
1986. It is probably one of the first fields where you reported
the outcome of whom you operated on, what was the outcome, what
was life, death, quality of life at 6 months, 1 year and 3
years, infectious disease outcome--all of a sudden, we had all
this data reported, and nobody knew what to do with it. Then it
winds up in the newspapers, and all of a sudden, transplant
centers were very threatened, because without a real definition
of case mix and how difficult the transplant cases you were
doing, all of a sudden, if somebody was doing easy ones, their
hospital or their transplant program looked real good, and the
others looked real bad. So for about 3 years, we really
struggled.
Therefore, I am a little bit suspicious based on that
experience of just getting raw data, without the sort of
expertise that you have been able to demonstrate, and report it
to any agency of the Government without a real careful,
thoughtful, sophisticated plan. It might be from the private
plans, it might be from JCAHCO, it might be from individual
hospitals, physicians. And again, the principles are good, but
before we get too far along, I think we need to think long and
hard about this information coming to the top, how it is
digested in a sophisticated way and then disseminated. I think
everybody says that that disclosure needs to be there. That is
why I want to hear exactly how it is going to be done as we go
through. That is why I keep bringing up points like that.
Dr. O'Leary, in your written comments, you talk about
error-related information, that Congress should enact again, I
am trying to figure out Federal Government versus State
Government. You say that Congress should enact Federal
protections for error-related information. I think I agree, but
what do you mean by that? How broad should these Federal
protections actually be?
Dr. O'Leary. I think the protections should be for the
report of the occurrence, a serious adverse event--however we
come to a definition of that--and for the root cause analysis,
the in-depth investigation of what happened at a systems level
within the organization. That is specifically what we are
talking about protecting.
Senator Frist. And in terms of the actual wording of that,
you are fairly confident that we could come in with legislation
that would circumscribe that, define it and take care of it?
Dr. O'Leary. I really am.
Senator Frist. Are there other comments on that whole issue
of legislating Federal protection for error-related
information? All of you think it can be done? Good.
Dr. O'Leary, you also stated that the problem of medical
errors is an information problem--actually, both of you did,
Dr. Udvarhelyi as well--and in your testimony, you went through
it. Some people, Dr. O'Leary, have suggested that we are not
making use of all the information that is out there today. Is
that accurate, and is there a role for Congress to make better
use of that information?
Dr. O'Leary. I do not know that we have a lot of useful
information in the medical errors arena. A lot of it is locked
within organizations. Even getting caregivers to report
significant medical errors inside organizations is a problem.
That is existing information, but it is not even known to
organization leaders, let alone to the Joint Commission or to
State agencies or to HCFA or anyone else. And until we know
what is happening inside our organizations, we have no ability
to leverage the analyses that need to be performed nor to
harvest those analyses for lessons learned and to share those
broadly across the country. Now, we do that on a very modest
scale. Last year, we had 333 sentinel events made known to us,
83 percent of which were self-reported. The root cause analyses
that we required in each of those cases were very rich sources
of information, and we publish quarterly something called
``Sentinel Event Alert'' on a topical error and medical errors,
and those are widely read and used, because we can show that in
some areas, we have seen a reduction in the frequency with
which certain errors are reported--potassium chloride-related
deaths being a case-in-point.
Senator Frist. Dr. Udvarhelyi, on the health plans, again,
you are in a unique situation because you are collecting so
much information. Most of it is claims information right now,
but still, you are the one in the group here whose plans are
talking to a range of providers, facilities, nurses, doctors;
they have to report to you, and you have to report to them.
Most of it is claims, dollars and cents. Is there information
that either you are receiving now that would help with the
medical errors or that in some way could be de-identified but
attached in such a way that it could address medical errors?
Dr. Udvarhelyi. Senator, I do not think that health plans
do have access to the type of information that would be useful
to identify medical errors. Again, as I said, earlier, we are
not there where care is being delivered, and that is where
these errors are identified.
I think it is important, as has been said before--there are
adverse events which may or may not be due to an error, and
then there are errors which may or may not lead to adverse
events. In order to have error reduction, you need to
understand the totality of errors, including those that do not
produce an adverse event. And really, it is the physicians and
hospitals that are in the best position, and other health care
providers, to know how the decisions are being made, and I
agree with Dr. Relman that you need to understand the context
of these events from a clinical standpoint, and again, the
health plans are not in a good position to do that. We can play
a supportive role, but I do not think we are in a very good
position at all for reporting.
Senator Frist. Dr. Russell.
Dr. Russell. I would just like to say that the ideal place
is the hospital, because that is where it happened, and that is
where it is disclosed. I think that in a lot of hospitals in
this country, when something happens, everybody knows about it.
That is the environment that you want to create.
For example, in our hospital, maybe once a year, there
would be a death in the operating room. I would know that
within 30 minutes of the event; the word would get around the
hospital. That is the kind of environment that you want to
create, so that when something comes up, the right committees
get involved, and it is handled internally. It is not hidden;
it is opened up to internal discussion, and then, if it needs
to be reported to an external organization, that is fine and
dandy. But I think it has to start and hopefully can get
finished locally, and then by improving the process. That is
the ideal way for it to work, and I think there are some
hospitals in this country where it works very effectively. We
should not always just look at where there are bad cases; we
should look at where we have good use of this data, and results
come from the analysis, and we should model our programs after
that.
Senator Frist. Thank you.
I am going to wrap it up shortly, but I want to give
everybody an opportunity to close with a minute apiece if you
would like to.
Dr. Relman, in terms of what other States are doing, do you
interact with other States at all?
Dr. Relman. No, we do not. But to the best of my knowledge
the particular combination of methods and procedures that we
follow are unique. I looked at the material that the Institute
of Medicine had collected, and none of it resembles what we do.
In fact, what is stated as being what Massachusetts does is
what the Department of Public Health does, not what we do, and
it is quite different.
Senator Frist. And the Federal role for you is maybe the
mandatory, just so every State will have to get in the
business--in terms of what the Congress needs to do--and number
two was the confidentiality end of it. And third was the grants
and other money.
Dr. Relman. Yes. And I agree with John Eisenberg that you
need to have a center where you receive nonidentifiable
information, statistical information. These are the common
problems that we are identifying. And then, you need to have
some research on whether they can be prevented and what works
and what does not.
There is an enormous amount of information on the
procedures of health care in hospitals, in clinics, and in
private offices, that we have to know about, and we need
research. And the Federal Government can support that
research--the States cannot afford to do that--and disseminate
the results of the research.
Senator Frist. Is the group that you work with a regulatory
agency?
Dr. Relman. Yes, we are. We regulate the practice of
medicine.
Senator Frist. Will you close down hospitals if you do
not----
Dr. Relman. We hope we do not have to, but we have the
statutory authority, State authority, to declare that a quality
assurance program in a given hospital is not satisfactory. We
also have the authority to determine the conditions under which
medical licensees can practice. We have never had to exercise
that authority, and we hope we do not, and all of our lawyers
are not quite sure what would happen if we came to that point.
But we do not have to. The hospitals get the word--they do not
want it to come to that point--and staffs respond.
Senator Frist. Thank you.
Dr. Udvarhelyi, do you have any closing comments?
Dr. Udvarhelyi. Thank you, Senator. I would just emphasize
that we think there is a role for legislation to create the
proper environment and that after that has been done, mandatory
reporting is a viable option, and within that context, we think
that if we can identify the errors and learn about the root
causes, then all parties will be able to make a concentrated
effort to reduce their frequency.
Senator Frist. Thank you.
Dr. Russell.
Dr. Russell. Senator, I would just like to say that I think
it is really worthwhile that we are looking at this, but I want
to hasten to say that we do a lot of good in hospitals today.
The severity of illness of patients in hospitals in this era is
amazing, and what we have to do with them, with comorbid
problems and a multitude of difficulties, with new diseases,
the ravages of AIDS and the way it affects patients--it is
remarkable what health care can do today. So we cannot lose
track of that.
We have a good system, but we are going to make it better.
So let us not beat ourselves totally over the back on this,
because we have to recognize the good of the system and then
build on that. Those would be my closing comments.
Senator Frist. Thank you very much.
Dr. O'Leary.
Dr. O'Leary. There are two points I want to emphasize. One
is the importance of information-sharing regarding medical
errors eventually amongst those with a legitimate need to know.
The oversight players are the private sector accrediting
bodies, the State agencies, HCFA and its subpart PROs.
The accountability surrounding medical errors is not just
for reporting or even doing root cause analyses, but eventually
for the implementation of action plans to reduce the likelihood
of future errors. We cannot tolerate a situation where medical
errors are being reported to one place, and we as an
accrediting body do not have access to that information and yet
are held accountable for improving patient safety through our
Federally-deemed status relationship.
I emphasize this point because it is not addressed in the
QuIC Task Force report, and we need to assure that there is
appropriate information-sharing.
The second issue more briefly is that most of the
recommendations in the QuIC Task Force report have significant
time lines associated with them, but the thing that can be done
now is the enactment of confidentiality protection information
for error-related information. Many hospitals tell us that they
would report serious adverse events and their root cause
analysis to the Joint Commission if they had that protection.
That can happen now.
Senator Frist. Thank you.
Dr. Relman.
Dr. Relman. The responsibility for medical care rests
clearly with the medical profession and allied professions, the
nursing profession and so on. If you are concerned about
improving the quality, you have to start by motivating doctors
and nurses to do everything they can to look at what they do
critically and carefully and honestly, identify what goes wrong
or what is unexpected, find out why it went wrong, and then do
something about it if it can be done. You cannot be too
draconian. You cannot be too bureaucratic. You cannot make too
many rules or have too many organizations requiring doctors and
nurses and health care personnel to do the right thing.
However, you can make sure that they do it by saying to
them: We want you to tell us that you are, and we understand
what you are telling us. We know. We have been there. We have
done it ourselves. We doctors. We are nurses. You convince us
that you are doing the right thing and that you are correcting
it.
That is all we can--now, patients have a right to expect
that their doctor tells them what they ought to know. That is
different from public disclosure. It has got to be
confidential. It cannot be just everything done in the public
arena. What is between a doctor and a patient, you know, is
private, and that should not transpire in the public arena. But
doctors have got to do it, and hospitals have got to do it, and
I believe that the Federal Government and the State Government
each have a role to play and can be very supportive, because it
does take money.
Hospitals, by the way--let me put in a word for the
hospitals--are being stressed terribly now, as you know very
well. This adds costs. The peer review function costs money and
costs time. Quality assurance nurses, reports being filed with
agencies and so on--it takes more money and more effort, and
they need some help.
Senator Frist. Thank you.
I want to thank all the witnesses. Today was a joint
hearing, and we do not hold joint hearings that often, to bring
together the Appropriations Committee's Subcommittee on Labor,
Health and Human Services, and Education, with Senator Specter,
and Senator Jeffords' committee, the Committee on Health,
Education, Labor, and Pensions. I think that that coming
together is a reflection of the way this has to be addressed,
both in terms of adequate financial resources, which we come
back to again and again, and in terms of the appropriate
authorizations given to the appropriate agency, which I am
delighted that we have come again and again back to the Agency
for Health Care Research and Quality, which was very specific,
in legislation that originated in this room 2 years ago, that
became a part of the Senate-passed Patients' Bill of Rights,
that was taken out and passed last year because of the critical
importance of addressing quality and medical errors in addition
to access and insurance is a critical component of that.
All this together, I think demonstrates what you said at
the end, Dr. Relman, that there have got to be a lot of
partnerships at the local doctor-patient/nurse-patient
relationship, traveling all the way up to the Federal
Government, how we collect, how we report, with everything from
the health plans to the accrediting agencies to the hospitals
to the professional societies out there today. I think it has
got to be addressed in very sophisticated, very inclusive and
very comprehensive way to achieve what we all recognize can be
achieved.
It boils down to accountability and how we can assure
accountability at every level, and I think that based on the
joint hearing today and the three previous hearings that we
have held on medical errors in the HELP Committee, we have a
great foundation. Now we need to all again in a partnering way
put our heads together, put on paper what needs to be put
there, usher it through the United States Congress, and set a
framework. Again, I do not think it has to be overly
regulatory, but it really does have to lower those barriers
where the accountability can flourish.
I think it can be done. I think it is now our
responsibility to do just that. It is going to take all of us
working together and listening very carefully in a bipartisan,
comprehensive way, House and Senate, to accomplish that.
I am sorry the hearing went on for so long, but it was
because of the amount of information that we wanted to listen
to, collect, and discuss.
CONCLUSION OF HEARING
Thank you all very much for being here, that concludes our
hearing. The joint hearing is recessed.
[Whereupon, at 12:35 p.m., Tuesday, February 22, the joint
hearing was concluded.]
Material Submitted Subsequent to the Conclusion of the Hearing
[Clerk's note.--The following statements were received by
the subcommittee subsequent to the conclusion of the hearing.
The statements will be inserted in the record at this point.]
Prepared Statement of the American Academy of Orthopaedic Surgeons and
the 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 Jeffords and Chairman Specter holding this
joint 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 toward 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 Chairmans Jeffords and Specter and
other members of the Committee and 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 these Committees and other
Members of Congress as you assess the need for legislation to address
medical error reporting.
______
Prepared Statement of the 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 reporting standards.
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.
THE PRESIDENT'S INITIATIVE TO REDUCE MEDICAL ERRORS AND IMPROVE PATIENT
SAFETY
On February 22, 2000, the President announced a series of
initiatives to reduce medical errors and improve patient safety. ACP-
ASIM concurs with the following IOM and Administration recommendations:
--Establish a new Center for Quality Improvement and Patient Safety
within the Agency for Healthcare Research and Quality (AHRQ).
We agree that the goals of this Center should be to work with
the medical profession, hospitals and consumers to develop
national goals for patient safety, to track progress on meeting
such goals, to promote the transition of research findings into
improved practices, and to educate the public. We support the
President's budget request to fund the Center.
--Launch new research to implement mandatory reporting of major
errors that cause serious injury or death to patients,
eventually leading to a requirement for standardized reporting
of such errors (emphasis added). We share the concerns of other
professional and hospital associations that mandatory reporting
can do more harm than good if it is designed to punish those
who make errors, rather than encouraging cooperation among all
stakeholders in preventing errors. The goal must be to enlist
physicians, nurses, hospitals and other providers in a
concerted drive to prevent major errors, rather than reporting
after a patient has been seriously harmed. We are encouraged
that the administration calls for the development of patient
safety measures by the National Quality Forum and pilot-testing
of mandatory reporting systems before uniform nationwide
reporting requirements are mandated. We believe strongly that
mandatory reporting must remain limited to major errors that
cause serious injury or death to a patient, and we will oppose
efforts that may be made by others to broaden mandatory
reporting requirements to other types of errors.
--Extend expansion of peer-review and confidentiality protections to
encourage development of post-error review processes. In our
view, the establishment of such protections is a pre-requisite
for an effective reporting system. ACP-ASIM's Code of Ethics
clearly states that a physician is obligated to inform
individuals and family members when a preventable medical error
occurs that causes serious injury or death. We agree with the
administration, however, that system shortcomings (root-cause
analysis) and subsequent action to prevent such errors in the
future should not be ``discoverable information'' used in
litigation. We support the President's call for legislation to
protect patient and provider confidentiality in order to
encourage post-error review. We also support broader reforms in
the medical liability system, including a cap on non-economic
damages, than the administration has been willing to support in
the past. ACP-ASIM agrees that legislation to protect peer
review and confidentiality should be enacted in conjunction
with, or prior to, implementation of nationwide mandatory and
voluntary reporting systems.
--Encourage the development of voluntary systems and learning from
existing systems. Although the IOM's support for mandatory
reporting of major errors has been the subject of the most
debate, we believe ``as does the IOM'' that encouragement of
voluntary reporting of problems that do not cause death or
serious injury to the patient must be a key element of a
national strategy to reduce preventable errors.
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 percent 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.
______
Prepared Statement of the American College of Radiology
The American College of Radiology (ACR), a professional society
whose purpose is to advance the science of radiology in order to
improve the health of patients, is pleased to present the following
statement regarding its efforts to improve and ensure patient safety.
The ACR has been involved in patient safety relative to ionizing
radiation for over 15 years. To that end, ACR has developed three
interrelated programs that speak to the characteristics of quality
improvement and patient safety in radiology and radiation oncology.
Protecting the patient and public are at the heart of these programs
that recognize that quality matters, quality varies, and quality can be
improved and measured. In light of the recent Institutes of Medicine
(IOM) Report on medical errors, ACR believes its expertise in
developing peer-reviewed, quality patient safety programs would benefit
Congress as it begins to address this serious problem. ACR's programs
are summarized below.
ACR ACCREDITATION PROGRAMS
In the mid 1960's, the ACR developed and implemented its first
accreditation programs that were designed to evaluate whether radiology
practices met certain criteria developed by their peers. These early
programs permitted ACR to develop the voluntary accreditation programs
of the mid 1980's that follow recognized principles of accreditation
law: provide public benefit/safety; available to all practitioners who
are able to meet the criteria; valid, credible, reasonable,
substantive, procedurally fair, and able to withstand external
scrutiny. Further, final written reports and certificates are issued;
there is an appeals process in place; corrective action procedures are
available to deficient facilities to assist them in meeting criteria;
and finally, denial of accreditation to those facilities unable to meet
the criteria.
The Mammography Accreditation Program serves as the model for all
other programs with the exception of Radiation Oncology. The voluntary
ACR mammography accreditation was implemented in 1987 because of
identified problems with the quality of mammography images as well as
concerns about radiation dose. The following areas are assessed:
personnel qualifications for physicians, physicists, and technologists
that includes training and education and continuing medical education,
clinical and phantom images are scored, and radiation dose is measured.
In 1992, the Mammography Quality Standards Act (MQSA) became federal
law with oversight provided by the FDA. This program was largely based
on that of the ACR and ACR was recognized as an approved accrediting
body with some 9000 facilities. Yearly, there is a federal inspection
and triennially, accreditation must be repeated. The main outcomes of
this program have been:
--Provide consumer information and listing of accredited facilities
--Provide standardized mammography practice across the United States
--Improve the quality of mammography (greatly)
--Decrease the radiation dose by 100 mRads on average
--Provide the mammography report directly to women
--Increase provider education
--Improve the standards for equipment
--Improve the provider list (10-12 percent no longer provide
mammography)
Although other ACR programs provide the same kind of improvement,
they do not operate under federal mandate. However, as third party
payers seek ways to provide quality to their enrollees, all ACR
programs have some third parties requiring them as a condition of
reimbursement, e.g., Aetna US Healthcare requires all MRI providers to
become accredited. The new Nuclear Medicine program incorporates the
Nuclear Regulatory Commission requirements.
The ACR has ``crosswalked'' their program with the Joint Commission
on Accreditation of Healthcare Organizations (JCAHO) and currently has
a cooperative agreement with the JCAHO, which recognizes the ACR
organizations accredited in radiation oncology. The same process is
being pursued for all of the diagnostic programs and, in fact, the
mammography program is recognized.
ACR APPROPRIATENESS CRITERIA FOR IMAGING AND TREATMENT DECISIONS
In 1993, the ACR determined that in a changing healthcare
environment a premium would be placed on the efficient use of resources
including the appropriate use of radiologic services. Thus the ACR
embarked on developing evidenced based, multidisciplinary
appropriateness criteria to assist radiologists and referring
physicians in making appropriate, initial imaging decisions for given
patient conditions. The ACR incorporated into the development process
medical guidelines' attributes developed by the Agency for Healthcare
Policy and Research (AHCPR) and the Institute of Medicine.
Following literature review and rating, a modified Delphi technique
was used by the ten expert panels, based on anatomic sites, to come to
consensus. A number of different imaging techniques were rated using a
scale of 1-9. Nine being most appropriate. Over 170 conditions and 900
variants have been completed and published. These are reviewed every
three year or sooner if warranted by new evidence.
These criteria are being used in research projects, physician
ordering systems, utilization management systems to identify outliers
for educational purposes and for reimbursement by third party payers.
Patients can also use these criteria in discussions with their
physicians regarding imaging/therapy. Further, certain of these
guidelines are on the AHCPR Guidelines WEB site.
ACR STANDARDS
The ACR Standards for performing radiological procedures attempt to
define principles of practice that should generally produce high-
quality radiological care. The standards recognize that the safe and
effective use of diagnostic and therapeutic radiology requires specific
training, skills and techniques as described in each standard. This
standardization effort should improve the quality of patient care
throughout the United States. Each standard has undergone a thorough
consensus process in which it has been subjected extensive review. The
ACR believes that these baseline standards are generic and pertinent to
any physician performing radiologic procedures regardless of the
setting. Existing standards are reviewed every four years or sooner if
necessary.
ACR Standards are used in practice policy, by third party payers,
by patients, and lawyers. Further, Physicians Insurance Association of
American (PIAA) has reviewed radiology closed claims and indicated that
ACR Standards serve as very good risk management tools. ACR has
addressed issues of communication between radiologists and referring
physicians by writing standards for communication for both diagnostic
radiology and radiation oncology.
ACR is committed to the continued improvement in the practice and
safety of radiologic services provided to the American people. The
College would be honored to provide any assistance to the Committee as
it begins to address the serious problem of reducing medical errors.
______
Prepared Statement of the Healthcare Provider Credentials Verification
Association
Mr. Chairman, and Members of the Committee: I am pleased to submit
the following testimony on behalf of the members of the Healthcare
Provider Credentials Verification Association (HPCVA). HPCVA is a non-
profit organization representing the interests of the credentials
verification industry and is headquartered in Washington, DC. HPCVA was
formed to work with legislative bodies, regulatory agencies and other
organizations in an effort to improve the healthcare provider
credentialing process and improve the relationships between providers
and our ability to meet requirements of the industry. It's mission is
to advance the efficiency, accuracy, and confidentiality in the
gathering, maintaining, and reporting of relevant information to
healthcare organizations, practitioners, and consumers as part of the
solution to improve the quality and reduce the cost of American
healthcare.
Credentialing is a very important part of the administration of
healthcare in this country. It is through an exacting credentialing
process that organizations know that they are offering quality
healthcare services to Americans. Credentialing certifies that
healthcare providers have the appropriate knowledge and experience to
provide care to patients. It is also a way in which organizations can
determine whether providers should be hired, have hospital privileges,
or be able to participate in a network or managed care contracts. In
addition, credentialing can expose those providers who have falsified
their applications or documentation.
WHAT IS CREDENTIALING?
Credentialing is the evaluation of providers defined in the Health
Care Quality Improvement act. Regulatory organizations such as the
Joint Commission on Accreditation of Healthcare Organizations (JCAHO),
the National Committee for Quality Assurance (NCQA) and the American
Accreditation HealthCare Commission/Utilization Review Accreditation
Commission (URAC) focus on the measurement of compliance to that act
which requires a peer review process. At first this process mostly
applied at hospitals. Now, with so many more options for the delivery
of healthcare, such as, managed care organizations, independent
practices, health maintenance organizations, preferred provider
organizations and other healthcare organizations, there has been more
need for credentialing than ever. JCAHO and NCQA require that all
providers with privileges be ``recredentialed'' very two years in order
to ensure that licensure is current and risk of future substandard care
to members is minimized.
During the credentialing process, areas of a provider's background
and training are verified through a variety of primary sources. This
process can be paper and labor intensive as well as time consuming.
Credentialing includes primary source verification of the
following:
--Licensure
--Hospital privileges
--Drug Enforcement registration and state controlled drug substance
registrations
--Medical education
--Board certification
--Professional Liability insurance
--Liability claims history
--National Practitioner Data Bank (NPDB) queries and HIPDB queries
--Medical board sanctions
--Medicare/Medicaid sanctions
The process begins with the provider completing the application and
signing it thereby attesting to its truthfulness and completeness. From
the date the application is signed the information must be verified,
according to NCQA, within 120 days. The client or healthcare
organization then has 60 days to review the file through its peer
review process. If the file is not completed and reviewed in these time
frames, the Credential Verification Organization (CVO) and healthcare
organization are out of compliance as the information is not considered
to be current. If the CVO exceeds the 120-day time frame, the
attestation document must be re-signed and dated in order for the
credentialing process to continue.
Discrepancies or incomplete information can relate to the
provider's professional history, which addresses any licensure
restrictions or revocations, felony convictions, Medicare/Medicaid
sanctions, reports to the NPDB, chemical dependency or substance abuse
problems, or physical or mental conditions that might limit the
provider's ability to provide services. If a discrepancy is noted, the
provider must then provide written clarification, including date and
signature, which then becomes part of the application.
Once the credentialing process is completed, the information is
sent to the client's credentialing committee for peer review. Peer
review is the process of reviewing a provider's professional and
educational background and experience to make a final determination as
to whether or not to accept the provider into the network, or grant
privileges because it is determined by the provider's peers that there
is no apparent risk of future substandard care that would be a risk to
members or patients.
CVOS ARE ACCREDITED
CVOs are accredited or certified by NCQA and URAC that they meet
criteria that comply with standards that these organizations have
established for the credential verification industry. Every two years
accredited CVOs must undergo an additional certification process by any
one of these organizations that verifies that the CVO demonstrates and
provides the required service to its clients in a manner that ensures
continuous quality assurance, handles the provider data in a
confidential manner, and has a sound management structure.
CVOs also monitor their own performance by implementing a
continuous quality improvement process to ensure accuracy and
compliance with regard to the credentialing process and to determine if
processes need to be improved in terms of efficiency, quality of
service, and customer satisfaction. It is important that established
performance measures are monitored, problems are investigated and
preventive action taken where necessary. CVOs also recognize the
importance of privacy and confidentiality in their businesses and
understand its criticality for effective credentialing. This being a
concern to the industry, CVOs develop policies that control access to
credentialing files to ensure confidentiality of all information and
protect it from unauthorized access and tampering.
WHY IS CREDENTIALING IMPORTANT?
Since credentialing provides thorough information on a healthcare
provider's background it is invaluable in terms of a way to ensure
quality healthcare and helps reduce the costs and risks involved for
healthcare organizations if it is not done correctly. As you can see
from the credentialing process described earlier, credentialing gives
these healthcare organizations a very comprehensive look at a
provider's background in order to make a determination with regards to
hiring a provider. Knowing a provider's history--whether there are
sanctions or there have been abuses or problems in the past, will help
to make these decisions thereby reducing the probability of instances
of medical errors. There was a situation where a provider responded
``no'' to the ``have you ever been convicted'' question. The
verification of the license from the state agency included a transcript
of a court case where it was clear that the provider had been convicted
and spent 30 days in jail for a drug charge. The official record from
the courts had been expunged and no record of the case could be
obtained from the previous state of residence. It was only through the
licensing agency that the information came to light. The provider was
placed on extreme probation as a result.
Not only does credentialing serve as a tool for healthcare
organizations to learn more about prospective providers under contract,
it also serves as a check on providers themselves. Since the provider
signs an attestation document as to the veracity of the information on
the application and all of the information requested is verified
through primary source, the provider must give all of the correct
information. Since the process also allows for written clarification, a
provider also has an opportunity to explain his/her behavior or
practice in those areas that would be flagged. Providers are keenly
aware that missing or inaccurate information will be discovered during
the credentialing process and are therefore more apt to fully disclose
areas of concern or derogatory information on their applications.
ISSUES AFFECTING THE CREDENTIALING INDUSTRY
Credentialing is an invaluable service to the American healthcare
system. However, there have been some initiatives that may result in
less effective credentialing and thereby lowering the quality of
healthcare in this country. The members of HPCVA are concerned about
the impact they may have on the healthcare industry.
Often CVOs are required to access the federal government's National
Practitioner Data Bank (NPDB) on behalf of clients who are qualified
and registered to query. CVOs compare information obtained by NPDB to
information obtained by other sources and can quickly discern incorrect
information contained in the NPDB. Since organizations are required to
obtain this information, it should and must be correct in order for
healthcare organizations to make informed decisions about healthcare
being provided in their facility. There need to be checks and balances
within this system to confirm that the information contained in the
NPBD is correct. As we await the implementation of the Healthcare
Integrity Protection Data Bank (HIPDB), there are no assurances that
this situation will not occur there.
CONCLUSION
In conclusion, credentialing is an important and necessary process
in the provision of healthcare in this country. From a risk management
perspective, a healthcare delivery organization is responsible for
protecting its patients and members from any unreasonable risk of harm.
That process begins with selecting the right provider to provide care.
Credentialing gives these organizations the data necessary to make that
determination.
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Prepared Statement of the National Association of Chain Drug Stores
INTRODUCTION
Mr. Chairman and Members of the committee, the National Association
of Chain Drug Stores (NACDS) appreciates the opportunity to submit a
statement on issues relating to the important role that community
pharmacies play in helping identify, prevent and reduce medication
errors in our nation's health care system.
Founded in 1933 and based in Alexandria, Virginia, the National
Association of Chain Drug Stores membership consists of 136 retail
chain community pharmacy companies. Collectively, chain community
pharmacy comprises the largest component of pharmacy practice with over
97,000 pharmacists. The chain community pharmacy industry is comprised
of more than 19,000 traditional chain drug stores, 7,000 supermarket
pharmacies and nearly 5,000 mass merchant pharmacies. The NACDS
membership base operates more than 31,000 retail community pharmacies
with annual sales totaling over $158 billion including prescription
drugs, over-the-counter (OTC) medications and health and beauty aids
(HBA). Chain operated community retail pharmacies fill over 60% of the
more than 2.73 billion prescriptions dispensed annually in the United
States. Additionally, NACDS membership includes nearly 1,400 suppliers
of goods and services to chain community pharmacies. NACDS
international membership has grown to include 105 members from 26
foreign countries.
I. COMMUNITY PHARMACY HELPS TO IMPROVE MEDICATION USE
Pharmaceuticals and medication therapy management services are
among the most commonly used and cost effective medical interventions
in the health care system. In 2000, about 3 billion prescriptions will
be dispensed to patients by retail pharmacies, with the goal of
improving an individual's health and quality of life.
A December 1999 study released by the Institute of Medicine (IOM),
``To Err is Human: Building a Safer Health Care System'', identified
the prevention of medication-related errors as a high priority for all
health care organizations, and suggested that ``health care
organizations should implement proven medication safety practices''
(Recommendation 8.2, page 136). This report focused primarily on the
incidence of medical errors in the hospital setting. Medical errors can
often result in the need for additional medical treatment, costing
billions of dollars in additional health care spending, and lost worker
productivity.
As primary care health providers, pharmacists have a critical role
in assuring the appropriate use of medications and reducing the
incidence of medication errors throughout the health care system.
Community retail pharmacies have made, and are continuing to make,
significant investments in patient care programs, operational
processes, computer information systems, and employee training in an
effort to build medication safety programs into the products and
services that are provided to patients. For example, almost all
community retail pharmacy providers already:
Use reliable, real time, computer software programs designed to
check prescriptions for duplicate drug therapies, potential drug-drug
and drug-allergy interactions, and out-of-range dosing, timing, and
routes of administration.
Provide comprehensive written information and verbal counseling to
consumers when they pick up their prescriptions, to help them
understand how to take their medications. The IOM report said that:
``whenever possible, patients (should) know which medications they are
receiving, the appearance of such medications, and their possible side
effects--patients should also be given verbal and written information
about the safe and effective use of their medications''
Provide ``reminders'' to patients to refill their medications when
the refill is due. This helps reduce the incidence of non-compliance
with medication therapy, especially for individuals who need ongoing
treatment for long-term chronic conditions, such as hypertension,
diabetes, and high cholesterol.
Consistent with state pharmacy practice acts, employ well-trained
pharmacy technicians, as well as up-to-date technology, such as
automated dispensing systems, to reduce the pharmacist's involvement in
administrative activities relating to filling the prescription. This
allows more time for patient education and interaction by the
pharmacist with the patient.
Are available seven-days a week, and in many locations 24-hours a
day, to provide prescriptions and over-the-counter medications, or
answer questions about health care products and services.
II. COMMUNITY PHARMACY'S RECOMMENDATIONS TO FURTHER IMPROVE MEDICATION
USE
Many of the suggestions in the Institute of Medicine's Report
focused on improving medication use in the hospital setting. However,
many of the strategies suggested in the report can also be applied in
the outpatient setting. For example, community retail pharmacy supports
the recommendation made in the IOM report that the Food and Drug
Administration (FDA) and pharmaceutical manufacturers seek to eliminate
``similar sounding'' names for pharmaceutical products. This can help
reduce confusion in the prescribing and dispensing of certain
prescriptions.
iom report: ensure the availability of pharmaceutical decision support
``Because of the immense variety and complexity of medications now
available, it is impossible for nurses and doctors to keep up with all
the information required for safe medication use. The pharmacist has
become an essential resource in modern hospital practice. Thus, access
to his or her expertise must be possible at all times.''
The IOM report recognizes the important role of the pharmacist in
the health care system. Not only are pharmacists important drug
information resources in the hospital setting, they are also important
primary health care providers in the outpatient setting.
Moreover, a January 2000 GAO report on Adverse Drug Events \1\ said
that ``increasing the role of community pharmacists in monitoring drug
therapy improves patients' compliance'' with their medications. The
report also said that the role of the pharmacist as advisers to
physicians in prescribing drugs should be increased. Based on the
recommendation made in the IOM report, and the findings of the GAO,
policymakers should consider the following ideas to help improve the
use and outcomes of medications:
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\1\ Adverse Drug Events, The Magnitude of the Health Risk is
Uncertain Because of Limited Incidence Data. General Accounting Office,
January 2000.
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Recommendation 1. Assure an a supply of well-trained pharmacists to
address the pharmacist shortage
Pharmacist Shortage Exists: Pharmacists are uniquely qualified to
play an important role in medication therapy management, helping to
assure the appropriate use of medications, and the avoidance of
medication-related errors. Pharmacists receive, at a minimum, 5 to 6
years of training and education in such subject areas as pharmacology,
disease management, and therapeutics.
However, there are currently over 5,000 unfilled chain community
pharmacist positions across the country, as well as a shortage in
hospitals, and in Federal health care agencies, such as the Public
Health Service (PHS). Almost one chain community pharmacy in five has
an unfilled pharmacist position. The shortage is expected to increase
over the next few years. It will only be exacerbated if some type of
Medicare prescription drug program is developed in the near future,
since the demand for prescriptions and medication therapy management
services will significantly increase.
Assure Supply of Well-Trained Pharmacy Providers: A sufficient
number of properly educated and trained pharmacists is necessary to
provide medication therapy management services. To help alleviate the
current shortage and encourage students to choose pharmacy as a career,
policymakers should consider directing additional funds toward pharmacy
education. First, policymakers may want to target loan or grant funds
specifically for students interested in a pharmacy education. Second,
policymakers may want to provide financial assistance for those
universities that want to start or expand their own college or school
of pharmacy.
Recommendation 2. Incorporate programs and policies into Federal
pharmaceutical benefit programs--such as Medicare, Medicaid,
and the Federal Employees Health Benefits Program (FEHBP)--that
will improve efficiencies and help improve medication use, such
as
Requiring pharmacy-based medication therapy management services,
such as disease management and medication compliance programs;
Adopting the NCPDP--developed standard prescription drug benefit
card for insured patients;
Allowing for electronic transmission of prescriptions to pharmacy
providers.
Medication Therapy Management Services Undervalued: Pharmacists are
trained to provide medication therapy management services. These
consist of a comprehensive range of programs and services delivered by
the pharmacist that help assure that patients take their medications
appropriately, and as prescribed by their physician.
Community retail pharmacy believes that the provision of medication
therapy management services is as important as providing the drug
product itself as part of a pharmaceutical benefit. Pharmaceuticals
have the potential to result in a significant amount of benefit if used
correctly, and the potential for harm if used incorrectly. As
prescription medication therapy becomes more potent and complex, the
need for these services will significantly increase.
However, the current pharmaceutical distribution system undervalues
the contributions made by pharmacist medication therapy management to
the health care system. This is because the system provides payment to
pharmacists for dispensing pharmaceuticals products, rather than paying
for both the product as well as the activities involved in managing the
appropriate use of pharmaceuticals in patients.
Policymakers should consider incorporating pharmacy-based
medication therapy management programs into Federal prescription drug
benefit programs--including Medicaid, Medicare, and FEHBP--as well as
payment for these services. Evidence suggests that these programs save
money by avoiding drug-related medication problems, reducing the need
for hospital stays and other medical services.
Precedent already exists in Federal health care programs for the
use of medication therapy management:
In 1987, long-term care facilities receiving Medicaid payments were
required to conduct drug regimen review (DRR) for nursing home
residents. This was done in response to the need to improve the use of
medications in nursing home residents, who are often taking multiple
chronic medications to treat serious medical conditions.
In 1993, Medicaid programs were required to adopt a comprehensive
program of drug use review (DUR) for Medicaid recipients to assure that
prescription medications are used correctly, and to reduce the
incidence of adverse drug reactions.
At a minimum, these pharmacy-based medication therapy management
standards should include disease state management, medication
compliance programs, and comprehensive drug use review. The program may
be structured so that it is risk-based; that is, those patients most at
risk for medication errors and adverse reactions can be identified and
their therapy managed by the pharmacist, in conjunction with the
physician.
Moreover, these services should be delivered as part of an
integrated approach to patient care. As such, it is important for
pharmacists to have flexibility to use patient-identifiable data to
interact with health professionals, payers, and others to develop and
implement these programs and manage the patient's drug therapy.
Requiring separate patient consent to use patient-identifiable
information for each activity would severely impair the delivery of
these services, and would prove burdensome and costly.
Adopt Standard Prescription Benefit Card: Significant efficiencies
in the delivery of prescription drug benefit programs would be realized
if ``standard'' benefit card format developed by the National Council
for Prescription Drug Programs (NCPDP) was used by all Federal
programs. This standard card format was developed, in part, in response
to the health care system's move toward developing uniform standards
for electronic health care transactions. These requirements will
ultimately enhance efficiencies.
However, there are still literally thousands of prescription drug
benefit plans, each with its own ``benefit card'', many with different
formats. Information about the patient has to be entered from these
cards into the pharmacy's computer in order for the pharmacist to fill
the prescription, creating incredible administrative burdens. This
reduces the amount of time that the pharmacist has available for
patient care activities. Over 80 percent of the 3 billion prescriptions
dispensed by pharmacies--or about 2.4 billion prescriptions--were paid
for through these benefit plans.
Two states--Texas and North Carolina--recently required that a
``uniform'' pharmacy benefit card be used to reduce the time that
pharmacies are involved with entering patient data. While these states
are to be commended for their actions, it will take several years for
all states to adopt this concept. Consistent with HIPAA's goal of
administrative simplification in the transaction of health care data,
Federal policymakers should facilitate the movement toward this uniform
prescription benefit card by taking action at the national level.
Allow for electronic transmission of prescriptions to pharmacies:
The IOM report states that:
``Having physicians enter and transmit medication orders on line
(computerized physician order entry) is a powerful method for
preventing medication errors due to misinterpretation of hand-written
orders.''
``A host of common shortcuts in prescribing have frequently been
found to cause errors. Abbreviations are major offenders because they
can have more than one meaning. Putting such information in
computerized order entry forms can eliminate such errors.''
New technologies exist that allow the physician to send the
prescription electronically to the pharmacy provider of the patient's
choice. Electronic prescribing helps eliminate ambiguous abbreviations
and specifies all elements needed for a complete order--drug name,
dosage, directions, and route of administration--reducing the chance
for medication-related errors. These technologies have been used in
hospitals for years. For example, an October 1998 study in the Journal
of the American Medical Association found that when electronic
prescribing was used instead of ``manual'' prescription writing at a
prestigious Massachusetts hospital, the medication error rate dropped
by 55 percent.
Some electronic prescribing technology also allows the physician to
have access to important medical and medication information about the
patient. This information helps the physician determine the best
medication for the patient, as well as avoids potential adverse
medication events, such as drug interactions, overdoses, and serious
side effects.
Federal policymakers should identify ways to incorporate electronic
prescription technologies into Federal health care programs. For
example, these technologies could be used in the Medicaid and Federal
Employees Health Benefits Program (FEHBP), which collectively provide
over hundreds of millions of prescriptions each year. Moreover, any new
Medicare prescription drug benefit program that is developed should
encourage the use of this technology.
Recommendation 3. Provide incentives to states to modernize their
pharmacy practice acts, such as allowing greater flexibility in
the use of pharmacy technicians and other new technologies
Efficiencies and Technology Help Pharmacists Fill Prescriptions,
Provide Patient Care Services: Efficiencies and technology in community
retail pharmacy have allowed the pharmacist to spend less time in the
administrative tasks of filling the prescription, and more time
interacting and counseling the patient about the prescription.
Technology can also help to reduce the potential human errors in
filling a prescription.
However, a recent study conducted by Arthur Andersen \2\ found that
pharmacists still perform many tasks in filling the prescription that
do not need to be performed by pharmacists. That is, pharmacists are
spending over two-thirds of their time on such tasks as computer data
entry; counting and packaging medications; resolving prescription
insurance program disputes; and other clerical activities. These non-
clinical tasks consume pharmacists' valuable time that could be better
devoted to patient care activities. With the number of prescriptions
expected to increase to 4 billion by 2004, the need for efficiencies in
delivering pharmacy services only increases.
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\2\ ``Pharmacy Activity Cost and Productivity Study'' Arthur
Andersen, November 1999.
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New technologies, such as automated dispensing systems, allow the
pharmacist to become more efficient in preparing the prescription.
Moreover, increased use of pharmacy technicians working under the
pharmacist's supervision helps the pharmacist prepare the prescription
for dispensing to the patient.
For various reasons, however, many state boards of pharmacy--which
regulate the practice of the professions--have been slow to adopt some
of these new technologies and efficiencies. Many states boards of
pharmacy still expect pharmacists to spend much of their time on non-
clinical functions. They often limit both the number of pharmacy
technicians that can be on duty at one time, and their scope of their
responsibility. This reduces the amount of time available to the
pharmacist to manage and monitor the patient's medication therapy.
Enhance Use of Pharmacy Technicians and Technology: Policymakers
should provide incentives to states to modernize their pharmacy
practice act. For example, pharmacists should have the latitude to
determine the nature and scope of the functions of pharmacy technicians
working under their supervision. Moreover, pharmacies should be
permitted to utilize new technologies, such as automated dispensing
systems, that help in the preparation of the prescription.
CONCLUSION
Community retail pharmacy continues to do its part to help assure
that prescription medications are used correctly, and the incidence of
medication errors is reduced. There are other steps that policymakers
can be taken to even further improve the use of medications in both the
inpatient and outpatient setting. NACDS and community retail pharmacy
looks forward to working with Federal and state policymakers on
developing responsible and reasonable approaches to improving the use
of medications.