[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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                      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

                              ----------                              

                       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.
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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!
----------------------------------------------------------------------------------------------------------------

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\
---------------------------------------------------------------------------
    \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\

---------------------------------------------------------------------------
    \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.
                                 ______
                                 
  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:
---------------------------------------------------------------------------
    \1\ Adverse Drug Events, The Magnitude of the Health Risk is 
Uncertain Because of Limited Incidence Data. General Accounting Office, 
January 2000.
---------------------------------------------------------------------------
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.

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