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[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]

                             MEDICAL ERRORS

=======================================================================

                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                      COMMITTEE ON WAYS AND MEANS
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 10, 2000

                               __________

                             Serial 106-101

                               __________

         Printed for the use of the Committee on Ways and Means

                   U.S. GOVERNMENT PRINTING OFFICE
69-818                     WASHINGTON : 2001

_______________________________________________________________________
            For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 
                                 20402

                      COMMITTEE ON WAYS AND MEANS

                      BILL ARCHER, Texas, Chairman

PHILIP M. CRANE, Illinois            CHARLES B. RANGEL, New York
BILL THOMAS, California              FORTNEY PETE STARK, California
E. CLAY SHAW, Jr., Florida           ROBERT T. MATSUI, California
NANCY L. JOHNSON, Connecticut        WILLIAM J. COYNE, Pennsylvania
AMO HOUGHTON, New York               SANDER M. LEVIN, Michigan
WALLY HERGER, California             BENJAMIN L. CARDIN, Maryland
JIM McCRERY, Louisiana               JIM McDERMOTT, Washington
DAVE CAMP, Michigan                  GERALD D. KLECZKA, Wisconsin
JIM RAMSTAD, Minnesota               JOHN LEWIS, Georgia
JIM NUSSLE, Iowa                     RICHARD E. NEAL, Massachusetts
SAM JOHNSON, Texas                   MICHAEL R. McNULTY, New York
JENNIFER DUNN, Washington            WILLIAM J. JEFFERSON, Louisiana
MAC COLLINS, Georgia                 JOHN S. TANNER, Tennessee
ROB PORTMAN, Ohio                    XAVIER BECERRA, California
PHILIP S. ENGLISH, Pennsylvania      KAREN L. THURMAN, Florida
WES WATKINS, Oklahoma                LLOYD DOGGETT, Texas
J.D. HAYWORTH, Arizona
JERRY WELLER, Illinois
KENNY HULSHOF, Missouri
SCOTT McINNIS, Colorado
RON LEWIS, Kentucky
MARK FOLEY, Florida

                     A.L. Singleton, Chief of Staff

                  Janice Mays, Minority Chief Counsel

                                 ______

                         Subcommittee on Health

                   BILL THOMAS, California, Chairman

NANCY L. JOHNSON, Connecticut        FORTNEY PETE STARK, California
JIM McCRERY, Louisiana               GERALD D. KLECZKA, Wisconsin
PHILIP M. CRANE, Illinois            JOHN LEWIS, Georgia
SAM JOHNSON, Texas                   JIM McDERMOTT, Washington
DAVE CAMP, Michigan                  KAREN L. THURMAN, Florida
JIM RAMSTAD, Minnesota
PHILIP S. ENGLISH, Pennsylvania

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Ways and Means are also published 
in electronic form. The printed hearing record remains the official 
version. Because electronic submissions are used to prepare both 
printed and electronic versions of the hearing record, the process of 
converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.

                            C O N T E N T S

                               __________

                                                                   Page

Advisory of February 3, 2000, announcing the hearing.............     2

                               WITNESSES

U.S. Department of Veterans, James P. Bagian, M.D., Director, 
  National Center for Patient Safety, Veterans Health 
  Administration.................................................    72
National Aeronautics and Space Administration, Moffett Field, 
  California, Linda J. Connell, Director, Aviation Safety 
  Reporting System...............................................    13

                                 ______

American Health Quality Association, William E. Golden, M.D......    92
American Hospital Association, and Cedars-Sinai Health System, 
  Michael Langberg, M.D..........................................    45
American Medical Association, Thomas R. Reardon, M.D.............    55
Institute of Medicine, Mount Sinai School and Medicine, and 
  Veterans Affairs Medical Center, Christine K. Cassel, M.D......     7
Joint Commission on Accrediation of Healthcare Organizations, 
  Dennis S. O'Leary, M.D.........................................    86
National Quality Forum for Health Care Measurement and Reporting, 
  Kenneth W. Kizer, M.D..........................................    79

                       SUBMISSIONS FOR THE RECORD

American Academy of Orthopaedic Surgeons, and American 
  Association of Orthopaedic Surgeons, joint statement...........   107
American College of Physicians-American Society of Internal 
  Medicine, statement............................................   110
American Osteopathic Association, and American Osteopathic 
  Healthcare Association, joint statement........................   112
Association of Women's Health, Obstetric and Neonatal Nurses, 
  statement......................................................   114
Health Care Liability Alliance, statement........................   116
Healthcare Compliance Packaging Council, Falls Church, VA, 
  statement......................................................   123
Honeywell, Annette Guarisco, statement...........................   124
New Medical Concepts, Inc., Fort Lauderdale, FL, Raymond T. 
  Hersh, statement...............................................   125
Shands Healthcare, Gainesville, FL, J. Richard Gaintner, 
  statement......................................................   127

 
                             MEDICAL ERRORS

                              ----------                              

                      THURSDAY, FEBRUARY 10, 2000

                  House of Representatives,
                       Committee on Ways and Means,
                                    Subcommittee on Health,
                                                   Washington, D.C.
    The Subcommittee met, pursuant to notice, at 9:40 a.m., in 
room 1310, Longworth House Office Building, Hon. Bill Thomas 
(Chairman of the Subcommittee) presiding.
    [The advisory announcing the hearing follows:]

ADVISORY FROM THE COMMITTEE ON WAYS AND MEANS

                         SUBCOMMITTEE ON HEALTH

                                                Contact: (202) 225-3943
FOR IMMEDIATE RELEASE
February 3, 2000
No. HL-11

               Thomas Announces Hearing on Medical Errors

    Congressman Bill Thomas (R-CA), Chairman, Subcommittee on 
Health of the Committee on Ways and Means, today announced that 
the Subcommittee will hold a hearing on the prevalence and 
nature of medical errors in the health care system. 
Additionally, proposed strategies to ensure patient safety 
through the reduction of errors will be discussed. The hearing 
will take place on Thursday, February 10, 2000, in room 1310 
Longworth House Office Building, beginning at 9:30 a.m.
    In view of the limited time available to hear witnesses, 
oral testimony at this hearing will be from invited witnesses 
only. However, any individual or organization not scheduled for 
an oral appearance may submit a written statement for 
consideration by the Committee and for inclusion in the printed 
record of the hearing.
      

BACKGROUND:

      
    Since Medicare's inception, a variety of measures have been 
utilized to help ensure the quality of medical care received by 
Medicare beneficiaries (e.g., Peer Review Organizations). 
Recently, the Institute of Medicine (IOM) released a report, To 
Err is Human: Building a Safer Health System, that has brought 
the issue of patient safety to the forefront of health policy 
discussion. This report cites studies that estimate the annual 
number of deaths resulting from medical errors in the United 
States to be at least 44,000, and possibly as high as 98,000. 
This number equates to the eighth leading cause of death in the 
nation and is more than the amounts attributed to auto 
accidents, cancer, or AIDS.
    The statistical data included in the IOM study were derived 
from the hospital inpatient environment. As the country's 
largest insurer, Medicare Part A is the primary source of 
funding for services provided in these locations. Authors of 
the IOM study recommend several potential strategies for 
government, industry, consumers, and health providers to reduce 
medical errors. Additionally, the authors encourage Congress to 
create a national patient safety center to develop new tools 
and systems in order to address persistent problems.
    In announcing the hearing, Chairman Thomas stated, ``As 
Congress prepares to act on patient protection legislation, we 
must examine the problem of medical errors this year. After 
all, isn't the ultimate patient protection to prevent deaths 
from medical errors? Congress should not complete patients' 
rights legislation without examining potential solutions to 
prevent patients from dying due to medical errors. I look 
forward to this hearing to learn how Congress might develop 
solutions that will help protect seniors and all other patients 
in the health care system.''
      

FOCUS OF THE HEARING:

      
    The hearing will provide the opportunity to hear from the 
administration, advisory bodies, and providers on why medical 
errors occur and what possible solutions could be utilized to 
prevent them.
      

DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:

      
    Any person or organization wishing to submit a written 
statement for the printed record of the hearing should submit 
six (6) single-spaced copies of their statement, along with an 
IBM compatible 3.5-inch diskette in WordPerfect or MS Word 
format, with their name, address, and hearing date noted on a 
label, by the close of business, Thursday, February 24, 2000, 
to A.L. Singleton, Chief of Staff, Committee on Ways and Means, 
U.S. House of Representatives, 1102 Longworth House Office 
Building, Washington, D.C. 20515. If those filing written 
statements wish to have their statements distributed to the 
press and interested public at the hearing, they may deliver 
200 additional copies for this purpose to the Subcommittee on 
Health office, room 1136 Longworth House Office Building, by 
close of business the day before the hearing.
      

FORMATTING REQUIREMENTS:

      
    Each statement presented for printing to the Committee by a 
witness, any written statement or exhibit submitted for the printed 
record or any written comments in response to a request for written 
comments must conform to the guidelines listed below. Any statement or 
exhibit not in compliance with these guidelines will not be printed, 
but will be maintained in the Committee files for review and use by the 
Committee.
      
    1. All statements and any accompanying exhibits for printing must 
be submitted on an IBM compatible 3.5-inch diskette in WordPerfect or 
MS Word format, typed in single space and may not exceed a total of 10 
pages including attachments. Witnesses are advised that the Committee 
will rely on electronic submissions for printing the official hearing 
record.
      
    2. Copies of whole documents submitted as exhibit material will not 
be accepted for printing. Instead, exhibit material should be 
referenced and quoted or paraphrased. All exhibit material not meeting 
these specifications will be maintained in the Committee files for 
review and use by the Committee.
      
    3. A witness appearing at a public hearing, or submitting a 
statement for the record of a public hearing, or submitting written 
comments in response to a published request for comments by the 
Committee, must include on his statement or submission a list of all 
clients, persons, or organizations on whose behalf the witness appears.
      
    4. A supplemental sheet must accompany each statement listing the 
name, company, address, telephone and fax numbers where the witness or 
the designated representative may be reached. This supplemental sheet 
will not be included in the printed record.
      
    The above restrictions and limitations apply only to material being 
submitted for printing. Statements and exhibits or supplementary 
material submitted solely for distribution to the Members, the press 
and the public during the course of a public hearing may be submitted 
in other forms.
      

    Note: All Committee advisories and news release are 
available on the World Wide Web at ``http://
waysandmeans.house.gov''.
      

    The Committee seeks to make its facilities accessible to 
persons with disabilities. If you are in need of special 
accommodations, please call 202-225-1721 or 202-226-3411 TTD/
TTY in advance of the event (four business days notice is 
requested). Questions with regard to special accommodation 
needs in general (including availability of Committee materials 
in alternative formats) may be directed to the Committee as 
noted above.

                                

    Chairman Thomas. The subcommittee will come to order. I 
want to thank everyone and apologize in advance for the 
unusually small room. This is the committee hearing room for 
House Administration. I am chairman of that committee and we 
rarely see this many people. It went from the District of 
Columbia, where you had no one. House Administration at least 
filled some of the seats.
    For centuries, healers have taken the Hippocratic oath, and 
we will hear this a number of times today. First, do no harm. 
Based upon the Institute of Medicine's report, not necessarily 
a significantly new report, but for some reason, either timing 
in a slow news cycle or the reaction or overreaction of some 
institutions to its presentation, it has become front-page 
news.
    This committee, and I believe this chairman and the ranking 
member, are not always interested in being the first with a 
piece of legislation. The rush to legislation has begun in this 
particular area. I have always been an advocate of get it right 
rather than get it first. However, it seems to me in reading 
the report and in reading the testimony today, there are 
clearly some steps that can be taken of an organizational or 
structural nature that would create a more fertile field for 
the continued development of error correction structures or 
systems. To the degree that the patient protection conference 
continues to be delayed, there may very well be an opportunity 
to present in a measure that will move relatively rapidly 
through the system.
    I was amazed to find that after I suggested this at the 
Hospital Association last week at their convention, that a 
member, not of this committee but a colleague of mine from 
California, suggested that dealing with procedures to reduce 
the number of patients killed would be a poison pill in the 
patient protection legislation, and I just find that ironic, 
because if there is anything fundamental to first do no harm, 
it is first do not kill. If there is something that can be 
done, I do not know why we do not move as expeditiously as 
possible.
    This morning, I really want to have as clear an 
understanding as we can bring to the issue about what is being 
done to prevent errors, but more importantly, what we can do to 
prevent these mistakes, and a know a number of folks are going 
to tell us that there has been a flurry of activity in recent 
years, while at the same time I have heard criticisms of the 
IOM report that the data is old, it has been around a long 
time. If that is the case, then why was there not a flurry 
earlier? My assumption is it is because it got more news than 
it ever has before.
    So in the course of this hearing, I hope we will learn why 
the current medical error reporting systems apparently are not 
working and what changes need to be made. Our objective, 
obviously, should be to make changes that result in more 
effective, accurate, and timely systems for reporting medical 
errors.
    We are going to start with Dr. Christine Cassel, who will 
provide an overview, given her unique history on the Institute 
of Medicine's recommendations, and then we will hear from Ms. 
Linda Connell, who directs the Aviation Safety Reporting System 
at NASA and who, coincidentally, is a nurse and may be able to 
provide some cross-fertilization between what is usually used 
as an example of an extremely successful model, based on her 
experience and involvement in the other world.
    We also want to learn about the characteristics of the 
internal reporting system used by the Veterans Health 
Administration, followed by witnesses that will describe other 
approaches that are currently being used or that should be put 
in place to correct medical errors.
    I look forward to the session. As I said, our goal is to 
see if there are not some initial steps that can be made 
relatively briefly. I do not think we need to wait until we 
reinvent an entire national system, but I will be very 
sensitive to the statements made about what should not be done 
or cannot be done, because even if the number of accidental 
deaths is not 100,000, even if it is 50,000, even if it is 
40,000, i.e., you pick the number, the current system is and 
will be unacceptable without fundamental and systematic change.
    With that, I will yield to the gentleman from California 
for any opening remarks he might wish to make.
    [The opening statement of Chairman Thomas follows:]

Opening Statement of Hon. William M. Thomas, a Representative in 
Congress from the State of California

    For centuries, healers have taken the Hippocratic Oath to 
``first do no harm.'' Yet, it seems that patients have reason 
to question their safety as they participate in today's health 
care system.
    Last November, the Institute of Medicine issued a report on 
patient safety and the staggering number of medical errors that 
occur in our nation's hospitals. As Congress prepares to act on 
patient protection legislation this year, I can think of no 
better reason to examine why these errors occur and how we can 
reduce the number of people who die from them. Some of my 
colleagues on the other side of the aisle have called this 
issue a ``poison pill''in patients' rights legislation but, 
isn't reducing medical errors the ultimate patient protection?
    This morning, I want to learn why people are suffering and 
dying from medical errors and what can be done to prevent these 
mistakes. We are not here to debate the number of errors, or 
the methods for calculating them. Even one death from a medical 
mistake is one too many. In the course of this hearing, we will 
learn why the current medical error reporting systems 
apparently are not working and what changes need to be made to 
prevent people from dying due to medical errors. Our objective 
should be to make changes that result in more effective, 
accurate, and timely systems for reporting medical errors.
    We will start with Dr. Christine Cassel, who will provide 
an overview of the Institute of Medicine's recommendations. 
Then we will hear from Ms. Linda Connell, who directs the 
Aviation Safety Reporting System at NASA, which has been cited 
by many in the quality field as a model system for reporting 
medical errors. We also will learn about the characteristics of 
the internal reporting system used by the Veterans Health 
Administration, followed by witnesses who will describe 
possible approaches to drive down the number of medical errors. 
I look forward to an informative session that helps us 
understand how we can protect and improve the safety of the 
health care system for all patients.

                                

    Mr. Stark. Thank you, Mr. Chairman, for calling this 
hearing. As the Institute of Medicine report tells us, medical 
errors result in injury and death to thousands of patients each 
year and billions of dollars in wasted costs. It is time for 
the health care industry to catch up with the rest of the world 
in preventing errors.
    Much information reported by the IOM, as you point out, has 
been known for some time. This recent report focuses our 
attention and helps us realize that it is time now to address 
the problem.
    We find, for example, that the dialysis program is the MD-
80 of the medical world. In 1997, we called for quality 
standards and HCFA is still working on the standards. That is 
three years. It is way past time for these standards to be 
implemented.
    Some dialysis centers are needlessly killing people today, 
and we have the data to show it, and yet HCFA and other 
regulators were not doing anything about it. So how many 
airplane crashes do we need to have in the medical delivery 
system before they wake up?
    The quality of care has never been a priority in Medicare, 
Mr. Chairman, and it certainly is not a priority in any of the 
managed care plans outside of Medicare. I believe that it is 
time that we make it a priority, and improving quality and 
preventing errors ought not to be partisan. I doubt if it will 
be. We want to improve that, and I look forward to working with 
you on this issue and I hope we can act on it this year. Thank 
you.
    Chairman Thomas. Thank you. I would now ask Dr. Cassel and 
Ms. Connell to come forward. There are a number of medical 
professionals who are concerned about this, and I will tell you 
only that some of us may even have to apologize ahead of time 
in terms of our terminology, because we may use the vernacular 
in discussing what is going on, and if the reference is that 
people are dying and being killed, there may be some terms that 
are used which somehow insulate you. I know in the spy business 
they used to talk about it as termination.
    It is, I think, partly necessary to confront the fact that 
what is happening in the system is that people are dying from 
medical errors. The argument that if they are being killed, 
there is some willfulness to it, is a concern I have because a 
willful refusal to change procedures when people are dying 
reaches a very interesting philosophical debate point about 
whether or not the system is killing people.
    Mr. Stark. Mr. Chairman?
    Chairman Thomas. The gentleman from California.
    Mr. Stark. By way of, I guess, apologizing for a harsh 
word, I would like to describe it in layman's terms. Going to 
the hospital, for example, is a dangerous trip. The difference 
in my mind, at least, is that if people are allergic, as I am, 
to penicillin, and if the person at the hospital asks me before 
I have an operation and I say, no, I am not, or I forget to 
tell them, or I am not wearing that little wrist bracelet, and 
I have a reaction, that is not the medical delivery system's 
fault; it is mine. Now, if I do not know whether I am allergic, 
that is different.
    Also, if the medical system forgets to ask, that, to me, is 
negligent or wrong. That is something in the system that is 
wrong, and I think those kinds of errors could be fatal. We 
certainly should be able to eliminate the errors where they 
forget to ask. What we can do to educate the populus, I think 
that is beyond our ability, but I would like to draw that 
difference. Thank you.
    Chairman Thomas. I appreciate it. An educated consumer is a 
goal that all of us want because that would help significantly.
    [The opening statement of Mr. Ramstad follows:]

Opening Statement of Hon. Rep. Jim Ramstad, a Representative in 
Congress from the State of Minnesota

    Mr. Chairman, thank you for calling this important hearing 
today to discuss the issue of medical errors within our health 
care system.
    Like all of my colleagues here, I was troubled to hear of 
the high number of medical errors that occur in our nation 
every year. The amazing and hard-working people who make up the 
health care industry in America--these people who have 
dedicated their lives to the health and welfare of those around 
them--are human and that means errors will happen. But the 
sheer numbers of errors is staggering.
    I know every physician, nurse and health care provider at 
any level is ready and willing to help us combat the prevalence 
of errors in the system. That's why we do not seek to blame 
anyone for these errors at this hearing today, and why we need 
to carefully identify ways to reduce the number of errors and 
establish a system for analyzing the problems and learning how 
to prevent future mistakes.
    I still believe the answers to these tragic issues lie 
within the health care industry itself, but I look forward to 
hearing the testimony of those coming before us today on how we 
can work together in an appropriate fashion to ensure errors 
and near-misses are reported, analyzed and prevented.
    Mr. Chairman, thanks again for calling this critical 
hearing.

                                

    We have your written testimony, and without objection, it 
will be made a part of the record and you can address us in any 
way you see fit in the time you have available. Dr. Cassel?

  STATEMENT OF CHRISTINE K. CASSEL, M.D., MEMBER, QUALITY OF 
   HEALTH CARE IN AMERICA COMMITTEE, INSTITUTE OF MEDICINE, 
    PROFESSOR AND CHAIRMAN, HENRY L. SCHWARTZ DEPARTMENT OF 
    GERIATRICS AND ADULT DEVELOPMENT, MOUNT SINAI SCHOOL OF 
MEDICINE, NEW YORK, NEW YORK, AND DIRECTOR, GERIATRIC RESEARCH 
EDUCATION AND CLINICAL CENTER, VETERANS AFFAIRS MEDICAL CENTER, 
                        BRONX, NEW YORK

    Dr. Cassel. Thank you. Congressman Thomas, Congressman 
Stark, and members of the committee, I am pleased to be here 
with you today to address this important topic.
    Chairman Thomas. Dr. Cassel, let me tell you that although 
it is a pretty room, the acoustics are not real good and these 
microphones are very unidirectional. You need to speak directly 
into it. Thank you.
    Dr. Cassel. I am an internist and geriatrician and 
professor and Chairman of the Henry L. Schwartz Department of 
Geriatrics and Adult Development at the Mount Sinai School of 
Medicine and Director of the Geriatric Research Education and 
Clinical Center at the Bronx Veterans Affairs Medical Center. I 
tell you this because in my field of geriatric medicine, it is 
an area that is one of the highest risks for complications of 
medical care. Errors are a small part of those kinds of 
complications.
    Today, I am pleased to be here representing the Institute 
of Medicine's Committee on the Quality of Health Care in 
America and our recently released report, ``To Err is Human: 
Building a Safer Health System.''
    Our committee concluded that medical mistakes rank eighth 
among the leading causes of death, ahead of traffic accidents, 
breast cancer, and AIDS. The good news is, we strongly believe 
that it is possible to achieve at least--at least--a 50 percent 
reduction in errors over the next five years. The knowledge and 
technology exists to prevent many of these mistakes.
    No physician or nurse wants to hurt patients, and doctors, 
nurses, and other health workers are highly trained to be 
careful and take precautions. They are held and they hold 
themselves to high standards. Paradoxically, it is precisely 
this exclusive focus on the individual as the source of 
mistakes that makes health care so unsafe.
    Errors are seldom due to carelessness in the sense of lack 
of trying hard enough. More commonly, they are caused by faulty 
systems, processes, and conditions that lead people to make 
mistakes or fail to prevent them. They can be prevented by 
designing systems that make it hard for people to do something 
wrong and easy for them to do it right.
    Safe industries, such as aviation, chemical manufacturing, 
and nuclear power learned this lesson a long time ago. While 
insisting on training and high standards of performance, they 
recognize that these alone are insufficient to ensure safety. 
They also pay attention to factors that affect performance, 
such as work hours, work conditions, information technology, 
team relationships, and the design of tasks so that errors are 
difficult to make. They create safety by design. Health care 
must do the same.
    To address this serious issue, our report puts forth a 
comprehensive strategy for government, industry, consumers, and 
providers all to take action. The strategy calls for four major 
things.
    One, the creation of a Center for Patient Safety within the 
Agency for Health Care Research and Quality to provide 
leadership, invest in research on medical errors, and build 
prototype systems to improve safety, and disseminate this 
information on best practices.
    Two, establishment of mandatory and voluntary reporting 
systems. A nationwide, State-based mandatory reporting system 
is needed to collect information on the most serious errors 
that result in death or permanent harm and to use this 
information to better understand the factors that contribute to 
errors, to encourage health care organizations to take 
necessary steps to prevent future errors, and to keep the 
public informed about safety issues. Voluntary reporting 
systems focusing on errors that result in lesser or no harm, 
what the aviation industry calls near misses, should be 
encouraged by extending peer review protections to the data and 
information in these systems.
    Third, strengthening the standards and expectations for 
improvements in safety that are set by accrediting and 
licensing organizations, group purchasers, and professional 
groups.
    And fourth, creating safety systems inside health care 
organizations, including integrated health plans, hospitals, 
nursing homes, and outpatient facilities.
    As you said, Mr. Chairman, the response to the IOM report 
has been phenomenal. This report received nearly saturation 
coverage in the national media. There were more than 100 live 
and taped appearances of committee members on local television 
and radio stations. In a recent survey conducted by the Kaiser 
Family Foundation, 51 percent of Americans closely followed the 
news of this release. Steady news coverage of this critical 
issue continues.
    Since the release of this report, questions have been 
raised regarding the recommendation, especially regarding two 
of our recommendations, one pertaining to the Center for 
Patient Safety and the second pertaining to mandatory and 
voluntary reporting systems. I would like to focus a few more 
words of my testimony in these two areas, but I would be happy 
to answer your questions about any part of the report.
    The Center for Patient Safety. Meeting this safety 
challenge, we feel, requires leadership and action at a 
national level. Attention and resources are critical to making 
safety the number one priority of other health care industries. 
Unless something like the Center for Patient Safety is created 
to keep attention focused on these issues and to enhance the 
base of knowledge and tools, meaningful progress is going to be 
very difficult.
    The Center for Patient Safety is not intended to be a 
regulatory or standard-setting body. It is expected to track 
progress and issue an annual report to the President and to 
Congress on patient safety and to enhance knowledge of safety 
by funding research into the application of safety sciences to 
health care and the development of prototype systems.
    At present, there is no national visibility for this issue 
outside of this alarm in the recent press. There is no stimulus 
or encouragement for health care organizations to get better at 
implementing safe practices. We will not achieve safety unless 
we know what we are striving for. We, therefore, need to set 
national goals like the U.S. Preventive Services Task Force or 
Healthy People 2000.
    The need for research is enormous. This is a new kind of 
research for the health care world to take on. The funding for 
this research has to be at a meaningful level in order to make 
a difference, and this is the agency that is responsible for 
our nation's health care quality information. It is an 
appropriate place to do that.
    Let me say a couple more words about the reporting of 
errors. Our committee believes there should be both mandatory 
and voluntary reporting systems. We understand many of the 
problems that have been raised about mandatory reporting 
systems, but we believe that without some kind of mandatory 
system, we will not know the rate of errors and we will not 
know if we have improved them. We must also be responsible to 
the public in this sense. The mandatory reporting will give us 
this information, will make us responsible to the public, and 
as importantly, will require that all health care organizations 
make some level of investment in this important area which will 
create a level playing field for health care so that people who 
spend money on this will not be penalized.
    The voluntary reporting is equally important, and I want to 
just say that these kinds of less-harmful errors are much more 
difficult to identify, and if we encourage voluntary systems, 
we can find ways like the aviation industry has to identify the 
so-called near misses and to improve our performance in the 
absence of harm to patients. These voluntary systems should be 
afforded legal protections from data discoverability in order 
to allow the free exchange of information within those systems.
    In conclusion, let me just say that the core message from 
safety experts that our committee heard and that I believe you 
will hear today is to avoid a system that is punitive towards 
individuals. That will inhibit accurate reporting and it will 
not reduce errors. The key is creating an environment where 
teams can be creative about reducing errors, where they have 
the information to work with, and where the health care systems 
are accountable to the public. Thank you very much.
    Chairman Thomas. Thank you, Dr. Cassel.
    [The prepared statement follows:]

Statement of Christine K. Cassel, M.D., Member, Quality of Health Care 
in America Committee Institute of Medicine, Professor and Chairman, 
Henry L. Schwartz Department of Geriatrics and Adult Development, Mount 
Sinai School of Medicine, New York, New York, and Director, Geriatric 
Research Education and Clinical Center, Veterans Affairs Medical 
Center, Bronx, New York

    Good morning, Congressman Thomas and members of the 
Committee. My name is Christine K. Cassel. I am an internist 
and geriatrician, and Professor and Chairman of The Henry L. 
Schwartz Department of Geriatrics and Adult Development at The 
Mount Sinai School of Medicine in New York and Director of the 
Geriatric Research Education and Clinical Center at the Bronx 
Veterans Affairs Medical Center. I am here today representing 
the Institute of Medicine's Committee on the Quality of Health 
Care in America which recently released the report To Err is 
Human: Building a Safer Health System.
    The IOM Committee on the Quality of Health Care in America 
concluded that medical mistakes rank eighth among the leading 
causes of death--ahead of traffic accidents, breast cancer, and 
AIDS. The good news is that we strongly believe that it is 
possible to achieve at least a 50 percent reduction in errors 
over the next five years. The knowledge and technology exists 
to prevent many of these mistakes.
    No physician or nurse wants to hurt patients, and doctors, 
nurses, and other health workers are highly trained to be 
careful and take precautions to prevent mistakes. They are held 
and hold themselves to high standards. Paradoxically, it is 
precisely this exclusive focus on the individual as the source 
of mistakes that makes health care so unsafe.
    Errors are seldom due to carelessness or lack of trying 
hard enough. More commonly, errors are caused by faulty 
systems, processes and conditions that lead people to make 
mistakes, or fail to prevent them. They can be prevented by 
designing systems that make it hard for people to do something 
wrong and easy to do it right. Safe industries, such as 
aviation, chemical manufacturing, and nuclear power, learned 
this lesson long ago. While insisting on training and high 
standards of performance, they recognize these are insufficient 
to insure safety. They also pay attention to factors that 
affect performance, such as work hours, work conditions, 
information technology, team relationships, and the design of 
tasks to make errors difficult to make. They create safety by 
design. Health care must do likewise.
    To address this serious issue, our report puts forth a 
comprehensive strategy for government, industry, consumers, and 
providers all to take action. The strategy calls for:
     The creation of a Center for Patient Safety within 
the Agency for Healthcare Research and Quality to provide 
leadership, invest in applied research on medical errors, build 
prototype systems to improve safety, and disseminate 
information on ``best practices'' throughout the health care 
system.
     Establishment of mandatory and voluntary reporting 
systems. A nationwide, state-based mandatory reporting system 
is needed to collect information on the most serious errors 
that result in death or permanent harm, and to use this 
information to better understand the factors that contribute to 
errors, to encourage health care organizations to take the 
necessary steps to prevent future errors, and to keep the 
public informed of safety issues. Voluntary reporting systems, 
focusing on errors that result in lesser or no harm (what the 
aviation industry calls ``near misses''), should be encouraged 
by extending peer review protections to data and information in 
these systems.
     Strengthening the standards and expectations for 
improvements in safety that are set by accrediting and 
licensing organizations, group purchasers, and professional 
groups.
     Creating safety systems inside health care 
organizations, including integrated health plans, hospitals, 
nursing homes and outpatient care facilities.
    The response to the IOM report on errors has been 
phenomenal. The report received near saturation coverage in the 
national media, including front page and leading news coverage 
in most of the major national newspapers and television news 
programs. There were also more than 100 live and taped 
appearances of Committee members on local television and radio 
stations. In a recent survey conducted by the Kaiser Family 
Foundation and Harvard School of Public Health, it was found 
that 51% of Americans closely followed news of the release of 
the report. Moreover, steady news coverage of this critical 
issue continues.
    Since the release of the report, questions have been raised 
especially regarding the recommendations pertaining to the 
creation of a Center for Patient Safety and the mandatory and 
voluntary reporting systems. I would like to focus my testimony 
on our Committee's thinking in these two areas, but I would be 
happy to answer questions about any part of the report.

Center for Patient Safety

    Meeting the patient safety challenge will require 
leadership and actions at all levels, but national leadership, 
attention and resources are absolutely critical to making 
safety the #1 priority of every health care institution. 
Experience from other industries, such as aviation, suggests 
that unless a Center is created to keep attention focused on 
patient safety and enhance the base of knowledge and tools, 
meaningful progress is not likely.
    The Center for Patient Safety is not intended to be a 
regulatory or standard-setting body, but it is expected to 
track progress and issue an annual report to the President and 
Congress on patient safety, and to enhance knowledge of safety 
by funding research into the application of safety sciences to 
health care and the development of prototype systems. The 
Center would also be responsible for dissemination of 
information on ``best practices.''
    Goal-setting. At present, there is no national visibility 
for patient safety, and no stimulus or encouragement for health 
care organizations to implement safe practices. We cannot 
achieve safety unless we know what we are striving for. By 
setting national goals, much like the U.S. Preventive Services 
Task Force, or Healthy People 2000, the Center for Patient 
Safety can ``raise the bar'' for achievement by all 
organizations.
    Research and development. While much is known from prior 
research and industrial experience about theories of error 
causation and prevention, relatively little is known about the 
application of those theories and methods in medical practice. 
Because principles of safety have been so sparsely used in 
health care, their usage needs to be studied in a number of 
applications (medication safety, surgical operations, new 
technologies, etc.) and in a variety of settings (e.g., 
emergency rooms, intensive care units, and doctors' offices). 
The Center for Patient Safety would set a research agenda and 
fund both intramural and extramural research projects to 
address those needs. The need is enormous. The funding should 
be at a meaningful level in order to make a difference.
    For its development role, the Center for Patient Safety 
would lead and facilitate the application of known principles 
and research findings in the definition of best practices and 
processes. These would apply to both clinical care and 
management, and are needed for virtually all systems in health 
care organizations: medication systems, operating rooms, 
emergency departments, diagnostic testing, care of the elderly, 
etc. Some of these activities can, and should, be led by 
professional societies who can mobilize the expertise and 
commitment of their members. The Center would also develop 
methods for consumer education and be responsible for 
disseminating safety information widely.
    The need to develop these research, education, 
dissemination, and facilitation activities is the principal 
reason for recommending that the Center for Patient Safety be 
lodged in the Agency for Healthcare Research and Quality. These 
functions are similar to those that the Agency has 
traditionally carried out over the past decade under its 
quality improvement agenda. It can easily provide both the 
leadership and the expertise needed by the Center for Patient 
Safety to establish new programs.
    Evaluation. The Center for Patient Safety could also 
perform the valuable function of coordinating, collecting and 
analyzing data provided by both voluntary and mandatory 
reporting systems. It would monitor national progress in 
improving patient safety and provide an annual report to 
Congress, including recommendations to health care 
organizations and the various agencies and associations for 
improving patient safety. Part of this function might also be 
served by the newly established National Forum on Health Care 
Quality Measurement and Reporting.

Reporting of Errors

    The IOM Committee also believes there should be mandatory 
and voluntary reporting systems. Mandatory reporting systems 
should focus on detection of errors that result in serious 
patient harm or death. While safety experts recognize that 
errors resulting in serious harm are the ``tip of the 
iceberg,'' they represent the small subset of errors that 
signal major system breakdowns with grave consequences for 
patients.
    Mandatory systems serve three purposes. First, they provide 
the public with a minimal level of protection by assuring that 
the most serious errors are reported and investigated and 
appropriate follow up action taken. Second, they provide an 
incentive to health care organizations to improve patient 
safety in order to avoid the potential penalties and public 
exposure. Third, they require all health care organizations to 
make some level of investment in patient safety, thus creating 
a more level playing field.
    We recommended that a nationwide, state-based system of 
mandatory reporting be established that provides for the 
collection of standardized information about the most serious 
errors. Congress should provide funds and technical expertise 
for state governments to establish or adapt their current error 
reporting systems to collect the standardized information, 
analyze it and conduct follow-up action as needed with health 
care organizations.
    The committee believes there is a serious problem of 
accountability for safety in health care and that current 
mechanisms for holding health care organizations accountable 
for safety are inadequate. We use the phrase ``holding 
accountable'' not as code for blame and punishment, but to mean 
insuring responsibility, i.e., making sure that health care 
organizations are doing everything they reasonably can for 
patient safety. If mandatory reporting systems are perceived as 
unfairly punitive, or embarrassing for the organization, 
compliance will be reluctant and incomplete. But, improvement 
cannot happen in the absence of reliable data. Reporting, 
alone, does not improve safety or reduce hazards. Unless 
reporting is followed by understanding and change, safety will 
not improve. Investigation of the circumstances surrounding 
incidents is required to determine the underlying causes. 
Improvements only occur if the analysis identifies systems 
failures and they are corrected. Success of the investigation 
and analysis depends in large measure on the degree to which 
individuals feel it is safe to participate. Systems that have 
been most successful in bringing about changes for safety 
combine mandatory reporting with some degree of confidentiality 
and protection of individual providers.
    Although state governments would be responsible for the 
mandatory reporting program, this does not mean that a state 
would have to collect and analyze the data themselves. A state 
may choose to rely on an accrediting body, a peer review 
organization or other private sector oversight entity to 
perform this function. Twenty states already have mandatory 
error reporting systems. Since the release of our report, a 
number of others are exploring this option. Flexibility and 
innovation in implementation is important at this stage of 
development because states that have existing adverse event 
programs have used different approaches to implement their 
programs and a ``best practice `` or preferred approach is not 
yet known.
    The IOM Committee believes that voluntary reporting systems 
play a valuable role in encouraging improvements in patient 
safety and are a complement to mandatory reporting systems. The 
focus of voluntary systems is usually on errors that resulted 
in no harm, or very minimal patient harm. Voluntary reporting 
systems are particularly useful for identifying types of errors 
that occur too infrequently for an individual health care 
organization to readily detect based on their own data, and 
patterns of errors that point to systemic issues affecting all 
health care organizations. The continued development of 
voluntary reporting systems should be encouraged, and voluntary 
reporting systems should be afforded legal protections from 
data discoverability. The core message from safety experts in 
other fields is to avoid a system that is punitive towards 
individuals--it will inhibit accurate reporting and won't 
reduce errors. The key is creating an environment where teams 
can be creative about reducing errors, where they have the 
information to work with, and where the health care systems are 
accountable to the public.
    Thank you for this opportunity to testify. I would be happy 
to answer any questions the Committee may have.

                                

    Chairman Thomas. Ms. Connell is the Aviation Safety 
Reporting System Director at the National Aeronautics and Space 
Administration Ames Research Center, Moffett Field, and, of 
course, the FAA and the reporting procedure associated with 
that is held up as a model. But something that some folks may 
not know, Ms. Connell is also a nurse, so that she has an 
opportunity to have a comparison of two different worlds, one 
in which many folk wear blue uniforms with epaulets and the 
other world in which they have a stethoscope around their neck 
and a white coat, one which has an open structure of reporting 
errors, the other one seems to have a degree of secrecy about 
the fact that errors even occur. Ms. Connell?

   STATEMENT OF LINDA J. CONNELL, DIRECTOR, AVIATION SAFETY 
       REPORTING SYSTEM, NATIONAL AERONAUTICS AND SPACE 
           ADMINISTRATION, MOFFETT FIELD, CALIFORNIA

    Ms. Connell. Mr. Chairman and members of the subcommittee, 
I thank you very much for the invitation to provide information 
to you on the Aviation Safety Reporting System, which I will 
call the ASRS from here on. This system in aviation is a 
voluntary, confidential, non-punitive safety reporting system 
that has been contributing to aviation safety since 1996. As 
the Director of the ASRS for NASA, I will attempt to highlight 
some of the aspects of this system that may be applicable to 
the current efforts in health care safety.
    The ASRS is a highly successful and trusted program that 
has served the needs of the aviation community for 24 years. 
The ASRS was established as a result of a very tragic accident 
in 1974, not far from here, when TWA 514 collided with a 
Virginia mountaintop on approach to Dulles. It was discovered 
in the ensuing NTSB accident investigation that a United 
Airlines crew had very narrowly escaped the same fate only six 
weeks prior.
    As a result, the NTSB provided a recommendation to the FAA 
and the ASRS began operation in 1976 under an agreement between 
the FAA and NASA. This cooperative safety program invites 
pilots, air traffic controllers, flight attendants, maintenance 
personnel, and others to voluntarily report to NASA any actual 
or potential hazard to safe aviation operations.
    As the medical community begins to consider the value of 
reporting systems within their discipline, there are several 
constructs that are a part of ASRS which could be beneficial. 
The guiding principles of the ASRS are that it is voluntary, it 
is non-punitive, and it is confidential. It is voluntary in the 
sense that any person involved in the daily operations of the 
system can report to NASA by their choice and describe any 
event they determine to be important. Although the system 
solely excludes accident and criminal event reporting, it was 
decided that the system should not restrict or influence what 
the people wanted to say about safety or their experiences. 
This was an opportune decision and has helped to expand the 
insights into human performance.
    The ASRS is considered non-punitive in that the reporters 
to the ASRS are guaranteed limited immunity by the FAA. The FAA 
will not use, nor will NASA provide, any information that has 
been filed with the ASRS in an enforcement action. The FAA will 
also waive fines and penalties for unintentional violations of 
any Federal Aviation regulation as long as those violations are 
reported within ten days to the ASRS and that all criteria 
written in an advisory circular are met.
    All the reports submitted to the ASRS are held in strict 
confidence. More than 470,000 reports have been submitted since 
the beginning of the program without a single reporter's 
identity being revealed in those 24 years. Currently, the ASRS 
program is receiving approximately 36,000 reports annually.
    I would like to point out that the ASRS is a unique safety 
information system. No other such system, voluntary or 
mandatory, offers and delivers the complete standard of 
confidentiality and subsequent anonymity provided by the ASRS 
program. The successful longevity of this system and its 
continuing trust and strength arises almost solely from the 
proven ability to protect the identity.
    It is important to remember that the ASRS is not an 
investigative system. There are two main purposes under the 
ASRS function. One is to identify any deficiencies or 
discrepancies in the system and alert the system. Two is to 
provide data for planning and safety improvement.
    The ASRS has released numerous alert messages concerning 
potential hazards and important occurrences and they are paid 
attention to. We also hold biweekly telecons with the FAA in 
order to highlight any significant report information. These 
discussions involve information that is fully de-identified by 
the NASA expert analysts, who are retired airline pilots, air 
traffic controllers, mechanics, flight attendants.
    The long-term purpose for the ASRS is met by the database, 
which provides de-identified reports that include an extensive 
narrative section which is a very complete description of the 
event. Due to the style of reporting and our ability to contact 
the reporters while processing their report, we are able to 
find out the ``why'' of the event, not just a terse 
description. Once this data is placed into the database, it is 
accessible to the public.
    The ASRS has accomplished over 5,800 database searches for 
the government, students, research organizations, international 
organizations, aircraft manufacturers, as well as others not in 
our discipline, as in nuclear power. The FAA is the top 
requester of this ASRS information.
    There are several factors that could be described as 
components for success. Briefly, some of these factors are the 
independence, perceived and actual independence, of the 
operating organization; the involvement of an advisory group 
representing the reporter community from the beginning; the 
availability of expert analysts for the report processing; 
continuous feedback of information to the reporter communities; 
and ongoing research utilizing this data.
    It is noteworthy as people consider the application of the 
aviation model to medicine that the ASRS model has generally 
been accepted in international aviation systems. There are 
currently seven countries that have operating voluntary 
systems.
    This concludes my remarks, and I would close in stating 
that we at the ASRS firmly believe that the collection of 
voluntary reports and the subsequent database provide the most 
authoritative source of human performance information that 
exists in aviation. I thank you.
    Chairman Thomas. Thank you very much.
    [The prepared statement follows:]

Statement of Linda J. Connell, Director, Aviation Safety Reporting 
System, National Aeronautics and Space Administration, Moffett Field, 
California

    Mr. Chairman and Members of the Subcommittee,
    I am pleased to respond to your request for information on 
the Aviation Safety Reporting System (ASRS). The ASRS is a 
model for voluntary, confidential, non-punitive safety 
reporting that has been contributing to aviation safety since 
1976. Some aspects of its applicability to the current efforts 
surrounding the improvement of healthcare have been addressed 
in the December 1999 Institute of Medicine report, ``To Err is 
Human: Building a Safer Health System.''
    The ASRS is a highly successful and trusted program that 
has served the needs of the aviation community for 24 years. It 
is available to all participants in the National Aviation 
System who wish to report safety incidents and situations. The 
ASRS was established in 1976 under an agreement between the 
Federal Aviation Administration (FAA) and the National 
Aeronautics and Space Administration (NASA). This cooperative 
safety program invites pilots, air traffic controllers, flight 
attendants, maintenance personnel, and others to voluntarily 
report to NASA any actual or potential hazard to safe aviation 
operations. The FAA, Office of System Safety, provides most of 
the program funding. NASA Ames Research Center administers the 
program, assures confidentiality, receives all reports 
submitted to the program, and sets policies in conjunction with 
the FAA and a fifteen member industry Advisory Committee.
    The ASRS collects and responds to these voluntarily 
submitted incident reports to lessen the likelihood of aviation 
accidents. The ASRS data are used to identify aviation system 
deficiencies for correction by appropriate authorities, support 
aviation system policy, planning and improvements, and 
strengthen the foundation of aviation human factors safety 
research.
    The ASRS reporters are protected when they report to this 
system. NASA and the FAA offer those who use the ASRS program 
two important reporting guarantees: confidentiality and limited 
immunity. These guarantees as expressed in Federal Aviation 
Regulation 14 CFR 91.25 and FAA Advisory Circular 00-46D are 
offered because this type of safety information is unique and 
its value can only be obtained as a result of the confidence 
and trust placed in the program by the reporters. The NASA 
preaddressed and postage-free form, NASA ARC 277A-D, is used by 
the aviation reporters to submit information. The reports sent 
to the ASRS are held in strict confidence. More than 470,000 
reports have been submitted since the program's beginning 
without a single reporter's identity being revealed. The ASRS 
removes all personal names and other potentially identifying 
information before entering reports into its database. 
Currently, the ASRS program is receiving 36,000 reports 
annually.
    The reporters to ASRS are guaranteed limited immunity by 
the FAA. This means that the FAA will not use, nor will NASA 
provide, information that has been filed with the ASRS in an 
enforcement action, and will waive fines and penalties for 
unintentional violations of Federal Aviation Regulations, as 
long as violations are reported within 10 days. However, 
accidents and criminal activities are not protected from 
enforcement actions, and should not be submitted to the ASRS. 
In addition to the immunity provisions associated with the ASRS 
program, reporters often mention other equally important 
motivations for using the program. The reporters feel increased 
satisfaction in knowing that they are helping to improve the 
aviation system by giving safety information to the ASRS and 
increased understanding of the factors contributing to their 
safety incident.
    I would like to point out that the ASRS is a unique safety 
information system. No other such system, voluntary or 
mandatory, offers and delivers the complete standard of 
confidentiality and anonymity provided by the ASRS program. An 
indication of the importance of confidentiality is provided by 
the fact that over 70% of the reports in the ASRS database 
contain statements revealing human error information. It is not 
unusual for reporters to discuss their own operational 
mistakes, mistakes they won't tell others (like other 
government agencies or organizations), let alone the reasons 
why it happened. Confidential incident reporting provides an 
insight into events from the human perspective that can rarely 
be obtained through other methods.
    The successful longevity of the ASRS and its continuing 
trust and strength arises from several factors. First and 
foremost is the promise of confidentiality which is further 
reinforced by the 24-year history of proven ability to protect 
the identity of a reporter. The next important factor is the 
program's independence, both actual and perceived. NASA, as the 
``honest broker'' between the regulator and the reporter, has 
been a significant reason the ASRS is trusted and the reports 
received are honest appraisals of the reporter's performance 
and that of others in the aviation system. NASA is a research 
organization with no regulatory authority and, therefore, is 
perceived as a safe place to report sensitive, possibly self-
incriminating, information. NASA's distinct position as an 
independent government agency with a strong influence on 
aviation safety policy and practice has been invaluable in 
instilling trust in the ASRS.
    Another important factor is the creation of the ASRS 
Advisory Committee. This body has assisted the ASRS by 
providing substantial advocacy, guidance concerning ASRS 
policy, assurance to reporter communities of bona fide 
confidentiality, and support for safety change as a result of 
incident reports. This Advisory Committee has been very crucial 
from the initial steps of the creation of the ASRS and 
throughout its history. The Advisory Committee attempts to 
represent all potential reporter communities, as well as other 
industry organizations and government. Currently, this group 
exists under the NASA Aero-Space Technology Advisory Committee 
as the ASRS Advisory Subcommittee.
    The Advisory Committee has substantially assisted the ASRS 
in providing another crucial factor important for its success. 
The importance of feedback to the reporter communities cannot 
be underestimated. The ability of the ASRS program to convert 
the aviation community's report input into constructive output 
is evidenced by the many products produced by the ASRS (see 
Attachments A & B and http://asrs.arc.nasa.gov). 
The ASRS has released 2,500 alert messages concerning potential 
hazards and important occurrences. Approximately 42% of the 
alert addressee responses indicate that a follow-up action was 
taken as a result of the safety alert message. A monthly 
newsletter, CALLBACK, is distributed to over 88,000 recipients 
which captures and presents safety information from the 
incidents received by ASRS. The participation of ASRS at 
significant safety organizational meetings, conventions, and 
workshops continues to reinforce the participation by these 
communities. The reporters can see evidence that information 
provided is utilized for constructive changes to improve 
safety.
    It is noteworthy as people consider the application of the 
aviation model to medicine that the ASRS model has generally 
been widely accepted in international aviation systems. There 
are currently seven countries that have operating voluntary, 
confidential incident reporting systems. These countries are 
United Kingdom, Australia, Canada, Russia, Taiwan, Korea, and 
the United States. Each country has preserved the concepts of 
voluntary and confidential as the necessary structure to 
accomplish the receipt of reports. Most countries have 
provisions for ``use immunity'' (i.e., prohibition from use in 
enforcement action), but none have ``transactional immunity'' 
(i.e., waiver of disciplinary action). But all countries are 
very aware of their survivability in relation to 
confidentiality. As an example to all systems, one country's 
first system was completely destroyed due to lack of reporting 
after a breach of a reporter's identity.
    As part of the process to protect a reporter's identity, 
methods for de-identification of the report are crucial. The 
ASRS employs aviation experts as its report analysts. These 
people are, in fact, retired aviation professionals who analyze 
each report and maximize the pertinent safety information 
available within the report. This analysis process is performed 
by pilots, air traffic controllers, flight attendants, and 
mechanics who have each had lengthy careers in aviation. Our 
system (as opposed to one which has anonymous reporting) has 
the capability of calling incident reporters and obtaining 
additional information as well as discussing the safety event 
with the reporter. When these interactions occur, you have 
pilots talking to pilots and controllers talking to 
controllers, etc. This process produces an increase in the 
validity of the data. We are able to find out the ``why'' of 
the event, not just a terse description. The narrative section 
of the report record is quite complete in its description of 
the event, as well as the inclusion of key words and coding for 
retrieval from the electronic database.
    The ASRS analysts, as well as providing their expertise and 
quality assurance, are able to reliably remove information that 
might identify a reporter. The ASRS places its highest priority 
on this protection. The goal is to remove enough information to 
protect the reporter and preserve the safety message from the 
actual words of the person reporting. This process of de-
identification also relates to other topics of interest which 
include the public release of information and legal discovery. 
The ASRS database includes the data that has been determined to 
be most important. Due to limited resources, the ASRS performs 
a type of triage to determine which reports will be fully 
analyzed for inclusion in the database. Once this data is 
placed into the database it is accessible to the public through 
the ASRS Search Request process, an internet site managed by 
the FAA (http://nasdac.faa.gov/safety--data) or by a private 
CD-ROM product on the market. The ASRS has accomplished over 
5,800 database searches for government agencies, students, 
research organizations, international organizations, aircraft 
manufacturers, etc. The FAA is the top requester of the ASRS 
information. Often, we are asked for information through the 
Freedom of Information Act (FOIA), but this is not needed, as 
NASA's ASRS database is openly available.
    In relation to legal issues, incidents rarely give rise to 
the issues of negligence and liability inherent in more serious 
events, like accidents. The reports are rapidly de-identified, 
the narrative may be altered when analysts add additional 
clarifying language, and a report from one reporter (e.g., a 
Capt.) will be paired with other reports (e.g., a First 
Officer) describing the same event, etc. These policies and 
procedures subsequently alter the original report content to 
some extent. ASRS has been informed that due to this the 
database report becomes hearsay evidence due to its lack of an 
identifiable source, which appears to be of less interest in 
legal cases. The ASRS has been told that in some cases the 
database reports have been used to defend a pilot, for example. 
Instead of the information being used against a person, it has 
been used to illustrate a potential system flaw that numerous 
humans have been victim to. Therefore, if the event's reporter 
does choose to share their experience with the ASRS, they are 
not faced with the added threat of complicating their own, or 
their employer's legal position. The de-identification process 
tends to drive out the fear of reporting.
    It is important to note that the ASRS is not an 
investigative system. The information contained in reports is 
evaluated carefully by experts, but the confidentiality 
requirements of the system prevent us from obtaining third 
party verification. The information relating to the existence 
and character of the phenomenon is relayed to the appropriate 
organizations in a manner that permits and encourages them to 
investigate the safety issue further and seek a solution, or 
implement interim procedures to accommodate the phenomenon 
until a solution can be identified and instituted. We firmly 
believe that the ASRS incident database is the most 
authoritative source of human performance information that 
exists in aviation today. This program is a paradigm that can 
be utilized in many other disciplines.
    Thank you for providing me with this opportunity to present 
information on the Aviation Safety Reporting System regarding 
our efforts and activities associated with improvements in 
safety. If the ASRS can be of any further assistance to the 
Subcommittee or its members, please feel free to call upon us 
at your convenience.
    Mr. Chairman, Members of the Subcommittee, this concludes 
my testimony.

  Aviation Safety Reporting System Significant Program Safety Products

    The following is a listing of the variety of safety 
products that were accomplished by the NASA ASRS staff:

                        General Accomplishments

     Since the implementation of the Aviation Safety 
Reporting System (ASRS) in 1976, over 474,000 reports have been 
submitted by pilots, mechanics, air traffic controllers, cabin 
attendants, and other aviation personnel.
     The ASRS is the largest repository of aviation 
human factors incidents in the world.
     The ASRS has an unblemished record of never 
breaching reporter confidentiality.
     The ASRS has accomplished over 5,800 database 
searches for government agencies, students, research 
organizations, international organizations, aircraft 
manufacturers, etc.
     Since 1976, the ASRS has issued over 2,500 safety 
alert messages in the form of Alert Bulletins & For Your 
Information Notices. Approximately, 42% of the addressee 
responses indicated that a follow-up action was taken as a 
result of the safety alert message.

                          Operational Impacts

     Identified and alerted the FAA Office of Aviation 
Safety & the NTSB to the wake vortices caused by B757 aircraft. 
Consequently, the FAA issued a directive requiring increased 
separation behind B757 aircraft and the issuance of wake 
turbulence advisories. Identified and alerted the FAA Office of 
Aviation Safety & the Air Transport Association to the affects 
of passenger electronic devices on air carrier communication & 
navigation systems.
     Issued an ASRS Alert Bulletin to the aircraft 
manufacturer that concerned an L-1011 electrical fire. The 
manufacturer subsequently issued a Flight Operations Advisory 
Bulletin to all L-1011 operators.
     Issued an ASRS Alert Bulletin to the air traffic 
managers at Los Angeles Control Tower and the Southern 
California TRACON concerning close-in instrument approach 
changes. The FAA collaborated with various manufacturers to 
implement a flight management system (FMS) program modification 
that would promptly display transitions to newly assigned 
runways.
     Issued an ASRS For Your Information Notice 
concerning the airport lighting and general conditions of the 
Pickens County Airport, Jasper, GA. The local FAA Flight 
Standards office conducted an on-site inspection of the airport 
and issued a warning notice to the Pickens County Commissioner 
to take corrective actions within 30 days of the notice.
     Issued an ASRS For Your Information Notice to the 
Airport Manager of Mitchell International Airport, Milwaukee, 
WI concerning an unsafe runway incursion incident. The airport 
authorities subsequently completed a project to install 
flashing warning lights at key runway intersections.
     Issued an ASRS Alert Bulletin to FAA Headquarters 
concerning a smoldering passenger's bag in a DC-10 aircraft 
that was caused by animal-shaped butane cigarette lighters. The 
FAA subsequently issued a notice to airport security personnel 
on the toy-shaped lighters.

                         NTSB Accident Support

     A database search of Jetstream-31 aircraft failure 
incidents was forwarded to the NTSB in conjunction with the 
Jetstream-31 accident at Raleigh-Durham, NC.
     A database search of EMB-120 aircraft engine 
incidents was forwarded to the NTSB in conjunction with the 
EMB-120 accident near Carrollton, GA.
     A database search of Colombian airspace incidents 
were forwarded to the NTSB in conjunction with the B757 
accident near Cali, Colombia.
     Accomplished a database search request for the 
NTSB in support of the investigation of the MD-11 accident near 
Halifax, Nova Scotia.

                                  NASA/ASRS RESEARCH IMPACT: A PARTIAL LISTING
----------------------------------------------------------------------------------------------------------------
 NASA/ASRS Research                                           Regulatory/Operational
  Product or Data                     Year                           Effects                    Cited In
----------------------------------------------------------------------------------------------------------------
     Human Factors                                  1978    Used as resource in NTSB             Runway
    Associated with                                         and FAA studies of runway  Incursions at Controlled
 Runway Incursions,                                         transgressions; 1991 FAA     Airports in the United
     C.E. Billings,                                            study resulted in new       States, NTSB special
      NASA TM 78540                                          procedures and improved      Investigation Report,
    (ASRS QR#8). An                                              runway/taxi marking          (NTSB.SIR-86/01).
   analysis of ASRS                                                          systems    Runway Incursion
     incident data.                                                                     Plan, DOT/FAA Associate
                                                                                       Administrator for System
                                                                                                Engineering and
                                                                                          Development, ARD-100,
                                                                                                  January 1991.
                                                                                          Pilot Surface
                                                                                         Incident Safety Study,
                                                                                         David R. Kelley and J.
                                                                                       Glenn Steinbacher, MITRE,
                                                                                       report prepared for DOT/
                                                                                       FAA Office of Integrated
                                                                                       Safety Analysis under the
                                                                                               direction of the
                                                                                        Associate Administrator
                                                                                            for Aviation Safety
                                                                                                  (March 1993).
  Knowledge of the                                  1978    .........................          Altitude
 limitations of the                                                                       Deviation Study:gT1 A
      ATC system in                                                                     Descriptive Analysis of
 conflict avoidance                                                                        Pilot and Controller
      capabilities,                                                                    Incidents , MiTech, Inc.
  William P. Monan,                                                                      and Carlow Associates,
     NASA TM 81197.                                                                        DOT/FAA Research and
                                                                                           Development Service,
                                                                                          Final Report, October
                                                                                                           1992
    Distraction--A                                  1979           Provided data and            Federal
    Human Factor in                                         motivation for FARs Part        Register, Notice of
 Air Carrier Hazard                                         121.542 and Part 135.100,  Proposed Rulemaking, Vol.
 Events (ASRS QR#9)                                              ``Flight Crewmember    45, No. 169, August 28,
                                                            Duties'' (``;The Sterile            1980, p. 57684.
                                                                     Cockpit Rule'')            Federal
                                                                                          Register, Final Rule,
                                                                                       Vol. 46, No. 12, January
                                                                                             19, 1981, p. 5500.
                                                                                          Flight Safety
                                                                                         Digest, ``Accident and
                                                                                          Incident Reports Show
                                                                                          Importance of Sterile
                                                                                          Cockpit Compliance,''
                                                                                           Vol. 13, No. 7, July
                                                                                                     1994, 1-8.
       Probability                                  1982     First in-depth study of           Altitude
   Distributions of                                           the characteristics of         Deviation Study: A
           Altitude                                           altitude deviations in    Descriptive Analysis of
     Deviations, R.                                               the ASRS database,       Pilot and Controller
      Thomas and L.                                           including geometry and    Incidents, MiTech, Inc.
 Rosenthal, NASA CR                                         distribution of altitude     and Carlow Associates,
            166339.                                                      deviations.       DOT/FAA Research and
                                                                                           Development Service,
                                                                                          Final Report, October
                                                                                                           1992
      Non-Airborne                                  1985    Used as resource in NTSB             Runway
     Conflicts: The                                         and FAA studies of runway  Incursions at Controlled
 Causes and Effects                                         transgressions; 1991 FAA     Airports in the United
          of Runway                                            study resulted in new       States, NTSB special
    Transgressions,                                          procedures and improved      Investigation Report,
 Richard J. Tarrel,                                              runway/taxi marking          (NTSB.SIR-86/01).
 NASA CR 177372. An                                                          systems    Runway Incursion
   analysis of ASRS                                                                     Plan, DOT/FAA Associate
     incident data.                                                                    Administrator for System
                                                                                                Engineering and
                                                                                          Development, ARD-100,
                                                                                                  January 1991.
                                                                                          Pilot Surface
                                                                                         Incident Safety Study,
                                                                                         David R. Kelley and J.
                                                                                       Glenn Steinbacher, MITRE,
                                                                                       report prepared for DOT/
                                                                                       FAA Office of Integrated
                                                                                       Safety Analysis under the
                                                                                               direction of the
                                                                                        Associate Administrator
                                                                                            for Aviation Safety
                                                                                                  (March 1993).
  Human Factors in                            March 1986    Motivated 1986 change to       FSF Accident
           Aviation                                          FAA Air Traffic Control   Prevention Bulletin, Vol.
    Operations: The                                          headbook order 7110.65)     43, No. 10(3), October
  Hearback Problem,                                         requiring comptrollers to     1986, ``The Hearback'
  William P. Monan,                                                ensure that pilot                  Problem''
     NASA CR 177398                                           readbacks are correct.      Flight Safety
                                                            Also Introduced the term        Foundation Accident
                                                                 ``hearback'' to the       Prevention, ``My Own
                                                                  aviation community    Mouth Shall Condemn Me,
                                                                (subsequently widely     ``Vol. 47, No. 6, June
                                                                           adopted);                      1990.
  Cockpit or Cabin                         February 1988           Motivated   .........................
 Crew Coordination,                                         issuance of FAA Advisory
 Kim M. Cardosi and                                           Circular 120-48 (7/13/
         M. Stephen                                         88), ``Communication and
 Huntley, Jr., DOT/                                             Coordination Between
 FAA/FS-88/1, Final                                           Flight Crewmembers and
   Report. Utilized                                              Flight Attendants''
         ASRS data.
   VFR Flight Near                         November 1989          Study performed at   .........................
   TCAs: Practices,                                         request of FAA Office of
      Perceptions &                                         Aviation Safety; believed
       Problems, R.                                               to have influenced
      Tarrel, et al                                                moderation of FAA
             (ASRS)                                              enforcement posture
                                                             toward General Aviation
                                                                              pilots
  Human Factors of                                  1990    Published as a mandatory    Incorporated in
        Flight-Deck                                          requirement for all FAA   FAA Advisory Circular 120-
    Checklists: The                                          inspectors that certify                        64.
  Normal Checklist,                                          checklists (1995); more          NASA/ASRS
    Asaf Degani and                                                than 2,400 copies                         CALLBACK, No. 136-137
  Earl Wiener, NASA                                         requested by operational           (Sept-Oct 1990).
         CR 177549.                                          community as the result    Aviation Daily,
  Findings based on                                                            of CALLBNovember 5, 1990, p. 241.
         ASRS data.                                                                     USAir Airwaves,
                                                                                          December 1990, 12-13.
                                                                                             Journal of
                                                                                       flight engineers (Varig),
                                                                                            Vol. 17 (63), 1990.
                                                                                            All Nippon Airlines
                                                                                       Journal, No. 149, 17-21,
                                                                                                          1991.
                                                                                         Journal of the
                                                                                           United Nations Civil
                                                                                         Aviation Organization,
                                                                                       Vol. 46 (6), 18-21, 1991.
                                                                                         Delta Airlines
                                                                                       Safety Newsletter, Vol. 6
                                                                                                   (1-2), 1991.
                                                                                         Human Factors,
                                                                                           Vol. 35, No. 2, June
                                                                                               1993, 345-359.  ``The
    Caused Altitude                                                 USAir's Altitude          Development of an
      Deviations: A                                            Awareness Program and         Altitude Awareness
      Human Factors                                          usefulness of ASRS data     Program: An Integrated
 Approach,'' Robert                                              in this enterprise.      Approach,'' Thomas M.
     L. Sumwalt, in                                                                             Granada, Carlow
 Proceedings of the                                                                    Associates; Capt. Donald
              Sixth                                                                               H. McClure, ALPA; Capt.
      International                                                                    James W. Fogarty, USAir,
       Symposium on                                                                      paper presented at the
           Aviation                                                                       Human Factors Society
    Psychology, The                                                                              Meeting, 1991.
         Ohio State                                                                            Altitude
        University.                                                                          Deviation Study: A
                                                                                        Descriptive Analysis of
                                                                                           Pilot and Controller
                                                                                       Incidents , MiTech, Inc.
                                                                                         and Carlow Associates,
                                                                                           DOT/FAA Research and
                                                                                           Development Service,
                                                                                          Final Report, October
                                                                                                           1992
The Use and Design                            April 1991      Study was supported by   .........................
      of Flightcrew                                            six Part 121 and nine
     Checklists and                                         Part 135 carriers, and an
   Manuals, John W.                                                                ALPA survey. Contained
      Turner and M.                                              recommendations for
   Stephen Huntley,                                         formatting and content of
      Jr., U.S. DOT                                          checklists and manuals,
       Research and                                         and use by flight crews.
   Special Programs
    Administration,
      Final Report.
  Findings based on
         ASRS data.
``One Zero Ways to                             Fall 1991          Distribution to an    United Airlines
            Bust an                                         estimated 50,000+ pilots      excerpted portions of
 Altitude,'' Donald                                               in US. and foreign    article and distributed
       George, ASRS                                                       operations        to all of its 9,000
 Directline. Review                                                                          pilots in a United
    of ASRS data on                                                                      Airlines Flight Safety
           altitude                                                                                   Brief. UAL also
        deviations.                                                                    reproduced a graphic from
                                                                                        the article and made it
                                                                                       into a poster for company-
                                                                                             wide distribution.
                                                                                                Article
                                                                                       reprinted by TWA, USAir,
                                                                                        New Zealand Air, GATCO,
                                                                                            Commercial Aviation
                                                                                       Safety (UK), and Focus on
                                                                                           Commercial Aviation.
     ``Air Carrier                            April 1993    FAA Advisory Circular 120-       ``Aircraft
    Ground Deicing/                                         60 (5/19/94) contained a   Ground Deicing Problems:
         Anti-Icing                                         provision recommended by       Recommendations from
 Problems,'' Robert                                           the ASRS study and its   Analysis of ASRS Incident
     L. Sumwalt, in                                              author requiring an         Data,'' SAE Ground
 Proceedings of the                                             outside-the-aircraft         Deicing Conference
            Seventh                                                  check for icing           Transcription of
      International                                                   contamination.   Proceedings, June 15-17,
       Symposium on                                                                                 1993, Salt Lake City,
           Aviation                                                                                       Utah.
    Psychology, The                                                                          ``Incident
         Ohio State                                                                           Reports Highlight
 University. Review                                                                      Problems Involving Air
    of ASRS data on                                                                     Carrier Ground Deicing/
     ground deicing                                                                       Anti-icing,'' Robert L.
    operations. The                                                                        Sumwalt, FSF Airport
  author summarized                                                                    Operations, Vol. 19, No.
     the results of                                                                        5, September/October
   this research in                                                                                       1993.
           personal
  correspondence to
   the FAA in April
  1993, in response
      to Docket No.
     26930 (interim
             NPRM).
      A Review and                         February 1992     Frequently requested by
      Discussion of                                         air carrier and aviation
  Flight Management                                           industry organizations
   System Incidents
    Reported to the
    Aviation Safety
  Reporting System,
   Donald Eldredge,
 Susan Mangold, and
  Robert Dodd, U.S.
   DOT/FAA Research
    and Development
  Service. Analysis
       of ASRS FMA-
   related database
            reports
 On the Typography                         December 1992    Published as a mandatory    Incorporated in
     of Flight Deck                                          requirement for all FAA   FAA Advisory Circular 120-
     Documentation,                                          inspectors that certify                        64.
  Asaf Degani, NASA                                          checklists (1995); more              Human
          CR 177605                                         than 800 copies requested               Performance
                                                            by operational community   Considerations in the Use
                                                                 as the result of CALLBACand Design of Aircraft
                                                                             summary        Checklists. Federal
                                                                                       Aviation Administration,
                                                                                       Office of Safety Services-
                                                                                       Safety Analysis Division,
                                                                                                          1995.
                                                                                              NASA/ASRS
                                                                                                             CALLBACK, No. 168 (May
                                                                                                         1993).
  On the Design of                             June 1994    Published as a mandatory    Incorporated in
        Flight Deck                                          requirement for all FAA   FAA Advisory Circular 120-
   Procedures, Asaf                                          inspectors that certify                        64.
    Degani and Earl                                           checklists (1995); 200              Human
    Wiener, NASA CR                                            copies requested from                Performance
   177642. Findings                                            NASA as the result of   Considerations in the Use
      based on ASRS                                                               CALLBACand Design of Aircraft
              data.                                                                         Checklists. Federal
                                                                                       Aviation Administration,
                                                                                       Office of Safety Services-
                                                                                       Safety Analysis Division,
                                                                                                          1995.
                                                                                              NASA/ASRS
                                                                                                             CALLBACK, No. 184 (Sept
                                                                                                         1994).
----------------------------------------------------------------------------------------------------------------

                                

    Chairman Thomas. We have a vote on now and we are running 
short of time, given the distance from the floor that this 
hearing room is, so I would ask for our witnesses to allow us 
to recess and I would like to reconvene at 10:25.
    [Recess.]
    Chairman Thomas. I want to thank you both for your 
testimony. During the debate on patient protection, which has 
passed both houses and is now in conference, there was a common 
reference to a movie, I think it was ``As Good As It Gets,'' 
and the throw-off lines about HMOs. It was obviously art and a 
work of fiction, but somehow, it was representative of the 
truth.
    I was struck by another movie called ``Malice'' in which 
Alec Baldwin plays a surgeon and there is a discussion going on 
in which there was great concern about the question of life 
hanging in the balance and the comment was that, well, they had 
better pray to God, and Alec Baldwin said that they had better 
pray to me because I am God.
    Now, that was as much a fictional script as ``As Good As It 
Gets,'' but I think it also focuses, as art often does, in a 
non-statistical way, on a general belief that, to a certain 
extent, one of the reasons there has been some great difficulty 
in getting the kind of error structure in place in the medical 
community is because of that type of an attitude. Is there any 
truth, any relevance to that? Is there any indication that the 
argument is that, after all, medicine is primarily an art and 
great artists have to be left alone so that they can do the 
best they can in a difficult environment?
    Dr. Cassel. Well, there is--I do not know so much about the 
art component. I think medicine is a skill and it deals with 
uncertainty and it deals with science and technology. It also 
deals with human beings, as we were talking about earlier.
    Chairman Thomas. I believe all of those are true in the 
aviation industry.
    Dr. Cassel. That is right.
    Chairman Thomas. Would you say, Ms. Connell, that that is 
probably a good profile of some fairly egotistical pilots who 
think they are really good at what they do?
    Ms. Connell. They are highly trained and highly skilled.
    Chairman Thomas. Yes.
    [Laughter.]
    Ms. Cassel. But, Mr. Thomas, I think it is also true that 
the culture of medicine has held physicians and nurses 
accountable as individuals for getting it right all the time. 
It has not been so much a systems approach. One specialty----
    Chairman Thomas. So if you do not get it right, do not talk 
about it?
    Ms. Cassel.--it is your fault. Do not talk about it, 
because it is your fault, and do it better next time. One 
specialty has begun to address this with remarkable success, 
and that is anesthesiology, which has recognized the high-risk 
environment in which they work and has begun actually to take 
some lessons from aviation to look at team interaction, to look 
at identifying----
    Chairman Thomas. Is there not a real world result, and that 
is the----
    Ms. Cassel. And there is a real world result.
    Chairman Thomas.--the insurance costs for that specialty 
have dropped dramatically because of the structure.
    Ms. Cassel. Dramatically, right. So it can be done.
    Chairman Thomas. Now, I understand there was some complaint 
or difficulty about that because what they really did was try 
to do a look-back dealing with history in trying to shape where 
they go forward. That may be difficult, but obviously, it is 
not impossible.
    Ms. Cassel. That is right.
    Chairman Thomas. And by stating that it is there does not 
mean other specialties could not adopt exactly the same 
procedure?
    Ms. Cassel. Probably not exactly the same procedure, 
because----
    Chairman Thomas. Roughly?
    Ms. Cassel.--other specialties operate in a different 
context. For example, my specialty, geriatric medicine, is not 
in the operating room. We are in the community. We are in 
nursing homes. But the same principles of being willing to sit 
down with your colleagues and talk about potential mistakes and 
how to prevent them can be applied just as well.
    Chairman Thomas. Ms. Connell, obviously, the statement that 
I made that you had an organization that is always used as an 
example of how to do it right, but you also have been 
historically involved in the medical community. Based upon your 
knowledge, is there no transferability, is there modest 
transferability, or is there significant transferability in 
what you have been doing in aviation to a medical model?
    Ms. Connell. My experience in medicine basically finished 
in 1986 and I have been inactive since that time. But when I 
became involved in the ASRS, I just intuitively saw ways in 
which this kind of information could transfer into medicine. I 
think it could significantly contribute to information systems 
that can help health care look at the human factor component.
    Chairman Thomas. Dr. Cassel, you indicated in your opening 
statement and kind of emphasized that you think you can have at 
least a 50 percent reduction over five years, but in the 
report, there was an allusion to what occurred in the aviation 
industry, that, in fact, since the middle of the century, it 
has been reduced by more than a third. That is a 40-year 
period.
    Are we in danger of creating a self-fulfilling failure if 
we are talking about we are going to get a culture structure 
reculturalized as well as a reporting system in place and do it 
so that you can reduce them by 50 percent, or is the opposite 
true, things are so sloppy and so disorganized with no 
structure whatsoever that any structure at all could produce a 
50 percent reduction in five years?
    Dr. Cassel. Well, it is not so much that the situation is 
as bad as you describe, but there is some very low-hanging 
fruit in this area. There are some things that could be done 
fairly easily that could achieve quite dramatic reductions in 
errors.
    Chairman Thomas. Then why have they not been done?
    Dr. Cassel. In part, they have not been done because the 
goals have not been so clearly articulated and because the 
resources have not been there, and let me give you an example. 
Medication is a place where a lot of error occurs. As Mr. Stark 
said----
    Chairman Thomas. Do we have any ability to quantify that, 
what percentage of the deaths occur from the medicine side 
versus operating room, for example?
    Dr. Cassel. There are hundreds of studies looking at error 
rates, and particularly problems with medications, and they 
come up with different numbers and some of our extrapolations 
used in the report come from those studies.
    Chairman Thomas. My concern is I do not necessarily want to 
quantify to simply look at a number and then compare where the 
greatest failure is, but it seems to me that if we are going to 
try to put some structure in place, you would kind of like to 
go to where, as you say, the low-hanging fruit orchard is.
    Dr. Cassel. Let me tell you a story. Last week, I was a 
consultant to a major academic health center in the country 
that wanted to do something. It was a senior management 
retreat. They wanted to do something about this errors issue. 
And their debate in looking at the medication issue was, should 
we think about in the current competitive environment spending 
huge amounts of money on big new information systems, or should 
we simply put a pharmacist on rounds with the medical team 
every morning, because that has been shown to be very 
effective, as well.
    Now, those are the kinds of discussions that I think we 
ought to be encouraging people to have, and we quite frankly, I 
think, need to try out both models. It is very clear that 
computerized order entry helps this problem, but it is also 
very clear that those are huge expenditures in the current 
environment and the same improvement can be achieved other 
ways.
    Chairman Thomas. I will tell you, it is kind of frightening 
to read some of the stories that we are beginning to focus on. 
You will recall the number of infant deaths because of the 
failure to keep household cleaning items away from children and 
where you place them on the shelves and keeping latches closed, 
and it sounds like hospitals are just now discovering that 
concentrated potassium chloride kept at a lower shelf level 
will result in deaths.
    This seems incredible, based upon all of the other safety 
discussions in the home, in the workplace. I mean, you go to 
any area that requires you to wear a hard hat and there is a 
sign on the wall that proudly says, we have had no accidents 
for X number of days. Now, the problem is, in hospitals today, 
it would be we have a sign that says, we are proud to say there 
have been no deaths for X number of hours, but they do not talk 
about that in terms of a culture of trying to get it right.
    Dr. Cassel. The potassium chloride issue has now been 
widely addressed because it was so obvious and such a quick 
fix, if you will, that made a lot of sense, similar to things 
that the anesthesiologists learned when they looked at their 
practices.
    One of the differences here is the liability environment 
and the fact that a hospital internally may decide to do some 
of these things, but they are sure not going to write articles 
about it for the popular press and say, look what we 
accomplished by reducing these errors because of that liability 
environment.
    I just want to say that that is a very complex area that 
our committee recognized we did not have the capability to 
address, but I think that should be another major step that we 
address----
    Chairman Thomas. Well, my concern is I do not think the 
liability is all that difficult. I think we may get into a 
discussion in terms of mandatory versus voluntary scope of 
information circulation, but Ms. Connell, do you not think that 
that was absolutely critical to the success of your structure, 
that whole ability to depersonalize the information and create 
an environment in which people had a comfort level that when 
they reported it, and I imagine at the beginning, it was fairly 
difficult. It is a chicken and an egg. How do you do it?
    Ms. Connell. I do not see large disparities over what I am 
hearing and what I know of the history of the ASRS. The 
extensive history is published in a NASA publication, and you 
can read in here some of the dilemmas that were being 
considered at that point in time, and one of them is this legal 
liability issue and how to get beyond it. The other is how do 
you encourage people to report and take the chance kind of 
thing. Even with the promises, how will they know?
    And one of the strategies used by the founders, Dr. 
Billings, Dr. Renard, Cheney, and Harding, is that they involve 
the trusted individuals in the industry, so they are union 
heads and representatives, they are pilot organizations, they 
are traffic organizations, flight attendant organizations, that 
went to their communities and said, we have looked at this 
thoroughly and in depth and we bona fide it as a system that 
will work. We have great promise for it. We would encourage you 
to support it by submitting. And if you have any difficulty 
with the program, I am the person you can talk to.
    Chairman Thomas. Just a couple of examples and then I will 
yield to my colleague. Everybody is familiar with a pilot and 
copilot getting ready, say, to take off, and notwithstanding 
the fact that they have spent thousands of hours in that seat 
and perhaps hundreds and even thousands of hours in that 
particular aircraft, they have a checklist and they go down the 
checklist systematically on items that you would think were old 
hat to them, and, in fact, they are, but they go down in a 
systematic way.
    That seems to me something that could be carried to a 
number of areas in which you think you are following a 
procedure, but perhaps it is not as structured. Let me give you 
a more controversial example.
    I am quite sure that the question of installing a device 
which would monitor not only all of the telemetry in the 
aircraft but the actual voices of the pilots in a stress 
situation was not universally accepted. Nevertheless, one of 
the more dramatic aspects of this amazingly public effort to 
find out what went wrong was recovering the black box and 
analyzing what occurred.
    Could you not talk about an analogous situation of having a 
black box in the operating room which would collect all of the 
telemetry and perhaps video cameras, so that instead of trying 
to recreate an event from hearsay or third-party testimony 
after the fact, you would have a medical black box that you 
could examine to determine exactly what happened. But most 
importantly, you would have a graphic teaching tool to show 
firsthand what you do not do. Is that an idea that might be 
transferrable to medicine?
    Ms. Connell. It is difficult for me to say. The black 
boxes--
    Chairman Thomas. I am going to ask Dr. Cassel in just a 
minute, so----
    Ms. Connell. Okay. Accident investigation with the NTSB is 
a very intensive and in-depth investigation, and I am just not 
familiar with what depth investigations occur on the medical 
side and whether that is a cost that would provide a large 
benefit. That is something they would have to assess. But in 
aviation, it was resisted and it was resisted by the pilots who 
are sitting up front, having every word recorded and every 
change in throttles recorded.
    But they did adopt it eventually as the accident prevention 
mentality. In other words, if we do, you know, have an accident 
and we do not survive, at least someone will know what has 
happened and we can prevent the next one. So it was an 
altruistic professional kind of argument that basically won 
over the day. It has still and is still remains a controversial 
issue in aviation in terms of it getting in public hands and 
getting outside of the walls of the accident investigation.
    Chairman Thomas. Dr. Cassel, I know that as well as being 
on the IOM, you are professor and Chairman at Mount Sinai 
Medical Center in terms of a well-respected teaching hospital. 
As I mentioned to you earlier, there were indications that 
doctors were not as adequately trained in a bedside manner in 
terms of the way in which they addressed patients, and there 
was some discussion of changing the curriculum to make sure 
that they were a bit more responsive in their communications.
    Has there been any change in the teaching curriculum about 
the Alec Baldwin syndrome and that there needs to be a 
commitment in an altruistic and a professional way to let 
people know what happened when errors are being made, or is 
there still this cult of secrecy developed and promoted in 
these teaching hospitals?
    Dr. Cassel. There have been a number of changes in medical 
curriculum to try to teach the students to interact on a whole 
range of scales in a better way with the patients, and as 
importantly, with the other members of the team, and that is 
part of what we have learned from these lessons from the 
aviation industry.
    There are probably specific environments, such as trauma 
units or operating rooms, where models like the black box might 
be useful, but in general, I think they are more useful for 
teaching purposes. We, for example, have some experience at 
Mount Sinai in using videos of medical students and residents 
interviewing patients and then talking with their colleagues 
about the management of the case, and then we do sort of a 
post-mortem on that interaction. We say, well, look how you 
were putting down that nurse and that nurse could not tell you 
what really needed to be said about that patient.
    So that kind of sort of an autopsy of the behavior, if you 
will, and taking it apart and having the faculty, the teachers, 
examine that with the students can really help. I have seen 
some very helpful videos of cockpit interactions when I was 
Chairman of the American Board of Internal Medicine saying 
doctors could learn a lot from how they sort of break down and 
examine the hierarchial behaviors in those settings.
    Chairman Thomas. I am just slightly concerned about your 
use of terms, post-mortem and autopsy in those situations.
    Dr. Cassel. I am sorry.
    [Laughter.]
    Chairman Thomas. The gentleman from California.
    Mr. Stark. Thank you, Mr. Chairman.
    Dr. Cassel, Ms. Connell, thank you for your testimony. I 
wanted to ask you, Dr. Cassel, in the IOM report, there is 
discussion about a national center to fund research and conduct 
analysis of the data, and I do not find any mention of a plan 
or a suggestion that we require hospitals to take action. We in 
Congress are now talking about education. We are forcing 
schools and principals to have a plan of action to improve the 
results of training kids.
    Ought we not to require, not just suggest, I think, a 
hospital to have a plan? The plan might be more intensive or 
less intensive, depending on the hospital's record, of how they 
are going to reduce errors and have targets to achieve that. 
Should we not, as part of that plan, include investigations 
where there is a serious or fatal accident to find out why the 
accident happened and add corrective measures to the plan and 
then follow up to make sure the corrective actions are taken?
    In other words, without the question of mandatory or 
voluntary reporting, ought there not to be some kind of 
required system? If hospitals already write up errors and get 
A-pluses, obviously, it would not be as much of a burden. If a 
hospital is way behind the curve, it might be more of a burden. 
Could you discuss how you think that would work and would it be 
helpful?
    Dr. Cassel. I think it would be very helpful. I would just 
also want to add that whatever we are thinking about for 
hospitals, we should also be thinking about for nursing homes--
--
    Mr. Stark. Okay.
    Dr. Cassel.--another very high-risk environment that 
actually has more beds in the United States than hospitals do 
any given day.
    Mr. Stark. I will lump them all together, as well.
    Dr. Cassel. Secondly, I think what you are describing is 
not what we envision as being a function of the Agency for 
Health Care Quality, which is to support research and setting 
some goals for the nation, but, in fact, could be done by any 
number of means. Some of the accreditation processes that are 
currently in place, perhaps Medicare standards and 
expectations.
    But the most important thing about requiring institutions 
to document their approaches to improving the rate of errors, 
or not the rate of errors, but the occurrence of errors and to 
learning from those is that there be a level playing field, 
that this not be something that is held against the system. The 
example you are going to hear later about the Department of 
Veterans Affairs, that there was a front page article in the 
New York Times that the VA has more errors than any other 
system, well, it is because they are doing a better job of 
reporting.
    Mr. Stark. Right.
    Dr. Cassel. But the public does not understand that, and so 
we need to make sure that the playing field is level if we are 
going to require all of the institutions to do the same thing.
    Mr. Stark. Or universal? Would you say----
    Dr. Cassel. Yes, even that. That is right.
    Mr. Stark. Why has the industry not done it up until now?
    Dr. Cassel. Well, that is----
    Mr. Stark. The hospital and nursing home. Why----
    Dr. Cassel. Why has the hospital industry not?
    Mr. Stark. Yes.
    Dr. Cassel. I think the answer to that is a very complex 
one and it is analyzed in some detail in our report. It has to 
do in part, as Mr. Thomas suggested, with the culture of 
medicine and the emphasis on the individual. I believe that the 
liability environment is a big, big piece of this, and I also 
believe that the competitive marketplace in which no hospital 
wants to go public saying, we are doing our best to prevent 
errors, that is not a big selling point in the marketplace. So 
until we require everybody to do the same thing, it is not 
going to happen.
    Mr. Stark. Let us switch to your profession. Several years 
ago, many years ago, it was suggested that we require 
physicians to recertify, be tested, say, every seven years. 
Now, most of the specialty groups do require that. The AMA came 
off the wall and said, oh, my God, you cannot do that. We will 
do it voluntarily. Well, you know what voluntarily means.
    We require pilots to be tested. We require lawyers to be 
tested. We require real estate brokers to be tested. Cops have 
to go out and shoot their guns every so often. We in Congress 
are tested, good point.
    [Laughter.]
    Mr. Stark. Is there anything so awful about suggesting that 
a physician, because of the rapid change in technology, ought 
to go back periodically and be recertified? Would that help?
    Dr. Cassel. We did not address this in detail in the 
report, but I will tell you my personal opinion is not only is 
there not something so awful about it, I think it is essential 
for our health care to be accountable to the public, as you 
point out, in this current environment of rapidly advancing 
science and also requiring physicians to know something about 
the systems that they work in and how to improve those systems.
    Certification boards do now require episodic 
recertification, but having just finished a year as chairman of 
one of those boards, I can tell you that we did not feel that a 
sit-down paper and pencil test every seven to ten years is 
really enough, either. We need more performance measures. We 
need what--the aviation industry does it every six months, I 
believe, in simulators. We need much more practice performance 
evaluation in addition to cognitive knowledge.
    Mr. Stark. One quick question, Ms. Connell.
    Ms. Connell. Yes.
    Mr. Stark. The VA system has a voluntary reporting system 
that permits employees and patients to report occurrences and 
protects them. Should any error reporting system permit 
confidential reporting by employees and patients or anybody 
else without fear of action being taken against them?
    Ms. Connell. I am not sure I could answer that question 
without knowing deeply the VA system.
    Mr. Stark. You have it in your system? Do you have a 
confidential reporting system----
    Ms. Connell. Ours is a confidential reporting system at the 
national level.
    Mr. Stark. And there is no fear of action being taken 
against somebody who reports, right?
    Ms. Connell. Not now. We have proven over 24 years that 
that is impossible with the structure the way it is.
    Mr. Stark. So you say that is important to your structure?
    Ms. Connell. It has been important in keeping the flow of 
information increasing and continuing.
    Mr. Stark. Thank you.
    Chairman Thomas. I thank the gentleman. We may need to do 
two rounds, so we will try to maintain the clock as we move 
through, not withstanding the chairman's unwillingness.
    Does the gentlewoman from Connecticut wish to inquire?
    Mrs. Johnson. Thank you, Mr. Chairman, and my apologies to 
some of the later speakers. I have to chair a hearing at 11:00, 
so I will not be able to stay through the whole hearing.
    I was very interested, Dr. Cassel, in your comment that 
errors are seldom due to carelessness or lack of trying hard 
enough and that, in fact, what we are looking for is safety by 
design. I think that is very, very important. I represent a 
manufacturing part of the country. I have seen what has 
happened as a result of system change, first through total 
quality management and then due to this ISO 9000. I had one of 
my hospitals say to me recently, why are you doing this? Do you 
not understand, we are going through ISO 9000. We have to 
because GE wants every one of its contractors to be ISO 9000 
and we take care of GM employees. I did not know that.
    So there are a lot of systems changes going on 
institutionally, and for us to adopt a mandatory reporting 
system, and I have never seen one that does not get to be 
punitive and does not, especially on top of malpractice and 
competition, foster as much cover-up as is possible.
    I think we have an enormous opportunity here to use the 
certifiers, the system, the office to help gain an 
understanding of what systems do improve safety, which has been 
something we have not been willing to look at and have not put 
the resources in, and then there are many ways in which we can 
get them to design it. The thing I hear most often in my 
hospitals is, do you understand that we have to reimburse for 
this drug, not because you require it but because it is the 
state of medical practice and we have to do it, and when is 
Medicare going to notice that we have to do this and up their 
reimbursements.
    So I worry about the emphasis on mandatoriness when there 
is so much we have not done, and I think this issue of 
reporters being absolutely free to just talk about something 
they saw--I saw a hospital go from individual insurance to the 
institutional self-insurance and then physicians did say, I do 
not think the way you are dealing with that case is really so 
hot.
    So I think we have an enormous opportunity here, but I 
think the confidentiality is terribly important. Someplace to 
report is very important, an office. How do we get visible some 
of the systems demands that, frankly, are being made in every 
other sector of the economy for quality, and safety is just a 
part of quality, but remember, OSHA made this mistake. OSHA 
came in--the original OSHA law was X, Y, Z. When it began to 
work was when we got OSHA consultation and without danger, you 
could get an OSHA person to come into your workplace and say, 
what are the problems here, and they were not allowed to come 
back and penalize you if you changed it within six months.
    So there is just such an enormous void here and the systems 
are so lacking because so many of our laws discouraged system 
views, and these are not bad people and we are never going to 
wipe out all mistakes. So I do not want--we found this out when 
we reported death rates in hospitals, and I had a VA hospital 
in my district and the director had the good sense to come to 
every one of the members of the Congressional delegation and 
make an appointment and sit down and say, I am going to provide 
services to very disturbed veterans and we are going to have 
problems. He said, the reason we do not have problems now is 
nobody will take care of them. So he opened his doors to the 
most severely distressed soldiers with very serious psychiatric 
problems and so on. Yes, he had a couple of batteries. Over the 
years, he had a couple of hangings and those kinds of things. 
But, boy, the lives he saved, the stories he can tell.
    I will be interested to look at your report and see more 
clearly where you want mandatory reporting and why, but there 
is just such a wide-open opportunity here for rapid improvement 
if we are able to integrate systems and approaches and spread 
the knowledge of them, and I worry about that.
    Dr. Cassel. I very much agree with your concerns and I 
would really welcome your input on this process. The committee 
spent a lot of time examining this issue and it is very aware 
of the potential for mandatory reporting having a negative 
effect, a silencing effect, if you will, and that is why we 
keep emphasizing this level playing field aspect of it.
    But we already have more than 20 States that have some form 
of mandatory reporting. There is experiments, if you will, out 
there at the State level that the Agency for Health Care 
Quality could, in fact, look at, see what seems to be working, 
what does not seem to be working, and follow that, and that is 
another reason why we call for this at the State level rather 
than in some uniform Federal way and then to learn from those 
individual experiences.
    The last thing in the world that you want is for a health 
care institution not to take care of the high-risk people, not 
to engage in a trauma unit because they are afraid that they 
are going to get in trouble for doing that.
    Mrs. Johnson. Right. I thank you and I thank the chairman 
for inviting you and also you, Ms. Connell, from the aviation 
system, because your system is very, very interesting and I 
always sort of wondered, how is it that we are able to have 
quite as safe an air traffic system as we do, a remarkable 
record, when people are people and errors happen, so thank you 
for your good work.
    Ms. Connell. Thank you.
    Mrs. Johnson. Thanks, Mr. Chairman.
    Chairman Thomas. I thank the gentlewoman.
    Does the gentleman from Washington wish to inquire?
    Mr. McDermott. Thank you, Mr. Chairman. Sitting here 
thinking about having practiced medicine, it seems to me that 
the issue we are discussing here has really two parts. One is, 
what do you do about the individual who has had a medical error 
occur in their treatment, and then what do you do about the 
system?
    I think that it is important for us in trying to fashion 
any kind of government response to that that we keep those 
clearly in mind, because my remembrance of the AMA 
responsibility for a doctor, I mean, it is that a doctor is 
required to be honest with his patient in spite of the fact 
that there may be, in fact, a legal responsibility or a 
liability may come out of it. Is that correct?
    Mr. McDermott. I believe that is part of the code of 
ethics.
    Mr. McDermott. Yes, it is, Section 8.12. I just want to get 
it in the record, that a doctor does not have the luxury of not 
telling a patient just because he is afraid of a lawsuit, and 
that is a responsibility that he or she has to deal with.
    [The information was not received at the time of printing.]
    Dr. Cassel. And that gets at another response to 
Congressman Johnson's question of why did we make this 
recommendation for mandatory reporting, understanding all of 
the challenges inherent in that, but that there is 
fundamentally this responsibility to the public which we felt 
was the overriding concern.
    Chairman Thomas. Would the gentleman yield on that point, 
since you are a practitioner and you are discussing this as two 
doctors and those of us who are watching, do you believe that, 
notwithstanding whatever number point subsection that is, that 
it is, in fact, working, that people do follow it?
    Mr. McDermott. I have no way of telling. I suspect that it 
goes on a lot more than we know because I suspect that in most 
cases where there is not a lawsuit brought, it is because the 
physician said to the patient, we made a mistake here. We did 
this, we did that, and we are going to correct it. Then the 
patient does not have to go to the legal system to get it 
corrected. So I do not know how you would--it would be very 
hard to say what the statistics are. I am sure there are 
physicians who do not tell.
    Chairman Thomas. I am sorry to interrupt, but my biggest 
concern is that I know we are going to hear from folk that, you 
know, we are professionals. We are on top of it. We have 
written statements. We have rules. Did you not have those five 
years ago and ten years ago and do you not have them today, and 
here this report comes out. My concern is that if we do not 
really look at it systematically this time, we may not get the 
impact of publicity that has occurred and we will not be able 
to make the changes that need to be made. That is one of my 
concerns about citing items that are already on the books and 
have been there for some time.
    I thank the gentleman for yielding.
    Mr. McDermott. What I said at the outset was, you had to 
talk about individual responsibility as physicians and then you 
have to talk about how you bring about systemic change. I, 
actually, early in my career when I was in the State 
legislature, worked in a PRO, so I pulled charts out of 
hospitals all over the State of Washington and looked at them 
and looked at what was going on. We looked at all the deaths in 
hospitals during a given period to see. So I have been in that 
process.
    The question, I think, is in the mandatory reporting. Do 
you then publish that this happened and this happened, or do 
you design a system by which you make the PRO deal with this 
both in investigating the root cause, why are there infections 
in the operating room or why are there whatevers going on, and 
then have a corrective action? Do you give that responsibility 
to them and say, it is your job to do this and see what 
happens?
    My view is that I am reluctant--the first rule of medicine 
is, above all things, do no harm, and I am afraid that if you 
start posting on the wall of every hospital everything that has 
gone on in the hospital, you will do neither the patients nor 
the physicians nor the hospital any good. So I am curious about 
if you think, from looking at your study, whether giving the 
responsibility for this, mandatorily reporting to the PRO every 
problem and then make them go out and do an investigation and 
do a corrective action, would that solve the problem or at 
least come at the problem in a reasonable way?
    Dr. Cassel. I do not know if it would solve it, but it 
seems a reasonable strategy to examine because the PROs are in 
place and they are charged with quality. They do not, however, 
by and large, have the technical analytical expertise to do the 
kinds of root cause analysis that aviation gives us as a model.
    That is why your example exactly, of why listing a list of 
something on the wall of any institution is not going to be 
what matters here. What is most valuable from the aviation 
example are these complex stories. These are complex issues 
involving lots of different people, communication, packaging, 
every dimension of a very complex industry, and so if you are 
going to ask the PROs or any other body to do this, there would 
really have to be the resources to get the analytical strength 
to make sense out of these stories so that they can be learning 
experiences to improve the situation.
    Mr. McDermott. Simply mandatorily reporting and publishing 
a great book of medical errors for the country----
    Dr. Cassel. That will not do, no.
    Mr. McDermott.--would not move the issue forward?
    Dr. Cassel. No, and in general, quantitative reporting is 
not going to tell us much about this because we never can know 
what the denominators are. So to try to measure how many we 
have got this month and how many we have a year from now of 
some sort of error in some geographic location is not really 
going to tell you what you need to know. You really need to dig 
down deeper and look at the human factors involved.
    Mr. McDermott. Let me just ask, if you indulge me for just 
a second longer----
    Chairman Thomas. I will indulge you.
    Mr. McDermott. Thank you. I like to be indulged.
    Chairman Thomas. The gentleman's time has expired.
    [Laughter.]
    Mr. McDermott. The question of medicine has changed 
dramatically since I began practicing in 1963, and what one of 
the changes is, that there are not three nurses on every floor, 
as there used to be. There is one nurse perhaps covering a 
couple of floors with some nurse assistants or licensed 
practical nurses or whatever and technicians operating at all 
sorts of levels. In your study, was there any attempt to refine 
where the errors occurred, what kind of categories they fell 
into, besides medication errors? I mean, the idea of putting a 
pharmacist on the team going around is a cost to the hospital, 
and under the present conditions, no hospital is going to pay a 
pharmacist to walk around for following 20 doctors going 
through rounds.
    Dr. Cassel. Well, some actually are because it costs less 
than the kinds of information systems that use computers to 
identify drug-drug interactions or somebody's handwriting, the 
nurse made a wrong interpretation of what the medication was. 
Those kinds of problems can be avoided by information systems, 
but for some hospitals, they think they are better off having 
human beings interact in teams. Ideally, of course, you would 
like to have both, but what you are describing with the change 
in the kinds of staffing in hospitals is a response to this 
very competitive environment that we are in and people trying 
to deliver much more high-tech care and to do it with as few 
people as possible.
    And that, to my mind, is an environment in which we should 
be even more interested and more concerned about these kinds of 
errors and hold ourselves more accountable, because there is 
all this reengineering going on. Now, we have seen this 
happening in industry and much of it has actually been for the 
better. They have gotten more efficient and produced better-
quality products. So it is not necessarily a bad thing, but if 
you are not following and reporting what you are doing, you are 
not going to know whether you are getting better or not.
    Mr. McDermott. I guess, Mr. Chairman, the reason I raised 
this whole thing is that having watched the change in 
hospitals, it is hard for me to know how you can train somebody 
at the community college for 30 days or 90 days or maybe a 
semester or maybe even a year to then come in and give one 
little slice of the treatment without looking at the whole rest 
of what is going on. I mean, that person cannot possibly know 
because they have only been trained to look at the thing they 
are to do.
    Dr. Cassel. Right.
    Mr. McDermott. That is where I have the----
    Dr. Cassel. That is where we need to look at the human 
investment the same way that industry does, to say these people 
are not widgets to be inserted into a health care system. They 
are a valuable part of the team and you invest in their ongoing 
education and in their ongoing communications with the other 
people involved.
    Mr. McDermott. Thank you, Mr. Chairman.
    Chairman Thomas. All that may be true, but it is rather 
frustrating when I continue to hear that one of the problems is 
that someone cannot read someone's handwriting. Now, I rent a 
car and I pull up, and by the time I have turned the auto off, 
opened the trunk, and retrieved my luggage, someone who is 
probably being paid pretty close to the minimum wage can hand 
me the totalization of the time, the mileage, the dollar 
amounts. There is a little computer that they use to assist 
them.
    Now, someone better not tell me that this world is so 
complicated and so difficult that you cannot create a palm-held 
interactive drug relationship of what is on that chart and that 
any of those very simple requirements like, hey, guy, type the 
Rx, the computer can do it for you today. To sit here at this 
level on the seriousness of this issue and say the problem is 
somebody's handwriting on an Rx tells me exactly how far we 
have to go with this culture that we have been talking about.
    Dr. Cassel. And what you describe does exist in many 
places. It just does not exist everywhere, and----
    Chairman Thomas. And the problem is, there is no systematic 
collection of data, there is no systematic confidentiality, and 
there is no willingness to share in a confidential way as there 
is, for example, in the aviation industry.
    Does the gentleman from Louisiana wish to inquire?
    Mr. McCrery. Thank you, Mr. Chairman. In fact, that is part 
of what I was going to pursue, is the use of technology and why 
we are not making greater strides in the use of technology in 
terms of patient protection, if you will. It seems to be a word 
or phrase that is bandied about a lot in Washington these days, 
so let us talk about patient protection.
    Is it necessary for the Federal Government to intervene 
here and mandate the use of certain technologies like these 
hand-held machines that are available, I believe, in which you 
type in, or actually just push a few numbers or letters and the 
prescription pops up, the interactions pop up, the patient's 
records are on there for other drugs that he or she is taking. 
Should we mandate that those things be used by doctors on their 
rounds in hospitals? It is for patient protection.
    Dr. Cassel. It certainly is, and the broader answer that I 
believe to your question about should the Federal Government do 
something is yes. Now, as Mr. Thomas said, I think the very 
important question is what exactly would really make the most 
difference and be the most productive role for government 
intervention, and there are a number of different approaches to 
that.
    Let us remember that the computer process is also not 
infallible, as we have been actually learning about Internet 
activities just this week. But even the thing about pushing the 
button, people also do push the wrong button. So the human 
factor--you can never escape the need for the human factor's 
dimension of this kind of work.
    But I think that information technology is very promising 
for reducing errors and improving quality of care, but it is 
expensive. I have been sitting at the table at a number of 
different health care organizations with discussions about the 
competitive environment, how many hundreds of millions of 
dollars they spend on information technology, and where is that 
going to come out of. So that is where part of the tension, the 
inevitable tension will be.
    Mr. McCrery. What is the role of the government, the 
Federal Government, in establishing a system of reporting 
disclosure of errors and near misses? Do we have a role? Should 
we implement a nationwide system of mandatory or voluntary 
disclosure?
    Dr. Cassel. Our reports suggest that there be a nationwide 
expectation or standard of reporting from every State and that 
the States get help from the Federal Government in implementing 
these systems and evaluating them and improving them going 
forward.
    Mr. McCrery. Only about a third of the States, as I 
understand it now----
    Dr. Cassel. Currently have that.
    Mr. McCrery.--have those, so why should we not mandate it 
from Washington?
    Dr. Cassel. Our reports suggest that you do that, but that 
you not mandate exactly the same system for every State because 
we do not know yet how best to do this and we can learn from 
what the States have been doing.
    Mr. McCrery. Since you are at a teaching hospital, one 
thing that I get from people often, Mr. Chairman, is why do 
doctors in residency programs have to stay up so many hours? Is 
that not dangerous? Why do you force them to work hours on end? 
Nobody else does that. Pilots cannot do that. In fact, pilots 
have just the opposite. They have to take off. They have to 
take off from their job. They also have to take off, but----
    [Laughter.]
    Ms. Connell. In order to land, they must take off.
    Mr. McCrery. Yes. But why is that? I am just curious, so I 
can answer all these people that bug me about this.
    Dr. Cassel. Now here, you will get my personal opinion. I 
think that medical training has been unreasonable and actually 
dehumanizing in those dimensions. It is getting better. The 
State of New York has very clear rules about how many hours a 
resident can work. But we still get arguments from physicians 
who say that the most important thing for the physician is to 
learn to work under stress and to learn the continuity of care, 
so you are responsible for one patient over a period of time in 
the illness.
    Chairman Thomas. Dr. Cassel, I am sorry to interrupt you, 
but on that basis, do you think it is primarily driven by 
economics, that is, it is cheap labor----
    Dr. Cassel. No.
    Chairman Thomas.--or it is part of the hazing process to 
join the culture?
    Dr. Cassel. Those are my two choices, those answers?
    [Laughter.]
    Dr. Cassel. I do not think it is because of economics. I 
think it is part of the culture of being a tough guy and 
getting it right no matter how stressed you are. I think this--
--
    Chairman Thomas. And learning how to not report it if you 
do not get it right.
    Dr. Cassel. Well, that probably has been part of that, and 
that is why I think this is something else we can learn from 
aviation, exactly what you suggest, that we probably do need to 
recognize that to err is human and that humans are fallible and 
that humans need to go to sleep periodically.
    Mr. McCrery. In conclusion, Mr. Chairman, I just want to 
say that I agree with Mrs. Johnson that, or at least I think 
this is what she concluded, that much of the problem is 
systemic and we really have to look at the reasons for the 
system, if not promoting errors, certainly putting in place 
systems that do create errors and afford the possibility for 
errors in greater numbers than we should.
    I really do not think that it is the individuals' faults. 
It is not the doctors' faults as individuals. But it is a 
systemic problem, but I do think that it is a culture, as part 
of the system, that has grown up over the years and the 
teaching hospitals, the medical schools, I think, are going to 
have to play a large role in correcting this culture and 
reversing some of these things that have been put in place by 
the system.
    Mr. Chairman, my time has expired, but this is very 
interesting. I appreciate the testimony.
    Chairman Thomas. I thank the gentleman. We may do a second 
round, but I did want Ms. Connell to respond, because as I 
understood your testimony on the structure that you oversee, it 
is just kind of open-ended and whoever wants to report gets to 
report. You were talking about, what was it, 36,000 reports.
    My guess is, if it were an open-ended reporting system in 
the medical structure, you would probably be overwhelmed and so 
perhaps there is a question of volume. But to what extent do 
you believe it has been fundamentally important in building the 
system to let every individual in the system believe that they 
can make a difference if they choose to make a difference?
    Ms. Connell. There definitely is a human concept there that 
people need to feel empowered, to feel engaged, to feel they 
can make a difference, and this system has provided that.
    Now, in all honesty, of all the information I receive, 
there is some percentage I cannot use because it does not fit 
into what we can do something about. But that does not mean I 
do not accept it.
    Chairman Thomas. I will go to the gentleman from Florida, 
but it seems to me that the reporting of information which is 
not all that useful is a minor problem compared to the enabling 
position of people believing that they can inform. I hear 
immediately, oh, we cannot do that because it is just going to 
be too much volume, and you immediately then begin a 
hierarchial structuring of who is important, what is important, 
who counts in the system and who does not, and I think that has 
been one of the fundamental problems in medicine, that there is 
this hierarchial structure and I do not think folks realize it 
when they begin saying, oh, there is no way we can create a 
system like the FAA where everybody reports.
    Just create a system of dealing with that volume, because 
one of the fundamental enabling aspects of a system, I think, 
is to be able to say, hey, anybody in this structure who feels 
strongly enough, on a confidential basis, let us have it. I 
think that probably would break down the culture of medicine 
almost as fast as anything else we could do.
    Ms. Connell. And we have learned a lot by taking that 
perspective, because--
    Chairman Thomas. I understand the volume problem, but boy--
    Ms. Connell.--you cannot anticipate what you are going to 
hear, but you have to be ready to listen.
    Chairman Thomas. You can if you can judge who is important 
and who is not to the system.
    Ms. Connell. But some rather innovative solutions to 
problems have come from an Embry Riddle student looking at an 
issue. So it is pretty wide open.
    Chairman Thomas. But it is the mental concept, the 
willingness to accept even the least in the system's report 
that there may be of some value. That, again, is part of that 
culture that has been built into medicine, that is not going to 
work.
    Ms. Connell. And I have to say, the support at the highest 
levels. The FAA under David Hinson made it very clear that all 
organizations would have safety departments that report 
directly to the CEO. They elevated safety as something very 
important, and there are, and we have managed to translate this 
to people. The economic advantage of putting money into safety 
far outweighs the accidents.
    Chairman Thomas. I thank the gentleman.
    The gentlewoman from Florida.
    Mrs. Thurman. Thank you, Mr. Chairman.
    Dr. Cassel, I am interested to know, is this the first time 
that this medical error issue has really hit this country?
    Dr. Cassel. Well, that is a wonderful question. No. Nothing 
in this report is new information. We did a very thorough 
examination of existing literature, and actually, we did not 
even go as far back as some other studies that have been done 
in the 1980s or 1970s that we were aware of. So it is not new 
information.
    Mrs. Thurman. Okay.
    Dr. Cassel. And that is why it is interesting that it has 
gotten the response that it has. I think some of that has to do 
perhaps with the current concern about the quality of care and 
the so-called managed care backlash and the environment of 
concern about patient protections, but I think it also has to 
do with having an organization like the Institute of Medicine 
look very systematically at this issue and package it in a way 
that sort of makes sense of it.
    Mrs. Thurman. The reason I asked is because in Florida, and 
I am going to tout Florida here a little bit because I think 
Florida has been a real leader in this issue. We were the first 
state to implement any kind of adverse incident reporting 
programs. We did that in 1975 and then we expanded it again in 
1985.
    I guess part of the question, with the recommendations that 
have been made and the fact that there are some 20 States that 
have actually put some kind of review system in place; what 
have we learned from those? Are we analyzing the information 
from those States that have implemented reporting programs? Has 
this been included as part of the proposal that is being put 
forward to us? Have we looked at the statistics of what 
happened before they did this to what they are doing today to 
what works in those States in reducing errors?
    I am just a little concerned that we are going to get so 
overpowered with some new regulatory something this, something 
that, when we have some models out there that potentially might 
be working. Because I think this is an issue that you have to 
move quickly on to make something happen and why would we 
reinvent what are we doing if it is similar to some of these 
States in their reporting mechanisms and what can we do quickly 
that can make a difference?
    Dr. Cassel. Some of our data did come from State-level 
studies exactly as you described, but there has not been an 
attempt at a national level to really follow over time what has 
occurred in those States, for example, that have some sort of 
mandatory reporting or that have other kinds of error reduction 
or patient safety strategies in place. That is one of the 
functions that we think that the Agency for Health Care Quality 
could take on, is to figure out how most accurately to really 
study those things.
    This is not traditional health care research. That is the 
other thing we need to learn from these other industries, that 
our approaches to even looking at quality of care research do 
not have the same dimensions that some of these other 
industries do in looking at the root cause analysis, for 
example, and sort of qualitative analysis. So that why I think 
we do need some very concerted research to exactly draw those 
lessons from people who are doing the right thing and are 
making progress, but we really do not know how to study it or 
explain it.
    Mrs. Thurman. Maybe to the chairman and others, we know 
that there are some things working out there. Are there things 
legislatively? For example, I think Florida is the only one now 
that through the practice acts makes risk managers in hospitals 
go through classes and have to be accredited for their 
practices. So we have done some things in those areas and those 
seem to be working. It just seems to me that we need to learn 
from some of those things.
    I know that talking about some of the technology issues, in 
Florida, for example, they are putting information on the Web. 
For example, information about medication safety is already up 
and running. And yet we are sitting here talking today that 
this is a major problem in this country. Wrong site surgery, 
restraint injury, these things are happening.
    I think part of it is that we need to make sure that some 
of this information is getting out. I think we also need to be 
talking to our State legislators who can put some of these 
quality boards in place immediately to take care of some of 
these situations. It is a pretty dismal thing to think that we 
have been talking about this for a long time and only 13 States 
have even looked at anything at this point.
    Dr. Cassel. I think it is actually more 20 or 22 at this 
point, so it is a little bit more promising, but I think there 
are things to learn from the States. You are absolutely right.
    Mrs. Thurman. Thanks.
    Chairman Thomas. I thank the gentlewoman.
    Does anyone have a burning desire to ask another question? 
The gentleman from California is burning first.
    Mr. Stark. Thank you, Mr. Chairman.
    Dr. Cassel, I have a hunch that we are going to hear some 
complaints during the course of the day about the costs of any 
program that we may encourage or require, and it is my sense 
that the health care costs due to preventable events is 
somewhere between $8 and $15 billion a year, or something like 
$2 billion a year, I have heard even, just through 
inappropriate or adverse drug events which have to be 
corrected.
    The National Quality Forum on its Internet site estimates 
that 30 percent of the acute care patients and 20 percent of 
the chronically ill patients receive care that is 
contraindicated. I guess that means unnecessary, or may be 
unnecessary.
    So ought the savings to the hospitals from preventing 
errors which may cause them to have to keep people longer--they 
are only getting a DRG payment, so if they do it wrong, 
obviously, it will cost them more than getting it right the 
first time--can you comment on the costs versus savings of any 
kind of program we might undertake to require all of the 
providers to be more involved in a system of reporting and 
corrective action?
    Dr. Cassel. I certainly can comment on that. But before I 
do that, I think we always have to remember that cost is not 
the first reason for addressing this issue. That first do no 
harm has to do with protection of patients first and foremost, 
and even if it did cost more it would be worth doing.
    But having said that, I think the cost issue is one that 
needs examination, but it is not quite as straightforward I 
believe as you describe it. For example, a hospital as a unit 
may gain or lose money if it improves its error rate depending 
on how that plays out in the DRGs. Because some patients who 
become very ill from a medication complication then may go home 
or may go to a nursing home and the hospital itself may not end 
up bearing the cost burden of that.
    The entity that is likely to save is Medicare when you look 
at the whole picture of patient care. I think it is harder to 
know whether a single individual hospital would gain or lose in 
a single year let us say from implementing some of these 
strategies.
    Mr. Thomas. The gentleman from Washington.
    Mr. McDermott. Thank you, Mr. Chairman. I am sitting here 
trying to figure out how to design this, because I think 
everybody wants to make it better. I remember the difficulty 
that the Agency for Healthcare Quality, they went through a 
sort of near-death experience here in the Congress around their 
analysis of certain procedures and whether or not they were 
effective and so forth.
    So as I think about putting this issue in their box and 
saying, this is something new we would like you to do, I would 
like you to distinguish something or at least talk about it, 
the whole question of confidentiality protections versus 
medical liability.
    If we require mandatory reporting, every hospital in the 
United States must report to the Agency for Quality Health 
Research any incidents of medical errors. Can that information 
then be used in a lawsuit against the hospital or the doctor or 
whoever? Or is it in fact--would it be possible to make it 
confidentially protected in such a way that it could be used 
for the purpose of systemic analysis and recommending changes? 
Or would it simply be a repository from which whoever would 
say, I think there is some information over there we need for 
the lawsuit?
    Dr. Cassel. Several important points. First, we do not 
recommend that the Agency for Healthcare Research and Quality 
become the regulatory agency because they need to, exactly as 
you say, to be free to really examine all of the data and set 
some goals for the Nation, and look ahead and invest in the 
research necessary to know how best to do this. So that is not 
a regulatory function that makes sense to place there, and as 
you point out it puts their most important function at risk, 
which is to support learning or about how to improve quality.
    Secondly, I think that a serious look at the liability 
environment is essential in really trying to answer this 
question. As I say, our existing IOM committee does not really 
have the capability to do that. But something like an IOM study 
about the whole environment of liability and how does it relate 
to quality or how does it inhibit quality. I tend to think that 
some very interesting strategies such as no-fault approaches to 
adverse events that happen in health care would compensate more 
people who are harmed at less cost, and it would get the money 
to the people who have been harmed rather than to the attorneys 
who are trying to find the cases.
    As you probably know, in one of the important studies here 
it was identified that only something like 1 percent of people 
who were harmed by negligence actually ever even were involved 
in a lawsuit. And the ones who did get compensated got 
compensated 10 years later. So that does not seem to me to say 
that our current liability environment is really protecting the 
patients. So from my point of view I think we need a much more 
expansive look at this whole situation.
    Mr. McDermott. Thank you, Mr. Chairman.
    Mr. Thomas. The gentleman from Louisiana.
    Mr. McCrery. That would be a great hearing for us to have, 
Mr. Chairman. I would like to pursue that, but I will not 
today.
    The matter that Dr. McDermott brought up earlier is an 
interesting one, this issue of cost savings that have been 
implemented by health care institutions, whether it is 
hospitals or health care plans or whatever. And if I am not 
mistaken, the data that you studied is 10 years old; is that 
right?
    Dr. Cassel. Much of it is.
    Mr. McCrery. Much of it is 10 years old?
    Dr. Cassel. Yes, eight to 10 years.
    Mr. McCrery. I do not know when all this cost saving took 
place but it is possible that it had not really reached its 
zenith 10 years ago and you still might have had two nurses on 
duty instead of one and those kind of things. So it may be hard 
to tell. It may be useful to do a new study or collect new data 
and study that in light of the changes that have taken place.
    But I wonder if you have, upon going through all that 
material, have you reached any conclusions or even developed 
any opinions on the quality of care today as opposed to say 10 
years ago because of cost-saving matters that have been brought 
into play in the health care institutions? Do you have any 
comments on that? And if you did not look at that and you did 
not develop any----
    Dr. Cassel. We did not specifically look at trends over 
time in this study and I think that the data does not really 
exist to allow us to do that. That is one of the reasons we 
think that the research in this area is so vitally important, 
and that we have some ability to look at trends over time and 
set some goals for ourselves as a nation. So that would be, to 
my mind, one of the most important things we can do. If we do 
not know whether it is getting better or worse, it is going to 
be hard to fix it.
    Mr. McCrery. So your panel did not reach any conclusions as 
to the deleterious effects, if any, of the various cost-saving 
devices that have been implemented by health plans?
    Dr. Cassel. That was not one of the things that we looked 
at. There is some literature in the health services research 
arena trying to look at changes in health care financing and 
the effects on quality. It requires very sophisticated studies 
so there are not a lot of really definitive ones in that area. 
But the current environment of concern about health care 
quality I believe is going to allow us to really make much 
better use of that kind of research.
    Mr. McCrery. Thank you, Mr. Chairman.
    Mr. Thomas. The gentlewoman from Florida have any 
questions?
    Mrs. Thurman. No.
    Mr. Thomas. I did want to just briefly follow up. Ms. 
Connell, you heard the statement that they have the goal of a 
50 percent reduction in five years. Do you think that that is 
really a realistic target based upon your experience in 
changing a culture, which I think is probably more sympathetic 
to resolving errors? That is not the right way to say it, but 
you know what I mean.
    Ms. Connell. You have got a large system, there is no doubt 
about it. It is real hard to say. We have a goal at NASA under 
a NASA safety program right now which was driven by the Gore 
Commission goal to reduce aviation worldwide accidents 80 
percent in 20 years. We are looking at that in terms of how are 
we going to do that when we have an accident rate that is 
already pretty low and we have a lot of data.
    Mr. Thomas. I certainly do not want to discourage anyone, 
but I also think if we are going to go into this we have to set 
some realistic targets so that goals are met in a realistic 
way. For example, the only legislation that has been introduced 
so far is a piece of legislation on the Senate side that is 
setting up three demonstration projects, vanilla, chocolate, 
and swirl, and they are going to report in five years. So good 
luck on voluntary compliance to meet your 50 percent if that is 
the direction that we are going to be going.
    My other really big concern, especially when we are talking 
about mandatory and the role of Government and the rest is that 
I have found that Government is really good being the sovereign 
at requiring people to report what.
    And what I am hearing, and I hope as we move into this next 
panel that what is not going to get us there. It has got to be 
an analysis structure that goes into the why with as much data 
available as possible, and that that is not always conducive 
when you want to, even in a non-punitive or litigiousness 
situation, point the finger at people and reward those who do 
well and try to stop those who do not do well. That tends to be 
the direction, notwithstanding the desire, of a mandatory 
system and a structure of, we have got to get data.
    Qualitative analysis thoughtfully done may in fact produce 
better results in my opinion than a whole lot of quantity 
mandated because somebody wants to do something about the 
problem. Any reaction to that?
    Dr. Cassel. I would just heartily endorse the emphasis on 
the qualitative aspect of the data.
    Ms. Connell. So would I.
    Mr. Thomas. Notwithstanding the fact that you want 
everybody to participate in the system because, one, you do not 
know where the qualitative data is going to come from. But 
secondly, in my opinion, the openness of that system is what 
creates the willingness to, within the quantity, get the 
quality.
    Dr. Cassel. Yes.
    Mr. Thomas. I want to thank the panel very much. We took 
some time, but I just thought the unique backgrounds of both of 
you and the perspective that you might bring to this would set 
the tone and I appreciate very much your willingness.
    Now I would ask the defendants to approach the bench.
    [Laughter.]
    Mr. Thomas. Oh, I am sorry. The next panel is Dr. Michael 
Langberg, senior vice president of medical affairs, chief 
medical officer of Cedars-Sinai in Los Angeles, on behalf of 
the American Hospital Association. And Dr. Thomas Reardon, 
president and executive committee member of the American 
Medical Association.
    We have a vote underway. It is a 15-minute vote. If we can 
get both of your testimony in, your written testimony will be 
made a part of the record, and if you will address us in the 
time that you have, which if both of you take five minutes we 
will have enough time to vote. I believe it is going to be 
difficult to do, and if we are not successful in doing it then 
we will recess and come back.
    Dr. Langberg, do you want to start?

 STATEMENT OF MICHAEL LANGBERG, M.D., SENIOR VICE PRESIDENT OF 
MEDICAL AFFAIRS, AND CHIEF MEDICAL OFFICER, CEDARS-SINAI HEALTH 
  SYSTEM, LOS ANGELES, CALIFORNIA, ON BEHALF OF THE AMERICAN 
                      HOSPITAL ASSOCIATION

    Dr. Langberg. Mr. Chairman, and members of the committee, 
my name is Dr. Michael Langberg. I am the senior vice president 
for medical affairs, chief medical officer for Cedars-Sinai 
Health System in Los Angeles. The Cedars-Sinai Medical Center 
is the largest not-for-profit acute care hospital in the 
western United States, and together with more than 2,000 
physicians associated with our system, Cedars-Sinai provides 
care to an urban population of considerable diversity.
    I have spent almost all of my professional career at 
Cedars-Sinai as a general internist. Since 1996, I have served 
as its chief medical officer and am responsible for overseeing 
systemwide quality initiatives and information systems. I have 
developed a deep knowledge of the complexity of modern health 
care and have a broad background in improving the quality and 
safety of the patient experience.
    I am here today on behalf of the American Hospital 
Association. The AHA realizes that the entire health community 
has to address the serious issues raised in the Institute of 
Medicine's report on medical safety. I also want to share with 
you some of what hospitals and health systems are doing in this 
critical area.
    To begin, I would like to remind the committee and the 
American public that hospitals provide care to millions of 
patients safely every year. The people who deliver health care, 
the doctors, the nurses, and others, are highly trained, 
receive continuous education, and strive every day to deliver 
safe and compassionate care. They do believe in the dictum, 
first do no harm. But health care today is extraordinarily 
complex and even our best intentions can have unwanted and 
unintended consequences.
    The IOM report, To Err is Human, points out that as good as 
our systems are for preventing and reducing medical errors of 
all kinds, we can and we must do better. We applaud the members 
of the IOM committee for developing a report that shines a 
bright light on the problem of medical errors and are heartened 
by the quick response this has received.
    We agree with the report in urging all to avoid blaming 
individuals for past errors, and instead to focus on preventing 
future errors by designing safety into the system. It stresses 
two principles that we have learned, reduce errors and increase 
patient safety.
    First, to err is human. We must understand and improve the 
systems in which people work to make errors less likely. As a 
result, reducing errors requires us to design and implement 
more error-resistant systems.
    Second, we have to create an environment where caregivers 
feel they can come forward when an unfortunate mistake is made. 
We need to create a non-punitive environment that allows for 
the candid discussion of errors, their sources, their causes. 
If we cannot discuss our mistakes, we cannot learn from them or 
prevent them in the future.
    The AHA also agrees that stepped-up efforts are needed. 
There are many organizations today that specialize in the area 
of reducing and preventing medical errors. We at the AHA are 
working with some of these experts.
    In December, the AHA announced an initiative to target and 
improve medication safety. Why? Because medication related 
errors are one of the most common sources of all medical 
errors.
    As part of this initiative, the AHA formed a partnership 
with the highly respected organization in this field, the 
Institute for Safe Medication Practices. This non-profit 
research and educational organization and its president, 
Michael Cohen, have been dedicated for over 25 years to the 
continual reduction of medication errors throughout the health 
care system. We are pleased that they will provide leadership 
as well as technical expertise for the AHA's initiative.
    As part of our effort we will share with every one of our 
members successful practices for improving medication safety. 
We have already sent out a quality advisory on improving 
medication safety to our 5,000 hospital and health system 
members. This advisory includes background on the issue, 
resources our members can turn to for help, and a three-page 
list of successful practices for improving medication safety.
    We will follow up on how these successful practices are 
being implemented with a medication safety awareness 
assessment. We will also serve as a clearinghouse for 
information and resources, and are planning a national summit 
involving other organizations and hospital leaders to discuss 
widespread efforts to improve medication safety.
    In summary, Mr. Chairman, the IOM's report is timely. It 
brings together a number of stakeholders all at the same time 
to collectively address this important issue. As the report 
notes, large, complex problems require thoughtful, multifaceted 
responses. The AHA has pledged and committed to help its member 
hospitals and health systems respond to this critical issue.
    I will be happy to answer questions.
    [The prepared statement and attachments follow:]

Statement of Michael Langberg, M.D., Senior Vice President for Medical 
Affairs and Chief Medical Officer, Cedars-Sinai Health System, Los 
Angeles, California, on behalf of the American Hospital Association

    Mr. Chairmen, I am Michael Langberg, M.D., senior vice 
president for medical affairs and chief medical officer of 
Cedars-Sinai Health System in Los Angeles. I am here today on 
behalf of the American Hospital Association's (AHA) nearly 
5,000 hospital, health system, network, and other health care 
provider members. We are pleased to have the opportunity to 
testify on an issue of critical importance for hospitals and 
the patients and communities they serve: the Institute of 
Medicine's (IOM) report on medical safety, and what hospitals 
and health systems are doing to improve patient safety.
    The Cedars-Sinai Health System includes a number of 
physician officers distributed across the Los Angeles 
metropolitan area. Cedars-Sinai Medical Center is the largest 
not-for-profit acute care hospital in the western United 
States. Together with the 2,000 physicians associated with our 
system, Cedars-Sinai provides care to an urban population of 
considerable racial, ethnical, social, linguistic, religious 
and economic diversity.
    I have spent almost all my professional career at Cedars-
Sinai on the faculty in General Internal Medicine, originally 
as Director of Medical Education. In 1996, I assumed the role 
of chief medical officer overseeing system-wide quality 
initiatives and information systems. I have developed a deep 
knowledge of the complexity of modern health care, and have a 
broad background in improving the quality and safety of the 
patient experience. I believe that much of what is outlined in 
the IOM report is accurate. The report has focused attention at 
a time when many other activities are under way to address 
these issues, which many of the members of the IOM panel first 
brought to national awareness several years ago.

BACKGROUND

    For thousands of years, healers have lived by the motto 
primum non-nocere--first, do no harm. The nurses, doctors, and 
others on the patient care team in hospitals strive every day 
to deliver the safe, compassionate care that patients deserve. 
But in today's complex, high-tech world of medicine, our best 
intentions can have unwanted and unintended consequences. The 
IOM report, ``To Err is Human: Building a Safer Health 
System,'' points out that, as good as our systems are for 
preventing and reducing medical errors of all kinds, we can and 
must do better.

THE IOM REPORT AND HOSPITALS

    We applaud the members of the IOM Committee on Health Care 
in America for developing a report that shines a bright yet 
objective spotlight on the problem of medical errors. The IOM 
report is important, outlining the significance of the medical 
error problem in this country.
    It acknowledges that medicine is delivered by people who 
are highly trained and receive continuous education to stay on 
top of their respective areas of discipline. Hospitals and 
caregivers already work under strict internal quality control 
procedures, in addition to federal, state, local and 
independent oversight. Hospitals have important systems in 
place--checks and balances to reduce the potential for human 
error. For example, they have quality teams, physicians and 
nurses who examine unexpected deaths, treatment errors and 
accidents, to identify and correct the cause. And most 
hospitals have teams of experts whose sole focus is to develop 
and oversee safety policies to prevent accidents before they 
happen.
    In addition, there are many organizations that specialize 
in the area of reducing and preventing medical errors. The AHA 
is working with several of these organizations so that we can 
help hospitals and health systems benefit from their knowledge 
and expertise. Among them: the National Patient Safety 
Partnership--a public/private partnership of organizations; the 
National Coordinating Council for Medication Error Reporting 
and Prevention; and the American Medical Association National 
Patient Safety Foundation. We're doing this because, as the IOM 
report points out, a vigilant, ongoing, stepped-up effort to 
improve patient safety is needed.
    We agree with the report that we need to avoid ``blaming 
individuals for past errors'' and instead ``focus on preventing 
future errors by designing safety into the system.'' We also 
agree that, as the report states, ``professional societies and 
groups should become active leaders in encouraging and 
demanding improvements in patient safety.'' The AHA is 
committed to being just that kind of leader, so that America's 
health care system does indeed focus not on blame, but on 
prevention.
    The IOM report focuses on the broad issue of medical 
safety. The AHA, at a White House event in December with 
President Clinton, announced an initiative to improve 
medication safety, because medication errors are one of the 
most common sources of overall medical errors. We used the 
opportunity to point out that whatever happens at the national 
level will only be valuable if it helps the women and men like 
me and those I work with at the Cedars-Sinai Health System--
people who are on the front lines of health care--do their jobs 
even better.
    Speaking of action at the national level, we understand the 
committee's interest in determining whether further legislation 
is needed to address medication errors. But before moving to 
consider new legislation, we urge Congress to consider the 
reporting mechanisms currently in place--by organizations like 
the Veterans Administration, the Joint Commission on the 
Accreditation of Healthcare Organizations, and the Institute 
for Safe Medication Practices--to collect and use information 
on errors. Congress should know how these current mechanisms 
work and consider ways to improve them, if necessary, before 
proposing new reporting systems.
    The AHA believes we need to be clear about what our 
objectives are in collecting information on events that may be 
related to errors. Reporting should be a tool for reducing and 
preventing errors. It should be designed to stimulate 
organizations and practitioners to analyze what went wrong and 
make the necessary changes to ensure that the mistakes do not 
happen again. In addition, lessons learned from one error 
should be widely shared with others. Provider accountability 
should be tied to these objectives.
    The quantity of reports is not nearly as important as the 
quality. One need not read 500 reports of workers mixing up two 
similar sounding medications, before it becomes obvious that 
the two medications need better labeling. Our goal should not 
be to ensure that every provider report every event, but rather 
to encourage dialogue to learning.

AHA ACTIVITIES

    More than a year ago, the AHA board and many of our 
hospital leaders attended a national forum in Cleveland. The 
topic: improving patient care. Though we have long been 
involved in improving the quality of care provided in the 
nation's hospitals, we came away from that particular meeting 
with a strong sense from hospital leaders that, on a national 
level, we could do more … we needed to address these 
issues head on.
    But the issue of medical error is very broad in scope. We 
set our sights specifically on improving medication safety--
reducing and preventing medication errors that result from 
things like different drugs being packaged in similar 
containers, use of confusing abbreviations on labels and 
prescriptions, illegible doctor handwriting, and more.
    Against the backdrop of all this activity came the IOM 
report, which led overnight to increased awareness of the 
importance and seriousness of this issue. The release of the 
report came as we were preparing to kick off our initiative to 
take a comprehensive look at hospitals' ability to prevent 
medication errors and help them make improvements where needed.
    As part of our initiative, we formed a partnership with a 
highly respected organization in this field, the Institute for 
Safe Medication Practices (ISMP). This non-profit research and 
education organization is dedicated to reducing the incidence 
of medication error throughout the health care system, and will 
provide leadership and technical expertise for the AHA's 
initiative. ISMP provides independent review of errors reported 
through the Medication Errors Reporting Program (MERP), which 
ISMP was instrumental in founding. Through MERP, health care 
professionals across the nation voluntarily complete pre-
addressed mailers or dial a toll-free number (800-23-ERROR) to 
report actual and potential medication errors with complete 
confidentiality. As an official MedWatch partner, ISMP shares 
all information and prevention ideas with the U.S. Food and 
Drug Administration (FDA) and other professional and policy 
organizations. Working with practitioners, regulatory agencies, 
health care institutions, professional organizations, and the 
pharmaceutical industry, ISMP provides timely and accurate 
medication safety information and works toward improvements in 
drug distribution, naming, packaging, labeling, and delivery 
system design.
    The following four objectives are key to our medication 
safety campaign with ISMP.

Develop a non-punitive process for discussing errors

    Most of what has been learned in recent years about how to 
reduce errors and increase patient safety is based on two 
principles. First, individuals, by the very nature of being 
human, are vulnerable to error. Although they are the focus of 
the error, errors happen because of the systems in which these 
individuals work. As a result, reducing errors will require us 
to design and implement more error-resistant systems.
    Second, we have to create an environment in which we learn 
from failure. This requires us to identify an effective 
mechanism for candid discussion of errors. This cannot be 
achieved in an environment of punishment or fear. Doctors, 
nurses and other caregivers should not be penalized for 
stepping forward after an unfortunate mistake is made. A more 
open environment can only occur when health care providers are 
afforded adequate legal protections.
    Today, when health care providers are required to disclose 
confidential internal information to health care oversight 
agencies, they may jeopardize state law that protects internal 
quality analysis discussions and expose themselves to crushing 
legal liabilities. There is no incentive to share this 
information with others to prevent similar events in other 
institutions. We believe protections that currently apply to 
such information should also apply when it's disclosed. We 
believe that evidentiary, confidentiality and other legal 
reforms should be considered to help foster an environment that 
promotes candor.
    Candor is absolutely critical if we are to be truly 
successful in identifying, learning from and reducing not only 
medication errors, but all medical errors, and making the 
health care system safer. We need to create a non-punitive 
culture at all levels that supports the collection of 
information about errors, along with candid discussion of 
errors, their causes, and ways to prevent them from happening 
again. A safe, non-punitive environment will encourage people 
to report and discuss errors--the first step in lessening the 
chance they will happen in the first place and making sure they 
do not happen again.

Share successful practices with every hospital and health 
system

    We sent to every AHA member the attached ``Quality Advisory 
on Improving Medication Safety.'' The advisory includes 
background on the issue, a long list of resources our members 
can turn to for help, and a three-page list of ``successful 
practices'' for improving medication safety. Some of these 
practices can be adopted easily and quickly, such as providing 
staff with information about ordering, dispensing, 
administering and monitoring medications, not storing certain 
concentrated solutions on hospital wards, and helping patients 
better understand what they are talking, why, and how to use it 
safely.
    Others are longer-term practices that, with time and money, 
can create significant changes throughout our members' 
organizations. Among these are the development of a voluntary, 
non-punitive system to monitor and report errors that might 
occur within hospitals, and the computerization of medication 
administration systems.
    We compiled the list of successful practices with the help 
and advice of some of the best experts in the field--including 
the ISMP, the Institute for Healthcare Improvement, the 
Massachusetts Coalition for the Prevention of Medical Errors, 
the National Coordinating Council for Medication Error 
Reporting and Prevention, the National Patient Safety 
Partnership and many others.

Develop a ``medication safety awareness test'' for use by 
hospitals

    To follow up on how the successful practices are being 
implemented, we are working with ISMP to develop a ``Medication 
Safety Awareness Test'' to help our members assess their 
progress. This tool will also help the AHA get an idea of what 
other help its members may need, and help us track and 
demonstrate hospitals' success at improving medication safety.

Serve as a clearinghouse of information and resources for 
hospitals

    The AHA will continue making available to its members up-
to-date information on improving medication safety. We will 
gather information from outside sources and work with other 
national organizations to develop information and data. We are 
planning a medication safety ``summit,'' gathering other 
organizations and hospital leaders together to discuss 
widespread efforts to improve medication safety. And we will be 
adding to our Web site (www.aha.org) a special area containing 
all the information, data, best practices, and other resources 
we compile in our medication safety improvement campaign.
CONCLUSION

    Mr. Chairman, the IOM report is very timely. It comes as 
America's health care system enters a new century of caring for 
people. It marks an opportunity for us to rebuild the public's 
confidence and trust in the health care system they rely on 
every day. And it reminds us that, despite setbacks, we still 
deliver the greatest health care in the world.
    But it also notes that ``large, complex problems require 
thoughtful, multifaceted responses.'' Reducing and preventing 
medication errors, and improving the overall safety of the 
health care system, will demand the thoughtful collaboration 
and participation of everyone involved in the health care 
field: hospital leaders, pharmacists, drug manufacturers, 
doctors, nurses, government agencies, other organizations, and 
consumers. America's hospitals and health systems are committed 
to this effort.

                          AHA Quality Advisory

    A Message to AHA Members:
    Primum non nocere. Above all, do no harm. Healers have 
lived by this motto for thousands of years. The minimum our 
patients expect from us is safe and compassionate care when 
they enter a hospital. And they deserve to get it.
    But in today's complex, high-tech world of medicine, our 
best intentions can have unwanted consequences. And those 
consequences are contributing to the public's eroding 
confidence and trust in the health care system.
    While the recently released Institute of Medicine study has 
drawn a lot of attention to medication errors, we have been 
working on this issue for some time. Following up on 
discussions with the AHA Board of Trustees and Regional Policy 
Boards on improving hospitals' accountability to their 
communities, the AHA is developing an initiative to help you 
improve patient safety by reducing and preventing medication 
errors. To provide leadership and technical expertise in this 
effort, we have formed a relationship with the Institute for 
Safe Medication Practices (ISMP), a not-for-profit research and 
education organization dedicated to reducing the incidence of 
medication error throughout the health system.
    This is what you can expect from us in the coming months.
    First, we will provide you with strategic and practical 
advice to reduce the potential for and incidence of medication 
error. To jump start this initiative, we are attaching several 
successful practice recommendations compiled from respected 
sources.
    Next, together with ISMP, we are developing a ``Medication 
Safety Awareness Test'' that will help you assess your progress 
on implementing recommendations in your hospital, and that will 
enable us to track and demonstrate your success at improving 
medication safety.
    The recommendations that follow can greatly improve patient 
safety. The first set can be implemented immediately; they 
focus on standardization and simplification of processes that 
will likely reduce the potential for human error. The second 
set require changes to existing organizational systems; they 
will likely require a longer-term implementation plan and may 
rely on computerization of the physician order-entry and 
pharmacy dispensing processes.
    Here are some ways to get started:
     Consider organizing a senior management team to 
review and discuss the attached recommendations. This team 
could include the CEO, chief medical officer, chief operating 
officer, chief nurse executive, director of pharmacy, risk 
manager, director of information systems, and others. Some 
organizations also include patients on this team. Assess your 
organization's processes as they compare to the recommendations 
and track your progress on implementing changes.
     Review your policies and procedures for reporting 
and investigating errors. Create an open, non-punitive culture 
that evaluates and corrects errors.
     Review information about incidents that occur 
within your institution and use it to find opportunities for 
improvement. Consider personally investigating an adverse event 
yourself, including talking directly with those involved.
     Help your organization's physicians, nurses, and 
other patient care staff be prepared to respond to patients' 
questions about adverse medical events and about the general 
quality of care in your organization.
     Make sure your staff is aware of the tremendous 
amount of information available from organizations like the 
ISMP, the Institute for Healthcare Improvement, the Food and 
Drug Administration, the U.S. Pharmacopeia, the Massachusetts 
Hospital Association, the National Coordinating Council on 
Medication Error Reporting and Prevention, the National Patient 
Safety Partnership, the National Patient Safety Foundation, the 
American Society for Health-System Pharmacists, and the 
American Society for Healthcare Risk Management.
     Lead the way with executive behavior: Declare the 
goal of safety to be a specific priority of you and your board. 
Be certain to keep your board and organized medical staff up to 
date on all the actions you're taking.
    Look for more from us in the near future. We'll provide 
strategic and practical advice on reducing errors, and we'll be 
your clearinghouse for information and resources. The AHA is 
committed to helping you create a safer, more effective, and 
more efficient health care system.
            Dick Davidson President

AHA Quality Advisory

                      Improving Medication Safety

Background

    Most of what has been learned in recent years about how to 
reduce medication errors and increase patient safety is based 
on two principles. First, individuals, by the very nature of 
being human, are vulnerable to error. Although individuals are 
the focus of the error, errors happen because of the systems in 
which those individuals work. As a result, reducing error will 
require us to design and implement more error-resistant 
systems. Second, we have to create an environment in which we 
can learn from failure--a safe, non-punitive environment that 
supports open discussion of errors, their causes, and ways to 
prevent them.
    These principles have a common denominator--they require 
the leadership and commitment of senior executives, medical, 
nursing, and clinical staff to create change within our 
organizations.

Common Sources of Error

    Medication systems in hospitals are complex and multi-
layered, involving many steps and many individuals. This 
complexity increases the probability of failure. While many 
errors are caught before they can cause harm, it can be tragic 
whenever a patient's safety is compromised. Error can occur at 
any stage--prescribing, ordering, dispensing, administering, or 
monitoring the effects of a medication. According to the 
Institute for Safe Medication Practices, some common sources of 
medication error in health systems include:

Unavailable Patient Information:

    Critical patient information (diagnoses, lab values, 
allergies, drug contradictions, etc.) is often unavailable to 
pharmacy, nursing, and medical staff prior to dispensing or 
administering drugs.

Unavailable Drug Information:

    Pharmacists often are not readily available on patient care 
units and written resources may not be up-to-date, which can 
lead to dose miscalculations or ignorance of drug interactions. 
Because errors occur most often during the prescribing and 
administration stages, accessible drug information must be 
readily available and close at hand for all staff who prescribe 
and administer drugs.

Miscommunication of Drug Orders:

    Failed communication is at the heart of many errors. This 
includes poor handwriting, confusion of drugs with similar 
names, careless use of zeroes and decimal points, confusion of 
metric and apothecary systems, use of inappropriate 
abbreviations, ambiguous or incomplete orders, and, sometimes, 
conflicts between practitioners.

Problems with Labeling, Packaging and Drug Nomenclature:

    Most drugs are dispensed through unit dose systems that 
parse medications into smaller-sized doses. These systems, 
however, do not always provide for thorough preparation, 
packaging, and labeling of medications, with screening and 
checking by both nursing and pharmacy personnel, and they may 
not be available throughout every unit in the hospital (e.g., 
ERs and ICUs). Drug administration procedures often do not 
ensure that medications remain labeled until they reach the 
patient's bedside, a frequent source of error.
Drug Standardization, Storage, and Stocking:

    Stocking multiple concentrations of the same drug, or 
storing drugs in look-alike containers or in ways that obscure 
drug labels, may contribute to error. Lack of safety procedures 
for use of automated dispensing technology or inadequate check 
systems may also contribute to errors.

Drug Device Acquisition, Use and Monitoring:

    Lack of standardization in drug delivery devices, improper 
default settings, unsafe equipment (e.g., free-flow infusion 
pumps), and the lack of independent check systems for verifying 
dose and rate settings can all contribute to device-related 
errors.

Environmental Stress:

    Environmental factors like lighting, heat, noise, and 
excessive interruptions, can affect individual performance. The 
process of transcribing orders is particularly vulnerable to 
distractions in the environment, as staff transcribing orders 
are exposed to noise, interruptions, non-stop unit activity, 
and too-long or double shifts.

Limited Staff Education:

    Many practitioners are not as aware as they should be of 
situations within their own organizations that have been 
reported as error-prone, or of similar information published in 
professional literature.

Limited Patient Education:

    Medication use is a multi-step, multidisciplinary process 
that begins and ends with the patient. Patient education about 
medications--what they are taking, why they are taking it, and 
how they should take it--is essential to successful medication 
administration. Patients can be partners in the prevention of 
error while hospitalized and need to be educated to safely 
self-administer medications when they go home.

Quality Improvement Processes and Risk Management:

    Health facilities need systems for identifying, reporting, 
analyzing, and correcting errors and identifying trends, and 
measurement systems for tracking the effect of system changes. 
Also, organizations need to take into consideration information 
from outside sources about errors that have occurred elsewhere. 
But above all, health organizations need to cultivate a non-
punitive approach to error that will encourage frank 
identification and analysis of errors when they occur.

Steps for Improving Medication Safety

    These potential sources of error can be controlled if we 
design safer systems. With this in mind, the AHA has attached 
to this advisory a list of successful practices for improving 
medication safety and for improving overall patient safety 
within our hospitals and health systems. We encourage your team 
to review this list of recommendations, plan for 
implementation, and begin to track your progress.

Our Sources

    The recommendations were culled from several reliable 
sources that are leaders in the effort to reduce and prevent 
medication errors, and we are grateful for their pioneering 
efforts. This list includes those organizations, as well as 
other resources for your organization's efforts.
     American Society of Health-System Pharmacists 
(www.ashp.org)
     American Society for Healthcare Risk Management 
(www.ashrm.org)
     Institute for Healthcare Improvement (www.ihi.org)
     Institute of Medicine (www.national-academies.org)
     Institute for Safe Medication Practices 
(www.ismp.org)
     Joint Commission on Accreditation of Healthcare 
Organizations (www.jcaho.org)
     Massachusetts Hospital Association 
(www.mhalink.org)
     Massachusetts Coalition for the Prevention of 
Medical Errors (www.mhalink.org/mcpme)
     National Coordinating Council on Medication Error 
Reporting and Prevention (www.nccmerp.org)
     National Patient Safety Foundation (www.npsf.org)
     U.S. Pharmacopeia (www.usp.org)

Books

    1. Cohen, Michael R., Ed. Medication Errors. Washington, 
D.C. American Pharmaceutical Association. 1999. (Contains a 
special chapter on high-alert medications and dangerous 
abbreviations; rich with insight and practical advice on 
reducing the risk of error.)
    2. Corrigan, Janet, et al. To Err is Human: Building a 
Safer Health System. Washington, D.C. National Academies Press. 
1999. (Comprehensive overview of medical error, containing many 
practical suggestions and recommendations from several trusted 
sources.)
    3. Leape, Lucian, et al. Reducing Adverse Drug Events. 
Boston, MA: Institute for Healthcare Improvement. 1998. 
(Concepts to reduce adverse events and a model for 
improvement.)

Patient Information Brochures

    1. Your Role in Safe Medication Use: A Guide for Patients 
and FamiliesgT1 is available from the Massachusetts Hospital 
Association at www.mhalink.org
    2. Partners in Quality: Taking an Active Role in Your 
Health Care is available from the Hospital & Healthsystem 
Association of Pennsylvania at www.hap2000.org
    3. How to Take Your Medications Safely is available from 
the ISMP at www.ismp.org
    4. Just Ask! is available from the U.S. Pharmacopeia at 
www.usp.org
    Information on Safe Medication Practices
    From the Institute for Safe Medication Practices
     ISMP Medication Safety Alert!
     Urgent Error Advisories
    From the U.S. Pharmacopeia
     Dangerous Abbreviations
     Practitioner Reporting Alerts
     Drug Quality Alerts
     Look-alike Sound-alike Name Lists
    From the Joint Commission on Accrediation of Healthcare 
Organizations
     Sentinel Event Alerts

          Successful Practices for Improving Medication Safety

             Easily implemented changes (process redesign)

    The following steps can be implemented immediately by 
hospitals and health systems. They focus on standardization and 
simplification of medication system processes.

                   Fully implement unit dose systems

     Maintain and systematically use unit-dose 
distribution systems (either manufacturer-prepared or 
repackaged by the pharmacy) for all non-emergency medications 
throughout the hospital. Unit dose systems should include, in 
addition to packaging, systems for labeling and order 
screening.
     Stress the need for dose adjustment in children, 
older persons, and patients with renal or hepatic impairment.

               Limit the variety of devices and equipment

     For example, limit the types of general purpose 
infusion pumps to one or two.

 Develop special procedures and written protocols for high-alert drugs

     Use written guidelines, checklists, dose limits, 
pre-printed orders, double-checks, special packaging, special 
labeling, and education.
     Remove concentrated potassium chloride/phosphate 
from floor stock.
     Limit the number of possible concentrations for a 
drug, particularly high-alert drugs like morphine and heparin. 
Such standardization will allow the use of premixed solutions 
from manufacturers or centralized preparation of IV medications 
in the pharmacy.
     Review JCAHO Sentinel Events Alert #11, Nov. 19, 
1999. Also, review Chapter 5 of Michael Cohen's 1999 book, 
``Medication Errors,'' published by the American Pharmaceutical 
Association.

         Ensure the availability of up-to-date drug information

     Make updated information on new drugs, 
infrequently used drugs, and non-formulary drugs easily 
accessible to clinicians prior to ordering, dispensing, and 
administering medications (e.g., have pharmacists do rounds 
with doctors and nurses; distribute newsletters and drug 
summary sheets; use computer aids; and provide access to 
formulary systems and other internal resources).
     Review error potential for all new products, 
including a literature review, before any drug or procedure is 
approved for use; reassess six months to one year later.

                             Educate staff

     Provide physicians, nurses, pharmacists, and all 
other clinicians involved in the medication administration 
process with orientation and periodic education on ordering, 
dispensing, administering, and monitoring medications.
     Distribute information about known drug errors 
from outside organizations like the Institute for Safe 
Medication Practices (ISMP) and the U.S. Pharmacopeia (USP).

                            Educate patients

     Patients should be educated in the hospital, at 
discharge, and in ambulatory settings about their medications, 
what they are taking, why they are taking it, and how to use it 
safely.
     Encourage patients to ask questions about their 
medications.
     Encourage health care providers to work with 
pharmacists on patient education when patients receive certain 
classes of medications or are discharged on more than five 
medications.

             Ensure the availability of pharmacy expertise

     Have a pharmacist available on-call when pharmacy 
does not operate 24-hours a day.
     Make the pharmacist more visible in patient care 
areas--consider having pharmacy personnel make daily rounds on 
units, or enter orders directly into computer terminals on 
patient care units.

          Standardize prescribing and communication practices

     Avoid certain dangerous abbreviations (see ISMP 
and USP for examples); identify a list of unacceptable 
abbreviations that will not be used in your institution.
     Include all elements of the order--dose, strength, 
units (metric), route, frequency, and rate.
     Use full names (preferably generic).
     Use computerized reminders for look-alike and 
sound-alike drug names.
     Use metric system only.
     Use preprinted order sheets whenever possible in 
non-computerized order systems.

                Standardize multiple processes, such as:

     Doses
     Times of administration (for example, antibiotics)
     Packaging and labeling
     Storage (for example, placing medications in the 
same place in each unit)
     Dosing scales (for example, insulin, potassium)
     Protocols for the use and storage of high-alert 
drugs

                 Longer-term changes (systems redesign)

    The following steps will require substantial changes to 
existing organizational systems; they will likely require a 
longer-term implementation plan and a continual focus on 
improvement. Many of the recommendations rely on 
computerization in the physician order-entry and pharmacy 
dispensing processes.

Develop a voluntary, non-punitive system to monitor and report adverse 
                              drug events

     Review policies for how your organization 
encourages reporting and analyzing errors throughout the 
institution.
     Encourage open communication and feedback.
     Ensure no reprisals for reporting of errors. 
Reports will increase if you make it safe to report.

 Increase the use of computers in the medication administration system

     Encourage the use of computer-generated or 
electronic medication administration records.
     Plan for the implementation of computerized 
prescriber order entry systems.
     Consider the use of machine-readable code (i.e., 
bar coding) in the medication administration process.
     Use computerized drug profiling in the pharmacy.
     Be a demanding customer of pharmacy system 
software; encourage vendors to incorporate and assist in 
implementing an adequate standardized set of checks into 
computerized hospital pharmacy systems (e.g., screening for 
duplicate drug therapies, patient allergies, potential drug 
interactions, drug/lab interactions, dose ranges, etc.).

          Institute 24-hour pharmacy service if possible . . .

    . . . alternatively, use night formularies and careful drug 
selection and storage procedures. To facilitate medication 
distribution after hours, develop policies and procedures to 
ensure access to consultation with a pharmacist if a pharmacist 
is not available on-site.

                     AMERICAN HOSPITAL ASSOCIATION

                            December 6, 1999

    Mr. Thomas. Thank you very much, Dr. Langberg.
    Dr. Reardon, welcome once again. Your testimony will be 
made a part of the record, and if you could do it slightly 
under five minutes we would be greatly appreciative because we 
are going to ask questions.

   STATEMENT OF THOMAS R. REARDON, M.D., PRESIDENT, AMERICAN 
                      MEDICAL ASSOCIATION

    Dr. Reardon. I will do my best. Good morning, Mr. Chairman, 
and members of the committee.
    The AMA appreciates your initiative in calling this hearing 
to focus attention on the major concern to all of us, the 
safety and quality of care for patients in our health system. 
The elimination of health system errors is not only a high 
priority for the AMA, it is an important ethic of the medical 
profession. We believe that any error that harms a patient is 
one error too many.
    In short, the AMA believes that Congress, States, and the 
private sector together can achieve significant advances in 
health system safety and quality without delay. We recommend 
that Congress do the following.
    One, fund research to analyze existing data. This would 
have an immediate impact on patient safety and provide guidance 
on designing future data collection methods. Two, fund the 
Agency for Healthcare Research and Quality, AHRQ, to provide 
grants for new private sector patient safety research centers 
across the country.
    Three, extend peer review liability and confidentiality 
protections to those involved in patient safety improvement 
initiatives. And four, fund AHRQ to disseminate effective 
patient safety strategies nationwide.
    Congress has already taken steps consistent with these 
recommendations. For example, in the Healthcare Research and 
Quality Act of 1999 which was just enacted in December, 
Congress directed the AHRQ to conduct and support research and 
build public-private partnerships to first of all identify the 
causes of preventable health care errors and prevent injury in 
the health care delivery; develop, demonstrate and evaluate 
strategies for reducing errors and improving patient safety; 
and disseminate such effective strategies throughout the health 
care system.
    AHRQ is also directed to coordinate all research, 
evaluations, and demonstrations related to quality measurement 
and quality improvement activities undertaken and supported by 
the Federal Government.
    In addition, in the BBA 1997, Congress directed the 
Medicare Payment Advisory Commission to look at issues related 
to quality of care for Medicare beneficiaries. Accordingly, the 
Medicare Payment Advisory Commission's 1997 report to Congress 
contains a chapter and seven recommendations to Congress 
addressing the issue of health care errors under Medicare.
    One Medicare Payment Advisory Commission recommendation was 
noted in the IOM is for Congress to pass legislation to protect 
the confidentiality of individually identified information 
relating to errors in health care delivery, and that when that 
information is reported for quality improvement purposes.
    The AMA strongly supports the principle under the IOM 
report that the health care system must be transformed from its 
existing culture of blame and punishment which suppresses 
information about errors into a culture of safety that focuses 
on an openness and information sharing to improve health care 
and prevent adverse outcomes.
    This does not mean that negligent actions should be 
protected. Accountability for negligent or incompetent actions 
is already well-established in our health care and judicial 
systems for physicians and other health care providers. State 
and Federal courts, State licensing boards, and accrediting 
bodies such as the JCAHO all function to maintain 
accountability and standards. Along with accountability though, 
we must have a system whereby medical professionals can convene 
to discuss patient safety issues and potential solutions 
without having their discussions, findings, or recommendations 
become the basis for lawsuits.
    The IOM report recommends a mandatory reporting system for 
deaths or serious outcomes. However, investing in expensive 
data collection without clear objectives may in fact divert 
resources from other, more productive approaches to improve 
patient safety. We believe that mandatory public reporting 
could have unintended consequences and elicit less information 
than a well-designed, well-run voluntary program. In fact, 
there is no evidence that patients in States that have a 
mandatory reporting system are any safer than those in States 
that do not have that mandatory reporting system.
    Congress can assist by providing funding to establish 
extramural research programs that would be administered by AHRQ 
with centers for patient safety established throughout the 
country to analyze available data on errors, deaths, and other 
adverse outcomes. Thus, the AMA strongly supports the IOM 
report recommendation for Congress to provide the funds and 
technical support necessary to analyze the information obtained 
from current error reporting systems and conduct follow-up 
actions.
    The AMA has been working in a concerted effort to 
accomplish many of the objectives outlined in the IOM report. 
For example, in 1996 and 1998, the AMA joined with other health 
care leaders to convene the Annenberg conferences which have 
already resulted in several initiatives in patient safety that 
are being undertaken at the State and national level, such as 
preventing injuries due to medication errors.
    In 1997, the AMA established the National Patient Safety 
Foundation, an independent, not-for-profit organization that 
convenes forums to discuss patient safety matters and provides 
grants to stimulate patient safety research. The NPSF was cited 
several times in the IOM report for its work and is well-
positioned to utilize its diverse group of health care leaders 
and other stakeholders to continue improving patient safety.
    I thank you for the opportunity to testify and look forward 
to your questions.
    [The prepared statement follows:]

Statement of Thomas R. Reardon, M.D., President, American Medical 
Association

    Good morning, Mr. Chairman and members of the Committee, my 
name is Thomas R. Reardon, MD. I am the President of the 
American Medical Association (AMA) and a general practice 
physician from Portland, Oregon.
    The AMA greatly appreciates Chairman Thomas' initiative in 
calling this hearing today to discuss the issue of patient 
safety and the recent report released by the Institute of 
Medicine (IOM). This IOM Report, entitled To Err is Human: 
Building a Safer Health System, has focused the nation's 
attention on a major concern to us all--the safety and quality 
of care for patients in our health care system. We commend the 
IOM for its efforts in examining the issues of patient safety 
and quality of care, and welcome the opportunity to work 
cooperatively with the IOM, Congress, and health care leaders 
to further advance the quality and safety of patient care.
    The elimination of health system errors is not only a high 
priority for the AMA, it is an important ethic of the medical 
profession. As an association founded on the commitment of 
physicians to improve the quality of medical care, we believe 
that any error that harms a patient is one error too many.
    And, clearly, the public shares the AMA's concerns. For 
example, the November/December 1999 Kaiser Family Foundation/
Harvard Health News Index reported that 51% of Americans 
closely followed news coverage on the IOM Report. While much of 
the information in the IOM Report is not new, there is much 
that is new and exciting in the private sector's response to 
the issues raised in the IOM Report. For instance, the AMA has 
a longstanding commitment to improving patient safety and 
quality of care, and has been working in a concerted manner, 
especially in recent years, towards many of the objectives 
outlined in the IOM Report. Several recent examples of these 
efforts are the AMA's creation of the American Medical 
Accreditation Program, the National Patient Safety Foundation, 
and the Performance Measurement Coordinating Council, and our 
active participation in the President's Advisory Commission on 
Consumer Protection and Quality in the Health Care Industry and 
the new National Quality Forum.
    We believe that Congress can make a significant positive 
impact on reducing health systems errors by:
     Funding research to analyze existing data to 
determine ways to improve patient safety and provide guidance 
on the advisability and potential design of future data 
collection methods;
     Funding the Agency for Healthcare Research and 
Quality (AHRQ) to provide grants for new private sector patient 
safety research centers around the country;
     Extending peer review liability protections to 
those involved in patient safety improvement initiatives, and 
confidentiality protections for individually identifiable 
information reported for health system safety and quality 
improvement purposes; and
     Funding AHRQ to disseminate effective patient 
safety strategies nationwide.

Creating a Culture of Safety

    The AMA strongly supports the principal underlying the IOM 
Report that the health care system needs to transform the 
existing culture of blame and punishment that suppresses 
information about errors into a culture of safety that focuses 
on openness and information sharing to improve health care and 
prevent adverse outcomes. The AMA also supports the IOM's focus 
on the need for a system-wide approach to eliminating adverse 
outcomes and improving safety and quality, instead of focusing 
on individual components of the health system in an isolated or 
punitive way.
    What can Congress do to help create a culture of safety?
    Congress has already taken several steps to help create a 
culture of safety. In fact, Congress recently passed specific 
legislative language to reduce errors in the health system. In 
December 1999, the Healthcare Research and Quality Act of 1999 
(P.L. 106-129) was enacted into law to reauthorize the AHRQ 
(formerly AHCPR). In Section 912(c) of this law, Congress 
clearly showed its commitment to reduce errors in the health 
care system by, inter alia, directing AHRQ to conduct and 
support research and build private-public partnerships to: 
``(1) identify the causes of preventable health care errors and 
patient injury in health care delivery; (2) develop, 
demonstrate, and evaluate strategies for reducing errors and 
improving patient safety; and (3) disseminate such effective 
strategies throughout the health care industry.'' (emphasis 
added) Further, by separating this bill from the Senate's 
patient protection legislation (S. 1344), Congress has sent a 
clear message on the way to ensure patient safety and quality.
    Also, when Congress passed the Balanced Budget Act of 1997 
and created the Medicare Payment Advisory Commission (MedPAC), 
it directed MedPAC to look at issues related to quality of care 
for Medicare beneficiaries. Accordingly, MedPAC's June 1999 
Report to Congress contains a chapter and seven recommendations 
to Congress addressing the issue of ``health care errors under 
Medicare.'' In its report, MedPAC recommends that the Secretary 
of Health and Human Services establish patient safety as a 
quality improvement priority for Medicare and take steps to 
minimize preventable errors in health care delivery.
    One area where we believe Congress additionally could be 
helpful would be to enact legislation to expand peer review and 
confidentiality protections for those seeking to identify 
safety problems and their solutions, as recommended by the IOM 
Report. Legislation excluding from liability those engaged in 
patient safety improvements, similar to the exclusions for 
biomaterials suppliers contained in the Biomaterials Access 
Assurance Act of 1998, could be an important step toward a new 
culture of safety.
    MedPAC and the Joint Commission on Accreditation of 
Healthcare Organizations (JCAHO) have made similar 
recommendations to Congress. The June 1999 MedPAC Report 
recommends that Congress enact legislation ``to protect the 
confidentiality of individually identifiable information 
relating to errors in health care delivery when that 
information is reported for quality improvement purposes.'' The 
IOM Report states that MedPAC's recommendation is a ``promising 
alternative.'' Likewise, JCAHO recently testified that it has 
been seeking federal legislative protection to protect from 
disclosure information developed in response to a sentinel 
event and shared with an accreditor.
    The matter of accountability for negligent or incompetent 
actions is already well established in our health care and 
judicial systems for physicians and other health care 
providers. State and Federal courts, state licensing boards, 
and accrediting bodies such as JCAHO all function to maintain 
accountability and standards. However, the very fear of 
existing legal liability or its misapplication are the greatest 
hurdles to pioneering patient safety efforts.
    For example, when the Anesthesia Patient Safety Foundation 
was founded, legal liability was a major concern. The creative 
approach employed by the anesthesiologists was to start by 
looking at claims that have already been settled or closed. 
Unfortunately, waiting for a case to settle or close before a 
problem can be discussed without the fear of litigation 
needlessly delays important feedback that otherwise could 
result in an immediate solution. Congress can help create a 
culture of safety by allowing medical professionals to convene 
to discuss patient safety problems and potential solutions 
without having their discussions, findings, or recommendations 
become the basis for class action or other lawsuits. If the 
fear of litigation continues to pervade efforts to improve 
patient safety and quality, our transformation into a culture 
of safety on behalf of our patients may never be fully realized
    The IOM Report recommends a mandatory reporting system for 
deaths or serious adverse outcomes. However, the AMA agrees 
with the AHRQ, the VA, and many leading organizations and 
experts on health care matters that mandatory public reporting 
could have unintended consequences and elicit less information 
than a well-designed, well-run voluntary program. We believe 
that other recommendations in the IOM Report offer more 
fruitful avenues for Congress to consider at this time. Past 
federal efforts to collect data on physicians and other health 
care providers in the name of quality improvement have had a 
negative effect on efforts to create an environment that 
fosters trust and open communication. Simply focusing on 
finding the individuals who contribute to an error completely 
ignores the epidemiological and health services research 
approaches that have produced many notable advances in the 
quality and safety of patient care.
    Any approach to improving patient safety should, at a 
minimum, include a non-punitive mechanism for reporting 
incidents, post-incident evaluations for identification of 
system changes to prevent subsequent occurrences, and federally 
guaranteed legislative protection from discovery for all 
aspects of information gathered to improve patient safety. 
System-wide trust and communication are fundamental elements 
for successful reform.
    Non-punitive approaches have yielded useful results in 
related contexts. For example, Congress should consider the 
experience of the past several decades in preventing hospital-
acquired infections. With the scientific support of the Centers 
for Disease Control and Prevention and AHRQ, hospital 
epidemiologists and physicians specializing in hospital-based 
infectious diseases have systematically undertaken thousands of 
investigations of endemic and epidemic infections. These 
studies have been done in a blame-free environment in which 
learning was the major goal. The infection controllers observed 
that spontaneous reporting of infections and broad, voluntary 
surveillance provided misleading information. They recognized 
the need for targeted surveillance and focused objectives for 
the infection control program, as well as for simple, clear 
definitions of infections. Hospital-acquired infection rates 
have declined precipitously as a result of these efforts.
    There is a great danger in oversimplifying the task of 
assuring patient safety. Like infant mortality, teen pregnancy, 
and flu virus, patient safety must be approached using the same 
epidemiological and health services research methods that we 
use to address other public health problems. Truly effective 
quality improvement requires intensive surveillance with 
monitoring, tracking, analysis of variations, assessment of 
interventions, feedback, and education. Organizations must 
focus on studying and improving the entire process of care, not 
just identifying blame. Enumeration of errors without sound 
scientific analysis is futile, and diversion of scarce 
resources to cataloguing all errors could be cost inefficient 
and unproductive.
    In other words, more data collection for the sake of having 
more data, absent specific goals and scientifically designed 
studies, is unlikely to yield real improvements in patient 
safety Indeed, investing in expensive data collection without 
clear objectives may in fact divert resources from other more 
productive approaches to improve patient safety. As MedPAC 
stated in its June 1999 Report, ``In devising error-reduction 
initiatives, the program should conduct small-scale tests of 
approaches that have been developed for other industries as 
well as for health care before adopting approaches for 
programwide use.''
    The AMA's approach to reducing medical errors is similar to 
that recommended by the IOM in its report. In fact, when the 
IOM Committee on Quality began to examine this issue, we were 
pleased that the National Patient Safety Foundation (NPSF) 
(which shares the AMA's goals to improve patient safety) was 
invited to discuss its efforts and provide information that 
contributed to the report. Thus, the AMA welcomes the IOM 
recommendation for a system-wide approach to reducing medical 
errors in which punitive efforts are rejected and instead, 
efforts to create a culture of safety are recommended.

Health Services Research for Patient Safety

    The AMA has been a pioneer in the effort to reduce health 
care system errors and ensure that our patients receive safe, 
quality health care. For example, in 1996, the American 
Association for the Advancement of Science, JCAHO, and the AMA 
joined with the Annenberg Center for Health Sciences to convene 
the first multidisciplinary conference on errors in health 
care. The outcome includes several initiatives in patient 
safety that are being undertaken at the state and national 
level, such as preventing patient injuries due to medication 
errors.
    Given the importance for this agenda and the imperative for 
physician leadership, the AMA established in 1997 the National 
Patient Safety Foundation (NPSF), a broad-based partnership of 
health care clinicians, consumer advocates, health product 
manufacturers, public and private employers and payers, 
researchers, regulators, and policymakers. The NPSF is an 
independent not-for-profit organization that now serves as the 
forum for a diverse group of concerned individuals to think and 
talk about the issues and impediments to patient safety.
    The initiatives undertaken by the NPSF are similar to those 
recommended in the IOM Report. For example, the NPSF has 
convened a group of national authorities concerned with 
reducing medication errors. This group has identified 41 
challenges for improvement and is now in an implementation 
phase. Also, the NPSF has developed an agenda for research that 
seeks to identify the core issues that should be targeted by 
the broader research community, and has awarded eight research 
grants to advance patient safety. Further, with the support of 
the AHRQ, the NPSF is cataloging patient safety research 
projects that will document the extent of patient safety 
research as well as identify gaps in existing knowledge.
    Congress can further assist with these private sector 
efforts to reduce health system errors and adverse outcomes by 
providing funding to private sector organizations to analyze 
available data on errors, deaths, and other adverse outcomes. 
This will help identify their root causes and potential 
solutions.
    Although the IOM has recommended a nationwide mandatory 
reporting system for deaths or serious adverse outcomes, we 
fail to see any linkage between the mandatory reporting systems 
established to date and real improvements in patient safety and 
quality of care. The IOM Report states, for example, that at 
least one-third of states already have adverse event reporting 
systems, and the IOM interviewed 13 of these states. However, 
there is no data to indicate that patients accessing the health 
care systems of states with mandatory reporting systems are any 
safer than those in states without reporting systems. Indeed, 
the IOM Report makes no such claim.
    The AMA strongly supports the IOM recommendation for 
Congress to provide the funds and technical support necessary 
to analyze the information obtained from current error 
reporting systems and conduct follow-up action as needed. A 
focus group that the IOM conducted with 20 states identified a 
clear need for resources, tools, methods, and protocols to 
allow them to constructively address this issue. In addition to 
the states and the FDA, private sector organizations such as 
JCAHO, NCQA, U.S, Pharmacopeia, as well as private health 
insurance companies, have a wealth of data that has yet to be 
mined for information that could be used to improve patient 
safety.
    The IOM Report does not describe how a nationwide mandatory 
reporting system--or even the state reporting systems that are 
in place right now--would lead to elimination of errors and 
improvements in patient safety and quality. The appropriate way 
to target the nation's scarce resources to improvements in 
health system safety is to fund research in the private sector 
to determine how best to utilize data to improve quality of 
care. What data elements are useful? How should these data be 
analyzed, tabulated, and evaluated to identify root causes, 
system problems, and safety problems? How can they be used to 
identify solutions and prevent future errors? How can such 
information be integrated into educational curriculums, 
practice guidelines, accreditation programs, and performance 
measurement? These are some of the questions upon which we must 
focus.
    As the IOM Report notes, the sheer volume of reports to a 
system does not determine the success of that system. To the 
contrary, obtaining data on all deaths or adverse outcomes in a 
national mandatory reporting system would represent an 
unnecessary and inefficient allocation of resources. Programs 
that collect larger numbers of error reports are unlikely to 
yield much new information beyond what can be learned from a 
comprehensive analysis of a limited sample of error reports.
    To date, the approaches that have been most successful in 
health services research provide government funding for 
targeted studies and demonstration projects conducted in the 
private sector or with private sector partners. Extramural 
research programs such as the Multipurpose Arthritis and 
Muskuloskeletal Disease Centers funded by the National 
Institutes of Health, the Veterans Administration's Health 
Services Research and Development Field Programs, and the 
Evidence-based Practice Centers (EPC) funded by the AHRQ are 
excellent examples. Similar extramural research centers could 
be established with AHRQ grants to focus on research in patient 
safety. As an alternative to establishing a Center for Patient 
Safety within the AHRQ, the EPC model could be used with AHRQ 
administering a program of grants for research and pilot 
projects to be conducted in several different patient safety 
centers. The nation's leading health systems, for example, 
could be funded to establish their own internal reporting 
systems and conduct research on patient safety problems and 
solutions using their own data. In addition, the activities of 
non-profit organizations, such as the NPSF, could be advanced 
considerably with new government funding.

Conclusion

    The AMA believes that true reform must include all 
components of the health care system and not focus only on 
individual components. Hospitals, physicians, nurses, 
pharmacists, drug and device manufacturers, nursing homes, and 
others must all work together and be encouraged to work 
together to identify, study, and solve system-wide problems 
that could cause errors or adverse outcomes. Our common goal 
must be to detect errors and system barriers to make 
corrections before a patient is harmed.
    Simply adding more regulation and more mandates are not the 
answer to improve patient safety and quality. The AMA strongly 
urges Congress to advance with the same caution and 
deliberation as the medical community in its efforts to create 
a culture of safety for patients in all health care settings. 
Congress must understand the efforts already being implemented 
in both the public and private health care delivery systems 
before passing legislation. When and if legislation is enacted, 
we must all be certain that it will support and enhance the 
initiatives already underway, and not set back these efforts. 
As stated in the IOM Report, a system must be designed to 
detect, prevent, and minimize health care system hazards to 
reduce errors. This can be achieved best by first acknowledging 
that the vast majority of health care system errors are not 
intentional and must be distinguished from truly negligent 
behavior. The focus must remain on reforming the system, not 
punishing the individual. We must collectively focus our 
efforts on identifying solutions that benefit patients.
    Nationwide dissemination of the identified solutions would 
do a great deal more to improve the safety of the nation's 
health care system than would a nationwide mandatory reporting 
system. As it has done with dissemination of practice 
guidelines, Congress should direct the AHQR to disseminate 
current information on patient safety and prevention of adverse 
events, and provide grants to research currently available 
data.
    The AMA is committed to continuing and redoubling our 
efforts to work with Congress and our partners in the medical 
care system to achieve a health system in which patients are 
assured of safe, quality health care. We appreciate having the 
opportunity to be here today to support the IOM's efforts to 
reduce health system errors. Thank you.

                                

    Mr. Thomas. Thank you, Doctor, and I am sure your 
handwriting is legible as well.
    [Laughter.]
    Mr. Thomas. We are going to recess until 12:15.
    [Recess.]
    Mr. McCrery. [presiding] The committee will come to order. 
Mr. Thomas has been unavoidably detained for a few minutes and 
he has asked me to reconvene the hearing, which I am pleased to 
do.
    Dr. Reardon, let me begin with you, if I may. As you know, 
I am very interested in this topic of liability. The AMA and 
members of Congress have talked for years about the liability 
system in this country and the flaws in the liability system, 
and we have tried mightily to correct some of those flaws 
through medical malpractice reform here at the national level, 
but not successfully. So we have depended on the States to go 
forward, and many have, with very reasonable reforms to their 
medical liability systems.
    I noticed in your testimony that you talked about the 
failure or the culture of blame and punishment. You were 
speaking a little fast, which we appreciated, but it sounded as 
if you were saying that this culture of blame and punishment 
was producing bad results. That it inhibited the discovery of 
errors, omissions, that could be corrected or addressed. Was 
that the implication of those remarks?
    Dr. Reardon. Yes, it was. Let me expand, if I may, just a 
moment. I think what I was talking about is that we need to 
change to a system of openness where we have open discussions 
and feel free that the information is not going to be 
discoverable, for instance, for medical malpractice.
    For instance, I made a statement that we do have a system 
of accountability which is the court system, and if there is a 
medical error for instance and there is a lawsuit on one side, 
at the same time we need to be able to have an open discussion 
and what went on with that medical error, what happened, why it 
happened, and what we can put into place so it will not happen 
again. Those discussions we would like to see protected. They 
could be peer review discussions of a medical error. But we 
would like to have those confidential and protected so that 
they could not be discovered and used against the physician in 
a lawsuit.
    We think if we do not have that, as was pointed out I think 
for the anesthesiologists when they first started their system, 
they sometimes put off the discussion of the medical error for 
three or four years until the suit was settled. I think you 
lose an opportunity there to talk about it when it is immediate 
and fresh and the information is fresh in everybody's mind and 
you can, I think, do a much better job.
    Mr. McCrery. Does the liability system itself and this 
culture of fear or blame and punishment account at all for the 
fact that very few doctors around the country have been brought 
up before voluntary licensing groups around the country? I have 
got some data here that says that in a typical year the number 
of physicians who are brought before State boards of medicine 
is less than 5,000 around the country. Whereas, the report that 
we got recently from the IOM estimates that between 44,000 and 
98,000 patients die a year from medical errors. I know that it 
not all doctors, but there does seem to be a disparity there.
    Is that culture of blame and punishment and the liability 
system partly to blame for the lack of enforcement in your 
licensing boards?
    Dr. Reardon. I think there are two issues here. First of 
all, many of the medical errors we are talking about are system 
errors, oftentimes not attributable to any particular 
individual but a fault in the system. The other issue I think, 
Congressman, is that a malpractice suit does not mean you are a 
bad doctor. You can provide the best care, do the best that you 
can and have an adverse outcome. So that the best doctors can 
get sued over the course of a lifetime.
    So this does not ordinarily come to the attention of a 
State licensing board unless there are a series of errors on an 
individual doctor, and then a licensing board may feel inclined 
to step in and review that particular physician. So I think 
there are two different issues there.
    Mr. McCrery. Yes, they are two different issues but why--
let me just ask you. Why are there so few doctors brought 
before licensing boards for discipline? I mean, I am concluding 
that it is few. It seems to me to be a few. Maybe you disagree 
and you can explain why. But it seems to me to be a few in 
comparison to the number of physicians we have and the number 
of instances of medical delivery.
    Dr. Reardon. I think the most common reason a physician is 
brought up before the licensing board is substance abuse, 
either alcohol or drugs. Probably the other issues can be 
sexual involvement with patients, sexual abuse, if there is a 
pattern of egregious medical practices, and those issues do 
come up. Now I think it also depends on the individual State. I 
come from the State of Oregon, which I think we have a very 
active board. There are probably 80 to 100 physicians on 
probation at any one time, being monitored by the State board.
    But also the State board of medical examiners are limited 
by two things. One is the powers invested in them by the State 
legislatures through the medical practice acts; and two, their 
funding. So I think those are the two issues that we look at, 
as we have criticism of boards and some boards are more active 
than others, they have some limitations based on what the 
legislature invests.
    I cannot really comment whether 5,000 is a lot or not a 
lot, but I can tell you what the most common investigations 
are.
    Mr. McCrery. If in fact most of the investigations are not 
related to the delivery of health care but rather with personal 
problems with the physician, that underscores to me the need to 
at least question whether the licensing procedures and the 
disciplinary procedures that are in place are effective.
    Again, I want to try to relate it to this culture of blame 
and punishment. Is it in fact part of the culture among 
physicians not to expose fellow physicians that they know may 
be guilty of errors, omissions in their practice because they 
do not want someone to put the finger on them in this liability 
system that we have for fear of being punished?
    Dr. Reardon. I can only comment on my own experience, and 
that is that I think it behooves all of us if we see a pattern 
with a physician of aberrant practice, of poor quality, to 
report that, and I think that is reported from time to time. 
But the fact of a medical error does not mean that he is a bad 
physician. We are taught in medical school to try and be 
perfect, to do everything right. And yet, because it is a 
complex system, patients are not--are different. You sometimes 
treat the same condition differently in different patients. So 
there is a lot of variation in that care.
    But an adverse outcome or a malpractice suit does not mean 
that is a bad doctor. I think there needs to be a pattern of 
behavior.
    Mr. McCrery. I agree, and I certainly do not mean to imply 
that every doctor who is guilty of some error or omission is a 
bad doctor. We all make mistakes, and unfortunately doctors are 
human too and they do make mistakes. But again, I think that we 
need to examine all the systems that we have put in place to 
try to exact quality care and reexamine those in light of the 
data that has come to light in the last few months. Certainly 
the disciplinary procedures that are in place are one of those 
systems that we need to look at.
    I am a lawyer. We have the same kind of similar 
disciplinary boards and so forth as the medical profession and 
ours probably does not work very well either, to tell you the 
truth. So maybe we should take a look at that, among other 
systems that we have in place.
    Now our chairman is back, and I am pleased to turn it back 
over to the chairman since I have to go to another function 
across the way. Mr. Chairman, I am going to return it to you. 
And before that, Mr. Stark, are you prepared to inquire of the 
witnesses?
    Mr. Stark. I am not really prepared, but I am ready.
    [Laughter.]
    Mr. Stark. I guess I would ask both Dr. Langberg and Dr. 
Reardon, my sense is that you both--I do not know whether you 
object to running a reporting system and improvement system 
through the PROs (Peer Review Organizations) or prefer to do it 
through the AMA or the AHA. But I think that is a basic theme 
that I am getting, that somehow you want to do it yourself--I 
mean, the organizations you represent--and not do it through an 
independent agency.
    But I think both of your constituencies have worked with 
PROs for 18, 20 years now, and the information I think is 
confidential, and I think the incentives are right. The AMA 
does not have half the doctors in the country. The AHA probably 
has all the hospitals or 90 percent of them. So if the AMA does 
it, we are not dealing with half the doctors, and that seems 
ineffective. The AHA would be investigating the people who pay 
their salaries, and that does not seem very productive.
    So what would be wrong with having the PROs run a system of 
supervising and setting up error reduction plans and dealing 
with it? Dr. Langberg? Dr. Reardon?
    Dr. Langberg. I think the fundamental question to any 
reporting system is what is the purpose of reporting and--
    Mr. Stark. We have talked about that this morning. We are 
all trying to reduce errors.
    Dr. Langberg. And in that light, the question is whether 
reporting to a PRO and having the PRO be responsible for 
improving errors within hospitals is the best way to get errors 
to be reduced. Working to improve care at my facility and 
watching the way in which people come together to address 
difficult, complex clinical circumstances and move forward.
    Mr. Stark. Doctor, you are missing the point. Cedars has a 
good plan. Let us stipulate to that. But there are some 
hospitals--the San Leandro Hospital that is owned by Columbia 
in San Leandro, California is not worth poop. They do not have 
a good plan. Now how are we going to get them to have as good a 
plan as you have? And what is wrong with having PROs say, 
``look, you have got to have a plan''? Then go ahead and let 
them review and report back. That is what I am getting at.
    I mean, what you are talking about is the plan in your 
hospital. Let us stipulate that that is excellent. Now how do 
we get the--you are suggesting the AHA is going to get other 
hospitals to do it? Well, I do not know. I think that the PRO 
groups would do it more efficiently and not be captive to the 
people who pay their salaries, which is the problem with the 
AHA.
    Dr. Langberg. I thank you for the stipulation about the 
quality of my institution's program. What I want to try to 
describe is that in our experience and in the hospitals' 
experience generally there already exists organizations to whom 
we report in one form or another our programs and plans to 
improve care around these kinds of issues.
    As you know, Congressman Stark, in California the 
accreditation process for hospitals involves a tripartite 
review of the California Medical Association, the State 
Department of Health, and the Joint Commission. They do a very 
thorough review not only of our outcomes, but of our internal 
processes and systems which identify and improve errors.
    Having recently gone through that experience in the last 
six months, it is a highly detailed, exhaustive experience. Our 
obligation is to respond to recommendations and improve any 
deficits that were found by that review within specific 
timeframes we face financial consequences if the recommended 
improvements aren't implemented and adhered to.
    So I guess the response I am making is, firstly, that I 
believe there already are in place organizations that can be 
engaged to assist hospitals in developing those programs if 
they do not already exist.
    Secondly, if I can make a couple comments about PROs. I 
agree with all the comments you made regarding our experience 
with them. My colleague, Dr. Golden, will be testifying later. 
I have a great deal of respect for the PRO. However, the PROs 
are generally viewed by practitioners as governmental agencies. 
I know they are technically not, but they are viewed as 
governmental agencies.
    Mr. Stark. Okay, that answers that. Let us try this, 
Doctor. We have had 500 reports of workers mixing up two 
similar sounding medications, and before you get around to 
saying it it becomes obvious, we need to label it.
    Each year we have 800,000 accidental needle sticks to 
health workers, some of which lead to death from AIDS and 
hepatitis. So it would seem that we need to reengineer needles 
for the safety of the workers, and in California, which you 
mentioned--I happen to be from there--we have legislated that 
that be necessary. Yet the AHA is still resisting doing that 
nationwide. Tell me how you are helping us there.
    Dr. Langberg. The AHA is working with OSHA--
    Mr. Stark. No, they are resisting it, not working with. Let 
us get that straight.
    Dr. Langberg. As I understand it, the AHA is at least in 
dialogue with OSHA about ways in which to look at this 
nationwide. I hesitate to go back to my own experience in my 
hospital, however, at this point needles will not go away, and 
sharp things will not go away. I do not mean--
    Mr. Stark. Okay, Doctor, thank you.
    Dr. Reardon, what does the AMA say about working with PROs 
to accomplish some kind of review and collection of data and a 
system for helping to reduce errors?
    Dr. Reardon. Mr. Stark, I think in my testimony I mentioned 
that we were supportive of the Agency for Health Research and 
Quality as being an agency potentially for doing that, with 
patient safety centers across the country for gathering data. 
Quite frankly, the answer I think from the physicians' point of 
view is that PROs, which are under HCFA, I think, are looked at 
by many as governmental and somewhat punitive in the past, and 
this I think would bother the physician community that they 
have been punitive. We would like to do this as an open 
process, to change the culture to one of safety away from 
punitive and punishment.
    Mr. Stark. Can you give me an example of punitive actions 
that PROs have taken against physicians?
    Dr. Reardon. I am not sure I can give you--I can give you 
in general terms----
    Mr. Stark. No, no, I would challenge that.
    Dr. Reardon. I cannot give you a specific example, I am 
sorry.
    Mr. Stark. I think what you are both saying then is, you 
have both said you do not want Government to do this, you want 
to do it yourselves basically, or through some voluntary 
means--which is what we have had for the past 20 years or more 
and you have not done it. The docs have resisted, the AMA has 
resisted recertification. The hospital association has resisted 
safe needle requirements.
    The indication is that the professional organizations are 
not willing to really do much on their own unless there is some 
requirement. Now I would be perfectly willing to let the courts 
do it, but then you want to be absolved from any chance that 
anybody will sue you.
    So in the absence of anybody being able to sue you, and the 
absence of anybody being able to require you to do it except 
the guys paying their dues where you are all in the same club, 
I am just a little worried that it will not get done without a 
little more incentive. It does not have to be Government, as 
long as it is independent. It is my understanding the PROs are 
independent. We happen to pay them.
    But the problem with JCAHO, which is a lousy organization, 
is that you guys pay them in the hospital community, so they 
cave in to you. And about every five years we have to threaten 
to fire them, and then they get tough and go look at some 
hospitals. But the rest of the time they just go out and have 
lunch with the hospital administrators and do not do poop.
    Well, we are back to the same-old, same-old, Mr. Chairman. 
I mean, if we do not have laws, then I do not think we will get 
anything done. But these guys do. Thank you, gentlemen.
    Chairman Thomas [presiding]. Thank the gentleman.
    Someone who has highlighted particular areas in medicine in 
a rather dramatic way is a doctor who also happens to be a 
fairly successful author by the name of Robin Cook. He has a 
penchant for one-word titles: Fever, Brain, Toxin. I read one 
called Coma, which was I guess, for wont of a better word, a 
diatribe against managed care, and that there was in essence at 
this one hospital a criminal conspiracy to kill people. You can 
imagine my reaction after having read that novel and looking at 
the IOM report, that those people who were consciously doing it 
are pikers.
    Now I anxiously await a novel by Robin Cook, and I would 
even be so bold as to suggest a title: Oops. But I do not think 
he is going to write one, because I think when you have a 
centristic view of the universe and that all planets orbit 
around you, it is extremely difficult to address the fact that 
problems may, in fact a majority of problems may initiate with 
you. Part of the gentleman from California's frustration is the 
fact that if we are going to do something in this area, the 
same-old, same-old is probably not going to be acceptable.
    Now I am willing to go along with you, and I would like to 
ask you a series of questions so that you can increase my 
comfort level that what you are advocating will in fact produce 
results. Dr. Langberg, in your testimony in fact you said that 
the American Hospital Association is working with several 
organizations--I think it was three, as a matter of fact--to 
help improve patient safety and reduce medical errors. Have you 
got any specific data to show that medical errors have been 
reduced?
    Dr. Langberg. The AHA's partnership with the Institute for 
Safe Medication Practices was announced in December, so I do 
not have any information in the last six weeks.
    Chairman Thomas. Do you know when we might get some 
evidence that the structure that you have initiated that you 
wish us to allow to self-nurture will produce changed behavior; 
i.e., fewer medical errors?
    Dr. Langberg. I can, Mr. Chairman, give you the timeframe 
for the program the AHA has created afterwards.
    Chairman Thomas. Okay. And you oppose mandatory reporting? 
Or are there conditions under which you would accept mandatory 
reporting?
    Dr. Langberg. Keeping in mind that the purpose of reporting 
is to improve care, I know from my own direct experience that 
virtually every meeting of physicians and other caregivers, 
every peer review meeting, every root cause analysis meeting 
generally starts off with a discussion about confidentiality, 
non-disclosability. In California we have an evidence code that 
goes by the number 1157 that allows for peer review to take 
place without fear of civil litigation, and that has been an 
extraordinary aid to open up discussions in our institution.
    My fear about mandatory reporting is along the lines of 
chilling what in my experience has been dramatically productive 
discussions among colleagues, inclusive but not only with 
physicians, as we try to improve things.
    Chairman Thomas. You mentioned California, and obviously 
Cedars-Sinai is in California, and California has a mandatory 
reporting law on particular events. I am reading from the back 
of the IOM book which is invaluable to give me a State by State 
analysis. Do you believe that the mandatory reporting structure 
in California has had an ongoing chilling effect in the 
collection of data and the correction of medical errors since 
it has been in place since like 1972?
    Dr. Langberg. No, I do not believe it has had a chilling 
effect.
    Mr. Thomas. So if we use a model kind of like California 
has then it would be okay?
    Dr. Langberg. I think the practice in California and the 
kind of things that have to be reported, to the best of my 
recollection, tend to be move of catastrophic in nature, 
epidemic kinds of issues that may be occurring in a hospital, 
in contrast to the output of individual peer review root cause 
analysis looking at what may have gone wrong or close calls in 
a given case.
    Chairman Thomas. It has as a list of reportable events, 
disappearance or loss of a patient. I assume that means not 
having them expire, but you simply lose track of them. So lost 
patients are critical to this reporting structure, but not 
patients who have been terminated by medical errors. Do you 
know of the California law and why maybe it would not include 
that as a reportable event? And would you then be adamantly 
opposed to the California law if it were amended to include 
that kind of an item as a reportable event?
    Dr. Langberg. I confess ignorance on the legislative intent 
of the California law, having been in place as you point out 
for a couple decades. The question of reporting a death due to 
medical error is obviously a complex one, and my earlier 
comments went back to the effect of having to report, and what 
in which settings that would hamper our ability to surface 
concerns about a case and the detailed analysis required to get 
the answers.
    Again from my direct experience, Mr. Chairman, the 
causality in any case of unexpected outcome is always complex. 
I have yet to be involved in an analysis of a case----
    Chairman. Thomas. As is the case of an airplane crash. As 
is the case in many other instances. Let me try to explain the 
situation we are in. I am trying to let you make your case. I 
want to turn to the gentleman from California on my left and 
say, I have a high comfort level that your push to get a 
mandatory structure is not one that I can support, and you guys 
have got to help me.
    The question is this, if we could show that mandatory 
reporting reduced deaths due to medical errors, is not the 
ultimate thing to make sure that people do not die through 
medical errors? And if a mandatory structure could show that 
would you be in favor of a mandatory structure? Or are you just 
philosophically opposed to the idea of mandatory? That is what 
I am trying to understand here.
    Dr. Langberg. For me it is not a matter of philosophy. For 
me it is a matter of direct experience with people going 
through this.
    Chairman Thomas. So I cannot create a comfort zone, change 
the liability laws, utilize that FAA total confidentiality 
structure? I have got a clean sheet of paper. What is it that 
you believe you need in place to have a minimal comfort level 
with a mandatory reporting system? Is there no list that we can 
write that would create a comfort level for you on a mandatory 
reporting system?
    Dr. Langberg. Given the context of a mandatory reporting 
system----
    Chairman Thomas. No, we write the context.
    Dr. Langberg. Right. No, given the question, which is given 
a mandatory reporting system, what would be required to make me 
more comfortable with that. That is the question.
    Chairman Thomas. Make you minimally acceptable of it.
    Dr. Langberg. Right. Even though, as I know you know 
already, our position is to support a voluntary system. But in 
the context of a mandatory system, our biggest, first concern 
would have to be on the protections of peer review and its 
discoverability, disclosability in any kind of public and legal 
setting.
    The ability to extend what are perhaps best practices in 
States and other locations that provide confidentiality 
protections resulting in full dialogue. These kinds of things I 
think ought to be identified and perhaps replicated on a 
national basis. They exist already in some locations. So that 
would be the first issue that I would want to put before you.
    Chairman Thomas. If we could come to an agreement over the 
next month on that, Dr. Reardon, if the conference on patient 
protection had not concluded and we were able to present that 
as an additional item, which after all on patient protection if 
you are going to reduce the number of patients that are being 
killed that would seem to be a useful location and a very 
timely vehicle. Would the American Medical Association consider 
that a poison pill?
    Dr. Reardon. Mandatory reporting are you asking me, Mr. 
Chairman?
    Chairman Thomas. No, all of the criteria that you folks 
write that you need to have acceptable mandatory reporting. Or 
better yet, your vision of voluntary reporting. If we offered 
that in the conference so that it could move through the House 
and the Senate expeditiously and be put in place, because I am 
quite sure the President would not veto something that would 
reduce medical errors and therefore accidental deaths; would 
that be a poison pill to you?
    Dr. Reardon. May I respond, Mr. Chairman, about my concerns 
about mandatory reporting?
    Chairman Thomas. No, I asked voluntary. We will do 
voluntary.
    Dr. Reardon. We would certainly be willing to look at a 
voluntary system and work with you on that.
    Chairman Thomas. Do you know how high a comfort level that 
is? Zero. You write it and give it to me, and then I put it in. 
Would you call that a poison pill in the patient protection 
bill?
    Dr. Reardon. I am sorry, sir, you are asking me that we 
would write it and give it to you?
    Chairman Thomas. Sure. I will put in what you write. Would 
that be a poison pill?
    Dr. Reardon. I would not look at that as a poison pill, no.
    Chairman Thomas. You would not.
    Dr. Reardon. No.
    Chairman Thomas. Okay, that is a starting point. Now we 
will work on it.
    Dr. Langberg, in your testimony you briefly mention JCAHO, 
the Joint Commission on the Accreditation of Hospitals. The 
commission has an external sentinel event reporting system in 
which hospitals participate. I believe that was started in 
1996. Was there general acceptance and willingness to go with 
that system when it was first put in place or did hospitals 
resist it?
    Dr. Langberg. There are two components to the sentinel 
event system and I actually would like to go on record as 
acknowledging the Joint Commission for coming up with this, and 
Dr. O'Leary personally for his role in advocating this.
    Chairman Thomas. And that was the basic position of 
virtually all hospitals, going on record, thanking, supporting, 
and willing to go forward?
    Dr. Langberg. I do not know what the former positions were 
in previous testimony. The two components had to do with the 
creation of a sentinel event system. The second component had 
to do with the reporting of the outcome of those systems.
    In my institution we have taken that direction to heart and 
have created, I think, an outstanding sentinel event--we call 
it significant adverse event system that tries to capture what 
might be sentinel events as defined by the Joint Commission as 
well as near misses, and encouraging all kinds of people in the 
institution from volunteers, nurses, transporters, to 
physicians, and administrators, to report anything they might 
see through a process that leads to a rapid root cause analysis 
and an identification of problems and attempts to fix them. 
That has been a great boon to our process to improve care.
    The question of reporting got a lot of evaluation at the 
hospital level, and from my recollection there were two primary 
considerations. The first consideration was that the 
protections under our State's non-disclosability law would only 
be valid if the discussions were taking place between 
designated peer review bodies within the State. So going to an 
out-of-State reporting peer review, according to legal 
evaluation, punch holes through the very protection in peer 
review that we were hoping to maintain.
    The second issue had to do with issues around liability and 
malpractice considerations, if again this information was 
reported out of State. Those two considerations, not the 
reporting concept but the concept of chilling the atmosphere 
where the good work was in fact able to be done, was what the 
general objections were about.
    Chairman Thomas. I will just tell you that my guess is that 
there is probably not a comfort level that the only response 
that we would make would be three five-year demonstration 
projects under HCFA as our only response to this problem. There 
will be a contest as to the question of mandatory versus 
voluntary, and I believe you people will have a significant 
role to play in whether or not someone such as myself look 
seriously at mandatory reporting.
    To the degree you are forthcoming, to the degree we 
actually set up a structure which does what we believe needs to 
be done, to the degree you minimize the arguments which I 
believe to have less merit than you attempt to present, since 
time I think they do not have merit, then we can try to put a 
fairly hefty voluntary structure. I still do not know that 
there may not need to be some mandatory.
    I will tell you that there is no question in my mind that 
there has to be an absolute guarantee of the privileged nature 
of the information, the confidentiality. And I am more than 
willing, since I have tried to offer six times in the past and 
I did on this bill which the AMA called medical malpractice 
reform a poison pill on the patient protection legislation, an 
opportunity to change the liability question.
    But somewhere in this matrix, looking a bit at the VA 
because they do, I believe, have a liability issue and I want 
to talk to them about that. Looking at what has occurred in 
aviation, notwithstanding all the differences that are involved 
in these two areas, there is, in my opinion, something that is 
going to be done.
    To the degree it is something that you would rather live 
with than not live with is basically up to your folks in your 
willingness to have positive input in the process. By positive, 
that is not to continue a dialogue of great concern, upset by, 
unwilling to. Otherwise we will just write it without your 
input.
    I would value your input in a constructive way in setting 
up a procedure which significantly--I would love to say 50 
percent in five years--which significantly reduces medical 
errors for which I can see no conceivable reason for 
continuing. You people are eminent professionals, both in the 
institutional area and in the personal practice area. And you 
cannot sit here and tell me your professions on their own, 
pledging a professional commitment to do no harm, have produced 
a significant shift.
    If you believe things are better than 10 years ago, show 
me. If you believe the things that you have done in the last 
three years are showing concrete results and we should wait for 
them to show more concrete results, show me.
    But if you cannot, then we are going to move. It is 
absolutely unacceptable, especially given the beginning of 
every statement by every medical person, our pledge is to do no 
harm. You are. Through errors and failures to set up a 
systematic procedure of examining why things went wrong. We 
have got a lot of what. If we do not get to the why we will 
never change the what.
    I want to thank you very much. I look forward to working 
with you. Apparently the conference on patient protection is 
going to extend longer than we thought. I have got a nice 
little slot available for a number of what I believe to be 
appropriate items that we could fit in there and expeditiously 
move them to the signature of the President. I would hope that 
you would examine your medicine chest and carefully reevaluate, 
Dr. Reardon, what you think is or is not a poison pill.
    Thank you very much.
    The gentleman from California.
    Mr. Stark. I just want to say that thus far I think you and 
I can work together on this. Whether there will be a conference 
to get it into or not is a question. I suppose it depends on 
the health of the Democrats at this point.
    But I am struck also by the Chair's interest in changing 
the way, for instance, the way we reimburse teaching hospitals. 
Now I have never heard any complaints from the American 
Hospital Association when we spend all that money to help them 
run their teaching hospitals. They like Government then, do you 
not, Dr. Langberg?
    Dr. Langberg. I think the teaching hospitals--
    Mr. Stark. It is kind of helpful, is it not?
    Dr. Langberg.--appreciate the reimbursement that is given 
them.
    Chairman Thomas. Like the recent readjustment which gave a 
couple of bucks to California, versus New York.
    Mr. Stark. They love us when we are paying them money. But 
when we suggest that maybe we get quality results and pass a 
law, then they do not want Government interfering.
    Chairman Thomas. Excuse me. Is the gentleman suggesting 
that they are in the human condition?
    Mr. Stark. I may be. I just want to remind you that the 
next time you come in to ask for money, that you were here 
today saying do not get in our way, in terms of passing laws 
that would require higher quality. We would just make a note of 
that, because we will remind you of that again the next time 
the AHA wants to come and ask for help.
    Chairman Thomas. Again, thank you and I look forward to 
working with you. We do have some opportunities here and I 
believe it is incumbent upon us to do what we can as much as we 
can, not just in the current framework but moving forward. 
Thank you very much.
    Now, thanking them for their indulgence, I would like to 
ask the last panel to come forward. There obviously was a 
reason why we did the panels in the order that we did, because 
I was anxious to have some interactive comment from some 
individuals who I think are actively involved in trying to make 
it happen in reflection of those to whom it is happening to.
    Our panel consists of Dr. James P. Bagian, Director, 
National Council for Patient Safety, Veterans Health 
Administration, U.S. Department of Veteran Affairs; Dr. Kenneth 
Kizer, recently from that environment, now President and Chief 
Executive Officer, National Quality Forum for Healthcare 
Measurement and Reporting; Dr. Dennis S. O'Leary, President on 
the Joint Commission on Accreditation of Health Care 
Organizations; and Dr. William Golden, President, American 
Health Quality Association.
    Thank you all. Your written testimony will be made a part 
of the record and, in the time that you have, you can address 
us in any way you see fit.
    Why do we not start with you, Dr. Bagian, and then move 
across the panel.

  STATEMENT OF JAMES P. BAGIAN, M.D., PE, DIRECTOR, NATIONAL 
CENTER FOR PATIENT SAFETY, VETERANS HEALTH ADMINISTRATION, U.S. 
                 DEPARTMENT OF VETERAN AFFAIRS

    Dr. Bagian. Thank you, Chairman.
    It is a pleasure to have been asked to come here today. You 
already have my record, as you mentioned. I will not talk 
directly about that, but try to address some of the issues you 
brought up earlier in the morning, because I think we have a 
number of things we can concretely point to that might be a 
source of discussion.
    To start out with one thing I would like to point out, and 
I know when Ms. Connell was up here she referred to it as well, 
about aviation. The problem in aviation was not much different 
from medicine 50 years ago. In fact, my father was a fighter 
pilot during World War II and stories he would tell me as a 
boy, it did not seem much different.
    He would talk about in the afternoon, at training command, 
you could look around the horizon on any given afternoon and 
see a pillar of smoke somewhere from a crash. In fact, if you 
look at the statistics during World War II, more planes were 
lost in training and non-combat than in combat. That is no 
longer the case. It is because aviation looked at it in a 
different way. They could not just keep doing the same thing, 
they had to do it differently.
    I think medicine is at the same point now, too, and that 
can refer to the comments that were made before, what has 
changed? I think things do need to change.
    In the VA, we think reporting is important. The purpose for 
reporting, as has been mentioned, is not just to report. I 
think you were the ones that mentioned about the qualitative 
versus quantitative. Just counting does not do it. If Linda 
Connell was here, she would tell you, or Charlie Billings, her 
predecessor, that it is not about counting. It is about 
identifying vulnerabilities and then what you do about them.
    To just know that they are there and do nothing serves no 
purpose. It might keep somebody employed, but that is not the 
point. The point is what do you do to make it better, and how 
do you test that.
    Along those lines, the VA looked at this system, and we 
have several systems. One of the ones I will talk about is an 
internal mandatory reporting system. When we say mandatory, I 
think there has been a lot of talk about mandatory and 
voluntary----
    Chairman Thomas. Dr. Bagian, as a backdrop, and if you are 
going to get to it then I apologize, but I have not been able 
to research it enough. If you would just give a brief overview, 
not necessary to come out of your time, about the legal 
difference, if there is any, of a physician or a medical 
employee of the VA versus the private sector. Because I do 
think you have some kind of a liability shield that we would 
have to take into consideration, while you describe your 
system, and that we would have to do something in the private 
sector if we like some of the things that you were doing. Is 
that true?
    Dr. Bagian. There is a difference, yes. The difference is, 
you might look at ours as enterprise liability. If a physician 
or caregiver is acting within their scope of practice, what 
they are privileged and supposed to do, then any error or 
anything that would result in a malpractice claim, the 
Government is responsible. The individual is not financially 
responsible.
    They still can sue the Government. In fact, there are 
pension benefits as well as tort redress they can take. So 
while you cannot come against the individual, it is not that 
much different. It might play a factor. I do not think it is 
the largest role. In fact, I will talk about that, if you will 
allow me. That is a good point.
    With the mandatory and voluntary reporting, one thing I 
would point out is it is not just a difference between 
mandatory reporting and voluntary. You also have to look at 
what is the purpose, accountability or to learn? And then you 
have to look at issues of is it going to be confidential once 
it is reported, whether it is mandatory or voluntary, or not?
    You could have mandatory systems that are confidential that 
you can get reporting to, whereas if it was mandatory and not 
confidential, it would be quite different. I think that is 
important. It is like a matrix. It is not just mandatory or 
voluntary, it is a little bit more complex than that.
    With ours, we have a mandatory internal system that we use 
and we first started it back in 1997 and we have revised it 
most recently at the end of last year, and we have started to 
roll out that change beginning in November in VISN 8, our 
Network 8 in Florida, South Georgia, Puerto Rico. And we 
started last week in Southern California, Nevada. We tried to 
learn as we went along, because we are kind of in uncharted 
waters, if you will.
    One of the things we found was that you have to make it 
very clear what people are reporting and why, so there is no 
ambiguity about whether they are sticking their head in the 
lion's mouth and not knowing. Because if people's perception is 
that it is a gotcha game, if they get surprised, they are not 
going to come back and talk to you again.
    So we made it very clear. The way we made the distinction, 
and we did this in conjunction with the Office of Medical 
Inspector, with the Office of Health Inspection which is kind 
of like our IG, with legal, and with the unions as well, and in 
our professional groups. We said look, we think what the whole 
point is here if someone reports an event, and I will not go 
into definitions of that, but an event and it is not thought to 
be the result of an intentionally unsafe act--and we define 
that as something that appears to be intentionally unsafe--
substance abuse on the part of the physician, which you heard 
about earlier; a criminal act, a frankly criminal act; or 
alleged patient abuse, then we think that goes in the safety 
system. And then it gets a confidentiality shield, if you will.
    We use it internally. We know what we need to do, but it 
will not result in individual discipline.
    However, if it falls in one of those other categories, the 
intentional acts if you will, then it goes the administrative 
route where we still want to find out what happened, why did it 
happen, how do we prevent it, but we know there is an inkling 
there could be discipline required here, that it was not just 
stuff happened. And then we take whatever appropriate action is 
required.
    By doing that, it appears that it has relieved some of the 
anxiety on the part of reporters to report, because they say we 
understand that. Everyone came forward and the various groups 
said that no one had a problem with intentionally unsafe acts 
getting more severe or a blame type of thing. So we have gone 
that way.
    I know my light is up, may I go on if that is okay, sir?
    Chairman Thomas. I used some of your time, so you can keep 
going.
    Dr. Bagian. Thank you.
    When we put ours in place, we realized that the point was 
protecting confidentiality, accepting reports from all comers. 
Not just physicians, not just nurses. I mean, if a patient 
turns a report in, we look at it. It is not like we say oh, 
that is not the right status. We look at all information as 
good. We do not want to censor it. It is for us to then look at 
it and decide what we do.
    Then we put a whole system, a very comprehensive system 
together, where we put teams together that will investigate 
whatever the particular event is and they not only say what 
happened, why did it happen, but then they come forward and 
also say what is the corrective action? What is the plan for 
implementing it? When will you check to make sure it worked?
    I mean, we can have great ideas about how to make things 
better but without testing them, we do not know that they work.
    And then we have one final thing, to have this 
accountability piece, if you will, that the facility director 
has to concur on not concur at each individual corrective 
action. If they non-concur, and they may. There may be a 
suggestion that is fiscally not possible or there are a number 
of things, they might have to make a risk-benefit analysis and 
then might say no, I do not think that is the right thing to 
do, we will do this. There has to be final concurrence before 
it is signed off.
    But that is part of the official record. It does not get 
buried somewhere. It is not like a year from now we wonder how 
did that happen? We know how it happened. We think that is 
important. It keeps it all in the bright light of day, people 
know how it happened, it is not like it is some secret thing, 
we do that. And we concentrate on system solutions.
    Another thing I will point out is, and it was mentioned I 
think by Mr. Stark and yourself in the last panel, is some of 
the tools we have had in the past in medicine, they have been 
available to others and that we just did not know were there or 
maybe were not generally appreciated. There are things about 
human factors, about things you have to look at. It is not 
enough to tell somebody, with the look-alike medications, to 
tell them to be more careful.
    I cannot tell you how many reports we have seen 
historically that say ``tell the nurse to be more careful.'' So 
does that mean they were not careful before? Oh, be careful, 
this is a new policy. Well no, that does not work. You have to 
do something different in systems.
    One of those things, when you mentioned about the rental 
car thing earlier today, actually in 1994 one of the nurses at 
Topeka came back from being on a trip and she says how come--
just what you said--they have this thing where a guy has a 
computer on his leg or whatever, and he does this.
    They actually went ahead and developed a prototype of bar 
code reading and everything else, which we are now in the 
process of rolling out. And they showed in their studies that 
they reduced medication administration error by about 67 
percent through using that. And now the VA is in the process of 
rolling that out nationwide in all of our facilities, and every 
one of our facilities should have that in place by June of this 
year, if not before.
    So we absolutely agree that there are uses for technology 
to design the system to make it harder to make an error. You 
want to recognize that people can make errors, people are 
people, and make them fault tolerant.
    From my previous life as an astronaut, we talked about 
fault tolerance all the time. We knew that errors can occur, 
whether it is equipment failures or personal failures. So you 
kind of have belt and suspenders. You do not just go out single 
string and take your chances.
    We think medicine has to think more proactively about that, 
and we think we are doing that.
    We have a number of other things. You mentioned about the 
black box. We actually have a medical simulator. In fact, at 
Palo Alto, Dr. Dave Gava is one of the pioneers in this area. 
We have a full operating room simulator with a mannequin that 
does everything like a real person. It changes the kind of gas 
it expires, CO2, O2 and the anesthetic agent. You actually can 
put a regular blood pressure cuff on its arm and you can change 
the blood pressure or anything you want. We run very 
sophisticated simulations to train people. We video them and 
use them for training.
    It helps not only in the evaluative process, but also as a 
learning process. And the interaction, somebody talked about 
the arrogance and why people do not work in teams. Many of the 
exercises are set up just to demonstrate that. That if you do 
not all get along together and realize that the OR tech might 
have the key, and not just the surgeon, that you are missing 
the boat. You are not using your people correctly.
    Aviation realized that, in the mid-1980s, and instituted it 
on a widespread basis. We are doing the same thing. In fact, at 
the center in Palo Alto, people come from around the country 
and the world, literally, to come train and learn how to do it. 
We are very aggressive in that area.
    You talk about other changes, KCL, potassium chloride was a 
problem. We realized it was a systems thing. I was heartened by 
what you said earlier about even if it is 40 or 50 deaths a 
year, that is too many. We agree. We do not think you have to 
count the numbers. We know we do not want to have a death. And 
if we identify a vulnerability and see a systems way, or any 
way, to correct it then we want to do it. We do not say oh, let 
us wait until we have 50 more deaths and then it is time. We do 
not need to do that.
    We did not do that with KCL, and we took that off the 
shelves. Dr. Kizer can say for sure, I think it was in the 
middle of 1998 we put out the--it was before I joined the VA. 
It was put out as a directive that KCL would not be kept in a 
concentrated manner on the floor, to take away this thing about 
telling the nurses to be careful. That old practice was 
foolish. That is not the way to do it.
    So anyway, that is just the highlights of some of the 
things we have done, and I would be happy to entertain 
questions.
    [The prepared statement follows:]

Statement of James P. Bagian, M.D., PE, Director, National Center for 
Patient Safety, Veterans Health Administration, U.S. Department of 
Veterans Affairs

    Mr. Chairman and Members of the Committee,
    I am pleased to appear before you to discuss VA's ongoing 
activities and initiatives to ensure the safety of patients who 
receive care from VA. In December 1999, the Institute of 
Medicine (IOM) released a report ``To Err is Human: Building a 
Safer Health System.'' The report reviewed existing studies and 
concluded that as many as 98,000 preventable deaths occur each 
year in United States' healthcare due to error. The IOM 
recommended creating a new National Center for Patient Safety 
that would focus on research and policy related to errors in 
healthcare, improved error reporting systems, improved 
analysis/feedback methods, performance standards for healthcare 
organizations and individuals, and other specific governmental 
actions. Importantly, they cautioned that the focus must be on 
creating a culture of safety that will require improving 
systems, not assigning blame.
    VA interpreted the IOM report as a validation of our 
commitment to improving patient safety in our healthcare 
system. All of the IOM recommendations applicable to VA have 
either been in place or were in the process of being 
implemented prior to the release of the report. While VA has 
had quality and safety related activities ongoing for many 
years, it was in 1997 that our formal patient safety program 
was launched (see Attachment 1). Leaders in the field of 
patient safety and medical error outside VA have participated 
in the design of our system and recognize VA as a pioneer in 
these efforts.
    During 1997, VA intensified its already extensive efforts 
in quality improvement by launching a major initiative on 
patient safety. We recognized that programs to improve quality 
and safety in healthcare often share purpose and corrective 
actions. However, we believed that patient safety required a 
new and different approach. We set out to create a new culture 
of safety in which our employees detect and tell us about 
unsafe situations and systems as part of their daily work. Once 
we know about unsafe situations and systems, we are committed 
to design and implement new systems and processes that diminish 
the chance of error.

Highlights of Patient Safety Activities at VA: 1997-Present

    VA recognized that patient safety is not a VA-specific 
issue, therefore we asked other health care organizations to 
join us in an effort to understand the issues and to act for 
patient safety. As a result, the National Patient Safety 
Partnership (NPSP), a public-private consortium of 
organizations with a shared interest and commitment to patient 
safety improvement, was formed in 1997. The charter members, in 
addition to VA, included the American Medical Association, the 
American Hospital Association, the American Nurses Association, 
the Joint Commission on Accreditation of Healthcare 
Organizations, the Association of American Medical Colleges, 
the Institute for Healthcare Improvement, and the National 
Patient Safety Foundation at the AMA. Five additional 
organizations have subsequently joined the charter members in 
the Partnership: the Department of Defense--Health Affairs, 
National Institute for Occupational Safety and Health, the Food 
and Drug Administration, Agency for Healthcare Quality and 
Research, and the Health Care Financing Administration. This 
group addresses high impact issues that are of importance to a 
broad cross section of the healthcare industry. An example of 
the Partnerships activity was the establishment of a 
clearinghouse for information related to the effect of Y2K 
computer issues on medical devices. The NPSP also called public 
and industry attention to Preventable Adverse Drug Events and 
promulgated simple actions that patients, providers, purchasers 
and organizations could take to minimize their chance of an 
adverse drug event. (See Attachment 2) The partnership serves 
as a model of what a private-public collaboration can do to 
improve patient safety.
    In 1998, VA created the National Center for Patient Safety 
(NCPS) to lead and integrate the patient safety efforts for VA. 
As the IOM report advises, VA created this center as a 
commitment to patient safety as a corporate priority with a 
direct reporting relationship to the Under Secretary for 
Health. The NCPS employs human factors engineering and safety 
system approaches in its activities. The first task for the 
Center was to devise systems to capture, analyze and fix 
weaknesses in our systems that affect patient safety.
    We sought to design reporting systems that would identify 
adverse events that might be preventable now or in the future. 
In addition, we sought systems to identify and analyze 
situations or events that would have resulted in an adverse 
event if not for either luck or the quick action of a 
healthcare provider--we call such events ``close calls.'' We 
believe that ``close calls'' provide the best opportunity to 
learn and institute preventive strategies, as they will unmask 
most system weaknesses before a patient is injured and avoid 
the liability issues implicit in investigation of injury. This 
emphasis on ``close calls'' has been employed by organizations 
outside of healthcare with great success.
    VA consulted with experts (Expert Advisory Panel for 
Patient Safety System Design) obtaining advice to enhance the 
design of VA's reporting systems. These experts in the safety 
field included Dr. Charles Billings, one of the founders of the 
Aviation Safety Reporting System, as well as other experts from 
NASA and the academic community. They advised us that an ideal 
reporting system a) must be non-punitive, voluntary, 
confidential and de-identified; b) must make extensive use of 
narratives; c) should have interdisciplinary review teams; and 
d) most importantly, must focus on identifying vulnerabilities 
rather than attempting to define rates of error. VA has used 
these principles to design the patient safety reporting systems 
we have in use or in development.
    Based on the expert advice and on lessons learned from our 
first generation mandatory adverse event reporting, the NCPS 
has developed a comprehensive adverse event, close call 
analysis and corrective action program which includes an end-
to-end handling of event reports. This system not only allows 
for the determination of the root causes, but also captures the 
corrective actions as well as the concurrence and support of 
local management for implementation. The system includes a 
number of innovations such as algorithms and computer aided 
analysis to determine the root cause of adverse events and 
close calls. The Joint Commission on Accreditation of 
Healthcare Organizations and the American Hospital Association 
are currently evaluating parts of the system for use.
    The improved event reporting system is being pilot tested 
in VA's VISN 8. Extensive training is used as the new system is 
introduced to assure full understanding of the search for the 
root cause and redesign of the system. To date, response from 
the pilot site is positive. The quality managers and clinicians 
using the system believe that the new methods analysis of error 
will make a significant difference in the care of veterans.
    A complementary, de-identified voluntary reporting system 
is in the process of being implemented. It is patterned after 
the highly successful Aviation Reporting System that NASA 
operates on behalf of the FAA. It will be external to VA and 
will allow employees and patients to report unsafe occurrences 
without fear of administrative or other action being taken 
against them.
    Based on lessons learned, VA has promulgated specific 
procedures and policies aimed at reducing risk of error. These 
include such things as restricting access to concentrated 
potassium chloride on patient care units, use of barcode 
technology for patient identification and blood transfusions in 
operating rooms, and for verification procedures prior to 
injection of radio-labeled blood products. (Attachments 3-6) 
Based on the observation of a VA nurse when she returned a 
rental car, VA developed a system for using wireless bar coding 
to improve medication administration. That system was piloted 
at the Topeka VA Medical Center and will be in all VA hospitals 
by June of this year. At least two-thirds of medication errors 
can be prevented with this system.
    In 1999, VA established four Patient Safety Centers of 
Inquiry. These Centers conduct research on critical patient 
safety challenges. Activities at the Centers of Inquiry range 
from fall prevention and operating room simulators to 
understanding the role of poor communication in patient safety. 
The Center in Palo Alto, which is affiliated with Stanford 
University, is a recognized leader in the area of simulation 
and has been featured prominently in the media. Their simulated 
operating room allows surgeons and anesthesiologists to train 
and do research without endangering a patient. VA expects to 
create additional simulation facilities to train its physicians 
and other healthcare professionals. One simulator with 
appropriate staff could train about 600 anesthesiologists and 
residents-in-training per year. This means that virtually all 
VA anesthesiologists/anesthetists can be trained in a year on 
clinical situations that could not be simulated safely in 
patients. As a result of analyzing common variations during 
simulated operations, the center has developed a checklist card 
of facts that should be kept close at hand. These checklist 
cards will be attached to all anesthesia machines across VA.
    VA is partnering with the Institute for Healthcare 
Improvement to build learning collaboratives aimed at reducing 
medication errors, a major issue identified in the Institute of 
Medicine report. IHI collaboratives will affect several hundred 
VHA personnel each year. Other IHI collaboratives have resulted 
in measurable improvements and similar results are anticipated 
with medication errors.
    Another key VA strategy to reduce medical errors involves 
the development of a new curriculum on safety. VA is moving 
forward with plans to provide education and training relevant 
to patient safety not only to those already in practice but 
also at the medical, nursing, and health professional school 
level. This will be the first time an extensive safety 
curriculum will be developed and broadly implemented. VA is 
particularly well situated to lead the educational effort due 
to the extensive role it plays in the education of healthcare 
professionals in the United States. (VA is affiliated with 105 
medical schools and up to one-half of all physicians train in a 
VA facility during medical school or residency.) Additionally, 
we have instituted a performance goal and measure to provide VA 
employees 20 hours of training on patient safety this year.
    VA instituted a Patient Safety Improvement Awards Program 
to focus interest on and reward innovations in identifying and 
fixing system weaknesses. Not only does this produce ideas for 
patient safety improvements that might otherwise go unnoticed 
but it further reinforces the importance that VA places on 
patient safety activities. (Attachment 7)
    In 1995, VA instituted a Performance Measurement System 
that uses objective measures of patient outcomes to set goals 
and reward achievement. Since 1998, VA has incorporated a 
performance goal and measure for its executives for 
accomplishment in patient safety activities. Last year, each 
network had to implement three patient safety initiatives to be 
fully successful and six initiatives to be outstanding.
    Other performance goals and measures assess the use of 
Clinical Practice Guidelines. By holding entire medical centers 
and geographic networks responsible for measured outcomes, we 
are able to institute reminder systems and redundancies that 
lead to dramatic improvements in performance. For example, 
patients who receive medications known as``beta-blockers'' 
following a heart attack are 43 percent less likely to die in 
the subsequent two years and are rehospitalized for heart 
ailments 22 percent less often. A goal of providing this 
therapy to 80 percent of eligible patients has been set in the 
private sector, and recent medical literature reports rates of 
use as low as only 21 percent in some settings. In the VA, over 
94 percent of heart-attack patients receive this life-saving 
medication.
    Another example of the power of using systems rather than 
relying on individual adherence to clinical guidelines is in 
immunization. It is estimated that 50% of elderly Americans and 
other high-risk individuals have not received the pneumococcal 
pneumonia vaccine despite its demonstrated ability to minimize 
death and hospitalization. VA's emphasis on preventive 
healthcare has led to achieving pneumonia vaccination rates 
that exceed standards set for HMOs by almost 20% and nearly 
double published community rates. Similar accomplishments have 
been achieved in providing annual influenza vaccinations.
    We believe that patient safety can only be achieved by 
working towards a ``culture of safety.'' Patient safety 
improvement requires a new mindset that recognizes that real 
solutions require an understanding of the ``hidden'' 
opportunities behind the more obvious errors. Unfortunately, 
systems thinking is not historically rooted in medicine. On the 
contrary, the field of medicine has typically ascribed errors 
to individuals and embraced the name-blame-shame-and-train 
approach to error reduction. Such an approach by its very 
nature forecloses the opportunity to find systems solutions to 
problems. Other industries such as aviation have recognized the 
failings of this approach and over many years have succeeded in 
transitioning from a similar blame and faultfinding approach to 
a system-based approach that seeks the root causes of errors. 
VA realized how pivotal culture is to improving safety and in 
1998, conducted a culture survey of a sample of employees. Of 
interest, the shame of making an error was a more powerful 
inhibitor of reporting than was fear of punishment. Employees 
readily forgave mistakes in others but were intolerant of their 
own. We plan to survey culture broadly in VA for several years 
to track the progress of our efforts.
    VA created a database of adverse events and asked our 
Medical Inspector to review it. The report has been widely, yet 
often inaccurately, quoted or critiqued in the media. The 
database was created to discover common and important adverse 
events in order to focus our efforts in patient system 
redesign. Commonly, the media assumed that all the adverse 
events (and deaths) were due to error. They were not. Neither 
the report nor the database cataloged which adverse events were 
preventable with today's state of knowledge and therefore could 
be characterized as errors. For example, most of the adverse 
events were falls, suicides and parasuicidal events (attempted 
suicides, suicide gestures), or medication errors. It is not 
possible with today's knowledge to operate a national system of 
nursing homes and acute-care hospitals treating the elderly and 
chronically ill without a number of falls. Yet, we know that it 
is important to look for common factors to allow us to reduce 
the frequency of falls in the future. Similarly, psychiatrists 
have tried unsuccessfully to predict which patients will commit 
suicide. By looking at our data we hope to be able to predict 
high-risk patients in the future and therefore be able to 
prevent suicides. We have already learned that men with a 
recent diagnosis of cancer, who live alone and who own a gun, 
are more likely to commit suicide. We plan to study the use of 
additional interventions in this subgroup of patients at high 
risk of suicide.

Conclusion

    With no successful models in large healthcare systems to 
guide us, VA turned to other high risk, high performance 
industries to learn principles for safety. We have borrowed 
both methods and people from safety-conscious settings such as 
aviation and space travel and from underutilized disciplines 
like human factors engineering. These efforts have already 
produced significant improvements in VA, and we believe will do 
the same in all healthcare settings.
    We would prefer that all of healthcare had begun to address 
the issue of patient safety long ago. For too long, the 
emphasis has been on holding individuals accountable and hoping 
that well-intended and well-educated professionals wouldn't 
make human mistakes. As the IOM aptly states in the title of 
its report: ``To err is human.'' We are pleased to be on the 
leading edge as healthcare takes a systems approach to patient 
safety. We are anxious to discover new ways to make VA and all 
healthcare safer. We appreciate your support of these efforts 
and intend to keep you fully informed of our progress.
    [Attachments are being retained in the Committee files.]

                                

    Mr. Thomas. I appreciate it and we will have some 
questions. Dr. Kizer?

  STATEMENT OF KENNETH W. KIZER, M.D., M.P.H., PRESIDENT AND 
CHIEF EXECUTIVE OFFICER, NATIONAL QUALITY FORUM FOR HEALTH CARE 
                   MEASUREMENT AND REPORTING

    Dr. Kizer. Thank you and good afternoon, Mr. Chairman, Mr. 
Stark. It is a pleasure to be here. I am Dr. Kenneth W. Kizer. 
I am currently the President and CEO of the National Quality 
Forum. This is a new private, non-profit organization whose 
mission is to improve the quality of U.S. health care by 
improving the mechanisms and technology of measuring and 
reporting of quality.
    I am pleased to appear before you this afternoon to discuss 
the urgent need to improve patient safety. I think for too long 
the topics of medical error, patient safety and therapeutic 
adverse events, if you will, have escaped public scrutiny.
    At the outset, I think we should acknowledge, and indeed I 
am probably reiterating what has been said before by others 
today, that it really should not come as a surprise that health 
care has errors. In the latter part of the 20th century health 
care has become one of the most complex, if not the most 
complex, of all human activities. It involves hundreds or 
thousands of interactions among scores of caregivers and myriad 
complex technologies that can cause harm as well as help 
patients. If there ever were a high risk, high hazard activity, 
modern health care certainly qualifies as such.
    While it should not be surprising that modern health care 
is a high risk, high hazard, and error-prone activity, I think 
what is perhaps surprising is that health care has lagged so 
far behind other high hazard industries in systematically 
implementing risk reduction and error reduction strategies.
    In my written testimony, Mr. Chairman, I comment about the 
state of health care quality in the U.S. overall. I describe 
the genesis and the operation of the National Quality Forum, 
which I head. And I outline 10 areas of action which should be 
pursued to improve patient safety in the United States. In the 
interest of time, I am not going to repeat those things here. I 
would like to take the remaining three minutes or so that I 
have in these opening comments to stress at least a few of 
those points.
    Despite the prevalence and the cost of medical errors, most 
health care executives, clinicians and consumers have largely 
been unaware of the magnitude of the problem, although aware 
that errors certainly occur. Many factors account for this lack 
of awareness, including especially the systematic 
underreporting of such events and the prevailing blame and 
punishment culture that discourages reporting and open 
discussion of errors, and that has been the focus of 
considerable comment already today at this hearing.
    One of the most pressing needs in reducing medical errors 
is getting more complete data on the occurrence of such. 
Indeed, fundamental to any improvement effort is defining and 
measuring the extent of the problem. At present, medical errors 
are grossly underreported and there is very limited data about 
their occurrence.
    The Institute of Medicine has recommended that a national 
reporting system be established that provides for the 
collection of standardized information about adverse events 
that result in death or serious harm to patients. They have 
also recommended that the National Quality Forum be tasked with 
promulgating and maintaining a core set of reporting standards.
    The IOM further recommends that Congress pass legislation 
to extend peer review protections to data related to patient 
safety and quality improvement that are collected, analyzed, 
and used solely for the purposes of improving safety and 
quality.
    I support those recommendations and I would strongly 
underscore the need for having a non-punitive approach to 
gaining these data.
    I would also emphasize a second needed area of action, and 
that is of making patient safety a priority. Government health 
programs, health care organizations, and health care executives 
should make reducing medical errors and improving patient 
safety key strategic priorities. This should occur at all 
levels of Government and at all levels of health care 
organizations or institutions.
    If patient safety is, indeed, to be a priority, it has to 
have a home within those health care organizations and within 
the relevant Government agencies and there must be individuals 
that are responsible for managing the data and the associated 
programs.
    The National Quality Forum supports the Institute of 
Medicine's recommendation that there be a national center for 
patient safety, although we defer to the Congress and the 
Administration as to where such a center should be housed 
within the Government.
    Finally, I would emphasize the need to implement medical 
error prevention best practices where such have been 
identified, and quite a few best practices have been identified 
and were referred to by others earlier today as the ``low 
hanging fruit'' that could be harvested quite readily. This is 
especially so in the area of medication safety practices, where 
a number of things have been identified and shown to be able to 
reduce errors in the short term.
    In closing, Mr. Chairman, I would just note that too often 
Americans equate high technology health care with high quality 
health care. In many situations, this nexus is true. But in 
other cases, more sophisticated technology simply creates a 
delusion of higher quality and increases the risk of medical 
error.
    With that, I will be happy to answer your questions.
    [The prepared statement follows:]

Statement of Kenneth W. Kizer, M.D., P.H., President and Chief 
Executive Officer National Quality Forum for Health Care Measurement 
and Reporting

    Mr. Chairman and Members of the Subcommittee, I am pleased 
to appear before you today to discuss the urgent need to 
improve patient safety in U.S. healthcare. For too long, the 
topics of medical error and therapeutic adverse events have 
escaped public scrutiny.
    It should come as no surprise to anyone that errors occur 
in healthcare, for in the past fifty years healthcare has 
become one of the most complex of all human activities, 
typically involving hundreds or even thousands of interactions 
between people and technology during even ``routine'' 
treatment. Today, medical care is typically provided by teams 
of healthcare professionals, each of whom is responsible for a 
part of a patient's care; myriad diagnostic tests are routinely 
performed, many of which may be hazardous to the patient; and 
treatment often involves complicated invasive procedures that 
could injure a patient in multiple ways. If ever there were a 
high risk, high hazard activity, modern healthcare certainly 
qualifies as such.
    Therefore, Mr. Chairman, I commend you and the Subcommittee 
for focusing on this important issue, and I welcome the chance 
to share with you some thoughts about policies and practices 
that might be employed to improve patient safety and, in turn, 
the quality of U.S. healthcare, as well as possible roles that 
the National Quality Forum might play in such efforts.

                     Healthcare Quality in the U.S.

    The quality of healthcare in the United States presents a 
paradox. On the one hand, the generally high level of training 
of U.S. healthcare practitioners today, our extensive and 
highly sophisticated biomedical research program, the rapid 
dissemination of new medical knowledge, the extent of 
government funding for healthcare, and the widespread ready 
availability of state-of-the-art diagnostic and treatment 
technology have brought life-saving treatments to more 
Americans than ever before, and are the envy of much of the 
world. On the other hand, a number of studies in recent years 
have documented serious and widespread quality of care problems 
in U.S. healthcare. Overuse, underuse and misuse of medical 
care occur too frequently in all types of healthcare delivery 
systems and with all types of healthcare financing.
    While tens of millions of Americans reap the benefits of 
modern medicine each year, millions of others are exposed to 
unnecessary risks or are denied opportunities for improved 
health. Likewise, too many patients are injured, disabled or 
killed as a result of medical errors and treatment-related 
mishaps.
    Quite simply, as good as American healthcare is, it could 
be markedly better!
    Further, some experts believe that U.S. healthcare, which 
is by far the world's most expensive healthcare, could be 
significantly cheaper, if as much attention were focused on 
improving its quality, as was done in a number of other U.S. 
industries in the latter part of the 20th century. Higher 
quality healthcare may well cost less.
    It is notable that interest in rigorously determining the 
quality of healthcare in America is only of relatively recent 
origin, arising largely in response to the managed care 
revolution and concern that the new healthcare organizational 
structures and reimbursement strategies brought by managed care 
might be creating incentives that were deleteriously affecting 
the quality of care. In evaluating this situation, however, the 
most striking finding is how little is really known about the 
quality of healthcare in America. (Not that it is known better 
any place else.) There is no mandatory national reporting or 
surveillance system, nor any regular systematic review of the 
state of healthcare quality to determine whether it is getting 
better or worse. Likewise, few healthcare systems or provider 
organizations even have rudimentary organized data systems that 
routinely inform them about the quality of care they provide.
    Overall, it is highly ironic and quite remarkable that we 
know much more about the quality of airlines, automobiles, 
televisions and toasters in America than we do about 
healthcare, the nation's largest enterprise, accounting for 
more than $1 trillion in annual expenditures and some 15% of 
the gross national product.
    In recognition of these problems and in response to growing 
consumer and purchaser demands for greater healthcare 
accountability, numerous efforts have been launched in the last 
10 to 15 years to promote quality improvement in American 
healthcare. And while incremental progress has been made, in 
the aggregate, and despite the good work of many dedicated 
individuals and organizations, healthcare quality has not 
progressed to where it can and should be. There continues to be 
large gaps between the care people should receive and the care 
that they actually do receive.
    This sentiment was clearly expressed in three independent 
reports published in 1998--i.e., reports by the National 
Academy of Sciences Institute of Medicine's National Roundtable 
on Health Care Quality, by investigators at RAND after an 
extensive review of the literature, and by the President's 
Advisory Commission on Consumer Protection and Quality in the 
Health Care Industry. Indeed, 1998 will probably come to be 
viewed as a watershed year for healthcare quality improvement 
because of these reports and actions they spawned.

                       The National Quality Forum

    One of the sequels to the 1998 reports and one of the most 
notable of recent efforts to improve the quality of American 
healthcare has been the establishment of The National Forum for 
Health Care Quality Measurement and Reporting, a private, non-
profit, membership organization proposed by the President's 
Advisory Commission on Consumer Protection and Quality in the 
Health Care Industry.
    The concept of the National Quality Forum arose in 
recognition of a strong American sentiment against government 
regulation and control of healthcare quality. Of note, the 
Commission proposed a public-private partnership involving two 
new organizations--a private-sector entity they referred to as 
the National Forum on Health Care Quality Measurement and 
Reporting (better known now as The National Quality Forum 
[NQF]) and a public entity they called the Advisory Council for 
Health Care Quality. The Commission's original vision was that 
the Advisory Council would identify national goals for quality 
improvement and provide oversight on the accomplishment of 
those goals, while the NQF would devise a national strategy for 
measuring and reporting healthcare quality that would advance 
the identified national aims for improvement. This paired 
public-private relationship seemed to reasonably balance 
concerns about the capacity of a private organization to meet 
important public needs against the prevailing negative 
sentiment towards vesting healthcare quality control with the 
government.
    The NQF was birthed in the fall of 1999, following the work 
of the Quality Forum Planning Committee that had been launched 
in June 1998.
    With in-kind support from the United Hospital Fund of New 
York, the Planning Committee drafted an initial mission 
statement for the NQF, proposed a governance structure and 
sought funding from selected foundations. Start-up funds were 
subsequently obtained from the Robert Wood Johnson, California 
HealthCare and Horace W. Goldsmith Foundations and the 
Commonwealth Fund. A president and chief executive officer was 
hired in the fall of 1999, and the NQF started to operate in 
late 1999.
    Of note, no action has been taken, so far, to establish the 
proposed Advisory Council for Health Care Quality, and some of 
its envisioned functions are now being reviewed by the NQF for 
implementation.
    The NQF sees its fundamental mission as being the 
improvement of healthcare quality--e.g., to promote delivery of 
care known to be effective; to achieve better health outcomes, 
greater patient functionality or a higher level of patient 
safety; or to make care easier to access or a more satisfying 
experience. The primary strategy the NQF will employ to 
accomplish its mission is to improve quality measurement and 
reporting mechanisms--i.e., to improve the technology for 
measuring and reporting quality. In doing so, however, the NQF 
does not envision itself developing quality indicators or 
measures de novo. There are myriad research, accreditation and 
oversight organizations and commercial interests already 
involved with developing measures.
    The NQF has identified five key enabling objectives. These 
include:
    (1) Developing a national strategy for measuring and 
reporting quality for the U.S. that is consistent with 
identified national goals for quality improvement;
    (2) Standardizing the measures of and processes for 
reporting quality-related data so that data collection is 
consistent and less arduous for healthcare providers, and so 
that the data are of greater value;
    (3) Promoting consumer choice by building consumer 
competence in using quality measures;
    (4) Enlarging the healthcare system's capacity to evaluate 
and report on the quality of care; and
    (5) Increasing the overall demand for healthcare quality 
data.
    While there is much that needs to be done in each of these 
areas, the NQF sees a particularly acute need to reduce the 
burden and increase the value of quality reporting methods.
    The NQF has convened a group of highly respected quality 
improvement, healthcare delivery and policy experts to help 
craft a strategic framework for healthcare quality measurement 
and reporting. This group is known as the Strategic Framework 
Board (SFB), and its essential mission is to determine the 
principles, intellectual framework and criteria for quality 
measurement and reporting.
    In pursuing its mission, the NQF will seek to provide a 
clear, coordinated and coherent over-arching strategy and a set 
of guiding principles to inform the choice of measures that it 
will ultimately endorse. The NQF will strive to endorse 
measures that are compelling and causally related to better 
outcomes, and especially outcomes related to processes or 
activities that improve something that actually happens to 
patients. Indeed, the NQF believes that the true test of a 
quality indicator or measure is how well, and for what cost, 
the measure and its reporting actually helps improve care. The 
more ways that a measure promotes better outcomes, the better.
    The NQF will also strive to ensure that its over-arching 
strategy has a sound theoretical framework that will inform and 
guide a strategic and proactive research agenda.
    In approaching its work, the NQF will explore issues of 
quality across the entire spectrum of healthcare and will seek 
to coordinate quality measurement between and among the various 
levels or elements of the system--e.g., health plan, hospital, 
medical group, nursing home, individual practitioner, home care 
etc.
    Likewise, the NQF believes that it must always ensure that 
the consumer's perspective is heard during the discussion of 
quality measures. In an effort to continuously actualize this, 
the NQF's Board of Directors is designed to have a majority of 
its members representing consumers and purchasers. This is an 
important structural precept that should facilitate keeping the 
consumer's perspective ever present.
    Finally, in approaching its work, the NQF is committed to 
working constructively with the many other parties involved in 
the healthcare quality measurement and reporting area, 
including especially the Joint Commission on Accreditation of 
Healthcare Organizations (JCAHO) and the National Committee for 
Quality Assurance (NCQA), to make certain that its work is not 
duplicative, but rather collaborative and helpful to the 
important work already begun by these entities. Improving 
healthcare quality is a matter of national importance that 
requires all of us to work together; there is neither time nor 
resources to pursue any strategy other than one of complete 
cooperation.

                   Medical Errors and Patient Safety

    Recently, as a result of the Institute of Medicine's 
seminal report on the subject in November 1999,\1\ considerable 
public attention has been focused on medical errors and other 
diagnostic or treatment-related mishaps that endanger patient 
safety--these will be further referred to here collectively as 
``therapeutic adverse events.'' The evidence is clear that 
therapeutic adverse events kill tens of thousands and injure or 
disable hundreds of thousands of Americans every year. They are 
a major public health problem that warrants immediate and 
decisive action, and the urgency for action is heightened by 
the fact that, for many problems, solutions to prevent their 
occurrence are known. In other cases there is a need for 
research to find the best practices that would prevent their 
occurrence.
---------------------------------------------------------------------------
    \1\ Institute of Medicine. To Err is Human: Building a Safer health 
System. Washington, DC. National Academy Press. 1999.
---------------------------------------------------------------------------
    Despite their prevalence and cost, most healthcare 
executives, clinicians and consumers are largely unaware of the 
burden of therapeutic adverse events. Many factors account for 
this lack of awareness, including especially the systematic 
underreporting of such events and the prevailing ``name and 
blame'' culture that discourages reporting and open discussion 
of the issue. This ``name and blame'' culture causes fear of 
punishment, fear of reprisal and/or fear of peer disapproval 
when an adverse event does occur; this has been particularly 
counter-productive in dealing with the issue in a forthright 
manner.
    It is widely known that error is inherent to anything that 
humans beings do, and substantial evidence exists that errors 
are the result of poorly designed processes and systems that 
fail to account for the inherent limitations of human 
performance. Indeed, because medical errors typically involve 
problematic processes or systems rather than the incompetence 
or malice of individual practitioners improvement strategies 
that punish clinicians for reporting errors are misguided.
    In my opinion, ten things, at a minimum, must be addressed 
if medical errors are to be reduced. These include the 
following:

1. Get more complete data on the occurrence of therapeutic 
adverse events.

    Foundational to any improvement effort is defining and 
measuring the extent of the problem. At present, medical errors 
are grossly under-reported, and there is extremely limited data 
about their occurrence. Creating a data collection system is 
essential to the success of efforts to reduce their occurrence. 
Likewise, sharing information about errors with frontline 
clinicians is needed to further their understanding of the 
issues, as well as to promote collaboration and a sense of 
shared mission.
    The Institute of Medicine recommended that a national 
mandatory reporting system be established that provides for the 
collection of standardized information about adverse events 
that result in death or serious harm to patients, and that the 
NQF be tasked with promulgating and maintaining a core set of 
reporting standards. The IOM further recommended that Congress 
pass legislation to extend peer review protections to data 
related to patient safety and quality improvement that are 
collected, analyzed and used solely for the purposes of 
improving safety and quality. I support those recommendations, 
and I would strongly underscore the need for having a non-
punitive approach to gaining this data.
    In considering the data, it is important to remember that 
reporting such events is for both public accountability and 
quality improvement purposes, and not everything reported for 
quality improvement purposes warrants public reporting. There 
is a set of adverse events or untoward situations about which I 
believe we could obtain widespread consensus on the need for 
reporting for public accountability purposes (e.g., maternal 
death during childbirth, restraint-related strangulation, 
wrong-site surgery, to name a few), but there is a larger pool 
of events or circumstances that, at least at this time, should 
be maintained confidential for quality improvement purposes.

2. Make patient safety a priority.

    Government health programs, healthcare organizations and 
healthcare executives should make reducing medical errors and 
improving patient safety key strategic priorities. This should 
occur at all levels of government and at all levels of 
healthcare organizations or institutions.
    Patient safety work should be built into the schedule of 
managers and should be a defined executive responsibility. 
Patient safety issues should receive as much attention by 
healthcare facility governing boards as do issues like 
financial performance, market share and strategic planning. 
Healthcare facility management should be held accountable for 
patient safety performance just as they are held accountable 
for other performance.

3. Create a patient safety infrastructure.

    If medical error data are to be collected and if patient 
safety is to be a priority, then it must have a ``home'' within 
healthcare facilities, healthcare organizations and relevant 
government agencies, and there must be individuals who are 
responsible for managing the data and associated programs. The 
NQF supports the notion of there being a national Center for 
Patient Safety, although we defer to the Congress and the 
Administration where such a center should be housed. Wherever 
it is located, though, it must be provided with adequate 
resources to accomplish its mission.

4. Create a culture of safety

    Healthcare executives and managers should strive to create 
a culture of safety in their institutions or organizations.
    A healthcare culture of safety can be defined as an 
integrated pattern of individual and organizational behavior, 
and the associated underlying philosophy and values, that 
continuously seeks to minimize hazards and harm to patients 
that may result from diagnosis and/or treatment-related 
processes. A culture of safety identifies safety as a priority 
and aligns organizational objectives and rewards accordingly.
    A number of characteristics define a healthcare culture of 
safety. For example, in a culture of safety there is open 
acknowledgement that modern healthcare is a high risk activity 
and that everyone in healthcare has a responsibility for risk 
reduction and error prevention. Errors are recognized and 
valued as opportunities for improvement, and there is a non-
punitive and safe environment in which errors can be learned 
from. There is honest and open communication about safety 
issues with well known mechanisms for reporting and learning 
from errors, and confidentiality of information. Likewise, in a 
culture of safety there are mechanisms for restitution and 
compensation for injuries that result from errors, and clear 
organizational commitment, structure and accountability for 
safety improvement.

5. Implement patient safety best practices.

    Healthcare leaders and organizations should implement 
medical error ``best practices'' when such have been 
identified--e.g., such as those identified by the Massachusetts 
Hospital Association, National Patient Safety Partnership and 
Institute for Safe Medication Practices. This is especially so 
for medication safety practices, where a number of practices 
have been shown to definitely reduce errors.

6. Professional misconduct must be recognized and dealt with.

    Gross negligence, malfeasance or unethical behavior should 
be recognized as a grave threat to patient safety and should be 
dealt with accordingly. Licensure, credentialing and 
privileging bodies should more aggressively discipline 
practitioners who have demonstrated impaired performance of 
this nature.

7. Healthcare regulators and accreditation organizations should 
embrace measures that enhance patient safety.

    Regulations and guidelines should encourage root cause 
analysis and facilitate non-punitive reporting. Similarly, 
pharmaceutical and medical device manufacturers should be 
required to complete and disclose human factors testing of 
naming, packaging and labeling of medications and post-market 
surveillance of adverse events.

8. Patient safety self-assessments should be conducted.

    All healthcare facilities should routinely conduct self-
assessments for risk reduction and error prevention. When 
available, structured and standardized self-assessment 
instruments should be utilized--e.g., the self-assessment 
instrument developed by the Institute for Safe Medication 
Practices for medication safety practices.

9. Patient safety research should be funded and otherwise 
supported.

    While a number of interventions are available that could 
improve patient safety in the short term, there is a need for 
additional research in the area of medical error reduction and 
patient safety. Research is needed in ways to make care 
processes safer, in how to make reporting systems optimally 
useful, and in ways of communicating information about 
healthcare hazards that do not unduly alarm patients, to name 
some fertile areas of research. Likewise, while basic research 
is needed in many areas, there is a need to investigate 
technology transfer and the application of safety lessons from 
other industries to healthcare. A good model for the latter are 
the Veteran Health Administration's Patient Safety Centers of 
Inquiry.

10. Medical education should address patient safety.

    Patient safety needs to be incorporated into the fabric of 
health professional training at all levels. Indeed, a 
significant part of the problem regarding the failure of 
physicians to report medical errors stems from attitudes and 
beliefs instilled during medical school. The fact that everyone 
makes mistakes, regardless of how well trained or how smart one 
is, and that modern healthcare is an inherently high risk, high 
hazard activity should be promoted throughout one's training, 
along with how mistakes should be managed.
    Professional organizations and credentialing bodies should 
also give consideration to requiring continuing education 
specifically in patient safety, such as is required of 
practitioners in the veterans healthcare system.

                               Conclusion

    In closing, Mr. Chairman, I would emphasize that even 
though improving patient safety in U.S. healthcare presents 
many challenges, improvement is eminently achievable, as has 
been demonstrated in the veterans healthcare system.
    I would further note that too often Americans equate high 
technology healthcare with high quality healthcare. In some 
cases, this nexus is true, but in many other situations more 
sophisticated technology simply creates a delusion of higher 
quality, while actually increasing the risk of medical error. 
As healthcare becomes more and more reliant on complicated 
technology there will be increasing need for vigilance against 
errors. Many actions need to be taken to ensure that such 
vigilance is actualized and that healthcare in the 21st century 
becomes safer than it is today. The ten action areas described 
above would be a good beginning in this regard.
    Again, thank you for the opportunity to testify before you 
this morning. I would be pleased to answer your questions.

                                

    Mr. Thomas. Thank you very much. Tools of diagnosis do not 
replace diagnosis. Dr. O'Leary?

    STATEMENT OF DENNIS S. O'LEARY, M.D., PRESIDENT, JOINT 
    COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS

    Dr. O'Leary. Thank you, Mr. Chairman.
    I am Dr. Dennis O'Leary, President of the Joint Commission 
on Accreditation of HealthCare Organizations. I am pleased to 
address you today concerning medical errors. This is perhaps 
the most pressing health care quality issue of our time.
    The Joint Commission accredits over 18,000 organizations 
whose services include acute care, long-term care, ambulatory 
care, behavioral health care, laboratory services, and home 
care. This broad experience gives the Joint Commission a 
panoramic view of the strengths and weaknesses inherent in our 
health care delivery system.
    My testimony will focus on the tasks that must be carried 
out to reduce errors nationwide. Dramatically reducing the 
numbers of errors will take a concerted effort by all 
responsible parties who participate in and oversee the delivery 
of health care. This coordinated approach must necessarily 
bridge the public and private sectors.
    Medical error reduction is fundamentally an information 
problem. The solution to reducing errors resides in developing 
mechanisms for collecting, analyzing, and applying existing 
information. With this in mind, there are five critical 
information-based tasks that are essential to an effective 
error reduction strategy.
    The first task is the creation of a blame-free protected 
environment that encourages the systematic surfacing and 
reporting of serious adverse events. Fear of reprisals, public 
castigation, and loss of business will continue to impede the 
reporting of serious errors unless we provide incentives for 
making mistakes known to accountable oversight bodies.
    Today, the blame and punishment orientation of our society 
drives errors underground. Indeed, we believe that most medical 
errors never reach the leadership levels of the organizations 
in which they occur. If we are to get a handle on the 
epidemiology of medical errors, we must create a protected 
blame-free environment that will lead to an active 
understanding of their scope and nature.
    Further, it is imperative that any medical error reporting 
program operate under a pragmatic and carefully crafted 
definition of what constitutes a serious adverse event.
    The second task is the production and credible root cause 
analyses of serious adverse events. When a serious error 
occurs, there must be an intensive, no holds barred vetting of 
all of the causes of the underlying event. These root cause 
analyses, which we believe hold the critical answers to future 
error reduction, focus primarily on organizations, systems and 
processes.
    Unfortunately, most reporting systems, both voluntary and 
mandatory, fail to require or encourage the performance of root 
cause analyses. Not surprisingly, organizations are hesitant to 
share these root cause analyses with the Joint Commission or 
anyone else. We must recognize that preparing a document that 
lays bare the weaknesses in the health care providers systems 
is akin to writing a plaintiffs' brief. Therefore, we cannot 
expect uniform preparation of these documents without Federal 
protections against their inappropriate disclosure.
    The third task is to implement concrete planned actions to 
reduce the likelihood of similar errors in the future. The 
principal derivative of a root cause analysis is an action plan 
that focuses on improving the organization's systems which 
related to the serious adverse occurrence. It is essential that 
implementation of this action plan be monitored and confirmed 
by an independent oversight body. The response to an error does 
not simply terminate with the report itself, or even an 
analysis of what went wrong. We view the monitoring of planned 
systems changes in organizations as a key element of public 
accountability.
    The fourth task is the establishment of patient safety 
standards which health care organizations must meet. The Joint 
Commission has recently established explicit patient safety 
standards for health care organizations. These standards were 
specifically created to establish patient safety as a high 
priority in these organizations. The new standards require that 
the leadership of a health care organization establish 
processes for identifying and managing sentinel events and put 
these into practice.
    The last task is dissemination of experiential information 
to all organizations at risk for adverse events. To have a 
positive national impact on patient safety, information gleaned 
from the analyses of errors must be disseminated so that all 
organizations may reduce the likelihood of adverse events.
    The Joint Commission does this through its series of 
sentinel event alerts. To date, we have issued alerts on 
medication errors, wrong site surgery, restraint related 
deaths, blood transfusion errors, inpatient suicides, infant 
abductions, and post-operative complications.
    Finally, it must be understood that access to error related 
data and information underride and drive this overall system of 
accountability and oversight. Therefore, we believe that any 
national reporting program must ensure appropriate data sharing 
amongst all of the responsible oversight parties.
    In conclusion, we believe that the work of the Joint 
Commission over the last four years provides significant 
lessons learned for policymakers grappling with solutions to 
the medical errors problem. Our sentinel event program has 
identified the critical information-based tasks that need to be 
carried out. But the sentinel event program also illustrates 
the harsh realities of the litigious atmosphere in health care 
that creates major barriers to the surfacing and reporting of 
error related information.
    It is abundantly clear that no reporting system for serious 
errors can fulfill its objectives without Congressional help. 
Without Federal legislation, the Joint Commission's error 
reporting program, and others like it, will continue to fall 
significantly short of their intended goals.
    Thank you.
    [The prepared statement follows:]

Statement of Dennis S. O'Leary, M.D., President, Joint Commission on 
Accreditation of Healthcare Organizations

    I am Dr. Dennis O'Leary, President of the Joint Commission 
on Accreditation of Healthcare Organizations. I am pleased to 
have the opportunity to address the House Ways and Means 
Subcommittee on Health regarding medical errors. The frequency 
and nature of medical errors is perhaps the most pressing 
quality of care issues we face in the health care today.
    The Joint Commission is the nation's oldest and largest 
standard-setting body for health care organizations. We 
accredit over 18,000 organizations that provide a wide range of 
services, including hospitalization; long term care; ambulatory 
care; behavioral health care; laboratory services; managed 
care; and home care. Based on its broad experience, the Joint 
Commission has a panoramic view of the strengths and weaknesses 
inherent to our health care delivery system. We believe that 
the problem of medical errors is endemic to the way health care 
is carried out, but that the health care providers have the 
tools and the commitment to sharply reduce their incidence.
    My testimony will focus on the activities that we believe 
must be carried to reduce errors nationwide. The release of the 
Institute of Medicine's report, ``To Err is Human: Building a 
Safer Health System,'' has galvanized the professional and 
policy making communities around this critical set of quality 
issues. Such synergy of purpose among stakeholders is a 
prerequisite for successfully addressing complex, 
multifactorial problems whose solutions depend upon information 
sharing among the parties. Dramatically reducing the numbers 
and types of errors will take a concerted effort by all who 
participant in and oversee the delivery of health care.
    The goal for the country should be to find ways to increase 
knowledge about why errors occur and to apply that information 
in a manner that will enhance patient safety. On the surface 
this sounds simply, but success, will in fact, require a 
cultural shift in how our society views and treats medical 
errors. Success will also require a coordinated approach, among 
responsible parties, particularly in the development and 
application of constructive information regarding medical 
errors. This coordinated approach must necessarily bridge the 
public and private sectors.

Medical error reduction is fundamentally an information 
problem.

    The solution to reducing the number and types of medical 
errors resides in developing mechanisms for collecting, 
analyzing, and applying existing information. If we are going 
to make significant strides in enhancing patient safety, we 
must think in terms of what information we need to obtain, 
create, disseminate and apply to the problem. With this in 
mind, there are five critical, information-driven activities 
that must be supported in the overall system. In theory, a 
single organization could perform all of these functions, but 
in fact, multiple public and private sector organizations will 
have roles to play.

1. Creation of a blame-free environment to encourage the system 
surfacing and reporting of serious adverse events.

    Fear of reprisals, public castigation, and loss of business 
will continue to impede the reporting of serious errors unless 
we provide incentives for making mistakes known to accountable 
oversight bodies. Today, the blame-and-punishment orientation 
of our society drives errors underground. We believe that most 
medical errors never reach the leadership levels of the 
organizations in which they occur. For the typical caregiver 
involved in a medical error that leads to a serious adverse 
event, the incentives to report are all negative--potential job 
loss, humiliation, shunning. It is a small wonder that we know 
so little about this terrible problem. If we are to get a 
handle on the epidemiology of the problem, we must create a 
climate that will led to an accurate understanding of its scope 
and nature.
    An important feature of the Joint Commission's Sentinel 
Event Program (Attachment A) is the non-punitive reporting 
environment it seeks to create. Hoping to foster a positive 
culture that will promote error reduction efforts, the Joint 
Commission has designed its policies not to penalize the 
accreditation status of an organization that surfaces an error 
and performs the appropriate due diligence required under the 
policy. The resulting atmosphere provides incentives that favor 
the surfacing of information about errors that eventually 
contributes to error reduction strategies that can be used by 
other organizations.
    Despite the incentive to report errors to the Joint 
Commission, the fear of litigation is a significant impediment 
for the majority of health care providers. Therefore, we have 
experienced only limited reporting to the Joint Commission's 
database since it was established in 1996. Indeed, our Sentinel 
Event Program has found it necessary to create procedureal 
accommodations to protect sensitive error-related information, 
such as having our surveyors review reported errors onsite 
rather than having information sent to the Joint Commission's 
central office. But these manipulations are only stop gap 
measures that we believe must be replaced by federal 
protections for error-related information.
    Further, it is imperative that any medical error-reporting 
program operate under a pragmatic and carefully crafted 
definition of what is a reportable event. Standardization of 
the information to be collected is an important prerequisite 
for aggregating events in a consistent and meaningful fashion. 
Further, without a pragmatic definition, a reporting program 
would be flooded with hundreds of thousands of lesser injuries 
that would overwhelm the system. With this in mind, the Joint 
Commission has identified a subset of sentinel event*--
including their nomenclature and taxonomy--that should be 
reported to the Joint Commission on a voluntary basis.
    Our definition of a reportable event minimizes the external 
reporting burden for health care organizations while focusing 
on the most serious occurrences that have a high likelihood of 
being preventable. The fact that the Sentinel Event program 
seeks to collect data on the most serious errors, or 
``crashes,'' distinguishes the Joint Commission's reporting 
program from the voluntary programs encouraged in the IOM 
report, which would collect information only on the ``near 
misses.''

2. Production of credible ``root cause'' analyses following the 
occurrence of serious adverse events.

    When a serious error occurs, there must be a requirement 
for an intensive, no-hold-barred vetting of all of the causes 
underlying the event. We call these responses ``root cause'' 
analyses--a term borrowed from the engineering world's reliance 
on a systems approach to both solving problems and producing 
desired outcomes.
    A root cause analysis focuses primarily on systems and 
processes, as opposed to individual performance. While an 
individual is invariably the proximal cause of error relate to 
systems failures distal to the error itself. For example, 
systems may fail to provide simple checks and balances; or they 
may be missing critical safeguards; or may have design flaws 
that actually promote the occurrence of errors.
    These intensive analyses are rich learning processes that 
can elucidate multiple factors that ultimately contributed to 
the error. Many of these are not readily apparent until the 
root cause analysis is undertaken. Therefore, the analysis must 
be comprehensive and thorough, and engage the personnel 
involved in all aspects of the care giving and support 
processes. These are also time consuming investigations, and 
their complexity may require external technical assistance. The 
Joint Commission has developed several comprehensive guides on 
how to conduct a ``thorough and credible'' root cause analysis, 
and continues to be the leading source of guidance for health 
care organizations in this area.
    Unfortunately, the majority of reporting systems--both 
voluntary and mandatory--fail to require or encourage the 
performance of these intensive assessments. This was evident 
during our recent review of many state reporting programs. A 
reporting system that ends with the report of the event itself 
is not a credible program and will not contribute to error 
prevention. Root cause analyses also offer extraordinary 
insights into how processes must change to control unwarranted 
variations, and they tell stories of what systems must be 
developed to guard against the occurrence of similar human 
error. Root cause analyses hold the promise of prevention. They 
are also the necessary substrate from which risk reduction 
action plans are created.
    While reporting is voluntary under our Sentinel Event 
Program, the production of a root cause analysis following a 
sentinel event is mandatory. Not surprisingly, organizations 
are hesitant to share these root cause analyses with the Joint 
Commission or anyone else. Although many organizations have 
done so, we must recognize that preparing a document that lays 
bare the weaknesses in a health care provider's system is akin 
to writing a plaintiff's brief for purposes of litigation. 
Therefore, we cannot expect uniform preparation of these 
documents without federal protections against their 
inappropriate disclosure.

3. Implementation of concrete, planned actions to reduce the 
likelihood of similar errors from happening in the future.

    Monitoring is an critical element of the strategy for 
preventing errors, to ensure that the response to an error does 
not terminate simply with the report itself or a discussion of 
what went wrong. The Joint Commission monitors the action plans 
of accredited organizations which have experienced serious 
medical errors, in a manner similar to the way it monitors any 
quality of care area in need of improvement. This ensures that 
there is an independent review of the milestones associated 
with planned systems changes. We expect to see an 
organizational response that results in preventive actions.
    We view the monitoring function as a key element of public 
accountability. The public must have confidence that there is 
an external body overseeing patient safety issues in the 
organization that are delivering their care. We believe that 
the public views safety as a threshold concern. While citizens 
probably do not wish to have detailed data about safety 
prevention in each health care organization, they should 
reasonably expect that responsible oversight bodies are acting 
conscientiously and effectively on their behalf. This includes 
aggressive and timely follow-up to the occurrence of a serious 
medical error and holding the organization accountable for 
making necessary systems improvements.
    At the same time, it is error-related data and information 
that undergird and drive this system of accountability and 
oversight. Therefore, we believe that any national response to 
the IOM report must ensure appropriate data sharing among all 
of the responsible oversight bodies which perform any of the 
functions discussed in this testimony. The health care quality 
oversight system involved a variety of private sector and 
public sector players today. Efforts should at least be made to 
better utilize existing structures through improved data 
sharing, and encourage the broad dissemination of what has been 
learned from medical mistakes. We do not want to end up with a 
fragmented, ineffective system where, for example, a single 
body is privy to reports of errors, yet organizations with 
public accountability for patient safety are not made aware of 
or do not have access to this information.

4. Establishment of patient safety standards which health care 
organizations must meet.

    The Joint Commission has established developed explicit 
patient safety standards that became applicable to accredited 
organizations beginning in January 1999. These new standards 
were specifically created to establish patient safety as a high 
priority in provider organizations.
    The new standards require that the leadership of a health 
care organization establish processes for identifying and 
managing sentinel events and put these into practice. The 
standards also require that the organization monitor the 
performance of particular processes that involve risks or may 
result in sentinel events, and intensely analyze undesirable 
patterns or trends in performance. The standards make patient 
safety a visible responsibility of health care organizations 
and a requirement for accreditation. Compliance with these new 
patient safety standards is evaluated through our periodic 
onsite inspection process.
    We would like to see other accreditors and quality of care 
oversight bodies include meaningful patient safety standards in 
their requirements. Further, it may be valuable to explore ways 
for oversight bodies to better inform the public and purchasers 
as to how well organizations are doing in terms of meeting 
these performance expectations.

5. Disseminating of experiential information learned from 
errors to all organizations at risk of similar adverse events.

    To have a positive national effect on patient safety, 
information gleaned from errors must be aggregated, analyzed 
and disseminated to the health care community at large. In 
1997, the Joint Commission began to issue periodic Sentinel 
Event Alerts Alerts to share the most important lessons 
learned--known risky behaviors as well as best practices--from 
its database of error-related information. To date we have 
issued Alerts in a number of areas, including medication 
errors; wrong site surgery; restraint-related deaths; blood 
transfusion errors; inpatient suicides; infant abductions; and 
post-operative complications.
    We are confident that these Alert have saved lives. 
Unfortunately, we cannot calculate real decreases in error 
rates with scientific certainty, because the full scope and 
frequency of serious adverse events is simply not known. 
However, we have some data, which illustrates the effects of 
our Sentinel Event program in selected areas. For example, we 
have seen a notable significant effect from our first Alert 
(Attachment B) dealing with the importance of appropriate 
storage and handling of potassium chloride (KCl)--a substance 
that is deadly when given in concentrated form and is easily 
mistaken for less benign substances. In analyzing the causes of 
KCl-related deaths, it became evident that accidental injection 
of KCl stored on hospital floors was an important cause of 
unanticipated deaths. The Joint Commission issued its Alert on 
the subject in February 1998. The number of reported deaths has 
dropped from 12 in 1997 to only one in 1998 and one in 1999.
    We also believe that significance should be attached to how 
information is disseminated and by whom. The risks associated 
with potassium chloride have long been known to practitioners. 
But when the principal accreditor of provider organizations 
issued a major alert, it caught the attention of organization 
leaders and health care practitioners. Moreover, it was clear 
to the recipients of the information that the Joint Commission 
would be paying attention to this particular issue and 
following up during onsite evaluations of the organization's 
performance. This program of Alerts is an example of the type 
of vehicle necessary to achieve behavior change in health care 
organizations.
    There is also a need for more research to inform health 
care evaluators on how to identify ``risk'' in organizations. 
We have some knowledge about the relationship of organizational 
structure to outcomes--for example, team approaches appear to 
be more effective than hierarchical structures--but the 
information is very limited. It may be useful to determine 
whether there are key characteristics of organizations that 
makes them more or less prone to errors such as how well they 
handle new information, communicate among their component 
services, etc. Investing in demonstrations of shared decision 
making may also prove fruitful. Shared decision-making tools 
that bring the latest information to both practitioner and 
patient could lead to reduced medical errors through more up to 
date medical knowledge, increased patient compliance, and other 
factors.

Conclusions and Need for Congressional Action

    We believe that the work of the Joint Commission over the 
last four years provides significant ``lessons learned'' for 
policy makers grappling with solutions to the medical errors 
problem. The Sentinel Event Program has identified the critical 
information-based functions for solving the medical error 
problem. In carrying out these functions, the Joint 
Commission's efforts have assuredly prevented additional errors 
and saved lives.
    But, the Sentinel Event program also illustrates the harsh 
realities of a litigious atmosphere in health care that creates 
major barriers to the surfacing and reporting of error-related 
information. It is abundantly clear that no reporting system 
for serious errors can fulfill its objectives without 
Congressional help. Without federal legislation, the Joint 
Commission's error reporting program and others like it 
continue to fall significantly short of their intended goals. 
This is true whether the reporting framework is public or 
private; mandatory or voluntary; national, state, or local.
    We urge, therefore, that Congress create statutory 
protections from disclosure and discoverability of the in-
depth, causal information which must be gathered in any 
mandatory or voluntary reporting program for serious adverse 
events.
    *The Joint Commission defines a reportable sentinel event 
as an event that has resulted in an unanticipated death or 
major permanent loss of function, not related to the natural 
course of the patient's illness or underlying condition, or one 
of the following: suicide of a patient in a round-the-clock 
care setting; infant abduction or discharge to the wrong 
family; rape; hemolytic transfusion reaction involving 
administration of blood or blood products having major blood 
group incompatibilities, or surgery on the wrong patient or 
wrong body part.

                                

    Mr. Thomas. Thank you very much, Dr. O'Leary. Dr. Golden?

STATEMENT OF WILLIAM E. GOLDEN, M.D., FACP, PRESIDENT, AMERICAN 
                   HEALTH QUALITY ASSOCIATION

    Dr. Golden. Thank you, Mr. Chairman, and good afternoon.
    As medical director for quality improvement at a Medicare 
peer review organization, I am pleased to be here today to talk 
about medical errors. I am also a professor of medicine at the 
University of Arkansas Medical School. The Arkansas PRO has 
extensive experience doing quality improvement, HEDIS 
measurement patient satisfaction surveys for Medicare as well 
as Medicaid.
    Today I am here as President of the American Health Quality 
Association. This organization represents quality improvement 
organizations in this country which are private, community 
based, and work in all health care settings, hospitals, 
physicians offices, nursing homes, home health agencies in all 
50 states, the District of Columbia, and U.S. territories.
    Unifying our activities is the Medicare peer review 
contract. Over the last 10 years, the PRO system has evolved 
into a national network of quality improvement experts that 
systematically evaluate the delivery of health care in a region 
and institute projects to educate and alter the clinical 
behavior of institutions, health professionals, and patients. 
Today's PRO system is and can be a core element of a national 
system for improving patient safety.
    We are already doing extensive work in this area to reduce 
errors. Our staffs have changed over the last 10 years to 
accomplish these goals. We currently have on staff clinical 
experts, nurses and physicians, who are trained in quality 
improvement techniques. We have data and statistical 
professionals on staff, medical record abstraction teams, an 
extensive infrastructure of community relationships to get 
change in the community structure and to communicate this 
information, as well as expertise in public relations and 
outreach strategies.
    Indeed, in the major study on errors out of Colorado and 
Utah, the data collection was subcontracted to PROs by the 
teams out of Harvard to get the research performed.
    The Institute of Medicine points out there are two kinds of 
errors, errors of omission and errors of commission. Much of 
the PRO system currently works to reduce errors of omission in 
prevention, diagnosis, and treatment. We are doing such things 
as increasing rates of mammography, increasing the use of 
pneumovax, pneumococcal vaccine, influenza vaccine. Appropriate 
drugs after the treatment of heart myocardial infarction 
improve the receipt of those drugs by appropriate patients. 
Timely administration of the correct antibiotics for the 
treatment of pneumonia. ACE inhibitors for heart failure, 
making sure patients receive this medicine to improve function 
and survival. Better monitoring of potential diabetic 
complications.
    We are even doing studies on errors of commission, such as 
the elimination of a dangerous drug in the treatment of stroke. 
I have a list of 22 performance measures attached to my 
testimony that goes into the areas we are currently working on 
to reduce errors.
    The strengths of these activities reflects the fact that 
they affect a large number of older Americans. They have strong 
scientific support. And they are standardized, so we can 
compare treatments and progress across states, within regions, 
and also within our own program.
    Given our experience over the last 10 years, we have seven 
recommendations to improve the system and improve patient 
safety. One is to expand the current performance monitoring 
system the PROs are using. We currently measure and improve 
medical errors. Our list of clinical topics could be expanded 
with new performance measures to improve care. Indeed, if we 
improve care for Medicare patients we often improve care for 
all patients, because once you have improvement for myocardial 
infarction, all patients with MI tend to benefit.
    Many of these recommendations are consistent with what was 
in the Medicare Payment Advisory Commission report in June 1999 
and was recommended by the Medicare Payment Advisory 
Commission.
    We could work on things like adverse drug events, hospital 
acquired infections, post-operative hemorrhage, et cetera. We 
agree that the Agency for Healthcare Research and Quality, 
HCFA, and other stakeholders should get together and work on 
new performance measures to reduce errors.
    It is important to note that this system would not increase 
burden to the hospitals because most of this could be done by 
using administrative databases, record abstraction, and does 
not require reporting. It can be done by data abstraction teams 
and rates of errors could be determined and improvements 
designed to improve safety.
    We believe that there should be a mandatory reporting of 
some catastrophic errors. Much of this, as I said, can be done 
by abstraction, but there are some random events which break 
through safety systems in hospitals, and the reporting of those 
errors to a regional entity would allow for many institutions 
to learn from these rare events so that additional patients 
would not be harmed by recurrences at other settings.
    We believe there needs to be accountability of this system 
and that this kind of activity should be handled by a qualified 
expert organization who can do root cause analysis, can 
communicate the information and can get behavior change.
    The PRO program right now is under agreements with the 
Health Care Financing Administration to actually improve care 
in their areas and make it measurable.
    We believe there needs to be confidential treatment of 
reported errors. It is very important that we do not punish 
people for reporting mistakes in their environment if it is 
under the rubric of improving patient safety. Right now the 
PROs have much of that confidentiality in place, so we can go 
forward. That is much in keeping with the protections as 
outlined by the Institute of Medicine report.
    We believe there also needs to be a mechanism for finding 
unreported errors. PROs, like Utah and Colorado did for their 
study, can do chart surveillance for either targeted errors or 
random errors, depending on the topics under review. That way, 
we can see whether there are additional events going on in the 
system that need to be addressed.
    The system must promote best practices with good 
collaboration between institutions and the entity that is 
collecting the information, collect best practices and promote 
quality improvement in the communities.
    And finally, we need to separate malpractice reform from 
error reduction programs. Malpractice is a very difficult topic 
and I believe we are here today to talk about how we can 
improve patient safety and reduce errors. That is our 
fundamental intent, and the malpractice reform, we will leave 
to other experts.
    At this point, I will stop and welcome questions. Thank you 
very much for the time.
    Chairman Thomas. Thank you.
    [The prepared statement follows:]

Statement of William E. Golden, MD, FACP, President, American Health 
Quality Association

    Good morning, Mr. Chairman. Thank you for inviting me to 
testify today.
    I am the Principal Clinical Coordinator for one of 
Medicare's Quality Improvement Organizations, or QIOs, called 
the Arkansas Foundation for Medical Care. I am also a Professor 
of Medicine and Director of General Internal Medicine at the 
University of Arkansas Medical School. My QIO has extensive 
experience in performance measurement and conducts quality 
improvement, HEDIS measurement, and patient satisfaction 
surveys for the state Medicaid program. We are also a 
recognized vendor for the Oryx Program of the Joint Commission 
on Accreditation of Healthcare Organizations (JCAHO). In fact, 
we created three of JCAHO's thirty performance measures in the 
proposed national core program.
    I am here, today, as President of the American Health 
Quality Association (AHQA), a national membership association 
of organizations and individuals dedicated to health care 
quality improvement. Our member QIOs are private, community-
based organizations that promote health care quality in all 
health care settings. QIOs work in all 50 states, the District 
of Columbia and the U.S. Territories.
    The QIOs have several lines of business including work with 
state governments and private health plans. The work that 
unites them all, however, is their 3-year, competitively 
awarded contracts from HCFA to evaluate and improve the quality 
of care delivered to Medicare beneficiaries. For this work, our 
members are more commonly referred to as Medicare Peer Review 
Organizations, or PROs.
    Congress established the PROs in 1983 to look for single 
case problems. During the 1990s, the PRO system evolved to 
become a national network of quality improvement experts that 
systematically evaluate the delivery of health care in a region 
and institute projects to educate and alter the clinical 
behavior of institutions, health professionals and patients. 
QIOs are staffed with clinical experts, communication experts, 
and data and statistical professionals who work together to 
analyze and collaborate with the health care system in their 
communities.
    Today's PRO system is uniquely qualified to serve as the 
core of a new national system for improving patient safety. One 
of the greatest strengths of the PRO system is its extensive 
infrastructure of relationships in every region of the country. 
PROs work individually with hospital staffs and physicians 
offices. They are also increasingly engaged with home health 
care systems, nursing homes, academic health centers, and 
community groups such as heart associations and cancer 
coalitions.
    In addition to technical expertise, they have developed 
public relations and outreach strategies with professional 
associations, public health authorities and state officials. 
This is critical for helping hospitals and other facilities 
implement improvement strategies as well as tailoring messages 
to the public about improving their health (e.g. public 
awareness of receiving pneumococcal vaccinations or getting 
regular eye examinations to reduce the risk of diabetes-related 
blindness). This is also critically important for the 
effectiveness of the PROs' required projects with underserved 
and disadvantaged populations. These projects often require 
forms of outreach and communication that are culturally 
appropriate.
    The Institute of Medicine (IOM) report released last 
November targets both medical errors of omission--care not 
provided that should have been--as well as errors of 
commission. In addition, the IOM Committee also states that 
errors occur and should be detected in all phases of medical 
care: prevention, diagnosis and treatment.

The Medicare PRO Program as a Model Error Reduction Program.

    Medicare's national PRO system has been identifying, 
measuring and reducing error rates for several years. The PRO 
program is now embarking on an expanded three--year mission to 
identify and eliminate medical errors. The new program is 
focused largely on errors of omission--such as prescriptions 
that were not ordered for prevention of heart attack--and on 
errors in all three categories mentioned by the IOM. For 
example, in the prevention area, PROs are working to promote 
immunizations to prevent the most common fatal infection, 
pneumococcal disease. In the area of missed diagnoses, the PROs 
will be working to increase mammography screening and diabetic 
retinopathy testing. An example of PRO work to reduce treatment 
errors is that PROs will be emphasizing timely administration 
of antibiotics for newly hospitalized pneumonia patients.
    I have attached a complete list of the 22 performance 
indicators in each of six clinical topic areas for which the 
PROs must reduce error rates. These PRO performance indicators 
serve as a useful model for a new medical error reduction 
system for several reasons. These clinical topics were 
carefully chosen because they affect a large percentage of 
older Americans and because the scientific basis for the 
desired therapy or action is well established. A national error 
reduction program should also focus on high priority problems 
and adopt a science-based approach.
    In addition, the standardized national set of performance 
indicators assures national comparability of data within and 
between all states, which is critical to accurately measure 
improvement. We believe this is a sound model for a national 
system of identification and reduction of medical errors.

Recommendations.

    Based on our experience working within a national system to 
identify quality problems and work collaboratively with 
providers to bring about improvement, here are our 
recommendations for a new system for improving patient safety.

1. Expand Monitoring System for Error Prevention.

    Congress should expand the current system utilized by 
Medicare to monitor a targeted list of health care processes 
and patient conditions known to be associated with a 
disproportionate amount of medical errors. This system will 
identify many errors and adverse events, which have not yet 
resulted in dramatic or catastrophic patient outcomes. The 
published literature identifies some categories of preventable 
adverse events that are both relatively frequent and frequently 
preventable, and might be targeted by a national monitoring 
system. Some examples include adverse drug events, hospital 
acquired infections, deep venous thrombosis, postoperative 
hemorrhage. The Agency for Healthcare Research and Quality 
(AHRQ) and the Health Care Financing Administration (HCFA) 
should collaborate with representatives of our national network 
of Quality Improvement Organizations (QIOs), as well as 
professional and provider groups to define the highest priority 
areas of scrutiny for error-prone health care processes, and to 
develop a standardized system for measurement.
    Congress will be asked to consider the burden of error 
reporting. The system of monitoring that I have described can 
be accomplished without imposing significant additional 
reporting burdens on hospitals or other providers. PROs can 
accomplish much of the data gathering necessary by expanding 
their current mechanisms for review of medical records and 
abstraction of key data for analysis. Quality improvements 
based on this kind of monitoring will probably continue to be 
the major method by which patient safety is enhanced. Because 
the PRO program has already established the relationships with 
hospitals necessary to perform this function, there is very 
little new work that hospitals must do to facilitate an 
expanded program to address errors in patient care planning and 
execution.
2. Mandatory Error Reporting.

    We have recommended that Congress devote substantial 
resources to monitoring and educating providers about the 
adverse events that have strong potential to harm patients, 
rather than wait for patient harm to occur. But the smaller 
number of more dramatic events that result in patient harm must 
also be addressed by an error reduction system because the 
results of such errors are so often tragic and irreversible. 
This subset of adverse events often captures the attention of 
local health professionals and often results in demands for 
system changes to eliminate recurrence.
    Health facilities should report the rare and seemingly 
random adverse events that result in patient harm to a regional 
entity to create a database. Monitoring and analysis of such a 
database can offer insight into better system design for all of 
our communities. The reporting of such errors allows for 
hindsight analysis to be available throughout the health 
system, so that more people can benefit from the analysis than 
just those in the local environment that witnessed the adverse 
event. The PROs are well qualified to manage and interpret such 
a database in each state, and have proven adept at educating 
providers and practitioners about ways to avoid errors in the 
future.

3. Ensure Accountability.

    Congress should hold providers accountable for measurably 
reducing the incidence of errors. A qualified expert 
organization, completely independent of hospital providers, 
should analyze the incidence of errors and judge whether 
improvements are being made. The PRO program is already 
performing this function on a more limited scale. For the 
period 2000-2002, PROs will be accountable under their Federal 
contracts for measuring and reducing the frequency of missed 
prescriptions to prevent strokes and heart attacks, or missed 
lab tests to help control diabetes. If a PRO cannot accomplish 
sufficient measurable improvement, it may lose its Federal 
contract. In a new medical error system, Congress can rely on 
the QIOs to measure error rates and identify providers that 
have made no progress in eliminating errors. Providers that are 
making no progress on errors could be reported to a federal or 
state regulatory agency, or to the Joint Commission for 
Accreditation of Healthcare Organizations (JCAHO).

4. Assure Confidential Treatment of Reported Errors.

    Reports identifying specific providers and individuals 
should generally not be disclosed. Part of the reason for this 
is that ``naming names'' tends to fix blame, even when this is 
inappropriate. The IOM report [page 45] noted, ``Complex 
coincidences that cause systems to fail rarely have been 
foreseen by the people involved.'' This suggests that it is 
more important to understand system failures than to attempt to 
affix blame on one or more individuals involved in a system 
failure.
    It is critically important to not to discourage, let alone 
punish, the active search for errors. Several studies 
demonstrate that errors are much more numerous than anyone can 
know without actively digging to find them. The IOM relied on 
two large studies of the prevalence of medical errors. PROs, in 
fact, did the medical record abstraction for the second study, 
based in Utah and Colorado. Both studies found a large number 
of preventable adverse events through careful review of the 
medical record. But these researchers also noted that many 
other errors could not be found in the medical record alone. 
When researchers at the LDS Hospital in Salt Lake City wanted 
to find out the true incidence of adverse drug events in their 
institution, they started by counting the incident reports 
filed by doctors, nurses, and pharmacists. They came up with 
about 20 reports a year. But after extensive mining of lab 
data, prescription records, and interviews with hospital 
personnel, they found the true incidence of adverse drug events 
was over 580 events a year. The hospital then tracked down the 
causes of these problems and reduced their true error rate 
below the original apparent rate.
    The LDS project puts the idea of public reporting in 
context. If hospital personnel know that any error they find 
involving patient harm will be subject to public reporting, few 
will undertake the costly and difficult investigations that are 
necessary to discover errors. If public disclosure and 
punishment await those who dig effectively to find the true 
extent of errors, few errors will be found, and fewer still 
will be eliminated.
    Congress has repeatedly recognized the importance of 
maintaining confidentiality for sensitive internal hospital 
quality improvement activities. For example, Federal law 
ensures that confidential data reported to PROs shall not be 
disclosed. Congress can ensure confidential treatment of this 
information by requiring that error reports be sent to the PRO 
in each state. The current PRO statute protects such 
information from unauthorized disclosure. Public reporting of 
errors should be reserved for those institutions identified by 
the PRO that cannot or will not improve error rates.
    At the state level, aggregate information without 
identifiers for individuals or institutions could be released 
to the general public. Data reported at the national level 
would first be encrypted for aggregate public reporting and 
would then be considered a publicly accessible dataset.

5. Establish a Mechanism to Find Unreported Errors.

    Experience with other mandatory reporting systems for 
errors and health quality problems reveals that no mandatory 
reporting system will receive all appropriate reports. A 
separate mechanism to identify unreported errors is needed. One 
such system is already in place nationwide. Individual PROs 
periodically request records and analyze them for indicators of 
errors such as delayed administration of antibiotics in newly 
hospitalized pneumonia patients, and missed opportunities to 
prescribe medications to heart attack and heart failure 
patients. In addition, the national PRO program also utilizes 
clinical data abstraction centers (CDACs) to accomplish this 
task. These centers also observe strict confidentiality in 
managing the records, and have achieved a high degree of 
reliability in finding and reporting errors to PROs, which then 
work with the hospitals to prevent their recurrence. This 
system can be utilized to find many more types of errors.
    Institutions should be required to provide information in 
response to a PRO request to actively identify or pursue 
information that may not be readily identifiable in 
standardized reports. This mechanism will help to ensure the 
integrity of the mandatory reporting system, as it may uncover 
reports that should have been filed with the PRO but were not.

6. Promote Best Practices.

    Once errors are found, their causes must be understood, and 
solutions must be implemented. This is now accomplished through 
the national Medicare PRO program by collecting from each PRO 
their successful interventions to improve care, and then 
sharing it with all the rest. In this way, every PRO can 
approach local institutions with the benefit of the best 
knowledge of all the PROs and providers that have previously 
tried to solve a problem. By assisting hospital personnel in 
finding best practices, the PROs go far beyond merely holding 
hospitals accountable for their failures.

7. Separate Malpractice Reform from the Error Reduction 
Program.

    Tort reform and facilitation or limitation of litigation is 
a matter for a separate set of public policy deliberations. All 
information should be reported to the PROs for the purpose of 
assuring that measurable quality improvement is accomplished. 
Neither regulatory remedies nor liability law need be affected 
by reports to the PRO or by the confidentiality protections 
afforded such reports.
    AHQA believes these are the basic elements necessary for 
creating a systematic approach to reducing medical errors that 
will assure both medical professionals and patients that the 
problem is being addressed fairly and effectively. The key to a 
successful solution to this problem will be giving the medical 
community the opportunity to fully identify the possible extent 
of their errors and do the work necessary to systematically and 
measurably improve. Without this measurable improvement, the 
problem will continue to be discussed but never solved and 
consumers will never be assured that the quality of their 
medical care will become any better. The nation's QIOs can 
provide the accountability and results that the system will 
require.
    Thank you again for the opportunity to share this 
information with Congress. I look forward to continued 
discussion as you work to improve the safety of patients across 
America.

                     National Health Quality Improvement Projects of Medicare PROs 1999-2002
----------------------------------------------------------------------------------------------------------------
                       Quality Indicators  (proportion of     Data Sources (Medicare
   Clinical Topic          beneficiaries receiving:)                FFS Only)          Expected Health  Outcomes
----------------------------------------------------------------------------------------------------------------
          Acute MI       Early administration of     Hospital medical         Inpatient
                                    aspirin on admission    records for AMI patients            mortality rates
                      Early administration of beta                              Mortality rates
                                   blockers on admission                                             at 30 days
                              Timely reperfusion                                Mortality rates
                      ACE inhibitors for low left                                             at 1 year
                           ventricular ejection fraction                                    Readmission
                      Smoking cessation counseling                                   rates with AMI CHF
                                  during hospitalization
                            Aspirin at discharge
                      Beta blockers at discharge
               CHF     Angiotensin-related drugs     Hospital medical         Inpatient
                           for left ventricular ejection    records for heart failure           mortality rates
                               fraction when appropriate                    patients    Mortality rates
                                                                                                     at 30 days
                                                                                        Mortality rates
                                                                                                      at 1 year
                                                                                            Readmission
                                                                                                    rates w/CHF
         Pneumonia    State Influenza vaccination            Flu and           Hospital
                                                    rate    pneumonia immunizations--           admission rates
                              State Pneumococcal    Claims or survey similar           Hospital
                                        vaccination rate              to CDC's BRFSS          readmission rates
                             Inpatient Influenza               Other          Inpatient
                              vaccination (or screening)        indicators: Hospital            mortality rates
                          Inpatient Pneumococcal         medical records for    Mortality rates
                              vaccination (or screening)          pneumonia patients                 at 30 days
                            Blood culture before                                    Readmission
                            antibiotics are administered                                   rates with Pneumonia
                      Appropriate initial empiric
                                    antibiotic selection
                         Initial antibiotic dose
                      within 8 hours of hospital arrival
    Stroke/TIA and       Discharged on warfarin,     Hospital medical         Inpatient
             Atrial   aspirin or other antiplatelet drug    records for stroke, TIA,            mortality rates
       Fibrillation                 (stroke or TIA only)          and chronic atrial    Mortality rates
                          Discharged on warfarin       fibrillation patients                 at 30 days
                      (chronic atrial fibrillation only)                                    Readmission
                      Avoiding inappropriate use                                  rates with stroke/TIA
                     of sublingual nifedipine (stroke or
                                               TIA only)
          Diabetes    Biennial retinal exam by an     Claims for all    Mortality rates
                                        eye professional      diabetic beneficiaries                  at 1 year
                            Annual HbA1c testing                                        Rate of
                          Biennial lipid profile                                development of diabetic
                                                                                                    retinopathy
                                                                                                Rate of
                                                                                            development of ESRD
     Breast Cancer          Biennial mammography      Claims for all     Percent of new
                                               screening        female beneficiaries     cases of breast cancer
                                                                                            detected at stage 1
----------------------------------------------------------------------------------------------------------------

                                

    Chairman Thomas. With all due respect, Dr. Golden, a major 
portion of your testimony sounded like a job interview.
    Dr. Golden. Sure.
    Chairman Thomas. You mentioned doing root cause analysis. 
Dr. O'Leary mentioned that they were engaged in root cause 
analysis. That sounds like a deep ``why'' probe is what it 
sounds like. Is that what it is?
    Dr. O'Leary. Why, yes.
    Chairman Thomas. Okay, a deep ``why'' probe, root cause 
analysis. Did you say, Dr. Golden, that you do it or that you 
need to have an agency that does it? Do you do root cause 
analysis?
    Dr. Golden. We facilitate it. As I said, most----
    Chairman Thomas. What does facilitate versus do it mean?
    Dr. Golden. As I said, we are doing data analysis to find 
rates of errors. We are suggesting improvement mechanisms to 
eliminate those errors. Some of these projects, we give to our 
collaborating institutions, and I will say right now that the 
average project we do attracts two-thirds of the hospitals in 
our State. We give them turnkey projects to effect fundamental 
system changes within those facilities.
    Now, every now and then, you run into an institution--I 
will give you an example--which is an outlier that has a unique 
set of problems. We had one hospital that had a very high rate 
of bypass mortality. We--
    Chairman Thomas. You have lost me to a certain extent.
    Dr. Golden. Sorry.
    Chairman Thomas. My question was, do you do deep root 
analysis? Do PROs do deep root analysis?
    Dr. Golden. We do not do analysis of single-case events. We 
find experts to assist. What we do do is evaluate systematic 
reforms.
    Chairman Thomas. That is fine.
    Dr. Golden. So that is a different issue, different kind of 
errors.
    Chairman Thomas. I understand.
    Dr. Golden. Right.
    Chairman Thomas. You do a lot of other things, but one of 
the concerns I have is that there may be a drive to provide a 
one-basket approach, and my concern is that if, in fact, there 
is expertise out there in a number of different areas, one, I 
do not want to duplicate or reproduce it----
    Dr. Golden. Absolutely.
    Chairman Thomas.--and two, I want to make sure that we 
maximize the opportunity of the information flow so that those 
who are performing functions can continue to perform them.
    Dr. O'Leary, you----
    Dr. Golden. We facilitate that deep root analysis and get 
the experts.
    Chairman Thomas. Right. I will not ask the obvious 
question. But Dr. O'Leary, the question I do want to ask is, 
did you find the hospitals as receptive as the statement that 
Dr. Langberg kind of intimated, that they had no problem at all 
accepting the sentinel reporting structure? Did you have any 
difficulty getting that system up and running? Were the 
hospitals fully cooperative, in your opinion?
    Dr. O'Leary. Well, I do not think it is any secret that 
there were a broad base of concerns, that those concerns were 
driven primarily over the potential waiver of confidentiality 
if they shared that information with us, and in fairness, there 
are now some State laws that protect that sharing. But there 
had been very little testing of existing peer review statutes. 
I will tell you that there are a large number of organizations 
who said that they would be pleased to share with us the 
occurrences and the root cause analyses if such protections 
were in place, and I accept that on good faith.
    Chairman Thomas. Does it make sense to go ahead, as was 
indicated by several others, that we need to continue to have a 
State-based structure? I mean, it is going to remain, given the 
police powers of the State in terms of health and welfare, but 
would it not facilitate things if we provided a shield at the 
national level for the confidentiality, the collection of data, 
so that you would have a uniform structure nationwide, 
notwithstanding what may or may not be done in the State?
    Dr. O'Leary. I think that is absolutely crucial. The time 
it would take to pass----
    Chairman Thomas. Now, let me get this straight. You are a 
private sector operation?
    Dr. O'Leary. Yes.
    Chairman Thomas. And I am a Republican?
    Dr. O'Leary. Yes.
    Chairman Thomas. And we just both came to agreement on the 
idea of a national uniform structure?
    Dr. O'Leary. There are certain compelling needs, and this 
is one of them.
    Chairman Thomas. I think somebody is going to come to the 
conclusion that that is what should be driving this process. It 
is too important to get down into the gutter of politics or 
anything else, and we are going to do everything we can to do 
it as best we can.
    I just have a lot of confusing information and I want to 
ask, Dr. Bagian, did I hear you say that you really have kind 
of like the FAA system, where it is kind of an all-comers 
reporting, that you accept voluntarily, although you do have 
the mandatory? Do you find that to be an information overload 
in your structure?
    Dr. Bagian. No, sir, at least not yet. One of the things we 
have, we have a mandatory system. We also have a voluntary 
system that we are in the process of putting in place. It is 
not fully in place. If you would ask Linda, I mean, I have 
known Linda for 20 years and Charlie Billings back when I was 
at NASA, so I am familiar with their program. They sometimes 
see different things from the mandatory systems as opposed to 
the voluntary system. For example, there is mandatory 
reporting. And then there is the ASRS you heard about. They in 
certain cases can compare reports from the different systems; I 
mean, it is the same event. The stories are not always the 
same. It is the same incident we are talking about, but the 
story you tell the cops----
    Chairman Thomas. Between the mandatory and the voluntary?
    Dr. Bagian. Yes, sir.
    Chairman Thomas. The coerced and the uncoerced?
    Dr. Bagian. I do not know if that was the term I would use.
    Chairman Thomas. Okay.
    Dr. Bagian. The one where you are more fearful than the 
other. Let us put it that way. At any rate----
    Chairman Thomas. That is better, yes.
    Dr. Bagian. I think what they found, and you should ask 
Linda to tell you about that, the issue is that you get 
valuable things from both. That is not to say that the 
mandatory system, where you are in fear because it is 
disclosable, you do not get anything valuable. You do. But they 
are synergistic. You learn different things from both, and they 
both are essential.
    One thing I might point out that I did not mention before 
is about close calls. You heard many comments about the need to 
get those severe, you know, the deaths, the severe thing. We 
think that misses the point by a lot.
    Chairman Thomas. Yes. You do not learn----
    Dr. Bagian. That is right. I mean, if we have to stack up 
the bodies like cordwood to learn, that is kind of like the 
hard way to learn. That is not really very progressive. What 
you want to do is you want to look at close calls, the risk 
thereof, as they talk about in the Joint Commission's 
definition of single event, and we think that is very powerful, 
because several things have been shown in the aviation world. 
Often, you can learn as much or more from close calls, because 
people are more likely to be candid because it is kind of--this 
is not a word--not tortable, right, if there was no damage. But 
yet, people can talk about it more candidly----
    Chairman Thomas. There are more of them around to talk 
about it.
    Dr. Bagian. And there are also more around to talk, that is 
correct. So we have emphasized very heavily to do the whole 
thing. The IOM report segregates it and says mandatory is just 
the real serious ones and voluntary is the other, and we 
disagree with that. We think you want to look at both, the 
whole thing, because you weave them together to learn even more 
than just saying that you want to look at one versus the other. 
We think that close calls are a very important thing not to 
lose sight of.
    Chairman Thomas. Okay, because that is one of the concerns. 
Now, have you had a breakdown of your system yet where 
information has been leaked, or have you been able to keep a 
lid on it?
    Dr. Bagian. So far, no problem yet, and we emphasize it 
very clearly that that is an integrity violation and it will 
not be tolerated.
    Chairman Thomas. I mean, it is very difficult sitting here 
when one of the first arguments is that you cannot have 
everybody reporting, that humans always make mistakes, and that 
even if you go to a computerized structure, you are going to 
push the wrong button. At some point when you go through those 
explanations, they quit being explanations and they start 
becoming excuses. My concern is that I am already hearing what 
I consider to be some excuses as to why you cannot do a 
relatively broad-based approach.
    Dr. Kizer, what I really liked in the ten points that you 
had in your written testimony was that you addressed what we 
have been alluding to and sometimes specifically referred to, 
and that is going back to the education structure and getting 
into the teaching hospitals and into those support, both the 
professional and quasi-professional, and figuring out how to 
change the curriculum so that you can begin to do that 
systematically.
    I find, interestingly, that the first thing I get out of 
most of these folk is we have to spend more money, we have to 
set up additional structures, and if, in fact, we are dealing 
with behavior and systems, there is a mental approach to 
behavior which allows the system to function that you do not 
necessarily have to spend a lot of money on, and that is 
basically behavioral alteration.
    So if we have to write off today's current professionals, 
we ought to at least make sure that as we make these changes, 
we get down in there early, and I am not just anxious to set up 
a Federal agency to collect data to get the why and begin to do 
that. I am very anxious to get some help in exactly where there 
are people who are doing this.
    Do you do any kind of, and notwithstanding the fact that 
you are no longer there, do you do any in-service training in 
the VA? Have you found that you have to set up a parallel 
program for those that are there to do training, to get people 
to understand, notwithstanding the fat that you put up a 
voluntary system and you can report? Even if it is voluntary, 
there are people who will be hesitant to do it because they 
have not been in that situation before. You have to create an 
environment of support, not just here is the environment.
    Dr. Kizer. It goes beyond that. The VA actually put in 
place a requirement, a continuing education requirement for our 
existing practitioners, not the usual continuing medical 
education but a requirement specifically on quality improvement 
and patient safety that went beyond what is required, and as 
far as I know, that is unique in the nation.
    But they also----
    Chairman Thomas. Now, was that an integral component of 
putting this plan in place or did you realize you had to have 
it as you were going along?
    Dr. Kizer. It was one of the areas where we knew that we 
had to change the behavior of the existing cadre of folks. You 
also have to look at the next generation and put in place 
things to deal with them, so it requires a multi-faceted 
approach. Recognizing the culture and the barriers that exist, 
VA also has a financial rewards system where practitioners can 
actually get financially rewarded for identifying problems and 
solutions. But it is trying to change the dynamics from one of 
hiding the information to one were it is the norm that you come 
forward and you are as forthright and open as possible.
    Chairman Thomas. But can you not at least get into that 
aspect of this readjustment we need to make on a carrot and a 
stick basis? That is, you reward those institutions and other 
places that are doing those sorts of things, not the question 
of the transmission of the data itself, which has to be in a 
positive, supportive structure.
    But it seems to me that one of the problems, and we have 
not really talked about it, is that we do not have the ability 
to collect the data, or we are beginning to get the ability, 
and even if we have it, we still do not have in place, except 
for maybe structures like yours that can impose it, kind of a 
best practices procedure so that once you get the data, it can 
get out there and actually be converted into a workplace 
change.
    In that sense, we ought to be able to reward and withhold, 
if not punish, for people who are picking up and making the 
changes that clearly have been indicated are the appropriate 
way to go. I think the medical culture causes problems there 
again, because now you are telling me how to practice the art 
of medicine for which I am my own best definer.
    Dr. Kizer. There is no question that there is much that 
could be done in reimbursement strategies and how health care 
is compensated that could get at the issues that you are 
talking about.
    Chairman Thomas. I am actually going to be looking, and I 
know you folks do not have a lot coming out the other end of 
the pipe yet, but from what I have heard, it sounds to me like 
we have got a little bit of a microcosm here that has got a 
number of pieces in place. Now, obviously, the liability 
question is different and that is something we have to look at 
over in the other area.
    But one of the things I hope people realize on this, and I 
hope in terms of the legislation, if we do move legislation 
this year or whenever we move legislation, is that it is not to 
do something simply to react to the publicity that occurred, 
and I am always concerned about that. But I do think there are 
some overdue at least first steps or positive steps about the 
control of information, the flow of information, the assisting 
in the collection of information, that certainly would lay a 
foundation for us to move forward, where governmental agencies 
or quasi-governmental agencies, although they may be thought of 
that way, and private commissions and agencies are going 
forward.
    Now, I know that some people are going to be suspicious of 
the IOM report and its data and most of the beginning dates of 
a lot of activities and they seem awfully close to what is 
occurring now, and my assumption is that it is just the 
timeline of the awareness. As you indicated, maybe the aviation 
industry was in the 1970s, the 1980s, and the medical 
community's time period is in the 1990s and the first few years 
of 2000. If that is the case, we will accept the very 
interesting coincidence of the movement in this area.
    My hope is that as much on a voluntary basis as we can, 
that we could move forward, but I am having a difficult time 
now accepting the belief that a totally voluntary structure 
will produce anywhere near 50 percent reduction in the time 
frame or a mandatory will create the climate which will allow 
us to build on what we are doing and move it forward as an 
ingrained culture rather than as another structure over which 
we are going to fight in terms of whether it helps or hurts.
    The gentleman from California.
    Dr. Golden. Mr. Chairman, can I give you a piece of good 
news, at least?
    Chairman Thomas. Yes, Dr. Golden. I am looking for it.
    Dr. Golden. I know you had concerns when you had talked to 
Dr. Cassel about the physicians' attitude toward data and 
changing performance, and I have been giving physicians' data 
for seven years in my State and I can tell you that when they 
see clinically pertinent data, they do respond. I have gotten 
two unsigned hate letters in seven years, and I can tell you 
now I send data to----
    Mr. Stark. Did they have a big red crayon?
    Chairman Thomas. Could you read the handwriting?
    Dr. Golden. No. Actually, one was from the east side of the 
State, one was from the West, but that was when we first 
started mailing to doctors' offices directly performances, and 
we get on average over 150 offices responding back to us now 
saying they were going to implement things in response to data 
on performance Statewide. So I think things are better than you 
think.
    Chairman Thomas. But also, in listening carefully to the 
aviation field structure, what was said if we were listening 
carefully was that when you are dealing with this data, they 
have pilots talk to pilots, air traffic controllers talk to air 
traffic controllers. They find a relationship in which there is 
a common understanding that you are in my business and we are 
all in this together, which is not always the case in the 
hierarchial structure of medicine. To the degree that we can 
learn from that, that also would be helpful.
    The gentleman from California.
    Mr. Stark. Thank you, Mr. Chairman, and I thank the panel. 
I guess, just quickly, Dr. Bagian, can you just very quickly 
give us some indication of whether on a dollars and cents 
basis, your program for quality in the Veterans Administration, 
has it saved you money, cost you money? What has been the 
result? Can you document that for us?
    Dr. Bagian. That is one of the things we are looking at, to 
look for the business case, if you will. We do not have enough 
data to give you that answer, but we suspect for a whole host 
of reasons when we do the whole accounting, but we do not have 
any data to supply at this time.
    Mr. Stark. If you save money, let us know. If you do not, 
shred it, okay?
    Dr. Bagian. We certainly think that is important. We will 
look at it. But it is the right thing to do, too. We do not 
think you can do anything but do it. We think you cannot lose.
    Mr. Stark. Dr. Kizer, your organization has got some, I 
guess, 29 standard performance measures that you have 
identified, maybe more now, I do not know, and my question, I 
guess to the panel, is does anybody feel that we should not try 
and develop and use standard performance measures for various 
aspects of quality control, that a single set of those 
performance measures should be used nationwide, and that the 
hospitals should be required to make public their progress in 
meeting these standard performance measures? Does anybody find 
anything wrong with that?
    I mean, I think that is different from reporting serious 
errors, but some way to measure--I guess I do not know whether 
they do it with airlines. They do it with passenger complaints. 
I am not sure that is a very good standard.
    Dr. Kizer, do you think that mandatory reporting has a 
place in this whole system? I mean, that is what IOM 
recommends. Do you want to comment?
    Dr. Kizer. I believe there is a set of events we can define 
that that are important both from a quality improvement and a 
public accountability point of view; there are certain things 
that just should not occur in health care today and that the 
public has a right to know about them.
    It is a fairly short list of things. I think some have 
alluded to them already, things like wrong-site surgery or 
perhaps medication error deaths or death during childbirth, 
things that just are not what one would expect today. I think 
that it would actually be quite possible to garner consensus 
among the health care professionals about that list of things 
that would be mandatorily reportable.
    I think the list of things that one might want to maintain 
confidential is a much longer list, things involving judgment, 
particularly professional judgment, was it a premature death, 
was it unexpected, those type of things. But there is a set of 
information that really should be available for public 
accountability purposes.
    Mr. Stark. Dr. Golden, I suggested earlier to the Hospital 
Association and the AMA that they might like to use PROs as the 
group that would oversee any kind of a reporting system, and I 
got the sense that they dismissed the PROs as merely another 
bureaucratic governmental agency. It is my understanding that 
your funding comes as a government contractor, but do you want 
to differentiate yourself from Lockheed or other government 
contractors?
    Dr. Golden. All the PROs are independent corporations, if 
you will. Some of them have different structures. But we have a 
contract with HCFA to perform tasks in our environment.
    As a member of the AMA House of Delegates off and on for 20 
years, I know that the approach, the quality improvement 
approach of PROs over the last seven years, has been very 
positively reviewed, and, in fact, the AMA House with their 
reports have said so. They have found the educational approach 
to be very much to the liking of the organization and its 
members.
    I think that they get nervous about government, but there 
is no question that in terms of relationships locally between 
PROs and physicians and hospitals, we have seen a great 
improvement over the last several years and it is a very 
collaborative and constructive relationship at this point.
    Mr. Stark. JCAHO, Dr. O'Leary, was set up in 1965 to create 
the oversight of quality in the hospital structure, was it not?
    Dr. O'Leary. Yes, sir. The Joint Commission was established 
in 1951. The Medicare Act created the deeming relationship in 
1965.
    Mr. Stark. Why did it take you until 1999, according to 
your testimony, January of 1999, to develop explicit patient 
safety standards?
    Dr. O'Leary. Well, let me clarify.
    Mr. Stark. That was 35 years, if you do not count going 
back to 1951, which even makes it longer. What was the problem? 
What were you doing all that time?
    Dr. O'Leary. Let me clarify that a large number of Joint 
Commission standards are patient safety standards in the sense 
that they reduce the risk of untoward occurrences, whether we 
are talking about credentialing and privileging standards or 
environmental safety standards or patient assessment standards. 
The particular standards that we referred to are standards 
specific to error identification or reporting inside 
organizations, where we now require organizations to set up 
processes or a plan, in line with your previous question.
    Mr. Stark. What was the problem in getting that done? What 
took you so long?
    Dr. O'Leary. I think it was the realization that the 
problem that we were experiencing had probably less to do with 
organizations not reporting errors to us than the fact that 
they were not--errors inside organizations were not made known 
to the leaders within organizations and it dawned on us that we 
had not really created a requirement that organizations create 
systems to identify serious adverse events and require internal 
reporting and internal root cause analyses and the development 
and implementation of action plans.
    So those specific standards to which that refers are those 
standards. You are requiring an internal plan, which was the 
question you asked earlier, inside organizations to surface 
these events and deal with them.
    Mr. Stark. So it took you 35 years to figure that out?
    Dr. O'Leary. At least that, yes.
    Mr. Stark. Thank you, Mr. Chairman.
    Chairman Thomas. Thank you. I do not remember whose 
testimony it was off the top of my head when I read it, but it 
may have been on this panel. It was an example of the Salt Lake 
City hospital situation, where there were 20 reported, and then 
when you went back and did an analysis inside the structure, 
there are actually 582. And by going back and doing it in a 
more systematic way, they actually wound up reducing it below 
the original 20 that were reported.
    That, to me, in a nutshell, is kind of where we want to go, 
and that is we have got to set up a structure that allows us to 
systematically address what is really there because we can make 
the corrections. It has been proven over and over again. It is 
just that cracking this nut of the culture of medicine and 
truly putting in place structures which provide a comfort level 
for all, in my opinion, to report and then deep root analysis 
so that you can make the kinds of changes.
    But what scares me the most is, and I guess it is the 
phrase low-hanging fruit, that low-hanging fruit has been 
hanging there for a long time and maybe this publicity will 
allow some folks to pick it. But my fear is, picking the fruit 
makes it look like movement has been made. There has been no 
systemic change, and we will have lost the opportunity to get 
in, and I am very, very nervous about that. That is why I want 
to make sure that we put at least some structure in place 
fairly quickly on, for want of a better term, an exoskeletal 
aspect of it, which would be liability or data collection that 
will allow the forces that seem now to be working to work in an 
environment in which they can actually perform better.
    I do not know that I want to put in place a total 
structural approach which will do government mandatory, deep 
root, and the rest of it, but I do think we have to, I think 
sometime this year, create an environment which is nurturing 
and supportive of clearly, whether it started in 1999 or not, 
the willingness apparently to go forward. We have got to give 
you some of those tools.
    I want to thank you folks. We are going to be back to you. 
Do not want for me. If you have got any additional information 
or direction or if you are alarmed by some of the legislation 
that is moving, I would appreciate a candid analysis of what is 
out there as legislation forms in terms of whether or not it is 
actually a help or a hindrance or if there are pieces of it 
that are better than not. We desperately need your help, your 
expertise, and your experience.
    The gentleman from California.
    Mr. Stark. I agree, and just a couple of anecdotes that may 
be helpful--just this last week, we heard about a report in 
Charlotte, North Carolina, where they found 28 questionable 
deaths in JCAHO-accredited mental health facilities, and yet 
JCAHO only knew about two of them. Now, that may not be their 
fault, but it indicates that it does not sound like people are 
stepping right up to report.
    Then in our own State, we must have at least twice the New 
York State population, both of our States have mandatory 
reporting, New York and California, yet we reported in 1998 
4,337 reports of serious events, and New York had some 15,000 
to 20,000 reports. Now, we have to come to some kind of closure 
on what is different and why this huge difference in reporting.
    Chairman Thomas. It may very well be the definition of a 
serious event.
    Mr. Stark. Yes, there may be a lot to it, but I think that 
is the problem.
    Chairman Thomas. But the point is, we have got to get to 
the bottom of it.
    Mr. Stark. Somehow, we need to find a way that we are 
collecting these data and then we can act on it, I think, or 
the institutions can act on it. So I look forward to working 
with you.
    Chairman Thomas. Based upon the statement you just made, I 
do not think I have to make the following statement, and that 
is what we heard, if we did not hear anything, was not to set 
up a system which is punitive, accusatory, but rather open, 
voluntary, looking for professionals to be able to operate. 
Stating any kind of evidence based upon the current lay of the 
land, to me, is relatively less useful than to begin to figure 
out how to set up a structure in which we can move forward.
    Personally, I am not interested in jettisoning anybody off 
of this vehicle of trying to reduce the staggering number of 
medical errors that produce deaths greater than what occur on 
the highway from cancer or from AIDS. I am enlisting everybody 
in both a voluntary and a mandatory effort to turn this around.
    Thank you all. The subcommittee stands adjourned.
    [Whereupon, at 2:06 p.m., the hearing was adjourned.]
    [Submissions for the record follow:]

Statement of the American Academy of Orthopaedic Surgeons, and American 
Association of Orthopaedic Surgeons

    The American Academy of Orthopaedic Surgeons and the 
American Association of Orthopaedic Surgeons (AAOS), 
representing 18,000 members, appreciate Chairman Thomas' 
initiative in holding this hearing to address patient safety 
and the recommendations of the recent Institute of Medicine 
(IOM) report, entitled To Err is Human: Building a Safer Health 
System. We would like to offer our perspective on the report 
and welcome the opportunity to work with you and other members 
of the Subcommittee as you consider appropriate policies with a 
goal toward reducing medical errors. We would also like to 
share with you some highlights of our work over the past 
several years to reduce or eliminate specific types of surgical 
errors.
    We share your concerns and those expressed in the IOM 
report that ensuring patient safety in hospitals, as well as 
other practice settings, must be given appropriate attention. 
AAOS is committed to the elimination of medical errors and has 
designated this as a high priority in the policies and 
practices of the AAOS. High quality patient care is the crux of 
AAOS' Principles of Medical Ethics in Orthopaedic Surgery and 
we have strived to create an expectation of high quality care 
and to assist our members in the practice of safe care by 
making this an important focus of our education program.
    More than a decade ago, the AAOS Board of Directors decided 
to commit significant financial and clinical resources into the 
development of a Continuous Quality Improvement Program (CQI) 
to help provide ``Best Care'' for our patients. The ``Best 
Care'' philosophy has been a cornerstone of the strategic plan 
of AAOS. Accordingly, clinical guidelines have been developed 
to serve as common treatment protocols for a number of 
musculoskeletal conditions. Corresponding outcomes instruments 
allow for the evaluation of patient outcomes, by identifying 
factors, including medical errors, associated with positive or 
negative patient outcomes in order to initiate change in the 
treatment guidelines. This process of Continuous Quality 
Improvement thus drives treatment towards optimum or ``Best 
Care.'' The AAOS is a recognized leader in this area.
    AAOS also has developed programs to address specific 
medical errors. In September 1997, AAOS established a task 
force to examine surgical errors and recommend prevention 
safeguards for the operating room. The task force developed 
``Sign Your Site,'' a protocol whereby before surgery, the 
surgeon checks the patient's chart and any radiographs, the 
patient identifies the correct site and side to be operated on, 
and then the site is marked with the surgeons initials using a 
permanent marking pen. The surgeon then operates through or 
adjacent to the initials. AAOS launched a major educational 
program among its members to eliminate wrong-site surgery, and, 
by mid-1998, AAOS mailed information to 19,000 operating room 
supervisors and surgeons in other specialties.
    Numerous hospitals throughout the country have responded 
positively to this campaign, and mandatory ``Sign Your Site'' 
programs have been initiated at an increasing number of 
hospitals. The AAOS has provided information on the ``Sign Your 
Site'' program at the request of the Joint Commission on the 
Accreditation of Hospital Organizations (JCAHO), the Physician 
Insurers Association of America and other organizations 
committed to reducing medical errors. AAOS believes that a 
unified effort among surgeons, hospitals and other health care 
providers to initiate pre-operative and other regulations is 
helping to prevent surgical error.
    Like many similar initiatives, feedback from the ``Sign 
Your Site'' campaign offers invaluable insight into the 
administrative operations of hospitals and other provider 
institutions to study how to reduce medical errors. What we 
have discovered in launching this campaign is that such efforts 
require long-term commitments and resources involving ongoing 
communication and research to ensure success. From our 
experience, we would caution you that policies cannot 
underestimate the planning involved. A comprehensive campaign 
requires intensive ongoing communication, networking, 
surveying, monitoring, research, feedback and education. That 
is one reason that the AAOS campaign was conceived as a multi-
year effort.
    Since 1990, the AAOS Committee on Professional Liability 
also has conducted a series of closed-claim professional 
liability insurance studies, through on-site retrospective 
review of the records of insurance companies across the 
country. Most major orthopaedic diagnoses and procedures have 
been studied, including foot and ankle surgery, spine surgery 
and spine fusion, total hip and knee replacement, knee 
arthroscopy, fractures of the hip, femur and tibia, and 
pediatric problems, in order to assist orthopaedic surgeons in 
providing optimum patient care. Many articles and two books 
have resulted from these studies--the purpose and result have 
been to identify trends in unexpected outcomes and medical 
errors, to provide risk management, and to promote safe and 
appropriate surgical practice. This guidance emphasizes 
thorough patient consent discussions about treatment options 
and alternatives, risks of treatment, non-treatment, and 
patient expectations regarding eventual functional ability 
after treatment.
    We commend the IOM for undertaking such an important study. 
Several critical points have been raised in the report that 
must not be overlooked when defining appropriate policies. 
Medical error is a multifaceted, complex issue. The 
comprehensiveness of the report alone illustrates the daunting 
task required to determine how to proceed. AAOS believes that:
     Policies must first determine, by supporting 
research, whether and how current medical error reporting 
programs, as well as prevention initiatives, have lead to 
reduction in medical errors.
     Funding must be available to redesign systems 
based on research findings and costs to hospitals and other 
providers for implementing these systems must be considered.
     Access to medical error data under the current 
liability system must be carefully and thoroughly analyzed and 
mechanisms for reporting must ensure patient and provider 
confidentiality and expand peer review liability protections.
     Resources must be available to communicate 
information on patient safety practices to hospitals, other 
institutional providers, health care professionals and 
consumers.
     Promotion of a system of Continuous Quality 
Improvement is among the best ways to provide patients ``Best 
Care'' and to eliminate medical errors. The traditional Quality 
Assurance (QA) method is a judgmental, confrontational and 
punitive approach, which is likely to negatively impact 
relations between physicians, patients and government.
    Patient safety is paramount and medical error reporting 
should lead to improvements in patient safety. As the IOM 
report points out, the underlying objective is to prevent 
patient harm. An important focus of legislation should be to 
examine existing mandatory and voluntary reporting systems 
across the states to determine if and how this information can 
be utilized constructively to prevent and reduce the number of 
medical errors. The progress of prevention programs and 
demonstration projects in reducing medical errors should also 
be examined. Follow-up is critical. Without some clear 
direction on how to integrate the results of the research into 
the health care system, you risk prematurely raising 
expectations that reporting will lead to a reduction in medical 
errors. It is disconcerting that, as the IOM report points out, 
while approximately one-third of the states have implemented 
mandatory adverse event reporting systems, there is no 
indication that these systems have resulted in safer 
environments for patients and this data has not been utilized 
to assist in reducing medical errors.
    The AAOS is encouraged by the IOM report's discussion of 
the need to create a culture of safety in reporting. If new 
reporting requirements, whether mandatory or voluntary, are 
legislated, then the approach should encourage open and candid 
discussions and disclosures through non-punitive mechanisms for 
reporting that ensure patient and provider confidentiality and 
expand peer review protections. Even if the reporting is 
institution-based and not individual-based, or just voluntary 
and not mandatory, implications for the availability and use of 
such data may result in unintended consequences. Discovery 
rules and statutes governing access, entitlement and use of 
such information must be carefully scrutinized. Policies must 
require appropriate definition of the type and use of data 
necessary for a successful medical error reporting program, as 
well as the process for reporting. A successful effort will 
require careful planning of the many critical components of a 
reporting mechanism.
    The difficulty in finding the right balance to prevent a 
punitive approach is evident in the IOM report itself. The 
report seems to send contradictory messages by expounding on 
the importance of creating a safe reporting environment on the 
one-hand, yet maintains that confidentiality is not appropriate 
for mandatory reporting systems. The impact of such reporting 
systems on patient confidentiality rights and provider peer 
review laws requires careful scrutiny. The AAOS is particularly 
concerned with the report's recommendation to proceed with 
reporting requirements, including mandatory reporting, while 
recognizing that the current liability system is not conducive 
to reporting and analysis.
    AAOS also believes that physicians and other health care 
professionals are already held accountable through a well-
established punitive-based judicial system, as well as 
licensing structures and ever-more-complicated accrediting 
processes. These systems are designed to substantially serve to 
prevent patient injuries and ensure good quality patient care. 
We believe all entities involved in making medical decisions 
should be equally accountable. But additional systems with 
punitive undertones could defeat efforts to foster an open 
dialogue on medical error and patient safety.
    Federal legislation should recognize the need to proceed 
with caution and with careful planning before medical error 
reporting is required or encouraged of hospitals and other 
health care providers. Consideration should be given to funding 
studies of existing data of mandatory and voluntary reporting 
systems, demonstration and prevention projects, and 
dissemination of information on patient safety. Funding should 
encourage private/public partnerships in these efforts. Careful 
consideration of the legal and statutory requirements governing 
the use of medical information should be required prior to 
implementation of any reporting systems, regardless of type or 
scope.
    We appreciate the leadership of Chairman Thomas and other 
members of the Subcommittee in drawing attention to the 
findings of the IOM report, To Err is Human: Building a Safer 
Health System. Please consider consulting with a broad range of 
the medical community, recognizing expertise in specific areas, 
and examining and involving efforts already underway through 
private funding.
    Thank you for taking the time to consider our comments. We 
look forward to working with the Members of the Subcommittee 
and other Members of Congress as you assess the need for 
legislation to address medical error reporting.

                                

Statement of American College of Physicians-American Society of 
Internal Medicine

    The American College of Physicians-American Society of 
Internal Medicine (ACP-ASIM), representing over 115,000 
physicians who specialize in internal medicine and medical 
students with an interest in internal medicine, appreciates the 
opportunity to comment on the report of the Institute of 
Medicine (IOM), To Err is Human: Building a Safer Health 
System. Our membership includes practicing physicians, teaching 
physicians, residents, students, researchers, and 
administrators who are dedicated to assuring high quality 
medical care.
    The IOM report highlights unacceptable quality and safety 
problems in the nation's health care system. The report reveals 
that more people die each year as a result of medical errors 
than from motor vehicle accidents, breast cancer, or AIDS. It 
notes that medication errors alone account for over 7,000 
deaths annually. This is a dismal record that exceeds the 6,000 
deaths each year due to workplace injuries. Significantly, the 
IOM report finds that ``the problem is that the system needs to 
be made safer'' and indicates that the ``problem is not bad 
people.''
    The IOM report concludes that the U.S. health care industry 
lacks a systematic way of identifying, analyzing, and 
correcting unsafe practices. In order to achieve this end, the 
report states: ``Preventing errors means designing the health 
care system at all levels to make it safer. Building safety 
into processes of care is a more effective way to reduce errors 
than blaming individuals. The focus must shift from blaming 
individuals for past errors to a focus on preventing future 
errors by designing safety into the system.'' The report lays 
out a comprehensive strategy for addressing these problems. It 
challenges the profession to make significant changes to 
achieve a safer health care system. We accept this challenge.
    ACP-ASIM offers the following comments regarding specific 
recommendations in the IOM report:

Creation of a Center for Patient Safety (IOM Recommendation 
4.1):

    ACP-ASIM agrees with the IOM recommendation that a highly 
visible center is needed with secure and adequate funding to 
set national goals, evaluate progress, and develop and 
coordinate a research agenda to achieve improvements in patient 
safety. We firmly believe that such an effort should involve 
the many private sector initiatives that are also now underway. 
We concur with the IOM that a coordinated national effort is 
needed and that adequate and stable funding must be assured. If 
the center is to be housed in a federal agency, it should be in 
a non-regulatory agency such as the Agency for Healthcare 
Research and Quality (AHRQ). A coordinated program for research 
and achievement of national goals for improvements in patient 
safety should be as objective as possible and should not be 
tied to a federal agency with regulatory responsibilities. AHRQ 
has the expertise and an existing infrastructure for funding 
research and coordinating activities concerning health care 
quality. ACP-ASIM, therefore, supports increased funding for 
AHRQ to accomplish these expanded functions.

Mandatory Reporting (IOM Recommendation 5.1):

    The IOM report recognizes the need for both mandatory and 
voluntary error reporting systems. It explains that mandatory 
reporting systems are needed to hold providers accountable for 
their performance. It further advises that mandatory reporting 
should focus on the identification of serious adverse events 
(deaths or injuries resulting from medical interventions). The 
IOM notes that the focus of a mandatory reporting system should 
be narrowly defined. It recommends that the Forum for Health 
Quality Care Measurement and Reporting (The Quality Forum), a 
recently formed public/private partnership charged with 
developing a comprehensive quality measurement and public 
reporting strategy, should be responsible for promulgating and 
maintaining
    The IOM report also calls for licensing and accreditation 
bodies to expand the scope and magnitude to which patient 
safety is reviewed and evaluated in rendering licensing/
accreditation decisions.
    ACP-ASIM agrees with the intent of this recommendation, but 
is concerned about its possible implementation. We strongly 
agree that physicians have a professional obligation to 
patients and society to report serious errors resulting in 
adverse events. It is appropriate that information on serious 
adverse events be reported to appropriate authorities and that 
a uniform, national reporting format be developed. We further 
agree that a public/private sector body, such as The Quality 
Forum, should be responsible for clearly defining what should 
be reported and developing the uniform reporting format. 
However, we are apprehensive about the possible role of the 
federal government in mandating what is to be reported and what 
will be done with the data. We urge Congress and federal 
agencies not to define reporting requirements too broadly or to 
be overly inclusive. We are concerned that mandatory reporting 
requirements could be excessively burdensome to institutions 
and individual physicians. We, therefore, agree with the IOM 
that a more narrowly defined program has a better chance of 
being successful.
    We also wish to highlight that the IOM calls for devoting 
adequate attention and resources for analyzing reports of 
adverse outcomes to identify those attributable to error. The 
IOM notes that it is only after careful analysis that the 
subset of reports attributable to error can be identified and 
follow up action taken. We agree with the IOM that the results 
of the analyses, not all data that are required to be reported, 
should be made available to the public.
    ACP-ASIM emphasizes that licensing and accreditation bodies 
considering patient safety issues in making licensing/
accreditation decisions should not review every case patient 
record, but should review representative samples of patient 
care. Patient safety reviews should be completed within a 
reasonable time and with minimal disruption or additional 
administrative burdens for physicians or institutions.

Voluntary Reporting Systems (IOM Recommendation 5.2 and 6.1):

    The IOM calls for voluntary reporting systems to collect 
information on errors that cause minimal or no harm. It notes 
that voluntary reporting of less serious errors can identify 
and remedy patterns of errors and systemic problems. It notes 
that the aim of voluntary systems is to lead to improvements in 
patient safety and that the cooperation of health care 
professionals is essential. The IOM clearly recommends that 
voluntary reporting systems must be protected from legal 
discovery. IOM further recommends that Congress pass 
legislation to extend peer review protections to data related 
to patient safety and quality improvement that are collected 
and analyzed by health care organizations for internal use or 
shared with others solely for purposes of improving safety and 
quality.
    ACP-ASIM supports voluntary reporting of incidents that do 
not result in fatalities or major errors, but could be 
symptomatic of systemic problems. However, protection of the 
confidentiality of data is essential to ensure that events 
involving medical errors or other incidents adversely effecting 
patient safety are reported and acted upon. Physicians and 
other health professionals have a responsibility to patients 
and the public to assure that all actions adversely affecting 
the quality and safety of patient care are reported and acted 
upon through a system of continuous quality improvement. 
However, ACP-ASIM recommends that voluntary quality improvement 
systems must protect individual confidentiality. The 
confidentiality of reported data must be protected so that 
physicians and other health care professionals are encouraged 
to report all adverse incidents without fear that their 
cooperation will increase their exposure to law suits for 
professional liability or other sanctions. Any potential 
increased exposure to fines, loss of hospital privileges, or 
even possible loss of medical licensure will discourage 
physicians from voluntarily reporting ``near misses'' and other 
adverse incidents. Consequently, we strongly suggest that any 
voluntary reporting system must be primarily educational rather 
than punitive.
    Nevertheless, ACP-ASIM acknowledges that physicians have a 
professional obligation to disclose to patients information 
about procedural or judgment errors made in the course of care 
if such information is material to the patient's well-being. 
Errors do not necessarily constitute improper, negligent, or 
unethical behavior, but failure to disclose them may. (ACP-ASIM 
Ethics Manual, 1998, p.8-9)

The President's Executive Order

    In response to the IOM report, President Clinton announced 
on December 7, 1999, that he had signed an executive order 
directing a task force to analyze the report and report back 
within 60 days about ways to implement its recommendations. He 
also directed the task force to evaluate the extent to which 
medical errors are caused by misuse of medications or medical 
devices, and to develop additional strategies to reduce these 
errors. He further directed each of the more than 300 private 
health plans participating in the Federal Employee Health 
Benefits Program to institute quality improvement and patient 
safety initiatives. He also signed legislation reauthorizing 
the Agency for Healthcare Research and Quality and providing 
$25 million for research to improve health care quality and 
prevent medical errors. The AHRQ will convene a national 
conference with state health officials to promote best 
practices in preventing medical errors. In addition, the 
President announced that he was directing his budget and health 
care teams to develop quality and patient safety initiatives 
for next year's budget.
    ACP-ASIM applauds all of these actions by the Executive 
branch to address the problems identified in the IOM report.

Issues for Further Review

    The IOM report raises many questions that will require 
further examination. We urge Congress to consider the 
following:
     What should be required for mandatory reporting? 
Should reporting be required only for the most egregious errors 
involving death or serious injury? How will ``serious errors'' 
be distinguished from ``less serious'' errors? Will mandatory 
reporting be cumulative, by institutions or by individual 
physicians?
     To whom should data be reported? Should it be 
reported to state agencies only, to states and the federal 
government, or to private agencies?
     What data should be released to the public? For 
errors causing serious injury or death, what should be the 
extent of data released? Should everything be reported or just 
the final analysis? Does the public have a right to know the 
number of adverse incidents reported by a physician?
     What happens to the information that is reported? 
Will there be follow-up actions, and if so, will these be 
released to the public? Who will have access to the raw data, 
and will there be adequate protections of confidentiality?
     Should licensing bodies use data on errors to deny 
or revoke physician licenses? Should data on physicians be 
available to hospitals for consideration in granting or denying 
hospital privileges?
     How can reporting requirements avoid creating 
excessive costs and administrative burdens for physicians and 
health care organizations?

Conclusion

    ACP-ASIM is strongly supportive of the recommendations of 
the IOM report, To Err is Human: Building a Safer Health 
System. The College agrees that far too many preventable errors 
are committed that do not get reported and that solutions are 
needed to improve the quality and safety of patient care. ACP-
ASIM concurs with the IOM's conclusion that the focus must be 
the reform of the system, not the punishment of individuals. 
ACP-ASIM encourages the profession to take up the challenge 
raised by the IOM to improve the quality and safety of patient 
care. The College supports setting a national goal of reducing 
medical errors by 50% within five years. Such an achievement 
will require substantial commitment of resources and effort. 
Substantial financial costs will be involved, but these may be 
largely offset by benefits in improved patient care and better 
health outcomes. Regardless of the costs, the public has a 
right to expect health care that is safe and effective. The 
profession is responsible to individual patients and to the 
public to continuously seek to improve the quality of medical 
care and make sure that health care services are provided as 
safely as possible.
    The College applauds the prompt initiatives instituted by 
the President and will look forward to working with Congress in 
addressing issues requiring legislative action. However, as we 
have indicated, there are many questions that need to be 
addressed before a national plan with mandatory and voluntary 
reporting requirements can be implemented. ACP-ASIM appreciates 
the deliberation that the Committee is giving to the IOM report 
and the opportunity to submit testimony. We are prepared to 
work with the Congress and the Administration to reduce the 
number of medical errors.

                                

Statement of American Osteopathic Association, and American Osteopathic 
Healthcare Association

    This statement is presented on behalf of the American 
Osteopathic Association (AOA) and the American Osteopathic 
Healthcare Association (AOHA). The AOA represents the 44,000 
osteopathic physicians throughout the United States who 
practice medicine and are committed to ensuring the highest 
standards of patient care. The AOA is the national professional 
organization for osteopathic physicians, and is the recognized 
accrediting authority for colleges of osteopathic medicine, 
osteopathic postdoctoral training programs and osteopathic 
continuing medical education. The AOHA represents the nation's 
hospitals and health systems that deliver osteopathic 
healthcare or osteopathic graduate medical education. Through a 
for-profit subsidiary, the AOHA provides its members with 
access to risk management assistance, among other products and 
services.
    Osteopathic medicine is one of two distinct branches of 
medical practice in the United States. While allopathic 
physicians (MDs) comprise the majority of the nation's 
physician workforce, osteopathic physicians (DOs) comprise more 
than five percent of the physicians who practice in the United 
States. Significantly, D.O.s represent more than 15 percent of 
the physicians practicing in communities of less than 10,000 
and 18 percent of physicians serving communities of 2,500 or 
less.
    The AOA and the AOHA are deeply concerned about the 
frequency of adverse events cited by the Institute of Medicine 
in its recent study, ``To Err is Human.'' The Institute 
reported that between 44,000 and 98,000 patients died or were 
injured in 1984 and 1992 as a result of these adverse events.
    The members of the osteopathic medical profession have long 
supported efforts to improve patient care by drastically 
reducing medical errors. In 1945, the AOA's Healthcare 
Facilities Accreditation Program (HFAP) was established. The 
HFAP is authorized by the Health Care Financing Administration 
(HCFA) to accredit osteopathic and allopathic hospitals and 
healthcare systems for Medicare purposes. The HFAP assists 
hospitals and their staffs in reducing or eliminating medical 
errors by developing Quality Monitoring and Improvement 
programs that monitor patient safety. On January 27, the AOHA 
held its first seminar on improving patient safety and reducing 
medical errors. Additional seminars are planned for March 24, 
and will be held throughout the year.
    The AOA and AOHA generally support the IOM's 
recommendations to bolster nationwide efforts to improve 
patient safety. We support forums that explore ways in which 
healthcare organizations can participate in the effort to 
reduce medical errors. The healthcare community can, and 
should, expand current activities to identify and address 
system failures that lead to medical errors.
    The osteopathic medical community will continue its efforts 
to strengthen existing quality improvement activities at every 
level, including the education and training of medical 
professionals and administrative personnel. We do not believe 
that the way to improve healthcare is to increase federal 
mandates, regulation, and administrative burdens, which could 
suppress reporting and inhibit open discussion of adverse 
events and medical errors.
    The AOA and the AOHA agree with the IOM that it is 
important to have reliable information about adverse events 
that healthcare professionals can use to assess, analyze and 
correct systemic and other failures that lead to such events. 
There is potential for such information to enhance the 
understanding of medical errors, while preventing future 
errors. Unfortunately, there is scant proof among the 
approximately 20 states currently reporting such data that the 
healthcare systems are any safer in those states than in states 
that do not have such reporting.
    We do believe, however, that state medical error reporting 
programs already in place may offer models for a federal effort 
to compile similar data. These should be closely reviewed and 
considered before federal action is taken. For instance, the 
data now being collected should be analyzed to determine 
whether or not the data used in the IOM study is reflective of 
the current state of affairs. Additionally, consideration ought 
to be given to the development of pilot projects designed to 
collect adverse event data. Finally, federal agencies should 
use the data compiled by states with mandatory reporting 
programs to determine whether their data is comparable with the 
IOM's data, which may be outdated.
    Outdated data may have distorted the IOM's conclusions 
about the alleged epidemic of medical errors. Accurate data 
could help federal agencies determine which areas of healthcare 
experience the most errors and are most in need of 
restructuring. Accordingly, the AOA and AOHA would recommend a 
revised study using more current data than 1984 or 1992 as 
reported by the IOM.
    Mandatory reporting of adverse events presents a number of 
serious problems. Healthcare facilities may be reluctant to 
cooperate with mandatory (or even voluntary) data reporting if 
they perceive that they will be disciplined. It will be 
difficult to learn from errors and to improve systems if 
facilities and individuals fear that the information will be 
used against them. Only after the IOM study and its supporting 
data have been analyzed fully and pilot projects established, 
should policymakers consider the establishment of a national 
database, with either voluntary or mandatory reporting.
    If a national effort to gather and analyze adverse event 
data goes forward, the information should not be solely 
available to federal healthcare agencies. Stripped of its 
identifiers, it also must be available to healthcare 
facilities, researchers, accreditation organizations, and other 
healthcare entities that, in turn, could use the data to 
benchmark and monitor changes in the occurrence of medical 
errors. In this way, the database would serve as a tool to 
promote higher standards of patient care. Healthcare facilities 
and providers who report and assess medical errors can attempt 
to rectify particular problems by monitoring their data and 
comparing it with federal, state and local trends. Identifiable 
data is not necessary for this function to be met.
    Identifiable data should not be available to the public 
because to do so would inhibit reporting due to a natural fear 
of punishment and litigation. Healthcare professions 
continuously work to correct medical errors. The AOA and the 
AOHA believe that the American healthcare system operates well 
on the whole. Public confidence in that system should not be 
undermined while healthcare providers seek to increase patient 
safety.
    Another reason that the AOA and the AOHA recommend national 
data remain confidential and secure is that such data could be 
used as background information for litigation. Any national 
data that is gathered should be considered information only for 
peer review. Since peer review protections vary greatly from 
state to state, at a minimum, any federal data gathering 
initiative must provide protection from discoverability and use 
in malpractice litigation. The data must be used only for the 
purpose of improving the safety standards of American 
healthcare.
    The AOA and the AOHA stand ready to support the IOM in 
improving patient safety in the United States. We welcome the 
opportunity to work with this committee and others dedicated to 
patient safety. Our members and staff are available to assist 
in the development of legislation that would lead to the 
continued improvement of the American healthcare system.

                                

Statement of Association of Women's Health, Obstetric and Neonatal 
Nurses

    AWHONN is a membership organization of 22,000 nurses who 
manage the complex health needs of women and newborns. Our 
membership includes registered and advance practice nurses who 
work in a variety of settings including clinical, research and 
academic.

AWHONN's Commitment

    As the IOM report indicates, the scope of the problem is 
massive, and AWHONN is committed to working with other health 
care provider organizations to develop solutions to help nurses 
combat the problem of medical errors. As an initial expression 
of our concern with the issue of medical errors, AWHONN has 
signed on to the following statement circulated by the American 
Nurses Association:
    The Institute of Medicine report, To Err is Human: Building 
a Safer Health System, shines a bright light on a significant 
problem within the U.S. health system. The patient care 
environment--across all health settings--is NOT conducive to 
the delivery of safe, quality nursing care despite the best 
efforts of dedicated nursing professionals. It is time to shine 
that same bright light on those qualities which create an 
environment that promotes the highest standard in patient care 
and excellence in nursing services. Qualities like sufficient 
nurse staffing, adequate support services; an appropriate skill 
mix of qualified providers that reflects patient acuity and 
needs; and dedicated nursing leadership in administration. 
Enhancing these qualities will result in better patient 
outcomes, fewer errors, and a stronger nursing profession 
emboldened to speak out on behalf of our patents.
    Over the years, AWHONN has been committed to promoting 
excellence in nursing practice to improve the health of women 
and newborns. Nurses can play a critical role in the prevention 
of medical errors, as they are often the first and last level 
of communication with the patient. Because of their 
comprehensive education and experiences, registered nurses are 
capable of providing both highly skilled technical care and 
complex emotional care. Furthermore, professional registered 
nurses are able to effectively implement patient management 
strategies for both low-risk and high-risk patients.
Support of System Solutions

    We strongly agree with the report's overall goal to look 
beyond using individual culpability as a means of correcting 
the significant problem of medical errors. Instead, the report 
places a great deal of weight on problem-solving across 
disciplines and developing various mechanisms to reduce the 
number of medical errors. Research has shown that because we 
are humans, we will commit errors...we are not perfect. 
Unfortunately, we cannot eliminate all medical errors, but we 
can strategize on ways to dramatically reduce them. We have 
learned that even the experts can commit errors--it is not 
simply a matter of lack of knowledge.
    AWHONN agrees with many of the study's recommendations, 
including the creation of a center for patient safety within 
the Agency for Healthcare Research and Quality that would set 
national safety goals, track the progress and report to the 
President and Congress on the achievement of those goals, and 
research methods for identifying and preventing errors. It is 
important to create one central location where information can 
be shared on findings and trials.

Need to Address Nursing Shortage

    While we support many of the recommendations of the report, 
we believe one critical component was not addressed. The report 
ignores the issue of inadequate and inappropriate nurse 
staffing, which increases the likelihood of medical errors, 
regardless of competency. In the managed care era, we have seen 
hospitals replacing highly qualified and educated nurses with 
less qualified technicians. AWHONN is greatly concerned with 
the growing nursing shortage and we challenge healthcare 
facilities to continuously evaluate the impact of patient-to-
nurse ratios on patient outcomes, patient satisfaction, 
resource utilization and overall operating expenses.
    Approximately 80% of our members provide bedside maternal/
child care on maternity floors and neonatal units. Hospital 
admissions for infant births account for more than twice the 
admissions for any other medical condition or procedure.\1\ We 
view the childbirth experience as an intensely physical and 
emotional event with lifelong implications. Only the registered 
nurse combines formal nursing education and clinical patient 
management skills with experience in providing emotional and 
psychological support and physical comfort measures to laboring 
women.
---------------------------------------------------------------------------
    \1\ Agency for Health Care Policy and Research. (1999). Most Common 
Diagnoses and Procedures in U.S. Community Hospitals, 1996 Health Care 
Cost and Utilization Project, Research Note. (AHCPR Publication No. 99-
0046). Rockville, MD: Author.
---------------------------------------------------------------------------
    AWHONN supports evaluation models that would measure the 
impact that a registered professional nurse has on indirect 
cost savings, such as savings resulting from lower cesarean 
section rates, shorter labors and fewer technologic 
interventions. With fewer qualified nurses available, it will 
be more difficult to ensure that quality patient care is being 
delivered. Knowing that this shortage will gradually increase 
and peak around 2010, we must be prepared to address their 
impact on patient safety.

Recertification is Not the Answer

    While we agree with the report's recommendation for health 
professional licensing bodies to work with certifying and 
credentialing organizations to develop more effective methods 
to identify unsafe providers and take action, we are concerned 
with the recommendation to require licensing bodies to 
implement periodic re-examinations and re-licensing of doctors, 
nurses, and other key providers, based on competence and 
knowledge of safe practices. Research has not proven that this 
intervention is any more effective than current strategies 
employed by the profession. The nursing profession is committed 
to ensuring competent practitioners through proven methods, 
such as appropriate education and competency validation. By 
including the re-examination component, the report contradicts 
its concept of not focusing on individual competency. Before 
determining a strategy, AWHONN urges true research to develop 
an evidence-based approach to professional certification.

Commitment to Providing Resources for AHWONN Members

    AWHONN has a long history of providing resources to our 
members to support them in expanding their knowledge in order 
to deliver quality nursing care. AWHONN recognizes that 
delivery of safe patient care is directly associated with 
appropriate education and competency validation, creation of 
evidence based policies and procedures and proper equipment 
management. AWHONN also promotes safe patient care practices 
through its journals, practice reference service, research-
based practice projects and legislative activities.
    In providing quality of care to pregnant women and newborns 
we know that:
     Proper fetal assessment is vital to the care of 
obstetric patients. AWHONN therefore addresses this area 
through its Fetal Monitoring Workshops, Fetal Heart Monitoring 
Principles & Practices book, videos, CD ROM, Antepartum and 
Intrapartum Fetal Heart Rate Monitoring Clinical Competencies 
and Education Guide and Fetal Heart Rate Auscultation symposia.
     Appropriate and timely patient assessment can 
elicit important information about potential risks. Proper 
assessments and subsequent interventions can promote positive 
patient outcomes. AWHONN resources which enhance nursing 
assessment skills include a presentation package targeting 
domestic violence, a compendium of postpartum care, tapes on 
mother-baby postpartum assessments, videos on critical-care 
obstetrics, cross training and compromised neonates.
     Safe medication administration contributes to safe 
clinical practice. AWHONN's Perinatal Medication Administration 
Competence Assessment Tool tests staff's current medication 
administration knowledge and critical thinking skills.
     Once training has been completed validation of 
competence is imperative. AWHONN resources which address 
competency validation include a reference book entitled 
Competence Validation for Perinatal Care Providers as well as 
numerous clinical competencies and education guides on such 
topics as perinatal education, home care and limited ultrasound 
examination. AWHONN's Assessment of Fetal Well-Being Competence 
Assessment Tool is designed to measure nurses' knowledge and 
application of perinatal facts and principles.
     Effective patient care guidelines, policies and 
procedures can guide quality patient care. AWHONN resources to 
assist our membership in this include the AWHONN handbook 
entitled Achieving Consistent Quality Care: Using Evidence to 
Guide Practice, AWHONN's Standards & Guidelines (5th Edition) 
and the AWHONN publications High Risk & Critical Care 
Intrapartum Nursing and Perinatal Nursing both of which contain 
actual guidelines and/or care paths.
     Equipment malfunction and misuse contributes to 
medical errors. AWHONN includes a section in its Fetal Heart 
Monitoring Principles & Practices book on instrumentation 
troubleshooting. The video series on OB/GYN limited ultrasound 
includes an orientation to the machine's instrumentation and 
controls. In AWHONN's Liability Issues in Perinatal Nursing, a 
section is devoted to the appropriate use of technology and 
equipment.

Summary

    AWHONN believes that nurses have the education and 
experience to deliver quality health care services, while 
monitoring the care their patient receives over the entire 
health care system. Nurses have long been known as strong 
patient advocates, working to ensure their patients receive 
access to the most appropriate care in a timely fashion. We 
would urge Congress to consider that the health care community 
needs to evaluate solutions that help address the issue of 
medical errors across the health care system.
    AWHONN appreciates the opportunity to offer our comments on 
this very important issue. We will continue to work with the 
members of AWHONN to ensure that they have the resources 
available to them to make decisions about the care their 
patients receive and we look forward to working with Congress 
on developing possible solutions to this problem.
    For further questions, please contact Melinda Mercer Ray, 
RN, MSN, Director, Health Policy/Legislative Affairs at 202-
261-2405 or Kristen LaRose, Senior Legislative Specialist at 
202-261-2402.

                                

Statement of Health Care Liability Alliance

    The Health Care Liability Alliance (HCLA) is a coalition of 
more than 30 organizations committed to reform of the health 
care litigation system to enhance its fairness, timeliness, and 
cost-effectiveness. HCLA's members are organizations and 
associations of physicians, hospitals, blood banks, health 
device manufacturers, health care insurers, pharmaceutical 
manufacturers, and biotechnology companies.
    HCLA applauds the Chairman's timely leadership in 
connection with the issue of patient safety. We appreciate the 
opportunity to submit our views regarding the report of the 
Institute of Medicine (IOM) entitled ``To Err is Human: 
Building a Safer Health System.'' We look forward to working 
with the Chairman, members of the Committee, and their staff as 
Congress debates this important issue.
    Because of its concern for the effect the tort system has 
on the quality of care, HCLA welcomes the IOM Report. The 
Report makes a significant contribution by recognizing that the 
tort system is a major barrier to improving the quality of 
care. That underlying conclusion provides the basis for 
meaningful tort reforms.

INTRODUCTION

    The tort system as it now operates in this country 
increases health care costs by forcing providers to practice 
defensive medicine and by imposing inordinate litigation costs 
on the health care system. These costs are borne by patients, 
people with insurance, people who are trying to buy insurance, 
people who need care, and taxpayers--through higher health care 
costs, higher insurance premiums, higher taxes, and reduced 
access to care.
    The tort system does not provide benefits that justify 
these costs. It does not carry out its intended functions. It 
does not establish a rational standard of care. Findings of 
liability, made in court with hindsight and with the benefit of 
leisurely contemplation that rarely are possible in the actual 
delivery of care, often do not provide an accurate standard of 
medical conduct. As one expert on the tort system has 
summarized this situation, ``The fundamental problem of tort 
liability, especially in the areas of products liability and 
medical malpractice, stems from the unpredictability of its 
imposition.'' \1\
---------------------------------------------------------------------------
    \1\ Jeffrey O'Connell, ``Two-Tier Tort Law: Neo No-Fault & Quasi-
Criminal Liability,'' 27 Wake Forest Law Review 871 (1992).
---------------------------------------------------------------------------
    This retroactive, case-by-case, and arbitrary standard 
making has caused doctors to practice defensive medicine--to 
order medical procedures out of a perceived need to have a 
defense available if there should be an adverse event. Cesarean 
delivery rates provide one example. Because juries awarded 
large recoveries for birth injuries where obstetricians did not 
perform a Cesarean section, doctors have performed them more 
often than they otherwise would have. Cesarean rates rose from 
4.5 per 100 births in 1965 to 24.1 in 1986.\2\
---------------------------------------------------------------------------
    \2\ Richard E. Anderson, ``Billions for Defense,'' Archives of 
Internal Medicine. 1999; 159: 2401
---------------------------------------------------------------------------
    The essentially unlimited power of juries to award non-
economic damages results in verdicts that are not just and that 
when publicized whet the appetite of trial lawyers and 
traumatize providers. In many cases, (enough to engender 
disdain for the litigation system and fear on the part of the 
provider), there is no logical or medical connection between 
the provider's action and liability or between the injury and 
the amount of damages awarded.
    The Harvard Study of hospital care in New York itself 
demonstrated that the filing of claims was not correlated to 
negligence.\3\ In a follow-on study of claims of malpractice 
filed by patients in the Study, several of the authors 
concluded that ``the severity of the patient's disability, not 
the occurrence of an adverse event or an adverse event due to 
negligence, was predictive of payment to the plaintiff.'' \4\ 
In other words, the amount patients recovered through the tort 
system was a function of their health condition, not any 
negligence by the health care system. The authors concluded 
more generally, therefore, that ``the standard of medical 
negligence performs poorly in malpractice litigation.'' \5\
---------------------------------------------------------------------------
    \3\ Paul Weiler et al., A Measure of Malpractice. Cambridge: 
Harvard University Press; 1993.
    \4\ Troyen A. Brennan et al, ``Relation Between Negligent Adverse 
Events and the Outcomes of Medical-Malpractice Litigation,'' N Engl J 
Med 1996; 335:1963-7.
    \5\ Ibid.
---------------------------------------------------------------------------
    The tort system thus presents a provider with the random 
risk of catastrophic financial injury. This causes some 
providers to quit practice and others to limit their practice, 
reducing patients' access to care, particularly in inner-city 
and rural areas. Most of those who continue to practice are 
forced to engage in defensive medicine. This results in more 
medical interventions for patients, as the increased rate of 
Cesarean deliveries demonstrates, thereby adding costs and 
putting patients at greater risk. It is estimated that 
defensive medicine costs at least $50 billion per year.\6\
---------------------------------------------------------------------------
    \6\ David Kessler and Mark McClellan, ``Do Doctors Practice 
Defensive Medicine,'' QJ Econ. 1996; 111: 353-390.
---------------------------------------------------------------------------
    At the same time, the litigation system does not provide 
fair and timely compensation for injured patients. They must 
wait on average 3\1/2\ years for resolution of their claims by 
the litigation system. If they prevail, they typically must 
give 33-60% of any recovery to their lawyers in contingency 
fees. Only 28 percent of the amount spent to provide insurance 
coverage actually goes to victims; the rest is spent in 
transaction costs and in operating the tort litigation 
system.\7\ The tort system imposes a 72% tax on patients and 
providers.
---------------------------------------------------------------------------
    \7\ Jeffrey O'Connell and C. Brian Kelly, The Blame Game. Lexington 
Books; 1987:127.
---------------------------------------------------------------------------
    Because of the threatening and contentious climate it 
creates, the litigation system, rather than protecting 
patients, is actually impeding efforts to improve the quality 
of care. It makes it difficult for providers to acknowledge 
mistakes. It deters open discussion of possible errors. And it 
discourages providers from filing reports, seeking assistance, 
and collaborating with other providers and experts to improve 
quality.
    The money spent on defensive medicine and litigation 
expenses could be better used to improve the quality of care 
and access to it. The energy and focus that the present system 
channels into litigation-related and litigation-induced actions 
should be redirected into developing better quality control 
systems and innovative ways of delivering care.

INSTITUTE OF MEDICINE REPORT

    With one exception, the IOM Report avoids inflated 
rhetoric. The exception is its statement that as many as 98,000 
people may die annually because of medical error. This figure 
is extrapolated in ways that are not explained from 71 deaths 
that the Harvard Study of the medical records of 31,429 
patients discharged from 51 New York hospitals in 1984 said 
were attributable to negligence.\8\ This extrapolation has no 
scientific basis, as the authors of the Study themselves have 
recognized.\9\
---------------------------------------------------------------------------
    \8\ Berkeley Rice, ``Do doctors kill 80,000 patients a year?'' 
Medical Economics. November 21, 1994; 1(discussing extrapolation to 
80,000 deaths).
    \9\ Troyen Brennan et al., ``Incidence of Adverse Events and 
Negligence in Hospitalized Patients: Results of the Harvard Medical 
Practice Study,'' N Eng. J Med 1991; 324: 370-6.
---------------------------------------------------------------------------
    The Harvard Study, moreover, suffered from methodological 
flaws, and its results have not been duplicated. The reviewers 
who determined which records reflected negligence agreed in 
only 10% of the cases. In an effort to confirm findings that 
rest on this shaky foundation, a second set of reviewers 
examined a subset of 318 of the records. Apparently they did 
not reach the same conclusions on individual records that were 
attributed to the primary set of reviewers.\10\
---------------------------------------------------------------------------
    \10\ ``Billions for Defense'' at 2400. The second set of reviewers 
found the same incidence of adverse events and adverse events due to 
negligence, but not in the same charts. Rather than confirming the 
reliability of the methodology used, this provides further 
demonstration of the uncertainty of what is an adverse event and what 
is negligence.
---------------------------------------------------------------------------
    The authors of the Harvard Study also applied their 
methodology to patients in Colorado and Utah hospitals in 1992. 
Extrapolating the results of this study, the authors concluded 
that 44,000 deaths were caused nationwide by medical error. The 
IOM Report finds this, and the unexplained figure of 98,000 
deaths, to represent a range.\11\ The more recent study, 
however, could equally be seen as an indication that health 
care improved in the 8 years after the New York study, that 
better care is provided in Colorado and Utah, or, since the 
results of the Harvard Study could not be duplicated, that the 
parameters of the Study are vague and the methodology is 
flawed.
---------------------------------------------------------------------------
    \11\ ``To Err is Human'' at 1, 22.
---------------------------------------------------------------------------
    It is not our purpose here to discuss the weaknesses of the 
Harvard Study or the exaggerated extrapolations that have been 
made from it. Patient safety and quality care should not be a 
numbers game. We should, as a health care system and as a 
society, endeavor to eliminate avoidable injuries. In doing so 
we must remember, as the Harvard Study reminds us,\12\ medical 
intervention is inherently risky and is provided by people. 
People are only human, and the title chosen for the IOM report 
reflects the reality this presents; ``To Err is Human.'' 
Because we are dealing with medical intervention by human 
beings, we must focus on what we can do together to reduce the 
number of unnecessary injuries suffered during the delivery of 
health care services.
---------------------------------------------------------------------------
    \12\ A Measure of Malpractice at 138.
---------------------------------------------------------------------------
    The IOM Report makes a vital contribution to this effort by 
its recognition and discussion of the three interrelated 
factors that now impede efforts to improve patient safety.
    First, it emphasizes that the problem is not ``bad 
apples,'' \13\ although there are some ``bad people'' and they 
must be weeded out. Mistakes are often caused, or are not 
prevented, by system (both technical and organizational) 
failures. As the Report suggests, because providers are only 
human, they need systems to help them avoid mistakes; but we 
cannot let reliance on systems dull the special intelligence 
that humans posses or lull them into lethargic complacency.
---------------------------------------------------------------------------
    \13\ ``To Err is Human'' at 42.
---------------------------------------------------------------------------
    The focus must be on developing systems that avoid future 
mistakes and not on attempting to pin blame for past conduct on 
an individual. This important observation leads the Report to 
balance public policy in favor of error prevention and away 
from faultfinding: ``When an error occurs, blaming an 
individual does little to make the system safer and prevent 
someone else from committing the same error.'' \14\ ``Although 
a punitive response may be appropriate in some cases (e.g., 
deliberate malfeasance), it is not an effective way to prevent 
recurrence.'' \15\
---------------------------------------------------------------------------
    \14\ Id. at 4.
    \15\ Id. at 47.
---------------------------------------------------------------------------
    Secondly, the Report emphasizes the need to report 
information about adverse events or potential adverse events in 
order to identify patterns of conduct that threaten safety and 
to assess the success of corrective actions. It correctly 
recognizes that reporting is essential to the primary goal of 
prevention. The Report provides a comprehensive summary of the 
numerous and varied reporting systems that are currently in 
effect.
    Thirdly, and most importantly, the Report recognizes that 
there is a critical and common element or impediment that 
prevents all the reporting systems, regardless of how they are 
structured, from collecting the information they need. That 
impediment is the tort system.
    Participants and witnesses to an adverse event are 
reluctant to report it (even if required by law to do so) out 
of fear that doing so will trigger or support a tort claim. The 
irrationality of the litigation system and the randomness of 
its results trigger a defensive reaction. Fear of being 
enmeshed in that system, even if one is ultimately found not to 
be liable, deters reporting.
    As the Report concludes, ``Patient safety is also hindered 
through the liability system and the threat of malpractice, 
which discourages the disclosure of errors. The discoverability 
of data under legal proceedings encourages silence about errors 
committed or observed.'' \16\
---------------------------------------------------------------------------
    \16\ Id. at 37.
---------------------------------------------------------------------------
    As a result, it finds ``All reporting systems, whether 
mandatory or voluntary, are perceived to suffer from 
underreporting. Indeed, some experts assert that all reporting 
is fundamentally voluntary since even mandated reporting can be 
avoided. . ..The volume of reporting is influenced by more 
factors than simply whether reporting is mandatory or 
voluntary. . ..One factor is related to confidentiality.'' \17\ 
``Thus,'' the Report concludes, ``the prominence of litigation 
can be a substantial deterrent to the development and 
maintenance of the reporting systems discussed in this 
report.'' \18\
---------------------------------------------------------------------------
    \17\ Id. at 85.
    \18\ Id. at 94.
---------------------------------------------------------------------------
    It is refreshing that the IOM Report recognizes this 
problem. It is important to the debate that it does so. The 
tort system impedes efforts to improve health care by deterring 
the reporting of data needed to make improvements in the health 
care system. Recognition of this fact by The IOM should provide 
the needed impetus for addressing this basic problem.
    As the Report recognizes, the tort system deters reporting 
even where confidentiality is promised. There is concern that 
confidential data will leak. There is also fear that what is 
confidential today may not be protected tomorrow. The Report 
cites the powerful example of the continuing political pressure 
to ``open up'' the National Practitioner Data Bank.\19\ 
Providers are concerned that the constant political pressure 
eventually will be successful, leading to a breach not only of 
a particular data source but also inserting the opening wedge 
for a more general release.
---------------------------------------------------------------------------
    \19\ Id. at 105.
---------------------------------------------------------------------------
    Confidentiality of adverse event reports, therefore, is 
necessary to develop an effective reporting system that will 
permit identification of safety problems and permit assessment 
of remedial actions. But there is on-going concern that even 
confidential reports will be fed into the litigation system--by 
leaks or by surrender to political pressure to remove the 
confidentiality protection. Confidentiality of reports is 
necessary to improve reporting, but it is not sufficient. The 
tort system also must be reformed.

Two reforms that are needed

    The findings of the IOM Report, therefore, confirm the need 
for a combination of two reforms: confidential protection for 
adverse event reports and a reformed tort system.

Confidential reporting

    It is important that Congress act on the findings of the 
Report by protecting the confidentiality of reports made of 
adverse events or of problems that could lead to adverse 
events.
    The Report in several places emphasizes the need for 
reporting to be confidential. It appears, in fact, to call for 
Federal legislation to protect confidentiality of all reports 
although it also makes an inconsistent recommendation that 
would deny confidentiality to reports of adverse events leading 
to serious injury. The Report recommends Federal legislation to 
``extend peer review protections to data related to patient 
safety and quality improvement that are collected and analyzed 
by health care organizations for internal use or shared with 
others solely for purposes of improving safety and quality.'' 
\20\
---------------------------------------------------------------------------
    \20\ Id. at 9.
---------------------------------------------------------------------------
    As the Report's discussion of peer review protection 
reflects, the nature and the scope of the current protection 
varies widely from state to state.\21\ Not only does the scope 
of the protection afforded by each state differ greatly, but in 
some instances the sharing of peer review materials with third 
parties engaged in health care quality efforts, such as The 
Joint Commission on Accreditation of Healthcare Organizations 
(JCAHO), has been held to waive any confidentiality 
protection.\22\ Moreover, the efficacy of these state 
protections is further undermined by uncertainty surrounding 
the application of the peer review privilege should the parties 
be drawn into federal court. This occurs, for instance, in 
actions brought under a Federal statute with related medical 
malpractice claims under state law (i.e., pendent state 
claims).
---------------------------------------------------------------------------
    \21\ Id. at 103-104.
    \22\ As the Report recognizes, ``One legal fear is that disclosure 
of internal quality data to outside reviewers not under a peer review 
statute will lead to discovery from JCAHO in lawsuits; indeed, many 
fear that disclosure to JCAHO would invalidate even the 
nondiscoverability protections each hospital enjoys for its own data 
under its state peer review statute.'' Id. at 108.
---------------------------------------------------------------------------
    As the Report recognizes, health care providers must have 
confidence that the peer review privilege will be applied with 
consistency and predictability if they are to come forward with 
information regarding medical errors.\23\ The discussion in the 
Report focuses on immunity and protection of peer review 
materials and deliberations from discovery. In urging that the 
protection be expanded, the Report at a minimum recommends that 
quality and safety information derived from reports or from 
investigation (the main areas now protected in different ways 
by peer review statutes) be protected from use in litigation 
and from public dissemination. The information derived through 
the peer review process may involve the ``most serious adverse 
events"; thus this recommendation calls for the appropriate 
confidential treatment of such information.
---------------------------------------------------------------------------
    \23\ Id. at 96.
---------------------------------------------------------------------------
    However, the Report also says that such information should 
be available for public consumption and that only reports of 
events other than the ``most serious adverse events'' should 
have confidentiality protection.\24\ We discuss this misplaced, 
and internally inconsistent, position below. The important fact 
is that the Report finds that confidentiality is necessary for 
effective reporting and patient safety improvements and 
recommends in, at least one place, across-the-board 
confidentiality.
---------------------------------------------------------------------------
    \24\ Id. at 9.

---------------------------------------------------------------------------
Tort reform

    Even where confidentiality would be provided, but 
particularly where it would not, reporting and improvements in 
the health care system quality can best be advanced by 
reforming the tort system to protect providers from random and 
excessive judgments. HCLA urges Congress to enact the tort 
reforms embodied in its proposed legislation which is modeled 
on the MICRA reforms enacted in California in 1975.
    These reforms would preserve the ability of injured 
patients to obtain compensation for their economic injury and 
to recover reasonable non-economic damages. They would: 1) 
encourage non-judicial resolution of claims and ensure that 
plantiffs' lawyers did not capture an excessive contingency fee 
from their clients; 2) prevent plaintiffs from obtaining double 
recovery (collateral source rule); 3) limit non-economic 
damages to a reasonable amount ($250,000); 4) require 
plaintiffs to bring any action in a reasonable time after the 
injury occurs or is recognized (statute of limitations and 
statute of repose); 5) protect any particular defendant from 
paying a larger percentage of any recovery than is warranted by 
his/her conduct (joint and several liability).
    Passage of these measures will restore a measure of balance 
to the tort system, give providers more faith in the system, 
and therefore facilitate reporting--which ultimately will 
result in greater patient safety.
    As the IOM Report recognizes, patient safety is not 
adequately served by the present system. If the tort system in 
its current state were adequately protecting patient safety, 
the Report would not have been necessary. The tort system is 
not only not the answer; it is the barrier to the enhanced 
quality systems that the Report correctly finds are the best 
way to improve safety. The underlying, if unarticulated, theme 
of the Report, therefore, is that tort reform is necessary to 
improve the quality of health care in this country.

Actions that should not be taken

    The Report correctly concludes that the barrier to systems 
improvements in health care is not the lack of reporting 
mechanisms but the tort-induced reluctance of participants to 
provide data through the existing avenues. There is no 
indication that there are not enough reporting requirements. 
The Report describes them comprehensively. The need is to make 
the changes necessary to encourage more reporting, and for the 
agencies and institutions to which reports are made to analyze 
the information and act on them more vigorously.
    HCLA questions, therefore, whether any purpose would be 
served by adding new reporting requirements or creating new 
agencies to collect or coordinate reports. In fact, adding new 
reporting requirements would only distract attention from the 
need to make the essential tort changes to support the existing 
reporting requirements.

No new reporting requirements without confidentiality

    While recognizing that the barrier to existing reporting 
requirements is a lack of confidentiality and fear of the tort 
system, the Report does not address this barrier, except in its 
recommendation that peer review protections be expanded.
    Instead it recommends that mandatory reporting of serious 
adverse events be expanded by federal statute, without 
corresponding confidentiality protection. Indeed, while it 
offers a gesture toward the states' role, it would make 
mandatory reporting a federal requirement in any state that did 
not on its own come to the conclusion that mandatory reporting 
is needed.\25\ Although The Report recognizes that the absence 
of confidentiality is impeding compliance with existing 
reporting requirements, it would make mandatory reporting a 
national requirement while providing no confidentiality 
protection.
---------------------------------------------------------------------------
    \25\ Id. at 8.
---------------------------------------------------------------------------
    The Report would permit confidentiality protection only for 
voluntary reporting of events that are not serious--where it is 
least useful. If an event results in little or no harm, there 
may be less concern about tort litigation. The Report offers 
confidentiality protection here, where it is worth less, but 
would deny it in the serious cases, where it is important to 
elicit reporting. Recommending confidentiality for voluntary 
reports is not a sufficient response to the problem identified 
by the Report itself--that lack of confidentiality deters 
reporting.
    Drawing a line, moreover, on when reporting is required and 
when it is confidential on the basis of whether the action 
resulted in ``serious'' harm will bog down the health care 
system in line-drawing and hair-splitting. What is serious 
harm? Who defines it? Suppose the event could have had a 
serious harm if it had not been caught? How long is serious? Is 
an extra day in a hospital serious? Is a false positive that 
leads to patient concern serious? Suppose the patient was not 
able to understand the test result; is a false positive serious 
in that case? \26\
---------------------------------------------------------------------------
    \26\ Unintentionally demonstrating the problem, the Report also 
refers to the kinds of acts that would fall under the voluntary (and 
confidential) reporting scheme as ones that resulted in ``no 
harm...(near misses) or very minimal patient harm.'' (p. 74) What is 
supposed to be done with respect to injuries that fall between serious 
and minimal?
---------------------------------------------------------------------------
    Rather than trying to impose reporting by regulation and 
mandates, and varying the protection for different types of 
reports, Congress should provide protection for all safety and 
quality reports, and for consideration of them. This is the 
best way to advance patient safety efforts.

No centralization of safety efforts

    It would be both unnecessary and harmful to create the new 
Federal Center proposed in the IOM Report. The Report envisages 
various roles for this new Center. HCLA believes these are 
unnecessary and would actually detract from efforts to improve 
patient safety.
    The Report sees a need for the Center to establish a 
``national focus to create leadership, research, tools, and 
protocols to enhance the knowledge base about safety.'' \27\ 
The premise that only the creation of a government Center can 
create a national focus and provide leadership is disturbing.
---------------------------------------------------------------------------
    \27\ ``To Err is Human'' at 5.
---------------------------------------------------------------------------
    As the Report indicates, efforts to enhance patient safety 
are being undertaken in different ways by a variety of 
individuals and institutions: insurers, manufacturers, 
providers, academic institutions, trade associations, etc. It 
may look messy and confused, but the pursuit of knowledge often 
is, particularly in an area as complex and varied as the design 
and manufacture of health care products and the delivery of 
health care.
    Commissions, meetings, and public awareness can all 
contribute to a national focus. So can efforts by political 
leaders, if conducted without demagogy and finger pointing. A 
new Center is not necessary to do this. This proposal is really 
symbolic; concern would be demonstrated by creating a new 
Center and spending more money.
    An approach based on centrally developing and collecting 
safety-related data could in fact impair safety research and 
promotion of safety activities. A centralized agency for safety 
research could well become hitched to a particular view or 
approach, subordinating all others. It is more effective for 
different people to try different approaches.
    Creating a ``highly visible [governmental] center'' is 
likely not only to diminish the diversity of research and views 
but to politicize patient safety. Once there is a ``highly 
visible'' government agency tasked to provide leadership and 
develop research and recommendations, every interest group will 
descend on it in an effort to gets its agenda adopted. Congress 
will inevitably be drawn in. It would be far more effective, if 
more research is needed, to provide funding to a variety of 
researchers on a scientific, non-political basis.
    The Report also has another role in mind for the new 
Federal safety Center. It would not be limited to research. It 
would receive and analyze reports (from the states)--apparently 
the mandatory reports of ``serious adverse events'' discussed 
above. The Center would become a national data bank for at 
least some kinds of reports. But it is unclear how the 
information would be used and who would have access to it. The 
Center apparently would ``identify persistent safety issues 
that require more intensive analysis and/or a broader-based 
response.'' \28\ In other words, it would use the data to do 
more studying. But would the agency act on the information? To 
whom would it give its findings?
---------------------------------------------------------------------------
    \28\ Id. at 76.
---------------------------------------------------------------------------
    What is needed is not central collection of information, 
nor more analysis and dissemination. Needed information should 
be given to those in a position, and with the most powerful 
incentive, to use it to improve patient safety. Instead of 
funneling data through a centralized, and possibly politicized, 
government agency, the focus should be on doing what is 
necessary to get the information to those who will actually use 
it to improve patient safety.
    Hospitals need more information about errors that are made 
there. Licensing boards need more information about their 
licensees. It is far simpler, and more effective, to inform a 
device manufacturer that the labeling is confusing than to 
report this to Washington. With this information, 
manufacturers, providers, and insurers would have the greatest 
incentive and the best ability to use it to improve safety.
    Instead of creating a centralized, nation-wide, government-
led reporting system, we should focus on doing what is 
necessary to get more information to the people on the front 
lines of health care quality.
    Compliance will be enhanced if reporters know they are 
reporting to an entity that will use the information 
effectively. A nurse is far more likely to report an error to 
her nursing supervisor or to report a problem with a device to 
its manufacturer than to file a form destined for a distant 
Federal bureaucracy. Health care providers are the people who 
are most concerned with quality of care and patient safety. 
They are more personally and directly concerned than is a 
distant government bureau. They strongly want to avoid adverse 
events. They want to provide good care.
    There is another practical factor that must be considered. 
Providers function under conditions of considerable stress. 
They are quite astute in distinguishing between what is real 
and what is more government make-work. They are more likely to 
report when they believe it will do good (particularly if they 
have protections of confidentiality) than where they are told 
to fill out another government-imposed form that seems to bear 
little or no relation to their real world--patient care.
    Providers, manufactures, suppliers, employers who sponsor 
health plans, and insurers, deal with each other and with 
various licensing and quality institutions on an on-going 
basis. They should be encouraged to report potential or 
existing problems and discuss improvements among themselves. 
This can best be achieved by protection of confidentiality for 
reports and discussions, and by reform of the tort system. 
Requirements that they file reports with a state agency for 
forwarding to Washington, D.C., will not encourage reporting or 
enhance collaborative efforts to improve the quality of care.
CONCLUSION

    The IOM Report documents the obstacles to greater patient 
safety efforts: the difficulties in securing more reporting 
that result from the lack of confidentiality and the shadow 
cast by the litigation system. But rather than addressing these 
problems, it recommends more reporting (but without 
confidentiality) and centralizing the reporting system.
    The problem, however, is not a lack of centralized 
reporting; it is the barriers to reporting and to safety-
improvement measures posed by the tort system.
    The problem is not a lack of reporting mechanisms, but a 
lack of assured confidentiality and fear on the part of the 
people who would report that they will be enmeshed in the 
litigation system.
    The primary need is not more data and more studies; it is 
for those in the field attempting to improve patient safety to 
have confidence that cooperating in safety-improvement measures 
will not result in involvement in burdensome tort litigation.
    The fears induced by the tort system cannot be resolved by 
expanding the already unsuccessful requirements to report. The 
problems of the tort system itself must be addressed.
    The solution should not be centralized or governmental; it 
should be private and dispersed. Medical errors, when they 
occur, happen at the local level, and local solutions are best 
crafted to solve local problems.
    The quality of health care, consequently, can best be 
improved by reforming the tort system to: 1) reduce the number 
of lawsuits, 2) make the system more fair and efficient, and 3) 
reduce its costs. Reforms in this direction would lessen the 
pressures to practice defensive medicine, lower health care 
costs, and increase access to care. At the same time, a fairer 
and less random tort system, and assurances of confidentiality, 
would reduce the barriers to reporting and enhance the ability 
of the field to identify problems and to make corrections.

                                

Statement of Healthcare Compliance Packaging Council, Falls Church, VA

    Falls Church, Virginia, February 10, 2000--The Healthcare 
Compliance Packaging Council, a not-for-profit trade 
association established in 1990 to promote the many benefits of 
superior pharmaceutical packaging, today commended the Health 
Subcommittee of the House Committee on Ways and Means for 
holding a hearing on the important national issue of medical 
errors. ``We are especially encouraged,'' noted Peter G. 
Mayberry, HCPC Executive Director, ``by the attention that is 
being paid to medication errors that take place in hospitals 
and other in-patient settings. Hopefully, these hearings will 
serve as a catalyst for change.'' Considering that, on average, 
an estimated seven percent of all hospitalized patients--some 2 
million people--experience an adverse drug event each year, the 
HCPC believes that inquiry by the Health Subcommittee is 
critical and timely. Moreover, in light of the fact that 
proven, cost-effective steps have already been identified to 
address the problem, the HCPC is hopeful that attention to the 
problem by the Health Subcommittee will lead to adoption of in-
patient pharmaceutical distribution systems that can reduce 
adverse drug event incidents by fifty percent or more. ``One 
element of such systems,'' Mr. Mayberry noted, ``is the 
adoption of unit dose pharmaceutical packaging by drug 
manufacturers, hospitals, and other inpatient facilities 
throughout the country.''
    Most people are familiar with unit dose formats, or blister 
packs and strips, through over-the-counter medications and 
prescription birth control pills. With solid oral dosages such 
as pills or tablets, these formats separate each dosage unit in 
its own compartment or blister cavity. As Mr. Mayberry 
explained, ``What many people may not know, is that unit dose 
formats can be combined with bar code technology such that no 
medication could be dispensed unless the doctor's prescription, 
the patient's medical chart, and the drug itself all match up 
correctly. These dispensing systems are already available, and 
are considered state-of-the-art when it comes to ensuring that 
the right drugs are given to the right patients at the right 
time.''
    ``As far as we know,'' Mr. Mayberry continued, ``every 
group that has examined the problem of in-patient adverse drug 
events has recommended the use of unit dose formats as a 
solution.''
    Indeed, in its list of recommendations released on May 12, 
1999, the National Patient Safety Partnership urged hospitals 
to ``Use unit dose drug distribution systems for inpatient 
care; also use such systems for outpatient care, where 
appropriate.'' Similarly, in its November 1999 report, To Err 
is Human: Building a Safer Health System, the Institute of 
Medicine (IoM) recommended that ``If medications are not 
packaged in single doses by the manufacturer, they should be 
prepared in unit doses by the central pharmacy.'' (page 166). 
The IoM report further stated that ``Unit dosing can reduce 
errors by eliminating the need for calculation, measurement, 
preparation, and handling on the nursing unit and by providing 
a fully labeled package that stays with the medication up to 
its point of use.'' The IoM report also noted that unit dosing 
has been recommended by the American Society of Health-System 
Pharmacists, the Joint Commission on the Accreditation of 
Health Care Organizations, the National Patient Safety 
Foundation of the AMA, and the Massachusetts Hospital 
Association as a means of reducing adverse drug events.
    Lucian L. Leape, M.D., Adjunct Professor of Health Policy 
at the Harvard School of Public Health, is also a proponent of 
unit dose packaging as a means of reducing adverse drug events. 
As Dr. Leape--who testified before the Senate Health Committee 
on January 26, 2000--told the FDA on January 8, 1998 during its 
workshop entitled ``Minimizing Medical Errors: A Systems 
Approach,'' distribution of drugs in unit dose formats is the 
``right thing'' for pharmaceutical manufacturers to do.
    Despite this widespread support, however, certain hospitals 
and other inpatient facilities have been directed to abandon 
unit dose formats in an effort to reduce pharmacy expenses. As 
the IoM explained in To Err is Human: Building a Safer Health 
System, ``As a cost-cutting measure, unfortunately some 
hospitals have recently returned to bulk dosing, which means 
that an increase in dosing errors is bound to occur.'' (page 
167). This is a penny wise/pound foolish approach that, as the 
IoM predicts, will surely lead to even greater numbers of 
adverse drug events. It is primarily for this reason that the 
HCPC lauds efforts by the Health Subcommittee to focus on such 
an important healthcare issue. Hopefully, by conducting this 
inquiry, the Health Subcommittee will help to underscore the 
importance of unit dose packaging, along with other recommended 
practices, as a systematic approach that can be immediately 
adopted to prevent adverse drug events.
    Mr. Mayberry may be contacted in care of the Healthcare 
Compliance Packaging Council at 7799 Leesburg Pike, Suite 900N, 
Falls Church, Virginia, 22043.

                                

Statement of Annette Guarisco, Honeywell

    We appreciate the opportunity to present the views of 
Honeywell on the important issue of medical errors in the 
health care system.
    As policymakers consider ways to reduce medical and 
medication errors, such as adverse drug effects, modernize the 
Medicare system and promote safety for children and adults, the 
promotion of unit dose/unit of use (known as blister packs) 
should be considered:
     Blister packs are inherently child resistant
     Blister packs are tamper-resistant and tamper-
evident
     Drugs packaged in unit dose formats are protected 
against cross-contamination
     Efficacy of the drug is maintained for a longer 
period of time without being compromised when unit dose formats 
are used
     Special labeling, color coding, is available to 
designate when and if the drug has been taken when unit dose 
formats are used
     Blister packaging provides for greater individual 
product barrier protection against moisture, light and oxygen
     The rate of compliance with unit dose packaging is 
significantly higher, resulting is fewer and less serious 
adverse health consequences:
    Contraception--92% compliance rate, vs. 70% for 
anticoagulants, 82% for organ transplant rejections drugs, 60% 
for hypertension medication, 80% for asthma, 50-70% for 
epilepsy, 50-60% for diabetes and 53% for estrogen deficiency 
drugs
     It was estimated in 1990 that nearly 10% of 
hospital admissions were the result of pharmaceutical non-
compliance and up to 23% of nursing home admissions were 
primarily due to an inability to manage medications at home.
     When drug regimens are not taken as prescribed, 
taxpayer dollars are wasted on drugs paid by Medicare, 
Medicaid, and VA programs, and unnecessary and longer hospital 
and nursing home stays.
     Unit dose packaging takes less pharmacist time to 
prepare and reduces the chance for errors, leaving them more 
time to consult with patients on the proper use of medications.
    The recent Institute of Medicine Report, To Err is Human: 
Building a Safer Health System, called for implementing unit 
dosing:
    If medications are not packaged in single doses by the 
manufacturer, they should be prepared in unit doses by the 
central pharmacy. Unit dosing--the preparation of each dose of 
each medication by the pharmacy--reduces handling as well as 
the chance of calculation and mixing errors. Unit dosing can 
reduce errors by eliminating the need for calculation, 
measurement, preparation, and handling on the nursing unit and 
by providing a fully labeled package that stays with the 
medication up to its point of use.
    Unit dosing was a major systems change that significantly 
reduced dosing errors when it was introduced nearly 20 years 
ago. Unit dosing has been recommended by the American Society 
of Health-System Pharmacists, JCAHO, NPSF, and the MHA in their 
``Best Practices Recommendations.'' As a cost-cutting measure, 
unfortunately some hospitals have recently returned to bulk 
dosing, which means that an increase in dosing errors is bound 
to occur. Page 166-167.
    Honeywell urges the Committee to consider ways to encourage 
drug manufacturers, hospitals, nursing homes, and other 
inpatient facilities to utilize unit dose formats, and to 
promote unit dosing in the Medicare and Medicaid systems as 
well as in the federal employee health benefit system.
    We appreciate the Committee's consideration of these 
recommendations and applaud the Committee for deliberating on 
the important subject of reducing medical errors.
                                           Annette Guarisco
       Corporate Director, Public Policy and Government Relations, 
                                           Honeywell (202) 662-2644

                                

Statement of New Medical Concepts, Inc., Fort Lauderdale, FL

     SAFE MEDICATION USE IN THE OUTPATIENT SETTING: THE PROBLEM OF 
                       MEDICATION NON-COMPLIANCE

    New Medical Concepts, Inc. (NMC), a telecommunications and 
healthcare information company headquartered in Fort 
Lauderdale, FL is pleased to present this statement for the 
hearing record to the House Committee on Ways and Means 
Subcommittee on Health it examines medical errors. We believe 
the Institute of Medicine's Report To Err Is Human: Building A 
Safer Health System and the report to Congress issued last week 
by the General Accounting Office on Adverse Drug Errors provide 
a strong basis for Congressional action on one of the most 
serious problems in our healthcare system: the need to improve 
patient safety.
    Our comments focus on problems associated with one of the 
most significant aspects of this problem in terms of impairment 
of quality of care and unnecessary costs: the need to assure 
safe prescription drug use by patients in the outpatient 
setting.

New Medical Concepts, Inc.

    NMC was founded in 1997 by a group of business, healthcare 
and telecommunications professionals with recognized expertise 
in innovative technology, medicine, pharmacy and healthcare 
operations. The firm has developed RxAlerts,gT1 a unique voice 
and text messaging alert system, using automated, personalized 
wireless and wired communications, which has the potential for 
dramatically reducing patient medication non-compliance and 
fostering more effective communications between healthcare 
providers and their patients.
    Most would acknowledge that drug therapy is often the most 
effective and cost-efficient way to achieve desired therapeutic 
outcomes in the treatment of patients. But drugs cannot work if 
they are not taken or are taken improperly. All drugs have side 
effects; some known, some unknown; some serious, some not. 
Because of the potential for harm and the increased 
significance of drug therapy as a treatment modality, safe 
medication use must be a priority objective in today's 
healthcare system. The problem of medication non-compliance is 
very real and demands practical solutions, the kind that foster 
integrated communication between patient and provider and which 
our company has developed.

Adverse Drug Events

    An adverse drug event (ADE) would typically be defined as 
any undesired effect associated with drug therapy such as 
harmful reactions (adverse drug reactions or ADRs), treatment 
failure, medication errors, overdoses and non-compliance. 
Consequences range from ineffective treatment to injuries, at 
times resulting in death. The population that is most at risk 
because of these events are the chronically ill patients of all 
ages and the elderly. With an aging population, the use of 
prescription drugs will rise and likewise, the risk of 
medication misuse and ADEs will also increase.

Medication Non-compliance

    We wish to emphasize to the Committee that the problems 
associated with medical errors and adverse drug events are just 
as significant (and probably more prevalent) in the outpatient 
setting as in the institutional setting. Certainly the 
overwhelming percentage of the several billion medications 
dispensed per year are to patients who are not in hospitals, 
nursing homes or other institutional settings, but who receive 
their drugs from community pharmacies. Safe medication use and 
the associated problem of medication non-compliance by patients 
in the ambulatory setting deserve this Committee's serious 
attention.
    Indeed, the General Accounting Office report on ``Adverse 
Drug Events'' released last week identified patient non-
compliance in the ambulatory setting as a major source of 
adverse drug events. The report also described medication non-
compliance as a major source of emergency room and hospital 
admissions. For example, the GAO cites a report finding that 58 
percent of adverse drug events in patients visiting an 
emergency room were caused by medication non-compliance. 
Another study it cites found that 11 percent of all elderly 
admissions to a hospital were related to medication non-
compliance. Among the proposals the GAO makes for reducing 
adverse drug events is improving communication between patients 
and physicians about the risks and benefits of medication.

Definition, Reasons, Those Most Seriously Affected

    Medication non-compliance, or not taking a medicine as it 
was prescribed, is a worldwide health issue. Non-compliance 
includes taking too much medication, taking medication not 
prescribed, not taking medication prescribed, altering the 
prescribed dosage, or altering the time between doses. The 
reasons for non-compliance vary and may include forgetfulness, 
confusion over generic and brand names, unclear information 
about how to take or how much to take of a medication, 
disappearing symptoms of an illness, no perceived improvement 
in a patient's condition or well-being and, for those with low 
income, the difficult choice of having to select food or heat 
over drug expenditures. As with ADEs generally, the elderly and 
the chronically ill are particularly susceptible to the problem 
of medication non-compliance. They usually take multiple 
prescriptions, and they are more susceptible to memory problems 
and confusion.

Relevant Statistics

     Thirty years ago (1970) only 650 medications were 
available; today the number approaches 10,000
     Over 2.7 billion retail prescriptions were 
dispensed in the U.S. in 1998.
     30-50 percent of all prescriptions are not taken 
correctly. (U.S. Food & Drug Administration)
     More than a billion prescriptions are taken 
incorrectly each year. (U.S. Chamber of Commerce)
     The estimated annual cost of medication non-
compliance exceeds $100 billion. (National Pharmaceutical 
Council)
     Non-compliance kills 125,000 Americans each year. 
(National Pharmaceutical Council)

Social and Economic Consequences

    Non-compliance with the taking of medication has 
significant implications not only in terms of poor health 
outcomes for the patient but for the healthcare system itself. 
Its full effect on morbidity, mortality, and the associated 
healthcare costs are only beginning to be recognized. One 
national study (Johnson, Jeffrey A. and J. Lyle Bootman. 
``Drug-Related Morbidity and Mortality: A Cost-of-Illness 
Model,'' Archives of Internal Medicine 155:1949-56, Oct. 6, 
1995) revealed more than $75 billion in direct annual costs 
(with variable assumptions, the range was from $31 to $137 
billion) as a result of medication use problems in the United 
States. It based its findings on preventable treatment 
associated with increased admissions to hospitals and nursing 
homes and increased visits to physician offices and hospital 
emergency rooms which resulted from medication non-compliance.
    The costs estimated in this study related only to the 
direct cost of first time events and did not address 
consequential adverse health events (i.e., new medical problems 
resulting from the primary illness) or the indirect cost of 
lost employee productivity/absenteeism and turnover. When 
indirect costs due to non-compliance are added to the direct 
cost figures, total economic costs exceed $150 billion. 
(Johnson, Jeffrey A. and J. Lyle Bootman. ``Drug-Related 
Morbidity and Mortality: A Cost-of-Illness Model,'' Archives of 
Internal Medicine 155:1949-56, Oct. 6, 1995) Drug-related 
morbidity and mortality costs are in the same range as 
diabetes, cardiovascular disease and obesity--leading some 
experts to suggest that drug-related problems should be 
considered a major category of disease.

Failure to Address the Problem

    Medication non-compliance has reached the forefront of the 
medical community's awareness, but efforts to focus on safe 
medication use and the problem of medication non-compliance 
have been limited. While there have been major efforts made in 
developing technologies to detect and minimize adverse drug 
reactions, essentially sophisticated computer systems utilized 
by pharmacies and hospitals, these innovations do not address 
the more complex and subtle causal factors associated with non-
compliance, notably communications between patient and 
healthcare professionals. Patient counseling requirements, 
consumer information sheets that accompany prescriptions, 
public service announcements, educational brochures and the 
specialized educational programs that are part of ``disease 
management'' programs are all positive developments, but have 
not proven sufficient to assure appropriate and safe medication 
use by patients. There have been few efforts made, 
technological or otherwise, to develop programs or products to 
assist health professionals and individual patients in dealing 
comprehensively with the problem.

Conclusion: Innovation That Addresses Medication Non-Compliance Must Be 
Encouraged

    The inescapable conclusion is that if patients are non-
compliant with medication therapy, desired outcomes (whether it 
be a cure, relief of symptoms or improved quality of life) are 
impaired. Indeed, it is clear that many emergency room and 
physician office visits and hospital and nursing home 
admissions could be prevented with interventions targeted at 
improving medication compliance. There can be little doubt that 
non-compliance is a significant health and economic burden on 
the healthcare system; that interventions directed at improving 
compliance will result in improved health outcomes; and that a 
significant cost savings will be realized through interventions 
directed at improving compliance.
    NMC believes our product RxAlerts is an effective and 
practical tool which will assist the healthcare system in 
addressing the problem of medication non-compliance. RxAlerts 
is a comprehensive medication compliance and support product/
program which uses sophisticated state-of-the-art software, 
utilizing proprietary computer time-clocking engines, to 
provide personal, customized health-related information to 
patients from their health providers through wired and wireless 
communication media--alphanumeric and voice paging, facsimile 
transmission, cellular telephony, the internet, wired 
telephones and television (pending). The product applications 
have two-way communications capability and are encrypted to 
assure patient confidentiality. NMC is initially focusing on 
disease states like HIV, asthma, diabetes, post-organ 
transplants and certain pulmonary and heart conditions where 
medicine regimens are difficult, where there is a criticality 
of maintaining consistent medicine levels, where there is a 
need to modify or enhance behavior and where there is an 
overall need to communicate with patients on a regular basis.
    New Medical Concepts is encouraged that the Committee is 
examining the issue of medical errors, and we pledge to work 
with Congress, federal and state health agencies and the 
healthcare community in finding real world ``Patient 
Connectivity'' solutions which will foster safe medication use 
and improve the quality of care patients receive.

                                

Statement of J. Richard Gaintner, Shands Healthcare, Gainesville, FL,

    Dear Mr. Chairman, Members of the Committee:
    I am writing as CEO of Shands HealthCare, with its mission 
of providing excellent patient care, improving community 
health, and supporting education and research for the State of 
Florida. Shands HealthCare is an integrated clinical delivery 
system, which offers the most comprehensive range of services 
in North Central Florida. The not-for-profit enterprise 
encompasses six acute care hospitals, two specialty hospitals, 
a home care company, and manages the University of Florida 
clinic operations as well as an extensive physician network. 
Shands at the University of Florida, the system's flagship 
hospital, is the academic medical center for the University of 
Florida Health Science Center and is recognized as one of the 
Southeast's leading tertiary care centers, and as such receives 
the majority of its patients from every county of Florida and 
Southeast Georgia. Shands at the University of Florida is 
closely linked with the College of Medicine at the University 
of Florida resulting in the development and delivery of cutting 
edge technology for the delivery of patient care.
    In addition, Shands HealthCare, the University of Florida, 
and University and Methodist Medical Centers have joined forces 
to form Shands Jacksonville, of which I am the Chairman of the 
Board of Directors.
    I also have the honor of serving as Chairman of the Council 
of Teaching Hospitals (COTH), a PO Box 100326 Gainesville, FL 
32610-0326 352.395.0421 352.395.0177 fax 
[email protected] of the Association of American 
Medical Colleges (AAMC), representing over 400 teaching 
hospitals across the nation. In addition, I serve on the Boards 
of the American Hospital Association and the Florida Hospital 
Association, and was recently elected Chair of the Florida 
Statutory Teaching Hospital Council. As a member of the Board 
of the National Committee for Quality Health Care, I have been 
directly involved in the promotion of quality for health care 
teams.
    We believe that we have a fundamental responsibility to 
continually improve the quality of care and services provided 
to our patients. As part of their mission, teaching hospitals 
provide a disproportionate share of the most complex health 
care services. This translates to patients entering the health 
system who are sicker and more complicated, yielding health 
needs greater than those traditionally seen elsewhere.
    Hospitals have long recognized their role in improving the 
care provided to patients. Initiatives already in place at 
teaching hospitals include, but are not limited to: leadership 
commitment to improving the care provided; internal reporting 
of incidents for the identification of possible opportunities 
for improvement; teaching conferences where cases are subjected 
to detailed review; use of external benchmarking; proactive 
attention to improving processes through the use of quality 
improvement tools and techniques; and, sharing of information 
related to trends and successes.
    Shands HealthCare participates in each of these, as well as 
required external reporting to the State of Florida for 
specified serious incidents. These reporting processes have 
only been successful because of the protections put in place by 
the Florida Legislature to maintain the confidentiality of the 
information reported. This is a crucial step to ensure that the 
process remains non-punitive and successful.
    One of the keys to success has been the focus of the 
Quality Committee of the Board of Directors on quality 
improvement, of which reducing errors is but one component. 
Reporting of issues and involvement of the Board has reinforced 
the commitment at all levels of the organization to improving 
and maintaining the health of people in the State of Florida 
and the Southeastern United States.
    Thank you for your consideration and response to our desire 
to work closely with Congress as it pursues ways to continue to 
improve the quality of health care services.
            Sincerely,
                                    J. Richard Gaintner, MD

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