[House Hearing, 107 Congress]
[From the U.S. Government Printing Office]



 
                  LEGISLATION TO REDUCE MEDICAL ERRORS
=======================================================================

                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                      COMMITTEE ON WAYS AND MEANS
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 10, 2002

                               __________

                           Serial No. 107-95

                               __________

         Printed for the use of the Committee on Ways and Means












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                      COMMITTEE ON WAYS AND MEANS

                   BILL THOMAS, California, Chairman

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

                     Allison Giles, Chief of Staff
                  Janice Mays, Minority Chief Counsel

                                 ______

                         Subcommittee on Health

                NANCY L. JOHNSON, Connecticut, Chairman

JIM MCCRERY, Louisiana               FORTNEY PETE STARK, California
PHILIP M. CRANE, Illinois            GERALD D. KLECZKA, Wisconsin
SAM JOHNSON, Texas                   JOHN LEWIS, Georgia
DAVE CAMP, Michigan                  JIM MCDERMOTT, Washington
JIM RAMSTAD, Minnesota               KAREN L. THURMAN, Florida
PHIL ENGLISH, Pennsylvania
JENNIFER DUNN, Washington

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

Advisories announcing the hearing................................  2, 4

                               WITNESSES

U.S. Department of Health and Human Services, Hon. Tommy G. 
  Thompson, Secretary, accompanied by Carolyn Clancy, Acting 
  Director, Agency for Healthcare Research Quality...............     9

                                 ______

Healthcare Leadership Council, and Mayo Foundation, Michael B. 
  Wood, M.D......................................................    33
Leape, Lucian L., M.D., Harvard School of Public Health, Harvard 
  University.....................................................    29
National Academy for State Health Policy, Jill Rosenthal.........    48
New York-Presbyterian Health Care System, Herbert Pardes, M.D....    42
Pittsburgh Regional Healthcare Initiative, Kenneth T. Segel......    38

                       SUBMISSIONS FOR THE RECORD

U.S. Department of the Treasury, Hon. Paul O'Neill, Secretary, 
  statement......................................................     9

                                 ______

American Academy of Family Physicians, statement.................    70
American College of Obstetricians and Gynecologists, statement...    71
American College of Physicians-American Society of Internal 
  Medicine, statement............................................    72
American Medical Association, statement..........................    73
American Medical Group Association, Alexandria, VA, Donald W. 
  Fisher, letter and attachment..................................    75
American Nurses Association, statement...........................    77
Biomedical Metatechnology Inc., Amherst, NY, Irwin D. Bross, 
  letter.........................................................    79
Bonner, Dena J., Los Angeles, CA, letter.........................    80
Carlson, Richard E., M.D., Centennial, CO, letter................    82
Coyne, Hon. William J., a Representative in Congress from the 
  State of Pennsylvania..........................................    26
ECRI, Plymouth Meeting, PA, Jeffrey C. Lerner, letter............    82
Society of Thoracic Surgeons, statement..........................    83

















                  LEGISLATION TO REDUCE MEDICAL ERRORS

                              ----------                              


                      TUESDAY, SEPTEMBER 10, 2002

                  House of Representatives,
                       Committee on Ways and Means,
                                    Subcommittee on Health,
                                                    Washington, DC.

    The Subcommittee met, pursuant to notice, at 11:48 a.m., in 
room B-318, Rayburn House Office Building, Hon. Nancy L. 
Johnson (Chairman of the Subcommittee) presiding.
    [The advisory and the revised advisory announcing the 
hearing follow:]

ADVISORY

FROM THE 
COMMITTEE
 ON WAYS 
AND 
MEANS

                         SUBCOMMITTEE ON HEALTH

                                                CONTACT: (202) 225-3943
FOR IMMEDIATE RELEASE
September 3, 2002
No. HL-17

                      Johnson Announces Hearing on

                  Legislation to Reduce Medical Errors

    Congresswoman Nancy L. Johnson (R-CT), Chairman, Subcommittee on 
Health of the Committee on Ways and Means, today announced that the 
Subcommittee will hold a hearing on legislation to reduce medical 
errors. The hearing will take place on Tuesday, September 10, 2002, in 
the main Committee hearing room, 1100 Longworth House Office Building, 
beginning at 10:00 a.m.
      
    In view of the limited time available to hear witnesses, oral 
testimony at this hearing will be from invited witnesses only. 
Witnesses will include academic experts and representatives from 
professional organizations. 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:

      
    H.R. 4889, the ``Patient Safety Improvement Act of 2002,'' was 
introduced by Chairman Johnson on June 6, 2002. The bill seeks to 
reduce medical errors by encouraging reporting of adverse events to new 
patient safety organizations. These new organizations would analyze 
what went wrong and provide feedback to health providers so that they 
can learn from their mistakes. This hearing builds on the testimony 
provided at the Subcommittee's March 7, 2002, hearing on medical 
errors.
      
    Medical errors permeate our health system. More than three years 
ago, the Institute of Medicine (IOM) reported that preventable medical 
errors are the eighth leading cause of death in America--ahead of 
breast cancer, AIDS and traffic deaths. Nearly 100,000 patients die in 
hospitals each year as a result of preventable mistakes. The number of 
injured is even greater. And yet in the three years since the release 
of the breakthrough IOM report, no legislation has passed either 
chamber of Congress.
      
    In announcing the hearing, Chairman Johnson stated, ``We have spent 
too much time discussing the potential for quality improvement and 
fewer errors in health care. It is clear that Federal leadership can 
make a difference and Congress can make that happen. I am looking 
forward to thoughtful input and a lively discussion to help us in our 
consideration of this bill.''
      

FOCUS OF THE HEARING:

      
    Tuesday's hearing will focus on the draft Chairman's mark of H.R. 
4889.
      

DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:

      
    Please Note: Due to the change in House mail policy, any person or 
organization wishing to submit a written statement for the printed 
record of the hearing should send it electronically to 
[email protected], along with a fax copy to 
(202) 225-2610, by the close of business, Thursday, September 12, 2002. 
Those filing written statements who wish to have their statements 
distributed to the press and interested public at the hearing should 
deliver their 200 copies to the Subcommittee on Health in room 1136 
Longworth House Office Building, in an open and searchable package 48 
hours before the hearing. The U.S. Capitol Police will refuse sealed-
packaged deliveries to all House Office Buildings.
      

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. Due to the change in House mail policy, all statements and any 
accompanying exhibits for printing must be submitted electronically to 
[email protected], along with a fax copy to 
(202) 225-2610, in Word Perfect or MS Word format and MUST 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. Any statements must include a list of all clients, persons, or 
organizations on whose behalf the witness appears. A supplemental sheet 
must accompany each statement listing the name, company, address, 
telephone and fax numbers of each witness.
      
    Note: All Committee advisories and news releases 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.

                                 

                   * * * NOTICE--CHANGE IN TIME * * *

ADVISORY

FROM THE 
COMMITTEE
 ON WAYS 
AND 
MEANS

                         SUBCOMMITTEE ON HEALTH

                                                CONTACT: (202) 225-3943
FOR IMMEDIATE RELEASE
September 6, 2002
No. HL-17-Revised

                      Johnson Announces Hearing on

                Change in Time for Subcommittee Hearing

                on Legislation to Reduce Medical Errors

    Congresswoman Nancy L. Johnson (R-CT), Chairman, Subcommittee on 
Health of the Committee on Ways and Means, today announced that the 
Subcommittee hearing on legislation to reduce medical errors, scheduled 
for Tuesday, September 10, 2002, at 10:00 a.m., in the main Committee 
hearing room, 1100 Longworth House Office Building, will now be held at 
11:00 a.m.
      
    All other details for the hearing remain the same. (See 
Subcommittee Advisory No. HL-17, dated September 3, 2002.)

                                 

    Chairman JOHNSON. The Committee will come to order. Mr. 
Stark is on his way back from the Floor and I thought I would 
get us moving. My apologies, Mr. Secretary, for the long delay. 
These things are beyond our control.
    I want to remind the Committee that it was more than 3 
years ago that the Institute of Medicine (IOM) reported that 
preventable medical errors are the eighth leading cause of 
death in America. These are ahead of breast cancer, AIDS, and 
traffic deaths. Yet no legislation has been approved by any 
Committee in either chamber of Congress to deal with this 
crisis. Nearly 100,000 patients die in hospitals each year as a 
result of preventable mistakes, and the number of injured is 
far greater. Clearly, it is time to act.
    The draft Chairman's mark, which is before the Committee at 
this time, extends confidentiality protection and privilege 
standards to patient safety data that is reported externally to 
new Patient Safety Organizations (PSO). These certified and 
independent organizations will analyze the reports from health 
care providers and provide feedback on what went wrong and how 
to fix it. Reporting adverse events and close calls allows us 
to gain insight into how to prevent errors. By protecting 
reporters, we will stimulate a rich process that should enable 
providers to dramatically improve the quality of health care.
    The bill also establishes a new Center for Patient Safety 
within U.S. Department of Health and Human Services (HHS) to be 
the focal point of Administration policy on patient safety. 
This center will administer a new medical errors database of 
non-identifiable information. Researchers will use this 
database to identify national trends and encourage best 
practices to prevent errors and improve health care quality.
    Finally, the bill establishes a process through which new 
voluntary standards for interoperability can be developed. In 
our quest for improved health care quality, the urgency for 
investing in health care information technology is exceeded 
only by that for investment in patient safety systems. The 
health care industry has lagged far behind other sectors of our 
economy in adopting the information systems that can assure 
continuous quality improvement.
    Consequently, we must not only shield the reporting of 
health care delivery problems from legal liability. We must 
also support the development of the infrastructure needed to 
gather data, analyze data, problem solve, and disseminate 
recommendations for quality improvement. Therefore, the bill 
establishes a new Technology Advisory Board to provide expert 
advice to the Secretary in creating interoperability standards. 
We simply cannot afford to establish broad information systems 
that do not talk to each other. Patient safety is too 
important.
    That is what H.R. 4889 is designed to do. H.R. 4889 would 
facilitate the identification of health care delivery problems 
through voluntary and confidential reporting. It supports the 
analysis of data and development of recommended best practices. 
The bill also provides for the dissemination of recommendations 
for best practices back to the health care industry. All of 
these activities would be privileged or shielded from discovery 
for litigation purposes. Fear of legal liability has had a 
chilling effect on the development of reporting and analysis of 
errors data that can save lives and create a health care 
delivery system capable of continuous quality improvement.
    This legislation incorporates the recommendations of 
experts, consumers, policy makers, and my colleagues in 
Congress. The overwhelming and positive response to our 
proposal is a testament to the broad recognition in the 
industry that much more can be done. I am pleased that 50 
provider, patient, quality improvement, and national 
accreditation organizations have endorsed this draft proposal.
    Secretary Thompson, you need no introduction to this 
Committee. I am very pleased that you have worked closely with 
us, as has Centers for Medicare and Medicaid Services (CMS), 
the Agency for Healthcare Research Quality (AHRQ), and the U.S. 
Department of the Treasury and the White House, in developing 
this draft. I am also very pleased that your testimony will 
review the great variety of initiatives that you have led to 
achieve these very same goals of improved patient safety and 
improved health care quality.
    Our second panel is also impressive. Dr. Lucian Leape from 
Harvard University is a member of the IOM's Committee on 
Quality of Health Care in America and one of the authors of the 
1999 report on errors.
    Dr. Michael Wood is President and Chief Executive Officer 
of the Mayo Foundation and is testifying on behalf of the 
Health Leadership Council. Also joining us is Ken Segel, 
Director of the Pittsburgh Regional Healthcare Initiative, 
whose organization testified at our initial hearing. Dr. 
Herbert Pardes is the President and Chief Executive Officer of 
the New York-Presbyterian Health Care System. He brings a 
wealth of expertise on information technology and computerized 
medical records. Jill Rosenthal is a project manager at the 
National Academy for State Health Policy who will give us a 
perspective from the State's point of view and experience.
    [The opening statement of Chairman Johnson follows:]
  Opening Statement of the Hon. Nancy L. Johnson, a Representative in 
 Congress from the State of Connecticut, and Chairman, Subcommittee on 
                                 Health
    More than three years ago, the Institute of Medicine (IOM) reported 
that preventable medical errors are the eighth leading cause of death 
in America--ahead of breast cancer, AIDS, and traffic deaths. And yet, 
no legislation has been approved by any committee or either chamber of 
Congress to deal with this crisis. Nearly 100,000 patients die in 
hospitals each year as a result of preventable mistakes. The number of 
injured is far greater.
    Just yesterday, newspapers reported on findings by researchers at 
Auburn University who analyzed data from 36 hospitals and nursing homes 
in Colorado and Georgia of an 81-day period in 1999. These researchers 
found medication errors in about 20% of the doses administered in a 
``typical'' 300-bed facility, and found 7% of the errors ``potentially 
harmful.'' Not only do medical errors harm and take the lives of 
innocent, often basically healthy patients, they are costly.
    According to the Pittsburgh Healthcare Initiative, medication 
errors result in $3,500 to $4,000 additional costs per incident, an 
unacceptable financial cost borne by hospitals, individuals, public 
health programs and, yes, Medicare.
    The evidence of the human and economic costs of errors is simply 
overwhelming! It's simply time we must act. On March 7 of this year, 
the Subcommittee held a hearing on this issue, with testimony from some 
of the country's most highly recognized experts on reducing medical 
errors. At that hearing, Mr. Stark stated that he hoped our next 
meeting on this would be a markup. And while we began work immediately, 
fear developed that any product developed could be used to make the 
prescription drug bill ``bipartisan.'' Despite assurances, that concern 
lingered and we laid aside our work on this topic until the 
prescription drug bill passed the House. Since that time I introduced a 
base bill on June 6 that was developed with experts' and Member input 
and then continued to explore aspects of this issue with my colleagues 
Mrs. Thurman, and Messrs. Houghton, Cardin and Stark that resulted in a 
new draft Chairman's mark in July.
    On August 2, I solicited comments from all members of the IOM 
Committee that produced the medical errors report. I am pleased that we 
received near-unanimous support for this new proposal, as well as 
suggestions for refinements and changes. From this hearing we will 
propose a final draft for consideration by the full Committee in the 
near future.
    The draft Chairman's mark extends confidentiality protection and 
privilege standards to patient safety data that are reported externally 
to new Patient Safety Organizations. These certified and independent 
organizations will analyze the reports from health care providers and 
provide feedback on what went wrong and how to fix it. Reporting 
adverse events and close calls allows us to gain insight into how to 
prevent errors. By protecting reporters we will stimulate a rich 
process that should enable providers to improve dramatically the 
quality of care.
    The bill also establishes a new Center for Patient Safety within 
HHS to be the focal point of Administration policy on patient safety. 
This center will administer a new medical errors database of non-
identifiable information that researchers will use to identify national 
trends and encourage best practices to prevent errors and improve 
health care quality.
    Finally, the bill establishes a process through which new, 
voluntary standards for interoperability can be developed.
    In our quest for improved health care quality, the urgency for 
investing in health care information technology is exceeded only by 
that for investment in patient safety systems. The health care industry 
has lagged far behind other sectors of our economy in adopting the 
information systems that can assure continuous quality improvement.
    Consequently, we must not only shield the reporting of health care 
delivery problems from legal liability, but also support the 
development of the infrastructure needed to gather data, analyze them, 
problem solve, and disseminate recommendations for quality improvement. 
Therefore, the bill establishes a new technology advisory board to 
provide expert advice to the Secretary in creating these 
interoperability standards. We simply cannot afford to establish 
different brand information systems that do not talk to each other. 
Patient safety is too important!
    That is what H.R. 4889 is designed to do. H.R. 4889 would 
facilitate the identification of health care delivery problems through 
voluntary and confidential reporting. It supports the analysis of data 
and development of recommended best practices. And it provides for the 
dissemination of recommendations for best practices back to the health 
care industry. All of these activities would be privileged--or shielded 
from discovery for litigation purposes--because it has been the fear of 
legal liability that has had such a chilling effect on the development 
of the reporting and analysis of errors data that can save lives and 
create a health care delivery system capable of continuous quality 
improvement.
    Throughout, we also recognize the need for establishing information 
systems that communicate with each other to support clinical decision 
making as well as quality improvement activities. We were told by many 
experts that national leadership is needed to speed the adoption of 
technology standards for health care information systems. This bill 
establishes an advisory board and process for the development of 
national information technology standards and will assure the 
development of interoperable systems in the competitive market with 
tremendous benefits for quality improvement in health care.
    This legislation incorporates the recommendations of experts, 
consumers, policymakers, and my colleagues in Congress. The 
overwhelming and positive response to our proposal is testimony to the 
broad recognition in the industry that much more can be done, and that 
the will is there to make it happen. I'm pleased that 50 provider, 
patient, quality improvement, and national accreditation organizations 
have endorsed this Chairman's draft.
    Of course, Secretary Thompson needs no introduction to this 
Subcommittee. In working with you and officials from CMS, the Agency 
for Healthcare Research and Quality, the Department of the Treasury and 
the White House, we believe we have shaped a good legislative product 
the Administration can endorse. Mr. Secretary, I welcome you here 
today.
    Our second panel is impressive. Dr. Lucian Leape from Harvard 
University is a member of the IOM's Committee on Quality of Health Care 
in America and an author of the 1999 report on errors. Dr. Michael Wood 
is the President and CEO of the Mayo Foundation and is testifying on 
behalf of the Healthcare Leadership Council.
    Also joining us is Ken Segal, Director of the Pittsburgh Regional 
Healthcare Initiative, and whose organization testified at our last 
hearing. Dr. Herbert Pardes is the President of New York-Presbyterian 
and CEO of the New York-Presbyterian Healthcare System. He brings a 
wealth of expertise on information technology and computerized medical 
records.
    Lastly, Jill Rosenthal is a Project Manager at the National Academy 
for State Health Policy who will give us a perspective from the states.
    Welcome, Secretary Thompson. We look forward to your testimony.

                                 

    Before I recognize Secretary Thompson, I would like to 
recognize my colleague, Mr. Stark.
    Mr. STARK. Thank you, Madam Chair, and thank you for 
holding these hearings. There are, indeed, some differences out 
in the land of patient protection and my hope is that those can 
be reconciled.
    I would quote here from an article from Medscape, Money, 
and Medicine, and it says that the approaches formed by IOM 
report were the basis of recommendations unveiled several years 
ago. This is an article in the year 2000. It says, ``However, 
groups are sharply split over whether health care organizations 
should be mandated to report serious or sentinel medical events 
to State agencies. Such information would be grouped together 
and submitted to a Federal agency, which would report the data 
to the public while maintaining the confidentiality of the 
patients and health care professionals involved. Data reported 
to a Federal entity would be analyzed to determine why the 
error occurred and how to reduce or eliminate the likelihood 
that such an event would be repeated.''
    Then in March of 2000, there was an editorial in, 
interestingly enough, the British Medical Journal, but it was 
co-authored by one of our witnesses today, speaking to the 
issue of medical errors, and I quote from the editorial. It 
says, ``If we can mobilize our resources and make safety our 
priority, health care can make tremendous strides in the next 
few years. Today's culture of blame and guilt too often 
shackles us. Achieving the culture we need, one of learning, 
trust, curiosity, systems thinking, and executive 
responsibility, will be immensely difficult. Harder still, we 
must now accomplish this cultural change under the spotlight of 
a newly aroused public that, given our track record,'' 
referring to the medical and hospital profession, ``it is 
understandably doubtful that health care can on its own do what 
needs to be done.''
    ``Indeed, the public's doubt in our commitment may be all 
too well founded. In truth, no other hazardous industry has 
achieved safety without substantial external pressure.'' I 
would like to repeat that. ``No other hazardous industry has 
achieved safety without substantial external pressure. Three 
decades of accumulating evidence of medical errors offers 
plenty of ammunition to those who claim that we may need to be 
forced to do what is at bottom right.''
    ``The need is obvious and the mandate is clear. Will we 
respond adequately and fast enough? Will hospitals and health 
care organizations get serious enough soon enough about patient 
safety? Will they make the changes that are needed, and will 
they be willing to hold themselves accountable for achieving 
improvements? Can we accept the legitimacy of the public's 
right to know when serious accidents occur and can we honor the 
public's legitimate expectation that we will admit our 
mistakes, investigate, and make changes necessary to prevent 
them in the future?''
    ``As we enter this new century, a key lesson from the old 
is that everyone benefits from transparency. Both the safety of 
our patients and the satisfaction of our workers require an 
open and non-punitive environment where information is freely 
shared and responsibility is broadly accepted.''
    I am afraid, Madam Chair, that by ignoring the mandatory 
portion of the IOM's recommendations for medical procedures 
that cause death or major harm, we are dancing this jig on one 
leg and that the bill may need some serious adjustment, but we 
will hear from witnesses about that as we proceed and maybe we 
can help the process through the enlightenment of these 
hearings. Thank you.
    Chairman JOHNSON. Thank you very much, Mr. Stark. I would 
like to recognize Chairman Thomas. I am delighted he has joined 
us for this important hearing, part of it, at least.
    Chairman THOMAS. Thank you very much, Madam Chairman. Thank 
you, Mr. Secretary, for being with us. Knowing that there has 
been some bipartisan movement on this, I would just react 
partially to the Ranking Member, the gentleman from California. 
I know one sure recipe for disaster, and that is to continue to 
ignore in any legislative form trying to move forward. I know 
that there are multiple Committee jurisdictions. There are 
different ways to do this. Perhaps this will need some 
additional examination as we move forward, as most legislation 
does.
    I want to compliment the Chair and this Subcommittee for 
beginning the process. It maybe is several years later than it 
should have begun, but it is beginning. I also know that there 
will be significant changes, hopefully, in the industry as they 
become more systematic and look at models that actually work 
and we may have to adjust the legislation to the realities of 
the changing work environment to produce a reduction of errors 
in the workplace, especially hospitals and other areas outside 
of hospitals. I understand there is going to be a cost, a new 
way of doing things.
    Given the information we know we have, a non-reaction is 
completely unacceptable. So, I want to underscore the fact that 
you need to begin to finish and I believe we have begun the 
process, certainly not too early, and we are open to any 
reasonable, rational, and appropriate changes, as we always 
are, in driving toward the end product, which is reducing 
medical errors and improving patient safety.
    I want to underscore the fact that the Secretary was kind 
enough to come, especially at a Subcommittee level, to give 
this a bit more impetus, because I believe although he may not 
agree the product is perfect the way it is and will have some 
suggestions as well, beginning the process is all important. I 
want to thank the Chairman for doing that, and thank you for 
allowing me to say a word. Thank you very much, Mr. Chairman.
    Mr. Secretary, it is a pleasure to have you. My apologies 
that the business of the House on the Floor delayed the 
beginning of this hearing. Welcome.

STATEMENT OF HON. TOMMY G. THOMPSON, SECRETARY, U.S. DEPARTMENT 
 OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY CAROLYN CLANCY, 
  ACTING DIRECTOR, AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

    Secretary THOMPSON. Thank you very much, Madam Chairwoman, 
and thank you so very much for holding this hearing, and the 
Ranking Member, Congressman Stark, and Chairman Thomas, and all 
Members of the Committee, it is a pleasure to be here. Madam 
Chairperson, I would like to ask your permission to introduce 
for the record a statement from Secretary Paul O'Neill of the 
U.S. Department of the Treasury who has asked me to submit it, 
and I will. I would also like to introduce Carolyn Clancy, who 
is the head of AHRQ, who is going to be able to stay on after I 
leave in order to answer any questions, if there are still 
questions after I leave.
    Chairman JOHNSON. Thank you. We will submit that statement.
    [The statement of Secretary O'Neill follows:]
 Statement of the Hon. Paul O'Neill, Secretary, U.S. Department of the 
                                Treasury

                     PATIENT SAFETY IMPROVEMENT ACT
    Today at least 100,000 Americans every year die because of medical 
errors and mistakes, despite the best efforts of the good doctors, 
nurses and hospitals in this country. The system they work in is 
broken. Everybody knows a story about a friend or relative who went 
into the hospital and had something go wrong. We can and must change 
that. We've tinkered long enough with our health care system--a band-
aid here, a cosmetic fix there. Mistakes and errors don't just cost 
money, they cost lives.
    I spent considerable time working to reform the health care 
delivery system in Pittsburgh, where I saw firsthand that it is 
possible to make systematic and far-reaching improvements in health 
care quality and safety. Every American deserves this kind of high-
quality, error free health care.
    We know from other high risk industries, such as aviation, that a 
fundamental requirement for improvement is that it must be safe to 
learn from errors. Punishment, ridicule and legal exposure drive error 
reporting underground so corrective action does not occur. Properly 
constructed health care quality and safety initiatives should be 
protected from liability. They are not now.
    Along with Secretary Thompson, our leader on national health care 
policy, I applaud the sponsors of the Patient Safety Improvement Act 
for tearing down the barriers to quality improvement so that we can 
move toward the goal of error-free health care for every American.

                                 

    Secretary THOMPSON. Members of the Subcommittee and Madam 
Chairwoman. It is always good to see you, Madam Chairwoman, and 
to thank you for your ongoing commitment and your passion and 
compassion to quality health care for all Americans. I am proud 
to be your partner in that effort.
    I am honored to appear before this very important 
Subcommittee today to discuss ways that the Federal Government 
can help reduce medical errors and improve the safety of the 
health care services that Americans receive.
    I first testified before Congress about this issue early in 
my tenure as Secretary of Health and Human Services. Reducing 
medical errors, and doing so dramatically, is a priority for 
this administration.
    In the last few years, the Department of Health and Human 
Services has developed a coordinated set of initiatives to 
identify and to reduce threats to patient safety and improve 
the quality of patient care. Yet, while these initiatives are 
important, they are, as the Chairman has already indicated, 
only a beginning.
    As we all know, the Institute of Medicine's landmark 1999 
report, ``To Err Is Human,'' alerted the Nation to the patient 
safety challenge in ways that prior studies had not. The IOM 
estimated that up to 98,000 Americans die each year as a result 
of medical errors, making such errors the eighth leading cause 
of death in the United States, as you indicated, Madam 
Chairwoman. More people die from medical errors than from 
automobile accidents, breast cancer, or AIDS. While there has 
been subsequent debate about the actual number of deaths, the 
precise number is less significant than the indisputable fact 
that the rate of medical errors is unacceptably high.
    So, for the sake of public health, much more can and must 
be done to eliminate the barriers that discourage health care 
providers from participating voluntarily and enthusiastically 
in local and regional patient safety and quality improvement 
efforts. Yet the main barrier is that professionals fear that 
if they report some event or some condition that is less than 
perfect, the report will be used to generate litigation, not 
redress or correct the problem.
    The savings generated by national malpractice litigation 
reform would help us provide a prescription drug benefit for 
seniors and help the uninsured obtain insurance. We in the Bush 
Administration are doing all we can to take those steps, and we 
will not stop until the job is done.
    One of the steps we must take is addressing your 
legislation, Madam Chairwoman. Without question, health care 
providers need assurances that if they report errors, the 
information will be used constructively, not as evidence in a 
trial. The President made this point explicit in his speech in 
my great home State medical college in Wisconsin when he said, 
and I quote, ``We actually have a system that penalizes doctors 
for trying to prevent errors and avoid complications in patient 
care, because when they discuss information about patient care, 
they put themselves or others at a risk of a lawsuit.''
    I am very pleased to say that the legislation this 
Committee is considering, legislation that you have authored, 
Madam Chairwoman, for which I thank you very deeply, represents 
an essential change in direction, taking us away from the blame 
game after there has been an injury and setting us on the more 
productive path of improving the system and preventing adverse 
events from occurring in the first place. It will do so by 
encouraging a culture of learning and constant quality 
improvement in our health care system.
    Of course, the vast majority of doctors, nurses, and other 
health care professionals are dedicated, conscientious people 
who work long hours under very difficult circumstances, and, in 
fact, health professionals are not opposed to quality 
improvement. Just the opposite, and you are going to hear about 
that this afternoon. They embrace it. As they have told all of 
us, it must be real, and it must be meaningful quality 
improvement done in a supportive and in a cooperative way. The 
legislation in this Committee meets these important principles, 
and I thank you.
    Madam Chairwoman, your legislation provides the types of 
protections that the President believes are essential to foster 
the development and the institutionalization of quality 
improvement efforts in our health care system. I commend you 
and your colleagues for your leadership in developing and, we 
hope, enacting this very important legislation.
    The proposal assures doctors and other health professionals 
that if they report information to expert Patient Safety 
Organizations, the information will be used for patient quality 
improvement efforts and will be kept confidential. This will 
encourage them to report and will greatly increase the amount 
of data available for analysis by the experts. Because they 
will receive information from more than one hospital and about 
more than one doctor, they will be able to detect patterns of 
good and bad practices that might not otherwise be noticeable 
on a single provider basis. They will be able to provide 
recommendations to local providers about system changes that 
the providers would not have been able to develop on their own. 
These new Patient Safety Organizations will promote 
collaboration and cooperation among providers on a regional 
basis. They will be proactive.
    The legislation recognizes that the new ways of addressing 
quality are needed. It focuses on system improvements, not 
attacks on the providers. It will make it easier to bring 
information about how the system works, rather than one 
provider, one doctor, or even one hospital. It will be able to 
gather information from a broad range of providers and see how 
the system works and how to improve it.
    Let me share with you one example of how detection of 
medical errors and sharing of information can bring significant 
changes when errors become much too extensive. 
Anesthesiologists have dramatically reduced the patient death 
rate from anesthesia administered during surgery, from 2 deaths 
per 10,000 anesthetics in the mid-eighties to, today, about 1 
death for every 200,000 to 300,000 anesthetics administered 
today. How did they do it?
    First, they acknowledged that a problem existed in the way 
the equipment was being used. They shared that information, and 
it changed the way anesthesiology was practiced. They 
standardized anesthesia machines to ensure consistency in the 
delivery of the drugs and also addressed issues of fatigue and 
sleep deprivation, changes in training, and competing 
institutional priorities.
    Anesthesiologists have shown us what can be done by using 
the example in your legislation, Madam Chairwoman. It is a 
combination of technology, work processes, human factors, 
institutional culture, and the working environment.
    The bill is forward-looking and proactive. The Patient 
Safety Organizations will be able to examine processes and look 
at outcomes at various institutions and make suggestions for 
improvements. The measure recognizes the value of local and 
private quality efforts. Doctors and hospitals will be able to 
work together with local Patient Safety Organizations to 
identify problems and experiment with different ways of 
improving care.
    Madam Chairwoman, your bill also complements existing HHS 
patient safety activities and, in turn, will help us to guide 
our ongoing technical assistance to private sector initiatives 
in the Patient Safety Organizations. Included in these efforts 
is our Patient Safety Task Force, which brings together the 
Centers for Disease Control and Prevention, the Centers for 
Medicare and Medicaid Services, and the Food and Drug 
Administration (FDA), along with our lead research agency on 
patient safety, the Agency for Healthcare Research and Quality.
    One of our initiatives which has been undertaken by the FDA 
includes our partnering with the private sector to develop new 
technologies, such as bar coding medications. That will produce 
electronic prescription programs that can be introduced widely 
and help diminish the number of medication errors. Bar coding 
is so simple. Grocery stores use it all the time. We are 
funding now the research to apply bar coding technology to the 
way that patient information is stored and reviewed and the way 
medications are dispensed. This is going to save money, and 
much more importantly, is going to save lives.
    In total, the FDA is receiving $5 million in new funding 
for patient safety, bringing its total funding for this issue 
to $22 million. The new funds will allow the agency to improve 
its ability to assess and follow up on reports of adverse 
events that occur after the use of FDA-regulated products.
    An important goal of the Task Force is to simplify the 
reporting of patient safety data to our agencies. The current 
system is unnecessarily burdensome. The same adverse event 
often needs to be reported in different ways, on separate 
forms, to different HHS components, and those who report the 
data never learn whether it is useful. The Patient Safety Task 
Force will replace this cumbersome system, providing a new 
streamlined system that uses new technologies to help collect 
and analyze incoming data.
    Our funding request also reflects our personal commitment. 
Included in AHRQ's fiscal year 2003 budget submission is a 
request for $2 million to launch a Patient Safety Improvement 
Corps, experts now who will work with State health departments 
and health care institutions to expand State and local capacity 
to use existing knowledge to identify and eliminate threats to 
patient safety.
    So, Madam Chairwoman, I look forward to working with you 
and all the Members on this Subcommittee on this legislation 
because it is not some matter of arcane public policy or some 
set of rules only an actuary could love. It is about saving 
lives, nothing more, nothing less, and that is worth our time, 
our energy, and our commitment.
    I would be more than happy to answer any questions that you 
or Members of the Subcommittee might have, and I thank you very 
much again, Madam Chairwoman and Members, for having me here 
and holding this hearing on this very important subject.
    [The prepared statement of Secretary Thompson follows:]
Statement of the Hon. Tommy G. Thompson, Secretary, U.S. Department of 
                       Health and Human Services
    Good morning, Madam Chairwoman and members of the Subcommittee. I 
am honored to appear before you today to discuss ways the Federal 
government can help reduce medical errors and improve the safety of the 
health care services that Americans receive.
    In the last few years the Department of Health and Human Services 
(HHS) has developed a coordinated set of initiatives to identify and 
reduce threats to patient safety and improve the quality of patient 
care. While these initiatives are important, they are only a beginning.
    President Bush and I recognize that significant progress will only 
be achieved when the talents and energies of health professionals are 
fully engaged in improving the quality of care. We have been heartened 
by the recent emergence of several notable private sector patient 
safety initiatives. But much more needs to be done--and can be done--to 
eliminate the barriers that discourage health care providers from 
participating, voluntarily and enthusiastically, in local and regional 
patient safety and quality improvement efforts.
    The main barrier, of course, is the fear professionals have that if 
they report some event or some condition that is less than perfect, 
their report will be used to stir up litigation rather than the fix the 
problem. They need assurances that if they report, the information will 
be used constructively, not destructively. The President made this 
point explicitly in his speech at the Medical College of Wisconsin, in 
Milwaukee, when he said, ``We actually have a system that penalizes 
doctors for trying to prevent errors and avoid complications in patient 
care,'' because when they discuss information about patient care they 
put themselves, or others, at risk of a lawsuit. As the President said, 
``This doesn't make much sense. These good faith efforts do not deserve 
the punishment of a lawsuit.'' He called on Congress to remedy this 
situation.
    I am pleased to say that the legislation this Committee is 
considering represents the change in direction that the President 
called for and that is essential to improving quality of care in this 
country. It will take us away from the blame game played after there 
has been an injury and will set us on the more productive path of 
working together to improve the system and to prevent adverse events 
from occurring in the first place, by encouraging a culture of learning 
and constant quality improvement in our health care system.
    The vast majority of doctors, nurses, and other health care 
professionals are dedicated, conscientious people who work long hours 
under very difficult circumstances. They are there when we need them. 
They would be a critical part of our front-line defense in the event of 
a bio-terrorism attack. They are heroes. And we should recognize this, 
to them and to ourselves. We should support, not attack them.
    Health professionals are not opposed to quality improvement. Just 
the opposite; they embrace it. We should support their efforts to 
improve quality. But it must be real and meaningful quality 
improvement, done in a supportive and cooperative way. The legislation 
this Committee proposes meets these important principles.
    Madam Chairwoman, your legislation provides the types of 
protections that the President believes are essential to foster the 
development and institutionalization of quality improvement efforts in 
our health care system. I commend you, and your colleagues, for your 
leadership in developing, and, we hope, moving this important 
legislation.
The Patient Safety Challenge
    The Institute of Medicine's (IOM) landmark 1999 report, To Err is 
Human, alerted the nation to the patient safety challenge in ways that 
prior studies had not. The IOM estimated that between 44,000 and 98,000 
Americans die each year as a result of medical errors, making them the 
eighth leading cause of death in the United States. More people die 
from medical errors than from automobile accidents, breast cancer, or 
AIDS. While there has been subsequent debate about the actual number of 
deaths, it is clear that the rate of medical errors is unacceptably 
high.
    I would like to highlight four of the IOM conclusions that are 
particularly relevant to today's hearing. First, the elimination of 
medical errors will not be accomplished by attempting to identify and 
discipline the ``bad apples''. The IOM report concludes that errors are 
not solely the fault of individual doctors, nurses, and other 
clinicians; they are often ``a failure in the process of delivering 
care in a complex delivery system.'' System failures result from a 
complex interaction of people, technology, work processes, and working 
conditions, but few health care providers have expertise in the 
identification and analysis of contributors to system failures.
    Second, the IOM report cautions that if a patient experiences an 
adverse event during the process of care, this does not necessarily 
mean that a medical error has occurred. Most medical care entails some 
level of risk, and there can be complications or side effects, even 
unforeseen ones, from the underlying condition or from the treatment 
itself. We should not equate problem outcomes with bad practice, but, 
rather, we should strive to differentiate one from the other.
    Third, the IOM concluded that much can be learned from the analysis 
of errors--from errors that result in serious patient injury or death 
as well as from errors that result in little or no patient injury, but 
which, when aggregated, can help identify patterns of system failures. 
To foster such analyses, the IOM urged health care organizations to 
implement non-punitive systems for reporting and analyzing errors 
within their organizations and encouraged the development of voluntary 
reporting systems.
    Fourth, the IOM concluded that health care providers need to be 
assured that if they report errors that are necessary to detect system 
problems, these reports will be used for that purpose in a culture of 
safety rather than unproductively as grist for the litigation mill. As 
the IOM report reminds us:

        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. Most 
        errors and safety issues go undetected and unreported, both 
        externally and within health care organizations.

    The failure to report errors hampers quality improvement efforts 
and threatens the quality of care for us. It also blocks our best 
efforts to improve the quality of health care information systems. If 
providers are reluctant to keep track of the information required to 
improve the quality and safety of health care delivery for fear of 
lawsuits, health care providers will continue to lag behind in 
electronic information systems, despite all our work to develop 
effective standards and support for 21st century medical information 
systems. The IOM urged Congress to guaranty the confidentiality of data 
related to patient safety and quality improvement.
Proposed Substitute for HR 4889
    Madam Chairwoman, the Administration supports your efforts to pass 
your proposed substitute for HR 4889, and enact legislation to remove 
the liability barriers to improving quality and safety of health care 
during this session of Congress. Your proposal appropriately responds 
to the IOM recommendations and advances the Administration's goal of 
facilitating health care professionals' ability to improve the quality 
of our health care.
    The proposal assures doctors and other health professionals that if 
they report information to expert Patient Safety Organizations (PSOs), 
that information will be used for patient quality improvement efforts 
and will be kept confidential. This will encourage them to report, and 
will greatly increase the amount of data available for analysis by 
experts. Because the PSOs will receive information about more than one 
hospital and about more than one doctor, they will be able to detect 
patterns of good and bad practices that might not otherwise be 
noticeable on a single provider basis. They will be able to provide 
recommendations to local providers about system changes that the 
providers would not have been able to develop on their own. These new 
Patient Safety Organizations will promote collaboration and cooperation 
among providers on a regional basis. They will be proactive.
    The legislation recognizes that new ways of addressing quality are 
needed. If we have too many deaths and injuries from medical care now, 
the current system--based on finding fault with individual providers--
must not be working. The bill changes the focus along the lines 
outlined by the President, and sets the new direction he identified. 
There are four important elements of the bill that start us down a new 
and better path.
    First, the legislation focuses on system improvement. Rather than 
focusing on finding individual ``bad actors,'' it recognizes the fact 
that health care is delivered a part of a system. No person, not even a 
doctor, is perfect. But by looking at the system in which care is 
delivered, we can provide protection against human frailties. The role 
of the individual provider is critical, but systems can help providers, 
give them more information, and warn them about possible mistakes. The 
legislation will help identify system failures by enabling PSOs to 
examine a wide range and large number of providers. It will make it 
easier to bring information about how the system works, rather than 
reviewing the practices of one doctor or even one hospital. It will be 
able to gather information from a broad range of providers and see how 
the system works.
    Second, the legislation is forward looking and proactive. The 
Patient Safety Organizations will be able to examine processes and look 
at outcomes at various institutions, and make suggestions for 
improvements. Rather than focusing only on adverse events that have 
occurred, they will proactively identify better ways of delivering 
care.
    Third, it is pragmatic. It takes the common sense approach that the 
way to improve quality is to identify problems and make improvements. 
Instead of playing the blame game and litigating against our doctors 
for particular events that may or may not represent malpractice, the 
legislation recognizes the importance of preventing the adverse event 
from occurring in the first place.
    It recognizes that more must be done to improve quality and safety. 
The Administration fully supports effective enforcement programs based 
on available data to identify ``bad actors'' and remove them from 
medical practice. Information from medical records and other existing 
data sources will continue to be available for plaintiffs who are 
injured negligently as a result of medical errors. What is desperately 
needed, however, is new information to help prevent errors in the first 
place. And that is what this bill will provide.
    Finally, the bill recognizes the value of local and private quality 
efforts. We cannot improve quality by imposing solutions from 
Washington. There is often no one right way, and if there were, 
Washington might be the last to know about it. The best way to improve 
quality is to integrate it in the thoughts and processes and habits of 
the people who actually deliver care. Doctors and hospitals will be 
able to work together with local Patient Safety Organizations to 
identify problems and experiment with different ways of improving care.
Current HHS Activities
    Madam Chairwoman, your bill also complements existing HHS patient 
safety activities and, in turn, will help to guide our ongoing 
technical assistance to private sector initiatives, including the new 
Patient Safety Organizations.
    One of my major management initiatives at HHS has been to foster 
better coordination and integration of related activities that cross 
agency lines so that we can speak as ``one Department.'' And we are 
here today as one Department, with the Centers for Medicare and 
Medicaid Services joining the Agency for Healthcare Research and 
Quality in supporting this legislation.
    I am delighted to report that patient safety is an exemplary model 
of inter-agency coordination. We have created a Patient Safety Task 
Force that brings together three agencies with regulatory and data 
collection responsibilities--the Centers for Disease Control and 
Prevention, the Centers for Medicare and Medicaid Services, and the 
Food and Drug Administration--and our lead research agency on patient 
safety, the Agency for Healthcare Research and Quality. An important 
goal of the Task Force is to simplify the reporting of patient safety 
data to HHS agencies. The current system is unnecessarily burdensome. 
The same adverse event often needs to be reported in different ways on 
separate forms to different HHS components, and those who report the 
data never learn whether it was useful.
    The Patient Safety Task Force will replace this cumbersome system 
in two ways. At the front end, it is creating a single computer 
interface and standardizing the required information so that those who 
are required to report this information will only have to enter the 
data once and will only be asked to report data that will be helpful 
for patient safety analyses; the computer systems will then route the 
information to the appropriate HHS components. At the back end, the 
Task Force wants to ensure that we close the ``reporting loop'' by 
ensuring that the data are integrated and analyzed and that the non-
identifiable data maintained by AHRQ and the results of its research 
can be searched in real time by those reporting the data. Patient 
safety improvement can only be a true public-private sector 
collaboration if those who report information also benefit from its 
analysis. Our experience in streamlining the reporting and analysis of 
data will be helpful as AHRQ provides technical assistance to the 
Patient Safety Organizations created by your bill.
    Let me now turn to specific initiatives at these agencies. With $55 
million in dedicated funding in FY 2002 and a request of $60 million 
for FY 2003, AHRQ is now the leading funder of patient safety research 
in the world. Its current research portfolio includes 5 large 
initiatives, including support for 24 demonstration projects related to 
the collection, analysis, and use of patient safety data; 22 projects 
developing and testing state-of-the-art clinical informatics 
applications; 8 projects related to working conditions (such as 
fatigue, stress, and sleep deprivation); 23 projects fostering 
innovative approaches to improving patient safety; and 7 projects to 
develop, demonstrate, and evaluate new approaches to improving provider 
education related to patient safety. In addition, AHRQ will soon 
receive a report from the IOM on structured approaches for reporting 
patient safety data. That report, and the ongoing results of these and 
future research projects, will be shared with Patient Safety 
Organizations as they become operational.
    AHRQ's FY 2003 budget submission requests $2 million to launch a 
Patient Safety Improvement Corps, experts who will work with State 
health departments and health care institutions to expand State and 
local capacity to use existing knowledge to identify and eliminate 
threats to patient safety. In recognition of the dearth of expertise in 
patient safety analysis, AHRQ will work with Patient Safety 
Organizations in the development of the Corps and will work to leverage 
existing Federal expertise across the government to ensure that these 
private sector initiatives can become operational as soon as possible.
    As you can see, AHRQ is well positioned to carry out its proposed 
statutory role as a ``science partner'' for Patient Safety 
Organizations. AHRQ sees the potential for tremendous synergy between 
the activities of Patient Safety Organizations and its ongoing national 
research. Moreover, the agency has already seen tremendous public and 
private sector interest--from States, health care institutions, health 
plans, and providers--in participating in such initiatives, if only 
protections of the type proposed in this bill can be provided for 
patient safety data. As a result, this legislation will greatly enhance 
AHRQ's ability to carry out its patient safety mission.
    The Centers for Disease Control and Prevention (CDC) is pursuing a 
number of patient safety initiatives, including the National Electronic 
Disease Surveillance System (NEDSS). NEDSS will electronically link 
data collected by private-sector health care organizations and public 
health departments. It can serve as a model for how to increase 
efficiency, volume, accuracy, completeness and timeliness of reporting 
and exchanging information. In FY 2000, CDC provided funding for 14 
States to develop NEDSS systems. CDC has also provided funding for 32 
States and three large metropolitan areas to assess their current 
health information systems and to determine how they can implement 
NEDSS specifications and standards. The FY 2003 budget request and the 
2002 enacted level include $2 million for CDC to collect more 
information on hospital-acquired infections.
    The Food and Drug Administration (FDA) also has several initiatives 
underway to improve patient safety. For example, the FY 2003 budget 
includes an increase of $5 million above the $17 million provided in FY 
2002 for the FDA to improve the collection and analysis of adverse 
event data, and to ensure that response to findings is timely and well 
communicated. FDA is working to improve labeling and packaging 
standards to reduce the chances of clinicians confusing drugs with 
similar names or making dosage errors, both of which can lead to 
adverse interactions between drugs. In addition, for biological 
products the FDA is requiring all establishments to report any event 
associated with biologics that were distributed by the manufacturer, 
including blood, blood components, and source plasma, that represents a 
deviation in manufacturing. FDA is also piloting a program of active 
collaboration with community medical programs to collect information 
about product safety that will supplement information from spontaneous 
reporting systems. And the FDA is developing a regulation to reduce 
drug administration errors by having bar coding technology apply to the 
administration of drugs.
    Further, as you are aware, the Centers for Medicare and Medicaid 
Services (CMS) already contracts with Quality Improvement Organizations 
(QIOs), formerly known as Peer Review Organizations (PROs), in each 
State to improve the quality of care and reduce errors through the 
collegial dissemination of best practices. They are accomplishing this 
in a number of ways, most of which are specified in our contract with 
the QIO. For example, CMS and the QIOs are working to improve clinical 
health outcomes of Medicare Beneficiaries and to prevent clinical 
disorders in a variety of health care settings. For instance, QIOs work 
with nursing homes in their states using the publicly reported Minimum 
Data Sets quality of care measures developed by CMS. QIOs also provide 
information to Medicare beneficiaries and their families, which can be 
used for selecting nursing homes, improving nursing home care, and 
obtaining a better understanding about nursing home care. Likewise, 
QIOs are working with home health agencies in their states, using the 
publicly reported OASIS quality of care measures developed by CMS. As 
with nursing homes, the QIOs provide information to Medicare 
beneficiaries and their families. QIOs also are continuing work with 
hospitals to reduce medication and other system failures related to 
acute myocardial infarction, heart failure, and pneumonia, and are 
adding a new clinical area focus, the prevention of surgical infection. 
The QIOs also focus some of their efforts on Critical Access Hospitals. 
Furthermore, in physician offices, QIOs are continuing work in the 
areas of care for chronic diseases like diabetes and preventative 
services like mammography and adult immunizations for flu and 
pneumonia. In addition to these various clinical settings, QIOs are 
focusing on different populations. They will continue work to eliminate 
health disparities between certain medically underserved populations 
and the general population. We also have added rural beneficiaries to 
the list of the groups eligible for these projects. And QIOs will 
continue work to ensure that Medicare+Choice Organizations are part of 
CMS' overall efforts to improve health outcomes and enrollee 
satisfaction for beneficiaries enrolled in a Medicare+Choice 
Organization.
    In addition to clinical quality improvement, QIOs are helping to 
improve patient safety and health through helpful information and 
effective communication. The QIOs play an active role in communicating 
publicly reported nursing home and home health agency quality of care 
measures; and provide assistance to providers and beneficiaries in 
their states in interpreting and using this information. Additionally, 
through coordination with JCAHO, the QIOs are assisting hospitals in 
their states in developing the infrastructure and tools to permit 
electronic self-reporting of quality of care measures. The QIOs also 
are continuing to conduct those communication activities required by 
law, such as preparing an annual report and providing beneficiary and 
provider information. Additionally, QIOs are establishing a Consumer 
Advisory Council to advise them regarding consumer-oriented activities.
    QIOs are also dedicated to improving beneficiary safety through 
Medicare beneficiary protection activities. The QIOs continue to 
provide review and beneficiary complaint responses as required by law 
and regulations. Additionally, the QIOs have implemented a new element 
of the beneficiary complaint response program utilizing the mediation 
process to supplement the more formal complaint review procedures. 
Moreover, a Payment Error Prevention Program has been revamped and 
included in the QIOs statement of work. Under the Hospital Payment 
Monitoring Review Program, the QIOs will continue to review medical 
records for coding and medical necessity in order to estimate national 
and statewide payment error rates for inpatient PPS services. Finally, 
CMS uses special studies to direct the QIOs to perform work or special 
projects that are not identified in the other tasks, but fall within 
the scope of our contract with them.
Patient Safety Coordination Beyond the Department
    Madam Chairwoman, I also want to note that my interest in improving 
the coordination of patient safety activities extends beyond my own 
Department. I recognize that other Departments have a strong interest 
and activities in patient safety, and it is critical that we not work 
at cross purposes. We are using the existing Quality Interagency 
Coordination (QuIC) Task Force, which includes all Departments, 
agencies, and entities with an interest in improving the quality of 
patient care, to coordinate the overall Federal response to the IOM's 
report on medical errors. The QuIC has held a national summit to set 
the agenda on patient safety research, initiated a breakthrough series 
with the Institute for Healthcare Improvement to foster improvements in 
high-risk settings in health care facilities that the Federal 
government manages, and helped produce materials for dissemination to 
the public on steps that people can take to prevent medical errors from 
happening to them.
    We are also working with other nations to leverage our resources 
and share our knowledge. On October 10, 2001, the Secretary of State 
for Health in the United Kingdom (UK), Alan Milburn, and I signed a 
cooperative agreement to support collaborative activities in quality 
improvement and patient safety. Already there have been positive 
activities between the United States (US) and the UK in the areas of 
adverse event reporting and patient safety research. We are working 
closely with the newly formed National Patient Safety Agency (NPSA) in 
the UK to standardize reporting formats and coordinate our research 
agendas. As I speak, UK and US patient safety researchers are meeting 
today to explore common research methods for patient safety.
Conclusion
    Madam Chairwoman, I look forward to working with you on this 
legislation and would like to convey, once again, the President's 
appreciation for your leadership in this area. I would be happy to 
answer any questions that you may have. Thank you.

                                 

    Chairman JOHNSON. Thank you very much, Secretary Thompson. 
I would like to just highlight, and then I will move to Members 
for questions, a couple of statements in your written 
testimony. These statements enlarge on the point that you have 
made very well, and that is that the point of an errors 
reporting system is system change, and you get system change 
only through a deep knowledge of lots of little things that are 
happening.
    You say in your testimony that errors that result in little 
or no patient injury can be aggregated to help identify 
patterns of system failure. It is not just errors that result 
in death or injury that can help you improve the quality of the 
health care system. It is all those little miscellaneous things 
that people observe and see. Some of them are not even actions 
taken. They are just thoughts about how actions could be better 
taken or possibilities avoided, as in the case of the 
anesthesiologist.
    You also say the best way to improve quality is to 
integrate quality in the thoughts, processes, and habits of the 
people who actually deliver care. I think those statements are 
extremely important. You cannot integrate quality into people's 
thoughts and actions if at the same time half their mind is 
compelled by fear.
    So, the underlying issue in this bill is to put in place a 
system that can use all those little perceptions and 
experiences of the actual online, frontline care givers who 
provide health care to Americans. These people use from their 
observations and experience, whether injury is involved, 
whether death is involved, or whether nothing like that is 
involved, their knowledge and experience to improve the systems 
and the environment of safety in our institutions. So, I thank 
you for your testimony and I am going to turn to Members. Mr. 
Chairman, would you like to question?
    Chairman THOMAS. No.
    Chairman JOHNSON. Mr. Stark, would you like to question?
    Mr. STARK. Thanks. Governor, welcome again. Just a couple 
of items here. One, it is my understanding that you or the 
Department is about to receive a National Quality Forum (NQF) 
report sometime this year and that they, I have also been 
informed, will have perhaps approximately 35 precise steps that 
should be taken to reduce medical errors, and this is a result 
of a study that has gone on for some time where it has taken 
patient safety information and reports from hospitals around 
the country.
    Would it not be a good idea for us to not only receive that 
report, but the other reports that you are spending $55 million 
on to see if we can focus not just on the voluntary side, 
because in your testimony, you do indicate that the IOM 
suggests voluntary reporting, but whoever typed your statement 
left out the other part of what IOM recommends and that is the 
mandatory reporting system on the sentinel events that they 
also feel should be part of a system.
    So, my sense is that what we are discussing here today is 
only half a loaf and your Department has a tremendous amount of 
information that could be used in cooperation. It is my 
understanding we have had no meetings with your staff to kind 
of coordinate where we are. I think we have learned a 
tremendous amount since the report in 1999 and all that this 
bill seems to do is release the hospitals from any liability, 
but we are not going forward. For example, we know, and you 
know, Mr. Secretary, I believe, that computerized prescribing 
will save lives.
    Secretary THOMPSON. Absolutely. I brought it up.
    Mr. STARK. I think we also know that requiring, and the 
only way we could do that is through a Federal law, the use of 
safe needles, which is going to reduce medical accidents. I 
think we also know, and we have got about 90 or 100 Members of 
Congress who subscribe that reducing mandatory overtime for 
professionals like nurses will have them making their rounds 
when they are not too tired to perform, and that could reduce 
errors.
    So, there are a lot of things that we all know can help. In 
some cases, they may be worth mandating. We do that. You know, 
we would not have air bags in cars if we did not mandate them. 
If we waited for the auto industry to do it, you and I would 
still be wondering about that.
    So, what I guess I am saying is, could we not come together 
with the information that you have that you are about to 
receive and broaden the scope of this to really come up with a 
Federal policy that would not hurt the States, who some States 
are ahead of us.
    Secretary THOMPSON. That is right.
    Mr. STARK. Some States have a combination, and some are 
having trouble. I would hate to forestall that or preempt it by 
doing really too little. So, I guess my question is, would it 
not be a good idea for us to wait and work together to bring 
all of the research that--and I am not talking a long time, I 
am talking a couple of months and you are going to have this 
information, and then we could pick and sort and decides what 
needs legislation, what you can do administratively, and expand 
on the Chairman's initial step in this direction.
    Secretary THOMPSON. Thank you, Congressman. I would like to 
respond by first thanking you for your interest in the subject, 
Congressman Stark, and secondly to tell you that you know 
quality improvement is not a static event. It is going to be an 
ongoing thing, and no matter what we do today, we are going to 
have to continue to address it in the future.
    I am a big believer in accumulating the data and then 
acting, but AHRQ has been working on this under John Eisenberg, 
under his late leadership, which had been exemplary.
    Mr. STARK. Right.
    Secretary THOMPSON. I have worked with him on many things. 
This is a cause celebre for AHRQ and for the Department. We 
want to move, and we think that this is a giant step forward, 
Congressman Stark, and that is why we think the Congress should 
act.
    We think that this proposal is a step in the right 
direction. There are going to be further steps, as you have 
indicated. A lot of the steps you have indicated, I could 
strongly support and believe that Congress should act in the 
future. This one, I do not think we should delay taking action 
on this one because I think it is so important. I think it 
needs to be done and this is a first step.
    Second, bar coding is something that we need to do. Grocery 
stores have it. Why do we not have it in the hospitals and 
clinics?
    Third, I would strongly suggest we take some of the fraud 
and abuse money and put it into a mini-Hill-Burton law for use 
for new technology for doctors and clinics. We would be able to 
solve a lot of the problems if we did that.
    There are so many things out there, but as you know much 
more so than I do, Congressman Stark, that at the end of the 
session, you try and get as much done as possible. I think this 
is doable. I think we should do it. It is a good step, and I 
would like to urge your support, Congressman.
    Mr. STARK. Do you think that there is any danger that this 
bill could preempt the States that now have mandatory reporting 
and frustrate their efforts to do that?
    Secretary THOMPSON. I do not, because 44 States right now 
across the country, including my home State of Wisconsin and 
your State of California and your former home State of 
Wisconsin, have peer review. This is an extension of peer 
review, because in most of those 44 States, they have put into 
the law that the peer review conference in the work product is 
not admissible into court. Not every one of them is the same, 
but the City of Washington, DC, probably has got the best law 
on the books in regards to that.
    So, I do not think it would in any way deter what the 
States are doing. In fact, I think it would encourage States to 
adopt further progress in quality improvement. We need it. We 
need quality improvement, especially in the health care field, 
and I think with technology and with the Patient Safety 
Organizations, we are going well down that road to helping to 
improve it and that is what I would strongly urge this Congress 
to take.
    Mr. STARK. You would have no objection to States that 
require, in addition, mandatory reporting, in addition to 
whatever we do?
    Secretary THOMPSON. I have none whatsoever. I am a big 
States' righter and if they want to do it, fine with them.
    Chairman JOHNSON. Mr. Crane?
    Mr. CRANE. Thank you, Madam Chairman. Mr. Secretary, in 
your testimony, you state that Quality Improvement 
Organizations (QIO) in each State are currently working to 
improve the quality of care and reduce errors through the 
collegial dissemination of best practices. What interaction 
would the Quality Improvement Organizations have with the PSOs, 
and how would the QIOs interpret and use the data collected by 
the PSOs?
    Secretary THOMPSON. I think they can work very 
collaboratively, Congressman Crane, and they could be 
synergistically connected. I think that Patient Safety 
Organizations are going to be much broader and are going to 
allow for much more systemic changes in the delivery of the 
medical system and improvement of quality.
    What is happening at the State level is more a collegial 
peer review kind of thing, and I believe that Quality 
Improvement Organizations are also of that category. The 
Patient Safety Organizations are going to be, I think, much 
broader and are going to allow for us to look at much more 
regional operations and hospitals and doctors and find out, you 
know, maybe small mistakes that, accumulated, could be changed 
and you could really have an impact on the system, like the 
anesthesiologists did.
    They found that in half the hospitals--I do not know if 
half, but a good share of the hospitals, you turn the nozzles 
one way to get the anesthesia out, and in other hospitals, they 
turn the other way, causing a lot of mistakes. They looked at 
it, and they examined it, and in standardizing it, they now 
have been able to reduce the number of deaths from 1 out of 
10,000 to 20,000 to now 1 out of 200,000 to 300,000. So, it is 
a tremendous improvement. We think we can do the same way with 
this legislation.
    Mr. CRANE. Quality Improvement Organizations might use the 
data collected by Patient Safety Organizations to inform 
Medicare beneficiaries of the level of care provided in certain 
areas without establishing best practice guidelines, is that 
not correct?
    Secretary THOMPSON. Well, that is entirely correct, but we 
just hope the latter is that they will develop best practices. 
This is the reason we are going to, because we think that this 
legislation is going to encourage best practices. We think that 
by setting this up and allowing this regional collection of 
data and being able to solve, hopefully, the problems, that 
this is going to establish standards that will create best 
practices, and that is what we are hoping is going to be the 
net result of this legislation.
    Mr. CRANE. That is the hope of all of us and best of luck 
to you.
    Secretary THOMPSON. I know it is.
    Mr. CRANE. Thank you.
    Secretary THOMPSON. Thank you, Congressman Crane.
    Chairman JOHNSON. Mr. English?
    Mr. ENGLISH. Thank you, Madam Chair, and thank you, Mr. 
Secretary, for taking on what I think is a very difficult issue 
and testifying on behalf of what I think has been a very fine 
bill that the Chairman has spent a lot of time on and has 
produced.
    I wonder with regard, as we try to create this regime to 
deal with the problem of medical errors, how important is it to 
have standards that are flexible enough to allow for new 
innovations in health care that are workable in a variety of 
settings, and do you feel that this bill meets that standard?
    Secretary THOMPSON. We do, and to answer your second 
question first, we do believe it does. Second, we believe that 
standards should be flexible enough to allow for new 
innovations.
    You, Congressman English, have been a leader in innovations 
in the medical field for as long as you have been in Congress 
and I applaud you for that. The only way you move ahead, 
especially in the delivery of health care systems, is by 
innovating. With the changing technology and the changing 
science out there, you have to allow for that. The embryonic 
stem cells, the research that is going to come out of that, is 
going to be something that is going to, hopefully, provide for 
new therapies, and you have got to provide for that. There is 
new technology out there that is going to help to deliver and, 
hopefully, save the medical delivery system in America. It is 
going to have to be allowed to be able to be modified and 
changed and improved, all of these things.
    So, you want to make sure that the standards are there, but 
also to allow for the flexibility to provide for innovation. 
That is what this country is all about, and especially in the 
field of medicine, which everybody is looking for the new 
therapy, the new drug, the new technology that is going to help 
cure the maladies and also improve the safety of patients.
    Mr. ENGLISH. Thank you, Mr. Secretary. Madam Chair, I will 
yield back the balance of my time.
    Chairman JOHNSON. Thank you, Mr. English. Mr. McDermott?
    Mr. MCDERMOTT. Thank you, Madam Chair. I come at this with 
sort of a personal feeling about it, having worked in the days 
when you worked 36 hours on and 12 off. I have some feeling 
about medical errors and what may bring it about. One of the 
reasons I think this bill of nursing is one of those things we 
could do, I think mandatory overtime ought to be something that 
we prohibit.
    I go beyond that. I have also worked on Peer Review 
Organizations (PRO). I have gone into hospitals all over 
Washington State and I discovered the best way to figure out 
who the bad doctors were was to go down and talk to the head 
nurse in the operating room and she could tell you in about 2 
minutes what was going on in that hospital. The PROs and that 
whole operation was an attempt.
    We in Washington State now have a situation of mandatory 
reporting of major mistakes that have caused death or major 
problems, and that is still discoverable in a lawsuit. One of 
the things, I am not clear on what you are saying. I do not 
think you want anything to be discoverable, and in some way, we 
have got to solve that problem, because if there has been an 
accident or an injury or some kind of problem in the hospital, 
someone has a right to have reimbursement or to have a 
settlement----
    Secretary THOMPSON. Sure.
    Mr. MCDERMOTT. So, you have got to be able to get the data, 
but if somebody says, well, this has been reported as an 
incident in our voluntary system, it is exempted by Federal law 
from being discovered, you prohibit the resolution of a case, 
it seems to me.
    I am sure you have thought of it, and I do not want you in 
a Federal law to override what we have set up in the State of 
Washington. You said it will not preempt the State of 
Washington. I am not sure if that is correct.
    Secretary THOMPSON. That depends upon how the law is 
written.
    Mr. MCDERMOTT. Yes, I understand, but I think it is one of 
those issues we have to clarify. The larger question is, if you 
make it all voluntary and then protect it with secrecy--the IOM 
did not suggest that. They said reportable incidents are 
protected, but when it comes to a death or more serious--they 
sort of distinguish between significant events and near-misses. 
Explain to me how, if you protect it all by Federal law, any of 
it is ever going to be discovered, if you treat it simply as an 
issue of improvement of care.
    Secretary THOMPSON. You have thrown out several things. If 
I could try and respond to several of them, I will try, 
Congressman.
    Mr. MCDERMOTT. I am sorry if my question was unclear. I am 
not a lawyer.
    [Laughter.]
    Secretary THOMPSON. First off, in regards to nursing, I 
think that we have to do a heck of a lot more to encourage 
young people to go into the nursing and all health fields, and 
I thank you for your leadership and all of the Congresspeople 
in regards to the bipartisan legislation in nursing 
improvements. It was well thought out, it was well executed, 
and I appreciate it.
    Mr. MCDERMOTT. Would you mind if it was part of this 
legislation?
    Secretary THOMPSON. Pardon?
    Mr. MCDERMOTT. Would you mind if we made this as an 
amendment to this legislation, the prohibiting of mandatory 
overtime?
    Secretary THOMPSON. That is not for me to say, sir. I am 
talking about the nursing professions, encouraging people to 
get into it and the funding of nurses to go into teaching.
    Mr. MCDERMOTT. Okay.
    Secretary THOMPSON. Second, in regards to the litigation, 
there is nothing in this proposal that would prevent anything 
being discovered that is discoverable today. It is only the 
extension, only the material that goes to the PSOs would not be 
discoverable.
    If, in fact, there is an underlying record that could be 
subpoenaed into court, you could still subpoena the nurse who 
is at the hospital. You could still subpoena the doctor and 
take depositions of those individuals. That is all 
discoverable. Nothing in this legislation would prevent 
anything that takes place currently in a Federal lawsuit to not 
be permitted. Only the extra step, the step of quality 
improvement, the step from getting the information collected 
from the incidents and from the various hospitals, that would 
be privileged and that would not be discoverable.
    Mr. MCDERMOTT. If that is true, why not make it mandatory 
that it be done? I understand that you do not like--I 
understand the philosophy of government that does not like to 
make the government force people to do things, but it seems to 
me in this issue that if you make it mandatory, since it is 
still discoverable and people are protected on that side, I do 
not see why anybody would not want to have that information 
gathered for hospitals to look at their system and discover a 
more good way for the patients.
    Secretary THOMPSON. I am fairly certain, Congressman, that 
once you start this, that is going to be the normal course of 
business, that even without requiring mandatory, it is going to 
be considered as a good health field, good health process to be 
able to do this, and I think you are going to encourage more to 
get started in this. I think that is what the Chairperson is 
looking for, is to get more buy-in. By doing it voluntary, I 
think you are getting a lot more initial buy-in, and then by 
that time, I think it is just going to be a normal course of 
business, and everybody is going to do it.
    Mr. MCDERMOTT. I wish I had your faith.
    Secretary THOMPSON. I am an Irishman, Congressman. I am 
very optimistic. I only wish you were as optimistic as I was, 
sir.
    [Laughter.]
    Mr. MCDERMOTT. I yield back the balance of my time.
    Chairman JOHNSON. Thank you. Congresswoman Thurman?
    Mrs. THURMAN. Thank you, Madam Chairman. Thank you for 
having this hearing today. I know that we have worked hard to 
try to come up with a piece of legislation and move it along. 
In saying that, I do think that there have been some issues 
that we have raised and certainly some that Mr. McDermott just 
questioned and talked about were of some concerns to us. In 
saying that, and I do not know if, Mr. Secretary, you have seen 
the letter from the National Academy for State Health Policy--
--
    Secretary THOMPSON. I do not think I have.
    Mrs. THURMAN. I will make sure you get a copy of this, 
because it is somewhat alarming to me. We have 20 States now, I 
believe, that are already doing a mandatory reporting system, 
and what they say here is that we actually, or IOM went out and 
said to these States, you need to do this. We have asked you to 
do this, and we particularly are concerned about collecting and 
standardizing information about adverse events that result in 
death or serious harm.
    I think that in this particular bill we are looking at, we 
really have no standards. We do not talk about whether it is 
harmful, how harmful. We really do not go into much detail. It 
just seems to be all information. So, I think there is a real 
concern that we will usurp what has happened in the States.
    I remember when we first started these hearings back in 
1996, when Chairman Thomas was the Chairman of the 
Subcommittee, we had several people come in and talk to this 
Committee and one of the things that they used in their 
testimony was actually the program that had been set up in 
Florida and I am very concerned that we may end up in a result 
not making this mandatory or, in fact, usurping what they are 
doing. In their estimation, the public is given some safeguards 
by having this, including to the point where they have a 
website that people can go look and see what is going on. So 
that, I think, is a real question for us in this, and I do 
believe that is a debatable question and it has been debate 
with and among this Committee over the last couple of months, 
trying to figure out how we could move forward. I am interested 
in----
    Secretary THOMPSON. Do you not think, Congresswoman 
Thurman, we could work that out? Do you not think that we could 
work out the legislation with the Chairwoman----
    Mrs. THURMAN. Mr. Secretary----
    Secretary THOMPSON. And the Department and get something 
that is compatible?
    Mrs. THURMAN. That----
    Secretary THOMPSON. I think we all want to move in that 
direction and get it done and----
    Mrs. THURMAN. I am not questioning that, and as I said, I 
think the Chairwoman, if you would have seen the bill we 
started with to where we are, she has worked very diligently 
and has worked at this. This just happens to be an issue----
    Secretary THOMPSON. Yes, I understand.
    Mrs. THURMAN. That sometimes you just do not come to some 
conclusion, and quite frankly, and we have had those 
conversations, I would have a very difficult time supporting 
something that did not track what my own State legislature put 
in----
    Secretary THOMPSON. I understand.
    Mrs. THURMAN. That is to say that I think she has done a 
fabulous job in this. There is another area that you mentioned, 
I think, a little bit in your testimony, or not in your 
testimony but in conversation, I think, maybe with Mr. English, 
on the technology part, that we should use fraud and abuse 
dollars to help pay for some of this. What I would like to know 
is, because in this bill there are no dollars to help----
    Secretary THOMPSON. Right.
    Mrs. THURMAN. In a bill that Mr. Houghton and I introduced, 
we had money in that piece of legislation to, in fact, help. 
Can you, in fact, then carry this out administratively?
    Secretary THOMPSON. No, I cannot.
    Mrs. THURMAN. Okay. So we need to figure out a way----
    Secretary THOMPSON. Congresswoman, I have been talking 
about this for a long time. I really--it bothers me immensely 
as Secretary of Health and Human Services to walk into a 
grocery store and know that a grocery store is more 
technologically advanced than a lot of our hospitals and 
clinics across America. When I talk to people in the health 
field, hospital administrators and so on, and they say the cost 
is so much that they cannot afford it because the changing of 
the technology, it is antiquated by the time they get it in 
and, therefore, they do not want to make the investments.
    So, I believe that we should have some sort of a 
demonstration fund. I think we can get to a paperless system in 
hospitals, and I have been talking about that for a long time, 
so that you could use your technology to get in and you would 
reduce the rates. If we could somehow use--the fraud and abuse 
money, I know, is--I am talking for myself now, nobody else--I 
just think it would be something that the medical profession 
would really rally around and say, you know, people that have 
done something wrong, we take money away from them, but instead 
of wasting, or not wasting money, but putting the money 
someplace else, identify the money to do something to improve 
the system.
    Mrs. THURMAN. You and I agree. I mean, that is why when we 
wrote the piece of legislation we did, we figured that, I mean, 
not only for large hospitals, but a lot of rural hospitals who 
are going to be affected by this. Let me just say two things at 
the end of this.
    Secretary THOMPSON. Okay.
    Mrs. THURMAN. Number one--I do not know, which do I do? Do 
I give the good or the bad first? I was really not very happy 
with the Graduate Medical Education issue on psychology, again. 
I mean, it was something this Committee worked on, had worked 
on, had been a proposed rule, had gone through its time period, 
and still we are back where we were 4 years ago. You know my 
feelings about that.
    Secretary THOMPSON. I know you----
    Mrs. THURMAN. The good news is, I do want to thank you very 
much for the dollars that you just gave to Florida on the Ron 
Silver prescription drug for our low-income seniors. We do 
appreciate what you have done in that, and also the 
demonstration programs on some of the HMO Medicare+Choice 
things, so----
    Secretary THOMPSON. We are trying a lot of demonstration 
programs, and on the psychologists, well, let us keep working 
on it.
    Mrs. THURMAN. I would like something more than that, but we 
will talk about it.
    Secretary THOMPSON. Thank you.
    Mrs. THURMAN. Thank you.
    Secretary THOMPSON. Thank you very much, and thank you.
    Chairman JOHNSON. Thank you very much, Mr. Secretary. I 
know you have to leave and I appreciate your being here. I 
think we have completed our questions and we have kept the 
other panel waiting so long.
    I do want to announce two things. First of all, we did just 
get a letter from Florida and the Greater New York area and 
they have very positive things to say about the voluntary 
reporting requirements and the interoperability standards, so 
we will be working on that.
    Mrs. THURMAN. Madam Chairman, I know that, but I also would 
go back to the letter that I think the State health people 
said, and that was that we also need to look at the breadth of 
that, because they are working well.
    Chairman JOHNSON. We will on the succeeding panel have a 
chance to ask those questions in regard to State issues.
    We have a 15-minute vote. We have about 5 minutes left 
before that concludes. Then we have two 5-minute votes, so we 
will reconvene at 1:00 with the final panel. Thank you very 
much.
    Before I recess the Committee, I am going to insert the 
statement of Bill Coyne for the record. Congressman Coyne has 
asked permission to insert his statement.
    [The statement of Mr. Coyne follows:]

 Statement of the Hon. William J. Coyne, a Representative in Congress 
                     from the State of Pennsylvania
    I am pleased that the Ways and Means Health Subcommittee has chosen 
to hold a hearing on medical errors. I have been concerned about the 
medication error aspect of this problem for quite some time. All 
medical errors are unacceptable, and the Federal government must work 
with the health care industry toward the goal of dramatically reducing 
such errors.
    In 1993, Steve Twedt of the Pittsburgh Post-Gazette did a series of 
articles on medication errors. The Pittsburgh Post-Gazette reported 
that the newspaper's study of 250 hospital pharmacists across the 
country produced an estimate of 16,000 medication errors in the 
surveyed institutions in 1992, with 106 of these errors causing patient 
deaths. Some of these errors were made by physicians, some by hospital 
personnel, some by pharmacists, and some by patients.
    The Post-Gazette reports offered clear evidence that a significant 
number of people die or become ill every year because of medication 
errors. Furthermore, David Work, the Executive Director of the North 
Carolina Board of Pharmacy, testified at a Ways and Means hearing on 
medication errors in 1995 that ``about 10,000 deaths occur nationwide 
from pharmaceuticals each year.'' There was certainly no doubt that the 
system for monitoring medication errors had to be improved.
    In 1993, I introduced The Safe Medications Act. This legislation 
would have required that deaths due to the prescribing, dispensing or 
administering of drugs be reported by the health care facility in which 
the error occurred to the U.S. Pharmacopeia, a private non-profit 
organization directed by Congress to set drug standards. Health care 
institutions covered by this bill included pharmacies, hospitals, long-
term care facilities, ambulatory care facilities and physician offices. 
Reports would have had to be made within 10 working days from the date 
the error was discovered. The Secretary of Health and Human Services 
would have worked with the U.S. Pharmacopeia and appropriate health 
care provider associations to notify and alert health care providers 
and manufacturers of potential problems. Information reported to U.S. 
Pharmacopeia would have remained confidential. I re-introduced this 
legislation in subsequent Congresses.
    In 1998, U.S. Pharmacopeia unveiled a voluntary reporting system 
for all errors, not just those resulting in death. Health care 
providers report the errors and U.S. Pharmacopeia organizes them into a 
searchable database. They also notify health professionals about the 
most common medication errors and their causes. This voluntary 
initiative constituted a commendable first step in reducing the number 
of deaths caused by medical errors.
    In 1999, the Institute of Medicine released the report, To Err is 
Human. The study described a fractured health care system that is prone 
to errors and detrimental to safe patient care. While this report 
prompted some debate on the issue, Federal legislation to reduce 
medical errors has not yet been enacted.
    In 1999, I joined my colleague Congressman Cardin in introducing 
the Medicare Chronic Disease Prescription Drug Benefit Act of 1999. 
This legislation would have provided for a chronic disease prescription 
drug benefit under the Medicare Program. Furthermore, it contained 
language that would have ensured that appropriate safety mechanisms 
were in place to prevent medication errors in this program. The 
legislation would have directed the Secretary of Health and Human 
Services to establish a model for comprehensive educational programs to 
assure appropriate prescribing, dispensing, and use of such covered 
drugs. Unfortunately, Congress has failed to act on Medicare 
prescription drug legislation as well.
    Finally, I want to thank the Pittsburgh Regional Healthcare 
Initiative for their hard work in reducing medical errors in 
Southwestern Pennsylvania and for coming today to share their 
experience.
    The issue of medical errors is of great importance and urgency. 
Thousands of lives are--literally--on the line. I am pleased to see 
that the Ways and Means Health Subcommittee is exploring this issue, 
and I hope that the Ways and Means Health Subcommittee and Full 
Committee will work together in a bipartisan fashion to find a prompt 
solution to this growing problem.

                                 

    Chairman JOHNSON. Congressman Stark has asked permission to 
insert an editorial, ``Safe Health Care: Are We Up To It?'' for 
the record.
    [The information follows:]

                                            British Medical Journal
                                                     March 18, 2002
Editorials
 Safe health care: are we up to it?

    We have to be

    In the 8 months since we put out the call for papers for this 
special issue of the BMJ devoted to medical errors, the landscape has 
changed considerably. In Britain the Bristol Inquiry has continued to 
focus professional and public attention on patient safety in a manner 
unprecedented both for its depth and for the extent of professional 
involvement.\1\ In the United States the recent publication of the 
report To Err is Human by the Institute of Medicine of the National 
Academy of Sciences \2\ received extraordinary media coverage as well 
as prompt responses to its recommendations from the President and 
Congress.\3\
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    \1\ www.bristol-inquiry.org.uk/brisphase2.htm; accessed 6 March 
2000.
    \2\ Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human. 
Building a safer health system. Washington, DC: National Academy Press, 
1999.
    \3\ Charatan F. Clinton acts to reduce medical mistakes. BMJ 2000; 
320: 597 [Full Text].
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    The error prevention ``movement'' has clearly accelerated. As the 
papers in this issue bear witness, major changes are occurring in the 
way we think about and carry out our daily work. For practicing 
physicians, some of the ideas and practices described here may be mind 
bending, or at least mind stretching. But most of the insights and 
solutions will, we think, have resonance for all those who strive to 
provide safe care for patients. All physicians, after all, have had the 
unwelcome experience of becoming what Wu calls ``the second victim,'' 
being involved in an error or patient injury and feeling the attendant 
sense of guilt or remorse as responsible professionals.\4\ Familiar, 
too, are Helmreich's findings that doctors, like pilots, tend to 
overestimate their ability to function flawlessly under adverse 
conditions, such as under the pressures of time, fatigue, or high 
anxiety.\5\
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    \4\ Wu A. Medical error: the second victim. BMJ 2000; 320: 726-727 
[Full Text].
    \5\ Helmreich RL. On error management: lessons from aviation. BMJ 
2000; 320: 781-785 [Full Text].
---------------------------------------------------------------------------
    Some of the solutions reported here are as simple as teaching 
emergency room doctors to read x ray films\6\; others require 
substantial capital investment.\7\ The new world of automation 
described by Bates and by Gaba seems ever closer,\8\ \9\ and, although 
every new technology will inevitably introduce new forms of error, it 
is high time for medicine to enter the computer age. We should now hope 
that the death knell has at last been sounded for the handwritten paper 
prescription; and the paper medical record, a dinosaur long overdue for 
extinction, may at last be en route to replacement by far more useful 
and reliable automated systems.
---------------------------------------------------------------------------
    \6\ Espinosa JA, Nolan TW. Reducing errors made by emergency 
physicians in interpreting radiographs: longitudinal study. BMJ 2000; 
320: 737-740 [Abstract/Full Text].
    \7\ Nightingale PG, Adu D, Richards NT, Peters M. Implementation of 
rules based computerised bedside prescribing and administration: 
intervention study. BMJ 2000; 320: 750-753 [Abstract/Full Text].
    \8\ Bates DW. Using information technology to reduce rates of 
medication errors in hospitals. BMJ 2000; 320: 788-791 [Full Text].
    \9\ Gaba DM. Anaesthesiology as a model for patient safety in 
health care. BMJ 2000; 320: 785-788 [Full Text].
---------------------------------------------------------------------------
    But, several of these authors warn us, making the more fundamental 
and lasting changes that will have a major impact on patient safety is 
much more difficult than simply installing new technologies. There are 
no ``quick fixes.'' We must re-examine all that we do and redesign our 
many and complex systems to make them less vulnerable to human 
error.\10\ \11\ The necessary changes are as much cultural as 
technical. Creating a culture of safety requires attention not only to 
the design of our tasks and processes, but to the conditions under 
which we work--hours, schedules and workloads; how we interact with one 
another; and, perhaps most importantly, how we train every Member of 
the healthcare team to participate in the quest for safer patient care.
---------------------------------------------------------------------------
    \10\ Reason J. Human error: models and management. BMJ 2000; 320: 
768-770 [Full Text].
    \11\ Nolan TW. System changes to improve patient safety. BMJ 2000; 
320: 771-773 [Full Text].
---------------------------------------------------------------------------
    We have already learnt a great deal from the early experiences of 
error reduction in healthcare organizations. First, we have discovered 
an immense reservoir of creativity and motivation among healthcare 
workers of all kinds. When given the opportunity to help, when the 
barriers of shame and punishment are removed, doctors, nurses, 
pharmacists, and others eagerly work to improve safety, implementing 
best practices or developing new ones.
    Secondly, we have learnt again that leadership is an essential 
ingredient of success in the search for safety, as it is throughout the 
enterprise of quality improvement. In the absence of commitment from 
professional and organizational leaders, efforts will be fragmentary 
and uncoordinated and will have only minor effects. We need leadership 
at all levels. While local ``champions''--individual doctors, 
pharmacists, or nurses--can, by their enthusiasm, motivate others to 
make improvements, major systems changes require direction and support 
from the top--leaders who communicate their own commitment by insisting 
on safety as an explicit organizational goal backed by adequate 
resources. The test, as Reinertsen tells us, is that senior managers 
feel personally responsible for each error.\12\
---------------------------------------------------------------------------
    \12\ Reinertsen JL. Let's talk about error. BMJ 2000; 320: 730 
[Full Text].
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    Thirdly, we have learnt that the problem of medical error is not 
fundamentally due to lack of knowledge. Though clearly we have much 
more to learn about how to make our systems safe, we already know far 
more than we put into practice. Simple measures of known effectiveness, 
such as unit dosing, marking the correct side before surgery on paired 
organs, and 24 hour availability of pharmacists and emergency 
physicians, are often ignored. Health care alone refuses to accept what 
other hazardous industries recognized long ago: safe performance cannot 
be expected from workers who are sleep deprived, who work double or 
triple shifts, or whose job designs involve multiple competing urgent 
priorities. Based on currently available knowledge, constructive, 
effective changes to improve patient safety can begin at once.
    If we can mobilize our resources and make safety our priority, 
health care can make tremendous strides in the next few years. But 
today's culture of blame and guilt too often shackles us. Achieving the 
culture we need--one of learning, trust, curiosity, systems thinking, 
and executive responsibility--will be immensely difficult. Harder 
still, we must now accomplish this cultural change under the spotlight 
of a newly aroused public that, given our track record, is 
understandably doubtful that health care can, on its own, do what needs 
to be done. Indeed, the public's doubt in our commitment may be all too 
well founded. In truth, no other hazardous industry has achieved safety 
without substantial external pressure. Safe industries are, by and 
large, highly regulated. Health care's track record of failure to act 
on over three decades of accumulating evidence of medical errors offers 
plenty of ammunition to those who claim that we may need to be forced 
to do what is, at bottom, right.
    The need is obvious, and the mandate is clear. Will we respond 
adequately and fast enough? Will hospitals and healthcare organizations 
get serious enough, soon enough, about patient safety? Will they make 
the changes that are needed, and will they be willing to hold 
themselves accountable for achieving improvements? Can we accept the 
legitimacy of the public's right to know when serious accidents occur, 
and can we honor the public's legitimate expectation that we will admit 
our mistakes, investigate them, and make the changes necessary to 
prevent them in the future? As we enter the new century, a key lesson 
from the old is that everyone benefits from transparency. Both the 
safety of our patients and the satisfaction of our workers require an 
open and non-punitive environment where information is freely shared 
and responsibility broadly accepted.
    Are we ready to change? Or will we procrastinate and dissemble--to 
lament later when the inevitable regulatory backlash occurs? It may 
seem to some that the race for patient safety has just begun, but the 
patience of the public we serve is already wearing thin. They are 
asking us to promise something reasonable, but more than we have ever 
promised before: that they will not be harmed by the care that is 
supposed to help them. We owe them nothing less, and that debt is now 
due.
                                                     Lucian L Leape
                                 Adjunct Professor of Health Policy
                Harvard School of Public Health, Harvard University
                                              Boston, MA 02115, USA

                                                   Donald M Berwick
                                            Chief Executive Officer
                               Institute for Healthcare Improvement
                                              Boston, MA 02215, USA

                                 

    Chairman JOHNSON. The Committee stands in recess.
    [Recess.]
    Chairman JOHNSON. The Subcommittee will come to order. My 
apologies to the panel for the delays. These things are beyond 
our control. Thank you. We will begin with Dr. Leape of the 
Harvard School of Public Health. Thank you for yours and Dr. 
Berwick's help, and of others from the Committee as we have 
developed this legislation. I appreciate it.

STATEMENT OF LUCIAN L. LEAPE, M.D., ADJUNCT PROFESSOR OF HEALTH 
 POLICY, HARVARD SCHOOL OF PUBLIC HEALTH, HARVARD UNIVERSITY, 
                    CAMBRIDGE, MASSACHUSETTS

    Dr. LEAPE. Thank you, Madam Chairman, and Mr. Stark, 
Members of the Committee, for the opportunity to meet with you, 
and thank you, Madam Chairman, for your leadership in safety. 
We all appreciate it and look forward to working with you.
    I think it is fair to say that in spite of all the gloomy 
news, progress in patient safety in the past few years has 
really been astounding. There has been an incredible amount of 
activity since the Institute of Medicine report came out now 
not quite 3 years ago; not as much as we would like, never as 
fast as we would like, but significant progress nonetheless. 
Hospitals are changing their systems, particularly in 
medication systems. Hundreds have reorganized what they do. 
Health care systems throughout the country are leading in 
systems change. Regulators are intensifying their efforts. 
Coalitions have sprung up in many States, bringing together 
stakeholders to work on safety. I think there is no question 
safety has become a priority in health care and it is about 
time.
    The Federal Government, I think, has played an important 
role in this and the proposed legislation, I believe, will 
expand that in the proper way. I would like to comment on just 
several aspects of it briefly.
    The first, the Center for Patient Safety, I think is very 
important. The Agency for Health Care Research and Quality has 
been the leading force in the safety movement. Under John 
Eisenberg's outstanding leadership, the agency became exactly 
what the Institute of Medicine visualized, a central focus, a 
symbol of national commitment for patient safety. It is 
government at its best, not telling doctors how to practice, 
but providing them the tools they need to do better what they 
want to do. You should be very proud of that. I strongly 
recommend that you assure its future by incorporating it in 
this legislation as proposed.
    I would like to make one comment about funding. Sixty-
million dollars sounds like a lot of money. It is not. It is a 
drop in the bucket. Congress has wisely over the years expanded 
the funding for the National Institutes of Health, which we all 
support and which has been responsible for the dramatic 
advances in science over the last 20 years that has so much 
improved health care. But congress has never funded the equally 
important task of evaluating those advances.
    We spend over $25 billion for the National Institutes of 
Health. We should spend at least 5 percent of that on 
developing the evidence of how those advances work. Five 
percent would be $1.25 billion a year. That should be the 
budget for AHRQ, and 20 or 30 percent of that should be 
earmarked for safety.
    The second part of the legislation which I would like to 
support is the proposal to develop interoperability standards 
for information technology. Dr. Pardes will address this in 
more detail, but I would like to make several comments.
    The first is that the idea of the computerized patient 
record has been before us in health care for over 40 years. We 
were talking about it when I was in medical school, and yet it 
has still eluded us. The benefits are obvious. For example, if 
you were taken to an emergency room in a hospital in a town 
1,000 miles from home, they could retrieve your record, in 
minutes, find out what medications you were taking, what 
medications you are allergic to, and so forth, and give you 
proper treatment. The computerized record would eliminate many 
of the serious communication barriers that are behind many of 
the errors and injuries that we see in health care. It would 
enable patients and doctors to access their information 
readily, and I think it would make a tremendous difference. It 
would also provide the data we need for the evidence for 
evidence-based medicine, again, something we need to move on 
with. We could discover, for example, complications from a new 
drug within months, instead of years as at the present time. 
So, I strongly urge you to pass those sections. I think the 
time has come.
    Clearly, the contentious part of the legislation has to do 
with the protection of voluntary reporting. Since the 
legislation does not address mandatory reporting, I will not 
either, but we can talk about that if desired. I think that no 
one questions the need for enhancing voluntary reporting. We 
all realize that sharing of information, learning from one 
another, is critical for improving safety.
    No reporting system will succeed unless it is safe. Safe 
means that when you report something, you are not at risk for 
being punished, for being sanctioned or being involved in a 
malpractice suit. At the present time, peer review statutes 
protect reporting within hospitals, but that protection is lost 
when the report leaves the hospital walls. This bill addresses 
that issue and is, I think, appropriate, timely, and necessary. 
I do not share the concerns that it will interfere with the 
mandatory reporting systems or other reporting systems 
presently available.
    I do think, however, that section 1182(D)(2) essentially 
nullifies the advantages that the bill provides. Removing 
protection for disciplinary proceedings is essentially removing 
protection. No right-thinking physician or nurse will talk 
about an error they have made if that remains in the bill 
because they will still be at risk. So, I think if you leave 
that in, you might as well not pass the legislation. I urge you 
to strike section 1182(D)(2). Thank you very much.
    [The prepared statement of Dr. Leape follows:]
Statement of Lucian L. Leape, M.D., Adjunct Professor of Health Policy, 
    Harvard School of Public Health, Harvard University, Cambridge, 
                             Massachusetts
    I wish to lend my strong support for the proposed Amendment to H.R. 
4889 offered by Mrs. Johnson, provided it is amended to provide full 
protection from discovery for voluntarily reported patient safety data.
    Progress in patient safety over the past two years has been 
astounding. Virtually every national organization and all hospitals are 
changing their practices to reduce hazards of patient injury. Many of 
those efforts have been facilitated by the strong leadership provided 
by the Agency for Healthcare Research and Quality. While progress is 
never as fast as one would wish, injury rates have been reduced, and 
the pace of improvement is accelerating.
    The proposed legislation addresses three important issues related 
to improving patient safety. Two of these, Section 1183, establishing a 
Center for Patient Safety within the Agency for Healthcare Research and 
Quality (AHRQ), and Section 1184, developing interoperability standards 
for health care information technology systems, are broadly supported; 
the third, protection for reporting, is more controversial. Let me 
comment on the easy ones first.
Center for Patient Safety within the Agency for Healthcare Research and 
        Quality (AHRQ)
    As I indicated in my testimony to the Senate Committee on Health, 
Education, Labor and Pensions last year, the Agency's role in advancing 
patient safety has been exemplary. With generous support from Congress, 
and under the outstanding leadership of the late John Eisenberg, AHRQ 
brought together diverse stakeholders to define areas in safety needing 
further research, disseminate information on known safe practices (such 
as medication safety), provided help for consumers, and requested and 
funded research proposals addressing a broad range of safety questions, 
including such diverse and important topics as the design and 
evaluation of reporting systems, improvement of medication systems, 
enhancing collaboration and teamwork, and the effect of working 
conditions on safe performance. It commissioned the National Quality 
Forum to convene a panel that developed a standard list of serious 
reportable events that states may use in their mandatory reporting 
systems, and an expert panel that will soon release a list of safety 
practices.
    In a very short time, the Agency has become what the IOM called 
for, and health care has desperately needed, both a central focus of 
activity in safety and a demonstration of a national commitment to 
safety that facilitates work at the local level, in hospitals and 
health care organizations. This is government at its best: not telling 
doctors and hospitals how to practice, but providing the research, 
resources and information needed for them to do what they need and want 
to do, make health care safe for all citizens. AHRQ is now the major 
force for improving patient safety, and with continuing support it can 
become even more useful. You should be very proud of this.
    I strongly recommend that the Center for Patient Safety be given 
your endorsement through the proposed legislation establishing it as a 
permanent Center within AHRQ.
    The initial funding of $50 million provided by Congress in fiscal 
year 2001 for the safety effort at AHRQ not only gave a ``jump start'' 
to safety research--over 90 projects in six areas--it has had another 
very important effect: it has attracted a number of talented 
researchers and practitioners to work in patient safety. This is 
particularly important at this time because this young field of health 
care safety has only a handful of experts. Developing that expertise, 
which is analogous to specialty training in medicine, will take time, 
but a good beginning has been made. It is, however, just a start. The 
number needed is huge: providing just one qualified person in each 
hospital, for example, requires nearly 5000. If the momentum and 
commitment are to be sustained, funding for the Center for Patient 
Safety must be increased substantially each year.
Developing interoperability standards for health care information 
        technology systems
    Few technological advances have been so long in coming as the 
electronic (computerized) patient record. For over 40 years, the 
prospect of having all of the patient's medical information 
computerized and, thereby, easily accessed and evaluated by those who 
need to know, has eluded us. A primary barrier has been the lack of 
standards for recording and retaining data that permit exchange between 
a diverse set of computers and data systems. The time has come to sort 
this mess out and move ahead with computerization of patients' medical 
records. With proper safeguards, currently available, computerization 
would enable both patients and their doctors to instantly access 
information, regardless of where they are. The benefits in terms of 
emergency care in far-off places are obvious. Less dramatic, but much 
more common usage will be to facilitate exchange of information between 
specialists and other providers, which has great potential to reduce 
one of the common cause of errors: faulty communication.
    Not only would a standardized electronic medical record vastly 
improve the efficiency and safety of patient care, the ability to 
easily and accurately collect large volumes of clinical data would 
vastly accelerate the development of evidence needed for the evidence 
based methods to be disseminated and adopted as wisely specified in 
Section 1185. In addition, with appropriate consent and confidentiality 
safeguards, the universal record could permit large population testing 
of new drugs within months of their release. Unsuspected side effects 
could be detected within months, instead of years at present, saving 
thousands of lives.
    I recommend not only passage of section 1184, and Section 3, 
establishment of a Medical Information Technology Advisory Board, but 
also that Congress provide financial incentives, such as bonuses by 
CMS, for hospitals that implement computerized patient records.
Protection of voluntarily reported patient safety data
    None of the recommendations from the IOM were as controversial as 
those for reporting of adverse events. Much of the controversy arose 
from misunderstandings about the nature of mandatory reporting. For 
many years, a number of states have had mandatory reporting systems in 
which hospitals (not doctors) are required to report particularly 
serious adverse events (not errors). The IOM recommended that all 
states implement such programs, and further recommended standardizing 
the types of events to be reported in order to facilitate aggregation 
of data for learning purposes. AHRQ commissioned the National Quality 
Forum (NQF) to develop such a list of serious reportable events, which 
it did and published last year.
    The IOM also recommended that voluntary reporting of less serious 
events be encouraged. Reporting systems can advance patient safety in 
several ways. First, if incidents are promptly reported, it can serve 
as an ``early warning system'' to alert all providers of new hazards. 
The medication error reporting program (MERP) run by the US 
Pharmacopoeia (USP) and the Institute for Safe Medication Practices 
(ISMP) has performed this function for medication errors for years, as 
does the FDA MedWatch program for adverse drug reactions. Second, by 
aggregating large numbers of reports from many institutions, a national 
reporting system can identify patterns of injury that are not obvious 
to those at the local level, particularly for rare events or those with 
unusual causes. Third, lessons learned by individual hospitals of new 
methods to prevent errors can be disseminated. Fourth, analysis can 
lead to recommendations for ``best practices'' for all to follow.
    It is important to recognize that reporting alone does not improve 
safety. Reports must be analyzed and lead to recommendations for 
changes in care, and those changes must be implemented. Analysis of 
reports is an expensive enterprise, requiring a high level of 
expertise. It is far more costly than the data entry component of a 
reporting system, yet those costs have rarely been considered when 
proposals are made for a national system. For example, the ASRS run by 
NASA for aviation receives over 30,000 reports annually and costs 
approximately $70 per case. The annual number of preventable injuries 
in health care is estimated to be over 1 million. A successful national 
reporting system for health care conducted at a similar level of expert 
analysis as ASRS could cost as much as $70 million per year.
    A more feasible option, which in fact is occurring, is the 
development of system-wide programs, such as that being developed by 
NASA for the VA, and specialty-based focused reporting programs, such 
as those developed by neonatal and adult intensivists. Similar programs 
could be developed by other health care systems and specialties.
    No voluntary reporting system will be successful, however, unless 
reporting is safe. Fear of discovery with potential adverse legal 
consequences is a major inhibitor of reporting by hospitals and doctors 
in all states. Evidence from many sources, within and outside of 
medicine, as well as the accumulated experience of several decades, 
demonstrates that people will not report or discuss information that 
puts them at risk of adverse personal consequences. If we want this 
information in order to learn from our mistakes, we must make it safe 
for people to report. The proposed legislation wisely provides legal 
protection for information submitted voluntarily to patient safety 
improvement systems. This feature is crucial for the success of all 
voluntary reporting systems, public or private.
    Unfortunately, in Section 1182 (d) (2) PERMISSIBLE DISCLOSURES, 
Disciplinary Proceedings, those protections are removed if the 
information is needed as part of a disciplinary procedure. That single 
clause nullifies all of the benefits of this section. No thinking 
doctor, nurse or hospital administrator will provide potentially 
incriminating information to anyone under these circumstances. They 
will not report. Nor should we expect them to. If this clause is 
retained, this legislation will have no impact on reporting. It will 
not change the status quo.
    Nor is this type of disclosure necessary. Current regulations 
already mandate reporting of serious adverse events, including the 
results of investigations carried out by hospitals, in many states. 
Disciplinary proceedings, whether within the hospital or conducted by 
State Medical Boards, are also governed by detailed and tested rules 
that assure fair and full exploration of instances of suspected 
misconduct. State regulatory bodies have many legitimate methods for 
obtaining information. It is only the reports that leave the hospital 
that need protection. Much of the information is available in other 
places. The medical record is available, for example, and while the 
individual at risk cannot (rightfully, under our Constitution) be 
forced to testify against himself, other parties have both contractual 
and legal obligations to provide information. That is more than 
sufficient to meet disciplinary needs.
    I strongly recommend that the Committee delete section 1182 (d) 
(2). If it remains, the so-called ``protection'' against discovery will 
be meaningless.

                                 

    Chairman JOHNSON. Thank you very much, Dr. Leape. Dr. Wood?

    STATEMENT OF MICHAEL B. WOOD, M.D., PRESIDENT AND CHIEF 
 EXECUTIVE OFFICER, MAYO FOUNDATION, ROCHESTER, MINNESOTA, AND 
             MEMBER, HEALTHCARE LEADERSHIP COUNCIL

    Dr. WOOD. Madam Chairman, I appreciate this opportunity to 
speak with you today on a matter of utmost importance to all 
Americans, that is, the level of safety afforded to each and 
every patient who enters our health care system. This Committee 
is to be commended for the attention you are giving this 
vitally important issue.
    I am President and Chief Executive Officer of the Mayo 
Foundation, based in Rochester, Minnesota. All of us at Mayo 
are proud of our institution's worldwide reputation for 
excellence in patient care, medical education, and medical 
research. We are devoted to innovation and constant 
improvement.
    Today, I am testifying on behalf of my colleagues and 
counterparts who are members of the Healthcare Leadership 
Council (HLC). The Healthcare Leadership Council is a coalition 
of chief executives of the Nation's leading health care 
companies and organizations representing all sectors of health 
care, from hospitals to health plans, from pharmaceutical 
companies to medical device manufacturers. These members are 
committed to patient safety, quality care, and continuous 
improvement and innovation.
    It is important to note that the health care industry is 
already taking numerous steps to reduce error rates and to 
continually increase the quality of care we provide for the 
patients. Many health care providers are reducing human error 
by upgrading systems technologies. At Mayo facilities, for 
example, we are moving toward a completely paperless 
environment, including the computerization of patient records 
for better access, clearer notations, and improved care.
    Other Healthcare Leadership Council Member companies are 
also involved in increasing the use of computerized physician 
order entry, computerized on-floor pharmacies, and scanning bar 
codes at the patient's bedside to reduce the potential for 
medication errors.
    As well, manufacturers are instituting dose-by-dose 
packaging, improving dosage and interaction instructions, and 
eliminating look-alike packages and product names, all measures 
well known to prevent drug-related accidents.
    Thus, we are seeing the development of a strong public-
private partnership to enhance patient safety. However, in 
addition to the innovations and improvements that are taking 
place, patients will be well served if Congress adopts 
measures, such as the bill that you have introduced, Madam 
Chairman, H.R. 4889, the Patient Safety Improvement Act of 
2002. Legislation such as this will provide a valuable assist 
to health care providers in conducting the kind of information 
sharing essential to quality improvement.
    In order to achieve widespread and continuous improvements 
in patient safety, there are three directions we must pursue. 
First, the health care industry must work together to develop 
standards that will encourage widespread use of information 
technology systems. You have strongly encouraged this, Madam 
Chairman, and you are absolutely right to do so. This is a 
priority of ours at Mayo Clinic because we know that modern 
information technology can make the patient record more 
complete, more accurate, and more accessible and reduce the 
possibility of errors.
    Second, we believe that continued emphasis must be placed 
on voluntary reporting of medical errors and confidentiality 
protections to encourage sharing of information. To make our 
health system safer, health providers must be able to collect 
and analyze patient safety data. We need to avoid punitive 
measures and an increased exposure to litigation that would 
simply drive critically important information underground.
    Your legislation, Madam Chairman, utilizes peer review 
protections in a very positive way to encourage the development 
and sharing of critical data and especially to bring near-
misses out in the open for analysis and process improvements 
before they do harm.
    In the discussions we have had thus far today, it is 
important to recognize that the major opportunity to prevent 
medical errors is to identify error-prone processes in health 
care. Voluntary non-punitive reporting brings these near-misses 
to light and, conversely, mandatory reporting will continue to 
drive the near-misses into the shadows.
    Witness, for example, that in the Joint Commission on 
Accreditation of Healthcare Organizations (JCAHO) Sentinel 
Events Project we have seen reported 2,000 sentinel events in 5 
years, whereas the MedMARx near-misses voluntary reporting 
system has brought forward 400,000 in 1 year, which represents 
the major opportunity we are seeing.
    Finally, the third area that we need to address is that we 
must adopt safe practice standards that are evidence-based and 
have the flexibility to accommodate evolving science and new 
medical technologies. It will not serve patients well to use 
regulatory mandates to freeze practices in place today that 
could well be outdated in mere months.
    In closing, I want to again commend this Committee for the 
energy and attention it is focusing on this important issue. 
Having a hearing like this is conducive to developing the 
culture of awareness to which I alluded earlier. I am confident 
that government and the health care industry can work together 
cooperatively and constructively to create an environment that 
encourages constant quality improvement. This is an important 
challenge affecting the lives and safety of every American 
patient and it is a challenge that we intend to meet.
    Once again, thank you for the opportunity to share these 
views of the Healthcare Leadership Council.
    [The prepared statement of Dr. Wood follows:]
   Statement of Michael B. Wood, M.D., President and Chief Executive 
Officer, Mayo Foundation, Rochester, Minnesota, and Member, Healthcare 
                           Leadership Council
    Madam Chairman, I appreciate this opportunity to speak with you 
today on a matter of utmost importance to all Americans, the level of 
safety afforded to each and every patient who enters our health care 
system. This committee is to be commended for the attention you are 
giving to this vitally-important issue.
    I am President and Chief Executive Officer of the Mayo Foundation, 
based in Rochester, Minnesota. All of us at Mayo are proud of our 
institution's worldwide reputation for excellence in clinical practice, 
education and medical research. We are devoted to innovation and 
constant improvement B principles that we apply intensely to the area 
of patient safety.
    Today, I am testifying on behalf of my colleagues and counterparts 
who are members of the Healthcare Leadership Council. The HLC is a 
coalition of chief executives of the nation's leading health care 
companies and organizations representing all sectors of health care. We 
meet on a regular basis to jointly develop policies, plans and programs 
to achieve our vision of a patient-centered 21st century health care 
system.
    It is important that an organization like the HLC be centrally 
involved in a national discussion on the best ways to improve patient 
safety. No single health care sector can act in a vacuum in addressing 
this issue. Hospitals, medical device manufacturers, health plans, 
pharmaceutical companies, pharmacies, purchasing companies B all must 
work in consensus to achieve new advances in patient safety, and to 
ensure that those advances have widespread implementation.
    The HLC is developing this consensus through its Chief Executive 
Task Force on Patient Safety. Through this task force, leaders from all 
sectors of health care are working cooperatively to elevate public 
confidence in patient safety. We are united behind a self-initiated 
protocol for addressing patient safety positively and responsibly.
    It is important to note that the health care industry is already 
taking numerous steps to reduce error rates and to continually increase 
the quality of care we provide to patients. Many health care providers 
are reducing human error by upgrading systems technologies. At Mayo 
facilities, we are moving toward completely paperless environments, 
including the computerization of patient records for better access, 
clearer notations and improved care.
    Other HLC member companies are involved in increased use of 
computerized physician order entry, computerized on-floor pharmacies, 
and scanning barcodes at the patient's bedside to reduce the potential 
for medication errors. As well, manufacturers are instituting dose-by-
dose packaging, improving dosage and interaction instructions, and 
eliminating look-alike packages and product names.
    Many hospitals are voluntarily submitting error data to 
organizations like the Joint Commission on Accreditation of Health 
Organizations and U.S. Pharmacopia, where they receive helpful analysis 
and feedback on how to avoid similar errors in the future. These are 
just a few of the many examples of activities underway within a health 
care industry that is committed to error reduction and improved safety.
    We are seeing the development of a strong public-private 
partnership to enhance patient safety. In addition to the innovations 
and improvements taking place in the public sector, patients will be 
well served if Congress adopts measures such as the bill you 
introduced, Madam Chairman, H.R. 4889, the ``Patient Safety Improvement 
Act of 2002.'' Legislation such as this will provide a valuable assist 
to health care providers in conducting the kind of information sharing 
essential to quality improvement. The members of the Healthcare 
Leadership Council stand ready to work with you to see this approach 
become law.
    In my testimony today, I would like to address three points that 
are absolutely critical if we are to significantly reduce medical 
errors and give all patients the confidence that they will receive care 
that is safe and of the highest quality. First, we must consider the 
critical role information technology will play in improving patient 
safety. Second, we need to emphasize the importance of confidentiality 
and voluntary reporting in the handling of errors, so that we can use 
the knowledge gained from medical errors to build better, safer health 
care systems. And, finally, we need to discuss the best methods for 
developing safe practice standards.
Information Technology Standards
    As I mentioned previously, the Mayo Clinic is moving toward a 
completely paperless environment, including paperless patient records. 
We have, in fact, completed this process at our Jacksonville, Florida 
facility. We are doing this because we believe the use of information 
technology can help ensure the completeness of the patient record, make 
it more accessible for all health professionals involved in the 
patient's care, and reduce the possibility of errors. With an 
electronic record, there is greater assurance that information 
concerning diagnoses, medication, imminent surgeries and the like is 
accurate and complete.
    There is no question that information technology has enormous 
potential to help us reduce the possibility of errors, and health care 
organizations, lawmakers and other policy officials should support the 
automation of patient safety systems to the greatest extent possible. 
The Institute of Medicine is urging a new generation of patient safety 
systems that are automated, information system-based and driven by 
sound technologies. Certainly, a voluntary health information 
infrastructure should be encouraged and facilitated as rapidly and as 
broadly as possible.
    There are challenges in this area for which we must develop 
solutions. Some hospitals, facing budget constraints, are reluctant to 
purchase these technologies because of concerns that they cannot be 
integrated with their current IT systems, or because they fear newer, 
better systems could soon be released which would make their major 
technology investments obsolete.
    The health care industry must work together to develop standards 
that will encourage widespread usage of information technology systems. 
HLC is a founding member of the National Association of Health 
Information Technology. Madam Chairman, you called upon the industry to 
act proactively in this area, saying that ``if you don't, we will.'' We 
take that charge very seriously and, with the creation of NAHIT, we 
intend to work toward standards that will maximize the advantages 
technology can bring in reducing medical errors. We also intend to work 
closely with the medical information technology board that H.R. 4889 
would create to ensure the development and dissemination of best 
practices in medical information technology.
Confidentiality and Voluntary Reporting
    Our success in improving patient safety will be largely dependent 
upon the environment we create for handling medical errors and mining 
the vitally-important knowledge that can be gained from those 
occurrences. We must have a culture of awareness, not a culture of 
blame.
    Health care providers must be able to collect and analyze patient 
safety data, and to use that information to develop better, safer 
systems. There is a mutual exclusivity between laws that perpetuate 
litigation and our efforts to transform adverse events and ``near 
mises'' into permanent and pervasive system improvements. To put it 
simply, an increased likelihood of lawsuits will drive this critically-
important information underground. The same philosophy applies to the 
issue of voluntary versus mandatory reporting. We must use positive 
incentives to encourage hospitals and providers to swiftly report 
health care delivery problems. Mandatory reporting would be viewed as a 
punitive effort by the government to extract information from private 
entities B information that could then be used against them in costly 
litigation.
    Current mandatory reporting programs have been less successful than 
their supporters envisioned. Compliance with these programs has been 
inconsistent, due to the punitive nature of the programs and 
ineffective use of the submitted data. Mandatory reporting 
requirements, and the increased likelihood of punitive results against 
health care professionals and organizations, has effectively suppressed 
error reporting and inhibited open discussion about medical errors.
    Existing voluntary reporting systems, on the other hand, have been 
successful because of their strong focus on improving practitioner 
performance instead of punitive results. Examples of successful 
voluntary systems, such as those from the aviation and motor vehicle 
industries, show dramatic improvements in reporting levels, product 
design and personnel training. We can learn from these examples that 
quality improvement requires the design of systems focused on 
prevention of human error rather than on assigning blame.
    Lawmakers must carefully consider any new laws or regulations that 
could actually do damage to the current health care system by making 
errors and ``near misses'' even harder to identify. Confidentiality 
protections should be instituted to protect organizations from the fear 
of litigation that would inhibit and prevent the sharing of 
information. We are pleased, Madam Chairman, to see such peer review 
protections included in your legislation. With this protection, 
hospitals will be encouraged to share information with organizations 
that can analyze it to determine common error patterns and recommend 
system improvements.
    To improve patient safety nationwide, we must create this culture 
of awareness nationwide as well. Today, some states have strong peer 
review protections while others do not. These inconsistencies serve as 
barriers for any patient safety initiatives that involve institutions 
in multiple states. Moreover, information relating to patient safety 
and ``near-misses'' may run the risk of losing peer review protection 
when shared outside of an institution. This often creates a greater 
degree of liability exposure than many providers are willing to 
tolerate.
Safe Practice Standards
    We would all agree that safe practice standards should be in effect 
to assure the highest quality of care for all patients, regardless of 
the physician or institution treating them. We must carefully consider, 
though, how to develop the most effective standards that will have 
widespread acceptance and the flexibility to accommodate new 
innovations in health care.
    We believe that nationally-recognized safe practice standards 
should be developed only through analysis of conclusive data on broad, 
evidence-based effectiveness and feasibility. And these standards must 
consider evolving science. Additionally, we must recognize that not all 
health care institutions or patient populations are exactly alike and, 
therefore, health care organizations should be encouraged to adopt safe 
practice programs that are applicable to their unique specialties, 
patient populations and specific risk points.
    Some have expressed the belief that government should develop and 
enforce universal standards of care. Rigid government regulations in 
this arena, we believe, would not serve the best interests of patients. 
Knowledge and innovation in health care is constantly evolving, 
constantly improving. The practices we freeze in place today with 
regulatory mandates could well be outdated in mere months.
    It is vitally important that practice standards not stifle 
scientific innovations. If a set of safe practices were to become 
universally-required standards of care, they could effectively 
establish a ceiling for patient safety practices, and discourage 
further innovations for even safer practices. While one might argue 
that national practice standards could be periodically reviewed and 
updated, the well-known reality is that our current regulatory process 
does not accommodate the kind of rapid and substantial changes that new 
technologies can necessitate. There is also concern that government-
enforced standards of care may not be feasible for all hospitals and 
health providers throughout the nation.
    There is a commitment on the part of the health care industry to 
develop safe practice standards B standards that are meaningful, 
feasible and that will encourage, not stifle, future improvements. The 
Healthcare Leadership Council is an active member of the National 
Quality Forum, and we will continue to work extensively to develop 
workable standards to achieve the best in patient care.
    In closing, I want to again commend this committee for the energy 
and attention it is focusing on this important issue. Having a hearing 
like this is conducive to developing the culture of awareness to which 
I alluded earlier. I am confident that government and the health care 
industry can work together cooperatively and constructively to create 
an environment that encourages constant quality improvement. This is an 
important challenge affecting the lives and safety of every American 
patient, and it is a challenge that we intend to meet. Once again, 
thank you for this opportunity to share the views of the Healthcare 
Leadership Council.

                                 

    Chairman JOHNSON. Thank you very much, Dr. Wood. Mr. Segel?

 STATEMENT OF KENNETH T. SEGEL, DIRECTOR, PITTSBURGH REGIONAL 
        HEALTHCARE INITIATIVE, PITTSBURGH, PENNSYLVANIA

    Mr. SEGEL. Chairman Johnson, Congressman Stark, and Members 
of the Subcommittee, thank you very much for the opportunity to 
testify on the Patient Safety Improvement Act of 2002.
    As brief background to my comments, I want to provide an 
update on the patient safety activities of the Pittsburgh 
Regional Healthcare Initiative (PRHI), which I direct. The PRHI 
is a collaborative effort among all of Southwestern 
Pennsylvania's major stakeholders in health care. Our goal is 
to establish the world benchmark for patient outcomes by 
identifying and solving problems at the point where patients 
are cared for.
    We have five major clinical improvement projects and two 
major patient safety projects. We take much of the inspiration 
for our efforts from Pittsburgh-based Alcoa, which under now-
U.S. Department of the Treasury Secretary Paul O'Neill became 
the world's safest organization.
    We now include 42 hospitals that are working 
collaboratively to eliminate medication errors and nosocomial, 
or health care acquired, infections. They are all using the 
same data reporting systems to share learning about these 
problems, including U.S. Pharmacopeia's MedMARx for medication 
errors and the Centers for Disease Control's National 
Nosocomial Infectious Surveillance system for infections. In 
this work, we have received invaluable assistance from critical 
Federal partners under Secretary Thompson's direction, 
including the Centers for Disease Control, the Agency for 
Health Care Research and Quality, and the Centers for Medicare 
and Medicaid Services.
    We have seen early signs of progress, including drops in 
our first targeted type of infection, catheter-associated 
bloodstream infections, which have fallen by 22 percent in 1 
year. We have also seen sharp increases in the number of 
medication errors reported in our community and a reduction in 
death following cardiac bypass surgery of 14 percent in 1 year. 
So, we are acting in our community to address the concerns 
identified by the Institute of Medicine and by our own 
community.
    Despite that progress, however, our efforts continue to be 
slowed, sometimes dramatically, by the cautiousness of most 
hospitals and clinicians to share information about errors 
openly due to fear of suit. This fear continues to introduce 
torturous procedures and cautions into the process of error 
reporting, analysis, sharing of learning, and improvement. In 
that context, we believe this legislation would promote the 
more open, honest, and effective reporting and analysis of 
errors that medicine so desperately requires.
    To be most useful to you, I want to use my final minutes to 
talk about some specific components of the bill, because our 
experience tells us that the devil really will be in the 
details in terms of how this legislation is interpreted by the 
health care legal community as well as the courts.
    In terms of patient safety data that is covered, we were 
very encouraged to see that the legislation does not limit 
protection to patient safety data collected solely for the 
purpose of reporting to a . This is essential to reflect the 
real world of health care delivery and hospital processes. The 
inclusion of the word ``solely'' or an equivalent would impose 
the creation of parallel processes of error identification, 
analysis, and corrective action on institutions. They would be 
left with the present faulty patchwork of peer review law, 
which itself has its own cumbersome restrictions on what 
happens within institutions, as well as providing too little 
external support to deal with error reporting. It would lead 
to, we fear, less than enthusiastic and complete use of the 
reporting process contemplated here.
    In this regard, we also strongly recommend that you make 
explicit that the bill's protections would apply to corrective 
actions taken by a provider internally in response to patient 
safety data, even before waiting for feedback from a . Again, 
this reflects operating reality and our shared goal for this 
bill, which is to have errors surfaced and resolved as close to 
real time as possible, and we do not want to make people wait 
to have to take action in terms of feedback coming back. The 
legislation's rules of construction seem to provide that 
protection, but we might even make it more explicit.
    In terms of the definition of health care provider, we 
would urge you to expand that to include health insurers. They 
have rich data sets that can be sources of information and 
learning on errors that should be explicitly covered.
    We strongly agree with the previous witnesses that the 
provisions on the interoperability of health care information 
technology systems be enacted. It is a critical step forward, 
with potentially incalculable gains for patient care.
    Finally, on the issue of voluntary or mandatory reporting, 
this is a challenging public policy question. It is one that 
will be played out in Pennsylvania over the next several years 
as a new mandatory reporting requirement goes into place. I do 
want to suggest strongly, based on our own experience and our 
own interactions with the health care systems, that there needs 
to be a significant period of trust building with the health 
care community via a voluntary non-punitive error reporting 
system before Congress consider it necessary to enact mandatory 
reporting provisions.
    If Congress proceeds with a mandatory emphasis right away, 
it will frame the issue in the traditional mode of regulatory 
compliance played between regulators and providers, and the 
providers have many quills in their arsenal. Within health care 
institutions, I can tell you it will leave implementation 
firmly in the hands of the conservative, cautious lawyers and 
risk managers that so influence hospital practice in these 
areas, not uniformly so, but significantly so, and an 
opportunity to redefine how we think and approach these issues 
by providing the protection and safety that people need to take 
action will have been lost.
    So, we strongly support this bill and we hope that its 
essential protections can be enacted into law so that we can 
move forward expeditiously to identify and solve problems 
quickly.
    [The prepared statement of Mr. Segel follows:]
Statement of Kenneth T. Segel, Director, Pittsburgh Regional Healthcare 
                  Initiative, Pittsburgh, Pennsylvania
    Chairman Johnson, Congressman Stark and Members of the 
Subcommittee:
    Thank you for your invitation to comment on H.R. 4889, the Patient 
Safety Improvement Act of 2002. It was an honor for Karen Wolk 
Feinstein, Ph.D., Chair of PRHI to testify before you on patient safety 
issues this spring, and we are honored to be asked to provide you with 
our perspective again today. Given the depth and sensitivity with which 
you have examined these issues, the importance of the legislation you 
have compiled is not a surprise.
    As brief background to my comments, I want to provide an update on 
the patient safety activities of the Pittsburgh Regional Healthcare 
Initiative (PRHI).
    PRHI is a collaborative effort among all of the region's major 
stakeholders in health care, including clinicians, hospitals, insurance 
plans, corporations and small-business purchasing alliances, labor, and 
even the Attorney General of Pennsylvania. Our goal is to establish the 
world benchmark for patient outcomes in Southwestern Pennsylvania, by 
identifying and solving problems ``at the point where patients are 
cared for.'' We have five major clinical improvement projects, and two 
major patient safety projects. We take much of the inspiration for our 
efforts from Pittsburgh-based Alcoa, which under now-Treasury Secretary 
Paul O'Neill, became the world's safest organization.
    PRHI now includes 42 hospitals working collaboratively to eliminate 
medication errors and nosocomial (healthcare acquired) infections. As 
part of that effort, participating hospitals are all using the same 
medication error (US Pharmacopeia's MedMARx) and nosocomial infection 
reporting systems (the Centers for Disease Control's NNIS). In this 
work, we have received invaluable assistance from critical federal 
partners, including the Centers for Disease Control, the Agency for 
Healthcare Research and Quality, and the Center for Medicare and 
Medicaid Services.
    We have seen encouraging but early signs of progress, including 
drops in our first targeted type of infection--catheter associated 
blood stream infections in intensive care units--which have fallen by 
28% in one year. We have also seen sharp increases in the number of 
medication errors reported. While Pittsburgh area hospitals constitute 
roughly 5% of the hospitals using MedMARx nationally, they contribute 
roughly 10% of the medication error reports. Of course this is 
encouraging news, because the vast majority of medication errors are 
unreported, and only by reporting can they be learned from and other 
errors prevented. Through our additional collaborative efforts to 
improve clinical outcomes for patients, we have seen a 14% drop in 
mortality following cardiac bypass operations in one year (between 1999 
and 2000), and are the only region in Pennsylvania with a lower death 
rate than could be expected given the risk-level of our cardiac 
patients. 40 more cardiac bypass patients are alive today because of 
the work of our cardiac surgery community.
    So, we are acting to address the concerns identified by the 
Institute of Medicine and our own community.
    Despite progress, however, our efforts continue to be slowed 
dramatically by the cautiousness of most hospitals and clinicians to 
share information about errors openly due to fear of suit for even the 
discussion and analysis of errors. This introduces tortuous procedures 
and cautions into the process of error reporting, analysis, sharing of 
learning, and improvement as a result.
    In that context, we believe H.R. 4889 would promote the more open, 
honest, and effective reporting, and analysis of errors that medicine 
desperately requires. You have modeled your efforts on other high-risk 
industries such as aviation and nuclear power where such approaches 
have proven to save lives. We hope your colleagues in Congress 
recognize the urgency of echoing these models in health care, where 
lives are being lost every day for lack of such a protected reporting 
and analysis structure.
    To be most useful to you, I want to comment on a few critical 
aspects of the bill as presently structured, and suggest modifications 
that might strengthen it. As our experience ``on the ground'' has 
taught us, the devil is in the details of how the critical provisions 
of this legislation would be interpreted in the courts and by the 
healthcare legal community.
Patient Safety Data Covered (section 1181(e)(1)(a) and 1181(e)(1)(c))
    1) We were very encouraged to see that your legislation does not 
limit protection to patient safety data collected ``solely'' for the 
purposes of reporting to a patient safety organization, such as other 
federal legislation has proposed. This is essential to reflect the 
``real world'' of healthcare delivery and hospital processes. The 
inclusion of the word ``solely'' or an equivalent restriction would 
impose the creation of parallel processes of error identification, 
analysis and corrective action on institutions. They would be left with 
the present faulty patchwork of peer review law to ``protect'' any 
internal error reporting and patient safety improvements that were not 
initiated ``solely'' in relation to a patient safety organization. This 
would lead to less than enthusiastic and complete use of the patient 
safety organization reporting process. We urge you to stand firm for 
your ``common sense'' approach to this critical definition.
    2) In this regard, we strongly recommend that you make explicit 
that the bill's protections would apply to corrective actions taken by 
a provider internally in response to patient safety data, even before 
waiting for feedback from a patient safety organization. Again, this 
reflects operating reality. The goal is to have errors surfaced and 
resolved as close to ``real time'' as possible. If providers are forced 
to wait for external direction and feedback from a PSO before taking 
any action on data they report in order to enjoy any legal protection 
regarding the corrective action having been taken, we would undermine 
the likely scale and impact of corrective steps.
    This clarification is especially important given the requirements 
for independence of the PSOs.
Definition of Health Care Provider (1181(d))
    3) We recommend that you expand the definition of covered entities 
to include health insurers. Because of their comprehensive data sets, 
insurers often have rich information about errors and error prevention 
efforts that should be available for learning under the protections of 
this act. Absent explicit inclusion of insurers as entities that can 
report and derive protection under the legislation, this source of 
knowledge will go untapped by the nation.
Interoperability of Health Care Information Technology Systems (1184)
    4) We want to applaud this component of the legislation and urge 
you to take all steps within your power to see that such 
interoperability standards are established. The gains to quality and 
safety of health care, and efficiency of the healthcare delivery system 
would be truly enormous.
Voluntary or Mandatory Reporting
    We understand that one of the issues under discussion is whether 
reporting by healthcare organizations under the proposed Act should be 
voluntary or mandatory. This is a challenging public policy question--
one that will be played out in Pennsylvania over the next several years 
due to the passage of legislation requiring reporting of safety 
incidents within 24 hours of confirmation. But let us suggest that 
there should be years of trust-building with the healthcare community 
in a voluntary error-reporting system before Congress consider 
mandatory reporting provisions. If Congress proceeds with a mandatory 
requirement right away, it will frame the issue in the traditional mode 
of regulatory compliance played between regulators and providers, and 
within healthcare institutions will leave implementation firmly in the 
hands of the conservative, cautious lawyers that so influence hospital 
practice in these areas. An opportunity to redefine how we approach 
issues of healthcare performance will have been lost.
    In that mode, we would encourage Congress to think boldly in terms 
of ``carrots'' instead of just sticks to encourage future reporting.
    In conclusion, we applaud your leadership and sensitivity in moving 
this essential legislation. We believe that if its essential 
protections can be enacted into law, it can make a profound impact on 
the safety, quality and value of healthcare services in our community, 
and the United States.

                                 

    Chairman JOHNSON. Thank you, Mr. Segel. Dr. Pardes?

    STATEMENT OF HERBERT PARDES, M.D., PRESIDENT AND CHIEF 
 EXECUTIVE OFFICER, NEW YORK-PRESBYTERIAN HEALTH CARE SYSTEM, 
                       NEW YORK, NEW YORK

    Dr. PARDES. Thank you very much, Chairman Johnson, thank 
you for your leadership both in our own tri-State area and 
nationally, and thank you, too, Mrs. Thurman, for your 
leadership.
    It is a wonderful opportunity to address this issue of very 
great seriousness and also to talk about a bill with which I 
think holds great promise to address that issue, the use of 
information technology to prevent medical errors.
    I am Herbert Pardes. I am a physician and President and 
Chief Executive Officer of New York-Presbyterian. We are the 
largest hospital system in New York State. We also have 
hospitals in Connecticut, New Jersey, and constitute one of the 
most comprehensive health care institutions in the world. We 
combined with New York Weill Cornell Medical Center and 
Columbia Presbyterian, and have two academic affiliates, the 
Weill Medical College of Cornell University and Columbia 
University College of Physicians and Surgeons.
    Our system has some 51 acute care facilities, hospital 
facilities, residential health care facilities, and specialty 
institutions, more than 13,000 affiliated doctors, over 40,000 
employees, and annually, over 400,000 inpatient discharges and 
3.3 million outpatient visits, providing health care to some 
5.5 million patients, some 22 percent of the Greater New York 
metropolitan region. We are placing a heavy focus, as some of 
my colleagues articulated, on health care quality and also 
patient services.
    I wanted to focus particularly on the interoperability 
provisions of H.R. 4889 and I want to acknowledge the 
extraordinary work of Members of this House in the area of 
using information technology to protect patient health. First, 
Mrs. Johnson, who by introducing this bill has advanced the 
cause of safety to a new level. This bill is a quantum leap in 
solving the medical errors problems with tools that have not 
been used effectively in the past and needed someone of vision 
to stand by it.
    Mr. Houghton of New York and Mrs. Thurman of Florida, your 
bill, H.R. 3292, the Medical Errors Reduction Act of 2001, 
paved the way for technology to be applied to patient safety. 
Your leadership has been central in this field.
    Mr. Rangel, too, of New York, has understood and supported 
the notion that a new solution based on technology must be 
applied to health care for us to solve the old problems that 
have bedeviled us.
    So, thank you all for your leadership. Thank you, too, Mr. 
Stark, for your leadership and concern about the needs of 
patients and the best interests of health care.
    Patients suffer for lack of standards that would allow 
computer systems to exchange and process information across 
different vendor and specialty platforms. The lack of standards 
has been a huge barrier to the wise and widespread use of 
technology to prevent medical errors. In the vast majority of 
health care settings, a great deal of disparate information is 
collected on a patient, but the information is not presented to 
a clinician in a single computer screen. So, the data is only 
coordinated for the care of that patient when a clinician 
reviews it, usually when it is brought together on paper. If a 
result does not make it to the paper record, the clinician 
often is not aware of it when she makes her care decisions.
    We feel there should be one computerized view of this 
information. Without adequate investment in elaborate interface 
technologies, different vendor systems cannot share all of the 
information. Standards would help obviate that need. Without 
standards, hospitals can never be sure of their investment in 
new technology. Will the existing systems work with new ones? 
Will new systems block the purchase of yet other equipment from 
different vendors?
    Hospitals do not have the capital to revisit major 
information technology purchases on a year-after-year basis. 
While American industry generally spends between 7 and 10 
percent of its revenues on information technology, health care, 
with its marginal economics, spends less than 3 percent.
    In its interoperability provisions, the bill wisely creates 
the Medical Information Technology Advisory Board, to ensure 
that producers and consumers of health information, as well as 
those who provide the tools for collecting, storing, and 
exchanging this information, are part of the development 
process. The legislation should seek to support the real world 
application of these information technology standards by 
testing them in real patient care settings.
    H.R. 4889 actualizes the potential of information 
technology in health care. Through an inclusive process that 
calls upon the expertise of industry, academic medicine, 
community medicine, public health, and government, the 
formation of the Medical Information Technology Advisory Board, 
which is thereby suggested or put forth, is necessary so 
interoperability solutions can be found that are applicable in 
the greatest number of health care settings, whether government 
or private.
    Those who use information technology and those who 
manufacture it must be aligned from the beginning to design the 
right solutions. We have seen too often in the past how good 
technology fails because what has been designed for one 
environment does not necessarily translate into another. For 
example, excellent systems for administrative data exchange do 
not necessarily translate well for clinical care.
    This bill coalesces those who produce health care data, 
those who consume it, and those who make the technology of 
storage and exchange around a single effort. There is one step, 
however, that is at least as important which is yet to be 
included in the legislation. H.R. 4889 needs to recognize that 
what happens at a theoretical level may not translate well into 
an operational environment, particularly in a field as complex 
as health care. For the vision of H.R. 4889 to be realized, we 
believe it is critical that demonstration projects to test the 
efficacy, use ability and scalability of information technology 
standards be conducted.
    Scalability is a key determinant of success. A technology 
that appears to be a great idea in the inventor's garage and 
works beautifully in a dozen physicians' offices can fail when 
it has to care for millions of patients. Medicare and 
Medicaid's patients are found in every setting in America, 
large inner cities, sparse rural counties, suburban tracts, and 
local neighborhoods, so standards must be tested in a diversity 
of settings to ensure they will work wherever these patients 
and all Americans receive their care.
    I urge you to add that support for demonstration projects 
to the legislation and I congratulate you again for this far-
sighted solution. Most of all, I thank you for acting to solve 
what we feel is a most knotty problem, not with yesterday's 
thinking, but with tomorrow's technology, today's resolve, and 
a commitment to do something concrete and necessary for the 
best health interests of the American people. Thank you.
    [The prepared statement of Dr. Pardes follows:]
   Statement of Herbert Pardes, M.D., President and Chief Executive 
 Officer, New York-Presbyterian Health Care System, New York, New York
Summary

           LNew York-Presbyterian Hospital is one of the 
        nation's largest academic medical centers and is a center of 
        excellence in the use of information technology (IT).
           LIT in the clinical setting can reduce medical 
        errors and increase quality of care through a wise national 
        investment policy. The Computer-based Patient Record (CPR) is 
        at the center of a technology strategy that would reduce 
        errors. A complete CPR is impossible without standards for 
        interoperability in healthcare IT.
           LHospitals are functioning at or below margin and 
        are hard pressed to pursue the necessary investments to 
        establish appropriate systems.
           LTwo major steps are needed: a standard setting 
        process to allow interoperability among diverse systems from 
        different vendors; and federal reimbursement. Academic medical 
        centers have the expertise and neutrality to lead this process 
        in collaboration with industry and government.
           LThe interoperability provisions of H.R. 4889 
        advance the right approach. They call for the formation of a 
        board of experts from every effected constituency to recognize 
        existing standards and develop or validate new standards. 
        However, another step is also needed. Congress needs to allow 
        for the demonstration projects that will assure the efficacy, 
        usability and scalability of standards. As technology is 
        developed for millions of patients rather than thousands, or 
        even tens of thousands, scalability becomes a major stumbling 
        block.

New York Presbyterian Hospital
    New York-Presbyterian Hospital (NYP) is the largest hospital system 
in New York State and one of the most comprehensive healthcare 
institutions in the world. NYP represents a combination of two of the 
world's greatest medical resources, New York Weill Cornell Medical 
Center and Columbia Presbyterian Medical Center with their academic 
affiliates, the Weill Medical College of Cornell University and 
Columbia University College of Physicians & Surgeons. The NYP Health 
Care System (HCS) has a total of 51 acute care hospital facilities, 
residential health care facilities and specialty institutions, more 
than 13,000 affiliated doctors, over 40,000 employees, and annually 
over 400,000 inpatient discharges and 3.3 million outpatient visits 
providing healthcare to 5.5 million patients--22 percent of the greater 
New York metropolitan region. The Hospital and its affiliated 
institutions and medical schools are engaged in a large number of 
medical research projects and receive about $300 million in research 
funding annually.
    NYP is the home of the Columbia University Department of Medical 
Informatics, which traces it roots to a 1981 National Library of 
Medicine (NLM) Integrated Academic Information Management System 
(IAIMS) initiative. The planning and prototype phases of that 
initiative led to the creation of the Center for Medical Informatics in 
1987. In 1994, Columbia University made the Center a full-fledged 
department in the health sciences campus, with the same rights and 
responsibilities as other departments such as Medicine and Surgery.
    Since the beginning, the Department's focus has been on research, 
teaching, and service. A phase III IAIMS grant and an IBM contract 
funded the development of the next generation Clinical Information 
System (CIS). CIS has served as the Department's living laboratory for 
medical informatics research, as a training ground for new informatics 
researchers, and as New York-Presbyterian Hospital's clinical system. 
The system is used by 95% of attending physicians and essentially all 
residents and fellows. It currently has 4000 unique users per month, 
and there are 2 million patients in the database.
Information Technology and Medical Errors
    Computers have great promise in healthcare as tools for monitoring 
patient care to the most minute detail. According to the IOM, ``The 
majority of medical errors do not result from individual recklessness 
but from basic flaws in the way the health system is organized--
illegible writing in medical records has resulted in administration of 
a drug for which the patient has a known allergy--And the health care 
system itself is evolving so quickly that it often lacks coordination. 
For example, when a patient is treated by several practitioners, they 
often do not have complete information about the medicines prescribed 
or the patient's illnesses.'' In short, even highly competent 
physicians can be stymied by a system that makes timely access to 
accurate and legible information difficult.
    Clinicians are very good at giving care. Information systems are 
very good at process. The errors described in the IOM report were 
seldom errors of judgment; they were mistakes in process. The man who 
had the wrong leg amputated; the woman who died from an overdose of 
chemotherapy; the child with the fatal allergy to anesthesia--if only 
the clinicians had been aware of that one missing vital piece of 
information, they would have known the right thing to do. In many 
industries, computers track such crucial information.
    If all pertinent patient information were made rapidly and 
seamlessly available to doctors when they needed it, clinicians who are 
trained to use their judgment based on the available facts would be in 
a better position to make optimal decisions. Does the patient have an 
allergy to anesthesia? The system would automatically alert the 
anesthesiologist if an inappropriate drug is prescribed. On which 
breast does the mammography report identify a tumor? The system 
automatically generates a diagram on the computer's display to verify 
the location. Does the clinician administer an excessive dosage of 
medicine because she has misread the prescription? The system compares 
the dosage with information about the patient's condition and alerts 
the clinician when the dosage is out of range.
    And thanks to the World Wide Web, the benefits of this technology 
are not limited to large academic medical centers. We have recently 
seen the introduction of technologies that can monitor patients at 
great distances over the Web. From the home or in other settings, 
patient data are analyzed before being passed on to clinicians, 
alerting them to changes that need attention and storing information 
for future reference.
    One branch of medical informatics, the science underlying the 
development of information systems to improve health care and other 
areas of biomedicine, is called automated medical decision support. It 
has been studied for more than 20 years at leading institutions across 
the nation. In fact, the standard computer language for generating 
computer-based medical warnings and reminders is the Arden Syntax, 
developed in part by researchers at Columbia University's Department of 
Medical Informatics located at the New York-Presbyterian Hospital.
    Yet, developing an integrated technology that meets all the needs 
of American health care will require research and development support. 
Transferring the technology to hospitals most in need will require 
additional funding support. Leading health care institutions have the 
expertise to develop these Clinical Information Systems, but not the 
funding.
    A wise national policy for healthcare Information Technology (IT) 
should target resources and expertise to increase the application of IT 
to reduce medical errors and improve health care quality. The Institute 
of Medicine suggests that at least 44,000 patients, and as many as 
98,000, die each year as a result of medical errors. Data on medication 
errors show that 2.8 percent of all hospitalized patients experience a 
preventable adverse drug event, resulting in increased morbidity and 
mortality as well as significant added cost to the healthcare system. 
The cost of preventable medication errors alone is estimated at $2 
billion annually. Emerging technologies to reduce medication errors at 
the stage of both ordering and administration hold significant promise, 
particularly if they are able to coordinate all information from the 
patient's medical record. Technologies such as the Computer-based 
Patient Record (CPR) and secure Web-based communication with patients 
can enhance the coordination of care, support implementation of 
evidence-based practice and engage patients more fully as partners in 
their medical treatment. It makes sense to focus efforts on the CPR, 
which lies at the center of a comprehensive hospital IT system, rather 
than on any single element of the system. For example, a stand-alone 
Computerized Physician Order Entry system (CPOE) will not attain the 
Institute of Medicine's goal of a 50 percent reduction in preventable 
medical errors by 2005, according to the Stamford, Connecticut.-based 
Gartner Group's top ten list of IT issues confronting healthcare 
professionals. A CPOE system that is part of a CPR system linked to 
clinical alerts and decision support will be the means to secure that 
objective.
    In fact, a broad-based national IT policy would address some of the 
most difficult problems in medicine in addition to preventing medical 
errors, including epidemiological data tracking to fight bioterrorism. 
It would ensure that patients receive the best care no matter where 
they live or travel. It would take advantage of the great global 
infrastructure--the Internet--and so be broadly available. It would 
incentivise industry--insurers, systems manufacturers and software 
companies--to participate in standards development.
Barriers to Bringing IT to Hospitals
    Health care lags behind almost every other major industry segment 
in investment in Information Technology. Average IT spending per 
employee per year among all U.S. industries is about $6,900 per year. 
The banking segment spends almost $15,000 per employee on IT. The 
insurance industry spends more than $13,000 per employee and 
telecommunications clocks-in at more than $11,000 per employee. Health 
care invests only about $3,000 per employee per year on IT. Another way 
of casting this is that other industries spend from 7-10% of revenues 
on IT; healthcare is below 3%.
    Yet Clinical Information Services can vastly improve the quality of 
health care with long-term benefits for overall costs. And it would be 
centered on the concept of the computerized patient record (CPR).
    A computerized patient record would carry a patient's entire 
medical history and related information in a secure, privacy-
protecting, Web-accessible database. There are three barriers to 
implementation of a national health information system policy.

           LThere is no standard platform technology or 
        terminology for the CPR as there is for business and other 
        applications;
           LThere is insufficient investment and financial 
        incentive, by the government and the private sector; and
           LThere is insufficient leadership

    The issue of standards, in particular, has been a huge barrier to 
the wise and widespread use of technology to prevent medical errors. In 
the vast majority of healthcare settings, a great deal of disparate 
information is collected on a patient but that information is not 
presented to a clinician on a single computer screen. Thus, the data is 
only coordinated for the care of that patient when a clinician reviews 
it, usually when it is brought together on paper. If a result doesn't 
make it to the paper record at the right time, the clinician will not 
be aware of it when she makes care decisions. Thus, there needs to be 
one computerized view of this information. This requires a large 
investment in elaborate interface technologies because different vendor 
systems can't automatically share all of the information with each 
other. Standards would obviate that need. Without standards, hospitals 
can never be sure of their investment in new technology. With 
standards, hospitals will be encouraged to invest in IT, knowing they 
will have a stable platform.
    The solutions to these problems are within grasp. The Federal 
Government has a clearly definable role in creating solutions that will 
deliver to Americans the error-reduction promise of the CPR without 
being intrusive to care providers or the industries that support them.
    These things must be done for an effective National Health 
Information System Policy to be accepted by health care providers, 
insurers and CIS manufacturers.

           LBefore standards that support interoperability can 
        be promulgated or driven by market demand, they must be 
        developed. There is room for much flexibility in such formats, 
        as described in the IOM study For the Record. Standard setting 
        efforts have been successful in creating protocols for 
        transmitting health data. One example is Health Level 7 (HL-7), 
        a protocol for transmitting health information that provides a 
        solution to one of the many issues in interoperability of 
        healthcare IT. HL-7 was supported by academic medical 
        institutions for years in the face of industry skepticism. As 
        more institutions adopted HL-7, the industry realized the 
        advantage of being able to design to a standard and embraced it 
        most profitably. The most important thing is to be able to 
        securely share patient information among different caregivers 
        and researchers. The Government should support research and 
        development for standards by credible institutions through a 
        demonstration process led by centers of excellence in academic 
        medicine, with full collaboration by industry.
           LCPR standards must aid hospitals in complying with 
        HIPAA, the Health Information Portability and Accountability 
        Act. HIPAA rightly mandates extreme care of confidential 
        patient data. But its enactment has been stymied by a 
        hodgepodge of competing interests and its implementation 
        promises to be one of the largest unfunded mandates ever levied 
        on the health care industry. A wise national health information 
        system policy will create standards for easier, more affordable 
        compliance.
           LMedicare and Medicaid should include incentives for 
        hospitals to comply with the standards of the National Health 
        Information System Policy, and provide disincentives for 
        noncompliance. It's cheaper to process an electronic 
        transaction than a paper one--that's why banks used to reward 
        customers to use ATMs instead of tellers. The Center for 
        Medicare and Medicaid Services (CMS) has, in the past, viewed 
        technology as a cost-center rather than an investment. Yet a 
        CPR can reduce difficulty in a variety of reporting and 
        compliance areas. Medicare can reap the same benefits from 
        technology that private sector industries have, increasing 
        productivity and quality through the strategic use of IT. The 
        Information Technology Association of America projects that an 
        industry-wide investment in IT of $18.1 billion would yield 
        gross savings of greater than $120 billion dollars for the 
        healthcare industry over a six-year period. But unlike other 
        industries, healthcare providers do not have the profit margins 
        to invest for the future in this area.
           LThe Federal Government should provide funding to 
        help hospitals invest in IT. Hospitals and academic medical 
        centers are at the center of an integrated health IT system and 
        will be among the greatest users of the technology. But they 
        cannot alone shoulder the cost of developing a system that must 
        be able to serve patients, doctors, government agencies and 
        insurers. Clearly there is justification for a national 
        investment in the development of such a system. In fact, a 
        nationally functional system will only be built 
        collaboratively. The system will be potentially useful for 
        those areas of increasing shortage in health care providers--
        rural areas and the inner city. Support is given in a variety 
        of underserved locales for aspects of care.

The Patient Safety Improvement Act Of 2002
    H.R. 4889, The Patient Safety Improvement Act Of 2002, contains 
provisions on interoperability of healthcare IT that will allow 
information technology to fulfill its promise in the area of patient 
safety. I want to acknowledge the extraordinary work of several Members 
of the House in the area of using IT to protect patient health. First 
Chairwoman Johnson, who by introducing this bill has advanced the cause 
of safety to a new level. This bill is a quantum leap in solving the 
medical errors problem with tools that have not been used effectively 
in the past and needed someone of vision to champion it. Mr. Houghton 
of New York and Ms. Thurman of Florida, your bill H.R. 3292, the 
Medication Errors Reduction Act of 2001, paved the way for technology 
to be applied to patient safety. Your leadership has been sine qua non 
in this field. Mr. Rangel of New York has long understood that a new 
solution based on technology must be applied to healthcare for us to 
solve the old problems that have bedeviled us. Thank you also for your 
leadership and support of the interoperability provisions.
    How does H.R. 4889 actualize the potential of IT in healthcare? The 
bill establishes an inclusive process that calls upon the expertise of 
industry, academic medicine, community medicine, public health and 
government. The formation of the Medical Information Technology 
Advisory Board (MITAB) is necessary so that interoperability solutions 
can be found that are applicable in the greatest number of healthcare 
settings, whether government or private. Those who use IT and those who 
manufacture it must be aligned from the beginning to design the right 
solutions. We have seen too often in the past how good technology fails 
because what has been designed for one environment does not translate 
to another. For example, excellent systems for administrative data 
exchange do not translate well for clinical care. The MITAB section of 
the bill would bring together those who produce healthcare data, those 
who consume it and those who make the media of storage and exchange 
around a single effort.
    However, there is a step that is at least as important, which has 
yet to be included in this legislation. H.R. 4889 needs to recognize 
that what happens at a theoretical level may not translate well into an 
operational environment, particularly in a field as complex as 
healthcare. For the vision of H.R. 4889 to be realized, it is critical 
that demonstration projects to test the efficacy, usability and 
scalability of IT standards be conducted. Scalability is a key 
determinant of success. A technology that appears to be a great idea in 
the inventor's garage, and works beautifully in a dozen physician 
offices, can fail when it has to care for millions of patients. 
Medicare and Medicaid's patients are found in every setting in America, 
large inner cities, sparse rural counties, suburban tracts and local 
neighborhoods. So standards must be tested in a diversity of settings 
to ensure they will work wherever these patients, and all Americans, 
receive their care.
    Congress has an opportunity rarely presented in history. It can 
instigate a paradigm shift by seizing today's revolutionary technology, 
and it can save lives by putting it in the hands of the nation's 
healers. It is time to convene the best minds in this field and develop 
the standards for technology that will be indispensable to our future 
health. Academic medical centers can collectively take the lead in 
developing the technology for patient and clinician needs, and billing 
and compliance requirements. But they must be part of a vigorous 
partnership with the government, physician organizations, insurers and 
corporations--all of which will benefit from a true national IT system.

                                 

    Chairman JOHNSON. Thank you very much, Dr. Pardes. Ms. 
Rosenthal?

  STATEMENT OF JILL ROSENTHAL, MPH, PROJECT MANAGER, NATIONAL 
        ACADEMY FOR STATE HEALTH POLICY, PORTLAND, MAINE

    Ms. ROSENTHAL. Thank you, Chairwoman Johnson, Congressman 
Stark, and Members of the Committee. My name is Jill Rosenthal 
and I am with the National Academy for State Health Policy, a 
nonpartisan, nonprofit public policy research organization that 
works with State governments to help them achieve excellence in 
health care policy and practice. Our organization has been 
working with the Institute of Medicine and States on the issue 
of patient safety since 1999.
    Among the recommendations outlined in the IOM report, ``To 
Err Is Human,'' is the call for two types of reporting systems, 
each designed to address a specific concern, mandatory 
reporting as part of a public system for holding health care 
organizations accountable for performance, and voluntary 
reporting to complement mandatory reporting by detecting system 
weaknesses before serious harm occurs. The IOM made clear there 
is the need for both mandatory public reporting and voluntary, 
confidential reporting.
    As the IOM envisioned, a nationwide mandatory reporting 
system would be established by building on current State 
systems with funding provided to States for this purpose. 
States would be given this role because they are on the front 
line in protecting the public's health. States have the unique 
role and legal responsibility to license and provide oversight 
of health care facilities and professionals. The public looks 
to State government to ensure that the health care system takes 
measures to ensure care is safe.
    Although States have struggled with lack of resources to 
implement reporting systems, they are embracing the challenge. 
Twenty States have created mandatory reporting systems. More 
States are considering them and others would follow if 
resources were available.
    According to State officials, mandatory systems play a 
vital role in facility oversight and provide a window into 
facility patient safety practices. In addition to investigating 
individual events and ensuring corrective action, many States 
share reported information with professional licensure boards 
when professional standards may have been violated and issue 
patient safety alerts and newsletters to help facilities 
improve safe practices. Unfortunately, this bill will likely 
interfere with States' capacity to meet their obligations.
    Here is where the bill creates problems. The bill does not 
recognize the importance of separate reporting systems for 
accountability and learning. Without a mandatory system that 
provides accountability, there will be no check and balance and 
Congress and the public will have no way to know that voluntary 
reporting is reducing serious medical errors.
    The bill does not distinguish between the purpose of 
collecting information about medical errors that result in 
serious harm and those that result in minimal harm. Voluntary 
systems are intended for events that cause minimal harm. Events 
that cause serious harm are intended for mandatory systems 
because these types of events may indicate serious system 
weaknesses. However, the bill defines patient safety so broadly 
that it applies to all events. As a result, the bill creates an 
additional burden on providers who may have to report the same 
events to two systems.
    The bill does not recognize or support the State's role in 
ensuring accountability through mandatory systems. The bill 
could have a chilling effect on State efforts to collect data 
for the purposes of accountability. If duplication exists, 
providers are unlikely to support two separate reporting 
mechanisms and will likely lobby against State efforts to 
create mandatory systems, even though they have a different 
scope, purpose, and function. The bill authorizes funding for 
voluntary reporting but does not address the IOM recommendation 
to fund State-based mandatory systems.
    The bill's confidentiality provisions may conflict with 
State reporting system provisions. The bill requires data 
reported to Patient Safety Organizations to be confidential and 
privileged. However, the IOM report recommended that analysis 
of individual serious events be made available to the public as 
part of a system of accountability. Since the bill requires 
reporting of all types of events, all events would fall under 
strict confidentiality protections.
    In a later study, the IOM called for the health systems to 
be accountable to the public, to do their work openly, to make 
their results known to the public and to build trust through 
disclosure, even of the system's own problems. According to the 
IOM, a transparent health care system will improve trust and be 
more patient-centered and safer because patients would have 
information to make informed decisions about their care.
    There are opportunities to improve the bill to meet the 
IOM's intent and eliminate some of the problems for States. 
One, clarify the scope, purpose, and function of voluntary 
reporting as separate from and complementary to State-based 
mandatory systems.
    Two, recognize that State-based mandatory systems focus on 
cases that cause serious harm and may make information known to 
the public. Events that cause serious harm, death, and criminal 
events should not be given legal protection under a voluntary 
system.
    Three, balance funding for improving national voluntary 
reporting with funding for State-based mandatory systems.
    In closing, State and Federal Government need to represent 
consumers and assure them that the health care system is being 
held accountable for safety. A public reporting system that 
provides both a check and balance and public information is 
needed, as is a voluntary system for quality improvement. 
Without both, we cannot realize the IOM's goals and we fail to 
provide needed public accountability for patient safety. Thank 
you.
    [The prepared statement of Ms. Rosenthal follows:]
Statement of Jill Rosenthal, MPH, Project Manager, National Academy for 
                  State Health Policy, Portland, Maine
    Chairman Johnson, Congressman Stark and distinguished Members of 
the Committee:
    My name is Jill Rosenthal and I am a project manager for the 
National Academy for State Health Policy, a non-partisan, non-profit 
public policy research organization that works with state governments 
to help them achieve excellence in their health care policy and 
practice.
    Our organization has been working with the Institute of Medicine 
and states on the issue of patient safety since 1999. We have provided 
policy analysis, training, and technical assistance to states as they 
have attempted to address the Institute of Medicine's recommendations.
    Among the recommendations outlined in the Institute of Medicine 
report To Err is Human is a call for two types of reporting systems, 
each designed to address a specific concern. Mandatory reporting was 
intended for events that cause serious harm or death, as part of a 
public system for holding health care organizations accountable for 
performance. Voluntary reporting was intended to complement mandatory 
reporting by detecting system weaknesses before the occurrence of 
serious harm. The Institute of Medicine made clear that there is a need 
for both mandatory, public reporting systems and voluntary, 
confidential reporting systems.
    As envisioned by the Institute of Medicine, a nationwide mandatory 
reporting system should be established by building on current state 
systems. The IOM recommended that funding be provided to states for 
this purpose.
    States are the appropriate entities to take on this role because 
they are on the front line in protecting the public's health. States 
have the unique role and legal responsibility to license and provide 
oversight of health care facilities and professionals. The public looks 
to state government to ensure that the healthcare system takes 
necessary measures to ensure care is safe.
    Although states have struggled with a lack of resources to 
implement reporting systems, they are embracing the challenge. Today 20 
states have created mandatory reporting systems. More states are 
considering enacting systems and others would follow if resources were 
available.
    According to state officials, mandatory reporting systems play a 
vital role in hospital oversight by providing a window into hospital 
patient safety practices and developing more complete facility 
profiles. In addition to investigating individual events and ensuring 
corrective action, many states share reported information with 
professional licensure boards when professional standards may have been 
violated, and they issue safety alerts and newsletters to help 
facilities improve safe practices.
Examples:

           LColorado shares copies of some incident reports 
        with professional licensing boards, the attorney general's 
        office, and other relevant state agencies.
           LTennessee reviews corrective action plans while 
        investigating complaints and during annual surveys to ensure 
        that facilities have carried out their plans.
           LIn Kansas, surveyors are given a summary of all 
        adverse findings for each facility. During surveys they examine 
        facility risk management and assure that corrective actions 
        have been implemented and if additional problems are noted, 
        that further corrective actions are taken.
           LMassachusetts provides data to the Massachusetts 
        Coalition for the Prevention of Medical Errors to determine 
        approaches for alerting and informing facilities about the risk 
        of errors and practices for addressing identified problems.
           LNew York's system includes a report generation 
        function that allows facilities to track and trend their own 
        incidents and to compare their performance against peer 
        facilities, within their regions, and statewide.

    States continually strive to improve their systems. We are 
currently working with states and the National Quality Forum to compare 
state lists of types of events with the National Quality Forum's (NQF) 
list of Serious Reportable Events in order to help states develop a 
standardized list of clearly defined events that can be easily 
implemented and that allows room for state flexibility.
    Unfortunately, the bill before you will likely interfere with 
states' capacity to meet their obligations.
Here's where this bill creates problems:
    The bill does not recognize the importance of establishing separate 
reporting systems for accountability and learning.

    Without a mandatory system that provides accountability, there will 
be no check and balance and Congress and the public will have no 
mechanism to know that voluntary reporting is working to reduce serious 
medical errors.

    The bill does not distinguish between the purpose of collecting 
information about medical errors that result in serious harm and those 
that result in minimal or no harm.

    Voluntary reporting systems are intended to collect information 
about events that cause minimal or no patient harm. Events that cause 
serious harm or death are intended for mandatory systems because these 
types of events may indicate serious system weaknesses. However, 
``patient safety data'' is so broadly defined in the bill that it 
applies to all types of events. As a result, the bill creates an 
additional burden on providers who may be required to report the same 
events to both state-based mandatory systems and the national voluntary 
system.

    The bill does not recognize or support the states' role of ensuring 
accountability through mandatory reporting systems.

    The bill could have a chilling effect on state efforts to collect 
data for purposes of accountability. If duplication exists, providers 
will be unlikely to support two separate reporting mechanisms and will 
likely lobby against state efforts to create mandatory reporting 
systems even though they have a different scope, purpose, and function 
than voluntary systems. The bill authorizes funding for the voluntary 
system but does not address the IOM recommendation to fund state-based 
mandatory systems.

    The bill's confidentiality provisions may conflict with state 
reporting system provisions.

    The bill requires data reported to patient safety organizations to 
be confidential and privileged. However, the IOM recommended that 
analyses of individual serious event reports should be made available 
to the public as part of a public system of accountability. Since the 
bill requires reporting of serious events in addition to those that 
cause minimal harm, all events would fall under strict confidentiality 
protections.
    In a later study, the IOM called for health systems to be 
accountable to the public; to do their work openly; to make their 
results known to the public and professionals; and to build trust 
through disclosure, even of the systems' own problems. According to the 
IOM, a transparent health care system will improve trust, be more 
patient-centered, and safer, because patients would have information to 
make informed decisions about their care. Some organizations, such as 
the Veteran's Administration, have increased transparency already. The 
IOM points out that although many providers fear increased transparency 
could increase liability, some evidence shows that open disclosure of 
errors may decrease the likelihood of malpractice loss.
There are opportunities to improve the bill that would meet IOM's 
        intent and eliminate some of the problems for states:

          1. LClarify the scope, purpose, and function of voluntary 
        reporting systems as separate and distinct from, and 
        complementary to, state-based mandatory reporting systems. This 
        would reduce duplication and confusion and lay the groundwork 
        to address IOM recommendations. Confidential, voluntary 
        reporting systems should not preempt state public mandatory 
        systems that collect information about events that cause death 
        or serious harm in the 20 states with existing systems or in 
        states that have yet to develop mandatory systems.
          2. LRecognize the role of state-based mandatory reporting 
        systems as identified in the IOM report: to collect information 
        on specific cases that cause serious harm or death for the 
        purpose of accountability and to collect information that may 
        become known to the public. Certain events, such as those that 
        cause serious harm, death, and criminal events, should not 
        inadvertently or intentionally be given legal protection under 
        a voluntary system.
          3. LBalance funding for improvement of national voluntary 
        reporting efforts with funding for state-based mandatory 
        systems, as envisioned by the IOM report.

    State and federal government need to represent consumers and assure 
them that the health care system is being held accountable for safety. 
A public reporting system that provides both a check and balance and 
public information is needed as is a voluntary system for quality 
improvement purposes. Without both, we cannot realize the Institute of 
Medicine's goals and we fail to provide needed public accountability 
for patient safety.
Background
The National Academy for State Health Policy
    National Academy for State Health Policy is a non-partisan, non-
profit public policy research organization that works with state 
governments to help them achieve excellence in their health care policy 
and practice. Since its inception in 1987, NASHP has provided state 
health policy leaders with access to timely, unbiased information on 
pressing healthcare issues. Because NASHP recognizes that 
responsibility for health care does not reside in a single state 
agency, department, or branch of government, it strives to foster 
productive interchange across all lines of authority. Each year, NASHP 
conducts policy analysis, provides training and technical assistance to 
states, and--through its publications, annual state health policy 
conference, media briefings, meetings, and website (www.nashp.org)--
disseminates information designed to assist states in the development 
of practical, innovative solutions to complex health policy issues.
States with mandatory reporting
    Twenty states have created mandatory reporting systems:

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California                          Nebraska           South Carolina
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Information that states collect
    Twenty state licensure and certification agencies require mandatory 
reporting of adverse events that occur in hospitals. Many of the 
reporting systems also collect information from ambulatory care centers 
and psychiatric hospitals. Some collect information from free-standing 
laboratories and outpatient mental health centers, nursing facilities, 
and other licensed facilities. For example, Colorado's reporting system 
requires reporting from general and acute care hospitals, ambulatory 
care centers, psychiatric hospitals, freestanding laboratories, 
freestanding outpatient mental health centers, nursing facilities, and 
other licensed facilities. Washington State's reporting system collects 
information from acute care hospitals only.
    States identify and define reportable events in different ways 
although they require fairly similar data elements to be reported. 
Facility name, type of incident, and date of occurrence are required by 
all states. Most states also include patient identification, provider 
identification, description of the incident, person reporting the 
incident, action taken by facility, patient outcome/status, and 
notification of other parties (e.g. professional licensing boards). 
Some include identification of witnesses as well.
Standardizing elements within state reporting systems
    One of the barriers that states face in implementing mandatory 
reporting systems is identifying an unambiguous and clearly defined 
list of reportable events. The IOM report called for a nationwide 
mandatory reporting system that provides for the collection of 
standardized information by state governments about adverse events that 
result in death or serious harm. The report urged Congress to designate 
the National Quality Forum (NQF) as the entity responsible for 
establishing and maintaining a core set of reporting standards to be 
used by the states. Through its Serious Reportable Events Project, the 
NQF used a voluntary consensus standards setting process to develop a 
set of serious, preventable adverse events that might form the basis 
for a national state-based event reporting system. Participants 
identified 27 serious adverse events that should be reported by all 
licensed healthcare facilities. As suggested in NQF's report, 
additional specification may need to be developed to ensure 
standardized data collection.
    The National Academy for State Health Policy (NASHP) is working 
with the NQF and a group of states (SAFER: State Alliance for Error 
Reporting) to compare state lists of reportable events with the 
National Quality Forum's (NQF) list of Serious Reportable Events in 
order to determine areas of overlap and areas of difference. The result 
of the project will be a user's guide to help states develop a 
standardized list of clearly defined events that can be easily 
implemented and that allows room for state flexibility.
States considering mandatory reporting
    Twelve bills dealing with some aspect of error reporting were 
introduced in seven states during the 2001 state legislative sessions. 
Of these, six bills (in MA, MD, NY, and PA) would require new types of 
mandatory reporting or would strengthen existing reporting 
requirements.
State protection and disclosure of data
    The IOM recommended that errors that are identified through 
mandatory reporting systems and are part of a public system of 
accountability should not be protected from discovery. State 
investigations of individual incidents are available on request in most 
states. One state makes investigation reports available on the 
Internet. All reporting systems (8) reviewed during NASHP site visits 
protect patient specific information. Reporting system officials 
unanimously support protecting patient confidentiality.
    Some states release aggregate data that does not identify the 
facilities or patients involved in the incidents (de-identified data). 
Data elements may include the most common injuries, the average number 
of incidents per facility, or the total number of incidents reported.
    States less commonly provide aggregate data that identifies 
incidents by facility name, in part because underreporting leads to 
incomplete data, making it difficult to distinguish between facilities 
that experience more errors and those that report more errors because 
they are more compliant with reporting requirements. However, some 
states have considered releasing information on the number, type, 
frequency, and causes of errors by facility. To do so requires risk 
adjustments for age, relative illness, and other complex factors so 
that users can interpret the data accurately. States continue to 
struggle with developing risk adjustment methodologies that take into 
account relevant factors that may help explain the frequency of adverse 
events.
    States may choose to change their approach to disclosure over time. 
Some may choose to release de-identified aggregate data in the early 
stages of the system's development and move toward facility-specific 
data as the system matures, reporting increases, and a risk-adjustment 
technique is identified.
Examples:

           LColorado's Internet site posts reported incidents 
        and findings from state investigations. The site can be found 
        at www.cdphe.state.co.us/hf/hfd.asp.
           LFlorida's statute makes reports confidential and 
        not subject to discovery or admissible as evidence in civil 
        lawsuits. Data cannot be shared with other state agencies. 
        Aggregate data are available upon request but names of 
        facilities and individuals are not available.
           LKansas prepares an annual report using aggregate 
        data by facility size for the average number of incidents 
        reviewed, the total number of reportable events, and the total 
        number of reportable events reported to each professional 
        board.
           LMassachusetts does not have any legal data 
        protections for reported incidents. However, patient specific 
        information and some peer review protected information may not 
        be released. All information in the reporting system, including 
        formal narrative reports, deficiency statements, and facility 
        personnel interviewed during investigations, is available to 
        the public upon request.
           LIn 2001, New York prepared its first annual report 
        that identifies hospitals with reporting rates significantly 
        below what is anticipated: www.health.state.ny.us/nysdoh/
        commish/2001/nyports/nyports.htm.
           LWashington incident reports are subject to public 
        disclosure but names of individuals are redacted.

How states use data
    The overriding reason for mandatory reporting systems is to hold 
healthcare facilities accountable for preventable adverse events that 
result in serious injury or death. Accountability is achieved by 
investigating the event, providing expertise or information to help 
remedy the problem, and insuring that appropriate changes are made and 
sustained to avoid the problem in the future. Investigation may be made 
on-site by clinicians.
    A secondary purpose of a mandatory reporting system may be to 
improve overall quality and patient safety across facilities. Over time 
as experience and expertise have grown, many state reporting systems 
have shared lessons learned from individual reporting incidents by 
aggregating data to identify trends. Some states issue patient safety 
alerts, distribute newsletters that highlight trends and best 
practices, and operate websites that can be used by facilities to 
compare their patient safety history to peer facilities.
    To varying degrees, all states share information with professional 
medical, nursing, and pharmacy boards if reports indicate that a 
professional violation may have occurred.
Examples:

           LColorado has established an Occurrence Advisory 
        Committee, composed of providers, consumers, and state 
        representatives, to assist the state in making better use of 
        reported data.
           LKansas publishes newsletters highlighting trends 
        and describing practices to reduce repeat incidents in those 
        areas.
           LMassachusetts provides data to the Massachusetts 
        Coalition for the Prevention of Medical Errors to determine 
        approaches for alerting and informing facilities about the risk 
        of errors and practices for addressing identified problems.
           LNew York's system includes a report generation 
        function that allows facilities to track and trend their own 
        incidents and to compare their performance against peer 
        facilities, within their regions, and statewide.

Other state patient safety activities

           LPublic/private partnerships: Coalitions have 
        diverse memberships, often including providers, government, 
        insurers, health plans, consumers, and community stakeholders 
        like major employers, labor unions, or teaching institutions. 
        Stakeholders determine the mission, goals, objectives, and 
        policies of the group. With the exception of peer review data, 
        these groups share knowledge and resources with other 
        interested parties in the community, including governmental 
        bodies. They take actions to address specific problem areas, 
        for example, medication errors, wrong site surgery, peer review 
        protections for reported adverse events, and education of 
        professionals about error prevention. Statewide public/private 
        patient safety coalitions have been formed in twelve states: 
        Arkansas, Colorado, Georgia, Maryland, Massachusetts, Michigan, 
        Minnesota, Ohio, Pennsylvania, Tennessee, Virginia, and 
        Wisconsin.
           LPublic purchasers: Public employee purchasers in 
        Maine, Massachusetts, Minnesota, Washington, and Wisconsin have 
        forged relationships with private providers to mobilize 
        employer purchasing power to improve health care safety and 
        give consumers information to make informed health care 
        choices.
           LState legislatures continue to increase their 
        efforts to address patient safety.

           SUMMARY OF STATE LEGISLATIVE ACTIVITY: 1999--2001*
------------------------------------------------------------------------
                                       1999         2000         2001
------------------------------------------------------------------------
No. of bills introduced            1\1\         34           61
����������������������������������                           No. of
����������������������������������
����������������������������������
                                                system-wide  system-wide
                                                 analysis;    analysis;
                                                 study        access to
                                                 commission   data,
                                                 ; report     study
                                                 to           commission
                                                 legislatur   , report
                                                 e            to
                                                              legislatur
                                                              e
                                                reporting    reporting
                                                 requiremen   requiremen
                                                 ts           ts
                                                improved     establishme
                                                 safety       nt of
                                                 through      patient
                                                 language     safety
                                                 access       center
                                                medication   required
                                                 error        activities
                                                 reduction    as
                                                              condition
                                                              of state
                                                              licensure
                                                public       public
                                                 disclosure   disclosure
                                                 of           of
                                                 informatio   informatio
                                                 n            n
------------------------------------------------------------------------
* most recent year available

NASHP documents on state activities related to patient safety
    Sharon Conrow Comden and Jill Rosenthal, Statewide Patient Safety 
Coalitions: A Status Report (Portland, ME: National Academy for State 
Health Policy, May 2002).
---------------------------------------------------------------------------
    \1\ A Virginia bill was not enacted but was implemented in 2000 by 
request of the Speaker. That bill is counted as an enacted bill for 
2000.
    \2\ HI, MA, NY, OK, and WA.
    \3\ CA, FL, HI, IL, MA, MN, MO, NJ, NY, PA, SD, VA, WA, and WV.
    \4\ CA, CT, FL, GA, IL, IN, IA, KY, ME, MD, MA, MI, MN, MO, NV, NH, 
NJ, NY, OR, PA, VA, and WV.
---------------------------------------------------------------------------
    Jill Rosenthal and Maureen Booth, How Safe is Your Health Care? A 
Workbook for States Seeking to Build Accountability and Quality 
Improvement through Mandatory Reporting Systems (Portland, ME: National 
Academy for State Health Policy, November 2001).
    Jill Rosenthal, Maureen Booth, and Anne Barry, Cost Implications of 
State Medical Error Reporting Programs: A Briefing Paper (Portland, ME: 
National Academy for State Health Policy, May 2001).
    Jill Rosenthal and Trish Riley, Patient Safety and Medical Errors: 
A Road Map for State Action (Portland, ME: National Academy for State 
Health Policy, March 2001).
    Jill Rosenthal et al., Current State Programs Addressing Medical 
Errors: An Analysis of Mandatory Reporting and Other Initiatives 
(Portland, ME: National Academy for State Health Policy, January 2001).
    Jill Rosenthal, Trish Riley, and Maureen Booth, State Reporting of 
Medical Errors and Adverse Events: Results of a 50-State Survey 
(Portland, ME: National Academy for State Health Policy, April 2000).

                                 

    Chairman JOHNSON. Thank you, Ms. Rosenthal. Dr. Leape, I 
would like to return to your statement, at the end of your 
prepared remarks. You stated that section 1182(D) that allows 
disclosure for disciplinary proceedings and removes protections 
of that information needed as part of a disciplinary 
proceeding, would nullify all the benefits of the bill. Would 
you enlarge on that?
    Dr. LEAPE. Yes, I would be pleased to. I think we ought to 
be clear that the bill provides protection for information that 
is shared from a hospital with a , and I think that is 
critically needed. Clearly, it does not mean that all the 
information is protected for any use whatsoever. For example, 
the information would include information that is in the 
medical record, the patient's diagnosis, what happened, all 
those things. Clearly, nobody has in mind that that should not 
be available.
    For disciplinary procedures, all of that information is 
currently available. We have mechanisms now for disciplinary 
procedures, as we do for malpractice, which include the ability 
to examine witnesses, to take depositions, to examine the 
records in the hospital, and all of these, as I understand it, 
would not be impacted nor should be impacted by this 
legislation.
    So, I do not think we need to remove that protection in 
order to achieve what we want in the way of appropriate 
disciplinary procedures. If that exclusion is there, then 
physicians and nurses will not report in the voluntary system. 
They will feel that they have, in effect, lost their peer 
review protection and I think it will literally set the process 
of voluntary reporting back.
    Chairman JOHNSON. Thank you. I thought that was a very 
strong statement and we will--I will, at least--give it very 
careful consideration.
    Dr. Wood, would you explain a little bit more thoroughly 
why the JCAHO process resulted in 2,000 events reported and why 
you think the MedMARx resulted in 400,000 in a year. That is an 
astounding difference in the amount of knowledge developed as a 
result of differently structured reporting systems. Now, what 
is the difference and why 2,000 versus 400,000?
    Dr. WOOD. Madam Chairman, I think this relates back to the 
statement you made earlier in this hearing, that what we are 
really trying to do is to improve the error-prone care 
processes, in other words, systematic improvement.
    What we see in the JCAHO sentinel events program is the 
reporting of the most egregious events, in other words, the 
events that result in death or harm. These are not the areas--
this is not the focus of attention, to try to get to 
improvement in health care processes. The much greater 
opportunity are those things that are recognized as a potential 
accident that do not result in egregious harm to the patient. I 
think the statistics I quoted give some idea of the relative 
magnitude of those two opportunities.
    That is why I think if we focus our attention through this 
bill on trying to draw out of the woodwork, if you will, the 
near misses, this will give us the best capacity to really get 
at and improve these processes, whereas if we continue to focus 
on those that are only the sentinel events, we will only see a 
small fraction and it will take us years and years to try to 
get at improved processes if those are the only ones that we 
are focusing on.
    I think that is where the fundamental discussion about 
voluntary versus mandatory reporting comes out. The voluntary 
will help bring these near-misses out, whereas the mandatory 
will always drive those underground.
    Chairman JOHNSON. A more concrete example, I think, in my 
life, is represented in a manufacturing portion of the country. 
For a long time, we focused on looking at our rate of 
perfection at the end of the manufacturing process and the 
amount of goods that you had to reject because they were not 
perfectly done. This was a very big issue, and we focused 
harder and harder and harder to try to bring down that error 
rate, if you will, at the end. Actually, it was not until we 
began to look at process that we actually reduced scrap in the 
more concrete setting of manufacturing. Certainly, I just have 
been very impressed in my life with how attention to tiny 
details that seem to be irrelevant to the end product end up 
affecting the end product very much.
    Now, I want all of you to respond to Ms. Rosenthal's 
concern, which I consider to be absolutely real and legitimate. 
States are pursuing mandatory systems. My own State adopted a 
mandatory system. However, they have a very narrow definition 
of what must be reported under that mandatory system. It has to 
be associated with death or serious measurable disability.
    So, I do not know whether the other States all have that 
narrow of a definition, but Ms. Rosenthal did imply that their 
focus primarily and that the IOM saw the mandatory system as 
focused primarily on that kind of an ``error.'' Now, we all 
know that some of those cases that end up to be death or 
disability are not the result of error, they are the result of 
high-risk surgery and the outcome was going to be bad and this 
was a chance to try to change it. So, I think you have to be 
careful about identifying all of those reports as necessarily 
error-related. States are requiring all those reports so that 
they can look and see which are error-related, and that is 
useful.
    Now, as I understand her testimony, and I will give her a 
chance to enlarge on it in a minute, but as I understand her 
testimony, she is saying two things. First of all, everybody 
needs a mandatory reporting system, we should mandate that. 
Second, she is saying it would create two reporting systems. 
Now, there is a slight contradiction in her testimony about 
this dual reporting system because the IOM is proposing a dual 
reporting system and they do overlap. There is no way of 
getting away from that.
    So, how do you currently, in your own institutions as the 
system is currently developing, deal with the dual reporting? I 
mean, if we put this in place and this system comes up, what 
will be its impact on the mandatory reporting system of your 
State? Dr. Wood?
    Dr. WOOD. Perhaps I could try to respond to that in this 
way.
    Chairman JOHNSON. I am really expecting all of you to. I 
want Ms. Rosenthal to be able to enter in whenever she wants 
to, and she can just sort of signal that, because we need to 
hear this discussion about the inevitable--I mean, inevitably, 
this is going to be a dual reporting system. Even if you do it 
the way the IOM wanted, it is going to be dual. So, let us talk 
about that straight out and get it out and see, make sure that 
we do this as well as we can. Dr. Wood?
    Dr. WOOD. I truly do not believe this is an either/or 
situation, and I agree with you, Mrs. Johnson, that having two 
pathways, if you will, for two different sets of problems would 
not be incompatible either with the IOM report or with maybe 
the direction that we should be heading in.
    Right now, I do think mandatory reporting is a reality when 
we are talking about the most egregious problems. It is a 
reality in 13 States by State mandate, and it is also a reality 
for the majority of accredited hospitals in this country who 
are associated with the JCAHO sentinel events policy.
    What we are lacking is the opportunity and the tool to 
bring those near-misses out so that we can get at the real 
opportunity for process improvement, and that is the value of a 
voluntary reporting relationship, in my opinion.
    Chairman JOHNSON. Also for the rest of you, in those States 
where there is no mandatory policy, you need to talk about 
that, too. Mr. Segel?
    Mr. SEGEL. The situation in Pennsylvania is still fluid 
because an act has been passed but regulations have not been 
issued. It will require mandatory reporting of serious 
incidents. By the way, a previous system existed that was 
mandatory but got very few reports because it was not 
appropriately supported and then there was deep mistrust in the 
system. Then the new act will define a reporting process for 
near-misses, as well.
    I think the reason why I disagree with the statements that 
have been made is because the purpose of this bill is to extend 
some additional protection to institutions that choose 
voluntarily to produce information and bring it out into the 
open. It is not, in my view, a duplication or an undermining of 
what might happen in our State or any other place. It is 
instead creating some additional protection and safety around 
information that is brought out into the open, and it is 
voluntary, so it is voluntary to the providers, whether they 
choose to accept that protection in exchange for that 
commitment to the learning system regionally and nationally.
    Chairman JOHNSON. That is an important distinction, that it 
is voluntary. Dr. Pardes?
    Dr. PARDES. I think my colleagues have already stated it 
rather well. I do not see why the one necessarily has to 
preempt or compromise the other. The idea is to get as much 
information out on the table, which I think will allow us to 
have much more ground on which to reduce medical errors in the 
broader sense.
    Chairman JOHNSON. Ms. Rosenthal, given the contradictory 
experience of JCAHO's system and MedMARx, why do you think it 
is a bad thing to have multiple approaches?
    Ms. ROSENTHAL. I very much think there should be multiple 
approaches. What I was trying to clarify was that the Institute 
of Medicine report recommends both mandatory and voluntary 
systems as complementary systems that are different in scope, 
purpose, and function, that mandatory reporting systems are 
intended for the State to hold health care providers 
accountable for safety, for reporting specifically of those 
events that cause serious harm or death, whereas voluntary 
reporting is intended for those events that cause less harm or 
no harm, and there is no reason not to protect that.
    I think the distinction was that if those serious events 
are reported into a voluntary system, then they are also going 
to be reported into the mandatory system, so they need to be 
separate----
    Chairman JOHNSON. That is right. In those States that have 
a mandatory law, there will be two pathways. However, the 
majority of States do not have a mandatory law, therefore will 
be one pathway and at least we will begin to get them started. 
If we do the two-pathway process, which the IOM envisioned, 
perhaps we just need to make a better accommodation in this 
bill to assure that HHS works with each State to minimize or to 
make as simple as possible the collaboration of these two 
systems. What would be your response to that, Ms. Rosenthal?
    Ms. ROSENTHAL. I think that is correct. I think the fear is 
that if all the attention and effort is going into voluntary 
reporting without support for States to do their part for 
mandatory reporting, then we cannot meet the IOM criteria and 
we cannot assure consumers that we are working to improve the 
health care system.
    Chairman JOHNSON. How long have the State laws been in 
place?
    Ms. ROSENTHAL. It depends. Many of them have been in place 
for 20 or so years, but they have been fairly dormant.
    Chairman JOHNSON. See, the 20 or so years have not worked--
--
    Ms. ROSENTHAL. Well----
    Chairman JOHNSON. In Pennsylvania, or we would know more 
about this. So, in a sense, it is because the old mandatory 
systems did not work that there is such division now in the 
community about whether we should go mandatory or voluntary. 
What about the more recent bills passed by the States? What 
evidence do we have that they are bringing up more than just 
the report of the incident of death, which I think in most 
cases was already reported, was it not anyway? It certainly was 
public information.
    Ms. ROSENTHAL. First of all, the reporting systems that 
were created many, many years ago were mostly created--intended 
for a different purpose, and when the Institute of Medicine 
called attention to this issue, they are now looking for ways 
to try to improve the system specifically for this purpose.
    Chairman JOHNSON. So were the old systems too narrow?
    Ms. ROSENTHAL. No, I think they were just focused on--they 
were not necessarily using the data to look for the types of 
things that they are looking for now.
    Chairman JOHNSON. Do we understand why they did not get 
many mandatory reports under the old systems?
    Ms. ROSENTHAL. Well, they were not developed to address 
medical errors, but some did report on what have come to be 
known as adverse events. In many cases, the requirements did 
not attract much attention and lay dormant until a tragic event 
occurred that led to media inquiries about State regulatory 
oversight of hospitals.
    Chairman JOHNSON. What I am really asking is, what do we 
know about the efforts of the States to do mandatory reporting 
and how successful they are? My view is that we do not know a 
lot yet because they have not been in place very long. So, part 
of my reluctance is to mandate that every State do this. I 
would like to get a little further down the road and see how 
the States are doing with that. Meanwhile, I think, not to move 
ahead with the voluntary system which IOM also recommended 
would be relatively irresponsible. Do you object to moving 
forward with the voluntary system, or is it just that you would 
like us to also mandate a mandatory system on the States?
    Ms. ROSENTHAL. There is no objection to voluntary, but that 
it be complemented with mandatory. I think that in looking at a 
State, often New York is the State that is used as an example 
of a successful system that receives more than 20,000 reports a 
year, which is quite a few, if you look at JCAHO receiving only 
2,000 reports in 5 years from all accredited facilities 
nationwide.
    Chairman JOHNSON. Two thousand, but it is not a lot if you 
look at MedMARx receiving 400,000.
    Ms. ROSENTHAL. Right, but just for New York State, over 
20,000 is a pretty good number. According to the States with 
the systems, their feeling is that this is an important 
opportunity for them to see what is happening within health 
care facilities and to monitor facilities and identify systems 
problems as part of their licensure process
    Chairman JOHNSON. What is there in our bill that would 
prohibit any State that does not currently have a mandatory 
system from adopting a law to have a mandatory system?
    Ms. ROSENTHAL. Resources, mostly, and the inclusion in this 
bill of information on those events that cause death and 
serious harm, which could have a chilling effect on the 
development of State mandatory reporting systems which are 
intended to collect this information.
    Chairman JOHNSON. It is not laws. In other words, we are 
not putting any legal barriers up to the development of 
mandatory reporting at the State level, correct?
    Ms. ROSENTHAL. That is correct.
    Chairman JOHNSON. Yes. I understand the resource issue, but 
that is true in every area across the country, I mean, in every 
sector, and it is certainly true in this sector. Dr. Leape?
    Dr. LEAPE. Madam Chairman, based on some of the excellent 
work of Dr. Rosenthal, I think it is a fair assessment to say 
that the reason State mandatory reporting systems have not 
worked is they have all been under-funded. Even New York, which 
everybody touts as being successful because they get 20,000 
reports, does not have the resources to analyze those reports 
and make recommendations, to give feedback to do what needs to 
be done. Reporting without analysis and recommendations is a 
waste of everybody's time, and that has been the situation in 
State mandatory reporting systems with few exceptions.
    One of the Institute of Medicine's recommendations which 
was acted upon was to develop a parsimonious list of reportable 
events, a list of events that everybody would agree are so 
egregious that States have a responsibility to make sure they 
are reported and investigated. The concept is that if the list 
is kept small and restricted to things that we all agree are 
serious, then there would be more likelihood of the State being 
able to insist that these be reported and to follow up and do 
something about them.
    The fact of the matter is that very few States do much 
about any of these reports, and as long as that is true, 
hospitals are not going to report because they see no benefit 
from it, leaving aside all of the problems of embarrassment and 
legal ramifications. I think it is beyond the purview of 
Congress to dictate to States how much they can spend for their 
mandatory reporting systems.
    Chairman JOHNSON. That is a problem, and one of the reasons 
in this bill--I mean, in my first bill, there was no setting 
aside in HHS of a patient safety agency department. There was 
also not a national databank. That is something that, in 
working together, in the draft before the Committee are there 
and they will require funding. As the Secretary pointed out, he 
wants to be sure he has the funding.
    I think we can take responsibility for eliciting reports 
and for analyzing them through the process we have set forward 
in this bill. If we mandate on the States, we would certainly 
have to mandate money. We are not yet agreed as to how much 
this bill will cost or how we will support that effort at the 
Federal level. I think one really has to begin to ask, do we 
need 50 abilities as well as a national ability to analyze this 
data?
    I thought your comments, I think it was Dr. Wood but I 
cannot quite remember now--one of you mentioned how some of the 
peer review organizations are providing some analysis of data 
from single institutions, so there is developing a conversation 
between those who have analytic capability on a smaller scale. 
That is very helpful. We do need to encourage the development 
of that analytical capability, and right now. I guess, as a 
Member of Congress, I would rather focus on the system that we 
need to develop for national purposes. That system has to be 
more encompassing on the number of incidents, the number of 
reports, and types of incidents and reports, because the 
national effort certainly has to be focused at prevention and 
at system change.
    We will, inevitably, encompass also for those States that 
do not have a mandatory reporting system all of the more 
serious reports, as well. So, we will have to watch this over 
time as each system develops and work closely with the States 
and with offices like yours that track all the State 
developments. I would be happy personally to think through with 
you if there is any way we can foster that collaboration in 
this bill. Mr. Stark?
    Mr. STARK. Thank you. I want to thank the panel and thank 
you, Ms. Rosenthal, for carrying the water for the IOM here and 
in the States.
    I think that, just to comment on the previous questions, 
that in the bill before us, there probably would not be 
transparency for what is called sentinel events. In other 
words, there is no distinction in this bill between a death and 
a near-miss. Therefore, the deaths and disfigurements and 
disabling accidents would not necessarily, or might be 
prohibited from being transparent, and Dr. Leape, you mentioned 
the importance of transparency in your testimony.
    The American Medical Association (AMA) Code of Medical 
Ethics says that significant medical complications may have 
resulted from the physician's mistake or judgment. In these 
situations, the physician is ethically required to inform the 
patient of all facts necessary to ensure understanding of what 
has concern and concern regarding legal liability which might 
result following truthful disclosure should not affect the 
physician's honesty with the patient, right? You subscribe to 
that, do you not? Dr. Wood does, I know. He is a big guy in the 
AMA.
    Well, then why would it not be--what would be the objection 
to requiring us patients from knowing that? Would you have any 
objection to that, Dr. Leape? Why should it not be the law of 
the land that if there is a mistake, that--if I am dead, I 
guess I do not know who you are going to tell, but if I am 
seriously harmed, why should I be told?
    Dr. LEAPE. I do not want to get into a metaphysical 
discussion about how you require people to be good, but I think 
that there is no question that physicians----
    Mr. STARK. What little time----
    Dr. LEAPE. Subscribe to the concept that the patient has a 
right to know everything that has happened to them, and I think 
we are making a lot of progress in achieving that. The idea 
that you can do that by legislation totally escapes me.
    Mr. STARK. The idea is that if somebody did a little time 
for lying, for not telling the patient, it would have a 
meritorious effect, it seems to me, on the rest of the 
profession. We have got 100,000 deaths, at least, from errors 
related to hospitals a year. Now, nobody dies from near-misses, 
and we seem to be ignoring those as not being very important. I 
would like to work on those for a while, and it seems to me 
that, yes, there would very likely, although there is some 
literature that suggests that perhaps if hospitals and doctors 
deal honestly with patients up front, they might not get mad 
and sue later. I do not know how you know that or would not 
know it.
    Do you not think that we should, where we have mandatory 
reporting, require that the patient should be informed?
    Dr. LEAPE. I think what we are interested in doing is 
preventing injury, and the way to prevent that is to change the 
systems. Now, most of those 100,000 deaths were not caused by 
bad doctors and bad nurses. They were caused by problems in the 
systems. If we want people to address those, we have to make it 
easy for them to talk about them and we have to make it easy to 
address the issues. If we do not do that----
    Mr. STARK. If you cannot tell the guy you hurt, who are you 
going to tell?
    Dr. LEAPE. I think there is no question that a physician 
has a moral obligation to be honest with his patient, no 
question about it.
    Mr. STARK. You do not want to make that----
    Dr. LEAPE. I do not think you achieve that by legislation.
    Mr. STARK. You do not want to make that a legal obligation.
    Dr. LEAPE. I would not make that illegal, no.
    Mr. STARK. Just so the doctors can lie, so they do not tell 
us?
    Dr. LEAPE. Not at all. We have a lot going on to change 
that right now and it will change.
    Mr. STARK. The patients do not--I mean, nobody gives a hoot 
about the patients here. It is just protecting the doctors from 
getting sued. That is what is the trouble with you guys.
    Now, Dr. Wood, your comments on the NQF patient safety 
draft report, you say there should be no efforts to Federally 
regulate or mandate any of the safe practices on the steering 
committee's list until such Federal protections have been 
legislated and fully implemented. That is your belief, right?
    Dr. WOOD. That is correct.
    Mr. STARK. Okay. Now, you also indicate that this bill and 
its reporting protections are sufficient. So, does that mean 
that the HLC would support federally regulating safe practices 
once the reporter protections in this bill are fully 
implemented?
    Dr. WOOD. I think I would be inclined to answer that 
affirmatively.
    Mr. STARK. Right on. We have made some progress. Would you 
mind if we had in this mandatory reporting the fact that the 
patient ought to know when there is an accident and there ought 
to be, I think, a criminal penalty for not telling them, but 
you cannot ever know whether somebody is going to be honest 
with a patient. That is the trust issue we have to have.
    Dr. WOOD. Mr. Stark, in getting back to your earlier 
questions also to Dr. Leape, I do not see anything in this bill 
that prohibits the health care profession from informing a 
patient when there has been an accident or error occurring. I 
think the point that I really am trying to make is that this 
legislation has the opportunity to actually benefit and make 
safer health care by, again, getting at the opportunity for 
process improvement.
    Mr. STARK. If we could start out those near-misses that you 
are talking about and make those only--and I think Ms. 
Rosenthal would buy into this--subject to this confidentiality, 
leaving what I think is referred to as sentinel events, that is 
bad things, big bad things, leaving those under the mandatory 
reporting structure, the problem is in this bill there is no 
distinction. So, we might start to get all the bad or the 
sentinel stuff in and it would not be transparent and nobody 
would know about it and that is a danger I see. Am I seeing 
this right, Ms. Rosenthal? I mean, if we could somehow define 
that, I think the bill would be better.
    Dr. WOOD. I think that a two-pronged approach like that 
would have a real opportunity to enhance patient safety and 
would be a step forward.
    Mr. STARK. Thank you. Does anybody else want to add 
anything that will help the patients while we are here? I do 
think, and I want to, again, I want to thank the IOM and all 
the people and John Eisenberg, who years ago--I hope you will 
name this after him someday when we get the agency going--it is 
a major concern, and I know that the liability is a concern and 
I know that the humility of making mistakes is awful. I do not 
know how I know that, because politicians never make mistakes, 
but I do know it.
    I hope that we can, and I think we have to mandate some 
stuff. I mean, I hope we can get the legislation. I would 
submit that we would not have air bags on cars if we had not 
passed a Federal law. I mean, I think we would still be talking 
about it and saying, well, it is voluntary and it costs too 
much. I think there are some things that are inconvenient, they 
are uncomfortable, they are a whole lot of things that do not 
fit into our making our life happy, but that are necessary.
    My concerns with the bill, and I think we could perhaps 
straighten them out, is that we do not stop doing that, whether 
it is not allowing your residents to work more than 60 hours a 
week because they will make a mistake, or whether it is using 
the safe needles that we finally had to legislate to get some 
of the hospitals to use. Those are things that I think, sooner 
or later, people are not going to like. They do not like 
regulations. We do not like them here. Madam Chair, I think 
that if we can decide those major events that have to be 
regulated and then let the profession and the industry or the 
providers work on the rest until they come up, I mean, I would 
be happy to have them decide, but then they are going to want 
to do it because it may be a competitive issue. If Mayo has got 
to do it, then why does Johns Hopkins not have to do it? The 
fact is, they probably should, so go to it.
    Chairman JOHNSON. I would like to come back to Dr. Woods' 
comment, but I had a long period to question him first. You 
have had a long period of questioning. I am going to turn to 
Congresswoman Thurman, and then if there is time, we will 
discuss that further, but there are a lot of questions raised 
by this discussion. Congresswoman Thurman?
    Mrs. THURMAN. Madam Chairman and Representative Stark, I 
have to tell you, this has been a good discussion because this 
is the discussion that has been going on in this Committee 
between the Members, I mean, in trying to figure out how do we 
meet this one issue that is now on the table.
    I was encouraged certainly by what Ms. Rosenthal said in 
the two-tier, one mandatory, in those areas, that seems to be 
where the States are heading and that is when there are adverse 
events, and then the one where we all recognize that there are 
some things that go on out there that potentially could cause 
harm, have not caused harm, but can be corrected just because 
we are seeing it happen over and over again.
    So, I am actually very encouraged by this and I think it is 
what I made a comment to Secretary Thompson earlier, was that 
if we could get that discovered in this--maybe discovered was 
not the right word to use in this case, but if we could come up 
with that verbiage to set those two aside, I think we have 
probably worked out a good majority of the issue that has been 
on the table, quite frankly.
    I guess that the only other thing I would say, and I thank 
Dr. Pardes for recognizing some of the work we have done on 
this in the money part of it. It is a huge issue for folks out 
there. As we all know this year, we were talking about cutting 
hospitals by 0.55 percent. We have now come back, thanks to 
HHS, with about a $10 billion appropriations on the table, but 
quite frankly, we are talking about a major system and the 
ability to talk.
    Dr. Leape, I have to tell you, I did not realize it had 
been 40 years that this has been going on, but it really 
certainly tells you how we have just come to a standstill on 
some of these issues. It is just not acceptable. I mean, 
whatever we are talking about here, the bottom line is it is 
lives. It is about people. It is about things that can be 
affected in a positive way, and we are seeing that happening 
and we are seeing it happening because there has been some push 
over the last couple of years and direction to the States and 
others to come up with some ways to do some reporting and find 
out where the problems are.
    If we are standing in the way of not making this where we 
are having a 90-percent success and only having 20-percent 
success, then we need to figure out how to do this. I mean, we 
are talking about one cost at one time to get into some 
compliance that would work. After that, you are on your own. 
Immediately, the upstart is always the hardest to get people to 
fall into line to do these things. Quite frankly, I think we 
are talking about people's lives and that, to me, is just kind 
of unacceptable. I would hope that after this discussion, if we 
look at, and I would say to the Chairwoman----
    Chairman JOHNSON. If the gentlelady would yield, because 
there is an aspect of this discussion that I think we need to 
get on the table----
    Mrs. THURMAN. I was just going to say, if we go to what Ms. 
Rosenthal has given us in the Academy, I do not know if this is 
a letter that you have, but it is on the second page, basically 
where it says the bill does not distinguish between the purpose 
of collecting information about medical errors that result in 
serious harm and those that result in minimal or no harm, that, 
in particular, I think, is the crux of the issue that we have 
been dealing with, and based on some of this conversation 
today, probably could take care of some of the issues we are 
concerned about.
    Chairman JOHNSON. Ms. Rosenthal, would you prefer a system 
in which matters of serious errors were reported at the State 
level, and in a sense, non-serious errors were reported to the 
Federal system? Would you prefer that system?
    Ms. ROSENTHAL. I am not sure I got that completely, a 
system where serious----
    Chairman JOHNSON. In other words, would you prefer a 
totally bifurcated system?
    Ms. ROSENTHAL. With serious events reported to mandatory 
State----
    Chairman JOHNSON. State level.
    Ms. ROSENTHAL. And near-misses, those that cause less 
serious harm reported to a voluntary system? Yes.
    Chairman JOHNSON. Well, and the voluntary system being 
national and the mandatory system being State. See, to me, I 
think this would be a terrible error of public policy because 
you are going to have every State having different analytical 
capabilities to understand the serious incidents in their 
States. You are going to have no national capability to look at 
incidents from the different States. You are probably going to 
have, not necessarily, but you are going to have very varied 
resources for analysis and feedback from State-to-State.
    It seems to me that you want a system that feeds these most 
serious errors up to the national level as well, and I want 
our--if I am going to fund this, I want to have both the little 
incidences and the big instances. It is from that body of 
knowledge that you develop system changes, and I do not 
object--my bill does absolutely nothing to prevent States from 
adopting mandatory reporting systems and moving right along the 
way they are. I think we need to get a little further along 
with that and see how useful it is and what it does. The States 
cannot do what we need to do, which is all of this voluntary 
reporting, because I want things voluntarily reported that have 
no risk at all but just are suppose, you know, we could do it 
better this way. I want people to feel that if I say, gee, we 
could do it better this way, that is not going to come back to 
haunt my institution in a court situation. Well, they should 
have listened to this person.
    So, we have got to protect voluntary reporting if we are 
going to get big ideas and flexibility so you get real systems 
information. Now, to disconnect that, first of all, I am not 
sure at all that in law you could define what information we 
would protect and collect if you try to dissect out of that 
information universe the information that is associated with 
serious errors, and I do not know why you would want to do 
that.
    Now, if you think we can define out that information for 
the voluntary system, you need to tell me what that definition 
would be and then justify why you think that would be a good 
thing, to have the Nation, the national analytical capability 
associated only with the less-serious data.
    Ms. ROSENTHAL. Well, I think it is possible to distinguish 
what is classified as an adverse event or serious harm 
according to----
    Chairman JOHNSON. Wait a minute now. See, we are not just 
talking about that. It is easy to say adverse event and serious 
harm. We are talking about the data associated with those 
incidents and how that data would not be under the voluntary 
reporting system, nor would it go to the national level.
    Ms. ROSENTHAL. There has been an effort on the Federal 
level through the National Quality Forum to develop that list 
of serious events----
    Chairman JOHNSON. Right.
    Ms. ROSENTHAL. That would be used by States to collect that 
kind of information, and part of the reason that States need 
that data is because they are responsible for licensing health 
care facilities, so if they do not have that data----
    Chairman JOHNSON. That is good. That is all good.
    Ms. ROSENTHAL. So, if this bill makes it more difficult for 
States to enact those systems----
    Chairman JOHNSON. It does not make it more difficult. I 
asked that earlier in the questioning and you said you did not 
see any barriers to State progress.
    Ms. ROSENTHAL. Well, I think in my testimony, I tried to 
describe that there is some--the duplication and not 
distinguishing between those events that cause serious harm 
versus those----
    Chairman JOHNSON. If you are required to report that 
information to the State, you report it. So, at least in all 
the States that have not passed a mandatory reporting 
requirement, which is the majority, they would be required 
under our law to report it to us, to report it to the--well, 
they would not be required, because it is voluntary, but the 
likelihood that they do it and the likelihood that Federal 
systems like JCAHO would require them is extremely great.
    Ms. ROSENTHAL. It makes it more difficult for the States 
that do not currently have systems. If there is a system that 
is conflicting on the Federal level and makes it easier for 
those who would be reporting into a mandatory system to say, 
well, there is already this system, you do not need to create 
one on the State level, so there is----
    Chairman JOHNSON. That is true, but you also acknowledge 
that the States have not put the resources in to analyze the 
data. So, if we get the data reported for the most serious 
things in the State and it is not analyzed and we cut that data 
out of the voluntary system at the national level, I mean--see, 
I do not have any problem with both. I am appalled that you 
would advocate this total bifurcation. What we want is 
integration, not bifurcation. We do not want side-by-side 
systems. We want rich reporting systems, and there is no harm 
in the State reporting and analyzing. Maybe some of their 
people will be better and that will be rich, but I see a lot of 
problems with bifurcation. Mr. Segel, and then----
    Mrs. THURMAN. Could I----
    Chairman JOHNSON. Let me let Mrs. Thurman clarify her 
thoughts on my thoughts, and then you can all respond to that.
    Mrs. THURMAN. You can tell we have kind of been through 
this already once.
    Chairman JOHNSON. Well, we have not been through this 
particular thing, and this is good.
    Mrs. THURMAN. It is very important, though, I agree.
    Chairman JOHNSON. Because you can have theoretical ideas, 
but if you cannot write them in law, you do not have a system 
and you do not have a law.
    Mrs. THURMAN. I think part of the problem is, if you 
develop one at a voluntary, at the Federal level, then that 
takes precedence over the State. So, if the States have put 
this mandatory in, they send it up to the Federal and say, 
well, I have already done this and it is voluntary. I do not 
know if that is part of the problem. I mean, we supercede State 
law in these kinds of issues, so you could potentially undo 
what some of these States have already done. Is that----
    Chairman JOHNSON. To that issue, though, let us get that 
clear, because I do not think Ms.----
    Mrs. THURMAN. That is what I am asking.
    Chairman JOHNSON. All right. Sorry, I thought you were 
saying--because I asked you this earlier, Ms. Rosenthal, so 
proceed. I think the question is, does this law supercede State 
law?
    Ms. ROSENTHAL. Well, some of the--if adverse events are 
required to be reported--if adverse events are included in a 
Federal voluntary system and there is confidentiality 
protections for that data, if that interferes with the State 
mandatory system that makes that information available to the 
public, there could be----
    Chairman JOHNSON. There is no provision in this bill that 
says if you report it to us, you do not have to report it to 
the State under the State law. There is no provision that does 
that. So it is true, your argument that they will have to 
report to two entities, that is a valid argument. To say that 
in any way this bill interferes with State law is really--you 
have to document if you are going to say that. I have said 
enough. Mr. Segel?
    Mr. SEGEL. Maybe it would be worth putting into the 
legislation a specific clause that says, nothing in this bill 
preempts the responsibility to report under State mandatory 
reporting systems. Something as simple as that might solve it.
    Chairman JOHNSON. Certainly, those things can be done.
    Ms. ROSENTHAL. I guess what that does--I would agree with 
that, also, but I think what that does not address is what the 
IOM recommendation called for was two types of systems, with 
State systems funded at the national level, and I think the 
concern of States is that if this bill goes forward as 
voluntary reporting only with funding, that there will not be 
future funding available as recommended in the IOM report for 
States for the mandatory systems.
    Chairman JOHNSON. With the pressure to fund prescription 
drugs, do you really think there is going to be very much 
future funding? I mean, if we can get this system funded, do 
you think we are going to fund State systems?
    Ms. ROSENTHAL. Honestly, no.
    Chairman JOHNSON. So, let us not kid ourselves. If we can 
get one system that clearly has to be voluntary if it is 
national, and it is going to be over all people, all incidents, 
and all providers, because most State systems are only over 
hospitals, most of them are not over doctors, it is my 
recollection, is that not true?
    Ms. ROSENTHAL. The systems are for facilities, not for 
individual----
    Chairman JOHNSON. Facilities and not for individuals. Ours 
is much broader than that. So, if you are going to do the big 
universe of reporters and the big universe of data and we can 
get the analytical capability to fund it, we are just not going 
to ever be able to do the other, and you might as well be 
honest about that.
    So, if States have not seen that it is important to fund 
analysis as well as to do the political thing of requiring 
reporting, that is something real. Look how States are under-
funding their Medicaid reimbursements. I mean, States are not 
doing a good job. So, if we could do a good job of this one 
thing, we would be ahead. Mr. Segel?
    Mr. SEGEL. Congresswoman, it has been a rich discussion. I 
just want to say I do agree with your reading of the bill and 
in its importance, further, and this is really a plea to the 
panel, health care professionals want to report. The JCAHO 
reports, at the level that they are at, they are essentially 
out the door of hospitals but stopped because of the lack of 
this kind of protection extending to those reports. I think if 
you are able to move where the great gap has been by providing 
some additional protection for voluntary reporting and again, 
it is not protecting the underlying events or a patient's right 
to their record at all, but it is to be able to talk about 
errors and analyze and provide some additional support for that 
process you are going to see the floodgates open. I can 
guarantee it from our own experience.
    The task is really to take it out of the sort of legal 
environment within the institutions as well as externally and 
allow what people are desperate to have happen internally 
happen, and if you conceive of it in those terms or conceive of 
it as taking away an excuse not to act, that is the opportunity 
before this panel and it is the one that health care 
professionals who want to do the right thing are crying out 
for.
    Chairman JOHNSON. Dr. Wood, since you supported a dual 
system, you had better have a few words here.
    Dr. WOOD. In responding to Congressman Stark's earlier 
question, I think what we really are trying to do is do 
anything positive that is realistically passable to improve the 
safety for patients. I really do believe that the more we have 
a mandatory requirement in the bill, the more obstacles we will 
have in front of us.
    In my own opinion, we already have a large number--for the 
kind of cases that Dr. Leape was referring to earlier, the 
truly egregious type areas, the cases that the IOM report was 
trying to get to, we actually have some mechanisms in place as 
we exist today through JCAHO and through some State mandates, 
and if putting a mandatory provision in this particular bill, I 
can't help but feel that it will increase some of the barriers 
to getting it passed.
    If we have the opportunity to move forward with the 
voluntary activity alone, to eliminate those barriers, and in 
order to bring those near-misses out of the woodwork, I think 
that would be the most positive step forward.
    Chairman JOHNSON. Well, I can tell you flat out, there is 
no way that I can get a bill on the House Floor to pass--I am 
not sure I can even get it as far as the House Floor, but you 
cannot pass a clear unfunded mandate on the States at this 
time, nor would it be fair. They all have deficits. You 
particularly cannot do that when you have not funded anything 
yourself----
    Dr. WOOD. Right----
    Chairman JOHNSON. That covers all that vast amount of 
opportunity to reduce errors that they cannot reach. So, if we 
have to go to mandatory, then this bill is dead, no question 
about that. Thank you very much. I really feel like we have 
to----
    Mrs. THURMAN. Can I just----
    Chairman JOHNSON. Yes. Congresswoman Thurman?
    Mrs. THURMAN. This is where some of our concern comes from. 
In the bill on page seven under the last, starting online 33, 
it talks about no limitation of other privileges. ``Nothing in 
this section shall be construed to limit other privileges that 
are available under Federal or State laws that provide greater 
peer review or confidentiality protections than the peer review 
and confidentiality protections provided in this section.'' I 
think that is where some of these questions are coming from as 
far as the supremacy of the States and those that, in fact, 
would have and are addressing mandatory. That is the problem. 
For us who live in States and have sunshine laws and things 
like that, it is very difficult to go against your State 
legislature that have put these protections in, and 
particularly when you look at the kinds of pieces of 
legislation that are being filed every day.
    I agree with Chairman Johnson in the fact that I would love 
to have this done so that we could get some of this information 
and make it national, but I also recognize that there are 
States out there that will continue to do this, and for us to 
get in their way when they have the licensing, they are going 
to get the phone calls in their offices, it makes it very 
difficult.
    Chairman JOHNSON. We will certainly look at trying to 
clarify that nothing we are intending to do here will in any 
way limit the responsibility of facilities to comply with State 
laws. We will certainly do that.
    Mrs. THURMAN. Thanks.
    Chairman JOHNSON. Thank you very much for your patience and 
for helping us on this discussion. It is an important one. The 
hearing is adjourned.
    [Whereupon, at 2:34 p.m., the hearing was adjourned.]
    [Submissions for the record follow:]
         Statement of the American Academy of Family Physicians
Introduction
    This statement is submitted to the Ways and Means Health 
Subcommittee regarding the Chairman's mark of H.R. 4889, the Patient 
Safety Improvement Act of 2002. This statement is offered on behalf of 
the 93,500 members of the American Academy of Family Physicians (AAFP).
Support for Confidentiality Provisions in H.R. 4889 as Introduced
    More than 12 times as many people are seen in primary care 
physicians' offices as in hospitals. Because the majority of patient 
encounters occur in the physicians' office, the Academy believes that 
the creation of a learning culture in ambulatory care settings has the 
capacity to improve care for the greatest number of patients. 
Developing such a culture depends on federal protections of 
confidentiality and voluntary reporting contained within the Patient 
Safety Improvement Act, as it was introduced.
    According to the bill, reporting non-identified patient safety 
information to patient safety organizations would be voluntary for 
every level of the health care delivery system--physician, health care 
provider, hospital or health care system. The Academy supports the 
creation of patient safety reporting systems based on the voluntary 
reporting of non-identified data. We believe that these provisions are 
prerequisites to building a non-punitive quality improvement culture 
that focuses on preventing and correcting system failures and not on 
assigning individual or organization culpability. As the IOM study 
noted, ``improving patient safety requires fixing the system, not 
fixing blame.''
    The bill classifies information documented, collected, or prepared 
for submission to a patient safety reporting system, as privileged and 
confidential. Furthermore, federal protections against disclosure in 
civil, criminal, or administrative proceedings are created unless a 
judge finds the release of the information meets a strong three-pronged 
test: that it is material to the case; that it is in the public 
interest; and that it is not available from any other source. The 
Academy appreciates the bill's treatment of sensitive information.
Concerns with H.R. 4889 and the Chairman's Mark
    The Academy has concerns that the Chairman's mark contains a 
weakening of the federal confidentiality protections against having 
patient safety reports introduced into a legal proceeding. As 
introduced, H.R. 4889 extends federal protections against disclosure in 
civil, criminal, or administrative proceedings unless a judge finds the 
release of the information meets a strong three-pronged test: that it 
is material to the case; that it is in the public interest; and that it 
is not available from any other source. The Academy believes that these 
protections are essential to an effective quality improvement system. 
However, the current Chairman's mark would remove these protections 
from criminal matters. Abandoning this protection seriously jeopardizes 
the likelihood that health care professionals will disclose to a PSO 
the non-criminal errors that they see in the course of delivering 
medical care since reports could be subpoenaed based on the claim that 
they were related to a crime.
    Likewise, the Academy is concerned H.R. 4889 amends the Social 
Security Act and places these protections under Medicare, instead of 
under the Agency for Healthcare Research and Quality (AHRQ) by amending 
the Public Health Service Act. AHRQ is the only agency dedicated to 
research that focuses on access to high quality, cost-effective 
services; and improved health status throughout the health care system. 
The Academy believes that existing error reporting systems, which are 
the first candidates for Patient Safety Organization (PSO) status, have 
existing research connections to AHRQ and see this national center for 
primary care research as the most appropriate place to house patient 
safety efforts.
    The protections offered under The Patient Safety Improvement Act 
are available solely to physicians with Medicare billing numbers. 
Therefore, under the bill, primary care physicians without Medicare 
billing numbers need to go through the Medicare physician billing 
application process solely for the purpose of obtaining a billing 
number in order to claim federal protections for reported data. This 
provision alone is likely to have a chilling effect on reported data. 
Likewise, the Academy has concerns that the application of all Medicare 
fraud and abuse laws to PSOs would have a chilling effect on reporting 
for both physicians and the PSO itself.
Conclusion
    The Academy appreciates this opportunity to submit a statement to 
the subcommittee and looks forward to working with you to develop 
effective patient safety legislation. This is a matter of continued 
interest to the Academy and we thank the Ways and Means Health 
Subcommittee for its interest in the topic.

                                 

  Statement of the American College of Obstetricians and Gynecologists
    The American College of Obstetricians and Gynecologists (ACOG), an 
organization representing nearly 45,000 physicians, commends you for 
your leadership to improve patient safety. As partners in women's 
health care, we strongly support legislation that works to eliminate 
health care errors and ensure quality care for every woman.
    The College encourages physicians and other health care 
professionals to participate in a voluntary, non-punitive system to 
report and evaluate errors and share their experiences with others. We 
support the principles that provided the foundation for the Institute 
of Medicine's 1999 report entitled, To Err is Human. It is imperative 
that we work together to transform the health care system into a 
culture of safety, which focuses on information sharing to prevent 
adverse outcomes. We believe that information must be subject to 
comprehensive analysis to identify actions that will minimize the risk 
that reported events would recur. Likewise, we find it equally 
important to protect the confidentiality of both physicians and 
patients and to defend all information submitted to patient safety 
reporting systems as privileged.
    One of the College's most successful programs to date is the 
Voluntary Review of Quality Care (VRQC) program, established in 1986. 
The mission of the VRQC program is to provide peer review consultations 
to departments of obstetrics and gynecology, assess the quality of care 
provided, and suggest possible alternative actions for improvement. At 
the request of hospitals, this program makes available two or more 
board-certified, practicing obstetrician-gynecologists to evaluate the 
hospital's clinical performance in obstetrics and gynecology. The 
program offers comprehensive, department-wide reviews that focus on all 
practitioners with obstetric-gynecologic privileges and focused reviews 
of an individual physician's quality of care.
    During the site visit, the reviewers use various quality 
improvement techniques, including an evaluation based on the College's 
policies and publications. Based on findings revealed from hospital 
data, medical record review, and interviews of key hospital staff, the 
review team provides a confidential comprehensive final report for the 
hospital containing specific recommendations. These reports are 
valuable tools in promoting constructive changes and helping to 
identify potential areas for improvement of quality of care provided. 
Typically, the report contains recommendations on how to improve the 
system, adopt new programs, and address the hospital's particular 
concerns.
    Programs like the VRQC serve as the foundation to our efforts to 
ensure quality care. This successful program, however, is only one of 
the many tools we offer our physicians. For three decades, the College 
has published a line of publications to inform and assist our 
physicians who participate in peer review and quality improvement 
activities. Our 2000 volume, Quality Improvement in Women's Health 
Care, is intended to serve as a primer for obstetricians and 
gynecologists starting or managing quality improvement programs within 
their respective hospitals. Because we believe that our role as a 
medical specialty society is to serve as a catalyst for improvement, we 
continue to reach out to our physicians through postgraduate continuing 
medical education courses as well.
    Thank you, Madam Chairwoman, for your leadership on this important 
issue and for the Subcommittee's attention to patient safety. ACOG 
appreciates the opportunity to present our concerns for the panel's 
consideration. The College looks forward to working with you as we push 
for a meaningful solution to ensure greater patient safety in the 
delivery of quality health care for every woman.

                                 

  Statement of the American College of Physicians-American Society of 
                           Internal Medicine
    The American College of Physicians-American Society of Internal 
Medicine (ACP-ASIM), representing more than 115,000 internal medicine 
physicians and medical students, is the nation's second largest medical 
association. The ACP-ASIM commends Chairwoman Nancy L. Johnson for her 
leadership on the issue of patient safety and for holding this hearing 
as well as the hearing on March 7.
    The findings of the late 1999 Institute of Medicine (IOM) report 
``To Err is Human: Building a Safer Health System'' are as dramatic and 
unacceptable now as they were two and a half years ago. The number of 
injuries and deaths from medical errors is open to some dispute, but 
there is universal agreement that the number is unacceptably high. 
Since the report was issued, both government and the private sector 
have made significant efforts to improve safety in the healthcare 
system, but much remains to be done.
    The College accepted the IOM's challenge to the medical profession 
by undertaking an ambitious effort to provide our members and other 
physicians with the information and tools they need to create a safer 
healthcare system.
    The ACP-ASIM quickly identified the need to address patient safety 
in the outpatient setting. Care is increasingly being delivered in 
ambulatory settings while most of the research has focused on errors in 
the hospital. The College embarked on a multi-year, multifaceted 
initiative, ``The Other Side of the Quality Equation,'' to raise 
physician awareness of quality issues and facilitate physician behavior 
that is likely to diminish the occurrence of medical errors. The 
cornerstone of this Agency for Healthcare Research and Quality (AHRQ)-
supported program is the development of a patient safety curriculum to 
teach physicians how to achieve patient safety in the ambulatory 
setting.
    In addition to the courses being given at state chapter scientific 
meetings, a web-based interactive learning tool, PSILC (the Patient 
Safety Interactive Learning Community), has been developed for 
physicians to review courses and participate in discussions online. The 
effectiveness of these interventions will be measured through surveys 
addressing awareness, attitudes and reported change in safety behavior.
    Beyond the College's efforts to provide physicians with significant 
patient safety education opportunities, the ACP-ASIM has strongly 
advocated for confidentiality protections to encourage voluntary 
reporting. We also support a strong national leadership role for the 
Center for Patient Safety in the development of uniform reporting 
methods and analysis of patient safety data.
Confidentiality Protections for Voluntary Reporting
    The IOM report found that medical errors are the result of problems 
in the healthcare system, not of individuals. It states ``The focus 
must shift from blaming individuals for past errors to a focus on 
preventing future errors by designing safety in the system.'' Medical 
errors often are complex events resulting from a series of undetected 
mishaps. To identify, correct and prevent medical errors, collaboration 
among health care professionals, administrators, and institutions is 
required. This cannot be done in a system where the fear of litigation 
is pervasive. Neither can it be done in a medical culture that 
discourages discussion of mistakes and the inevitable human error is a 
source of shame.
    The College supports the expansion of peer-review and 
confidentiality protections to encourage providers and others in the 
healthcare system to come forward with vital information needed to make 
improvements. Information that is developed with respect to system 
shortcomings (root-cause analysis) and subsequent analysis to prevent 
such errors in the future should not be ``discoverable information'' 
used in litigation. However, this privilege should not interfere with 
disclosure of information that is otherwise available.
    The chairman's mark limits protections to civil and administrative 
proceedings and appropriately excludes criminal proceedings. In 
addition, disclosures are permissible in a disciplinary proceeding if 
the disclosure is material to the proceeding, within the public 
interest and not available from any other source. Since the rules that 
govern disciplinary hearings vary substantially, it would be useful to 
address whether this limitation creates a loophole sufficiently large 
to discourage reporting of medical errors. The challenge is to strike a 
balance between the need for confidentiality to encourage reporting and 
the public's right to information that will provide protection from 
incompetent providers.
A Strong Role for AHRQ in Patient Safety
    The legislation establishes a strong role for AHRQ's Center for 
Patient Safety. The Agency will continue to take the federal lead on 
research, evaluation and demonstrations on patient safety either 
directly or through grants. The Center will certify patient safety 
organizations, defined in the bill as private or public organizations 
that collect and analyze voluntary reports and develop and disseminate 
information on best practices in patient safety. The Center will 
establish a National Patient Safety Database to collect and analyze 
non-identifiable data. The Agency has built an impressive record in 
patient safety and this legislation allows that legacy to continue.
Medical Information Technology Board (MITB)
    The bill establishes a new Medical Information Technology Board 
(MITB) to report on best practices in medical information technology 
and methods for implementing interoperability (e.g., compatibility of 
information technology architecture) standardization and records 
security. The Board is required to report to the Secretary after 30 
months and to report each year for two years on advances in information 
technology, best practices and on private sector efforts to implement 
interoperability standards.
    Advances in medical technology will play an enormous role in 
improving clinical care and efficiencies in the healthcare system. ACP-
ASIM recommends that the Board meet on an ongoing basis beyond the 30 
months specified in order to keep pace with the rapidly evolving field 
of informatics and be evaluated for permanent status after a three-year 
period.
    The bill establishes a diverse board of 17 members, including staff 
representatives from the Centers for Medicare and Medicaid Services, 
AHRQ, IOM and public health agencies, and representatives with 
expertise in informatics from industry and educational institutions. 
Significantly, the bill also includes ``individual and institutional 
health care clinical providers.'' We strongly support the inclusion of 
clinicians who can provide a practical assessment of what is feasible 
in day-to-day practice. We also suggest that the Board draw upon the 
expertise of existing organizations such as the American Medical 
Informatics Association and Health Level Seven (HL7), an American 
National Standards Institute-accredited Standards Developing 
Organization. It would be a significant contribution if the Board could 
facilitate communication and coordination among myriad organizations in 
the field of informatics.
    Finally, the number one goal among the six enumerated for the Board 
is to maximize positive outcomes in clinical care, including decision 
support for diagnosis and care. The College has invested significantly 
in a decision support tool, the ``Physicians' Information and 
EducationResource (PIER),'' and continues to expand the electronic Web-
based resource. Modules are available now on the diagnosis and 
treatment of diseases such as lymphoma and asthma. Strides in 
healthcare quality will be realized through medical informatics tools 
that provide physicians with evidence-based guidance at the point of 
care.
Conclusion
    It would be a significant accomplishment for the Committee to 
report legislation that could be passed in this Congress. 
Confidentiality protections for patient safety data and a strong role 
for AHRQ would result in improved safety and quality in the healthcare 
system.

                                 

             Statement of the American Medical Association
    On behalf of our physician and medical student members, the 
American Medical Association (AMA) applauds Chairwoman Johnson's 
continuing leadership to improve patient safety and quality of health 
care in our nation through federal legislation that would remove the 
barriers that prevent the reporting and analysis of health care errors. 
The AMA shares Chairwoman Johnson's goal, and supports the Chairwoman's 
bill, H.R. 4889 (the ``Patient Safety Improvement Act of 2002''), as 
introduced on June 6, 2002. We do, however, have concerns about the 
draft chairman's mark of the legislation which are discussed below. We 
submit this statement as a supplement to our March 7, 2002, Statement 
for the Record to the Ways and Means Health Subcommittee, which 
provides a detailed account of the myriad efforts on behalf of the AMA 
and other public and private health care organizations to improve 
patient safety and health care quality.
    We believe that H.R. 4889, as introduced, would provide a framework 
by which our nation's health care system could more effectively advance 
patient safety initiatives and further promote the reporting and 
analysis of health care errors. Such a framework was envisioned by the 
Institute of Medicine (IOM) in its 1999 report, To Err is Human: 
Building a Safer Health System. In that report the IOM recommended that 
``Congress should 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.'' The IOM also noted that a federal approach is required 
because ``many current state peer review statutes . . . may not protect 
data about errors shared in collaborative networks, especially across 
state lines, or reported to voluntary reporting systems.''
Concerns About the Draft Chairman's Mark of H.R. 4889
    Upon reviewing a draft of the chairman's mark of H.R. 4889 (dated 
August 2, 2002), we noted several changes to the original language. One 
of these changes that raises concerns would alter the scope of the 
confidentiality and legal protections for the unique ``patient safety 
data'' that would be reported to a ``patient safety organization.'' 
Section 1182 in H.R. 4889, as introduced, extends the federal 
confidentiality and legal protections to a `` civil, criminal, or 
administrative'' subpoena and proceeding. The draft chairman's mark 
would limit the protections to a `` civil or administrative'' subpoena 
and proceeding.
    The reporting of a criminal act is a fundamental requirement under 
state and federal laws and should not in any way be limited. The AMA 
believes that discovering adverse patient safety events that occur as a 
result of a criminal act is an inherent benefit of a patient safety 
system. The original language in H.R. 4889 (in section 1182) would 
allow any information about criminal behavior that is uncovered or 
otherwise discovered by a ``patient safety organization'' to be 
disclosed to the appropriate ``health care provider'' (hospital, 
clinic, etc.), which must then report such crimes under numerous 
existing state and federal laws.
    For criminal or disciplinary proceedings, the original language of 
H.R. 4889 (in section 1182) already allows for the disclosure of 
``patient safety data'' in situations where such data would be ``(A) 
material to the proceeding; (B) within the public interest; and (C) not 
available from any other source.'' Therefore, the protections in the 
original legislation would in no way limit or affect the availability 
of any information or evidence that is currently available under 
existing law. More important, maintaining the legal protections in the 
original language could result in criminal behavior being identified by 
``patient safety organizations'' sooner or where it might have 
altogether been missed.
    The AMA is concerned about the provision in section 1182(h), which 
would treat patient safety organizations as business associates under 
the Department of Health and Human Services Privacy Rule promulgated 
pursuant to the Health Insurance Portability and Accountability Act of 
1996 (HIPAA). The provision would also deem activities of ``patient 
safety organizations'' to be health care operations of health care 
providers under the Privacy Rule. This could be problematic for 
physicians and other health care providers.
    HIPAA only applies to ``covered entities'' (all health care 
providers, including physicians and hospitals, health plans and 
clearinghouses). The Privacy Rule requires ``covered entities'' to 
ensure that any patient information disclosed to business associates 
(accountants, consultants, billing companies, etc., and other entities 
that may not be covered by HIPAA) remains protected. Covered entities 
must enter into or amend written contracts with their business 
associates, correct or report any known wrongful use or disclosure of 
patient information made by a business associate, and ultimately 
mitigate any harm caused by such use or disclosure. These business 
associate provisions clearly attempt to stretch the regulatory reach of 
the rule by placing on physicians extra burdens and liabilities with 
respect to the privacy practices of those who fall outside the rule's 
reach.
    The only purpose of the business associate provisions is to extend 
privacy protections to patient information passed on to entities not 
covered by the Privacy Rule. Yet, the chairman's mark would already 
require ``patient safety organizations'' to maintain the 
confidentiality of any patient information that is disclosed to them by 
``health care providers'' in the process of reporting. Therefore, it 
seems unnecessary to also require ``health care providers'' to first 
negotiate a written contract with a ``patient safety organization'' 
before any information is disclosed, not to mention placing extra 
responsibility and liability on ``health care providers'' for a 
potential privacy breach by a ``patient safety organization.'' This 
could serve as a strong disincentive to participate in a reporting 
system.
    We recognize that ``health care providers'' must obtain a patient 
authorization under the Privacy Rule prior to any disclosures of 
patient information that fall outside of treatment, payment or health 
care operations, unless otherwise permitted by the Privacy Rule. 
Although treating ``patient safety organizations'' as business 
associates and deeming their activities ``health care operations'' 
eliminates the need for prior authorization, it triggers the need for 
business associate agreements. We believe it would be much less 
burdensome for ``health care providers'' if the chairman's mark could 
instead provide that reporting errors to a ``patient safety 
organization'' by ``health care providers'' would be a permitted 
disclosure under the Privacy Rule.
    This could be accomplished by providing that: ``For purposes of 
applying the regulations promulgated pursuant to 264(c) of the Health 
Insurance Portability and Accountability Act of 1996 (Public Law 104-
191; 110 Stat. 2033), a disclosure of patient safety data under this 
section made by a provider to a patient safety organization shall be 
treated as a permissible disclosure for public health activities for 
which an authorization or opportunity to agree or object is not 
required.'' The result would be that voluntary reporting of ``patient 
safety data'' would be a permitted disclosure under section 164.512 of 
the Privacy Rule. That section provides exceptions to the general 
requirement to obtain prior authorization for a disclosure of patient 
information for various public health and safety purposes, including 
voluntary reporting of adverse events related to FDA-regulated 
products.
    The AMA is pleased that section 1183 of the chairman's mark would 
place the ``Center for Patient Safety'' under the Director of the 
Agency for Healthcare Research and Quality (AHRQ). This change places 
such Center in the appropriate government agency to conduct patient 
safety research and quality improvement. Congress recognizes the AHRQ's 
leadership role in improving patient safety. In December 1999, the 
Healthcare Research and Quality Act of 1999 (P.L. 106-129) was enacted 
into law to reauthorize the AHRQ (formerly the Agency for Health Care 
Policy and Research). In Section 912(c) of this law, Congress directed 
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.'' We recommend that the AHRQ be 
consulted regarding this language, as well as the activities currently 
underway within the AHRQ's Center for Quality Improvement and Patient 
Safety (CQuIPS).
    The AMA is committed to continuing and redoubling our efforts to 
work with Congress and our partners in the health care system to 
achieve a system in which patients are assured of safe, quality health 
care. The AMA appreciates the opportunity to provide our comments on 
the chairman's mark to H.R. 4889 and commend Chairwoman Johnson and 
this committee for focusing on needed improvements in patient safety 
and quality of care.

                                 

                 American Medical Group Association
                                 Alexandria, Virginia 22314
                                                  September 9, 2002
The Honorable Nancy J. Johnson
Chairwoman, Health Subcommittee
House Committee on Ways and Means
1136 Longworth HOB
Washington, DC 20515-6438
    Dear Congresswoman Johnson:
    On behalf of the American Medical Group Association (AMGA), I am 
pleased to write in support of your bill, H.R. 4889, ``The Patient 
Safety Improvement Act of 2002.'' We appreciate your commitment to this 
critical issue and for holding this hearing.
    As you are aware, AMGA is an association that represents some of 
the nation's largest and most prestigious, physician-directed medical 
groups organized as integrated health care delivery systems. The 
members of AMGA deliver health care to more than 50 million patients in 
40 states, including 15 million capitated lives. The average AMGA 
member group has 186 physicians and 12 satellite locations. Member 
groups include the Mayo Foundation, the Cleveland Clinic, the Palo Alto 
Medical Foundation, the Henry Ford Health System, the Ochsner Clinic, 
the Lahey Clinic and, in your own state, the Connecticut Surgical 
Group. AMGA's mission is to shape the health care environment by 
advancing high quality, cost-effective, medically safe, patient-
centered and physician-directed health care.
    AMGA supports the sound provisions contained in your bill. We would 
request, however, that you further strengthen the intent of ``Health 
Care Provider'' under Definitions (Part D Section b.3). Specifically, 
the definition of ``Health Care Provider,'' as currently set forth in 
your bill under subsections (A) and (B), appears to be related only to 
those practitioners who are associated with hospitals, skilled nursing 
facilities, home health agencies, etc. For the sake of clarity and 
inclusiveness, we would request that you add a subsection that reads:
    ``C'' a physician (as defined in section 1861(r) of the Social 
Security Act;
    ``D'' any other person who is engaged in the delivery of medical or 
other health care services (as defined in section 1861(s) (1) and (2) 
of such Act) in a State and who is required by the State law or 
regulation to be licensed or certified by the State to engage in the 
delivery of such services in the State;
    ``E'' any other person or entity specified in regulations by the 
Secretary after public notice and comment.
    As you know, the settings in which physicians practice have become 
quite varied and, therefore, it is important to acknowledge the 
demographic diversity of today's medical practitioners as an integral 
part of your legislation.
    AMGA also applauds your clarification of key issues regarding the 
confidential and voluntary nature of the reporting and collection of 
patient safety data. AMGA strongly advocates a ``. . . national, 
voluntary, confidential and protected reporting system that is non-
regulatory.'' Additionally, AMGA advocates that ``public reporting of 
such events should focus on the implementation of effective safety 
practices and the means by which they may be maintained by the provider 
and the patient.''
    In previous forums, AMGA has conveyed the need for all health 
organizations to instill a ``culture of safety'' in order to improve 
upon the assurance of safety of care for patients. Your new bill 
accomplishes this concept in a legislative mode that is instructive, 
objective and responsible.
    Thank you for your continued dedication to the access, quality and 
reasonable cost of health care for our patients as well as the 
concomitant re-institution of professional respect and fairness for our 
practitioners. Please do not hesitate to let us know if we may be of 
further assistance. We look forward to working with you and your staff 
to move this bill forward.
            Sincerely yours,
                                    Donald W. Fisher, Ph.D.
                              President and Chief Executive Officer
    Attachments
    AMGA Statement on Patient Safety
    Information on AMGA's Initiative, ``Safety Collaborative for the 
Outpatient Environment'' (SCOPE)
    Cc: Members of Health Subcommittee
                               __________

                   American Medical Group Association

                      Statement on Patient Safety

    Members of the American Medical Group Association (AMGA) are 
committed to providing the highest quality of healthcare, using 
advanced and proven technologies in a safe and effective manner. An 
emphasis on patient safety is a primary aspect of quality management 
processes within organized systems of care. Systems, here, are the 
imperfect consequence of human design and maintenance. We believe 
continuous efforts to improve processes of care in order to eliminate 
medical errors are both an absolute necessity and the responsibility of 
all healthcare providers. AMGA supports policies that promote a 
comprehensive strategy to improve patient safety by creating 
environments encouraging organizations to identify errors, preserve 
confidentiality, evaluate causes and take appropriate actions to 
improve on future performance.
    Furthermore, AMGA believes that methodical approaches to the 
prevention of injuries due to medical care hold the first promise for 
the prevention of adverse events. Strategies to prevent errors must 
become an integral part of the broad continuum of care improvement. 
This continuum presently includes methodical processes, outcomes 
management, patient satisfaction measurements, improved clinical 
techniques and innovations, peer review, information sharing among 
clinicians and patients and a commitment to details. Patient safety is 
best promoted within organizations that are vigilant and sensitive to 
the gravity of even the smallest error indicative of a potentially 
harmful process.
    Patient-oriented organizations continually improve their capacities 
by using error sensitive management as a model for improvement. Such 
organizations surface errors when they occur, implement recovery 
strategies to mitigate harm and develop strategies to prevent repeat 
occurrences. Learning derived from such organizational introspection 
promotes continuous improvements of delivered products.
    To improve patient safety, all health care organizations must 
instill a ``culture of safety'' that focuses the organization's care 
processes and workforce on improving the assurance of safety of care 
for patients. Safety must be an explicit organizational goal that is 
demonstrated by the strong direction and involvement of the governance, 
management and clinical leadership of the organization. Meaningful 
patient safety programs must include defined program objectives, 
personnel, adequate budgets and regular oversight and assessment by 
governance.
    The standardization of treatment processes targeted to the highest 
quality outcomes and the avoidance of mistakes has been an integral 
part of AMGA's group practice model of care. Examples of how AMGA 
members have been active in managing patient safety include:
    1. Reducing medical errors through process improvement and 
enhancing patient services as the major focus areas of quality 
improvement areas;
    2. Minimizing medication errors, especially common for elderly 
patients taking 12-20 different daily medications, by instituting 
protocols for new hospital admissions and protocols for patient 
medication management when the patient is transferred to another 
facility or discharged to home;
    3. Monitoring and investigating ``sentinel'' events (adverse 
medical occurrences which are unexpected, but potentially preventable 
as occurrences) as an active part of the group's norm in practice 
routines.
    AMGA believes that health care providers have a professional and 
ethical obligation to inform patients and their families about events 
that lead to adverse events and injuries. Furthermore, we believe that 
improvements in patient safety can best be achieved through a national, 
voluntary, confidential and protected reporting system that is non-
regulatory. Public reporting of such events should focus on the 
implementation of effective safety practices and the means by which 
they may be maintained by the provider and the patient. Lastly, 
legislative measures emphasizing patient safety should include 
provisions to reform the current culture of unbridled malpractice 
litigation.
    In summary, AMGA advocates that:
    1. Health care organizations and their professional providers 
should make continuous improvements of patient safety an overt and 
explicit objective--This can done by establishing patient safety 
programs, including medication safety practices, beginning at the most 
senior levels of responsibility and including defined executive 
leadership, responsibility and oversight.
    2. Patient safety programs should:

           Lprovide strong, clear and visible attention to 
        safety issues;
           Limplement voluntary, non-punitive systems for 
        reporting errors and analyzing errors within their 
        organizations;
           Lincorporate well-understood safety principles such 
        as, standardizing and simplifying equipment, supplies, and 
        processes; and,
           Lestablish interdisciplinary team training programs 
        for providers that incorporate proven methods of team training, 
        such as simulation.

    3. Voluntary, non-punitive protocols for reporting adverse events 
can most readily be implemented throughout entire organizations by 
incorporation of incentives structured to promote error detection and 
notification while minimizing punitive fears.
    Last updated: February 8, 2001

                                 

              Statement of the American Nurses Association
    The American Nurses Association (ANA) appreciates the opportunity 
to share our concerns about patient safety and medical errors. This 
issue is one of great importance to the nursing profession. As front 
line health care workers, nurses have substantial contributions to make 
in the effort to reduce health care error. ANA is the only full-service 
professional organization representing the nation's 2.7 million 
registered nurses (RN), including staff nurses, nurse practitioners, 
clinical nurse specialists, certified nurse midwives and certified 
registered nurse anesthetists through its 54 constituent member nurses 
associations. ANA submits this statement as a supplement to our March 
7, 2002 testimony to the House Ways and Means Health Subcommittee. On 
that statement, ANA made several recommendations towards reducing 
medical errors.
    First ANA believes it must address a crisis issue affecting all of 
us in the health care community. The nursing shortage has reached 
epidemic proportions. A recent survey by the American Hospital 
Association reports that hospitals are currently attempting to fill at 
least 126,000 vacant RN positions. The demand for nurses will increase 
by 25.6 percent between 2000 and 2010, this is more than 10 percent 
greater than the average growth across all professions. Adequate 
registered nurses in the hospitals and at the bedside make a difference 
in patient outcomes. Studies show that where there are more nurses, 
there are lower mortality rates, shorter lengths of stay, better care 
plans, lower costs and fewer medical errors.
    The majority of medical errors do not result from individual 
recklessness, but from basic flaws in the way the health delivery 
system is organized. Stocking patient-care units in hospitals, for 
example, with certain full-strength drugs--even though they are toxic 
unless diluted--has resulted in deadly mistakes. Illegible writing in 
medical records has resulted in administration of a drug for which the 
patient has a known allergy. Our evolving and increasingly complex 
health care system often lacks adequate coordination and appropriate 
systems to ensure patient safety.
    Despite increasing evidence that systems fail, institutions are 
continuing to assign and emphasize individual ``blame'' for errors, 
misjudgements and patient dissatisfaction. Hospital systems and 
administrators are assuming that the appropriate way to deal with the 
complexity of errors made in the delivery of health care is to manage 
the workers--through oversight and discipline--as opposed to 
identifying and resolving the true problem in the spirit of 
partnership. ANA has long advocated for investigation of system changes 
that may result in egregious errors by individual practitioners, noting 
that health care systems have downsized, restructured and reorganized 
to the point where processes, initially put in place to protect the 
public, are breaking down.
    As these systems increasingly are failing to protect patients, the 
severity of discipline applied to individual providers for mistakes is 
increasing. Health care organizations must approach problem solving 
strategies through shared accountability and partnership for quality 
improvement. A shared accountability approach diminishes focus on 
individual blaming and enhances long-range process improvements.
    ANA supports the concept of a Patient Safety Organization (PSO). 
Such an organization would provide a focal point for safety and quality 
activities by focusing on safety issues applicable to the full range of 
providers and health delivery systems. This entity must include 
adequate representation by nurses and other health professionals who 
are the front-line individuals in patient care.
    This PSO must support research to determine what factors lead to 
errors. Specifically, the PSO must be charged with collecting data on 
organizational practices and other factors that may be associated with 
the occurrence of errors. In our current knowledge, no one can state 
with any certainty what practices could or are more likely to lead to 
errors. Some practices are more obvious than others. For example, bad 
handwriting or open stock of certain powerful drugs have been observed 
to be the cause for errors in health care delivery. Other casual 
factors that may contribute to health care errors may not be as 
apparent. For example, relationship between system errors and 
appropriate nurse staffing.
    Inadequate or inappropriate staffing may mean too few registered 
nurses, lack of appropriate training or orientation for an RN assigned 
to the unit or inappropriate use of unlicensed personnel. Adequate 
numbers of staff are necessary to reach a safe level of patient care 
services. Ongoing evaluation and bench marking related to staffing are 
necessary elements in the provision of quality care. At a minimum, the 
PSO should collect data related to: average ratio of patients to 
registered nurses and licensed practical nurses, and unlicensed 
personnel, measures which differentiate between severity of patient 
illness, mortality and morbidity rates, readmission rates, incidence of 
post-discharge professional care, and length of stay, in order to 
examine the relationship of these variables to occurrence of health 
care errors.
    Another issue that the PSO should examine is the relationship 
between the error rates and continuous hours worked by health care 
professionals. Just as there is concern about the number of hours 
worked by medical residents, ANA has become increasingly concerned by 
hospitals increased reliance on the use of overtime, particularly 
mandatory overtime, by its registered nurse staff. In today's health 
care workplace, 16 hour shifts are becoming increasingly commonplace 
and 24 hour shifts are not unheard of. Too many hospitals have come to 
rely on the use of overtime as a substitute for adequate supply of 
staff.
    In reference to the issue of voluntary reporting the ANA supports 
the call for a nationwide mandatory reporting system under which health 
care systems would be responsible for reporting medical errors to state 
governments. Currently, about a third of all states have such a system 
in place. ANA would argue however that such a system of reporting and 
tracking adverse events must not only maintain data on when the errors 
are occurring, but include information on what organizational variables 
are responsible for the errors.
    In addition, ANA maintains that nurses must be able to speak out 
about quality-of-care problems without fear of retaliation or the loss 
of their jobs. Patient advocacy is at the heart of nurses' professional 
commitment. In turn, patients depend on nurses to ensure that they 
receive proper care. Patients must be assured that nurses and other 
health care professionals, acting within the scope of their expertise, 
will be able to speak for them without fear of reprisal.
    Current whistle-blowing laws remain a patchwork of incomplete 
coverage. This lack of coverage leaves many nurses fearing reprisals 
such as dismissal, harassment and blacklisting. This lack of a blame-
free reporting system prevents many nurses from taking the risk of 
trying to protect their patients' health and safety. In order to allow 
nurses to function as successful patient advocates, effective whistle 
blower protection for nurses who report unsafe patient care must be 
enacted.
    ANA strongly supports any effort that makes patient safety a 
coordinated focused element of the health care system. The 
establishment of safety programs must include balanced and appropriate 
representation of the key players and this means more than token 
nursing representation. Nurses are pivotal to improving patient 
outcomes and excellent evaluators of the work environment for deficits 
and solutions for quality improvements. There must be clear 
responsibility at the top levels of associations and organizations to 
make sure that needed practices are articulated and implemented.
    Madam Chairman, the membership of the ANA wishes to thank you again 
for this opportunity to comment on this important issue. We look 
forward to working with you on legislation that creates an environment 
that supports both the patients and health care providers and assures 
safe quality patient care.

                                 

                     Biomedical Metatechnology Inc.
                                    Amherst, New York 14226
                                                  September 8, 2002
To: Congresswoman Nancy L. Johnson (R-CT)
Chairman, Subcommittee on Health of the Committee on Ways and Means

    Re: Testimony for hearing on legislation to reduce medical errors

To: Congresswoman Nancy L. Johnson (R-CT)
Chairman, Subcommittee on Health of the Committee on Ways and Means

    If the subcommittee is determined to drastically cut the error rate 
in medical services, it should know this fact:
    It is now technically feasible--and highly cost-effective--to cut 
the error rates by 50% or more.
    In my view the only real question is whether it is politically 
feasible to do so.
    I always speak as an individual, not for an organization. My name 
is Irwin D. Bross. I have been a biostatistician, cancer researcher and 
public health scientist for more than half a century. I don't include 
my CV because it is in Who's Who in Medicine and Healthcare.
    How can we cut the error rates in medical services by 50% and 
thereby prevent much unnecessary suffering--and save many billions of 
dollars a year in medicare and health in medicaid and health insurance 
costs?
    The basic idea is simple: Simply exploit our existing computer and 
off-the-shelf software resources to create statewide or nationwide 
medical databases which would serve the public interest rather 
professional or corporate interests.
    One example will show what I mean. Here is my letter which was 
printed in the Buffalo News (9/19/2002):

          Secure database is feasible for patients
          In his column, ``Pursuit of privacy may interfere with 
        patient care,'' Dr. Mike Merrill said, ``The privacy instinct . 
        . . comes partly from a Puritanical shame.'' In fact, the 
        current emphasis of privacy advocates is mainly on the 
        misconduct of doctors who permit confidential medical records 
        to be used by various predators--including drug companies, 
        marketing departments of corporations and other unauthorized 
        people. The medical profession does show an interest in keeping 
        patient records private when it comes to malpractice lawyers.
          Merrill is quite right when he says, ``Given the 
        informational deficiencies in the current health care system, 
        adding new, more rigorous standards . . . can only worsen 
        care.'' On the other hand, correcting those informational 
        deficiencies by providing a single, secure, state database for 
        all patient data that is accessible only to authorized people 
        would compensate for the privacy restrictions.
          A master statewide database has been technologically feasible 
        for at least five years. It would save many lives in emergency 
        situations, such as the side-effects of multiple drug 
        interactions. Robotic programs operating within the system 
        could actually prevent many such side-effects. Uploads and 
        downloads can be made secure.
          Is it the privacy advocates who have successfully blocked 
        such informational upgrades, or is it the doctors and the rest 
        of the health care system?

    As you can see, the basic idea really is relatively simple: Exploit 
our existing computer and off-the-shelf software resources to create 
statewide or nationwide medical databases which would serve the public 
interest rather professional or corporate interests. Use technical 
tricks like ``data bots'' to constantly ``patrol'' the databases and 
which look for the situations where ``human errors'' are likely to 
occur. When potential trouble is found, then trained paramedicals can 
look into it. For example, they can warn the primary physician when a 
patient is taking multiple drugs where dangerous interactions may 
occur.
    The legislation to do the job should (1) state that its purpose is 
to cut the error rate by at least 50% within 5 years, (2) authorize the 
secure databases which would be used for this purpose, and (3) fund at 
least one test database for this purpose.
    In New York State, this could be done mainly by consolidating 
existing databases in some area and I would estimate that it could be 
done for less than $20 million per year for a five year period.
    The subcommittee should be careful (and perhaps innovative) in 
seeking advice on cutting error rates.
    If the committee chooses to rely on lobbyists or professional 
groups or ``do-gooder activists'' for advice on computerized systems 
designed to cut the currently high error rates in medical services, it 
will get advice that is advantageous to these advisors rather to 
ordinary Americans with health problems.
    What it needs to do is to convene a panel which would act like a 
grand jury: It would consist of ordinary citizens who listen to 
conflicting testimony from ``expert'' witnesses and then use common 
sense to make its ``verdict''.
    In other words, any persons who may be in conflict of interest 
(i.e., have a special interest in the issue) would be excluded from the 
panel. This is the opposite of the ``blue ribbon'' panels ordinarily 
convened for medical issues. These have rarely operated in the public 
interest and a different approach to getting advice is worth trying.
    My main point, however, is that if the committee wants to cut the 
error rates in medical services by 50% or more, it is now 
technologically feasible to do this within five years.
                                      Irwin D. Bross, Ph.D.
                                                          President

                                 

                         Los Angeles, California 90083-0008
                                                 September 10, 2002
Mr. Joel White
C/O Committee on Ways and Means
Subcommittee on Health
1136 Longworth Office Building
Washington, DC 20515

Re: Statement and commentary

HR 4889: Patient Safety Improvement Act of 2002

    Please note that the following is being written on behalf of my 
father, RONALD LEE BONNER (1941-2000). The title of my presentation is 
``Gone But Not Forgotten: The Eradication of Dirty Lab Coat Secrets''.

    Dear Health Subcommittee:
    It is with earnest hope that by coming forward and speaking out 
about how this bill would impact me; that it would serve as a catalyst 
to enable other families to tell their stories about bad medical 
experiences. While my story on behalf of my father is no different than 
1,000 other stories of similar note, I offer his story as just one 
example of what happens frequently without mention.
    Everyday, countless people die unexpectedly in the midst of medical 
treatment/mistakes. These senseless deaths hardly register a beep or a 
blip on our collective EEG consciousness. Sure, surviving family 
members know when something doesn't feel right about what they're being 
told. However, more often than not they're told their medical 
interpretation of the results are somehow skewed. Doctors attempt to 
console grieving relatives in terms of a Phase I, Phase II, and Phase 
III analysis of their work. Yet, all the while never completely 
justifying their approach to methodology to the satisfaction of the 
listener.
    Many times doctors pump themselves full of their version of a 
medical truth serum and employing tactics in a vain, emotionless 
attempt to explain their deadly actions to an unsuspecting public. 
Families are indiscriminately, and pointedly coaxed into silence for 
fear of reprisals or being mocked. Doctors try and make people feel 
uneducated and dumb against their verbose and often ethereal language. 
Over and over again this scenario is played out in sharp contrast to 
their starch white clean image of perfection. The backdrop to this 
whole drama is a scrim-dividing wall, separating self-described 
``mistake-free'' doctors away from the inquiring minds of patients and 
their families. I urge the members of the Committee not to allow, ``The 
Patients Safety Act Bill'' (HR 4889), to become shrouded in as much 
mystery as some forms of patient healthcare. This bill must proceed in 
a fair and equitable manner for all involved; while not forgetting the 
very people it was meant to protect.
    Bill 4889 should not be thought of as a lopsided pendulum never 
quite swinging evenly in favor of patients as well as the doctors it 
already serves. Nor should you be hasty in passing the bill without 
some changes which I will expound upon, shortly. Gone are the days when 
our nation's citizens will accept and be pacified by intellectually 
numbing, ``broken limb'', half-hearted excuses for doctors fateful 
decisions and false chart remarks. In order for this bill to become 
successful it must include a level of sanctioning and accountability 
(Proposed Change #1). One needs to include disciplinary action if 
you're going to speak of a bill whose underlying theme is patient 
safety!! The public will not stand by and idly allow our loved ones to 
be swept away in a morass of ``Dirty Lab Coat'' secrets. The only way 
to place ``systematic steps to reduce the incidence'' \1\ of errors is 
to send a clear message to the medical community that such 
miscalculations will no longer be tolerated. The best way to accomplish 
this is through corrective action.
---------------------------------------------------------------------------
    \1\ Quote taken from H.R. Bill 4889.
---------------------------------------------------------------------------
    Contrary to what is suggested in Section 1185 of this proposed bill 
I think we should create (Proposed change #2) ``methods which would 
constitute national practice guidelines''.\2\ Other countries have 
them, why not the United States? The repeated squelching of critical 
safety errors have led and will continue to lend itself to the 
subsequent suppression and washing away of gross mistakes and errors 
the kinds of which led to my father's death. Visualize this picture if 
you will:
---------------------------------------------------------------------------
    \2\ Quote taken from Section 1185 of H.R. Bill 4889.
---------------------------------------------------------------------------
    a) A male patient being given pregnancy and breast cancer medicine.
    b) A patient on 6 diuretics compacted with in a six-month period.
    c) For that matter a CHF patient being prescribed foot cream. ``Go 
Figure'' on this one.
    d) A patient suddenly with a need of multiple ambulance/emergency 
generated pick ups and (coincidently) having doctors involved in his 
case who (ironically) specialize in E.R. care (how convenient!!); when 
at no other time in my father's life has he ever been ill enough to 
warrant such health scares.
    e) Psychiatric meds given to him when he openly questioned the 
treatment he was receiving, and no doctor of appropriate degreed 
capacity (specifically a psychiatric doctor) on his team. This in turn 
generated comments of him being in an ``altered state of 
consciousness'' to justify what was wrongfully written and assessed in 
his medical records.
    f) One medication in particular XELODA, had warnings against its 
continued use for at least 6 months prior (to prescription to my 
father) informing doctors of the mandate for immediate discontinuance.
    g) The possibility the doctors knew in advance that certain drugs 
would produce numerous readmissions thus boosting their medical 
intervention at almost the same alarming rate as his continual 
hospitalizations.
    h) The combination of poly-pharmacy left my father without enough 
blood circulating through his body to even maintain adequate oxygen 
flow.
    In an earlier speech our current president asked us ``all to pray 
for this great nation of ours''.\3\ His own father once said, ``Read my 
lips'' \4\; to which my late grandmother, Sadie Mike countered with, 
``Hear what I say!'' \5\. To merge some of those same words and ideas I 
pray upon the members of this Committee to heed my words. Make no 
mistake. I meant every bit of what has been presented here before you, 
today. Your bill is palatable overall but some changes are in order.
---------------------------------------------------------------------------
    \3\ (Current) President Bush, in an earlier speech.
    \4\ (Former/Elder) President Bush, famous quote from the 1980's.
    \5\ Popular saying of the late Mrs. Sadie Ann Mike.
---------------------------------------------------------------------------
    Thank you one and all for allowing me to present these remarks to 
you on this most important of bills.
            Very truly yours,
                                             Dena J. Bonner

                                 

                                 Centennial, Colorado 80016
                                                  September 5, 2002
    Sirs:
    I have recently retired after 30 years of medical practice in the 
specialty of Otolaryngology/Head and Neck Surgery. I served in a 
variety of roles during this time: Surgery Chief, Quality Assurance 
Committee, Chief of Medical Staff, Board of Governors, etc., etc.
    I can affirm without equivocation that the rate of medical errors 
resulting in severe injury or death is remarkably overstated and 
without validity. The Institute of Medicine has created a climate of 
fear that is devoid of validity.
    I would urge Congress to avoid making the costs of healthcare even 
more unacceptable by introducing even more costly regulations.
            Best wishes.
                                   Richard E. Carlson, M.D.

                                 

                                                               ECRI
                          Plymouth Meeting, Pennsylvania 19462-1298
                                                 September 11, 2002
The Honorable Phil English
Committee on Ways and Means
Pennsylvania--21st, Republican
1410 Longworth HOB
Washington, D.C. 20515-3821

Re: H.R. 4889: Patient Safety Improvement Act of 2002

    Dear Congressman English:
    On behalf of ECRI, I am writing to express our strong support for 
HR 4889, the ``Patient Safety Improvement Act of 2002.'' As a 
Pennsylvania nonprofit patient safety organization with over thirty 
years of experience, ECRI commends your leadership in recognizing the 
critical need for redressing patient safety problems in our nation's 
healthcare system. ECRI runs a voluntary problem-reporting program 
(initiated in 1971), analyzes and investigates patient safety data, 
conducts evidenced-based systematic reviews, and disseminates risk 
reduction tools and information to healthcare providers. We work 
collaboratively with other organizations, hospitals, and providers on 
medication safety and other patient safety programs. Over the years, 
ECRI has been very successful in producing strides in patient safety--
medical products, systems and practices have improved and injuries 
avoided. However, we remain all too aware of the longstanding barriers 
to problem reporting, and all too distressed when we see those problems 
repeat. Until healthcare providers are confident that their safety 
efforts will be used to help patients rather than hurt their own 
organizations, they will not divulge important information that can 
ultimately help to avoid another repeat performance.
    We strongly recommend that the definition of a ``patient safety 
organization'' include organizations like ECRI, which has been 
collecting voluntary problem reports and safety data for over three 
decades. Our protocols mirror many of the ones outlined in the bill. We 
are an independent agency, we de-identify institutions, we disseminate 
safety information, and we provide feedback and assistance. We also 
have strict conflict-of-interest rules. We have worked very hard to 
maintain the trust and confidence of healthcare providers. The 
protections offered by the bill would promote even better reporting to 
ECRI, and better analysis and data as a result. The bill should 
recognize the importance of established safety organizations with a 
track record. Otherwise, it might thwart its own goals by inadvertently 
chilling the dissemination of data that is currently being shared on a 
voluntary basis.
    ECRI provides highly regarded health technology assessment 
programs, issues numerous publications, and works on many government 
contracts--all of which bear on the safety and quality of healthcare. 
Our programs serve hospitals, long-term care facilities, government 
agencies, and payers across the nation as well as the public (see 
www.ecri.org for a more detailed description). We mention these other 
programs to emphasize that a patient safety organization may provide 
many programs and services. It is important that multifaceted 
activities should not preclude an organization from being designated as 
a ``patient safety organization'' under the Act. The current bill 
addresses this in Section 1181 (b) (2) by defining a patient safety 
organization as a private or public organization or component thereof 
that certifies that it conducts, as a primary activity, efforts to 
assist providers that report to such an organization. We urge you to 
retain this flexibility in the Act. It would be very distressing if an 
organization like ECRI, which has received thousands of patient safety 
reports and data from healthcare providers, were unable to be certified 
as a patient safety organization simply because its reporting program 
is one of many safety programs it operates. In fact, our 
interdisciplinary scope and breadth is an important factor in 
strengthening the quality of our work in patient safety.
    ECRI is available to work with Congress to address improvements in 
patient safety and the matters addressed in HR 4889. Please feel free 
to contact me at (610) 825-6000 x5142 or Ronni P. Solomon, Esq. at 
(610)-825-6000 X5158.
            Sincerely,
                                   Jeffrey C. Lerner, Ph.D.
                              President and Chief Executive Officer

                                 

             Statement of the Society of Thoracic Surgeons
    The Society of Thoracic Surgeons, representing essentially all 
board certified cardiac and thoracic surgeons in the United States, 
strongly urges the Congress to pass H.R. 4889, the Patient Safety 
Improvement Act of 2002.
    This bill has been drafted following two years of careful study and 
numerous hearings on the ways in which Congress can best encourage 
hospitals, physicians, and other health care providers to collect and 
analyze adverse events and to share information on the means by which 
quality can continuously be improved. As the Institute of Medicine has 
emphasized, most weaknesses in health care are systemic and local; 
improvement requires the cooperation and participation of many 
individuals, and only through voluntary sharing of information is such 
systemic improvement possible at the local level.
    H.R. 4889 will encourage the establishment of a voluntary national 
database, with confidentiality of reporting, that will permit the 
Department of Health and Human Services to analyze non-identifiable 
patient safety data. The bill will also encourage the analysis and 
sharing of this information at the local provider level. The Agency for 
Health Care Research and Quality should also be intimately involved in 
these data analyses.
    The Society of Thoracic Surgeons established its voluntary National 
Cardiac Database (NCD) in 1989, and it has evolved into the type of 
analysis and feedback system for outcomes analysis that HR 4889 is 
proposing. The benefits of such a system, with analysis of data by 
objective professionals with the requisite medical and technical 
expertise, have been demonstrated by improvements in the care of 
cardiac surgery patients nationwide. Several state and regional cardiac 
surgical organizations, most notably the Northern New England 
Cardiovascular Disease Study Group have also demonstrated that, under 
conditions of confidentiality, information on best practices can 
readily be shared and analyzed within local and regional quality 
improvement organizations, with demonstrable improvements in medical 
practice.
    The Society of Thoracic Surgeons' NCD for outcomes in cardiac 
surgery now includes over 1.8 million patient records. Currently, 529 
institutions are submitting detailed data to the program. Through a 
partnership with the Duke Clinical Research Institute, database members 
are provided with site-specific risk-adjusted operative mortality, 
morbidity, and post-operative length of stay outcomes data. These 
feedback data permit the participating institutions to benchmark their 
own risk-adjusted--results against national and regional outcomes 
benchmarks and identify areas for process improvement.
    In addition to the impetus provided for systemic quality 
improvement at participating institutions, the NCD enables qualified 
researchers to identify specific surgical techniques and processes of 
patient care that can improve outcomes following cardiac surgery.
    A specific example of such a change is the increase in internal 
thoracic artery (ITA) use for primary CABG (Coronary Artery Bypass 
Grafting). In 1994, data from the STS NCD documented an overall 
increase in the use of ITA in the years 1989-1994; moreover, this study 
confirmed that ITA grafting was associated with a significant 
improvement in 30-day survival after CABG. Recently, a subsequent 
analysis from the NCD documented that even in elderly patients > age 75 
years undergoing CABG, ITA grafting was strongly associated with 
decreased operative mortality (Ferguson, JTCVS, 2002). As a result of 
these and other studies, ITA use in CABG in the U.S. has increased 
steadily each year resulting in improved patient safety. This 
demonstrates the positive impact on outcomes that can--and has--
resulted from a voluntary, confidential database. These data have been 
used in a national quality improvement randomized trial funded by the 
Agency for Healthcare Research and Quality (AHRQ) to the STS to promote 
the use of ITA grafting in the elderly, the results of which will be 
presented at the American Heart Association Meeting in November. Other 
STS led quality improvement efforts, most notably CQI efforts 
addressing the use of pre-operative beta-blockers to reduce mortality 
and morbidity following CABG, have been documented to improve CABG 
mortality (Ferguson, JAMA, 2002).
    We believe that it is essential that health care data developed and 
reported for the purposes of quality improvement will remain 
confidential, and that this is true for this and other physician-led 
efforts in error identification and quality improvement. Within the STS 
database, this has been achieved through a sophisticated system of de-
identifying data. It is equally essential that the data must be 
available locally, where it can be most effectively used by the 
providers to evaluate the processes of care, and that the data 
analyses, both local and national, be done by an objective 
3rd party entity with the requisite medical and technical 
expertise to draw valid conclusions.
    The STS as a medical specialty society with a documented track 
record in quality measurement and quality improvement believes that 
H.R. 4889 will encourage and facilitate greater exchange of needed 
patient safety and outcomes information throughout our nation's health 
care system. The combined professional ethic to ``do the right thing'' 
combined with such a NCD system has in part contributed to an almost 
40% reduction in operative mortality nationwide for CABG between 1990-
1999 in the US, despite an almost 40% increase in preoperative 
predicted surgical risk. We strongly support this proposed legislation 
and are proud that voluntary initiatives begun years ago by the Society 
of Thoracic Surgeons can now demonstrate that patient safety and 
outcomes reporting initiatives have directly and positively impacted on 
the safety and quality of CABG care nationwide.

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