[House Hearing, 107 Congress]
[From the U.S. Government Publishing 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
U. S. GOVERNMENT PRINTING OFFICE
86-199 WASHINGTON : 2003
____________________________________________________________________________
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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].
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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].
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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.
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\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].
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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\
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\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*
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1999 2000 2001
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No. of bills introduced 1\1\ 34 61
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; report study
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requiremen requiremen
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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
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* 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).
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\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.
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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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