[Congressional Record Volume 148, Number 72 (Wednesday, June 5, 2002)]
[Senate]
[Pages S5052-S5054]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. JEFFORDS (for himself, Mr. Frist, Mr. Breaux, and Mr. 
        Gregg):
  S. 2590. A bill to amend title IX of the Public Heath Service Act to 
provide for the improvement of patient safety and to reduce the 
incidence of events that adversely effect patient safety; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. FRIST. Mr. President, I am pleased to join today with my 
colleagues Senators Jeffords, Breaux, and Gregg in introducing crucial 
legislation, the Patient Safety and Quality Improvement Act.
  Each year, as many as 98,000 people in the United States die as a 
result of medical errors. More Americans die each year from medical 
errors than from breast cancer, AIDS, or motor vehicle accidents. As a 
physician who has taken the Hippocratic oath ``To do no harm,'' the 
status quo is simply unacceptable. As the Institute of Medicine wrote 
in its landmark 1999 report, To Err is Human: ``[I]t is simply not 
acceptable for patients to be harmed by the same health care system 
that is supposed to offer healing and comfort.''
  The legislation we are introducing today will go a long way toward 
preventing many of these tragedies. Although a variety of patient 
safety initiatives are underway in the private sector as well as within 
the Department of Health and Human Services, and in the states, 
Congress has an important role to play in reinforcing, encouraging, and 
enhancing these efforts.
  The major contribution of this legislation is to foster an open, 
collaborative environment where doctors, nurses, and other health 
professionals can share information freely and analyze it thoroughly. 
Health care providers should not be punished for trying to learn from 
their mistakes, reduce medical errors, and improve the quality of care 
they deliver to patients.
  As a physician and a scientist, I know first hand about the enormous 
complexities of medicine today and the intricate system in which 
providers deliver care. I also recognize the need to examine medical 
errors closely in order to determine where the system has failed 
patients, and how it can be improved. Yet, adequate protections do not 
exist today to foster this type of learning and improvement 
environment. For example, hospitals currently rely upon Mortality and 
Morbidity Conference to share information about medical errors that 
occur with respect to individual patients. Unfortunately, because these 
conferences are focused

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on events involving individual patients within a single hospital, it is 
impossible to address system-wide quality and safety problems that may 
exist across hospital systems and within broader communities. Fear of 
litigation is the primary barrier to sharing and analyzing information 
that could save lives and improve treatment within the broader health 
care community.
  We have seen this type of non-punitive reporting model work to vastly 
improve safety in other situations. In 1975, the Federal Aviation 
Administration established the Aviation Safety Reporting System, ASRS, 
to encourage pilots, controllers, flight attendants, mechanics, and the 
public to voluntarily report actual or potential discrepancies and 
deficiencies involving the safety of aviation operations. Because this 
information was widely shared and analyzed, the ASRS helped to 
significantly improve aviation safety in the United States. The risk of 
dying in a domestic jet flight decreased from one in two million in 
1967 to 1976 to only one in eight million in the 1990s.
  The Institute of Medicine, as well as many experts who have testified 
before Congress during the past few years, have strongly recommended 
that Congress provide the same type of legal protections for 
information gathered and reported to improve health care quality and 
increase patient safety. Without these protections, patient safety 
improvements will continue to be hampered by fears of retribution and 
recrimination. If we are to change the health care culture from ``name, 
shame, and blame'' to a culture of safety and continuous quality 
improvement, we must provide these basic protections.
  In extending these protections, we have tried to encourage widespread 
voluntary error reporting while continuing to allow access to medical 
records and other information that should be available to patients for 
litigation or other purposes. Protecting data reported to a certified 
patient safety reporting system does not mean that such information 
cannot be obtained through other avenues if it is important to securing 
redress for harm. At the same time, information generated by this new 
reporting system designed specifically to reduce errors and broadly 
benefit patients should not become fodder for increased litigation. 
Moreover, the legislation expressly allows for patient safety 
information to be disclosed in the context of a disciplinary proceeding 
or criminal case where it is 1. material to the proceeding; 2. within 
the public interest; and 3. not available from any other source.
  I want to thank Senators Jeffords, Breaux, and Gregg for their 
support, and input into this legislation. I look forward to working 
with them, Senator Kennedy, and my other colleagues in both the House 
and Senate, to pass legislation that will advance patient safety 
efforts.
  I also value the leadership of the Bush Administration on this 
critical issue. The Administration's efforts to improve patient safety 
are underscored by the commitment, support and direct involvement of 
both Secretary Thompson of the Department of Health and Human Services 
and Secretary O'Neill of the Department of Treasury in helping to shape 
this legislation.
  Americans take pride in offering the most advanced medical care in 
the world. A bounty of new devices, new treatments, and new techniques 
offer the hope of living longer and healthier than ever before. Yet, 
medical mistakes continue to take thousands of lives and cost billions 
of dollars each year. We must not let the miracle of modern medicine be 
extinguished by medical errors. This bill will make the changes in 
culture and communications that are needed to increase the safety of 
America's health care system, and improve the quality of care delivered 
to America's patients.
  Mr. JEFFORDS. Mr. President, I am happy to have the opportunity today 
to speak on the vital issue of patient safety and medical errors, and 
to introduce legislation that will ensure better health care for all 
Americans. In 1999, the Institute of Medicine published a classic 
reference book titled To Err is Human, which reported that hospital 
medical errors contribute to approximately 100,000 deaths a year.
  This troubling statistic has been verified by research done by the 
Commonwealth Foundation and reviewed by articles in the Journal of the 
American Medical Association, the Annals of Internal Medicine, and the 
New England Journal of Medicine. This statistic shows that medical 
errors are a more common cause of death than motor vehicle accidents or 
breast cancer, and it puts medical errors as the eighth leading cause 
of death in the United States.
  This is totally unacceptable and it need not be occuring at all. 
Today, I am pleased to introduce legislation with my colleagues 
Senators Frist, Breaux, and Gregg, the ``Patient Safety and Quality 
Improvement Act,'' that will put us on the path to correcting these 
medical errors.
  The ``Patient Safety and Quality Improvement Act'' lays the 
groundwork for preventing these unnecessary deaths and injuries. Only 
by providing a framework through which medical errors can be reported 
and analyzed will we be able to make changes, strengthen and improve 
our health-care system and reduce morbidity and mortality.
  Since the 106th Congress, the Senate Health, Education, Labor, and 
Pensions Committee has held five hearings on this important issue. The 
testimony given during these hearings reflected an overwelling 
agreement with the IOM report and the ``Patient Safety and Quality 
Improvement Act,'' acts upon the IOM's findings and recommendations
  Key elements of To Err is Human call for improvements in patient 
safety by developing a learning, rather than a punitive environment; 
legal protections of privacy and privilege that would foster care 
systems to be reviewed and appropriate collaborations to occur in 
developing and implementing patient safety improvement strategies.
  Our legislation addresses all of these concerns. Currently, adequate 
legal protections and a non-punitive environment do not exist to foster 
the exchange of information and the analysis that is needed to deal 
with the complex issues of improving patient safety. Our measure 
creates opportunities for higher standards of continuous safety 
improvement, and encourages a new culture of patient safety dialogue to 
insure that safety information will be shared voluntarily and that 
appropriate collaboration and analysis will occur. It can not be overly 
stress that an environment where information, data, process, and 
recommendations enjoy legal protection and privilege it is essential to 
any safety organization.
  These are the key elements of what the ``Patient Safety and Quality 
Improvement Act'' will do. It promotes a ``culture of safety'' in our 
health care system by providing for the legal protection of information 
reported voluntarily for the purposes of quality improvement and 
patient safety. It creates incentives for creating voluntary reporting 
systems that are non-punitive and promote learning. It recognizes that 
to be effective, these systems must have the buy-in, trust, and 
cooperation of the health care providers. It recognizes the Agency for 
Healthcare Research and Quality (AHRQ) as the leader in patient; safety 
for funding research and for dissemination of information learned about 
improving patient safety; and finally, it complements many ongoing 
patient safety initiatives in the public and private sector.
  Finally, I want to point out what the bill does not do: It does not 
change existing remedies available to injured patients or limit a 
patient's access to their medical record; it does not ``shield'' or put 
patient information that is otherwise available beyond the reach for 
the purposes of disciplinary, civil or criminal proceedings; it does 
not change current regulatory processes or add new regulatory 
requirements; and it does not create mandatory, punitive reporting 
systems.
  Our bill enjoys widespread endorsement by over 40 hospital, patient, 
doctor, and consumer advocacy organizations, and this degree of support 
underscores the broad appeal and essential nature of this proposed 
legislation. It is my strong desire that this bill receive the prompt 
attention that the issue clearly deserves.
  All of us are justifiably proud of our hospital system and the 
wonders of medicine and technology. But we can no longer ignore the 
well documented incidence of medical errors, which waste needed medical 
resources and

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cause excessive medical complications and unacceptable loss of life. 
Without attention to this matter, it is reasonable to expect that 
thousands of innocents will suffer unnecessarily in our hospitals. We 
simply must not allow this to happen.
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