[Congressional Record Volume 146, Number 75 (Thursday, June 15, 2000)]
[Senate]
[Pages S5268-S5271]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY (for himself, Mr. Dodd, and Mrs. Murray):
  S. 2743. A bill to amend the Public Health Service Act to develop an 
infrastructure for creating a national voluntary reporting system to 
continually reduce medical errors and improve patient safety to ensure 
that individuals receive high quality health care; to the Committee on 
Health, Education, Labor, and Pensions.


  THE VOLUNTARY ERROR REDUCTION AND IMPROVEMENT IN PATIENT SAFETY ACT

 Mr. KENNEDY. Mr. President, between 44,000 and 98,000 patients 
die each year from medical errors, making it the eighth leading cause 
of death in the United States. Each day, more than 250 people die 
because of medical errors--the equivalent of a major airplane crash 
every day. Estimates of the annual financial cost of preventable errors 
run as high as $29 billion a year. We can do better for our citizens. 
We must do better.
  The Voluntary Error Reduction and Improvement in Patient Safety Act 
of 2000, which Senator Dodd and I are introducing today, will provide 
the federal investment and framework necessary to take the first steps 
to effectively treat this continuing epidemic of medical errors. Today, 
there errors are a stealth plague hidden deep within the world's best 
health care system. This legislation will support needed research in 
this area, and identify and reduce common mistakes.
  Reducing medical errors can save lives and health care dollars, and 
avoid countless family tragedies. The field of anesthesia had the 
foresight to undertake such an effort almost 20 years ago, and today, 
the number of fatalities from errors in administering anesthesia has 
dropped by 98 percent. Our goal should be to achieve equal or even 
greater success in reducing other types of medical mistakes. This 
legislation lays the foundation to achieve this goal.
  The 1999 Institute of Medicine report, To Err is Human, documented 
the compelling need for aggressive national action on the issue. The 
IOM report recommended the creation of two reporting systems, each with 
different goals. The first is a voluntary confidential reporting system 
to learn about medical errors and help researchers develop solutions 
for future error prevention and reduction. The second is a mandatory 
public reporting system for certain serious errors and deaths in order 
to inform the public and hold health care facilities responsible for 
their mistakes.
  Our legislation today deals with the first issue, but the second 
issue is also critical. I believe that the public has a right-to-know 
about certain serious events, and public disclosure is an important 
tool to assure that institutions

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put safety on the front burner, not the back burner.
  I commend the Administration for recognizing the value of mandatory 
reporting by recently establishing such programs in the Department of 
Veterans Affairs and Department of Defense health care systems. The 
Agency for Healthcare Research and Quality is also in the process of 
evaluating existing mandatory reporting systems, and the Health Care 
Financing Administration is planning to sponsor a mandatory reporting 
demonstration project for selected private hospitals. I believe our 
next step should be to move ahead with mandatory reporting, and the 
results of these studies will shed needed light on the effectiveness of 
different options.

  The bill we introduce today would take a significant first step 
toward implementing and providing support for the recommendations in 
the IOM report.
  The overwhelming majority of errors are caused by flaws in the health 
care system, not the outright negligence of individual doctors and 
nurses. Our hospitals, doctors, nurses, and other health care providers 
want to do the right thing. Our proposal gives the health care 
community the tools to identify the causes of medical errors, the 
resources to develop strategies to prevent them, and the encouragement 
to implement those solutions.
  First, the Act creates a new patient safety center in the Agency for 
Healthcare Research and Quality. The Center for Quality Improvement and 
Patient Safety will improve and promote patient safety by conducting 
and supporting research on medical errors, administering the national 
medical error reporting systems created under this bill, and 
disseminating evidence-based practices and other error reduction and 
prevention strategies to health care providers, purchasers and the 
public.
  Second, the legislation would establish national voluntary reporting 
and surveillance systems under AHRQ to identify, track, prevent and 
reduce medical errors. The National Patient Safety Reporting System 
will allow health care professionals, health care facilities, and 
patients to voluntarily report adverse events and close calls. The 
National Patient Safety Surveillance System would establish a 
surveillance system, which is modeled on a successful CDC initiative 
that tracks hospital-acquired infections, for health care facilities 
that choose to participate. Participating facilities will include a 
representative sample of various institutions, which will monitor, 
analyze, and report selected adverse events and close calls. 
Researchers will provide feedback to the participating facilities.
  Reports submitted to both programs will be analyzed to identify 
systemic faults that led to the errors, and recommend solutions to 
prevent similar errors in the future.
  In order to encourage participation, reports and analyses from both 
programs will be protected from discovery, and health care workers who 
submit reports to the programs will be protected against workplace 
retaliation based on their participation in the reporting systems.
  In exchange for establishing this reporting system, health care 
facilities and professionals would be expected to voluntarily implement 
appropriate patient safety solutions as they are developed. In 
addition, in recognition of the significant federal investments in 
error reduction strategies and the provision of health services, the 
Secretary of Health and Human Services will be required to develop a 
process for determining which evidence-based practices should be 
applied to programs under the Secretary's authority. The Secretary will 
take appropriate, reasonable steps to assure implementation of these 
practices.
  Our proposal also requires the Director of the Office of Personnel 
Management to develop a similar process for determining which evidence-
based practices should be used as purchasing standards for the Federal 
Employees Health Benefits Program. Plans will also be rated on how well 
they met these standards, and compliance ratings will be provided to 
federal employees and retirees during the annual enrollment period.
  The bill authorizes $50,000,000 for the Agency for Healthcare 
Research and Quality for FY 2001, increasing to $200,000,000 in FY 
2005, to fund error-related research and the reporting systems.
  Systemic errors in the health care system put every patient at risk 
of injury. The measure we propose today is designed to reduce that risk 
as much as possible. Americans deserve the highest quality health care. 
This bill will raise patient safety to a high national priority, and 
ensure that patient safety becomes part of every citizen's expectation 
of high quality health care. This is essential legislation, and I look 
forward to working with my colleagues to expedite its passage and to 
develop companion legislation that establishes a mandatory reporting 
system.
  I ask unanimous consent that the following summary, fact sheet, and 
letters of support be inserted into the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

  Voluntary Error Reduction and Improvement in Patient Safety Act of 
                             2000: Summary

       According to the November 1999 Institute of Medicine 
     report, ``To Err is Human: Building a Safer Health System,'' 
     between 44,000 and 98,000 patients die each year as a result 
     of mistakes. Estimates of total annual national costs for 
     preventable errors range from $17 to $29 billion. This 
     legislation amends the Public Health Service Act to establish 
     a national non-punitive system to prevent and reduce medical 
     errors. Provisions are designed to: (1) identify and 
     investigate certain medical errors; (2) develop and 
     disseminate best practices to prevent and reduce medical 
     errors; and (3) assure implementation of evidence-based error 
     reduction strategies.


                       CENTER FOR PATIENT SAFETY

       Authorizes the Agency for Healthcare Research and Quality 
     (AHRQ) to: (1) create a Center for Quality Improvement and 
     Patient Safety to promote patient safety; (2) serve as a 
     central publicly accessible clearinghouse for information 
     concerning patient safety; (3) administer the reporting 
     systems created under this legislation; (4) conduct and fund 
     research on the causes of and best practices to reduce 
     medical errors; and (5) disseminate evidence-based 
     information to guide in the development and continuous 
     improvement of best practices.


                           REPORTING SYSTEMS

       Creates two national voluntary, and confidential reporting 
     systems under AHRQ: (1) a reporting system of adverse events 
     and close calls that uses uniform reporting standards and 
     forms; and (2) a surveillance system in which participating 
     health care facilities agree to monitor, analyze, and report 
     specified adverse events and close calls that occur in their 
     institutions. Reports submitted to both programs will be 
     protected from discovery, and analyzed to identify errors 
     that result from faults in the health care system. Neither 
     program will preempt existing nor preclude the later 
     development of new reporting systems.
       Health care professionals who submit reports to the 
     reporting systems, their employer, or an appropriate 
     regulatory agency or private accrediting body may not be 
     discriminated against in their employment for reporting.


                          AUTHORIZATION LEVELS

       Authorizes $50,000,000 for AHRQ for fiscal year 2001, with 
     gradual increases to $200,000,000 for fiscal year 2005, to 
     fund error-related research and the reporting systems.


                    APPLICATION TO FEDERAL PROGRAMS

       Requires the Secretary of the Department of Health and 
     Human Services to: (1) develop a process for determining 
     which evidence-based best practices disseminated by AHRQ 
     should be applied to programs under the Secretary's 
     authority; and (2) take reasonable steps as may be 
     appropriate to bring about the implementation of such 
     practices. Requires the Director of the Office of Personnel 
     Management to develop a process for determining which 
     evidence-based best practices disseminated by AHRQ should be 
     used as purchasing standards for the Federal Employees Health 
     Benefits Program.
                                  ____


Fact Sheet: The Need for the Voluntary Error Reduction and Improvement 
                    of Patient Safety Act (VERIPSA)

       In December, 1999, the Institute of Medicine issued a 
     report, To Err is Human: Building a Safer Health Care System, 
     that documents the compelling need for national action to 
     reduce errors and improve patient safety:
       Between 44,000 and 98,000 patients die each year as a 
     result of medical errors, making medical errors the eighth 
     leading cause of death.
       Errors in the health care system result in more deaths each 
     year than highway accidents, breast cancer or AIDS. Errors 
     that seriously injure or otherwise harm patients are even 
     more prevalent.
       In 1993, medication errors alone are estimated to have 
     accounted for 7,000 deaths. Two percent of patients admitted 
     to hospitals experience an adverse event caused by medication 
     errors, resulting in $2 billion in

[[Page S5270]]

     national spending for additional hospital costs related to 
     preventable medication errors for inpatients.
       Total annual national costs (e.g., health care, lost wages/
     productivity, disability) resulting from medical errors are 
     estimated to be between $38 and $50 billion, including $17-29 
     billion for preventable events.


          VERIPSA Can Save Lives and Reduce Health Care Costs

       The report found that most medical errors are the result of 
     flaws in the health care system, rather than carelessness by 
     health professionals, including, for example, errors that 
     arise from misreading a physician's handwritten prescription. 
     Many of these problems can be minimized through better 
     systems and computerization.
       Over the last two decades, a systematic effort to reduce 
     deaths from errors in administering anesthesia has resulted 
     in a decline from two deaths per 10,000 patients in the early 
     1980s to one death per 300,000 patients today.
       One study found that 60 percent of preventable adverse drug 
     events could be avoided by physician computer-entry order 
     systems.
       The experience on other industries has shown the 
     effectiveness of concerted efforts to reduce errors. Since 
     1976, the death rate from airline accidents has declined 
     400%. Since the creation of the Occupational Safey and Health 
     Administration in 1970, the workplace death rate has been cut 
     in half.
       The Institute of Medicine report concludes that a reduction 
     in medical errors of 50% over the next five years is 
     achievable and should be a minimum target for national 
     action.
                                  ____

                                                   American Health


                                          Quality Association,

                                    Washington, DC, June 15, 2000.

Statement on the ``Voluntary Error Reduction and Improvement in Patient 
                              Safety Act''

       The American Health Quality Association (AHQA) represents 
     the national network of Quality Improvement Organizations 
     (QIOs), which are known as the Peer Review Organizations 
     (PROs), for their Medicare quality improvement work. The QIOs 
     have vast clinical and analytic expertise, work daily with 
     providers across the country, and know how to affect systemic 
     change and bring about measurable improvement in care. They 
     are experts at translating the literature and research 
     regarding best practices from ``bookshelf to bedside'' and 
     teaching providers how to perform ongoing measurement of 
     their progress.
       Senator Kennedy and Senator Dodd have done a commendable 
     job of addressing all of the various aspects of what is 
     necessary for a national system for improving patient safety. 
     In their ``Voluntary Error Reduction and Improvement in 
     Patient Safety Act,'' they direct AHRQ to establish a Center 
     for Quality Improvement and Patient Safety to conduct 
     research of medical errors and disseminate information on the 
     best practices for reducing them. The bill also proposes two 
     reporting systems that are voluntary, non-punitive, and 
     confidential. One system asks providers to report adverse 
     events and close calls to AHRQ using uniformed standards and 
     forms. The other asks providers to agree to monitor specific 
     types of adverse events as directed by AHRQ.
       AHQA is pleased that AHRQ is given the authority to 
     contract with experts in the field to work with health care 
     providers and practitioners to identify adverse events and 
     determine what systemic changes are necessary to prevent them 
     for recurring. AHQA's goal in the patient safety debate is to 
     make sure that true quality improvement is achieved. We do 
     not support error reporting for the sake of reporting. 
     Organizations, such as the QIOs, should be encouraged to work 
     side by side with providers and practitioners to improve 
     their health care delivery systems.
       ``The Voluntary Error Reduction and Improvement in Patient 
     Safety Act'' then goes beyond reporting and research by 
     directing the Secretary of HHS to take the best practices 
     disseminated by AHRQ and apply them, as may be appropriate, 
     to programs under the Secretary's authority. The bill 
     specifically directs the Secretary to enter into agreements 
     with the QIOs (through their PRO work) to provide, upon 
     request, technical assistance regarding best practices and 
     root-cause analysis to health care providers participating in 
     HHS funded health programs.
       AHQA believes it is the appropriate next step to regime HHS 
     to apply the most up-to-date methods for assuring patient 
     safety to its health care programs. The QIOs stand ready to 
     assist the Director of AHRQ and the Secretary of HHS in their 
     efforts to help the medical community find the root cause of 
     adverse events that are occurring and help develop strategies 
     for preventing them in the future.
                                  ____



                           Massachusetts Hospital Association,

                                    Burlington, MA, June 15, 2000.
     Hon. Edward M. Kennedy,
     U.S. Senate,
     Washington, DC.
       Dear Senator Kennedy: On behalf of the hospitals in 
     Massachusetts, I am writing to applaud the introduction of 
     your legislation ``The Error Reduction and Improvement in 
     Patient Safety Act.'' This bill will no doubt serve as a 
     major step toward making patient safety a national priority.
       We hope that many aspects of this legislation will become 
     law. In particular, we support your suggested process to 
     ensure that proven practices to reduce medical errors are 
     implemented. In addition, we also believe that your efforts 
     to improve confidentiality protections for reporting will go 
     a long way towards creating a safe environment that supports 
     open dialogue about errors, their causes, and solutions.
       Thanks to you and your staff, Massachusetts continues to be 
     on the forefront of the national debate about how best to 
     address this important issue.
           Sincerely,
                                                   Andrew Dreyfus,
     Executive Vice President.
                                  ____

         Federation of Behavioral, Psychological and Cognitive 
           Sciences,
                                    Washington, DC, June 15, 2000.
     Hon. Edward Kennedy,
     Health, Education, Labor and Pensions Committee, U.S. Senate, 
         Washington, DC.
       Dear Senator Kennedy: I am writing on behalf of the 
     Federation of Behavioral, Psychological and Cognitive 
     Sciences, a coalition of 19 scientific associations. Among 
     its scientists are human factors researchers whose work is 
     devoted to understanding and reducing the adverse effects of 
     medical errors. I write to endorse the ``Voluntary Error 
     Reduction and Improvement in Patient Safety Act.''
       This bill recognizes that human error in healthcare 
     settings has reached epidemic proportions and will provide an 
     infrastructure for centralized error reporting systems. 
     Important provisions of the bill will allow healthcare 
     providers to learn from such reporting systems by creating 
     interdisciplinary partnerships to conduct root cause analyses 
     across a wide range of health care settings.
       Such analyses will help detect error trends and inform new 
     lines of directed inquiry and hypothesis-driven research to 
     reduce errors. The bill highlights the pivotal role of human 
     factors research in understanding human error in any context 
     and would draw upon the success of human factors as it has 
     been applied in many other industries such as aviation, 
     maritime shipping, and nuclear power to improve safety.
       As in these other industries, particularly as evidenced in 
     aviation, the real value of error reporting lies in the 
     development of useful applications of the reported data to 
     improve safety. The ``Voluntary Error Reduction and 
     Improvement in Patient Safety Act'' clearly lays out the 
     infrastructure to promote the development of evidence-based 
     interventions to improve safety. Further, unique features of 
     this learning system include basic behavioral principles of 
     positive reinforcement to stimulate voluntary reporting. Such 
     a positive feedback loop will surely strengthen the quality 
     of the database this bill will structure. The database will 
     form the foundation for a bold new way of thinking about 
     patient safety. The data and the research, in turn, will make 
     attainable the goal we all strive for, the dramatic reduction 
     of adverse events in health care settings.
       We believe the Kennedy-Dodd bill is a very strong plan for 
     reducing adverse events due to medical error. We also find 
     much to praise in the Jeffords bill. So we take the unusual 
     step of endorsing both and encourage work to meld the unique 
     features of these two extraordinary bills into a coherent 
     whole that will then surely receive the overwhelming support 
     of the Congress.
           Sincerely,
                                                    David Johnson,
                                       Executive Director.

 Mr. FRIST. Mr. President, I am pleased to join with my 
colleague, the distinguished chairman of the Health, Education, Labor, 
and Pensions Committee (HELP), Senator Jeffords, in introducing today a 
critical piece of legislation that will take needed steps to improve 
the quality of health care delivered in this country. The goal of our 
legislation today is to improve patient safety by reducing medical 
errors throughout the health care system.
  The Institute of Medicine Report (IOM), released last November, 
sparked a national debate about how safe our hospitals and health care 
settings actually are for patients. The scope of the problem identified 
in the findings were shocking. The IOM found that each year an 
estimated 44,000 to 98,000 hospital deaths occur as a result of 
preventable adverse events. This makes medical errors the 8th leading 
cause of death, with more deaths than vehicle accidents, breast cancer 
or AIDS. These errors cost our Nation $37.6 billion to $50 billion per 
year, representing 4 percent of national health expenditures.
  Despite the recent IOM findings, this is not a new debate. Many 
experts have told us that the health care industry is a decade or more 
behind in utilizing new technologies to reduce medical errors. Just 
last year, the HELP Committee took initial steps last year to reduce 
medical errors through the reauthorization of the Agency for Healthcare 
Research and Quality (AHRQ), revitalizing this agency as the

[[Page S5271]]

federal agency focused on improving the quality of health care in this 
country. Part of the core mission of AHRQ is to further our 
understanding of the causes of medical errors and the best strategies 
we can employ to reduce these errors. The legislation authorized the 
Director of AHRQ to conduct and support research; to build private-
public partnerships to identify the causes of preventable health care 
errors and patient injury in health care delivery; to develop, 
demonstrate, and evaluate strategies for reducing errors and improving 
patient safety; and to disseminate such effective strategies throughout 
the health care industry.
  The legislation we introduce today builds upon the further 
recommendations of the IOM report and reflects the culmination of 
testimony received throughout the past several months in a series of 
hearings held by the HELP Committee.
  The central goal of this legislation is quality improvement 
throughout the health care system. We heard over and over throughout 
our hearings that we need to develop our knowledge base about the best 
mechanisms to reduce medical errors. This can only be achieved if we 
build a system where errors can be reported and understood to improve 
care, not to punish individuals. We need to create a ``culture of 
safety'' in which errors can be reported, and analyzed, and then change 
can be implemented.
  I will not go into the details of this legislation, which Senator 
Jeffords has already outlined, I would simply outline the three main 
goals of this legislation, the creation of a national center for 
quality improvement and patient safety at the AHRQ, the creation of a 
voluntary reporting system to collect and analyze medical errors, and 
the establishment of strong confidentiality provisions for the 
information submitted under quality improvement and medical error 
reporting systems.
  I am very supportive of the goals of this legislation and will 
continue to examine the best ways to reduce medical errors in our 
health care system. It is essential that we pass medical errors 
legislation this year. We will continue to seek input from patients and 
provider groups as we work to pass this legislation.
  Mr. DODD. Mr. President, I am pleased to join Senator Kennedy in 
sponsoring the ``Error Reduction and Improvement in Patient Safety 
Act,'' legislation which will establish a national system to identify, 
track and prevent medical errors.
  Last November, the Institute of Medicine reported that between 44,000 
and 98,000 deaths per year are attributable to medical errors, ranging 
from illegible prescriptions to amputations of the wrong limb. In other 
words, patients are being harmed not because of a failure of science or 
medical knowledge, but because of the inability of our health care 
system to mitigate common human mistakes.
  Most Americans feel confident that the health care they receive will 
make them better--or at the very least, not make them feel worse. And 
in the vast majority of circumstances, that confidence is deserved. The 
dedication, knowledge and training of our doctors, nurses, surgeons and 
pharmacists in this country are unparalleled. But, as the IOM report 
starkly notes, the quality of our health care system is showing some 
cracks. If we are to maintain public confidence, we must respond 
quickly and thoroughly to this crisis.
  One thing is certain: the paradigm of individual blame that we've 
been operating under discourages providers from reporting mistakes--and 
thwarts efforts to learn from those mistakes. We have to move beyond 
finger-pointing and encourage the reporting and analysis of medical 
errors if we want to make real progress towards improving patient 
safety.
  This legislation will do just that. It authorizes the creation of a 
national Center for Quality Improvement and Patient Safety to set and 
track national patient safety goals and conduct and fund safety 
research. The bill also sets up national non-punitive, voluntary, and 
confidential reporting systems for medical errors. By analyzing and 
learning from mistakes, we will be better able to determine what 
systems and procedures are most effective in preventing errors in the 
future.
  Identification and analysis of errors is critical to improving the 
quality of health care. But we must also develop measures of 
accountability that ensure that the information that is generated by a 
national error reporting system is actually used to improve patient 
safety. Our bill takes those practices shown to be most effective in 
preventing errors and creates a mechanism for integrating those 
practices into federally-funded health care programs. These evidence-
based ``best practices'' will also be used as standards for health care 
organizations seeking to participate in the Federal Employees Health 
Benefits Program.
  Mr. President, the ``Error Reduction and Improvement in Patient 
Safety Act'' addresses the complex problem of medical errors in the 
most comprehensive manner possible--from the identification of errors, 
to the analysis of the errors, to the application of best practices to 
prevent those errors from ever occurring again. Simply put, this 
legislation will save lives. I look forward to working with my 
colleagues to enact this legislation expeditiously, because frankly, 
one medical error is one too many.
                                 ______