Mr. President, I came to the floor today to commend our colleagues and extend my appreciation to them because last night the Senate unanimously passed S. 544, the Patient Safety and Quality Improvement Act of 2005. I do not believe it is…
Mr. President, I came to the floor today to commend our colleagues and extend my appreciation to them because last night the Senate unanimously passed S. 544, the Patient Safety and Quality Improvement Act of 2005. I do not believe it is too great an exaggeration to say that this bill will be among the most significant healthcare legislation the Senate will consider during this Congress. I say that because I believe this legislation will contribute immensely to the current efforts that are underway to save lives and reduce the tragedy of needless medical errors.
This legislation starts with a simple premise. Let us set up a system that helps our health care providers learn from each other. Let us set up a system that promotes the reporting and analysis of medical errors. Let us set up a system that engenders the trust of providers and the patients they serve.
The passage of this legislation represents the successful culmination of efforts, by many of our colleagues, that began with the publication of a small but significant report about medical errors.
With the publication of the Institute of Medicine, IOM, study, To Err is Human in 1999, we were all reminded
that Hippocrates' maxim to ``first, do no harm'' is as relevant to the practice of medicine today as it was in 400 B.C. That IOM report was among the first to galvanize national attention on the issue of patient safety when it reported that medical errors contribute to approximately 100,000 patient deaths a year. This startling and troubling statistic has been verified in subsequent studies and cited in peer reviewed articles in the leading journals of biomedical research, including the Journal of the American Medical Association, the Lancet, and the New England Journal of Medicine.
When I was Chairman of the Senate Committee on Health, Education, Labor, and Pensions in 1999, I undertook several hearings--5 in all--to examine this issue and discuss the recommendations of the To Err is Human report. The preponderance of testimony overwhelmingly agreed with several of the original Institute of Medicine recommendations.
Perhaps the most important of these recommendations stresses that improving patient safety requires a learning environment rather than a punitive environment; voluntary data gathering systems as opposed to mandatory systems; and appropriate legal protections--including confidentiality and privilege from discovery--that allow for the review and analysis of medical error information.
In response to this attention to patient safety issues, a myriad of public and private patient safety initiatives have begun. The Department of Health and Human Services has initiated several patient safety projects, including project grants funded by the Agency for Healthcare Research and Quality, AHRQ. The work of the Veterans' Administration in developing and implementing innovative patient safety systems--especially in the area of medication management--has drawn attention from throughout the country. In addition, the Quality Interagency Coordination Taskforce has recommended steps to improve patient safety that can be taken by each Federal agency involved in health care; and agency activities to implement these steps are ongoing. Finally, efforts are well underway to bring the advanced electronic technology of the information-age to bear on solving many of the problems associated with medical errors.
Several non-governmental organizations and professional societies have also ``stepped up to the plate'' on patient safety. The Joint Commission on Accreditation of Healthcare Organizations, the U.S. Pharmacopoeia, the American Medical Association, medical specialty societies and other health care providers including the American Hospital Association and the American Federation of Hospitals have launched innovative efforts dedicated to improving patient safety.
Consumers of healthcare and academia are involved in reducing errors in patient care as well. Examples of these include: ``The Leapfrog Group'' an initiative driven by organizations that buy health care that are working to initiate breakthrough improvements in the safety, quality and affordability of healthcare; and the Institute for Healthcare Improvement, led by an original IOM panel member, Dr. Don Berwick, which has provided seminal work advancing the goals of patient safety. All of these efforts deserve our gratitude because without them deaths and injuries stemming from medical errors would continue to increase.
However, many of the organizations currently collecting patient safety data have expressed the need for legal protections that will allow them to review protected information so that they may collaborate in the development and implementation of patient safety improvement strategies.
The work of Lucien Leape, another member of the IOM panel and adjunct professor of health policy at Harvard University, has supported this view. Dr. Leape has argued persuasively that we, as a society, will continue to have difficulty reducing medical errors and improving patient safety because our institutions are ``still locked into a blame and punish approach to errors and a focus on individual culpability . . .'' in turn, ``the fear of malpractice litigation thus becomes a major barrier to openly discussing and reporting errors.''
To respond to these needs, I and several of our colleagues have for many years introduced legislation that would promote the open discussion of medical errors that is so needed to curb these needless deaths and injuries. Last year, this legislation passed the Senate unanimously, but unfortunately, a conference with our House colleagues never occurred.
This Congress, I reintroduced S. 544, the Patient Safety and Quality Improvement Act, with the bipartisan support of Senators Gregg, Bingaman, Enzi, Frist, and Murray. Our group was soon joined in this effort by Senators Sessions, Landrieu and Collins. Early in this session, the Health, Education, Labor, and Pensions Committee unanimously passed S. 544. To Chairman Enzi's great credit, he recognized the significance of this legislation early-on and, enlisting the support of Senator Kennedy, led the way to resolving differences between S. 544 and language that was being considered by our colleagues in the House of Representatives. Together, these Members worked untiringly to hone and improve this legislation, which resulted in its consideration by, and the unanimous support of, our colleagues last night.
The legislation raises expectations for higher standards for continuous patient safety improvement and it encourages a new and needed culture of patient safety among health care providers and American hospitals. The bill accomplishes these goals by establishing appropriate legal protections for patient safety information voluntarily shared among patient safety organizations and providers. Our legislation reflects the belief that a culture of patient safety can flourish best in an environment where information, data, processes, and recommendations enjoy legal protection and privilege.
Because it appropriately addresses an obvious need and concern, the Patient Safety and Quality Improvement Act has enjoyed widespread endorsement by hospital, patient, doctor, and consumer advocacy organizations. This degree of support underscores the broad appeal and essential nature of this proposed legislation.
In the time since the release of To Err is Human, the Congress has been unable to enact sensible legislation to reduce medical errors and increase patient safety. In that time, assuming that the IOM data are accurate, approximately one-half million more individuals have died and countless others have experienced significant injuries through medical errors.
With the leadership of Chairman Enzi and Senator Kennedy we have met to work out differences with our colleagues in the House and it too will soon consider legislation. I am encouraged that we have reconciled disagreements that have previously stopped this legislation from moving forward and I hope the House will act favorably so that this legislation can become law.
We need to apply Hippocrates' admonition to ``first, do no harm'' beyond the medical community to the legislative community. We need to pass legislation now that will help the health care community stop the needless injury caused by unintentional medical errors.
Of course, we also live in a complex society--one in which medical errors that may have harmed a patient might also be the basis for litigation. It is a right under our laws to seek a remedy when harmed, and we need to preserve access to certain information for this redress of grievances.
However, an unfortunate consequence of living in a litigious society is that hospitals and providers often feel that it's not in their best interests to share information openly and honestly. We know, in fact, that their attorneys and risk managers often advise them not to do so. So, in order for our system to work, it needs to balance these sometimes competing demands.
I believe the Patient Safety and Quality Improvement Act strikes this balance. It calls for the creation of new entities we call Patient Safety Organizations that would collect voluntarily reported data in the form of patient safety workproducts. This bill provides the protections of confidentiality and privilege to that patient safety data--but this bill also sets definite limitations on what can be considered confidential and privileged.
This legislation does nothing to reduce or affect other Federal, State or
local legal requirements pertaining to health related information. Nor does this bill alter any existing rights or remedies available to injured patients. The bottom line is that this legislation neither strengthens nor weakens the existing system of tort and liability law.
Instead, the legislation before us creates a new, parallel system of information collection and analysis, designed to educate our doctors and protect patients' safety everywhere. This bill reflects difficult negotiations and many compromises over almost 5 years of consideration. Through the contributions of Members on both sides of the aisle, this legislation has been greatly strengthened since I first introduced it back in the 106th Congress.
I offer my appreciation to the many contributions from several colleagues who have worked to reach an agreement on this legislation. But I believe Chairman Enzi and Ranking Member Kennedy deserve special recognition in their efforts to reach a consensus and so I commend them once again. I also want to commend the work of Chairman Barton and that of the Dean of the House, Representative Dingell, for their work to address our differences. It is my true hope that they can persuade their colleagues to favorably consider this bill.
When a significant bill makes its way through the many hoops of the legislative process and is destined to be signed into law, as I believe this one is, we have a custom in the Senate that we take a moment to acknowledge those whose work on that measure often has made difference between success and failure.
Chainnan Enzi's staff, Katherine McGuire, Steve Northrup, and especially Andrew Patzman deserve many thanks for their contributions and for reflecting so well the leadership of the Chairman. From Senator Kennedy's office Michael Myers' commitment to this effort over the many years has often served to keep discussions going and David Bowen has once again demonstrated his ability to find common ground on difficult issues. Vince Ventimiglia and Peggy Binzer of Senator Gregg's office deserve special acknowledgement, not only for ``advancing the ball'' throughout the last Congress, but also for the legal expertise and insights they brought to the process.
The majority leader has been a partner in this effort from the very beginning and Dean Rosen and Liz Hall have contributed both their subject expertise and their legislative navigational skills. Bruce Lesley of Senator Bingaman's office and Anne Grady with Senator Murray led the way with improvements to the bill that helped start its way down the bipartisan path to success. Finally, I want to commend Sean Donohue, of my staff, for his contributions to the bill and also to his tenacious commitment over several years to get this legislation enacted.
We legislate on many issues in the Congress, but it is not often we can say that what we do makes a difference as a matter of life and death. Patient safety, however, is one of those issues. When this legislation is signed into law, everyone that has worked to improve it can know that, in this instance, they have made that difference.