[Congressional Record (Bound Edition), Volume 148 (2002), Part 11]
[Senate]
[Pages 14460-14461]
[From the U.S. Government Publishing Office, www.gpo.gov]




               PATIENT SAFETY AND QUALITY IMPROVEMENT ACT

  Mr. FRIST. Madam President, I rise today to discuss a very critical 
bill--S. 2590, the ``Patient Safety and Quality Improvement Act.'' This 
bill, which Senators Jeffords, Breaux, Gregg, and I introduced in May, 
represents our next step in reducing the number of patients harmed each 
year by medical errors. Although a variety of patient safety 
initiatives are underway in the private sector as well as within the 
Department of Health and Human Services, Congress has an important role 
to play in reinforcing and assisting these efforts.
  Today, the House Ways and Means Committee is expected to report a 
bipartisan bill--a bill that is almost identical to its Senate 
counterpart--that will help improve the safety of our health care 
system. Additionally, President Bush has highlighted the importance of 
this issue by formally supporting this crucial legislation. Moreover, 
this bill is supported by over thirty different health care 
organizations. Mr. President, I will ask that a list of those 
supporting organizations be included in the Record.
  As a physician and a scientist, I know 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 filed the patient. One method 
used in hospitals is the Mortality and Morbidity Conferences, in which 
individuals can openly discuss patients' cases and examine problems in 
detail. Unfortunately, because those conferences represent a single, 
internal hospital event, we cannot obtain valuable, systematic 
information about problems or information that could be shared to allow 
providers to learn from each other's mishaps. Therefore, there is a 
need to create a broader, more inclusive learning system that 
encompasses all components of the health care system.
  One impediment to that learning system is an inability to more 
closely examine patient safety events without the threat of increased 
litigation. The Institute of Medicine's report, To Err is Human, as 
well as experts who testified for the past few years in a series of 
Senate and House hearings, strongly recommended that Congress provide 
legal protections for information gathered 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,

[[Page 14461]]

shame, and blame'' to a culture of safety and continuous quality 
improvement, we must provide these basic protections.
  However, we must be careful not to provide legal immunity for 
information that would normally be available for litigation, such as 
medical records. Rather, we should protect information that would be 
gleaned from providers' investigations of patient safety events. This 
information is not currently being reported in a way that would allow 
us to learn from our errors and improve the safety and quality of care 
for our patients.
  Additionally, we must ensure that, in extreme circumstances, such as 
a criminal or disciplinary proceeding, the patient safety data is not 
used as a shield. In those circumstances, it is imperative that the 
information be shared, as disclosing that information is material to 
the proceeding, within the public interest, and not available for any 
other source. In this manner, we provide a balancing test--weighing the 
public good in sharing the information and providing the appropriate 
legal protections so that the system can be improved with the people 
good in weeding out the ``bad apples.''
  In crafting this legislation with Senators Jeffords, Breaux, and 
Gregg, we were careful to concentrate on the learning system and 
provide appropriate legal protections for that system. We view this as 
an essential first step in the ongoing, dynamic process of improving 
patient safety.
  I also want to reassure my colleagues that this approach to improving 
medical care--providing limited confidentiality protections to ensure 
that we learn from the system--is not new to health care. Currently, 
there are at least five health care examples which use Federal 
confidentiality and peer review protections--the Centers for Disease 
Control and Prevention's National Nosocomial Infections Surveillance 
System, NNIS, the Food and Drug Administration's MedWatch, Veterans 
Health Administration, VHA, and the Centers for Medicare & Medicaid 
Services Quality Improvement Organizations, QIOs. Each of these 
confidentiality and peer review protections have improved the delivery 
of health care.
  NNIS is a voluntary, hospital-based reporting system established to 
monitor hospital-acquired infections and guide the prevention efforts 
through description of the epidemiology of nosocomial infections, 
antimicrobial resistance trends, and nosocomial infection rates to use 
for comparison purposes. Since its inception in 1970, there has been a 
34 percent reduction in the number of nosocomial infections. This 
dramatic decrease can be attributed, in part, to the availability of 
data for analysis and identification of system errors that were 
contributing to high rates. By law, CDC assures participating hospitals 
that any information that would permit identification of any individual 
or institution will be held in strict confidence. This allows hospitals 
to report accurately without fear of negative repercussions.
  MedWatch is a voluntary Medical Products Reporting Program for 
quickly identifying unsafe medical products on the market. Through 
MedWatch, the Food and Drug Administration officials work to improve 
the safety of drugs, biologics, medical devices, dietary supplements, 
medical foods, infant formulas, and other regulated products by 
encouraging health professionals to report serious adverse events and 
product defects. Once an adverse event or product problem is 
identified, FDA can take any of the following actions: labeling 
changes, boxed warnings, product recalls and withdrawals, and medical 
and safety alerts. The aggregation of information through MedWatch has 
lead to drug recalls, such as Felbatol and Omniflox, and to label 
changes on approximately 30 percent of the New Molecular Entities each 
year.
  To address the need for a non-punitive confidential reporting system, 
the VHA developed and continues to implement an innovative systems 
approach to prevent harm to patients within Veterans Administration's 
163 medical centers. VHA has already implemented nationwide internal 
and external reporting systems that supplement the current 
accountability systems. Thus far, efforts have led to the 
implementation of physician ordering systems and safety bulletins, such 
as the proper handling of MRI equipment.
  QIOs monitor and improve the quality of care delivered to Medicare 
beneficiaries. All information collected by QIOs for quality 
improvement work is non-discoverable. QIOs work directly and 
cooperatively with hospitals and medical professionals across the 
country to implement quality improvement projects that address the root 
causes of medical errors. QIOs use data to track progress towards 
eliminating errors and improving treatment processes. For example, the 
latest available national data, 1996-1998, show QIO projects resulted 
in 34 percent more patients getting medications to prevent a second 
heart attack; 23 percent more stroke patients receiving drugs that 
prevent subsequent strokes; 12 percent more heart failure patients 
getting treatment needed to extend their active lives; and 20 percent 
more patients hospitalized with pneumonia receiving rapid antibiotic 
therapy.
  I appreciate the efforts made by Senators Jeffords, Breaux, and Gregg 
thus far and look forward to working with them and others to pass this 
bipartisan legislation. I also value the leadership of the Bush 
Administration and my House colleagues on this critical issue. I hope 
that the Senate can also consider this important issue and come to a 
resolution in the near future.
  I ask unanimous consent that the list of supporting organizations be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

 Organizations Supporting the ``Patient Safety and Quality Improvement 
                           Act'' June 6, 2002

       Alliance of Community Health Plans, Alliance of Medical 
     Societies, American Academy of Dermatology Association, 
     American Academy of Family Physicians, American Academy of 
     Neurology, American Academy of Pediatrics, American 
     Association of Health Plans, Association of American Medical 
     Colleges, American Association of Neurological Surgeons, 
     American Association of Orthopaedic Surgeons, American 
     Association of Thoracic Surgery, American College of 
     Cardiology, American College of Emergency Physicians, 
     American College of Osteopathic Family Physicians, American 
     College of Osteopathic Surgeons, American College of 
     Physicians-American Society of Internal Medicine.
         American College of Radiology, American 
           Gastroenterological Association, American Geriatrics 
           Society, American Hospital Association, American 
           Medical Association, American Medical Group 
           Association, American Osteopathic Association, American 
           Pharmaceutical Association, American Psychiatric 
           Association, American Society for Clinical Pathology, 
           American Society for Quality, American Society of 
           Anesthesiologists, American Society of Cataract and 
           Refractive Surgery, Congress of Neurological Surgeons, 
           eHealth Initiative, Federation of American Hospitals.
         General Motors, Healthcare Leadership Council, Institute 
           for Safe Medication Practices, Joint Commission on the 
           Accreditation of Healthcare Organizations, Joseph H. 
           Kanter Family Foundation, Marshfield Clinic, Medical 
           Group Management Association, National Association of 
           Manufacturers, Premier, Society of Critical Care 
           Medicine, Society of Thoracic Surgeons, Tennessee 
           Hospital Association, U.S. Chamber of Commerce, U.S. 
           Pharmacopeia, Vanderbilt University Medical Center, VHA 
           Inc.

                          ____________________