[Congressional Record Volume 146, Number 42 (Thursday, April 6, 2000)]
[Senate]
[Pages S2348-S2350]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. GRASSLEY (for himself, Mr. Lieberman, Mr. Kerrey, and Mr. 
        Bryan):
  S. 2378. A bill to amend titles XVIII and XIX of the Social Security 
Act to improve the safety of the Medicare and Medicaid programs, and 
for other purposes; to the Committee on Finance.


  stop all frequent errors (safe) in medicare and medicaid act of 2000

 Mr. GRASSLEY. Mr. President, I am pleased to introduce this 
important legislation today with my colleagues, Senator Lieberman, 
Senator Kerrey, and Senator Bryan. This bill represents an important 
step toward ensuring patients receive safe, quality health care in our 
nation's hospitals and healthcare facilities.
  The Institute of Medicine (IOM) Report released last fall indicates 
that nearly 44,000 to 98,000 people die or are seriously hurt in 
hospitals every year. That is equivalent to having three jumbo jets 
filled with passengers crash every two days. Should we be safer flying 
in an airplane than going to a hospital for routine surgery?
  Take the case of Gary Masiello, who lost his daughter when her 
breathing tube was accidentally disconnected. Nine months later he lost 
his wife in another hospital when she choked on her medication. He no 
longer has the confidence that he or his family are safe when entering 
the hospital.
  The case of Betsy Lehman, a Boston Globe health reporter, is yet 
another example of how medical mistakes can lead to death. She received 
a drug overdose in 1994 during her chemotherapy treatment.
  Ironically, even one of the contributors to the IOM report was 
touched by a medical error. Mary Wakefield, while she was preparing the 
report, discovered that her 83 year old mother was operated on the 
wrong hand.
  Today, Senator Lieberman, Senator Kerrey, Senator Bryan, and I are 
introducing a bipartisan bill to make patient safety a national 
healthcare priority. We recognize that mistakes happen, and that in our 
complex healthcare system, problems will occur. But in a country that 
is the leader in healthcare research, technology, and advancement, we 
should be able to do much, much better when it comes to patient safety.
  We are not here today to point the finger or to blame. We are here to 
provide a solution to this disturbing problem--a problem we think is 
preventable.
  Our legislation establishes a reporting and patient safety program 
for hospitals and other healthcare providers that participate in the 
Medicare and Medicaid programs, which would include virtually every 
healthcare facility in the United States. Billions of federal tax 
dollars go to these programs. The taxpayers deserve to know that the 
healthcare system they invest in provides safe, high-quality care.
  This bill extends confidentiality protections to ensure that 
providers will report without risk of retaliation by trial lawyers. By 
creating a safe environment, this bill will foster reporting and 
corrective action plans in hospitals and healthcare facilities across 
the country.
  Our legislation will improve patient safety and give providers the 
tools they need to address medical mistakes before patients are harmed. 
These errors are not intentional by any means, but they are 
preventable. So, I ask that my colleagues on both sides of the aisle to 
support this bill to ensure that medical errors become a thing of the 
past.
  I ask unanimous consent that a summary of the bill be printed in the 
Record.
  There being no objection, the summary was ordered to be printed in 
the Record, as follows:

 Section-By-Section of the Stop All Frequent Errors (SAFE) in Medicare 
                        and Medicaid Act of 2000

       Section I. Title and Table of Contents.
       Section II. Purpose--This section describes the intent of 
     the legislation which is to create a non-punitive medical 
     error reduction program under the Medicare and Medicaid 
     programs through identification of medical errors, extension 
     of confidentiality with limited disclosure, and 
     implementation of systems and processes to reduce the number 
     of adverse events that occur.
       Section III. Improvement of Patient Safety under the 
     Medicare Program--This section establishes the guidelines for 
     the medical error reduction program in the Medicare and 
     Medicaid programs as a condition of participation.
       Facilities that choose to participate in the Medicare and 
     Medicaid programs including hospitals, critical access 
     hospitals, skilled nursing facilities, comprehensive 
     outpatient rehabilitation facilities, home health agencies, 
     hospice, renal dialysis facilities, and ambulatory surgery 
     centers would have to meet the requirements of this Act.
       Hospitals would be required to participate one year after 
     the date of enactment of this Act. The other institutions 
     would be phased-in on a timetable to be determined by the 
     Secretary of Health and Human Services.
       Providers would have to implement a patient safety program 
     to reduce medical errors. The program will target both 
     sentinel events and additional events associated with injury 
     as targeted by the Secretary, or local providers. The program 
     shall utilize active investigation to discover health care 
     errors and achieve measurable improvement in the rates of 
     health care errors.

[[Page S2350]]

       In addition, providers would be required to report sentinel 
     events and additional designated errors to the following: (1) 
     their state health department; (2) a national accrediting 
     organization when applicable, i.e. the Joint Commission on 
     the Accreditation of Healthcare Organizations (JCAHO); and 
     (3) the Medicare peer review organizations. The facility 
     would be responsible for performing a root-cause analysis and 
     implementing a corrective action plan that reduces the risk 
     of such event happening in the future. Providers can 
     designate which agency or entity described above to approve 
     their compliance with the reporting and correction program. 
     Aggregated reports without identifiers would be submitted to 
     the Secretary by the agency or entity.
       Confidentiality and privacy protections based on current 
     peer review protections would be extended to ensure that 
     institutions would be encouraged to report and to implement 
     effective patient safety programs. Information would also be 
     protected for the purposes of conducting peer review 
     activities and root cause analysis.
       A definition of poor performance is complying with the 
     reporting and correction program will be specified by the 
     Secretary, JCAHO, the Agency for Healthcare Research and 
     Quality (AHRQ), the peer review organizations, providers and 
     consumer organizations. When a facility has a pattern of 
     poor performance, this information is reported to the 
     Secretary and the Secretary shall then release this 
     information to the public. This would occur if the pattern 
     of poor performance continues for more than two years, and 
     a provider fails to report sentinel events and implement 
     corrective actions to address safety problems.
       Section IV. Improvement of Patient Safety Under the 
     Medicaid Program--This section extends the Medicare 
     provisions above to congregate care providers in the Medicaid 
     program. Congregate care provider is defined as facilities in 
     the Medicaid program that provide hospital services, nursing 
     facility services, services of intermediate care facilities 
     for the mentally retarded, hospice care, residential 
     treatment centers for children, services in an institution 
     for mental diseases, and inpatient psychiatric hospital 
     services for individuals under age of 21.
       Section V. Establishment of the Center for Patient Safety--
     This section establishes a Center for Patient Safety (Center) 
     within HHS. The mission of the Center is to improve patient 
     safety and reduce the incidence of medical errors. The Center 
     would establish national goals for patient safety and 
     mechanisms to track such goals. In addition, the Center would 
     prepare and submit an annual report to the President and 
     Congress with recommendations concerning patient safety. 
     Among some of its duties, the Center would develop a national 
     health care patient safety research agenda, disseminate 
     information and evaluate mechanisms to improve patient 
     safety, and conduct pilot projects to conduct new or 
     innovative patient safety reporting systems.
       Section VI. Grants to Establish Patient Safety Programs--
     This section authorizes the Center to award grants to 
     providers and health professionals affiliated with such 
     providers for the establishment and operation of patient 
     safety programs.
       Section VII. Authorization of Appropriations--This section 
     authorizes the following amounts:
       (1) For fiscal year 2001, $30,000,000.
       (2) For fiscal year 2002, $35,000,000.
       (3) For fiscal year 2003, $40,000,000.
       (4) For each fiscal year thereafter, such sums as may be 
     necessary.
                                 ______