Alarmed by the tens of thousands of deaths apparently caused each year by medical errors, a bipartisan coalition of Senators Thursday urged Congress to approve legislation that would require health care facilities to establish safety procedures and report instances of serious error.
The S.A.F.E. bill - Stop All Frequent Errors in Medicare and Medicaid Act of 2000 - was introduced by Senators Charles Grassley, R-Iowa, Joseph Lieberman, D-Conn., Bob Kerrey, D-Neb., and Richard Bryan, D-Nev. The bill, which targets health care purchased through Medicare and Medicaid, is based on a report last November from the Institute of Medicine, which found up to 98,000 patients die every year because of medical error. The goal of the S.A.F.E. Act is to reduce the error rate by 50 percent over the next five years.
"Our health care system stresses prevention of illness," said Grassley. "It should also stress prevention of errors. We expect people to eat well, exercise and do all the right things to stay healthy. In return, they deserve careful medical treatment when they get sick."
"Through Medicare and Medicaid, we can work to reduce medical errors in almost every health facility in the country," said Lieberman. "Most people are patients at one point or another in their lives. We need to make certain they are patients in the safest possible setting."
Senator Kerrey said: "Our legislation addresses the needs of both patients and providers and creates a more dependable system for both. Health care effects all of us from young to old and this legislation takes us in the right direction for safe and reliable services."
Senator Bryan added, "This legislation is a first attempt at correcting the staggering number of deadly medical errors that occur in this country. The bottom line is that we have got to do better, and this legislation will take the first step in improving this bleak situation."
The SAFE Act is built on a simple principle: health care purchased by the government should be error-free. The goal is to reduce medical error by 50 percent over the next five years.
The S.A.F.E. Act would require health institutions to: establish a medical safety program that produces measurable reductions in error report deaths and serious injuries, identify their causes, take steps to prevent further accidents disclose to the public the name and address of a facility if it fails to comply with the reporting requirements or implement corrective actions to address safety problems
The bill also would establish a Center for Patient Safety to conduct research and dispense grants related to medical error reduction and it would afford providers with peer review confidentiality protections to cover the new error reduction reports.
Section-By-Section
"Stop All Frequent Errors (SAFE) in Medicare and Medicaid Act of 2000"
Section I. Title and Table of Contents
Section II. Purposes - 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.
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 in 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.
