[Congressional Record Volume 146, Number 10 (Tuesday, February 8, 2000)]
[Senate]
[Pages S489-S491]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SPECTER (for himself, Mr. Harkin, and Mr. Inouye):
  S. 2038. A bill to amend the Public Health Service Act to reduce 
accidental injury and death resulting from medical mistakes and to 
reduce medication-related errors, and for other purposes; to the 
Committee on Health, Education, Labor, and Pensions.


                  medical error reduction act of 2000

  Mr. SPECTER. Mr. President, on behalf of Senator Harkin and myself, I 
am introducing legislation captioned the Medical Error Reduction Act of 
2000. This legislation is introduced in response to a report from the 
Institute of Medicine which shows a very high death rate as a result of 
errors in hospitals.
  The statistics show that the death rate from errors in hospitals may 
be as high as 98,000 people. A chart has been prepared demonstrating 
that at the 98,000 figure, which is the uppermost estimate, medical 
errors are the fifth

[[Page S490]]

leading cause of death in the United States, problems which certainly 
need to be addressed.
  The legislation we are proposing follows a hearing which our 
Subcommittee on Labor, Health and Human Services, and Education 
conducted on December 13, 1999, and also a hearing conducted on January 
25, 2000, in conjunction with the Veterans' Affairs Committee. Our 
legislation has input--not support, but input--taking into account 
concerns from the American Hospital Association, the American Medical 
Association, the American Nurses Association, the Institute for Safe 
Medication Practices, the American Psychological Association, and 
others.
  The core provisions of the bill will provide for 15 competitively 
awarded research demonstration projects to make a determination of the 
scope of medical errors and the ways to correct these medical errors 
systemically. Five of these demonstrations will have a mandatory 
reporting requirement with confidentiality when there is a medical 
error. Five of these demonstration projects will have a voluntary 
reporting program with confidentiality, and five of these demonstration 
projects will have a mandatory reporting requirement and also a mandate 
that the patient and/or the family be notified of the error.
  This, we think, is fundamental in terms of the professional 
responsibility of a doctor and the professional responsibility of a 
hospital to notify the injured party where error has occurred. 
Parenthetically, a similar obligation, I believe, is incumbent upon 
professionals generally.
  The legislation has further provisions for the studies to be 
conducted in a way to make a determination as to what is feasible on 
hand-held prescription pads and on other technical devices which will 
look to the system's errors which are encapsulated and encompassed in 
hospitals and medical care.
  On November 29, 1999, the Institute of Medicine (IOM) issued a 
report, ``To Err Is Human: Building a Safer Health System.'' The report 
concluded that medical mistakes have led to numerous injuries and 
deaths, affecting an estimated three to four percent of all hospital 
patients. The IOM report also concluded that health care is a decade or 
more behind other high-risk industries in its attention to ensuring 
basic safety.
  According to the IOM, at least 44,000 Americans die each year as a 
result of medical errors, and the number may be as high as 98,000. We 
must put this statistic into perspective, as noted in this chart: at 
98,000 deaths per year, medical errors are catapulted into the ranking 
of fifth leading cause of death nationwide. This total outnumbers 
deaths from motor vehicle accidents, breast cancer, and AIDS. Further, 
medical errors resulting in injury are estimated to cost the nation 
between $17 billion and $29 billion, including additional health care 
costs, lost income, lost household production, and disability costs.
  The IOM findings are startling and beg for national attention to 
determine ways to reduce the number of medical errors. We have all 
heard and read media reports detailing the case of Betsy Lehman, a 
health reporter for the Boston Globe, who died from a chemotherapy 
overdose; or the tragedy of Willie King, who had the wrong leg 
amputated in a Florida hospital. Unfortunately, these are not isolated 
cases.
  On December 13, 1999, I chaired a hearing of the Labor-HHS-Education 
Appropriations Subcommittee to hear details of IOM's report findings. 
On January 25, 2000, I chaired a joint Labor-HHS-Education 
Appropriations Subcommittee/Veterans' Affairs Committee hearing to 
consider mandatory and voluntary reporting requirements and to begin to 
determine ways to reduce medical errors. Today, Senator Harkin and I 
are introducing legislation that seeks to find solutions to the problem 
of medical errors. This legislation was developed based on our hearings 
and with input from many health groups and experts in the field, 
including the American Hospital Association; American Medical 
Association; American Nurses Association; Institute for Safe Medication 
Practices; American Psychological Association; Federation of 
Behavioral, Psychological, and Cognitive Sciences; American Osteopathic 
Association; Association of American Medical Colleges; American 
Association of Health Plans; Hospital and Healthsystem Association of 
Pennsylvania; and Iowa Hospital Association. It is our hope that we can 
continue to work together to reduce the number of injuries and deaths 
related to medical mistakes.
  Let me review the key provisions of this bill. It would:
  Make grants available to states so they can establish their own error 
reporting systems and collect data to provide to Federal researchers. 
The compilation of such data will help researchers understand trends in 
errors and determine ways to reduce them.
  Require the Agency for Healthcare Research and Quality, in 
conjunction with the Health Care Financing Administration, to establish 
15 competitively-awarded research demonstration projects throughout the 
nation, in geographically diverse areas, to assess the causes of 
medical errors and determine ways to reduce those errors.

  Facilities participating in these demonstrations will be required to 
employ appropriate technologies to reduce the probability of future 
errors. Such technologies might include hand-held electronic 
prescription pads, training simulators for medical education, and bar-
coding of prescription drugs and patient bracelets.
  Facilities participating in the demonstrations will also provide 
staff training to reduce the number of errors, and encourage prompt 
review of errors to determine ways to prevent them from recurring.
  Of the 15 facilities who choose to participate in the demonstrations, 
5 will have a mandatory reporting requirement of all medical errors to 
HHS, 5 will have a voluntary reporting requirement to HHS, and 5 will 
have a mandatory reporting requirement to HHS as well as to the patient 
and/or his family.
  Require the Secretary of HHS to provide information to all patients 
who participate in Federally-funded health care programs, educating 
them on ways to reduce medical errors. Require the Secretary to develop 
patient education programs to encourage all patients to take a more 
active role in their healthcare.
  Make grants available to health professional associations and other 
organizations to provide training and continuing education in order to 
reduce medical errors.
  Require the Secretary to report to the Congress within 180 days of 
enactment on the costs of implementing a program that identifies 
factors that reduce medical errors, including computerized health care 
systems. Require the Secretary to report on the results of the fifteen 
health system demonstration projects, focusing on best practices and 
costs/benefits of applying these practices nationally.
  Mr. President, patients must have confidence that when they seek 
medical treatment, they will receive the highest quality health care in 
the world. They should not be fearful of injuries or even death due to 
medical mistakes. The Institute of Medicine panel projected that with 
current knowledge and with implementation of medical error reduction 
methods that are proven to work, we can achieve no less than a 50 
percent reduction in medical errors over the next five years. I believe 
that the research efforts authorized by this legislation will allow us 
to far exceed this goal, and immeasurably improve patient safety. I 
think my colleagues will agree that America has zero tolerance for 
preventable medical mistakes, and that we should act immediately to 
prevent further deaths and injuries.
  I yield to my distinguished colleague from Iowa.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. HARKIN. Mr. President, I am pleased to join my colleague, Senator 
Specter, in the introduction of the Medical Errors Reduction Act of 
2000. Senator Specter just outlined the major provisions of the bill. I 
will not go back over that; only suffice to say our bill addresses a 
critical problem facing America's health care system, a problem that 
places millions of Americans at risk of serious injury or death every 
time they seek medical attention.
  Again, I thank my distinguished chairman, Senator Specter, for 
putting this bill together in such a timely

[[Page S491]]

fashion. This is something we have to address, and we have to focus on 
this immediately.
  Many of my colleagues are aware of the recently released Institute of 
Medicine report which describes a health care industry plagued with 
systems errors and provider mistakes. If you are familiar with the 
report, then you have discovered something I do not think a lot of 
people are aware of and of which I was not aware, and that is, we are 
more likely to die from a medical mistake than diabetes, breast cancer, 
or a traffic accident.
  The report found that deaths due to medical errors are the fifth 
leading cause of death in this country. This chart is from the Centers 
for Disease Control and Prevention, National Center for Health 
Statistics. It shows medical errors as the fifth leading cause of 
death. Some say it is the eighth leading cause of death. More people 
die from medical errors than pneumonia, diabetes, accidents, or kidney 
disease.
  Whether it is the fifth or eighth, we have been given a wake-up call. 
The cost to our health care system and national economy from medical 
errors is enormous.
  The total cost, we are told by the Institute of Medicine, of injuries 
due to medical errors is $17 billion to $29 billion annually. This 
estimate cannot accurately reflect the true personal cost to patients 
and their families when a diagnostic test is misread, a drug that is 
known to cause an allergic reaction is prescribed, or a surgery goes 
awry.
  One does not have to look too far for stories. I know some personally 
in my own family. Another came from one of my staff members who told me 
about the disastrous outcome of a conventional gall bladder procedure 
performed on her father in 1991.
  It seems he went in for a laparoscopy and came out with a severed 
bile duct. The gall bladder was removed surgically, and the patient was 
sent home to recuperate. Within days, he experienced great abdominal 
pain, could not eat, and began to lose weight. His wife is a 
nutritionist and could tell something was very wrong. They kept going 
back to the doctors who performed the surgery only to be told they 
could not find anything wrong and that his problems were probably 
psychological.
  Finally, in great frustration, the man and his wife turned to a 
neighbor, an old-fashioned country doctor who sent them to a surgeon 
friend of his. Sure enough, this doctor discovered the problem and it 
was corrected, but only after several months of pain and frustration.
  Deaths from medication errors total more than 7,000 annually. These 
errors erode the trust Americans have in their health care system.
  Let me be clear, most medical errors that occur in our health care 
system are not the fault of any one individual or institution. We have 
the best trained, most sophisticated health care workforce in the 
world. Thousands of highly skilled and conscientious doctors, nurses, 
pharmacists, and other medical professionals operate under tremendous 
pressure and time constraints.

  It is a complex problem which must be addressed with comprehensive 
solutions and rigorous changes that will help providers better perform 
their jobs and prevent medical errors from happening in the future. It 
is a problem that is systemic, not personal.
  Again, we must work together, in a bipartisan way, because all 
Americans enjoy the right to be free from accidental injury, accidental 
death, and medication-related errors when they need care.
  Again, I thank my distinguished chairman for his leadership on this 
issue, for putting this bill together. I am proud to be his chief 
cosponsor.
  In closing, this Congress now has an opportunity to join together to 
address a problem that has the potential to impact the life of every 
citizen who seeks health care. I hope all of my colleagues on both 
sides of the aisle will join Senator Specter and me in supporting this 
important legislation.
  I yield the floor to my distinguished chairman.
  Mr. SPECTER. I thank my distinguished colleague, Senator Harkin, for 
his cosponsorship and his work on this very important piece of 
legislation, coming principally out of the subcommittee which Senator 
Harkin is the ranking Democrat and which I chair.
  There are other Senators who are working on legislation arising out 
of the Institute of Medicine report. There is no doubt that it is a 
problem of enormous magnitude. It is a life-and-death matter. We have 
taken the lead early to bring this legislation to the floor in the 
hopes that this will stimulate other ideas, other legislative 
proposals, so we may address this very serious issue.
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