When the august Institute of Medicine (IOM) issued its blunt
assessment of medical errors three years ago, Lucian L. Leape,
the pioneering Harvard physician researcher who helped write
the report figured it would meet a fate common to such documents:
The initial flurry of media accounts would be followed by a
swift descent into obscurity.
Instead, the report's conclusion that as many as 98,000 hospitalized
Americans die every year and 1 million more are injured as
a result of preventable medical errors that cost the nation
an estimated $29 billion commanded attention in a way Leape
and his co-authors never imagined.
Beginning in January hospitals will be required by accreditors
to show they meet six basic standards that reduce errors, which
the IOM said kill more Americans than breast cancer, traffic
accidents or AIDS.
"Frankly we were all very surprised," recalled Leape,
a former pediatric surgeon and the author of several earlier
groundbreaking studies of medical errors. "Before the
IOM report, nobody was doing diddly squat. Now there are a
lot of good people involved and a tremendous amount of activity," he
said. "Of course, activity is not the same as progress."
The distinction drawn by Leape underscores the reality of
the nascent movement to reduce medical mistakes: There's a
lot of talk, but no significant progress. The reasons, observers
say, include fierce resistance by doctors and hospitals to
mandatory reporting and other IOM recommendations, a lack of
oversight by the federal government and the absence of an effective
consumer lobby.
As a result, experts contend, it's doubtful that patients
checking into most of America's 5,200 hospitals today are any
less likely to be killed or injured than they were on November
29, 1999, when the report was issued. With the conspicuous
exception of the Department of Veterans Affairs (VA) medical
system, whose hospitals have embraced the ethic and many of
the methods that have made aviation and other industries safer,
most hospitals have taken few new steps to protect patients
from errors.
"I'd say patients are safer today in some hospitals,
and certainly in the VA, but it's still a pretty small minority," said
physician Don Berwick, a member of the IOM panel who is president
of the Boston-based Institute for Healthcare Improvement, a
nonprofit group dedicated to bettering the quality of health
care. "Safety is a very hard thing to accomplish and it
has to be pushed way up to the top of the list, and that still
hasn't happened" in most places.
The vast majority of hospitals still rely on paper charts
that often can't be located and are difficult to decipher,
rather than more accessible and legible computerized medical
records. Fewer than 3 percent have fully implemented computerized
drug ordering systems, which have consistently shown dramatic
reductions in drug errors. Operations performed on the wrong
body part or the wrong patient have increased, according to
the Joint Commission on the Accreditation of Healthcare Organizations
(JCAHO), which inspects hospitals.
The nation's most exhausted and inexperienced doctors -- the
100,000 interns and residents who staff teaching hospitals
-- continue to work as many as 130 hours a week, often with
little or no supervision. Hospital-acquired infections, which
kill about 90,000 patients annually, have increased 36 percent
since 1980, a rise that coincides with the proliferation of
bacteria capable of resisting the most potent antibiotics,
according to the Centers for Disease Control and Prevention
(CDC).
Although the estimates of death and injury contained in the
report are huge, the actual number of deaths is undoubtedly
higher. The IOM considered only errors committed in hospitals,
and not in other medical settings where they undoubtedly also
abound: clinics, outpatient surgery centers and doctors' offices.
Experts say the nationwide shortage of registered nurses as
well as the unprecedented demands on emergency rooms have exacerbated
an already bad situation.
Well, in medicine, if someone makes a mistake, who gets hurt?
It's not the doctor. Who pays? It's not the hospital.
Medication errors
Medication errors are among the most common preventable mistakes,
the IOM report found, and they remain rampant in hospitals;
experts have estimated that more than one million serious drug
errors occur annually in hospitals alone. A recent report in
the Archives of Internal Medicine found that one in five doses
of medication dispensed at 36 hospitals and nursing homes around
the country was either the wrong drug or the wrong dose, or
given at the wrong time or to the wrong patient.
The more drugs a patient is taking and the more people involved
in the delivery of a medicine, the greater the chance of a
mistake. The explosion in the number of drugs on the market
-- there are now more than 10,000 -- has increased the chances
of error. So has the similarity of names that can be easily
confused, such as Lamisil, a drug prescribed for fungal nail
infections, and Lamictal, an epilepsy drug.
While many drug errors don't injure patients, others are lethal.
The most notorious of these, cited in the IOM report, is the
massive chemotherapy overdose that killed Boston Globe health
reporter Betsy Lehman, 39, in 1994 and gravely injured another
woman. The circumstances of Lehman's death, which was the subject
of a front page story in the Globe, rocked the Boston medical
establishment as well as cancer treatment centers around the
country. It is widely regarded as a watershed event that led
to the birth of the fledgling patient safety movement.
The Lehman overdose, which a dozen doctors, nurses and pharmacists
failed to notice, was caused by an initial miscalculation of
a toxic breast cancer drug, a mistake compounded by a cascade
of other errors. They include the failure of doctors at the
prestigious Dana-Farber Cancer Institute in Boston, a federally
designated comprehensive cancer center, to investigate complaints
by Lehman's husband, a scientist at Dana-Farber, or lab tests
that indicated something was terribly wrong.
Other fatal medication errors have resulted from the accidental
overdose of concentrated drugs, particularly potassium chloride.
For decades these drugs were stored on hospital wards where
they were administered to critically ill patients as an additive
to intravenous solutions to restore electryolyte balance.
Sometimes harried or distracted nurses forgot to dilute them
and mistakenly administered a lethal injection. (Potassium
chloride instantly stops the heart and is used for this purpose
in states that administer the death penalty by lethal injection.)
Starting in January, the JCAHO will require that hospitals
remove potassium chloride and other hazardous concentrated
drugs from patient floors. While most have done so, "occasionally
we still see holdouts on specific nursing units," Cohen
said.
Other common causes of drug errors include the use of abbreviations
such as "u" (short for units) which can be mistaken
for a zero, misplaced decimal points and doctors' legendarily
illegible handwriting. Three years ago a Texas jury awarded
$450,000 to the family of a 42-year-old man who sued a cardiologist
and a pharmacist after he was given a massive overdose of the
wrong drug and died. The pharmacist said he had trouble reading
the doctor's writing.
To address the legibility problem, some hospitals have sent
doctors to remedial penmanship classes. Most experts consider
this a poor substitute for the more effective and expensive
remedy endorsed by the IOM: computerized drug ordering systems
linked to a hospital pharmacy, which one study found reduced
medication errors by 86 percent. These systems also can help
prevent accidental overdoses, like the one that killed Lehman,
and make it virtually impossible for a doctor to prescribe
a drug to which the patient has a known allergy, another common
mistake.
But so far, according to Suzanne Delbanco, executive director
of the Leapfrog Group, an organization of Fortune 500 companies
that is pressuring hospitals to improve quality and reduce
errors, only 2.5 percent of hospitals have fully implemented
computerized drug ordering systems.
Nielsen agreed that physician resistance remains an obstacle. "Doctors
will give the nurse a verbal medication order and will write
it down and tell her" to enter it in the computer, thereby
subverting the system, he said.
Wrong-Site Surgery
Dennis S. O'Leary, the internist who directs the JCAHO, is
adamant: Surgeries in which doctors perform the wrong operation
or operate on the wrong side of the body or on the wrong patient "should
never happen."
Yet every year since 1995, O'Leary said, the commission has
seen an increase in voluntary, confidential reports of what
is known as wrong-site surgery. Since 1998, the JCAHO has issued
two warnings to hospitals about the problem.
The lack of a national error-reporting system means there
is no way to tell how often the problem occurs. Although cases
reported to JCAHO include the removal of the wrong breast or
kidney or a biopsy on the wrong side of the brain, the problem
is believed to be most common in orthopedic surgery.
In the case of Kevin Walsh, a 41-year-old construction worker
from Staten Island, N.Y., they were not. Last year, neurosurgeons
at Long Island College Hospital in Brooklyn operated on the
wrong side of his brain because a CT scan they were working
from was reversed.
Canale said he was surprised at the opposition he encountered. "All
these famous prima donna orthopedic surgeons said, 'I don't
have time to go talk to a patient before surgery' or 'I've
never made a mistake, why should I do this?' And I said, 'You're
exactly the kind of guy who's going to get into trouble.' "
"In an airplane, the pilot and co-pilot go through a
checklist every time before they take off," O'Leary noted. "We
don't do that in a hospital."
Hospital-Acquired Infections
After years of mostly futile attempts to persuade doctors,
nurses and other health care workers to wash their hands between
patients, the CDC recently unveiled its new "hand hygiene
campaign." This is the agency's latest effort to reduce
the estimated 2 million infections and 90,000 deaths annually
caused by infections that patients pick up in hospitals. Half
of these infections could be prevented by proper hand washing,
according to the CDC.
Studies have found that hand washing is the exception rather
than the rule and is inversely related to status: Doctors are
less likely to wash than nurses' aides.
"There is no evidence that hospitals are doing anything
about this problem," said Inlander of the People's Medical
Society. "This is one of the most common errors and one
of the biggest problems confronting patients. And there's no
pressure on hospitals to institute vigorous hand washing programs."
Fatigue and Supervision
Despite numerous studies from aviation, aerospace, the military
and other industries linking fatigue with mistakes, sometimes
fatal ones, most of the nation's 100,000 interns and residents
continue to work 80 to 120 hours per week. At night and on
weekends, when senior doctors are largely absent, these neophyte
physicians are expected to make life-and-death decisions with
minimal guidance. Defenders of the current system say that
no studies have linked fatigue or inadequate supervision to
medical errors; some have said that doctors are different than
other professionals and learn to transcend exhaustion, in defiance
of the laws of human physiology.
That may change. The federal Agency for Healthcare Research
and Quality is funding eight studies examining the relationship
of fatigue, stress and sleep deprivation to mistakes made by
doctors and nurses in hospitals.
Long work hours by doctors "especially residents . .
. are incompatible with a safe, high quality health care system," warned
Stanford anesthesiologists David M. Gaba and Steven K. Howard
in a recent article in the New England Journal of Medicine.
If organized medicine doesn't reduce these excessive hours,
they warn, "change may be ultimately forced on us."
It's hard to know what role long hours might have played in
the death of Mike Hurewitz last January at New York's Mount
Sinai Hospital, but inadequate supervision was a factor, according
to state investigators. The 57-year-old Albany resident died
after choking on his own vomit, three days after he donated
part of his liver to his brother, a physician. Hurewitz was
being cared for by an intern who told officials she felt "overwhelmed" after
being left alone in charge of 34 patients.
Nursing Shortage
Experts say that the rapid turnover of registered nurses and
their increasingly large caseloads contribute to errors; so
far there are few studies that prove this. Two reports published
in the past six months in the New England Journal and the Journal
of the American Medical Association concluded that patients
in hospitals where nurses had heavier workloads had a higher
risk of dying.
"Anyone who thinks that the nursing shortage and medical
errors are not causally related is not in this planetary system," said
O'Leary, who notes that an analysis of 1,609 serious errors
reported to the JCAHO over the last five years involved nurse
understaffing. The problem was also cited in New York's investigation
of Hurewitz's death.
According to the AHA, 126,000 nursing jobs are vacant at American
hospitals, sometimes as the result of poor working conditions,
and 56 percent of hospitals are using temporary nurses who
are far less likely to be familiar with a hospital, its staff
and its machinery than permanent staff. These factors are all
potential sources of error: Studies in aviation show that people
trained to work in teams make fewer mistakes than those with
no such experience.
Reformer Don Berwick said he remains hopeful that the awareness
raised by the IOM report will translate into programs that
demonstrably reducte errors. "I don't know why the public
isn't more pissed off about this. Imagine what the reaction
would be if we had a similar mortality in aviation." Find
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