'Treat Systems,
BETSY LEHMAN did not die in vain. 1995;273:1503-1508), all of which are rec¬
The death in March 1995 of the re-
spected Boston Globe medical reporter
of a cancer chemotherapy overdose at
the renowned Dana-Farber Cancer In-
stitute in Boston, Mass, sent shock waves
through the medical community.
"That such a thing could happen at
such a famous and well-regarded insti-
tution seemed incredible," says Lucian-
Leape, MD, adjunct professor of health
policy at Harvard School of Public Health
in Boston and an expert in medical er-
rors. But Lehman's death was followed
by a spate of highly publicized errors,
including the amputation in Tampa, Fla,
of a patient's healthy leg.
Speaking last month in Rancho Mi-
rage, Calif, before a national meeting con-
vened to seek ways to reduce medical
errors, Leape said Lehman's death, more
than any other single event, has galva-
nized the movement toward improved
error reduction. "Our meeting here is
proof that she did not die in vain."
Extent of the Problem
Figures from the Harvard Medical
Practice Study, in which Leape was an
investigator, indicate that about 1 mil¬
lion potentially preventable medical er¬
rors result in 120 000 deaths each year
(Qual Rev Bull. 1993;19:144-149).
Despite the Harvard study and many
others that attempt to determine the
incidence of medical errors, "most doc¬
tors and hospitals really don't know how
many errors they have," Leape said.
"The reason is quite simple. We rely
almost entirely on self-report."
He used reporting of adverse drug
events as an example. Depending on the
method of reporting—traditional inci¬
dent reports, computerized detection,
intensive chart review, interviews with
hospital personnel, or the last 3 com¬
bined—rates of adverse drug events can
vary from 0.2 per 100 admissions to 10
per 100, Leape said.
"If we're relying on self-reporting,
we're missing 90% or more of our er¬
rors," he noted.
He also pointed out that, perhaps with¬
out realizing it, the US health care sys¬
tem tolerates an amazingly high error
rate. Leape mentioned a 3-state study of
Medicare patients with diabetes that
showed only 16% received an annual he¬
moglobin Ale measurement, 46% got an
ophthalmologic examination, and 55% re¬
ceived serum cholesterol testing (JAMA.
Downloaded From: http://jama.jamanetwork.com/ by a Carleton University User on 06/21/2015
Not Errors,' Experts Say
surgery were transferred to a sterile field.
ommended annually by the American
Diabetic Association and American Col¬
lege of Physicians.
Such results, Leape said, represent
defect rates that in industry "would be
staggering."
Perfection Is a Myth
Successful medical error reduction will
require system modifications and atti-
tudinal changes, Leape said. "Our ap¬
proach to the way you reduce errors is
to require perfect performance. This is
a myth. It's impossible to do."
The quest for perfection throughout
society, he noted, has created sanctions
deeply rooted in a philosophy of pun¬
ishment for poor performance.
"Regulators ask hospitals to report
adverse events and then put them on
probation when they do. States publish
cardiac mortality rates not just by hos¬
pital, but by individual surgeons, sham¬
ing them."
The outcome results in guilt instead
of substantial error reduction. "We're
judgmental about our colleagues. When
they make an error we feel negative
about it. We look down on them, but we
look down on ourselves as well. It's
wrong; it's inappropriate," he said.
In the vast majority of cases medical
errors are the result of system failures
rather than negligence or incompetence.
"Just as we teach our young doctors to
treat the disease, not the symptom, we
need to treat the system, not the error,"
Leape said.
In a heart-wrenching session at the
Rancho Mirage meeting, a panel ofhealth
professionals explained how they did just
that following a 7-year-old boy's death
that was attributed to an operating room
error.
Do the
Right Thing
Young Ben was scheduled for elec¬
tive tympanomastoidectomy for choles-
teatoma last December at Martin Me¬
morial Hospital in Stuart, Fla. "We were
supposed to get happy results," said
George McLain, MD, anesthesiologist
during the surgery.
However, 2 syringes that were sup¬
posed to contain lidocaine for local injec¬
tion had been filled with epinephrine. Ben
received 2.5 mL of epinephrine injected
aslocal anesthesia. He suffered cardiac
arrest and died the next day. The drug
mix-up occurred as medications for the
Martin Memorial's procedure, which did
not differ drastically from that used by
most other hospitals, included placing
medications in a cup, from which syringes
were filled. The syringes used in Ben's
surgery also were not labeled.
The law firm representing Ben's par¬
ents videotaped a walk-through of the
hospital's operating room procedures.
Within days, said Dick Harman, presi¬
dent and chief executive officer of Mar¬
tin Memorial, new operating room pro¬
cedures were established. Medication
contents are read aloud by a circulating
nurse and verified by the scrub techni¬
cian. Medications then are drawn into
prelabeled syringes directly from their
verified vials.
The cup, assumed to be the point
where the mix-up occurred, has been
removed from the surgical table setup.
"We had the best [surgical] team, but a
flawed process," Harman said.
The hospital fully disclosed the error
to Ben's family and to the public. The
legal case was settled in 3 weeks. "The
truth brought closure instead of pro¬
tracted grief," for Ben's parents, said
Jill Dobrinsky, RN, a medical-legal rep¬
resentative at the Ft Lauderdale, Fla,
law firm of Krupnick, Campbell, Malone,
Roselli, Buser, Slama & Hancock. "We're
proud that the medical and legal pro¬
fessions can work together toward the
common good."
McLain said the tragedy was marked
by a great deal of trust—of the hospi¬
tal's risk manager in the clinicians in¬
volved, of the liability insurer in the
hospital, and ultimately of Ben's family
in the physicians who treated their son:
they asked if they still could obtain health
care from them. "The best advice in han¬
dling such a tragedy is to do the right
thing," McLain said.
James Conway, chief operations of¬
ficer at Dana-Farber, stressed the im¬
portance of honesty and openness. He
called Lehman's death and the serious
injury of another patient from a similar
overdose "a redefining moment" for his
institution.
More than a year later, he said, not a
day goes by that staff don't talk about
the error. "Unless we say it, unless we
understand it, we can't move forward in
the process of improvement."
Part of that forward motion includes
thanking employees who report errors
or ways to avoid them. He said a Dana-
Farber nurse recently received a hand¬
written thank-you note from top man¬
agement after reporting an error. "That
note moved through the institution like
a flash," he noted. "It begins to send a
message."
Organizational Responses
Echoing Leape's call to move beyond
risk identification and risk management,
several national medical organizations
explained programs they are working
on to improve error reduction.
The American Medical Association
(AMA) is spearheading the National Pa¬
tient Safety Foundation, which will go
into operation in January. The founda¬
tion, to be funded by an initial AMA
outlay and subsequent endowment do¬
nations from interested individuals and
organizations, has several objectives.
Overall, the foundation represents a
collaborative effort to improve patient
safety by identifying flaws in systems
and processes that contribute to errors.
Intended to be self-supporting through
its endowment by the year 2000, the foun¬
dation also is being planned as a source
of research grants and a clearinghouse
for patient safety information. Among
its specific objectives is the development
and dissemination of patient safety stan¬
dards and performance measures.
"It is important to realize that not
every mistake, not every injury, is nec¬
essarily the result of human error," said
AMA Executive Vice President Emeri¬
tus James S. Todd, MD. "It may be the
result of a system or process that was
inappropriate to begin with."
The AMA recently launched the Medi¬
cation Error Reduction Initiative, which
created a coalition of representatives
from key organizations, including the
Food and Drug Administration and
Health Care Financing Administration,
and researchers from the fields of phar¬
macy, behavioral medicine, information
technology, and others.
AMA's Science Reporters Conference Focuses on
Contraception and Prevention of Premature Birth
THE 15th Annual Science Reporters
Conference ofthe American Medical As-
sociation (AMA), held in San Francisco,
Calif, focused in large part on women's
health issues. One morning of the 3-day
conference was devoted to presentations
that were simulcast via satellite to news
reporters in New York, NY.
Two of the 3 presentations con-
cerned what patients need to know about
birth control options; the third ad-
Downloaded From: http://jama.jamanetwork.com/ by a Carleton University User on 06/21/2015
The coalition's goals include improv¬
ing medication management, patient
education, and patient outcomes by iden¬
tifying barriers to sound medication
practices in ambulatory health care set¬
tings and in office practice.
One of the coalition members, the Na¬
tional Council on Patient Information
and Education (NCPIE), is working with
several organizations to meet a Decem¬
ber 4 deadline set by Congress to de¬
velop a plan to disseminate written con¬
sumer information to at least 75% of
people receiving new prescription medi¬
cations. According to the congressional
stipulation, the information must reach
95% of new prescription recipients by
2000. "More than two thirds of all phy¬
sician visits end with a prescription,"
noted N. Lee Rucker, MSPH, associate
executive director of NCPIE.
In a related area, the Institute for
Safe Medical Practices helped obtain a
label change for irinotecan hydrochlo-
ride after 1 death and 6 injuries or near
overdoses were attributed to confusing
dosage information on the label. The in¬
stitute also operates, along with the
United States Pharmacopeia, the Medi¬
cation Errors Reporting Program that
physicians can call anonymously to re¬
port errors or potential errors with medi¬
cations and medical devices. The num¬
ber is (800) 23-ERROR (233-7767).
At the Joint Commission on Accredi¬
tation of Healthcare Organizations, Presi¬
dent Dennis O'Leary, MD, said Lehman's
death and other highly publicized errors
that followed came as a "cold shower to
show us where we needed to go." The
result is "accreditation watch," an addi¬
tional designation the Joint Commission
gives to health care facilities where an
apparent treatment-related death or se¬
rious injury has occurred.
O'Leary said the additional designa¬
tion doesn't change the facility's accredi¬
tation status, but it does require an in-
depth investigation of the so-called
dressed strategies that can help reduce
health problems and costs associated with
premature birth.
Before the investigators spoke, Timo-
thy T. Flaherty, MD, a member of the
AMA's Board of Trustees, introduced
the Association's new consumer book,
American Medical Association Com-
plete Guide to Women's Health (New
York, NY: Random House Inc; 1996),
edited by Ramona I. Slupik, MD. More
sentinel event. The Joint Commission
provides on-site assistance with inves¬
tigations. "We do a backward march of
whys, [asking] what could be done to
change the process and avert the like¬
lihood of a reoccurrence in the future."
Facilities that don't cooperate risk los¬
ing their accreditation. Those that do,
said O'Leary, encounter a "more blame¬
less, less punitive approach in ferreting
out the cause of errors."
The federal Agency for Health Care
Policy and Research is setting its sights
on "the next generation of outcomes and
effectiveness research," said Lisa Simp¬
son, MB, deputy administrator at the
agency. One of the areas its researchers
will examine is geographic variations in
practice. The agency recently funded a
study of what Simpson said are "huge
variations" in hysterectomies performed
for noncancerous uterine conditions.
The Possible Dream
Some variations in practice probably
always will exist. But Leape asked meet¬
ing participants to envision the features
"an ideal system" would have. His own
vision is one of strict liability in which
hospitals bear the responsibility of com¬
pensating for every injury regardless of
fault. "They would have a lot of incen¬
tive to make error prevention job 1."
But it will take more, Leape said. The
medical community "would have to tar¬
get systems, not people. We would have
to succeed in driving out fear so that
errors were freely reported and their
causes were investigated." It would also
take new training to teach physicians to
work in teams and the creation of mul-
tidisciplinary teamsto redesign error-
prone systems. A new focus on working
conditions would target long hours and
double shifts.
"Is this a dream?" Leape asked. "Yes.
An impossible dream? No. The parts
are all there. All we have to do is work
together." by Rebecca Voelker
than 30 specialists contributed to mak-
ing the guide the most thorough and
up-to-date source of information on
health concerns of women of all ages,
Flaherty said.
Preventing Unwanted Pregnancies
Despite recent advances in contracep-
tive technology, unintended pregnancy
remains a huge problem in the United
States. More than half of all pregnancies