We all recognize and accept that adverse events occur with some frequency in surgery and that all departments meet regularly to
review them. Since adverse events and "mistakes" have the potential
for delaying recovery and injuring surgical patients, an ethical
mandate exists to do all that can be done to prevent harm. This
article suggests that there are 5 issues within the practice of
surgery that have inhibited improvement in quality: (1) inadequate
data about the incidence of adverse events, (2) inadequate practice
guidelines or protocols and poor outcome analysis, (3) a culture of
blame, (4) a need to compensate "injured" patients, and (5)
difficulty in truth telling.
INTRODUCTION
There are 98,000 deaths per year that result from medical error.—the Institute of Medicine,
December 1999
The opening quotation is a widely published and discussed claim that
made me think of W. Edwards Deming. When I composed my list of the
most influential persons of the 20th century, I included Deming. It
was he who introduced many important quality controls into the
manufacture of automobiles, electronics, and televisions, first in
Japan and later in the United States. His fundamental belief was that
the people doing the work were the best able to recognize and correct
error. Accordingly, he empowered those at the site of production
where errors occurred to correct the identified problems.
He proved that with proper protocols, ongoing data collection, and
early identification of problems, defect-free products could be
produced. If these recent data from the Institute of Medicineon the occurence of between 44,000 and 98,000 fatal errors per year were applied to auto makers, they
would be out of business. Although we in medicine have come to expect
defect-free televisions and automobiles with 100,000-mile warranties,
we have been loathe to accept the same processes into our delivery of
surgical care.
I would like to present an illustrative case:
A then 56-year-old chairman of surgery, who was also serving as the
interim dean of the medical school at a Midwestern university, was eating
lunch in the faculty dining room when he accidentally ingested eggs,
to which he had been violently allergic all his life. He developed
some minor laryngeal edema which made him lose his voice but there
was no respiratory distress. Dr George Block, a close friend and
colleague who was at the table, performed a Heimlich maneuver, not
noted for its success in treating allergic reactions. It was the
characteristic "activist" performance of a great surgeon. A
cardiologist also at the table left and returned a bit later with an
electrocardiogram machine, also not noted for its effectiveness in
treating egg allergies.
I was that person, and I was admitted to the coronary care unit where
the very first meal I was served contained eggs. Despite repeated
discussions with nutritionists and others in authority, eggs appeared
in many of the meals I was served, albeit cleverly disguised in
salads, cakes, or brownies. My wife, who coincidentally was one of
the hospital's attorneys with some responsibility for quality, began
informally to take note of these and other errors, which in my own case resulted in no adverse events. Accordingly, the errors were not officially noted, much less recorded.
I told her that this was a common occurrence in intensive care units.
We both, along with colleagues, began to multiply the number of
recognized errors by the number of patients in our hospital. We
obtained a grant from the Robert Wood Johnson Foundation (Princeton,
NJ) to study error in surgical units. The results of that study are
briefly presented.
Suggestions for change, in addition to the 5 issues within the practice of surgery that have inhibited improvement in quality are
addressed in this article: (1) inadequate data about the incidence of
adverse events, (2) inadequate practice guidelines or protocols and
poor outcome analysis, (3) a culture of blame, (4) a need to
compensate "injured" patients, and (5) difficulty in truth telling.
Data about the frequency of adverse events related to inappropriate care have traditionally been obtained from retrospective review of
written medical records, and yet we know how reluctant health care workers are to record adverse events in the official medical record. In addition, there is an acceptance
on the basketball floor and in the intensive care unit of "no harm .
. . no foul," which in both places is an ineffective prevention tool.
This was important to us since even a thorough review of my medical record would not have triggered any effort to
correct a flawed process that as yet could not be identified, one
that repeatedly offered me the very agent that had caused my
hospitalization.
The reluctance to document error in the official medical record, largely because of legal liability
issues, is one of the major limitations of all previous studies of
the incidence of adverse events. The most widely accepted and quoted
study on adverse events was the Harvard Medical Practice Study of 30,121 written medical records of patients in the New York hospital system. The data collected were directed largely toward a possible change in
legal policy. The researchers hoped to determine whether a "no-fault"
approach to error would be feasible. Using fairly stringent criteria,
they found errors in the care of approximately 10% of patients,
of which approximately 3.7% were considered critical. The 10%
incidence was considered high. Recognizing how reluctant people are
to enter anything in the medical record that could later be interpreted as
negligence, we felt that these study results vastly underestimated
the incidence of error.
Published studies on medication errors, surgical complications (such as infection
rates), and most current approaches to "quality improvement" continue
to depend largely on self-reporting (incident reports) or on similar
retrospective analyses of hospital records. These are exactly the
methods of data collection that Deming attempted to change. Disturbed
by a high incidence of defective products, like the automobiles known
as "lemons," Deming suggested that it would be better to identify
problems before a defective product rolled off the assembly line. His
process was to collect ongoing rather than retrospective data and to
obtain the data in a nonpunitive manner. Our study demonstrates that
(1) ongoing data collection in the surgical care of patients is
feasible and (2) when data are obtained in a nonjudgmental context,
the incidence of error is far greater than other studies have
suggested.
We conducted a prospective study of patients admitted to 3 surgical units, a surgical intensive care unit, a burn unit, and a surgical floor. We used trained observers who attended all day-to-day activities during which adverse events were likely to be discussed by
nurses and physicians, such as nurses' reports, physicians' rounds,
morbidity and mortality (M&M) conferences, quality-assurance meetings, and many other less official gatherings of staff in the 3
units. The observers became marvelously attuned to what health care
workers were discussing and recognized when something adverse was
being discussed. We wryly developed our own red flag that we called
"eyebrow-raising events," so named when that part of the face
expressed concern or surprise. Their observations were carefully
reviewed and matched against other available data from meetings, medical records, or incident reports. Generally, there was agreement among the observers, surgeons, and other investigators.
We attempted to observe the process fairly; we did not include errors that were averted, such as my not eating the eggs, the wrong blood sent but not transfused, or the incorrect medication order not followed. We used our judgment to determine whether error
really occurred or whether there was only a misunderstanding. We did
not include errors without consequence or those with no
measurable adverse effects. It was, of course, necessary for us to
categorize and itemize error, and we did so by identifying the 9
major problem areas depicted in. Each of the 9 problem areas had its
own set of categories, so that we arrived at 368 specific categories.
RESULTS
A total of 1047 patients were admitted to the 3 study units during
the course of the study. One or more adverse events or errors occurred in 480 patients (45.8%). A total of 2183 errors were identified, of which 462 (21.2%) were
considered serious (ie, a potentially life- or limb-threatening
event). One hundred seventy-five patients (17.7%) had at least 1
serious event.
These errors were distributed among all 9 problem areas. The most common problem areas in which error occurred were daily
patient care (29.3%) and management of other complications (19.5%).
Among the more serious errors, most were related to the management of
complications (38.1%) or to surgery itself (19.7%). It is noteworthy
that diagnosis was responsible for fewer than 10% of errors, and anesthesia, the involvement of which is
often invoked in our surgical M&M conferences, accounted for a small
percentage of errors; however, when they occurred, they tended to
be serious and accounted for 2.4% of all serious errors.
An analysis of the 40 most frequently encountered categories of adverse events showed that a single individual who might be
considered responsible for the error could be identified in only
37.8% of the cases, and in more than one third of these cases, it was
simply not possible to assign any responsibility. Much like airplane
mishaps, the errors are often individually small and seemingly
insignificant but seem to cascade to compound the problem. Patients
who had already experienced a complication or adverse event were the
most likely to experience additional problems. Gertrude Stein
observed that, "A difference, to be a difference, must make a
difference." These data seemed to confirm that adverse events make a
difference. The patients who experienced no identifiable adverse
events had an average length of stay of 8.8 days. Those who did
experience adverse events spent an average of 23.8 days in the
hospital, and those with "serious" adverse events were hospitalized
for an average of 32 days.
A legitimate concern for all health care providers is that of litigation. Of the 1047 patients in this study, 13 filed claims against the physicians or hospital. Of 13 claims, 11 occurred among
480 patients whom our study had identified as having experienced an
error. For the 2 patients who were not in the error group, an
unfortunate outcome was judged to not be the result of error. Of all
claims, 3 resulted in compensation, 8 were dropped, and 2 were
favorably resolved.
These observations were made under strict university and hospital research protocols. Except in the most obvious and serious observed errors, the observers were empowered neither to intervene and change the course of events nor to officially report to the hospital
or university staff. As reported, some of the errors were officially recognized and became the
subject of conferences and reviews. There were varying degrees of
action in the various categories, ranging from official action in
2.6% of cases that involved surgery, and to identify a medication
error in 5.3% of cases. An additional 15% to 20% of cases involved
some form of unofficial action, such as discussion at M&M conferences or a report to those who oversee quality assurance. Almost 80% of the
adverse events or errors that we observed were not officially recognized and recorded, and the events resulted in no identifiable action on either a personal or institutional level.
COMMENT
Although our patients were perhaps more seriously ill than those in
other published series, to our knowledge, the incidence of error was
substantially higher than any previous report. A 45.8% incidence of
error and a 21.2% incidence of serious error is many times larger
than the reported 10% error (3.7% serious error) published elsewhere.
Although the data were collected as concurrently as we could devise,
it is probable that errors were missed in our study as well, suggesting strongly that the probable incidence of error involves a staggering half of
all patients admitted to surgical intensive care units. Traditionally, we have approached error by attempting to identify and then correct
or punish the person(s) responsible. Our data show that such persons
held responsible could be identified less than 40% of the time, and
we believe that the patient was more often the victim of one of the
other types of error explained in the following section and presented
in. It became clear that errors could be categorized in several different ways. This is important since each type of error would lead to a different type of individual or institutional response.
TYPES OF ERRORS
Judgmental Errors
Judgmental errors are usually discussed at conferences and are referred to as "errors"
that are the result of inadequate knowledge or failure to employ
knowledge. These errors include failure to obtain appropriate
consultation and failure to order the proper tests or to interpret
them improperly. The seemingly obvious way to correct these
deficiencies is education. We as surgical educators spend inordinate
amounts of time in such educational pursuits. If there are unhappy
consequences that are predictable, such as the death of terminally
ill patients, we spend relatively little time in discussion.
Similarly, we do not frequently discuss good results since these are
also expected. Unexpected adverse consequences are discussed at M&M conferences, and unexpected successes are presented at grand rounds.
Perhaps we should reexamine how we direct our energies.
Our data show that diagnosis and treatment decisions in surgery resulted in fewer than 20% of all errors. Even among those that seem to be errors of judgment, the fault was more often found to
be systemic. In Tampa, Fla, for instance, a surgeon removed the wrong
leg. Despite wide national publicity and subsequent punishment of the
surgeon, 2 other surgeons in the same year operated on the wrong
finger. They also were disciplined, but are these truly judgment errors or are they matters of system failure? I
believe that a class of high school students could design a system of
finger identification, which if the system worked, would make it
impossible for anyone to operate on the wrong digit, limb, or
patient.
Conferences improve information and knowledge. Deming's experience in
industry and our data show that adverse events are frequently neither
the result of a lack of knowledge, nor reflective of "bad" surgeons.
Deming showed that well-designed protocols minimize defects in
industry and that well-defined protocols based on objective outcome
standards and analysis would accomplish the same in surgery.
Technical Errors
Technical errors are part of surgery and are often referred to
as "tricks of the trade." Technical errors do occur and are accepted as part of a
learning process in a residency, but they may also be the result of
defective equipment or the use of equipment in an inappropriate
fashion. Audiences roll their eyes when I ask them whether they had
ever observed an intensive care unit patient monitor with the alarm
shut off so as not to disturb patients or nurses. The previously
mentioned amputation performed on the wrong leg was often referred to
as a technical error, but I believe that the operation was performed
in a technically satisfactory way. It may not have been the fault of
the surgeon not knowing which leg to operate on, and it does not take
M&M conferences to demonstrate that operating on the wrong limb, lung, or eye should be avoided. Despite widespread attention, the
same type of error occurred twice in the same city within months of
the initial error. Publicity, education, and discipline all failed to
correct the problem. We found that technical problems were involved
in our list of adverse events in fewer than 10% of cases.
Expectations Errors
Misplaced expectations are an often-ignored cause of error. In most medical practice, there are no strict guidelines as to the process for performing or the individual expertise required for a given task. It is an unspoken tenet of surgical residencies that young surgeons are to be supervised and given graduated responsibility as their abilities expand. However, in most residencies, the milestones to be achieved are vague, poorly established, and
rarely confirmed by any objective measure. Rarely is there an
established checklist, or at least one that is actually followed. Several years ago I attended an M&M conference where a discussion involved a junior resident's inadvertent division of a central line
that resulted in tubing entering the patient's body. Much of the
discussion was devoted to the question of discipline, and whether
this particular house officer should be discharged from the program.
The house officer had never been supervised in this task, and though
it was early in the year, it was mistakenly assumed that the resident
possessed the requisite skill. We all know that residents seem to be
more capable after the sun goes down and when the attending
physician's personal supervision is most inconvenient. The resident
who cut the line, some years later now, is among the best and the
brightest. The tragedy was revealed by our finding that this same
error had previously been made by other residents in the same
program, yet no effort was made to change either the educational
program or the system for managing catheter changes.
In the broader hospital system, the error of expectation in the face
of dwindling resources is more egregious and relentless. On recent
rounds during a weekend at the burn center I directed, it became
clear to me that I did not recognize a single nurse, therapist, or
technician; discussion confirmed that no single person on duty had
ever worked in the burn unit before. Even if all are assumed to be
exceptionally qualified for surgical care, the special protocols of
the burn unit were not known to them, and they could not have been
expected to perform at a high level in an emergency.
Systems Errors
Deming documented that most errors in industry are within the system itself and
are usually not generated by individual failure. He strongly argued
for the introduction of meticulously designed protocols at every step
of the production. Additionally, these were to be monitored
meticulously and continuously so that deviation would be immediately
identified and corrected. Our study confirms that an analogous
situation and opportunity is present within the hospital. More than
60% of all errors were identified as being in the system, and
even among those for which an individual was identified, the person
was also acting within the system. The tradition of identification
and discipline of the person responsible is not sufficient to change
the system.
Mechanical Errors
The final and most infrequent cause of error is from the mechanical failure of equipment. The maintenance of equipment is, in most hospitals, outside the mainstream of medical hierarchy and follows strict protocols,
schedules, and criteria established by other industries.
IDENTIFICATION OF PRACTICE PROTOCOLS AND OUTCOME ANALYSIS
The first part of this article presents the situation as we identified it by the concurrent observation of adverse events in
surgical patients. This offered us the opportunity to examine some of
the intrinsic problems within surgical practice and to make some
recommendations for change.
Other industries have long demanded meticulous adherence to well-defined protocols. My brother-in-law has retired from a position
as a senior pilot for a major airline. He flew the most modern planes
in the world and was one of the earliest pilots certified to fly the
Airbus. He and his copilot followed meticulous checklists and
protocols. He occasionally reminisced about and longed for some of
the thrills and freedom of his earlier days as a freelance pilot.
However, as he settles into his single-engine plane, he and his
copilot wife meticulously follow a checklist similar to what he
followed with the airline.
It is arrogant to think that each surgeon's approach to a given problem is as good as any other surgeon's approach. It is inexcusable to ignore the fact that there are documented approaches to some conditions that are demonstrated to be superior to others. In one
city, early breast cancer in a certain hospital is treated most of
the time by lumpectomy and radiation with lymph node sampling. Across
town, it is treated 80% of the time by modified radical mastectomy
with complete lymph node dissection. Among the surgeons at all
hospitals, there are a variety of approaches to drains, dressings,
antibiotics, and other approaches that are idiosyncratic and not
subjected to objective evaluation. Is everyone correct? Our beginning
efforts to develop consensus approaches are laudatory and sensible.
Studies on left colon surgery demonstrate that with meticulous
attention to protocol, hospitalization can be reduced to a few days,
and complications and adverse events can be all but eliminated.
Many senior surgeons have spent the bulk of their professional careers working in the same operating room with the same nurses and
anesthesiologist for decades. In such a situation, an unspoken practice protocol evolves, which may or not be as up-to-date as some
others but is dependable and reproducible. Under such circumstances,
judgment is second nature to all involved, technical and mechanical
problems are probably rare, and there are few problems regarding
expectations. In short, a good system would be developed almost
intuitively by those involved.
That is rarely the situation in major hospitals today, particularly in the major teaching hospitals. The surgeon who sees the same anesthesiologist or nursing team every day is fortunate. Certainly, if emergency surgery is required during "off hours," a group of
highly trained strangers is gathered, rather than a highly trained
and experienced team. Even though everyone involved may be talented,
they are not a team (even the worst professional football or
basketball team will usually beat a team of "all-stars"). The absence
of strict protocols, not just "doctor preference cards," denies the
patient a critical safety factor. Pilots can fly with copilots whom
they have never met only because they are assured that they are going
to follow the same procedures. Patients, too, have a right to expect
that surgeons provide them the same assurance of comparability and
skill.
CULTURE OF
BLAME
Charles Bosk conducted a seminal study at the same institution where
I ate eggs, to determine how surgical faculty members evaluate the
progress of young residents and to determine who among them are to be
surgeons.While Bosk was observing surgeons at work, he also identified error
and response to error. He noted that some types of errors made by residents are forgiven and remembered,
whereas other errors are determinative and not forgiven. He divided
the errors into 4 categories: judgment, technical,
normative, and quasi-normative.
Judgment errors are much as described earlier and they refer to situations in which lack of knowledge or experience is believed to
have led to the error. We surgeons have devoted much of our educational efforts to expanding knowledge by conducting didactic grand rounds and journal clubs that are traditionally informational. Walking rounds with residents and students and operating room activities are largely devoted to sharing technical expertise and the
value of previous experiences. Surgical M&M conferences have
traditionally had the slightly different focus of reviewing adverse
events and outcomes. The format has usually involved a resident
presenting and attempting an explanation of the case. Although the
attending physician is tacitly known to be responsible, the resident
is expected to accept blame for whatever occurred. Much of the
criticism may be based on "off-the-cuff" comments by senior surgeons
and may reflect their own, sometimes idiosyncratic approaches to
similar cases. The considerable time and effort devoted to such case
reviews is presumably based on the assumption that error can be
ascribed to the individual actions of people or groups of
participants. It is further tacitly implied that perfect knowledge
would lead to perfect judgment and elimination of error. Our data
show that this belief is ultimately false and more than two thirds of
all adverse events have nothing to do with judgments as such.
Bosk named a second type of error: technical. This type was infrequent and unless repetitive, was forgivable.
The third and most critical error was called normative and had to do
with personal behavior. It involved assumption of responsibility relating to patients, staff, and faculty. Errors in this category (such as failure to visit a
patient when called at night) are interpreted as character flaws and
suggest that the resident does not have the "right stuff" to be a
surgeon. Character flaws are still identified among surgeons and
require courage to address.
The final category was intriguingly titled quasi-normative. It
referred to a failure of the resident to identify, acknowledge, and
follow the desires of a faculty member. These desires were often
idiosyncratic and not based on any common practice or science that
might be learned from the literature. The resident's failure to
observe these practices was evidence of hubris, considered insulting
to the attending physician, and generally unacceptable. Since the
activity was not dictated by any known protocol but rather as "just
the way he does things," residents could not accurately predict the
practice pattern. It is hard to imagine a situation more prone to
error. It is comparable to the airline pilot having his own way of
flying and the copilot having to guess how to assist.
NEED TO
COMPENSATE THE VICTIM
Workers' compensation legislation is designed to be a "no fault" approach to injuries on the job. Workers are cared for and compensated without having to prove who was at fault when an injury is sustained. It was felt that tort law could not handle this situation; companies and unions would wrangle endlessly while the injured worker was not
being covered. A similar problem has developed within the medical field. The patient who has experienced an adverse event is, at present, charged with the expensive effort of finding the responsible person in the institution. Since all health care
workers fear being singled out for blame and litigation, we are not
eager to come forward when error occurs, sometimes even to help
correct the situation. We in the system have responded by handling
adverse events with silence, disapproval, and fear of liability. One
of the observations in our study was that the more egregious and
serious the error, the more eager people were to talk about it.
Actually, risk management teams and lawyers usually strongly urge
great care in discussing the issues of a serious adverse event. There
is in our educational system a tendency to blame residents, and the
more senior or popular the surgeon, the more he or she is protected
by the system. Those who would attempt to discipline more senior
surgeons may be isolated as whistleblowers, and the colleagues of the
individual, no matter how ill-informed they may be, rally around the
accused. The culture of blame is a difficult 2-edged sword in our
profession. We seem to know no other approach than blame. Even
workers' compensation laws are fading as the no-fault approach to
injury fails to serve the needs of plaintiffs. Litigation based on medical error also leads to circling wagons against an outside threat. The threat of litigation makes public discussion of the
systemic problems almost impossible. The fact that the tort system is
not very efficient (of 480 patients in our study, only 3 with adverse
events received compensation) does not take away the awesome fear of
litigation.
DIFFICULTY
IN TRUTH TELLING
Telling the truth continues to be a difficult issue for physicians and surgeons. To my knowledge, all patients and medical students, without exception, believe that
professionals have a responsibility to tell the truth. Truth telling
has not long been part of the culture of medicine. Hippocrates
advised us do good and to protect our patients from harm; both of
these are to be found in the oath that we take in his name at
graduation. Regarding truth-telling, Hippocrates was notably silent.
He advised that we should "treat patients calmly and adroitly . . .
concealing most things from the patient." When I survey medical students on their second or third week on a
surgical rotation about whether they have heard surgeons lie to their
patients, they respond with a rather blank look. All of them have
heard surgeons (and other physicians) withhold information and lie
about some aspect of the patient's care.
Truth telling does not have to be brutal and unkind. Leveling with
patients and delivering truth in an artful fashion does not have to
be a lie. In what circumstance are we most likely to participate in
deception? It surely isn't when we have just performed an imaginative
and dexterous life-saving procedure. Rather, it is during the
situations of adverse events and medical errors when we are individually and as a profession most
challenged.
RECOMMENDATIONS
I would like to offer the premise that the health care industry, hospitals, and the practice of surgery are not so different from
other industries that they can afford to ignore the wisdom of W.
Edwards Deming. We have every reason to believe that there is a real,
tangible, measurable incidence of error in the practice of surgery.
It is an ethical imperative for all surgeons to attempt to minimize
these errors. We cannot claim that errors are either unavoidable or not preventable. The
analogy to airline pilots and airplanes is applicable; none of us
would readily accept a 45.8% (our data) or even a 10% (Harvard data)
error rate in the cockpit. How can we accept such an egregious rate of error in the operating room and the other units where our patients
are treated? Let us apply some of the wisdom of Deming.
Collect Data
The retrospective collection of data from the medical record is simply inadequate. Any quality
assurance program that purports to be effective but collects its data
after the fact is doomed. Workers do not record errors for all the understandable reasons described.
Deming showed that the people who should collect the data are the
workers on the line. We must allow nurses, technicians, pharmacists,
therapists, residents, and secretaries to collect data at the point
of care. I have worked with a software company (Safety-Centered
Solutions, Tampa, Fla) that has used essentially the same problem
areas and categories that we used in our study, and have introduced
these to several hospitals. They have confirmed that such a process
of data collection can be conducted. They can demonstrate dramatic
reduction in adverse events with resultant cost savings.
Develop
Practice Protocols and Outcome Measurements
Unless there is a specified protocol, those at the point where the
care is being delivered may not even be sure whether there has been a
deviation from accepted standards of care. How can we correct error
when those involved may be unaware that error has occurred? Accurate
data collection, even retrospectively, requires that those involved
have an understanding of correct procedure. As reluctant as
physicians are regarding health maintenance organization and other
cost-conscious third-party payers, the outside insistence on
protocols and efforts to document that certain outcomes can be
anticipated from various therapeutic approaches is appropriate.
Almost belatedly, surgeons are required to arrive at a consensus on
the best approach to any given situation. Procedure protocols are
nothing more than logical algorithms and outcome analysis requires
only that results be objectively measured. One of Bosk's most
insightful observations was the pervasive presence of quasi-normative
behavior among surgeons, idiosyncrasies that are lacking in
scientific basis. That this is confusing to residents and other
members of the health care team is self-evident; that it should
predispose to error is obvious.
Eliminate
the Culture of Blame
There are bad surgeons and their faults are usually what Bosk referred to as "normative" (ie, the result of character flaws). The
culture of silence in our profession should no longer protect them.
That persons in authority abrogate their responsibilities and
participate in cover-up has recently been emphasized in the case of
Dr Swango who seems to have actually murdered persons during surgical
services but was able to move from institution to institution because
those in responsibility failed to take principled stands.The culture of silence should not lead to the punishment of those who
are legitimately trying to maintain quality, even when it involves
disciplining or removing a popular surgeon.
Adverse events and medical errors occur when good surgeons are doing their best.
They involve good residents doing their best. They involve good
health care workers trying to do their best. True negligence is
unusual. This is important since the system will change only when all
of these people, doing their best, redirect their efforts toward the
system. Our data clearly demonstrate that the problems are most often
systemic, that is, within the system. Attempts to find the parties
responsible when the system itself is at fault is fruitless. It makes
it most difficult for good people to volunteer information when they
become victims of blame, silence, disapproval, or liability.
Those who are involved at the scene of the error are the ones who are
most likely to identify the error and, most importantly, are in the
best position to correct it. Those at the scene should be empowered
to enter data about the error at the time and place of the error and,
as part of the ongoing quality improvement, be the team that fixes
it. Only when we stop blaming individuals will workers voluntarily
enter the data and allow the Deming process to lead to continuous
improvement.
Compensate
the Patients Who Are Injured
The workers' compensation model worked when workers and industry agreed to a "no fault" approach to injury. The tort system failed to
protect the workers and as tort has begun to displace no fault, we
encounter more workers for whom the possibility of a large tort
judgment becomes a disincentive to successful rehabilitation. Those
of us who treated burns and other injuries became adept at marking
the date that the patient hired an attorney; progress in recovery
often stopped. Surgeons have spoken long and emotionally about tort
reform but almost always in terms of protecting our own interests.
The recognition that error is frequent may lead to increased
litigation, but not all of these errors are negligence nor should litigation
ultimately occur with increased frequency, at least for a period of
time. Adherence to standardized protocols protects surgeons. As we
recognize the incidence of adverse events, and begin gathering more
data and taking action at the point of care, the incidence of error
can drop dramatically. In the meantime, we need to work with
industry, third-party payers, and the government to explore other
ways to fairly compensate the injured. We can use as a starting point
the fact that the profusion of malpractice litigation has not
eliminated error; it has only made it desirable to hide and thus that
much more difficult to correct.
Tell the
Truth
We are not infallible, but we are not nearly so fallible as we appear
to be; surgeons rarely "botch" the case. The medical profession needs to take the leadership in
correcting the system. It is hard to maintain the posture that we are
rendering elegant and safe care when we lack protocols that would
allow us to compare processes; when we lack strict outcome criteria,
which would allow us compare results; and when we continue to fail to address systemic problems. We cannot resist change in the face of
data that show that 45.8% of our patients experience an adverse event
and that 21.2% of these patients experience a "serious" adverse
event. We must tell the truth. First, we must tell the truth to each
other, then to our patients, and finally to the public, since the
culture of silence will not serve us or allow us to change. The medical students who rotate on our services know when
they hear lies. We must tell the truth.
ETHICAL
CHALLENGES
Ethical decisions are not a separate part of life. There are, in our
pluralistic society, dominant religious determinants of what is
ethical behavior. There are certain values on which we can agree. We
all believe that murder, slavery, and genocide are wrong. We all
believe that there are certain virtuous characteristics that surgeons
should possess. Surgeons should possess prudence, which implies
knowledge and skill in our profession. Surgeons should possess
temperance, maintaining our own health and having an awareness of
chemical dependency in our colleagues and patients. Surgeons should
possess fortitude, which is the courage to perform when we are tired,
scared, or not getting paid, and the courage to speak out even if it
means loss of income or friendships. Surgeons, finally, should
possess a sense of justice for our society and for those in our
society who are least able to speak for themselves: the poor, those
who suffer discrimination, and those who may be contagious or even
dangerous to our own health. These virtues of prudence, temperance,
fortitude, and justice must be exhibited by us in addressing the
issue of surgical error. The ethical imperative is to exhaust our
efforts in correcting the processes and situations that lead to
error. Almost all religions have adopted this last tenet as a true
virtue; some call it love, some call it charity, and all describe it
as a willingness to "to welcome the stranger." In a sense, all our patients are strangers and we should welcome them, respect them, and
keep them from harm.
AUTHOR INFORMATION
In this article, I referred to the company Safety-Centered Solutions, Tampa, Fla (formerly Management Prescriptives Inc), established by
David and Carolyn Spencer. The company has recently been acquired and
is in partnership with Thomson Healthcare Information Group,
Montvale, NJ. I have no financial interest in either of these
companies.
I would like to acknowledge and express my gratitude to my coinvestigators and coauthors of the original publication in Lancet. They are my wife, Claudette Krizek, who was one of the hospital attorneys; Lori Andrews, then an attorney with the American Bar Foundation, Chicago, Ill; Carol Stocking, PhD, and Mark Siegler, MD, of the
MacLean Center for Clinical Medical Ethics at the University of Chicago; and my 2
surgical colleagues, Tom Vargish, MD, and Larry Gottlieb, MD. We
employed university students completing their work in cultural
anthropology. All had field experience (we joked that their
experience of observing gorillas in the wild would make them ideal
observers of surgical personnel).
Corresponding author: Thomas J. Krizek, MD, University of South Florida, 4 Columbus Dr, Suite 650, Tampa, FL 33606.
From the Division of Medical Ethics, The Ethics Center, University of South Florida,
Tampa.
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