President Tolo, members of the Academy, and guests:
Thank you for giving me this opportunity to speak to you this morning and the honor of serving our Academy and its members. As your President, I pledge unflagging commitment and dedication to the support of orthopaedics. I also pledge to you, the leaders of our profession, to help our profession to focus on some whole truths about a situation that threatens the things we value most—the trust of our patients and our autonomy as professionals. When our health-care system began its strained relationship with managed care, leaders forecasted that enormous change would continue for ten years before the marketplace stabilized. Nothing could be further from the truth. Today, just as ten years ago, we are continuing to experience tremendous turmoil in our troubled health-care system. Physicians, patients, employers, and policy makers seek stability, but change is constant and will continue. The current wave of change is being driven by increased concerns about costs, quality, and accountability. Is our system delivering to its potential? Are patients receiving the right care of the highest quality?
The truth is that the orthopaedic surgery being practiced in this country is the finest in the world. The truth is that our medical school faculty and residency faculty teach the best medical and surgical practices in the world. The whole truth is that we can do better. We can and we must do better to ensure our patients' safety or risk losing what we cherish most, the trust and respect of our patients. Concerns about quality and safety are having a tremendous effect on the relationship between physicians and patients—in the best case, we act as equal partners and, in the worst case, as adversaries. The truth is that our Academy is the premier professional organization offering education and leadership for orthopaedic surgeons. The whole truth, and the painful truth, is that we can and we must do better to serve our patients, our colleagues, and our profession. So, given all of the issues of concern to us as surgeons, I believe that the most pressing are those of patient safety and medical error and the impact they have on the quality of care that our patients receive. I believe that patient safety is the most crucial issue because it appears to be the problem that we are least willing to recognize and address and it most seriously threatens our autonomy as professionals.
Just this past December, a paper in
The New England Journal of Medicine noted that nearly 35% of the physicians surveyed had seen a serious error while working in the past year
1 . However, less than 25% of the physicians thought that ordering medications with use of computers, instead of paper forms, would be very effective even though the use of computers has been shown to reduce medication errors in hospitals. An editorial in
The New York Times about this issue stated that physicians were "lukewarm toward many reforms . . . [W]ith the evidence growing ever stronger that medical errors are a danger to many patients, it is disturbing to find such retrograde attitudes among physicians."
2 Reform can succeed only if the medical profession gets behind changes that expert groups and plain common sense suggest could substantially reduce the harm caused by medical errors. Tom Lee, in a recent editorial, stated: "An emotional assessment is that the status quo is intolerable."
3 In December 2002, Massachusetts lawmakers filed eight bills that would hold doctors and their employers accountable for mistakes and for questionable ethical behavior. They argued "that the medical establishment has done too little to reduce errors . . . acting instead as an isolated club."
4 This problem has and will continue to erode public confidence in our profession. Major payers, businesses, and government are all concerned about safety and quality.
For these reasons, I have chosen to focus on patient safety and medical error both in my address to you today and throughout the coming year. In addition to providing you with information about the magnitude and dimensions of the problem, I would like to share with you some of the reasons why many in our profession continue to ignore this problem, or think it does not apply to them, and what the risks are to the profession if action is not taken. Lastly, I will suggest ways in which each of us can make changes in our practices and ways in which we can be leaders in our institutions to effect change. In many cases, the measures and programs to address safety and medical error are not complicated but do require participation. Quite clearly, "Patient Safety is No Accident"
(which is the logo of the patient-safety program of the American Academy of Orthopaedic Surgeons). If we continue to be complacent about the level of medical error in the face of evidence that it can be eliminated, our patients may abandon us and may begin to accuse us of incompetence or, at a minimum, of being complacent in their care. Therefore, I suggest to you today that one more turn of the wrench is needed by each of us and by our profession. It is no longer adequate to first do no harm—we must do good. One more turn of the wrench, an expression taken from the automobile industry, recognizes that error is unacceptable and that improvement in quality is needed. A top executive officer of Ford stated that the issue for Ford, after the Firestone disaster, was "quality, quality, quality." They needed one more turn of the wrench. And, I think that is exactly what is needed in medicine. One more turn of the wrench—by each of us, by all of us.
There is currently a major patient-safety movement gaining momentum in the United States and other countries of the Western world. In our country, it began with the 2000 publication of
To Err is Human: Building a Safer Health System, by the Institute of Medicine, which catalyzed public and payer concerns about quality, specifically patient safety and medical error
5 . While the problem of patient safety and medical error is not new, what captured the attention of the public and the insurers was the estimate that as many as 98,000 deaths occur each year because of problems with patient safety and medical error. In that report, patient safety was defined as freedom from accidental injury; medical error, as a failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim; and an adverse event, as a serious injury or death resulting from medical management, not from the underlying condition of the patient.
The estimate by the Institute of Medicine was based on two studies that measured the impact of medical error on hospitalized patients. The first, the Harvard Medical Practice Study, published in 1991, found that 4% of the patients in New York hospitals suffered an injury that prolonged their hospital stay or resulted in disability; 14% of those injuries were fatal
6 . Extending the data to all hospitalizations in the United States, Leape estimated that approximately 180,000 patients die each year partly because of iatrogenic injury in the hospital—"the equivalent of three jumbo jets crashing every two days."
7 The second investigation, the Utah and Colorado study, using information similar to that collected in the New York study, estimated that 44,000 deaths occur annually
8 . These studies and the Institute of Medicine estimate have been challenged by McDonald et al. on the basis that they provide no information about the baseline risk of death for these patients without medical care and that seriously ill patients would have more than likely died anyway
9 . Despite these objections, Dr. Lucian Leape and others involved in this work have stated that they believe that the reported numbers are probably too small
10 . Whether the actual number of deaths is higher or lower, as has been debated, the fact remains that all medical error is unacceptable.
Interestingly, there have been publications on medical error before the Institute of Medicine study
11 . While the Institute of Medicine study was not the first to estimate the impact in lives lost annually, it was the first to become widely available to the public. One example is a study done in the mid-1970s, by the American College of Surgeons and the American Surgical Association, which reported that one-half of nonfatal complications and one-third of patient deaths from surgery were preventable
12 . In 1978, a medical insurance feasibility study in California, which was based on a review of 20,864 charts of patients in twenty-three hospitals, found that 5% of the patients were harmed by treatment, 4% were disabled, and 10% died
13 . After eliminating the inevitable deaths, another study estimated that 121,000 premature deaths occurred annually or about 2300 occurred every week in the United States in 1978
14 . This estimate was not significantly different in magnitude from the number reported in the Institute of Medicine study.
A more recent study, completed in 1997, reported that 46% of the patients admitted to a surgical intensive care or burn unit experienced one or more adverse events or errors
15 . In more than one-third of the cases, the authors were unable to assign any individual responsibility. Of greatest importance, 80% of the adverse events were errors that had been neither officially recorded nor recognized by the institution. In other words, providers and institutions could not and, therefore, did not change to improve patient safety because adverse events were not identified and disclosed. No change in behavior to improve safety occurred. No one turned the wrench. One more turn of the wrench was clearly needed.
Data from the Joint Commission on Accreditation of Healthcare Organizations in their Sentinel Event Alert provided a more complete picture of the types of medical errors occurring in our hospitals
16 . The Alert described nineteen major events of which six, in my opinion, are relevant to orthopaedic surgery: medication errors (11.4%), operative or postoperative complications (12.8%), wrong-site surgery (11.9%), a delay in diagnosis (6%), patient falls and leg-length issues (4.7%), and transfusion errors (2.7%). Because hospitals rely on voluntary reporting for detecting adverse events, it has been suggested by experts that these numbers are vastly underreported.
Little is known of the prevalence of medical error outside hospitals. In one Australian study, 25% of adverse events leading to permanent disability or death occurred among outpatients
17 . The investigators judged that approximately two-thirds of these events could have been prevented. In other studies, iatrogenic injury accounted for up to 36% of hospital admissions
18-20 . These studies only revealed errors serious enough for hospital admission and, therefore, underestimated the extent of errors associated with outpatient care.
I would like to stress three points about the scope and magnitude of medical error. First, just because the estimates of lives lost and errors made annually do not agree does not mean that there is no problem. In the case of error, any level is unacceptable. Second, medical errors are the responsibility of everyone in health care, from physicians to the hospital administrator. There is no one point of blame. Third, the Institute of Medicine's report has had an enormous impact on the public, the payers, and the press. Everyone recognizes the tremendous achievements in American medicine; however, it has become apparent that the quality of care in our country can be, and needs to be, improved
21 .
Why have we as a profession failed to acknowledge patient safety as a problem? Unlike the public, physicians in general do not believe that the quality of medical care in the United States is a problem. In a survey by Robinson et al., only 35% of the physicians viewed quality as a problem compared with 68% of the households
22 . Sixty percent of the households surveyed felt that there should be a national agency to address medical errors, but only 24% of the physicians agreed. Ninety percent of the public demanded mandatory reporting of serious medical errors, compared with 55% of the physicians. Both the public and the physicians thought that reducing medical errors should be a national priority. Last year, the Commonwealth Fund conducted a survey of Americans regarding their faith in the health-care system
23 . For years, public polls have demonstrated that the patient has a great deal of confidence and trust in his or her physician. This remains true today, but sadly the overall trust and confidence in health care is eroding. Twenty-two percent of the respondents reported that they or a family member had experienced a medical error of some type. This means that twenty-three million people experienced a mistake in a doctor's office or in the hospital. Half of the respondents reported that the problem was serious, and 22% who experienced a medication error reported that the error caused a serious problem. They concluded that the Institute of Medicine report,
To Err is Human, may be only the tip of the iceberg concerning the adverse health consequences for patients resulting from medical errors. Eight percent of those surveyed by the Commonwealth Fund
23 , only one in twelve, were satisfied with their health care.
Why have we as a profession failed to act on information about the scope and magnitude of the problem? One explanation is reflected in the words of David Barr, who, in 1955, summarized the beliefs of the medical profession at that time and that are generally true today: "Unfortunate sequelae and accidents attributable to sanctioned and well-intentioned diagnosis and therapy . . . these accidents, risks and dangers, may be regarded as the price we, as responsible physicians, must pay for the inestimable benefits of modern diagnosis and therapy. They are the hazards to which, with the best intent and most correct practice, we must occasionally subject our patients."
24 I don't accept Dr. Barr's opinion because the risks and dangers are the price that is paid by our patients, not us. We must move beyond Dr. Barr's opinion. It requires a culture change. It requires one more turn of the wrench. We did make a good start five years ago when we initiated the "Sign Your Site" educational program
25 . This program is one of the clearest examples of how a simple action, done routinely with patient involvement, can reduce medical error. Unfortunately, our profession's adoption of this measure seems to be inadequate. As Drs. Meinberg and Stern reported in a paper published earlier this year about orthopaedic hand surgeons, only 70% of a sample of hand surgeons were aware of the "Sign Your Site" program and only 45% of those who were aware of the program had actually changed their practice habits
26 . I find this very discouraging
27 .
Most errors are committed by good, well-intentioned professionals. Each of us feels tremendous responsibility and guilt when an error occurs or when a patient has an adverse event, an unacceptable complication, or dies. But to explain or justify the incident by rationalizing that the patient would have died anyway or that the complication is the risk of doing business should not be a mechanism for us to lessen the burden of guilt. As Lucian Leape pointed out
10 , since errors are rarely due to carelessness, this fact, coupled with our feelings of shame and guilt when an error occurs, results in a failure to understand the main message of the Institute of Medicine's report. The mortality figures are not the main message, but, as Leape stated, it is that "errors are rarely due to personal failings, inadequacies, and carelessness. Rather, they result from defects in the design and conditions of medical work that lead careful, competent, caring physicians and nurses to make mistakes that are often no different from the simple mistakes people make every day, but which can have devastating consequences for patients. . . . Errors are excusable; ignoring them is not. . . . Errors and `excess' mortality can be eliminated, but only if concern and attention is shifted away from individuals and toward the error-prone systems in which clinicians work. . . . Physicians should embrace this message with enthusiasm and vigor."
10 One more turn of the wrench is required.
Krizek, in an article on surgical error and the ethical issues of adverse events, identified five issues within the practice of surgery that have inhibited improvement in quality. They include: "(1) inadequate data about the incidence of adverse events, (2) inadequate practice guidelines or protocols and poor outcomes analysis, (3) a culture of blame, (4) a need to compensate `injured' patients, and (5) difficulty in truth telling."
28
Krizek noted that, to his knowledge, "all patients and medical students, without exception, believe that professionals have a responsibility to tell the truth, but truth telling continues to be a difficult issue for physicians and surgeons."
28 He surveyed medical students on their second or third week on a rotation and asked if they had heard surgeons lie to their patients. "All of them have heard surgeons and other physicians withhold information or lie about some aspect of the patient's care."
28 Leveling with patients and delivering the truth is an obligation even during a situation of adverse events and medical error. He recommended that it should be an ethical imperative for all surgeons to attempt to minimize the errors. We cannot claim that errors are avoidable or nonpreventable. The analogy to airline pilots and airplanes is applicable. "None of us would readily accept a 46% or even a 10% 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?"
28 He recommended, like Deming, that the people who are workers on the line should collect the data. It shouldn't be a retrospective collection from the medical record, which is totally inadequate. Nurses, technicians, pharmacists, therapists, residents, secretaries, and physicians need to collect the data at the point of care. He argued that, if we do not use specific protocols at the point of care, "how can we correct error when those involved may be unaware that an error has occurred?"
28 If we do not use protocols, there will be an outside insistence on protocols and efforts to document that certain outcomes can be anticipated for various therapeutic approaches.
Other reasons why physicians have not done more to address this problem, given the numerous documented reports of adverse events, include a belief that there is an acceptable level of error to be expected—that is, a built-in tolerance for complications. Surgeons often believe that they do not make mistakes and therefore it is not their problem. Some believe that errors are the result of poor hospital management and staffing and are not the fault of the physicians; others believe that the patients would have died anyway. Finally, we are not reminded of the cause of death. When I was a resident, autopsies were common and studies showed that high rates, up to 40%, of deaths were caused by a misdiagnosis
29 . But, today, physicians are not reminded of the error rate in the cause of death because autopsies are rarely, if ever, performed. Use of new imaging technologies such as computed tomography and magnetic resonance imaging have proven to be unreliable compared with autopsy in establishing the cause of death. There is no doubt that we will always see complications
30 . After all, each patient is different and often has serious problems. But, I ask, are not the rates of complications and errors that occur in medicine too high and shouldn't we all be doing something to reduce them? Shouldn't we be partners with our patients by demonstrating that we are making every effort to ensure their safety? Going one step further, is there any doubt that near misses occur too often? Don't we need to reduce them? I think that most of us have been unaware of the severity of the problem. I know I was until I began to study the subject in depth. Also, importantly, most of the errors that we see in our daily practices do not usually harm the patient, and no one feels that any change is needed. I would like to take a little license here and attempt to relate the error rate that we accept to what such a rate would mean in our daily lives and in industry. For example, an intensive care unit study established a 1% error rate
15 . A 99% rate of freedom of error means twenty unsafe landings per day at O'Hare International Airport, 160,000 pieces of lost mail every hour, or 320,000 bank checks deducted from the wrong bank account each hour
7 . Deming stated that an error rate of even a 0.1%, however, is too high
31 .
Finally, Eisenberg described the barriers to this change in the culture of health care to one of safety
32 . He emphasized the need for greater input from the medical professional societies. While recognizing that the perception of physicians is that health-care quality does not need to improve, physicians need to learn more about quality and accept objective assessments of clinical performance as an opportunity to learn and improve. He recognized that physicians lack the motivation to change and that the current system encourages overuse of certain procedures. He described technical barriers with complex classifications that need to be simplified and standardized. Finally, he recognized that physicians have difficulty discussing safety without producing fear of legal consequences and professional shame.
There are risks if physicians do not address the problem of medical error. Insurers are moving from an emphasis on costs to an emphasis on quality. Some private plans and even the federal government are offering or developing plans to pay bonuses to physicians for meeting certain quality standards. We should be at the table to set these quality standards. There is increased interest in public disclosure of medical error
22 . If we do not deal with this issue, it will be taken out of our hands. We, as a profession, need to recognize and help to shape these initiatives. There is no doubt that a patient has the right to know if a mistake has occurred in his or her care. I do not agree that the public has the right to know. But I do believe that the error should be reported to hospital oversight groups and to the state medical board if the injury is serious. The report must be protected from discovery, however. We have such a reporting system in Massachusetts
33 . Only with such a confidential system can the institutions discover root causes and effect changes to minimize a recurrence of the error. The public deserves and will demand to have an overall quality assessment of hospitals and physicians. Anything further is problematic. But, I submit that, if physicians do not fully participate in this evolving process, we will not be in charge and will have rules imposed upon us. It is our responsibility to keep this matter in our profession. One more turn of the wrench is required. As you can anticipate, if we do not act, the government, as protector of the public welfare and as the major health-care insurer, will be forced to enter this arena.
This can be a defining moment for our profession. How do we move beyond debate about the nature and magnitude of the problem? Lucian Leape advises physicians to learn from errors; to ignore them is the problem. How do we turn the wrench?
One of the most important messages on the topic of patient safety and medical error is that change is coming regardless of our actions. As noted by Coye, "the health sector has been exceptionally untouched by the transforming principles of quality management that revolutionized manufacturing and service industries in the 1980s."
37 She argued that there has not been a business case for quality in health care, but it is emerging following the Institute of Medicine's second report,
Crossing the Quality Chasm: A New Health System for the 21st Century38 . Even though health care is in turmoil, it is not approaching a near-death experience such as the one that industry faced at the end of the twentieth century. According to Coye, if it were, quality improvement would become a core strategy that allowed some industries to survive after failure of all other strategies. The challenge to our profession and the Academy is how to be involved in shaping these strategies. Change in how we think about and deal with patient safety and medical error will be shaped by the following forces.
The first driver for change will be the business coalition known as the Leapfrog Group
39 . The Leapfrog Group, a coalition of public and private organizations that provide health-care benefits, is now adopting standards of quality because it makes business sense for them. They have already effected change in some regions of the country by demanding computerized physician order-entry systems in hospitals, fully trained internists in hospital intensive care units, and referral of patients with certain conditions to high-volume centers. In fact, a recent law was passed in California requiring all hospitals to have computerized physician order-entry systems by 2005. As many already know, the Academy's Board of Directors has invited a member of the Leapfrog Group to join the Board.
I believe that a second driver will be the consumer—our patients. As they assume responsibility for more of the costs of their care, they will demand higher-quality services, especially as the baby boomers experience more chronic disease. As the public receives more information on quality in health care, the variations in care, and the differences in current clinical practice, there will be increasing demands for improved quality, more information, and the redesign of services. Coye predicted that consumer outrage will eventually push safety improvement as it did in the auto industry when the public became aware of "industry arrogance, and shoddy design and production."
37
A potential third driver for change will be the government. The Institute of Medicine recently submitted its third report to Congress calling for increased regulation and purchasing strategies to reward providers who achieve higher levels of quality
40 . The federal government is already planning pilot projects in several states, and it has announced a program for additional payment to physicians for quality performance achievements. We are beginning to see other payers rewarding physicians and hospitals for improved quality
41,42 . But I believe that most insurers will still emphasize cost reductions, and the federal government will not commit the money that is needed to enforce the regulations that they establish. As Coye stated, "until payment policies reward quality improvement, providers will not place it at the core of their business strategy."
37
Knowing that these pressures for change are occurring should be enough of a stimulus for us, the physician providers of patient care, to begin to change our thinking. We need to be informed—not only participators in this movement but leaders for change. Not only is it the right thing to do, it is essential. If we do not take the lead, then our professional rights and obligations will be taken away from us. It will be done to us and maybe not even with us.
Quality Improvement
Becher and Chassin stated that "physicians now enjoy a moment of tactical advantage" and need to "establish strong and visionary leadership in healthcare quality improvement."
43 Defining, measuring, and improving health-care quality can be in the hands of physicians. To succeed, physicians must understand the relationships between the different kinds of quality problems that plague our health-care system, the kinds of errors that lead to the problems, and how to correct these errors. They made the following recommendations: "Physicians in all practice settings will need to conduct quality improvement as an integral part of patient care rather than seeing it as a burdensome externally imposed task that is irrelevant to the core goals of their practices . . . [M]ajor reductions in the use of antibiotics . . . reduction in prescribing errors[,] and a host of other clinically meaningful objectives such as participating in a National Joint Registry are within the reach of most if not all physician practices."
43 Physician leadership and quality will also be defined by accountability. Physicians should seize the initiative by leading the effort to remedy the quality problems associated with overuse, underuse, and misuse. Becher and Chassin made the charge: "What are we waiting for?" and asked: "Do we wish to solve the problems by defining for ourselves and our patients what excellent quality is and how it may be achieved consistently or do we wish to cede that responsibility to others?" They argued that "the choice is ours to make for now, but not perhaps for much longer."
43
Stern, in an editorial, called for leadership in quality
44 . He stated that there must be a uniform line of approach transcending controversies. Each individual is concerned with quality improvement performance in accordance with his or her own experience, his or her own resources, and in the pursuit of his or her own goals. There must be a culture change among physicians. But, physicians have barriers to this new approach because of a professional psychological culture that prevents their recognition and participation in the implementation of the change necessary to develop a culture of safety. When institutions attempt to perform quality projects, physicians tend to be unavailable for work teams; they are too busy to join, perhaps they are too skeptical about the possible effectiveness of the quality improvement, or they do not think that the effort is needed. There are, however, instances of tremendous success in some hospitals where physicians have played a leadership role. Physicians must be prepared to invest their time and energies in these issues of quality. They need to understand that quality improvement is one of the chief goals in every aspect of patient care, and it is an obligation of every physician and hospital director to promote quality improvement. While calls for quality improvement have not been ignored, there still remains no coherent strategy and there is a large leadership void. The quality chasm remains unbridged
45 . Physicians can be and should be leaders, but quality improvement on a substantial scale requires a major investment that only hospitals can provide. Evidence-based performance measures are needed to convince clinicians and to impel them to action. In the past, there has been a lack of demand for improvement, but everyone can sense the movement for consumer demand for quality improvement; it is in the press daily throughout the United States. As public awareness increases and as the consumers assume more responsibility for the costs of their care, the demand for safety improvements will follow. Physicians need to be positioned to be part of this change or the change will be forced upon us by the government sector or the public sector, or both.
Standards
Physicians would dramatically improve quality as well as meet their own needs by accepting evidence-based principles of standardization, simplification, clinical relevance, and accountability. Krizek noted that it is inexcusable to ignore the fact that there are documented approaches to some conditions that are demonstrated to be superior to others. "It is arrogant to think that each surgeon's approach to a given problem is as good as any other surgeon's approach."
28 The result is an unacceptable rate of variation in care. Reviewing the
Dartmouth Atlas of Health Care is a lesson for each of us
46 . Krizek applauded the beginning efforts to develop consensus approaches. Some hospitals have information protocols in which senior surgeons work with senior nurses and senior anesthesiologists and have done so for decades. They have developed a system almost intuitively. The surgical team discusses the patient before the operation is started. However, this is rare in most hospitals today, especially in major teaching hospitals. I rarely see the same anesthesiologist or nursing team every day in the operating room. Emergency operations done at night or on weekends usually assemble a group of highly trained strangers. The absence of strict protocols denies the patient a critical safety factor. "Pilots can fly with co-pilots whom they have never met only because they are assured that they are going to follow the same procedures."
28 Patients have a right to expect surgeons to provide them with the same assurance of comparability and skill. Even doctors' preference cards in the operating room are not used routinely today. I know of one example where they are kept locked up in the operating room for safekeeping; they are never reviewed!
Charles Bosk, in his study of residents, identified error and response to error
47 . He noted that sometimes errors made by residents are forgiven and remembered, whereas others are not forgiven. One error that Bosk described was entitled quasi normative, which referred to a failure of the resident to identify and follow the desires of a faculty member. These desires were often idiosyncratic and were not based on any common practice or science but rather just the way that the faculty member does things. It is hard to imagine, as Krizek pointed out, comparing this with an "airline pilot having his own way of flying and the copilot having to guess how to assist."
28 We cannot claim that errors are avoidable or nonpreventable. The analogy to airline pilots and airplanes is applicable. The quasi normative behavior of surgeons, described by Bosk, totally lacks scientific basis. This is confusing to residents and to other members of the health-care team. That it could lead to error is obvious. "Adverse events and medical errors occur when good surgeons . . . good residents . . . are doing their best."
28 Any health-care worker doing his or her best can be involved. But "true negligence is unusual." Data today clearly show that "problems are most often systemic," and the attempt to blame individuals "makes it most difficult for good people to volunteer information when they become victims of blame, silence, disapproval or liability."
28 Those involved at the scene of the error are most likely to identify it and, importantly, are in the best position to correct it. Krizek went on to state that "Only when we stop blaming individuals will workers voluntarily enter the data and allow the Deming process to lead to continuous improvement."
28 He argued for a no-fault compensation system, like Workers' Compensation, to fairly compensate the injured. "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."
28 The medical profession needs to take leadership in correcting the system. He stated that it is hard to maintain the posture that we are rendering safe care while lacking protocols and strict outcome criteria that would allow us to compare results. In addition, "we continue to fail to address systemic problems . . . [F]irst we must tell the truth to each other, then to our patients, and finally to the public."
28 The truly important issue for the prevention of injury is not who caused the injury in a particular instance, but, rather, what can be addressed in similar instances in the future to avoid another error. For the physician, it may mean remedial training or education or, in rare instances, some limitation of practice. For the system, it involves a proper diagnosis of the problem and instituting change to minimize that problem from occurring in the future. I believe that patient safety is a more powerful tool than disciplined liability alone.
Physicians must work harder to improve quality and to use science to measure what is done for patients
48 . This simple measurement of quality outcomes was described years ago by Dr. Ernest Codman, who urged hospitals "if they wish to be sure of improvement, they must find out what the results are, must analyze the results, find their strong and weak points, must compare the results with those of other hospitals . . . and must welcome publicity, not only for their successes but for their errors."
49 Dr. Codman wrote this in 1917. His words are as true today as they were then.
Adopting Core Safety Practices
The Agency for Healthcare Research and Quality in a report,
Making Health Care Safer: A Critical Analysis of Patient Safety Practices, used an evidence-based approach and expert consultation to identify patient-safety practices for physicians
50 . The National Quality Forum also published a list of core safety practices that each of us could do in our practices
51 . They include the following measures: promote a culture of safety by incident reporting, root-cause analysis, and public disclosure of a health system's progress toward the implemention of safe practices; reduce adverse events resulting from high-risk procedures and treatments through proper informed consent and referral to hospitals likely to have the best outcomes; promote accurate communication of treatment and procedures by avoiding verbal orders; reduce adverse events during manual transfer of information by eliminating manual transcription and using computerized records and physician order-entry systems; ensure that there is adequate nursing staff to provide care; ensure that the most critically ill or injured persons have appropriate skilled provider care in the intensive care unit; and ensure that the patients understand their proposed treatment by proper user-friendly informed-consent forms and identification of the specific site of a procedure. I would add the following measures: ensure full disclosure of risk for patients entering clinical trials or research; ensure that the patients receive only the care that they desire; promote safe and accurate prescribing, filing, and dispensing of medications through a computerized physician order-entry system; ensure that practitioners and patients know what medications the patient is taking; ensure that the patients have an advocate who can assist or stand up for them during their care; ensure that medications are used in safe and effective ways; reduce failure to follow through on test results by developing systems that ensure that all markedly abnormal results receive appropriate follow-up; and establish ongoing drug use evaluation programs by monitoring all medications including off-label uses.
In terms of new and emerging practices, the National Quality Forum recommended that we promote effective teamwork and the safe and effective use of medications, reduce the occurrence of venous thromboembolism by appropriate prophylaxis, ensure the safe use of high-alert drugs, prevent person-to-person transmission of infections by hand-washing, reduce surgical site infections by ensuring that a prophylactic antibiotic is administered in time so that a bactericidal level is established in the tissues when the incision is made, reduce radiographic misinterpretation due to miscommunication, prevent adverse events due to wrong-site procedures and wrong-patient procedures by marking the operative site, prevent pneumatic tourniquet complications, promote the use of safe health-care products, and reduce confusion about the method or manner of medication administration
51 .
Attention to the System
Physicians focus their energy on individual patients and tackle difficult problems as they appear. Barach and Moss emphasized the need for focusing attention on the system
52 , for example, by avoiding inadequate turnovers of care, during which vital patient information may be lost. They noted that the entire system of care must be redesigned and physicians must instill a chronic sense of unease in themselves, a constant awareness of risk in every action. Safety must be our goal. There is a great deal known about how to build a safer system and to reduce risk, but little of this knowledge is embedded into our daily practices. Our professional organizations, our health-care institutions, and individual physicians should support the development of understanding about safety. Physician involvement in patient-safety initiatives is vital
45 . Leadership includes the physicians and the hospital administration. It is not easy to establish an improved patient-safety program. It is a massive effort, with input and participation required from everyone. An extensive communication and education program is essential
15 . Safety is an active process that systematically employs preventive and corrective actions to avoid injury. It is an attitude and a discipline. It must be part of the culture of any entity. The process of improving patient safety must obviously involve the patient. If we can partner successfully with our patients by ensuring their safety, demonstrating how we have reduced medical error, improving their quality of care in our hands and in our institutions, disciplining our own bad apples by adopting a confidential means of reporting to effect change, and participating fully with consumer reports, we may have the possibility to establish a constructive alternative to patients seeking relief in our malpractice courts.
According to Berwick, improvements in performance in a complex system are achievable simultaneously if one is bold enough, committed enough, and creative enough to continually design and redesign the system
53 . Berwick suggested that it is necessary to (1) design a system to prevent errors and to make them less likely to occur, (2) design procedures to make errors more visible, and (3) design procedures to mitigate the effect of errors when they do occur.
Educating New Physicians About Patient Safety and Medical Error: Changing the Culture
Currently, I know of only one residency program with a curriculum on patient safety, the family medicine residency program at New York University, which includes the subject in their core curriculum
54 . Only ten medical schools have lectures for students on patient safety. I could find no medical school that reported an actual required course on patient safety. Most lectures are included in ethics or preventive medicine courses. Teaching the next generation of physicians, nurses, and other health-care providers is probably going to be the most effective way to implement this culture change. An important part of medical education is teaching and learning effective communication skills. It is imperative that students learn how to communicate with patients and their colleagues. The American Medical Association, the Joint Commission on Accreditation of Healthcare Organizations, the National Patient Safety Foundation, and some states agree that, if an adverse outcome occurs, the patient or a family member should be fully informed about the event. In fact, poor communication with the team, laboratory, or others was the third most common factor associated with anesthesia errors. Louis Gerstner, former chief executive officer of IBM, who led that company's major turnaround, stated in his new book: "I came to see in my decade at IBM that culture isn't just one aspect of the game—it is the game."
55 We need to teach medical students and residents, as well as practicing physicians, how to improve patient safety by reducing medical errors as well as identifying and eliminating near misses. We have an opportunity to teach new physicians and students about errors in systems of care, methods to reduce errors, and a nonpunitive approach to error reporting. As long as we embrace the system of shame and blame and finger-pointing, where individuals are singled out for punishment when an error occurs, we will be unlikely to change the culture.
Everett Rogers described the diffusion of innovations as a progression from innovators to early adopters and finally to full acceptance
56 . Once an innovation has been adopted by the first 15% to 20% of the individuals in a field, it becomes almost unstoppable. We are at the early adoption phase with patient safety and error reduction. Coye recommended that, to achieve an industrial strength improvement in quality, three issues must be addressed: competitive advantage, market demand and public policy, and alignment and linked incentives
37 . With regard to the first issue, competitive advantage, Berwick stated that "healthcare is missing a comprehensive example of a breakthrough performance" that will make reform unstoppable
53 . If the Leapfrog effort demonstrates substantial cost savings by improvements in quality, reduced variations in care, and reduction of medical error, they will make the safety movement almost unstoppable. In terms of the second issue, market demand and public policy, as the public receives more information on quality in health care, variations in care, and differences in current clinical practice, the demands for improved quality, more information, and the redesign of services will increase. Not only will patients (consumers) shop with their feet as public report cards become available but physicians and hospitals will also have added strong incentives to evaluate themselves more critically. The reality may be that physicians are not doing as well as they think. In fact, hospital and physician quality data are already being released in New York, Pennsylvania, and Texas and will be law in California by 2004 for hospitals and by 2005 for surgeons. These laws have been driven by the consumers. With regard to the third issue, alignment and linked incentives, it boggles the imagination that there are so many contradictory and conflicting incentives in medicine today. To date, none of these strategies have caught on fire nationally, but the payers and consumers may be strong enough to do it
37 . It may come as incentives begin to be aligned by payments to providers for improved quality. We can help by partnering with our patients and the payers to move patient safety toward a Six Sigma level of excellence.
The Agency for Healthcare Research and Quality, in partnership with the Joint Commission on Accreditation of Healthcare Organizations, recently held a symposium on building the business case for patient safety
57 . They developed what they called "Prioritized Category A Strategies for Implementation," which would cost less than $1 million and would provide quick fixes to the system. The strategies included recommendations to mark the surgical site, appoint an operating room safety officer, monitor all patients under sedation with a pulse oximeter, have a briefing of the operating room team preoperatively, enhance the process for granting surgical privileges, use appropriate prophylactic antibiotics, and implement verbal order read-back as a standard practice.
They also had Category B strategies that required further research, would cost more than $1 million to implement, and would take more than two years to effect change. They included the use of a black box recorder in the operating room, volume-based referrals for surgery, simulation training for technical and crisis response skills, and the use of postoperative intensivists. Some of these initiatives, in both Category A and B, have already been activated by the Leapfrog movement.
One of the first hospital systems to address patient safety was the Veterans Administration
33 . In 1990, they required that all employees complete thirty hours of continuing education each year, with ten of those hours focused on quality improvement and ten hours on patient safety. Simulators are used to allow doctors and nurses to practice procedures and emergency drills and to make mistakes using equipment including computerized human dummies.
One hospital system in the Midwest decided to build a framework for patient-safety improvement
4 . If their system was 99.9% error free, they knew that there would still be 5000 errors per year. If only 1% resulted in a serious adverse event, fifty patients in their hospital would be harmed. They studied Reason's "Swiss cheese model" of latent failure, illustrating how errors emerge as safety flaws
58 . Lying dormant most of the time, errors occasionally lined up like the tunnels in Swiss cheese and reached the patient. Management supported the work, the physicians and other leaders led safety efforts throughout the entire organization, and their goal of a 99.9% error-free system was reached. Other hospitals, such as the Brigham and Women's Hospital in Boston, have established a physician order-entry system that has reduced errors substantially. They also use information technology to monitor adverse drug events and to provide a system provider communication network as well as computerized sign-outs.
Increased public awareness and consumer insistence will help to move the health-care industry toward a new standard of patient safety. I believe that the Academy should seize this initiative in its educational campaign. Our Academy should become a leading advocate for making quality a central focus of every provider's practice. When businesses adopt a Six Sigma strategy, they do so because it makes business sense. The Leapfrog Group, a coalition of large corporations, is now adopting standards of quality because it makes business sense for them. We must be ready for marketplace pressures. The marketplace will prove itself an important force for improvement of quality
63 . The government as well must invest in the production of continuous quality improvement in health care. The government can serve as a neutral focal point for the collection, publication, and dissemination of data on quality of care. Goode et al. added, however, that there must be more incentives for physicians in addition to professionalism and pride in doing a good job
64 . There must be financial incentives with added payments for improvements in quality as well as for elimination of activities in which errors lead to increased hospital payments such as prolonged hospital stay or readmission. However, such incentive programs must be implemented with the goal of keeping patient safety first and foremost so that our profession's contract with society is not weakened.
Bovbjerg et al. wrote that "it is desirable to tap both professional sanctions and systems safety motivations and responsibilities for keeping patients safe." Strategies to do this can be categorized as ways "to turn down the heat and turn up the light."
34 They include:
Regulatory shifts with root-cause analysis of serious injuries (now required by the Joint Commission on Accreditation of Healthcare Organizations).
Patient and purchaser pressure. Some progress is being made by purchasers like the Leapfrog Group and a consortium of large firms and the government in Minnesota.
Liability changes. If clinicians and other health-care workers are to accurately report incidents of adverse events and error, the reports need to be insulated from personal injury lawsuits. Congress needs to establish laws to protect this information as confidential. One approach is that of the airline industry, in which decedents' families sue the airlines but not the pilot, the mechanics, or the administrator. Shifting the liability from the providers to the organizations that are capable of making systemic changes has the advantage of removing the fear of personal liability and eliminating disincentives to report errors.
Use of no-fault payment in place of litigation, similar to the system used for workplace injuries, which would make it easier for practitioners to disclose problems
34 .
Coalitions and collaboratives are being formed to improve patient safety. The Academy has started one. The University of California hospitals have organized a strategic alliance for error reduction, entitled "SAFER," which recently held its first patient-safety summit. A collaborative consisting of twenty-two organizations, including integrated delivery systems, hospitals, academic medical centers, and specialty clinics, has been formed to provide more effective care for low-back pain. The Institute of Medicine has a patient-safety program and an ongoing committee on patient-safety data standards that meets frequently. There is a medical event reporting system in transfusion medicine entitled "MERS-TM" with a primer for health-care executives
65 . States have begun to pass reforms in malpractice, and there are parallel efforts underway to link this issue with patient-safety programs and reporting of medical errors. Many state societies such as the Florida Hospital Association have a Patient Safety Steering Committee. There is a patient-safety organizational assessment tool entitled "MEDSTAT" that can be used by hospitals of all sizes
66 . This partial list of the many efforts across our society to confront patient safety and medical error reduction is not exhaustive. It is imperative that our Academy and our membership be knowledgeable about these organizations, participate with them when necessary, and utilize their services when necessary. For instance, in the states where initiatives on patient safety and reporting of medical errors are being tied to possible malpractice reforms, it is important that we are fully knowledgeable about these efforts. Our state societies and our Board of Councilors need to work with these programs to ensure that any reporting requirements are linked with appropriate confidentiality and discovery protections.
Our Academy needs to use information technology to continue to improve access to information by our fellows and to support evidence-based clinical decision-making. Guidelines must be developed by physicians for the right reason—to improve quality and reduce error. Guidelines should not limit care or be developed simply to reduce costs as has been suggested for the infamous Milliman and Robertson guidelines
67 . Surgeons must have more sophisticated measures of improvement and outcomes, learn ways to better coordinate care among services in our health-care facilities, learn how to develop effective teams and teamwork, and have available more robust ways to find and use the best practices. The Academy and our members must use the best known clinical models as organization standards. New York has recently posted a report card of care for twenty-five inpatient procedures, including hip replacement
68 . Our state societies and physicians have to be involved with such efforts to establish standards to ensure that proper measures of quality are used.
Numerous web sites on patient safety are available both to professionals and the public. Our Academy has such a web site for patients. Another web site, entitled "Black Ink," is designed for senior-level health-care executives. It provides visitors with news and tools to conduct health-care business in today's marketplace with articles designed around a quality theme addressing patient safety
69 .
Everyone seems to have gotten involved with patient safety. We are the providers of care and should be directing the safety movement. To do so requires leadership, understanding, and commitment. As Benjamin Franklin wisely said, "Although we may all fail even if we work together, we will surely fail if we do not."
70 Our profession and our Academy have the power to create change. It will probably be slow and incremental, but every doctor needs to be involved. As Goode et al. noted, "Even modest change can lead to substantial improvements" in decreasing errors and improving patient safety
64 . Long-term issues will require coordinated efforts among professionals, hospitals, and patients. Goode et al. identified ten strategies that we as an Academy can do (or already are doing) to improve patient safety: use tools of certification and recertification; develop payment incentives; use established standards of care in our offices; make a business case for interventions and practice; identify and train leaders and champions in patient safety; develop a focused external positive message; involve local groups in measuring, monitoring, and improving quality; develop a common language and measures for safety; create awards for individuals, groups, and organizations; and maintain patient safety information in the public domain
64 . Your Academy is already involved with five of these efforts and is developing plans for implementing the others. We need to let our patients know what we are doing to maintain their trust and confidence in us. We are beginning to turn the wrench, but everyone in orthopaedics must also turn his or her own wrench one more time.