Retrospective look at landmark report: Are patients safer now?

[Editor’s note: Five years ago, the Institute of Medicine (IOM) caused a stir with a landmark report, To Err is Human, which said the number of people who die in the United States as a result of medical errors is equivalent to a jumbo jet crashing each day. The report cited evidence that as many as 98,000 Americans die in any given year from medical errors — more than from motor vehicle accidents, breast cancer, or AIDS. This past fall, many organizations and individuals recognized the fifth anniversary of that report with assessments of how far we’ve come in addressing the problem from the perspective of providers, the general public, and the health care system. While providers and health system analysts are cautiously optimistic about the progress that has been made, consumers say they don’t feel safer, perhaps because they’re not aware of some of the changes that have taken place. Also in the discussion is an initial report on patient safety centers in several states — one attempt to take bold steps to improve patient safety.]

A provider assessment, supported by the Commonwealth Fund and published as a Health Affairs web exclusive, said the United States has made insufficient progress to improve the safety of patients in hospitals, giving an overall grade of C+. Though the report noted some improvement, it also acknowledged considerable deficiencies in key areas.

The report was written by Robert Wachter, associate chairman of the Department of Medicine at the University of California at San Francisco, who said a lack of funding, training, organizational structure, and culture have created barriers to meeting the goals laid out in the IOM 1999 report, which called for reducing medical errors by half by 2004.

In his analysis, Mr. Wachter gives high marks to the effects of strong regulation and broader use of information technology, but said error reporting systems have had little impact on fostering patient safety and there has been virtually no progress on making clinicians or health care systems more accountable for their actions over the past five years.

Wachter looked back at history to discover how health care has become so unsafe. "When the tools of medicine were the doctor’s intellect and the nurse’s empathy, and a few simple surgical procedures and potions, there was little price to be paid for absent safety systems and lack of coordination. As medicine’s tools became more powerful and technologically sophisticated, highly specialized teams were needed to deliver care. The modern intensive care unit [ICU], an invention of the 1960s and 1970s, vividly illustrates the problem," he writes.

"Patients there are supported by an extraordinary array of breathtaking technologies and pharmaceuticals, each accompanied by an armada of skilled professionals to manage their use. A critically ill patient might be seen by a half-dozen different physician specialists and scores of nurses, respiratory therapists, pharmacists, social workers, clergy, and others and receive hundreds of medications and tests. It should come as no surprise, then, that without a culture, procedures, and technology focused on flawless execution, errors would become commonplace. One study found that the average ICU patient experiences 17 errors per day, nearly one-third of which are potentially life-threatening. Most involve communication problems," he adds.

According to Mr. Wachter, as care became potentially more dangerous, several main forces limited ability of those working in the system to answer the challenge:

1. a flawed mental model and collective inattention that before 1999 saw medical errors in terms of individual culpability rather than as a system problem;

2. a reimbursement system that pays hospitals and physicians the same regardless of the safety of the care they deliver and thus creates no incentive to invest in safety, and an organizational structure that separates physicians from the rest of the hospital enterprise, creating divergent bottom lines and incentive structures;

3. a milieu in which patient safety was quite naturally ignored, with a focus, as in most industries, on production or progress rather than safety.

His report card assesses progress in several broad areas seen as necessary to meet a goal of significantly reducing medical errors: regulation, error reporting systems, information technology (IT), the malpractice system and other vehicles for accountability, and work force and training issues.

Mr. Wachter gives regulation an A-, noting the work done by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). A survey of hospitalists (physicians specializing in inpatient care) indicated JCAHO was the second most important force for change, while hospital leaders said it was the most important driver of progress in patient safety. He cites two examples: First, before JCAHO’s safety goal requiring read-backs of patients’ names and oral orders, virtually no U.S. hospital had a strict policy mandating what Mr. Wachter calls a commonsensical redundancy, despite the fact that many restaurants have long performed read backs to avoid errors in processing takeout orders.

Second, he says, during the pre-regulatory days of "sign your site," some surgeons placed an "X" on the site to be operated on, while others put an "X" on the wrong site, as in "don’t cut here," another argument for standardization.

"JCAHO’s revamping of its methods to use more clinically realistic assessment tools (following patients through the course of their care, a process known as the tracer methodology) instead of its traditional focus on policies and procedures, has helped as well," Mr. Wachter writes.

Most grades not high

Error-reporting systems were assigned a grade of C, in part, because of the flawed notion that reporting has any intrinsic value in and of itself. "Error reporting systems can be powerful tools when the reports are used to improve systems or educate providers," he adds, "and they are particularly valuable when those who submit reports subsequently learn that their submissions made a difference. There are certainly examples of successes; one is hospitals where incident reports do lead to meaningful actions instead of pie charts. Another is the federally supported web-based journal that I am privileged to edit . . . in which interesting reports of errors, submitted anonymously by readers, are accompanied by expert commentaries. But, unlike in aviation, in which reports of near misses help illustrate human factor problems that catalyze action, in health care, errors are so frequent, the number of man-machine interfaces are so voluminous, and we have so much catching up to do that the average patient safety officer would have a full plate for the next five years without a single new report. Reporting is an area in which new models, and far greater resources devoted to translating submissions into action, will be needed."

IT also got one of the higher grades, a B-. Mr. Wachter notes we may finally be nearing a time when institutions and providers will not be seen as credible providers of safe, high-quality care if they lack a strong IT backbone. He also credits the 2004 appointment of David Brailer as a national health information technology coordinator, the recent awarding of $139 million in IT grants by the U.S. Department of Health and Human Services, and the efforts to develop uniform data sharing standards as clear evidence that the federal government is taking the IT issue seriously. A caution he reports from the hospitalist survey is that patient safety and clinical IT are not synonymous, and the greatest danger from IT is that institutions that have invested heavily in it may feel that they have spent all they can on safety.

The lowest grade, D, went to the malpractice system and other vehicles for accountability. Research has demonstrated, he writes, that the nation’s medical malpractice system is terribly broken, doing a poor job of compensating patients, punishing the negligent, and protecting the innocent. The system also demoralizes physicians and is beginning to lead to major access problems in some locations and among some specialists.

Mr. Wachter says he believes the malpractice system’s impact — both positive and negative — on patient safety tends to be overemphasized. Also, the debate over tort reform has centered on caps on pain and suffering awards, which would not fundamentally alter the dynamics of the malpractice system in terms of its influence on patient safety. Switching to a no-fault system for compensating victims of medical errors would alter the dynamics, he says, but has not generated much political support. More promising, he adds, is the notion of "enterprise liability," in which malpractice suits are directed at organizations such as hospitals rather than at individual providers, creating an incentive for system change.

In contrast to malpractice, Mr. Wachter says, the lack of accountability for poor performance does harm patient safety, but also presents some of the most complex issues in patient safety — how to promote a no-blame culture for providers who make innocent slips or mistakes, while holding persistent rule violators or incompetent providers accountable; how to compensate patients for harm without necessarily invoking the heavy hand of tort law; how to hold institutions accountable for allowing unsafe conditions to persist without hammering them in the newspapers or courts when they acknowledge their flaws.

"I believe that we have made virtually no progress in tackling these exceptionally thorny questions in the past five years," Mr. Wachter concludes.

Work force and training issues are given a B in the report, a grade that he says represented a growing appreciation of the importance of work force issues and a few examples of action. He cites the emergence of hospitalists as a specialty as the most positive development for inpatient care, while the situation is less hopeful on the ambulatory side.

Time an issue for PCPs

"Although, ideally, primary care physicians would assume leadership roles in ambulatory safety," Mr. Wachter writes, "few have the time to do so. Moreover, the perceived unattractiveness of primary care careers has led to a marked drop-off in applicants for these positions, and is likely to result in a major shortage in coming years. Finally, few small practices have had the resources to invest in office-based IT, although larger ambulatory systems are proving that progress is possible."

He also is critical of medical education in terms of duty-hour requirements and also the neglect of teamwork and simulation training. "Despite the fact that patient outcomes are increasingly determined by how well teams function under pressure (for example, promptly facilitating emergency coronary angioplasty and stenting in patients with acute myocardial infarction), no teamwork training is yet required of providers, and few medical and nursing schools include it in their curricula," Mr. Wachter explains.

"Even when institutions have invested in such training, it is usually offered in small organizational units [the neonatal ICU, for example], not institutionwide. Simulator training, because it is more resource intensive, is even less well developed," he notes.

Mr. Wachter tells State Health Watch that it is easy to become demoralized over the level of progress in reducing medical errors in the last five years, and it’s important to remember that many of the things that have been accomplished are quite important and will be the building blocks for the next five years.

The next steps, he notes, involving moving from procedural and regulatory safety to the three biggest items that can’t be regulated: educating providers in very different ways, starting in medical schools, change the culture to increase and improve communication; and expanding use of information technology.

Have to get past regulations

"The regulatory part is the low-hanging fruit," he continues. "If the Joint Commission remains the most important thing between 2004 and 2009, we won’t have done the job. We need a different level of effort and a different kind of commitment. There are no simple answers. We have to attack the problem from 15 different directions."

At the level of individual institutions, Mr. Wachter says, the CEO and board must say that safety is the top item in their strategic plan and actually mean it. Then they have to ask their staff what it means to make safety the top priority.

While there are no cookie-cutter approaches that will work for all, he points out, there are general themes that will emerge, including:

1. a recognition that it’s hard to believe an institution can be as safe as possible without computerizing key processes;
2. training for health care workers;
3. reasonable numbers of doctors and nurses;
4. new training methods.

Incentives for institutions to change — which Mr. Wachter describes as too wimpy — need to be beefed up. He says pressures from patients, the news media, and providers can’t be ignored and will lead to change. Investing safety has to be seen has a rational business decision.

Mr. Wachter sees a difference between safety and the quality movement’s ability to provide incentives through pay for performance because there is no easy way to measure safety. "Until there are equivalent safety measures, it will be hard to develop an incentive system," he points out. "But I would have said the same thing about quality five years ago, and that landscape has changed."

According to Mr. Wachter, in the last five years, a momentum has developed that is very impressive because safety is an issue that resonates with providers as well as patients. "There’s a lot of energy and passion being applied to tackle this," he adds.

"The momentum on computerization will only grow. I hope there will be increased federal support for IT development. The biggest question we’ll have to face over the next five years is the extent to which we can really change the culture and change training. A lot depends on the incentives. It may be that we’ll make slow — but not breathtaking — progress," Mr. Wachter continues. "Five years after To Err is Human, we have reached the end of the beginning. Our patients clearly do not think that our work is done. Do we?" he poses.

[To read Mr. Wachter’s article, go to www.healthaffairs.org. Contact Mr. Wachter at (415) 476-5632. E-mail: bobw@medicine.ucsf.edu.]