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Are patients safe now? Reviews mixed on progress

There's been a lot of talk and even some action. But safety advocates say people are still dying and much more remains to be done.

By Andis Robeznieks, amednews staff. Oct. 13, 2003.

Patient safety experts, used to toiling away in near obscurity, were both blessed and cursed by the Institute of Medicine report, "To Err is Human," claiming that up to 98,000 people die each year because of medical errors.

The resulting publicity from that 1999 report brought new faces to the movement, and an infusion of cash as business groups and the government pitched in to study the problem. But it also brought heightened scrutiny and a push for quick change in institutions used to moving slowly.

Anatomy of a movement
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How successful medicine has been at instituting changes that increase patient safety is heavily debated. Experts agree more can be done. But when they discuss progress to date, they take divergent paths, with some celebrating incremental steps and others wanting measurable results sooner rather than later.

Donald Berwick, MD, president of the Boston-based Institute for Healthcare Improvement and a member of the IOM committee that wrote "To Err is Human," is disappointed by what he sees as a lack of progress.

"Studies continue to show problem rates nearly as high as those that started our concerns," he said.

Dr. Berwick recently stirred the pot by making it known he has seen no evidence that health care is safer. Despite the harshness of his message, the feedback, he said, has mostly been positive.

"I received an e-mail from the chief medical officer at a hospital who said, 'We want to take this more seriously. What can we do to be more aggressive?' A lot of people have suggested to me that we [in the medical profession] have not made enough progress."

Another common criticism of the patient safety movement is that the focus on hospitals tends to ignore the setting where most health care takes place: the doctor's office. Most notably, the American Academy of Family Physicians has criticized the hospital-based safety standards put forth by The Leapfrog Group, a coalition of major employers, as not having much relevance to primary care doctors.

Dr. Berwick does not take issue with hospitals receiving most of the attention to date because that's "where the deaths are," where the sickest patients receive the most hazardous therapies and treatments, and where there is often centralized leadership with the power to make changes. But he added that the focus is starting to shift to the outpatient setting where the error rate is also dismal.

"We do have new data on hazards and errors in outpatient care. To no one's surprise, they're showing error rates that are higher than hospitals, but the rate of injury is much, much lower."

How to measure?

Yet not everyone is as pessimistic. "I respectfully disagree with Don Berwick," said David Nash, MD, professor of medicine at Philadelphia's Jefferson Medical College of Thomas Jefferson University. "Don is right that there is little published evidence that errors have gone down. Though the dramatic movement Don calls for has not occurred, we're making incremental progress."

Dr. Nash said encouraging signs include the appointments of hospital patient safety officers, increased use of computerized physician order entry and the addition of patient safety instruction at medical schools. Studies indicate half of all hospitals are either implementing or considering CPOE.

In addition, some patient safety officers are rising to the top level of hospital leadership. Barbara Balik, EdD, RN, was promoted from her job as a patient safety officer at United Hospital in Minneapolis to executive vice president, safety and quality systems, of Minnesota's Allina Hospitals & Clinics.

Under her leadership, Allina -- which owns or manages 13 hospitals and 42 clinics -- has instituted a patient fall-prevention program, conducted a study showing how medication errors in the Allina system led to 26,000 extra patient days and $15 million in direct costs in 2001, and provided continuous patient safety education.

At Allina, Dr. Balik said, the key phrase is "everyone plays," and all top-level officials -- even those in finance and human resources -- are instructed on patient safety. "There were some questions of 'I'm not sure how this fits with my role,' but there were no questions about it being important."

Dr. Balik, however, noted that there are few other safety directors who serve at the executive level. "I've had trouble finding a peer group."

Dr. Balik said she thought progress was being made, but "the issue for us is how fast can we make the obviously complex changes we need to make."

Lucian Leape, MD, adjunct professor of health policy at the Harvard School of Public Health in Boston and a patient safety pioneer, said the proof Dr. Berwick seeks exists, but finding it would be expensive and would require measuring thousands of factors that contribute to medical errors.

"I think we have inductive proof: It has got to be better if everyone is working on it," said Dr. Leape, who was also a member of the IOM committee that wrote "To Err is Human." "Every hospital in the land is doing something with patient safety."

Getting no satisfaction

But Dr. Berwick isn't satisfied. He acknowledged there is a lot going on, but instead of "activity reports," he wants to see evidence that interventions have made health care safer.

Both doctors agree, however, that change is not occurring quickly enough.

"It's not enough and it's not fast enough," Dr. Leape said. "We haven't gotten the patient safety movement into high gear yet. What bothers me most is how hospital and medical leadership are dragging their feet."

Among Dr. Leape's complaints is the failure of hospital leadership to adopt a nonpunitive culture concerning the reporting of medical errors.

"You don't have to be a professor of psychology to know that people aren't going to do things that make them look bad," he said, adding that failure to follow up on error reports or take seriously staff ideas for improvement also has slowed progress.

"When you make reporting safe and make it worthwhile, you get more than you can handle," Dr. Leape said. "Every report is a potential treasure."

Another factor in the slow improvement has been the piecemeal approach to instituting changes. Sanford Kurtz, MD, chief medical officer of the Lahey Clinic in Burlington, Mass, told the American Assn. of Health Plan's recent medical management forum in Chicago, "Our health care is based on random acts of improvement, not a systematic approach to improved health of the population."

Dr. Berwick agreed and offered a solution: Start from scratch and create new operating rooms and other health care settings specifically designed to cut variables, increase teamwork and communication, and, in the process, reduce errors.

Just as there are "centers of excellence" for cancer care and spinal cord injuries, he thinks there should be similar institutions for designing health care settings.

"We need to put everything on the table instead of dealing with changes one at a time," he said. "I don't see why we can't have health care that is 100 times safer than we have today. ... This is nothing less than social change and taking an industry with deeply ingrained beliefs and habits and having it redirect itself."

Dr. Leape called for the creation of nonpunitive error-reporting systems, government subsidies to finance implementation of CPOE, and systems that "identify doctors before they hurt people."

"We can only do that if we recognize what we're doing now is not enough," he said. "My favorite saying is: 'We made this mess. We can fix it.' "

ADDITIONAL INFORMATION:

Anatomy of a movement

The patient safety movement was boosted by response to the 1999 Institute of Medicine report "To Err is Human." But it has early roots among anesthesiologists who created one of the first patient safety foundations.

1954: "A Study of the Deaths Associated with Anesthesia and Surgery," published in the July Annals of Surgery.

1961: "The Role of Anesthesia in Surgical Mortality," published in the Oct. 21 Journal of the American Medical Association.

1982: ABC's "20/20" airs "The deep sleep: 6,000 will die or suffer brain damage," April 22.

1984: Anesthesia Patient Safety Foundation created.

1989: U.S. Agency for Health Care Policy and Research created. Reauthorized Dec. 6, 1999, as the Agency for Healthcare Research and Quality.

1991: "Incidence of Adverse Events and Negligence in Hospitalized Patients: Results of the Harvard Medical Practice Study I," by Troyen A. Brennan, MD, Lucian Leape, MD, and colleagues, published in the Feb. 7 New England Journal of Medicine.

1994: "Error in Medicine" by Dr. Leape, published in the Dec. 21 JAMA.

1995: Institute for Safe Medication Practices sends letter to hospitals instructing removal of potassium chloride from patient care areas.

1996: The National Patient Safety Foundation created by the American Medical Association, CNA HealthPro, 3M and contributions from the Schering-Plough Corp.

1998: Persons United Limiting Substandards and Errors in Health Care (PULSE) founded by survivors of medical errors and adverse events.

1999: "To Err is Human" published by the Institute of Medicine.

2000: Business Roundtable launches Leapfrog Initiative to encourage large employers to reward health plans and hospitals that make breakthrough improvements in patient safety and quality.

2001: "Crossing the Quality Chasm" published by the Institute of Medicine.

2002: Joint Commission on Accreditation of Healthcare Organizations and the National Quality Forum initiate the John M. Eisenberg Patient Safety Awards.

2003: Patient Safety and Quality Improvement Act introduced into U.S. Congress. It has been approved by the House of Representatives and is awaiting Senate action.

Start in the office

Much of the patient safety movement to date has focused on errors or adverse events that occur in hospitals.

But there appears to be an effort to engage primary care physicians in the movement. More research is being done to find where improvements are most needed, but some experts have suggestions for office-based physicians who want to assess patient safety.

James Mold, MD, professor and director of research at the Dept. of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, recommends doctors do a self-audit of their practices by keeping a log of all errors (big and small) and instructing their staff to do the same. "If they're really brave, they can ask their patients to do the same thing. The general principle is: We make a lot more errors than we think we do."

After two weeks, he said, review the log, see where problems exist and decide if outside help is necessary.

Errors can be as small as not making a note of every visit in a patient's chart, not documenting prescription refills or mishandling test results, Dr. Mold said. Consequences are usually negligible, but he has heard of a case where results of an abnormal mammogram were lost and a woman with a potentially curable cancer was not called.

Bruce Bagley, MD, medical director of quality improvement for the American Academy of Family Physicians, said the normal pressures doctors face are the biggest obstacles to improving office safety.

"They're working so hard in a system that doesn't properly reward what they do well," he said. "A change takes energy and resources, and they're resource and energy poor right now."