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Infection control professionals and their clinical partners must lead health care out of a culture of "blame and shame" to reach an unprecedented approach to safety where medical errors are more openly discussed and patients are actually informed of adverse outcomes. That was the consensus recently in Baltimore at a patient safety education course attended primarily by ICPs and other quality clinicians seeking key roles in the nation’s growing patient safety movement.
The Jan. 10-11 meeting was sponsored by the Centers for Disease Control and Prevention (CDC) in Atlanta, the Association of Professionals in Infection Control and Epidemiology (APIC) in Washington, DC, and the Society for Healthcare Epidemiology of America (SHEA) in Mount Royal, NJ. Speaker after speaker drove home these common themes: the need for clinical partnerships, improved tracking and reporting methods, and taking a larger view of medical errors as a systems problem rather than an individual failure.
For example, preventable adverse drug events (ADEs) imperil hospital patients every day and cost billions nationwide. Yet these medication errors are occurring at an alarming regularity — often without even being reported — in part because "it’s no one’s job," said William Jarvis, MD, associate director of program development in the CDC division of healthcare quality promotion. (See "Computers, epidemiology the Rx for drug errors" in this issue.) "Why are [ADEs] so hard to detect? One of the major reasons is that we have a culture of blame," Jarvis said.
"Medicine and society fault the person, the individual associated with that adverse drug event — not the system. Health care workers are concerned about personal consequences. [We must] create a culture of safety. All people make mistakes. We need to improve the systems to help prevent those mistakes from occurring. We need to avoid blaming and punishing the clinicians associated with these ADEs," he added.
Indeed, medication errors are on a recently finalized list of serious adverse medical events that should be reported by the nation’s hospitals. (See "Serious errors that should be reported," in this issue.) Developed by the National Quality Forum in Washington, DC, the list provides one of the first frameworks for state or national medical error reporting systems.
"The project was undertaken at the request of the federal government to see if we could reach an agreement about a list of serious, preventable adverse events that might form the basis for a national, state-based medical error reporting system," said Kenneth Kizer, MD, MPH, president of the forum. "One way of thinking about it is, when a plane goes down or a train derails, you expect to hear about it. You know that something will be done about it. The things that are on this list are health care’s crashes.’"
The list is one of several patient safety initiatives that came out of the landmark Institute of Medicine (IOM) medical error report in 1999. Projecting that between 44,000 to 98,000 patient deaths may occur annually due to medical errors, the report by the Washington, DC-based IOM called for Congress to establish a national patient safety center and require reporting of adverse events by states.1 While critics have charged that the IOM overestimated the death toll, that argument appears to be increasingly moot as patient safety concerns become a given in today’s health care climate.
"Very large numbers of Americans are harmed as a direct result of these problems of quality in health care in the United States," Kizer said. "They don’t all happen in one single disastrous event as happened on Sept. 11th. They happen one or two at a time at facilities across the country — day in, day out. The actual toll in loss of life and morbidity is, unfortunately, substantially greater."
However, while patient safety still has considerable interest, Kizer and several other speakers acknowledged that it has cooled somewhat as a political issue with the change of presidential administrations. "This [list] project was undertaken with the idea that there would be federally funded state-based projects," Kizer said. "The interest in doing that seems to have waned with the current administration, so we are pursuing it with a number of [individual] states who are interested in developing this."
Currently, medical errors are "grossly underreported," and there is no standardization of what little is reported, he said. "There is no way that you can compare the data from one state to another," he said. "The bottom line is that we really have very little reliable or consistent data."
Many critical questions remain to be answered if such a system is to be built, including whether reporting of errors will be mandatory, voluntary, or in some combination. "There is a strong feeling among a lot of folks that these type of events should be mandatorily reported," he said. "There was not consensus on that, and that is an issue that will continue to be debated and played out, probably at the state level. [We’re] talking about reporting, and not necessarily disclosure, because reporting, particularly reporting to public agencies, does not necessarily mean there is going to be disclosure."
In addition, who is going to be the point person who collects and reports the data? ICPs have stepped in fairly strongly, but public safety leaders have consciously avoided assigning a single profession with patient safety responsibilities. "If we collect this information it shouldn’t go into a black hole," Kizer said. "Someone has to work the data and make them meaningful."
Similarly — even amid all the discussions of systems and emphasis on clinical teams — Julie Gerberding, MD, MPH, director of the CDC division of healthcare quality promotion, said "sooner or later somebody is going to have to take charge. Somebody is going to have to have the lead role and say, Yes, I am the person who is ultimately responsible.’" Asked by Hospital Infection Control to clarify that point, Gerberding said, "The person who is in charge should be the person who best qualifies to be in charge. In a lot of cases, that will be someone from the infection control program, but not always. The job should go to the person who can get it done right."
Certainly, health care epidemiology is an essential patient safety discipline — a model of promoting patient safety, she said. "Infection prevention programs will improve by using the tools from other patient safety disciplines," Gerberding said. "Infection control and health care epidemiology have something to offer for patient safety; we have something to learn as well. We can’t really do this in isolation."
For example, the use of rates and benchmarks for infectious events could be applied to noninfectious adverse outcomes, she said. "I think we all agree that infections are a patient safety issue. The models that we used traditionally to measure and respond to infectious diseases are excellent models for measuring and responding to other patient safety factors and [medical] errors. Really, there is an opportunity here for us to be the [catalyst] to improvements that require good science, good measures, and good methodology." While the current focus is on hospital patients, programs eventually will have to expand to ambulatory settings and include health care worker safety issues, she said. "A real culture of safety has to encompass the entire delivery system," Gerberding told attendees. "I think the fact that we are all here indicates that we are ready for that change."
Gigi Dash, RN, MS, CIC, APIC incoming president, said patient safety’s focus on noninfectious outcomes is a logical extension of infection control’s effort to prevent infections. But ICPs must be given the appropriate resources to do the job, she noted. In that regard, the Joint Commission on Accreditation of Healthcare Organizations — in patient safety standards issued July 1, 2001 — clearly states that hospitals must assess the adequacy of resources allocation for patient safety.
"If you have a whole series of expectations but give no money or personnel to that, then nothing is going to [change]," said Robert Wise, MD, vice president for standards in the Joint Commission’s division of research. The Joint Commission also now requires that accredited organizations submit an annual report on patient safety to the facility’s governing body. "We expect this to be such an important program that it gets to the top of the organization," he said. "Now whether the governing body’s eyes get opened or not, that we can’t control. But at least there will be a document that comes to them on an annual basis."
Addressing an area that tilts somewhat toward contradiction, Wise said the Joint Commission requires a hospitalwide patient safety program but not a new structure. "There has been confusion at times," he said. "There was a feeling that now you have to create a patient safety office. That is not what we want to happen. . . . What we really want to do is have an integration and coordination of the existing programs of the hospital. The real issue is having the organization take everything that currently exists in the hospital and get [staff] out of their silos and bring them together. That is really the important point."
Rather than simply responding to medical errors, the hospital must improve patient safety through an ongoing proactive effort, he said. "We are expecting organizations to look at high-risk activities in a proactive way," he said. "To actually, sit down and say, OK. Where might this thing go wrong?’ This is something that, not only in medicine, but people in general don’t do very well. But for the first time, we have said we expect this to happen."
The Joint Commission’s new standards strive to create a culture where medical staff have a willingness to report errors and patients have the right to be informed if their care has an adverse outcome. "They should be informed of the outcome of their care," Wise said. "Our twist is that we have also said that includes the adverse outcomes. If something has happened to patients that is good, you tell them about it. If it is bad, you tell them about that also."
Asked how the Joint Commission will assess whether patients are being informed, Wise said the first expectation is a "dialogue" with the accredited institution. "There is at least a minimum expectation that the surveyor would ask about reviewable sentinel events’ — in other words, [events in which] there really was serious harm to the patient," he said. "Those would be specifically looked at, but we would expect again that it is not to be limited to that. The hospital really has a responsibility to do it much broader. Even though, where the rubber meets the road, [it may] end up being much narrower than that."
Indeed, hospitals and health care providers may have disincentives to relay such information unless there is some assurance they will not be sued. The Joint Commission is lobbying for federal legislation to protect the "root-cause analysis" of sentinel events from plaintiffs’ attorneys. "Until the root-cause analysis is protected from the plaintiff’s attorney, there is going to continue to be reluctance to do this," he said. "We keep getting close; we keep getting [resistance]. Hopefully, we will eventually be successful."
Regardless, other major medical groups have cited ethical concerns in advocating patients be informed of adverse care outcomes. "Both the American Hospital Association and the American Medical Association have clear statements on what their expectations are in ethics that, in fact, this [adverse outcome] needs to be revealed to the patient," Wise said. "We are not the first people who have come out with that."
1. Institute of Medicine Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press; 1999.