Are We Finally Getting Serious About Medical Errors?

Hospitals have made astonishingly little progress, but CMS is forcing the issue

Patient safety is emerging as a top priority among health plans. In a study published in the April Health Affairs, researchers found that the adverse event detection methods commonly used to track patient safety in the United States today miss 90 percent of the adverse events. Using the Institute for Healthcare Improvement’s Global Trigger Tool for Measuring Adverse Events (more on this below), the researchers found at least 10 times as many confirmed, serious events than the standard methods and said that adverse events occurred in one third of hospital admissions.

In another study, published in the New England Journal of Medicine Nov. 25, researchers used the Global Trigger Tool and showed that the rate of patient harm continues to be high despite a decade of effort to improve safety following the publication of the Institute of Medicine’s report, To Err Is Human: Building a Safer Health System, in November 1999.

Common problem

Medical errors are a leading cause of death and injury, causing about 44,000 to 98,000 fatalities annually, the well-known 12-year-old IOM report says.

In the NEJM study, researcher Christopher P. Landrigan, MD, and colleagues showed that in 10 North Carolina hospitals, patient harm remains common and there is little evidence that improvements are being made. The researchers chose North Carolina hospitals because the facilities there had a high level of engagement in patient-safety improvement efforts compared with the national average and extensive participation in statewide safety training programs and improvement collaboratives, the researchers say.

Yet they found no significant change in the rate of harm caused to patients and say that further efforts are needed to monitor health care safety and translate effective safety interventions into routine practice. Given that these studies focused on harm to hospitalized patients, safety experts and health plan medical directors offer proven ideas that the Department of Health and Human Services could adopt to improve patient safety. According to these experts and medical directors, HHS could focus on these:

  • Improving the culture in hospitals to promote patient safety. Hospitals that have success reducing harm to patients have a culture that promotes safety from the top executives to all physicians and all staff.
  • Developing collaborative initiatives in which several hospitals work together to identify and share best practices.
  • Standardizing the delivery of care. Sometimes doing so involves simply using checklists. Other times, setting standard procedures means educating staff and physicians about delivering evidenced-based care.
  • Using tools to identify harm, such as the Global Trigger Tool.
  • Aligning payment incentives and establishing policies not to pay for serious adverse events. Since Oct. 1, 2008, the Centers for Medicare & Medicaid Services (CMS) has not paid for what it defines as nonreimbursable serious hospital-acquired conditions (HACs), which are preventable harms that occur in hospitals. Some health plans do not pay for the 28 serious reportable events (SREs), as the National Quality Forum in Washington, D.C., defines its list of preventable harms that can happen to patients.

Improving the culture. Almost everyone interviewed for this article says the culture of health care must change to promote improvements in patient safety.

“A culture of safety is the necessary context for successful and sustainable safety improvements,” says Diane Pinakiewicz, president of the National Patient Safety Foundation. “Such a culture is patient-centered, grounded in teamwork and accountability, motivated by inspired leadership and characterized by a learning environment where every voice is heard and every worker is empowered to prevent system breakdowns and to correct them when they occur. This is very different from the culture we have traditionally had in our health care system, which has been very physician-centric.

“Since NPSF’s founding in 1997, we have seen significant transformation in the culture of medicine as the patient safety work has been embraced, but we are still a long way from where we need to be. One of the keys to expediting these changes lies in reform of the payment system so that it gives incentives to providers to do the work necessary for the delivery of safe, high quality care and the culture that supports it.”

Barbara Crawford, RN, vice president for quality and regulatory services at Kaiser Permanente Northern California, agreed. “Health plans can use their contracts with hospitals to facilitate the safety culture,” she says. “Your culture can affect all areas of performance, not just harm events. The airline industry has done a lot of work to improve crew management and build teams that work together and foster a culture where any team member can speak up when something is wrong and feel comfortable when speaking up. Those things are at the heart of a good safety culture. Health plans should ask hospitals what they are doing to ensure that there is a culture of safety, and a culture of teamwork that ensures that anyone in the house can speak up if they see a problem.”

Establishing a culture that fosters patient safety can be challenging, however, says Paul M. Schyve, MD, the senior vice president for health care improvement at the Joint Commission. “An organization needs to have a culture that says, ‘Number one, patient safety is really important, and number two, we have to take the time to fix this.’ What happens, though, is that a hospital will put a checklist in place, but physicians will say, ‘I don’t think I need to follow that checklist. It won’t help because I don’t have this problem.’ But too often, surgeons and other proceduralists operate on the wrong patient. Somewhat more common is doing the wrong procedure or operating on the wrong site, such as the left knee instead of the right knee.

“Here’s another example,” he adds. “For years, we’ve known that infections spread if you don’t wash your hands in between patients. Every doctor and nurse is trained to wash hands between patients and yet too often, it doesn’t happen.

“Having said that, it’s also clear that all doctors, nurses, pharmacists, or hospital administrators want to do the right thing, and they’re in this business to help people get better,” Schyve adds.

“Patient safety failures don’t happen because people have decided safety is unimportant. If anything, medical providers are more aware of the need to improve patient safety and every day they are struggling to do something about it. The challenge is what do we do?”

Developing collaborative initiatives. One way to improve patient safety is to have hospitals and providers work collaboratively. The Hawaii Medical Service Association (HMSA), a health plan affiliated with the Blue Cross & Blue Shield Association, developed a collaborative program for 17 island hospitals in 2000 and has had significant success in improving patient safety, says John T. Berthiaume, MD, HMSA’s vice president and medical director of care management.

“In our pilot year, we had executives and the quality folks from 6 of our 17 participating hospitals,” he says. “Now we have all but two of the islands’ hospitals participating and have seen improvements in some areas and less so in other areas. Linking cause and effect is always difficult but we have measured procedural complications and given hospitals feedback on some 20 surgical procedures and two obstetrical procedures for the past seven or eight years. Our data show that in the Medicare population we have the lowest procedural complication rates among all 50 states and the District of Columbia. We don’t think that’s a coincidence.”

In addition, HMSA participates in a large national collaborative involving hospitals organized by Premier, a performance improvement alliance of more than 2,500 hospitals. In November, Premier reported that the 200 hospitals in 34 states that participate in the QUEST: High Performing Hospitals national collaborative were outperforming national averages.

By outperforming the national averages, Premier estimated that the participating hospitals had saved 22,164 lives and reduced health care spending by $2.13 billion. The observed mortality rate in participating hospitals was 5 percent lower than the expected mortality rate for nonparticipants, Premier says.

The University of Michigan Health System is part of a collaborative to improve patient safety, the Michigan Surgical Quality Collaborative, sponsored by BlueCross BlueShield of Michigan and led by Darrell Campbell Jr., MD, the chief medical officer at the university. “We have developed a standardized quality outcomes initiative for surgery. Using this system we find out which hospitals have the best results. We then determine what best practices are accounting for the good results,” he explains. “Then we distribute that information to the other hospitals. The idea that we can all learn from each other, no matter how big or small the facility, is a transforming concept in health care.”

Blue Cross & Blue Shield of Alabama collaborates with the Alabama Hospital Association, the Medical Association of the State of Alabama, and the Alabama Quality Assurance Foundation, among other organizations, in a group called the Quality Forum. The forum seeks to improve care by having hospitals adopt practices that enhance patient safety and quality outcomes, by having network hospitals adopt best practices, and by collecting statewide data for benchmarking, says Eddie Harris, vice president for network contracting.

As a result of participating in the forum, Alabama hospitals have reduced the incidence of hospital-acquired infections by 20 percent since 2004, he adds. In addition, almost all Alabama hospitals participated in the IHI’s 5 Million Lives Campaign, and 70 percent of the state’s hospitals exchanged mortality data with IHI each month, he adds. The campaign was a voluntary initiative to protect patients from 5 million incidents of medical harm from December 2006 to December 2008.

Establishing procedures to standardize the delivery of care. Just as collaboratives allow participants to standardized the use of best practices, Kaiser Permanente is establishing standards for many of the procedures in its hospitals, says Crawford. “When I started in this new role in 2005, we had a 21-year-old die in one of our hospitals because of a medication error, and that profoundly affected me, the staff, and the leadership of that hospital,” she says. “After doing a root-cause analysis of the event, we found that the medication that young man was given was not on the list of high-risk medications that every hospital maintains. At the time we had 16 hospitals, and every one had a different high-risk medication list. We asked, ‘How could it be that every hospital has a different list of high-risk medications and some very high-risk medications are not on these lists?’ So we created one list for all hospitals and this is the list we use now.

“We aim to put in place a process to reduce variation and to make it difficult for nursing and pharmacy staff and physicians to do the wrong thing,” she continues. “To do that, the equipment had to change so we couldn’t connect the wrong medication to a certain piece of equipment.

“In addition, the nurses recommended that we have a quiet zone around the medication machine so that when they were providing medications, they were in a silent area,” Crawford reports. “They also wore a sash that says, ‘I’m delivering medications. Don’t bother me.’ And no one bothered them or distracted them while they were delivering medications. That idea came from front-line staff and that program is now making it’s way across the nation in Kaiser and non-Kaiser hospitals.

“Since 2006 and up until a few months ago, we had no deaths from high-risk medication errors,” Crawford notes. “But a few months ago we had a death where a medication that is considered high risk was given, and we are evaluating that event to learn how it happened. It wasn’t the wrong patient, the wrong medication, or the wrong route. It was more complicated than that.”

Using data mining tools. Kaiser also uses the IHI Global Trigger Tool to identify when patients are harmed. Crawford believes all hospitals should use the tool to manage the care they deliver and all health plans should monitor trigger tool reports.

The IHI says, “The Global Trigger Tool for Measuring Adverse Events provides an easy-to-use method for accurately identifying adverse events (harm) and measuring the rate of adverse events over time. Tracking adverse events over time is a useful way to tell if changes being made are improving the safety of the care processes. The Trigger Tool methodology includes a retrospective review of a random sample of patient records using ‘triggers’ (or clues) to identify possible adverse events. Many hospitals have used this tool to identify adverse events, to measure the level of harm from each adverse event, and to identify areas for improvement in their organizations.”

“The Global Trigger Tool allows you to mine data for harm, as opposed to just having self-reported events,” Crawford explains. “Health plans should ask each hospital: Are you using the Global Trigger Tool? Are you reporting harm events? These questions lead to deeper conversations.

“We use the trigger tool for certain frequently used high-risk medications, such as insulin and heparin,” Crawford says. “After using the tool, we adjusted our protocols for those two medications. At about that time, Dennis Quaid had his twins in Cedars Sinai Hospital and they had a mistake that would not have happened here because we adjusted our protocols to prevent that kind of error.”

In November 2007, Quaid’s 10-day-old twins twice got an adult dose of heparin at Cedars-Sinai Medical Center in Los Angeles.

“Now we are working to get the trigger tool linked to our electronic medical record to automate the tool and not have to rely on self reports of errors,” she adds. “We also audit for compliance with our high-risk medication program, and in the last several years we have done almost 89,000 observational audits, which involve watching the front-line nurses and physicians when they administer high-risk medications.

“These audits are independent double checks on medication calculations,” Crawford says. “If a nurse has to adjust a dose, then we have one nurse do the math and then a second nurse does the math and then they compare the results. The calculations have to be done independently. Those audits are required if you’re going to be safe.

“If there are errors, the nursing staff and the nurse leadership report the results to the quality department in real time and they do so in a nonpunitive way,” she adds. “We don’t want to drive errors underground. We want people to feel safe to speak up.”

Aligning payment incentives and not paying for errors. HMSA in Hawaii gives a bonus to the hospitals that get high scores on safety measures. “Those hospitals that do well get a 2 percent bonus at year-end and the percentage is based on the overall payments HMSA makes in the year on its commercial business lines,” Berthiaume says. “Over the next three years we hope to increase that percentage to 5 percent, 10 percent, and 15 percent while also continuing to measure our results.” Such pay-for-performance programs are common and are likely to spread, according to the patient safety experts.

In addition to an increased focus on P4P, states and CMS have instituted policies stating that they will not pay for errors or what the National Quality Forum defines as serious reportable events (SREs). NQF lists 28 SREs on its Web site. CMS lists what it calls “nonreimbursable serious hospital-acquired conditions” (HACs), which are preventable harms that occur in hospitals.

In 2003, Minnesota became the first state to require reporting SREs and 10 other states have since agreed to do so. Health plans, such as HealthPartners in Minnesota, have policies not to pay for SREs. Often, SREs are called “never events,” but NQF does not use this term.

In 2004, HealthPartners implemented a policy not to pay for SREs, and the policy has had a sentinel effect on hospitals, says Babette Apland, senior vice president for health and care management at HealthPartners. “The policy has been an important signal to hospitals about the importance of safety and the need to avoid never events,” she explains. “It moved Minnesota hospitals to a place where they are systematically avoiding billing for never events and it’s part of an overall strategy to promote patient safety.”

Minnesota’s Department of Health Web site posts extensive data on the quality of hospital care and the frequency of SREs each year. “We were the first state to enact the Adverse Health Care Events Reporting Act, which requires hospitals to report all incidences of never events and it also requires them to investigate each never event, report the underlying cause, and take corrective actions,” Apland says. “While it’s true that we have not seen a dramatic decrease in the number of never events nationwide and that result is very disappointing, I believe that explicitly and intentionally reporting them is an important step in eliminating them.” (See “Minnesota’s experience” below.)

Minnesota’s experience

Between Oct. 7, 2009, and Oct. 6, 2010, a total of 305 adverse health events were reported to the Minnesota Department of Health, a slight increase from the 301 events in the previous reporting cycle.

Overall, the monthly average number of events declined from 30 in the first quarter of the year to 21 in the last quarter. Much of this decline was driven by a reduction over the year in pressure ulcers, which dropped from 14 per month in the first quarter to eight per month in the fourth quarter. Retained foreign objects also declined over the year, falling from more than four events per month in the first quarter to two events per month in the fourth quarter. Other event categories stayed roughly constant across the year.

Average monthly events by quarter

Source: Division of Health Policy. Minnesota Department of Health. “Adverse Health Events in Minnesota. Seventh Annual Report.” January 2011.

Kaiser is working on a similar policy, says Crawford. “Believing that when harm is identified, patients should not be charged, we have been working on a national do-not-bill policy for never events,” she explains. “It is complicated to implement because the quality department might not learn of a harm immediately after it occurs. If it’s not reported to us directly, we might see it in the patient record or sometimes the first person to see it could be a hospital coder.

“If the coder doesn’t know to send it to us, it might go through as a bill. So we need to ensure that we have good integration between the coders, the quality and risk department, and the billing folks to make sure that we identify those incidents of harm and then make sure billing does not charge the patient.”

Blue Cross & Blue Shield of Alabama does not pay hospitals for adverse events at inpatient facilities.

Given the success these strategies have had, it is likely that CMS will introduce similar efforts in the coming weeks or months. And while each of these strategies is likely to improve care incrementally, when they are taken together it is possible that they could have a significant effect on reducing patient harm.

Joseph Burns is a health care writer in Falmouth, Mass. Contact him regarding this article at [email protected]

Common adverse-event reporting systems inadequate to the task

Recent research shows adverse events occurred in one third of all hospital admissions and the voluntary, sentinel event, and “never event” reporting systems that are common in hospitals today (including those mandated by states and other oversight bodies) missed 90 percent of the adverse events.

“Hospitals that use such methods alone to measure their overall performance on patient safety may be seriously misjudging actual performance,” the researchers write in the April issue of the journal, Health Affairs. “Reliance on voluntary reporting and the Patient Safety Indicators (from the federal Agency for Healthcare Research and Quality) could produce misleading conclusions about the current safety of care in the U.S. health care system and misdirect efforts to improve patient safety.

The Institute for Healthcare Improvement’s Global Trigger Tool for Measuring Adverse Events found at least 10 times as many confirmed serious events than these other methods, the researchers report.

Although no accepted gold standard exists for the detection of adverse events in hospital patients, the Global Trigger Tool is a well-developed, well-documented, and publicly available tool, the researchers write. Its use in hospitals has been increasing, but it could increase further with appropriate guidance from policy makers, they add.

Source: Classen DC, Resar R, Griffin F, Federico F, Frankel T, Kimmel N, Whittington JC, Frankel A, Seger A, and James BC. ‘Global trigger tool’ shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff. 2011;30(4):581-589.

Health plans should track patient harm continuously

Christopher P. Landrigan, MD, MPH, believes one of the most important findings from the research he and his colleagues did on patient harm in 10 North Carolina hospitals was that they learned it is important to measure rates of harm over a number of years. The director of the Sleep and Patient Safety Program at Brigham and Women’s Hospital in Boston and research director in the Children’s Hospital Boston Inpatient Pediatrics Service, Landrigan says the Global Trigger Tool for Adverse Health Care Events can be used to monitor rates of harm reliably and continuously over several years.

“For example, if these data are collected monthly or quarterly over a two-, five-, or 10- year period, health researchers could evaluate changes over time to determine if hospitals are making improvements,” Landrigan says.

The tool was developed by the Institute for Healthcare Improvement in Cambridge, Mass.

In an interview, Landrigan says he was surprised to find that patient harm has not been measured consistently. “Tracking patient harm hasn’t really started to happen in earnest yet,” he says. “We have many measures of quality that health plans use to determine whether hospitals and other providers are performing well, but we don’t have an overall measure of safety that is used consistently.

“One thing that should happen on a consistent basis is that federal entities such as Medicare and Medicaid as well as individual health plans could require that these things be monitored in a standardized fashion over time,” Landrigan says. “Once we start to do that we will have a much better sense of whether what we are doing is effective or not. And then we can offer incentives for better performance more effectively.”

Landrigan and his colleagues reported that some interventions, such as computerized physician order-entry (CPOE) systems, limiting residents’ work hours, and evidence-based care “bundles” such as infection control bundles to reduce central venous line infections have reduced errors, but many of these interventions have not been evaluated rigorously or implemented reliably on a large scale.

“Part of the problem is that we need to invest more in the things that we know work but that have not been well disseminated yet, such as CPOE,” he adds. “For 15 year, studies have been showing that CPOE is an effective tool for reducing medication errors, but recent research shows that only about 17 percent of hospitals nationwide have adopted it.”

Christopher P. Landrigan, MD, MPH

The Global Trigger Tool is an effective way to discover safety faults, says Barbara Crawford, RN, vice president for quality and regulatory services at Kaiser Permanente Northern California.

A culture of safety has not been characteristic of the health care system, says Diane Pinakiewicz, president of the National Patient Safety Foundation.

Physicians sometimes resist simple but effective safety measures, says Paul M. Schyve, MD, a senior vice president at the Joint Commission.

“Health plans should ask each hospital: Are you using the Global Trigger Tool? Are you reporting harm events?”
—Barbara Crawford, RN, vice president for quality and regulatory services at Kaiser Permanente Northern California