This article appears in the December 2012 issue of HealthLeaders magazine.
Reporting and analyzing every error that almost harmed a patient may be an expensive hassle. But for Paula Holbrook, RN, BHS, JD, CPHRM, associate director of risk management and clinical risk manager for the University of Kentucky Healthcare's A.B. Chandler Medical Center, it's just as valuable for preventing harm as reviewing those mistakes that did hurt patients.
Holbrook and her team want to capture the "near misses, the little things that don't reach the patient," she says. "They signal the need for change because of a potentially or actively defective process." Near misses happen more frequently, and thus are goldmines for process improvement.
Here's one example, she says. "A patient with the same last name as another patient is taken to the operating room and is nearly at the point of anesthesia induction when someone reports, 'Hey, we took the wrong patient.'
"It didn't result in harm, but we want to know how this happened, and as soon as I got the call, we mobilized people and analyzed it quickly. It gives us an opportunity to intervene early and prevent these hazards—even small ones—from becoming losses. You want to get this before you have that 'Oh my God' moment.' "
In this case, Common Formats, an electronic tool developed by the Agency for Healthcare Research and Quality, helped Holbrook and her team identify failure points in communication and "the breach of the patient identification process at several points that didn't stop the line until it got nearly to the point where we put the patient to sleep. That was a big deal to us."
The 600-bed hospital is working with its patient safety organizations to use Common Formats, a taxonomic decision tree that allows providers to categorize each such event in one of three buckets—near misses, unsafe conditions, or actual patient harm incidents—and then drill down to what might have led to the circumstance and where it occurred.
Nine types of events are captured, including those involving blood products; devices, medical or surgical supplies, and health information technology; falls; healthcare-associated infections; medications; perinatal care; pressure ulcers; surgery or anesthesia; and venous thromboembolism.
The system also grades the level of harm to a patient, visitor, or staff member, as to whether it caused death, severe permanent harm, permanent harm, or temporary harm; required additional treatment; caused emotional distress or inconvenience; or did not cause harm.
The voluntary information collected by the PSOs is protected from discovery, litigation, or punitive action under the Patient Safety and Quality Act of 2005. The data is also stripped of details that would link these incidents to specific hospitals or individual patients.
"Such Common Formats provide the opportunity to define patient safety events in a way that's scientifically sound and consistent from place to place to allow people to report events in the same way," says William B. Munier, MD, AHRQ's director of the center for quality improvement and patient safety.
Today around the country, "what's defined as an adverse event in one hospital might not be defined as one in another. With the Common Formats, we can standardize reporting, improve the value of information collected, and, through feedback, constantly improve the formats themselves," he says.
Nonidentifiable information from the PSOs will be rolled up into a Network of Patient Safety Databases clearinghouse starting in 2013, which will enable reviewers to see how an event that almost happened once in one hospital, or actually did happen, may be much more common than anyone knew.
About 20 of the nation's 78 PSOs in 30 states and the District of Columbia are now collecting data from hundreds of hospitals, and many vendors are now incorporating the Common Formats into their electronic software, Munier says.
The tool provides a decision pathway that allows the person reporting to detail specifics about where and how the mistake was made—for example, why an expired drug wasn't removed from a pharmacy refrigerator according to protocol, or the realization that half of patient falls that did not result in harm occurred next to the toilet.
Julie Cerese, RN, MSN, is vice president of performance improvement for UHC, a Chicago-based PSO alliance with 116 academic medical center members and more than 250 of their affiliate hospitals, 50 of which have elected UHC as their performance improvement PSO. She notes that a severe adverse event happens rarely at a hospital, and once the investigation and evaluation is concluded, it may be viewed as an isolated event when, in fact, other organizations are experiencing similar problems.
But as UHC collected reports from its member hospitals, "we discovered that retained guidewires—a very obscure event—happened 26 separate times" over the course of a few years. Each organization may have identified the cause of its own incident, not realizing that other organizations had other root causes.
"We were able to understand the breadth of potential or latent errors that led to this problem and share that information," Cerese says.
Now in version 1.2, the Common Formats tool, under development for six years by AHRQ, is also geared to enable hospitals to report problematic systems or conditions in the same way—whether they caused harm or just had the potential to—so that hospitals everywhere can learn from the experience.
"The drafters of the act said that PSOs should use common definitions for reporting. Such Common Formats provide the opportunity to define patient safety events in a way that's scientifically sound and consistent from place to place to allow people to report events in the same way," says Munier.
To date, only about 26 states have requirements for adverse event reporting systems, and different states want different types of events reported. That makes it difficult to understand the scope of the problem and whether providers are improving, especially when for each hospital a serious reportable event is extremely rare.
Some use a full or modified version of the National Quality Forum's list of 28 Serious Reportable Events. Only Pennsylvania, through its Patient Safety Authority, collects information on near misses.
A July report from the Office of Inspector General, one in a series, detailed the wide variation in the way hospitals report. Investigators reviewed a sample of patient records and discovered that 60% of the adverse and temporary harm events it found occurred in states that had reporting systems, "yet only an estimated 12% of events nationally met state requirements for reporting ... [and] that hospitals reported only 1% of events."
Compounding the problem, the OIG report said, most of the unreported events were not identified by hospitals' internal incident reporting systems.
In May, the 1,491-bed Montefiore Medical Center in New York began using Common Formats to count near misses and is already seeking ways to change processes to avert patient harm, says Jennifer Lapponese, BSHA, systems administrator for Montefiore's Common Formats program.
For example, the hospital has realized that some patients who typically use a walker at home are at increased risk of in-hospital falls after their walkers are stored for safekeeping during their stay. "It's like their right arm is missing," she says. The hospital now asks patients on admission if they're accustomed to using a walker at home. If so, the hospital may issue them a walker to help them get around and use the bathroom without falling.
As part of the push to identify near misses, Montefiore's pharmacy department is examining all of its processes, such as how its decentralized medication supply dispensers are managed, Lapponese says.
"It could be the Pyxis drawer was empty when you went to get a medication," she says. Some staff may not understand why that's a near miss, she adds, so she asks them, " 'What happens when your patient is coding, you go into the Pyxis machine that's supposed to have 10 vials of atropine to save someone's life, but the drawer is empty?' Then it becomes an incident."
Lapponese encourages floor staff to report every near miss they can. "I say, 'When you report a near miss, that's you documenting that you're doing your job.' "
Now, the Common Formats system is capturing near misses that may never have been fully appreciated before, says Montefiore's patient safety officer, Jason Adelman, MD, MS.
For example, recently a patient with a pacemaker was sent downstairs for an MRI, which could have caused the pacemaker to misfire. "Thankfully the MRI staff caught it in time ... but it was much closer to happening than we were comfortable with." Now, processes are in place to make sure that can't happen again.
Adelman says the data is revealing something that has surprised Montefiore leadership: that 10% of reported events are near misses. That is prompting a campaign to increase near-miss reporting even more in hope of learning how processes might be improved.
Karen P. Zimmer, MD, MPH, FAAP, medical director of the ECRI Institute PSO, which has 700 hospitals across the country, says "regardless of what the outcome is, if there's a broken process, there's a broken process. We often say the near misses are wonderful lessons to learn from because they're free. And they help us learn what safeguards prevent an incident from reaching the patient," and share that with other hospitals.
Another benefit of using Common Formats is how it clarifies what hospital staff should report, especially in the case of near misses or incidents that are seen as just part of the downside of caring for very sick patients, such as an unintended drug side-effect.
Christina Tickner, RN, MSN, CPHQ, interim director for the Los Angeles County Department of Health Services Quality, which oversees quality for four hospitals, including LA County USC, gave an example of how double-checking a patient's file may turn up a medication that shouldn't be there. "They caught it. But it prompts a look back at the process, whether it's a pharmacy issue or an input issue."
At other organizations, staff may not report that incident because it was caught, she says.
Holbrook of the University of Kentucky echoed that view.
Before Common Formats, "we didn't have a very good system for reporting. It was hit or miss," and frontline staff didn't have a good understanding of what they should report.
"It might never escalate to my level, and we would never have taken action. It might have just been back chatter in the hallway, like, 'We nearly operated on the wrong patient. Well, you know, if you don't tell, I won't tell. And it would have been swept under the rug."
Of course, moving frontline providers to this reporting system has its obstacles, one of which is cost and hours spent in reviewing them.
"It requires resources to look at this data, to put it in these buckets and analyze it," Tickner says. "And that's where we find the greatest challenge. It takes time and people. But if you prevent events from happening to patients, that's the tradeoff."
She added that despite the county's encouragement for providers to report as much as possible, "that's not to say that the message has gotten out. I'm not claiming we're saturated with people who are willing to report. It takes time and judgment for people to not think that an event was not important because it didn't reach the patient, but that it still can be a significant event."
Holbrook says she now spends "hours logging and analyzing and classifying" 200 or more reports each week, and doing root-cause analyses involving serious issues, including those that don't harm a patient. But for her, the effort has been worth it. "We're not talking about just lost life, limb, and function, and the financial losses and the cost of litigation that preventing these events avoids; we're also talking about the secondary losses and impact on healthcare providers who may suffer grief, lose a license, suffer posttraumatic stress disorder, or not be able to work with certain patients anymore," she says. "If you don't use Common Formats and you don't actively support, advocate, or encourage and reward incident reporting, you're going to have mistakes blow up in your face," Holbrook says.
Reprint HLR1212-9
This article appears in the December 2012 issue of HealthLeaders magazine.