Utahns who want information on their local hospital's patient safety record are out of luck. State health officials consider information on serious adverse events "privileged," bucking a growing national trend of making such information public.
And despite offering juicy enticements — confidentiality and no penalties for problems — total reports from Utah's 53 hospitals and 30 surgical centers average a paltry 35 "sentinel events" a year. Those, by definition, are the ones that kill or cause permanent major injury.
The facilities need not tell the state about lesser events, even those that are life-threatening or extremely costly.
Nobody, including patient safety experts, believes that number comes close to a real reckoning of sentinel events.
Utah Department of Health patient safety pointwoman Iona Thraen says the voluntary self-reports capture about one-tenth of actual cases. A national patient safety assessment by the Institute of Medicine (IOM) estimates Utah hospitals would average about 300 deaths a year caused by "medical harm," which includes both human error and unforeseen events that complicate care or hurt patients in the course of treatment.
Calling the state's reported number "grossly low," Dr. Brent James says a recent study by the IOM estimates a single high-complexity hospital should have reported more than 130 such events in a single year — about 30 times what's being reported.
"Health care and hospitals are between the fourth and sixth cause of preventable death in the United States — responsible for more deaths than the entire AIDS epidemic, or breast cancer or all motor vehicle accidents in a year," says James, Intermountain Healthcare's vice president of medical research.
Still, hospitals and their staffs "do far more good than bad. It's just that treatment powerful enough to heal can also harm, and it's often a thin line between," says James, also executive director of the Institute for Health Care Delivery Research, and who helped produce the IOM's unnerving 1999 "To Err Is Human" report.
Despite lack of reporting, Utah is considered a patient safety leader and innovator. And this, too, is perplexing but true: Those hospitals and surgical centers that report the most sentinel events may provide the best care. At least they're aware of their patient safety issues, says Dr. Jonathan Nebeker, associate director of the SL Informatics Decision Enhancement and Surveillance Center at the VA medical center.
Utah health experts defend the state's vow of silence in exchange for information, even though that information's not forthcoming. "We want to create a culture of safety for patients, but we also want to create such a culture for the care providers," Thraen says.
Without that, says James, problems — and patients — get buried.
Tracking patient safety is tricky for many reasons, not just the lack of reporting.
Experts use some terms — sentinel events, adverse events, patient harm — interchangeably or in completely different ways. They refer to "adverse drug events" and "never" events (because they should "never" happen) and "sentinel" events, but they don't all categorize them the same way. There are errors and "things that just happen, nobody's fault."
And they talk of "patient harm" that doesn't actually hurt anyone. Ask for specifics and you may not get any, thanks in part to patient privacy laws, fear of lawsuits and differing interpretations of those aforementioned words. It's complex and the confusion doesn't seem confined solely to the public, which gets limited information.
But those experts agree on one thing: Only if you track events — regardless of what you call them — can you find patterns that suggest solutions.
In April, health officials changed reporting requirements from eight general sentinel-event categories to mandating that 34 specific examples of life-altering, major injury be reported. Thraen hopes the new rule, requested by facility representatives, will paint a more realistic picture for hospitals as they strive to identify and fix patient safety issues.
Reportable events range from the dramatic — wrong-site or wrong-patient surgeries, infants being discharged to the wrong person, giving a patient too much radiation or any sexual assault on a patient — to the less startling, including infections and adverse reaction to medications, among others.
The fancy term is "iatrogenic harm," meaning any harm that occurs in the course of care, whether it actually hurts the patient or not. Getting a wrong medicine may just mean you don't get the right one, not that it causes a medical problem, for example. Nebeker says mistakes account for less than 25 percent of such harm, and "we believe we should be preventing all kinds of harm, not just those from errors."
James remembers a patient in intensive care with a life-threatening infection. The only drug that offered a small hope of survival was imipenem, a penicillin-derived antibiotic. But the patient was allergic to penicillin. What to do? Doctors talked it over with the woman's family and decided she had a better chance of surviving the allergy than the infection. They gave her the drug. Still, the allergic reaction qualified as a "patient safety event," James says. "These sorts of judgments are quite common."
Nebeker's definition of "harm" is now accepted nationally and includes any care-delivery action that creates long-term impairment or death, that raises the cost of care by requiring additional monitoring or intervention or that creates significant patient symptoms. The definition is deliberately broad.
"When you are trying to find opportunities to improve, you turn over every rock," James says. "The only reason to define events narrowly is if they are directly associated with blame. In this sense, systems that try to identify failure in order to fix blame work directly against well-proven actions that intend to make the system safer for future patients."
Nebeker and others also wonder what to do about the "lesser" harms that keep patients in the hospital longer and may impair a patient's future function, without rising to the "sentinel" level. "That's happening more frequently than sentinel events. Maybe by 1,000 times."
It's a simple fact that bad things can happen and it may not be someone's fault, numerous health experts told the Morning News. A hospital's procedures may increase the chance a patient will be harmed by an unexpected reaction to medicine, for instance. And mistakes are part of being human.
Rather than tackle those one at a time or try to blame an individual, safeguard-builders say they go after "system failures" that contribute to lots of harm. That's led to a proliferation of tools, from pharmacy robots and bar codes to electronic medical records.
"It usually speaks to process rather than human error," says Christopher Nelson, spokesman for University Hospital. "And the more adverse events reported, the more chance to look at these things and really investigate the root cause. Nine times out of 10 it's a process rather than a person, and we can make corrections."
But only, Utah safety experts add, if you know about them.
An IOM patient safety report laid out a plan for capturing and curing medical harm: Find every case that might have had an adverse event associated with care. Analyze it in detail. And classify it and store it in a database so "people can start to come up with clever ways to make care safer," says James.
Fear of lawsuits makes some practitioners leery of mentioning things that might have gone wrong. "That is a barrier to even more rapid improvement. ... The fear suppresses information," Michael Silver, director of scientific affairs and patient safety for HealthInsight, says.
Silver's among those watching avidly the baby steps to creation of what's being called enterprise liability, a kind of no-fault insurance to compensate patients who are harmed.
Fear — and federal medical-information privacy rules — also make it hard for news media to tell individual patient safety stories. Facilities won't answer questions about cases, which reporters may not know about anyway unless a patient or family member calls. Then the information's hard to verify. Care providers who keep information from the state aren't volunteering it to the media.
While Utah has opted for a nonpunitive approach, it reserved one stick to go with its carrot. Sort of.
If the state disagrees with the root cause analysis that each facility must conduct after a sentinel event, it can write a dissent that goes to the facility. It can also express its dissatisfaction to health facility licensing. The drawback? State health officials must be invited to participate in the root cause analysis to begin with.
If the facility violates certain rules, it could lose certification or its license. Losing certification would end being paid to treat Medicare and Medicaid patients, says Douglas Springmeyer, Utah assistant attorney general.
Making care safer has been an evolutionary process. Several years ago, Utah broadened the search for patient-harm events by tying in hospital discharge codes and death certificate data. And it began to require hospitals to send it the same forms they send Medicare to be paid. By looking for certain care codes, they "found all sorts of patient safety red flags," James says.
They teamed those codes with LDS Hospital's "clinical triggers" system, and the level of detection surged again. With triggers, the electronic medical records system is programmed to look for signs care is not going as planned and notify care providers.
Nationwide, the fine-tuning and experimentation in the quest for safer health care has been ongoing. Not long ago, LDS Hospital joined the Mayo Clinic to test Mayo's list of 55 "events" chart reviewers should look for. Two independent doctors examined those they found.
"We found 26 percent of cases had some sort of care-associated events. Most we don't know how to prevent. They're not bad care, just the consequence of high-powered treatment," James says.
For example, doctors prescribing narcotic pain relievers after surgery know that a small subset of patients will have severe nausea and vomiting, but they don't know which patients. And they'll need anti-nausea drugs to control that, which means additional medical monitoring or intervention in response to an earlier treatment — a patient safety "event."
Nationwide, more hospitals are adopting clinical triggers, improved chart reviews and other tools to find unintended consequences of treatment. The evidence collected by Mayo and LDS Hospital's collaboration has been folded into a national 5 Million Lives campaign.
Intermountain and the University Healthcare System, Columbia hospitals and others are using high-tech tools to help spot problems.
But a community that already doesn't understand the issues needs to be warned. The reported injury rate will skyrocket, James predicts, and it will look like things are getting a lot worse, when in fact they're simply being counted.
Take clinical triggers nationwide and report what you find, he cautions, and it will be "ice water down your back. It would be breathtaking. And we'd all go through a period of denial. But when we get through that, we are good at coming together to work on these things."
Not everyone's convinced that keeping the public in the dark is the best approach. But critics of public disclosure worry someone will take the numbers at face value and not realize what they mean, which might be that a facility that looks safety-challenged is the one seriously tracking problems they all have but most are not owning up to or perhaps even recognizing.
Most patients wouldn't look at the numbers if they were public. They make decisions about where to seek treatment based not on safety stats or sentinel events but on where their physician has privileges or where their insurance will pay, says Nebeker. The institutions themselves, however, do pay attention to patient harm data.
"What we want is an open environment, where (care providers) get into the routine of reviewing so problems can be fixed," says Jill Vicory, Utah Hospital and Healthcare Association (UHA) spokeswoman. "It's a very personal thing when there's an accident or you harm a patient, so we need to keep it open and not be guilt-based. ... Having said that, it may be time to revisit it and make sure we are getting everything reported."
Adds Deb Wynkoop, UHA safety pro, "I don't think hospitals are against public reporting; they just want to make sure it's good science and the data is valid."
Utah's health care providers and public health officials say Utah is making care safer for patients, whether it's apparent or not.
In the adverse drug event arena, user groups formed of hospital representatives are targeting anticoagulants and insulin, where mistakes can cause great harm. Hospitals use computer programs to look at interactions and doses. The VA and others are part of a project that combines triggers and clinical care to "identify patients who have harm that we can intervene on," Nebeker says. And they want to figure out a way to help smaller, cash-strapped hospitals get the technology they need to use the triggers.
Utah hospitals and surgical centers have adopted a uniform way of marking the correct surgical site. The patient, if capable, is asked to write "yes" on the body part that's being fixed. That came after the very limited reporting showed that 21 percent of sentinel errors were wrong-site surgeries.
Another group is tackling pressure ulcers and surgical-site infections.
Individual hospitals are changing their routines. At St. Mark's Hospital, for instance, patients who are about to undergo certain types of surgery are tested to see if they carry bacteria that can lead to specific infections. If so, they get antibiotics early on.
Says the VA's Nebeker, "It's probably safe to say everybody has made some progress."
Still, reporting is clearly inadequate. When even enticements can't bring answers, patient safety advocates are looking for something that does. One unusual "carrot" is being floated: There's talk nationally of a safety "seal of approval" modeled after one created by the College of Surgeons. Every three years, independent auditors would pore over a facility's list of patient harms to see that occurrences are being traced and safety measures implemented.
They'd be the medical field's equivalent of certified public accounts, a field James credits for much of what works well in corporate America. They root out corruption in the financial world, where the definition of transparency was born.
If Utah did create a system where sentinel events are reported, the information transparent to the public, there are still things it won't do. It won't prevent things that are missed or the judgment calls that are simply wrong. It won't change what happened recently to a Utah man who was sent home from an emergency room with "bursitis," only to be hospitalized the next day with what was actually a life-threatening infection. It won't prevent a Utah woman's search for a cause of her fatigue, finally diagnosed and treated years later. Those are both cases reported to the Deseret Morning News by readers recently.
"The thing we're missing is the near misses, or near hits," Wynkoop says. "I think that's what we may not be doing very well. We could definitely do some improvement by enhancing communication among the entire health care system."
And despite strides in making hospitals safer, James emphasizes there's a long way to go. He likes to quote one of his colleagues in the field, who quips that, with all the improvements, "we're still the cream of the crap."
E-mail: lois@desnews.com