Articles of Interest

The Lurking Danger In The “Business Case” For Patient Safety

The highly publicized crashes of two Boeing 737 Max aircraft quickly triggered pointed questions about the company’s commitment to safety versus profits. As we near the twentieth anniversary of the landmark Institute of Medicine (IOM) report on medical error, To Err is Human, that same level of scrutiny should apply to hospitals. The IOM report, emerging just after Thanksgiving in 1999, put patient safety on the policy map with its startling estimate that up to 98,000 Americans die each year due to medical care in hospitals and up to another one million are injured. Despite then-President Bill Clinton’s quick endorsement of the call to cut preventable deaths in half within five years, however, a major study in 2010 found no significant progress over the decade. Writing in a Health Affairs blog post, I blamed that dismal result on three factors: the invisibility of medical error, clinical inertia, and income. “Put bluntly,” I wrote of that last factor, “many hospital executives believe they make money from complications.” Although all three barriers remain to varying degrees, the most perturbing is the persistence of ethically questionable profitability tests for avoiding harm. Recent research in the journal of the American College of Healthcare Executives, for example, was entitled, “Does Patient Safety Pay?” It concluded that “targeted” investments in infection prevention after major surgery could generate “substantially higher” earnings.Cost-benefit analysis is both a legitimate and crucial management function. But the criteria used in those calculations can range from appropriate to appalling. It’s long past time to examine how the “business case for safety” can sometimes represent a serious threat to patients’ lives. Making The Business Case In a 2002 article, patient safety pioneer Lucian Leape and colleagues explicitly acknowledged that cost considerations can be legitimate. “It would not be practical,” to immediately implement all effective safety improvement practices, they wrote, then suggested that the frequency and severity of a problem should guide priorities. Others drilled down into return-on-investment (ROI) details. Specific ROI calculations, wrote Jared Schmidek and William Weeks in 2005, should include only direct organizational benefits. As an illustration, they noted that improved brand image accrues to the hospital, while lessened pain and suffering accrues only to the patient. The assumptions underlying this type of economic guidance are unfortunate. The relief of pain and suffering is health care’s essential purpose. A preventable death or injury that doesn’t result in a malpractice judgment or inflict measurable damage to “brand image” may not affect margin, but it is still a grievous failure of mission. One stark example of where this kind of reasoning can lead is a 2014 study in the American Journal of Infection Control meant to demonstrate to decision makers “the value of investing in efforts to prevent…CLABSIs in the vulnerable pediatric hematology/oncology population.” CLABSIs are “central-line associated bloodstream infections;” they’re sometimes fatal and always serious. The “vulnerable pediatric hematology/oncology population” referred to children hospitalized with cancer. The study authors estimated the average cost per CLABSI in the pediatric hematology/oncology unit as $70,000. That price tag meant “prevention efforts in this population are of high value, particularly given that known prevention efforts themselves carry a low cost of implementation and have been demonstrated to be highly effective.” The implication is that if the fixes weren’t so affordable, a hospital might not undertake them. Is this an example of legitimate “prioritization” or of losing track of mission?   Whose Cost? Whose Benefit? There’s an even more disturbing dilemma: What if the “cost” of patient harm registers as hospital revenue? Evidence that some hospitals may “suffer financially” from reducing surgical complications surfaced in the policy literature in a 2012 Health Affairs study by Dan Krupka and colleagues. That conclusion was reaffirmed by research in JAMAthe American Journal of Medical QualityAnnals of Surgery, and elsewhere. Surgeon and writer Atul Gawande, senior author of the JAMA article, told the Wall Street Journal he undertook the research because he suspected financial motivations might explain why hospitals weren’t adopting an inexpensive surgical checklist proven to reduce complications more than a third. The ensuing study, published in 2013, found that hospitals earned a greater “contribution margin” on patients with complications compared to those without: $39,000 more per patient with private insurance and $1,700 extra per Medicare patient. The Health Affairs article by Krupka and colleagues did raise one ROI scenario in which the profitability of complications would be derailed. Hospital executives, they said, could calculate whether a bed left empty because a patient was not harmed by care would remain empty or be filled instead by a new, more profitable patient. They summarized this deeply discomfiting version of “Does patient safety pay?” in a 2014 letter to JAMA Internal Medicine: “We agree that the primary purpose of preventing infections is to save lives and that health care professionals have a moral obligation to [do so],” they wrote. But, they added, “perhaps the strongest incentive” is that this infection reduction “might unleash capacity that can be used to generate additional revenue, provided that the procedures that fill that unleashed capacity are profitable.” This line of reasoning is not just theoretical. I saw it play out in real life in a vendor’s sales pitch for a system to detect whether patients who’ve recently left surgery have stopped breathing. Opioids are widely used as part of the anesthesia process, particularly in major surgery. There is, however, a risk of post-surgical, opioid-induced respiratory depression caused by release of the opioids from fat cells into the bloodstream. The condition can lead to severe brain damage (as happened to a colleague’s relative) or even death. The vendor extolled the clinical and financial benefits of a sensor system that enabled continuous patient monitoring. A slide presenting the cost-benefit analysis done by an academic medical center customer showed that the hospital quickly recouped its investment by freeing intensive care unit beds for more profitable patients. Later, I asked the salesperson, a senior nurse, about the ethics of this ROI math. “It’s what the customers demand,” came the uncomfortable reply. Changing The Calculus Back in 2007, the Society for Healthcare Epidemiology of America decided to help its members demonstrate they weren’t just a “cost center,” but that there was a genuine “business case for infection control.” A dozen years later, infection control specialists still feel they need “an administrative champion.” Payers have tried to stem the potential flow of black ink from bad care. In 2008, the federal government and some insurers began refusing payment and/or imposing modest penalties for a growing list of “never events” and errors. However, just-published research in Health Affairs that carefully examined the program’s impact over a multi-year period in Michigan found none. Of course, just as Boeing reportedly charged airlines extra for 737 Max stall-warning sensors, we could let consumers decide how much safety they want to purchase. Are you willing to buy Mom an upgrade to continuous respiratory monitoring after her surgery? During your child’s hospital stay, do you want “targeted” or “comprehensive” infection prevention? Grandpa’s lived a long life: Is the “basic” safety package okay? This approach, for all its ethical absurdity, would at least bring the dangers of an inappropriate business case for safety into the open. Do we believe in “First, do no harm”? or “First, do no unprofitable harm,” even if it means blurring the moral boundary between filling hospital beds with those we’re trying to help and those who we have just hurt? To be clear, the problem is not evil administrators, clinicians who are indifferent to suffering, or anyone padding their own pockets. To the contrary, as David L. Katz, a physician who lost a loved one to medical error beautifully wrote on HuffPost, dangerous care persists not because of “a nefarious conspiracy,” but due to “unwitting delusion” in “a system populated mostly by genuinely caring and often highly expert people that nonetheless devolves into routine and dangerous dysfunction.” The “unwitting delusion” that Katz identifies is enabled by a misplaced conviction that the overwhelming evidence about the commonplace nature of medical harm does not apply to “my hospital” or “my practice.” As a study of clinician overconfidence in infection control delicately concluded, providers “do not recognize the need for training [for themselves] but express this need for others.” In that context, we perhaps should not be surprised that 40 percent of respondents to a recent nationwide survey on hospital safety culture agreed that “hospital management seems interested in patient safety only after an adverse event happens.” Meanwhile, the “routine and dangerous dysfunction” shows its ugly face every time someone making the “business case for safety” accepts the notion that mission and margin must conflict. That is simply not true. The evidence can be seen on the front lines of care. Across the country, a cadre of diverse institutions—community hospitalsacademic medical centers, and health systems—have taken dramatic steps toward zero preventable harm. None have compromised their ability to flourish financially and also serve their patients. Unfortunately, these institutions likely represent fewer than 10 percent of all hospitals. (An informal poll of knowledgeable colleagues agreed.) In part, that’s because their achievements have largely gone unrecognized by the public and their peers, both locally and nationally. The good news, two decades after To Err is Human, is that virtually every US hospital is doing something to reduce medical harm. But half measures are no longer enough. Hospital boards and leaders have a duty to their community to make replicating the “zero preventable harm” exemplars’ achievements a measurable, accountable, and urgent goal. As the chief executive of one safety-net hospital declared, “It’s not about money, it’s about how you manage.” Recent research concluded that one in 20 hospitalized patients suffers preventable harm, with one in eight of those incidents resulting in permanent disability or death. Beyond those statistics, however, the safe care approach each of us would want for our own parent, spouse, or child is on quiet display in a conference room at Florida’s Parrish Medical Center. Arranged in a circle on a whiteboard are three photos of small children, one photo of a young adult, and a small drawing with a childish illustration. The pictures are of kids killed by their hospital care. The drawing is by the sibling of an 18-month-old girl who died, depicting her in heaven. In the center of the circle the words, “Never Again!!” are handwritten in large red letters. None of these young victims died at Parrish Medical, but perhaps that only magnifies the moral power of the message. The montage reminds all who see it of a different kind of cost-benefit calculation. In the words of the Talmud, “He who saves one life is as if he saved the entire world.”

Michael Millenson
President, Health Quality Advisors LLC and
Adjunct Associate Professor of Medicine, Northwestern University Feinberg School of Medicine

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