See one, do one, harm one?

Pronovost with groupI recently cared for Ms. K, an elderly black woman who had been sitting in the intensive care unit for more than a month. She was, frail, weak and intermittently delirious, with a hopeful smile. She had a big problem: She had undergone an esophagectomy at an outside hospital and suffered a horrible complication, leading her to be transferred to The Johns Hopkins Hospital. Ms. K had a large hole in her posterior trachea, far too large to directly fix, extending from her vocal cords to where her trachea splits into right and left bronchus. She had a trachea tube so she can breathe, and her esophagus was tied off high in her throat so oral secretions containing bacteria did not fall through the hole and infect her heart and lungs. It is unclear if she will survive, and the costs of her medical care will be in the millions.

Ms K’s complication is tragic—and largely preventable. For the type of surgery she had, there is a strong volume-outcome relationship: Those hospitals that perform more than 12 cases a year have significantly lower mortality. This finding, based on significant research, is made transparent by the Leapfrog Group and several insurers, who use a performance measure that combines the number of cases performed with the mortality rate. Hopkins Hospital performs more than 100 of these procedures a year, and across town, the University of Maryland tallies about 60. The hospital where Ms. K had her surgery did one last year. One. While the exact relationship between volume and outcome is imprecise, it is no wonder she had a complication.

Ms. K is not alone. Of the 45 Maryland hospitals that perform this surgery, 56 percent had fewer than 12 cases last year and 38 percent had fewer than six.

One day, after the ICU team—nurses, medical students, residents, critical care fellows and the attending—made rounds on Ms. K, we stepped outside of her room. We talked about what we could do to help get her well and to a lower level of care. But we also discussed the evidence for the volume-outcome relationship, highlighting that the hospital that performed Ms. K’s operation performed one in the previous year. Upon hearing this, the medical students cringed, quizzically looking at each other as if observing a violent act. The residents and fellows, the more experienced clinicians, stood expressionless; they commonly see this type of tragedy.

The team asked why the hospital would perform an operation in which it has little experience. The medical students were especially concerned. As the conversation ensued, the team discussed issues of professionalism, health care disparities and accountability—issues that don’t typically come up in rounds but should more often. Don’t the hospital’s trustees and leaders have a responsibility to ensure that their physicians are competent to perform certain procedures? Doesn’t the surgeon have a moral obligation to tell the patient that the hospital did this procedure infrequently? Is it possible that Ms. K’s gender, race and socioeconomic status influenced the discussion about risks?

We don’t know all of the factors that led Ms. K to undergo the procedure where she did. However, the care team rounding on Ms. K agreed that surgeons should inform the patient about the volume-outcome relationship and that she would likely have a lower chance of dying if she had the operation at a higher volume hospital.

(Privately, later in the day, I asked Ms. K whether the hospital mentioned that her risks at this hospital may be higher. Unable to speak due to her tracheostomy, she shook her head no. I did not tell her that the surgeon and hospital put her at increased risk. I thought about it, reflected on what moral obligations I had to give her this information, and weighed what it would do to her, to the surgeon and hospital that performed the operation, to me and my hospital. Perhaps I protect the “tribe”—fellow physicians. In the end, I remained silent.)

At one point our team had been discussing Ms. K for 20 minutes. We had 10 more patients to round on, and two were due out of the operating room in an hour. We felt production pressure to continue rounds, discharge patients and make room for new admissions, yet no one wanted to stop the discussion. The ICU fellow said, “We spend too little time discussing safety, ethical and policy issues. We should continue and shorten rounds on less sick patients.”

As our conversation continued, we talked about what could be done to prevent these situations in the future. The ensuing discussion revealed deep political convictions regarding the role of regulation and free markets in addressing societal ills. Trying to unite the care team, I observed that our markets are the best wealth-generation machine humanity has ever known, as they have lifted more people out of poverty than any other intervention. Yet the markets work best when participants compete fairly, when all traders transparently know the risks and costs. Left to their own devices, markets often fail, competing on half-truths or sometimes outright lies.

The Leapfrog Group helps to level the playing field for consumers, by making public which hospitals meet its standards. However, only 20 percent of hospitals will voluntarily submit information to Leapfrog in its annual survey. Outside of the social pressure engendered by the group’s public reporting, there is no mechanism to make this information available and no regulatory requirement that doctors and hospitals with low volumes in a given procedure tell patients that they are at increased risk.

The ICU team discussed how policymakers have a spectrum of regulatory tools to use, ranging in restrictiveness. On the less restrictive end, legislation could require transparency by hospitals, ensuring that all patients in the market understand risks and benefits related to volumes. Policymakers could also create economic incentives for patients to use hospitals with better outcomes or higher volumes. On the more restrictive end, legislators could prohibit hospitals from performing certain procedures in which they have low volumes or poor outcomes.

One model that we can look to for solutions comes from the Centers for Medicare and Medicaid Services in how it ensures high quality care in transplant surgery. It is not perfect, yet it works reasonably well. Only CMS-approved centers of excellence perform transplants. These centers’ outcomes are closely monitored, and if a hospital’s outcomes fall below a threshold, CMS may eventually revoke its ability to do transplants. Our ICU team concluded that CMS should take the lead, replicate what it did in transplant surgery, and ensure safe care for other high-risk surgical procedures.

Ms. K may die needlessly, and the error will remain invisible. We need policies to protect her and to reduce the chance that what happened to Ms. K and thousands of others like her, never happens again.

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