No new elective pediatric congenital heart surgeries will be scheduled at St. Mary's Medical Center in West Palm Beach, Fla., until a comprehensive review of the facility's program has been completed.
But cardiologists and health quality researchers say the mortality rates reported in this case may not paint an accurate picture of performance without risk adjustment. Still, the case is drawing attention to other issues facing healthcare facilities as they work to improve quality and achieve better outcomes.
St. Mary's, which is owned by Tenet Healthcare Corp., announced the suspension Monday while still disputing claims that its death rate is three times higher than the national average and that its patients receive poor quality care.
“We carefully considered this decision … and believe it is the right thing to do,” said the hospital in a defensive statement issued Monday. Operating on pediatric patients with severe congenital abnormalities is complicated and the mortality risk is “considerable,” the hospital said.
According to the hospital, its risk-adjusted mortality—which takes into account case severity and other inherent risk factors—was only 5.3% for the four-year period ended June 30, 2014.
Last week, CNN reported on the deaths of at least nine children since 2011 and put mortality at 12.5%, far exceeding national estimates. On Friday, the CMS announced plans to investigate the claims.
Several studies have found that facilities are more likely to have worse outcomes if they perform only a few procedures each year. And in general, many continue to struggle with establishing effective care coordination and communication across both internal care teams and systems.
Those types of issues are notable in the legal claims filed in 2014 by the families of two patients treated at St. Mary's. The claims accuse the hospital of not being able to quickly recognize and treat intra-operative and post-surgical complications, they allude to “systematic failures across the program” and point out failures “to employ a team approach” and “adequately communicate and work in concert.”
St. Mary's also acknowledged in its statement that it had performed fewer than the recommended volume of congenital heart surgeries. Between July 2011 and June 2014, it performed 132 separate surgical procedures (less than 50 a year) on only about 90 patients (about 30 a year).
A 2012 study in the journal Pediatrics found death rates after pediatric heart surgery were higher in places performing 150 or fewer surgeries annually compared to those performing 350 or more.
Low-volume centers may not have enough patients to justify the expense of hiring full cardiac-care teams available 24/7, explained Dr. Jennifer Li, division chief of pediatric cardiology at Duke University Medical Center, Durham, N.C., and author of the Pediatrics study. "You can't just hire one or two people; it takes a village and a lot of resources.”
St. Mary's noted in its statement the hiring in 2011 of Dr. Michael Black, a trained congenital cardiac surgeon. However, St. Mary's officials have not responded to Modern Healthcare's questions about whether that team also included a suite of other clinicians, specializing in pediatric heart care—such as intensive-care nurses or anesthesiologists. Such multidisciplinary teams have been key factors of success for top-performing U.S. heart hospitals.
There has to be "a big and noticeable enough blow to the balance sheet" to make sure others get the message, said Chris Searcy, president and CEO of the law firm Searcy Denney Scarola Barnhart & Shipley. He represents at least four families suing the hospital, and expressed plans to amend the original claim to seek punitive damages.
No hospital should “just start up a pediatric heart surgery unit on the cheap,” Searcy said. “If you're going to open a pediatric heart surgery unit, you need to make sure you staff it correctly and, make sure it comports with all of the applicable standards of care.”