Following a report by CNN of an infant death of three times the national average rate following open heart surgery, the federal government has launched an investigation into at least nine deaths St. Mary’s Medical Center in Florida.
The Centers for Medicare and Medicaid Services (CMS) launched the investigation was after a CNN report showing St. Mary’s, in West Palm Beach, had a mortality rate of 12.5 percent for infant open heart surgery from 2011 to 2013. CNN calculated that this rate is three times the national average.
Aaron Albright, a spokesman for the Centers for Medicare and Medicaid Services, wrote in an email, “We take these allegations very seriously. CMS is actively investigating these complaints.” CMS is investigating because most of the infants who had heart surgery at St. Mary’s were Medicaid patients. Tenet Healthcare, which owns St. Mary’s, did not respond to a for comment on the investigation, nor did Florida Gov. Rick Scott, the state’s Agency for Healthcare Administration, or the state’s Department of Health, according to CNN.
On Friday, a federal official told CNN, “We want to make sure people are not exposed unnecessarily to harm.” A mother whose 10-month-old daughter died after heart surgery at St. Mary’s in 2012, said she was encouraged by the federal investigation but said, “They need to close this place down.” CNN reported last week that even after infants had died, Dr. Michael Black, who had been brought in from Stanford University to head the St. Mary’s program, told parents of other infants who needed surgery that he had never lost a single patient during his time at St. Mary’s.
Hospitals that perform fewer surgeries—especially complex procedures—tend to have higher death rates, studies show. CNN reports that St. Mary’s numbers of pediatric open heart surgeries are very low. Documents filed with the Florida Agency for Health Care Administration show that the number of cases at St. Mary’s fell from 27 in 2012 to 18 in 2014. The Society of Thoracic Surgeons says 40 percent of pediatric heart surgery centers in the United States perform more than 250 surgeries a year and 80 percent of centers handle more than 100 cases a year. The society considers anything less than 100 cases a year “low volume.” Dr. Roger Mee, former chief of pediatric heart surgery at the Cleveland Clinic argues that it is hard to develop a skill if it is used “only occasionally.” For something “as complex and dangerous as children’s heart surgery, you have to develop a whole team, and it’s hard to develop a team around 27 cases,” Mee said.
CNN reported that nine babies have died after heart surgery since St. Mary’s began the program began in 2011, with the most recent death coming last week, and a tenth child was left paralyzed.
In 2014, an expert review panel recommended that the hospital stop performing heart surgeries on babies under six months of age and for older children, the hospital should not perform complex procedures that fall into categories four and five on the scale devised by the Society of Thoracic Surgeons, according to CNN.