Pediatric Cardiac Surgery Standards Eyed

Nneka Campbell spent the third anniversary of her daughter's death at a hearing at the Florida Department of Health in Tallahassee -- to honor, she said, the memory of 10-month-old Amelia, who died of complications following heart surgery at St. Mary's Medical Center in West Palm Beach.

Amelia was one of nine infants who died after heart surgery at St Mary's over four years, a death toll that drew national attention when CNN reported it in early June. At the time, St. Mary's and the state contested CNN's allegations.

But in August, the hospital shuttered its pediatric cardiology unit; its chief executive resigned.

"When a mom walks through the doors of any hospital with her child who has special health-care needs, she is very aware of the risk that she is taking when she entrusts her child's the life to another," Campbell told Department of Health officials Monday.

"I trusted that St. Mary's Medical Center was one of the facilities that I could choose from for the care of my Amelia because it had met the standards of care for the procedure to be performed. I no longer trust this to be the case."

Campbell traveled from Boynton Beach to the state capital because of a proposal by the Department of Health that would reduce state oversight of hospitals where cardiac surgery is performed on children.

The debate is centered on the role of a long-running state program known as Children's Medical Services, which oversees care for tens of thousands of children with special health-care needs. Behind the scenes, it also has standards of care that hospitals can choose to meet -- but they're not required to by law.

On Monday, the Department of Health held a hearing on a proposal to repeal a rule for the Children's Medical Services program. More than 30 years ago, the rule established standards and criteria for staffing, minimum physician and facility volumes, and data reporting for hospitals that perform pediatric cardiology surgery.

But the law behind the rule was abolished in 2001, and the Department of Health says it must fix the discrepancy.

"We think these standards have value," said Jennifer Tschetter, the department's chief operating officer. "They're just not law."

Currently, there are eight hospitals statewide approved by Children's Medical Services to perform heart surgery on infants.

What's more, the program's standards are nationally respected, said Tallahassee attorney Jon Moyle, who arrived with a group of pediatric cardiologists from around the state and a stack of letters of support.

"The Florida CMS cardiac facility standards have been a model for other states," William Mahle, the director of pediatric cardiology at Emory University School of Medicine, wrote to the Department of Health. "I would strongly advocate that these standards remain in place."

Moyle contended that no one had filed a challenge to the rule, but Tschetter said the department had been reviewing all its rules and weeding out those that didn't reflect the intent of the Legislature.

"We can only do what's been delegated to us legislatively," she said.

Moyle, however, said lawmakers had never indicated a wish to dismantle the Children's Medical Services cardiac standards.

"There hasn't been a legislative direction to that effect that I can locate," he said.

But Tschetter said the department "can't force our way into hospitals."

"I'm not overly optimistic that we have a way that we can keep these (CMS standards) in the law of the state of Florida," she said. "But I am optimistic that if we continue to work together, the department remains open to solutions, to good ideas, because we're committed to kids."

St. Mary's never received approval from Children's Medical Services for its pediatric-cardiology program and was not required do so. But after some children died, it allowed a team of pediatric cardiologists from the state's CMS Cardiac Technical Advisory Panel to visit in 2014. While the doctors advised the hospital not to operate on babies younger than 6 months old until it had upgraded its standards, St. Mary's was free to disregard the advice -- and did.

That prompted doctors affiliated with Children's Medical Services to call for more state control over infant cardiac surgery programs. Some wanted the standards put into state law, as was the case before 2001. Such standards would have required the St. Mary's program, in part, to reach a certain volume of infant cardiac surgeries.

Tschetter said Monday the plan to repeal the rule was not related to the St. Mary's issue. She said the department has been considering a repeal since 2013.